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NCT ID: NCT06417541 Not yet recruiting - Clinical trials for Central Venous Catheter Thrombosis

Autopsy and Photon Counting Computed Tomography to Evaluate Thromboses Related to Central Venous Catheters

PHOTO CAT
Start date: September 2024
Phase:
Study type: Observational

Central venous (CVC) is essential in modern healthcare but unfortunately associated with complications, including thrombosis. In a recently published study, it was showed that 12 out of 12 deceased patients had subclinical CVK-related thrombosis (Rockholt et al.). To shed light on this problem, the current studies were designed. In sub-study 1, deceased patients with CVC who are referred for clinical autopsy are included. Before the autopsy, the deceased will be examined with a photon-counting computed tomography (CT) scan and the results will be compared. In sub-study 2, living patients with CVC who are referred for various CT scans without contrast, are included. After informed consent, the patient will be examined with the photon-counting CT, whose reliability has been validated in Part 1 and the incidence of subclinical CVC-related thrombosis will be reported.

NCT ID: NCT06404684 Not yet recruiting - Clinical trials for Paraphilic Disorders

Psychological Treatment for Paraphilic Disorders

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

The goal of this randomized study is to learn if a psychological intervention can treat help-seeking patients with paraphilic disorders. The main questions it aims to answer are: 1. Is psychological therapy helpful for the reduction of problematic sexual behaviors among patients with paraphilic disorders? 2. Is psychological helpful for the reduction of psychiatric symptoms and risk factors for sexual violence and improving quality of life among patients with paraphilic disorders? 3. How do patients with paraphilic disorders describe pathways to care (e.g. perceived obstacles to seeking care) and how do they experience the treatment? The treatment addresses specific sexual problems. It also addresses mental symptoms (e.g. depression and anxiety). A psychologist provides the treatment face to face (on site or video). The aim is to finish the treatment within 12 weeks. The patient will report symptoms on a daily basis. The patient will also be interviewed after completion of treatment. The investigator will pose questions such as "Was there anything that was experienced as particularly helpful in the treatment?", "Was there anything that was not helpful?". The investigator will also ask about treatment seeking behavior with questions such as "What kinds of resources would be helpful if they were available?"

NCT ID: NCT06394843 Not yet recruiting - Clinical trials for Patients Undergoing Hemodialysis

Fluid Currents During Hemodialysis

Start date: May 6, 2024
Phase:
Study type: Observational

During dialysis, three objectives are achieved. 1. Blood is cleansed from waste products. 2. Excess water is removed. 3. Electrolytes are regulated. These processes occur simultaneously but vary from patient to patient depending on their specific needs. Some patients still produce urine, but of poor quality. Others have no residual urine production at all and require removal of fluid from both blood and tissues. Hypotension may occur during dialysis, related to intravascular hypovolemia and inadequate fluid reinfusion, which is common during ultrafiltration exceeding 400 ml/h. The amount of fluid removed is influenced by fluid recruitment from tissues. This mainly occurs in two different ways: osmotic recruitment across capillary membranes from the perivascular space or via lymphatic reflow. The proportions are not fully understood. When fluid is recruited from the perivascular space, the influx of albumin and immunoglobulins is unlikely. However, these should accompany lymph to the blood if lymphatic flow is increased. The content of albumin and immunoglobulins differs between lymph and plasma. Thus, the proportions of fluid recruitment from tissues should be calculable using mass balance calculations based on ultrafiltrate, colloid osmotic pressure, hemoglobin, albumin, and immunoglobulin concentrations. The rate and proportions of fluid reinfusion into the bloodstream are not fully understood. Therefore, in this study, the aim is to monitor fluid reinfusion and its proportions of lymph/osmotic recruitment into the bloodstream.

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: 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: NCT06374875 Not yet recruiting - Obesity Clinical Trials

Fibrosis Lessens After Metabolic Surgery

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

Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), a major global public health concern, is commonly associated with obesity, diabetes, and dyslipidemia. MASLD is currently the most common cause of chronic liver disease affecting about 80% of people with obesity, ranging from simple fat deposits in the liver to Metabolic Dysfunction-Associated Steatohepatitis (MASH), cellular injury, advanced fibrosis, cirrhosis, or hepatocellular carcinoma. Patients with MASH are also at risk for cardiovascular disease and mortality. There is no universally approved medication for MASH. Weight loss remains the cornerstone of MASH treatment. Patients meeting the inclusion and exclusion criteria and who give informed consent will be enrolled in the trial and undergo the baseline liver biopsy (if none available). Approximately 120 patients with MASH and liver fibrosis (F1-F4 in baseline liver biopsy) will be randomized in a 1:1 ratio to metabolic surgery or medical treatment (incretin-based therapies ± other medical therapies for MASH) and followed for 2 years at which time a repeat liver biopsy will be performed for the assessment of the primary end point.

NCT ID: NCT06374407 Not yet recruiting - Obesity Clinical Trials

The MIND-GUT Digital Pilot Intervention Study

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

This 12-week pilot study aims to evaluate the feasibility and effectiveness of a dietary intervention targeting diet, obesity, mental health, and the gut microbiome in promoting weight loss and enhancing mental health among obese men and women aged 30-50. Participants, excluding those with specific medical conditions, will be randomly assigned to either an intervention or control group using a meal planning smartphone app. Clinical assessments will include anthropometry, mental health questionnaires, dietary recalls, and stool sample collections. The study's endpoints include program retention, adherence, changes in body weight, mental health, and gut microbiome diversity. Statistical analyses will evaluate intervention effects and the potential mediating roles of the gut microbiome. This pilot study has implications for health policies, public healthcare, digital health companies, and the biotech and pharmacology industries. Future plans involve a large-scale intervention study in multiple countries with ongoing collaborations.

NCT ID: NCT06363786 Not yet recruiting - Clinical trials for Incontinence-associated Dermatitis

Reducing Skin Surface pH During Skin Occlusion: Changes to Skin Microbiome and Skin Parameters

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

The main aim of this exploratory research study is to investigate how exposure to a material with low pH affects the skin microbiome and skin parameters. This investigation involves an experimental setup in which application of test patches with lowered pH levels or control patches without lowered pH are used. The test patches are applied on healthy adult volunteers. About 20 subjects are planned for the study. The skin microbiome preservation and diversity will be addressed employing Molecular Sequencing and qPCR. In addition, skin pH, composition and hydration will be measured with various methods, e.g., AquaFlux, Moisture Meter, TEWL and Confocal Raman spectroscopy. The study will span three consecutive days in total. Each participant will be provided with four patches on each forearm: two patches will be applied to each dorsal forearm and two on each volar forearm. The first day will be for study inclusion and application of pathces. In day two the patches will be changed and on day three measurements for pH, TEWL, skin hydration, Raman and tape stripping will be conducted and sampling for Molecular Sequencing and qPCR measurements will be done. There is no formal hypothesis in the study but our idea is that utilizing patches with a lower pH could maintain the diversity and richness of the natural skin microbiome while retaining and even enhancing key skin barrier parameters. A descriptive analysis will be conducted for all measurements with approproate statistical tests on 5% level for varaibles. In addition to descriptive data analysis statistics, Clinical Microbiomics and Bio-Me Microbiome Profiling will employ various statistical methods, such as paired Mann-Whitney U tests. The Benjamini-Hochberg (BH) method to control the false discovery rate (FDR) will be employed.

NCT ID: NCT06360640 Not yet recruiting - Healthy Subjects Clinical Trials

A First-in-human Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of APC148 in Healthy Adults

Start date: June 2024
Phase: Phase 1
Study type: Interventional

The purpose of this first-in-human trial is to investigate the safety, tolerability, and pharmacokinetics of APC148 after intravenous (IV) infusion of single ascending doses in healthy adults.