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NCT ID: NCT06134219 Recruiting - Graves Disease Clinical Trials

Course for Brain Fatigue After Graves' Disease Controlled Study

MF-Course
Start date: October 10, 2023
Phase: N/A
Study type: Interventional

BACKGROUND. Mental fatigue (MF) is common in the most common form of hyperthyroidism, Graves' disease (GD). Clinically, MF is the primary mental symptom in patients with GD and is characterized by difficulties maintaining attention, exhaustion during cognitively demanding tasks, memory difficulties, irritability, and emotional lability. It may be the main contributing factor to the continued low quality of life in many patients with GD. MF can be measured with an MF score (MFS). The pathophysiology is unknown. There is no medical treatment, which requires patients to adapt to the situation. AIM. In this project, the investigators want to test the hypothesis that mental fatigue improves - with secondary benefits on mental capacity, quality of life (QoL), and function - in patients with persistent mental fatigue in GD, through an MF course as an addition to standard care, compared to patients who receive only standard care. The investigators also test the hypothesis that the MF course is a cost-effective intervention. METHOD. In a randomized controlled study, the investigators evaluate the effect of the MF course compared to standard care only in 96 patients with persistent MF in GD. Markers of mental health, QoL, and activity capacity are evaluated at baseline, 3, 6, and 12 months after intervention/inclusion. The primary outcome measure is MFS at 3 months. CLINICAL SIGNIFICANCE. Patients report feeling neglected by healthcare for decades, and healthcare professionals are frustrated by the lack of guidance. Patient organizations highlight the need for research; they want mental symptoms to be characterized as a consequence of thyroid disease, they demand biomarkers, specific treatments, and personalized care. Our research group is working to address the cause of MF in GD and also to alleviate the symptoms. The MF course may prove to be an important tool that can be quickly implemented in clinical practice, especially in primary care. Our involvement in regional/national working groups will facilitate implementation in other units. In this project, the investigators want to test the hypothesis that mental fatigue improves - with secondary benefits on mental capacity, quality of life (QoL), and function - in patients with persistent mental fatigue at GD, through an MF course as an addition to regular healthcare, compared to patients receiving only regular healthcare.

NCT ID: NCT06133595 Recruiting - Child Sexual Abuse Clinical Trials

Mi Bridge - Motivational Interviewing to Facilitate Help-seeking Among Minor Attracted Individuals

Mi Bridge
Start date: September 18, 2023
Phase: N/A
Study type: Interventional

The overall aim of the study is to evaluate the effectiveness of Mi Bridge to motivate high risk participants to admit to treatment. The main research question is: Is Mi Bridge, an anonymous online program based on the principles for Motivational Interviewing, effective in making high risk individuals for committing child sexual abuse prone to seek treatment for problems related to sexual urges involving minors at a health care facility?

NCT ID: NCT06133569 Recruiting - Pedophilia Clinical Trials

ReDirection - Self Help Program for Minor Attracted Individuals

ReDirection
Start date: September 27, 2023
Phase: N/A
Study type: Interventional

The overall aim of the study is to evaluate the effectiveness of the ReDirection program for individuals with low or medium risk to commit child sexual abuse. Primary question: Is ReDirection a feasible, effective, and safe method in reducing low to medium risk participants' use of CSAM and related behaviors?

NCT ID: NCT06132958 Recruiting - Endometrial Cancer Clinical Trials

Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)

Start date: December 6, 2023
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to compare sacituzumab tirumotecan to Treatment of Physician's Choice (TPC) with respect to progression-free survival (PFS) per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (BICR), and overall survival (OS). The primary hypotheses are that sacituzumab tirumotecan is superior to TPC with respect to PFS per RECIST 1.1, as assessed by BICR, and that sacituzumab tirumotecan is superior to TPC with respect to OS.

NCT ID: NCT06132568 Recruiting - Clinical trials for High-risk Percutaneous Coronary Intervention

VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)

VITALYST EFS
Start date: May 9, 2024
Phase: N/A
Study type: Interventional

The VITALYST Early Feasibility study (EFS) is designed to evaluate the feasibility and safety of the VITALYST System in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).

NCT ID: NCT06127940 Recruiting - Clinical trials for Non-small Cell Lung Cancer Metastatic

K-SAB Trial - Sotorasib Followed by SBRT to 1-3 Lesions in Advanced NSCLC With KRASG12C Mutation

K-SAB
Start date: October 15, 2023
Phase: Phase 1
Study type: Interventional

The goal of this interventional study is to learn about the combination of sotorasib and stereotactic radiation therapy (SBRT) in patients with metastatic non-small cell lung cancer (NSCLC) with KRASG12C mutations. The main question it aims to answer is: • can SBRT be safely delivered in patients treated with sotorasib Participants will be treated with sotorasib for an 8-week-induction period and if the patient has stable disease or partial response, 1-3 of the remaining lesions will be irradiated with SBRT and sotorasib will then be contiuned after irradiation. The patients will then be followed and evaluated for toxicity to identify if grade 3-5 toxicity attributed to SBRT occurs within 6 months post SBRT. Tumour effects measured according to RECIST v1.1 will also be evaluated.

NCT ID: NCT06127290 Recruiting - HIV-1-infection Clinical Trials

HIV Resistance, Molecular Epidemiology and New Treatment Strategies in the Eastern European Region and in Russia

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

Cohort based prospective monitoring of the spread of HIV drug resistance during a phase when new anti-HIV drugs are introduced.

NCT ID: NCT06127004 Recruiting - Clinical trials for Negative Symptoms in Schizophrenia

Metacognitive Training for Negative Symptoms

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

There is a clear rationale for developing interventions targeting negative symptoms of schizophrenia as these are a stronger indicator of current and future functioning than positive symptoms and because they respond poorly to medication and existing psychological interventions. This is reflected in the NIMH-MATRICS consensus statement that emphasised that persistent negative symptoms represent an unmet therapeutic need for patients suffering from schizophrenia. The purpose of this study is to evaluate, in a scientific manner, the intervention developed by Swanson et al. 2021: Metacognitive Training (MCT) Minus. The MCT was adapted to target negative symptoms in psychotic disorders (e.g. schizophrenia, schizoaffective or non-affective functional psychosis) as the original version of the intervention focused exclusively on positive symptoms. The specific aim is to study whether MCT Minus is a promising treatment for the intended population in terms of reductions in negative symptoms, severity of defeatist attitudes, internalised stigma, and depression as well as improvements in reflective ability and overall functioning. The research will add to existing research by identifying and measuring potential mechanisms of change for negative symptoms (i.e., defeatist attitudes, reflective functioning, stigma and depression). It will also add to the existing evidence base by measuring whether the cognitive biases addressed in MCT lead to changes in the wider conceptualisation of metacognition used elsewhere and whether the promising results seen in the feasibility study of MCT Minus can be replicated in a randomised controlled trial (RCT) with a control group and a blinded assessor. The researchers also hope to replicate the findings of a previous study, where MCT was found to be related to the modulation of default-mode network (DMN) homogeneity in schizophrenia, an area thought to be involved in self- and other-reflectivity.

NCT ID: NCT06124391 Recruiting - Clinical trials for Polycystic Ovary Syndrome

Novel Subtypes of Polycystic Ovary Syndrome

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

To classify subtypes of Polycystic Ovary Syndrome (PCOS) using machine-learning algorithms, and compare the reproductive and metabolic characteristics and IVF outcomes across these identified subtypes.

NCT ID: NCT06123299 Recruiting - Bacterial Vaginosis Clinical Trials

A Randomised, Partly-blinded Investigation to Evaluate the Clinical Performance and Safety of pHyph in Adult Women With Bacterial Vaginosis Compared With an Untreated Control Group

Nefertiti 2
Start date: November 20, 2023
Phase: N/A
Study type: Interventional

This is a randomised, parallel group, partly blinded investigation to evaluate the clinical performance and safety of pHyph in adult women with bacterial vaginosis. Patients will be randomised to active treatment or no treatment (untreated controls) in a 1:1 ratio. The Investigators carrying out the gynaecological assessments will be blinded. Patients will not be blinded. The population of this investigation will consist of post-menarchal, pre-menopausal females 18 years or older seeking treatment for BV symptoms ("fishy smell", irritation and burning). Approximately 82-92 patients will be recruited and randomised. BV will be diagnosed according to Amsel's criteria, defined as having at least 3 of the 4 criteria. Active treatment (from the start of the investigation) will be compared to no treatment at day 7 after screening (primary endpoint). Clinical cure rate on Day 7 is defined as the absence of all of the following 3 Amsel criteria: - Thin, white, yellow, homogeneous discharge. - Clue cells on microscopy (>20% of epithelial cells). - Release of a "fishy odour", i.e., a positive "whiff test" when alkali (10% KOH solution) is added. Patients receiving rescue treatment before Day 7 will be considered as treatment failures. Patients in the "no treatment group" will receive pHyph as rescue treatment if they are not cured day 7. They will thereafter follow the same scheme as the patients starting with pHyph treatment. After the initial pHyph treatment, daily during 6 days, patients will continue with pHyph twice weekly until day 25 when an additional assessment will be performed. If the patients are cured, they will continue to receive pHyph as preventive treatment during 6 weeks and possible BV recurrences will be assessed.