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NCT ID: NCT05676567 Recruiting - Knee Osteoarthritis Clinical Trials

Golf After Orthopaedic Surgery: A Longitudinal Follow-up (GOLF) Study

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

Aims The primary aim of this prospective, multi-centre study is to describe the rates of returning to golf following hip, knee and shoulder arthroplasty in an active golfing population. Secondary aims will include determining the timing of return to golf, changes in ability, handicap, and mobility, and assessing joint-specific and health-related outcomes following surgery. Methods This is a multi-centre, prospective, longitudinal study between the Hospital for Special Surgery, New York City and Edinburgh Orthopaedics, Royal Infirmary of Edinburgh, United Kingdom. Both centres are high-volume arthroplasty centres, specialising in upper and lower limb arthroplasty. Patients undergoing hip, knee or shoulder arthroplasty at either centres, and who report being golfers prior to arthroplasty will be included. Patient-reported outcome measures will obtained at 6 weeks, 3 months, 6 months and 12 months. A one-year period of recruitment will be undertaken of arthroplasty patients at both sites. Conclusions The results of this prospective study will provide clinicians with accurate data to deliver to patients with regards to the likelihood of return to golf and timing of when they can expect to return to golf following their hip, knee or shoulder arthroplasty, as well as their joint-specific functional outcomes. This will help patients to manage their postoperative expectations and plan their postoperative recovery pathway.

NCT ID: NCT05675618 Recruiting - Knee Osteoarthritis Clinical Trials

Return to Golf After Orthopaedic Surgery

Start date: January 9, 2023
Phase:
Study type: Observational

The GOLF study is a multicenter, prospective study with the goal to investigate golfers' return to the sport following hip, knee or shoulder arthroplasty. The prevalence of return to golf, by level of returning to golf will be assessed at 6 weeks, 3 months, 6 months, and 12 months postoperatively. Patients who are active golfers undergoing joint replacement will be identified from outpatient clinics and pre-assessment clinics and given information about the study at least two weeks prior to surgery. Participants in this study must have a desire to return to golf after surgery. Previous studies have only been able to report the return to golf after arthroplasty retrospectively; the prospective nature of this study will allow for a greater understanding of this process.

NCT ID: NCT05674929 Recruiting - Clinical trials for Alcohol Use Disorder

An Open-Label, Single Dose Study in Patients With Alcohol Use Disorder

Start date: May 30, 2023
Phase: Phase 2
Study type: Interventional

An open-label, Phase 2a study to evaluate the safety, tolerability, and pharmacodynamic effects of a single intranasal dose of BPL-003 combined with relapse prevention psychological support, to explore the potential effects on alcohol use and related symptoms in patients with Alcohol Use Disorder.

NCT ID: NCT05673499 Recruiting - Clinical trials for Congenital Disorders

International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery

Start date: August 12, 2022
Phase:
Study type: Observational

The goal of this observational study is to determine the incidence of perioperative cerebral desaturation in neonates undergoing surgery for congenital malformations. The main questions it aims to answer are: 1. The perioperative factors associated with occurrence of cerebral desaturation 2. The association between perioperative cerebral desaturation, perioperative/hospital outcomes, and physiological conditions. Participants will undergo Near-infrared spectroscopy (NIRS) and electroencephalogram (EEG) monitoring for one hour before surgery, during surgery, and up to 24 hours after surgery.

NCT ID: NCT05673278 Recruiting - Ulcerative Colitis Clinical Trials

Non-Invasive Monitoring Through Bowel Ultrasound in Paediatric Inflammatory Bowel Disease Study

NIMBUS
Start date: May 1, 2023
Phase:
Study type: Observational [Patient Registry]

Rates of inflammatory bowel disease (IBD) are increasing rapidly in children and young people, and targets for management are becoming more demanding, with better control of disease to prevent complications, cancers and surgeries. This project "Non-Invasive Monitoring Through Bowel Ultrasound in Paediatric Inflammatory Bowel Disease" or NIMBUS study will aim to explore the possibility of using ultrasound to examine inflammation in this group. Monitoring inflammation in this population currently is done with regular endoscopy (camera tests) and/ or MRI enterography scans which are invasive, can be uncomfortable, expensive and may have long waiting lists. These studies also require bowel prep, in the form of laxative medicines which can be distressing and cause time off from school. Direct visualisation through ultrasound could allow better monitoring of disease, and is quick, accurate, non-invasive and relatively low-cost. This could also allow for more appropriate medication use and a decrease in over/under use of medicines. This study will aim to recruit 50 children and young people with inflammatory bowel disease. Each child will have an ultrasound scan after enrolment and the investigators will use the information from these scans, as well as routine blood tests (already taken in normal care) and follow up medical information to explore the use of ultrasound in this group. The investigating team will aim to contribute to the global discussion around this topic and if results are positive will aim to improve monitoring for this population managed at the Noah's Ark Children's Hospital for Wales.

NCT ID: NCT05673187 Recruiting - NSCLC Stage IV Clinical Trials

Adagrasib in Patients With KRASG12C-mutant NSCLC Who Are Elderly or Have Poor Performance Status

ADEPPT
Start date: June 12, 2023
Phase: Phase 2
Study type: Interventional

ADEPPT is an international, multicentre, single-arm phase II trial. The protocol treatment consists of adagrasib, which is administered at a dose of 600 mg orally, twice daily until progression or unacceptable toxicity.The primary objective of this trial is to assess the clinical efficacy of adagrasib treatment, in terms of objective response, in patients with KRASG12C-mutant NSCLC, including the elderly (≥70 years) or patients with poor performance status (ECOG PS=2).

NCT ID: NCT05671562 Recruiting - Clinical trials for Total Motile Sperm Count

The Effect of Lycopene on Sperm Quality in Men Attending Fertility Clinic

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

The goal of this clinical trial is to test whether lycopene (an antioxidant found in cooked tomatoes) will improve the number of swimming sperm in the ejaculates of men with low total motile sperm count. Participants will take either lycopene capsules or identical capsules containing no lycopene for 12 weeks. We will analyse the quality of their semen before and after taking the capsules, and compare the results. Hypothesis: Supplementation with lycopene will improve testicular function (semen quality) in males with low total motile sperm count (TMSC).

NCT ID: NCT05671510 Recruiting - Clinical trials for Non Small Cell Lung Cancer

ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors

PRESERVE-003
Start date: June 28, 2023
Phase: Phase 3
Study type: Interventional

The goal of this Phase 3 clinical trial is study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could prolong the life for NSCLC patients. Patients will be randomized to be treated with either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in approximately one year.

NCT ID: NCT05670314 Recruiting - Clinical trials for Osteoarthritis, Knee

lIfestyle iNterventionS for PaIn ReliEf (INSPIRE)

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

This pilot study will be a placebo controlled randomised intervention study in which participants with knee pain will be grouped into the diet intervention, exercise intervention, diet and exercise intervention or placebo arm. The study involves intake of dietary supplements and performing routine exercises which are commonly used and are not pharmacological agents. The end-points of the study are non-clinical outcomes. N= 120. 2x2 intervention with 30 individuals per block: placebo, diet only, exercise only, diet + exercise

NCT ID: NCT05670197 Recruiting - Schizophrenia Clinical Trials

Service User and Staff Views on Digital Remote Monitoring for Psychosis

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

Psychosis is a severe mental health problem. Symptoms of psychosis include hallucinations (e.g. hearing voices that others cannot hear) and delusions (unusual, often troubling beliefs). People who experience psychosis often have times when their symptoms are relatively stable. At other times, their symptoms may increase and become much more problematic (a 'relapse'). Helping people with psychosis to stay well (preventing relapses) is an important and time-consuming challenge for mental health services. Smartphones and other digital technologies are now widespread. This offers a solution to help tackle the overwhelming demand on services and to enable people with psychosis to access mental health support when they need it most (e.g. when relapsing). Research shows that people with psychosis are often willing to report their symptoms using a smartphone app. Apps like this can alert health professionals when someone needs extra support, but can be burdensome to use long-term. The investigators want to make a system that is less burdensome and is personalised to users' needs and experiences (a 'complex digital remote monitoring system'). Recent research shows that information gathered routinely by individuals' smartphones (e.g. GPS, step count) might help predict relapses of psychosis. The investigators want to use this method in a complex digital remote monitoring system. First, the investigators need to know what people with psychosis and mental health staff think about this idea. The investigators will interview around sixty adults with psychosis and around forty staff, recruited from UK mental health services (Manchester, Glasgow, Edinburgh, Cardiff, London, Sussex). These one-off, audio-recorded interviews will last up to 60 minutes. The interviewer will ask about participants' views on complex digital remote monitoring. The investigators will then systematically analyse the interviews. Findings will inform the design of the investigators' own complex digital remote monitoring system and future digital tools designed by other researchers. NIHR and Wellcome are funding this study.