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NCT ID: NCT06254625 Not yet recruiting - Clinical trials for Diverticulitis, Colonic

Fecal Transplantation in Patients Colonic Diverticulitis

Start date: April 1, 2024
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to investigate the safety and effect of fecal microbiome transplantation (FMT) in patients with a former episode of acute colonic diverticulitis. The main question[s] it aims to answer are: - Is FMT in patients with a former episode of acute colonic diverticulitis a safe procedure without severe adverse events - What is the impact of FMT on patient-reported outcomes and re-admission rate Participants will be asked to: - to ingest either 25-30 capsules with FMT or placebo capsules - Fill-in GI-QLI questionnaire prior to treatment/placebo and 3 months post baseline - Fill-in eating habit questionnaire - deliver blood-and stool samples prior to treatment/placebo and 3 months post baseline - In both the treatment and placebo group 5 patients will be offered sigmoideoscopy for mucosal biopsies if it is more than 2 items]. If there is a comparison group: Researchers will compare [insert groups] to see if [insert effects]

NCT ID: NCT06254547 Recruiting - Melanoma (Skin) Clinical Trials

Leaderboard Influence on Self-Regulated Training in a Gamified Dermoscopy Training App

Start date: January 27, 2024
Phase: N/A
Study type: Interventional

This study aims to examine the isolated effect of leaderboards (scoreboards) and daily training motivation on dermatology skill acquisition and training engagement within a gamified dermoscopy training platform. Research Questions: What is the effect of leaderboards and/or daily motivation on diagnostic accuracy? What is the effect of leaderboards and/or daily motivation on self-regulated learning: time spent training and case amount? What is the effect of leaderboards and/or daily motivation on training distribution? Method: 150 danish medical students will upon inclusion and end of trial answer a Multiple Choice Questionnaire (MCQ). Participants will be asked to download the gamified training platform onto their mobile devices. Within the app participants can access quizzes on a library of 10,000+ skin lesions combined with written educational modules on histopathological skin diagnosis. Participants receive instant feedback on quiz answered. Points are awarded for correct answers and removed for incorrect answers. Participants will be randomized to one of three groups; either receiving no communication from the principal investigator, receiving a daily motivational message, or receiving a once daily updated leaderboard ranking participant's scores. The intervention will last for seven days, followed by a 14-day washout period.

NCT ID: NCT06254365 Recruiting - Obesity Clinical Trials

Investigating Glucose Metabolism of LEAP2 With Total-body PET/CT

LEAP2-PET/CT
Start date: February 5, 2024
Phase: N/A
Study type: Interventional

The naturally occurring hormone LEAP2 is proposed to have opposite effects to that of the 'hunger hormone' ghrelin. Other that appetite regulation, LEAP2 is involved in glucose metabolism through mechanisms yet not fully understood. With two experimental days; one recieving LEAP2 and one recieving placebo infusion in a randomized order, the study will explore the effect of LEAP2 (vs. placebo) on glucose metabolism through total-body PET/CT-scans and thereby gain a deeper understanding of the ghrelin/LEAP2 system and its interaction with glucose metabolism. Furthermore, the project will generate scanning references in individuals with obesity that are usable in forthcoming research projects.

NCT ID: NCT06254105 Recruiting - Hand Osteoarthritis Clinical Trials

Feasibility of a Cross-sectorial Management Program in Hand Osteoarthritis

HANDY
Start date: January 5, 2024
Phase: N/A
Study type: Interventional

To support the referral of people with Hand Osteoarthritis (HOA) to evidence-based occupational therapy addressing decreased ADL ability, a cross-sectorial management program for people with HOA, named HANDY, was developed. The HANDY program includes procedures for needs evaluation and referral, and a group-based occupational therapy program. The development was based on the United Kingdom's Medical Research Councils recommendations. A core element is involvement of stakeholders. Therefore, the research group has worked closely with GPs, OTs, people with HOA and specialist within rheumatology. Through a co-productional process the HANDY program was developed based on theories, research evidence, current best practice and the preferences of people with HOA. The aim of this study is to evaluate the feasibility of the HANDY

NCT ID: NCT06251908 Enrolling by invitation - Clinical trials for Schizophrenia Spectrum and Other Psychotic Disorders

REWRITALIZE Your Recovery - Evaluation of a Creative Writing Group Intervention

REWR
Start date: February 12, 2024
Phase: N/A
Study type: Interventional

Health institutes call for psychosocial interventions and recovery-oriented approaches as supplement to pharmacological treatment for mental health disorders. Participatory art interventions have been suggested to be promising in promoting recovery by stimulating connectedness, hope, renegotiation of identity, participatory meaning-making and empowerment. In spite of promising findings, the evidence base is still thin. We have developed Rewritalize (REWR), a manualised, recovery-oriented fifteen-session participatory creative writing group intervention, led by a professional author and attended by a mental health professional. Participants are introduced to literary forms, write spontaneously on those forms, share their texts and engage in reflective discussions about them. It is designed to provide a holding and non-stigmatising environment, structure and continuity, and to promote self-expression, playful experimentation, agency, recognition, participatory meaning-making, renegotiation of identity and social engagement. The aim of the present project is to evaluate REWR for persons with schizophrenia spectrum disorders. This study is a randomised controlled clinical trial focusing on clinical and personal recovery. This study is an investigator-initiated, randomised, two-arm, single-blinded, multi-center, waiting list trial. Participants (n=266) with schizophrenia spectrum disorders (age: 18-35) will be recruited at six psychiatric centres in region Zealand and randomised to active (creative writing group + treatment as usual) or control (waiting list + treatment as usual) condition. Assessments will be collected pre- and post-intervention and six months after end of intervention. The primary outcome measure will be the questionnaire of the process of recovery administered at the end of the intervention. Secondary outcome measures comprise measures of recovery, self-efficacy and mentalising assessed at the end of the intervention and six months after the the intervention ends. The post-intervention measures will be compared between active and control groups by means of independent sample t-tests.

NCT ID: NCT06250985 Recruiting - Clinical trials for Endocarditis, Bacterial

New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected System

POET-PPM
Start date: April 1, 2024
Phase: Phase 3
Study type: Interventional

The goal of this randomized clinical trials is to ascertain the safety and efficacy of immediate reimplantation of cardiac electronic implantable devices in patients with endocarditis and device-infections, compared to standard care, i.e. reimplantation at a later procedure date. The primary outcome is the occurence of the composite primary endpoint within 6 months of randomization consisting of - Death - Symptomatic embolism (systemic arterial embolism or pulmonary embolism) - Bacteremia og pocket-infection - Removal of a CIED due to new infection

NCT ID: NCT06250192 Recruiting - Diabetes Mellitus Clinical Trials

Educational TOolS for Pregnant Women With Diabetes Mellitus.

ETOS-DM
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

A randomized controlled trial evaluating whether a patient-centered virtual educational tool based on small videos focusing on optimization of mental health, diet, physical activity, self-adjustment of insulin dose and use of diabetes technology in addition to usual individual face-to-face education, will improve glycemic control and pregnancy outcome ij women with pre-existing diabetes mellitus compared to women receiving usual individual face-to-face education alone.

NCT ID: NCT06250023 Recruiting - Clinical trials for Osteomyelitis; Vertebra

SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis

SAVE
Start date: February 1, 2024
Phase:
Study type: Observational

Background The current Danish National Guideline for treatment of pyogenic vertebral osteomyelitis (PVO) recommends 6 weeks antibiotic (AB) treatment, with a 2-week intravenous (IV) AB lead-in followed by 4 weeks oral AB for uncomplicated PVO, and 12 weeks AB treatment with a 2-4-week IV AB lead-in followed by 8 weeks oral AB for complicated PVO. The primary objective of the current study is to investigate whether shortening the duration of IV AB to one week for both complicated and uncomplicated PVO is non-inferior to the current Danish National Guideline.

NCT ID: NCT06249763 Not yet recruiting - Ulcerative Colitis Clinical Trials

Effects of Gluten Free Diet in Ulcerative Colitis

Start date: February 2024
Phase: N/A
Study type: Interventional

The goal is to evaluate gastrointestinal symptoms and fatigue levels during a period of eating gluten free compared to a period of high gluten consumption in individuals with confirmed Ulcerative Colitis, and to identify clinical characteristics in the blood and microbiome of those improving from a gluten free diet. The main questions, the project aims to answer are: - What is the effect of eating gluten free on patient-reported gastrointestinal symptoms in patients with Ulcerative Colitis? - What is the effect of eating gluten free on patient-reported fatigue levels in patients with Ulcerative Colitis? - What are clinical differences between those improving and not improving on fatigue levels and gastrointestinal symptoms? During two study periods of one week each, participants will be eating gluten free supplemented with daily granola bars without and with high gluten content, respectively. During each active week, participants are asked to: - Eat gluten free and two daily granola bars delivered by the research team - Collect blood, stool and urine samples - Answer questionnaires about their symptoms, disease course, habitual lifestyle, and compliance to the protocol

NCT ID: NCT06247852 Recruiting - Chronic Pain Clinical Trials

Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study

Start date: September 1, 2023
Phase:
Study type: Observational

In Denmark, around 12,700 patients undergo Cesarean delivery (CD) annually, constituting approximately 20% of all childbirths in the country. Worldwide, the number is increasing each year, with more than 20 million CD performed annually. Postoperative pain after CD is typically moderate to severe in intensity and still constitutes a significant challenge, balancing effective pain relief and potential side effects. Correlations between moderate to severe acute pain and the development of persistent pain after CD is still unclear. Postsurgical persistent pain is a significant, often unrecognized clinical problem that causes distress and diminishes the quality of life for patients. Despite advances in understanding the factors contributing to persistent postsurgical pain and an increased focus on identifying patients at risk, the management and prevention of postsurgical persistent pain are still inadequate. It is important to gain further insights into this population, and we have a unique opportunity to do so by following the national cohort from the ongoing Danish multicenter cohort study on pain after cesarean section (ClinicalTrials.gov Identifier: NCT06012747) over an extended follow-up period. This involves continued prospective registration of Patient-Reported Outcome Measures (PROM) collected by SMS-based questionnaires in the months and years after the CD, thereby investigating the occurrence of both acute and persistent pain after CD. The outcomes are focused on pain levels, the impact of pain on physical function and neuropathic pain characteristics in the months and years following the CD. The study also aims to explore the relationship between persistent and acute pain.