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NCT ID: NCT04632940 Terminated - Clinical trials for Duchenne Muscular Dystrophy

Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMD

LELANTOS-2
Start date: December 11, 2020
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of pamrevlumab versus placebo in combination with systemic corticosteroids administered every 2 weeks in ambulatory participants with Duchenne muscular dystrophy (DMD) (age 6 to <12 years).

NCT ID: NCT04632784 Recruiting - Myopia Clinical Trials

Clinical Trial With Artiflex Presbyopic

Start date: November 12, 2021
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is to evaluate the effectiveness and safety of the multifocal Artiflex Presbyopic intraocular lens.

NCT ID: NCT04632316 Recruiting - Clinical trials for Acute Myeloid Leukemia

A Trial to Evaluate the Safety and Efficacy of oNKord® in Subjects With Acute Myeloid Leukemia

Start date: December 8, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

WiNK is a Phase I/IIa trial to evaluate the safety and efficacy of oNKord® in 33 adults with acute myeloid leukemia (AML) who are in morphologic complete remission with residual measurable disease and who are currently not proceeding to allogeneic hematopoietic stem cell transplantation.

NCT ID: NCT04631016 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess MEDI3506 in Participants With COPD and Chronic Bronchitis

FRONTIER-4
Start date: December 14, 2020
Phase: Phase 2
Study type: Interventional

This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis.

NCT ID: NCT04628494 Active, not recruiting - Clinical trials for Diffuse Large B-cell Lymphoma

A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL

EPCORE DLBCL-1
Start date: January 13, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to find out if epcoritamab, also known as EPKINLYâ„¢ and GEN3013, is safe and works well as treatment for patients with diffuse large B-cell lymphoma (DLBCL) that are not responding to treatment, have grown in size, or have come back following treatment with at least 1 prior systemic cancer therapy. All participants in this trial will be randomly assigned to receive either epcoritamab or a pre-specified investigator's choice (standard of care) chemotherapy (either rituximab + gemcitabine + oxaliplatin [R-GemOx], or bendamustine + rituximab [BR]). Participants must have failed or be ineligible to receive an autologous stem cell transplant (ASCT). Epcoritamab will be injected under the skin. Investigator's choice chemotherapy will be given intravenously. Trial details include: - The trial duration will be up to 5 years. - All trial participants have a 21-day screening period, a treatment period, and a follow-up period that continues until death. - The estimated trial duration for an individual subject depends upon the treatment arm assigned: - Participants who receive epcoritamab will have 28-day treatment cycles. Epcoritamab will be given once weekly for the first 3 months, then every other week for 6 months, then every 28 days until lymphoma progression or unacceptable adverse events. - Participants who receive investigator's choice (standard of care) chemotherapy will receive treatments either: - R-GemOx: On Day 1 (or Day 1 & Day 2), and Day 15 (or Day 15 & Day 16) every 28 days, for up to 4 months; or - BR: On Day 1 and Day 2 every 3 weeks for up to 4.5 months.

NCT ID: NCT04627974 Active, not recruiting - Chronic Pain Clinical Trials

Long-term Effectiveness, Safety, and Performance of the Evoke Closed-Loop SCS System to Treat Patients With Chronic Pain of the Trunk and/or Limbs

Domburg
Start date: August 5, 2020
Phase:
Study type: Observational

The objective of this multicountry, multicentre, prospective study is to evaluate the long-term clinical effectiveness, safety, and performance of the Evoke System in the treatment of chronic pain of the trunk and/or limbs in a real-world population.

NCT ID: NCT04626661 Completed - Healthy Clinical Trials

Mitochondrial Oxygen Measurement Variability in Critically Ill Patients (INOX Variability Study)

Start date: June 15, 2020
Phase:
Study type: Observational

To determine the between- and within-subject variability of the mitochondrial oxygenation measurement with the COMET device over time in healthy subjects and in hemodynamically stable subjects admitted to the intensive care unit.

NCT ID: NCT04626518 Active, not recruiting - Clinical trials for Carcinoma, Renal Cell

Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B)

Start date: December 17, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Substudy 03B is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03). The goal of substudy 03B is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced second line plus (2L+) clear cell renal cell carcinoma (ccRCC). This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.

NCT ID: NCT04626479 Active, not recruiting - Clinical trials for Carcinoma, Renal Cell

Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)

Start date: December 16, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Substudy 03A is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03). The goal of substudy 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) clear cell renal cell carcinoma (ccRCC). This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.

NCT ID: NCT04626349 Completed - Advanced Cancer Clinical Trials

International Study to Evaluate Two Programs of Support for Patients With Advanced Cancer and Their Families

DIAdIC
Start date: February 24, 2021
Phase: N/A
Study type: Interventional

The overall aim of this project is to evaluate the effectiveness, cost-effectiveness and mechanisms of action of two psychoeducational interventions (a face-to-face nurse-led intervention called FOCUS+ and an eHealth intervention called iFOCUS) aimed at improving the emotional function and self-efficacy of patients with advanced cancer and their family caregiver. Both interventions are compared to care as usual. Both interventions focus on teaching dyads optimal ways to jointly manage the implications of advanced cancer and responding to their priority concerns and are designed to be tailored to the specific needs and wishes of the patient-caregiver dyads. Tailoring is based on information about the dyad obtained at enrollment (e.g. age, relationship, etc.) and the responses in the intervention sessions. The overarching aim is addressed by five core intervention components: 1. supporting family involvement and improving the dyads mutual communication, 2. supporting outlook (i.e. increasing the dyad's capacity to identify positive or meaningful aspects related to their situation), 3. increasing dyads' coping skills, i.e. their capacity to identify their coping strategies and take action 4. help dyads reduce their uncertainty 5. teaching symptom management and giving them confidence to handle specific tasks and problems Project objectives: 1. To compare 1) the face-to-face FOCUS+ intervention and 2) the iFOCUS web intervention to 3) care as usual in terms of their: - Effect on the emotional function and self-efficacy (primary outcomes), appraisal of illness, uncertainty, hopelessness, coping, dyad communication, quality of life and healthcare resource use of patients with advanced cancer and their family caregivers - Cost-effectiveness - Effects on vulnerable subgroups (particularly women and those of lower socioeconomic status) - Effectiveness in different healthcare systems 2. To evaluate the implementation process of the interventions in terms of the acceptability, feasibility, usefulness as perceived by patients, family caregivers and healthcare staff in each country, and their mechanisms of action. Data will be collected three times from patient-caregiver dyads: 1) baseline measure (t0) after which the dyad will immediately be randomized to one of the study arms, 2) first follow-up at 12 weeks after baseline (t1) and 3) second follow-up at 24 weeks after baseline (t2).