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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 Stenosis Valvular Heart Disease Transcatheter Aortic Valve Replacement At least 18 years old Be willing and able to provide informed consent to participate in the study Not share Watch, phone with anyone else Patient has severe aortic stenosis with echocardiographically derived mean gradient > 40mmHg or maximum velocity greater than 4.0 m/s or an initial aortic valve area of < 1.0 cm2 Patient who undergoing elective transfemoral transcatheter aortic valve replacement Severe complications of TAVR, such as death, and conversion to SAVR Life expectancy is less than 12 months due to non-heart disease (such as cancer, chronic liver disease, chronic kidney disease, or chronic end-stage lung disease, etc.) Severe dementia (cannot sign research informed consent, cannot take care of themselves or complete the study visit) The investigator believes that the patient is not suitable to participate in the study or complete the follow-up prescribed by the protocol from other medical, social and psychological aspects The patient is currently participating in another randomized 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): 18.0-85.0, Neuropathic Pain Informed Consent as documented by signature Male or female participants (if female: post-menopausal or surgically sterile, or using a highly effective method of contraception) Between 18 and 85 years of age Body mass index between 18 and 30 (kg/m2) Patients diagnosed with small fiber neuropathy OR suffering from peripheral neuropathic pain related to diabetic peripheral neuropathy; post-herpetic neuralgia; HIV-associated neuropathic pain; post-traumatic/postoperative peripheral neuropathy; chemotherapy associated peripheral neuropathy or radicular low back pain with sensory deficit AND who presented insufficient response to at least one attempt with one of the currently recommended pharmacological treatment for neuropathic pain taken at efficacious dose OR who have interrupted treatment because of tolerance issue OR who have previously declined pharmacological pain management Pain duration for at least 3 months Preceding week pain recall score ≥ 4 on NRS Scale Score ≥ 4 on DN4 questionnaire Willing to withdraw from prohibited medications Poor-metabolizers (PM) for CYP2C19 are only eligible for Sequence 3 Contraindications to benzodiazepines.(including known hypersensitivity reaction) Women who are pregnant or breast feeding or who intend on becoming pregnant during the course of the study Woman of childbearing potential, not using and not willing to continue using a highly effective method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases Abnormal ASAT or ALAT plasma levels (> 3x ULN) Reduced renal function (GFR < 60 mL/min/1.73m2) Changes in existing (or addition of new) concomitant interventional pain management (including local anaesthetic infiltration, local nerve block, central neurostimulation therapy) and other non-pharmacological intervention such as desensitization techniques, acupuncture, transcutaneous electrostimulation, hypnosis Co-existing nociceptive or inflammatory aetiology to the current pain symptoms Unable to withdraw from prohibited medications before randomization Epilepsy History of drug, alcohol or substance abuse in the past 5 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): 65.0-999.0, Diabetes Mellitus, Type 2 Gait Disorders, Neurologic willingness to participate in the study age over 65 diagnosed type 2 diabetes, subjected to pharmacological treatment (study group) no type 2 diabetes (control group) unwillingness to participate in the study age below 65 years surgical intervention in the lower limbs or spine during the last 6 months symptoms of osteoarthritis or pain of another origin around the lower limbs or spine rheumatic diseases (eg. rheumatoid arthritis, ankylosing spondylitis) diagnosed neuromuscular disease strongly manifested imbalances due to impairment of central or peripheral nervous system neurological disorders with dizziness, nystagmus, dermatologic or profound (cerebrospinal syndrome, dizziness, multiple sclerosis, Parkinson's disease, etc.) | 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): 20.0-999.0, Virtual Reality If all of the following conditions are met A person with chronic low back pain that lasts more than 3 months due to spinal stenosis or lumbar disc disease Adults over 20 Those who decided to participate out of his/her own free will and signed in written consent If the patient meets one or more of the following He or She cannot participate this clinical trial In case of contraindication to general lumbar catheterization (e.g. coatulopathy, infection, etc) Hearing and vision impairments Affective disorder History of epilepsy or seizure If communication is not possible due to impaired cognitive ability Those who have been deemed inappropriate by the researchers | 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, Urothelial Cancer Ability to understand the purpose of the study, provide signed and dated informed consent, and able to comply with all procedures Male or female patients aged greater than or equal to 18 years of age at time of consent Patients with histologically confirmed diagnosis of urothelial carcinoma of the urinary tract, including the renal pelvis, ureter, bladder, or urethra. Differentiation with variant histologies (e.g. squamous cell differentiated) will be permitted. Mixed histologies are required to have a dominant urothelial/transitional cell pattern Patients must have metastatic disease defined as new or progressive lesions on cross- sectional imaging. Radiological evaluation should occur within 21 days prior to enrollment Patient must have evaluable and measurable disease, per 1.1 Patients may have been previously treated with prior cytotoxic chemotherapy regimen or targeted agent. Patients may have received any number of prior cytotoxic agents Patients may have had prior immunomodulating therapy including therapy targeting the PD-1/PDL-1 axis (cohort 2A and B) but excluding prior treatment with M7824 Pre-treatment tissue biopsy and/or archival tissue availability for PD-L1 expression testing is mandatory for enrollment Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 Required laboratory values reflective of organ function are listed below History of allergic reactions attributed to compounds of similar chemical or biologic composition to M7824 investigational agents used in the study Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Symptomatic central nervous system metastasis Pregnant women are excluded from this study because M7824 is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M7824, breastfeeding should be discontinued if the mother is treated with these agents Patients with any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required treatment with either systemic corticosteroids (>10 mg daily prednisone equivalent) or immunosuppressive medications. Inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease Patients with prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast or low risk Gleason 6 prostate cancer Patients having tumor lesion(s) in the liver or chest which are 10 cm or larger Patients previously treated with M7824 Patients previously treated with PD-1/PD-L1 checkpoint inhibitors (for Cohorts 1A and 1B only) | 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, Bladder Cancer Invasive Bladder Cancer Histologically confirmed urinary BC planned to be treated with RC with or without neoadjuvant chemotherapy. 2. Histologically confirmed urinary BC planned to be treated with palliative cystectomy 2) Signed informed consent 3) Patient age >18 years RC for other reasons than BC 2. Other forms of surgical treatment of BC than RC (e.g. bladder resection). 3. Patient unwillingness to participate in the study for any reason (i.e. lack of signed 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): 40.0-999.0, Chronic Obstructive Pulmonary Disease Diagnosed COPD patients of Age 40 and above (Razzaq et al., 2018) COPD grade 2 and 3 according to GOLD classification (Berry et al., 2018) (Goldcopd.org, 2019) COPD patient both male and female Individuals with either fractures of ribs or upper limb Pulmonary Effusion Pulmonary Edema Embolism Pneumothorax Hemothorax | 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 Owns or has access to a smartphone Newly diagnosed moderate to severe heart failure (NYHA II-IV and left ventricular ejection fraction ≤ 40%) Earlier atrial fibrillation/atrial flutter with indication for oral anticoagulant (OAC) treatment Pacemaker Cardiac resynchronization device Indications for OAC treatment (also low molecular weight heparin) due to atrial arrhythmias, mechanical heart valve, deep vein thrombosis, or pulmonary embolism Expected survival ≤ 6 months Absolute contraindications for starting OAC 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): 18.0-999.0, Back Pain Age greater than or equal to 18 years of age at day of enrollment. 2. Clinical diagnosis of refractory low back pain for >3 months. 3. Magnetic resonance imaging pathology consistent with clinical symptoms/signs at one or two levels. 4. Back pain of at least 4/10 or higher using the Numerical Rating Scale (NRS). 5. Pain duration of more than 12 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care) for 2 months Refusal to participate, provide consent, or provide follow-up information for the 24-month duration of the study. 2. Contraindications to medial branch targeted PNS (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to iodinated contrast, penicillin or clindamycin and pregnancy or breastfeeding). 3. More than 2 levels of clinical proven pain. 4. Active moderate to severe lumbar radiculopathy. 5. Intradural disc herniation. 6. Spinal fracture of posterior elements within the past 6 months. 7. Steroid injection in the spine within the last 30 days. 8. Any intradiscal injection other than contrast dye or anesthetic in the last 30 days. 9. Prior fusion at level considered to be the source of the pain. 10. Prior lumbar spine surgery within the last 6 months. 11. AP diameter of spinal canal less than or equal to 9mm at level to be treated. 12. Severe uncontrolled medical condition. 13. Severe psychological illness. 14. History of Inflammatory arthritis. 15. Malignancy within past 5 years except basal cell or squamous cell skin cancer. 16. Current use of equal to greater than 45mg morphine-equivalent per day of opioid use. 17. A history of alcohol or drug abuse within past 5 years. 18. Use of any investigational drug within past 30 days. 19. Severe anaphylactic/anaphylactoid reaction to any medications used. 20. Pending litigation involving subject's back pain. 21. No insurance coverage for any subsequent tests or procedures. 22. Inability or unwillingness to continue rehabilitation protocols | 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): 1.0-30.0, Down Syndrome Recurrent B Acute Lymphoblastic Leukemia Patients must be >= 1 and < 31 years at time of enrollment Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories Isolated bone marrow relapse Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes Patients with Down syndrome (DS) are eligible in the following categories Isolated bone marrow relapse Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Patients with B-lymphoblastic lymphoma (B-LLy) Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia Patients with Philadelphia chromosome positive (Ph+) B-ALL Patients with mixed phenotype acute leukemia (MPAL) Patients with known Charcot-Marie-Tooth disease Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype Patients with active, uncontrolled infection defined as Positive bacterial blood culture within 48 hours of study enrollment Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed as long as blood cultures are negative for > 48 hours | 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, Acute Ischemic Stroke General to 80 years of age Presenting with symptoms consistent with an AIS Pre-stroke mRS score 0-1 NIHSS score 6-30 at the time of randomization Ability to randomize within 24 hours of stroke onset Ability to obtain signed informed consent Specific Neuroimaging Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1) segment Imaging evidence of moderate-large infarct defined by either NCCT (ASPECTS: 3-5) advanced perfusion imaging ([rCBF<30%] on CTP or [ADC<620] on MRI: 70-100cc) (>6h/ <6h and 0-2) or both General Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test Known severe allergy (more than a rash) to contrast media uncontrolled by medications Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg) Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >1.7 or Partial Thromboplastin Time (APTT) >35s; baseline platelet count <100X10^9/L Biopsy of parenchymatous organs with 1 month Active bleeding within 1 month (such as gastrointestinal or urinary hemorrhage) Known severe renal failure (GFR <30ml/min or Scr>220mmol/L（2.5mg/dl）) or under the treatment of hematodialysis or peritoneal dialysis Life expectancy less than 1 year prior to stroke onset (combined with malignant tumor, severe heart failure) All-cause acute intracranial hemorrhage or intracranial tumors with mass effect | 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): 45.0-75.0, Glucose Metabolism Disorders BMI 25.0-34.9 kg/m² Prediabetes defined as a 2-h oral glucose tolerance test plasma glucose of 140-199 mg/dL with or without a fasting plasma glucose of 100-125 mg/dL, or HbA1C ≥5.7 Women who are still having menses Persons who take niacin, nicotinamide, or other vitamin B3-related supplementation and are not willing to discontinue supplementation for 3 weeks before medical screening and during the entire study period Persons who consume moderate-large amounts of caffeine daily (>2 cups of coffee or 8 oz caffeinated drinks per day) or consume less amounts of caffeine but believe withdrawal symptoms (e.g. headache) are likely if caffeine is stopped Unstable weight (>3% change during the last 2 months before entering 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): 18.0-99.0, Ischemic Stroke Adult patients, ≥ 18 years of age History of ischemic stroke, defined as an episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction (American Heart Association definition) Large vessel atherosclerosis of an intracranial artery in the circle of Willis with 50-99% stenosis by WASID (percent stenosis = (1-[diameter stenosis/diameter normal]) x 100%) on MRA, CTA or DSA ----- Eligible arteries: vertebral (V4), basilar, PCA (P1, P2), MCA (M1, M2), tICA, ACA (A1) Current statin use or contraindication to statin Fasting LDL-C ≥ 70 mg/dL or LDL-C ≥ 60 mg/dL if lipoprotein (a) > 30 mg/ dL Gadolinium or PCSK9 inhibitor allergy Acute or chronic kidney disease with eGFR<30 ml/min/1.73m2 Pacemaker or other MRI contraindications per American College of Radiology guidelines Inability to return for 78 week follow-up clinic visit and vwMRI | 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 Age between 18-75 years old 2. First-ever acute ischemic stroke of anterior circulation system (anterior cerebral artery or middle cerebral artery territory) 3. Stroke onset from 2-10 days 4. Having a stable medical condition 5. Alert of consciousness 6. Able to follow commands 7. Modified Rankin Scale (mRS) ≤ 4 Hemorrhagic stroke 2. Recurrent stroke 3. Presence of other neurological disorders such as unilateral neglect 4. Presence of metal implantation, intracranial shunt, cochlear implantation or cardiac pacemakers 5. Presence of opened wound or infectious wound around scalp 6. History of epilepsy or any neurological antecedent or unstable condition which can lead to seizure 7. Body Mass Index (BMI) > 30 kg/m2 8. Received hormonal treatment 9. Ischemic heart disease and peripheral vascular ischemia 10. Last stage of kidney disease and liver disease | 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): 45.0-999.0, HIV Infections HIV-infected patients >= 45 years with 2 or more CV risk factors currently on ART HIV-RNA < 50 copies >= 12 months (one blip allowed) Asymptomatic regarding cardiac symptoms (chest pain, syncope, dyspnea) Stable ART for more than 6 months Sign of coronary pathology (chest pain, syncope, dyspnea) ATCD of allergy to IV contrast agents Chronic inflammatory disease other than HIV Subject to a measure for the protection of justice | 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 Bypass Surgery Prior CABG-operation Age>18 years Indication for coronary angiography Informed consent STEMI very high risk or high risk (GRACE score >140, dynamic new ST/T ECG changes) Hemodynamic instability High probability of patient's non-compliance with the study's procedures Severe kidney disease with GFR<30 mL/min/1.73m2 Known allergic reaction to contrast Uncontrolled Arrhythmias (mostly afib) with heart rate over 80 bpm or frequent ectopic beats which could affect the ECG-gated cCTA protocol BMI>40 | 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, Elbow Fracture Elbow Arthropathy Elbow Osteoarthritis Total elbow arthroplasty, all indication combined Less than 24 months of follow up Revision of total elbow arthroplasty | 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, Osteoarthritis, Knee Osteoarthritis, Hip Heart Failure Coronary Heart Disease Hypertension Type2 Diabetes Chronic Obstructive Pulmonary Disease Depression At least two of the following conditions: OA (knee or hip), COPD, heart condition (HF or CHD), hypertension, T2DM, depression (having other comorbidities does not a patient) Adults aged 18 years or above Able to walk 3 meters without any assistance A score of 3 or above on the Bayliss' Disease Burden: Morbidity Assessment by Self- Report scale Willingness and ability to participate in a 12-week supervised exercise therapy and self management program twice a week Participation in supervised systematic exercise for one of their diseases within the last 3 months Patients with an unstable health condition or at risk of serious adverse events as evaluated by a medical specialist Patients categorized as Class IV on the New York Heart Association (NYHA) Functional Classification scale Terminal patients and patients with life expectancy of less than 12 months Patients with psychosis disorders, post-traumatic stress disorder, Obsessive Compulsive Disorder, attention deficit hyperactivity disorder, autism, anorexia nervosa/bulimia nervosa and patients with an abuse Other reasons (unable to understand Danish, mentally unable to participate, etc.) | 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): 35.0-80.0, Carotid Artery Stenosis 35-80 years old 2. Severe carotid stenosis (MRA or CTA confirmed stenosis rate of 70% , standard) 3. Asymptomatic or mild stroke (NIHSS ≤ 3) or TIA 4. Agree to participate in the clinical trial and sign the informed consent Severe stenosis or occlusion of vertebrobasilar artery and other intracranial arteries (70% ) 2. Left ventricular ejection fraction < 50% or heart failure 3. Other types of dementia have been diagnosed 4. Severe depression, mental illness, epilepsy 5. Not cooperating with cognitive task evaluation | 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): 55.0-100.0, Cerebral Amyloid Angiopathy Clinical diagnosis of CAA Must be able to swallow tablets Clopidogrel gene was non-CYP2C19 *1 patients Patients with surgical thrombolysis Patients with arteritis, aneurysms, arterial trauma and other risk factors were excluded Patients with tumours, infections, fever, inflammatory diseases, post-embolization bleeding, peripheral vascular thrombosis or embolization, and other blood diseases such as hemophilia were excluded Currently receiving treatment in another experimental device or drug study, or completing treatment in another experimental device or drug study ≤30 days Patients are allergic to any of the ingredients known to be given aspirin or clopidogrel Patients has an unstable medical condition, or is otherwise considered unstable by the investigator, based on medical history, physical examination, and routine laboratory tests Patients who need to change or discontinue aspirin or clopidogrel, fail to take medication, or fail to come to the hospital on time due to their condition, and some information is missing | 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, Cataract Diabetic Retinopathy Macular Edema Due to Diabetes Mellitus All patients at Uptown Eye Specialists undergoing uneventful cataract surgery who have provided informed consent to the study Other ocular co-morbidities such as axial length < 22.0 mm or > 25.0 mm, previous ocular surgeries, previous history of uveitis, previous ocular trauma, cornea pathologies or glaucoma, intraocular pressures over 22 mmHg In groups 1 and 2: previous retinal laser treatments OCT-A signal strength < 6 Use of multifocal intraocular lens Second eye (if first eye recruited) In Group 1: No diabetes mellitus as past medical history | 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, Hemorrhoids Patients older than 18 years with symptomatic hemorrhoidal disease grade II and III (Goligher's classification) Refractory to conservative therapy (dietary modification, intestinal transit modifiers, topical and phlebotonic medications) for a period of not less than 4 weeks Cirrhosis Pregnant or breast-feeding women Known allergy to polidocanol Another perianal disease that can cause symptoms similar to hemorrhoidal disease Colorectal malignancy Concomitant presence of external hemorrhoidal disease and/or hemorrhoidal thrombosis - Office or surgical treatment for hemorrhoids within 6 months prior to Antiplatelet or hypocoagulant medication Hematological disorders Immunosuppressive states | 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, Covid19 Patients must satisfy all of the following unless otherwise stated: 1. Willing and able to provide informed consent 2. Male or female patients > 18 years of age on the day of informed consent 3. Have received a confirmed diagnosis of COVID-19 (positive for SARS CoV 2), as assessed by PCR or point-of-care within 72 hours of first dose on Day 1 4. Have mild to moderate signs or symptoms of COVID-19 with onset within 5 days of first dose on Day 1, at least two of the following symptoms stuffy or runny nose sore throat shortness of breath cough fatigue myalgia headache chills or shivering feeling hot or feverish Patients will be excluded from the study if they satisfy any of the following unless otherwise stated: 1. Females who are pregnant (negative pregnancy test required for all women of child bearing potential at Screening) or breast-feeding 2. Male patients and women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using at least one protocol specified method of contraception 3. Severe COVID-19 disease as defined by the WHO COVID-19 Clinical Improvement Ordinal Scale, scores of 5 (non invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation), or 7 (ventilation + additional organ support pressors, renal replacement therapy [RRT], extracorporeal membrane oxygenation [ECMO]) 4. Expected survival less than 72 hours 5. Peripheral capillary oxygen saturation (SpO2) <90% while breathing room air 6. Treatment with other drugs thought to possibly have activity against SARS CoV 2 infection like remdesivir, favipiravir, within 7 days prior to enrollment or concurrently 7. History of abuse of drugs or alcohol that could interfere with adherence to study requirements as judged by the Investigator 8. Use of any other concurrent investigational drugs while participating in the present study 9. Patient requires frequent or prolonged use of systemic corticosteroids (≥20 mg of prednisone/day or equivalent for >4 weeks) or other immunosuppressive drugs (e.g., for organ transplantation or autoimmune conditions) 10. Known renal disease with an estimated glomerular filtration rate (eGFR) <50 mL/min based on local laboratory results 11. Patients with clinically apparent liver disease, e.g., jaundice, cholestasis, hepatic synthetic impairment, or active hepatitis 12. Alanine transaminase (ALT) or aspartate transaminase (AST) >3 × upper limit of normal (ULN) or alkaline phosphatase or bilirubin levels > 2 × ULN based on local laboratory results 13. Co administration of clinical doses of orlistat with dalcetrapib 14. Inability to swallow oral medications or a gastrointestinal disorder with diarrhea (e.g., Crohn's disease) or malabsorption at Screening 15. Any other clinically significant medical condition or laboratory abnormality that, in the opinion of the Investigator, would jeopardize the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study 16. History of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation | 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, Polyarthritis Have been diagnosed with RA after the age of 18 Have had RA for at least 1 year Meet the 2010 ACR/EULAR criteria Stable disease status for at least 3 months Low to moderate activity as measured by the Clinical Disease Activity Index (CDAI) Stable dose of DMARD (conventional synthetic Disease Modifying Anti-Rheumatic Drug) for at least 3 months Stable dose of NSAIDs and corticosteroids for at least 1 month Do not take > 10 mg per day of prednisone Have been diagnosed with another rheumatologic autoimmune disease Have been diagnosed with inflammatory bowel disease (ulcerative colitis or Crohn's disease) Have a disease that may interfere with the physician's assessment (e.g. severe osteoarthritis) Have fibromyalgia Consume omega-3 fatty acid supplements other than those given during the project Have an allergy or intolerance to seafood Consume natural health products that may potentially affect inflammation (e.g. glucosamine, chondroitin, devil's claw, curcumin products) during the project Consume more than two servings (1 serving = 90 g or 3 ounces) of fish and seafood per week for the duration of the study Take anticoagulant medication Be treated or have previously received biological agents or inhibitors of JAK (Janus kinase) (family of tyrosine kinases) | 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, Dyspnea dyspnea NYHA II-III age 18-90 years left ventricular ejection fraction ≥ 50% ability to give informed consent unstable cardiac disease with acute decompensation documented former LVEF ≤ 40% heart valve disease with medium or high grade insufficiency or stenosis coronary heart disease with hemodynamically relevant coronary stenosis specific cardiomyopathia acute or chronic cardiac inflammation (myocarditis, pericarditis) former heart transplantation relevant pulmonary disease (e.g. COPD) assumably causing the dyspnea FEV1/VC < 70% hemoglobin < 5 mmol/l | 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): 12.0-90.0, Scoliosis Spinal Deformity Acute Pain Chronic Pain Postoperative Pain Anesthesia Regional Anesthesia Morbidity Anesthesia, Local Anesthesia Complication Hyperalgesia Intraoperative Complications Intraoperative Hypotension Intraoperative Blood Loss Intraoperative Bleeding Intraoperative Neurological Injury Intraoperative Injury Coagulation Disorder Postoperative Nausea and Vomiting Postoperative Cognitive Dysfunction Neuropathic Pain Nutrient Deficiency Nutrition Disorders Ventilator-Induced Lung Injury Informed consent of the patient or his legal representatives to participate the study. 2. Spinal deformity that requires surgical correction. 3. No known allergies to local anaesthetics. 4. Negative intradermal test for sensitivity to local anaesthetics Refusal of the patient or his legal representatives to participate the study 2. Diabetes mellitus, known allergy to local anaesthetics 3. Acute spinal cord injury 4. Physical status according to classification ASA III and more 5. A positive intradermal test for sensitivity to a local anaesthetic | 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, Coronary Artery Disease Signed written informed consent Stenosis ≥70% of the LAD and/or ≥50% of left main coronary artery in combination with at least one stenosis ≥70% of the Cx or RCA, suitable for revascularization (decided by a heart team) value ≥22 Clinical indications for coronary revascularization (angina refractory to optimal medical treatment, ischemia on non-invasive tests, reduced left ventricular ejection fraction) Previous heart surgery of any kind, including CABG Previous surgery involving the left pleural space The need for concomitant vascular or other cardiac surgery during index procedure (valve surgery, aortic surgery, left ventricular aneurysmectomy, endarterectomy, etc.) Chronic lung disease Chronic kidney disease determined as eGFR<60 ml/min/sq.m Failure to give informed consent Life expectancy due to non-heart disease is less than 1 year | 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, Atrial Fibrillation General AGE > 50 years No history of supraventricular arrhythmia Sinus rhythm at score > 2 in men (> 3 in female) More than 3 specific for Written informed consent is obtained before any study-related assessment is performed Specific Age > 65 Age > 75 BMI > 30 History of any supraventricular or ventricular arrhythmia (excluding premature contractions and 1st degree AV block) Therapy with anticoagulants at the time of Acute coronary syndrome less than 1 month prior to History of cardiac surgery Diabetes mellitus type 2 Reduced LVEF (<50%) Acute or decompensated heart failure at the time of Cardiomyopathy Systemic inflammatory disease or acute inflammatory disease Active malignancy | 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 Artery Disease asymptomatic patients with uni or bilateral carotid artery stenosis ≥50% and LDL-C values ≥100 mg/dL despite ongoing lipid lowering therapy age <18 or ≥81 years old known intolerance to evolocumab ongoing or previous treatment with PCSK9i prior stroke or transient ischemic attack total carotid occlusion major active infection or major hematologic, renal, hepatic, or endocrine dysfunction malignancy with life expectancy below 24 months failure to sign informed consent | 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, Behcet Syndrome patient more than 18 years old All patients fulfill the modified International for Behçet's Disease Patients under 16 years old patients with hyperlipidemia, hypertension, diabetes mellitus and all other risk factors affecting blood vessel intimal thickness | 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): 18.0-60.0, Rheumatoid Arthritis • Patients with active rheumatoid arthritis based on DAS28 score. Patients received the standard therapy (i.e. one or more conventional DMARDs) for at least three months Known hypersensitivity to metformin Patients who have a prior diagnosis with diabetes mellitus Patients receive metformin for any other indications Patients with congestive heart failure Patients with a history of myocardial infarction Patients with severe anemia Patients with active infections or other inflammatory diseases Patients receiving biological therapy Pregnancy or lactation Patients with impaired liver functions | 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): 40.0-90.0, Carotid Artery Stenosis Patients undergoing elective carotid endarterectomy or other peripheral vascular surgical procedures Ages 40-90 History of Substance Use: History of cocaine use within the past 12 months. Tetrahydrocannabinol use within the past 12 months. 2. Conditions that affect brain MRI/contraindications for MRI: Diagnosis of HIV. History of any traumatic brain injury. History or current diagnosis with any form of brain tumor. Current normal pressure hydrocephalus. Patients with any implanted metallic medical device, or non-removable metallic material in their body 3. Conditions that affect neuropsychological assessment: Diagnosis with Attention Deficit/Hyperactivity Disorder. Current major depressive episode. Current manic episode. Current psychotic episode. Diagnosis with any developmental disorder. Diagnosis with any form of dementia (MMSE<24). A score higher than 3 on the Modified Rankin Scale indicating a major stroke. 4. General Contraindications: Diagnosis with or history of any medical condition that, based on reasonable clinical judgment, would clinically contraindicate the patient undergoing any of the study procedures | 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): 18.0-65.0, Covid19 Sequelae of; Infection Cognitive Symptom History of SARS-CoV-2 PCR+ at least 2 months prior to study entry SARS-CoV-2 negative (PCR) at study entry Persistent cognitive difficulties (esp. "brain fog") that began around the time of the acute COVID-19 At least two neurological and/or physical symptoms that started at COVID-19 infection and are ongoing at study entry, including fatigue, weakness, headache, loss of smell, tingling/numbness, shortness of breath, loss of appetite, palpitations/tachycardia, hair loss, musculoskeletal and/or chest pain Willing and able to consent, complete all assessment and study procedures Not pregnant or lactating Any specific central nervous system disease history (e.g. major clinical stroke, brain tumor, normal pressure hydrocephalus, etc) Clinically significant unstable medical condition that could affect safety or compliance with the study Was intubated due to COVID-19 Major active or chronic unstable psychiatric illness (e.g. depression, bipolar disorder, obsessive compulsive disorder, schizophrenia) within the previous year History of alcohol or other substance abuse or dependence within the past two years Any significant systemic illness or medical condition that could affect safety or compliance with study Current use of medications with psychoactive properties that may be deleteriously affecting cognition Any known hypersensitivity to nicotinamide riboside, or its principal metabolite, nicotinamide mononucleotide Use of other investigational agents or interventions one month prior to entry and for the duration of the trial If participating in the optional magnetic resonance imaging (MRI) sub-study: Any contraindication to undergo 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, Multivessel Coronary Artery Disease 18 Years and older 2. signed the informed consent 3. indicated for revascularization, with possible bypass segment in LAD and amendable lesions by PCI in other vessels 4. anatomy requiring as following: (1) Multivessel CAD involving the LAD (proximal or mid) and/or LM (ostial, mid-shaft or distal) with at least 1 other epicardial coronary artery requiring treatment in LCX or RCA, including: (2) LAD disease, and a major diagonal lesion, either bifurcation or independent in location, with both requiring revascularization (determined by QFR or FFR) (3) LM distal bifurcation lesion (Medina 1,1,1), intended for 2-stent approach if randomized to PCI 5. Heart team discussion after angiogram, with conclusion of suitable candidate for either PCI or HCR 6. Able to tolerate and no plans to interrupt dual anti-platelet therapy for 3~12 months 7. Willing to comply with 2-year clinical follow-up Previous cardiac or thoracic surgery 2. Previous PCI of the LM and/or LAD within 12 months 3. Totally occluded left main vessel 4. Cardiogenic shock or LVEF <30% 5. Previous STEMI within 30-day prior to randomization 6. Concomitant vascular or other cardiac disease with plan of surgical treatment 7. Indication for chronic oral anticoagulation therapy 8. Previous stroke history within 6-month prior to randomization 9. Survival expectation less than 3 years due to non-cardiac illness 10. Allergy or hypersensitivity to any of the study drugs or devices used in the trial 11. Enrolled in additional clinical study 12. Informed consent not available or noncompliance with follow-up 13. Pregnant | 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, Pancreatic Adenocarcinoma Pancreatic adenocarcinoma proven histologically or cytologically in favor of pancreatic adenocarcinoma Mesurable disease according to 1.1 or non measurable disease Metastatic disease (synchronous or metachronous) or locally advanced / borderline deemed unresectable and / or patient inoperable due to his co-morbidities and / or local recurrence after surgery Thrombosis of the main portal vein and/or of one of its branches (endo-luminal defect on the injected CTscan) of cruoric or tumoral origin or circumferential stenosis of the portal vein trunk, the spleno-mesaraic confluence or one of its venous branches with or without signs of portal hypertension on CTscan and / or upper GIendoscopy Post-surgical portal vein thrombosis and / or in patients considered in remission Non-adenocarcinomatous pancreatic tumor (endocrine, etc.) | 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): 40.0-80.0, Knee Osteoarthritis Moderate to severe OA pain (corresponding to NRS Pain ≥5 to ≤9) in the target knee for the majority of days in the last 3 months prior to Screening KOOS pain subscale <60 for the target knee at Screening 1 and at Day 1 High sensitivity C-reactive Protein (hsCRP) ≥2 mg/L Radiographic KL grade 2 or 3 knee OA and joint space width (JSW) 2-4 mm (men) or 1.5-3.5 mm (women) in the medial tibiofemoral compartment (TFC) in the target knee Contrast-enhanced MRI (CE-MRI) diagnosed moderate or severe knee synovitis based on an established synovititis scoring system (moderate score 9-12 or severe score ≥13) History of, or planned; knee replacement (partial or total) in either knee; arthroscopy or lavage of the target knee within 6 months prior to screening; any other previous surgical intervention in the target knee, including mosaicplasty, microfracture, meniscectomy >50% or osteotomy Moderate to severe pain in the contralateral knee for the majority of days in the last 3 months prior to screening Malalignment >7.5° in the target knee (either varus or valgus) Any diagnosis of inflammatory arthritis or connective tissue disease (e.g. rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, Paget's disease, systemic lupus erythematosus) or other systemic condition that might confound assessment of OA Ipsilateral hip OA or hip prosthesis recently implanted (within 1 year prior to screening) or hip replacement on either side planned within the study period | 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): 6.0-18.0, Congenital Heart Disease for CHD group children with CHD included in the first study carried out from 2010 to 2015 6 and who have had at least 1 CPET 1 year after the first. for control group children referred for a nonsevere functional symptom linked to exercise (murmur, palpitation or dyspnoea) or for a medical sports certificate completely normal check-up, including physical examination, ECG, echocardiography and spirometry for control group Children with any chronic disease, medical condition (cardiac, neurological, respiratory, muscular or renal) Children with any medical treatment Children requiring any further specialised medical consultation | 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, Low Back Pain primary care practitioners and their patients, who suffer from back pain and receive treatment patients who suffer from back pain and receive treatment with or without leg radiation | 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, Asymptomatic Carotid Artery Stenosis asymptomatic carotid artery stenosis (according to the ESVS guidelines) >60% (NASCET criteria) with a physical examination and a DUS at the S. Orsola Malpighi hospital from 2019 to 2025 Patients submitted to carotid revascularization will be included until the revascularization Patients who underwent a transient ischemic attach or a stroke within the 6-months before the enrollment are excluded from the study Restenosis Carotid total 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): 18.0-80.0, Carotid Stenosis Carotid Artery Plaque Carotid Atherosclerosis Carotid plaques with a cut-off at doppler flow velocity ≥ 1.3 m/sec at a Doppler angle of 50-60°, which corresponds to a ≥ 50% stenosis according to these criteria Performed or planned carotid surgery Carotid occlusion Renal failure (GFR <45 ml/h) Inflammatory diseases, anti-inflammatory treatment or malignancies Stroke <30 days before admission Co-morbidities that disable informed consent or participation in the study investigations (e.g. contraindications for MRI) | 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, Intracranial Artery Occlusion With Infarction (Disorder) Age ≥ 18 years old 2. Diagnosis of acute ischemic stroke 3. Imaging confirmed intracranial large artery occlusion (LVO): intracranial internal carotid artery (ICA T/L), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA V4), and posterior cerebral artery (PCA P1);ASPECT or PC-ASPECT ≥ 6 4. Initiation of any type of endovascular treatment (EVT), including intra-arterial thrombolysis, mechanical thrombectomy, angioplasty, and stenting 5. The patient or the patient's legal representative is able and willing to sign the informed consent Isolated cervical ICA or VA occlusion; 2. No evidence of LVO on DSA | 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, Magnetic Resonance Imaging Asymptomatic Intracranial Stenosis Medical Treatment Patients with intracranial stenosis which was defined as stenosis of 50% or more in Intracranial segment of internal carotid artery and middle cerebral artery (MCA) The degree of stenosis was measured by transcranial doppler, computed magnetic resonance angiography (MRA),tomography angiography (CTA) and digital subtraction angiography (DSA) History of stroke,transient ischemic attack,seizures or unexplained loss of consciousness Organic brain defects on T1 or T2 images Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder) Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator. History of substance abuse within the last 6 months | 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, Sleep Apnea, Obstructive Apnea, Sleep Age ≥ 18 years old 2. Body mass index <38 kg/m2 3. Prior documented diagnosis of OSA by means of a polysomnography (PSG) test or home sleep test (HST) 4. Documented evidence from a screening HST following consent to demonstrate: 1. AHI 15 hour 2. >80% of the apneas and hypopneas are obstructive 5. Previous treatment attempt with CPAP resulting in failure to treat or discontinuation due to intolerance, subject choice, or struggle to use CPAP 6. Have not used CPAP or oral appliances within 1 week of the screening home sleep test and agree not to use CPAP or oral appliances throughout the study duration 7. Access to and ability to use a smart device such as a smartphone or tablet 8. Able to speak, read, and write English 9. In the opinion of the investigator, the subject will be able to understand and comply with all study procedures Known sleep disorder other than OSA, such as narcolepsy, restless leg syndrome, idiopathic hypersomnolence or chronic insomnia 2. Craniofacial abnormalities that may be contributing to OSA 3. Previous surgery, injury, or radiation to the neck which, in the Investigator's judgment, could interfere with collar fit or comfort 4. Excessive hair or beard in the area of the neck where the collar will be placed, and/or unwillingness to shave that area for the duration of this study 5. Inflammatory skin condition, such as acne or eczema in the area where the collar will be affixed to the skin, which, in the Investigator's judgment, could interfere with collar fit or comfort 6. Known silicone allergy 7. Night shift work because of irregular sleep-wake cycles 8. Excessive alcohol intake, defined as that leading to interference with work, home life, or the ability to optimally perform normal everyday duties and tasks 9. Use of illicit drugs (including marijuana) currently or within the past 5 years 10. Serious pulmonary disease (e.g., cor pulmonale, CO2 retention, or poorly controlled asthma) 11. Use of home oxygen or baseline oxygen saturation <94% 12. Cancer that has been in remission for less than one year 13. Psychiatric illness that, in the opinion of the Investigator, is not reasonably well-controlled with treatment 14. Serious cardiac disease (e.g., congestive heart failure, unstable coronary artery disease, or poorly controlled rhythm disturbance) 15. Prior carotid endarterectomy, prior percutaneous coronary angiography (including any placement of carotid stents), or known stenosis of either internal carotid artery > 70% from prior carotid imaging (e.g., carotid duplex ultrasound, angiography, computed tomography angiography, or magnetic resonance angiography) 16. Previous surgery for peripheral arterial disease 17. Presence of possible or definite carotid artery disease, defined as any of the following: 1. history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) with uncertain etiology that is compatible with carotid artery disease 2. diminished carotid pulse on screening physical examination* 3. > 70% stenosis in either extra-cranial internal carotid artery as determined by duplex ultrasound* (only performed on those who do not exhibit 17 a. or b.) 18. Tonsil size 3 or 4 (Appendix C)* 19. Currently pregnant* or planning to become pregnant during participation in this study 20. Unable to obtain adequate collar fit* 21. Any condition or circumstance that, in the opinion of the investigator, may preclude study completion, interfere with accurate data collection, or bias the results 22. The investigator believes that the subject's participation may not be in his or her best interest | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-99.0, Stage IV Melanoma Histologically confirmed stage IV melanoma that is recurrent or progressing and unlikely to respond to existing therapy Measurable disease by MRI or CT scan Tumor must be at least 2 cm in the lymph nodes in the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in other locations Age and over Performance status Karnofsky 60-100% Life expectancy At least 2 months Hematopoietic WBC at least 2,000/mm3 Platelet count at least 50,000/mm3 Hepatic Bilirubin no greater than 2.5 mg/dL SGOT and SGPT no greater than 5 times the upper limit of normal | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-99.0, Stage IV Kidney Cancer Histologically confirmed stage IV adenocarcinoma or transitional cell carcinoma of the kidney that is unlikely to respond to existing therapy Measurable disease by MRI or CT scan Tumor must be more than 2 cm for lymph nodes in head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm for other locations Age and over Performance status Karnofsky 60-100% Life expectancy At least 2 months Hematopoietic WBC at least 2,000/mm^3 Platelet count at least 50,000/mm^3 Hepatic No hepatic insufficiency Bilirubin no greater than 2.5 mg/dL | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Major Depression Major depression assessed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID; First et al, 1995) Minimum score greater than or equal to 20 on the 17-item Hamilton Depression (HAM-D) Scale at screen and at baseline GAF of 60 or less (moderate symptoms) at screen and at baseline HAM-D cannot decrease by 25% or more between screening and baseline Capacity to give informed consent and to follow study procedures Abstinence or effective method of contraception throughout the study Scores greater than 2 on the "suicide" item of HAM-D, or history of suicide attempt(s) in the past 12 months Current suicidal or homicidal risk, as determined by the investigator Women of childbearing age who are pregnant, planning pregnancy in the next 6 months, breast-feeding, or not using medically acceptable means of birth control (hormonal treatment such as birth control pill, injection or implant, IUD, or double barrier of condom and diaphragm together is acceptable; primary use of condom, sponge or diaphragm alone (single barrier) is not acceptable because these may carry a higher rate of failure when used alone Clinically significant liver disease (such as hepatitis, cirrhosis, etc); or clinically significant elevation of liver enzyme tests (two times the upper limit of normal; asymptomatic Gilbert's syndrome is not an exclusion). 4. Serious or unstable medical illness. 5. History of seizure disorder (other than febrile) Any of the following DSM-IV diagnoses by SCID: current (within past 6 months) alcohol or other substance abuse disorder; schizophrenia, schizo-affective, or other psychotic disorder; bipolar disorder; current panic disorder or obsessive compulsive disorder; history of psychotic features of affective disorder (mood congruent or incongruent) Clinical or laboratory evidence of untreated or unstable thyroid disorder Failed to respond to at least two adequate antidepressant trials (defined as 6 weeks or more treatment with either greater than or equal to 150 mg imipramine, or tricyclic equivalent), or greater than or equal to 60 mg of phenelzine, or MAOI equivalent, or greater than or equal to 100 mg of sertraline, or its SSRI equivalent Have taken sertraline or any form of hypericum during this current episode of depression at any dose level, daily, for at least one month, within the past 6 months Current (within past 6 months) use of other prescription or non-prescription drugs, including anticonvulsants and other medications with significant psychotropic properties, antiretroviral medications, cyclosporine, digoxin, coumadin, dietary supplements, natural remedies, and botanical preparations (eg, hypericum, kava, valerian) Have had other investigational drugs within 30 days or other psychotropic medication within 21 days of baseline (6 weeks for fluoxetine) | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-100.0, Cardiovascular Diseases Heart Diseases Hypertension Kidney Failure, Chronic | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-1.0, Idiopathic Pulmonary Hemorrhage infant (<12 mo old) with unexplained pulmonary hemorrhage, discharged home from newborn nursery hemorrhage occurred in hospital prior to going home prior to discharge from newborn nursery | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Carcinoma, Non-small-cell Lung Clinical diagnosis of stage IIIB or IV non-small cell lung cancer Must have evidence of disease (clinical or radiological) Have failed 1 but no more than 2 prior chemotherapy regimens, have recovered from any side effects and have not had any chemotherapy for at least 21 days If the patient has had surgery, the surgery was at least 2 weeks ago Patients whose cancer has spread to their brain or central nervous system are eligible, providing that they have been on stable dose of steroids for at least 4 weeks and are free of symptoms If the patient received radiation therapy, treatment was at least 4 weeks ago | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Lung Neoplasms Carcinoma, Non-Small-Cell Lung Brain Neoplasms Metastases, Neoplasm Patients will be eligible for the study if they Are male or non-pregnant, non-lactating females 18 years of age or older (must agree to use an appropriate and effective method of birth control during the study and for 2 weeks after study) Have an ECOG performance status of Zero or One Are being evaluated for known or suspected non-small-cell lung cancer (NSCLC), or known brain lesions consistent with metastatic lung cancer (For NSCLC patients)Have been previously scheduled for biopsy or surgical excision of the suspected NSCLC, or have a pathological diagnosis of lung cancer within 2 months of enrollment but have received no previous treatment (For brain cancer patients) Have clinical signs and symptoms consistent with a primary NSCLC with histological or cytopathological confirmation. Patients cannot have received previous treatment with radiation to the brain Have signed an informed consent form Patients will not be eligible for this study if they Have a history or suspicion of significant allergic reaction or anaphylaxis to any of the 111In-DAC components Have a clinically unstable medical condition or opportunistic infection, a life-threatening disease state, impaired renal or hepatic function or are immunosuppressed Are taking or have taken part in any investigational study within 30 days of start of study Have received an indium agent within 30 days of start of study Are not able to remain immobile during scanning time Have taken drugs that may damage the kidneys within 2 weeks of start of study Have abnormal laboratory test results: hemoglobin<9.5 gms/dl, serum creatinine>1.5mg/100ml, alkaline phosphatase 2X the upper limit of normal Have undergone an excisional and/or needle localization biopsy within 4 days prior to study drug administration Have undergone a PET scan within 7 days prior to study drug administration | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-85.0, Sepsis Shock, Septic Sepsis Syndrome Septicemia Infection Presently admitted, or about to be transferred, to the ICU Women of Child-bearing potential must have a negative serum (or urine) hCG assay within 24 hours prior to drug administration Any Race Severe Sepsis [newly developed respiratory failure, refractory shock, renal dysfunction, hepatic dysfunction, or metabolic acidosis and at least three signs of SIRS (systematic inflammatory response syndrome)] Objective signs of infection likely to be caused by a bacterial or fungal pathogen Patients must receive study medication within 8 to 12 hours of recognition of the initial sepsis-related organ failure Predicted risk of mortality score between 20% and 80% An intent by physicians and family to aggressively treat the patient for the 28 day study period Cardiogenic or hypovolemic shock Acute third degree burns involving >20% of body surface Recipients of non-autologous organ transplants within the past year Pregnancy Chronic vegetative state Uncontrolled serious hemorrhage (.2 units of blood/platelets in the previous 24 hours). Patients may be considered for enrollment if bleeding has stopped and patients are still otherwise qualified Unwilling or unable to be fully evaluated for all follow-up visits Patients who are classified as "Do not resusitate" or "Do not treat." Patients who develop severe sepsis <36 hours post trauma or post-surgery. Patients may be considered for enrollment >36 hours post-trauma or post-surgery, if they meet other criteria Patients with a predicted risk of mortality score of <20% or >80% after recognition of qualifying organ failure | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-55.0, End-stage Renal Disease Renal Transplantation Kidney Transplantation End-stage renal disease (ESRD) without prior sensitization (defined as Panel Reactive Antibody [PRA] greater than 20%) within the 60 days prior to transplant as measured by cytotoxicity assays, ELISA, and flow cytometry Undergoing a first or second transplant Receiving a transplant from a living related donor who is ABO (blood type) compatible and haploidentical (3, 4, or 5 antigen match by serologic typing) Cardiac ejection fraction greater than 40% Forced expiratory volume (FEV1) greater than 50% Liver function tests, bilirubin, and coagulation studies less than 2 X normal White blood cells greater than 2000/mm^3; abd Platelets greater than 100,000/mm^3 Positive donor lymphocyte cross-match HIV-1 infected Positive hepatitis B surface antigen (HbsAg) Hepatitis C virus infected History of cancer Prior dose-limiting radiation therapy Pregnant, breastfeeding, or planning pregnancy within the time frame of the study Enrolled in another investigational drug study within 30 days prior to study entry; or Receiving maintenance immunosuppression within 3 months before the conditioning regimen begins | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, West Nile Virus In order to participate in this clinical trial, all subjects (or legal representative) must provide written informed consent. Only patients meeting entry will be enrolled. Eligible subjects must fall into one of two categories: A. Hospitalized patients greater than or equal to 18 years of age with encephalitis and/or myelitis as defined below: New neurologic abnormality Asymmetric extremity weakness without sensory abnormality; or Other neurologic abnormality (including altered level of consciousness, dysarthria and dysphagia) plus fever (subjective or objective) within the previous 4 days AND CSF examination within the previous 96 hours showing Absence of organism on gram or fungal stain White blood cell count greater than or equal to 4 per cubic mm corrected for significant red blood cell contamination Ratio of CSF: plasma glucose of greater than or equal to 40% (CSF glucose / plasma glucose greater than or equal to 0.4) Serum and CSF glucose levels should be obtained within 8 hours of each other for this calculation. OR B. Hospitalized patients, without encephalitis and/or myelitis as defined below, who meet the following A positive IgM serology or PCR test for WNV in blood or cerebrospinal fluid, AND Clinical illness compatible with WNV infection as described by occurrence of greater than or equal to 3 of the following findings during the preceding less than or equal to 10 days Diarrhea Headache Fever > 38º C Nausea and/or vomiting Unable to obtain valid informed consent History of intolerance (including anaphylaxis) to IVIg or related compounds Known history of IgA deficiency Known history of hypersensitivity to maltose History of (or at time of study entry) hyperviscosity syndrome, such as but not limited to Waldenstrom's macroglobulinemia Multiple myeloma Total white blood cell count > 80,000/cubic mm Hematocrit > 55% Platelet count > 700,000/cubic mm Meets of Class III or IV of the New York Heart Association Classification for congestive heart failure patients Serum creatinine > 2.5 mg/dL or requires dialysis Alternate explanation (as determined by the investigator) for clinical findings (such as structural brain lesion, cerebrovascular accident, or other infectious disease, including confirmed infections with other flaviviruses) Pregnant or breastfeeding (negative serum or urine pregnancy test within previous 72 hours if woman is not postmenopausal or has not been surgically sterilized) Investigator's opinion that patient would be unable to adhere to protocol requirements Receipt of ribavirin, interferon alpha, intravenous immunoglobulin, or any investigational drug for treatment of WNV or hepatitis within 15 days prior to study entry | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, End Stage Renal Disease Completed one of the qualifying studies (i.e., patient previously took part in an Amgen study investigating the drug AMG 073 and its effects on secondary hyperparathyroidism [HPT]; in particular parathyroid hormone [PTH], calcium and phosphorus levels in blood associated with kidney failure) Must agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study Pregnant or nursing females Experienced a myocardial infarction within 3 months before day 1 Have an unstable medical condition, defined as having been hospitalized, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Secondary Hyperparathyroidism End Stage Renal Disease CKD patients requiring dialysis (HD, HDF, HF) for at least 1 month before enrolment An iPTH determination within 14 days before randomisation must be greater than or equal to 300 pg/mL (biPTH greater than or equal to 150 pg/mL) A serum calcium determination (corrected for calcium) within 14 days before randomisation must be greater than or equal to 8.4 mg/dL [2.1 mmol/L] Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator Are currently breast-feeding Are performing peritoneal dialysis Have had a parathyroidectomy in the 3 months before day 1 Have a gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.5-10.0, Gastroenteritis Vomiting Diarrhea Dehydration Acute gastroenteritis Non-bilious and non-bloody vomiting within 4 hours of triage Diarrhea Mild to moderate dehydration Weight less than 8 kilograms Severe dehydration Underlying disease which might affect the assessment of hydration status (e.g., chronic renal failure, hypoalbuminemia, congestive heart failure, on diuretics) History of abdominal surgery Hypersensitivity to the drug or any components in its formulation | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-999.0, Urinary Tract Infection Parturients planned for vaginal delivery Parturients receiving antibiotic treatment during delivery or in the week before | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Multiple Organ Dysfunction Syndrome Main Patients with established, unresolving, refractory MODS, in whom all reversible and treatable causes of persistent MODS have been treated or ruled out Patients under endotracheal intubation and mechanical ventilation for at least 7 days Aggregate Multiple Organ Dysfunction Score (5) of greater than 8 over the first seven days of mechanical ventilation and greater than 5 on the day of inclusion Written informed consent to participate in the trial signed by next of kin or other authorized person. Additional Main cause or disease at admission: Adequate "source control" is required and refers to optimal, complete, and definitive surgical and/or medical therapy Infections: 1. Infectious causes of persistence of MODS have reasonably been ruled out on clinical or other grounds (infectious endocarditis, undrained abscesses like sinusitis, empyema or abdominal pus). Consider sampling for culture of broncho-alveolar lavage fluid, protected specimen brush or other (empyema fluid, lung tissue) in order to rule out respiratory infection, as well as intra-vascular catheter change and culture. 2. Present or previous infections, either documented or strongly suspected, have been treated for at least 3 days before inclusion Supportive Care: Optimal hemodynamic, renal, hematologic, nutritional "supportive care" is provided Decision not to provide full support Immune status and steroid therapy. 1. Steroid therapy Currently indicated for chronic or concurrent disease (meningitis, auto-immune disease, asthma, acute exacerbation of chronic obstructive pulmonary disease [COPD], or other). Inhaled steroids are allowed Administered during current admission (> 20 mg/day of 6-methyl-prednisolone or equivalent for >48 hours) Chronic steroid therapy prior to current admission (> 20 mg of 6-methyl-prednisolone or equivalent/day for > 1 month during previous 3 months). 2. Other immune-suppressive therapy within the previous 6 months. 3. Known AIDS. 4. Neutropenia < 500/mcl. 5. Preceding organ transplantation Irreversible and or ultimately fatal clinical conditions like metastatic malignant disease or cardiogenic shock caused by coronary artery disease Presence of invasive fungal infection Other significant pre-existing underlying chronic diseases: 1. Severe parenchymal liver disease (Child-Pugh grade C) 2. Severe and irreversible acute or chronic central nervous system disease. 3. Severe end-stage chronic obstructive pulmonary disease (home oxygen or more than 1 exacerbation in previous year) 4. End-stage renal disease (Chronic dialysis) Age less than 18 years Pregnancy | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Stage IV (Metastatic) Breast Cancer Patient has microscopically confirmed invasive breast carcinoma with clinical and/or radiographic evidence of stage 4 disease. If diagnosis is based on pleural effusion, positive cytology must be confirmed Patient has had no prior chemotherapy for Stage 4 disease (hormone therapy is permitted). Prior adjuvant paclitaxel by 3-hour infusion is permitted, if there is no residual neuropathy. Prior adjuvant docetaxel on an every 3 week schedule is permitted Disease must be measurable (unidimensional by Response Evaluation In Solid Tumors (RECIST) criteria) or evaluable (e.g., malignant effusion, marrow involvement). Elevated tumor markers alone are insufficient Age >18 Southwest Oncology Group (SWOG)/Eastern Oncology Group (ECOG) performance status must be < or =2 at screen and on treatment day one Life expectancy must be estimated at >16 weeks Prior irradiation is permitted, provided Does not exceed 25% of the estimated bone marrow volume Measurable/evaluable disease exists outside the radiation field, or progressive disease is documented within the radiation field Informed consent must be obtained prior to registration Granulocytes < 1,500/mm^3 Platelets < 100,000/mm^3 Hemoglobin < 9 gm/dl Creatinine > 2.0 mg/dl Total bilirubin > 2 mg/dl Visceral crisis characterized by rapidly progressive hepatic or lymphangitic lung metastases Medically unstable as judged by the patient's physician Pregnancy or lactation; failure to employ adequate contraception Uncontrolled central nervous system (CNS) disease Pre-existing Grade ≥ 2 peripheral neuropathy except for abnormalities due to cancer | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-75.0, End-Stage Kidney Disease Eighteen years or older, 2. On the waiting list for a kidney transplant list 3. On hemodialysis or peritoneal dialysis Pregnant woman 2. Patients who need ongoing blood products 3. Patients with failed organs having active rejection 4. Other therapies to decrease PRA 5. Patients listed for multi-organ transplants (other than kidney-pancreas) | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Head and Neck Cancer Patients must have documented advanced, locally recurrent, or metastatic head and neck carcinoma, which is untreatable by surgical resection or radiation therapy Prior chemotherapy for advanced/metastatic disease is allowed (1 regimen only) Patients must be taxane-naïve (no prior docetaxel or paclitaxel) Patients who have received chemoradiation as a primary therapy for advanced head and neck cancer are eligible Patients must have measurable or evaluable disease. Pre-study imaging for disease assessment must be done within 28 days of registration Patients with brain metastases are eligible if they have been stable for at least six weeks post-radiation therapy Aged 18 years or older Performance status of 0-2 by Zubrod criteria Life expectancy of at least 12 weeks Hematologic: absolute neutrophil count (ANC) equal to or > 1,500/mm3; hemoglobin equal to or > 8.0 g/dl; platelets equal to or > 100,000/mm3 Patients with congestive heart failure, second or third degree heart block or recent myocardial infarction within 12 months from registration are not eligible Peripheral neuropathy equal to or greater than grade 2 Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 Use of standard chemotherapy or investigational agents for treatment of head and neck cancer within 28 days of 1st dose of study drug Any medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimen Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test (PPT) at baseline, or sexually active females not using a reliable contraceptive method while on study and for at least six months after chemotherapy. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.) Sexually active patients not using a reliable contraceptive method while on study and for at least six months after chemotherapy Patients with malabsorption syndromes will be excluded. Administration of capecitabine through feeding tubes is permitted Serious concurrent infections | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-999.0, End-Stage Renal Disease Clinical diagnosis on ESRD under regular maintenance hemodialysis, no active infection, no allergy to chosen AK, informed consent acquired Not ESRD, temporary HD, active infection, during admission, allergy to chosen AK, without informed consent | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Clostridium Difficile-associated Diarrhea (CDAD) Males and female greater than 18 years of age 2. Positive stool C. difficile cytotoxin assay and/or biopsy evidence of Pseudomembranous Colitis (PMC) at onset of illness 3. Current history of severe, relapsing CDAD or Current history of severe, refractory CDAD 4. A score of 6 or 7 on the C.Diff Severity and Prognosis Score (CDSPS) scale27,28,29,30 OR failure to respond (as identified by a score of 4 or more on the CDSPS scale below) to any of the following: a 4-day or more course of oral or IV metronidazole 500 mg po TID or QID; or to a 4-day course of oral vancomycin 125-500 mg po Q6 hours; or to a 4-day course of vancomycin enemas; or failure to respond to a 4-day course of combination therapy of oral vancomycin 125-500 mg po Q6 hours and IV metronidazole 500mg IV Q8 or Q6 hours and/or vancomycin enemas. CDSPS SCALE (each item is scored as one point for a 7 point maximum total) 1. underlying immunosuppression/chronic medical condition 2. altered or depressed mental status as defined by medical chart documentation 3. abdominal pain and/or distention 4. WBC > 20,000 or < 1,500 and/or bandemia > 10% 5. hypoalbuminemia (<3 mg/dL) 6. ascites (clinically or per CT scan findings per medical chart) 7. abnormal CT scan findings per medical chart - Pregnant or lactating women 2. Selective IgA deficiency 3. Hypersensitivity to immune globulin, human albumin, or thimerosal - | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-70.0, Chronic Hepatitis C All eligible adult patients with compensated liver disease due to chronic infection with HCV and genotype 1 infection who are treatment naïve will be enrolled into the study All racial and ethnic groups will be recruited into this study Males and females: age > 18 years Chronic hepatitis C: history of serum positive for HCV antibody (anti-HCV) and HCV RNA. Patients should have evidence of chronic hepatitis with a minimum fibrosis score of 1 on liver biopsy done within 6 months of enrollment Insulin resistance based on HOMA index value (HOMA-IR) of > 2.0 during screening. HOMA-IR is a well recognized and validated index of insulin resistance in both non-diabetic and diabetic populations and has been shown to have a good correlation with 'clamp' techniques that are intensive. HOMA is also used routinely to assess longitudinal changes including assessment of the effects of treatment. In general, a HOMA-IR value of > 1.5 is considered abnormal based on repeat testing measurements performed by both HOMA assessment and by euglycemic clamp technique and is considered representative of decreased insulin sensitivity. Although insulin secretion is pulsatile, the correlation between HOMA computed from repeat sampling (using a mean of three samples taken at 5-minute intervals to compute HOMA) and the value obtained from a single basal sample to determine insulin sensitivity has been shown to be near perfect even in patients with type 2 diabetes (r = 0.99, p < 0.0001). The investigators will use a HOMA-IR value of > 2.0 as part of the in this study Able and willing to provide written informed consent Hepatitis C patients who underwent previous therapy for their liver disease Genotype other than type 1 Histological evidence of cirrhosis or confirmed hepatocellular carcinoma (HCC) Patients with cirrhosis and decompensated liver disease and any patient, in whom a liver biopsy is contraindicated, will be excluded Evidence of other causes of chronic liver disease Diabetes mellitus New York Heart Association (NYHA) functional classification for cardiac disease: class III and IV patients Human immunodeficiency virus (HIV) antibody positive Patients with solid organ transplants Pregnancy or breast feeding | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-45.0, Asthma Mild asthma, adults - children. on inhaled or systemic steroids - | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-55.0, HIV Infections Subject is able to provide independent informed consent Subject is able to complete a questionnaire as part of her enrollment visit and agrees to complete follow-up questionnaires monthly Subject presents symptoms of acute diarrhea: at least 3 loose stools during 24 hours as reported by mother; persistent diarrhea: an episode of diarrhea lasting 14 days; recurrent diarrhea: a new episode of diarrhea after an interval of at least two diarrhea-free days. For HIV-infected subjects Mother: HIV antibody is detected by dual HIV-1 ELISA and confirmed by western blot. Infant: HIV antigen is detected by PCR on 2 samples during the follow-up period, or on 1 sample followed by the death of the infant Subject cannot provide legal independent informed consent | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Hyperglycemia Critical Illness Patients are eligible for in the study if ALL the following are met: 1. At time of the patient's admission to the ICU the treating ICU specialist expects the patient will require treatment in the ICU that extends beyond the calendar day following the day of admission. 2. Patient has an arterial line in situ or placement of an arterial line is imminent (within the next hour) as part of routine ICU management Patients will be from the study if ONE or MORE of the following are present: 1. Age < 18 years. 2. Imminent death (cardiac standstill or brain death anticipated in less than 24 hours) and the treating clinicians are not committed to full supportive care. This should be confirmed by a documented treatment-limitation order that exceeds a "not-for-resuscitation" order. 3. Patients admitted to the ICU for treatment of diabetic ketoacidosis or hyperosmolar state. 4. Patient is expected to be eating before the end of the day following admission 5. Patients who have suffered hypoglycaemia without documented full neurological recovery. 6. Patient thought to be at abnormally high risk of suffering hypoglycaemia ( e.g. known insulin secreting tumour or history of unexplained or recurrent hypoglycaemia or fulminant hepatic failure) 7. If a patient has previously been enrolled in the NICE-SUGAR Study (patients cannot be enrolled in the NICE-SUGAR Study more than once). 8. If the patient can not provide prior informed consent, there is documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent 9. The patient has been in the study ICU or another ICU for longer than 24 hours for this admission. There is no upper age limit for into the study unless any of the specific are present. - | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 3.0-18.0, Children Chronic Renal Failure Hypertension Acquired Kidney Disease Congenital Kidney Disease Age 3-18 years Moderate state of renal failure (creatinine clearance 15 ml / min / 1.73 m²) Mean arterial blood pressure (ABPM) > 50.percentile and/or antihypertensive treatment Written informed consent Age <3 years or >18 years at start of study Unstable clinical condition (vomiting, anorexia, etc) or superimposed important disease Unilateral or bilateral renal artery stenosis Urological surgery possibly affecting renal function expected during study period Insufficient compliance with prescribed antihypertensive medication during the run-in period Secondary renal diseases such as lupus, amyloidosis and primary hyperoxaluria, and patients treated with immunosuppressive agents (including corticosteroids) Severe primary cardiac disease, hepatic insufficiency and malabsorption syndrome Erythropoietin or growth hormone therapy with a duration of less than 3 months prior to run-in period Pregnancy | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-999.0, Relapsing Fever, Tick-Borne Jarisch Herxheimer Reaction suspected exposure to tick-borne relapsing fever after returning from field exercise in a tick-borne relapsing fever infected area having a tick bite or staying in field in close proximity to a subject with tick bite sign known sensitivity to tetracycline or doxycycline febrile illness on recruitment | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Subarachnoid Hemorrhage (SAH) Subarachnoid hemorrhage, acute Intracerebral pressure monitoring device inserted No intracranial pressure monitoring Age < 18 years | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Breast Cancer Patients must be women with a histologically confirmed diagnosis of breast cancer that is more than 2 cm and/or lymph node positive. Histologic confirmation shall be by either core needle biopsy or incisional biopsy. Punch biopsy is allowed if invasive breast cancer is documented Patients must meet one of the defined below (indicate one): 1. Selected Stage IIB (T3, N0, M0) or IIIA (T3, N1-2, M0) disease judged primarily unresectable by an experienced breast surgeon; or otherwise deemed appropriate candidates for neoadjuvant treatment. 2. Stage IIIB (T4, Any N, M0) or (Any T, N3, M0) disease Physical examination, chest x-ray and any x-rays or scans needed for tumor assessment must be performed within 90 days prior to registration All patients must have a multiple gated acquisition (MUGA) scan or echocardiogram scan performed within 90 days prior to registration and left ventricular ejection fraction (LVEF) percentage must be greater than the institutional lower limit of normal Patients must have a serum creatinine and bilirubin ≤ the institutional upper limit of normal, and an serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) ≤ 2x the institutional upper limit of normal. These tests must have been performed within 90 days prior to registration Patients must have an absolute neutrophil count (ANC) of ≥ 1,500/μl and a platelet count of ≥ 100,000/μl. These tests must have been performed within 90 days prior to registration Patients must have a performance status of 0-2 by Zubrod In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday four weeks later would be considered Day 28. This allows for efficient patient scheduling without exceeding the guidelines. If Day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients with the clinical diagnosis of congestive heart failure or angina pectoris are NOT eligible Pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. A urine pregnancy test is required for women of childbearing potential | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-60.0, HIV Associate Weight Loss HIV positive men, 18-60 years of age, with objective evidence of HIV-infection with low to low-normal testosterone levels (<400 ng/dL). In boys before the age of 18, the hormonal and body composition changes of puberty can confound the data. We will men over 60 because of age-related changes in testosterone levels and body composition, and increased risk of prostate disease Documented weight loss within the previous 6 months of between 5-15% of body weight, or an actual body mass index (BMI) at screening of between 17 and 20 (= 85-95% of the lower limit of ideal weight) An energy intake of at least 80% of the estimated requirements. On stable and potent antiretroviral therapy for at least 12 weeks, and in whom, in the opinion of the primary care provider, a change in antiretroviral therapy is unlikely in the next 4 months. Stable therapy may those not on any antiretroviral therapies and whom, in the opinion of the primary care provider, will not be starting antiretroviral therapy in the next 4 months CD4 cell count >50 /mm3, and HIV-copy number less than 10,000 copies/ml Testosterone levels <400ng/dL Able and willing to provide informed consent and comply with the protocol Concurrent severe lipodystrophy* according to the patient and the investigator, defined as "the new appearance of thin extremities due to loss of subcutaneous fat (especially the medial compartment of the thigh) along with the new appearance of prominent veins. Loss of tissue in the buccal fat pad and subgluteal region provides further evidence that thin extremities may be in large part due to loss of fat and not just muscles." History of prostatic or mammary cancer Significant diarrhea defined as 6 or more stools per day with recent change in bowel habits towards more frequent stools, especially if associated with weight loss and fever Use of any androgen, growth hormone, or other anabolic or orexigenic agents within the past 6 months Use of systemic corticosteroids, except for topical application Significant cardiac, renal, hepatic or other diseases that, in the opinion of the Investigator, may put the subject at risk if entered onto the trial or prevent successful completion of the trial AIDS defining illness (CDC HIV Classification, 1993: Clinical Category C) within the previous 3 months (except HIV wasting syndrome) Malignancy, other than Kaposi's Sarcoma localized to the skin Involvement in (vigorous) resistance exercise training programs (body building) in the past 3 months Diabetes mellitus Limiting neuromuscular, joint or bone disease, or history of stroke with residual neurological defect that would preclude measurements of muscle strength or physical function | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-75.0, Diabetes Mellitus For physician intervention included; 1)primary care (general internist or family) physician in HealthPartners Medical Group. 2)Provided ongoing care to 20 or more adult patients with diabetes For patients included; An established diagnosis of diabetes based on either (a) two or more ICD-9 diagnosis codes for diabetes in a 12-month period of time, or (b) a filled prescription for a diabetes-specific drug within a 12-month period of time. In addition, participating patients met all of the following (a) age less than 75 years, (b) Charlson comorbidity score of 3 or less, (c) linked to the a primary care physician who was participating in the study in two consecutive calendar years, (d) had pharmacy coverage at the time of the intervention and for the previous 12-month period, and (e) had either HBA1c > 7% or LDL > 130 mg/dl (or LDL > 100 mg/dl if the patient also had CHD) none | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Clostridium Infections Diarrhea Subject is 18 years of age or older, has acute diarrhea and at least 1 other sign of enteric infection present, such as fever, nausea/loss of appetite, vomiting, severe abdominal pain or discomfort Subject has a positive Clostridium difficile stool toxin assay at screening Subject has had a previous episode of clinically diagnosed Clostridium difficile within the past 6 months Subject has chronic diseases associated with diarrhea (e.g., inflammatory bowel disease or diarrhea predominant irritable bowel syndrome [DIBS]) Subject has had any therapy with any agent administered for the treatment of Clostridium difficile prior to randomization | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Clostridium Enterocolitis Pseudomembranous Colitis Patient must be > 18 years of age Clinical diagnosis of C. difficile associated disease, based on the new onset of diarrhea, abdominal discomfort, or otherwise unexplained fever or leukocytosis Diagnosis of C. difficile colitis proven by positive assay for C. difficile toxin in feces Disease has been treated, and the symptoms failed to respond to treatment with metronidazole or vancomycin, or symptoms promptly relapsed after completing a course of therapy with either of these drugs Able to take oral medication Patients with other recognized causes of diarrhea or colitis Women of child bearing age who are pregnant, breast feeding, or not using birth control Patients taking coumadin, phenytoin, celecoxib, or losartan Patients with renal insufficiency (BUN or creatinine >2 times baseline) Serious systemic disorder incompatible with the study | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-64.0, Clostridium Enterocolitis Pseudomembranous Colitis Antibiotic-Associated Colitis records of patients who have a fecal sample positive for C. difficile toxin and who are then treated for C. difficile colitis with oral metronidazole will be included in this study Patients who did not receive at least 7 days of metronidazole | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-999.0, Clostridium Enterocolitis Pseudomembranous Colitis Antibiotic-Associated Colitis All patients at the Houston VA with documented C. difficile infection None | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Enterocolitis Pseudomembranous Colitis Antibiotic-associated Colitis Subjects will be identified based on the diagnosis of CDAD. This diagnosis is made bases on the presence of diarrhea, fever, abdominal pain and/or leukocytosis together with a positive fecal assay for Clostridium difficile toxin Patients who are unable to take oral medications and those with underlying gastrointestinal disease or colonostomy will be excluded Patients currently taking penicillins, cephalosporins, quinolones or tetracyclines will be excluded because these drugs are active against Lactobacillus | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Enterocolitis Pseudomembranous Colitis Antibiotic-Associated Colitis Patients with antibiotic-associated diarrhea with a positive assay for C. difficile toxin Patients with antibiotic-associated diarrhea with 3 negative assays for C. difficile toxin Patients with antibiotic-associated diarrhea that has failed to respond to conventional therapy Hospitalized patients who have received >2 antibiotics and who have no symptoms of diarrhea or abdominal discomfort none | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Clostridium Enterocolitis Pseudomembranous Colitis Antibiotic-Associated Colitis Patients >18 years of age clinical diagnosis of C. difficile associated disease, based on the new onset of diarrhea, abdominal discomfort, or otherwise unexplained fever or leukocytosis diagnosis of C. difficile colitis proven by positive assay for C. difficile toxin in feces disease has been treated, and the symptoms failed to respond to treatment with metronidazole, or symptoms recurred after the patient has completed a course of metronidazole therapy able to take oral medication patients with other recognized causes of diarrhea or colitis women of child bearing age who are pregnant, breast feeding, or not using birth control patients of known causes of diarrhea, such as inflammatory bowel disease patients in whom diarrhea can not be evaluated, such as those with colostomy patients with renal insufficiency (BUN or creatinine >3.0 times baseline) patients who are medically unstable, for example in an ICU and on medications to maintain blood pressure patients who are regarded as unlikely to survive for 3 months | 1 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, LIVER TRANSPLANTATION Signed informed consent Adult patients scheduled to receive a liver transplant Donors older than 65 and/or has liver macrosteatosis >15% Female patients of childbearing potential agree to maintain effective birth control during the study and must have negative pregnancy test at baseline Patient has previously received or is receiving an organ transplant other than liver, or a liver re-transplantation Patient has significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, or active peptic ulcer Patient is receiving an auxiliary graft or a bio-artificial liver has been used Any pathology or medical condition that can interfere with this protocol study proposal Other applies | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.5-3.0, Diarrhoea Severe Malnutrition History of acute watery diarrhoea of <72 hrs 2. Either sex 3. Age months to 60 months 4. Some or severe dehydration 5. Wt for Ht <70% of NCHS median: with or without edema 6. Dark field examination positive for Vibrio cholerae 7. Consent Bloody diarrhoea 2. Severe infection (e.g. severe pneumonia, clinical sepsis, meningitis) 3.Those who received antibiotics/antimicrobial for the current illness | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 10.0-999.0, Cystic Fibrosis would those subjects with known CF who are able to give informed consent to undergo capsule endoscopy and whose guardians provide consent as well, if applicable. - Subjects would be excluded if they were felt to be poor surgical candidates as patients may need to undergo surgery in the rare event of retention of the capsule. Patients genotype and lung function will be noted; patients will be excluded if FEV1 < 40%. - | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-50.0, Abortion, Septic Patients admitted at the hospital with a diagnosis of infected abortion and about to be discharged from the hospital Use of intravenous antibiotics (gentamicin and clindamycin) Improvement of the clinical conditions for at least 48 hours (no fever, eating and walking normally, reduced vaginal bleeding) Unwilling to participate in the study Use of antibiotics previously within one week Presence of tubo-ovarian abscess Known allergy to doxycycline or metronidazole | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-999.0, Stroke Confirmed diagnosis of stroke in the last 1-6 months Persisting upper limb weakness - Alcohol/ Drug abuse Psychiatric history Previous illness that has impacted on individuals Activity of Daily living Dementia (assessed by MSQ) Severe Aphasia | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Diarrhea Eligible subjects included men or women, recently arrived in Mexico, at least 18 years of age, who developed acute diarrhea, which was defined as passage of 3 or more unformed stools in the preceding 24 hours accompanied by one or more signs or symptoms of enteric infection (e.g., nausea, vomiting, abdominal cramps, tenesmus, passage of grossly bloody stools or fecal urgency) with a duration of illness of less than or equal to 72 hours included pregnancy, breast feeding, an unstable medical condition, taking two or more doses of an antidiarrheal medication in the 24 hours before enrollment or any number of doses of symptomatic therapy within 2 hours of enrollment, or receiving an antimicrobial drug with expected activity against enteric bacterial pathogens within 7 days prior to enrollment | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Peritoneal Diseases Patients over 18 years old, of either sex, who have given their informed consent to participate in the study. 2. Patients in stable treatment with peritoneal dialysis for more than 6 weeks who present peritoneal dysfunction defined by capacity for standardized ultrafiltration (3.86% glucose maintained in the peritoneum for 4 hours) less than 600 ml and/or elevated creatinine transport (defined by D/P of creatinine higher than 0.65 after 4 hours). 3. Patients treated with icodextrin solution for peritoneal dialysis for at least one month before their inclusion. 4. Patients in whom the remaining dialyzing liquids used in their PD contain glucose and GDP (glucose degradation products) Peritonitis in the past 2 months. 2. Patients with bleeding at the time of or patients with a history of clinically evident bleeding episodes and/or with increased bleeding due to any other homeostatic alteration that contradicts anticoagulant treatment and/or in the past two months have presented at least one of the following situations: active hemorrhaging or organic lesions susceptible to bleeding (e.g. active peptic ulcer, hemorrhagic cerebrovascular accident, or aneurysms). 3. Major surgery in the past month. 4. Known hypersensitivity to low molecular weight heparin (LMWH), heparin or substances of porcine origin. 5. Known hypersensitivity to icodextrin. 6. Patients treated with systemic anticoagulation. 7. Patients with congenital or acquired bleeding diathesis. 8. Damage to, or surgical interventions of, the central nervous system, eyes or ears within the past 2 months. 9. Acute bacterial endocarditis or slow endocarditis. 10. Patients with a history of heparin-associated thrombocytopenia. 11. Patients with hepatic insufficiency (with values of AST and/or ALT > 5 times the normal value established in the reference range of the local hospital laboratory). 12. Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure over 120 mmHg). 13. Patients with inability or suspected inability to comply with treatment and/or complete the study. 14. Patients who are participating in another clinical trial or have done so in the past 30 days. 15. Patients with a life expectancy less than 6 months. 16. Women who are pregnant, breast-feeding or fertile women who are not using an effective contraceptive method | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.083-3.0, Diarrhea Dehydration Males Age 1 month up to 36 months Passage of 3 or more liquid stools in a 24-hour period, every day, and at least one in 12 hours prior to admission Diarrhea for < 7days (168 hours) severe systemic illness requiring intensive care management; systemic infection will be suspected if there is a general appearance of non-wellbeing with one or more of the following symptoms: shrill cry and irritability, temperature instability, hypotension, hypoglycemia, altered sensorium, lethargy or refusal of feeds, abdominal distension chronic illness like Tuberculosis, Nephrotic syndrome, malignancy etc or any surgical disorder severe malnutrition (weight for age <65% of NCHS median gross blood in stool refusal of consent | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 0.0-2.5, Pyelonephritis Renal Scars presence of vesico-ureteral reflux (VUR) grade II, III or IV, based on the International Classification, mono or bilateral, diagnosed between one day and 30 months of age after a first episode of acute pyelonephritis, or after birth during diagnostic procedures planned as a consequence of prenatal ultrasonographic evidence of pyelectasia previous episodes of urinary tract infection (UTI), even if only suspected (e.g. an episode of fever treated with antibiotics without performing urine culture) VUR grade I, because of the high probability of rapid spontaneous resolution VUR grade V, as requested by the Technical Scientific Committee, concerned by the high incidence of associated renal dysplasia recurrence of acute pyelonephritis before the first dimercaptosuccinic acid (DMSA) renal scan, if this was positive for scars | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 15.0-999.0, Hepatitis B A male or female > = 15 years of age at the time of the first vaccination Written informed consent obtained from the subject/ from the parents or guardians of the subject Seronegative for anti-HBs antibodies, anti-HBc antibodies & Hepatitis B Surface antigen (HBsAg) If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination Pre-haemodialysis patient* or a patient on haemodialysis Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine Previous vaccination against hepatitis B History of hepatitis B infection Known exposure to hepatitis B virus within 6 weeks. Pregnant or lactating female Clinically abnormal ALT/AST values (> 3 times normal values) | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 15.0-999.0, Hepatitis B Subjects were to have completed primary vaccination course. A male or female > = 15 years of age at the time of the first vaccination Written informed consent obtained from the subject/ from the parents or guardians of the subject If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she was to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period Pregnant or lactating female | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Acute Lymphoblastic Leukemia BCR-ABL1 Fusion Protein Expression Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Philadelphia Chromosome Positive Recurrent Acute Lymphoblastic Leukemia t(9;22) Diagnosis of one of the following: Previously untreated Ph-positive acute lymphoblastic leukemia (ALL) (either t(9;22) and/or BCR-ABL positive) (includes patients initiated on first course of hyper-CVAD before cytogenetics known). These groups will be analyzed separately. After 1-2 courses of chemotherapy with or without imatinib mesylate (Gleevec). If they achieved complete response (CR), they are assessable only for event-free and overall survival, or if they failed to achieve CR, they are assessable for CR, event-free, and overall survival. Patients with relapsed Ph-positive ALL or lymphoid blast phase of chronic myelogenous leukemia (CML) Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 Adequate liver function (bilirubin less than or equal to 3.0 mg/dl, unless considered due to tumor), and renal function (creatinine less than or equal to 3.0 mg/dl, unless considered due to tumor) Adequate cardiac function as assessed clinically Signed informed consent Active serious infection not controlled by oral or intravenous antibiotics Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year Active grade III-V cardiac failure as defined by the New York Heart Association criteria. Uncontrolled angina, or myocardial infarction (MI) within 6 months. Diagnosed or suspected congenital long QT syndrome. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes). Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 470 msec). Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes (unless these can be changed to acceptable alternatives) Prior history of treatment with dasatinib Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control History of significant bleeding disorder unrelated to cancer, including Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease) Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies) Patients with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Peritoneal Dialysis Hypertriglyceridemia written informed consent CAPD/APD on dialysis for at least 3 months Elevated fasting triglyceride levels enrolled in another study requiring IRB approval allergy to starch-based polymers glycogen storage disease maltose or isomaltose intolerance active alcohol/substance abuse Pregnant or nursing received an investigational drug within 30 days of screening | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 1.0-30.0, T Acute Lymphoblastic Leukemia T Lymphoblastic Lymphoma T-ALL patients must be enrolled on AALL08B1 prior to treatment and enrollment on AALL0434 Patients must have newly diagnosed T-ALL or T-lineage lymphoblastic lymphoma (T-NHL) stage II-IV; B-lineage lymphoblastic lymphoma will not be eligible for this study; a diagnosis of T-ALL is established when leukemic blasts lack myeloperoxidase or evidence of B-lineage derivation (cluster of differentiation [CD]19/CD22/CD20), and express either surface or cytoplasmic CD3 or two or more of the antigens CD8, CD7, CD5, CD4, CD2 or CD1a; if surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including transmission disequilibrium test (TdT), CD34 or CD99 will be assessed for expression; cases with uncertain expression will receive additional review within the appropriate Children's Oncology Group (COG) reference laboratory T-NHL For T-NHL patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to T-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and for immunophenotypic analysis to establish the diagnosis of T-NHL defined by the submitting institution will be accepted Prior therapy restrictions Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and/or IT cytarabine IT chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); systemic chemotherapy must begin within 72 hours of this IT therapy Patients diagnosed as having T-NHL or T-ALL with respiratory distress or hyperleukocytosis may require steroids prior to the initiation of additional systemic therapy; they are eligible for AALL0434 and will be stratified, based on the initial complete blood count (CBC); steroid pretreatment may alter the risk group assessment; if the T-ALL patient's clinical status precludes a lumbar puncture within 48 hours of the initiation of steroid therapy, T-ALL patients be classified as low risk and will be Intermediate or high risk based on the results of the day 29 marrow as above; patients with T-NHL who receive steroid pre-treatment will be classified as high risk; the dose and duration of previous steroid therapy should be carefully documented For the management of airway compromise, patients who have received emergent chest irradiation up to 600 cGy will be eligible for this study Patients with a prior seizure disorder requiring anti-convulsant therapy are not eligible to receive nelarabine; in addition, patients with pre-existing grade 2 (or greater) peripheral neurotoxicity, as determined prior to Induction treatment by the treating physician or a neurologist, are not eligible to receive nelarabine; these restrictions in are designed to prevent excessive nelarabine-induced central and peripheral neurotoxicity in at-risk patients; for the purposes of this study, this includes any patient that has received anticonvulsant therapy to prevent/treat seizures in the prior two years Pregnant or lactating females are ineligible Patients with Down syndrome are ineligible to enroll onto this study For T-NHL patients the following additional apply B-precursor lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma CNS3-positive or testicular involvement | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 13.0-999.0, Coccidioidomycosis Thirteen years of age or older, 34 kg (75 lb) or more, either sex, and any race Coccidioides immitis (C. immitis) or Coccidioides posadasii (C. posadasii) identified by culture or microscopic examination from skeletal disease, chronic active pulmonary disease, or soft tissue disease Coccidioidomycosis score of >=6 Clinical laboratory safety tests within normal limits or clinically acceptable to the sponsor Free of any clinically significant disease that would interfere with study evaluations Willing to give written informed consent and able to adhere to study medication dose, mandatory procedures (including human immunodeficiency virus (HIV) testing), and visit schedules Able to swallow food or a nutritional supplement Use of a medically accepted method of contraception Negative serum pregnancy test at Screening and negative urine pregnancy test at Randomization Women of childbearing potential not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study Key Excluded Medications at Enrollment Medications that are known to interact with POS or FLU and that may lead to serious or life threatening side effects within 7 days prior to initiating study drug Medications known to lower the serum concentration/efficacy of azole antifungals within 7 days prior to study drug start Prior investigational drug use or biologic product administration within 30 days before study drug start Prior antifungal treatment for the current episode of infection with a total cumulative dose of >=8 g of any azole, >=4 mg/kg of amphotericin B deoxycholate, or >=20 mg/kg of lipid amphotericin B Antiretrovirals that are substrates of CYP3A4 administered to HIV-positive subjects, as it is not currently known how POS or FLU may affect such drugs or the potential to cause adverse reactions Excluded Concomitant Conditions Immediately life-threatening coccidioidomycosis Confirmed or suspected meningeal coccidioidomycosis | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, Rheumatoid Arthritis Other protocol-defined inclusion/ may apply CORE STUDY Core Study At Screening 1. Cooperative male or non-pregnant, non-lactating female patients at least 18 years of age who signed an informed consent before the initiation of any study procedure. 2. Diagnosis of rheumatoid arthritis (RA) classified by American College of Rheumatology (ACR) 1987 revised and with symptoms for at least 3 months before randomization. 3. Functional status class I, II or III classified according to the ACR 1991 revised criteria. 4. Patients treated with methotrexate (MTX) at the maximum tolerated (≤25 mg/week) and stable dose of ≥7.5 mg/week for at least 12 weeks before randomization. 5. Patients who had failed any disease-modifying antirheumatic drugs (DMARDs) (including biologic agents and any DMARD used in combination with MTX) were allowed. 6. For patients with previous treatment of biological therapy, the following wash-out periods were required before randomization days for Kineret™ (anakinra) with a terminal half-life of 4 to 6 hours (s.c. route) weeks for Enbrel® (etanercept) with a terminal half-life of 102 ± 30 hours (s.c. route) weeks for Remicade® (infliximab) with a terminal half-life of 8.0-9. 5 days (intravenous (i.v.) infusion) weeks for Humira® (adalimumab) with a terminal half-life of 10-20 days (average 2 weeks) (subcutaneous (s.c.) route) weeks for Orencia® (abatacept) | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-50.0, Allergy Allergy to at least one aero allergen Increased serum IgE level Diagnosis of asthma Recent use of systemic corticosteroids or immunosuppressive treatment Allergy vaccination therapy | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 50.0-999.0, Osteoporosis Postmenopausal women at or above the age of 50, diagnosed with primary osteoporosis may be enrolled in the trial if the following inclusion/ apply. All must be answered "yes" for a subject to be enrolled in the trial. 1. Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject). 2. Is the subject female and at or above the age of 50? 3. Has the subject been postmenopausal for more than 5 years in the judgement of the investigator? 4. Does the subject have primary osteoporosis and a T-score equal to or lower than -2.5 SD; T-scores must be assessed by DXA at the lumbar spine L1-L4, with a minimum of two assessable vertebrae, or at the total hip (right hip, if there is a right hip prosthesis, left hip can be used. If both hips are replaced the subject can be included with a lumbar scan only). 5. Is the subject currently taking calcium and vitamin D3 or is she willing to start such supplemental treatment and continue throughout the trial period, unless she develops hypercalcaemia? 6. Has the subject been taking supplemental calcium (1,000 mg) and vitamin D3 (800 IU) daily for at least 14 days (after screening) before blood sampling for evaluation? [*] 7. Is the subject able to self-inject PTH(1-84), or get the injections by a helper? [*] Note that no. 6 can not be evaluated at the time for screening, must be evaluated at randomisation, visit 2. See also and note [**] All must be answered "no" for a subject to be enrolled in the trial. Has the subject: 1. been treated with SERMS (selective oestrogen receptor modulators) or calcitonin within the last 1 month? 2. ever been treated with any bisphosphonate in intravenous form (i.v.)? 3. been treated with any bisphosphonates (alendronate, risedronate, or other bisphosphonates) for more than 3 years in total, or within the last 6 months? 4. been treated with fluoride for more than 3 months within the last 10 years? 5. ever been treated with strontium ranelate? 6. ever been treated with teriparatide or PTH(1-84)? 7. received or is the subject currently receiving chronic glucocorticosteroid treatment? Defined as more or equal to: 5.0 mg prednisolon or equivalent daily for 3 months during the last year or 2.5 mg prednisolon or equivalent daily for 6 months during the last year. Local and inhalation steroids are permitted. 8. been treated for cancer (other than basocellular skin cancer) within the last 5 years? 9. ever received radiation therapy to the skeleton? 10. ever had malignant disease affecting the skeleton? or does the subject: 11. currently receive antiepileptic medication? 12. take any other medication (other than calcium and vitamin D3) that is known to affect bone metabolism? according to the investigator's opinion. 13. have any known clinically significant diseases affecting calcium metabolism? 14. have any known history of metabolic bone diseases other than primary osteoporosis including hyperparathyroidism, Paget's disease, osteogenesis imperfecta, or osteomalacia)? 15. have any known history of hypersensitivity to parathyroid hormone or strontium or any of the excipients in the products? 16. have a serum vitamin D3, (serum 25(OH)D) level <20 ng/ml after at least 14 days of calcium and vitamin D3 supplementation? [**] 17. have a serum PTH of > 65 pg/ml and also a total serum calcium value >2.49 mmol/l? [**] 18. have hypercalcaemia (total serum calcium value >2.55 mmol/l), measured after at least 14 days of calcium and vitamin D3 supplementation? [**] 19. have elevated serum alkaline phosphatase? Defined as > 3X ULN [**] 20. have impaired kidney function with creatinine clearance < 30 ml/min (indirect measurement by serum creatinine)? [**] 21. have severe impaired liver function ? [**] 22. have phenylketonuria? or is the subject: 23. at risk of having venous thromboembolism including pulmonary embolism? according to the investigator's opinion. 24. scheduled for vertebroplasty? 25. currently participating in a clinical trial with an investigational medical product, or has done so within the last 90 days, or plan to do so within the next 32 weeks? Previous and current participation in non-interventional trials is allowed. [**] no. 16 to 21 can not be evaluated before the result of the blood sampling (planned within the screening period and after at least 14 days of supplemental calcium/vitamin D3 intake) is available | 0 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 18.0-999.0, End Stage Renal Disease Male or female patients who are at least 18 years of age. 2. Patients who have read, understood and given written informed consent after the nature of the study has been explained. 3. Patients who have a diagnosis of ESRD (GFR ≤ 10 ml/min), without a permanent access for dialysis. 4. Patients who are able to comprehend a modality education program. 5. Patients who are judged as capable of being trained for home based PD. 6. Patients as justified by their physicians requiring dialysis treatment within 6 weeks after randomization (Patients who require urgent temporary dialysis before randomization may also be eligible for recruitment after being stabilized with temporary HD or PD) 7. Patients who are expected to remain on dialysis for at least 6 months. 8. Patients must have a negative HIV test at screening. - Patients that have already received a permanent catheter or access that is intended for permanent therapy use before receiving modality information, or have already received permanent dialysis (If an access is present within 4 weeks prior to screening for back-up purposes, or for acute treatment for life threatening uremic symptoms, electrolyte abnormalities or fluid overload, this does not the patient from enrollment). 2. Patients who previously have received renal transplantation and are still prescribed immunosuppressive therapy. 3. Patients who are unwilling or unable to follow the protocol. 4. Patients with concomitant participation in any other interventional study, or who have received any investigational drug, biologic or device within five half-lives of the physiological action or 30 days, whichever is longer, prior to screening. 5. Patients justified as not eligible for either PD or HD due to PD: documented extensive intra-peritoneal adhesions, severe infective skin disorder, or other situation contradicting PD (eg., active inflammatory bowel disease) HD: severe cardiac instability and inability to a gain permanent vascular access. 6. Patients who have a history of drug or alcohol abuse within the six months prior to entering the study 7. Patients who have active systemic infections, such as tuberculosis, septicemia or systemic fungal infections. 8. Patients who have malignancies requiring active chemotherapy or radiation therapy. 9. The presence of other terminal illness likely to cause death within 6 months 10. Patients who have any other serious acute or active conditions that in the investigator's opinion would preclude their participation in the study. 11. Female patients who are pregnant, lactating or planning on becoming pregnant during the study period. 12. Patients who are allergic to starch-based polymers, maltose or isomaltose 13. Patients who have glycogen storage disease. 14. Patients who have a significant psychiatric disorder or mental disability that could interfere with the patient's ability to provide informed consent and/or comply with protocol procedures - | 2 |
Patient is a 55yo woman with h/o ESRD on HD and peritoneal dialysis who presented with watery, non bloody diarrhea and weakness. She has a history of 2 prior C diff infections, the most recent just 1 month ago. Recent antibx use in the last month on prior admission. Was also txd for Cdiff at that time for 14 d. course with po vanco. Pt was initially admitted to the ICU and was septic on pressors (levophed) until the morning of [**8-26**] with leukocytosis but no fever. C diff assay positive on admission, and pt had leukocytosis consistent with C diff. Patient was placed on Vanco po, Flagyl IV and Flagyl po initially, and when patient improved she was transitioned to Vanco oral and Flagyl oral on [**8-29**]. Patient was treated with Vanco for an extended course of 6 weeks given her recurrent C diff. Pt was also encouraged to take probiotics and to bleach her home when she was discharged. | eligible ages (years): 20.0-999.0, Type 2 Diabetes Mellitus Diagnosed with type 2 diabetes Have been exposed to exenatide for at least 3 months in previous Amylin/Lilly Studies H8O-MC-GWAO, H8O-MC-GWAP, H8O-MC-GWAT, or H8O-MC-GWBA Have interrupted exenatide treatment for a period of at least 2 months HbA1c of ≤10.5% Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry Have previously completed or withdrawn from this study Have taken marketed exenatide (Byetta) during the interim period between studies GWAO, GWAP, GWAT, or GWBA and the current study Used drugs for weight loss (for example, Xenical® [orlistat], Meridia® [sibutramine], Acutrim® [phenylpropanolamine], Accomplia® [rimonabant], or similar over-the-counter medications) within 3 months of screening Are currently treated with any of the following excluded medications: Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics Use insulin with daily dosage exceeding 1 U/kg | 0 |
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