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NCT ID: NCT06392165 Not yet recruiting - Clinical trials for Adhesion Properties of Wound Care Devices

Evaluation of Adhesion Properties in Wound Care Devices

Start date: April 24, 2024
Phase: N/A
Study type: Interventional

Molnlycke manufactures and markets self-adhesive wound care devices intended to protect various types of wounds during treatment. This study aims to measure and evaluate the adhesion properties of self-adhesive wound care devices. To measure the adhesion properties test strips will be applied to the participant's skin for a predetermined time and will be removed while measuring the adhesion properties afterwards. This method has been chosen since there is no in vitro method available that can simulate adhesion to human skin

NCT ID: NCT06389799 Not yet recruiting - Clinical trials for Dedifferentiated Liposarcoma

A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI)

PERELI
Start date: May 7, 2024
Phase: Phase 2
Study type: Interventional

Dedifferentiated liposarcomas (DDLPS) are aggressive soft tissue sarcomas with no effective medical treatment options. Immunotherapy with checkpoint inhibitors, so-called PD-1 inhibitors, have shown some effect in DDLPS in previous studies. Effect of immunotherapy can be improved by combining it with other types of tumor drugs. Medicines that inhibit signaling via the FGF receptor, so-called FGFR inhibitors, have shown a tumor-slowing effect in DDLPS in early studies. FGFR inhibitors can also induce changes that make the tumor more available to treatment with immunotherapy. The study aims to investigate whether the combination of an FGFR inhibitor, pemigatinib, with a PD-1 inhibitor, retifanlimab can provide a tumor-slowing effect in patients with advanced DDLPS who have progressed on first-line treatment.

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

NCT ID: NCT06386484 Recruiting - Clinical trials for Selective Head and Neck Cooling

Selective Head-and-neck Cooling on Biomarker Levels and Symptom Rating Following a Boxing Bout

Start date: November 2, 2021
Phase: N/A
Study type: Interventional

Young, healthy elite boxers ≥ 18 years old are recruited. Prior to, and immediately after a competitive boxing bout over 3x2 or 3x3 minutes, blood samples are drawn. Boxers are randomized to intervention or control management by 1:1 allocation prior to baseline testing. After the initial post-fight blood sample is drawn and symptom rating using the sports concussion assessment tool-5 (SCAT-5) has been collected, the boxers receive either acute selective head-and-neck cooling for 45 min, or routine post-fight management. The number of head impacts are counted in all boxers on match video recordings. In both groups, blood samples are drawn 45 minutes after the initial post-bout blood sample, as well as 3 and 6 days post-fight.

NCT ID: NCT06386172 Recruiting - Clinical trials for Chronic Kidney Diseases

Electronic Decision-support System to Improve Detection and Care of Patients With Chronic Kidney Disease in Stockholm

ALMA-CKD
Start date: September 9, 2023
Phase: N/A
Study type: Interventional

One in 10 adults in Region Stockholm have chronic kidney disease (CKD), which dramatically increases healthcare costs and the risk of medication errors or adverse health outcomes, including cardiovascular disease and death. Identification and early management of these patients is done in primary care settings. However, most adults with CKD in our region are under detected, undiagnosed and undertreated, with low rates of referral to nephrology-specialist care. This is a pragmatic cluster randomized controlled trial (RCT) involving 66 primary healthcare centers in Region Stockholm, and testing the effect of an electronic clinical decision support (CDS) triggering system to assist general practitioners through the guideline-recommended processes of CKD care. The centers, providing healthcare to approximately 780.000 citizens, will be randomized 50:50 to this CDS trigger (vs basic advice) for 18 months. Study outcomes will consider the improvement in the indicators of CKD care. As a pragmatic trial there is no active recruitment or active data collection. The trial is embedded into the ongoing Stockholm CREAtinine Measurements (SCREAM) project, a database collection of healthcare use for the complete population of Stockholm. Using this real-world healthcare data collection, the investigators will be able to measure with precision the impact of our CDS trigger and its potential to improve clinical care.

NCT ID: NCT06385249 Recruiting - Bowel Dysfunction Clinical Trials

An Evaluation of Navina Mini, a New Trans-anal Irrigation (TAI) Device in Children and Adolescents

Start date: April 3, 2024
Phase: N/A
Study type: Interventional

The study is designed to deliver further information on clinical benefit, patients' satisfaction, and perception of handling and to confirm safety of Navina Mini when used in children and adolescents.

NCT ID: NCT06381856 Not yet recruiting - Clinical trials for Autism Spectrum Disorders

Improving Participation of Autistic Children and Adolescents in the Habilitation Process

IMPAC
Start date: September 2024
Phase:
Study type: Observational

This project aims to explore the impact of a survey-based and a meeting-based needs assessment models on 7 to 17 year old autistic children's participation in the needs assessment process at the initial reception when enrolled at a Child and Youth Habilitation Centre.

NCT ID: NCT06379802 Recruiting - Overweight Clinical Trials

Lifestyle Intervention With Physical Activity and Diet

LI-PAD
Start date: February 12, 2024
Phase: N/A
Study type: Interventional

The aim of this pilot randomized controlled trial LI-PAD is to identify whether a 6-month intervention approach to individually optimize lifestyle behavior, physical activity, and diet, is feasible and leads to larger improvements in body weight, cardiovascular disease risk factors, and health-related quality of life compared to simple written lifestyle advice, in individuals with overweight or obesity. The intervention group will be offered individual support for lifestyle behavioral change (precision health) and the control group will be offered written lifestyle advice, following national recommendations. In total, 60 population-based participants and 60 controls from the Gothenburg area, aged 45-65 years, will be recruited.

NCT ID: NCT06379581 Recruiting - Skin Cancer Clinical Trials

Skin Cancer Diagnostics Using Photoacoustic Imaging

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

In this clinical study, photoacoustic imaging will be used on patients with suspected skin cancer (primarily melanoma, basal cell carcinoma, and squamous cell carcinoma) to determine the tumor borders both superficially and at a depth.

NCT ID: NCT06377280 Recruiting - Bowel Dysfunction Clinical Trials

En Evaluation of Navina Mini, a New Low-volume Transanal Irrigation Device.

Start date: January 18, 2024
Phase: N/A
Study type: Interventional

This is an un-controlled, prospective, multi center, post market clinical follow-up investigation that will enroll male and female subjects in need of bowel management with low-volume transanal irrigation (TAI) as judged by the investigator. A total of 40 investigational subjects in need of low-volume TAI will be recruited from 2-3 sites in Sweden and will be treated with Navina Mini as per product intended purpose and per instruction of use during a period of four weeks. Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four weeks. The first visit, Visit 1, will be performed at the investigational clinic to assess eligibility, collect demographics, baseline data and instruct how to use the device. Visit 2 will be performed after two weeks of treatment through telephone contact. The final visit, Visit 3, will be performed after additional two weeks of treatment, and can be performed either at the investigational clinic or through telephone contact.