There are about 25435 clinical studies being (or have been) conducted in United Kingdom. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
According to the World Health Organization, only 15% of 11-17-year-old girls meet the recommended daily physical movement guidelines (e.g., 60 minutes per day). Despite extensive research highlighting the protective factors associated with sport on both mental and physical health, body image concerns are a key barrier to girls' participation in, and enjoyment of, sport. Sports-related environments and society more broadly further exacerbate these concerns through harmful gender stereotypes that perpetuate female objectification, discrimination, and harassment. This includes the promotion of unrealistic and sexualized appearances of female athletes, uncomfortable and objectifying uniforms, and appearance and competence-related teasing from male and female peers, as well as coaches. The magnitude of this issue and how best to address it can be understood from a socioecological perspective. Researchers suggest developing multi-faceted and multi-tiered approaches that have scope for targeting the individual, interpersonal, organizational, and societal levels. The current research will test the first coach-led body image program for girls in sport. The Body Confident Athletes program was co-created with girls and coaches through an international multi-disciplinary partnership between academics, health professionals, industry, and community organizations. Multi-disciplinary partnerships can create a supportive landscape by upskilling girls and influential community members (e.g., coaches) in dealing with body image concerns, which will likely lead to sustained sports participation and biopsychosocial benefits. As such, the aim of the present study is to conduct a large-scale randomized controlled trial (RCT) to evaluate the effectiveness of the Body Confident Athletes program. The program consists of three 60-minute sessions delivered by coaches to adolescent girls. Each session tackles a distinct theme related to body image in the sport context. Outcomes will be assessed at pre-intervention, post-intervention (three weeks later), and follow-up (at one and three months). Outcomes will include body image and sport enjoyment (primary outcomes); body appreciation, attuned self-care, resisting objectification, and positive and negative affect (secondary outcomes); and intervention acceptability, fidelity, and adherence (process outcomes). The comparison control arm will be a waitlist control condition. To undertake this project, sports organizations will be cluster-randomized into the intervention group or the control group, with 800 girls anticipated in each arm. Those in the intervention condition will complete baseline assessments (target outcomes and demographic information), take part in the three-week intervention, and then complete the post-intervention and follow-up assessments (target and process outcomes). Those in the waitlist control condition will complete the baseline assessments (target outcomes and demographic information), a second assessment three weeks later (target outcomes only), and follow-up assessments after one and three months, after which they will get access to the intervention. However, their engagement with the intervention will not be monitored or assessed. At completion of the post-intervention survey, all participants will receive a debrief form, outlining the study aims and objectives, and support resources for body image and eating concerns. The investigators hypothesize that girls who take part in the Body Confident Athletes intervention will report higher levels of body esteem, sport enjoyment, body appreciation, attuned self-care, resisting objectification, and positive affect and lower levels of negative affect at post-intervention and follow-up, compared to girls who do not take part in the intervention. Note: This research has been approved by the University of the West of England Research Ethics Committee (ref no. HAS.21.03.120) and the University of Minnesota Institutional Review Board (ref no. STUDY00012457).
The purpose of this study is to measure local and systemic safety and tolerability as well as improvement of Achilles tendon mechanical properties after a single peritendon injection of NGI226 MP in comparison to placebo MP in patients with mid-portion Achilles tendinopathy.
Assess the feasibility of performing a RCT comparing videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in men diagnosed with genital cancer requiring inguinal lymphadenectomy, and determine the design of such an RCT.
This study will collect real-world clinical and patient reported outcomes (PRO) and diary data from eligible patients with documented Human Epidermal Growth Factor Receptor 2 (HER2+) [globally] or HER2-low [North America only] in routine clinical practice.
The main purpose of this study is to assess the efficacy and safety of LY3540378 in adults with worsening heart failure with preserved ejection fraction
The goal of this multi-centre, randomised, pilot feasibility study is to assess the feasibility of recruiting intensive care survivors, with symptoms of traumatic stress, to a study evaluating the use of eye movement desensitisation and reprocessing (EMDR). The main purpose is to determine whether it is feasible and acceptable to patients, clinicians and researchers. In addition, this study aims to identify design criteria that may be of use in a subsequent randomised controlled trial of clinical effectiveness. Participants will: - be recruited at hospital discharge - undergo a psychological assessment at 2-3 months post-hospital discharge - Those exhibiting symptoms of post-traumatic stress disorder (PTSD), will be randomised (1:1) to receive either usual care or usual care plus EMDR - Participants who do not exhibit PTSD symptoms at the 2-3 month assessment will enter a light-touch observation arm. - All participants will repeat the psychological assessment 12-months after hospital discharge. Feasibility parameters; recruitment, adherence, retention and safety data. Primary clinical outcomes; change in PTSD symptoms between 2-3 months and 12-months. The investigators will undertake a qualitative process evaluation using clinical ethnography and reported according to the Theoretical Framework of Acceptability.
A post-market registry evaluating the EmboTrap® Revascularization Device and CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.
This is an international, multicenter study with two components: Registry - A standardized genetic screening and a prospective, standardized, cross-sectional clinical data collection - Enrollment is open to all genes on the RD Rare Gene List Natural History Study - A prospective, standardized, longitudinal Natural History Study - Enrollment opens gene-by-gene, based on funding and within-gene Registry enrollment The study objectives are as follows. Registry Objectives 1. Genotype Characterization 2. Cross-Sectional Phenotype Characterization (within gene) 3. Establish a Link to My Retina Tracker Registry (MRTR) 4. Ancillary Exploratory Studies - Pooling of Genes Natural History Study Objectives 1. Natural History (within gene) 2. Structure-Function Relationship (within gene) 3. Risk Factors for Progression (within gene) 4. Ancillary Exploratory Studies - Pooling of Genes
The goal of this single centre observational study is to use near-infrared spectroscopy (NIRS) monitoring to investigate cerebral oxygenation in two groups of newborn infants who are at high risk of brain injury. The NIRS monitor used in this study will be the Masimo O3 regional oximeter with neonatal sensors. Near-infrared spectroscopy (NIRS) monitoring uses near-infrared light to measure oxygen levels in the brain tissue (cerebral oxygenation). It provides information about blood flow to the brain and the balance between oxygen supply and demand in the brain tissue. It is non-invasive, safe and used routinely to monitor term and premature babies in the neonatal intensive care unit (NICU). This study will recruit two groups of infants admitted to the NICU who are at risk of brain injury in the newborn period, namely: - Term and near-term babies who are undergoing cooling treatment (therapeutic hypothermia) for moderate to severe hypoxic ischaemic encephalopathy (HIE). - Preterm babies who are born extremely prematurely (before 28 weeks of pregnancy). In the term/near-term group, the primary aims of the study are: - To investigate if cerebral oxygenation during and after cooling treatment relates to markers of brain injury detected on detailed brain scans (MRI and MRS scans). - To describe any changes in cerebral oxygenation which occur during and after seizures (fits) in babies undergoing cooling treatment. In the preterm group, the primary aims of the study are: - To investigate if any changes in cerebral oxygenation occurring during skin-to-skin care are different in premature babies with brain injury (bleeding or cysts in the brain seen on ultrasound scan) compared to babies without these changes. - To investigate if cerebral oxygenation at 36 weeks corrected gestational age differs in babies with bronchopulmonary dysplasia (BDP, a chronic lung disease of prematurity) compared to babies without BPD.
This is a randomized, double-blind, placebo controlled, dose-ranging Phase 2 study. The primary objective is to evaluate the efficacy and safety of SAR443122 compared to placebo in participants with moderate to severe UC. Dose selection for further clinical development will be based on the multiple efficacy, safety and PK parameters. The study consists of 4 parallel arms (3 dose groups of SAR443122 vs placebo) to assess the efficacy and safety of SAR443122 in participants with moderate to severe UC. All participants will receive a total of 52 weeks (a 12-week induction treatment phase and a 40-week maintenance phase) of study treatment, except if treatment should be discontinued per investigator's assessment. At the end of the first 12 weeks of induction treatment, all participants in clinical response or remission will be offered study treatment up to 40 weeks and will continue with the same blinded treatment that was assigned. Participants who do not achieve clinical response or remission at the end of the initial 12 weeks induction treatment will roll over in an open-label treatment arm and will be treated with SAR443122 at the highest tested dose. In addition, participants from the maintenance treatment that lose clinical efficacy at any time up to V10/Week 40 (Week 28 of maintenance) will be offered to roll over in the open-label treatment arm with SAR443122 at the highest dose.