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NCT ID: NCT05327062 Recruiting - Clinical trials for Chronic Heart Failure

Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment

CRT-DRIVE
Start date: March 6, 2023
Phase: N/A
Study type: Interventional

The objective of this prospective, multicenter controlled study is to assess the feasibility of a patient-tailored implantation by creating a cloud-based pre-procedural multimodality CRT-roadmap by integration of 3D images from 3D activation sequence from ECG, and coronary venous anatomy from cardiac computed tomography. This CRT-roadmap will be used to guide LV lead placement to a coronary vein in an electrically late-activated region. Study Hypothesis: At least 75% of patients undergoing a CRT implantation guided by non-invasive electrical and venous anatomy assessment (XSPLINE technology) will show a reduction of left ventricular end-systolic volume of 15% or more at 6-month evaluation.

NCT ID: NCT05326620 Recruiting - Clinical trials for Renal Cell Carcinoma

National PROspective Infrastructure for Renal Cell Carcinoma (PRO-RCC)

PRO-RCC
Start date: January 19, 2023
Phase:
Study type: Observational [Patient Registry]

PRO-RCC is a nationwide long-term cohort for the collection of real-world clinical data, patient reported outcome measures (PROMs) and patient reported experience measures (PREMs) that provides an infrastructure for observational research and (randomized) interventional studies with the TwiCs (Trial within cohorts) design.

NCT ID: NCT05326412 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD

AERIFY-3
Start date: May 19, 2022
Phase: Phase 2
Study type: Interventional

This study is an exploratory, two-part, 12-week, Phase 2a study to evaluate the mechanism of action of Itepekimab (anti-IL-33-mAb) and its impact on airway inflammation in former and current smokers with COPD, aged 40 to 70 years. This study consists of participants who have been on a standard-of-care (SoC) mono (long-acting β2-agonist [LABA]) or long-acting muscarinic antagonist [LAMA]), double (inhaled corticosteroid [ICS] + LABA, LABA + LAMA or ICS + LAMA), or triple (ICS + LABA + LAMA) controller therapy for COPD for at least 3 months prior to Screening (Visit 1) with stable dose and regimen for controller therapy for ≥1 month prior to Screening (Visit 1) and during the screening period. Participants will stay on their established controller medications for COPD throughout the duration of the study, with the exception of systemic corticosteroids and/or antibiotics used for acute exacerbation of COPD (AECOPD). The total study duration for each part (Part A and Part B) is approximately 36 weeks: - 4-week screening period - 12-week treatment period - 20-week followup period

NCT ID: NCT05325866 Recruiting - Solid Tumors Clinical Trials

A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

FORTITUDE-301
Start date: September 23, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objectives of this study are to observe the safety and tolerability of bemarituzumab and to evaluate preliminary antitumor activity.

NCT ID: NCT05324748 Recruiting - Cluster Headache Clinical Trials

Repeated GON Injections in CCH

REGON
Start date: November 7, 2022
Phase: Phase 3
Study type: Interventional

Background: - The effect of repeated GON-injections has never been studied in a double-blind randomized trial as a prophylactic therapy in a well-documented group of chronic patients. As such, (repeated) GON-injection has not yet found its place in current (inter)national treatment protocols for chronic cluster headache. Objectives: - The primary objective is to determine if repeated GON-injection result in effective control of cluster headache attacks for more days compared to placebo in chronic cluster headache. Eligibility: - Patients will be selected from the LUMC (Leiden University Medical Center) and CWZ (Canisius Wilhelmina Hospital) chronic cluster headache populations, diagnosed based upon the ICHD-3. Design: - Bi-centre, randomized, double-blind, placebo-controlled retention trial with a maximum follow-up of one year.

NCT ID: NCT05323812 Recruiting - Alzheimer Disease Clinical Trials

ASURE: Alzheimer Study Using oRal Edaravone

Start date: March 1, 2023
Phase: Phase 2
Study type: Interventional

This is a multi-center, Phase IIa, randomized, double-blind, placebo-controlled study in patients with Alzheimer's Disease (AD).

NCT ID: NCT05323162 Recruiting - Type 1 Diabetes Clinical Trials

Encapsulated Faecal Microbiota Transplantation to Preserve Residual Beta Cell Function in Type 1 Diabetes Mellitus

ENCAPSULATE
Start date: April 2022
Phase: N/A
Study type: Interventional

In this single arm pilot study it will be investigated whether encapsulated autologous fecal microbiota transplantation may be used to halt the decline in residual beta cell function in individuals with recent onset Type 1 diabetes mellitus.

NCT ID: NCT05323045 Active, not recruiting - Solid Tumor Clinical Trials

A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate BYON3521

Start date: March 21, 2022
Phase: Phase 1
Study type: Interventional

This is the first-in-human trial with BYON3521, an antibody-drug conjugate (ADC) comprising a humanized IgG1 monoclonal antibody directed against the c-MET receptor covalently conjugated to a duocarmycin-containing linker-drug.

NCT ID: NCT05322473 Completed - Clinical trials for Hidradenitis Suppurativa

Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa

Start date: April 25, 2022
Phase: Phase 2
Study type: Interventional

This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa.

NCT ID: NCT05321927 Recruiting - Multiple Sclerosis Clinical Trials

TENS in Persons With MS

Start date: January 5, 2022
Phase: N/A
Study type: Interventional

Persons with multiple sclerosis (pwMS) often have an increased sense of fatigue. Furthermore, they present walking difficulties which negatively affects their mobility and results in an additional increase of fatigue. Previous literature suggests that transcutaneous electrical nerve stimulation (TENS) of leg muscles might increase their walking capacity and decrease perception of fatigue. In the present study we aim to investigate whether TENS of leg muscles reduces walking difficulties and sense of fatigue in pwMS in comparison with a short strength training protocol or no training. A similar aim is addressed after TENS of elbow flexor muscles. Subjects with relapsing remitting or progressive MS, age between 18 and 65 years, will undergo transcutaneous electrical nerve stimulation (TENS), strength exercises (SExerc), both TENS and SExerc (COMB) simultaneously, or sham stimulation without training (CON) of both leg and arm muscles. Force and fatigue measurements are performed before, directly after and three weeks after the training sessions and contain walking, fatigue, and strength assessments. Main study parameters are changes in the scores of i) the six-minute walking test (6-MWT), ii) the perceived walking disability (MSWS-12) and iii) fatigue questionnaires (FSS and MFIS). Additional study parameters are changes in muscle force and muscle fatigability.