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NCT ID: NCT05043090 Recruiting - Clinical trials for Papillary Renal Cell Carcinoma

Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC

SAMETA
Start date: October 28, 2021
Phase: Phase 3
Study type: Interventional

A clinical trial to compare the effectiveness of savolitinib plus durvalumab versus sunitinib in MET-driven (hepatocyte growth factor receptor), unresectable and locally advanced or metastatic PRCC (Papillary Renal Cell Carcinoma).

NCT ID: NCT05042453 Recruiting - Clinical trials for Pelvic Organ Prolapse

Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse

SAXO
Start date: December 19, 2022
Phase:
Study type: Observational

This prospective, multi center cohort trial aims to evaluate the efficacy and safety of hysteropexy using Splentis via the vaginal route in primary uterine prolapse

NCT ID: NCT05042219 Recruiting - COPD Clinical Trials

Effects of Pulmonary Diseases and Their Treatment on Cardiac Function

Start date: June 1, 2022
Phase:
Study type: Observational

While the bidirectional relationship between the lung and the right heart are well studied, the cardiopulmonary interactions between the lung and the left heart are largely unresearched and not well understood. However, in recent years, there is a growing evidence that partially explains the bidirectional interaction between COPD and left heart. Systemic inflammation with multiorgan involvement is thought to play a role in COPD as a systemic disease. Some therapeutic approaches to COPD also appear to influence these cardiopulmonary interactions. While understanding these interactions is very important for clinicians, scientific data are scarce. Cardiac magnetic resonance imaging (cardiac MRI) is the gold standard for assessing cardiac function and dimensions as well as myocardial inflammation. Despite this excellent suitability of cardiac MRI for the assessment of cardiovascular function, only few studies have investigated cardiac function and myocardial structure in patients with pulmonary disease using cardiac MRI. Such a study is therefore very important for understanding the effects of pulmonary disease and its management on the heart. The objective is to determine cardiac function in patients with pulmonary disease and to analyze the cardiovascular effects of the treatment of the pulmonary disease. Specifically, the following will be studied: - Using cardiac MRI: Cardiac function and volumes and indications of myocardial fibrosis and edema in patients with chronic pulmonary disease at the time of first diagnosis. - the vascular function of pulmonary arteries in these patients, also using cardiac MRI - the relationship between pulmonary function parameters and cardiac dysfunction to identify patients at increased risk, if applicable. - Echocardiographic assessment of left heart including strain analysis. - the course of these cardiovascular parameters (using cardiac MRI and echocardiography) 3-6 months after initiation of guideline-based therapy for pulmonary disease.

NCT ID: NCT05041452 Recruiting - Cardiomyopathies Clinical Trials

Multiparametric Cardio-hepatic MRI in Patients With Noncirrhotic Portal Hypertension

Start date: April 29, 2021
Phase:
Study type: Observational

The aim of this study is to use multiparametric MRI to investigate any differences in myocardial structure and function in patients with noncirrhotic portal hypertension compared with a control group with liver cirrhosis.

NCT ID: NCT05041296 Recruiting - Epilepsy Clinical Trials

Cardiac MRI for Detection of Acute and Chronic Cardiac Involvement in Patients With Epilepsy

Start date: March 7, 2021
Phase:
Study type: Observational

The aim of the study is to use multiparametric cardiac MRI to identify any abnormalities in myocardial structure and function in patients with epilepsy. A two-stage study design is planned as part of the study: 1. In the acute setting, cardiac MRI will be performed in patients before and after a tonic-clonic seizure and compared intraindividually. In this study arm, potential acute seizure-induced myocardial damage will be detected. 2. In the chronic setting, cardiac MRI will be performed in patients with known chronic epilepsy during the seizure-free interval to detect potential chronic myocardial damage (myocardial fibrosis) and compared with a control population. Within the group of epilepsy patients, possible associations with various epilepsy-specific characteristics (e.g., form, cause, onset, duration, and severity of epilepsy) will be investigated.

NCT ID: NCT05041283 Recruiting - Bowel Preparation Clinical Trials

Impact of Artificial Intelligence-based Patient Reinforcement on Quality of Colonoscopy

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

In order to improve bowel preparation for colonoscopy and consequently enhance detection rate of malignant and premalignant findings, a prospective, randomized and controlled three-arm study was developed. Patients who undergo ambulatory colonoscopy are randomly assigned into a control group with standard preparation, a phone call supported preparation group or a group supported by an artificial intelligence based chatbot. Primary endpoint is defined as quality of bowel preparation (Boston Bowel Preparation Score), secondary endpoints are patients satisfaction, comprehensiveness of bowel preparation, sedation dose, rate of coecal intubation and the rate of adenoma and polyp detection, anxiety referred to colonoscopy and patients satisfaction with preparation support.

NCT ID: NCT05040373 Recruiting - Polyneuropathy Clinical Trials

Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program

Start date: August 1, 2020
Phase:
Study type: Observational

The purpose of this study is to collect and evaluate pregnancy outcomes, pregnancy complications, and fetal/neonatal/infant outcomes in women exposed to patisiran-LNP.

NCT ID: NCT05040035 Recruiting - Atrial Fibrillation Clinical Trials

ACT-Measurement at Different Location During Left Atrial Ablation Procedures

ACT
Start date: August 26, 2021
Phase:
Study type: Observational

Ablation of atrial fibrillation is standard therapy for symptomatic patients or patients with severely reduced systolic left ventricular ejection fraction. Complications of the procedure are ischemic thrombembolic stroke. Therefore periprocedural treatment with heparin is administered to acchieve a therapeutic anticoagulation. The efficacy of anticoagulation is measured by active-clotting time (ACT) which is measured with blood drawn mostly from the V. femoralis. Despite controlled anticoagulation periprocedural stroke is published with an incidence of up to 2% and asymptomatic cerebral embolization from 2% to 15%. The ACT-Trial has two aims: 1. Analysis of the influence of the localization of blood drawing on the measured ACT: blood from central venous line, from LA and from LAA. 2. Dependency of the ACT measured in the blood of the LAA with regard to anatomic und functional LAA-measurements. Patients will be included scheduled for left atrial ablation procedure and will be divided in two groups: atrial fibrillation at time of procedure and sinus rhythm at time of procedure.

NCT ID: NCT05039515 Recruiting - Clinical trials for Fibrodysplasia Ossificans Progressiva

A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP).

FALKON
Start date: December 1, 2021
Phase: Phase 2
Study type: Interventional

Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by the presence of bone in soft tissue where bone normally does not exist, known as Heterotopic Ossification (HO). It is often associated with painful, recurrent episodes of soft tissue swelling (flare-ups) that lead to abnormal stiffening and immobility (ankyloses) of major joints with cumulative and irreversible loss of movement and disability. This study will evaluate the efficacy of 2 dosing regimens of IPN60130 in inhibiting new HO volume compared with placebo (a dummy treatment) in adult and paediatric participants with FOP. It will be assessed by a scan (provides internal images of the body) called low dose Whole Body Computed Tomography (WBCT), excluding head. Adults and participants 5 years of age or older are also eligible for a sub study to evaluate HO lesions assessed by another type of scan, Fluorine-18-labelled natrium fluoride Positron Emission Tomography-Computed Tomography ([18F]NaF PET-CT ).

NCT ID: NCT05039099 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

A Study to Evaluate, Safety, Tolerability, Pharmacodynamic (PD) Markers and Pharmacokinetics (PK) of AP-101 in Participants With Amyotrophic Lateral Sclerosis (ALS)

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

The purpose of this study is to evaluate the safety, tolerability, PK, and PD of AP-101 in participants with fALS and sALS.