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NCT ID: NCT02793154 Terminated - Clinical trials for Diabetes Mellitus, Type 2

An Exploratory Study on the Effects of Repeat Doses of Albiglutide Compared to Exenatide on Gastric Myoelectrical Activity and Gastric Emptying in Type 2 Diabetes Mellitus Subjects

Start date: September 26, 2016
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to compare the effect of albiglutide and exenatide on gastric myoelectrical activity (GMA), gastric emptying (GE) and nausea (as measured by visual analogue scale [VAS]) in subjects with type 2 diabetes mellitus (T2DM). The study is divided in two parts. Part A will characterize the GMA, GE and nausea response to exenatide and confirm exenatide as a positive control for Part B. Part B will compare the effects of albiglutide and exenatide on GMA, GE and nausea. Part A is a single arm, open-label design and all subjects will receive 10 microgram (mcg) subcutaneous exenatide twice daily for 5 days. This part will comprise 3 study periods: a 3-week screening/wash-out, 5-day treatment, and follow-up (within 7 days after the last dose of exenatide). The total duration of a subject's participation in Part A will be approximately 5 weeks. Once Part A is complete, data will be reviewed and a decision to progress to Part B will be made. In Part B, subjects will be randomized 1:1 to receive either albiglutide (starting dose of 30 milligrams [mg] once weekly for 4 weeks, followed by 50 mg once weekly for 4 weeks) or exenatide (starting dose of 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 4 weeks). The total duration of a subject's participation in the study will be approximately 15 weeks.

NCT ID: NCT02792192 Terminated - Bladder Cancer Clinical Trials

Safety and Pharmacology Study of Atezolizumab Alone and in Combination With Bacille Calmette-Guérin (BCG) in High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Participants

Start date: June 13, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This Phase Ib/II study is designed to assess the safety, tolerability, pharmacokinetics, immunogenicity, patient reported outcomes (PROs), and preliminary anti-tumor activity of atezolizumab administered by intravenous (IV) infusion alone and in combination with intravesical BCG in high-risk NMIBC participants. The study will be conducted in following cohorts: Cohort 1A, Cohort 1B, Cohort 2, and Cohort 3. Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) every 3 weeks (q3w) for a maximum of 96 weeks. BCG will be administered to evaluate dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), or maximum administered dose (MAD). De-escalation will be allowed for up to three dose levels of BCG (full dose [50 mg], 66 percent [%] of a full dose, and 33% of a full dose [Cohort 1B only]). After the MTD or MAD is determined for Cohort 1B, this dose will be used for all subsequent participants enrolled into Cohorts 1B, 2, and 3, unless the MTD is determined to be 33% of a full BCG dose. If MTD is determined to be 33% of a full BCG dose, then, no participants will be enrolled into Cohorts 2 and 3 until an assessment of the safety and activity of the combination of atezolizumab plus 33% of a full BCG dose is completed.

NCT ID: NCT02791906 Terminated - Clinical trials for Renal Insufficiency, Chronic

Targeting Central Pulsatile Hemodynamics in Chronic Kidney Disease

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

Heart failure (HF) is an epidemic and is a major burden on the US healthcare system. The most common cardiovascular endpoint is HF. Thus, novel interventions to prevent HF in chronic kidney disease (CKD) are highly desirable. This study will assess: the variability in the response to isosorbide mononitrate (ISMN) therapy; the degree of change in central hemodynamics and cardiac endpoints through analysis of changes in left ventricle (LV) mass, diffuse myocardial fibrosis, and myocardial systolic and diastolic function.

NCT ID: NCT02791555 Terminated - Atrial Fibrillation Clinical Trials

Effect of Pradaxa vs Warfarin on Bone Mass and Bone Turnover Markers

Start date: June 2016
Phase: N/A
Study type: Observational

The investigators are evaluating the effect of Pradaxa in comparison to warfarin on bone turnover and bone density in men and women with atrial fibrillation.

NCT ID: NCT02791425 Terminated - Critical Illness Clinical Trials

Brain Computer Interface for Communication in Ventilated Patients

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Objectives: Specific Aim 1: To demonstrate the feasibility of using a Steady State Visual Evoked Potential (SSVEP) based Brain Computer Interface (BCI) device to facilitate communication of common patient needs in alert mechanically ventilated patients in the Intensive Care Unit (ICU). Specific Aim 2: To determine patient, family and bedside nurse satisfaction with communication using the BCI device and elicit open-ended feedback to guide future device improvements Design: Translational pilot study of a Steady State Visual Evoked Potential (SSVEP) based BCI system to facilitate communication in intubated patients, with sequential use of the BCI device and a picture board. Selection of the primary self-identified primary patient need on the BCI device will be compared to the icon selected on the picture board (reference standard). A patient satisfaction survey will then be provided to the patient or a family member following use for 2 hours a day for 3 consecutive days. Primary outcome: Accurate selection of the illustrative icon on the brain computer interface representing the physical or emotional need self-identified by the patient as being the most common trigger for communication with the bedside nurse during their admission. Secondary outcome: Selection by patients or family of "agree" or "strongly agree" with the statement "The Brain computer interface device allowed me to communicate my needs to the bedside nurse adequately". Intervention: Use of the brain computer device in the ICU for communication for 2 hours a day for 3 consecutive days Control/ Comparator: Sequential use of a communication picture board for 2 hours a day for 3 consecutive days, on the same days that the BCI device is used Sample Size: 30 mechanically ventilated but alert patients in the Intensive Care Unit

NCT ID: NCT02791191 Terminated - Alzheimer's Disease Clinical Trials

A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia

NAVIGATE-AD
Start date: June 16, 2016
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the safety and the effect on brain tau of the study drug LY3202626 in participants with mild Alzheimer's disease (AD) dementia.

NCT ID: NCT02790736 Terminated - Clinical trials for Social Anxiety Disorder

Brief Intervention to Reduce Fear of Public Speaking

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

The study will test the efficacy of propranolol or placebo, administered after retrieval of a previously acquired public speaking fear, in reducing fear and avoidance of public speaking.

NCT ID: NCT02790632 Terminated - Clinical trials for Subarachnoid Hemorrhage, Aneurysmal

Study of EG-1962 Compared to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage

NEWTON2
Start date: July 2016
Phase: Phase 3
Study type: Interventional

This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage.

NCT ID: NCT02790242 Terminated - Heart Failure Clinical Trials

Registry for Cardiogenic Shock: Utility and Efficacy of Device Therapy

RESCUE
Start date: November 2013
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to gather information on patients who have heart failure and are eligible for one of the following two procedures: 1) mechanical support, i.e. ventricular assist device (VAD) or 2) heart transplant. the study seeks to determine which patient populations benefit from heart transplant or ventricular assist device. This will allow to offer the state-of-the-art care to the patients in heart failure.

NCT ID: NCT02790034 Terminated - Rett Syndrome Clinical Trials

Evaluation of the Efficacy, Safety, and Tolerability of Sarizotan in Rett Syndrome With Respiratory Symptoms

STARS
Start date: October 26, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This study evaluates the safety, tolerability and efficacy of Sarizotan in reducing respiratory abnormalities in Rett Syndrome in an initial double blind 24 week period followed by an open label treatment phase of up to 168 weeks (the latter for patients with no safety and tolerability issues).