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NCT ID: NCT05617339 Not yet recruiting - Clinical trials for Migraine Without Aura

Tailored Digital Treatment for Migraine

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

Background: An individualized internet-based treatment program from a biopsychosocial perspective has been developed within the Västra Götaland region (VGR) with funds from the Innovation Fund. The treatment program is called Learn to live with migraine and goes by the abbreviation I AM (Internet Approach to Migraine). I AM is a complement to the medical treatment and focuses on pain management and learning to live as good a life as possible with the disease migraine. During the spring of 2022, I AM has been tested regarding the feasibility of primary care on 29 research subjects in a pilot RCT (DNR 2020-02359). A weighted preliminary assessment shows moderate effect size on mental health, that the participants accept the intervention, and that I AM with recruitment and care process can be carried out in a primary care context. Purpose: An overall purpose of the study is to evaluate the effect of the addition of the internet-based biopsychosocial treatment I AM compared to usual treatment (TREATMENT as usual - TAU) in primary care regarding frequency and severity of migraine attacks, functional level, mental health, quality of life and employment rate with a randomized controlled trial design (RCT). An additional aim is to evaluate whether it is possible to prevent episodic migraine from developing into chronic migraine among those who have episodic migraine at the start of the study via the supplement treatment program I AM. Expected results: The greatest expected benefit of I AM is to reduce the burden and suffering of migraines for all the people affected. AM is also expected to increase the availability of treatment with a biopsychosocial perspective, have a quality-enhancing effect in terms of method and increase the patient's participation in their treatment. An environmental aspect is that neither patient nor therapist need to travel, accessibility also increases for individuals living in smaller communities who receive equal treatment.

NCT ID: NCT05617092 Recruiting - Clinical trials for Pelvic Floor Disorders

The Effect of a Postpartum Training Program on Women Who Have Suffered a Levator Ani Injury.

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

The goal of this pilot randomized pilot controlled trial (RTC)is to collect acceptability and feasibility outcomes of a physiotherapy individualized program in women with levator injury that is intended to be used in a larger scale multicenter randomized controlled trial (RTC) in the future. The main questions it aims to answer are if a physiotherapy program in women with a levator injury: 1. Can improve the pelvic floor morphometry (PFM). 2. Can improve urogynecological symptoms 3. The effect of a physiotherapy program in the sexual function 4. The effect of a physiotherapy program in the patient's fear avoidance beliefs about physical activity and work Type of study: randomized pilot controlled trial (RTC) The design of this trial will be a pilot randomized controlled trial with 3 arms. Participants will be randomized in 2 arm of women with levator ani injury to either physiotherapy or standard care and an arm of woman without levator injury Researchers will compare the 3 groups to see if a physiotherapy program have benefits in morphometry of the pelvic floor, urogynecological symptoms, sexual function and to avoid fear avoidance beliefs about physical activity and work.

NCT ID: NCT05612113 Active, not recruiting - Competence Clinical Trials

Live Supervision in Psychotherapy: Study Protocol for a Single Case Experimental Design Study (SCED)

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Although clinical supervision is an essential part of psychotherapy training and development, the empirical evidence for effects on therapist competence and patient outcome is limited. However, a novel format, Live Supervision (LS), enables real time feedback during the patient session which counteracts on several of the major identified problems with standard supervision. Pilot studies of LS show promising results, but the effects of LS has never been assessed in a clinical setting with licensed psychologists. Furthermore, manualized LS with a stringent focus at therapists' idiosyncratic challenges has never been evaluated. The primary aim of this study is to evaluate the effects of LS on therapist competence and perceived therapy challenges in a clinical outpatient setting with licensed psychologists as therapists. Secondary aims are to examine when and how LS is optimal for clinical supervision.

NCT ID: NCT05611983 Recruiting - Nerve Injury Clinical Trials

Experience and Feasibility of Methods for Early Sensory Training

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

The good effects of using guided plasticity for a rehabilitative purpose in case of nerve damage have been shown, but a problem that has been presented is that some individuals find it difficult to assimilate these effects due to difficulties in carrying out abstract training or due to a lack of motivation. In early sensory training, the plasticity of the brain is used. Methods for early sensory training that have been described are: 1) mental imagery of touch (mental imagery), 2) observation of touch, 3) mirror training, 4) use of images for visualization of touch. The method needs to be developed and refined to be able to offer individual training plans in order to find a motivating and meaningful form of training.

NCT ID: NCT05611619 Completed - Sleep Disturbance Clinical Trials

Low Particle Emission and Low Noise Tyres

LEON-T
Start date: January 30, 2023
Phase: N/A
Study type: Interventional

This study will investigate the biological mechanisms linking sleep disruption by noise and the development of disease. In a laboratory sleep study, the investigators will play synthesised automotive tyre sounds, investigating how acoustical characteristics of tyre noise impact on sleep macrostructure, cardiometabolic profile and cognitive performance (continuous traffic flow or a few individual, but higher level, traffic pass-bys). The investigators will also measure objective sleep quality and quantity, cognitive performance across multiple domains, self-reported sleep and wellbeing outcomes, and blood samples. Blood samples will be analysed to identify metabolic changes in different nights. Identifying biomarkers that are impacted by sleep fragmentation will establish the currently unclear pathways by which chronic noise exposure at night can lead to the development of diseases in the long term, especially cardiometabolic disorders.

NCT ID: NCT05611138 Completed - Healthy Clinical Trials

Dietary Proteins: Metagenomic and Metabolomics Approaches for Human Biomarkers Identification

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

This project aims to create a methodological framework, including the discovery and validation of novel biomarker panels to decipher the impact of plant-based protein intake on health biomarkers. Moreover, the possibility of predicting biomarkers production will be tested by a colonic in vitro fermentation study using study participants' faecal samples.

NCT ID: NCT05610501 Recruiting - Ovarian Cancer Clinical Trials

Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.

Start date: May 1, 2021
Phase:
Study type: Observational

In a transvaginal tru-cut biopsy, guided by ultrasound, a needle is inserted through the vaginal wall into a pelvic lesion and a few pieces of tissue are obtained for examination. This clinical trial is organized to evaluate the safety and efficacy of transvaginal tru-cut biopsy in a large group of patients with tumors in the small pelvis.

NCT ID: NCT05609734 Completed - Clinical trials for Traumatic Brain Injury

No Cases of Delayed Intracranial Hemorrhage (d-ICH) Among Patients With Mild Traumatic Brain Injury (mTBI) on Oral Anticoagulation Therapy

Start date: January 1, 2021
Phase:
Study type: Observational

Abstract Purpose Patients with anticoagulation therapy has a higher risk of developing traumatic Intracranial Hemorrhage (tICH). Delayed Intracranial Hemorrhage (d-ICH) is a rarer clinical manifestation; however, the incidence varies from 0-9,6 % in other studies. Some studies have also questioned the clinical relevance of d-ICH, since the mortality and the need of neurosurgical intervention is reported to be very low. The aim of this study is to determine the incidence of d-ICH at Sundsvall Regional Hospital. Methods A retrospective observational study of patients with mTBI and oral anticoagulation therapy. Data from medical records and radiology registry in Sundsvall hospital for 29 months during 2018-2020 in Sundsvall identified 249 patients with an initial negative CT scan who performed a follow-up CT scan. Outcome measure was incidence of d-ICH.

NCT ID: NCT05609721 Completed - Brain Injuries Clinical Trials

Mild Traumatic Brain Injury and the Risk for Traumatic Intracranial Hemorrhage

Start date: January 1, 2021
Phase:
Study type: Observational

Management of traumatic brain injuries causes significant efforts on emergency departments (ED) and overall health care. Patients on antithrombotic treatment with even minor trauma to the head, although without significant clinical findings, represent special challenges because the risk of traumatic intracranial hemorrhage (tICH) with these agents. The aim of this study was to compare the prevalence of tICH in patients on various pre-injury antithrombotic treatment exposed to minor Traumatic Brain injuries (mTBI) in Sundsvall with untreated patients. Secondary aim was to explore different risk factors for tICH. Data from medical records and radiology registry with mTBI in Sundsvall hospital between 2018-2020 in Sundsvall identified 2044 patients. Demographic data, pre-injury medications with antithrombotic treatment, state of consciousness at admission and the results of CT-scans of brain was investigated.

NCT ID: NCT05608278 Recruiting - Clinical trials for Obsessive-Compulsive Disorder

Four-day Intensive Treatment Versus Standard Cognitive Behavioral Therapy for Adults With Obsessive-compulsive Disorder

Start date: November 17, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare a novel, condensed version of cognitive behavioral therapy (Bergen 4-Day Treatment, B4DT) to the gold standard psychological treatment (gold-standard CBT) for obsessive compulsive disorder (OCD). The main question it aims to answer is: • Is B4DT non-inferior to standard cognitive behavioral therapy (CBT) with regard to OCD symptoms 14 weeks after treatment start? Adult patients with obsessive compulsive disorder will be randomly assigned to receive either gold standard CBT one to two times per week for 14 weeks, or 4 days of B4DT during one week.