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NCT ID: NCT04986995 Active, not recruiting - Parkinson Disease Clinical Trials

OpicApone Sleep dISorder

OASIS
Start date: June 9, 2021
Phase: Phase 4
Study type: Interventional

The aim of this study is to To investigate in an exploratory manner the efficacy of 50 mg opicapone when administered with the existing treatment of levodopa (L-dopa) plus a dopa decarboxylase inhibitor (DDCI), in Parkinson's disease (PD) patients with end-of-dose motor fluctuations and associated sleep disorders

NCT ID: NCT04985968 Terminated - Ulcerative Colitis Clinical Trials

The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis

CONCLUDE
Start date: November 24, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in inducing or maintaining clinical remission at week 52, in participants with clinical response at week 6 after induction treatment with cobitolimod.

NCT ID: NCT04979676 Completed - Clinical trials for Social Anxiety Disorder

Changing the Course of Social Anxiety in Adolescence

TeenSAD
Start date: March 15, 2019
Phase: N/A
Study type: Interventional

Social anxiety often reaches its peak during adolescence and may hold a noteworthy impact both at the social and academic levels. Though some adolescents easily learn to adequately cope with it, others become overwhelmed by social fears and end up avoiding social events or facing them with intense suffering. Adolescents with social anxiety disorder (SAD) seldom seek professional help and often become adults with SAD, making it necessary to timely intervene during early stages of the disorder and determine what works better, why, and for whom when trying to change the course of social anxiety in adolescence. Cognitive therapy (CT) has been the treatment of choice for adult SAD, but research within adolescent samples is scarce. More recently, third-wave cognitive approaches, namely compassion-focused therapy (CFT) and acceptance and commitment therapy (ACT), have also proven effective in treating mental disorders, but their efficacy towards adolescents' SAD remains unclear. This research project intended to evaluate and compare the therapeutic efficacy of CT, CFT, and ACT as applied to adolescents with SAD, in comparison with waiting-listed, after intervention and over a 12-weeks and a 24-weeks follow-up, using a randomized parallel trial approach. This methodology will allow to test if intervened subjects diverge from the non-intervened SAD subjects, and if therapeutic change differs across intervention conditions. Therapeutic change process will be investigated, specifically if efficacy is mediated by change in the core constructs of each theoretical framework. Finally, moderators of change such the initial level of symptomology will be examined, as to determine which intervention works best for whom. The same procedures will be repeated for each intervention condition, namely recruitment, intervention, and assessment. This research will provide evidence on which form of therapy may be the optimal choice in to intervene in SAD in general, and when dealing with diverse specific vulnerabilities associated with social fears. It will also add to the field of empirically validated therapies, with a specific focus on adolescence. From a societal perspective, the project will assist in empowering schools to contribute to shape how their students act and develop into socially apt adults.

NCT ID: NCT04975997 Recruiting - Multiple Myeloma Clinical Trials

Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

EXCALIBER-RRMM
Start date: June 23, 2022
Phase: Phase 3
Study type: Interventional

This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).

NCT ID: NCT04973787 Recruiting - Clinical trials for Arthritis, Rheumatoid

The Role of Microbiome on Biological Therapy Efficacy in axSpA and RA

MicroSpA & RA
Start date: August 1, 2020
Phase:
Study type: Observational [Patient Registry]

Spondyloarthritis (SpA) and Rheumatoid arthritis (RA) are among the most common chronic inflammatory rheumatic diseases. Introduction of Tumor Necrosis Factor alpha inhibitors (TNFi) to the therapeutic strategy improved acute inflammation and pain, but a significant percentage of patients develop severe adverse events or are still non responders or incomplete responders to these expensive treatments. There is an urgent need to identify new predictors of biological therapy response. It has been described the role of microbiota in some rheumatic diseases, however, clinical trials are scarce. We hypothesized that microbiota or their metabolites may play a role in therapeutic response to TNFi.

NCT ID: NCT04973137 Recruiting - Clinical trials for Light Chain (AL) Amyloidosis

A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis

AFFIRM-AL
Start date: August 30, 2021
Phase: Phase 3
Study type: Interventional

A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.

NCT ID: NCT04971226 Active, not recruiting - Clinical trials for Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

Start date: October 6, 2021
Phase: Phase 3
Study type: Interventional

The study is designed to compare the efficacy of asciminib 80 mg QD versus Investigator selected TKI for the treatment of newly diagnosed, previously untreated patients with Ph+ CML-CP. The Investigator selected TKI will be one of the following treatment options for first-line treatment of CML-CP - imatinib 400 mg QD or nilotinib 300 mg BID or dasatinib 100 mg QD or bosutinib 400 mg QD.

NCT ID: NCT04968912 Completed - Sjogren's Syndrome Clinical Trials

A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)

Start date: September 21, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of nipocalimab in participants with primary Sjogren's syndrome (pSS) versus placebo.

NCT ID: NCT04967378 Completed - Clinical trials for Mild Cognitive Impairment

Homebound Elderly People Psychotherapeutic Intervention

HEPPI
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

This study aims to develop, implement, and assess the feasibility, acceptability, and preliminary efficacy of a 10-week structured and individualized cognitive-emotional intervention program for homebound older adults with Mild Cognitive Impairment (MCI) and with depressive and/or anxiety symptoms. Homebound Elderly People Psychotherapeutic Intervention (HEPPI) is designed to maintain or improve memory functioning, reduce depressive and/or anxiety symptoms, and help participants to compensate or adapt to impaired cognitive performance, improving their quality of life and their subjective perception of memory and health.

NCT ID: NCT04967287 Active, not recruiting - Myopia Clinical Trials

MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation

MyopiaX-1
Start date: November 16, 2021
Phase: N/A
Study type: Interventional

The purpose of this trial is to investigate the safety and efficacy of MyopiaX - a digital treatment intended to slow the progression of myopia in children and adolescents.