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NCT ID: NCT05717465 Completed - Clinical trials for Informed Consent, Health Literacy, Risk, Spinal Puncture, Neurosurgery

Communicating Risks: Consent for Lumbar Puncture

Start date: March 27, 2022
Phase: N/A
Study type: Interventional

The goal of this randomized control trial is to compare the effect of visual aids on the recall of probabilistic risks in healthy participants. The main questions it aims to answer are: - Will participants consented using a consent process incorporating visual aids recall the consent process better? - Will participants consented with a consent process incorporating visual aids have higher acceptability if a hypothetical, simulated complication were to occur? - Is this method of consent (visual aids) usable, appropriate and acceptable? Participants will be required to watch a brief video containing information on how a lumbar puncture is performed as well as the associated risks. - Participants in the intervention group will receive information in the form of various visual aids (e.g. anatomical diagrams, paling palettes and paling perspective scales). The audio narration and information provided in both groups is identical. - Participants will be tested on their knowledge of the procedure - Participants will be asked to rate their response to a series of procedure specific statements and statements from other validated scales. Researchers will compare the control and intervention group to see if there is improvement in the recall of information and which consent process is more acceptable, appropriate and usable.

NCT ID: NCT05717452 Recruiting - Mood Clinical Trials

Effects of a Single Dose of Wild Blueberries on Mood and Executive Function in Healthy Emerging Adults

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

This study aims to investigate whether consuming a drink containing powdered blueberries (equivalent to 150 g of fresh fruit) can improve mood and executive function in healthy emerging adults.

NCT ID: NCT05717023 Completed - Sexual Dysfunction Clinical Trials

Guided Self-help Following Sexual Assault - SCED

Start date: February 17, 2023
Phase: N/A
Study type: Interventional

This single-case experimental design aims to evaluate the acceptability & feasibility of an online guided self-help intervention for female survivors of sexual assault who experience difficulties returning to sex. The main questions it aims to answer are: • Is the intervention viewed as acceptable by female survivors of sexual assault? Acceptability is defined as as how willing participants are to use the materials and their satisfaction with its content. The secondary question is, are there initial indicators that the intervention is effective? Effectiveness is measured by a reduction in the measure of sexual distress and improvement of sexual satisfaction - specifically confidence and motivation in practising strategies that will improve their experience of sex. Participants will complete the intervention independently. There will be 4-sessions which involve watching videos, with one session completed weekly. The developed materials aim to to help women understand their difficulties, learn practical strategies and build confidence in returning to sex. The materials are also guided by a piloted group for sexual distress by Bart's National Health Service (NHS) trust Sexual Wellbeing Service. The NHS is the publicly funded healthcare system in England.

NCT ID: NCT05714969 Recruiting - Clinical trials for Thrombotic Thrombocytopenic Purpura (TTP)

A Study of TAK-755 (rADAMTS13) With Little to No Plasma Exchange (PEX) Treatment in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)

Start date: March 21, 2023
Phase: Phase 2
Study type: Interventional

This is a study of TAK-755 in adults with immune-mediated thrombotic thrombocytopenic purpura (iTTP). The main aim of this study is to determine the percentage of participants with a clinical response without plasma exchange during the study. Participants who have an acute attack of iTTP will receive TAK-755 and immunosuppressive therapy during their stay at the hospital until they achieve a clinical response. Participants will also be treated with TAK-755 for an additional time of up to 6 weeks after the acute phase. In total, participants will stay in the study for approximately 3 months.

NCT ID: NCT05714839 Recruiting - Multiple Myeloma Clinical Trials

A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments

DREAMM-20
Start date: June 14, 2023
Phase: Phase 1
Study type: Interventional

The study consists of three parts - Part 1: The primary purpose of this part is to determine the safety, and recommended part 2 dose of belantamab (bela) in participants with relapsed or refractory multiple myeloma (RRMM). - Part 2: The primary purpose of this part is to determine safety, tolerability and percentage of adverse events (AEs) that happen to eyes in participants with RRMM treated with bela in combination with other treatments. - Part 3: The primary objective of this part is to assess the safety, tolerability and rate of ocular AEs in participants with transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) treated with either belantamab mafodotin (belamaf) or bela in combination with other treatments.

NCT ID: NCT05714553 Recruiting - Gastric Cancer Clinical Trials

NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours

Start date: March 8, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This study is an open-label, multi-arm, parallel cohort, dose validation and expansion design. The study is modular in design, allowing evaluation of the safety, efficacy and pharmacokinetics (PK) of NUC-3373 in combination with other agents for the treatment of patients with different tumour types. Each module is designed to evaluate a different NUC-3373 combination and consists of a dose-validation phase (Phase Ib) and a dose-expansion phase (Phase II). Phase Ib of each module will determine the safety and tolerability of the combinations for further clinical evaluation in Phase II. Approximately 6-20 evaluable patients will be enrolled in the Phase Ib stage of each module to determine safety, tolerability, and preliminary efficacy of NUC-3373 in combination with other agents. Each module will then move into Phase II to enable a further assessment of safety and efficacy in approximately 20-40 patients. Module 1 will assess NUC-3373 + leucovorin (LV) in combination with pembrolizumab for the treatment of patients with advanced/metastatic solid tumours who have progressed on ≤2 prior therapies for metastatic disease, that may have included 1 prior immunotherapy-containing regimen (either monotherapy or in combination with chemotherapy) or who have not progressed but where addition of NUC-3373 + LV to standard pembrolizumab monotherapy may be appropriate (e.g., patients who could not tolerate post- immuno-oncology (IO) standard of care therapy). Module 2 will assess NUC-3373 + LV in combination with docetaxel for the treatment of patients with advanced/metastatic non-small cell lung cancer (NSCLC) or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease. The opening of each module will be at the discretion of the Sponsor. Further modules may be added as non-clinical and clinical data become available to support additional NUC-3373 combinations and tumour types.

NCT ID: NCT05714436 Recruiting - Clinical trials for Head and Neck Cancer

Ii-HANC Improving Incurable Head and Neck Cancer Healthcare Experiences

Start date: April 19, 2023
Phase:
Study type: Observational

This research aims to improve experiences of patients with incurable head and neck cancer (IHNC) by finding out the most pressing issues for them and developing solutions to improve these. Patients with IHNC have many complex needs and the level of support they require is often greater than other illnesses. IHNC symptoms cause major changes to basic functions, such as: being unable to talk; severe swallowing problems with a high choking risk; breathing difficulties requiring a hole in the neck (tracheostomy). The manner of death can be highly traumatic and frightening e.g. catastrophic bleeding from the neck. Despite this poor outlook, little is known about patients' needs in the last year of life. However, IHNC patients have more emergency hospital visits compared with other cancer groups. Patients from poorer areas are more likely to die in hospital. Furthermore, head and neck cancer (HNC) units are centralised, with access to specialist services dependent on where the patient lives. The researcher wishes to understand 'stress points' in the patients' journey, where things do not go as planned, identify priorities for change and develop patient-led solutions. There are two main parts to this work, occurring over 21-months across Yorkshire, Northwest and Northeast England. 1. A series of up to three interviews with approximately 25 IHNC patients and their families, along with group discussions with healthcare workers involved in IHNC care. These will explore how patients' needs and use of healthcare change over time. 2. Using interview and group discussion findings, the study team will hold a series of workshops with patients, families, clinical service leaders, and healthcare workers. The study team will identify priorities and develop ways to improve care experiences. The research is funded by the National Institute for Health Research (NIHR) Research for Patient Benefit programme.

NCT ID: NCT05714202 Recruiting - Bladder Cancer Clinical Trials

A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)

SunRISe-3
Start date: March 23, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).

NCT ID: NCT05714085 Recruiting - Heart Failure Clinical Trials

Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)

Start date: May 31, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16. The primary hypothesis is Vericiguat is superior to placebo in reducing NT-proBNP at Week 16.

NCT ID: NCT05713942 Enrolling by invitation - Brain Concussion Clinical Trials

Concussion Assessments in Football

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

Diagnosing and determining the severity of a sports-related concussion immediately on- or off-field is challenging, especially because clinical signs can evolve minutes to hours after the mechanism of injury. Hence, repeated follow-up and serial assessments of a player are recommended following such an injury. Current advice, when a player sustains a confirmed or suspected concussive injury, is to remove them from play immediately and not return to competition or unrestricted training until signs and symptoms have been managed as per relevant guidelines. To support this decision the International football Association Board has introduced a trial allowing an additional permanent concussion substitution in participating competitions. Follow-up assessment of concussion incidents is recommended to include the Sport Concussion Assessment Tool 5th Edition. For further assessment of neurocognitive deficits and to inform return to play decisions, it is recommended that a computerised assessment is also adopted, such as the Immediate Post-Concussion Assessment and Cognitive Testing tool. The aims of this study are: 1. To determine the incidence of head trauma and use of concussion substitutions in football competitions that are participating in the IFAB's permanent concussion substitution trial. 2. To evaluate the immediate severity of reported concussion signs and symptoms for football players with a confirmed or suspected concussion. 3. To evaluate the ability of neurocognitive assessments completed post-incident to inform the clinical diagnosis of concussion.