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NCT ID: NCT04755569 Recruiting - Clinical trials for Evaluate the Safety and Useability of the ODOCOR II Intra-cardiac Lead

Optimizer System With ODOCOR II CCMâ„¢ Leads

Start date: March 1, 2021
Phase:
Study type: Observational [Patient Registry]

The objective of the ODOCOR II CCM lead study is to evaluate the safety and useability of the ODOCOR II intra-cardiac lead specifically intended to deliver CCM as an accessory lead to the Optimizer IPG.

NCT ID: NCT04754854 Recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Reduction of Blood Recirculation in Veno-Venous ECMO

Start date: November 20, 2020
Phase:
Study type: Observational

Blood which recirculates through the circuit of a veno-venous Extracorporeal Membrane Oxygenation (V-V ECMO) does not contribute to the systemic oxygenation of a patient on V-V ECMO and is called the recirculation fraction (Rf). Theoretically, the optimization of ECMO blood flow is possible using Rf measurements. A prospective, observational study will be performed measuring the Rf of total ECMO blood flow in patients with acute respiratory distress syndrome (ARDS) on V-V ECMO with an ultrasound dilution technique. ECMO blood flow will be optimized by reducing ECMO blood flow in accordance with the measured Rf as long as systemic oxygenation is not compromised.

NCT ID: NCT04754217 Recruiting - Clinical trials for Aortic Valve Disease

Valved Graft PMCF Study

Start date: July 13, 2021
Phase:
Study type: Observational

Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.

NCT ID: NCT04753801 Recruiting - Clinical trials for Healthy Participants

What Are the Ingredients for the Best Form of the Best Possible Self (BPS) Intervention?

BestBPS
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

This study aims to determine the relevant 'ingredients' to make the best possible self (BPS) intervention most efficacious and test whether the BPS's efficacy can be enhanced by including mindfulness aspects.

NCT ID: NCT04753541 Recruiting - Atrial Fibrillation Clinical Trials

The Influence of Genetic Predisposition on Outcome After Catheter Ablation of Atrial Fibrillation.

AF GEN
Start date: November 1, 2020
Phase:
Study type: Observational

Catheter ablation is an established standard therapy in interventional treatment of atrial fibrillation.The trial investigates the influence of genetic risk for the recurrence of atrial fibrillation after catheter ablation.

NCT ID: NCT04753073 Recruiting - Clinical trials for Cervical Intraepithelial Neoplasia III

Treatment of Cervical Intraepithelial Neoplasia (CIN) Grade III With Non-invasive Physical Plasma

ZGynO_CINIII
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

The aim of the prospective, unicenter proof-of-principle study is to investigate the anti-neoplastic effectiveness of NIPP against CIN III lesions. - The aim of this project is to evaluate the potential of a previous NIPP treatment to significantly reduce the invasiveness of the LEEP excision. - Another aim of this study is to investigate cellular / molecular effects of NIPP following the in-vivo treatment of the cervix using molecular biological methods. For this purpose, tissue treated with plasma is taken after defined periods of time by mini biopsy and examined using molecular biological, histological and microscopic methods.

NCT ID: NCT04752280 Recruiting - Glioblastoma Clinical Trials

Glioblastoma Radiotherapy Using IMRT or Proton Beams

GRIPS
Start date: April 19, 2021
Phase: N/A
Study type: Interventional

Radiation therapy is an integral part of the multimodal primary therapy of glioblastomas. As the overall prognosis in this tumor entity remains unfavorable, current research is focused on additional drug therapies, which are often accompanied by increases in toxicity. By using proton beams instead of photon beams, it is possible to protect large parts of the brain which are not affected by the tumor more effectively. An initial retrospective matched-pair analysis showed that this theoretical physical benefit is also clinically associated with a reduction in toxicity during therapy and in the first few months thereafter. The aim of the GRIPS study is to prospectively test this clinical benefit in a randomized, open-label Phase III study. Patients are treated in the study using either modern photon radiation techniques (standard arm) or proton beams (experimental arm). The primary endpoint is the cumulative toxicity CTC grade 2 and higher in the first 4 months. Secondary endpoints include overall survival, progression-free survival, quality of life, and neurocognition.

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: NCT04750798 Recruiting - Cardiac Arrhythmias Clinical Trials

An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias

Start date: February 22, 2021
Phase:
Study type: Observational

The purpose of this study is to prospectively collect clinical data evaluating the ongoing safety and performance during routine-use standard cardiac arrhythmia mapping and/or ablation procedures while using commercial Biosense Webster Inc. (BWI) medical devices. Data generated from the study will be used to confirm safety and performance of BWI medical devices in the marketed phase and to expand the body of evidence on the use of these devices and techniques in treatment of cardiac arrhythmias.

NCT ID: NCT04750408 Recruiting - Clinical trials for Hypercapnic Respiratory Failure

NHF vs. COT in Hypoxemic Pandemic Viral Illness

HIVI
Start date: January 22, 2021
Phase: N/A
Study type: Interventional

The study compares oxygen and NHF in patients with acute viral illness. The duration will be 72h. After them physiological parameters and the outcome will be evaluated.