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NCT ID: NCT03505723 Completed - Venous Thrombosis Clinical Trials

PeriOperative ISchemic Evaluation-3 Trial

POISE-3
Start date: June 27, 2018
Phase: Phase 3
Study type: Interventional

This study is a multicentre, international, randomized controlled trial of tranexamic acid (TXA) versus placebo and, using a partial factorial design, of a perioperative hypotension-avoidance versus hypertension-avoidance strategy.

NCT ID: NCT03505177 Completed - Healthy Clinical Trials

Characterization of the Gut Microbiota Composition and Activity After Three Weeks of Chitin-glucan Supplementation

Start date: April 22, 2018
Phase: N/A
Study type: Interventional

The aim of this research study is to characterize gut microbiota composition and activity after a daily supplementation of 4.5 g of chitin-glucan during 3 weeks. For this purpose, a monocentric longitudinal intervention study without control will be performed. Fecal microbiota composition and fecal concentrations of gut microbiota-derived metabolites (bile acids, conjugated-polyunsaturated fatty acids and short-chain fatty acids) will be measured. In addition, during ten hours following the ingestion of a test meal rich in fibers, the kinetic of production of H2, methane and volatile compounds exhaled from breath will be evaluated.

NCT ID: NCT03505099 Completed - Clinical trials for Spinal Muscular Atrophy

Pre-Symptomatic Study of Intravenous Onasemnogene Abeparvovec-xioi in Spinal Muscular Atrophy (SMA) for Patients With Multiple Copies of SMN2

SPR1NT
Start date: April 2, 2018
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of intravenous onasemnogene abeparvovec-xioi in pre-symptomatic patients with SMA and 2 or 3 copies SMN2

NCT ID: NCT03505021 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS

REFALS
Start date: June 21, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate whether prolonged oral levosimendan can preserve respiratory function more effectively than placebo, resulting in better patient functionality as measured by the ALSFRS-R scale. In this randomized, double-blind, placebo-controlled, parallel-group, multicenter study, subjects are allocated in a 2:1 ratio to receive either levosimendan (1 -2 mg daily) or placebo for 48 weeks. The primary endpoint is slow vital capacity (SVC) at 12 weeks, with the impact on patient function assessed through 48 weeks, adjusted for patient outcome, using ALSFRS-R (combined assessment of function and survival, CAFS). Other important efficacy measures include time to respiratory events, clinical global impression (CGI), assessment of dyspnea using the Borg scale and sleep scales (Pittsburgh sleep quality index and Epworth sleepiness scale). Patient safety is monitored using conventional methods including adverse events, safety laboratory tests, vital signs and 12-lead EKG. Following screening and baseline visits, patients attend the clinic at 2, 4, 8, 12, 24, 36 and 48 weeks, with telephone assessments conducted at weeks 18, 30 and 42. An end of study visit is performed 14-25 days after the last study treatment administration. The study will be monitored by an independent data and safety monitoring board. A long-term extension study will be available for patients completing the study.

NCT ID: NCT03504423 Completed - Clinical trials for Pancreatic Cancer Metastatic

Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas

Start date: November 9, 2018
Phase: Phase 3
Study type: Interventional

A prospective, multicenter, open label, randomized phase III study to evaluate efficacy and safety of FFX versus CPI-613 + mFFX in patients with metastatic adenocarcinoma of the pancreas with age range of 18 to 75 years

NCT ID: NCT03504228 Completed - Clinical trials for Carotid Artery Stenosis

Prospective Single Arm CAS - ROADSAVER Study

ROADSAVER
Start date: January 23, 2018
Phase:
Study type: Observational

Approximately 2000 patients eligible for elective treatment with a Carotid Stent according to hospital routine practice in centers across Europe will be enrolled in the study. The maximum number of patients enrolled at each site will be not limited. Follow-ups are scheduled at discharge, 30 days, and 1 year, as per local practice. Each patient will have follow-up contacts via hospital visit and/or telephone.

NCT ID: NCT03504020 Completed - Heart Failure Clinical Trials

ECG Belt for CRT Response

Start date: July 13, 2018
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling.

NCT ID: NCT03503357 Completed - Clinical trials for Anesthesia Awareness

ConsCIOUS2 Study of the Isolated Forearm Technique Commands

Start date: April 4, 2018
Phase: N/A
Study type: Interventional

ConsCIOUS-2 is a multi-site study exploring the cognitive state of the Isolated Forearm Test (IFT) responder while under anesthetic.

NCT ID: NCT03500887 Completed - Clinical trials for Functional Disorders of Stomach

Monitoring Stomach Function With an Intragastric Balloon - a Pilot

ANTERO-AC-1
Start date: November 2015
Phase: N/A
Study type: Interventional

In this pilot study the investigators test the hypothesis that gastric motility can be measured with an intragastric balloon.

NCT ID: NCT03500549 Completed - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Start date: June 14, 2018
Phase: Phase 3
Study type: Interventional

Evaluation of the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria