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NCT ID: NCT06136650 Recruiting - Prostatic Neoplasms Clinical Trials

A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)

Start date: December 18, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypotheses are that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.

NCT ID: NCT06136624 Recruiting - Clinical trials for Prostate Cancer Metastatic

Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)

Start date: December 31, 2023
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) and to radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria In Solid Tumors (RECIST 1.1) as assessed by blinded independent central review (BICR) in participants with mCRPC previously treated with next-generation hormonal agent (NHA) and taxane-based chemotherapy. It is hypothesized that opevesostat is superior with respect to OS and rPFS per PCWG Modified RECIST 1.1 as assessed by BICR in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.

NCT ID: NCT06136494 Recruiting - Clinical trials for Non-cardiac Chest Pain

iCBT for Cardiac Anxiety in Patients With NCCP

IKSIT2
Start date: March 15, 2024
Phase: N/A
Study type: Interventional

Non-cardiac chest pain (NCCP) is a common condition that significantly affects patients' mental well-being, overall quality of life, and healthcare use. Even after ruling out cardiac issues, many patients still worry about having an undiagnosed cardiac illness, leading to cardiac anxiety since no other explanation is provided. Consequently, they avoid activities they believe might harm their heart, worsening their overall health and resulting in increased healthcare visits and societal costs. Addressing cardiac anxiety through psychological interventions could help break this viscious cycle and enhance patient outcomes. Internet-delivered cognitive behavioural therapy (iCBT) can assist patients in reassessing their perceptions, emotions and behaviours in order to handle their chest pain and therby reduce their cardiac anxiety. The aim of this study is to evaluate the short- and long-term effects of a guided 8-week iCBT program on cardiac anxiety, generalized anxiety, kinesiophobia, fear of body sensations, depressive symptoms, health-related quality of life, chest pain frequency and illness perception. Also to examine how participants' personality traits influence the effectiveness of the iCBT program. Furthermore, to assess the cost-effectiveness of the iCBT program compared to attention control. In addition, we will explore the perceptions of participants regarding the therapeutic alliance during the treatment.

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: NCT06132074 Enrolling by invitation - Clinical trials for Violence Prevention Intervention Evaluation Among Youth

Adolescent Consent & Sexual Violence: A School Intervention Evaluation

Start date: October 11, 2023
Phase: N/A
Study type: Interventional

Since 2015, Uppsala Tjej- och Transjour has run school sessions for secondary school pupils in Uppsala municipality, from year 9 to year 2. The school session is a 120-minute workshop and focuses on increasing knowledge and changing attitudes about consent, reciprocity and sexual violence. The intervention aims to increase participants' knowledge about consent, reciprocity, sex, sexuality and sexual violence in order to create positive attitudinal changes around gender and sexual violence and influence behaviour. The purpose of the study is to evaluate the effect of Uppsala Tjej- och Transjour's school intervention on young people's knowledge, attitudes and behaviour regarding consent, reciprocity and sexual violence. A cluster randomised controlled trial with 16 clusters (89 participants in each cluster) in each arm, a total of 32 clusters. Schools are randomised after baseline measurement to receive the intervention in autumn 2023 or spring 2024 (waiting list). Data collection is done through a questionnaire at two measurement points. A baseline measurement before the intervention (T1) and measurement two (T2) 6 months later. There are still few violence prevention programmes in Sweden that have been evaluated for effectiveness, and several programmes come from the USA. This study is based on a Swedish material and constitutes an important contribution to the development of more effective methods for violence prevention and increased insights into reciprocity and consent.

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.