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79761. Mediterranean Lifestyle Intervention in Patients With Non-alcoholic Fatty Liver Disease

Collaborator: University of Athens Information provided by (Responsible Party): Meropi Kontogianni, Harokopio University Study Details Study Description Go to Brief Summary: Non-alcoholic fatty liver disease (NAFLD) is considered as the hepatic manifestation of the metabolic syndrome. NAFLD is a pathologic condition which involves both hepatic steatosis and non alcoholic steatohepatitis (NASH), as the result of fat accumulation in the liver (liver fat >5-10% of liver weight), not due to excess alcohol (...) the potential benefits of an intervention based on the Mediterranean lifestyle in a sample of patients with NAFLD. Condition or disease Intervention/treatment Phase Non-alcoholic Fatty Liver Disease (NAFLD) Non-alcoholic Steatohepatitis (NASH) Behavioral: Mediterranean lifestyle Behavioral: Mediterranean Diet Not Applicable Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 63 participants Allocation: Randomized Intervention Model: Parallel

2013 Clinical Trials

79762. Calcitriol in Preventing Lung Cancer in High-Risk Patients

is not in excess of the recommended daily dose No concurrent thiazides, phenobarbital, or digitalis No concurrent digoxin No concurrent bile acid binding drugs (i.e., cholestyramine, colestipol) No concurrent danazol or aluminum-based antacids No concurrent ketoconazole or other azole antifungals 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

2013 Clinical Trials

79763. Safety and Efficacy of Melflufen and Dexamethasone in Relapsed and/or Relapsed-Refractory Multiple Myeloma Patients

performance status ≤ 2 (Patients with lower performance status based solely on bone pain secondary to multiple myeloma will be eligible) Females of childbearing potential must have a negative serum or urine pregnancy test prior to patient registration Female patients of child bearing potential and non-vasectomized male patients agree to practice appropriate methods of birth control Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization (...) ≤ 2.5 mg/dL AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN Exclusion Criteria: Patient has evidence of mucosal or internal bleeding and/or is platelet transfusion refractory Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participation in this study Known active infection requiring parenteral or oral anti-infective treatment Other malignancy within the past 3 years with the exception of adequately treated basal cell

2013 Clinical Trials

79764. Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection

administered orally in a divided daily dose using weight-based dosing (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) Experimental: SOF+RBV 24 Weeks SOF+RBV for 24 weeks Drug: SOF Sofosbuvir (SOF) 400 mg tablet administered orally once daily Other Names: Sovaldi® PSI-7977 GS-7977 Drug: RBV Ribavirin (RBV) tablets administered orally in a divided daily dose using weight-based dosing (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) Outcome Measures Go to Primary Outcome Measures : Percentage of Participants (...) to ribavirin therapy Excessive alcohol ingestion as defined by protocol History of solid organ transplantation Current or prior history of clinical hepatic decompensation History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol 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

2013 Clinical Trials

79765. Preventing Stem Cell Transplant Complications With a Blood Separator Machine

syndromes. Subjects will receive a myeloablative conditioning regimen of cyclophosphamide (120 mg/kg total), fludarabine (125 mg/m(2) total) and total body irradiation (1200 cGy with lung shielding to 600 cGy), followed by an infusion of a stem cell product selected for CD34+ progenitors using the Miltenyi CliniMACS[registered] system. Older subjects will receive a lower dose of irradiation (800 or 600 cGy based on age) to reduce the regimen intensity. The overall objective is to assess the feasibility (...) - refractory anemia with transfusion dependence, refractory anemia with ANC<500/microL, refractory anemia with excess of blasts, transformation to acute leukemia, chronic myelomonocytic leukemia, atypical MDS/myeloproliferative syndromes. OR Myeloproliferative disorders including atypical (Ph-negative) chronic myeloid and neutrophilic leukemias, progressing myelofibrosis, and polycythemia vera, essential thrombocythemia either in transformation to acute leukemia or with progressive transfusion

2013 Clinical Trials

79766. Diagnostic Value of Lung Ultrasound for Ventilator-Associated Pneumonia

by (Responsible Party): bélaid BOUHEMAD, Groupe Hospitalier Paris Saint Joseph Study Details Study Description Go to Brief Summary: Ventilator-associated pneumonia (VAP) is the most common nosocomial infection acquired by mechanically-ventilated patients in the intensive care unit (ICU). It has significant clinical and economic consequences, as it is associated with considerable morbidity, increased mortality, and excess health care costs. Appropriate antibiotic therapy for patients with VAP significantly (...) . Examination will specifically identify the presence or absence of the following lung ultrasound findings: normal pleural A lines, non-coalescent B lines, coalescent B lines, consolidations (subpleural or lobar), and linear air bronchograms. A Lung Ultrasound Aeration Score will be calculated based on these findings. Ultrasonographic diagnosis of VAP will be defined based on the presence of subpleural consolidation, entire lobar consolidation, or air bronchogram within consolidation. The results

2013 Clinical Trials

79767. A preliminary assessment of a novel pneumatic unloading knee brace on the gait mechanics of patients with knee osteoarthritis. (Abstract)

Rheumatism Association.Instrumented gait analysis was performed while subjects walked with and without the knee brace. When subjects wore the knee brace, the air bladders were either uninflated or inflated to 7 psi. The net external knee adduction moment was obtained by subtracting the abduction moment produced by the knee brace (estimated using a finite element analysis model) from the external knee adduction moment (estimated using a camera-based motion analysis system).The net external knee adduction (...) to an improved correction of the excessive peak external knee adduction moment observed in patients with medial compartment knee osteoarthritis.Copyright © 2013. Published by Elsevier Inc.

2013 PM & R : the journal of injury, function, and rehabilitation Controlled trial quality: uncertain

79768. Nutrigenomics: Personalizing Weight Loss for Obese Veterans

, outline eating behaviors and suggest responses to various exercise regimens. The overall goal of this project is to evaluate if this supplemental genetic information with a genomically-derived diet built around packaged meals to improve adherence, in parallel with the MOVE! program at the VA in San Diego, will promote weight loss in more obese veterans than those receiving usual care and eating diets based around packaged meals. Our primary hypotheses are that more obese veterans in the MOVE! program (...) ). Veterans with fasting LDL > 190 mg/dl. Veterans with fasting triglyceride levels > 1000 mg/dl. Excessive caffeine use (>6 caffeinated beverages/days). Prior gastrointestinal surgery with the exception of distal appendectomy. Acute infections or current use of antibiotic therapy. 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

2013 Clinical Trials

79769. Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal Hyperplasia

steroids for diseases other than CAH Use of estrogen-containing birth control pills Use of medicines that cross-react with hydrocortisone Use of stress dose steroids for illness during the last 30 days prior to joining the study Condition or disease Intervention/treatment Phase Adrenal Insufficiency Excess Androgen Congenital Adrenal Hyperplasia (CAH) Drug: Hydrocortisone (Solucortef) Device: Insulin pump (Medtronic) Phase 2 Detailed Description: Congenital adrenal hyperplasia (CAH) is a common genetic (...) and accumulation of adrenal androgens. Glucocorticoid treatment of patients with classic CAH focuses on cortisol replacement and prevention of the ACTH-driven androgen excess. Current conventional glucocorticoid treatment regimens (short or long-acting agents dosed once, twice or thrice daily) have failed to simulate physiological cortisol secretion and suppress adrenal androgen overproduction, without supraphysiologic replacement. Short-term overtreatment with glucocorticoids can lead to iatrogenic Cushing

2013 Clinical Trials

79770. Dim Light at Night in Patients With Obstructive Sleep Apnea

this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years to 60 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: • 18 -60 years of age. Willing and able to give informed consent AHI >10 episodes per hour based on a prior PSG. Patients who have been started on treatment for OSA with either Continuous Positive (...) Airway Pressure (CPAP) or dental device will be eligible for the study as long as they have been compliant with treatment for at least 30 days. Exclusion Criteria: • Incapable of giving informed consent Under the age of 18 Currently sleeping with lights on in the bedroom Excessive alcohol consumption Excessive alcohol use is defined as: More than 3 glasses of wine a day More than 3 beers a day More than 60 mL of hard liquor a day Room air oxyhemoglobin saturation < 88% Use of home oxygen Use

2013 Clinical Trials

79771. BCI and FES for Hand Therapy in Spinal Cord Injury

because patients cannot use either of their hands. In our previous pilot study performed on two acute tetraplegic patients we tested feasibility of using brain-computer interface (BCI) to control FES on patient's will. BCI is based on recording the patient's brain activity. BCI can detect the patient's intention to move the hand even if they are not able to physically move it. Using BCI, patients control the FES by thinking to move their hand. A BCI-FES therapy will provide a simultaneous training (...) ) Patients must not suffer from recurring pressure sore which prevent patient from sitting for at least an hour Patients must not suffer from excessive spasm that would increase with electrical stimulation. 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 identifier (NCT number

2013 Clinical Trials

79772. CASH- Children Active to Stay Healthy

: Moderate exercise Other: High Intensity Interval Exercise Not Applicable Detailed Description: Obesity, even in children, is generally accompanied by a state of chronic inflammation. To combat childhood obesity, clinicians and scientists recommend lifestyle interventions that include increased physical activity and exercise in an attempt to promote weight loss and, consequently, decrease comorbidities associated with excess adiposity. More importantly, it appears that the influence of regular exercise (...) , in children with obesity before and after an exercise intervention. The data will then be used to determine if changes in these values differ in magnitude based on the intensity of exercise. Children with obesity will be randomized into either moderate exercise or HIIE groups, and attend sessions 3 times per week for 6 weeks. The moderate group will cycle continuously for 30 minutes at 65%-70% of maximal heart rate and the HIIE group will perform ten, 2-minute bouts at 90%-95% of maximal heart rate

2013 Clinical Trials

79773. Reproductive Aging and Obstructive Sleep Apnea

Institutional Review Board (IRB) -approved informed consent. Severe OSA requiring immediate CPAP treatment (severe OSA defined as AHI >80 events/h or minimum oxygen saturation <85% Excessive sleepiness in relation to the subject's occupation which thereby increases their associated risk in the physician's judgement (e.g. truck driver or transport worker) Sleepiness-related automobile accident in previous 12 months Diabetes mellitus (historically or based on screening Hemoglobin A1c >6.5%) Patients

2013 Clinical Trials

79774. An Open-label Trial to Determine Increased Red Blood Cell Production in Subjects With Anemia of Chronic Disease

Medical Pharma. Recruitment status was: Not yet recruiting First Posted : May 3, 2013 Last Update Posted : May 3, 2013 Sponsor: Targeted Medical Pharma Information provided by (Responsible Party): Targeted Medical Pharma Study Details Study Description Go to Brief Summary: The objective of this study is to measure the change in blood values after the administration of an amino acid based erythropoietin stimulating system. Condition or disease Intervention/treatment Phase Anemia of Chronic Disease Drug (...) control for the duration of the study. Excessive alcohol or illicit drug use. Unwilling or unable to sign informed consent. Myocardial infarction within the last 6 months. Patients ever having taken or currently taking an erythropoietin medication. Iron deficiency (add criteria). On dialysis. Malignancy other than non-melanoma skin cancer within the last 5 years. If has such malignancy, must have documentation of no recurrence for at least 5 years. Liver cirrhosis (add criteria). Contacts

2013 Clinical Trials

79775. Brain Muscle Axis During Treatment of Hepatic Encephalopathy With L-ornithine L-aspartate

treatment at 12 weeks. Samples will also be taken for ex vivo MRS of blood and urine to identify potential biomarkers. Histological analysis and MRS would also be performed on the muscle tissue at the same time points. Hypotheses Primary objective 1) Improvement in mental state by paper and pencil based Psychometric Hepatic Encephalopathy Score (PHES) and Cogstate Research test (computer based cognitive research assessment tool) Secondary objectives Brain volume reduction due to reduction in brain (...) : Improvement in mental state on paper and pencil Hepatic Encephalopathy score (PHES) testing and Cogstate testing (computer based cognitive assessment research tool) [ Time Frame: At 0, 4 and 12 weeks ] Secondary Outcome Measures : Brain Volume [ Time Frame: At 0 , 4 and 12 weeks ] The effect of brain volume reduction due to reduction of brain swelling will be measured by serial brain MRI (at 0, 4 and 12 weeks) Brain chemical structure [ Time Frame: 0, 4, 12 weeks ] Improvement in brain chemical structure

2013 Clinical Trials

79776. Alisertib, Abiraterone Acetate and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer

with evidence of any of the following disease progression based on PCWG2 criteria while on abiraterone acetate and prednisone: Clinical progression (such as symptoms related to prostate cancer) with PSA progression (defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL and a baseline PSA of 2 ng/ml or above). Progression of one dimension measurable soft tissue (nodal or visceral metastasis) assessed within 30 days prior to registration by a CT scan or MRI (...) of antacids or H2 antagonists are allowed (to manage gastric acidity or reflux) during the study day 8 - 20. [Histamine-2 (H2) receptor antagonists are not permitted from the day prior (Day -1) through to the end of Alisertib dosing (Day 7)] Ongoing nausea or vomiting of any severity without improvement after appropriate treatment. > Grade 1 diarrhea, not controlled with appropriate treatment. History of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime

2013 Clinical Trials

79777. Ambulatory Versus Conventional Approach Diagnosing OSA

Shu Cheong Hui, Chinese University of Hong Kong Study Details Study Description Go to Brief Summary: Very few studies have examined different models of care involving initial ambulatory home-based diagnosis in diagnosing obstructive sleep apnea (OSA), identifying patients who benefit from continuous positive airway pressure (CPAP), and reducing the need for polysomnography (PSG). This study aims to assess the role of an ambulatory approach with home diagnostic sleep study. We hypothesize (...) Hospital, with suspected obstructive sleep apnea (OSAS). OSAS was defined by apnea-hypopnea index(AHI) 5/hr or more of sleep plus excessive daytime sleepiness or two of the following symptoms: choking or gasping during sleep, recurrent awakenings from sleep, unrefreshed sleep, daytime fatigue, and impaired concentration. All patients with suspected OSAS underwent assessment at the clinic with the Epworth sleepiness score(ESS) and symptoms evaluation. Patients who had ESS score>9 or at least two OSAS

2013 Clinical Trials

79778. A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-54861911 in Healthy Volunteers Compared With Placebo

medical or psychiatric illness Alcohol or substance abuse; excessive nicotine or caffeine use Recently received an investigational drug, vaccine, or invasive medical device Unable to abide by protocol restrictions on use of other medications History or family history of spontaneous, prolonged or severe bleeding of unclear origin or of blood clotting Current anemia Specific Exclusion Criteria for Part 2: History of lower back pain or scoliosis and/or major (lumbar) back surgery Allergic to local (...) anesthetics and/or iodine Increased intracranial pressure based on fundoscopy 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 identifier (NCT number): NCT01827982 Locations Layout table for location information Belgium Antwerpen, Belgium Sponsors and Collaborators Janssen Research

2013 Clinical Trials

79779. Study to Evaluate the Pharmacokinetics and Safety of GSK2336805 in Subjects With Hepatic Impairment and Healthy Matched Control Subjects

subjects with mild and moderate hepatic impairment and healthy control subjects matched to the subjects in the moderate hepatic impairment category. The decision to commence Part 2 will be based on a review of the preliminary safety and pharmacokinetic data from subjects with moderate hepatic impairment. Part 2 will enroll subjects with severe hepatic impairment. Additionally, based on emergent data from Part 1, matched controls to the severe hepatic group may be enrolled (optional). Due (...) will be enrolled in Cohort 2 and will receive a single dose of 60 mg GSK2336805. The decision to move forward into Part 2 (severe hepatic impairment) will be based on a review of the preliminary safety and pharmacokinetic data from subjects with moderate hepatic impairment Drug: GSK2336805 Two 30 mg GSK2336805 tablets for a 60 mg single dose will be administered in this study Experimental: Part 2 Cohort 5 - Matched healthy volunteers to Cohort 4 Based on emerging data from Part 1, the sponsor may decide

2013 Clinical Trials

79780. Bioavailability and Food Effect of the Original Gelatin Formulation and Two New Formulations of Afuresertib in Normal Healthy Volunteers

Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. Male or female between 18 and 40 years of age inclusive, at the time of signing the informed consent Body weight >=50 kilograms (kg) and body mass index (BMI) <=32 kg/m^2 (square meter) A female subject is eligible to participate if she is of: (A) Non (...) . Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <=1.5 x Upper Limit of Normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). Based on single or averaged corrected QT interval (QTc) values of triplicate electrocardiograms (ECGs) obtained over a brief recording period: QTc <450 milliseconds

2013 Clinical Trials

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