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NCT ID: NCT04138056 Completed - Clinical trials for Respiratory Syncytial Virus Infections

A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women

Start date: November 5, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, ability of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) to generate an immune response and the degree to which the vaccine can cause side effects, when administered alone and in combination with Boostrix vaccine in healthy non-pregnant women 18-45 years of age. Two dose levels of RSVPreF3 and 2 Boostrix [Diphtheria, Tetanus and acellular Pertussis (dTpa) vaccine] formulations (US and ex-US) will be evaluated. A 2nd dose of RSVPreF3 will be administered in an extension of the study to assess the durability of the immune response after the first dose vaccination, and to assess the safety and immunogenicity following a second dose vaccination of the RSVPreF3 maternal vaccine.

NCT ID: NCT04137991 Completed - Cardiac Surgery Clinical Trials

Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery

Start date: October 10, 2019
Phase: N/A
Study type: Interventional

This study will investigate the potential of guiding remifentanil analgesia during cardiac and vascular surgery in moderate to high risk patients requiring general anesthesia.

NCT ID: NCT04137510 Completed - Clinical trials for Coronary Artery Disease

Bioflow-DAPT Study

Start date: February 24, 2020
Phase: Phase 4
Study type: Interventional

BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study. A total of 1'948 subjects will be randomized 1:1 to receive either Orsiro Mission or Resolute Onyx. After index procedure, all patients will receive DAPT (ASA + P2Y12 inhibitor) for 30 days, followed by monotherapy with either P2Y12 inhibitor or ASA only until the end of the study. Clinical follow-up visits will be scheduled at 1, 6 and 12 months post-procedure.

NCT ID: NCT04137289 Completed - Cholangiocarcinoma Clinical Trials

A Study to Find a Safe and Effective Dose of BI 905711 in Patients With Advanced Gastrointestinal Cancer

Start date: March 11, 2020
Phase: Phase 1
Study type: Interventional

Phase Ia - Explore safety and establish the maximum tolerated dose (MTD)/recommended dose levels for phase Ib expansion phase of BI 905711 based on the frequency of patients experiencing dose limiting toxicities (DLTs) during the MTD evaluation period. The MTD evaluation period is defined as the first two treatment cycles (from first dose administration until the day preceding the third dose administration or end of REP in case of discontinuation before start of Cycle 3). Phase Ia - Explore pharmacokinetics/pharmacodynamics, and efficacy to guide the determination of a potentially effective dose range for phase Ib in the absence of MTD. Phase Ib - Evaluate efficacy and safety of BI 905711 at a potentially effective dose range and determine the Recommended Phase 2 Dose (RP2D)

NCT ID: NCT04134936 Completed - Clinical trials for Diffuse Large B-cell Lymphoma

Phase Ib Study to Assess Safety and Preliminary Efficacy of Tafasitamab or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients With Newly Diagnosed DLBCL

Start date: December 11, 2019
Phase: Phase 1
Study type: Interventional

This is an open-label, randomized, multicentre study to evaluate safety and preliminary efficacy of the human anti-CD19 antibody Tafasitamab in addition to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristin, Prednison) or Tafasitamab and Lenalidomide in addition to R-CHOP in adult patients with newly diagnosed, previously untreated Diffuse Large B-cell Lymphoma (DLBCL).

NCT ID: NCT04134728 Completed - Clinical trials for Arthritis, Rheumatoid

Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors

contRAst 3
Start date: October 31, 2019
Phase: Phase 3
Study type: Interventional

This study (contRAst 3 [202018: NCT04134728]) is a Phase 3, randomized, multicenter, double-blind study to assess the safety and efficacy of GSK3196165 in combination with conventional (cs) DMARD[s]) or the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to biologic (b) DMARD[s]) and/or JAK inhibitors. The study will consist of a screening phase of up to 6 weeks followed by 24 week treatment phase in which participants will be randomized in ratio of 6:6:6:1:1:1 to GSK3196165 150 milligrams (mg) subcutaneously (SC) weekly,GSK3196165 90 mg SC weekly, sarilumab 200 mg SC every other week or placebo (three arms) respectively, all in combination with background csDMARD(s). At Week 12, participants in the three placebo arms will switch from placebo to active intervention (either GSK3196165 150 mg SC weekly, GSK3196165 90 mg SC weekly, or sarilumab 200 mg SC every other week). Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165, may be included in the long-term extension study (contRAst X [209564: NCT04333147]). Any participant who does not transition into study 209564 will undergo a safety follow-up visit at Week 34 (corresponding to 12 weeks after the last potential dose of sarilumab, at Week 22).

NCT ID: NCT04133168 Completed - Clinical trials for Paroxysmal Atrial Fibrillation

Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation

FROZEN-AF
Start date: June 24, 2020
Phase: N/A
Study type: Interventional

To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).

NCT ID: NCT04129554 Completed - Clinical trials for Hepatitis B, Chronic

A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

Start date: November 6, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of 48-week study intervention with JNJ-73763989+JNJ-56136379+nucleos(t)ide analog (NA) regimen compared to NA alone assessed by HBsAg levels. This study is part of HepB Wings Platform Trial (PLATFORMPAHPB2001).

NCT ID: NCT04129528 Completed - Clinical trials for Type 1 Diabetes Mellitus

Study of Safety and Efficacy of CFZ533 in Type 1 Diabetes Pediatric and Young Adult Subjects

CCFZ533X2207
Start date: November 8, 2019
Phase: Phase 2
Study type: Interventional

The study is a Phase 2, multicounty, multicenter, non-confirmatory, investigator- and subject masked, randomized, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CFZ533 on preservation of residual pancreatic β-cell function in new onset T1DM in pediatric and young adult subjects.

NCT ID: NCT04128982 Completed - Videolaryngoscopy Clinical Trials

Vidéolaryngoscopy Study of the LPEC in Obese Patients

Start date: November 5, 2019
Phase:
Study type: Observational

1. Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression in obese patient 2. International surveys comparing tracheal intubation difficulty on a scale of 1 to 3 between cricoid pressure, Left Paratracheal Esophageal Compression and neutral position