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NCT ID: NCT04602468 Active, not recruiting - Cystic Fibrosis Clinical Trials

Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER)

RECOVER
Start date: September 3, 2020
Phase: Phase 4
Study type: Interventional

RECOVER is a prospective, multicenter observational study designed to measure the real world clinical effectiveness of elexacaftor, tezacaftor and ivacaftor triple combination therapy (Kaftrio) in people with cystic fibrosis over a two year period. Measured outcomes include measures of lung function, lung inflammation, lung imaging, abdominal symptoms, gut inflammation, liver function, pancreatic exocrine function, nasal inflammation, quality of life and adherence to therapy. The study will examine outcomes in children aged six years and above over a period of two years. The first phase of the study will commence in 2020, recruiting children 12 years and older who have started on clinical treatment with Kaftrio.

NCT ID: NCT04595968 Active, not recruiting - Type 2 Diabetes Clinical Trials

Electrical Vestibular Nerve Stimulation (VeNS) Compared to Sham Control as a Means of Improving Glycemic Control in Adults With Type 2 Diabetes Mellitus

Start date: May 21, 2021
Phase: N/A
Study type: Interventional

Trial Title A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS), together with a lifestyle modification program, compared to a sham control with a lifestyle modification program, as a means of improving glycemic control in adults with type 2 diabetes mellitus. The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS), together with a lifestyle modification program, as a method of reducing HbA1c, as compared to a sham control. Allocation: Randomized to either active device or control device usage. All subjects will receive the same lifestyle advice. Endpoint classification: Efficacy Study Intervention Model: Parallel Assignment in 1:1 active to control allocation Trial Participants: Those who have been diagnosed with Type 2 diabetes mellitus. Sample Size: The aim is to recruit a total of 200 participants. Planned Trial Period: The study will last 24 weeks in total for each subject. The primary analysis will be conducted at the 24 weeks timepoint. The study in total is estimated to take about 1.5 years to complete.

NCT ID: NCT04595565 Active, not recruiting - Clinical trials for Triple Negative Breast Cancer

Sacituzumab Govitecan in Primary HER2-negative Breast Cancer

SASCIA
Start date: October 28, 2020
Phase: Phase 3
Study type: Interventional

Phase III, prospective, multi-center, randomized, open label, parallel group, study in patients with HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy with 1:1 allocation to: - Arm A: Sacituzumab govitecan (days 1, 8 q3w for eight cycles); - Arm B: treatment of physician´s choice (TPC, defined as capecitabine or platinum-based chemotherapy for eight cycles or observation. Treatment in either arm will be given for eight cycles. In patients with HR-positive breast cancer, endocrine-based therapy, which includes the use of CDK4/6 inhibitors, will be administered according to local guidelines. The start of endocrine therapy will be at the discretion of the investigator; however, it will be encouraged to start after surgery/radiotherapy in patients without additional cytotoxic agents. Adjuvant pembrolizumab can be given until the completion of radiotherapy before randomization. Within the study the use of pembrolizumab in patients with TNBC who received pembrolizumab as neoadjuvant therapy is allowed as monotherapy in the TPC arm, according to the approval of pembrolizumab in this setting.

NCT ID: NCT04594369 Active, not recruiting - Clinical trials for Non-Cystic Fibrosis Bronchiectasis

A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis

ASPEN
Start date: December 1, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.

NCT ID: NCT04588311 Recruiting - Clinical trials for Traumatic Brain Injury

ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients

EPO-TRAUMA
Start date: November 9, 2020
Phase: Phase 3
Study type: Interventional

The EPO-TRAUMA study is a prospective, multi-centre, double-blind, phase III, randomised controlled trial evaluating the efficacy of epoetin alfa compared to placebo in reducing mortality and severe disability at six months in critically ill trauma patients. 2500 mechanically ventilated ICU patients admitted with a primary trauma diagnosis presenting to the ICU will be recruited into the study from participating study centres in Australia, New Zealand, Europe, and Saudi Arabia.

NCT ID: NCT04587635 Completed - Clinical trials for Constipation - Functional

Evaluation of Changes in Bowel Movement Frequency Following the Consumption of PHGG in Adults With Constipation

TYPHOON
Start date: September 16, 2020
Phase: N/A
Study type: Interventional

Evaluation of Changes in Bowel Movement Frequency Following the Consumption of Partially Hydrolyzed Guar Gum (PHGG) in Adults with Constipation

NCT ID: NCT04586231 Active, not recruiting - Clinical trials for Carcinoma, Renal Cell

A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)

Start date: February 25, 2021
Phase: Phase 3
Study type: Interventional

This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival.

NCT ID: NCT04581070 Terminated - Cancer Clinical Trials

The COVID-IYON Study - Study Examining Data Pertaining to Clinical Outcomes and Organisational Responses to the 2020 SARS-CoV-2 Pandemic"

Start date: April 29, 2020
Phase:
Study type: Observational

This is a prospective, multisite, descriptive, observational clinical/epidemiological study examining both quantitative and qualitative data pertaining to clinical outcomes and organizational responses to the 2020 SARS-Coronavirus-2 (SARS-CoV-2) pandemic.

NCT ID: NCT04579666 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)

Start date: September 30, 2020
Phase: Phase 2
Study type: Interventional

This is a 24-month, Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS)

NCT ID: NCT04544293 Active, not recruiting - Clinical trials for Autoimmune Pulmonary Alveolar Proteinosis

Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

IMPALA-2
Start date: May 10, 2021
Phase: Phase 3
Study type: Interventional

160 subjects with autoimmune pulmonary alveolar proteinosis (aPAP) will be randomized to receive once daily treatment with inhaled molgramostim or placebo for 48 weeks. Subjects completing the 48 week placebo-controlled period will receive open-label treatment with once daily inhaled molgramostim for 96 weeks.