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NCT ID: NCT05536609 Recruiting - Clinical trials for Digital Nerve Injury

Cast Or ePineural Suture for Digital Nerve Injuries - a Randomised Controlled Study

COPS
Start date: August 29, 2022
Phase: N/A
Study type: Interventional

Nerve injury in the fingers is a common injury and affects people of all ages. The treatment usually offered to patients is surgery and various types of rehabilitation. There is a lack of knowledge and research on how these injuries should be treated in the best way and how well sensory function can be restored after an injury. In this research project, we will investigate results after treatment for digital nerve injuries by entailing a randomised controlled trial allocating patients with isolated digital nerve injuries to either surgical repair or non-operative treatment in a cast. Primary outcome is digital nerve function as measured by 2-points discrimination at 1 year after treatment. Secondary outcomes include finger mobility, dexterity, handfunction, occurence of pain and anxiety and time on sick leave.

NCT ID: NCT05535296 Completed - Clinical trials for Lifestyle Risk Reduction

Prevention of Lifestyle-related Ill-health With Early Functional Examinations and Individualized Risk Profiles

PREVFUNKTION
Start date: August 15, 2022
Phase: N/A
Study type: Interventional

Background: Many lifestyle-related health disorders are influenced by physical activity level and physical function. Health examinations which focus on musculoskeletal function of people who have risk factors for lifestyle-related disorders, combined with person-centered advice based on risk profiles can give people knowledge and guidance to manage their own lifestyle priorities. Aim: To investigate the feasibility of a protocol for a randomized controlled trial (RCT) which will examine the preventive effects of musculoskeletal function examinations and person-centered advice on inactive middle-aged people. Methods: Physically inactive middle-aged people will be invited to participate in a two-part health examination with follow-up after three months in a pilot study. Part 1 is a standard health examination including blood tests and Part 2 is a functional examination of fitness, strength, mobility, balance and posture according to our protocol based on validated tests. The intervention group receives feedback based on both parts of the examination while the control group receives feedback only from Part 1. Physical activity level will be measured objectively with accelerometers at inclusion and follow-up. Expected results: The pilot study is expected to show whether the planned RCT is practically feasible and to give relevant support for the power analysis for a later full-scale RCT. Better understanding of personal physical function and risk factors can facilitate lifestyle decisions on the individual level which can reduce the risk for later ill-health and need of health-care. Preventive interventions may contribute to reduce the ever-increasing level of lifestyle-related ill-health.

NCT ID: NCT05534763 Completed - Emotion Regulation Clinical Trials

Internet-delivered Treatment for Transgender Individuals With Co-occurring Mental Health Problems

IERGD
Start date: August 24, 2022
Phase: N/A
Study type: Interventional

This project aims to develop and evaluate if an internet delivered psychological intervention for transgender individuals undergoing assessment for gender dysphoria and a support person, is feasible, acceptable and effective in increasing emotional skills, strengthening a healthy identity development, social support and resilience to current and future mental illness. In two studies, a psychological treatment for transgender adults (18+) seeking health care for gender dysphoria and a support person (i.e., relative, friend) will be evaluated. The project will be carried out at a specialized unit for transgender health care (ANOVA) at Karolinska University Hospital

NCT ID: NCT05533138 Recruiting - Clinical trials for Antenatal Depression

Internet CBT for Antenatal Depression

Start date: February 25, 2021
Phase: N/A
Study type: Interventional

Pregnant women in pregnancy week 8-29 screening positive for antenatal depression will be randomized to either choose or to be allotted by chance to different forms of diagnostic assessment; i.e. telephone, video or face-to-face assessment. Those diagnosed with mild to moderate major depression will then be randomized to treatment with therapist-guided Internet-delivered Cognitive Behavioral Therapy (ICBT) adapted for women suffering from antenatal depression or to the same treatment with addition of up to three contacts with extra support by a midwife or experienced perinatal mental health nurse. The primary aim is to assess whether extrasupport in addition to internet-guided pregnancy adapted ICBT decreases depressive symptoms more than internet-guided pregnancy adapted ICBT only. Secondary aims include effects of extrasupport and assessment mode on treatment satisfaction, fidelity and credibility.

NCT ID: NCT05531565 Recruiting - Clinical trials for Subacute Cutaneous Lupus Erythematosus

A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

AMETHYST
Start date: September 13, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab) compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B].

NCT ID: NCT05531305 Completed - Critical Illness Clinical Trials

Longitudinal Changes in Muscle Mass After Intensive Care

Start date: September 26, 2022
Phase: N/A
Study type: Interventional

Critically ill patients often suffer from dramatic muscle loss while in the ICU. Recovery of muscle structure and function have been proposed as core outcome measures for interventional studies in ICU survivors. Ultrasound is an accessible and validated tool to monitor muscle mass over time, with quadriceps muscle layer thickness (MLT) corresponding well to more invasive or cumbersome modalities. In order to design adequately powered studies investigating the effects of nutritional or metabolic interventions on post-ICU recovery, an estimate of the population standard deviation in MLT change over time is required. Currently there is a paucity of data describing changes in muscle mass during the subsequent period of hospitalization in ICU survivors. The aim of this study is to estimate the mean change and standard deviation in quadriceps MLT over time, in patients discharged alive from intensive care. Patients will be followed until hospital discharge or up to 28 days after ICU discharge. Interactions with nutritional intake, inflammation and metabolic rate will be analyzed for hypothesis-generating purposes.

NCT ID: NCT05531240 Recruiting - Clinical trials for Prostate Hyperplasia

Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE)

Start date: October 2022
Phase: N/A
Study type: Interventional

This study focuses on the treatment of benign prostatic hyperplasia which causes lower urinary tract symptoms. The purpose of the research project is to evaluate PAE in terms of both medical and health economic outcomes. To evaluate whether there are any differences in effect (IPSS), complications, costs and perceived quality of life compared with TUR-P.

NCT ID: NCT05529043 Not yet recruiting - Obesity, Childhood Clinical Trials

MINISTOP Plus Program for Pre-school Children With Overweight and Obesity

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The Mobile-based intervention intended to stop obesity in preschoolers (MINISTOP) program has been developed to be a comprehensive digital support program for all children irrespective of weight status. However, a one size fits all approach may not be sufficient as some families may require extra support through in-person activities to achieve the required lifestyle behaviour change in order to attain and maintain a healthy weight. Therefore, the aims of this pilot randomized controlled trial are to evaluate the efficacy and feasibility of the MINISTOP Plus Program in pre-school children with overweight and obesity on: (i) children's BMI z-scores; (ii) intake of fruit and vegetables, sweet and savoury snacks, and sweet drinks; (iii) time spent in different physical activity intensities; (iv) screen time; and (v) parental self-efficacy.

NCT ID: NCT05526950 Recruiting - Clinical trials for Lung Transplant; Complications

Cytokine Filtration in Lung Transplantation: A Swedish National Study (GLUSorb)

Start date: September 7, 2023
Phase: N/A
Study type: Interventional

Lung transplantation (LTx) remains the gold standard for treating patients with irreversible end-stage pulmonary disease. Of the major organs transplanted, survival in LTx recipients remains the lowest (mean 5 years). Despite improvements, primary graft dysfunction (PGD), as defined by respiratory insufficiency and edema up to 72 hours post LTx, remains the leading cause of early mortality and contributes to the development of chronic lung allograft dysfunction (CLAD) which is the leading cause of late mortality. PGD develops within the first 72 hours after LTx. The development of CLAD increases quickly with cumulative incidence of 40-80 % within the first 3-5 years. There is a general lack of efficient treatments for PGD and CLAD. Prevention of PGD is therefore of crucial importance and has a direct impact on survival. The present study is a randomized controlled study which aims to compare patients undergoing LTx with and without the utilization of cytokine adsorption.

NCT ID: NCT05526261 Recruiting - Thyroid Nodule Clinical Trials

Benign Thyroid Nodules / Benign Goiter. What Subjective Problems Are Improved With an Operation and Can This be Predicted Preoperatively?

Start date: May 30, 2020
Phase:
Study type: Observational

Nodules in the thyroid gland are common. Patients discover these lumps either because of their visible size increase or because of local discomforts such as difficulty swallowing, difficulty breathing or voice changes. The thyroid gland is in close connection with the esophagus, trachea and the vocal nerve. Thus, a lump in the thyroid gland can cause pressure symptoms from these organs. In the event of such complaints, patients are referred for investigation. If it turns out that the patient has a lump in the thyroid gland ("goiter"), further investigation is carried out with an ultrasound examination and sampling with a needle from the lump (puncture). At present, most thyroid nodules are examined cytologically, ie the thyroid nodules are punctured with a thin needle and the cells that are obtained are analyzed by a cytologist. The material is graded according to Bethesda classification. Higher grading is associated with a higher risk that the tuber is malignant. Lower grading is associated with a lower probability that the tuber can be malignant. If these patients are operated on, it is usually with the hope that their local ailments improve. We want to investigate which patients who have a lump in the thyroid gland and experience pressure problems experience an improvement after a thyroid operation.