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NCT ID: NCT05684237 Enrolling by invitation - Myopia Clinical Trials

Using the VisuMax Femtosecond Laser System to Perform SMILE Optimized for Presbyopia by Modulation of Postoperative Spherical Aberration

Start date: October 13, 2023
Phase: N/A
Study type: Interventional

The intended purpose of the investigational device in the study is the correction of myopia and myopia with astigmatism in the CE (Conformité Européene) approved range and optimized for presbyopic patients using the treatment option HiSMILE, installed on the VisuMax femtosecond laser.

NCT ID: NCT05683795 Enrolling by invitation - Rectal Cancer Clinical Trials

PelvEx - Beating the Empty Pelvis Syndrome

Start date: January 3, 2023
Phase:
Study type: Observational

The empty pelvis syndrome is an unsolved and poorly defined problem severely affecting patients that have pelvic exenteration surgery, and also the teams looking after them. It is unclear what the anatomical and pathophysiological causes of the empty pelvis syndrome are, how it can be prevented, and how its sequelae can be measured. The evidence to guide decisions around the empty pelvis syndrome is of low quality, and so there is a large amount of variation in approaches between different hospitals. This consensus study will define a core outcome set for the empty pelvis syndrome, and establish current levels of consensus on pathophysiology and mitigation of the empty pelvis syndrome through a modified-Delphi process involving both healthcare professionals and patient representatives.

NCT ID: NCT05672017 Enrolling by invitation - Dietary Behaviour Clinical Trials

Sweet Consumption and Subsequent Sweet Food Preferences and Intakes

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

This study will assess the effects of repeated sweet versus non-sweet food consumption on subsequent sweet and non-sweet food preferences and intakes.

NCT ID: NCT05668520 Enrolling by invitation - Huntington Disease Clinical Trials

A Pilot Study of Nutritional Status in Patients With Huntington's Disease

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

It is known that weight loss is a poor prognostic marker in HD, but it is not known which dietary interventions are optimal at different stages of the disease. Current guidelines for HD treatment are informed only by studies in people with other causes of weight loss. Our long term goal is to create the evidence base for improved nutritional management in HD. This study will pilot the tools to inform the development of clinical trials protocols. We want to know which measures can be used by patients manifesting obvious clinical features of HD, and which are most helpful in detecting clinically meaningful changes in nutrition status.

NCT ID: NCT05647226 Enrolling by invitation - Clinical trials for Diabetes Mellitus, Type 2

Digital Diabetes Remission Trial

DIGEST
Start date: January 9, 2022
Phase: N/A
Study type: Interventional

This is a multicentre, open-label Randomised Controlled Trial run in the United Kingdom. The main aims are to assess whether the Habitual Remission Programme (digital therapeutics + 12-week 800kcal/day low-energy diet, delivered remotely) is more likely to lead to weight loss and remission in adults with type 2 diabetes, when compared to standard of care.

NCT ID: NCT05626751 Enrolling by invitation - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)

Start date: November 4, 2022
Phase: Phase 2
Study type: Interventional

Primary Objectives: 1. The primary efficacy objective is to assess the efficacy of 52 weeks of open-label treatment with HZN-825 in participants with diffuse cutaneous systemic sclerosis, as measured by change from both baselines in forced vital capacity percent (FVC %) predicted. 2. The primary safety objective is to examine the safety and tolerability of 52 weeks of open-label treatment with HZN-825, inclusive of, but not limited to, adverse events (AEs), serious AEs (SAEs) and the adverse event of special interest (AESI), from Day 1 to 4 weeks after last dose.

NCT ID: NCT05623332 Enrolling by invitation - Endometriosis Clinical Trials

DETECT (Detecting Endometriosis inTEgrins Using teChneTium-99m Imaging Study)

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

Endometriosis is a common gynaecological disease affecting 10% of the female population due to the presence of uterus-like tissue outside of the uterus, often in the pelvis. The disease causes severe lower abdominal pain mostly during the monthly period, during or after sexual intercourse, and when emptying the bowel and bladder. Currently, imaging methods such as ultrasound are ineffective at diagnosing the most common type of endometriosis, pelvic endometriosis. Therefore, we are heavily reliant on invasive surgery to make the diagnosis. This study aims to investigate the presence of binding proteins (integrins) in endometriotic tissue which will expand our understanding of endometriosis and could be used as a target to develop a non-invasive imaging test in the future. Women with symptoms consistent with endometriosis, who are due to undergo surgery to diagnose endometriosis at the EndoCare Unit in Oxford, will be eligible to participate. To attempt to visualise the integrins, participants will be asked to attend 2-7 days before their surgery to undergo an imaging scan with a molecular marker that has been found to highlight integrins in other conditions. The possibility of machine learning enhancement of integrin expression will be tested. The findings on the scan will be compared to the findings at surgery. Samples during surgery of endometriosis tissues, the endometrium, and salty water that has been flushed through the uterus, will be analysed in the lab to look for differences in the amount of integrin present in women with and without endometriosis and whether factors such as the phase of the menstrual cycle or hormonal treatment effect the amount seen.

NCT ID: NCT05619783 Enrolling by invitation - Clinical trials for Amyotrophic Lateral Sclerosis

Extension Study Evaluating The Safety And Tolerability of AMX0035

Start date: December 29, 2022
Phase: Phase 3
Study type: Interventional

The primary objective is to evaluate the safety and tolerability of AMX0035 over 108 weeks of open label treatment for participants previously enrolled in Study A35-004 (PHOENIX).

NCT ID: NCT05609201 Enrolling by invitation - Clinical trials for Interstitial Lung Disease

PRospective Evaluation of Interstitial Lung DIsease Progression With Quantitative CT

PREDICT-ILD
Start date: June 1, 2023
Phase:
Study type: Observational

The interstitial lung diseases (ILD) are a heterogenous group of conditions with varying degrees of inflammation and scarring (fibrosis) of the lungs. ILD progression is unpredictable, making prognostication challenging. A proportion of patients will develop inexorably progressive disease termed progressive fibrosing ILD (PF-ILD). Forced vital capacity (FVC), a lung function variable, is routinely used to monitor disease progression. However FVC can be a poor disease marker as it can be influenced by patient effort and can be difficult to perform. High resolution computed tomography (HRCT) is a necessary investigation for suspected fibrotic-ILD, making it a promising tool for research. A quantitative-CT (qCT) approach uses computer software to analyse HRCT scans and has advantage over visual radiologist assessments which are limited by inter/intra-observer variance. The investigators will undertake a feasibility study to determine whether baseline and longitudinal qCT can predict and quantify disease progression in fibrotic-ILD. The endothelial glycocalyx (EG) is a mesh-like layer that lines the small blood vessels. Injury to this layer has been implicated in non-thoracic fibrotic diseases. Telomeres are repetitive genetic sequences which cap chromosomes preventing their damage during cell replication. Prematurely shortened leucocyte telomere lengths (LTL) have been demonstrated in a wide range of ILDs. We will evaluate role of measuring EG health and LTL in disease prognostication. Adult participants with fibrotic-ILD from 3 centres in England will be recruited alongside healthy controls. Case (disease) participants will undergo investigations at 0, 6 and 12 months from recruitment including: - HRCT with quantitative analysis (qCT) - Lung function testing - EG and LTL measurement - Health related quality of life assessments The primary outcome will assess the correlation of disease progression status measured by standard of care (FVC) with baseline qCT and EG assessment. Healthy controls will only undergo EG assessment at all time points. Feasibility outcomes will be assessed including recruitment, consent and attrition rates. The results will inform a subsequent multi-centre study to assess the clinical benefit of disease monitoring with the measures assessed in this study.

NCT ID: NCT05604170 Enrolling by invitation - Clinical trials for Tuberous Sclerosis Complex

Open-label Study of Adjunctive GNX Treatment in Children and Adults With TSC-related Epilepsy

Start date: May 16, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, global, open-label extension (OLE) study of adjunctive GNX treatment in children and adults with TSC who previously participated in either Study 1042-TSC-3001 or Study 1042-TSC-2001