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34741. Cyclophosphamide, Topotecan, and Bevacizumab (CTB) in Patients With Relapsed/Refractory Ewing's Sarcoma and Neuroblastoma

Posted : December 15, 2011 Last Update Posted : November 1, 2018 Sponsor: Memorial Sloan Kettering Cancer Center Collaborators: Genentech, Inc. Children's Mercy Hospital Kansas City Penn State University University of Colorado, Denver Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Phoenix Children's Hospital Center for Cancer & Blood Disorders Alberta Children's Hospital MD Anderson Cancer Center Orlando M.D. Anderson Cancer Center Information provided by (Responsible Party): Memorial (...) an antibody that targets a protein important in the growth of cancer cells called vascular endothelial growth factor (VEGF). VEGF is made by tumor and other surrounding cells to help make blood vessels needed for the growth and spread of cancer cells in the body. The way that bevacizumab works is to stop the cancer cells from making their own blood supply, causing the tumor to stop growing bigger or from spreading. In adult clinical trials, bevacizumab has shown promising anti-cancer activity in patients

2011 Clinical Trials

34742. Functional Electrical Stimulation (FES) Driven Stepping in Individuals With Spinal Cord Injury

a muscle grade less than 3. D = Incomplete: Motor function is preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade of 3 or more. E = Normal: motor and sensory function are normal. Secondary Outcome Measures : Change in Heart Rate [ Time Frame: Baseline, 8 weeks ] Change in heart rate following 8 weeks of FES. Change in heart rate from baseline was computed from week 8 parameters. Change in Systolic Blood Pressure [ Time Frame (...) : Baseline, 8 weeks ] Change in systolic blood pressure following 8 weeks. Change in systolic blood pressure from baseline was computed from week 8 parameters. Change in Diastolic Plood Pressure [ Time Frame: Baseline, 8 weeks ] Change in distolic blood pressure following 8 weeks. Change in diastolic blood pressure from baseline was computed from week 8 parameters. Change in Rate of Perceived Exertion [ Time Frame: Baseline, 8 weeks ] Change in rate of perceived exertion (RPE) following 8 weeks of FES

2011 Clinical Trials

34743. Immunoadsorption Therapy for Patients With Non-Ischemic Dilated Cardiomyopathy (DCM)

infection requiring treatment with antibiotics. Subject currently has hemodynamic instability defined as systolic blood pressure < 90 mm Hg without afterload reduction, or cardiogenic shock, or the need for inotropic support or intra-aortic balloon pump. Subject has previously undergone immunosuppressive or immunomodulation therapy. Subject has known hypersensitivity or contraindication to heparin including history of heparin induced thrombocytopenia (HIT). Subject has history of drug or alcohol abuse (...) or is currently abusing alcohol or drugs. Subject has active malignancy or tumor, or other non-cardiac medical condition, which causes life expectancy to be less than one year. History of neutropenia (WBC < 3,000/mm3), coagulopathy, or thrombocytopenia (platelet count < 100,000/μL) that has not resolved or has required treatment in the past 6 months. Subject weighs less than 40 kg (88 lbs). Subject requires major elective procedures (AHA-defined intermediate to high risk surgery) within 6 months post

2011 Clinical Trials

34744. Efficacy and Safety of Simtuzumab With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma

coronary heart disease or cardiomyopathy, or ECG abnormalities consistent with ischemia. Uncontrolled hypertension (seated systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) at Screening. Clinically active liver disease, including active hepatitis (any etiology) or cirrhosis. Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) within 21 days prior to randomization Prior irinotecan therapy for metastatic disease (...) to the earliest (event) time of either death regardless of cause or first indication of disease progression. Secondary Outcome Measures : Overall survival [ Time Frame: Up to 20 months ] Overall survival (OS) is measured as time from date of randomization to death regardless of cause. Objective response [ Time Frame: Up to 20 months ] Objective response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) as Complete Response, Partial Response, Stable Disease

2011 Clinical Trials

34745. Losartan to Reverse Sickle Nephropathy

to Brief Summary: Sickle cell disease causes kidney damage with increasing age, leading to chronic kidney disease and renal failure in nearly one third of patients with sickle cell disease. Currently, there is no treatment for sickle cell related kidney disease. Condition or disease Intervention/treatment Phase Nephropathy Sickle Cell Anemia Drug: Losartan Phase 2 Detailed Description: The purpose of this research study is to see if losartan can help reduce or reverse damage done to the kidneys (...) (Clcr) <60 mL/minute/1.73 m2 Gross (not microscopic) hematuria. If hematuria has resolved for 2 weeks or more, patients will be eligible. Hyperkalemia (K≥5.5) at baseline despite a low potassium diet Concurrent condition that predisposes to nephropathy, such as lupus, diabetes, and hypertension, not controlled with medications.. On a renin-angiotensin pathway inhibitor (e.g., captopril, lisinopril, Losartan, valsartan, etc) for the last two weeks prior to enrollment. Hypersensitivity to Angiotensin

2011 Clinical Trials

34746. Efficacy of Hypofractionated XRT w/Bev. + Temozolomide for Recurrent Gliomas

(ALT) =< 3 x ULN Blood urea nitrogen (BUN) =< 1.5 x ULN Creatinine =< 1.5 x ULN Urine protein/creatinine ratio should be =< 1 Patients' baseline blood pressure must be adequately controlled with or without antihypertensive medications prior to enrollment (systolic < 140 mmHg, diastolic < 90 mmHg) Patients must have a baseline evaluation including history and physical examination with neurological evaluation and magnetic resonance imaging (MRI) of the brain (with and without gadolinium-based (...) by (Responsible Party): Northwestern University Study Details Study Description Go to Brief Summary: This phase II trial studies how well giving hypofractionated radiation therapy together with temozolomide and bevacizumab works in treating patients with high-grade glioblastoma multiforme or anaplastic glioma. Specialized radiation therapy, such as hypofractionated radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue

2011 Clinical Trials

34747. A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler in Adolescents and Adults Who Have Asthma That is Not Controlled by Asthma Medications Not Containing Steroids

) Current or untreated tuberculosis; History of tuberculosis is acceptable only if a subject has received an approved prophylactic treatment regimen or an approved active treatment regimen and has had no evidence of active disease for a minimum of 2 years • Uncontrolled hypertension (systolic BP ≥160 or diastolic BP >100) Stroke within 3 months prior to the Screening Visit Immunologic compromise History of a positive test for HIV, hepatitis B or hepatitis C infection. Clinical visual evidence of oral (...) . Presence of glaucoma, cataracts, ocular herpes simplex, or malignancy other than basal cell carcinoma. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (e.g., congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (e.g., uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's

2011 Clinical Trials

34748. Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema

, 2017 Last Update Posted : February 17, 2017 Sponsor: Vanderbilt University Medical Center Collaborator: Shire Information provided by (Responsible Party): Nancy J. Brown, Vanderbilt University Medical Center Study Details Study Description Go to Brief Summary: Individuals with heart disease or high blood pressure are often prescribed angiotensin converting enzyme (ACE) inhibitors to treat their disease. However, the use of ACE inhibitors can be associated with angioedema, a rare but life (...) pressure measurements, blood collection, a physical exam to determine the extent and duration of swelling, and photographs of the swelling will occur at 2, 4, 8, 16, and 24 hours following the start of treatment. Questionnaires will be completed by study staff and participants to assess changes in angioedema symptoms and the extent of swelling. Participants will remain in the hospital for 24 to 48 hours, depending on the severity of their symptoms. Blood will be collected at a follow-up visit

2011 Clinical Trials

34749. Safety and Efficacy of Triamcinolone Acetonide Combined With Laser, Bevacizumab Combined With Laser Versus Laser Alone for the Treatment of Diffuse Non-tractional Diabetic Macular Edema

and lactation. Pregnancy test was performed before starting treatment. Chronic renal failure requiring dialysis or kidney transplantation. Allergy to any of the drugs included in the study. Systemic use of steroids in the last 4 months. Patient intends to change his place of residence within 3 years after recruitment, whenever you go to an area not covered by the study. Blood pressure>180/110. If blood pressure is brought below 180/110 by anti-hypertensive treatment, patient can become eligible. HbA1c> 11 (...) in the first 4 months of treatment. History of prior pars plana vitrectomy. Major ocular surgery (including cataract extraction, scleral buckle, vitrectomy, etc.) within prior 6 months or anticipated within the next 6 months following randomization. History of YAG capsulotomy performed within 2 months prior to randomization. Intraocular pressure >25mmHg. History of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma; note: angle-closure glaucoma is not an exclusion

2011 Clinical Trials

34750. First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NOX-H94

sensitivity to treatment with erythropoiesis stimulating agents (ESAs), due to the limited availability of serum iron. Antagonism of hepcidin by NOX-H94 therefore leads to elevated levels of iron and transferrin saturation in the peripheral blood and could supply iron for erythropoiesis thereby correcting the anemia. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 64 participants Allocation: Randomized Intervention Model: Factorial (...) than chronic disease. Iron overload or disturbances in utilization of iron. Intravenous iron treatment or blood transfusion within 4 weeks prior to screening visit. Erythropoietin treatment within 4 weeks prior to screening visit. Intake of Intravenous iron, Blood transfusions, Erythropoietin during their trial participation. Resting supine pulse rate < 40 or > 100 beats / min. Resting supine blood pressure: Systolic blood pressure < 90 or > 160 mmHg Diastolic blood pressure < 40 or > 100 mmHg

2011 Clinical Trials

34751. A Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia

with pneumonia, Difficulty in breathing, short breath, or decreased partial pressure of oxygen in blood, Fever greater than 38ºC oral or body temperature lower than that required for normal body function(< 35ºC), White blood cell count greater than or less than the normal, Greater than 15% immature neutrophils (bands) irrespective of white blood cell count, AND Moderate lung infection The subject must require initial hospitalization, or treatment in an emergency room or urgent care setting, by the standard (...) alternative antimicrobial therapy •Treatment-limiting AE leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia •Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome Secondary Outcome Measures : Clinical Response at End of Treatment (EOT) Visit in MITT Population [ Time Frame: Last day of study drug administration ] Clinical Response at End of Treatment (EOT) Visit in CE

2011 Clinical Trials

34752. STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

for investigational use within 4 weeks of initial screening. Currently receiving high dose corticosteroid, cytotoxic therapy (e.g., chlorambucil, azathioprine, cyclophosphamide, methotrexate), nintedanib (Ofev®), vasodilator therapy for pulmonary hypertension (e.g., bosentan), unapproved and/or investigational therapy for IPF or administration of such therapeutics within 5 half-lives of the agent prior to initial screening in this study. End-stage fibrotic disease requiring organ transplantation within 6 months (...) of BG00011 in participants with IPF, and to assess the effect of BG00011 on biomarkers isolated from bronchoalveolar lavage (BAL) and peripheral blood in participants with IPF. Condition or disease Intervention/treatment Phase Idiopathic Pulmonary Fibrosis (IPF) Drug: BG00011 Drug: Placebo Phase 2 Detailed Description: This study was previously posted by Stromedix, Inc. In April, 2014, sponsorship of the trial was transferred to Biogen. The study drug name was changed from STX-100 to BG00011

2011 Clinical Trials

34753. A Study of JNS002 (Doxorubicin Hydrochloride Liposome Injection) in Relapsed or Refractory Multiple Myeloma

and the incidence of dose limiting toxicity (DLT) will be determined at the end of Cycle 1 to evaluate the study doses against the maximum tolerated dose (MTD). If the incidence is =2/3, additional 3 patients will be enrolled to define the MTD. Safety endpoints include adverse events, laboratory tests (hematology, blood biochemistry, and urinalysis), electrocardiogram (ECG), LVEF, chest X-ray, vital signs (body temperature, pulse rate, and blood pressure), and body weight. Efficacy evaluation will be performed (...) Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Doxorubicin Bortezomib Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

2011 Clinical Trials

34754. First International Randomized Study in Malignant Progressive Pheochromocytoma and Paraganglioma

in subjects with progressive malignant pheochromocytoma and paraganglioma treated with sunitinib at a starting dose of 37.5 mg daily (continuous dosing). SECONDARY OBJECTIVES: To determine overall survival and progression free survival. To determine time to progression. To determine objective response rate at one year. To determine time to and duration of tumor response. To assess safety profile including a dedicated cardiovascular management (home-blood pressure monitoring, ECG and echocardiography (...) of Adverse Events assessed using NCI -CTC V4 criteria [ Time Frame: 12 months ] Number and description of adverse events and number of patients with adverse events according to NCI -CTC V4 criteria Number of patients with cardiovascular toxicity tolerance assessed by specific organisation for blood pressure monitoring [ Time Frame: 12 months ] Cardiovascular tolerance will be assessed by specific organisation for blood pressure monitoring Bone Pain evaluation on the Visual Analog Scale [ Time Frame: 12

2011 Clinical Trials

34755. A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease

and embarrassment. In general, treatment options are limited because of the underlying chronic disease. The objective of the proposed low-dose, new combination drug, OC Oral solution is to develop a new treatment option that can be used to titrate saliva secretion rates to a level that is low enough to prevent unintentional loss (i.e. drooling) but not so low as to cause an uncomfortably dry mouth. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual (...) Date : September 2012 Resource links provided by the National Library of Medicine related topics: related topics: Arms and Interventions Go to Arm Intervention/treatment Placebo Comparator: OC oral solution treatment D Placebo Drug: OC oral solution treatment D Placebo Other Name: Placebo Experimental: OC oral solution treatment C High dose oxybutynin and clonidine Drug: OC oral solution treatment C Other Name: OP-014 Experimental: OC oral solution treatment A Low dose oxybutynin and clonidine Drug

2011 Clinical Trials

34756. A Study to Assess the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan

to have hepatitis or is a carrier of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or is known to be HIV positive or has HIV antibodies Subject has an impaired ability to sense thirst Subject has serum sodium less than 115mEg/L or greater than 140 mEg/L Subject has either a systolic blood pressure (BP) of greater than 140 mmHg or a diastolic BP of less than 56 mmHg Subject has taken any prescription or over-the-counter medications except for contraceptives, hormone replacement (...) symptoms, medical condition, or laboratory abnormality within past 3 months that would preclude participation in the study. Subjects with controlled hypertension may be allowed Subject has a condition associated with hepatic disease including; biliary obstruction, or other cause of hepatic impairment not related to parenchymal disorder and/or disease of the liver, fluctuating or rapidly deteriorating hepatic function, biliary liver cirrhosis, history or presence of hepatic encephalopathy greater than

2011 Clinical Trials

34757. Effects of Weight Loss on Cardio-respiratory Function

increases the risk for heart disease independent of other known risk factors such as coronary artery disease, hypertension, diabetes mellitus, and obstructive sleep apnea. Obesity also causes significant changes in pulmonary function, including a decrease in expiratory reserve volume and functional residual capacity and closure of peripheral airways. The exact mechanisms for the development of cardiopulmonary disease are not well understood - the pathophysiology is complex and likely multifactorial (...) Details Study Description Go to Brief Summary: Obesity is a medical problem of epidemic proportions and is associated with high mortality. Obesity has significant effects on the cardiovascular system, producing structural cardiovascular changes including myocardial hypertrophy, fatty infiltration, and fibrosis; diastolic and systolic dysfunction; changes in pulmonary artery compliance; and increased aortic stiffness - all of which can lead to heart failure. Indeed, evidence suggests that obesity

2011 Clinical Trials

34758. Vasoprotective Activities of Low-Fat Milk in Individuals With Metabolic Syndrome

: specific criteria of the metabolic syndrome (waist circumference (102-137 or 88-123 cm for men and women, respectively), fasting triglycerides 150-300 mg/dL, and fasting glucose (110-180 mg/dL) BMI: >30 kg/m2, non-dietary supplement users for >2-mo no use of any prescription or over-the-counter medications known to affect vasodilatory responses no known history of vascular disease nonsmokers resting blood pressure <140 mmHg not taking any medications that control hypertension Exclusion Criteria (...) milk that protect against vascular endothelial dysfunction in individuals at high risk for developing CVD. Condition or disease Intervention/treatment Phase Cardiovascular Disease Metabolic Syndrome Obesity Other: Low-Fat Milk Other: Rice Milk Not Applicable Detailed Description: Cardiovascular disease (CVD) is the leading cause of death in the United States, accounting for ~830,000 deaths annually. Oxidative stress and inflammatory responses are fundamental mechanisms leading to vascular

2011 Clinical Trials

34759. Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly

pulmonary disease or other systemic disorders which affect glucose hemostasis Use of growth hormone, corticosteroids, thiazide diuretics, estrogen supplements or androgen supplements Inability to perform strength or performance testing Uncontrolled hypertension (blood pressure >160/95 NYHA Class III or IV heart failure Current smoking Alcohol use > or = to 30g/day Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety (...) people have low levels of GH. The overall goal of this research is to determine the efficacy of GHRH to raise levels of GH and improve these body tissues. Healthy men and women age 65 and older will receive GHRH in four doses nightly for 12 weeks and assessed for changes in muscle strength, body mass, physical performance, and how the body uses sugar. Condition or disease Intervention/treatment Phase Hormone Deficiency Aging Drug: Growth Hormone Releasing Hormone (GHRH ) Phase 2 Detailed Description

2011 Clinical Trials

34760. Glaucoma Eye Drop Instillation: Impact of Education

on proper eye drop instillation technique Other: Placebo video education on healthy eating tips Not Applicable Detailed Description: Glaucoma is a leading cause of irreversible vision loss worldwide, and as such has a large public health impact. The only treatment proven to slow or arrest the progression of the disease process is intraocular pressure (IOP) reduction, which relies heavily on patient cooperation. Previously, nonadherence to glaucoma medications has ranged from 24% to 59%. Barriers (...) ophthalmologist for at least 6 months Diagnosis of open-angle glaucoma or ocular hypertension The use of one, two or three self-instilled eye drop medications in one or two eyes Age 40-85 years Fluency in English Best corrected visual acuity (BCVA) of 20/50 or better in each eye Exclusion Criteria: Presence of moderate to severe cognitive deficits Presence of a clinically significant tremor Mini Mental Status Exam score ≤ 20 Contacts and Locations Go to Information from the National Library of Medicine

2011 Clinical Trials

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