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NCT ID: NCT04157348 Active, not recruiting - Clinical trials for Eosinophilic Granulomatous Vasculitis

Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.

MANDARA
Start date: October 29, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized, double blind, active-controlled, parallel group, multicenter 52-week Phase 3 study to compare the efficacy and safety of benralizumab 30 mg versus mepolizumab 300 mg administered by subcutaneous (SC) injection in patients with relapsing or refractory EGPA on corticosteroid therapy with or without stable immunosuppressive therapy. All patients who complete the 52-week double-blind treatment period on IP may be eligible to continue into an open label extension (OLE) period. The OLE period is intended to allow each patient at least 1 year of treatment with open-label benralizumab 30 mg administered SC (earlier enrolled patients may therefore be in the OLE for longer than 1 year).

NCT ID: NCT04154956 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer Metastatic

SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients

CARMEN-LC03
Start date: February 6, 2020
Phase: Phase 3
Study type: Interventional

Primary Objectives: - Study is designed with two primary endpoints that will be analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival [PFS] and overall survival [OS]) - Study success is defined either on PFS or OS - The primary objective is to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous non-small-cell lung cancer (NSCLC) expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) - The primary objective is to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor. Secondary Objectives: - To compare the objective response rate (ORR) of tusamitamab ravtansine with docetaxel - To compare the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel - To evaluate the safety of tusamitamab ravtansine compared to docetaxel - To assess the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel

NCT ID: NCT04153149 Active, not recruiting - Clinical trials for Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

Start date: November 26, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M) compared to placebo in patients with ATTR amyloidosis with cardiomyopathy.

NCT ID: NCT04148508 Active, not recruiting - Mental Disorder Clinical Trials

App-based Mental Health Promotion in Young European Adults

ECoWeB
Start date: October 9, 2020
Phase: N/A
Study type: Interventional

The ECoWeB Project aims to develop and disseminate a mobile application (App) to provide engaging and personalized tools and psychological skills to promote emotional wellbeing and prevent mental health problems in adolescents and young adults. The project team involves 8 European nations (the United Kingdom, Germany, Belgium, Spain, Greece, the Czech Republic, Denmark, and Switzerland) working together in order to improve mental health care and access for adolescents and young adults: - To use technology as a tool to assess and promote emotional well-being. - To deliver empirically supported psychological interventions through a smart phone application to address the needs of adolescents and young adults. - To improve mental well-being and prevent mental health problems in European adolescents and young adults. The ECoWeb project will consist of 2 RCT's within a longitudinal prospective cohort called ECoWeB-PROMOTE (indicating PROMOTION of well-being and good mental health) and ECoWeB-PREVENT (indicating PREVENTION of general distress, poor mental health and emotional disorders) respectively. These trials share the same recruitment procedure, interventions, outcomes (including self-report measures of well-being, anxiety, and depression) and design. Both are interested in the promotion of well-being and the prevention of general poor mental health in young people. The key difference is whether the participants are deemed to be at higher or lower risk criteria for poor mental health based on their general emotional competence skills, i.e., for those at low risk, do the interventions further enhance well-being, for those at higher risk, do the interventions prevent the worsening of poor mental health, general stress and distress, as well as enhancing well-being. In all cases the recruitment procedure will be the same, but the inclusion and exclusion criteria are different and the primary outcome measures are different hence they are 2 trials, rather than one, all running within the same cohort.

NCT ID: NCT04145349 Active, not recruiting - Clinical trials for Desmoplastic Small Round Cell Tumor

CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor

Start date: January 22, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory desmoplastic small round cell tumor (DSRCT) in children and young adults. This trial is part of the CAMPFIRE master protocol (NCT05999994) which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.

NCT ID: NCT04142905 Active, not recruiting - Asthma Clinical Trials

Is Asthma in Subjects With Obstructive Sleep Apnoea (OSA) Due to Dysanapsis

Start date: February 10, 2021
Phase:
Study type: Observational

Intention to review patient letters from sleep clinic to see if their lung function fit in with Dysynapsis in wheezing patients or if it is true asthma

NCT ID: NCT04140760 Active, not recruiting - Parkinson Disease Clinical Trials

Probiotic Use in Parkinson's Disease

Start date: August 14, 2019
Phase: N/A
Study type: Interventional

1. To evaluate the components and processes needed for a full-scale clinical study: recruitment, randomisation, attrition, probiotic use, stool sample collection, microbiome sequencing and behavioural/cognitive measures and determine the feasibility and patient acceptability of these processes to inform a full-scale study in line with NIHR pilot study guidance. 2. To collect pilot data to determine sample size and power, reliability and sensitivity of selected measures, to maximise the findings and minimise patient burden.

NCT ID: NCT04138277 Active, not recruiting - Clinical trials for Pompe Disease (Late-onset)

A Study to Assess the Long-term Safety and Efficacy of ATB200/AT2221 in Adult Subjects With LOPD

Start date: December 18, 2019
Phase: Phase 3
Study type: Interventional

This is a multicenter, international open-label extension study of ATB200/AT2221 in adult subjects with late-onset Pompe disease (LOPD) who completed Study ATB200-03.

NCT ID: NCT04136418 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Predict&Prevent: Use of a Personalised Early Warning Decision Support System to Predict and Prevent Acute Exacerbations of COPD

Start date: October 7, 2020
Phase: N/A
Study type: Interventional

COPD is a common complex disease with debilitating breathlessness; mortality and reduced quality of life, accelerated by frequent lung attacks (exacerbations). Changes in breathlessness, cough and/or sputum production often change before exacerbations but patients cannot judge the importance of such changes so they remain unreported and untreated. Remote monitoring systems have been developed but none have yet convincingly shown the ability to identify these early changes of an exacerbation and how severe they can be. This study asks if a smart digital health intervention (COPDPredict™) can be used by both COPD patients and clinicians to improve self-management, predict lung attacks early, intervene promptly, and avoid hospitalisation. COPDPredict™ consists of a patient-facing App and clinician-facing smart early warning decision support system. It collects and processes information to determine a patient's health through a combination of wellbeing scores, lung function and biomarker measurements. This information is combined to generate personalised lung health profiles. As each patient is monitored over time, the system detects changes from an individual's 'usual health' and indicates the likelihood of imminent exacerbation of COPD. When this happens, alerts are sent to both the individual and the clinician, with instructions to the patient on what actions to take. Any advice from clinicians can be exchanged via the App's secure messaging facility. If patients have followed the action plan but fail to improve or if an episode triggers an 'at high risk alert', clinicians are further prompted to case manage and intervene with escalated treatment, including home visits, if necessary. The COPDPredict™ intervention aims to assist patients and clinicians in preventing clinical deterioration from COPD exacerbations with prompt appropriate intervention. This study will randomise 384 patients who have frequent exacerbations, from hospitals in the West Midlands, to either (1) standard self-management plan (SSMP) with rescue medication (RM), or (2) COPDPredict™ and RM.

NCT ID: NCT04136353 Active, not recruiting - Prostate Cancer Clinical Trials

Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate

DASL-HiCaP
Start date: March 31, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the effectiveness of darolutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinising hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at very high risk of recurrence.