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NCT ID: NCT04333147 Terminated - Clinical trials for Arthritis, Rheumatoid

Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)

contRAst X
Start date: May 12, 2020
Phase: Phase 3
Study type: Interventional

RA is a chronic, systemic inflammatory autoimmune disease which requires treatment for a long time period, hence it is important to study the long-term safety and efficacy of the continuous treatment with GSK3196165 over several years. This is a Phase 3, multicenter, parallel group treatment and long-term extension study primarily to assess safety with efficacy assessment as a secondary objective. Adult participants with RA who have completed the treatment phase of a qualifying GSK3196165 clinical studies (Phase 3 studies contRAst 1 (201790: NCT03980483), contRAst 2 (201791: NCT03970837) and contRAst 3 (202018: NCT04134728) and who, in investigator's judgement will benefit from extended treatment with GSK3196165 will be included in this study (contRAst X [209564: NCT04333147]). Participants will continue to receive the same background conventional synthetic disease modifying anti-rheumatic drug(s) [csDMARD(s)] treatment as they received in their qualifying study. Eligible participants will be enrolled to receive weekly GSK3196165 90 milligrams (mg) or 150 mg by subcutaneous (SC) injection. The anticipated study duration is approximately 4 years which will enable participants to receive treatment with GSK3196165 until it is expected to become commercially available. Approximately 3000 participants from the qualifying studies will participate in this long-term extension study

NCT ID: NCT04323761 Approved for marketing - SARS-CoV2 Infection Clinical Trials

Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection (COVID-19)

Start date: n/a
Phase:
Study type: Expanded Access

The primary objective of this study is to provide expanded access of remdesivir (RDV) for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.

NCT ID: NCT04314921 Completed - Aging Clinical Trials

10-week Yoga Practice Effect on Cognitive and Motor Function in Older Adults

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

Thirty-three healthy elderly people, who were classified into two age groups, participated in this study. All participants had not practiced yoga before and were asked not to perform any sports activities while the research was ongoing. In the experimental group, participants (n = 18) had to participate in 10 weeks of yoga classes. In the control group, participants (n = 15) did not perform any exercises or other changes in their daily living life. Experimental measurements: Brunel, PSS-14 and HAD questionnaires

NCT ID: NCT04307576 Recruiting - Clinical trials for Leukemia, Acute Lymphoblastic

A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia

Start date: July 13, 2020
Phase: Phase 3
Study type: Interventional

ALLTogether collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new master protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised and interventional trials included in the study-design.

NCT ID: NCT04295434 Recruiting - Blood Pressure Clinical Trials

Blood Pressure Control in ESH Excellence Centres

BP-CON
Start date: October 1, 2018
Phase:
Study type: Observational

In the BP-CON-ESH study we are going to include and analyze treated hypertensive patients seen consecutively by the ESH Excellence Centres. Blood pressure will be measured as usually done in the office, but care will be adopted to make measurements highly standardized in all Centres. The primary goals will be to determine the global, regional and country rates of hypertension control in Europe. Other goals will be to identify global and regional factors associated with blood pressure control in different European regions. The results obtained in the BP-CON-ESH project will be used to refine treatment strategies for improvement of blood pressure control and will serve as a basis for assessing future changes and trends in Europe.

NCT ID: NCT04295395 Completed - Pre-Term Clinical Trials

Evaluation of the Brain and Renal Regional Oxygenation Using NIRS in Preterm Infants

Start date: November 9, 2017
Phase:
Study type: Observational

This study evaluates the brain and renal oxygenation using near infrared spectroscopy in preterm infants with persistent ductus arteriosus

NCT ID: NCT04281927 Completed - Atrial Fibrillation Clinical Trials

A Wearable With Photoplethysmography and 6-lead Electrocardiography for Atrial Fibrillation Detection

DoubleCheckAF
Start date: March 6, 2019
Phase:
Study type: Observational

A single center prospective case-control study to evaluate ability of a wearable to differentiate between atrial fibrillation (AF) and sinus rhythm (SR).

NCT ID: NCT04271475 Terminated - Clinical trials for Chronic Thromboembolic Pulmonary Hypertension

A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension

MACiTEPH
Start date: July 7, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH).

NCT ID: NCT04270747 Completed - Clinical trials for Neovascular (Wet) Age-related Macular Degeneration (AMD)

A Study to Understand Effectiveness and Safety of ABP 938 Compared to Aflibercept (Eylea®) in Patients Suffering With Neovascular Age-related Macular Degeneration [Neovascular (Wet) AMD]

Start date: June 22, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of ABP 938 versus Aflibercept (Eylea®) in the treatment of neovascular age-related macular degeneration. Subjects will be randomized in a masked 1:1 ratio to receive 2 mg (0.05 mL) of either ABP 938 (Treatment Group A) or aflibercept (Treatment Group B) administered by intravitreal (IVT) injection.

NCT ID: NCT04270409 Active, not recruiting - Plasma Cell Myeloma Clinical Trials

A Phase 3 Randomized, Open-label, Multicenter Study of Isatuximab (SAR650984) in Combination With Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With High-risk Smoldering Multiple Myeloma

Start date: June 16, 2020
Phase: Phase 3
Study type: Interventional

Primary Objectives: - Safety run-in: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) - Randomized Phase 3: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMM Secondary Objectives: Safety run-in - To assess overall response rate (ORR) - To assess duration of response (DOR) - To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR) - To assess time to diagnostic (SLiM CRAB) progression or death - To assess time to first-line treatment for multiple myeloma (MM) - To assess the potential immunogenicity of isatuximab - Impact of abnormal cytogenetic subtype on participant outcome Randomized Phase 3 - Key Secondary Objectives: To compare between the arms - MRD negativity - Sustained MRD negativity - Second progression-free survival (PFS2) - Overall survival Other Secondary Objectives: To evaluate in both arms - CR rate - ORR - DOR - Time to diagnostic (SLiM CRAB) progression - Time to biochemical progression - Time to first-line treatment for MM - Safety and tolerability - Pharmacokinetics (PK) - Potential of isatuximab immunogenicity - Clinical outcome assessments (COAs)