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NCT ID: NCT02128958 Completed - Clinical trials for Hepatocellular Carcinoma

Phase 2, Randomized, Double-Blind, Placebo-Controlled of the Efficacy and Safety of CF102 in Hepatocellular Carcinoma (HCC)

Start date: September 2014
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in subjects with advanced HCC and CPB cirrhosis whose disease has progressed while taking 1 prior systemic drug therapy for HCC.

NCT ID: NCT02128360 Not yet recruiting - Infertility Clinical Trials

Comparison of 2 Ovarian Stimulation Protocols for Women With Low Ovarian Reserve

Start date: March 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether minimal ovarian stimulation for in vitro fertilization is superior to high dose stimulation. Number of mature eggs, number of embryos as well as pregnancy rates will be compared.

NCT ID: NCT02128074 Completed - Clinical trials for Anemia of Chronic Kidney Disease

A Pilot Study of KRX-0502 (Ferric Citrate, Administered Without Food, in Treating Iron-deficiency Anemia

Start date: April 2014
Phase: Phase 2
Study type: Interventional

The objective of the study is to evaluate the efficacy and safety of KRX-0502, administered without food, in treating iron deficiency anemia in subjects with stage 3 to 5 non-dialysis dependent chronic kidney disease (NDD-CKD).

NCT ID: NCT02128048 Completed - Smoking Cessation Clinical Trials

The Effect of Cigarette Smoking / Smoking Cessation on Skeletal Muscle Mass, Strength and Functional Capabilities

Start date: June 2012
Phase: N/A
Study type: Observational

Tobacco smoke is probably the single most significant source of toxic chemicals that humans are exposed to. Smoking is associated with a variety of pathological conditions such as cardiovascular and pulmonary diseases. In addition to the known harmful effects of cigarette smoking, several epidemiological studies identified tobacco use as a risk factor for sarcopenia, the loss of skeletal muscle mass and strength with advancing age. Previous studies examined skeletal muscles of smokers in comparison with muscles of non-smokers and found structural and metabolic damage in muscles of smokers. Quitting of smoking is known to be associated with weight gain. A previous study examined the effects of smoking cessation on body composition of post-menopausal women using dual-energy x-ray absorptiometry (DEXA). It was found that women who successfully quit smoking for a period of 16 months have significantly increased their body weight, fat mass, muscle mass and functional muscle mass in comparison with non-quitters women. For the first time, it was shown that smoking cessation is associated with an increase of functional muscle mass. Yet, the effects of quitting of smoking on muscle mass and muscle functional capabilities of younger subjects remain unclear. Therefore, we aim to investigate the effects of smoking cessation on muscle mass, muscle function and strength in heavy smoker's subjects. Our findings may shed light on the beneficial effects of smoking cessation regarding the status and function of skeletal muscle in heavy smokers and as a possible strategy to prevent or delay the progression of sarcopenia. Research hypothesis: Smoking cessation among adult heavy smokers will lead to increase in skeletal muscle mass and improvement of muscle function and strength compared with continued smokers.

NCT ID: NCT02127827 Not yet recruiting - Clinical trials for To Demonstrate That the Closed Loop System Can be Used Safely Over a Few Consecutive Days.

Multiday Fully Closed Loop Insulin Delivery in Monitored Outpatient Conditions

Start date: May 2014
Phase: N/A
Study type: Interventional

Insulin replacement therapy is absolutely required for patients with Type 1 diabetes. The insulin pump provides for continuous subcutaneous insulin infusion (CSII), which can approximate the insulin release patterns of the normal pancreas. Timely and accurate knowledge of ambient glucose levels is important for insulin dose adjustments. Typically, glucose values are measured volitionally, several times a day, using capillary "fingerstick" samples. In addition, glucose in the interstitial fluid can be measured automatically and continuously using implantable glucose oxidase-based sensors. Recent study showed that this continuous measurement of glucose levels allows for a fully automated "closed-loop" insulin replacement therapy which requires an algorithm that receives glucose data, calculates an appropriate insulin dose, and directs the pump to deliver the insulin dose.The need for development of a closed-loop insulin replacement system that integrates insulin delivery, glucose measurement, and control subsystems will present several challenges to biomedical engineers.

NCT ID: NCT02126995 Completed - Fragile X Syndrome Clinical Trials

A 6-week, Study of MG01CI Low Dose and High Dose Compared With Placebo in Adults and Adolescents With Fragile X Syndrome

Start date: June 2014
Phase: Phase 2
Study type: Interventional

This study is a multisite, randomized, double-blind, placebo-controlled, phase 2 study of MG01CI (low dose and high dose once daily) for 6 weeks compared with placebo in a 1:1 ratio of 60 adolescent and adult subjects with Fragile X Syndrome (FXS). Following Screening, subjects will be randomized to MG01CI or matching placebo at Baseline (Day 0) and the 6 week Double-blind Treatment Period will begin on Day 1. The first 4 weeks of the treatment period will be a dose-optimization period, All subjects will start with two daily tablets: low dose metadoxine or matching blinded placebo. At weekly visits/phone assessments, the investigator will evaluate the dose based upon the investigator's assessment of safety and tolerability. If the subject demonstrates safety or tolerability concerns with the low dose after 1 or 2 weeks of treatment, then the subject will be discontinued. If there are no concerns about safety and tolerability after 2 weeks of treatment, then the dose will be increased to high dose or placebo. If at the high dose there are concerns about safety and tolerability, then the dose will be either kept the same or reduced to low dose for the remainder of the treatment period. There will be a 2-week Follow-up Period after the last dose of study treatment or early termination.

NCT ID: NCT02126254 Completed - Heart Failure Clinical Trials

Optimization of the Treatment of Acute HF by a Non Invasive Cardiac System-a Randomized Control Trial

HFNICAS
Start date: April 2014
Phase: N/A
Study type: Interventional

The aim of this trial is to compare the efficacy of NICaS-directed treatment strategy to the common treatment strategy (based on clinical judgment) on morbidity and mortality in patients with decompensated congestive heart failure, and accordingly to assess whether the NICaS system can optimize and individualize the treatment of decompensated heart failure patients. A prospective randomized controlled trial in which Known HF patients, with reduced EF <40%, admitted due to decompensated HF, will be randomly assigned, in a 1:1: ratio, to either: 1) Control group that will be treated in the cardiology and internal medicine departments according to the guidelines for the management of Heart Failure. 2) Hemodynamic group patients will be examined in the cardiology and internal medicine departments and treated according to the NICaS system in addition to current guidelines. Patients in this group will be tested within 12 hours from hospitalization and thereafter on an everyday basis until discharge. For all patients randomized, therapy will be tailored to the ultimate goal of discharge on an oral medical regimen to provide better relief of CHF symptoms, to reduce filling pressures and to maintain adequate perfusion. These goals are the same for both groups, but in the control group therapy will be adjusted according to clinical assessment alone, while in the NICaS-directed group, actual measurement of hemodynamics will be used to supplement clinical assessment.

NCT ID: NCT02126241 Completed - Clinical trials for Congestive Heart Failure

Non-Invasive Cardiac Output Measurement for CRT Optimization

NICaS-CRT
Start date: April 2014
Phase: N/A
Study type: Interventional

This proposal aims to evaluate the added clinical and echocardiographic benefit of using the non-invasive impedance-based cardiac output measurement system (NICaS) for optimizing atrio-ventricular and inter-ventricular delays in chronic (more than 6 months) CRT recipients.

NCT ID: NCT02126124 Completed - Smoking Cessation Clinical Trials

Evaluation of Deep Transcranial Magnetic Stimulation (DTMS) With the H-ADD Coil as an Aid to Smoking Cessation.

Start date: August 20, 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of DTMS compared to sham treatment as an aid to smoking cessation in chronic, heavy (>10 cigarettes/day) cigarette smokers.

NCT ID: NCT02125461 Completed - Clinical trials for Non-Small Cell Lung Cancer

A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer

PACIFIC
Start date: May 7, 2014
Phase: Phase 3
Study type: Interventional

A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in Patients with Stage III Unresectable Non-Small Cell Lung Cancer.