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NCT ID: NCT03986138 Completed - Clinical trials for Lesion in Body Region

Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)

PROMISE
Start date: August 27, 2019
Phase: Phase 3
Study type: Interventional

The trial aims at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)

NCT ID: NCT03985293 Completed - Clinical trials for Diabetes Mellitus, Type 2

A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus

Start date: October 15, 2019
Phase: Phase 2
Study type: Interventional

This multicenter, randomized, double-blind, placebo controlled, parallel group study is being conducted to provide data on efficacy, safety, tolerability and pharmacokinetics (PK) of multiple dose levels of PF-06882961 in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin and/or diet and exercise. In addition, the study is intended to enable selection of efficacious doses for future clinical development of PF-06882961.

NCT ID: NCT03980483 Completed - Clinical trials for Arthritis, Rheumatoid

Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

contRAst 1
Start date: May 16, 2019
Phase: Phase 3
Study type: Interventional

This study [contRAst 1 (201790: NCT03980483)] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165, in combination with methotrexate (MTX), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to MTX. The study will consist of a screening phase of up to 6 weeks followed by a 52-week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with MTX. 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)]. For those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.

NCT ID: NCT03978520 Completed - Clinical trials for Systemic Lupus Erythematosus (SLE)

A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)

SLEek
Start date: July 25, 2019
Phase: Phase 2
Study type: Interventional

The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.

NCT ID: NCT03971422 Completed - Clinical trials for Generalized Myasthenia Gravis

A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

Start date: June 3, 2019
Phase: Phase 3
Study type: Interventional

The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG).

NCT ID: NCT03971071 Completed - Migraine Headache Clinical Trials

A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache

Start date: October 7, 2019
Phase: Phase 4
Study type: Interventional

Study 20170703 is a phase 4, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of erenumab against placebo in participants with chronic migraine (CM) who have a history of at least 1 preventive treatment failure and are diagnosed with medication overuse headache (MOH).

NCT ID: NCT03969901 Completed - Clinical trials for Suspected or Documented Gram-negative Bacterial Infection

Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)

Start date: October 8, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the safety and tolerability of imipenem/cilastatin/relebactam (IMI/REL) in participants from birth to less than 18 years of age with confirmed or suspected gram-negative bacterial infection. Participants are expected to require hospitalization through completion of intravenous (IV) study intervention, and have at least one of the following primary infection types: hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP); complicated intra-abdominal infection (cIAI); or complicated urinary tract infection (cUTI). Participants will be randomized in a 3:1 ratio to receive IMI/REL or active control. This study will also evaluate the efficacy of IMI/REL by assessing all-cause mortality at Day 28 post-randomization, as well as clinical and microbiological response to treatment. It will also evaluate the pharmacokinetics of IMI/REL.

NCT ID: NCT03969888 Completed - Cystic Fibrosis Clinical Trials

A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222

Start date: December 11, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are homozygous for the F508del mutation.

NCT ID: NCT03969212 Completed - Influenza Clinical Trials

Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households

Start date: October 10, 2019
Phase: Phase 3
Study type: Interventional

Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. Their households are enrolled within 24 hours of randomization if at least 1 household contacts (HHC) have not received influenza vaccine within 6 months of screening and if all HHC screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from both IP and HHC up to 9 (+/-1) days post IP randomization, and through the assessment of symptoms.

NCT ID: NCT03968120 Completed - Pneumonia Clinical Trials

Effect of Lung Protective One-lung Ventilation With Fix and Variable PEEP on Oxygenation and Outcome

Start date: February 1, 2018
Phase: N/A
Study type: Interventional

During One-lung ventilation, the use of lower tidal volumes (VT) is helpful to avoid over-distension, provide sufficient oxygenation, but can result in increased atelectasis. Nevertheless, it is not known if, during one-lung ventilation with constant low VT, moderate levels of PEEP combined with lung recruitment maneuvers are superior to variable PEEP for intraoperative oxygenation and protection against PPCs. Aim of the study is to compare a strategy using constant tidal volume with recruitment maneuvers versus variable PEEP with recruitment maneuvers during thoracic surgery in adults. The investigators hypothesize that in adult, non-obese patients undergoing thoracic surgery under standardized OLV with variable PEEP and recruitment maneuvers as compared to constant PEEP without recruitment maneuvers prevent PPCs. Patients will be randomly assigned to one of two groups: FIX PEEP VOLUME GROUP (Groupfix): mechanical ventilation with constant (6 ml/kgIBW) tidal volume and PEEP of 5 cmH2O with recruitment maneuvers VARIABLE PEEP GROUP (Groupvar): mechanical ventilation with constant (6 ml/kgIBW) tidal volume with variable PEEP with recruitment maneuvers.