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NCT ID: NCT05876754 Recruiting - Cholangiocarcinoma Clinical Trials

An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma

ProvIDHe
Start date: May 3, 2023
Phase: Phase 3
Study type: Interventional

A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained. There will be a minimum of 6 study visits from screening until the final follow-up, if one cycle of treatment is completed and consent is maintained through 18 months of follow-up. Each additional cycle completed will add one study visit, on the first day of each cycle.

NCT ID: NCT05876416 Recruiting - Skeletal Dysplasia Clinical Trials

Decoding the Genetic Landscape of Skeletal Diseases

SKDLAND
Start date: January 1, 2015
Phase:
Study type: Observational

This 5-year project aims to (1) search for genetic causes for yet unsolved congenital skeletal disorders (GSDs); (2) study consequences of the newly identified pathogenic variants in cells and in transgenic mice, (3) summarize data on natural course and complications for different GSD groups. For patients with unsolved GSD, the investigators search for molecular causes of GSDs using whole genome sequencing (WGS) and total ribonucleic acid (RNA) sequencing. Candidate gene variants are selected using genome or transcriptome sequencing data, clinical findings and screening of omics databases. Causality of the new variants is studied in cells and in transgenic mice models. Molecular and clinical findings are summarized for different GSD groups.

NCT ID: NCT05869838 Recruiting - Colonic Polyp Clinical Trials

A Clinical Study on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies

CODACO
Start date: March 12, 2024
Phase:
Study type: Observational

The objective of this study is to collect colonoscopy data for use in the development and testing of artificial intelligence (AI) devices for colonoscopies.

NCT ID: NCT05867940 Recruiting - Cerebral Palsy Clinical Trials

Effects of Physical Activity on Prescription (PAP) as a Health-enhancing Intervention in People With Disabilities

PAP
Start date: June 5, 2023
Phase: N/A
Study type: Interventional

Physical inactivity is an increasing problem in the general population in society. However, in people with disabilities, inactivity is even more frequently reported. Physical activity on prescription (PAP) is a well-established method to enhance physical activity. The prescribed physical activity can be activities such as walking, cycling, swimming, or gardening, and should be performed over a longer period. In children with cerebral palsy, PAP has shown to be feasible to increase participation in physical activity and to reduce sedentary behaviour, and the habilitation services in the Region of Skåne have decided to offer PAP to all children and youth with disabilities. It is of great importance to study these interventions when applied on a broader group of patients than previously studied. The aim is to study the effects of an individualised and health-enhancing intervention in physically inactive people with autism, intellectual and physical disabilities. Also, the cost-effectiveness of PAP will be studied. 60 physically inactive children, aged 8- 17 years, and 20 adults, with autism, intellectual or physical disability will be included. The participants are recruited by their clinical physiotherapists, who also will be carrying out the PAP-intervention. The self-selected physical activity/activities may either be a physical activity organized by a club and/or an everyday activity such as walking a dog or riding a bicycle to school. Each participant fills in an activity logbook. Motivational interviewing will be used to support the participants. The Canadian Occupational Performance Measure can be used to identify what activities the participants are motivated to do, and to detect changes in the participants' perception of their performance of the activity. Quality of life will be monitored. Physical activity will be measured through the International Physical Activity Questionnaire (IPAQ) and a movement monitor (accelerometer). Study specific questionnaires will be filled in regarding costs and background information. Data on health care use of the participants will retrospectively be collected and studied using the health care database in Region Skåne. Data will be collected at 3 months prior to the intervention, just before the intervention starts, when the intervention is finished, and at 6, 12 and 24 months after the intervention. The study has been approved by the Swedish Ethical Review Authority.

NCT ID: NCT05865782 Recruiting - Physical Inactivity Clinical Trials

Reconstructing Schoolyards With Greenery to Increase Schoolchildren's Physical Activity and Mitigate Climate Changes

Start date: May 22, 2024
Phase: N/A
Study type: Interventional

By reconstructing schoolyards with greenery, physical activity levels among children can be increased at the population level and also mitigate health and environmental risks resulting from rising climate changes in urban areas. The overarching purpose of the proposed project is to: i. increase physical activity levels among school-aged children, independent of socioeconomic factors, and thus affect short- and long-term health outcomes on a population level ii. establish an evidence-based bottom-up approach for schoolyard reconstructions iii. evaluate the cost-effectiveness of schoolyard reconstructions with greening on health outcomes and its environmental impact

NCT ID: NCT05863598 Recruiting - Eating Disorders Clinical Trials

Prevention of Eating Disorders Through Optimization of Protective Factors

Start date: May 15, 2023
Phase: N/A
Study type: Interventional

The goal of thin randomized controlled trial is to investigate the efficacy of a prevention program for reducing the incidence of eating disorders among youth (15-20). We target youth at these ages who experience a subjective sense of body dissatisfaction, and are thus at increased risk of developing an eating disorder. The prevention program is based on improving protective factors such as body appreciation, body image flexibility, intuitive eating, and acceptance. It will be compared to a credible placebo (expressive writing).

NCT ID: NCT05861752 Recruiting - Sexual Addiction Clinical Trials

Paraphilic Disorders and Other Conditions With Risk for Sexual Violence: a Case-control Study

Start date: October 19, 2022
Phase:
Study type: Observational

The goal of this case-control study is to compare clinical characteristics in help-seeking individuals with paraphilic disorders or sexsomnia (sexual behaviors during sleep- a diagnosis in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5)), as compared to healthy controls. The main questions this study aims to answer are: (1a) Is there a difference in experience of violence between the clinical population and healthy controls? Is there a difference between the clinical groups? (1b) What are the clinical characteristics of these conditions (psychiatric, sociodemographic, and genetic/epigenetic factors)? Does the clinical population differ from healthy controls? (1c) How are the psychometric properties of the assessment forms (primarily those addressing sexual deviance and compulsive sexuality) in the project? (1d) How has sexual interest developed over time among patients with paraphilic disorders? (including the person's own description of e.g. triggers and expectations). Follow-up of clinical population: (2) What is the typical treatment as usual (TAU) for the patient population? (e.g., average length of care, the percentage of dropouts and what kind of treatment has been given) (3) Are there any factors at baseline (e.g., presence of neuropsychiatric symptoms, age, symptom burden) that predict treatment outcome? (i.e., symptom burden based on self-assessments at follow-up 3, 6 and 12 months from the start of treatment and records in offence registers after 10 years).

NCT ID: NCT05860504 Recruiting - Clinical trials for Myocardial Infarction

Acute Cardiac Dysfunction in Critical Illnes

Start date: May 29, 2023
Phase:
Study type: Observational

The overall aim of the study is to establish the clinical importance of cardiac dysfunction, by estimating its incidence and impact on short- and long-term outcomes, in a mixed population of critically ill patients with multi-organ failure. Pathogenesis of cardiac dysfunction in critical illness and key molecules linked to this will be explored.

NCT ID: NCT05855941 Recruiting - Endometrial Cancer Clinical Trials

Prognostic and Diagnostic Added Value of Medical Imaging in Gynecological Cancer (PRODIGYN)

PRODIGYN
Start date: May 23, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about the added diagnostic and prognostic value of advanced medical imaging procedures in cervical cancer, endometrial cancer and ovarian cancer. The main questions it aims to answer are: - Does advanced medical imaging predict survival? - Can advanced medical imaging improve radiotherapy target planning? - Are advanced medical imaging results associated with risk markers found in tumor tissue? Participants will - Undergo four additional imaging procedures, as compared to clinical routine examinations, two at baseline and two after three months. - Be subject to clinical follow-up for five years.

NCT ID: NCT05855200 Recruiting - Colonic Neoplasms Clinical Trials

Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

AZUR-2
Start date: August 2, 2023
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair/ microsatellite instability high (dMMR/MSI-H) colon cancer.