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A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-85.0, Lung Abscess Adult 18-85 years of age Patients referred to pulmonologists, oncologists, or thoracic surgeons for the evaluation of peripheral lung nodules found on CT scan Repeat CT scans, biopsy or surgical excision are clinically indicated to determine the etiology of the nodule One or more lung nodules must be between 8 mm and 30 mm in the greatest diameter Patients must be fully informed of the investigational nature of the procedure and sign an informed consent Lung nodules or masses greater than 30 mm in the greatest dimention Lung nodules that have solid calification Lung nodules or masses with CT evidence of partial or complete obstruciton of a lobar bronshus, mainstem bronchus or the trachea No prior cancer with the exception of non-melanoma skin cancer Life expectany of < t months Any indifidual who does not give oral and written consent for participation - | 1 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-45.0, Schizophrenia, Undifferentiated Type For patients Men and women, right handed, 18 to 45 years Having given their written informed consent Presenting a diagnosis of schizophrenia made by DMS IV, hospitalized or followed regularly in a hospital proper, and whose symptoms are stable for at least 6 weeks, at the discretion of the psychiatrist Receiving antipsychotic treatment (risperidone or aripiprazole) monotherapy stable (treatment and dose) for at least than 6 weeks Showing no contra-indication for fMRI Patients whose physical examination is unremarkable clinically significant Patients without serious somatic pathology Affiliated to a social security system For women of childbearing potential, an appropriate contraception is mandatory and an negative pregnancy test For patients Patients in menstruation without effective contraception (oral, intramuscular hormonal, intrauterine device, or surgical) Patients who are pregnant or breastfeeding Patients not meeting for schizophrenia according to DSM IV or those with resistant schizophrenia (Kane criteria) Introducing a somatic disease or serious neurological, particularly Parkinson's disease, epilepsy, tardive dyskinesia and disabling cardiovascular disease, liver or kidney disease Presenting a contra-indication to MRI Having a history of alcoholism or drug addiction during the past year Participating in another clinical trial or are in a period of from a previous protocol Patients likely to have behavioral self aggression from the trial investigators During the study | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-80.0, Lung Cancer Chronic Obstructive Airway Disease age 18-80 competent confirmed lung cancer history of other cancers | 1 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Solitary Pulmonary Nodule Age> 18 years in patients with solitary pulmonary nodule who had percutaneous needle biopsy for diagnosis of lung nodule patients who do not agree the study enrollment | 1 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Lung Cancer Patients undergoing elective, open and thoracoscopic thoracic surgery for any indication Age < 18 years old Inability to consent for the study Chest wall anatomy precluding SATS Inability to sit upright | 1 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Melanoma Histologically documented cutaneous malignant melanoma which is recurrent or metastatic and is not curable by surgical or other means Patients must have tumour tissue from their primary and/or metastatic tumour available to assess putative molecular markers of response (paraffin block or 12 unstained slides) Presence of clinically and/or radiologically documented disease. At least one site of disease must be unidimensionally measurable as follows Chest X-ray > 20 mm, CT scan (with slice thickness of < 5 mm) >10 mm (longest diameter), Physical exam (using calipers) > 10 mm, Lymph nodes by CT scan > 15 mm measured in short axis All radiology studies must be performed within 21 days prior to randomization (Exception: Within 28 days if negative) Patients must have either maximum tumour lesion size of ≤ 50 mm OR if tumour lesion is > 50 mm, LDH must be ≤ 2.5 x ULN Patients must have a life expectancy of at least 12 weeks Age > 18 years ECOG performance status of 0-1 Previous Therapy Patients with known HIV, Hepatitis B or Hepatitis C infection History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for > 5 years Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction, other interventional cardiac procedure within the past 12 months, autoimmune conditions requiring chronic immunosuppressive therapy, or psychiatric illness/social situations that would limit compliance with study requirements Patients may not have received any other investigational agents within 28 days of study entry, and may not receive concurrent treatment with other anti-cancer therapy or investigational agents while on protocol therapy Patients with known brain metastases or history of CNS metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. A head CT or MRI is required on all patients to rule out brain metastases Pregnant or lactating women. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with rIL-21 or dacarbazine, breastfeeding should be discontinued if the mother is treated with protocol therapy Prohibited Medications: Long Term (> 7 days) Systemic Corticosteroids (e.g. prednisone, dexamethasone, etc.) because these may counteract the stimulatory effects of rIL-21 on lymphocytes. (Note: Topical steroids are allowed) | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Lung Cancer All patients with CT identified pulmonary nodules not deemed to be visualizable during VATS who are candidates for VATS resection Inability to consent for the study Patients less than 18 years old Patients with pulmonary nodules easily located during VATS Patients with tumours extending to visceral pleura or chest wall Patients who have chest anatomy precluding VATS resection | 1 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 40.0-80.0, Yield of Cryo Biopsy in Lung Cancer Solitary Pulmonary Nodule solitary pulmonary nodule < 4 cm no endobronchial lesion indication for bronchoscopy coagulopathy pulmonary hypertension pregnancy | 1 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 0.0-18.0, Craniopharyngioma Obesity Diagnosed with craniopharyngioma for the first time Age at diagnosis 18 years or less of age Agreement from patient's parents or legal guardian as well as the patient for in randomization study Histological diagnosis of craniopharyngioma Age at diagnosis 18 years or less of age Age at primary surgery over 5 years of age Incomplete primary resection Reference radiological confirmation of an incomplete resection Agreement from patient's parents or legal guardian as well as the patient Age at diagnosis over 18 years of age No QoL measurement for randomization (3 months after surgery) | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Incisional Hernia age ≥18 years asymptomatic/ oligosymptomatic incisional hernia no hernia detectable by physical examination acute incarcerated hernia emergency hernia repair pain or discomfort associated with the hernia during normal activities local or systemic infection ASA score >3 inability to complete or comprehend the preoperative questionnaire repair with biologic prothesis | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 4.0-22.0, Medulloblastoma Age at diagnosis at least 4 years or 5 years (according to the policy of the National Brain Tumour Group) and less than 22 years Histologically proven medulloblastoma, including the following variants(WHO classification : classic medulloblastoma, nodular / desmoplastic medulloblastoma, melanotic medulloblastoma, medullomyoblastoma No CNS metastasis on MRI supratentorial, arachnoid of the posterior fossa or spine No clinical evidence of extra-CNS metastasis No tumour cells on the cytospin of lumbar CSF. Central Review of CSF cytology is recommended but not mandatory. It will be left to national policy Radiotherapy to start no more than 40 days after surgery Ability to receive twice daily radiotherapy Vital functions within normal range for their age group CTC grades < 2 for liver, renal, haematological and audiological function One of the is lacking Brainstem or supratentorial primitive neuroectodermal tumour Atypical teratoid rhabdoid tumour Medulloepithelioma Ependymoblastoma Large cell médulloblastoma Metastatic medulloblastoma (on CNS MRI and/or positive cytospin of postoperative lumbar CSF) Patient previously treated for a brain tumour or any type of malignant disease Patients who are pregnant Females who are sexually active and not taking reliable contraception | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-90.0, Bronchiectasis Bronchiolitis All patients with bronchiectasis or bronchiolitis All patients with severe lung disease other than bronchiectasis Active lung infection Active infection other site except the lung | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Lung Cancer Participant is a lung cancer patient Participant is under 18 years old Participant is not a lung cancer patient | 2 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 50.0-999.0, Solitary Pulmonary Nodules Multiple Pulmonary Nodules Renal Neoplasms Adrenal Gland Neoplasms Aortic Aneurysm, Abdominal Liver Neoplasms Adnexal and Skin Appendage Neoplasms Lymphadenopathy Pancreatic Neoplasms No participant sub-populations will be excluded prior to selection (the E1 population will be matched to the Case Group populations) Data from the 15 participating sites from the ACRIN 6664 trial provide a study data set of 2531 participants, broken down into a total target study data set of 520 participants. Participants will be distributed into one of three cohorts as follows The Case Group will target consenting 141 participants from the cases with indeterminate but potentially significant findings (E3/E4s) other than pulmonary nodules The Pulmonary Nodules Case Group will comprise 119 cases with E3/E4 ECFs characterized as pulmonary nodules The E1 Control Group will be drawn from the 866 E1 ECF cases to create a cohort of 260 E1ECF cases. The Control Group for comparison with the Case Group and the Pulmonary Nodules Case Group will be selected at the Biostatistics and Data Management Center (BDMC). The BDMC will match E1 141 controls to the 141 case-group participants with indeterminate but potentially significant findings (E3/E4s). The BDMC will also match 119 E1 controls to the 119 E3/E4 pulmonary nodules cases. Controls will be matched by site, age caliper (5 years), and sex where possible. Where an appropriate match cannot be obtained, the matching will be relaxed. If potential participants decline study consent, we will then best-match additional cases for the appropriate group to maintain target populations. Any additional cases beyond the initial 520 participants identified for medical record collection will be matched as feasible | 2 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Small Bowel Obstruction Gastrointestinal Hemorrhage Patients 18 years and older Patient or proxy willing to provide informed consent Patients who require placement of a nasogastric/orogastric tube, in the ED or ICU, as standard of care, AND a member of the study staff is available and present for NG/OG tube placement It is anticipated that the patient will remain in the ED/ICU in order to obtain RightSpot pH Indicator reading and verifying CXR Patients less than 18 years of age Patient or proxy unwilling or unable to provide informed consent Patient with known or suspected pregnancy | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Solitary Pulmonary Nodule Multiple Pulmonary Nodules Subjects who meet all of the following may be enrolled in this Study Subject is male or female, age 18 or older Subject has undergone CT scan of the lung(s) that indicates one or more nodules or lesions suspicious for lung cancer Subject's pulmonary nodule or lesion is greater than 4mm. Size is determined by the largest nodule or lesion dimension identified from CT imaging Subject meets one or more of the following conditions indicated for a tissue biopsy of the lung indicated for surgical resection of the lung being followed by CT for nodule growth within a 1-year time frame* subject must receive at least one follow-up CT by their 1-year enrollment anniversary or within 60 days after their 1-year enrollment anniversary to continue in the Study Subject must be able to receive a ProLung Test The following will disqualify a subject from enrollment into this Study Subject has an implanted electronic device in the chest Subject receiving therapy for suspected chest infection such as fungal infection or tuberculosis Subject with diagnosed malignancy other than lung cancer who has 2 or more suspicious pulmonary nodules Subject has received an invasive medical or surgical procedure within the thoracic cavity within 30 days prior to the ProLung Test or within the previous 14 days for a bronchoscopic procedure Subject presents with an anomalous physical or anatomical condition that precludes ProLung Test measurement Subject will have undergone unusually strenuous exercise within 24 hours Subject who has significant systemic diseases such as uncontrolled diabetes, advanced heart failure, or a recent myocardial infarction, or other medical condition such as severe morbid obesity that in the judgment of the Principal Investigator would make him/her unsuitable for the Study | 1 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 16.0-999.0, Hypotension Arterial pressure <100 mm/Hg at presentation At least one of the following symptoms Unresponsive Syncope Impaired mental status Respiratory distress Severe malaise and fatigue Patients undergoing cardiopulmonary resuscitation Trauma patients Electrocardiographic and clinical diagnosis of STEMI or Clear cause of shock that needs immediate intervention (hemorrhage, gastrointestinal bleeding, drugs overdose) Late evolution of shock state in a patient already treated with known diagnostic tests | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 16.0-90.0, Pneumothorax Radiologic diagnosis of pneumothorax Clinical need to perform a CT scan Ability to perform the lung ultrasound imaging within 20 minutes from the CT study age less than 16 years | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Metastatic Pancreas Cancer Histologically documented metastatic pancreatic adenocarcinoma not previously treated with palliative systemic therapy Metastatic disease based on the presence of clinically and/or radiologically documents Measurable disease base on Adequate tissue (core biopsy) available for IHC testing of hENT1. This may be from primary tumour or metastatic site. Fine needle aspiration biopsies will not be allowed. Histological/cytological confirmation of tissue to ensure sufficient material is available for hENT1 analysis by the Cross Cancer Institute is required prior to starting a patient on study. Biopsies from metastatic sites must be obtained ≥ 3 months after any adjuvant chemotherapy (if applicable). If a patient has had previous surgical resection of their primary tumours, that tissue can be utilized. Tissue sufficient for preparing ≥ 10 unstained slides for central storage and testing is required ECOG performance status of 0 Age ≥ 18 years Life expectancy of at least 3 months based on discretion of treating oncologist Adequate hematologic function defined by the following laboratory parameters Hemoglobin ≥ 100 Platelet count ≥ 100 Absolute granulocyte count ≥ 1.5 Patients who have received prior palliative chemotherapy for their metastatic pancreatic adenocarcinoma Radical pancreatic resections (e.g. Whipple procedure) are not allowed < 6 months prior to randomization. Exploratory laparotomy, palliative (e.g. bypass) surgery, or other procedures (e.g. stents) are not allowed < 14 days prior to randomization. In any of the above cases, patients must be adequately recovered and stable prior to randomization Prior treatment with > 6 cycles of traditional alkylating agent-based chemotherapy, > 2 cycles of carboplatin-based chemotherapy, prior treatment with irinotecan or oxaliplatin chemotherapy, or concurrent treatment with other experimental drugs or anti-cancer therapy Curative radiation treatment to the pelvis or radiation therapy to ≥ 25% of bone marrow stores Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, short gut syndrome, or history of bowel obstruction due to peritoneal metastases Previous or concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix or non-melanoma skin cancer, unless at least 5 years have elapsed since last treatment and the patient is considered cured Any serious medical condition within 6 months prior to study entry such as myocardial infarction, uncontrolled congestive heart failure, unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, cerebrovascular diseases, uncontrolled hypertension, uncontrolled diabetes, uncontrolled psychiatric disorder, serious infection, active peptic ulcer disease, or other medical condition that may be aggravated by treatment Known dihydropyrimidine dehydrogenase (DPD) deficiency Pre-existing neuropathy ≥ grade 2 from any cause Patients with unstable metastasis to the central nervous system are excluded. Patients who have treated brain metastasis and are off steroids, anticonvulsants, and have documented stability of lesions for at least 3 months may be eligible. A CT scan or MRI is NOT required to rule out brain metastases unless there is clinical suspicion of CNS involvement | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Primary Graft Dysfunction All consecutive bilateral lung transplant recipients Immediate need for extracorporeal life support following transplant (those requiring ECLS four hours after intensive care admission can be included as the investigators would have obtained some ELWI measurements) Contraindications to femoral artery catheterization (eg, abdominal aortic aneurysm) | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 20.0-40.0, Assess the Efficacy of Differentiated and Undifferentiated Stem Cell Therapy in Improving Endometrial Receptivity. ICSI candidates with repeated implantation failure and history of development of good embryos in previous ICSI cycles Advanced maternal age above 38 years Poor endometrial response to ovulation induction drugs Endometrial atrophy Presence of infection in the form of vaginitis, cervicitis or hydrosalpinx Presence of uterine abnormality as uterine septum Presence of any pathology distorting the uterine cavity as submucus polyp or submucus myoma Marked sperm morphology abnormality High FSH > 12 IU | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 0.0-999.0, Pneumonia All patients who present to the ED with respiratory symptoms suspicious for pneumonia In whom the treating physician believes would benefit from diagnostic imaging Patients who arrive at the ED with a previously performed CXR Unstable patients with life-threatening injuries who require ongoing resuscitation | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 40.0-75.0, Lung Cancer ages 40-75 years If ages 40-59, then one of the following needs to be met Current or ex-smoker with >25 pack years and a family history of lung cancer(parent or sibling) OR current or ex-smoker with > 25 pack years and COPD OR current or ex-smoker with a > 35 pack year history If ages 60-75, then one of the following additional needs to be met Current or ex-smoker with >25 pack years and a family history of lung cancer (parent or sibling) OR Current or ex-smoker with >25 pack years and COPD OR Current or ex-smoker with a >30 pack year history Subject is able to return to Cleveland Clinic for annual follow-up screening Current health requires oxygen Have had a chest x-ray or CT of the chest within the last 6 months Previous pneumonectomy Lobectomy of the lung within the last 5 years Diagnosed malignancy within the last 5 years, excluding non-melanoma skin cancer, carcinoma in situ of the cervix and localized prostate cancer A medical condition that would prevent treatment for lung cancer Within the last 6 weeks, one of the following has occured A new cough or chronic cough that has gotten worse Either new shortness of breath, or any worsening of shortness of breath A cough producing blood | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Transitional Cell Carcinoma Written informed consent Age ≥ 18 Life expectancy ≥ 12 weeks Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) including mixed pathology with predominantly TCC, with locally advanced (T4b) or metastatic (lymph node or visceral) TCC arising from bladder or upper urinary tracts Treated patients with incidental prostate cancer (pT2, Gleason ≤ 6) and PSA (Prostate Specific Antigen) ≤ 0.5 ng/mL are eligible Measurable disease as per 1.1 ECOG Performance Status 0-1 Previously received first line platinum based treatment Recurrence within 12 months (by version 1.1) from last cycle of chemotherapy Previous therapy with a taxane Pure non TCC histologies Grade II or more peripheral neuropathy Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrolment in the study Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus) Inadequate organ and bone marrow function as evidenced by Hemoglobin < 9.0 g/dL Absolute neutrophil count < 1.5 x 109/L Platelet count < 100 x 109/L AST/SGOT and/or ALT/SGPT > 2.5 x ULN | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-48.0, Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean Delivery Term healthy parturients Body Mass Index > 35 preeclampsia neurological,cardiovascular, respiratory disease | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 8.0-17.0, Persons With Frontal Lobe Damage With no Specific Language Disorder frontal lobe damage at least one year after injury native hebrew speaker specific language disorder premorbid learning disability | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 55.0-74.0, Lung Carcinoma Men and women who at the time of randomization are less than 55 or greater than or equal to 75 years of age Individuals undergoing treatment for cancer at this time, excluding basal-cell and squamous-cell skin cancer Individuals with known prior cancer of the colon, rectum, lung, prostate (men only) or ovary (women only) This includes primary or metastatic PLCO cancers Individuals with previous surgical removal of the entire colon, one lung, or the entire prostate (men only) Until October 1996, women with previous surgical removal of both ovaries were excluded from the trial. In order to increase the enrollment of women into the trial, beginning in October 1996, these women were no longer excluded for this reason Individuals who are participating in another cancer screening or cancer primary prevention trial Males who have taken Proscar/Propecia/finasteride in the past 6 months NOTE: Individuals who are already enrolled in the trial when their physician prescribes finasteride are not prevented from taking this medication. As a result, these participants will continue to be screened and followed just as those participants who are not on finasteride NOTE: Men who are taking Tamoxifen are not excluded from any part of the PLCO Screening Trial | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 50.0-75.0, High Risk of Developing Lung Cancer Smokers or former smokers At least 20 pack year history of smoking Ages 50 Had a CT scan of chest within last 24 months History of any cancer within 10 yrs (except skin cancer or cervical cancer) A serious illness that decreases life expectancy to less than 5 years Any current use of Oxygen Uncontrolled congestive heart failure or cardiac arrhythmia that would prevent surgery for a lung lesion Severe COPD or dyspnea that would prevent lung surgery or stereotactic body radiotherapy | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 21.0-999.0, Lung Cancer All patients aged above 21 years, capable of giving consent and suspected of lung cancer with radiological lung nodules and masses Patients with contra-indications to bronchoscopy and CT-TTNA that active myocardial ischemia, uncorrected coagulopathy, severe respiratory distress, uncontrollable cough, and pregnancy will be excluded. Before females in the reproductive age are recruited, urine pregnancy test will be performed and confirmed negative | 2 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 0.0-999.0, Soft Tissue Sarcoma cases of undifferentiated sarcomas from ARST0332 (additional cases may be ascertained as eligible for this current project that also fall under ARST0332 to be requested later if necessary) | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Non-small Cell Lung Cancer Metastasis From Other Cancers Histological confirmation of malignancy, unless the risks of biopsy are unacceptable and the lesion has grown on serial CT scan and/or is PET positive Eligible patients must have staging studies (e.g. chest radiograph, CT scan, MRI/CT Brain/Bone Scan) identifying them as patients with stage I or II, non-metastatic NSCLC (T1, N0, M0; T2, N0, M0; or T3, N0, M0 chest wall primary tumors only) patients with a non-lung primary that is controlled and which has metastasized to the lungs alone, in whom potentially curative surgery would otherwise be an option (e.g. colorectal, breast, sarcoma…etc) the subset of patients with limited (low) volume metastatic NSCLC or other primary site tumors whom it is felt may derive benefit from highdose SBRT treatment to the primary or metastatic lung tumor. And in whom other sites of metastatic disease are being treated with the desire to achieve long term control. Lesions must meet size in 4.1.2.1 Patients who have potentially resectable disease should be considered medically inoperable, or else in the judgement of the thoracic surgeon and lung team, surgery is not considered the preferred management option Early stage lung cancer: ≤3 parenchymal lung lesions, Metastatic disease to lungs: ≤5 parenchymal lung lesions Patients with early stage primary NSCLC should have hilar or mediastinal lymph nodes that are considered N0 on clinico-radiological grounds (i.e. no clinico-radiological evidence of lymph node spread) In patients with early stage primary NSCLC and a co-existing malignancy, the co-existing malignancy must have an expected prognosis better than primary lung lesion Adequate lung function to tolerate the planned stereotactic radiation Patients with active systemic, pulmonary or pericardial infection No concurrent systemic therapy (chemotherapy, immunotherapy or biological therapy), apart from hormone therapy, is allowed History of active auto-immune diseases, including systemic lupus erythematous, rheumatoid arthritis, C.R.E.S.T., systemic sclerosis,scleroderma Potential candidate for concurrent chemo-radiation therapy Patient enrollment on other studies may be permissible. This will depend on patient and study characteristics | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Lung Cancer peripheral lung nodules < 3cm in size Surgical candidate Non surgical candidate | 1 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-45.0, Multiple Sclerosis (MS) Must be between the ages of 18 and 45 years, inclusive Must have a body mass index (BMI) of 19 to 28 kilograms/height (m)2, inclusive, and have a minimum body weight of 50 kilograms (at screening and baseline) Must give written informed consent History of severe allergic or anaphylactic reactions History of hypersensitivity to acetaminophen (paracetamol) or ibuprofen. Subjects in Part III of the study will also be excluded for history of hypersensitivity to human albumin History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease History of asthma, as defined by wheezing, dyspnea, or cough requiring treatment with either inhaled beta-2-agonists, inhaled corticosteroids, inhaled cromolyn sodium, or oral steroids or history of chronic obstructive pulmonary disease (including chronic bronchitis, bronchiectasis, or emphysema) Abnormal screening full pulmonary function tests (PFTs) or baseline spirometry (predicted values are those of the European Coal and Steel Community (Quanjer, 1983)) or abnormal screening or baseline oximetry, as defined by any one of the following <80% predicted Forced expiratory volume (FEV1) <80% predicted forced vital capacity (FVC) <70% FEV1/FVC ratio <80% predicted total lung capacity (TLC) <80% predicted diffusion capacity, corrected for hemoglobin (DLCOcorr) | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Metastatic Melanoma At least 18 years of age Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's Regional Ethics Board/Independent Ethics Committee (REB/IEC) Histologically documented cutaneous or mucosal malignant melanoma, which is recurrent or metastatic and is not curable by surgical or other means Adequate tumour tissue (greater than 0.5cm3 preferred, 3 X core biopsy acceptable) available and agreement from subjects that this tissue from their primary and/or metastatic tumour be made available for assessment of potential biomarkers Ability and availability to complete all prescribed biomarker studies (Screening and after Cycle 2) Recovered to Grade 1 from reversible toxicities of prior therapy Presence of clinically and/or radiologically documented disease. At least one site of disease (which will not be removed during the course of the study) must be uni-dimensionally measurable as per 1.1 or clinically quantifiable (such as in the case of skin disease) ECOG performance status of 0 Prior treatment with any number of immunotherapies (e.g., IL2, ipilimumab), targeted therapies (e.g., vemurafenib) are permitted but no more than one 1 prior chemotherapy Acceptable liver function Anticancer treatment with radiation therapy, targeted therapies, chemotherapy, immunotherapy, hormones or other antitumour therapies within 28 days prior to first dose of TH-302 Subjects who have received any other investigational drug or agent within 28 days of first dose of TH-302 Current use of drugs with known cardiotoxicity Significant cardiac dysfunction Seizure disorders requiring anticonvulsant therapy Progressing brain metastases (unless previously treated and stable disease for a period of greater than or equal to 3 months on repeat MRI following definitive treatment) History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for greater than 2 years Severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation less than 90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause hypoxia of normal tissue Major surgery, other than diagnostic surgery, within 4 weeks prior to Cycle 1 Day 1, without complete recovery Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 40.0-999.0, Emphysema Chronic Obstructive Pulmonary Disease (COPD) Willing and able to provide informed consent and to participate in the study Age > or = 40 years at the time of the screening Advanced lower or lower and upper lobe predominant heterogeneous emphysema by CT scan Minimum of 2 subsegments appropriate for treatment MRCD questionnaire score of 2 or greater at screening Failure of medical therapy to provide relief of symptoms Spirometry 15 minutes after administration of bronchodilator (BOTH) FEV1 < 50 % predicted FEV1/FVC ratio <70 % Lung volumes by plethysmography (BOTH) Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, or prior lung transplantation Requirement for ventilator support (invasive or non-invasive) Three (3) or more COPD exacerbations requiring hospitalization within 1 year of Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks of Screening visit Pulmonary hypertension, defined as Echocardiogram with estimated peak systolic pressure > 45 mmHg in the presence of tricuspid valve regurgitation stated in the echocardiogram report If the echocardiogram shows peak systolic pressure > 45 mmHg, right heart catheterization is required to rule out pulmonary hypertension, defined as peak systolic pressure > 45 mmHg or mean pressure > 35 mmHg Clinically significant asthma (reversible airway obstruction) or bronchiectasis CT scan: Presence of the following radiologic abnormalities Pulmonary nodule on CT scan greater that 1.0 cm in diameter (Does not apply if present for 2 years or more without increase in size or if proven benign by biopsy/PET) Radiologic picture consistent with active pulmonary infection, e.g., unexplained parenchymal infiltrate | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Malignant Solid Tumour Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment Evaluable tumour deposits by one or more techniques (X-ray, CT, MRI, ultrasound) Age 18 years or older Life expectancy of at least three months Patients had to give written informed consent (which must be consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) and local legislation) Eastern Cooperative Oncology Group (ECOG) performance score < 2 Full recovery from all therapy-related toxicities from previous chemo-, hormone-,immuno-, or radiotherapy History of relevant surgical procedures during the last four weeks prior to treatment with the trial drug, or active ulcers, or injuries with incomplete wound healing Pregnancy or breastfeeding Active infectious disease Brain metastases requiring therapy Absolute neutrophil count less than 1500 / mm3 Platelet count less than 100 000 / mm3 Bilirubin greater than 1.5 mg / dl (> 26 μmol / L, International System of Units (SI unit) equivalent) Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal) Serum creatinine greater than 1.5 mg / dl (> 132 μmol / L, SI unit equivalent) Uncontrolled, severe hypertension | 1 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Malignant Neoplasm of Lung A soft tissue solitary dominant pulmonary nodule of ≥ 8mm and ≤30mm on axial plane Measured on lung window using conventional CT scan No other ancillary evidence strongly indicative of malignancy (e.g. distant metastases or unequivocal local invasion) If clinicians and reporting radiologists believe the patient is being treated as having a single pulmonary nodule and there are other small lesions <4mm that would normally be disregarded, the patient should be included in the trial Nodules already under surveillance can be included provided they have a recent or scheduled FDG-PET/CT18 years of age or over at time of providing consent Able and willing to consent to study Pregnancy History of malignancy within the past 2 years Confirmed aetiology of the nodule at the time of qualifying CT scan As this is a diagnostic study, should the aetiology of the nodule be confirmed by investigation such as FDG-PET/CT or bronchoscopy prior to consent the patient remains eligible as the intention to is made on the analysis of the qualifying CT scan Biopsy of nodule prior to DCE-CT scan Contra-indication to potential radiotherapy or surgery Contra indication to scans (assessed by local procedures) | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, PROSTATE CANCER Treatment naïve group Men with no prior diagnosis of prostate cancer undergoing prostate biopsy based on identified lesions on imaging Men with a raised PSA above 15ng/ml Men giving informed consent Treated men Men undergoing tissue biopsy for suspicion of prostate cancer recurrence following previous local or systemic therapy based on identified lesions in multi-parametric MRI, bone-scan, choline PET/CT, or PET/MRI Unable to have MRI scan or CT scan, or in whom artefact would reduce scan quality Unable to have prostate biopsy Unable to undergo biopsy for metastatic evaluation On immunosuppression or predefined immunosuppressed state A coagulopathy predisposing to bleeding Unable to give informed consent | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Solitary Pulmonary Nodule Bronchial Neoplasms age over 18 years Planed thoracoscopic surgery of a pulmonary nodule Informed consent mental incapacity contraindications for this treatment pregnancy | 1 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Squamous Cell Carcinoma of the Anus Histologically or cytologically verified, uni-dimensionally measurable, inoperable, locally recurrent or metastatic squamous cell carcinoma of the anus Age ≥18 years ECOG Performance status ≤2 Measurable disease according to Response Evaluation in Solid Tumours (RECIST) version 1.1 Previous definitive chemoradiotherapy is permitted for early stage squamous cell carcinoma of the anus HIV+ patients will be considered eligible with a CD4 count of ≥200 Adequate cardiac and respiratory function; absolute neutrophil count (ANC) ≥1.5x10^9/l; white blood cell (WBC) count ≥3x10^9/l; platelets >100x10^9/l; haemoglobin (Hb) ≥9g/dl; creatinine clearance >50ml/minute; serum bilirubin ≤1.5x upper limit of normal (ULN); alanine transaminase (ALT)/aspartate transaminase (AST) ≤2.5x ULN; alkaline phosphatase (ALP) ≤3x ULN Fertile men and women must agree to take adequate contraceptive precautions during, and for at least six months after therapy Life expectancy of at least 3 months Tumours of adenocarcinoma, melanoma, small cell and basal cell histology are excluded Previous chemotherapy, radiotherapy or other investigational drug for surgically unresectable locally recurrent or advanced squamous cell carcinoma of the anus Current or recent (within 30 days of first study dosing) treatment with another investigational drug or participation in another investigational study Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease Surgery or palliative radiotherapy within 28 days of randomisation Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease, uncontrolled cardiac arrhythmia, or myocardial infarction within the last 6 months). Any history of clinically significant cardiac failure History of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan Lack of physical integrity of the gastro-intestinal tract, malabsorption syndrome (naso-gastric or jejunostomy feeding tube is permitted) Acute hepatitis C and/or chronic active hepatitis B infection Serious active infection requiring i.v. antibiotics at enrolment | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Acute Respiratory Distress Syndrome (ARDS) intubation and mechanical ventilation in the ICU Ramsay score 6 under sedation and analgesia ICU respirator implemented with pressure-volume curve device age equal to or greater than 18 years ARDS defined from the Berlin absence of pneumothorax on the CXR before the study Absence of pleural effusion greater than 500 ml estimated from ultrasonography no child-bearing woman written inform consent signed by the next of kin Pneumothorax Pleural effusion greater than 500 ml estimated from ultrasonography Thoracic surgery in the last 3 months Contra-indication to CXR contra-indication to PEEP of 15 cm H2O contra-indication to PEEP of 15 or PEEP 15 mandated pressure-volume curve not feasible refusal to participate language barrier of the next of kin child-bearing woman | 1 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Lung Cancer Subjects of all races and ethnic origins over 18 years of age will be recruited Patients must have suspicious or known to be malignant solitary pulmonary nodule,5cm or less in size Patients with a contraindication to MRI examinations will be excluded from this study Contraindications to MRI examinations Medically unstable Heart failure Unstable angina Child bearing Lactating Not a surgical candidate Any contraindication per MRI Screening Form (Appendix A attached). This is the same form used in clinical practice at UT Southwestern Titanium implants, pacemakers | 2 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-90.0, Stroke Upper Extremity Paresis age between 18-90 years old hemisyndrome (central paralysis of the upper extremity, and all degrees of weakness: M0 M5 on the paresis scale) as a result of a first stroke sub-acute lesion not more than 6 weeks post ictus insufficient state of consciousness severe aphasia severe cognitive deficits severe pathologies of the upper extremity of traumatic or rheumatic nature severe pain in the affected arm Patients with pacemakers and other active implants | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 21.0-999.0, Video-assisted Thoracoscopic Surgery (VATS) One-lung Ventilation signed informed consent elective left video-assisted thoracoscopy one lung ventilation Anticipated difficult mask ventilation or intubation tracheal or high bronchial origin of the right upper lobe main bronchus severe COPD or asthma pleural disease previous left thoracic surgery chest radiotherapy chimiotherapy significant systemic co-morbidity active or chronic pulmonary infection fibrosis, other interstitial diseases | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-65.0, Asthma Bronchial Asthma Males or females age 18 or greater and 65 or less The diagnosis of asthma confirmed by at least one of the following as assessed at least once during the past 5 years before the study Reversibility to β2-agonists ≥12% predicted and ≥200ml after 400μg inhaled salbutamol or equivalent Bronchial hyper-responsiveness to methacholine or histamine Peak-flow variability of >20% over a period of 14 days Fall in FEV1 >12% and >200ml when tapering treatment (ICS, oral steroid, LABA and/or LTRA) Subject is taking regular maintenance medication (GINA step 4-5) for past 6 months that includes Inhaled corticosteroid at a dosage ≥500μg fluticasone equivalent per day AND Long acting ß2-agonist at a dosage of ≥100μg per day salmeterol dose aerosol or equivalent) Per protocol bronchial hyper-responsiveness to methacholine (PC20<4 mg/ml) Asthma exacerbation during the prior 4 weeks Subject has 5 or more hospitalizations for exacerbations of asthma in the previous year or 1 or more ICU admission for mechanical or endotracheal intubation for asthma in the previous year Respiratory tract infection within past 4 weeks Subject has a known sensitivity to medications required to perform bronchoscopy Subject is using immunosuppressant therapy other than oral steroid therapy Subject is on anticoagulant medication including anti-platelet agents Subject has bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 125,000/mm2 or known coagulopathy (INR >1.5) Subject has other respiratory diseases including interstitial lung disease, emphysema, cystic fibrosis, mechanical upper airway obstruction, Churg-Strauss syndrome, and allergic bronchopulmonary aspergillosis (total IgE of >1000 Units/mL with positive specific IgE to aspergillus and evidence of central bronchiectasis) Subject has segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax, confirmed on x-ray. Bronchiectasis on HR-CT-of the chest, both centrally or peripherally will be excluded Subject has clinically significant cardiovascular disease, including myocardial infarction, angina, cardiac dysrhythmia, conduction defect, cardiomyopathy, aortic aneurysm, or stroke at the discretion of the investigator | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Metastatic Anaplastic/Undifferentiated Thyroid Cancer Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer Histologically or cytologically confirmed diagnosis of anaplastic thyroid cancer or undifferentiated thyroid cancer that demonstrates mutation in the ALK gene as assessed by sequencing of the tumor specimen for Arm A. Other ALK abnormalities as detected by the approved FISH test (Abbott Molecular Inc), using Vysis breakapart probes (defined as 15% or more positive tumor cells); or the Ventana IHC test will also be seen as evidence of ALK abnormality and meeting requirement Patients will not have any other curative therapeutic option, such as radiation or surgery WHO performance status 0-2 Age greater then or equal to 18 years Patients must have recovered from all toxicities related to prior anticancer therapies to ≤ Grade 2 (CTCAE v 4.03), provided that any concomitant medication is given prior to initiation of treatment with ceritinib. Exception to this criterion: patients with any grade of alopecia are allowed to enter the treatment Adequate organ function: the following laboratory have been met Absolute neutrophil count (ANC) greater then or equal to 1.5 x 109/L Hemoglobin (Hgb) ≥ 8 g/dL Platelets greater then or equal to 75 x 109/L Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN), except for patients with Gilbert's syndrome who may be included if total bilirubin ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN Patients eligible must not meet any of the following Patients with known hypersensitivity to any of the excipients of ceritinib (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate) Patients with symptomatic CNS metastases who are neurologically unstable or have required increasing doses of steroids within the 1 week prior to study entry to manage CNS symptoms Prior therapy with ceritinib Presence or history of a malignant disease other than thyroid cancer that has been diagnosed and/or required therapy within the past year and is undergoing active anticancer treatment. Exceptions to this the following: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type Patients with known history of extensive disseminated bilateral interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and clinically significant radiation pneumonitis (i.e. affecting activities of daily living or requiring therapeutic intervention) Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as unstable angina within 6 months prior to screening myocardial infarction within 6 months prior to screening history of documented congestive heart failure (New York Heart Association functional classification III-IV) | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Melanoma Brain Metastases Cohort 1 and 3 ≥18 years of age Written informed consent AJCC Stage IV (any T, any N, M1c) histologically confirmed melanoma or unknown primary melanoma. Patients must have at least 1 radiological definitive brain metastasis that is ≥ 5mm and ≤40mm measurable per version 1.1 guidelines In patients with prior BRAF inhibitor treatment, intracranial disease progression must be demonstrated (RECIST >20% or new measurable brain metastases) compared with nadir of intracranial response during BRAF inhibitor treatment, and confirmed with a second MRI brain scan after drug washout period (+/‐ 3 days) No prior localised treatment for brain metastases (eg. surgery or radiotherapy) Neurologically asymptomatic from brain metastases Eastern Cooperative Oncology Group (ECOG) Performance Status of 0‐2, and life expectancy > 30 days Able to undergo MRI with Gadolinium contrast agent Adequate haematological, hepatic and renal organ function Any melanoma brain metastasis >40mm Ocular melanoma Prior treatment with an anti‐PD‐1 or anti‐PD‐L1 , anti‐PD‐L2, anti‐CD137, or anti‐CTLA‐4 antibody, or any other antibody or drug specifically targeting T‐cell co‐stimulation or checkpoint pathways Patients with active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll Current systemic treatment with corticosteroids, except prednisone at nonimmunosuppressive doses of ≤ 10 mg/day (or equivalent). Past treatment for non‐neurological symptoms allowed, if ceased 2 weeks prior to starting study treatment. Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if patient on a stable dose. Non‐absorbed intraarticular steroid injections will be permitted Any investigational drug or other systemic drug therapy for melanoma within 28 days or 5 half‐lives from baseline Known to be HIV positive, or a positive test for hepatitis B and C Another malignancy or concurrent malignancy unless disease‐free for 3 years Serious or unstable pre‐existing medical conditions or other conditions that could interfere with the patient's safety, consent, or compliance Pregnant or breastfeeding females | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-75.0, Melanoma Cutaneous melanoma with a tumour thickness of at least 1,00mm Positive sentinel node with micro metastases of max. 2mm in diameter Mucosal or ocular melanoma Cutaneous melanoma located in the head/neck region Evidence of satellite, in transit or local metastases / recurrences Macro metastases of the SN or micro metastases of >2mm in diameter Additional immune-suppressive therapy Pregnant of lactating women | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 0.0-999.0, Rectal Neoplasms Patients with biopsy-proven confirmed rectal cancer MRI stage: T3/T4 and/or N1/N0 No contraindication to MRI and PET-CT Contraindication to MRI and/or PET-CT Inability to consent Severe claustrophobia Distant metastases Synchronous tumour | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-50.0, Frontal Lobe Epilepsies (Patients) Age between 18 and 50 Diagnosis of frontal lobe epilepsy Written consent to participate Right-handed Hospital Anxiety and Depression Scale Score under 10 Obsessive Compulsive Inventory Score under 40 Sufficient language skills Social insurance (controls) (Patients) Seizures types other than epileptic (psychogenic etc.) Mental retardation Epilepsies other than FLE Other known neurological diseases Hospital Anxiety and Depression Scale Score over 10 Obsessive Compulsive Inventory Score over 40 Pregnancy non-MRI suitable transplants (cardiac pacemaker etc.), claustrophobia, orthopedic diseases that prevent lying in the scanner During period of other studies | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 40.0-999.0, Lung Cancer COPD Subjects must meet all of the following Be enrolled in COPDGene® Phase 1 with or without enrollment in Phase 2 with newly diagnosed, (within the time of enrollment), non-small cell lung cancer (NSCLC) or small-cell lung cancer (SCLC) Documented GOLD stage 1-4 COPD or a history of smoking with no COPD Signed HIPAA Research Authorization and a Release of Protected Health Information form to collect and review medical records regarding lung cancer diagnosis, treatment, and outcome | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 55.0-74.0, Lung Carcinoma Solitary Pulmonary Nodule Cigarette Smoker Patients at high risk for lung cancer as defined by the United States Preventive Services Task Force (USPSTF) for lung cancer screening, with a newly discovered indeterminate pulmonary nodules (IPN) (7-30 mm diameter) on CT (newly seen on medical imaging, without prior examinations to demonstrate that the lesion has been stable for two or more years), untreated The patient is aged 55 to 74 years of age, AND Has a 30 or more pack-year history of smoking, AND Currently smokes, or, if the patient has quit smoking, has quit within the last 15 years, or An adult patient with a newly diagnosed, untreated primary lung cancer, with a minimum diameter of 7 mm The patient must be able to give informed consent, which will a layman's explanation of the estimated amount of additional radiation that the patient will receive from the investigational PET/CT scan using 18F-FSPG Pregnant or lactating patients will be excluded, as will females of childbearing potential who refuse to undergo a serum or urinary beta-human chorionic gonadotropin (HCG) pregnancy test the day of either the 18F-FSPG or the 18F-FDG PET/CT scans Patients with a body weight of 400 pounds or more or a body habitus or disability that will not permit the imaging protocol to be performed The patient's inability to lie still for the entire imaging time (such as due to cough, severe arthritis), as assessed upon pre-enrollment screening, will not be enrolled A recognized active lung infection Previous systemic or radiation treatment for cancer of any type within 2 years Refusal to undergo a clinically indicated biopsy or a 24-month period of follow-up, if needed, to resolve the etiology of their IPN (benign versus cancer) Non-oncologic co-morbidities suggesting a life span of less than two years if not treated, as determined by the potential subjects' treating physician | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Lung Cancer Pulmonary nodule on a recent CT non-visible on standard-size bronchoscopy missing informed consent | 1 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 40.0-999.0, Lung Diseases, Interstitial Lung Cancer equal to above 40 years old | 2 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Rectal Neoplasms Adenocarcinoma of the rectum classified clinically T2, T3a, T3b (penetration in the mesorectal fat between 1 to 5 mm) by TNM classification (Tumour Node Metastase), < 5 cm largest diameter, < half rectal circumference (by MRI staging), N0-N1 (any node < 8 mm diameter on MRI), M0 Operable patient Tumour accessible to endocavitary contact X-Ray Brachytherapy with a distance from the lower tumour border to the anal verge ≤ 10cm 18 years or above No comorbidity preventing treatment Adequate birth control Patient having read the information note and having signed the informed consent Health care insurance available Follow-up possible Inoperable patient T1, T3cd, T4, T≥ 5cm, T≥ ½ circumference Patient N2 at diagnosis or N1 with any node > 8 mm diameter Patient presenting metastasis at diagnosis Previous pelvic irradiation Tumour with extramural vascular invasion Simultaneous progressive cancer Tumour invading external anal sphincter and within 1 mm, and the levator muscle Patient unable to receive CXB or CRT Tumour with poor differentiation (G3) | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 55.0-75.0, Lung Cancer relatives of the lung cancer patients age older than 55 years old or age older than the age of onset of lung cancer proband if the family members were less than 55 years old compulsory signing the consent agreement after understanding the purpose of study and the exposure of radiation proved lung cancer either with or without treatment presence of hemoptysis or history of remarkable lung fibrosis any other cancer history or chest CT examination within one year | 2 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 18.0-999.0, Prostatic Neoplasms Able to provide informed consent ECOG performance status 0-1 Histologic confirmation of prostate adenocarcinoma Stage IV disease, with up to 5 metastatic tumours outside of the prostate and pelvic lymph nodes ≤ 3 tumours within any given organ system (e.g. up to 3 brain metastases, or 3 liver metastases) All sites of disease are amenable to stereotactic radiotherapy Castrate resistant prostate cancer Evidence of spinal cord compression Previous radiotherapy for current cancer (with the exception of upfront management of the primary prostate tumour, brain metastasis(es) prior to androgen deprivation therapy) Inability to safely treat all sites of visible disease Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, and in-situ cancer | 0 |
A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. | eligible ages (years): 21.0-999.0, Solitary Pulmonary Nodule Coin Lesion, Pulmonary Lung Neoplasms Carcinoma, Non-small-cell Lung The target population includes adults with small lung nodules that may represent a new diagnosis of lung cancer, who typically would be managed by CT surveillance in usual clinical practice. Thus, we will enroll all adult patients aged ≥21 years at least one nodule measuring ≤15 mm in widest axial diameter on chest CT Pregnant Women Children Known diagnosis of cancer (except non-melanoma skin cancer) within 5 years Multiple (>10) nodules on chest CT scan | 1 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 45.0-74.0, Cardiovascular Diseases Heart Diseases Atherosclerosis Asthma Carotid Artery Diseases Coronary Disease Hypercholesterolemia Hypertension Diabetes Mellitus Obesity | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 0.0-999.0, Atherosclerosis Coronary Disease Arterial Occlusive Diseases Peripheral Vascular Diseases Cardiovascular Diseases | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 0.0-999.0, Cardiovascular Diseases Peripheral Vascular Diseases Atherosclerosis Cerebrovascular Disorders Myocardial Infarction Heart Diseases Hyperhomocysteinemia | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Diabetes Mellitus, Type 2 Intermittent Claudication Group I (n=25 PAD patients). This sample will represent the population of veterans with PAD with mild mobility impairment secondary to intermittent claudication in the gastrocsoleus muscles for PAD Subjects diagnosis of PAD (acute or chronic occlusive arterial disease), with or without diabetes mellitus positive Edinburgh Claudication Questionnaire Fontaine stage IIa only (mild claudication, walking distance > 200 feet (one-half block) ambulatory, without assistive devices calf muscle claudication within 10 minutes of treadmill walking and calf muscle exercise Group II (n=25 normal control/reference subjects). This reference sample will represent the population of adults without PAD and related problems. They will undergo the PET-exercise testing for perfusion and glucose metabolism measurements, but will not perform the exercise training intervention for Controls healthy adults, matched by age and sex to PAD subjects for PAD and Control Subjects PAD secondary to Buerger's disease, autoimmune arteritis, fibromuscular dysplasia, chronic and repetitive occupational trauma, venous stasis, hypercoagulability disorder, or arterial embolic disease inability to perform ankle dorsi and plantar flexion exercise cigarette smoking within last 6 months severe claudication, leg rest pain, skin ulceration, necrosis or gangrene (Fontaine stage >= IIa) poorly controlled diabetes mellitus (bA1c >= 9%) poorly controlled hypertension (resting BP > 140/90 mmHg) Raynaud's syndrome changes in prescribed cardiovascular medications within the past 6 months exertional angina, dyspnea, fatigue, or dizziness | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 50.0-75.0, Hypertension Postmenopausal women Mild to moderate hypertension Statin therapy or LDL≤ 4.1 mmol/L Severe hypertension LDL > 4.1 mmol/L if not taking anti-hyperlipidemic medication Certain hormonal therapy History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm Liver, kidney, or pancreas disease Diabetes Raynaud's disease or any other significant peripheral vascular disease Allergy to certain medications used to treat high blood pressure Other protocol-defined inclusion/ | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-90.0, Peripheral Vascular Diseases Receive stable peritoneal dialysis patients for more than 3 months Active infection, malignancy and recent hospitalization | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Hypertension 18 years of age Patients with stage II systolic hypertension If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study Hypertensive encephalopathy, stroke or transient ischemic attack (TIA) within the past 6 months History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months Severe hypertension (DBP greater than or equal to 110 mm Hg or SBP > 200 mm Hg) History of secondary hypertension including renal disease, phaeochromocytoma, or Cushing's disease Type I diabetes mellitus. 6. Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial Flutter Laboratory test values considered clinically significant by the investigator Evidence of liver disease as indicated by SGOT or SGPT and/or total bilirubin > 3 times the upper limit of normal Pregnant or lactating females Patients with malignancy during the past 5 years excluding squamous cell or basal cell carcinoma of the skin | 1 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-70.0, Tachycardia Chronic Orthostatic Intolerance Chronic symptoms (> 6 months) with standing upright Obvious cause of hypovolemia or drugs that could worsen tachycardia Chronic severe medical conditions such as cancer or ischemic heart disease | 1 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-80.0, Venous Insufficiency Diabetes Diabetic ulcer, OR Venous insufficiency ulcer Age range: 18-80 years Wound max. diameter range: 1.5 centimeters Wound San Antonio assessment system: grade 1 and 2, stage A and B Palpable pulses in the Posterior Tibial and the Dorsalis Pedis arteries Ankle-Brachial Index > 0.7 by Doppler Wound present for at least 6 weeks Wound location: foot or calf, at a location where the device can be attached properly Lack of purulent discharge from the wound Hypoalbuminemia: Albumin < 2gr/dl Right-side congestive heart failure with edema of legs: +2 or higher Renal insufficiency: Cr > 2 mg/dl Abnormal liver function: ALT or AST>300 Skin disorders adjacent to the wound, unrelated to the pathology of the wound Non-cooperative patient | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 21.0-999.0, Peripheral Artery Disease Severe Intermittent Claudication Males or females equal to or greater than 21 years old Patients with infra-inguinal atherosclerosis with a stenosis or occlusion of a major vessel in the affected limb(s) of one or more of the following arteries: superficial femoral, popliteal, or one or more infrapopliteal arteries, which is/are non-reconstructable Patients with symptoms of Severe Intermittent Claudication in at least 1 lower limb persisting for at least 6 months (Rutherford Class 3) Patients who have a diagnosis of Peripheral Arterial Disease (PAD) in at least 1 lower limb secondary to atherosclerosis, for at least 6 months Patients who have had successful aortic or lower extremity arterial surgery, angioplasty, or lumbar sympathectomy within 3 month preceding screening Patients with iliac disease amenable to revascularization Patients judged to be a suitable candidate for surgical or percutaneous revascularization in the limb in which treatment is proposed Patients with Critical Limb Ischemia (CLI), Rutherford Symptom Score of 4,5, or 6 Patients in who arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 16.0-999.0, Diabetes Mellitus Hypertension Dyslipidemia Obesity Cardiovascular Disease Coronary Artery Disease Age 16 years or more Informed consent Living in selected community (Health Promotion area of Rajavithi Hospital) | 1 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Peripheral Vascular Disease Written informed consent Age > 18 years If female patient with child bearing potential, patient may not be pregnant at the study entry and must utilize reliable birth control for the duration of her participation into the study Patient is willing and able to comply with the specified follow-up evaluation Critical Limb Ischaemia, this is Fontaine stage III (ischaemic rest pain) and IV (ischaemic ulcers or gangrene) or Rutherford category 4 (ischaemic rest pain), 5 (minor tissue loss) or 6 (major tissue loss) Stenotic (>50% luminal loss) or occluded infrapopliteal artery, including the tibiofibular trunk, the anterior tibial artery, the posterior tibial artery and the peroneal artery, with a lesion length ≤ 60 mm Artery to be treated with a diameter more tham or equal to 2mm and less than or equal to 4mm Patent common iliac, external iliac, superficial femoral and popliteal artery on the ipsilateral side prior to randomisation, possibly after treatment during the same session At least one patent crural (anterior tibial, posterior tibial or peroneal) artery with expected unobstructed runoff to ankle level after treatment Acute limb ischaemia Subacute limb ischaemia which requires thrombolysis as first treatment modality Active bleeding or bleeding diathesis Recent (less than 3 months) hemorrhagic stroke or other any other CNS abnormality with increased risk of haemorrhage, such as intracranial neoplasm, arteriovenous malformation, intracranial aneurysm or aneurysm repair Gastrointestinal or genitourinary bleeding of clinical significance within the previous 6 weeks before treatment Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateral side Revascularization involving the same limb within 30 days prior to the index procedure or planned revascularization of the same limb within 30 days of the index procedure Previous implanted stent at the index site Life expectancy of less than 6 months or other factors making clinical follow-up difficult Known allergy to acetylsalicylic acid (aspirin), clopidogrel, heparin or paclitaxel | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Coronary Artery Disease Peripheral Vascular Disease Patient ≥ 18 years old Coronary or peripheral vascular intervention 6 French arterial sheath used Overnight hospitalization following procedure Hematoma or persistent bleeding around the vascular sheath Previous AV fistula or pseudoaneurysm in the ipsilateral femoral artery History of bleeding diathesis or coagulopathy Hemoglobin level < 9 g/dl Inability to ambulate at baseline Known allergy to any of the materials used in the SafeSeal Female patients known to be pregnant or lactating Evidence of ongoing systemic or cutaneous infection Uncontrolled blood pressure following PCI (systolic blood pressure > 180 or diastolic blood pressure >110) Current enrolment in another ongoing investigational drug/device trial | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-85.0, Lower Extremity Chronic Venous Ulcers Patient must have a venous leg ulcer Participants, either men or women are between 18 and 85 years of age Clinical presentation of venous insufficiency demonstrated by Doppler Ankle-Brachial Index > 0.7 by Doppler Good palpable pulses in the Posterior Tibial and the Dorsalis Pedis arteries Wound present for at least 6 weeks prior to enrolment Wound length is in the range of: 1.5 centimeters The necrotic tissue area is at least 20% of wound area. (by clinical evaluation, i.e., inspection) Wound San Antonio classification: Grade 1 or 2, Stage A or B Documented sensitivity to Papain, by medical history records Patients in need of surgical debridement Patients with general skin disorders (Psoriasis, Peniculitis ect) that might deteriorate as a result of local trauma Patients with skin disorders unrelated to the ulcer that are presented adjacent to the wound Pain sensation is completely absent (wound area is anesthetic) Patients with renal failure. (Cr > 2 mg/dl) Patients with impaired hepatic function (ALT, AST or GGT 2-fold higher than normal upper limit value) Patients having Hypoalbuminemia: (Albumin < 2gr/dl ) Patients with general Immunological disorders that might deteriorate as a result of local trauma Right-side congestive heart failure (CHF) with edema of legs: (NYHA class 2 or higher see 5) | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 50.0-80.0, Cardiovascular Disease Hypertension Hyperlipidemia Heart Disease All men over 50 to 80 and all women 55 to 80 who are resident in Kalaleh, Golestan, for at least one year Existing cardiovascular disease (stroke, transient ischaemic attack, myocardial infarction or angina) Already taking antihypertensive drugs, aspirin or statins Already have clinical indications for treatment with antihypertensive drugs, aspirin or statins Blood pressure >160/100 mm Hg Total Cholesterol > 240 mg/dL (or LDL >190 mg/dL) Probable diabetes: HbA1c >6.0 Contraindication to a component of the Polypill Contraindications to aspirin Previous history of allergy to aspirin History of peptic ulcer bleeding in whole life or endoscopic evidence of peptic ulcer within the past 3 months | 1 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 19.0-999.0, Critical Limb Ischemia Severe Leg Ischemia Peripheral Artery Disease Peripheral Vascular Disease Males or females older than 18 years of age Limb ischemia with ABI of < 0.7 in the index lower extremity in two consecutive examinations done at least 1 week apart Limb ischemia with resting ischemic pain and/or claudication at 100 meters and/or non-healing ulcers Claudication Patients not considered candidates for surgical or percutaneous revascularization, due to poor target vessels, inability to cross total occlusions, or a morbidity which precludes general anesthesia Inability to provide informed consent Previous angiogenic therapy Known sensitivity to gentamycin and/or amphotericin B Use or expected use of antineoplastic drugs Any illness, which might affect the patient's survival after enrollment in the protocol Any illness or significant laboratory abnormality, which in the investigator's judgment will interfere with the patient's ability to comply with the protocol, compromise the patient's safety, or interfere with the interpretation of the study results No evidence of acute infection WBC > 15000 WBC < 4000 Serum Creatinine > 3.0 mg/dL in patients who are not in hemodialysis | 2 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 40.0-999.0, Intermittent Claudication Aged 40 or older, male or female mo. history of walking limitation or symptoms of intermittent claudication (IC) in at least 1 lower limb, severity of which has not changed in the past 3 mo. and diagnosed by principal investigator as clinically stable Fontaine Stage II peripheral artery disease (PAD) Diagnosis of PAD secondary to atherosclerosis If ankle-brachial index (ABI) is > 1.3 or cannot be measured in either leg, vascular etiology documented by toe-brachial index (TBI) ≤ 0.7 in at least 1 leg Claudication severity, meds. for the treatment of coronary artery disease (CAD), PAD and IC, and exercise habits should be clinically stable for 3 mo. prior to Screening (SCRN) and during study. Pt. is not likely to change smoking and/or exercise habits during study On an exercise treadmill test (ETT), peak walking time (PWT) of at least 1 min., but no more than 12 min. at Baseline Willing and able to discontinue Pletal or Trental for 21 days before SCRN and during study Antihypertensive therapy, cholesterol-lowering therapy, chronic oral nitrates, and diabetic therapy have been stable for 30 days prior to SCRN Willing and able to provide written, signed, informed consent after the nature of the study has been explained and prior to any research-related procedures Willing and able to comply with all study-related procedures Pregnant or lactating Current or history of critical limb ischemia (CLI) Pts. in whom artery insufficiency in the lower extremity is the result of acute limb ischemia (ALI) or an immunological or inflammatory non-atherosclerotic disorder Pts. in whom walking impairment due to pain is the result of other non-atherosclerotic co-morbid conditions A surgical intervention to alleviate symptoms of IC or PAD-specific endovascular intervention or cardiovascular surgery within 3 mo. of SCRN Walking limited by reasons other than claudication Conditions other than IC of significant severity that could confound PWT on the ETT Concurrent severe congestive heart failure (CHF) Life-threatening ventricular arrhythmias, unstable angina, and/or myocardial infarction (MI) within 3 mo. before enrollment (ENRL) Coronary artery bypass grafting or percutaneous coronary intervention within 4 mo. before ENRL | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Hypertension Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed Men or women 18 years and older of African American background; self identified Patients with stage 2 hypertension. Patients must have a MSSBP ≥ 160 mmHg and < 200 mmHg at Visit 5 (randomization) Office blood pressure measured by cuff (MSSBP ≥ 200 mmHg and/or MSDBP ≥ 110 mmHg) at any visit Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives whichever is longer History of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (CCBs or thiazide diuretics) as the study drugs Long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL) Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method Adequate barrier methods of contraception diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives any marketed contraceptive agent that includes an estrogen and/or a progestational agent. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL [and estradiol < 20 pg/mL] or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment History or evidence of a secondary form of hypertension | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 39.0-70.0, Lower Extremity Ischemia an obliterating lower extremity atherosclerosis IIB a stage (on Fontaine classification) a painless walking distance of 10-50 m pulse absence on аа. dorsalis pedis, tibialis posterior, poplitea absence of a ischemia in a rest and necrotic changes mainly distal form of disease (a lesion of a superficial femoral artery, a popliteal artery, anticnemion arteries) according to an angiography that testifies to impossibility of reconstructive operation performance patients after a lumbar sympathectomy and a tibial bone osteoperforations executed previously heavy smokers insulin depended diabetes myocardial infarction or a stroke within last year an idiopathic hypertensia III stage anaemia and other diseases of blood decompensation of the chronic diseases which are contraindications to any surgical operation HIV infection a virus hepatitis oncologic diseases chemotherapy in the anamnesis | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-90.0, Peripheral Arterial Disease Male or female subject 18 to 90 years, of any race Patients with proven Peripheral Arterial Disease (PAD) in Doppler Ultrasound and Ankle-Brachial Pressure Index (ABPI ≤ 0.9 in one leg) Subject with stable (>3 month) PAD Fontaine Stage II Aortoiliac vessels with no significant hemodynamic disturbances , as confirmed by recent (<30 days) clinical examination Subject has intermittent claudication and claudication pain of the calf Subject has stable intermittent claudication (>3 month and not more than one year) with initial claudication distance not more than 250 meters, as determined by treadmill test (3.2 km/h, 10% grade) Subject willing to participate as evidenced by signing the written informed consent Treatment with Aspirin or Clopidogrel for at least 7 days Willingness to undergo standardized walking exercise Ankle-Brachial Pressure Index (ABI) above 0.8 in both legs. In Diabetic patients with no compressible arteries ABI above 40 mm/Hg of the higher pressure measured in both arms Inability to walk Chronic respiratory insufficiency (severe obstructive or restrictive) Coronary artery disease with angina Stroke, myocardial infarction or other acute vascular events in the last 3 months Mild-Severe congestive heart failure Degenerative or inflammatory hip, knee, ankle or foot joint lesions interfering with walking Spinal stenosis or disc lesions with lower limb motor sensory defects Leg trauma, limb or skin infection or edema Recent (6 months) abdominal, cardiothoracic, vascular or orthopedic (lower limb) surgery | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 50.0-85.0, Chronic Limb Ischemia Non-Healing Ulcers Patients with established diagnosis of lower limb ischemic based on their symptoms of claudication, rest pain, non-healing ulcers or gangrene and other vascular laboratory tests that are currently used to make this diagnosis and have been scheduled for endovascular revascularization Age group between 50-85 Gender Male or Female Race all race and ethnicities Patients with known cardiac disease new MI (within 3 months) Patients with hypertension with the systolic BP >200 or diastolic BP>110 on the day of testing Patients on supplemental O2 for chronic obstructive lung disease Bed-ridden subjects either due to chronic disability or neurological problems | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 40.0-999.0, Peripheral Arterial Disease Subjects with peripheral arterial disease for more than 6 months Male or female with claudication secondary to lower extremity atherosclerotic arterial disease. (with limited IC but not incapacitated for walking on the level) confirmed with ankle/brachial pressures< or = to 0.9 in one or both legs) or who have had a previous intervention for peripheral arterial disease Over 40 years old Able to comply with protocol requirements Able to provide informed consent Subjects taking anti-platelet therapy medication must be on a stable dose for 3 months prior to as well as during the study Subjects taking lipid lowering medication must be on a stable dose for 3 months prior to as well as during the study Patients with ischemic rest pain in limbs, ulceration, or gangrene At baseline, any condition that prevents walking on a treadmill History of major bleeding Patients with bowel disease (including Crohn's disease, celiac disease, peptic ulcer disease, irritable bowel syndrome and diverticulosis) Patients with an estimated life expectancy less than 2 years and with high baseline cardiac risk (post ischemic or diabetic cardiomyopathy with EF<40%, Canadian Cardiovascular Society Class 3 or 4 angina or need for coronary revascularization procedures) Moderate to severe renal failure Subjects that are on supplements other that those prescribed by their clinician for the entire duration of the study Fish limitations (no more than 2 fish meals per week) Gluten allergy Subjects with allergies to any ingredient in the study product or placebo | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Peripheral Arterial Disease Claudication Critical Limb Ischemia Has a Rutherford Clinical Category Score of 1 Has evidence of ≥ 50% stenosis or occlusion in the superficial femoral, popliteal, anterior tibial, posterior tibial and/or peroneal arteries, confirmed by angiography Has identifiable distal target vessel which upon completion of the intervention, is anticipated to provide re-constitution of blood flow to the foot Exchangeable guidewire must cross lesion(s), with ability of catheter to cross lesion Each discrete target lesion's length is ≤ 20 cm Reference vessel diameter is ≥ 1.5 mm and ≤ 7 mm Has surgical or endovascular procedure of the target vessel within 14 days prior to the index procedure Has any planned surgical intervention or endovascular procedure within 30 days after the index procedure Has had a previous peripheral bypass affecting the target limb Has end-stage renal disease defined as undergoing hemodialysis for kidney failure Has presence of severe calcification in target lesion(s) Has in-stent restenosis of the target lesion Has an aneurysmal target vessel Has significant stenosis or occlusion of inflow tract that has not been revascularized prior to treatment of the target vessel Has perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to enrollment Has disease that precludes safe advancement of the SilverHawk/TurboHawk device to the target lesion(s) | 1 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 0.0-0.019, Cerebral Oxygenation Cerebral Blood Flow Prematurity Preterm infant (Gestational Age <37+0) Peripheral arterial catheter (ulnary or radial artery) Complex organ malformation | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 30.0-999.0, Peripheral Arterial Disease Peripheral arterial disease post surgery > 1 month No discharge of surgical incision Intermittent claudication post invasive treatment Necrosis Above/below knee amputee Other conditions might affect peripheral vascular elasticity | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Essential Hypertension Is treated with antihypertensive therapy and has a post-washout mean sitting clinic systolic blood pressure greater than or equal to 160 and less than or equal to 190 mm Hg on Day, or has not received antihypertensive treatment within 14 days prior to Screening and has a mean sitting clinic systolic blood pressure greater than or equal to 160 and less than or equal to 190 mm Hg at the Screening Visit and on Day 1 Females of childbearing potential who are sexually active agree to routinely use adequate contraception, and can neither be pregnant nor lactating from before study participation to Screening to 30 days after the last study drug dose Has clinical laboratory test results within the reference range for the testing laboratory or the investigator does not consider the results to be clinically significant Is willing to discontinue current antihypertensive medications up to 3 weeks before enrollment Has a mean clinic diastolic blood pressure (sitting, trough) greater than 119 mm Hg on Day 1 Has secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing's syndrome) Has a recent history (within the last 6 months) of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack Has clinically significant cardiac conduction defects (ie, third-degree atrioventricular block, sick sinus syndrome) Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease Has severe renal dysfunction or disease Has known or suspected unilateral or bilateral renal artery stenosis Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug Has poorly-controlled type 1 or 2 diabetes mellitus at Screening Has hypokalemia or hyperkalemia at Screening | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-75.0, Painful Diabetic Neuropathy Age ≥ 18 years to 75 years Documented history of Type I or II diabetes with current treatment control (glycosylated hemoglobin A1c of ≤ 10.0%) Diagnosis of painful diabetic peripheral neuropathy in both lower extremities The physical examination component of the Michigan Neuropathy Screening Instrument Score (MNSI) is ≥ 3 at Screening Visual analog scale (VAS) score of ≥ 4 cm at Screening (0 cm = no pain cm worst imaginable pain) Stable treatment of diabetes for at least 3 months with no anticipated changes in medication regimen, and no new symptoms associated with diabetes Lower extremity pain for at least 6 months If female of childbearing potential, negative pregnancy test at screening and using acceptable method of birth control during the study Peripheral neuropathy caused by condition other than diabetes Other pain more severe than neuropathic pain Progressive or degenerative neurological disorder Myopathy Inflammatory disorder of the blood vessels (inflammatory angiopathy, such as Buerger's disease) Active infection Chronic inflammatory disease (e.g. Crohn's, Rheumatoid Arthritis) Positive HIV or HTLV at Screening Positive Hepatitis B or C as determined by Hepatitis B core antibody (HBcAB), antibody to Hepatitis B antigen (IgG and IgM; HbsAB), Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV), at Screening or known immunosuppression or on chronic treatment with immunosuppressive drugs, chemotherapy or radiation therapy Stroke or myocardial infarction within last 6 months | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-72.0, Critical Limb Ischemia Atherosclerotic ischemic peripheral vascular disease or Thromboangiitis Obliterans with Critical Limb Ischemia (Fontaine stages III and IV) Participant must match either a or b Ankle brachial index (ABI) ≤ 0.7 Doppler waveforms at posterior tibial artery and dorsalis pedis artery are monophasic with toe pressure < 30 mmHg A non-surgical candidate for revascularization e.g. prior vascular reconstruction, inability to locate a suitable vein for grafting, diffuse multi segment disease, or extensive infra-popliteal disease not amenable to a vascular graft Age > 18 years old The non-index leg may be treated only in the event and it full fills the same and used in this protocol for the treatment leg Patients must be on maximal tolerated medical therapy for PVD including A) Cessation of smoking B) Referral to endocrinologist for control of HgA1c to < 7.0 mg/dl, control of hyperlipidemia with statins or other anti-hyperlipidemic drugs as indicated, control of hypertension as indicated C) Antiplatelet therapy with aspirin and / or cilostazol (unless medically contraindicated, e.g. bleeding or allergy) Popliteal vascular entrapment syndrome Lower extremity infection or infected ulcer Hypercoagulable state HIV positive HBsAg positive Uncontrolled arrhythmia, that is, persistence of an arrhythmia despite medical therapy Unstable angina Thrombocytopenia < 50,000/ul | 1 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Peripheral Arterial Disease patients at the time of diagnosis of Fontaine grade II peripheral arterial disease (PAD), confirmed by hemodynamic evaluation (Doppler ultrasound) over 18 years old patients had previously undergone revascularization patients were receiving treatment with statins patients with contraindications to statin use patients with coexistence of chronic inflammatory diseases or steroidal medication | 1 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Peripheral Vascular Diseases Documented acute coronary syndrome (Unstable angina, non-Q-wave myocardial infarction, Q-wave myocardial infarction) or/and documented ischemic stroke/transient ischemic attack (IS/TIA) Previously known symptomatic or asymptomatic PAD confirmed by one of the following diagnostic methods or interventions (documented in the patient's medical record) Non-invasive or invasive vascular diagnostic tools (e.g.: ABI, Toe-brachial index, Duplex ultrasound, Magnetic resonance angiography, Computer tomographic angiography, Contrast angiography) Previous related intervention (such as angioplasty, stenting, atherectomy, peripheral arterial bypass graft, other vascular intervention including amputation) Patients whose ABI cannot be measured accurately Patients already in a clinical trial or a product registry Hospitalized patients | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 20.0-30.0, Ischemic Preconditioning healthy volunteers aging 20-30 years old no cardiac，hepatic or renal，peripheral vascular diseases be willing to enter our study and sign an written informed consent younger than 20 years old or older than 30 years old having cardiac，hepatic or renal，peripheral vascular diseases refuse to enter our study or sign an written informed consent | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 40.0-999.0, Peripheral Arterial Disease Criteria:Healthy age-matched participants (acute phase of the study) Healthy volunteers, male or female, > 40 years of age Body Mass Index 18-30 Glycated hemoglobin <6.5% Fasting serum total cholesterol <4 mmol/L and triglycerides <2.5 mmol/L Blood pressure <140/90 mm Hg Ankle-brachial index of >0.9 Willing to comply with the protocol requirements Willing to provide informed consent Participants having completed another food-related study are eligible to participate if it has been more than 3 months since their participation healthy age-matched participants (acute phase of the study) Currently smoking, or smoking within the last 6 months (Note: cigar smoking on an occasional basis will be permitted) Presence of a clinically diagnosed disease affecting the heart, liver, kidneys, lungs,gastrointestinal, endocrine or blood/immune systems that requires medical treatment Taking any prescribed medication within the last 3 months with the exception of anti-depressants, birth control and hormone (estrogen) replacement therapy Pregnancy Amputation of upper or lower extremity on both sides Has undergone a surgical procedure requiring local or general anesthetic within the last 3 months History of gastrointestinal reactions or allergies to dietary oils and other ingredients in banana bread such as wheat and eggs Daily consumption of omega-3 supplements Peripheral arterial disease participants (acute and chronic phases of the study) | 1 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 0.0-999.0, Kidney Diseases Kidney Failure, Chronic Kidney Failure Renal Insufficiency Renal Insufficiency, Chronic Urologic Diseases Subject capable of giving written informed consent, with end-stage kidney disease, who is a suitable candidate for primary kidney transplantation Living donors Compatible ABO blood type PRA < 20% Re-transplant patients Those with peripheral vascular disease affecting the lower limbs | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Cardiovascular Diseases Cardiovascular Risk Factor African American adults > 18 years old | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Hypertension Essential hypertensive patient no less than 18 yeas old Patient who gave informed consent form Patient was diagnosed as secondary hypertension Patient who have white-coat hypertension | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-75.0, Hyperlipidemia Coronary Artery Disease Written informed consent Men or women, aged 18 -75 Diagnosed with coronary heart disease (CHD) stable angina for more than 1 month and meet the following any one History of myocardial infarction CHD confirmed by coronary angiography Excercise ECG positive for CHD or perfusion defect One or more main branch of coronary artery stenosis ≥ 50% confirmed by CT scanning Hyperlipidemia (lipid-lowering treatment naïve: LDL-C ≥130mg/dl, or having received lipid-lowering treatment: LDL-C ≥100mg/dl) The 64 slice CT shows at least one significant coronary artery stenosis ≥20% with the narrowest ≤60% and meeting the following Diameter of coronary artery lesion ≥2mm, length ≥5mm; distance between multiple lesions ＞1cm Acute myocardial infarction within 6 months PCI or CABG therapy within 6 months Anticipated PCI or CABG therapy in the following 3 months Tropnin I/Tropnin T higher than ULN Cardiac failure NYHA III or above Coronary artery left main stenosis >50% Emergency coronary angiography(CAG) is needed Serious arrhythmia or tachycardia Secondary hyperlipidemia Familial hypercholestrolemia | 1 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-85.0, Sepsis Severe Sepsis All adult patients (>18 years) admitted to the intensive care with 1) hemodynamic instability due to severe sepsis, and 2) a mean arterial pressure < 65 mmHg and 3) an arterial lactate concentration > 3.0 mmol/L will be considered for participation moribund severe coagulation disorder (contraindication for central venous catheter placement) severe peripheral vascular disease (interfering with peripheral perfusion measurement) | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 60.0-85.0, Peripheral Vascular Diseases male or female 85 years femoro-popliteal stenosis TASC B or C category HBA1c <9%, if diabetic creatinine <130µg/ml blood pressure <160/95mmHg thrombocyte aggregation inhibitors or coumarine derivatives <60 or >85 years stenosis not in femoro-popliteal axis TASC A or D category HBA1c >9%, if diabetic creatinine >130µg/ml blood pressure >160/95mmHg major trauma malignancy anti-phospholipid syndrome relevant hepatic disease | 1 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Drug Safety The subject is over 18 years old Subjects are referred to undergo a peripheral arteriography as part of their routine clinical care The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within the 24 hour follow-up period The subject is pregnant or lactating The subject is taking metformin (e.g., Glucophage®) but is not willing or unable to discontinue at the time of the study procedure The subject manifests thyrotoxicosis or is on dialysis | 1 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-75.0, Painful Diabetic Neuropathies Age ≥ 18 years to ≤ 75 years Documented history of Type I or II diabetes with current treatment control (glycosylated hemoglobin A1c of ≤ 10.0% at Screening) and currently on oral medication and/or insulin Diagnosis of painful diabetic peripheral neuropathy in both lower extremities Lower extremity pain for at least 6 months Visual analog scale (VAS) score of ≥ 40 mm at Initial Screening (0 mm = no pain mm very severe pain) Symptoms from the Brief Pain Neuropathy Screening (BPNS) is ≤ 5 point difference between legs at Initial Screening The average daily pain intensity score of the Daily Pain and Sleep Interference Diary completed after medication wash-out is ≥ 4 with a standard deviation ≤ 2 The physical examination component of the Michigan Neuropathy Screening Instrument Score (MNSI) is ≥ 3 at Screening Stable treatment of diabetes for at least 3 months with no anticipated changes in medication regimen, and no new symptoms associated with diabetes Peripheral neuropathy caused by condition other than diabetes Other pain more severe than neuropathic pain Progressive or degenerative neurological disorder Myopathy Inflammatory disorder of the blood vessels (inflammatory angiopathy, such as Buerger's disease) Active infection Chronic inflammatory disease (e.g., Crohn's disease, rheumatoid arthritis) Positive HIV or HTLV at Screening Active Hepatitis B or C as determined by Hepatitis B core antibody (HBcAB), antibody to Hepatitis B antigen (IgG and IgM; HbsAb), Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV) at Screening Subjects with known immunosuppression or currently receiving immunosuppressive drugs, chemotherapy or radiation therapy | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Peripheral Artery Disease Hypertension Men and non-pregnant, non-lactating women 45 years of age or older Able to give informed consent and complete scheduled visits Mild-moderate bilateral lower extremity peripheral arterial disease as defined by an ankle-brachial index (ABI measurement of 0.6-0.9. If a subject has baseline claudication symptoms, the symptoms must be stable for the 3 months preceding enrollment History of hypertension. Blood pressure at the screening visit must be ≤160/100 mmHg and ≥100/60 mmHg for all subjects. If a subject is currently prescribed beta-blocker therapy, BP at the screening visit must be ≤140/90 mmHg. In addition, heart rate must be ≥55 beats per minute if currently prescribed a beta-blocker and ≤60 beats per minute if not currently prescribed a beta-blocker At least moderate risk for CAD Participation in another clinical trial Ongoing ischemic (resting) limb pain, or lower extremity ulceration due to arterial insufficiency, or an ABI indicating <0.6 indicating disease potentially requiring revascularization History of limb or digit amputation due to arterial insufficiency Revascularization of peripheral vessels within the preceding 6 months Uncontrolled hypertension as defined by systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg Contraindication or allergy to beta blocker therapy History of myocardial infarction , coronary revascularization, or a cerebrovascular event within the preceding 6 months Class III or IV angina Current or past history of New York Heart Association (NYHA) class III or IV heart failure Inability to walk on a treadmill for any reason | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Lower Limb Ischaemia Aneurysm need for lower limb vascular by-pass surgery allergic to cefuroxime patients refusal to participate | 1 |
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