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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: NCT05578157 Not yet recruiting - Clinical trials for Erectile Dysfunction

MENDiP: Measurements of Overnight Penile Temperature to Evaluate Nocturnal Erection Detection in Patients With Absence of Erectile Functioning After Robot-assisted Radical Prostatectomy

MENDiP
Start date: January 18, 2023
Phase:
Study type: Observational

Nocturnal erection detection with the outdated RigiScan is the golden standard for erectile dysfunction (ED) nature differentiation. The Staying Hot and Feeling Hot study have shown that nocturnal erection detection is feasible with patient-friendly overnight penile temperature measurements. The question has arisen whether the penile temperature methodology is also capable to detect the absence of nocturnal erections, which is essential for clinical implementation in erectile dysfunction diagnostics. The objective of the MENDiP-study is to determine the feasibility to detect the absence of nocturnal erections with overnight penile temperature sensors. Furthermore, the MENDiP study functions as a first pilot trial to investigate the effect of age on the penile temperature during nocturnal erections in test subjects with normal erectile functioning. This is done in an observational study with a longitudinal design in which pre- and postoperative ambulatory overnight measurements are performed in patients, aged 55 - 70 years with preoperative normal sexual functioning, undergoing a non- or unilateral nerve-sparing robot assisted radical prostatectomy.

NCT ID: NCT05576883 Completed - Anxiety Clinical Trials

Optimization of a Mobile Transdiagnostic Emotion Regulation Intervention for University Students

Start date: February 10, 2023
Phase: N/A
Study type: Interventional

This study will explore the functioning of a mobile transdiagnostic emotion regulation intervention designed for university students to optimize the uptake and the effectiveness of the intervention.

NCT ID: NCT05576805 Completed - Clinical trials for Cytomegalovirus (CMV)

A Study on Cytomegalovirus (CMV) Infection Outcomes Among Solid Organ Transplant (SOT) Participants in Europe and Canada

Start date: June 19, 2023
Phase:
Study type: Observational

The main aim of the study is to assess the clinical outcomes of current CMV management across different regions of the world (Europe [EU] and Canada [CAN]). Data will be collected retrospectively from medical charts. No study medicines will be provided to participants in this study.

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: NCT05575687 Completed - Clinical trials for Normal Physiological Response to Sweet Drinks

Brain and Glycemic Responses to Sweet Soft Drinks

SWEETBRAIN
Start date: January 9, 2023
Phase: N/A
Study type: Interventional

The goal of this observational study is to determine changes in brain activity and blood sugar in response to the ingestion of flavored waters sweetened with either the nutritive sugar sucrose or different low-caloric sweeteners in healthy normal-weight individuals aged between 18 and 30 years. The main question it aims to answer is in how far brain and glycemic responses differ between a sugar-sweetened drink and drinks sweetened with different low-caloric sweeteners. Participants will visit after an overnight fast six times and then have an MRI brain scan before and after consumption of 500 ml of one of the study drinks (beverage sweetened with sucrose or one of four non-caloric sweeteners, or water).

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.