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NCT ID: NCT06025240 Not yet recruiting - Frailty Clinical Trials

Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients

HLA-AB
Start date: September 1, 2023
Phase:
Study type: Observational

The purpose of this study is to assess a new test to detect antibodies which may form following kidney transplant. These antibodies can be difficult to detect as they do not cause any symptoms but can lead to kidney damage. A new blood test will be performed alongside existing antibody tests to see how well the test functions in comparison and to see how well it is able to distinguish between inflammation caused by antibodies and other sorts of inflammation such as a urinary tract infection. The investigators also want to determine whether it is predictable whom will develop antibodies after a transplant and use these results to change the current way patients are monitored for antibodies after receiving a transplant. In addition to this, the investigators want to establish if patients over 60 years of age are relatively protected against immunological events such as rejection compared to patients who are under 60 years of age. The results could potentially lead to using a different immunosuppression regime based on which population age group patients belong to and lowering the risks associated with these drugs.

NCT ID: NCT06025110 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

A Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients

STRIDE
Start date: January 23, 2023
Phase: Phase 2
Study type: Interventional

The goal of this study is to determine if treatment with TCD601 improves beta-cell function in adults recently diagnosed with type 1 diabetes compared to placebo.

NCT ID: NCT06024681 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Impact of FMT on the Phenome in Patients With NAFLD and Fibrosis

Start date: July 20, 2021
Phase: N/A
Study type: Interventional

The goal of this pilot experimental medicine interventional study is to explore the degree of transferability of the gut microbiome and associated metabolomic changes in patients with non-alcoholic fatty liver disease (NAFLD) and fibrosis who receive faecal microbiota transplant (FMT). The main questions is aims to answer is: - To what extent is the gut microbiome transferable from donor to recipient in patients with NAFLD with fibrosis who receive FMT? - What are the dynamics of how the gut microbiome changes over time in these patients? - To what degree does the recipient metabolome change in association with this? Participants will receive up to three capsulised FMT preparations prepared from a donor selected rationally based upon their metabolomic characteristics. They will be asked to attend for serial clinical assessments (including FibroScan and MRE/ MRI-PDFF), and will also be asked to provide serial blood, urine and stool samples for assessment of microbiome and metabolome profiling.

NCT ID: NCT06023589 Recruiting - Asthma Clinical Trials

A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma

HORIZON
Start date: August 24, 2023
Phase: Phase 3
Study type: Interventional

To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.

NCT ID: NCT06022991 Recruiting - Premature Birth Clinical Trials

Fathers and Partners in Family Integrated Care Study

TARGET
Start date: November 1, 2022
Phase:
Study type: Observational

AIMS: The primary aim is to investigate the impact of enhancing father/partner engagement in FICare of preterm infants on their mental health (MH) up to 6 weeks post discharge. Secondary aims are to investigate the impact on maternal MH. METHOD and ANALYSIS: This is a two-phase study: Phase-1 to gather baseline information and Phase-2 to assess the impact of improved father/partner engagement in FICare involving two NUs (a tertiary and level 2). 20 families of infants born at <33 weeks will be studied in each phase (40 fathers, 40 mothers, 40 babies). Father/partner MH will be assessed using validated questionnaires: Generalised Anxiety Disorder Assessment (GAD-7), Patient Health Questionnaire (PHQ-9), Parental Stressor Scale: NICU (PSS:NICU), and by semi-structured qualitative interviews. Similarly, mothers will be assessed by the same questionnaires and focus groups. The Neonatal DadPad materials will be updated using information from phase 1 study, systematic review of Fathers experiences of FICare and advice from parent advisory group. Father's engagement in FICare will be enhanced using Neonatal DadPad information booklet and app, father-specific peer support and bitesize teaching on caring for NU babies (Phase 2). Thematic analysis of the qualitative data will be performed. Phase 1 and Phase 2 study findings will be compared by performing appropriate statistical analysis.

NCT ID: NCT06022848 Recruiting - Migraines Clinical Trials

Quantitative Sensory Testing and Occipital Nerve Stimulator

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

The primary aim of this study is to assess the reversibility of a range of psychophysical markers of pain processing in patients with chronic migraine or cluster headache before and after ONS insertion and comparing to patients having a general anaesthetic (GA) for a non-painful aetiology at Barts Health NHS Trust. We will also compare with healthy volunteers not undergoing surgery. To establish whether pain perception alters in patients with chronic migraine/cluster headache having ONS using questionnaires and compare to patients having a general anaesthetic for a non- painful procedure D & C at Barts Health NHS Trust. Are pain markers (Glutamate, TGF-B1) altered with ONS?

NCT ID: NCT06022601 Recruiting - Clinical trials for Gestational Diabetes

Post Delivery Intervention in Women With Previous Gestational Diabetes Mellitus to Improve Glycaemia

Post-GDM-DNA
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

STUDY SUMMARY TITLE Post-delivery intervention in women with previous gestational diabetes mellitus for weight loss, glycaemia and cardiovascular health DESIGN Feasibility study Allocation: RCT AIMS To determine the feasibility of a post-delivery intervention to improve glycemia and cardiovascular function and promote weight loss in women who have had gestational diabetes. OUTCOME MEASURES Primary outcome; Effect of intervention on HbA1c: difference in HbA1c between intervention arm and control arm measured at 12 weeks. Secondary Outcomes; - Adherence to intervention; - Willingness to be randomised to post-delivery intervention; - Process measures to evaluate patient experience of study and intervention; - Participants' preferred time to commence the study, within the start date allowance of 6 weeks - 6 month post-delivery. - Between-arm differences and within-arm differences to evaluate: - Effect of intervention on HbA1c at 12 and 24 weeks - Effect of intervention on weight and BMI at 12 and 24 weeks - Effect of intervention on systolic and diastolic blood pressure at 12 and 24 weeks - Effect of intervention on lipid profile (total cholesterol, HDL, LDL) at 12 and 24 weeks - Effect of intervention on physical activity at 12 and 24 weeks POPULATION We will recruit 50 women aged 18-45 with previous gestational diabetes and randomise them to 1 of 2 arms to commence study at 6 weeks - 6 months post-delivery. Women starting the study at 13 weeks post-delivery will have their routine post-delivery HbA1c act as baseline HBA1c. ELIGIBILITY Pregnant women with gestational diabetes (women will be given the option to start the study between 6 weeks and 6 months post-delivery) or women who have given birth in the last 12 months and had gestational diabetes during that pregnancy; aged 18-45; and access to a smartphone with an operating system of iOS 9.0 or above, or Android 5.0 or above. DURATION Study duration: 1/4/21-1/9/22. Participant duration: 24 weeks

NCT ID: NCT06022380 Completed - Clinical trials for Mucopolysaccharidosis Type II

Core Outcome Set for Head, Neck and Respiratory Disease in Mucopolysaccharidosis II

COHERE
Start date: September 28, 2020
Phase:
Study type: Observational

The Mucopolysaccharidoses (MPS) are a family of genetic metabolic disorders, caused by specific enzyme deficiencies which result in accumulation of partially degraded glycosaminoglycans (GAGs) within various tissues. As GAGs are common in the body a number of different organ systems can be affected. Involvement of the upper and lower respiratory tract in MPS Type II results in significant airway compromise, with progressive airway obstruction being responsible for a significant proportion of the morbidity and mortality associated with this condition. Hearing loss is a universal finding in MPS, with a third of patients suffering with severe profound hearing loss. There is an unmet need for strong clinical evidence to guide treatment of head, neck and respiratory disease in MPS disorders. A Core Outcome Set (COS) describes the minimum outcome data that should be measured in a clinical study for a particular condition. The lack of an agreed COS for MPS II in general, and specifically head, neck and respiratory disease, makes comparison between studies difficult. There is also a lack of information detailing patient and parent perspectives on the MPS disorders. The ideal COS for head, neck and respiratory disease associated with MPS II would combine both patient/parent and clinician opinion and could be used in the design of all subsequent clinical studies. Following literature review the investigators have created a list of outcomes previously reported for qualitative and quantitative studies investigating head, neck and respiratory disease in MPS II. For the proposed research the investigators will seek opinions of patients, parents, clinicians and scientists to rate these outcomes via the Delphi method. Outcomes scored highest by patients, parents, clinicians and scientists will form a COS for head, neck and respiratory disease in MPS II. The development of a COS can help limit variability outcomes in studies investigating different interventions in MPS II.

NCT ID: NCT06022367 Completed - Clinical trials for Activation Technique in cVEMP Testing

Activation Technique in cVEMPs

ACTIVE
Start date: December 15, 2022
Phase: N/A
Study type: Interventional

This study will investigate two different techniques used for eliciting sternocleidomastoid (SCM) muscle contraction. Sustained contraction of the SCM muscle is necessary for accurate recording of cervical vestibular evoked myogenic potentials (cVEMPs). These responses are used clinically to assess the function of structures within the vestibular system. The British Society of Audiology (BSA) guidelines recommend the head turn and head raise techniques as effective methods for eliciting SCM contraction. However, they do not recommend which technique to employ, leaving that to the discretion of the clinician. The purpose of this study is to determine which activation technique to recommend in the local standard operating procedure on cVEMP testing developed by the Audiology and Vestibular Function Testing service based at the Royal Liverpool University Hospital. Healthy volunteers will be recruited to the study. The study will be conducted at the Royal Liverpool University Hospital, Liverpool, UK. The participants will each be invited to attend one appointment in which they will undergo cVEMP testing, performed using each activation technique in turn. After testing the participants will be asked to complete a questionnaire in which they will comment on their experience of performing each technique and assign each a tolerability rating.

NCT ID: NCT06022315 Recruiting - Clinical trials for Gastrointestinal Hormones

Impact of Macronutrient Composition of Energy-restricted Diet and Exercise on Body Composition and Appetite Hormones.

Start date: September 3, 2023
Phase: N/A
Study type: Interventional

The main aim of this study is to investigate the effect of energy-restricted low and high-carbohydrate diet combined with exercise training on appetite regulatory hormones, subjective appetite and energy intake in overweight and obese women. In addition, since the macronutrient composition of meals and exercise impacts biomarkers of cardiovascular disease, the impact of these interactions on metabolic risk factors of cardiovascular diseases will also be investigated .