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NCT ID: NCT02733614 Terminated - PTSD Clinical Trials

Proof-of-concept Study to Assess the Efficacy and Safety of SRX246 in Adults With PTSD

Start date: December 2016
Phase: Phase 2
Study type: Interventional

18-week, crossover, double-blind, randomized, placebo controlled proof-of-concept study to assess the efficacy and safety of SRX246 (160 mg bid) vs placebo in 52 adult veterans and civilians with a primary diagnosis of PTSD. Subjects will be randomly assigned in a double-blind fashion to 2 groups in a crossover design. The first group will receive SRX246 for 8 weeks followed by 8 weeks of placebo, while the second group will receive placebo for 8 weeks followed by 8 weeks of SRX246. Both groups will engage in a 7-day washout period between treatments. Subjects will be assessed at baseline and then every 2 weeks during the trial using the CAPS.

NCT ID: NCT02732938 Terminated - Clinical trials for Metastatic Pancreatic Ductal Adenocarcinoma

Ph1b/2 Study of PF-04136309 in Combination With Gem/Nab-P in First-line Metastatic Pancreatic Patients

CCR2i
Start date: May 4, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this Phase 1b/2 study is to evaluate the safety and tolerability of PF-04136309 in combination with nab-paclitaxel and gemcitabine, characterize the dose-limiting toxicities (DLTs) and overall safety profile of escalated doses of PF-04136309 and the associated schedule, determine the maximum tolerated dose (MTD), and to assess the enhancement of efficacy of PF-04136309 in combination with nab-paclitaxel and gemcitabine versus nab-paclitaxel + gemcitabine + placebo in terms of Progression Free Survival.

NCT ID: NCT02732327 Terminated - Neoplasms Clinical Trials

Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer

Start date: May 2016
Phase: Phase 2
Study type: Interventional

This study will evaluate the effect, safety, and tolerability of ceftazidime-avibactam (CAZ-AVI) plus vancomycin or linezolid compared to standard of care plus vancomycin or linezolid as empiric therapy in febrile neutropenic adults with cancer.

NCT ID: NCT02732288 Terminated - Clinical trials for Disorders of Consciousness

Exploratory Study of Melatonin Induced Sleep Regularization in Severe Brain Injury

Start date: May 2016
Phase: N/A
Study type: Interventional

Patients with severe brain injuries often have slow accumulating recoveries of function. In ongoing studies, we have discovered that elements of electrical activity during sleep may correlate with the level of behavioral recovery observed in patients. It is unknown whether such changes are causally linked to behavioral recovery. Sleep processes are, however, associated with several critical processes supporting the cellular integrity of neurons and neuronal mechanisms associated with learning and synaptic modifications. These known associations suggest the possibility that targeting the normalization of brain electrical activity during sleep may aid the recovery process. A well-studied mechanism organizing the pattern of electrical activity that characterizes sleep is the body's release of the substance melatonin. Melatonin is produced in the brain and released at a precise time during the day (normally around 8-10PM) to signal the brain to initiate aspects of the sleep process each day. Ongoing research by other scientists has demonstrated that providing a small dose of melatonin can improve the regular pattern of sleep and help aid sleep induction. Melatonin use has been shown to be effective in the treatment of time change effects on sleep ("jet lag") and mood disturbances associated with changes in daily light cues such as seasonal affective disorder. We propose to study the effects of melatonin administration in patients with severe structural brain injuries and disorders of consciousness. We will measure the patient's own timing of release of melatonin and provide a dose of melatonin at night to test the effects on the electrical activity of sleep over a three month period. In addition to brain electrical activity we will record sleep behavioral data and physical activity using activity monitors worn by the patients. Patient subjects in this study will be studied twice during the three month period in three day inpatient visits where they will undergo video monitoring and sampling of brain electrical activity using pasted electrodes ("EEG"), hourly saliva sampling for one day, and participation in behavioral testing.

NCT ID: NCT02732015 Terminated - Clinical trials for Locally Advanced Sarcoma

Rolapitant Hydrochloride in Preventing Nausea/Vomiting in Patients With Sarcoma Receiving Chemotherapy

Start date: October 12, 2016
Phase: Phase 2
Study type: Interventional

This randomized phase II trial studies how well rolapitant hydrochloride works in preventing nausea/vomiting in patients with sarcoma receiving chemotherapy. Antiemetic drugs, such as rolapitant hydrochloride, may help control or prevent nausea and vomiting in patients treated with chemotherapy.

NCT ID: NCT02731690 Terminated - GNE Myopathy Clinical Trials

A Study to Evaluate the Safety of Aceneuramic Acid Extended Release (Ace-ER; UX001) Tablets in Glucosamine (UDP-N-acetyl)-2-Epimerase (GNE) Myopathy (GNEM) (Also Known as Hereditary Inclusion Body Myopathy [HIBM]) Patients With Severe Ambulatory Impairment

Start date: April 29, 2016
Phase: Phase 2
Study type: Interventional

The primary objective of this Phase 2 study is to evaluate the safety of open-label 6 g/day Ace-ER in GNEM participants with severe ambulatory impairment.

NCT ID: NCT02731625 Terminated - Clinical trials for Athletic Performance

Kettlebell Training Measured Across Power and Performance

Start date: April 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the performance benefits of supplementing Army standard Physical Readiness Training (PRT) with a defined kettlebell (KB) deadlift and swing training program as compared to standalone PRT. Power and performance will be measured on horizontal (broad) and vertical jumps, 40 yard sprint, 60 yard shuttle, and the Army Physical Fitness Test (APFT). It is hypothesized that the unique force distributions of kettlebell training will promote improved power, particularly across the horizontal plane, when compared to standalone Army PRT. Findings will potentially provide insight as to how Army units can effectively utilize kettlebells to further diversify their training programs.

NCT ID: NCT02730962 Terminated - Pre-Diabetes Clinical Trials

Interventional Bioremediation of Microbiota in Metabolic Syndrome

Start date: June 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether changing the microbial composition in the colon can improve metabolism of sugar in people who are on the verge of developing diabetes (pre-diabetics). Study participants will undergo a fecal microbiota transplantation (FMT) using material from lean donors, as well as a series of tests prior to and after the transplant. The investigators will examine any changes in fecal bacterial composition associated with FMT and determine if any observed changes have an influence on blood sugar metabolism.

NCT ID: NCT02730884 Terminated - Leukemia Clinical Trials

Single-Arm Study of the Efficacy and Safety of Oral Rigosertib in Patients With Myelofibrosis (MF) and Anemia

Start date: August 16, 2017
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if rigosertib can help to control MF in patients with anemia. The safety of this drug will also be studied. This is an investigational study. Rigosertib is not FDA-approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work. Up to 35 participants will be enrolled in this study. All will be enrolled at MD Anderson.

NCT ID: NCT02730871 Terminated - Ocular Hypertension Clinical Trials

Safety and Efficacy of SIMBRINZA® BID as an Adjunctive to DUOTRAV®

Start date: June 24, 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering effect of Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) dosed twice daily (BID) when added to Travoprost 0.004%/Timolol 0.5% (DUOTRAV®) in subjects with open-angle glaucoma or ocular hypertension.