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NCT ID: NCT05718960 Recruiting - Dyspepsia Clinical Trials

Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia

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

Functional dyspepsia is common, affecting 7.2% of the global population, and associated with substantial health impairment. Almost 80% of patients with functional dyspepsia report meal-related symptoms and are classified as having the postprandial distress syndrome (PDS) variant. However, studies evaluating dietary modifications in PDS are sparse. The investigators will perform a single-centre randomised trial evaluating traditional dietary advice (TDA) in PDS. 50 patients with PDS will be randomly assigned to a leaflet explaining reassurance-alone +/- TDA. The reassurance-alone group will be informed of the absence of organic disease and provided a diagnostic explanation of functional dyspepsia. The TDA group will receive the same information but also be recommended to eat smaller, regular meals and reduce the intake of caffeine/alcohol/fizzy drinks, fatty/processed/spicy foods, and fibre. Questionnaires are to be completed during the 4-week trial, including self-reported adequate relief of dyspeptic symptoms, and the validated Leuven Postprandial Distress Scale (LPDS), Gastrointestinal Symptom Rating Scale, and Napean Dyspepsia Quality of Life Index. The primary endpoint(s) to define clinical response will be evaluated over weeks 3-4 as, i) ≥50% adequate relief of dyspeptic symptoms, and ii) >0.5-point reduction in the PDS subscale of the LPDS (calculated as the mean scores for early satiety, postprandial fullness, and upper abdominal bloating).

NCT ID: NCT05718726 Recruiting - Peritoneal Cancer Clinical Trials

Post Splenectomy Infections After Surgery for Peritoneal Malignancies (OPSI)

OPSI
Start date: March 25, 2021
Phase:
Study type: Observational

The spleen is involved in maintaining immunity and plays an important role in the elimination of encapsulated bacteria and parasites. Patients who undergo splenectomy in conjunction with complete CRS for peritoneal malignancy are at risk of overwhelming post-splenectomy infections post-operatively. These patients are therefore administered vaccinations to lower the risk of infections but as they do not completely eliminate the risk, patients are also prescribed prophylactic antibiotics without clear evidence that they are useful in preventing OPSI. The use of prophylactic antibiotics is not without risk with potential short and long-term risks including resistance, interaction with other medication, clostridium difficile infections, fungal infections, other changes to the microbiome and cost. This study will investigate the incidence of OPSI post splenectomy and assess compliance with prophylactic antibiotics. This is an observational study where consented patients will be telephoned at fixed time points which are 1,6,12 weekly and 6 monthly for a period of five years post-operatively. As part of routine care patients will be telephoned by the clinical nurse specialist at weeks 1,6 and 12. In addition to this the research nurse will telephone the patient 6 monthly for a period of 5 years and complete a questionnaire. The research nurse will complete the questionnaire during each telephone call and this should not take more than 20 minutes. At the start of the telephone call, consent will be confirmed each time and the research nurse will check that the patient is still happy to participate before going ahead.

NCT ID: NCT05718297 Recruiting - NSCLC, Stage III Clinical Trials

Brigatinib Post Definitive Chemo-radiotherapy in Patients With ALK-fusion Non-small Cell Lung Cancer

BOUNCE
Start date: June 7, 2024
Phase: Phase 2
Study type: Interventional

BOUNCE is an international multicentre randomised phase II trial. The trial treatment consists of brigatinib 180 mg once daily p.o., with seven day lead-in at 90 mg once daily, for 3 years or until progression of disease. The primary objective of this trial is to evaluate the efficacy in terms of progression-free survival (PFS) for brigatinib consolidation, compared to observation/durvalumab, in patients with unresectable stage III NSCLC and ALK-rearrangement who completed definitive chemo-radiotherapy without disease progression.

NCT ID: NCT05717647 Recruiting - Clinical trials for Traumatic Brain Injury

Cerebral Oxygenation and Metabolism and Severe Head Injury in Paediatrics (COMetSHIP)

COMetSHIP
Start date: March 1, 2023
Phase:
Study type: Observational

Children suffer proportionally more head injuries than any other age group and children with head injuries have the highest mortality of all children admitted with traumatic injuries. The investigators aim to investigate the factors that contribute to poor outcomes after paediatric acute brain injury by collecting observational and outcome data. Much of the brain damage that results in poor outcomes actually happens in the hours and days after the injury. This is due to several factors such as brain swelling and poor oxygen delivery to the brain. Treatment is directed to try and protect the brain against these factors. Current management of the head injured child focuses on monitoring pressure within the head. However, this does not detect all the factors that cause continuing brain damage. Special monitors that follow oxygen levels and chemical changes in the brain are used safely in adult patients but have not been widely employed in children despite their potential benefit. There is therefore the opportunity to evaluate extra monitoring of the child brain, and in doing so, help refine the management of these patients.

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: 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).