topic
stringlengths 245
1.29k
| doc
stringlengths 52
16.9k
| label
stringclasses 3
values |
|---|---|---|
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Stroke, Acute New focal neurologic deficit consistent with AIS 2. NIHSS≥4 or NIHSS <4 in the presence of disabling deficits 3. Age>18; 4. Presence of any cortical vessel occlusion including ICA, branches of MCA, Anterior Cerebral artery (ACA), Posterior Cerebral artery (PCA), Posterior-Inferior cerebellar artery (PICA); 5. Presence of salvageable penumbra with Tmax> 6 sec/ ischemic core volume (ADC < 620 μm2/s or rCBF< 30%) ≥ 1.2 6. Patient ineligible for IV tPA, per national AHA/ASA Guidelines 7. Patient ineligible for endovascular therapy per AHA/ASA national Guidelines one or more of: poor prestroke functional status (mRS score >1), mild neurological symptoms (NIHSS <6), large ischemic core (ASPECTS <6), thrombectomy not technically performable due to severe vessel tortuosity, cervical artery chronic occlusion, or other unfavorable angioarchitectural features that preclude endovascular access to the target intracranial vessel. 8) Subject is able to be treated with tDCS within 24 hours of last known well time; 9) A signed informed consent is obtained from the patient or patient's legally authorized representative Acute intracranial hemorrhage 2. Evidence of a large Ischemic core volume (ADC < 620 μm2/s or rCBF< 30%) ≥ 100 3. Presence of tDCS contraindications electrically or magnetically activated intracranial metal and non-metal implants. 4. Severe MR contrast allergy or renal dysfunction with eGFR<30ml/min, precluding MRI gadolinium or CT iodine contrast 5. Pregnancy 6. Signs or symptoms of acute myocardial infarction, including EKG findings, on admission 7. Suspicion of aortic dissection on admission 8. History of seizure disorder or new seizures with presentation of current stroke 9. Evidence of any other major life-threatening or serious medical condition that would prevent completion of the study protocol including attendance at the 3-month follow-up visit 10. Concomitant experimental therapy 11. Preexisting scalp lesion at the site of the stimulation or presence of skull defects (may alter current flow pattern) 12. Preexisting coagulopathy, consist of platelet count of ≤ 100, INR ≥ 3, PTT ≥ 90 | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-80.0, Optical Coherence Tomography Intravascular Ultrasound Angiography Subject must be 18 to 80 years age Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed Subject is eligible for percutaneous coronary intervention (PCI) Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia (including NST-ACS, stable CAD and STEMI（duration over 4 weeks）) Subjects are eligible candidates for coronary artery bypass graft surgery (CABG) Left ventricular ejection fraction (LVEF) detected by cardiac ultrasound within 30 days ≥ 30% Subject is willing to comply with all protocol-required follow-up evaluation. Angiographic (visual estimate) The target lesion must be a new lesion and has moderate-to-severe calcification which located in a visually estimated reference diameter ≥2.5 mm and ≤4.0 mm in native coronary artery Target lesion diameter stenosis ≥70% and ≤99% Target lesion length ≤70mm Subjects recently suffer from STEMI (within 4 week), and ECG changes/clinical symptoms consistent with AMI or accompanied with increased cardiac biomarkers (CK-MB, CK, TNT or TNI) , and if any of the following is meet in the procedure, patients are excluded; CK-MB> 2ULN, regardless of the value of total CK; total CK> 2ULN, CK-MB or Tn is abnormal; If CK-MB or CK was not detected, but cTN> 1ULN, and at least one of the following: schemic symptoms and ECG changes of new ischemia; Development of pathologic Q waves in the ECG; Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality Subject with hemodynamic instability or severely decreased activity tolerance (KILLIP classification >2 or NYHA classification >2 ) Severely ejection fraction reduced heart failure ( LVEF < 30%) Subjects were detected ventricular aneurysm greater than 3.0*2.0cm or intraventricular thrombosis by cardiac ultrasonography in 30 days Subjects had an organ transplant or are waiting for an organ transplant Subjects are receiving chemotherapy or will receive a chemotherapy within 30 days after PCI Subjects are undergoing chronic (over 72 hours) anticoagulant therapy (such as heparin and coumarin) other than acute coronary syndrome Subjects have confirmed or suspected liver disease, including hepatitis lab results Subjects with elevated serum creatinine level >3.0mg/dL or undergoing dialysis therapy Subjects with active peptic ulcer, active gastrointestinal (GI) bleeding or other bleeding diathesis or coagulopathy, or refused a blood transfusion | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-95.0, Elbow Fracture Elbow Injury Elbow Dislocation Age ≥ 18 years old; skeletally mature with no growth plates in the elbow Distal humerus (AO/OTA type 13) and/or proximal ulna and/or proximal radius fractures (AO/OTA type 2U1 or 2R1) and/or elbow dislocations (open fractures with or without nerve injury may be included) Operative treatment of the elbow fracture or dislocation Injury ≤ 7 days Participant has a negative urine or blood serum pregnancy test Pre-existing elbow contracture Elbow arthritis (osteoarthritis, inflammatory arthritis, or nonspecific monoarticular arthritis) Inability to mobilize elbow within 21 days of injury Bilateral elbow injury Concomitant musculoskeletal or visceral injuries preventing post-operative elbow therapy Oral hypoglycemic medications History of epilepsy Lactose intolerance Language or Cognitive difficulties preventing reliable completion of questionnaires Females who are pregnant or breast feeding | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Chest Pain Coronary Artery Disease Acute Coronary Syndrome Ischemic Heart Disease Patients above 18 years of age with ischaemic sounding chest pain prompting visit to the emergency department (suspected ACS). 2. No-ischaemic ECG changes (i.e. no ST-segment elevation or depression 1mm in 2 or more contiguous leads, and/or T-wave inversions). 3. Episode of chest pain within last 12 hours. 4. Initial troponin in the intermediate range (5-50ng/L) STEMI. 2. Signs and symptoms of acute heart failure and/or haemodynamic instability. 3. Dynamic ischaemic ECG changes. 4. Patient not suitable to undergo CTCA 1. Inability to breath hold for 10 seconds 2. Severe renal impairment (eGFR <30 mL/min) 3. Contraindication to beta-blockers (not relevant for patients with baseline sinus rhythm at rate of <63bpm) 5. Atrial Fibrillation on ECG. 6. Patients with known significant obstructive coronary artery disease (>50% stenosis) on previous invasive or CT coronary angiogram. 7. Patients with previous PCI/CABG revascularisation. 8. Patients with a history of congenital heart disease. 9. Patients with known coronary artery anomalies. 10. Patients who lack capacity to give consent or participate in the study. 11. Previous recruitment to the present study. 12. Known pregnancy or patients who are currently breast feeding. 13. Prisoners. 14. Patients involved in current or a recent (within the last 4 months) CTIMP trial | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 25.0-70.0, Cerebrovascular Circulation male or female age 25 years suspicion of cervical or intracranial vascular pathology signed informed consent contraindication to magnetic resonance uncontrolled involuntary movements other condition preventing long-term quiet lying | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 40.0-999.0, Lumbar Facet Syndrome Adult patients aged > 40 capable of understanding and providing consent in English and capable of complying with the outcome instruments used Axial (non-radicular) back pain for at least 3 months (ie Chronic Low Back Pain), with pain lasting at least half of the days within those 3 months, that did not respond to conventional treatment such as physical therapy, oral analgesic agents, and non-invasive adjunctive treatments. The pain can be unilateral or bilateral. The pain can also referred lower limb pain day worst numeric pain rating score (NPRS) for back pain of 5/10 or greater at baseline evaluation Positive responses to dual comparative diagnostic MBN blocks using 0.5mL of 0.5% bupivacaine and 4% lidocaine, on respective encounters on separate days, at each of the appropriate MBNs. The blocks are administered in a double-blind fashion so that neither the subject nor the independent assessor is aware of the local anesthetic used Focal neurologic signs or symptoms Radiologic evidence of a symptomatic herniated disc or nerve root impingement related to spinal stenosis Active systemic or local infections at the site of proposed needle and electrode placement Coagulopathy or other bleeding disorder Receipt of remuneration for their pain treatment (e.g. disability, worker's compensation, auto injury in litigation or pending litigation) History of prior spine surgery Grade 2 Spondylolisthesis at an affected or adjacent level BMI >35 Incarceration Cognitive deficit affecting ability to complete the assessment instruments | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-75.0, Arthritis, Rheumatoid Arthritis, Psoriatic Patients with RA fulfilled the 2010 ACR/EULAR classification or PsA fulfilled the Classification of Psoriatic Arthritis (CASPAR) aged between 18 and 75 will be recruited had a history of overt CVD (ie, symptomatic coronary artery disease [CAD] or ischemic stroke or transient ischemic attack or peripheral vascular disease) had significant co-morbidities including severe renal impairment or severe deranged liver function female of childbearing potential who are unwilling to use adequate contraception, pregnant or breastfeeding women patients who are already taking lipid lowering therapy | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Hypertension Diabetes Mellitus Clinical Staff Subjects Must be a current clinic or pharmacy service employee who works as a provider, pharmacist, nurse, clerk or administrator Patient Subjects English or Spanish speaking Seen in the clinic at least once in the previous 12 months Currently has one of the following diseases: 1. Diabetes with HA1c 9.0% or greater and/or 2. Hypertension (uncomplicated) with systolic blood pressure 150 mm Hg or greater Informal Caregiver Subjects Person identified by the patient subject who assists the patient subject with activities of daily living or other aspects of the patient subject's healthcare Study wide exclusions Inability to give consent Nursing home residence No telephone Additional patient subject exclusions Cancer with a life expectancy less than 24 months Pregnancy Diagnosis of dementia Plans to terminate care from the clinic within 24 months | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Vascular Diseases Carotid Artery Diseases Aneurysmal Disease Peripheral Artery Disease All patients attending for aortic aneurysm repair, carotid artery surgery and lower limb revascularisation under the care of the Vascular Surgery team 2. Willing and able to give informed written consent Those unable to give informed written consent 2. Those <18 years of age 3. In the opinion of the investigator unable or unwilling to comply with the requirements of the study | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Internal Carotid Artery Stenosis With Infarction Atherosclerotic carotid stenosis >50% with or without cerebrovascular symptoms Malignancies Inflammatory disease | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, THA Male or female, at least 18 years of age at screening Scheduled for unilateral DAA THA American Society of Anesthesiologists (ASA) physical status 1, 2 or 3 Able to demonstrate sensory function by exhibiting sensitivity to light touch, pinprick and cold Able to ambulate Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments Previous open hip surgery History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics Contraindication to bupivacaine or morphine Concurrent physical condition that may require analgesic treatment (such as NSAID or opioid) in the postsurgical period for pain that is not strictly related to the hip surgery and which may confound the postsurgical assessments Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®) Body weight <40 kg (88 pounds) or a body mass index >44 kg/m2 Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 19.0-999.0, Osteochondral Defect The subject has signed the REB approved informed consent form (ICF) specific to this study prior to enrollment. 2. The subject has an isolated OCD with minimum dimensions of 0.07 cm2 (0.3 cm in diameter) and maximum dimensions of 2.25 cm2 as confirmed by a pre-op MRI. 3. The subject is independent, ambulatory, and can comply with all post-operative evaluations and visits. 4. The subject is at least nineteen (19) years of age and considered to be skeletally mature. 5. The subject has a combined bone and cartilage defect as determined by an MRI. 6. The patient has a stable ankle joint on history and has similar ligament stability with the opposite ankle. 7. The subject has less than 15 degrees of hindfoot valgus and 5 degrees of hindfoot varus. 8. The subject has a chronic defect not secondary to acute trauma within the last 6 months. 9. The patient (if having suffered a fracture) has no residual deformity of the tibia, fibula or syndesmosis. 10. The subject has a BMI of ≤ 40 kg/m². 11. The subject has exhausted non-operative treatment. 12. The subject has symptoms for less than a year. 13. Lesions on the subject must be contained The subject has over 15 degrees of hindfoot valgus or 5 degrees of hindfoot varus. 2. The subject has an isolated OCD with dimensions greater than 2.0 cm2 on an MRI assessment. 3. The subject has an allergy to yeast-derived products. 4. The subject has implanted metallic devices (cardiac pacemakers, insulin pumps, and nerve stimulators), medically implanted clips, or other electronically, magnetically or mechanically activated implants that would contraindicate an MRI scan of the foot. 5. The subject has claustrophobia that would inhibit their ability to undergo an MRI scan of the foot. 6. The subject has tested positive or has been treated for a malignancy in the past, is suspected of having a malignancy, or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed BioCartilage® site. 7. The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the investigator judges the subject to be unable or unlikely to remain compliant to follow-up. 8. The subject is a prisoner, or is known or suspected to be transient. 9. The subject has documented evidence of a history (e.g. liver testing) of drug/alcohol abuse within the 12 months prior to screening for study entry. 10. The subject is pregnant or able to become pregnant but not practicing a medically-accepted form of birth control, and/or intending to become pregnant during this study period. 11. The subject currently has an acute infection in the area surrounding the surgical site. 12. The subject has a history of anaphylaxis or of multiple non-environmental allergies that may precipitate an anaphylactic reaction. 13. The subject's condition is bilateral and surgery is scheduled or to be scheduled over the course of this trial for both feet. 14. The subject requires a concomitant osteotomy of the tibia, fibula, or calcaneus for hindfoot deformity. 15. The subject requires a concomitant hindfoot fusion or has had a hindfoot fusion for hindfoot arthritis or deformity. 16. The subject is undergoing any concomitant surgery that may invalidate the outcome scores such as forefoot surgery or fusions, tendon transfers or ligament reconstructions. Heel cord lengthening is permitted. 17. The subject has an OCD of the tibia in isolation or in combination with the talar lesion 18. The subject is addicted to nicotine and on nicotine containing medication such as gum or a patch; or using nicotine containing substances such as cigarettes, cigars, pipe smoking or chewing tobacco. 19. The subject abuses cocaine or cocaine derivative drugs. 20. The subject has a known hypersensitivity to aprotinin. 21. The subject has diabetes with an HBA1c> 7.5. 22. The subject is unable to give informed consent. 23. The subject is unable to comply with follow-up. 24. The subject is unable to communicate with the research team | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-75.0, Rheumatoid Arthritis Cardiovascular Diseases Criteria:Qualified patients should have all 4 main 1. Age 18-75 years of age for patients who regularly use NSAIDs. 2. Age 18-65 years of age for patients who do not regularly use NSAIDs 3. Able to give informed consent 4. Subjects with CVD or increased CV risk. Please see definitions for each below Increased CV risk (Subjects should have at least 3 of the following) > 55 years of age Hypertension Dyslipidemia (LDL > 160 mg/dL or HDL < 40 mg/dL in females and < 35 mg/dL in males or subjects currently receiving lipid lowering therapy as standard of care (i.e. statin drugs, prescription ω 3-acid ethyl esters, fibrates or prescription niacin [≥1,000 mg/d]) Family history of premature CV disease (MI, angina pectoris, heart failure, cardiac death or coronary revascularization, stroke, carotid endarterectomy, or other arterial surgery or angioplasty for atherosclerotic vascular disease in a parent, grandparent, or sibling with symptom onset or diagnosis before age 55 y for males and 65 y for females) Current smoker Left ventricular hypertrophy Documented ankle brachial index of <0.9 History of microalbuminuria, urine protein-creatinine ratio of >2 Subjects with any of the following will be excluded from this study: 1. Unstable angina, MI, CVA, CABG <3 months from screening visit 2. Planned coronary, cerebrovascular, or peripheral revascularization 3. Undergone major surgery within 3 months prior to screening visit or has planned major surgery during the study period 4. Uncontrolled hypertension (SBP >190, DBP >100 mm Hg) during screening visit 5. Uncontrolled arrhythmia < 3 months from screening visit 6. NYHA class III-IV heart failure or if available, ejection fraction ≤ 35 % 7. Within 6 months prior to screening visit, a history of ACS or hospitalization for heart failure 8. Oral corticosteroid, prednisone (or equivalent) > 20 mg daily 9. Anticoagulation therapy 10. Antiplatelet therapy except for aspirin 11. GI ulceration < 60 days before screening visit 12. GI bleeding, perforation, obstruction < 6 months of screening visit 13. Inflammatory bowel disease, diverticulitis active < 6 months of screening visit 14. AST, ALT, or BUN >2x the upper limit normal (within 30 days prior to screening visit) 15. Creatinine level >1.7 mg/dL in men, 1.5 mg/dL in women (within 30 days prior to screening visit) 16. On fluconazole, methotrexate, or lithium therapy 17. Malignancy < 5 years before screening visit 18. Other known, active, significant GI, hepatic, renal, or coagulation disorders 19. Allergy, allergic-type reactions or hypersensitivity (e.g. asthma, urticaria, etc.) to any of the study medications and its components (i.e. sulfonamides) 20. History of any disease of condition that, in the opinion of the investigator would place the subject at an unacceptable risk to participate in this study 21. Any clinically relevant abnormal findings in physical examination, vital signs, or previous laboratory works that, in the opinion of the investigator, may compromise the safety of the subject to participate 22. Subjects who are legally institutionalized 23. Lactating females or females of childbearing potential except for those who are surgically sterile or postmenopausal- | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Coronary Artery Disease (all must be present): 1. Age ≥18 years 2. Stable typical or atypical symptoms suggesting possible significant coronary artery disease (CAD) with further non-emergent testing or elective catheterization recommended to evaluate the presence of suspected significant CAD. Stable chest pain (or equivalent) includes those who have fully been ruled out for Acute Coronary Syndrome (ACS) and for whom elective testing is recommended, regardless of the venue in which they are seen. 3. If prior CV testing has occurred, it must have been performed greater than one year prior to randomization, and the following must be met: 1. cCTA or invasive coronary angiography (ICA) with stenosis < 50% 2. Quantified coronary artery calcium (CAC) < 100 AG 4. Safe performance of cCTA: 1. Creatinine clearance ≥45 ml/min per most recent measurement within 90 days 2. For a female participant of childbearing potential (those who have not been surgically sterilized or are not postmenopausal), a pregnancy test must be performed with negative results known within 7 days prior to randomization 5. Willingness to comply with all aspects of the protocol, including adherence to the assigned strategy and follow-up visits 6. Ability to provide written informed consent (all must be absent): 1. Acute chest pain (in patients who have not been ruled out for ACS) 2. Unstable clinical status 3. Noninvasive or invasive CV testing for CAD within 1 year. CV testing for CAD refers to any stress tests, invasive coronary angiography (ICA) and cCTA (including calcium scoring) only. a. Resting ECG, resting echocardiogram and resting CMR (MRI) are not exclusionary regardless of when were performed 4. Lifetime history of known obstructive CAD (prior myocardial infarction, CABG or PCI, stenosis ≥50%), known EF ≤40% or other moderate to severe valvular or congenital cardiac disease 5. Contraindications to cCTA including but not limited to creatinine clearance (GFR) <45 ml/min as per most recent measurement taken within 90 days 6. Exceeds the site's weight or size limit for cCTA or cardiac catheterization 7. Any condition leading to possible inability to comply with the protocol procedures or follow-up 8. Any condition that might interfere with the study procedures or follow-up 9. Enrolled in an investigational trial that involves a non-approved cardiac drug or device which has not reached its primary endpoint 10. Life expectancy less than 2 years due to non-cardiovascular comorbidities | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Cardiac Arrythmias Syncope Atrial Fibrillation Atrial Flutter Tachycardia Stroke Patient is 18 years of age or older Patient is willing and able to provide written informed consent Patient is willing and able to comply with the protocol, including follow-up visits and MyCareLink™ and Merlin™ transmissions (standard of care) Candidates for implantable cardiac monitor Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a study manager Patient has existing IPG, ICD, CRT-D or CRT-P device Adequate sensing in one week post implant. If sensing not adequate, patient will be in the registry | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-999.0, Carotid Artery Diseases Stroke Transient Ischemic Attack Patients with capacity to give informed consent. All patients who have suffered a Partial Anterior Circulatory Stroke (PACS) or Transient Ischaemic Attack (TIA). Carotid Stenosis >50% Lacking capacity. Carotid Artery occlusion. Allergy to contrast agent. Significant disability or immobility such that participation would cause stress | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-100.0, Intracranial Atherosclerotic Disease Stroke Participants must meet all for enrollment into the study Non-severe recent stroke (within 30 days) attributed to 70-99% stenosis of intracranial artery (ICA, MCA, VA, BA) may be diagnosed by MRA, CTA or DSA to qualify for angiogram performed as part of the study, but must be confirmed by catheter angiography for enrollment into the trial Hemodynamic compromise based on borderzone infarct pattern for the anterior circulation (ICA and MCA) and by low flow state on QMRA for the posterior circulation (VA and BA) Target vessel with minimal nominal diameter of 2mm Target length of stenosis <18mm Symptoms within 30 days of enrollment Age 18 and above Able to provide informed consent An individual who meets any of the following will be excluded from study participation Neurologic Major disabling stroke mRS >3; progressive or fluctuating deficit within 24 hours Hemorrhagic infarction (based on CT) within 14 days of enrollment Any large stroke (>5cm) to be at risk for hemorrhagic conversion Medical Any neurological disease which would confound follow-up assessment Any co-morbid disease condition with <12 month life expectancy Known cardiac disease associated with elevated cardioembolic risk, specifically, atrial fibrillation, prosthetic valve, endocarditis, left atrial/ventricular thrombus, cardiomyopathy with EF<25%, cardiac myxoma Blood dyscrasias, specifically polycythemia vera, essential thrombocytosis, sickle cell disease Active bleeding diathesis, h/o major systemic hemorrhage within 30 days, active PUD, platelets<100K (severe liver impairment (AST or ALT>3 x normal, cirrhosis) Target lesion Non-atherosclerotic stenosis including dissection, fibromuscular dysplasia, vasculitis, radiation induced vasculopathy, suspected recanalized embolus, suspected vasospastic process | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 50.0-999.0, Carotid Stenosis Clinical 1. Age≥50 years，sex unlimited； 2. Asymptomatic carotid stenosis ，ie no transient ischemic attack、stroke or other related neurological symptom caused by carotid stenosis in the past 6 months.(Only the clinical manifestations of dizziness or mild headache are considered asymptomatic carotid stenosis.)； 3. The patient understands the trial objective，understands and accepts the duration of the study，is able and willing to comply with all requirements，including follow-up and evaluation of it, voluntarily participates in the study and signs Informed Consent Form. Anatomy 4. Internal carotid artery independent disease.（ Involving or not involving adjacent common carotid arteries is permitted.）； 5. Carotid stenosis satisfies one of the following ： 1. Ultrasonography suggests stenosis ≥ 70%，or angiography showed stenosis ≥ 60%； 2. Ultrasonography suggests stenosis < 70%，but angiography or other examination showed stenosis in an unstable state； 6. Patients with bilateral carotid stenosis, the treatment time for target vessel contralateral vessels is required 30 days before enrollment or 30 days after completion of study procedure； 7. The stent can reach the site of lesion smoothly as expected Clinical 1. Patients with progressive stroke in the past 3 months or recent (Within 7 days)， CT or MRI suggested that the lesion is large，and may be with the risk of hemorrhagic transformation； 2. Patients with anesthesia contraindications； 3. Serious ipsilateral stroke occurred in the past and may confuse the judgment of the study endpoint； 4. Patients with severe dementia； 5. Patients with spontaneous intracerebral hemorrhage in the past 12 months； 6. Large size of cerebral infarction or myocardial infarction occurred within 30 days ； 7. Patients with large intracranial aneurysms (diameter> 5mm)，and cannot be treated in advance or contemporaneous； 8. Chronic total occlusion without obvious cerebral ischemia symptoms； 9. Hemoglobin <100 g/l， Platelet count <125×109/L， INR>1.5， Bleeding time > 1 min，patients with exceeding the upper limits of normal，or heparin-related thrombocytopenia； 10. Patients unable to perform normal angiographic evaluation or unsafe percutaneous puncture point； 11. Patients with neurologic disorder that caused transient or permanent neurological deficits within 2 years before the surgery and can not be identified with transient ischemic attack or stroke； 12. Patients with other cardiac emboli sources, such as left ventricular aneurysm, intraluminal filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, infective endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma； 13. Recent gastrointestinal bleeding and affects antiplatelet therapy； 14. Surgical contraindications or patients with high risk of surgery defined as having any of the following： It is known that two or more proximal or main coronary artery stenosis ≥70%, untreated or unable to pass； Ejection fraction <30% or New York Heart Association (NYHA) functional class III or higher； Unstable angina，ie angina at resting state and electrocardiogram changes； Currently waiting main organ transplants (ie heart, lung, liver, kidney), or are doing relevant evaluate； Malignant tumor or respiratory insufficiency, life expectancy < 5 years or forced expiratory volume at one second < 30% (predicted)； Dialysis-dependent renal failure； Poor control of diabetes, fasting blood glucose >22mmol/L and ketone body > +2； Need to perform other general anesthesia during the same period； 15. There may be one or more anatomical conditions affecting the normal operative approach in patients with contraindications for carotid endarterectomy operation； there may be one or more anatomic situations to increase the risk of adverse events in patients with high operative risk；including： Neck radiation therapy history； Radical neck surgery history； Inoperable lesions (ie more than C2 lesions)； Spinal brake unable to bend neck, or kyphotic deformity； Symptomatic dissection of the carotid siphon below； Common carotid artery opening lesion；present tracheotomy； Contralateral recurrent laryngeal nerve paralysis； Previously performed ipsilateral carotid endarterectomy，intracranial or subclavian arterial bypass surgery； Contralateral carotid artery occlusion； Lesions series； Severe long segment calcification of the carotid artery； Inaccessible lesions by endoluminal methods (Severe distortion of the aortic arch branch, no suitable introduction of arteries, aortic arch anatomy special）； 16. Investigators consider the patient inappropriate to participate in this clinical trial； 17. Those who participated in clinical trials of other drugs or medical devices before the did not reach the end of the time limit. Angiography 18. Severe vascular tortuosity, or anatomical conditions may affect the safe locomotion of guide catheter, guide sheath or stent； 19. Patients with ipsilateral carotid artery stenting or having a graft； 20. Patients with severe or extensive arteriosclerosis, involving the aortic arch and the proximal common carotid artery, causing locomotion danger of guide catheter or guide sheath； 21. Carotid endarterectomy contraindications by angiography：severity of intracranial or extracranial arterial stenosis that exceeds target lesions; cerebrovascular arteriovenous malformations; or other contraindications; 22. Patients with contralateral carotid artery stenosis, are expected to be performed within 30 days of the perioperative period of the study； 23. Occlusion | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Cardiac Sarcoidosis Participants will be ≥ 18 years of age 2. History of biopsy-proven sarcoidosis OR suspected sarcoidosis based on standard clinical imaging (e.g. FDG PET/CT, MRI) without biopsy confirmation 3. Clinical suspicion of cardiac involvement defined as the presence of any of the following: 1. High degree A-V nodal block 2. Complete bundle branch block 3. Reduced left or right ventricular systolic fusion 4. Any cardiac arrhythmia 5. Chest pain, dyspnea or syncope without clear etiology 4. FDG PET/CT scan demonstrating abnormal myocardial FDG uptake 5. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening. 2. History of neuroendocrine tumors 3. Currently taking the medication Octreotide 4. Currently on total parenteral nutrition (TPN) 5. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician 6. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 25.0-70.0, Cataract Diabetic Patients with bilateral cataract and diabetic retinopathy History of ocular surgery Active ocular inflammation Corneal opacities Pseudoexfoliation syndrome Anterior chamber flare and (or) other signs of possibly altered blood queous barrier Iris neovascularization (rubeosis) Uncontrolled glaucoma Congenital or traumatic cataracts History or present chronic use of topical or systemic steroids Poor papillary dilatation (<6 mm) | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Lateral Elbow Tendinopathy Elbow Pain Elbows Tendonitis Elbow Sprain Elbow Injury years old or older Currently has lateral elbow pain If bilateral lateral elbow pain is present, the more symptomatic side will be assessed At the time of presentation, individuals have been evaluated as having clinical diagnosed LET for at least 4 weeks AND: Positive pain response to at least two of the following tests Pain with palpation on the affected elbow Pain with resisted wrist or middle finger extension Pain while stretching the lateral forearm muscles (Mills Test) At least 30% deficit of pain-free grip compared with the unaffected side Radicular/Cervical conditions reproducing elbow symptoms rheumatoid arthritis Other elbow pathologies: bursitis, medial epicondylalgia, radial nerve entrapment, posterolateral rotary instability History of fracture to the radius, ulna, or humerus with resultant deformity of the involved extremity History of an injection within 6 months Inability to place the shoulder, elbow and wrist in the required testing position The affected elbow had been operated on | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Carotid Artery Stenosis Carotid Atherosclerosis Stroke, Ischemic comprised patient's age ≥ 18 years 99% stenosis of the internal carotid artery (degree of stenosis assessed by means of Doppler sonography, CT angiography or catheter angiography) diameter of the target internal carotid artery not more than 7 mm symptomatic lesion (a history of ipsilateral stroke, transient ischaemic attack or reversible ischaemic neurological deficit) localisation and morphology of the lesion making possible surgical eversion endarterectomy or endovascular angioplasty with stent implantation written informed consent comprised target lesion that has been previously stented highly calcified lesions very tortuous common and internal carotid arteries occlusion of the contralateral carotid artery without adequate collateral circulation through the circle of Willis (revealed by means of transcranial Doppler sonography) anatomical contraindications for eversion endarterectomy acute ipsilateral stroke disabling stroke at any side other severe pathologies of the brain resulting is significant loss of cerebral tissue and/or significant neurological deficits, such as extensive previous stroke or multiple lacunar infarcts history of haemorrhagic transformation of ischaemic stroke | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 20.0-999.0, Dietary Modification Cardiovascular Diseases Patient with risks of cardiovascular disease (CAD) or CAD patients proved by coronary angiography age < 20, hx of GI surgery, hx of malignancy, antibiotic or probiotic or carnitine supplement use within one month, liver cirrhosis, end stage chronic renal disease | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-40.0, Knee Cap Adults aged 18-40 Be able to understand and converse in English Clinical diagnosis of PFPS Be able to attend for up-to 12 weeks of physiotherapy Patients who present with referred pain from the spine or hip, or have tibiofemoral pathology of any nature on the ipsilateral side A diagnosis of PFJ osteoarthritis as confirmed by X-Ray or MRI | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, THROMBOLYSIS Patient/legally authorized representative has signed the Informed Consent Form Age >= 18 years AIS symptom onset within 4.5 to 24 hours Signs and symptoms consistent with the diagnosis of an acute anterior circulation ischemic stroke involving occlusion of the ICA, M1, or M2 vessels Functionally independent (mRS 0-2) prior to stroke onset Baseline NIHSS >=5 and that remains >=5 immediately prior to randomization Neuroimaging: ICA or M1, M2 occlusion (carotid occlusions can be cervical or intracranial, with or without tandem MCA lesions) by magnetic resonance angiography (MRA) or computed tomography angiography (CTA) AND target mismatch profile on CT perfusion or MR perfusion (ischemic core volume <70 mL, mismatch ratio is >=1.8 and mismatch volume is >= 15 mL) The mismatch volume is determined by FDA-approved imaging software in real time based on the difference between the ischemic core lesion volume and the Tmax>6s lesion volume. If both a CT perfusion and a multimodal MRI scan are performed prior to enrollment, the later of the 2 scans is assessed to determine eligibility. Only an intracranial MRA is required for patients screened with MRA; cervical MRA is not required. Cervical and intracranial CTA are typically obtained simultaneously in patients screened with CTA, but only the intracranial CTA is required for enrollment. Alternative neuroimaging If CTA (or MRA) is technically inadequate: Tmax>6s perfusion deficit consistent with an ICA or M1, M2 occlusion AND target mismatch profile (ischemic core volume <70 mL, mismatch ratio >= 1.8 and mismatch volume >= 15 mL as determined by RAPID software) If magnetic resonance perfusion (MRP) is technically inadequate: ICA or M1, M2 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA (or CTA, if MRA is technically inadequate and a CTA was performed within 60 minutes prior to the MRI) AND diffusion-weighted imaging (DWI) lesion volume <=25 mL for an M1 or ICA occlusion and =<15 mL for an M2 occlusion If CTP is technically inadequate: patient can be screened with MRI and randomized if neuroimaging are met General Current participation in another investigational drug or device study Active internal bleeding Known hypersensitivity or allergy to any ingredients of tenecteplase Known bleeding diathesis Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR >1.7 Use of one of the new oral anticoagulants within the last 48 hours (dabigatran, rivaroxaban, apixaban, edoxaban) Pregnant Intracranial neoplasm (except small meningioma), arteriovenous malformation, or aneurysm Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-85.0, Stroke Patients with carotid artery severe (70-99%) stenosis or occlusion diagnosed by CDFI and confirmed by CTA or DSA. 2) Patient has the indications for carotid artery stenting or CEA according to the guidelines published by the Stroke Prevention Engineering Committee, the National Health Commission of China. 3) Patient with complete imaging evaluation and can be followed up to at least 1 year Patients with non-atherosclerotic carotid artery stenosis or occlusion, such as dissection, aneurysm, arteritis, cardiac embolism and et al. 2) Patients with cerebral hemorrhage. 3) Pregnant | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-999.0, Ischemic Heart Disease Patients who suspected ischemic heart disease, and underwent invasive physiologic assessment and intravascular ultrasound Cardiogenic shock Graft vessel In-stent restenosis | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-75.0, Pulmonary Arterial Hypertension Non smoker or tobacco stopped for minimum 2 years ans maximum 10 year-pack. - Idiopathic, heritable, related to drug or toxics, associated with controlled pulmonary hypertension. Diagnosis and treatment of pulmonary hypertension for more than 4 months Optimal control of pulmonary hypertension (no right heart failure symptom and NTproBNP < 300ng/L or Brain Natriuretic Peptide(BNP) < 50 ng/L and optimal hemodynamic results measured by a right heart catheterization in the last year: right atrial pressure < 8 mmHg, cardiac index > 2,5 L/min/m2, veinous saturation in oxygen > 65%) Informed and written consent Non-affiliation to a social security Existence of another form of pulmonary hypertension Existence of vocal cord dysfunction Pregnancy Obesity> stage 2 (BMI 35 kg / m2) Age ≥ 75 years | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 30.0-80.0, Hemiplegia Having a chart of hemiplegia or hemiparesis due to the first story of cerebrovascular accident (SVO) 2. At least 3 months after SVO 3. Mini-mental State Examination (MMSE) value ≥ 15 4. Being in the 30 to 80 age range 5. Back extensor muscle spasticity value <4 according to modified Ashworth Scale Ataxia, dystonia, dyskinesia 2. The presence of lower motor neuron or peripheral nerve lesion 3. Degraded deep senses 4. Detection disorder and dementia 5. Skin and peripheral circulatory disorder 6. History of CVO, bilateral hemiplegia | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-85.0, Diabetes Diabetic Foot Ulcer Peripheral Neuropathy Peripheral Arterial Disease Able to provide informed consent 85 years old Clinically confirmed diabetes (ADA criteria) Clinically confirmed Peripheral Neuropathy One or more active non-infected ulcers Subject or responsible caregiver is willing and to maintain the required offloading (as applicable the location of the ulcer) and applicable dressing changes and electrical stimulation application Subject has a demand-type cardiac pacemaker, implanted defibrillator or other implanted electronic device Is pregnant Is nursing or actively lactating Has Renal Disease Active wound infection Active Charcot foot Non-ambulatory (unable to walk 40 feet with or without assistive device) Bilateral AK/BK amputation Active drug/alcohol abuse Dementia or impaired cognitive function | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Renal Cell Carcinoma Urothelial Carcinoma Cervical Cancer Ovarian Cancer Recurrent Endometrial Cancer Be willing and able to provide written informed consent/ for the trial. 2. Be at least 18 years of age on day of signing informed consent, male or female. 3. Patients with one of the following tumors Histologically or cytologically confirmed diagnosis of advanced renal cell carcinoma (defined as more than 50% clear cell component) after failure of IL-2 and/or anti-VEGF TKI treatment. If patients didn't want to use anti-VEGF TKI medicine or couldn't stand anti-VEGF TKI medicine costs, they will also be considered Histologically or cytologically confirmed diagnosis of unresectable urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra (defined as more than 50% transitional cell component) after failure of no more than two prior platinum-based chemotherapeutic regimen Histologically or cytologically confirmed diagnosis of advanced squamous cell carcinoma of the cervix after failure of first-line system treatment Histologically confirmed diagnosis of recurrent or refractory epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer that are relapsed and resistant (recurred less than 6 months after chemotherapy) or refractory (progressed on chemotherapy) to prior platinum-based standard care systemic regimen Histologically confirmed diagnosis of recurrent or refractory endometrial cancer that are relapsed and resistant or refractory (progressed on chemotherapy) to prior platinum-based standard care systemic regimen. 4. At least one measurable lesion according to 1.1. 5. The patients can swallow pills. 6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. 7. Life expectancy of at least 12 weeks. 8. The results of patients' blood tests are as follows:-Neutrophils≥1.5E+9/L; - Plt≥90E+9/L; -Hb≥90g/L; -ALB≥30g/L ;-TSH≤1×ULN;-TBIL ≤ 1 ×ULN;-ALT and AST ≤ 3 ×ULN; AKP≤ 2.5×ULN; -Creatinine ≤ 1.5×ULN. 9. Male or Female patient of childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test), who agrees to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded. 2. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration. 3. Known history of hypersensitivity to other antibody formulation. 4. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 2 weeks prior to trial treatment. 5. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents: systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥ 90 mmHg. 6. Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to（1）Congestive heart failure (New York heart association (NYHA) class > 2)；（2）unstable or severe angina; （3）myocardial infarction within 12 months before enrollment；（4） ventricular arrhythmia which need medical intervention.（5）QTc>450ms（male）/QTc>470ms (female)； 7. Coagulation abnormalities (INR>2.0、PT>16s), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy. 8. Bleeding history, having bleeding event（≥3 Grade according CTCAE 4.0 ）within 4 weeks before screening. 9. Tumor invasion around major vessels shown by imaging, high risk of major vascular invasion leading to massive hemorrhage judged by investigators. 10. Previous Arterial/venous thrombosis events within 6 months. 11. Known hereditary or acquired bleeding and thrombosis tendency. 12. Proteinuria ≥ (++) and 24 hours total urine protein > 1.0 g. 13. Prior chemotherapy, radiotherapy, surgery therapy within 4 weeks or palliative radiotherapy within 2 weeks or target therapy within 5 half-life of the drug before the study drug administration, or any unresolved AEs > Common Terminology for Adverse Events (CTCAE) Grade 1. 14. Active infection or an unexplained fever > 38.5°C within 7 days before the study drug administration, or baseline WBC>15×E+9/L . 15. Has known history of Interstitial lung disease, or using steroids evidence of active, non-infectious pneumonitis, or would interfere with the detection and handling of suspicious drug-related pulmonary toxicity. 16. History of immunodeficiency or human immunodeficiency virus (HIV) infection. 17. HBV DNA>500 IU/ml，HCV RNA>1000copies/ml，HBsAg+ and anti-HCV+； 18. Has a known additional malignancy within the last 5 years, or that is progressing or requires active treatment. Exceptions basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or patients with recurrent ovarian cancer has a known additional breast cancer that has been radical mastectomy and doesn't relapse within 3 years. 19. Patients with treatment history of SHR-1210 or any other PD-L1 or PD-1 antagonists or famitinib. 20. Patients who may receive live vaccine during the study, or previous had vaccination within 4 weeks. 21. Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's safety and participate in the study or would interfere with the interpretation of the results or lead to the trial being terminated early | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 65.0-100.0, Mild Cognitive Impairment Fall At least 65 years old Had a fall at least 3 months prior to the baseline assessment Can ambulate independently Has mild cognitive impairment Cannot ambulate independently and communicate with researchers Have a major unstable cardiopulmonary disease (e.g., ischemic chest pain, shortness of breath, recurrent syncopal episodes, orthopnea, paroxysmal nocturnal dyspnea, palpitations, or tachycardia) Have a contraindication to physical exercise (e.g., severe osteoarthritis or severe pulmonary hypertension) | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 50.0-999.0, Carotid Stenosis Carotid Artery Plaque Cerebrovascular Embolism and Thrombosis signed informed consent significant carotid artery stenosis Age under 50 years Neurological event 15 days before operation Chronic kidney disease Pacemaker or ICD implantation Atrial fibrillation | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Aortic Valve Stenosis I1. Patients with symptomatic native aortic valve stenosis and age ≥18 years I2. Aortic valve area (AVA) ≤ 1 cm2 or indexed AVA ≤ 0.6 cm2/m2, mean aortic gradient < 40 mmHg and stroke volume index (SVI) < 35ml/m2 I3. Left ventricular ejection fraction ≥ 50% I4. MDCT aortic valve calcium score men > 2000AU, women > 1200AU OR the likelihood are fulfilled (symptoms without other explanation and LV hypertrophy; age < 70 yrs., AVS < 0.8 cm2; SVI < 35ml/m2 confirmed by 3D TOE, MRI or invasive; reduced LV longitudinal function without other reason) I5. Heart team agrees on for TAVR I6. Written informed consent I7. Negative pregnancy test in women with childbearing potential E1. Hemodynamic instability E2. Cardiogenic shock E3. Pre-existing mechanical or bio-prosthetic valve in any position E4. Concomitant severe valvular heart disease E5. Pre-existing or active endocarditis E6. Need for heart surgery due to other conditions E7. Aortic valve is congenital unicuspid or congenital bicuspid E8. Hypertrophic cardiomyopathy with or without obstruction E9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation E10. Acute myocardial infarction within 1 month before intended AS-treatment | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-79.0, Facet Joint Pain Facet Syndrome of Lumbar Spine Facet Joints; Degeneration Lumbar facet syndrome diagnosed by the referring specialist: Rehabilitation, Traumatology or Neurosurgery 2 -Mechanical low back pain that increases with rotation and flexion-extension, without radicular irradiation. 3 failure of conservative treatment (pharmacological and physical therapy). 4-Symptoms present more than 3 months Previous back surgery and other ablative treatments. 2. Contraindication for the use of corticosteroid or local anesthetic. 3. Uncontrolled acute or chronic medical illness. 4. Pregnancy or lactation. 5. Presence of inflammatory arthropathy or neuropathy. 6. Wounds or skin lesions in the area. 7. Diabetes mellitus. 8. Psychiatric disorders 9. Refusal to participate in the study. 10. Demonstration by imaging techniques of other causes that could justify the symptomatology | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-80.0, Carotid Atherosclerosis Age 18 years Carotid artery with 30%~70% stenosis by ultrasound and plaque thickness>2.5mm Patients without transient ischemic attack, minor stroke or amaurosis fugax within 6 months Patients' LDL-c level below 100 mg/dL(2.6mmol/L), well-controlled blood pressure(systolic BP<140 and diastolic BP<90 under resting conditions) and diabetes(HbA1c<7%) Written informed consent Non-atherosclerotic carotid artery stenosis Contraindication to MRI( uses pacemaker, has metallic implants, claustrophobia) Acute MI, acute coronary syndrome or stroke within 4 weeks prior to visit Severe cerebral artery stenosis, atrial fibrillation or MRI detected thrombosis that would cause stroke Previous significant adverse reaction to a statin Systemic disorders such as hepatic, renal, hematologic, and malignant disease Medical history that might limit the individual's ability to take trial treatments for the duration of the study Allergic to DVDMS or sonovue Diagnosis of porphyria Pregnant women and nursing mothers | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-35.0, Reproducibility of Results Age ≥18 ≤35 Healthy individual Normal electrocardiogram (ECG) Normal physical examination, including neurological examination, auscultation of the heart and lungs, and measurement of blood pressure and pulse Speaks and understands Danish Provides oral and written informed consent Right-handed American Society of Anaesthesiologists (ASA) class 1 (2) Mallampati I-II and simplified airway risk index (SARI) 0-2 (i.e. no indication of difficult intubation. See Appendix for details) BMI ≥18 kg/m2 and ≤30kg/m2 Cannot cooperate to tests Left-handedness or ambidexterity History of cancer, immune disease, autoimmune disease, chronic pain, neurological / psychiatric illness or other serious illness Pregnancy Weakly intake of >21 (males) or >14 (females) units of alcohol Substance abuse (assessed by the investigator) Daily use of any medication (contraceptives allowed) Consumed anti-depressants during the last 30 days before study days Heavy intake of caffeine (> 5 cups/day) Smoking during the last 30 days before study days | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-65.0, Takayasu Arteritis Mechanisms, Defense Pregnancy Related Treatment Refusal Outcome onset at age ≤40 years claudication of an extremity decreased brachial artery pulse >10 mm Hg difference in systolic blood pressure between arms a bruit over the subclavian arteries or the aorta angiographic evidence of narrowing or occlusion of the entire aorta, its primary branches, or large arteries in the proximal upper or lower extremities Patients should meet at least 3 of the above 6 articles Sign the informed consent autoimmune diseases, such as ANCA-associated vasculitis, systemic lupus erythematosus, Behcet's disease, rheumatoid arthritis, ankylosing spondylitis, etc complicated medical abnormal conditions, un-related with TA but engendering the unpredictable risks, such as severe, progressive, or uncontrollable kidney, liver, blood, gastrointestinal, pulmonary, heart, neuron or others malignant tumors serious acute or chronic infections high risk of tuberculosis infection such as clinical, radiological or laboratory evidence of active or occult tuberculosis, or the history of active tuberculosis Having received or plan to receive plasma exchange or lymphocyte replacement or immunoabsorption therapy within 1 year Preparing to receive an attenuated vaccine during the trial Having received or plan to receive an organ transplant; Exit participants require to withdraw during the study participants who believe that they need to withdraw due to clinical adverse events | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-80.0, Cerebrovascular Disorders Age 18 years or older. 2. Diagnosis of Acute Ischemic Stroke secondary to LVO 3. LVO from presumed embolic source (<50% ICA) 4. CT perfusion/RAPID images showing salvageable penumbra (evaluated by PI) 1. >50% stenosis of internal carotid artery 2. >50% stenosis of bilateral vertebral arteries. 3. Patients with moderate to severe intracranial atherosclerotic disease as seen in CTA of head and neck. 4. Known moderate to severe PVD or symptomatic CAD 5. Past medical history of stent or coronary artery bypass surgery 6. Prisoners 7. Pregnant women 8. Previous stroke within 30 days 9. Intracranial vascular malformation or evidence of moya-moya disease 10. Serious advanced or terminal illness per judgment of the investigator with life expectancy <1yr 11. Known allergy to iodine that precludes CTA or CTP studies 12. Presumed septic embolus or suspected bacterial endocarditis | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 5.0-94.0, Cataract Patients with the explicit diagnosis of cataract (including senile cataract, congenital cataract, complicated cataract, metabolic cataract, traumatic cataract, etc.) in the operated eye are willing to undergo cataract surgery Patients whose cataracts need not be operated Patients with any contraindications to cataract surgery Patients are unwilling to undergo cataract surgery | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 55.0-90.0, Sleep Disorder All subjects will have participated in prior CBH studies and have agreed to an FDG, PIB and MRI scans Diagnosis of sleep apnea and under treatment with a continuous positive airway pressure (CPAP) machine Active depressive episode during the evaluation with a Geriatric Depression Scale score >7 and/or a Clinical Global Impression scale for depression score >4 Moderate Cognitive decline (GDS >3) Severe primary or secondary insomnia except insomnia due to SDB | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Coronary Artery Calcification Age ≥ 18 ans Diabetes mellitus (type 1 or 2) Patients addressed to a one-day hospitalization to assess cardiovascular comorbidities, between January 2014 and May 2017, in the diabetes department, in the Pitié-Salpêtrière hospital Coronary artery calcium score available Toe-brachial index available History of coronary artery disease History of Raynaud's syndrome Opposition of the patient | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 21.0-999.0, Ischemic Stroke Patients with recent stroke/TIA and severe stenosis of intracranial ICA or MCA and impaired CVR within previous three months but not before 3 weeks after acute stroke. This is to differentiate between patients with a long-standing fixed-stenosis from patients with partially recanalized intracranial artery (masquerading as severe stenosis). 2. Age >21 years Patients with atrial fibrillation/ arrhythmias. 2. Within 2 weeks of cardiac catheterization or arterial puncture at femoral puncture site. 3. Decompensated heart failure , usually class 3 or 4 4. LV EF <30% 5. Moderate or severe AR 6. Persistent and uncontrolled hypertension (BP persistently >160/100 mmHg) 7. Bleeding diathesis 8. Active thrombophlebitis/ venous disease of lower limbs 9. Severe lower extremity vaso-occlusive disease 10. Presence of a documented aortic aneurysm/ dissection requiring surgical repair 11. Pregnancy | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Kidney Failure Receiving HHD or ICHDF for more than 3 months and less than 36 months Haemoglobin equal to or greater than100 g/L at enrolment Willing and physically able to undertake the study assessments/tests Willing to provide blood for storage and future analysis Able to give informed consent Living donor transplant or change to peritoneal dialysis planned Physical assessments contraindicated for the following clinical reasons Acute Coronary Syndrome (ACS) within the last 3 months (chest pain, ECG changes or typical biomarker elevation) Any current uncontrolled cardiac dysrhythmias causing symptoms (chest pain, palpitations, syncope or dizziness) Symptomatic aortic stenosis New York Heart Association grade IV Heart failure Severe chronic obstructive pulmonary disease Acute pulmonary embolus or pulmonary infarction in the last 3 months Current acute myocarditis or pericarditis Suspected or known dissecting aneurysm | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Diabetes Mellitus, Type 2 Cardiovascular Diseases Age ≥ 18 years old Diagnosis of Type 2 diabetes mellitus (T2DM) History of at least one of the following conditions: 1. Coronary artery disease (defined as prior MI, coronary revascularization (CABG or PCI), and/or obstructive CAD (≥50%) as documented by angiography or CTA) 2. Stroke and/or carotid artery stenosis (≥50%) 3. Peripheral Arterial disease (defined as claudication with ABI<0.9, prior peripheral revascularization, and/or amputation due to circulatory insufficiency) Ability to communicate with site staff and understand and provide written informed consent and proof of Health Insurance Portability and Accountability Act (HIPAA) authorization Determined to be highly unlikely to survive and/or to continue follow-up in that clinic for at least 1 year, as identified by site investigator GFR<30 mL/min/1.73m2 Already on all guideline-recommended therapies for T2DM and CVD Absolute contraindication to any of the guideline recommended therapies for T2DM and CVD | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Carotid Artery Injuries Patient aged 18 or over Indication of treatment with a carotid revascularization procedure (conventional surgery or angioplasty and stent) Acceptance to participate in the protocol Associated retinal ophthalmological pathology: diabetic retinopathy, age-related macular degeneration, retinal vein occlusion, CRSC (Central serous chorioretinopathy) Refusal to participate in the study Not affiliated to a social security scheme | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-85.0, Atrial Fibrillation Syncope Tachycardia Arrhythmias, Cardiac Heart Diseases Patient is able to understand the nature of study and has provided written informed consent Patient with Acute Coronary Syndrome, with or without elevation of the ST segment at the EKG (the last with elevation of troponins) Patient with coronariography at the episode of ACS showing severe lesions treated with stent Patient with risk index for 6-month mortality (GRACE score) of more than 118 Patient with risk index for stroke (CHA2DS2-VACS score) of more than 2 Patient with history of AF Patient with episodes of AF during admission at the current episode Patient with pacemaker or ICD (implantable cardioverter-defibrillator) previously Patient with indication of pacemaker or ICD in current or short-term phase Patient is participating in another interventional clinical investigation Patient is pregnant or breast feeding Patient´s life-expectancy is less than 24 months | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Type 1 Diabetes Mellitus Participants must have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year Participants must have HbA1c of ≥7.0 and ≤10.0% Participants must have been treated for at least 90 days prior to screening with either multiple daily injection(s) (MDI) or premixed analog/human insulin regimens at least twice daily Participants must have body mass index (BMI) of ≤35.0 kilograms per square meter (kg/m2) Participants must not have used other anti-hyperglycemic medications or therapies (inhaled, oral or injectable) except for metformin within 90-days of screening Participants must not have had more than 1 severe hypoglycemic episode within 6 months of screening Participants must not have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months of screening | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-90.0, Catheter Related Complication Patients who are undergoing cardiac catheterization or PCI Peripheral vascular disease Renal failure, Creatinine >2.5 mg/dL Hemodynamic instability, acute myocardial infarction Heart failure with EF<25% | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 1.0-24.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Central Nervous System Leukemia Mixed Phenotype Acute Leukemia Testicular Leukemia B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 7 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732 White blood cell count (WBC) for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy) Age 1-9.99 years: WBC >= 50,000/uL Age 10-24.99 years: Any WBC Age 1-9.99 years: WBC < 50,000/uL with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment White blood cell count (WBC) for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy) Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group) With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732 Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patients with acute undifferentiated leukemia (AUL) are not eligible For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional apply T-lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Carotid Artery Diseases Carotid Atherosclerosis Carotid Stenosis Carotid Artery Plaque Carotid Disease Stenosis must be >50% as determined by ultrasound or angiogram1 and the patient has a history of stroke (minor or non-disabling; NIHSS ≤4 or mRS ≤2), TIA and/or amaurosis fugax within 180 days of the procedure ipsilateral to the carotid artery to be stented Stenosis must be >80% as determined by ultrasound or angiogram without any neurological symptoms within the prior 180 days Target vessel must meet diameter requirements for stent (refer to stent IFU for diameter requirements) Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA) Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations Patient must have a life expectancy ≥ 3 years at the time of the index procedure without contingencies related to other medical, surgical or endovascular intervention Patient meets at least one of the surgical high-risk listed in CMS National Coverage Determination (NCD) for Percutaneous Transluminal Angioplasty (20.7) Alternative source of cerebral embolus Patient has chronic atrial fibrillation Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation Knowledge of cardiac sources of emboli. e.g. left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma) Recently (<60 days) implanted heart valve (either surgically or endovascularly), which is a known source of emboli as confirmed on echocardiogram Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis (as determined by angiography or CTA/MRA ≤ 6 months prior to index procedure) greater in severity than the lesion to be treated, cerebral aneurysm > 5 mm, AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings Patient has a history of spontaneous intracranial hemorrhage within the past 12 months, or has had a recent (<7 days) stroke of sufficient size (on CT or MRI) to place him or her at risk of hemorrhagic conversion during the procedure (less than one-third middle cerebral artery volume) Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days Patient with a history of major stroke attributable to either carotid artery (CVA or retinal embolus) with major neurological deficit (NIHSS ≥ 5 OR mRS ≥ 3) likely to confound study endpoints within 1 month of index procedure Patient has an evolving stroke | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Carotid Stenosis Carotid Artery Diseases Carotid Atherosclerosis Carotid Artery Plaque Patient is symptomatic and has a history of stroke (minor or non-disabling), TIA and/or amaurosis fugax within 60 days of the procedure Target vessel must meet diameter requirements for stent (refer to selected stent IFU for diameter requirements) Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA) Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations Patient has chronic atrial fibrillation Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation Patient has an evolving stroke Patient has a history of spontaneous intracranial hemorrhage within the past 12 months Patient has had a recent (<7 days) stroke of sufficient size (on CT or MRI) to place him or her at risk of hemorrhagic conversion during the procedure Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days Patient has active bleeding diathesis or coagulopathy or will refuse blood transfusion Patient had or will have CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention Patient has had a recent GI bleed that would interfere with antiplatelet therapy Patient has history of intolerance or allergic reaction to any of the study medications or stent materials (refer to stent IFU), including aspirin (ASA), ticlopidine, clopidogrel, prasugrel, statin or contrast media (that can't be pre medicated). Patients must be able to tolerate statins and a combination of ASA and ticlopidine, ASA and clopidogrel or ASA and prasugrel | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 21.0-999.0, Stenosis of Artery Peripheral Arterial Disease Iliac Artery Disease Iliac Artery Occlusion Subject has signed informed consent 2. Subject is ≥ 21 years of age 3. Subject is able and willing to comply with study requirements 4. Male, infertile female, or female practicing contraception and a negative pregnancy test within 7 days prior to the study procedure 5. Symptomatic claudication or rest pain without tissue loss, Rutherford category 2-4 6. Angiographic evidence of de novo or restenotic target lesion(s) in native vessels in the common and/or external iliac artery(ies) (multiple stenoses may exist within the target lesion) 7. Total lesion(s) length is ≤ 110mm 8. Target lesion(s) is at least 3 cm from an existing stent or stent graft 9. At least 1 stenosis in the target vessel has ≥ 50% stenosis 10. Target vessel diameter is between 4.6 and 14.4mm at angiographic screening for device placement 11. Adequate ipsilateral blood flow, including at least 1 patent (<50% stenotic) superficial femoral or profundal femoral artery 12. Full expansion of an appropriately sized (in the investigator's opinion) standard angioplasty balloon has been achieved during primary angioplasty at the target lesion prior to enrollment Subject has undergone an intervention (surgical or percutaneous) in the target limb(s) <30 days from the date of the index study procedure 2. Subject has a surgical or percutaneous procedure in the target limb(s) planned within 30 days following the index study procedure 3. Previous or planned bypass surgery in the target limb(s) 4. Coronary intervention within 30 days prior to enrollment or planned within 12 months after index study procedure 5. Subject has had a stroke within 90 days prior to the index study procedure 6. Subject has had a transient ischemic attack within 30 days prior to the index study procedure 7. Uncorrectable coagulation disorder 8. Subject cannot receive heparin, dual antiplatelet treatment, or anticoagulant(s) appropriate in the opinion of the investigator 9. Condition unrelated to study anticipated to require indefinite anticoagulation 10. Evidence of blood borne infection 11. Hypersensitivity to nickel titanium alloy 12. Allergy to radiographic contrast material which cannot be adequately premedicated 13. Serum creatinine >2.5mg/dL 14. The subject is enrolled in another investigational study 15. Life expectancy is ≤ 12 months 16. Active malignancy other than non-melanomatous skin cancer 17. Stenosis/restenosis is located within a previously placed stent or stent graft 18. Angiographic evidence of thrombus within or adjacent to the target lesion(s) 19. Aneurysmal dilation proximal or distal to the target lesion(s) that could interfere with placement of the study device 20. Abdominal aortic artery stent, if it could interfere with placement of the study device 21. Target lesion(s) are located such that the stent graft would prevent blood flow to the internal iliac artery, if patent 22. Lesions requiring atherectomy or ablation to facilitate stent graft delivery 23. Any other condition deemed exclusionary in the opinion of the investigator for documented reasons relating to the health and/or welfare of the subject | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Carotid Artery Stenosis 18 years of age and older 2. Having carotid endarterectomy surgery 3. Able to undergo a preoperative neurological exam Pregnant patients 2. Prisoners 3. Patients with dementia or reduced mental status acute or chronic 4. Known brain tumor or head trauma 5. Known severe, uncorrected coronary artery disease (CAD) 6. Ejection fraction (EF) less than 15% 7. Patients with intraaortic ballon pump (IABP) or other mechanical circulatory assist device 8. Patients with severe chronic obstructive pulmonary disease (COPD) 9. Combined surgical procedures (CABG and CAD) 10. Patients with uncontrolled or severe anxiety requiring benzodiazepine administration 11. Patients with history of difficult airway 12. Sedation other than propofol, dexmedetomidine or volatile anesthetic agent (VAA) is needed for patient (i.e. ketamine in patients with history of neuropathic pain) 13. Intubated or unconscious patients 14. Patients on methadone or fentanyl patch 15. Patients with known unusual or extreme anesthetic requirements 16. Patients who would require an unusual amount of narcotic to control pain 17. Patients having endarterectomy wherein surgeon requests local-regional anesthesia only 18. Patients with known history of prolonged emergence from anesthesia 19. Morbidly obese patients (BMI >40) 20. Patients with scalp or forehead defects that prohibit application of BIS monitor strip | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 61.0-75.0, Anterior Segment Ischemia (Diagnosis) The patients of Ocular ischemic syndrome (OIS) were the stenosis of the ipsilateral (to the affected eye) internal carotid artery (ICA) was >50% The patients of Ocular ischemic syndrome (OIS) who the ICA blood flow velocity was abnormal Abnormal ocular symptoms and/or signs that could not be explained by other ocular diseases The patients who were suffered from other ocular diseases( primary glaucoma, uveitis, age-related macular degeneration, symmetrical proliferative diabetic retinopathy, choroidal detachment, retinal detachment, hereditary eye diseases, ocular tumor, or ocular trauma) | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Pain, Postoperative Knee Pain Chronic Subjects undergoing TKR Acceptance to participate ASA physical status II-III Age > 18 years Refusal to participate in the study Allergy to local anesthetics History of substance abuse | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 60.0-95.0, Heart Valve Diseases Aortic Valve Disease Heart Murmurs Adult subjects >60 years of age 2. Ability to understand and sign informed consent 3. Willingness to undergo study protocol (in Pasadena CA) Inability to provide informed consent 2. History of carotid sinus hypersensitivity (fainting in response to minimal touching or positioning of the neck) 3. History of significant or symptomatic carotid artery disease, or carotid artery stenting or surgery 4. History of aortic valve surgery or transcatheter aortic valve replacement 5. Absent carotid pulse on initial examination (inability to palpate the carotid pulse) 6. Open skin lesions at the site of Vivio application/examination 7. Presence of a carotid bruit on examination | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Healthy Volunteer COVID-19 Individuals must meet all of the following to be eligible for study participation: 1. Aged 18 years and older (no upper age limit). 2. Able to provide informed consent. 3. Willing to have samples and data stored for future research. 4. Able to proficiently speak, read, and write English Individuals meeting any of the following will be excluded from study participation: 1. CBC with differential, lymphocyte phenotyping with T, B, and natural killer cells (TBNK), acute care, mineral, and hepatic panels, anti-CMV immunoglobulin (Ig) G and IgM, and/or anti-Epstein-Barr virus (EBV) antibody panel values outside of the NIH Department of Laboratory Medicine normal reference ranges and deemed clinically significant by the PI at the time of screening. 2. Positive result for anti-HIV 1/2 antibody, antibody to hepatitis B surface antigen, or anti-hepatitis C virus antibody screening at the time of screening. 3. Prior receipt of a current seasonal influenza vaccine (for the season of participation). 4. History of allergy or hypersensitivity to any components of the study vaccine (e.g., egg protein, latex). 5. History of severe reactions to vaccines. 6. Use of an oral glucocorticoid within the past 30 days. 7. Receipt of a live-attenuated vaccine within the past 30 days. 8. Receipt of any experimental vaccine. 9. Receipt of any other type of vaccine (non-live and non-experimental, e.g., tetanus, diphtheria, and pertussis [TDaP]) within the past 14 days. 10. Planned vaccination before day 100 after study vaccination. 11. Current or recent use (within the past 90 days) of immunoglobulin therapy. 12. Surgery within the past 8 weeks, or planned surgery before day 100. 13. Current (within the past 30 days) treatment for active malignancy. 14. Cancer chemotherapy in the past 5 years. 15. Administration of any blood products within 90 days of the screening, or planned administration before day 100. 16. History of parasitic, amebic, fungal, or mycobacterial infections within the past 1 year with the exception of tinea pedis and onychomycosis. 17. Diabetes mellitus. 18. History of autoimmune or autoinflammatory disease. 19. History of a bleeding disorder. 20. Current use (within the past 30 days) of illicit drugs (per subject report). 21. Current use (within the past 30 days) of nicotine-containing products, including cigarettes and chewing tobacco, nicotine patches, gum, electronic cigarettes, etc. 22. Current alcohol use disorders (criteria per Diagnostic and Statistical Manual of Mental Disorders, fifth edition), within the past 30 days. 23. Serious, ongoing, uncontrolled infection within the past 30 days as per the judgement of the PI. 24. History of Guillain-Barre syndrome (GBS). 25. BMI greater than or equal to 30. 26. Known or suspected immunodeficiency within 1 year, including documented HIV infection. 27. Pregnancy or planning to become pregnant during the study period. (Women of childbearing potential must have a negative urine or serum pregnancy test at screening.) 28. Presence of conditions that, in the judgment of the PI, may put the individual at undue risk or compromise the scientific objectives of the study | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-76.0, Rheumatoid Arthritis Patients previously enrolled in the ABX464-301 clinical study who have completed the initial 12 weeks of treatment period; that should be met by patients at week 52 to be eligible for 52 additional weeks of study treatment: ▪ Patients should be in clinical response. Clinical response is defined as: DAS28-CRP ≤ 2,6 for anti-TNFα naïve patients or DAS-28-CRP ≤ 3,2 for patients previously treated by anti-TNFα Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-75.0, Stroke Acute Between 18 and 75 years of age 2. First ever-acute ischemic unilateral stroke in the anterior circulation (ACA or MCA territory), MRI/CT scan result is thus required. 3. Stroke onset from 2-10 days 4. Good level of consciousness (alert) 5. Free of any neurological antecedent, unstable condition that may increase the risk of stimulation such as epilepsy; although tDCS is believed to induce less or no risk of seizure and epileptic seizure have never been reported in tDCS study even in a study with active epilepsy (19). 6. No significant carotid artery occlusive disease (< 50% internal carotid artery stenosis) as assessed by carotid duplex ultrasonography 7. Presence of bilateral temporal acoustic window for optimal TCCD evaluation 8. Modified Ranking Scale ≤ 4 Recurrent stroke 2. Having score more than 20 points on the National Institute of Health Stroke Scale 3. Be unable to understand the instruction. 4. Presence of intracranial metal implantation, cochlear implant, or cardiac pacemaker. 5. Having as excessive pain in any joint of the lower limb (numerical pain rating score > 7) 6. Open wound or wound infraction on scalp | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 65.0-999.0, Carotid Stenosis Patients age ≥ 65 years scheduled for a diagnostic carotid artery duplex ultrasound study AND with one or more of the following Hypertension Hyperlipidemia Diabetes Tobacco usage Current or past Known CAD/PAD Family history of early onset of atherosclerotic disease Unable / unwilling to provide Informed Consent Prior carotid endarterectomy or carotid artery stent Aortic stenosis Congestive heart failure BMI > 35 | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Coronary Artery Disease Peripheral Artery Disease to qualify, all subjects must meet have CAD and PAD as according to specified below Subjects meeting for CAD$ must have one or more of the following Myocardial infarction within the past 20 years, or Multivessel coronary disease* with symptoms or with history of stable or unstable angina, or Multivessel percutaneous coronary intervention, or Multivessel CABG surgery (* Refers to stenosis of ≥ 50% in 2 or more coronary arteries, confirmed using invasive coronary angiography, or noninvasive imaging or stress studies (eg, exercise or pharmacologic) suggestive of significant ischemia in 2 ≥ coronary territories; or in 1 coronary territory if at least 1 other territory has been revascularized.) $Subjects with the qualifying of CAD must also met at least one of the following Age > 65 years, or Age <65 years and documented atherosclerosis or revascularization involving at least 2 vascular beds+, or at least 2 additional cardiovascular risk factors: 1. Current smoker (within 1 year of randomization) 2. Diabetes mellitus 3. Renal dysfunction with estimated glomerular filtration rate of <60 ml/min 4. Heart failure 5. Non-lacunar ischemic stroke > 1 month ago Because CAD involves disease in the coronary vasculature, only one additional vascular bed is required: e.g. the aorta and arterial supply to the brain, gastro-intestinal tract, lower limbs, upper limbs, or kidneys Subjects meeting for PAD must have one or more of the following Subjects will be excluded from entry if ANY of the listed below are met High risk of bleeding Stroke within 1 month or any history of hemorrhagic or lacunar stroke Severe heart failure with known ejection fraction <30% or New York Heart Association (NYHA) class III or IV symptoms Estimated glomerular filtration rate (eGFR)<15 mL/min Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy Known non-cardiovascular disease that is associated with poor prognosis (e.g., metastatic cancer) or that increases the risk of an adverse reaction to study interventions History of hypersensitivity or known contraindication for rivaroxaban, aspirin, or its excipients. Systemic treatment with strong inhibitors of both CYP 3A4 and p-glycoprotein (P-gp) (e.g., systemic azole antimycotics, such as ketoconazole, and human immunodeficiency virus [HIV]-protease inhibitors, such as ritonavir), or strong inducers of CYP 3A4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin, and carbamazepine Participation in any investigational study within the last 60 days Active liver disease or hepatic dysfunction, defined as AST or ALT >3 x ULN as determined by laboratory test results drawn at or available during screening | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-18.0, Cystic Fibrosis Hirschprung's Disease Obstructive Sleep Apnea Healthy Are aged between 0 and 18 years Have been diagnosed with a chronic gastrointestinal and/or respiratory condition defined by consensus diagnostic criteria; or Are free of any chronic health condition (healthy control group); and Have a parent(s)/carer(s) who provides informed consent, or are at least 16 years old and provide informed consent Children who have an unrelated coexisting chronic medical illness(es) associated with alterations in dietary intake or suspected alterations in the intestinal and/or respiratory microbiomes Inability to comply with study requirements Parent(s)/guardian(s) are unable to speak English or do not have a reading level age of at least 12 years | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Acute Ischemic Stroke Age ≥ 18 years A new focal disabling neurologic deficit consistent with acute cerebral ischemia NIHSS score ≥ 6 Prestroke mRS score of ≤ 2 Angiographic confirmation by DSA of an occlusion (eTICI 0-1) of the intracranial ICA, MCA-M1, MCA-M2, basilar artery, or intracranial vertebral artery with or without tandem involvement of the cervical ICA or cervical vertebral artery Imaging 1. Strokes in the Anterior Circulation Non-Contrast CT (NCCT): 6 to 10 on baseline CT, or CT perfusion (with Automated Volume Calculation): core infarct volume ≤ 70cc and Mismatch Ratio ≥ 1.5 CT perfusion (without Automated Volume Calculation): 6 to 10 on the CBV maps with Visualized MTT or TMax CBV Mismatch greater than 50%, or Rapid neurological improvement prior to groin puncture suggestive of resolution of stroke Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment Note: Subjects with a questionable seizure at onset of stroke should not be excluded if DSA confirms the presence of intracranial ICA and/or M1 occlusion, and accurate NIHSS can be obtained Pre-existing medical neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept) Cardiopulmonary resuscitation, significant cardiac arrhythmia, evidence of ongoing myocardial infarction, concern for pre-treatment pulmonary aspiration Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories Cerebral vasculitis History of severe allergy to contrast medium Known allergy to stent retriever materials (nitinol, stainless steel) Suspicion of aortic dissection, septic embolus, or bacterial endocarditis | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-999.0, Langerhan's Cell Histiocytosis Juvenile Xanthogranuloma Erdheim-Chester Disease Rosai Dorfman Disease Neuro-Degenerative Disease Histiocytic Sarcoma Histiocytic Disorders, Malignant For Group 1: Participant must be less than 30 years of age at the time of enrollment For Group 2: Participant may be any age at the time of enrollment For Group 3: Participant must be less than 30 years of age at the time of enrollment For Group 4: Participant must be 30 years of age or older at the time of enrollment Participant must be able to take an enteral dose and formulation of medication. Study medication is only available as an oral suspension or tablet which may be taken by mouth or other enteral route such as nasogastric or gastric tube Biopsy proven LCH -AND Failure of at least front-line therapy for high-risk LCH with evaluable disease. -OR Failure of at least second-line therapy for low-risk LCH with evaluable disease. -OR Diagnosis of LCH-associated neurodegenerative disease with radiologic or clinical progression within the past 3 months. -OR Biopsy proven JXG, ECD, RDD, histiocytic sarcoma, or other histiocytic lesion (newly diagnosed or relapsed/refractory disease) with evaluable active disease. Performance Level: -Karnofsky ≥ 50% for patients > 16 years of age and Lansky ≥ 50% for patients ≤ 16 years of age. Adequate Hematologic Function Defined as Prior and Concomitant Use of Drugs with CYP3A4 inducing/inhibiting activity: Patient taking strong inducers or inhibitors of CYP3A4 within 14 days prior to study enrollment, including but not limited to the following: erythromycin, clarithromycin, ketoconazole, azithromycin, itraconazole, grapefruit juice or St. John's wort Prior Therapy Restrictions Completion of previous chemotherapy, immunotherapy, radiotherapy, or targeted therapy for LCH (or other histiocytic disorder) at least 28 days (except where specified below) prior to study database registration, with resolution of all associated toxicity to ≤ Grade 1 prior to study enrollment (exception for alopecia and ototoxicity which do not need to be resolved ≤ Grade 1). Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the laboratory are met, the patient is considered to have recovered adequately Radiation therapy within the last 28 days Any prior treatment with Cobimetinib Treatment with a long-acting hematopoietic growth factor within 14 days prior to initiation of study drug or a short-acting hematopoietic growth factor within 7 days prior to database registration Treatment with hormonal therapy (except hormone replacement therapy or oral contraceptives), immunotherapy, biologic therapy, investigational therapy, or herbal cancer therapy within 28 days or < 5 half-lives, whichever is longer, prior to database registration Treatment with high-dose chemotherapy and stem-cell rescue (autologous stem cell transplant) or allogeneic stem cell transplant within 90 days prior to study database registration. Anti-GVHD agents post-transplant: Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial For patients with brain tumors (intracranial masses), use of anticoagulants within 7 days prior to study database registration Corticosteroid therapy <0.5 mg/kg/day averaged during the month prior to study database registration is permissible but must be discontinued fourteen (14) days prior to prior to study database registration. Patients with documented brain lesions receiving corticosteroids for management of cerebral edema must be on a stable dose for fourteen (14) days prior to study database registration Patient has received treatment with investigational therapy within 4 weeks prior to initiation of study drug | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Acute Cerebrovascular Accident Endovascular Procedures Acute stroke with a demonstrated occlusion in the anterior circulation (M1 or M2 segment of middle cerebral artery with or without ipsilateral internal carotid artery (ICA)significant stenosis or occlusion diagnosed by CT angiography (CTA) or angio-MRI) undergoing urgent thrombectomy procedure Prestroke functional independence of 2 or less on the modified Rankin scale (ranging from 0 [no symptoms] to 6 [death]) Baseline score of at least 6 points on the National Institutes of Health Stroke Scale (NIHSS), which ranges from 0 to 42, with higher values indicating more severe deficit Evidence by imaging of a large ischemic core, as indicated by an Alberta Stroke Program Early Computed Tomography Score (ASPECTS) of less than 5 on computed tomography (CT) without the use of contrast material or a score of less than 4 on diffusion-weighted magnetic resonance imaging (MRI) (ASPECTS values range from 0 to 10, with higher values indicating less infarct burden). These cutoff values of the ischemic core have been selected in agreement with the treatment effect showed in the trial meta-analysis collaboration (Presented at the International Stroke Conference, Houston, 2017) Well-documented history of neuromuscular disorders, stroke or central nervous system tumors that could interfere in the SEPs assessment | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Rhizolysis Diagnosis of Facet Joint Origin Lumbago Patient suffering from chronic lower back pain developing for more than 6 months and resistant to the medical treatments Patients with an indication of lumbar rhizolysis for their chronic lower back pain with a facet component, the starting point of which corresponds to the L4L5 and/or L5S1 stages Patient not objecting to their participation in the study Subject registered with a social security scheme Adults under judicial protection Adult under guardianship or trusteeship Pregnant women Minors | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-85.0, NSTEMI - Non-ST Segment Elevation MI ACS - Acute Coronary Syndrome Acute onset (>1 hour) chest pain (or angina pectoris equivalent) suspected of non-ST-elevation myocardial infarction (NSTEMI) Hospital admission and scheduling for ICA Hs-cTn levels meeting the 'observe' (figure 2, p17) Age between 18 years years old Written informed consent Refractory angina or on-going severe ischemia requiring immediate ICA Patients requiring ICA < 24 hours after admission (see previous bullet) Hemodynamic instability and/or cardiogenic shock (mean arterial pressure <60 mmHg) Heart failure (Killip Class ≥ III) requiring intravenously medication (nitroglycerine, diuretics, etc.) ST-Elevation Myocardial Infarction (ST-elevation in 2 contiguous leads: ≥0.2mV in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads or new left bundle branch block) Symptoms highly suggestive of non-cardiac origin at presentation (as judged by the cardiac ED physician/cardiologist) Symptoms highly suggestive of AAD, PE, or acute peri-myocarditis Inability to organize ICA and CMR <72 hours after admission (especially for patients admitted on Friday evenings/nights (logistic restrictions) Life threatening arrhythmias prior to or during presentation (sustained ventricular tachycardia, repetitive non-sustained ventricular tachycardia, ventricular fibrillation, sinoatrial or atrio-ventricular block) Atrial fibrillation with persistent ventricular rate ≥100 beats per minute (bpm) after treatment | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-999.0, Stroke Subject has documented aortic valve stenosis and is treated with an approved TAVR device via transfemoral access Subject has the recommended artery diameter at the site of filter placement per the Sentinel® Cerebral Protection System Instructions For Use: 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery Subject (or legal representative) provides written informed consent Subject has arterial stenosis >70% in either the left common carotid artery or the brachiocephalic artery Subject's brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium Subject has compromised blood flow to the right upper extremity Subject has access vessels with excessive tortuosity Subject has uncorrected bleeding disorders Subject is contraindicated for anticoagulant and antiplatelet therapy | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 40.0-999.0, Ischemic Stroke Carotid Stenosis Carotid TIA (transient ischemic attack) it should, however, be focal and usually motor-sensory to implicate the carotid artery system or ischemic stroke involving carotid territory Asymptomatic patients with carotid stenosis or anterior circulation stenosis discovered accidentally during investigations for further risk factors Major functional impairment (Modified Rankin Scale >/= 3) Significant cognitive impairment Contraindication to acetylsalicylic or dual antiplatelet Renal dysfunction precluding safe contrast medium administration pregnancy or refusal Intracranial aneurysm or AVM Intra cerebral hemorrhage or hemorrhagic infarction | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Small-cell Lung Cancer confirmed histologically small cell lung cancer, confirmed by staging limited disease SCLC, complete or good response to local chemoradiotherapy, good performance status (ECOG/WHO=0-2), signed informed consent disseminated disease (ED-SCLC), contraindication to MRI, not able to perform cognitive function tests, poor PS (ECOG/WHO >2) | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 50.0-85.0, Diabetes Mellitus, Type 2 HbA1c higher than 6.8% or fasting blood sugar higher than 126mg/dL Conscious, mental and cognitively normal no obstacles in action can read, write and communicate with mandarin, taiwanese and hakka Inflammatory skin wounds on the neck, back, lower back or lower leg obstacles in communication People with disabilities, epilepsy, and other unacceptable warming treatments When the subject finds that he or she is unwell during the procedure, the experiment is terminated and take care by the medical staff | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-75.0, Coronary Artery Disease General 1. Age from 18 to 75 years old, man or non-pregnant woman. 2. Subjects with asymptomatic ischemic evidence, stable or unstable angina, or old myocardial infarction, are suitable for selective PCI. 3. Subjects without contraindications of coronary artery bypass grafting (CABG). 4. Subjects are able to understand the purpose of this study, volunteer to participate and sign informed consent. Angiographic 1. One or two de novo target lesions 1. If subject has only one target lesion, the second non-target lesion must be treated but the non-target lesion must be present in a different epicardial vessel; the non target lesion must be treated first and successfully prior to the subjects' register. 2. If there are two target lesions, they must be present in different epicardial vessels. 3. The definition of epicardial vessels means the left anterior descending artery (LAD), the left circumflex artery (LCX), and the right coronary artery (RCA) and their branches. Thus, for example, the subject must not have lesions requiring treatment in both the LAD and a branch. 2. Target lesion diameter stenosis is estimated visually ≥ 70% (or ≥ 50% with clinical evidence of myocardial ischemia), with TIMI flow grade ≥1; Target lesion length ≤24mm (visually); target lesion diameter between ≥2.5 mm to ≤ 4.00 mm. 3. Each target lesion must be covered completely by one scaffold General Any newly onset acute myocardial infarction within 1 week or, myocardial enzymes does not return to normal level after myocardial infarction. 2. Target vessel has been implanted with stents within 1 year before procedure. 3. Subjects with severe heart failure (≥ grade III NYHA) or left ventricular ejection fraction <35% (accessed by ultrasound or left ventricular angiography). 4. subject with severe kidney functional damaged before procedure: serum creatinine>2.0mg /dl (176.8μmol / L) or subject is receiving hemodialysis. 5. Subjects with high bleeding risk, with active gastrointestinal ulcers, history of cerebral hemorrhage or history of subarachnoid hemorrhage, history of ischemic stroke within the past six months, with contraindications of anti-platelet agents and anticoagulants, and subjects cannot receive antithrombolytic therapy. 6. subject is known hypersensitive or allergic to aspirin, clopidogrel, heparin, contrast agent, polylactic acid polymer and rapamycin. 7. The subject's life expectancy is less than 24 months. 8. Subjects is currently participating in other drug or medical device clinical trial that has not yet completed its primary endpoint . 9. Subjects have received any solid organ transplants or are ready to undergo organ transplant. 10. Subjects have unstable arrhythmia, such as high-risk ventricular premature beats, and ventricular tachycardia. 11. Subjects receive chemotherapy for tumor. 12. Subjects have received or planning to receive coronary or chest radiotherapy. 13. Subjects with Immunosuppressive, autoimmune diseases, have planned to receive or underwent immunosuppressive therapy. 14. Subjects have planned to receive or are receiving long-term anticoagulation therapy, such as heparin, warfarin and so on. 15. Subjects have planned to receive selective surgery within 6 months, which requires them to discontinue aspirin or clopidogrel. 16. Blood tests showed that the platelet count is less than 100 × 10^9 / L, or more than 700 × 10^9 / L, the white blood cells count is less than 3 × 10^9 /L. 17. subject with diagnosed or suspected liver cirrhosis. 18. Subjects with diffuse peripheral vascular disease, that precludes safe 6 French sheath insertion. Angiographic These apply to the target or non-target lesion(s), target or non-target vessel(s): 1. Target or non-target lesion(s) located in left main. 2. Subjects with triple vessel lesion in LAD, LCX or RCA, which all need to be treated. These apply to the target lesion(s) or target vessel(s): 1. Target lesion located in left main. 2. Target lesion located in the aorto-ostial of RCA (within 3 mm of the origin of the RCA). 3. Target lesion located within 3 mm of the origin of the LAD and LCX. 4. Lesion involving a bifurcation with a: 1. Side branch ≥ 2.5 mm in diameter, or 2. Side branch with diameter stenosis ≥ 50%, or 3. Side branch requiring protection guide wire, or 4. Side branch requiring pre-dilatation. 5. Anatomy proximal to or within the lesion that may affect delivery of the Bioheart, including: 1. Extreme angulation (≥ 90°) proximal to or within the target lesion, or 2. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion, or 3. Moderate or heavy calcification proximal to or within the target lesion. 6. Target lesion involves a myocardial bridge. 7. Target vessel contains thrombus as indicated in the angiographic images or IVUS. 8. Prior to the index procedure target vessel has been previously treated with a stent at any time such that the Bioheart stent would need to cross the stent to reach the target lesion. 9. Target vessel has been previously treated with a stent and the target lesion is within 5 mm proximal to a previously treated lesion. 10. Target lesion cannot meet the following outcomes, after the complete balloon pre-dilatation: 1. Residual (DS %) is < 40% (per visual estimation), ≤ 20% is strongly recommended; 2. TIMI Grade-3 flow (per visual estimation); 3. No angiographic complications (e.g., no-reflow, distal embolization, side branch closure) 4. No dissections NHLBI grade D-F; 5. No chest pain lasting > 5 minutes, and; 6. No ST depression or elevation lasting > 5 minutes | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-130.0, Stroke, Ischemic Cardiovascular Risk Factor Cardiovascular Diseases Cardiovascular Morbidity All patients with acute ischemic stroke registered in the Athens Stroke registry will be included in the analysis regardless of the underlying etiology or pathophysiologic mechanism Patients with intracranial haemorrhage or transient ischemic attack | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-45.0, Cannabis Ketamine 18 to approximately 45 years old 2. Good physical and mental health as determined by history, the Structured Clinical Interview for DSM-5 TR (SCID-NP) and collateral information, physical and laboratory examinations, ECG and vital signs. 3. Weight of 100 kg (220.46 lbs.) or less (inclusive) Unstable serious medical conditions. At the discretion of the investigator, subjects with unstable medical conditions that may necessitate changes in medical treatment and hence influence study outcomes will be excluded. 2. Uncontrolled hypertension, long QT syndrome, and seriously abnormal EKG results. EKG abnormalities will be reviewed by the PI and decisions will be made at the discretion of the PI. 3. A hearing deficit in greater than one band in an ear detected using a Welch-Allyn audioscope (500, 1000, 2000 and 4000 Hz threshold will be evaluated) 4. Positive pregnancy test | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 20.0-80.0, Carotid Artery Stenosis Carotid Artery Diseases Carotid Stenosis General 1. Male and non-pregnant female subjects whose age is ≥ 20 years and ≤ 80. 2. Patient is willing and capable of complying with all study protocol requirements, including the specified follow-up visits and can be contacted by telephone. 3. Patient or his/her authorized legal representative must sign a written informed consent form that has been approved by the local governing Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site. 4. Patient is diagnosed with carotid artery stenosis treatable with carotid artery stenting and is considered a high operative risk for CEA. 5. Patient is diagnosed with either: 1. Symptomatic carotid stenosis ≥ 50% as determined by angiography using methodology. Symptomatic is defined as ipsilateral transient monocular blindness: amaurosis fugax; ipsilateral carotid transient ischemic attack (TIA), with neurologic symptoms persisting less than 24 hours; or ipsilateral non-disabling stroke within 180 days of the procedure; or 2. Asymptomatic carotid stenosis ≥ 80% as determined by angiography using methodology. 6. Patient has a modified Rankin Scale score of ≤ 2 at the time of informed consent. 7. Patient is willing and able to take dual antiplatelet therapy for a minimum of 30 days. Angiographic 1. Target lesion located at the carotid bifurcation and/or proximal internal carotid artery (ICA). 2. Single de novo or restenotic (post carotid endarterectomy (CEA)) target lesion or severe tandem lesions that can be covered by a single Neuroguard stent. 3. Target lesion length is ≤ 20 mm (for 30 mm stents) or is ≤ 30 mm (for 40 mm stents) 4. Index vessel diameter (segment covered by the mid-portion of the stent) between 4.0 mm and 6.0 mm at the site of the target lesion. 5. Distal vessel diameter at the site of filter deployment is between 4.0 mm to 7.0 mm. 6. Distal common carotid artery diameter (segment covered by proximal portion of the stent) between 4.0 mm and 8.0 mm 7. Sufficient landing zone exists in the cervical internal carotid artery distal to the target lesion to allow for the safe and successful deployment of both the primary embolic protection filter and the Neuroguard integrated filter. High Risk for CEA Conditions For in the study, a patient must meet at least one significant anatomic or comorbid high risk conditions listed below. Patients at high risk for CEA are defined as having significant comorbidities and/or anatomic risk factors and would be poor candidates for carotid endarterectomy (CEA) in the opinion of a physician. High Anatomic Risk for CEA Conditions 1. Target lesion at or above C2 (level of jaw) or below the clavicle. 2. Inability to extend the head due to cervical arthritis or other cervical disorders. 3. History of radiation treatment to the neck or radical neck dissection 4. Prior head and neck surgery in the region of the carotid artery. 5. Spinal immobility of the neck. 6. Tracheostomy or tracheostoma. 7. Hostile neck or surgically inaccessible lesion 8. Laryngeal palsy or laryngectomy. 9. Severe tandem lesions (total length must be ≤ 30 mm and must be covered with one stent). 10. Occlusion of the contralateral CCA or ICA. 11. Severe bilateral ICA stenosis requiring treatment. High Co-morbid Risk Conditions for CEA 1. Patient is ≥ 70 years of age (maximum 80 years) at the time of enrollment. 2. NYHA Class III or IV congestive heart failure (CHF) 3. Chronic obstructive pulmonary disease (COPD) with FEV1 < 50 4. Left ventricular ejection fraction (LVEF) ≤ 35% 5. Unstable angina 6. History of recent MI (Between 14 days and 6 weeks prior to index the procedure) 7. Coronary artery disease with two or more vessels with ≥ 70% stenosis 8. Planned coronary artery bypass grafting (CABG) or valve replacement surgery between 31 days after CAS procedure 9. Peripheral vascular surgery or abdominal aortic aneurysm repair is required between 31 days following CAS procedure 10. Contralateral laryngeal nerve paralysis 11. Restenosis following a prior carotid endarterectomy (CEA) Life expectancy of less than one year, cancer with metastatic spread and/or undergoing active chemotherapy treatment, or currently requiring an organ transplantation. 2. An evolving, acute, or recent disabling stroke in the last 30 days. 3. Anticipated or potential sources of emboli including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area < 1.0 cm2), endocarditis, moderate to severe mitral stenosis, known previously symptomatic PFO, left atrial thrombus, any intracardiac mass or DVT or PE treated within the past 12 months. 4. History of paroxysmal atrial fibrillation that requires chronic anticoagulation 5. History of chronic atrial fibrillation. 6. Anticoagulation with Phenprocoumon (Marcumar®), warfarin, or a direct thrombin inhibitor, or anti-Xa agents. 7. Acute myocardial infarction < 14 days prior to index procedure. 8. Any major surgical procedure (i.e. intraabdominal or intrathoracic surgery or any surgery / interventional procedure involving cardiac or vascular system) 30 days prior to or following the index procedure. 9. History of major disabling stroke with substantial residual disability (modified Rankin score ≥ 3) 10. Known severe carotid stenosis or complete occlusion contralateral to the target lesion requiring treatment within 30 days of the index procedure. 11. Other neurological deficit not due to stroke that may confound the neurological assessments. 12. Dementia considered other than mild. 13. Known hypersensitivity to nitinol or its components (e.g. nickel, titanium). 14. History of intracranial hemorrhage within 90 days prior to the index procedure. 15. History of GI bleed within 30 days prior to the index procedure 16. Chronic renal insufficiency (serum creatinine ≥ 2.5 ml/dL or estimated GFR < 30 cc/min) 17. History of severe hepatic impairment, malignant hypertension, and/or is morbidly obese. 18. Known hypersensitivity to contrast media that cannot be adequately premedicated. 19. Hemoglobin (Hgb) < 8 gm/dL, platelet count < 100,000, INR > 1.5 (irreversible), or heparin-induced thrombocytopenia. 20. History or current indication of bleeding diathesis or coagulopathy including thrombocytopenia or an inability to receive heparin in amounts sufficient to maintain an activated clot time at > 250 seconds 21. Contraindication to standard of care study medications, including antiplatelet therapy or aspirin. 22. Currently enrolled in another interventional device or drug study that has not yet reached the primary endpoint. Angiographic Total occlusion of the target carotid artery. 2. Previously placed stent in the ipsilateral carotid artery. 3. Severe calcification or vascular tortuosity of the target vessel that may preclude the safe introduction of the sheath, guiding catheter, integrated EPD or stent. Severe vascular tortuosity is defined as 2 or more bends of 90 degrees or more within 4 cm of the target lesion. 4. Qualitative characteristics of stenosis and stenosis-length of carotid bifurcation (common carotid) and/or ipsilateral external carotid artery, that preclude the safe introduction of the sheath. 5. Angulation or tortuosity (≥ 90 degree) of the innominate and common carotid artery (CCA) that precludes safe, expeditious sheath placement or that will transmit a severe loop to the internal carotid after sheath placement. 6. Angiographic evidence of a mobile filling defect or fresh thrombus in the target carotid artery. 7. Presence of "string sign" of the target lesion (a tiny, long segment of contrast in the true lumen of the artery). 8. Non-atherosclerotic carotid stenosis (e.g. dissection, fibromuscular dysplasia) 9. Proximal/ostial CCA, innominate stenosis, or intracranial stenosis located distal to the target stenosis that is more severe that target stenosis. Excessive circumferential calcification of the target lesion is defined as > 3 mm of thickness of calcification seen in orthogonal views on fluoroscopy. 10. Patient in whom femoral access is not possible. Furthermore, occlusive or critical iliofemoral disease, including severe tortuosity or stenosis that requires additional endovascular procedures to facilitate aortic arch access or that prevents safe and expeditious femoral access to the aortic arch. 11. Arteriovenous malformations of the territory of the target carotid artery and cerebral vasculature. 12. Known mobile plaque or thrombus in the aortic arch. 13. Type III aortic arch. 14. Angiographic, CT, MR or ultrasound evidence of severe atherosclerosis, tortuosity or angulation of the aortic arch or origin of the innominate or common carotid arteries that would preclude safe passage of the sheath and other endovascular devices to the target artery as needed for carotid stenting | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Osteoarthritis, Hip Age 18 years or older 2. Body Mass Index (BMI) ≤ 35 kg/m2 3. Diagnosis of symptomatic osteoarthritic joint in the index joint (Kellgren-Lawrence grade I to III) to be treated with injection. 4. Failed conservative treatment for joint osteoarthritis. 5. NRS pain on walking ≥4 and ≤ 9 in index joint. 6. Subject must be willing to abstain from other treatments of the index joint for the duration of the study. 7. Subject is willing to discontinue all analgesics including NSAIDs, except acetaminophen/paracetamol, at least seven days before the treatment injection and through the completion of the study. 8. Subject is willing to use only acetaminophen/paracetamol (up to a maximum of 4.0 grams per day per the package insert) for the treatment of joint pain for the duration of the study. At least forty-eight hours prior to the Baseline Visit and each follow-up visit, the subject is willing to discontinue use of acetaminophen/paracetamol. 9. Subject is willing to maintain a stable dose of oral glucosamine and/or chondroitin sulfate products throughout the study, if taken prior to signing the informed consent form (ICF). 10. Able and willing to provide signed informed consent History of hypersensitivity to any of the ingredients in the hyaluronan 2. Infection or skin disease in the area of the injection site or index joint 3. NRS pain on walking > 3 in the contralateral joint 4. NRS pain on walking > 3 in the ipsilateral knee or ankle 5. Subject received an injection of Hyaluronic Acid (HA) and/or steroid in either joint within 6 months of signing the informed consent form (ICF). A subject will be excluded if they are planning to receive an HA or steroid injection (other than the study injection) in either joint during the course of this study. 6. Known inflammatory or autoimmune disorders (including rheumatoid arthritis, gout), or other pre-existing medical conditions that, in the opinion of the investigator, could impact treatment of the index joint or affect the ability of the subject to accurately complete the study questionnaires and comply with the study requirements. 7. Subject is taking medications at the time of signing the ICF which could interfere with the treatment procedure, healing and/or assessments. This includes but is not limited to oral or injectable anticoagulant treatments, anti-aggregant platelet treatment, chronic opioid analgesics. Low dose aspirin used for cardiovascular protection is allowed if a stable regimen is maintained for the duration of the study. 8. Subjects who had an oral, intramuscular, intravenous, rectal suppository or topical (excluded in index joint only) corticosteroid prior 30 days of signing the ICF are excluded. Topical corticosteroid use at any site other than the index joint is allowed. 9. Significant trauma to the index hip within 26 weeks of screening 10. Chronic use of narcotics or cannabis. 11. Ligament instability or tear in index joint. 12. Diagnosis of fibromyalgia 13. Diagnosis of osteonecrosis in index joint 14. Subject has significant varus or valgus deformity greater than 10 degrees in either knee. 15. Subject requires consistent use of an assistive device (e.g. wheelchair, walker, etc.) Occasional use of a cane is acceptable. 16. Uncontrolled diabetes with HbA1c of >7%. 17. Subject is a woman who is pregnant or breastfeeding at the Screening Visit or a woman of child bearing potential who refuses to use effective contraception during the course of the study. 18. Subject is receiving or in litigation for worker's compensation. 19. Otherwise determined by the investigator to be medically unsuitable for participation in this study | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-999.0, Spinal Stenosis Lumbar Disk Herniated Lumbar patients with low back pain and/or leg radicular pain under diagnoses as disc herniation or spinal stenosis allergy to local anesthetics or contrast medium, coagulopathy, local infection at the injection site, and systemic infection | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Diabetes Mellitus, Type 2 Veterans active VHA patients with type 2 diabetes have had at least 4 VA outpatient encounters in the previous year have a future appointment scheduled, and not be hospitalized or institutionalized or have participated in Aim 1 DD-TXT development must have access to their own or a cohabiting family member's cell phone or smartphone for participation. --must be willing and able to text, not have any visual impairment that would prevent them from reading or replying to text messages, and must be cognitively capable of consent to participate must also have HbA1c lab data (2+ values) for the 12 months prior to RCT recruitment must have inadequate glycemic control for at least 50% of the 6 months before enrollment -Non-Veterans | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-18.0, Traumatic Brain Injury Brain Injuries Brain Injury, Vascular Ages 28 days-18 years admitted to the PICU at Children's Medical Center Dallas Acute presentation (< 24 hour) onset of neurologic injury Acute neurologic injury can be due to any of the following mechanisms Severe accidental or abusive traumatic brain injury Severe encephalopathy secondary to cardiac arrest Spontaneous intracranial hemorrhage Status epilepticus Stroke Presence of or pending placement of invasive indwelling arterial line for stand medical care Any patient with an ICP monitor placed as standard of care Patients without an arterial line placed as standard of care Patients unable to cooperate with wearing a TCD headpiece device Expected death within 24-48 hours Inability to place NIRS probes or insonate TCD signal due to massive facial or cranial injury Receiving an inhalational anesthetic agent Hemoglobinopathy, myoglobinemia or and hyperbilirubinemia (due to inaccurate NIRS readings) | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Syncope Diagnosis of vasovagal syncope with positive TILT TEST and recurrent episodes (≥2 episode within 6 months) Signed Free and Informed Consent Form Severe comorbidity with life expectancy <1 year Age <18 years Current psychotherapeutic follow-up Cardiac or neurological syncope Pregnancy | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-85.0, Carotid Stenosis Carotid Artery Diseases patients with stenosis of ICA 70-99% (ultrasound and CT angiography) patients with a extensive lesion of the ICA (plaque < 2 cm) by ultrasound and CT angiography patients with a extensive lesion of the ICA (plaque < 2 cm) patients with a contralateral occlusion of the ICA patients with stroke in ischemic type in the acute period | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Stroke, Ischemic Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment or the treatment is contraindicated (e.g., subject presents beyond recommended time from symptom onset), or where patient has received IV thrombolytic therapy without clinical improvement. 2. No significant pre-stroke functional disability (mRS ≤2) 3. Baseline NIHSS score obtained prior to randomization must be equal or higher than 8 points (assessed within one hour prior to qualifying imaging) 4. Age ≥18 years (no upper age limit) 5. Occlusion (TICI 0-1) of the intracranial ICA (distal ICA or T occlusions) and/or MCA-M1 segment suitable for endovascular treatment, as evidenced by CTA, MRA or angiogram, with or without concomitant cervical carotid occlusion or stenosis. 6. The presence of Age-Adjusted modified Clinical Mismatch (mCAM) defined as 5-10 and one of the following 1. NIHSS ≥ 8 and >50% involvement in 0-1 Cortical (e.g. M1-6) areas (any age); 2. NIHSS ≥ 8 and >50% involvement in 0-2 Cortical (e.g. M1-6) areas (and age < 80 years old); 3. NIHSS ≥ 15 and >50% involvement in 0-3 Cortical (e.g. M1-6) areas (and age < 80 years old). 7. Patient treatable within 6-24 hours of symptom onset. Symptoms onset is defined as point in time the patient was last seen well (at baseline). Treatment start is defined as arterial puncture. 8. Informed consent obtained from patient or acceptable patient surrogate -Clinical 1. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0 2. Baseline platelet count < 30.000/µL 3. Baseline blood glucose of < 50mg/dL 4. Severe, sustained hypertension (SBP > 185 mm Hg or DBP > 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using AHA guidelines recommended medication (including iv antihypertensive drips), the patient can be enrolled. 5. Patients in coma defined as totally unresponsive; responding only with reflexes or being areflexic (Intubated patients for transfer could be randomized only in case an NIHSS is obtained by a neurologist prior transportation). 6. Seizures at stroke onset which would preclude obtaining a baseline NIHSS 7. Serious, advanced, or terminal illness with anticipated life expectancy of less than one year. 8. History of life-threatening allergy (more than rash) to contrast medium 9. Subjects who has received IV t-PA treatment beyond 4.5 hours from the beginning of the symptoms 10. Woman of childbearing potential who is known to be pregnant or who has a positive pregnancy test on admission. 11. Subject participating in a study involving an investigational drug or device that would impact this study. 12. Cerebral vasculitis 13. Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, mRS score at baseline must be ≤2. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.) 14. Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas) Neuroimaging 15. Hypodensity on CT or restricted diffusion on MRI amounting to an score of <5. 16. Complete involvement of more than 3 cortical areas (e.g. M1, M2, M3, M4, M5, or M6). 17. Complete absence of leptomeningeal collaterals on CT angiography (e.g. Malignant CTA pattern or score 0). 18. CT or MR evidence of hemorrhage (the presence of GRE microbleeds is allowed). 19. Significant mass effect with midline shift. 20. Evidence of ipsilateral carotid occlusion, high grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery that cannot be treated or will prevent access to the intracranial clot or excessive tortuosity of cervical vessels precluding device delivery/deployment 21. Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation) 22. Evidence of intracranial tumor (except small meningioma) | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Stroke, Acute Carotid Stenosis Carotid Artery Diseases Acute ischemic anterior circulation stroke eligible for endovascular therapy according to local guidelines, with or without prior intravenous thrombolysis Occlusion of the carotid terminus, M1 or M2 segments of the middle cerebral artery (MCA) A neurological deficit judged to be disabling by the patient and/or treating physician Any acute imaging judged by the treating physician to demonstrate salvageable brain tissue possibly amenable to EVT Groin puncture within 24-hours of onset or last known normal Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion of presumed atherosclerotic etiology on initial non-invasive vascular imaging Informed consent from patient or surrogate or deferral of consent, according to local ethics policies Pre-existing neurological impairment (modified Rankin score ≥3) Any underlying disease or condition making protocol adherence and/or 3-month follow-up unlikely Any known contra-indication to EVT, angioplasty/stenting, or antiplatelet therapy Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion NOT confirmed on conventional angiography Ipsilateral ICA stenosis or occlusion attributable to clinically or radiologically confirmed arterial dissection Isolated cervical carotid occlusion without intracranial occlusion Pregnancy | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Carotid Artery Diseases General Patient > 18 years old qualified by NeuroVascular Team for carotid revascularization according to local standards of care Signed informed consent Agreement (routin un this group of patients) to clinical and ultrasonographis follow up. Angiographic De-novo atherosclerotic lesions or neo-atherosclerosis Symptomatic patients (history of transient ischemic attack, ischaemic stroke or amaurosis fugax within 6 months from index procedure) with index artery stenosis ≥50% assessed in angiography with method or Asymptomatic patients with index artery stenosis ≥70-80% assessed in angiography with method General Lack of NeuroVascular Team agreement on carotid revascularization indication Lack of signed informed consent Estimated life expectancy less than 1 year Chronic renal failure with serum creatinine level > 3.0 mg/dL Myocardial Infarction within 72 hours prior to index procedure Pregnant women Diagnosed coagulopathies History of contrast media allergy, not reacting to pharmacotherapy Angiographic Index lesion occlusion Common carotid artery stent protruding to aortic arch | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 14.0-100.0, Takayasu Arteritis Methotrexate Inhibition Treatment age≥14 years; 2. active status: Kerr score≥ 2; 3. mild and moderate: 1. Blood pressure (maximum) < 180/110mmHg; 2. 1-2 branches with the stenotic rate < 70% involved; 3. mildly ischemic manifestation relative to activity but relieve after rest; 4. no or low degree of organ insufficiency: NYHF I~II; eGFR (MRDR) ≥ 60ml/min Severe organ insufficiency; 2. Acute or chronic active infections including tuberculosis, hepatitis virus, etc.; 3. Other autoimmune diseases including systemic lupus erythematosus, Behcet disease, IgG4 relative disease; 4. malignant tumors; 5. history of severe drug allergy; 6. successive twice relapse occurs even after the intervention adjustment ( for the benefits of patients) | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 14.0-100.0, Takayasu Arteritis Tocilizumab Adalimumab Treatment age≥14 years old; 2. active: Kerr score≥ 2; 3. severe: 1. Blood pressure > 180/110mmHg; 2. ≥ 3 branches with the stenotic rate > 70% involved; 3. high degree of organ insufficiency: NYHF III~IV; eGFR (MRDR) 15~ 60ml/min Severe organ insufficiency; 2. Acute or chronic active infections including tuberculosis, hepatitis virus, etc.; 3. Other autoimmune diseases including systemic lupus erythematosus, Behcet disease, IgG4 relative disease; 4. malignant tumors; 5. history of severe drug allergy; 6. successive twice relapse occurs even after the intervention adjustment ( for the benefits of patients) | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-98.0, Atherosclerosis of Artery subjects who underwent cerebral angiography at Guangdong Provincial Hospital of Chinese Medicine from April 2020 to December 2021 2. subjects who voluntarily participated in this study and provided informed consent intracranial and extracranial artery stenosis caused by vascular inflammation, systemic connective tissue disease, and muscle fibre structure hypoplasia 2. inability to cooperate with the investigation 3. intracranial aneurysm and cerebral arteriovenous malformation confirmed by cerebral angiography 4. receipt of periodontal treatment in the previous 24 months | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Right-sided Colon Cancer Right-sided Colon Adenoma for track 1 and 2a Male and female patients above 18 years of age with either: right-sided colon cancer tumor with adenocarcinoma histologically verified scheduled for open or laparoscopic resection at the Department of Surgery, Herlev Hospital or Zealand University Hospital for track 1. Right-sided adenomas ≥2cm in diameter endoscopically verified scheduled for endoscopic mucosal resection at the Department of Surgery, Herlev Hospital or Zealand University Hospital for track 2a ASA I,II or III The caecum must be reached by the endoscope. for retrospective controls (track 2b): Male and female patients above 18 years of age who were operated for colon adenoma ≥2cm in diameter in the right hemicolon in 2018 at Department of Surgery, Zealand University Hospital. They will be matched 2:1 with the patients included in track 2a (cases) based on age and gender and pathology of the tumor for track 1 and track 2a 1. Patients with previous allergic reaction to fosfomycin and/or metronidazole 2. Patients under current antibiotic treatment or patient who had the last dose of antibiotics 30 days prior to inclusion. 3. Patients with a non-passable tumor or patients where a part of the tumor is not visible during endoscopy (Track 1) 4. Patients with neoadjuvant chemotherapy or radiation 12 months prior to the resection. 5. Patients with a history of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC) 6. Patients with a history of inflammatory bowel disease (IBD) 7. Patients under current treatment with warfarin (Marevan) and phenprocoumon (Marcoumar), or NOAK such as dabigatran (Pradaxa®), rivaroxiban (Xarelto®), edoxaban (Lixiana®) or apixaban (Eliquis®) 8. Patients under current treatment with Fenemal (Phenobarbital) 9. Patients who previously have received a fecal transplantation 10. Patients who have previously had colorectal cancer, and are now presenting with a secondary colon tumor. 11. Patients with a current alcohol use disorder (AUD): defined as a patient who are currently drinking 8 or more drinks/week for women and 15 or more drinks/week for men. 12. Predictable poor compliance (psychiatric disease, not speaking fluent Danish, mentally, impaired etc) 13. Patients with an American Society of Anaesthesiologists physical status 14. Classification (ASAscore) of IV. 15. Patients unable to be sedated 16. Pregnancy or lactation (fertile women must have a negative serum or urine pregnancy test to participate) 17. Fertile women who do not use safe contraception during the study period 18. Following contraceptive methods are acceptable when used consistently and in accordance, with both the product label and the instructions of the physician are Oral contraceptive, either combined or progestogen alone Injectable progestogen Implants of levonorgestrel Estrogenic vaginal ring Percutaneous contraceptive patches Intrauterine device or intrauterine system with a documented failure rate < 1% per year Male partner sterilization (vasectomy with documented azoospermia) prior to female patient ́s entry into the study, and this male is the sole partner for that patient Double barrier method: condom with spermicidal agent (foam/gel/film/cream/suppository), condom and occlusive cap (diaphragm or cervical/vault cap) with vaginal spermicidal agent (foam/gel/film/cream/suppository) for retrospective controls (track 2b) | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 16.0-999.0, Diabetic Polyneuropathy Diabetes Mellitus, Type 2 Patient's agreement to participate Diabetic peripheral neuropathy Causes of neuropathy other than diabetes Severe renal disease Recent treatment for cancer or haematological malignancies Presence of foot ulcers Peripheral arterial disease Use of agents in the previous 3 months that could interfere with the interpretation of results, such as opiates, vitamin B compounds or antioxidants Pregnancy Lactation | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-100.0, Carotid Stenosis Clinical diagnosis of carotid artery stenosis Age-gender-race-matched controls age <18 years intraocular pressure (IOP) >21 mmHg VA >logMAR 1.0 spherical equivalent (SE) between >1.00 or < -6.00 D other serious eye diseases which may affect OCTA results including diabetic retinopathy, hypertensive retinopathy, retinal vascular occlusion, age-related macular degeneration, and uveitis major intraocular surgery performed in the past 6 months or a history of laser photocoagulation or intravitreal injection glaucoma or first-degree relatives with a history of glaucoma; and any disease that might cause poor scan quality (image quality <6) | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Multifocal Motor Neuropathy (MMN) Chronic Inflammatory Demyelinating Polyradiculoneuropathy Adult patients with CIDP or MMN who are starting Intravenous immunoglobulin in the Walton Centre Informed consent Previous Intravenous immunoglobulin use in the last year Age under 18 Lack of mental capacity to consent to treatment or to study participation Concurrent treatment with steroids or other immunosuppressants | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 21.0-89.0, Coronary Artery Disease Hypertension Hyperlipidemias Peripheral Vascular Diseases Cerebral Arterial Diseases Have at least one of the following conditions Hypertension Hyperlipidemia Diabetes mellitus (Type 1 or Type 2) Peripheral vascular disease Cerebrovascular disease Cardiovascular disease Unstable angina or myocardial infarction by history, ECG, and/or enzymatic within 1 month of enrollment LV dysfunction as defined by an LV ejection fraction documented as < 45% within 1 year of enrollment by an echocardiogram, MRI, or nuclear imaging. Uncontrolled hypertension with blood pressure greater than 170/100 mmHg at the screening visit Known history of chronic renal insufficiency, liver dysfunction, or cancer besides non-melanoma skin carcinomas or localized prostate cancer requiring systemic treatment within five years of enrollment Known history of cognitive impairment or inability to follow study procedures Patient with an implanted defibrillator or permanent pacemaker on which the potential participant is known to rely upon for greater than 50% of ventricular depolarizations Patients who received probiotics, prebiotics, and antibiotics in the last 12 weeks Patients with dosing changes of vasoactive medications and HMG-CoA reductase inhibitors in the 6 weeks prior to enrollment Pregnancy Patients who are currently taking Vitamin K antagonists such as coumadin, warfarin Those who are daily drinkers | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-80.0, Hemiplegia Following Ischemic Stroke Adult subjects (18 years<male or female≤80 years ) 2. Ischemic stroke diagnosed by MRI within 1 month before randomization 3. Unilateral upper limb dysfunction with NIHSS score 1-3 at the time of randomization 4. Informed consent signed Unable to understand or cooperate because of severe aphasia or cognitive impairment (CDR >0.5) or mental illness 2. A history of epilepsy 3. Sensory disorders or hallucinations 4. Internal carotid artery dissection or thrombolysis 5. Apraxia 6. Agnosia 7. Other diseases that may interfere with motor function 8. Severe cardiopulmonary disease, severe illness, and unstable vital signs 9. Severe balance dysfunction 10. Participating in other clinical trial 11. During pregnancy and lactation 12. The Numerical Rating Scale (NRS) scores of upper extremities>4 | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 30.0-80.0, Stroke, Ischemic Patients age between 30-80 years. 2. Symptomatic ICAS: presented with TIA or stroke, attributed to 70%-99% stenosis of a major intracranial artery: Internal carotid artery (ICA), middle cerebral artery (MCA) [M1segment], vertebral artery (VA), or basilar artery (BA). 3. Patient with recurrent TIA or stroke despite medical therapy, including anti-coagulation or antiplatelet and control of all vascular risk factors (DM, HTN and Hyperlipidemia) Patients previously stented at the target lesion or had extracranial stenosis. 2. Patient with acute stroke (within two weeks from the onset). 3. Complete occlusion of the artery on the imaging assessment. 4. Massive cerebral infarction (more than half the MCA territory), intracranial hemorrhage, epidural or subdural hemorrhage, and intracranial brain tumor on CT or MRI scans. 5. Contraindications to antithrombotic and/or anticoagulant therapies | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 2.0-999.0, Immunodeficiency Aged greater than or equal to 2 years. 2. Meets 1 of the following a. Patient with a suspected or known/molecularly defined but incompletely characterized immune disorder (as determined by a referring NIH study staff member) AND meeting at least one of the following: i. within 1 year of screening, abnormal immune function demonstrated by at least one laboratory test result outside the normal range ii. history of severe or atypical infection, immune dysregulation (defined as autoimmunity, lymphoproliferation, or HLH), or autoinflammatory symptoms (defined as episodic fever often associated with dermatitis, gastrointestinal symptoms, and arthropathy). b. Biological unaffected relative of an individual meeting criterion 2a but who does not meet criterion 2a himself/herself. Unaffected relatives may be mother, father, siblings, children, grandparents, aunts, uncles, or first cousins to the individual. 3. Willing to allow storage of samples and data for future research. 4. For patients, currently or previously enrolled on an NIH protocol that performs WES or WGS and that allows sharing of sequence data. 5. For unaffected relatives, able to provide informed consent Individuals meeting any of the following will be excluded from study participation: 1. History of secondary causes of immunodeficiency or dysregulation (e.g., HIV infection, immunodeficiency from chronic use of immunosuppressive or chemotherapeutic agents), at the discretion of the investigator. 2. Pregnancy. 3. Any condition that, in the opinion of the investigator, contraindicates participation in this study | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Heart Failure Patients with HF defined by Framingham diagnostic criteria Stage C or D of the ACCF / AHA classification Full capacity to decide Signing of informed consent Cognitive impairment, measured by Mini-Mental Status Examination (< 27) Presence of another disease other than HF that may severely affect the quality of life: stroke with significant residual deficit, end-stage renal failure, Child C cirrhosis, extreme obesity, haemoglobin <8 g / dl, advanced peripheral artery disease (stage III-IV), severe thyroid or adrenal disease, neoplastic with estimated survival of less than 2 years Patients who do not sign the informed consent | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 35.0-75.0, Atherosclerotic Heart Disease With Angina Nos Patients aged from 35 to 75 years old, male or female. 2. Those who were hospitalized between September 1, 2014 and September 1, 2019. 3. Patients with Coronary heart disease angina pectoris and have undergone coronary angiography in the inpatient department of cardiovascular internal medicine. 4. The diagnosis of hypercholesterolemia, Coronary heart disease angina pectoris and hypertension is accorded with the diagnostic criteria Those with other cardiac diseases, gastroesophageal reflux disease or hiatal hernia, neurosis, spinal or vertebral artery cervical spondylosis, hyperthyroidism, climacteric syndrome, etc. 2. Those with myocarditis, cardiomyopathy, acute myocardial infarction, third degree of heart failure, severe heart valve disease, major diseases such as malignant tumor and serious metabolic diseases, liver failure or renal failure. 3. Those with psychotic disorders, or cognitive dysfunction. 4. Those of childbearing age and have fertility requirements, or pregnant women or lactating women. 5. Those allergic to iodine contrast medium. 6. Those who are not suitable for the study, as judged by the researcher | 1 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.