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34801. Trial of Alternating Current Stimulation in Optic Neuropathy

artefacts in head and truncus epileptic seizure within the last 3 years photosensitive epilepsy as determined by EEG mental diseases (schizophrenia etc.) unstable diabetes, diabetes causing diabetic retinopathy macular degeneration, maculopathy with decimal visual acuity below 0.4 high blood pressure instable or high level of intraocular pressure (i.e. >27 mmHg) presence of an un-operated tumor anywhere in the body total blindness primary or secondary glaucoma pathological nystagmus Contacts (...) field measures, visual acuity and EEG-recordings were collected before and after a daily 20-40min treatment for 10-days and at a 2-months-follow-up. Primary outcome measure was detection accuracy (DA) in defective visual field sectors of computer-based high resolution perimetry (HRP). Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra. Study Design Go to Layout table for study information

2011 Clinical Trials

34802. Study of Continuous Dosing of Sunitinib in Non GIST Sarcomas With Concomitant Radiotherapy

using MRI (magnetic resonance imaging) [ Time Frame: 6 months after the start of treatment ] progression free survival measured from the date of inclusion to the date of first evidence of progression or date of death of any cause, or to the date of last follow up [ Time Frame: within 12 months after the start of treatment ] evolution of neo-angiogenesis during treatment measured by DCE-US [ Time Frame: within 6 weeks after the start of treatment ] correlation between clinical response and change (...) ECOG performance status ≤ 2 Blood tests, renal and liver functions in the normal range with, in the 7 days prior to study entry, blood or serum values as follows: Absolute neutrophil count ≥ 1.,5 G/L Platelet count ≥ 100 G/L Bilirubin ≤ 1.5 mg/dL PT and INR ≤ 1.5 times upper limit of normal [Patients under preventive anticoagulant therapy are allowed to participate] AST and ALT ≤ 2.5 times upper limit of normal Creatinine ≤ 150 umol/L Calcium ≤ 12 mg/dL Blood glucose < 150 mg/dL Fertile patients

2011 Clinical Trials

34803. Comparison Of Surfactant Lung Lavage With Standard Care In The Treatment Of Meconium Aspiration Syndrome

of meconium aspiration syndrome includes airway obstruction, surfactant inactivation, inflammation and pulmonary hypertension. Meconium itself inactivates the surfactant in the alveoli and its presence also causes secondary surfactant deficiency as meconium is toxic to type 2 alveolar cells which secrete surfactant. There is no specific treatment recommended for meconium aspiration syndrome .Treatment for MAS is generally supportive and includes supplemental oxygen as needed, assisted ventilation (...) ). MAS is defined as respiratory distress with compatible chest x-ray finding in an infant born through MSAF whose symptoms cannot be otherwise explained. Despite current interventions such as intubation with tracheal suction, it is estimated that 5-20 % of infants born through MSAF develop MAS. It represents a leading cause of perinatal morbidity. Approximately 50% of the infants with MAS require mechanical ventilation; 15%-30% develop pulmonary air leaks and 5%-12% die. The pathophysiology

2011 Clinical Trials

34804. Study of Oral Lucitanib (E-3810), a Dual VEGFR-FGFR Tyrosine Kinase Inhibitor, in Patients With Solid Tumors

Acquisition Scan (MUGA) Uncontrolled hypertension (defined as systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg with optimized antihypertensive therapy) Myocardial infarction (MI) within 6 months prior to administration of the first dose > Class I cardiovascular disease according to the New York Heart Association's (NYHA) Functional Criteria Ongoing treatment with Warfarin Unavoidable concomitant treatment with any drug known for potential risk of causing Torsades de Pointes (...) carcinoma). Serial safety assessments, including evaluation of symptoms, physical examination and blood and urine laboratory analyses are performed throughout the study. Cardiac functions and blood pressure are monitored in consultation with a cardiologist. PK parameters are determined on plasma samples collected during the first 4-week cycle and analyzed using a validated LC-MS/MS method. Correlative studies include: (i) quantitative assessment of the effects of E-3810 on tumor vasculature by DCE-MRI

2011 Clinical Trials

34805. A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections

oxidases A or B or within 2 weeks of Screening Hypertension as defined by a systolic blood pressure of ≥ 180 mmHg or a diastolic blood pressure of ≥110 mmHg with confirmed re-check within 20 minutes of initial reading Subjects with pheochromocytoma, thyrotoxicosis and/or subjects taking any of the following types of medications: sympathomimetic agents, vasopressive agents, dopaminergic agents, or other agents with the potential for serotonergic interactions Subjects with carcinoid syndrome (...) of systemic infection: fever ≥ 38°C, lymphangitis, WBC (white blood cell) count ≥ 15,000 cells/μL, elevated C-reactive protein (> 5.0mg/L) In the opinion of the investigator, the subject must require and be a suitable candidate for IV antibiotic therapy Exclusion Criteria: A medical history of significant hypersensitivity or allergic reaction to quinolones, linezolid, vancomycin, or vancomycin derivatives Women who are pregnant or lactating Any chronic or underlying skin condition at the site of infection

2011 Clinical Trials

34806. Investigation of the Athero-Protective Effects of Clopidogrel

on their prescribed medical therapy during the duration of the 12 week study. Condition or disease Intervention/treatment Phase Coronary Artery Disease Drug: Clopidogrel Drug: Placebo Phase 4 Detailed Description: Blockages in the blood vessels of the heart are caused by atherosclerosis. Atherosclerosis is the main cause for chest pain and heart attacks. Gradual narrowing of the vessels of the heart caused by blockages causes chronic symptoms, such as chest pain. Those with these findings often have a cardiac (...) catheterization to detect these blockages. Additionally these patients may have an angioplasty or stent placed to help relieve these symptoms. With this angioplasty/stent procedure, patients are placed on the drug clopidogrel to help prevent clots from forming and narrowing of the blood vessels. Clopidogrel is a blood thinner that prevents clots from forming similar to an aspirin, but is more powerful and effective. Markers, or substances, have been identified that cause worsening of the blockages

2011 Clinical Trials

34807. Effect of Aerobic Exercise Training on Cardiorespiratory Function in Patients With Traumatic Brain Injury

heart disease, including those with CABG and PTCA Dilated or hypertrophic cardiomyopathy Non-idiopathic cardiomyopathy Uncontrolled hypertension, defined as a resting blood pressure above 140/90 mmHg Diagnosis or history of right or left-sided heart failure or pulmonary hypertension Diagnosis or history of restrictive or obstructive lung disease Diagnosis or history of stroke Type I or Type II Diabetes Mellitus Diagnosis of chronic kidney disease, chronic liver disease, acute kidney injury or acute (...) capacity or ability to exercise and/or treatment for mood disorders EXCLUSION CRITERIA: Subjects are not eligible for participation in this research study if any of the following medical conditions that would impair aerobic capacity or the ability to engage in physical activity exist, including diseases of the cardiovascular (other than hypertension controlled by medication to below 140/90 mmHg), pulmonary, neurological, metabolic, or musculoskeletal systems such as: Diagnosis or history of ischemic

2011 Clinical Trials

34808. Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy

(Child, Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Dilated Cardiomyopathy (LVEF ≤ 45%) Exclusion Criteria: Secondary dilated cardiomyopathy (such as ischemic cardiomyopathy, valvular cardiomyopathy, hyperthyroid cardiomyopathy, diabetic cardiomyopathy, anemia cardiomyopathy, and etc.) Coronary heart disease Rheumatic heart disease Pulmonary heart disease Continuous dysarteriotony: hypertension(systolic blood pressure [SBP] ≥ 60mmHg (...) /diastolic blood pressure [DBP] ≥ 100mmHg); hypotension(SBP < 90mmHg/DBP < 60mmHg) Resting heart rate ≤ 50bpm Atrioventricular block patients without permanent pacemaker Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293903 Locations Layout table

2011 Clinical Trials

34809. Adherence to Medication and Its Impact on Chronic Obstructive Pulmonary Disease (COPD) Exacerbations: The AMICE Prospective Study

leading cause of death by 2030. COPD is characterized by pulmonary and extra-pulmonary systemic manifestations caused by partly irreversible expiratory airflow obstruction. The cornerstone of COPD management is the prescription of single or combined inhalation therapy, such as short- and long-acting bronchodilators, inhaled corticosteroids to possibly prevent disease progression, preserve lung function, relieve respiratory symptoms and prevent or treat exacerbations. Given the complex and lifelong (...) such as hypertension, cancer, epilepsia, infections and HIV. The existing evidence on risk factors for nonadherence in COPD is mostly anecdotic and not guided by behavioral models. According to the integrated model of behavioral prediction (IMBP), barriers, skills and ability and intention are the most important drivers of adherence (i.e. medication adherence). The aims of the study are the following: To prospectively investigate the impact of medication nonadherence on time to exacerbation (primary end-point

2011 Clinical Trials

34810. Extended Steroid in CAP(e)

count < 4000 cells/mm3) Platelet count < 100,000 cells/mm3 or > 400,000 cells/mm3 Multilobar infiltrates Exclusion Criteria: - Patient's age 17 years or younger. - Vasopressor-dependent shock requiring moderate-to-high dose vasopressor (i.e., norepinephrine >=0.3 mcg/Kg/min) treatment for greater than 2 hours in patient that is adequately fluid-resuscitated (at least 4 liters of crystalloids) WITH central venous pressure (CVP) equal to or greater than 8 mm Hg for nonventilated patients and equal (...) the treatment each participating site, and whether or not the patient requires mechanical ventilation at the time of assignment. Patients will be followed clinically for 180 days. The primary outcome is all cause 60-day mortality. Secondary outcomes are (1) in-hospital morbidity-mortality, including ventilator-free days, multiorgan dysfunction syndrome (MODS)-free days, duration of ICU and hospital stay, and hospital discharge; and (2) posthospital discharge morbidity-mortality, including cardiovascular

2011 Clinical Trials

34811. Paraorbital-Occipital Electric Stimulation in Patients With Optic Neuropathy (BCT_optnerve)

defect Exclusion Criteria: electric or electronic implants such as pace maker any metal artefacts in head and truncus epilepsia photosensitive epilepsy as determines by EEG autoimmune illnesses in acute stage mental diseases such e.g. schizophrenia etc. diabetes causing diabetic retinopathy addiction high blood pressure unstable or high level intraocular pressure (i.e. > 27 mmHg) retinitis pigmentosa pathological nystagmus presence of an un-operated tumor or tumor recidive Contacts and Locations Go (...) baseline within defective visual field sectors [ Time Frame: between baseline and 60 days after stimulation ] Central visus fields were assessed with computer based high-resolution perimetry (HRP). Based on such plots, areas of the visual field were characterized as intact, partially damaged or absolutely impaired (blind). Secondary Outcome Measures : Visual Parameters 1 [ Time Frame: baseline to 60 days after stimulation ] DA in static and kinetic perimetry Visual Parameters 2 [ Time Frame: baseline

2011 Clinical Trials

34812. Pharmacogenomics Study of CPT-11 as the First-line Chemotherapy for mCRC

) transporters. Genetic variations of those enzymes may cause the heterogeneity in safety and efficacy of CPT-11. The aim of this study is to figure out the correlation between the genetic polymorphism and the drug response. Condition or disease Colorectal Cancer Detailed Description: collect blood samples,determining genetic contribution to the safety and efficacy of CPT-11. Study Design Go to Layout table for study information Study Type : Observational Estimated Enrollment : 200 participants Observational (...) Model: Cohort Time Perspective: Prospective Official Title: Genetic Variants and the Efficacy or Severe Adverse Reactions of CPT-11 Based Regimens in mCRC Study Start Date : November 2010 Estimated Primary Completion Date : December 2012 Estimated Study Completion Date : May 2013 Resource links provided by the National Library of Medicine related topics: available for: Groups and Cohorts Go to Group/Cohort Colorectal cancer Outcome Measures Go to Biospecimen Retention: Samples With DNA whole blood

2011 Clinical Trials

34813. Efficacy and Safety Study of Idelalisib in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma

of drug-induced liver injury, chronic active hepatitis B infection, chronic active hepatitis C infection, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver, or portal hypertension History of prior allogeneic bone marrow progenitor cell or solid organ transplantation Ongoing immunosuppressive therapy, including systemic corticosteroids. Patients may be using topical or inhaled corticosteroids (...) Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, B-Cell, Marginal Zone Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, B-Cell Waldenstrom Macroglobulinemia Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Leukemia, Lymphoid Leukemia Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic

2011 Clinical Trials

34814. MR WITNESS: A Study of Intravenous Thrombolysis With Alteplase in MRI-Selected Patients

cubic millimeter Uncontrolled hypertension defined as systolic blood pressure > 185 mm Hg or diastolic blood pressure > 110 mm Hg that cannot be controlled except with continuous parenteral antihypertensive medication Blood glucose less than 50 mg per deciliter or greater than 400 mg per deciliter Symptoms suggestive of subarachnoid hemorrhage, even if CT/MRI scan was normal Oral anticoagulant treatment, regardless of INR. Major surgery or severe trauma within the previous 3 months Other major (...) Schwamm Collaborators: National Institute of Neurological Disorders and Stroke (NINDS) Genentech, Inc. Information provided by (Responsible Party): Lee Schwamm, Massachusetts General Hospital Study Details Study Description Go to Brief Summary: This study was jointly developed and is jointly led by investigators at Massachusetts General Hospital and the intramural division of NINDS. We are doing this research study to find out if Activase ® (also called alteplase or rt-PA) can safely be given

2011 Clinical Trials

34815. Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy

to evaluate whether mycophenolate mofetil (MMF) could be a reasonable alternative with fewer side effect. Condition or disease Intervention/treatment Phase Glomerulonephritis, Membranous Drug: Mycophenolate mofetil, low dose steroid Drug: Cyclosporin, low dose steroid Phase 3 Detailed Description: Idiopathic membranous nephropathy is most common cause of glomerulonephritis in adults. Persistent high grade proteinuria or progressively decrease of renal function is a risk factor for end stage renal disease (...) : eGFR < 60 ml/min/1.73m2 Hypertension (BP above 140/90mmHg or BP above 120/80 in patients taking anti-hypertensive agents) 24 hours urine protein or spot urine protein/creatinine ratio > 5.0 g/day Serum albumin (g/dL) < 3.0 Selectivity index > 0.2 Exclusion Criteria: Severe digestive organ disease Allergy history to clinical trial medication and acute or chronic allergy for 4 weeks recently. Clinical history of treatment with other immunosuppressive medication Probability of pregnancy, breast

2011 Clinical Trials

34816. Association Between Glycaemic Control and Morbi/Mortality After 5 Years of Follow-up in Type 2 Diabetic Patients 70 Years Old and Over : a Cohort Study.

the link between glycaemic balance and the mortality rate with specific causes. To assess the link between glycaemic balance and the onset of or change in diabetes-related complications: cardiovascular diseases, change in renal function, diabetic retinopathy, peripheral neuropathy, perforating ulcer of the foot and acute metabolic complications. To assess the link between glycaemic balance and nutritional status, the onset of or changes in cognitive disorders and a loss of autonomy. To specify the role (...) in cognitive disorders. [ Time Frame: 5 years ] To assess the link between glycaemic balance and the onset of or changes in cognitive disorders. Link between HbA1c level and loss of autonomy. [ Time Frame: 5 years ] To assess the link between glycaemic balance and loss of autonomy. Role of other cardiovascular risk factors [ Time Frame: 5 years ] To specify the role of other cardiovascular risk factors (primarily, arterial hypertension, dyslipidaemia and obesity) in association with glycaemic balance

2011 Clinical Trials

34817. Lipid Rich Necrotic Core Lesion Detected by Cardiac Magnetic Resonance Imaging (CMR)

magnetic resonance imaging (MRI) study before the heart catheterization to look for scarring in the heart muscle. During the heart catheterization, participants undergo an intravascular ultrasound (IVUS) exam to look at the make-up of the plaques before the stent placement and the investigators will measure the pressures in the arteries to look at how severe the blockage is. Within 30 days after the heart catheterization, participants will have a second MRI done to look for any new scar in the heart (...) muscle. Condition or disease Intervention/treatment Phase Coronary Disease Other: Cardiac MRI Not Applicable Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 0 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Official Title: High Amount of Lipid Rich Necrotic Core Lesion Identified by Pre-interventional Intravascular Ultrasound (IVUS) is Associated With High Rate of Delayed Hyper-enhancement

2011 Clinical Trials

34818. ExAblate Transcranial MR Guided Focused Ultrasound in the Treatment of Essential Tremor

by the effects of the substance (for example, arguments with spouse about consequences of intoxication and physical fights). Severe hypertension (diastolic BP > 100 on medication) Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease Severely impaired renal function (estimated (...) history and examination by a movement disorder neurologist Tremor refractory to adequate trials of at least two medications, one of which should be either propranolol or primidone. An adequate medication trial is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated. Vim nucleus of thalamus can be target by the ExAblate device. The Vim/ region of the thalamus must be apparent on MRI such that targeting can be performed with either direct

2011 Clinical Trials

34819. Evolution With CPAP Treatment of a Cohort of Type 2 Diabetic Patients With Apnea-hypopnea Syndrome

Phase Sleep Apnea Type 2 Diabetes Device: Continuous Positive Airway Pressure CPAP Not Applicable Detailed Description: Subjects with poorly controlled type 2 diabetes are a high cardiovascular risk group in which a high prevalence of moderate to severe sleep apnea is expected. Studies based on interstitial glycemic measurement demonstrate a reduction in glucose levels when treating sleep apnea with CPAP. Nevertheless, the effectiveness of CPAP in improving glycemic control has been questioned (...) (CPAP) Device: Continuous Positive Airway Pressure CPAP CPAP treatment Other Name: no other name Outcome Measures Go to Primary Outcome Measures : Change in Hemoglobine A1C from baseline [ Time Frame: 14, 28, 42 and 56 weeks after initial intervention. ] Secondary Outcome Measures : Blood levels of fasting glucose from baseline [ Time Frame: 14 weeks after initial intervention ] Self measured capillary glucose profile [ Time Frame: 14 weeks after initial intervention ] Evening saliva collection

2011 Clinical Trials

34820. Efficacy and Safety Study of Udenafil Tablets in Erectile Dysfunction.

within the past 6 months. Patients with a history of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or a radical prostatectomy or radical pelvic surgery. Patients with hypotension (<90/50) or uncontrolled hypertension (>170/100), uncontrolled diabetes, hepatic impairment (SGOT or SGPT levels > 3 x Upper Normal Limit), renal impairment (serum creatinine > 2.5mg/dl), hematological disorders such as bleeding disorders. Patients with a history (...) of retinitis pigmentosa, proliferative diabetic retinopathy or non-arteritic anterior ischemic optic neuropathy (NAION). Patients with a history of sickle cell disease, multiple myeloma, leukemia or any other disorders that may cause priapism. Patients on concomitant treatment with nitrates/nitrites(NO) donor, CYP3A4 inhibitors, CYP3A4 inducers, anticoagulants, androgens, antiandrogens or trazodone. Patients with known hypersensitivity to PDE 5 inhibitors like Sildenafil, Vardenafil or Tadalafil. Patient

2011 Clinical Trials

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