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NCT ID: NCT03297294 Terminated - Clinical trials for Painful Diabetic Neuropathy

Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy (PDN)

EMPADINE
Start date: March 14, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate safety and efficacy of EMA401 compared to placebo in patients with painful diabetic neuropathy (PDN).

NCT ID: NCT03294200 Terminated - Clinical trials for Tricuspid Regurgitation

Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System

Start date: August 28, 2017
Phase: N/A
Study type: Interventional

The objective of the study is to generate safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from significant functional tricuspid regurgitation with annular dilatation. The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve repair.

NCT ID: NCT03292172 Terminated - Clinical trials for Triple Negative Breast Cancer

A Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of RO6870810 and Atezolizumab (PD-L1 Antibody) in Participants With Advanced Ovarian Cancer or Triple Negative Breast Cancer

Start date: November 8, 2017
Phase: Phase 1
Study type: Interventional

This is Phase IB, open label, non-randomized study designed to investigate the dose, safety, pharmacokinetics and anti-tumor activity of RO6870810 in combination with a fixed dose of atezolizumab. The study consists of four groups, Group 1 (Dose Escalation Group) and Group 2 (Sequential Dose Group), and Groups 3 and 4 (Expansion Groups), which will further evaluate the safety, pharmacokinetic, pharmacodynamic and preliminary clinical activity in patients with triple negaive breast cancer and/or ovarian cancer.

NCT ID: NCT03289143 Terminated - Alzheimer's Disease Clinical Trials

A Study to Evaluate the Efficacy and Safety of Semorinemab in Patients With Prodromal to Mild Alzheimer's Disease

Start date: October 4, 2017
Phase: Phase 2
Study type: Interventional

This was a phase II, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of Semorinemab in participants with prodromal to mild Alzheimer's disease. An optional 96-week open-label extension period was available to participants who completed the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label Semorinemab treatment.

NCT ID: NCT03288766 Terminated - Atrial Flutter Clinical Trials

SHERLOCK 3CG™ Diamond Tip Confirmation System

MODUS II
Start date: April 19, 2018
Phase:
Study type: Observational

This study is a single-arm, prospective, multi-center study to assess clinical performance of the SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) with MODUS II software for confirming correct tip position of peripherally inserted central catheters (PICCs) in adult subjects with altered cardiac rhythm.

NCT ID: NCT03287908 Terminated - Clinical trials for Relapsed/Refractory Multiple Myeloma

A Study to Assess AMG 701 Montherapy, or in Combination With Pomalidomide, With or Without, Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Start date: November 13, 2017
Phase: Phase 1
Study type: Interventional

The primary purpose of the phase 1 part of the study is to evaluate safety and tolerability of AMG 701 monotherapy to identify the RP2D for AMG 701 monotherapy followed by a dose-confirmation part to gather further safety data for AMG 701 monotherapy at the RP2D in adult subjects with relapsed/refractory multiple myeloma (RRMM). In addition, this study will include a sequential dose exploration part to identify the RP2D of AMG 701 in combination with pomalidomide, with and without dexamethasone (AMG 701-P+/-d). Phase 2 will consist of the dose-expansion part to gain further efficacy and safety experience with AMG 701 monotherapy in adult subjects with RRMM.

NCT ID: NCT03287245 Terminated - Polycythemia Vera Clinical Trials

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Idasanutlin Monotherapy in Participants With Hydroxyurea-Resistant/Intolerant Polycythemia Vera

Start date: February 21, 2018
Phase: Phase 2
Study type: Interventional

This is an open-label, single-arm study of idasanutlin monotherapy in participants with hydroxyurea (HU)-resistant/intolerant Polycythemia vera (PV). The study will include two phases: initial phase and expansion phase. The initial phase will assess the safety and efficacy of idasanutlin monotherapy in ruxolitinib naïve and ruxolitinib-resistant or intolerant patients, respectively. If the initial phase shows promising results for ruxolitinib-resistant or intolerant patients, an expansion phase will be opened to further characterize the efficacy of idasanutlin.

NCT ID: NCT03285308 Terminated - Diabetes Mellitus Clinical Trials

A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01

Start date: September 29, 2017
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.

NCT ID: NCT03283826 Terminated - Clinical trials for Secondary Progressive Multiple Sclerosis

Phase 1/2 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis

EMBOLD
Start date: October 19, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of ATA188 as a monotherapy in Parts 1 and 2, to determine the recommended Part 2 dose (RP2D) of ATA188 as monotherapy in Part 1, and to evaluate the effect of ATA188 treatment on clinical disability, as assessed by confirmed Expanded Disability Status Scale (EDSS) improvement at 12 months in Part 2 in participants with progressive forms of multiple sclerosis (MS) (primary progressive multiple sclerosis [PPMS] and secondary progressive multiple sclerosis [SPMS]).

NCT ID: NCT03278236 Terminated - Insulin Resistance Clinical Trials

Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men?

RESHAPE2
Start date: September 21, 2017
Phase: N/A
Study type: Interventional

Obesity is a serious medical condition, the adverse consequences of which include increased risk of cardiovascular disease, diabetes mellitus, reduced fertility and cancer. The economic cost of obesity was placed at $58 billion dollars in Australia in 2008 [1]. Studies in mice and non-human primates have shown that moderate caloric restriction (CR) increases lifespan and reduces the incidence of cardiovascular disease, cancer, and type 2 diabetes [2]. Reduced risk of chronic diseases is also observed in humans following CR [3]. However, daily CR is difficult to maintain long term, since the body defends against weight loss by inducing "metabolic adaptation"[3] and altering the hormonal appetite response [4]. An emerging number of studies are examining the effects of limiting food intake to prescribed time periods per day, or every other day. Time restricted feeding (TRF) describes a dieting approach where food is available ad libitum, however only for a limited period of time (i.e. 3-12 hours). This pilot study will examine the effects of restricting daily food intake to within a 10 hour period on glycaemic control, body weight and biomarkers of metabolic health for 6-weeks. This study will build on the existing knowledge base in humans as to whether meal timing, rather than caloric restriction per se, is important to provide the stimulus required to improve metabolic health and reduce risk of chronic disease.