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NCT ID: NCT05496101 Recruiting - Clinical trials for Breast Cancer Female

CLI and FAR for Intraoperative Margin Assessment

CLI-FAR
Start date: November 21, 2022
Phase: Phase 2
Study type: Interventional

This study is a prospective, single arm interventional study to evaluate the diagnostic accuracy of intraoperative Cerenkov luminescence imaging (CLI) plus flexible autoradiography (FAR) using the LightPath® Imaging System for intraoperative tumour margin assessment compared to post-operative standard-of-care histopathology in women undergoing breast-conserving surgery for breast cancer.

NCT ID: NCT05495412 Recruiting - Clinical trials for Respiratory Tract Infections

Rebound for Respiratory in School Aged Children and Young People With Neurodisability

RforR
Start date: March 25, 2022
Phase: N/A
Study type: Interventional

Background: Respiratory illness is the most common reason to attend primary and hospital care in children with neurodisability, accruing significant healthcare costs. Moreover, it remains the primary cause of death in this population. Exercise plays an important role in the prevention and management of respiratory illness in children with neurodisability. Rebound therapy is a popular form of therapeutic exercise using trampolines to facilitate movement. It is highly accessible for children with complex neurodisabilities and has been shown to improve muscle tone, balance, sitting posture, behaviour and quality of life. Additional chest health benefits have been observed in other populations, but has yet to be established in children with neurodisability. Aim: This clinical study seeks to explore the impact of community-based rebound therapy on chest health outcomes in school-aged children and young people with complex neurodisability and respiratory issues. Method: A single case study ABA design, inviting 4-6 children with neurodisability and respiratory issues to participate. The study will comprise of: Phase A: 6-week observational baseline measures alongside usual care Phase B: 6-week of rebound therapy, delivered twice weekly alongside usual care Phase A: 6-week observational follow up measures alongside usual care. Measurements: 1. Chest health parameters, measured using respiratory rate, cough frequency, time taken to complete chest care, hospital days, emergency days and primary care consultation days 2. Caregiver-reported chest health, measured using the Respiratory Questionnaire for Children with Neurological Impairment questionnaire. 3. Caregiver reported quality of life, measured using the CPCHILD Questionnaire and an optional exit interview at week 18 of the study 4. Posture will be measured using the Chailey Levels of Ability Scale. 5. Adverse Events, measured through safety monitoring of new symptoms, worsening symptoms, hospital days, emergency department days and primary consultation days. 6. Adherence, measured through % attendance to 12 rebound sessions. Data Analysis: For each single case study, serial data will be subjected to within-phase (A) analysis of stability criterion and across phase (AB) analysis. Single outcome measure data will be plotted alongside serial data findings, providing visual analysis and interpretation of trends. The exit interview will provide textual data that will be subject to thematic analysis methods. Anticipated Results: Results will provide early proof of concept data informing the short term effects of exercise-based rebound therapy intervention on chest health, posture and quality of life for children with complex neurodisabilities. A composite of passive respiratory clinical measurements and participant/caregiver-reported outcomes will be proposed, implementing a combination of serial and single measurements to inform feasibility of future hypothesis testing research. The close monitoring of adverse events and adherence will inform safety of intervention prescribed and feasibility of delivering intervention to children with complex neurodisabilities and respiratory impairment.

NCT ID: NCT05495126 Recruiting - Mental Health Issue Clinical Trials

Evaluate Treatment Outcomes For AI-Enabled Information Collection Tool For Clinical Assessments In Mental Healthcare

Start date: February 28, 2023
Phase: N/A
Study type: Interventional

In the proposed study, the investigators aim to test an AI-prototype which adaptively collects information about a patient's mental health symptoms at the time of referral in order to support and facilitate the clinical assessment.

NCT ID: NCT05494710 Recruiting - Clinical trials for Vascular Malformations

Bleomycin Electrosclerotherapy Treatment of Vascular Malformations: A Feasibility Study

BEST
Start date: December 1, 2020
Phase: N/A
Study type: Interventional

The aim of the BEST study is to examine the feasibility of assessing patient and clinician reported outcome of a single electrosclerotherapy treatment of vascular malformations. - Sclerotherapy = injection of Bleomycin into vascular birthmarks to seal off abnormal vascular channels - Electroporation = application of an electric field to vessels treated with a handheld needle electrode - Electrosclerotherapy = a combination of Bleomycin sclerotherapy and electroporation

NCT ID: NCT05494606 Recruiting - Ulcerative Colitis Clinical Trials

An Observational Study to Assess Change in Disease Activity and Adverse Events of Upadacitinib in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Real-World Practice

PROFUNDUS
Start date: August 15, 2022
Phase:
Study type: Observational

Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed. Upadacitinib is a drug approved for the treatment of Ulcerative colitis (UC). All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1000 adult participants will be enrolled worldwide. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

NCT ID: NCT05493397 Recruiting - Ultrasound Clinical Trials

Ultrasound to Detect Vocal Fold Movement in Neurological Disease

Start date: August 1, 2022
Phase:
Study type: Observational

This study aims to investigate the accuracy and viability of transcutaneous laryngeal ultrasound (US) in detecting impairments of vocal fold movement in people with neurological disorders. The accuracy and viability of laryngeal US compared with reference standard fibreoptic nasendoscopic examination (FNE) will be evaluated. The study also includes measurements of clinician reliability in US image acquisition and interpretation, and assess the acceptability of US assessment to people with neurological disorders. Data will be used to assess the ability of US to detect other laryngeal pathology, and to calculate the sample size required for a validation study.

NCT ID: NCT05492578 Recruiting - Dermatitis Atopic Clinical Trials

Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials

RIVER-AD
Start date: August 22, 2022
Phase: Phase 2
Study type: Interventional

This is a single group, Phase 2, long-term extension study for treatment. The purpose of this study is to characterize the safety and efficacy of amlitelimab in treated adult participants with moderate to severe AD who have previously been enrolled in an amlitelimab clinical trial. Visits during the on-treatment period will be at Week 0, 1, 2, 4 and every 4 weeks (Q4W) thereafter. If remote visits are considered appropriate for participants instead of clinic visits at the timepoints indicated in the schedule of activities (SoA) participants/caregivers/legally authorized representatives (LAR) are allowed to perform participant-injections at home according to the schedule of dosing. This decision is at the discretion of the investigator.

NCT ID: NCT05492500 Recruiting - Heart Failure Clinical Trials

A Study of Ponsegromab in People With Heart Failure

GARDEN TIMI 74
Start date: September 26, 2022
Phase: Phase 2
Study type: Interventional

The primary purpose of this clinical trial is to compare the effects of study medicine (Ponsegromab/PF-06946860) with a placebo (an injection that looks like the study medicine but does not contain the active medicine) to find out if the study medicine is better than the placebo (an injection that looks like the study medicine but does not contain the active medicine) for treatment of symptoms related to heart failure. Participants will not know which treatment group they are assigned to. Most participants in this study will receive the study medicine or placebo by shots under the skin every four weeks. People may be able to participate in this study if they have heart failure. Participants will take part in this study for about 9 months. During this time participants will visit the study clinic once a month. A separate PK cohort within this clinical trial will receive open-label study medicine (Ponsegromab/PF-06946860) only. Participants in this open-label, PK cohort will not receive placebo. These participants will receive the study medicine by shots under the skin every four weeks. People may be able to participate in this study cohort if they also have heart failure. Participants will take part in the open-label, PK cohort for about 7 months.

NCT ID: NCT05492305 Recruiting - Obesity Clinical Trials

Glucagon-like Peptide 1 (GLP1) Receptor Agonists and Mental Health

Start date: September 2022
Phase:
Study type: Observational

This study is investigating the effect of a medication called glucagon-like peptide 1 (GLP1) receptor agonists on mental health. GLP1 receptor agonists are a type of medication that are used to treat obesity and type 2 diabetes (T2D). Obesity and T2D are very common health conditions, and research has shown that people living with obesity and T2D are more likely to experience mental health disorders. Some recent research has suggested that GLP1 receptor agonists might help with mental health problems such as depression and binge eating disorder, and the investigators want to expand on this in this study. The investigators will be recruiting patients from community diabetes services, and tier 3 weight management services in South East London. Patients will be eligible if they are starting on GLP1 receptor agonists for the management of either T2D or obesity. The study is a mixed methods, longitudinal observations study with two components - a quantitative and a qualitative aspect. Firstly, the investigators will be interviewing patients before and 12-16 weeks after starting the medication, using short questionnaires which asks participants about different mental health symptoms that they may be experiencing. The investigators will use this information to see if there are any objective changes in mental health after taking GLP1 receptor agonists. Secondly, the investigators will be conducting a longer semi-structured interview after the second set of short questionnaires (at 12-16 weeks after starting GLP1 receptor agonist), asking about patient's experiences of taking the medication and how it has affected their mental health and general wellbeing. The investigators will qualitatively analyse this data to determine the subjective effect of GLP1 receptor agonists on mental health and wellbeing.

NCT ID: NCT05492201 Recruiting - Healthy Clinical Trials

A Study of LY3873862 in Healthy Participants

Start date: August 11, 2022
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate the safety and tolerability of LY3873862 when administered either in single or multiple doses in healthy participants. The study will also assess how fast LY3873862 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 58, 72, and 72 days for Part A, B, and C, respectively.