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NCT ID: NCT01970449 Withdrawn - HIV Infections Clinical Trials

Evaluating the Safety and Immune Response to Three Different Prime-Boost HIV Vaccine Regimens in Healthy, HIV-Uninfected Adults

Start date: n/a
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the safety and immune response to three different sets of HIV vaccines in healthy, HIV-uninfected adults.

NCT ID: NCT01981668 Withdrawn - Prostatic Neoplasms Clinical Trials

The JET Study: a Phase I Trial of Cabazitaxel, Radiotherapy and Long-term Androgen Deprivation

Start date: n/a
Phase: Phase 1
Study type: Interventional

This study utilizes a conventional phase I study design with a '3+3 cohort expansion' design(15), to determine the maximum tolerated dose(MTD) of 1) Cabazitaxel, in Part A, and 2) Radiotherapy, in Part B. The determination of the MTD is given in Section 5.2, Definition of Dose - Limiting Toxicity. All patients who enter the study, and begin concurrent chemo-radiation are analyzable for the primary endpoint of the study.

NCT ID: NCT01991535 Withdrawn - Clinical trials for Obesity Hypoventilation Syndrome (OHS)

Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern

Start date: n/a
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether breathing pattern (specifically the inspiratory time/total respiratory cycle value) has an influence over the response to the noninvasive mechanical ventilation.

NCT ID: NCT01997268 Withdrawn - Clinical trials for Severe Hypertriglyceridemia

The Efficacy of EPA+DHA (SC401B) for Lowering Triglyceride Levels (≥ 500 mg/dL)

Start date: n/a
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effects of SC401B (ethyl esters of eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] 2 (~1260 mg EPA+DHA), 4 (~2520 mg EPA+DHA) or 6 (~3780 mg EPA+DHA) capsules per day in subjects with hypertriglyceridemia (triglyceride [TG] ≥500 mg/dL and ≤ 2,000 mg/dL). SC401B capsules also contain certain surfactants that may aid in the absorption of EPA and DHA. Based on the results of pharmacokinetic studies of healthy human subjects, unlike Lovaza®, EPA and DHA in SC401B are bioavailable in both the fasted and fed states. The protocol specified primary endpoint is the difference from the placebo group in the percent change in TG concentration from baseline to week 12 for groups receiving 2, 4, or 6 capsules of SC401B per day. The protocol specified secondary endpoints include percent changes from baseline to week 12 for total cholesterol (TC), LDL-cholesterol (LDL-C), HDL-cholesterol (HDL-C), and non-HDL-cholesterol (non-HDL-C). Additional exploratory variables include VLDL-cholesterol (VLDL-C), LDL-cholesterol particle size, apolipoprotein (Apo) A1, Apo B, Apo C-III, and lipoprotein-associated phospholipase A2 (Lp-PLA2). An additional objective is to determine the tolerability and safety of SC401B 2, 4 and 6 capsules per day for 12 weeks. Adverse events for SC401B and placebo including burping, fishy taste, upset stomach, loose stools, stools with fishy smell or any other self-reported observations will be evaluated. Additional safety measures will include changes in liver enzymes (AST/ALT) occurring from baseline to week 12 for groups receiving 2, 4, and 6 capsules of SC401B and placebo.

NCT ID: NCT02005523 Withdrawn - Hip Labral Tear Clinical Trials

Study of RNS60 on Pain and Function After Hip Labral Repair

Start date: n/a
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see if use of RNS60 during hip labral repair surgery decreases pain and improves functional capacity post-operation.

NCT ID: NCT02006173 Withdrawn - Pain Clinical Trials

Safety and Efficacy Study of Lidocaine Mixed Hyaluronate on Nasolabial Folds Correction

Start date: n/a
Phase: N/A
Study type: Interventional

This clinical trial is a double-blind, randomized, within-subject controlled, 2-armed, single-center study sponsored by SciVision Biotech Inc. and approved by National Taiwan University Hospital Research Ethics Committee. The aim of this post-marketing study is to evaluate the safety and efficacy of Hya-Dermis mixed with lidocaine, as well as the effectiveness of corrections of Hya-Dermis mixed with lidocaine. Accounting for potential loss to follow-up, the minimum enrollment was statistically determined to be 40 patients. The study was estimated to be held one and half year including a 0-2 weeks screening period, a day of treatment, and follow-up at month 1, 3, 6, 9, 12. Patient informed consent forms will be obtained before the treatment. A pre-treatment photograph, nasolabial folds (NLF) severity scale scores, and individual aesthetic satisfaction will be the baseline. Two sets of randomized numbers are used, patient numbers and treatment numbers. Participants with odd patient numbers will be assigned to nasolabial group and those with even patient numbers will be assigned to nasolabial&cheekbone group. Participants receive experiment treatment (Hya-Dermis mixed with lidocaine) in one side and control treatment (Hya-Dermis mixed with normal saline) in the other side of the face randomly depending on the treatment numbers. Both physicians and participants are only blind to the treatment assignment. 30 minutes after the injection, a post-photograph will be used to evaluate NLF severity scale scores and global aesthetic improvement scale (GAIS) by physicians. A questionnaire including the Visual Analog Scale (VAS) of pain during the treatment and individual aesthetic satisfaction will be collected from patients. The effectiveness analyses compare NLF severity scale scores and GAIS based on photograph records from physicians, as well as participant questionnaires for each group on every visit. The safety assessment evaluates any recorded adverse events following the device treatment.

NCT ID: NCT02025946 Withdrawn - Arthritis Clinical Trials

Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis

Start date: n/a
Phase: N/A
Study type: Observational

In case of severe ankle arthritis, the two common surgical treatments are tibiotalar arthrodesis and total ankle arthroplasty. Few studies have compared these treatments and it remains difficult to determine which operation is the better solution for end stage ankle arthritis. The purpose of the present study is to analyze patient's outcome after each type of ankle surgery and to describe the decision making process.

NCT ID: NCT02028897 Withdrawn - Infertility Clinical Trials

Comparison of Alternative Embryo Culture Systems

Start date: n/a
Phase: N/A
Study type: Interventional

This study will compare two alternative embryo culture systems. Embryos from each patient will be randomly assigned to one of two systems. One group will be cultured conventionally in oil-covered droplets in dishes. The other group will be assigned to an enclosed system.

NCT ID: NCT02036723 Withdrawn - Clinical trials for Wet Age-related Macular Degeneration

Safety and Efficacy Study of BCD-021 Compared to Lucentis® in Patients With Neovascular Wet Age-related Macular Degeneration

GALATIR
Start date: n/a
Phase: Phase 3
Study type: Interventional

GALATIR is a double blind randomized clinical trial comparing efficacy and safety of BCD-021 (bevacizumab) and Lucentis® (ranibizumab) in patients with neovascular wet age-related macular degeneration. The purpose of the study is to demonstrate the non-inferiority of efficacy and safety of BCD-021 compared to Lucentis®.

NCT ID: NCT02039869 Withdrawn - Clinical trials for Gastroesophageal Reflux Disease

Confocal Endomicroscopy for Non-Erosive Reflux Disease (CE NERD)

CE_NERD
Start date: n/a
Phase: N/A
Study type: Interventional

The purpose of this study is to find out if people who have non-erosive reflux disease (NERD) have changes the investigators can see with a microscope (called confocal endomicroscopy) that is used during endoscopy (a camera scope evaluation of the inside of your stomach and swallowing tube). Traditionally the investigators have used trials of acid blocking medications (PPIs), endoscopy and measurements of acid in the swallowing tube (the esophagus) to determine if the investigators think acid is causing troublesome symptoms. The medical community believes that these symptoms are due to increased spaces between the cells that make up the swallowing tube. The investigators can directly see those spaces with a new microscope that the investigators can pass through the camera scope. Participants will be assigned to take one of two medications omeprazole and sucralfate (both approved medications for stomach symptoms) to treat their symptoms and record how well the treatment works. The investigators then will look to see if the microscope can predict which medication will work best for patients in the future. The investigators also plan to measure the acid levels in your swallowing tube and do a camera evaluation of your swallowing tube and stomach as this is standard for patients with your symptoms. The investigators will compare the results of those studies to the microscope findings.