Clinical Trials Logo

Filter by:
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: NCT06136559 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)

Start date: December 13, 2023
Phase: Phase 3
Study type: Interventional

The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per iwCLL Criteria 2018 by BICR.

NCT ID: NCT06134401 Not yet recruiting - Cerebral Palsy Clinical Trials

Nebulised Hypertonic Saline to Decrease Respiratory Exacerbations in Neuromuscular Disease or Neurodisability

SPICE-UP
Start date: April 2024
Phase: N/A
Study type: Interventional

Research Aim: This study investigates whether a 12-month treatment with hypertonic saline (salty water) can reduce antibiotic use in individuals with neuromuscular disease or cerebral palsy who frequently experience chest infections due to difficulty clearing mucus from their airways. Methodology: Participants will be randomly assigned to receive nebulised hypertonic saline (7% salt in water) or normal saline (0.9% salt in water). The study is open-label as both participants and researchers are aware of the treatment, necessary due to the differing tastes of the solutions. Two centers, Royal Brompton Hospital in London and Queens Medical Centre in Nottingham, will conduct the research. Before starting the treatment, participants will undergo various assessments, including questionnaires to measure quality of life and treatment satisfaction, sputum/throat swab collection, lung clearance index, forced oscillation technique, electrical impedance tomography, and lung ultrasound. Once these assessments are completed, participants will take the assigned treatment at home, administered twice daily for 12 months, with monthly follow-ups regarding difficulties and chest infections. After 12 months, the treatment will cease, and participants will repeat the assessments. Significance: This research will provide valuable insights into the efficacy of nebulised hypertonic saline for individuals with neuromuscular disease or cerebral palsy, potentially aiding both patients and doctors in making informed treatment decisions. Dissemination: The study's findings will be shared through publication in scientific journals and presentation at conferences.

NCT ID: NCT06133673 Recruiting - Quality of Life Clinical Trials

KSS Autism: Parameters and Future Care

Start date: September 18, 2023
Phase:
Study type: Observational

Referrals for autism assessment have greatly increased in the last few years. This means that waiting times are longer for families, and children and young people are struggling to get the support they need. This also means that the number of autistic children and young people there is assumed to be is not correct. A better understanding of the true number of autistic children and young people is needed so that better support for them can be provided. This research aims to understand what autism looks like in Kent, Surrey, and Sussex (KSS) to better help autistic children and young people. To do this, schools will be asked about the number of autistic children in their school to better understand the number of children and young people with autism in KSS. Secondly, autistic children and young people will be interviewed to find out about the support they need. The information gathered will help the research team to develop a quality-of-life measure, which can be used by schools to help autistic children and young people get the support they need.

NCT ID: NCT06133582 Active, not recruiting - Depression, Anxiety Clinical Trials

Mood Awareness Psychotherapy Support

MAPS
Start date: November 27, 2023
Phase: N/A
Study type: Interventional

The aim of this single arm feasibility trial is to examine an internet delivered, self-help program for depression and anxiety, based on psychodynamic therapy. The study will evaluate the psychodynamic program with therapist support. The participants will be university students.

NCT ID: NCT06133270 Recruiting - Clinical trials for Healthy Volunteers - Liver Diseases

A First Human Dose Study Investigating Safety and Concentration of Study Medicine in the Blood Following Once Daily Oral Dosing of NNC0560-0004 in Healthy Adults.

Start date: November 13, 2023
Phase: Phase 1
Study type: Interventional

In this trial, medicine NNC0560-0004 given in capsule form will be compared to placebo in healthy volunteers. Participants will either get NNC0560-0004 or placebo. Which treatment they get is decided by chance. This is a first in human trial, which means that this is the first time that NNC0560-0004 is given to humans. The study will last for about two weeks plus the screening period (approximately 42 days) which in all is about 8 weeks. Women must be of non-childbearing potential thus you cannot take part if you are pregnant, can become pregnant, breast-feeding or plan to get pregnant during the study period.

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: NCT06132841 Recruiting - Clinical trials for Healthy Participants

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD6234 After Repeat Dose Administration in Participants Who Are Overweight or Obese

Start date: November 13, 2023
Phase: Phase 1
Study type: Interventional

A study in healthy male and female participants of non-childbearing potential who have overweight or obesity

NCT ID: NCT06130397 Recruiting - Fracture Clinical Trials

AI Assisted Detection of Fractures on X-Rays (FRACT-AI)

FRACT-AI
Start date: February 8, 2024
Phase:
Study type: Observational

This study has been added as a sub study to the Simulation Training for Emergency Department Imaging 2 study (ClinicalTrials.gov ID NCT05427838). This work aims to evaluate the impact of an Artificial Intelligence (AI)-enhanced algorithm called Boneview on the diagnostic accuracy of clinicians in the detection of fractures on plain XR (X-Ray). The study will create a dataset of 500 plain X-Rays involving standard images of all bones other than the skull and cervical spine, with 50% normal cases and 50% containing fractures. A reference 'ground truth' for each image to confirm the presence or absence of a fracture will be established by a senior radiologist panel. This dataset will then be inferenced by the Gleamer Boneview algorithm to identify fractures. Performance of the algorithm will be compared against the reference standard. The study will then undertake a Multiple-Reader Multiple-Case study in which clinicians interpret all images without AI and then subsequently with access to the output of the AI algorithm. 18 clinicians will be recruited as readers with 3 from each of six distinct clinical groups: Emergency Medicine, Trauma and Orthopedic Surgery, Emergency Nurse Practitioners, Physiotherapy, Radiology and Radiographers, with three levels of seniority in each group. Changes in reporting accuracy (sensitivity, specificity), confidence, and speed of readers in two sessions will be compared. The results will be analyzed in a pooled analysis for all readers as well as for the following subgroups: Clinical role, Level of seniority, Pathological finding, Difficulty of image. The study will demonstrate the impact of an AI interpretation as compared with interpretation by clinicians, and as compared with clinicians using the AI as an adjunct to their interpretation. The study will represent a range of professional backgrounds and levels of experience among the clinical element. The study will use plain film x-rays that will represent a range of anatomical views and pathological presentations, however x-rays will present equal numbers of pathological and non-pathological x-rays, giving equal weight to assessment of specificity and sensitivity. Ethics approval has already been granted, and the study will be disseminated through publication in peer-reviewed journals and presentation at relevant conferences.

NCT ID: NCT06129968 Recruiting - Ovarian Cancer Clinical Trials

Transforming Ovarian Cancer Diagnostic Pathways

SONATA
Start date: January 23, 2024
Phase:
Study type: Observational

The goal of this observational cohort study is to compare the diagnostic accuracy and cost effectiveness of Risk of Malignancy Algorithm (ROMA) compared with CA125 in the diagnosis of ovarian cancer in patients attending their general practitioner (GP) with symptoms that sometimes might indicate ovarian cancer. The main questions it aims to answer are: • what is the accuracy of the ROMA algorithm which uses the blood tests CA125 and Human epididymis protein 4 (HE4) compared to CA125 in diagnosing ovarian cancer, particularly early-stage ovarian cancer, in women tested for suspected ovarian cancer from primary care? • What is the cost-effectiveness of ROMA versus CA125 testing in primary care to diagnose ovarian cancer? When a participant's GP orders a CA125 blood test, the blood will also be tested for HE4 and the ROMA algorithm calculated. The diagnostic accuracy of ROMA and CA125 will be compared to see if ROMA would be a better diagnostic test for ovarian cancer when used in the primary care setting.