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NCT ID: NCT05402501 Recruiting - Multiple Sclerosis Clinical Trials

Lifestyle Intervention for Patients With Multiple Sclerosis

LIMS
Start date: April 15, 2021
Phase:
Study type: Observational

The LIMS study is an observational study that investigates the effectiveness of an online lifestyle program for patients with multiple sclerosis (MS). The patients will be monitored during 27 months, starting 3 months prior to the start of the lifestyle program.

NCT ID: NCT05401786 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Anti-PD-1 Re-challenge After Immune Priming by Ipilimumab and Immune Boosting by Radiotherapy in Advanced NSCLC

RAD-IO
Start date: January 3, 2023
Phase: Phase 2
Study type: Interventional

Still many advanced non-small cell lung cancer (NSCLC) patients do not benefit from PD-(L)1 inhibition or will eventually develop progression through secondary resistance. Inhibition of CTLA-4, application of radiotherapy together with PD-1 inhibition showed synergistic effects and is deemed safe.

NCT ID: NCT05401136 Recruiting - Clinical trials for Hepatitis C, Chronic

Evaluating the Chain of Addiction Care (CAC)

HepC:CAC
Start date: March 1, 2020
Phase:
Study type: Observational

The investigators want to evaluate the feasibility of a decentralised hepatitis C care pathway (the Chain of Addiction Care (CAC) pathway) in several addiction care centres in the east of the Netherlands. Secondary objective: to measure the impact of hepatitis C clearance on MET (+metabolite) and BUP (+metabolite) trough levels in patients on Opioid substitution Therapy (OST). This is an exploratory, observational study.

NCT ID: NCT05400954 Enrolling by invitation - Breast Cancer Clinical Trials

Association of Silicone Breast Implants With Overall Wellbeingand Auto-immune Diseases

AREOLA-B
Start date: July 1, 2022
Phase:
Study type: Observational

Background: Implant-based breast reconstructions contribute considerably to the quality of life of breast cancer patients. A knowledge gap exists concerning the potential role of breast implants in the development of so called 'breast implant illness' and autoimmune diseases in breast cancer survivors with a silicone breast implant-based reconstruction. Breast implant illness is a constellation of non-specific symptoms reported by a small group of women with silicone breast implants. Methods/Design: The Areola study is a multi-centre historic cohort study with prospective follow-up aiming to assess the risk of 'breast implant illness' and autoimmune diseases in female breast cancer survivors with and without silicone breast implants. The cohort consists of breast cancer survivors who received surgical treatment with silicone implant-based reconstruction in six major hospitals across the Netherlands in the period between 2000 and 2015. As comparison group, a frequency-matched sample of breast cancer survivors without breast implants will be selected. An additional group of women who received breast augmentation surgery in the same years will be selected to compare their characteristics and health outcomes with those of breast cancer patients with implants. All women still alive will be invited to complete a web-based questionnaire covering various health related topics. The entire cohort including deceased women will be linked to the population based computerized databases of Statistics Netherlands. These databases include a registry of diagnostic codes, a pharmacotherapeutic prescriptions registry and a cause-of-death registry in which diagnoses of autoimmune diseases will be identified. Outcomes of interest are the prevalence and incidence of BII and the prevalence and incidence of autoimmune diseases. In addition, risk factors for the development of BII and autoimmune disorders will be assessed among women with implants. Discussion: The Areola study will contribute to the availability of reliable information on the risks of breast implant illness and autoimmune diseases in Dutch breast cancer survivors with silicone breast implants. This will inform breast cancer survivors and aid future breast cancer patients and their treating physicians to make informed decisions about reconstructive strategies after mastectomy. Keywords: Silicone breast implants, Breast reconstruction, Breast cancer, Breast Implant Illness, Autoimmune disease

NCT ID: NCT05399888 Recruiting - Clinical trials for Mild Cognitive Impairment Due to Alzheimer's Disease

A Study to Learn About the Safety of BIIB080 and Whether it Can Improve Symptoms of Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD Dementia Between 50 to 80 Years of Age

CELIA
Start date: August 24, 2022
Phase: Phase 2
Study type: Interventional

In this study, researchers will learn more about a study drug called BIIB080. The study will focus on participants with mild cognitive impairment or mild dementia due to AD. The main question researchers are trying to answer is if BIIB080 can slow the worsening of AD more than placebo. It will focus on what dose of BIIB080 slows worsening of AD the most. To help answer this question, researchers will use the Clinical Dementia Rating-Sum of Boxes, also known as the CDR-SB. - Clinicians use the CDR-SB to measure several categories of dementia symptoms. - The results for each category are added together for a total score. Lower scores are better. Researchers will also learn more about the safety of BIIB080. The study will be split into 2 parts. The 1st part is the Placebo-Controlled Period. The 2nd part is the Long-Term Extension Period. The 2nd part of the study will help researchers learn about the long-term safety of BIIB080, and how it affects the participant's daily life, thinking, and memory abilities in the longer term. A description of how the study will be done is given below. - After screening, participants will first receive either a low dose or high dose of BIIB080, or a placebo, as an injection into the fluid around the spinal cord (cerebrospinal fluid). A placebo looks like the study drug but contains no real medicine. - Participants will receive BIIB080 or placebo once every 12 weeks or 24 weeks. - After 76 weeks of treatment in the Placebo-Controlled Period, eligible participants will move onto the Extension Treatment period, which will last 96 weeks. - In the extension period, participants who received placebo will be switched to high dose BIIB080 every 12 or 24 weeks. - Participants may be in the study for up to 201 weeks, or about 4 years. This includes the screening and follow-up periods. - Participants can continue to take certain medications for AD. Participants must be on the same dose of medication for at least 8 weeks before the screening period. - After the screening period, most participants will visit the clinic every 6 weeks.

NCT ID: NCT05399446 Recruiting - Type 1 Diabetes Clinical Trials

Multi-Site Eating Disorder Prevention Program for Type 1 Diabetes

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

This study aims to test the effectiveness of an evidence-based eating-disorder prevention program specifically targeted for individuals with Type 1 Diabetes (T1D) compared to an educational control group. The Diabetes Body Project (DBP), is an adaptation of the Body Project which is the only eating disorder prevention program to have repeatedly produced effects when evaluated by independent researchers, produced stronger effects than credible alternative interventions, and affected objective outcomes. DBP has been adapted slightly for individuals with T1D who are at ultra-high risk for eating disorders. The study aims to test the effectiveness of the DBP of reducing body image concerns and reducing eating pathology and improving glycemic control.

NCT ID: NCT05398445 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)

ROCKET-Ignite
Start date: May 31, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.

NCT ID: NCT05397821 Recruiting - Clinical trials for Kidney Transplant; Complications

Pediatric Kidney Transplantation, Ureteroneocystostomy Techniques

TUIKIT
Start date: June 1, 2023
Phase:
Study type: Observational

In this study the researchers want to retrospectively compare non-refluxing ureteroneocystostomy (UNC techniques to reflux UNC techniques in paediatric kidney recipients with regard to urinary tract infections and uteral obstruction.

NCT ID: NCT05397470 Active, not recruiting - Clinical trials for Facioscapulohumeral Muscular Dystrophy (FSHD)

Efficacy and Safety of Losmapimod in Treating Participants With Facioscapulohumeral Muscular Dystrophy (FSHD) (REACH)

Start date: June 16, 2022
Phase: Phase 3
Study type: Interventional

This is a study to evaluate the safety and efficacy of losmapimod in treating participants with Facioscapulohumeral Muscular Dystrophy (FSHD). Participants diagnosed with Facioscapulohumeral muscular dystrophy type 1 (FSHD1) or Facioscapulohumeral muscular dystrophy type 2 (FSHD2) will participate in Part A (Placebo-controlled treatment period) and will be randomized in a 1:1 ratio to receive losmapimod 15 milligrams (mg) or placebo orally twice daily (BID). Upon completion of Part A, participants will have the option to rollover into Part B (open-label extension) to evaluate the long-term safety, tolerability, and efficacy of losmapimod and will receive losmapimod 15 mg orally BID.

NCT ID: NCT05397327 Not yet recruiting - Clinical trials for Tibial Plateau Fracture

3D Virtual Planning for Tibial Plateau Fractures

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Tibial plateau fractures are often complex fractures and need a good preoperative planning. The investigators think that a 3D virtual planning software will help the surgeons to get a better understanding of the fracture and therefore want to study the value of 3D virtual planning software in the preoperative planning of tibial plateau fractures. The investigators hypothesize that this software will shorten the duration of surgery, decrease the peroperative bloodloss and the number of complications. Patients with tibial plateau fractures who need surgical treatment will be asked to participate in this study. After participants have given informed consent, they will be randomized between a 'traditional preoperative planning' and a '3D virtual preoperative planning' group. Surgeons will plan their surgery using traditional planning tools (X-rays and CT scan) or traditional planning tools ánd the 3D virtual planning software. 6 weeks, 3 months and 6 months after surgery, participants will be asked to fill in 2 questionnaires about knee pain and knee function. After surgery a CT scan or X-ray will be performed conform standard of care in the hospital.