Clinical Research Directory

Impact of MetaCalm on Stress of Healthy People With Acute Stress

This Open-Label, Non-Randomized Clinical Study involving 280 participants who will undergo a total participation of 6 hours.

Comparative Effects of Scooping Mobilization and Dynamic Cupping Therapy on Elbow Stiffness

The current study is a randomized clinical trial, data is collected from Alqamar Hospital Shakarghar. The study includes 28 patients equally divided into two groups and randomly allocated. Inclusion criteria for the study will be children of age group 6-13, children with diagonosis of post fracture stiff elbow minimal immobilized period of 3 weeks. Patients with any neurological impairment, children with MSK disorders, Infection or tumors will be excluded from the study. Experimental Scooping mobilization group will receive scooping mobilization combined with electrotherapy for 2 minutes per session 5 days a week. Experimental dynamic cupping group will receive dynamic cupping therapy combined with electrotherapy for 10 minutes per session 5 days a week. Total intervention period will be of 4 weeks. Data collection will be done before and after the intervention. Tools used for data collection will be Goniometer and Quick DASH Questionnaire. Data will be analyzed through SPSS version 27.00.

Study of LGW16-03 To Identify Nerves

The primary goal of this study is to determine the safety and tolerability of LGW16-03, a novel nerve-labeling fluorophore, in participants undergoing open-field orthopaedic surgery. Secondary goals include: 1) identifying the lowest dose without adverse events that provides peak florescence imaging contrast, and 2) characterizing the pharmacokinetics of LGW16-03. Participants will receive a one-time intravenous infusion of the investigational drug (LGW16-03) prior to their planned surgery. Participants' vitals will be closely monitored and will have blood samples taken at regular intervals. Fluorescence images of their major nerve will be taken during surgery. Participants will have one study follow-up visit approximately 30 days after their surgery.

Cycling-Based Aerobic Exercise Intervention for Individuals With Chemotherapy-Induced Peripheral Neuropathy (CIPN)

CYCLE-CIPN is a proof-of-concept study designed to evaluate whether a prescribed aerobic exercise intervention has the potential to reduce the symptoms and functional impact of CIPN. The small number of participants in the proposed study will allow us to make decisions on the feasibility ("go/no-go") of a future larger-scale trial. The protocol will assess feasibility and acceptability through recruitment, completion, adherence, program satisfaction, and safety. The study will also evaluate CIPN symptoms using both patient-reported and objective outcome measures, as well as fitness and quality of life outcomes. We aim to recruit 30 participants. The Health Research Board of Alberta Cancer Committee has approved this study. Participants will participate in a stationary cycling-based aerobic exercise program biweekly for 12 weeks. Exercise sessions will be supervised and progressive, between 30 and 60 minutes each.

High Phenolic Olive Oil for Enhancing Metabolic Health: a Randomized-controlled Trial in Patients With cEntral Obesity (HOPE)

Olive oil is a fundamental component of the Mediterranean diet and a major source of monounsaturated fatty acids with well-established cardioprotective properties. When rich in phenolic compounds-such as hydroxytyrosol, tyrosol, oleuropein, oleocanthal, oleacein, and ligstroside aglycone-it is considered a functional food with antioxidant, anti-inflammatory, cardioprotective, chemoprotective, and neuroprotective effects. According to EU Regulation 432/2012, daily consumption of 20 g of extra virgin olive oil containing at least 5 mg of hydroxytyrosol and tyrosol derivatives (250 mg/kg) contributes to the protection of blood lipids from oxidative stress and qualifies for a health claim. Overweight/obesity, characterized by excessive fat accumulation, is strongly associated with non-communicable diseases, including cardiovascular disease, type 2 diabetes, hypertension, certain cancers, and neurodegenerative disorders. Chronic low-grade inflammation and oxidative stress are key mechanisms underlying obesity-related metabolic disorders. Although dietary energy restriction remains the primary approach for weight management, growing research interest focuses on natural products rich in phenolic compounds as potential modulators of molecular pathways involved in central obesity. However, robust clinical evidence in humans with central obesity and metabolic abnormalities remains limited. Therefore, this double-blind, randomized, controlled trial aims to investigate the effects of extra virgin, high-phenolic olive oil (HPOO) compared with low-phenolic olive oil (LPOO) in adults with overweight/obesity with metabolic abnormalities. Participants will consume the assigned olive oil type (HPOO or LPOO) for eight weeks. At baseline and trial endpoint (8 weeks), data collection will include anthropometric measurements, dietary intake, biochemical indices, inflammatory and oxidative stress markers in blood samples, hormones, bioavailability of phenolic compounds, as well as lifestyle parameters i.e., health-related quality of life, physical activity levels, sleep quality. Ethical approval, informed consent, and data protection procedures will be strictly followed. Statistical analyses will be conducted using SPSS software (SPSS Inc, ΙΒΜ, Chicago, IL, USA). The study is anticipated to explore whether consumption of high-phenolic olive oil favorably modulates markers related to obesity and metabolic abnormalities, while also improving nutritional status and quality-of-life parameters.

Exploring the Feasibility of Using Virtual Reality as an Educational Tool in Chronic Pain Rehabilitation

Introduction: Chronic pain significantly impacts quality of life and requires comprehensive management strategies. Traditional pain education programs are beneficial but often require significant and prolonged patient engagement. Virtual reality (VR) offers a novel approach by creating immersive environments that may enhance the effectiveness of pain education. This protocol outlines a feasibility study to investigate the use of a Virtual Reality (VR) pain education program for people living with chronic pain (PwCP). Aim of the investigation: To evaluate the feasibility and acceptability of delivering a VR pain education program for PwCP. The secondary aim will explore the pre-to-post-test changes in clinical outcomes as proof of concept for a future larger scale investigation. Methods: We will use Reality Health™ as the VR tool to deliver pain science education. The study will be conducted as a single-arm feasibility study using a pretest:posttest design. Fifty PwCP will engage in the six-week Reality Health™ programme. This education programme focuses on the neurophysiology of pain, pain modulation techniques, cognitive-behavioural strategies and guided virtual exercises. Results: Primary outcome measures will include the feasibility, acceptability and safety of Reality Health™ including recruitment, retention, intervention adherence and attrition rates. Secondary outcomes will explore the pre-to-post-test changes in outcome measures relating to pain intensity, pain interference, pain self-efficacy, pain self catastrophizing, quality of life and depression as proof of concept for a future larger scale investigation. Conclusions: Results will establish the feasibility, acceptability and safety of using Reality Health™ in the treatment of chronic pain, informing a future randomised control trial. Ethical approval: Ethics has been granted from University College Dublin's Human Research Ethics Board (HREC-LS-25-868587). Acknowledgements: This work is funded through the Interreg north-west Europe project 'Scale-Up Rehab,'approved and funded by the European Commission \[NWE0100082\]. Disclosures: None. Keywords: Virtual Reality, Chronic Pain, Pain Education, Feasibility Study, Protocol

Turkish Validity-Reliability of the Outcome Expectations For Yoga Scale

Evaluation of the Turkish validity and reliability of the outcome Expectations for Yoga (OEY) Scale, which was developed to evaluate attitudes and beliefs related to yoga practice

Biomarker-estimated Flavanol Intake in Davis (FID)

Flavanols are compounds present in plants, including apples, berries, peaches, cocoa-derived products and certain beverages like tea. Following intake, they are absorbed and broken down into smaller compounds called 'metabolites'. Some of these metabolites are excreted in urine. In this study, we hope to collect urine and examine the metabolites to learn more about the types and amounts of flavanols that people are consuming as part of their usual diet.

PhoRTE® Therapy Efficacy: In-Person Versus Telehealth

This study compares how well voice therapy works when delivered in-person versus through telehealth for older adults with age-related voice problems. Researchers are testing whether Phonation Resistance Training Exercises (PhoRTE®) can be just as effective when delivered remotely as when done face-to-face, which could make treatment more accessible and affordable for seniors. The two primary hypotheses are: 1. Does voice therapy (called PhoRTE®) work as well through video calls as it does face-to-face? 2. Can online therapy be a more accessible way for older adults to get help for their voice problems? Adults aged 55 or older with voice changes and an applicable diagnosis will be randomly assigned to receive either in-person or telehealth therapy, consisting of four 45-minute sessions. After treatment, researchers will measure improvements through: * Changes in voice function * Patient reports about their voice * Scientific measurements of voice quality * Patient satisfaction with treatment * Impact on quality of life The results will help determine if telehealth can be a good alternative to in-person voice therapy, especially important as telehealth coverage may be changing.

Mindfulness Walking Intervention to Enhance Resilience (iWalk)

This study is a randomized controlled trial of the walking meditation intervention (iWalk) program, a multi-component intervention integrating walking meditation, education, and group sessions designed to enhance resilience in individuals with multiple sclerosis (MS). The objectives are to evaluate: 1. Recruitment capability and retention rates, 2. Acceptability and adherence to the intervention, 3. Feasibility of assessment procedures, and 4. Preliminary effects on psychological, physiological, and behavioral outcomes.

Adapting, Implementing and Evaluating the Effectiveness of HARP for People With Disabilities

The Home Hazard Removal Program (HARP) is an effective fall prevention intervention program which targets home hazard identification/removal. In this study the investigators will examine the effectiveness and implementation potential of HARP, adapted for PwD. Investigators will conduct a pilot randomized control trial (RCT) to test the implementation, cost, and preliminary efficacy of an adapted version of HARP for community-dwelling PwD. The single-blinded feasibility RCT will randomize 40 participants to treatment (adapted HARP) and 40 to a waitlist control group. Data on specific types of fall hazards and resulting home modifications as well as falls and fall-related injuries (collected monthly over 12 months) and fear of falling (collected at baseline and 12 months) will inform the preliminary efficacy of adapted HARP among PwD. To ensure usefulness, relevance, and broad dissemination of findings, the investigators will adopt a "designing for implementation and dissemination" approach. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework will guide intervention adaptation, trial design, and future implementation. The Practical Robust Implementation and Sustainability Model (PRISM) guides study development by identifying multi-level contextual factors hypothesized to affect the RE-AIM outcomes.

Impact of Probiotic (UltraFlora® Triplebiotic) on Weight Evolution on People After Discontinuation of GLP-1 Treatment.

This is a randomized, double-blind, double arm study involving 128 participants who will undergo a total participation period of 12 weeks.

Impact of Multivitamin (PhytoMulti®) and a Probiotic (UltraFlora® Balance Probiotic) on Gut Health of People Taking GLP-1 Medication

This is a single-arm, open-label clinical trial involving 100 participants who will undergo a total participation period of 12 weeks.

A Feasibility Randomised Controlled Trial of an Online Exercise Programme for Adults With Cerebral Palsy

Adults with cerebral palsy (CP) often face challenges in accessing exercise programmes that are appropriate for their needs. Barriers such as limited mobility, a lack of tailored options, and restricted access to physiotherapy services can make participation difficult. Exercise is important for improving physical health, mental well-being, and overall quality of life. However, many adults with CP do not have regular opportunities to take part in structured physical activity. This study aims to investigate whether an online exercise programme can serve as an effective and accessible alternative. The main aim of the study is to assess the feasibility of delivering an online exercise programme for adults with CP. Key areas of focus will include demand, implementation, practicality, adaptability, acceptability, and potential benefits to physical, mental, and social well-being. A total of 60 adults with CP will be recruited and randomly assigned to one of two groups (30 participants per group). One group will complete an 8-week online exercise and education programme. The second group will receive the same educational materials during the study and will be provided with information about the home exercise programme after the 8-week intervention period. Data will be collected on attendance, completion rates, engagement with exercises, and any reported adverse events. Health-related surveys will be completed before and after the programme to assess any changes. In addition, a selected group of participants from the intervention group will take part in interviews to provide feedback on their experiences. Findings from this study may support the development of accessible, effective, and person-centred online exercise programmes for adults with CP. Results may help improve future programme design and contribute to better care and support for adults with CP in Ireland.

Pain Science Education for Labour and Postpartum Pain

This Delphi study aims to establish expert consensus on the role, content, and delivery of pain science education (PSE) for labour and postpartum pain management. Despite the growing application of PSE in other populations, its use in maternity care remains underexplored. Through a three-round electronic Delphi survey, multidisciplinary experts-including physiotherapists, midwives, gynaecologists, pain specialists, nurses, and psychologists-will contribute their perspectives to guide the development of a structured PSE intervention for future clinical testing.

Ultra-Long Peripheral Catheter Versus Accelerated Seldinger Technique Long Peripheral Catheter in Difficult IV Access Patients

The aim of this study is to perform a comparative analysis of clinical outcomes associated with the use of an ultra-long peripheral catheter using (catheter-over-the-needle technique) versus an AST-long peripheral catheter in adult patients with difficult intravenous access (DIVA) in a real-world clinical setting. Specifically, the study will assess potential benefits, including longer mean catheter dwell time and improved catheter usability, as well as potential harms, such as increased incidence of catheter-related thrombosis, infections, phlebitis, infiltration, and unplanned catheter removal.

Dexmedetomidine-Esketamine Combination and Sleep Disturbances After Major Noncardiac Surgery

Sleep disturbances are common early after major surgery, and are associated with delayed recovery. A previous study showed that dexmedetomidine-esketamine combination as a supplement to patient-controlled intravenous analgesia improved postoperative analgesia and subjective sleep quality in patients after scoliosis correction surgery. The purpose of this trial is to test the hypothesis that dexmedetomidine-esketamine combination used as a supplement during general anesthesia and postoperative intravenous analgesia may reduce sleep disturbances in adult after major noncardiac surgery.

Pupillometric Evaluation in Patients Declared Brain Dead - a Prospective Quality Control Study

The aim of the study is to verify the reliability of the current purely clinical examination of the pupils (without the support of a pupillometer) in the context of clinically suspected brain death, compared to the results of a non-invasive, automated, and highly precise monocular pupillometric examination.

Digital Art and Artificial Intelligence

The study aims at examining the impact of an immersive and interactive digital application (App) that uses impressionist artworks to promote the mental well-being of both young and older adults. The goal is to study the usability and accessibility of this App, particularly for older adults, who may have sensory impairments and lower digital literacy compared to younger adults. The study is based on the hypothesis that the App, which allows interaction with paintings by Claude Monet and Helen McNicoll, can trigger positive emotions, thereby improving users' well-being. The App uses artificial intelligence to create extensions of the paintings and music based on the sonification of electrophysiological signals captured from plants. The study seeks to answer four research questions: 1. The usage behaviors of young and older adults with the App. 2. The impressions and feedback from users after testing the App. 3. The obstacles and enablers to the App's use. 4. The expectations and needs of users for better use of the App. The study's objectives include analyzing the usage behaviors, impressions, barriers, and needs of both young and older adults. It is a qualitative study based on non-participatory observations and semi-structured interviews with young and older participants who have used the App. The App is based on impressionist artworks, a style known for evoking positive emotions, and aims to promote mental health by harnessing the emotional power of digital art and artificial intelligence.

Turkish Version of Digital Eye Strain Questionnaire (DESQ)

The aims of this study were to perform cultural adaptation of the DESQ and provide information regarding the factor structure, reliability and validity of the instrument in Turkish speaking adults.

ALgerian Cholecystectomy Outcomes and Determinants Study (AL-CODS)

Cholecystectomy, the surgical removal of the gallbladder, is a common procedure performed to treat benign gallbladder diseases such as cholelithiasis (gallstones), cholecystitis (inflammation of the gallbladder), and biliary dyskinesia. While generally considered safe, this surgery can be associated with significant morbidity and mortality, particularly in certain populations or healthcare settings. Understanding these outcomes and the factors influencing them is crucial for improving patient care and surgical practices. In Algeria, the healthcare landscape presents unique challenges and opportunities for evaluating surgical outcomes. Limited studies have specifically focused on the morbidity and mortality associated with cholecystectomy in this context. This study aims to fill that gap by providing comprehensive data on 30-day postoperative outcomes following cholecystectomy for benign gallbladder diseases in Algeria. Such data is essential for benchmarking current practices, identifying areas for improvement, and ultimately enhancing patient safety and surgical efficacy.

Effects of Exercise Therapy and Soft Brace on Knee Osteoarthritis

The primary aim of the study is to investigate the effects of supervised exercise therapy and education on the immediate response to using a soft knee brace in patients with knee osteoarthritis (OA).