Clinical Research Directory

Evaluation of the ADD'Pro Vocational Reintegration Program (ADD-PRO-EVAL)

The goal of this clinical trial is to evaluate whether an integrated medico-psychosocial vocational support program (ADD'Pro) can improve employment outcomes in adults with substance use disorders receiving care at a specialized addiction day hospital. The main question it aims to answer is: \- Does participation in the ADD'Pro program increase the rate of competitive employment (at least one day worked in the open labour market) at 6 months compared to standard employment services? Researchers will compare participants enrolled in the ADD'Pro program to participants referred to conventional employment services (France Travail or Cap Emploi) to see if structured, dual medico-psychosocial support leads to higher rates of vocational reintegration, better employment preparation, improved quality of life, and reduced physiological stress reactivity. Participants will: * Be randomly assigned to either the ADD'Pro program or standard employment services * If assigned to ADD'Pro: receive immediate individualised support from a vocational counsellor (CIP) at the CeCler Association, running in parallel with their hospital addiction care, with no fixed end date * If assigned to standard care: be referred to conventional employment services with monthly follow-up interviews at the hospital, and the option to join ADD'Pro after 6 months * Complete structured interviews and validated questionnaires at inclusion, 3, 6, and 12 months * A sub-sample of up to 50 participants will additionally take part in a simulated job interview stress test (adapted TSST) with salivary biomarker collection and heart rate monitoring at inclusion and 6 months

Bracing After Ankle Fracture

Ankle fractures are common, debilitating and usually treated with immobilisation using a foot-ankle brace (walker). Emerging evidence suggests that a less restrictive brace may reduce recovery time without increasing the risk of complications, and patients tend to prefer ankle stirrups. However, evidence supporting their non-inferiority remains limited and inconclusive. Thus, the aim is assess if an ankle stirrup is non-inferior to a standard walker in reducing pain and function measured by the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after ankle fracture. The hypothesis is that ankel stirrups align better with patients preferenes for less immobilising braces and offer sufficient stability while the fracture heals. Secondarily it may lead to faster recovery of function, return to work and reduced cost. The sample size of a maximum of 1400 patients allow us to assess non-inferiority in age and sex specific subgroups and treatment (surgical or non-sugical). Non-inferiority will be assessed in a pragmatic, multicenter, randomised controlled trial involving Scandinavian orthopedic departments.

Using Integrated Care and Wearable Technology to Evaluate Outcomes of the Shields & Stripes Program for Veterans and First Responders

This study aims to evaluate outcomes from the Shields \& Stripes (S\&S) program - a 12-week, multidisciplinary wellness intervention designed for veterans and first responders. The S\&S program integrates occupational therapy (OT), mental health (MH), physical therapy (PT), and registered dietitian (RD) services to promote recovery, resilience, and performance in individuals who have experienced cumulative stress, trauma exposure, or occupational burnout. This research will use a retrospective mixed-methods observational design to analyze data collected from previous S\&S participants who consent to research use of their de-identified information. No intervention or treatment changes will occur as part of this study. Quantitative data will include biometric information (e.g., sleep, activity, and heart rate variability via Oura Ring), standardized self-report measures (GAD-7, PHQ-9, PCL-5, RAND-36, PSQI, ISI), satisfaction surveys, and laboratory nutrition panels. Qualitative data will include semi-structured interviews with consenting participants and S\&S providers following program completion. The purpose of the study is to identify patterns of improvement in physical, psychological, and occupational functioning and to explore how integrated, team-based care supports holistic recovery. Findings may inform the development of future evidence-based wellness programs for military and first-responder populations. Participation involves minimal risk, and all data will be de-identified before analysis.

The Effect of a Bioactive Fabric Sleeve

In-season pitch volume have been shown to relate to arm soreness in collegiate baseball players. Arm soreness is a common ailment following a pitching appearance due to the adaptation to soft tissue in response to a repetitive load to the throwing arm. Specifically, ongoing and accumulated fatigue and soreness to the flexor pronator mass region of the arm may be a predecessor for UCL injury. Different recovery modalities such as a bioactive fabric sleeve may give pitchers a recovery advantage throughout a baseball season. The primary purpose of this study is to determine if there is a difference in subjective soreness of the flexor pronator mass the day following a game pitching appearance using a sleeve with bioactive fabric which potentially improves cellular function versus a control sleeve.

The RECOVER Study - Postpartum Recovery of Pelvic Floor Structures and the Impact of Early Rehabilitation

The goal of this observational study with an embedded pilot clinical trial is to learn how the pelvic floor recovers after vaginal childbirth and whether early individualized pelvic floor muscle training can improve recovery in people who experience pelvic floor symptoms after vaginal delivery. The main questions it aims to answer are: * How do pelvic floor muscles and surrounding tissues change and recover during the first year after vaginal childbirth? * How are these structural changes and their recovery related to urinary, bowel, and vaginal symptoms? * In participants with pelvic floor symptoms after vaginal childbirth, does early individualized pelvic floor muscle training improve symptoms and support structural recovery compared with usual care? Researchers will compare participants who receive the early pelvic floor muscle training to those receiving standard postpartum care to see if the training helps improve pelvic floor function and reduce symptoms. Participants will: Attend clinic visits at six weeks, and six months after childbirth Complete questionnaires about urinary, bowel, and vaginal symptoms, as well as physical activity and quality of life at six weeks, and four, six months, and twelve months after childbirth Undergo clinical pelvic floor assessments, including vaginal palpation of muscle strength, tone, and perineal body stability Have ultrasound examinations of the pelvic floor to assess muscle structure, tissue integrity, and perineal body morphology For those in the pilot trial, participate in an early, individualized pelvic floor muscle training program This study will provide important information about how the pelvic floor heals after childbirth, how structural changes are linked to symptoms, and whether early personalized training can help prevent long-term problems.

The Effectiveness and Efficacy of an Online Cognitive Behavioral Psychotherapeutic Program

An online group cognitive behavioral psychotherapeutic program will be offered to patients with cystic fibrosis and to caregivers by the Hellenic Cystic Fibrosis Association. These 2 above therapy groups will be compared with control groups in a randomized controlled trial

Evaluating the Feasibility, Acceptability, and Preliminary Outcomes of Heart Rate Variability Biofeedback for Individuals With Opioid Use Disorder.

The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary outcomes of a heart rate variability biofeedback (HRVB) intervention among adults with opioid use disorder (OUD) receiving residential treatment. The study aims to learn whether HRVB can be implemented successfully in this setting and whether it may help participants manage stress, emotional regulation, and cravings. The main questions this study aims to answer are: Is HRVB feasible and acceptable for adults with OUD in a residential treatment program, as indicated by recruitment, retention, adherence, and participant satisfaction? Do participants show preliminary improvements in stress, affect, emotional regulation, self-efficacy, and cravings following participation in the HRVB intervention? Participants will be adults with OUD enrolled in a residential treatment program. Participants will: 1. Complete baseline and post-intervention questionnaires assessing stress, affect, emotional regulation, social support, self-efficacy, and cravings 2. Participate in daily HRVB practice using a portable biofeedback device for approximately 3 weeks 3. Complete brief daily diary assessments related to mood, stress, and cravings This is a single-arm pilot study designed to inform the feasibility and future refinement of HRVB as an adjunct intervention for individuals with OUD in residential treatment settings.

Impact of Haskap Berries on Recovery From High Intensity Resistance Training

The purpose of this clinical trial is to determine how certain food items affect oxidative stress, inflammation, and performance recovery from exercise induced muscle damage in a resistance trained population. The main questions The investigators aim to answer are the following: * Do Haskaps speed the recovery of oxidative stress and inflammation markers after an intense lower body workout in resistance trained adults? * Do Haskaps speed the recovery of performance measures after an intense lower body workout in resistance trained adults? * The data collected in this investigation may also be used to ask additional questions not yet identified. For example, the investigators may use the stored samples to evaluate how the blood metabolites of participants differ before and after intense exercise. These additional questions are called secondary analyses. Please note that no genetic analysis will be conducted and racial and ethnic differences among participants will not be used in any secondary analyses. Researches will compare Haskap juice to a color, flavor and carbohydrate matched placebo to see if Haskaps speed recovery in inflammation, oxidative stress and performance. * Participants will be asked to drink either Haskap juice or placebo and follow a low polyphenolic diet * Participants will perform an intense resistance workout * Participants will have their blood drawn before and after the workout * Performance will be analyzed at 24, 48 and 72 hours after the workout

Effects of Root Extract Ashwagandha (KSM-66) on Physiological Stress, Perception of Recovery and Muscle Strength in Youth Elite Footballers

This trial examines if six weeks of taking 450 mg Ashwagandha root extract affects exercise performance and recovery in youth male elite football players. Ashwagandha root extract is increasingly used by athletes, but controlled research in adolescent athletes is limited and the majority of evidence is in an adult population. This study will assess short-term responses in youth players. Participants will be randomly assigned to take either Ashwagandha root extract or a placebo once daily for six weeks. Players will complete training-based tests, provide saliva samples and complete a short, validated questionnaire on perception of wellness. Any adverse events will be documented and reported.

Effect of Blood Flow Restriction on Recovery After Maximal Resistance Exercise

Resistance training has been widely performed due to its health benefits. However, performing this training at high intensity causes significant muscle stress, leading to fatigue and compromising performance. It is essential to implement effective recovery strategies to optimize physiological adaptations. Among the accessible techniques, blood flow restriction (BFR) has shown promise for its potential to accelerate muscle recovery.

Romanian Validation and Cross-cultural Adaptation of the QoR-15Ro

Optimal postoperative recovery after any surgical procedure requiring anesthesia is essential to achieving high-quality care. The Quality of Recovery questionnaire (QoR-15) was validated by its authors in 2013 in the study "Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15." This instrument enables a comprehensive evaluation by integrating traditional physiological measures with the patient's subjective perception of their health status. With the consent of the original author, the present study aims to validate the Romanian version of the questionnaire and adapt it to our clinical environment.

An Evaluation of the WHO QUAlityRights Program

The World Health Organization's (WHO) QualityRights (QR) program offers assessments and recommendations to help mental health facilities, on a voluntary basis, improve their care practices towards better respect of the rights of service users. The aim of this study is to evaluate the QR program in a French national context. The main questions it aims to answer are: * Does the QR program improve perceived satisfaction with care among mental health service users? * What are the implementation procedures of the program? * What is its budgetary impact? Researchers will compare the QR program intervention with usual practices.

Ashwagandha (Withania Somnifera) and Its Effects on Recovery Perceived and Muscle Strength in Male Handball Players

This study aims to assess the potential recovery and strength effects of male handball players.

Cheers Health Restore Study

This observational cohort study, sponsored by Cheers Health and conducted by Principal Investigator Dr. Nirav Shah, aims to evaluate the potential role of Cheers Restore in supporting sleep quality, physiological recovery, and next-day well-being following alcohol consumption in healthy adults. Over a 6 week period, the study will utilize wearable devices and self-reported outcomes captured via the Alethios platform to assess real-world responses to use of Cheers Restore. Outcomes will be compared across three behavioral conditions: (1) alcohol consumption followed by Cheers Restore use, (2) alcohol-only nights without use of Cheers Restore, and (3) non-drinking nights.

Optimized Recovery After Trauma in Geriatric Patient

Currently, there is evidence that structured care within the healthcare system increases the conditions for good care and better recovery. We want to investigate whether a new care concept (gero-ERAT) that combines two variants of structured care can improve the recovery of elderly patients affected by a physical trauma. Our hope is that the project will reduce the complications, short care times, fewer re-admissions and that more patients can return to regular living, which reduces the suffering for the patient and his relatives. In addition to patient benefit, a successful outcome will also result in reduced costs for healthcare and society as a whole. The concept of care is based on an increased patient participation, which is in line with the values of the Västra Götaland region and the Sahlgrenska university hospital Through the PhD project, four studies will be published. A qualitative interview study to investigate patients' experiences of care and recovery after trauma. After that, a prospective cohort survey of two groups is carried out; conventional care and gero-ERAT. Data will begin to be collected in the control group and when the control group is full geroRATAT will be implemented in the care department and we then collect data in the intervention group. Based on collected data, we will publish two additional studies one with a focus on health economics as well as one focusing on care time and recovery based on age and harvest estimation.

Evaluation of a New Recovery-oriented Model of Psychiatric Inpatient Care

This project will study the effects of a major reorganization of psychiatric inpatient wards. This reorganization will affect many aspects of day-to-day work, with the aim of improving the individualization of care, the integration of relatives and the participation of the patients in treatment planning. This new organization will initially involve a first pilot ward, before being extended to other wards. The aim of this project is to understand whether this new organization has positive effects on the use of coercive measures, the average length of stay, the improvement in patients' clinical condition, as well as on patient satisfaction, their perception of coercion, the wards' atmosphere on the unit and patients' personal recovery. All patients admitted to three wards of the Division of adult psychiatry of the Geneva University Hospital aged 18 and over, with a good knowledge of French and being treated for any type of diagnosis except dementia, are invited to take part in the study. They will be assessed at discharge regarding the selected outcomes. The study will last 18 months: during the first 9 months, the new model will be applied on the pilot ward, and the wo other wards will serve as comparison wards. After 9 months, the model will also be applied to these other two wards.

HMB and Exercise-induced Muscle Damage

The study aims at assessing the influence of β-hydroxy-β-methylbutyrate (HMB) supplementation (4.0 g/day) supplemented for 7 days in a group of speed-strength trained individuals on lower-body strength performance, selected muscle histological, molecular and blood markers of muscle recovery in response to resistance exercise-induced muscle damage.

Dundrum Forensic Redevelopment Evaluation Study: D-FOREST Study.

The DUNDRUM Forensic Redevelopment Evaluation study (D-FOREST study) is a multi-site comprehensive evaluation of a complete National Forensic Mental Health Service. The study will have a prospective, observational, longitudinal design which will permit the evaluation of benefit over time for individual patients, groups of patients and the evaluation of the benefit in terms of service based outcomes of the redevelopment of a complete National Forensic Mental Health Service e.g. effects on waiting list times, length of stay. The study will systematically evaluate multiple domains of recovery in a complete National Forensic Service, including patients' physical health, mental health, offending behaviours and social and occupational functioning.