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NCT ID: NCT05985018 Recruiting - Clinical trials for Irritable Bowel Syndrome

Traditional Dietary Advice Vs. Mediterranean Diet in IBS

Start date: September 30, 2023
Phase: N/A
Study type: Interventional

Irritable bowel syndrome (IBS) affects 5-10% of the population, and incurs substantial health impairment and healthcare utilization. Over 80% of individuals with IBS report food to trigger or aggravate symptoms, with many seeking to undertake dietary modifications. Current guidelines recommend first-line therapy with the relatively straightforward traditional dietary advice, with the more complex and restrictive low FODMAP diet reserved as second-line therapy. There is emerging data suggesting that the Mediterranean diet may also improve the symptoms of IBS, although it has not yet been subject to any head-to-head randomized dietary trials to help position it within the treatment algorithm. Given the relative ease of implementing the Mediterranean diet, alongside its recognized cardio-metabolic and mental health benefits, studying its efficacy in IBS is attractive as it could potentially pave the way for another first-line dietary option being available to patients before escalating to the demanding and resource intensive second-line therapies. The investigators will perform a randomized trial comparing the clinical efficacy of traditional dietary advice vs. a Mediterranean diet in IBS. Following dietary randomization, participants will complete validated questionnaires to assess changes in IBS symptoms, quality of life, mood, somatic symptoms, nutritional status, as well as dietary satisfaction and adherence.

NCT ID: NCT05984901 Recruiting - Vestibular Migraine Clinical Trials

The CAVA Multicentre Dizziness Trial

CAVA 2
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

The CAVA trial is a diagnostic accuracy multicentre device trial which aims to quantify the extent to which the CAVA system can differentiate three common inner-ear causes of dizziness: Ménière's disease, vestibular migraine and Benign Paroxysmal Positional Vertigo (BPPV). The CAVA device is composed of two components: a set of bespoke single-use sensor arrays that adhere to the left and right side of the participant's face; and a small reusable module fitting over the ear that contains a battery, microcomputer data storage facility and connection ports for the arrays. The CAVA device will be worn by all participants for 30 days with the aim of capturing eye movement data during a dizzy attack. The first objective is to develop an algorithm that can discriminate between the 3 listed dizziness conditions. The second is to quantify the financial and patient benefits of deployment in the NHS. The final objective is to expedite a plan to deploy the system in the NHS.

NCT ID: NCT05984823 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Home-based Body Weight Exercise With Blood Flow Restriction (BFR): Feasibility of a Novel Rehabilitation Intervention in COPD Patients (HomeBFR-COPD)

HomeBFR-COPD
Start date: January 26, 2024
Phase: N/A
Study type: Interventional

The primary aim of this randomised controlled trial is to investigate the feasibility and acceptability of low-intensity exercise with blood flow restriction (BFR) in patients with Chronic Obstructive Pulmonary disease (COPD). The investigators will also collect functional and physiological outcome data to explore potential mechanisms and provide data for a power calculation to be used in a future randomised controlled trial (RCT) to ensure that subsequent full scale clinical RCT has maximum reach and benefit. The primary experimental hypothesis that underpins these aims is: • Low-intensity exercise with BFR is a tolerable, acceptable, and safe exercise modality in COPD patients. 40 patients attending clinics at University Hospitals of Leicester (UHL) National Health Service (NHS) Trust with diagnosed COPD will be randomly allocated to a home-based body weight exercise intervention either with or without the blood flow restriction (n=20 in each group). The body weight exercise will consist of five body weight exercises including: sitting knee extensions, standing knee raise, heel-toe raises, bilateral mini-squat behind a chair, and chair rise/sit to stand. In addition to the pre and post intervention visits, the initial two training sessions for both groups will be directly supervised in the research centre. These sessions are to ensure all exercises are performed correctly and safely and the patient become familiar with the exercises and BFR equipment and mobile application, which provides exercise guidance and session recording.

NCT ID: NCT05984797 Recruiting - Cancer Clinical Trials

Integrated Short-Term Palliative Rehabilitation in Incurable Cancer

INSPIRE
Start date: April 18, 2024
Phase: N/A
Study type: Interventional

The goal of this intervention trial is to determine if palliative rehabilitation in addition to usual care is more effective than usual care at improving health-related quality of life in patients with incurable solid cancer.

NCT ID: NCT05984498 Recruiting - Healthy Volunteers Clinical Trials

Understanding Balance Impairment in COPD

Start date: July 17, 2023
Phase:
Study type: Observational

This study is an observational study investigating the mechanisms of balance problems in people with COPD and how COPD impacts them living their daily lives. The main objectives of this study are: - To quantify the relationship between balance and aspects of neuromuscular function in individuals with COPD, and compared to age-matched healthy controls - To understand the lived experience of people with COPD and their carers Participants will attend an appointment at the University rehab lab to: - Complete a balance test - Fill out some questionnaires on mood, health status and balance and falls - Complete some walking tests - Have their body composition measured - Have the function and strength of their leg nerves and muscles tested Researchers will compare people with COPD and healthy controls (older adults without COPD or other conditions known to impact balance) to see if any of the things measured are impacting the balance of people with COPD more than their peers without COPD. - For 10 people with COPD only they will be visited at home to observe how they carry out everyday tasks and 5 of those 10 will have a follow up interview. Researchers will take notes and record interviews and look for similarities and interesting points in the notes and transcripts of the interviews to build a picture of what living with COPD is like.

NCT ID: NCT05984277 Recruiting - Clinical trials for Metastatic Non-small Cell Lung Cancer

A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.

eVOLVE-Lung02
Start date: October 24, 2023
Phase: Phase 3
Study type: Interventional

The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the safety of volrustomig in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 < 50%.

NCT ID: NCT05983068 Recruiting - Dermatitis Atopic Clinical Trials

A Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis

PELISTAD-EX2
Start date: February 22, 2024
Phase: Phase 4
Study type: Interventional

This is a 2-year, open-label, exploratory study with a 4-week screening period and a 104-week treatment phase designed to investigate dupilumab's long-term effect on skin barrier function as measured by transepidermal water loss (TEWL) before and after skin tape stripping (STS) in approximately 48 pediatric participants (aged ≥6 and <15 years at study entry) with moderate-to-severe AD. All eligible participants with AD will be treated with Dupixent® for 104 weeks according to locally approved Dupixent® product label (in country/region where the study is conducted). After the 104-week treatment phase and the last assessment at the End of Treatment (EoT), participants will be followed-up for 4 weeks and an End-of-Study (EoS) visit by telephone at 4 weeks after the EoT visit will end the study for each participant. The maximum duration of the study per participant will be 112 weeks (including screening period). The study population will include approximately 48 pediatric participants with AD for long-term treatment with dupilumab: - Treatment cohort 1 - newly recruited participants with AD (aged ≥6 to <12 years at study entry) - Treatment cohort 2 - any former PELISTAD participants (from the previous 16-week treatment study [PELISTAD/LPS16764] who consent to participate in this long-term study; aged ≥6 to <15 years at entry to this study)

NCT ID: NCT05983029 Recruiting - Clinical trials for Obstetric Anesthesia Problems

Determination of Utility of Intergluteal Cleft as Landmark for Neuraxial Midline in Obstetrics

CLEFT
Start date: December 7, 2023
Phase:
Study type: Observational

Our aim is to investigate whether a novel landmark, the groove between the buttocks or the intergluteal cleft, can facilitate the identification of the neuraxial midline in obstetric patients when compared to ultrasound as the reference standard for the determination of this midline

NCT ID: NCT05981547 Recruiting - Clinical trials for Gestational Diabetes

Patterns and Glycaemic Endpoints for Diagnosing Gestational Diabetes

PAGED-GDM
Start date: November 22, 2023
Phase:
Study type: Observational

Gestational diabetes (GDM) develops during pregnancy and is becoming increasingly common. The condition is associated with adverse outcomes for mother and baby during both the pregnancy and delivery period. This study compares glucose variability (recorded by a continuous glucose monitoring (CGM) sensor) in pregnant women who have been diagnosed with GDM with pregnant woman who do not have the diagnosis but are at high risk. The sensors will be applied to 400 participants around the time of their standard test for GDM, with a randomly selected 60 of these patients forming a sub-group later in the study to assess for progression of high blood glucose. At present, a positive oral glucose tolerance test (OGTT) is used to confirm the diagnosis of GDM but the test can be unreliable leading to potential diagnostic error. CGM devices are used extensively in the management of Type 1 diabetes and GDM, and have also shown potential to be used in the diagnosis of Type 2 diabetes. If this study can demonstrate similar trends in glucose variability between OGTT positive patients and those who are OGTT negative but are at high risk for the condition, then further research into the utility of CGM as a diagnostic alternative or supplement to the OGTT would be indicated. The investigators will recruit 400 patients at high risk for GDM, give them a blinded CGM device, and compare the CGM glucose data with their OGTT result, their initial risk factors for GDM, their pregnancy outcome and their need for treatment. The investigators will use the data to test our hypothesis that a positive OGTT result does not predict hyperglycaemia in pregnancy.

NCT ID: NCT05981482 Recruiting - Stroke Clinical Trials

Visual Perception Difficulties After Stroke

Start date: June 20, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn how well the Oxford Visual Perception Screening (OxVPS) tool can identify stroke survivors with visual perception difficulties. The main aim is to determine the accuracy and utility of the OxVPS compared to the current gold standard assessment in stroke survivors. In other words, how well can the Oxford Visual Perception Screening tool (OxVPS) identify stroke patients with visual perception problems? Participants will completed the OxVPS and the current gold standards visual perception screening tool.