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NCT ID: NCT03038113 Completed - Chronic Hepatitis B Clinical Trials

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of RO7062931in Healthy Volunteers and Subjects With Chronic Hepatitis B

Start date: February 6, 2017
Phase: Phase 1
Study type: Interventional

This randomized study will be conducted in two parts to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of subcutaneous administration of RO7062931. Part 1 will include only healthy participants and Part 2 will include only participants with chronic hepatitis B (CHB). Part 1 is an adaptive, single-ascending dose study with an adaptive dose-escalating schedule to determine the best dose to be evaluated in participants with CHB. Part 2 is an adaptive, parallel multiple-dose study comprised of three sub-parts which will be used to further refine the dose and dosing regimen, and to evaluate the safety and efficacy of RO7062931 when administered with standard-of-care (SoC) therapy.

NCT ID: NCT03037931 Completed - Heart Failure Clinical Trials

Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency

HEART-FID
Start date: March 15, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo in the treatment of participants in heart failure with a reduced ejection fraction and with iron deficiency

NCT ID: NCT03036852 Completed - Chronic Hepatitis C Clinical Trials

Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease

SOF/VEL ESRD
Start date: March 22, 2017
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.

NCT ID: NCT03030430 Completed - NSCLC Clinical Trials

Study of Bevacizumab(BAT1706) and Comparators in Healthy Subjects

Start date: March 15, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to establish PK similarity in the treatment of BAT1706 and comparators.

NCT ID: NCT03029624 Completed - Clinical trials for Urgency Urinary Incontinence

eCoin Tibial Nerve Stimulation for OAB

Start date: April 3, 2017
Phase: N/A
Study type: Interventional

The study is a single arm, prospective study of the safety and effectiveness of the Valencia Technologies eCoin System to stimulate the tibial nerve for the treatment of patients with refractory urgency urinary incontinence.

NCT ID: NCT03009929 Completed - Clinical trials for Postoperative Complications

Validation Study of ClassIntra®

ClassIntra®
Start date: February 15, 2017
Phase:
Study type: Observational

Whereas there are several validated systems for reporting postoperative complications, there are only a few and not prospectively validated systems for reporting intraoperative complications. The investigators developed a definition and CLASSification for Intraoperative Complications CLASSIC within a Delphi study involving international interdisciplinary experts. As both surgery and anaesthesia may be involved in complications in the perioperative period, all patient-related intraoperative complications occurring between skin incision and closure are considered in this reporting system. CLASSIC was updated to ClassIntra® v1·0, by encompassing five severity grades to align with the validated Clavien-Dindo Classification for grading postoperative complications. The aim of this international multicentre observational cohort study is to assess the validity and practicability of this newly derived and updated classification system ClassIntra® in patient undergoing an in-hospital surgical procedure. Providing an easy applicable and internationally validated classification system is a contribution to improve quality of health care and patient safety.

NCT ID: NCT03009396 Completed - Crohn Disease Clinical Trials

Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease

MAPUS2
Start date: March 18, 2017
Phase: Phase 3
Study type: Interventional

An open label extension to the RHB-104-01 Study.

NCT ID: NCT03005145 Completed - Sepsis Clinical Trials

Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness

BALANCE
Start date: February 24, 2017
Phase: N/A
Study type: Interventional

The World Health Organization, U.S. Centers for Disease Control and Prevention, Association of Medical Microbiology and Infectious Diseases (AMMI) Canada, and Health Canada have all declared antimicrobial resistance a global threat to health, based on rapidly increasing resistance rates and declining new drug development. Up to 30-50% of antibiotic use is inappropriate, and excessive durations of treatment are the greatest contributor to inappropriate use. Shorter duration treatment (≤7 days) has been shown in meta-analyses to be as effective as longer antibiotic treatment for a range of mild to moderate infections. A landmark trial in critically ill patients with ventilator-associated pneumonia showed that mortality and relapse rates were non-inferior in patients who received 8 vs 15 days of treatment. Similar adequately powered randomized trial evidence is lacking for the treatment of patients with bloodstream infections caused by a wide spectrum of organisms.

NCT ID: NCT03001700 Completed - Clinical trials for Peripheral Arterial Disease

PRospective Study for the TrEatment of Atherosclerotic Lesions in the Superficial Femoral and/or Popliteal Arteries Using the Serranator DevicE

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

To assess preliminary safety and efficacy of the Serranatorâ„¢ Alto PTA Serration Balloon Catheter in subjects with atherosclerotic peripheral artery disease of the superficial femoral and popliteal arteries.

NCT ID: NCT02997202 Completed - Clinical trials for Acute Myeloid Leukemia

A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)

Start date: June 7, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who undergo hematopoietic stem cell transplant (HCT) and are randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.