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NCT ID: NCT06418763 Recruiting - Healthy Subjects Clinical Trials

The Effects of Fermented Brown Seaweed Intake on Glucose Metabolism and Gut Health

SEAPRO01
Start date: April 22, 2024
Phase: N/A
Study type: Interventional

The aim of this randomised, controlled, cross-over study is to investigate whether the intake of fermented brown seaweed can lower postprandial blood glucose levels and influence the composition of the gut microbiota in 25 healthy volunteers. Well-being and gastrointestinal symptoms as well as sensory properties of the products will also be evaluated using questionnaires. At the screening visit, the subjects will be informed about the study procedures and inclusion/exclusion criteria will be checked. Informed consent will be signed by each subject before participating in the study. The participants will consume the active and control product, respectively, for 5 days with a 14-day wash-out period in between. Capillary blood samples will be drawn for glucose measurement at the first day of each 5-day intervention period. Faecal samples will be collected before and after each 5-day intervention period to analyse changes in gut microbial composition.

NCT ID: NCT06413004 Recruiting - Clinical trials for Irritable Bowel Syndrome

Brachyspira and Intestinal Allergy-like Immune Reactions in Patients With Irritable Bowel Syndrome (IBS)

Start date: August 3, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to define local immune responses in the GI tract to food antigens in IBS patients, with and without Brachyspira infection, using advanced imaging. We hypothesize that Brachyspira infection can cause IBS symptoms by inducing loss of oral tolerance to dietary antigens through development of food-specific intestinal immune reactions and subsequent development of visceral hypersensitivity. During this study, the investigators will perform either confocal laser endomiscroscopy (CLE) or colonoscopic antigen provocation test (COLAP) to test to which food items the participants react to. Furthermore, the investigators will perform rectal barostat examination and a sigmoidoscopy without laxatives. The investigators will collect biological samples and the participants will complete several questionnaires.

NCT ID: NCT06410963 Recruiting - Chronic Pain Clinical Trials

ReActivate: Physiotherapist Led Intervention for Adolescents With Pain and Psychological Distress.

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Recurrent or persistent pain and psychological distress are alarmingly common problems among adolescents, in Sweden as well as globally. They often co-occur and have been shown to be predictors of sustained problems in adulthood. Adequate treatment early on in the development of problems has been shown important in order to decrease the risk of sustained problems in adulthood but available treatments have only modest effects. There is thus a need for treatment development, not in the least for (secondary) preventative purposes. The aim of this project is therefore to develop an evidence based and cost-effective secondary preventative intervention. Specifically, this project aims to develop and test a physiotherapist led treatment for adolescents with recurrent or persistent pain and psychological distress based upon graded exposure to physical activity and reactivation.

NCT ID: NCT06408441 Recruiting - Sarcoma,Soft Tissue Clinical Trials

The Epithelioid Hemangioendothelioma Registry of the European Reference Network on Rare Adult Solid Cancers (EURACAN)

EHE
Start date: December 1, 2023
Phase:
Study type: Observational [Patient Registry]

Epithelioid hemangioendothelioma (EHE) is an ultra-rare sarcoma, marked by distinctive molecular and pathological features and with a variable clinical behavior. Its natural history is still partially understood, reliable prognostic and predictive factors are lacking and many questions are still open on the optimal management. In the context of EURACAN, a prospective registry specifically dedicated to EHE was developed and launched with the aim of providing, through high-quality prospective data collection, a better understanding of this disease. The study design is a registry-based cohort study including only new cases of patients with a pathological and molecularly confirmed diagnosis of EHE. The objectives are to improve the understanding of EHE natural history, validate and identify new prognostic and predictive factors, clarify the activity and efficacy of currently available treatment options, describe treatment pattern. It is an hospital-based registry established in centres with expertise in EHE including adult patients with a new pathological and molecularly confirmed diagnosis of EHE starting from the 1st December 2023. The characteristics of each patient in the facility who meets the above-mentioned inclusion criteria will be collected prospectively and longitudinally with follow-up at cancer progression and / or cancer relapse or patient death. The data analyses will include descriptive statistics and analytical analyses. Multivariable Cox's proportional hazards model and Hazard ratios (HR) for all-cause or cause-specific mortality will be used to determine independent predictors of overall survival, recurrence and progression. The registry has been joined by 21 sarcoma reference centers across EU and UK, covering 10 countries. Patients' recruitment started in December 2023. The estimated completion date is December 2033 upon agreement on the achievement of all the registry objectives. The already established collaboration and participation of EHE patient's associations involved in the project will help in promoting the registry and fostering accrual. This registry has been developed with the support of EHE Rare Cancer Charity UK, STATER (Grant Agreement number: 947604, HP-PJ-2019) and EURACAN 2022 (Grant Agreement number: 101085486, EU4H-2022-ERN-IBA) European Health and Digital Executive Agency (HaDEA)

NCT ID: NCT06406972 Recruiting - Suicide Clinical Trials

Brief Admission by Self-referral for Individuals With Self-harm: Effects on Compulsory Care

Start date: September 15, 2010
Phase:
Study type: Observational [Patient Registry]

Brief Admission by self-referral (BA) is a standardized treatment model, providing patient-controlled and person-centered care. It was developed to reduce self-harm and compulsory care by promoting autonomy. Randomized clinical trials have not yielded significant between group differences with respect to inpatient care, including compulsory care. The major difficulty in evaluating BA is preventing the control group from cross-contamination, as in the implementation process of BA, all physicians, all inpatient and outpatient staff as well as managers need to be informed and undergo basic education regarding the intervention. As BA addresses a prevalent and frustrating issue in psychiatric health care, there is considerable risk that the approach leaks to the control group, reducing the possibility to detect between-group differences. In the current study this will be addressed through a register-based approach, comparing similar clinics, implementing BA at different timepoints over time. Individuals with traits of borderline personality disorder will be included and comparisons will be made with respect to compulsory care, voluntary inpatient care and mortality.

NCT ID: NCT06404632 Recruiting - Disability Physical Clinical Trials

A Group Intervention for Promoting Health-related Habits (LEV-G)

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

Health-related habits influences mental and physical health. Still, treatment of health-related habits, which can help to remedy health problems, is often not done at all or very superficially. Multiple guidelines emphasize the importance of prioritizing health-related habits, but there is a lack of implemented models. To solve this, the investigators have developed a transdiagnostic, interprofessional material intended for several care settings. The Lev-g intervention is intended for groups. There is also an individual version of Lev that has its on registration in Clinical Trails.

NCT ID: NCT06401304 Recruiting - Breast Cancer Clinical Trials

Oncologic, Cosmetic and Patient Reported Outcomes in Value-Based Breast Surgery (OnCoPRO Value)

OncoPROValue-1
Start date: January 1, 2020
Phase:
Study type: Observational

The study aspires to provide outcomes on surgery, quality of life and time-to-event outcomes following the development and validation of a standardised surgical assessment tool in a shared decision-making framework for patients with pre-invasive or invasive breast cancer with breast conservation.

NCT ID: NCT06399666 Recruiting - Atrial Fibrillation Clinical Trials

Impact of Inflammatory Indexes and Gene Scores in Prediction of Atrial Fibrillation Recurrence Following Electrical Cardioversion

IERV
Start date: October 30, 2023
Phase:
Study type: Observational

Because of the high recurrence rates following electrical cardioversion and high morbidity in AF patients there is a need to explore prediction models for AF recurrence following ECV. Previous studies have primarily focused on high-sensitivity CRP (hsCRP), CRP, and IL-6, while other inflammatory indexes and gene scores might hold greater value. This prospective cohort study is planning to include 205 patients with persistent atrial fibrillation, planned for electrical cardioversion, and >18 years at two medium-sized hospitals in Sweden. Blood samples will be collected prior to electrical cardioversion and at 7-, 30-, 90-, and 180-days follow-up. Atrial fibrillation recurrence will be evaluated at follow-up or upon patient request and diagnosed with 12-lead ECG.

NCT ID: NCT06393569 Recruiting - Cancer Clinical Trials

Sense of Security With Access to Palliative Outpatient Clinic

Start date: March 14, 2024
Phase:
Study type: Observational

The aim of the study is to evaluate experience of security, accessibility, and avoidable utilization of health care services in patients who have had access to specialized palliative care clinic (SPCC) compared to those who have not, and to evaluate the relatives' experience of the care.

NCT ID: NCT06389435 Recruiting - Clinical trials for Osteoarthritis of the Knee

RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques

ROCKETS
Start date: March 4, 2024
Phase: N/A
Study type: Interventional

Rationale for conducting the study: The study aims to systematically evaluate the clinical and economic impacts of Robotic-Assisted Total Knee Replacement (RTKR) compared to conventional Total Knee Replacement (TKR). It focuses on the potential benefits of RTKR, including improved precision in surgery, potentially leading to better patient outcomes and reduced healthcare costs. Our primary endpoint is the Forgotten Joint Score (FJS), aimed at measuring patients awareness of their knee joint in everyday life, indicating the success of the knee replacement surgery in restoring natural joint function. Secondary endpoints include patient-reported outcome measures (PROMs), patient activity levels, the accuracy of implant positioning on x-ray, and the incidence of adverse events. Study design: Multicentre,, preference-tolerant, randomized, controlled, superiority trial with two treatment arms that compares the outcomes of RTKR with traditional TKR techniques. Study population: Adult patients aged 18 years and older who are eligible for TKR as per local guidelines and who have given informed consent to participate in the study. Number of patients: 400 Inclusion criteria: Patients must be adults aged 18 years and older, eligible for TKR according to local guidelines, and willing to participate in the study. Exclusion criteria: Patients with extreme malalignment requiring special implants or techniques, patients unfit for surgery due to medical reasons, and those deemed unsuitable to participate in the study for other reasons. Primary outcome variables: The Forgotten Joint Score (FJS) at 2 years after surgery