Clinical Trials Logo

Filter by:
NCT ID: NCT04834869 Recruiting - COVID19 Vaccine Clinical Trials

COVID-19 Vaccines Safety Tracking (CoVaST)

Start date: April 1, 2021
Phase:
Study type: Observational

This project aims to monitor the side effects of COVID-19 vaccines worldwide actively. The primary objectives of the project include a) to estimate the prevalence of each local and systemic side effect of each COVID-19 vaccine among healthcare workers (HCW), old adults over +65 (OA), and schoolteachers (ST); b) to evaluate the potential demographic and medical risk factors for side effects frequency and intensity; c) to evaluate the long-term consequences of COVID-19 vaccines. The secondary objectives include a) to evaluate the relative safety of COVID-19 vaccines compared to each other; b) to evaluate the impact of palliative drugs used by the recently vaccinated individuals on their short-term side effects resolution.

NCT ID: NCT04812132 Recruiting - Obesity Clinical Trials

RCT Comparing OAGB and Long Limb Roux Gastric Bypass

OAGBvsLLbypass
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

A prospective multicenter randomized controlled trial to compare the outcomes of one-anastomosis gastric bypass to long biliary limb Roux gastric bypass. We plan to enroll up to 500 patients from three different clinics in Estonia. Outcomes are excess weight loss %, impact on type 2 diabetes, hypertension, hyperlipidemia and obstructive sleep apnea. Other outcomes are nutritional deficiencies, occurrence of reflux disease and impact on quality of life. There are planned outpatient visits 1, 5 and 10 years after the surgery to measure the impacts. There are a lot of studies comparing OAGB to standard Roux gastric bypass but non comparing it to long biliary limb gastric bypass.

NCT ID: NCT04762589 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

RT001 in Amyotrophic Lateral Sclerosis

Start date: March 10, 2021
Phase: Phase 2
Study type: Interventional

RT001-014 is a Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects with Amyotrophic Lateral Sclerosis

NCT ID: NCT04761120 Recruiting - Clinical trials for Mitral Regurgitation

Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study

ARB-PMCF
Start date: February 1, 2021
Phase:
Study type: Observational

ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation. The devices included in this study are the SJM™ Rigid Saddle Ring and SJM Séguin Annuloplasty Ring, indicated for mitral valve repair, and the SJM Tailor™ Annuloplasty Ring and SJM Tailor Annuloplasty Band, indicated for mitral or tricuspid repair. Participants will be enrolled prior to undergoing mitral or tricuspid valve repair surgery including an Abbott annuloplasty implant and will complete annual follow-up visits through five years from implant. The study is being conducted to meet post-market clinical follow-up requirements of the European Union Medical Device Directives.

NCT ID: NCT04751487 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) (AERIFY-2)

Start date: February 12, 2021
Phase: Phase 3
Study type: Interventional

Primary Objective: Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD Secondary Objectives: Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD - Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD - Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD - Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD Secondary population (current smokers cohort) - Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD - Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD - Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD - Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD - Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD

NCT ID: NCT04703699 Recruiting - Clinical trials for Aortic Valve Stenosis

Myval Global Study of Myval™ THV Series Implanted in Patients With Native Severe Aortic Valve Stenosis.

Start date: August 7, 2020
Phase:
Study type: Observational

A retrospective, multinational, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve Series in real-world setting.

NCT ID: NCT04636814 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)

PILLAR
Start date: July 12, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and the safety of two doses of CHF6001 (Tanimilast) as add-on to maintenance triple therapy in the target patient population.

NCT ID: NCT04624204 Recruiting - Clinical trials for Small Cell Lung Cancer

Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)

Start date: December 8, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR). Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR. Hypothesis (H2): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR. Hypothesis (H3): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to OS. Hypothesis (H4): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to OS.

NCT ID: NCT04529122 Recruiting - Solid Tumours Clinical Trials

A Worldwide Cancer Registry Enrolling Participants Profiled With a Next-Generation Sequencing Test

Start date: August 27, 2020
Phase:
Study type: Observational [Patient Registry]

WAYFIND-R is a registry that aims to capture high-quality real-world data linking next-generation sequencing, treatments and outcomes from cancer patients diagnosed with a solid tumour. The WAYFIND-R has three main overarching objectives: 1. To provide a platform to support the design and conduct of clinical and epidemiological research; 2. To develop an evidence-generation platform to better understand health outcomes and cancer care processes; and 3. To characterize the treatments and clinical course of solid tumor cancers in patients who have undergone NGS testing.

NCT ID: NCT04464226 Recruiting - Cancer Clinical Trials

Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

Start date: October 20, 2020
Phase: Phase 3
Study type: Interventional

The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor's visits as often as they did in the previous study.