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NCT ID: NCT05578768 Recruiting - IBD Clinical Trials

Prediction of IBD Disease Activity in Individual Patients Based on PROMs and Clinical Data

PrePro
Start date: October 3, 2022
Phase:
Study type: Observational

The proposed study will use a PROM (Patient report Outcome Measurement)-tool in combination with clinical and biochemical data to train and validate a Relapse Prediction Model for individual patients.

NCT ID: NCT05578235 Recruiting - Crohn Disease Clinical Trials

Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis in Ileocolic Resection for Crohn's Disease

END2END
Start date: July 13, 2023
Phase: N/A
Study type: Interventional

The aim of this multicenter randomised controlled trial is to compare the handsewn (end-to-end and Kono-S) to the stapled side-to-side ileocolic anastomosis after ileocolic resection for Crohn's disease with respect to 6 months endoscopic recurrence, functional outcome and health care consumption.

NCT ID: NCT05576025 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

Acute Effects of Cold-induced Shivering on 24-hour the Glucose Profile in Metabolically Compromised Populations

SHIVER
Start date: November 23, 2022
Phase: N/A
Study type: Interventional

Type 2 Diabetes Mellitus (T2DM) and its associated comorbidities pose a major health concern worldwide. Although lifestyle strategies, such as exercise and diet-induced weight loss are effective interventions to counteract the development and progression of the disease, its prevalence continues to increase. Therefore, alternative therapeutic strategies are warranted. One such method, which has increasingly been gaining attention, is cold exposure. Previously, investigators have shown that exposing T2DM patients to mild cold (14-16 oC) for 6 hours per day for 10 consecutive days enhanced their insulin sensitivity by ~43%. This remarkable improvement in insulin sensitivity was accompanied by robust GLUT4 translocation in the skeletal muscle of participants, which likely mediated the improvements in insulin-stimulated glucose uptake. Follow-up research suggested that a certain degree of muscle activation/shivering appears to be a prerequisite for the cold-induced enhancement in skeletal muscle insulin-stimulated glucose uptake. In humans however, very little information is available about the effects of shivering on glucose metabolism, especially in metabolically compromised individuals. Therefore, in this study, the aim to investigate the acute effects of (different intensities of) shivering on 24-hour glucose profiles in pre-diabetic individuals as well as in T2DM patients. For that purpose, a focus will be placed on clinically relevant glycaemic parameters by means of continuous glucose monitoring, which is increasingly being used in T2DM management and prevention.

NCT ID: NCT05576012 Recruiting - Clinical trials for Rheumatoid Arthritis

First in Human Study of a Monoclonal Antibody (SOL-116) Targeting BSSL (Bile Salt-Stimulated Lipase), Single and Multiple Dose Parts

Start date: October 13, 2022
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, first-in-human phase I study. It consists of a single ascending dose part in healthy subjects (Part 1) and in patients with rheumatoid arthritis (Part 2) as well as a multiple dose part in healthy subjects (Part 3). The study will collect information on pharmacokinetics, safety and tolerability.

NCT ID: NCT05575323 Recruiting - Spinal Metastases Clinical Trials

Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases

BLEND
Start date: October 15, 2022
Phase: N/A
Study type: Interventional

The BLEND RCT aims to evaluate the (cost-)effectiveness of same-day SBRT and surgical stabilization with or without decompression for the treatment of symptomatic, unstable spinal metastases on physical functioning four weeks after the start of treatment, compared with the standard of care (surgery followed by radiotherapy as soon as the wound healed sufficiently).

NCT ID: NCT05575011 Recruiting - Healthy Volunteer Clinical Trials

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB115

Start date: October 10, 2022
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to evaluate the safety and tolerability of single ascending dose of BIIB115 administered via intrathecal (IT) bolus injection to healthy male participants in Part A and multiple ascending doses of BIIB115 administered via IT bolus injection to pediatric Spinal Muscular Atrophy (SMA) participants previously treated with onasemnogene abeparvovec in Part B. The secondary objective of the study is to evaluate the pharmacokinetics (PK) of single-dose of BIIB115 administered via IT bolus injection to healthy male participants in Part A and multiple ascending doses of BIIB115 administered via IT bolus injection to pediatric SMA participants who previously received onasemnogene abeparvovec in Part B.

NCT ID: NCT05574530 Recruiting - Stress Clinical Trials

Vitamin (VIT) for Vigilance Study

Start date: October 12, 2022
Phase: N/A
Study type: Interventional

This study aims to examine the effects of a 6-week colon-delivered multi-vitamin supplement intervention on cognitive performance and stress levels in military under real-life, stressful working conditions. The study is a randomized, double-blind, placebo-controlled, parallel trial in a real-life setting (military field exercise). The intervention product is a nutritional supplement, composed of vitamins B2, B3, B6, B9, C, and D3. These vitamins will be delivered in the colon where most of these vitamins can be utilized by the gut microbiota, as they act as cofactors for important cellular functions. The main study outcome is the backward digit span (DS) score in a cognitive test, during the field exercise as compared to the start of the 6-week supplementation period. Secondary parameters are other cognitive test scores and a combined (z-scored) cognitive performance score. Stress levels will be measured in salivary cortisol and self-perceived stress levels will be derived from the HADS and PSS-10 questionnaire. Other stress biomarkers (e.g. heart rate variability) will be measured by a wearable.

NCT ID: NCT05572710 Recruiting - Clinical trials for Aortic Valve Stenosis

Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population

Avalus
Start date: June 10, 2020
Phase:
Study type: Observational [Patient Registry]

This is a prospective, observational, single-arm, multi-center registry of patients undergoing bioprosthetic aortic valve replacement with the Avalus valve. This prospective registry aims to examine the outcome and performance of surgical aortic valve replacement with the Avalus pericardial bioprosthesis.

NCT ID: NCT05572515 Recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

MajesTEC-9
Start date: March 29, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd.

NCT ID: NCT05572359 Recruiting - Clinical trials for Osteo Arthritis Knee

Cryo and Compression Therapy After TKA and UKA

Start date: May 25, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the use of a cold and compression brace during the first 6 weeks after surgery in patients who had a total or partial knee replacement. The main question[s] it aims to answer are: - What is the effect of the use of cryo- and compression therapy during the first 6 postoperative weeks after knee replacement surgery on pain in rest? - What is the effect of the use of cryo- and compression therapy during the first 6 postoperative weeks after knee replacement surgery on pain while loading, opioid use, functioning, patient satisfaction and general health, and do participants comply with the therapy? Participants will be asked to use the cold and compression brace during the six weeks after surgery five times a day, for a maximum of 20 minutes. Researchers will compare with usual care to see the effect on pain, opioid use, functioning, satisfaction and general health.