Clinical Research Directory

Strength for Caregiving

The goal of this single-arm pre-post study is to promote elderly (≥ 65 years) family caregivers' dietary habits, well-being and functional capacity through comprehensive nutritional guidance. The main goals of the project are to: * Improve the well-being, resilience, and functional capacity of the participating family caregivers through the comprehensive nutritional counseling implemented as part of the project. * Create a nutrition counseling model that promotes the well-being and coping of family caregivers and can also be utilized in well-being services counties after the project concludes. * Produce up-to-date and practical nutrition materials for family caregivers. The project participants will participate in two individual nutrition counselling sessions and three group nutrition counseling sessions over a period of ten months. Researchers will compare the results of the participants' baseline and final measurements to see if nutrition counseling is effective in improving family caregivers' well-being, resilience, and functional capacity.

Assessing the Effectiveness of Digital Wellness Modules on Perceived Quality of Life

The study will examine the role of digital wellness modules (brief mindfulness and light to moderate physical exercise) delivered through a smartphone wellness application and their short-term effects on health behavior motivation and change, and longer-term quality of life and non-pathological affective states.

Physical Activity for Myeloma Autograft Longitudinal Study

Physical exercises program is known to improve quality of life, chronical fatigue and appears to be a behavioural recommendation against cancer as primary and tertiary prevention. Nutritional status is also important in cancer patients: a loss of 5% of weight increases the complication risks and decreases survival and the quality of life. Interactions between physical activity and haematological malignancies are less described compared to solid cancers. Methodology and protocols are also heterogeneous. Supervised exercises program improves the physical condition and the quality of life; however there are few randomised studies versus a controlled group. Post autograft evaluation for myeloma patients showed a physical deficit with increased fat mass, but in this particular population physical exercises need to be more explored. This project is a randomised study versus controlled group that evaluates supervised physical exercises program in a homogenous population: patients under-65-years-old with multiple myeloma and who will undergo autologous stem cell transplantation.

The Impact of Fatigue on Quality of Life and Activities of Daily Living in Pediatric Oncology Patients

This study aims to examine the impact of fatigue on the quality of life and daily living activities of children undergoing cancer treatment.In this cross-sectional study of 89 children aged 2-18 years, fatigue, quality of life, and functional independence were assessed using various scales.The basic hypothesis of the study is that as fatigue increases, children's daily activities and quality of life will be negatively affected.

REACTION-VAD Trial: Remote Exercise Training Via Telemedicine in Patients With Long-Term Ventricular Assist Devices

Current international guidelines recommend that patients with a heart pump (left ventricular assist device, LVAD) participate in supervised exercise cardiac rehabilitation programs. However, not all patients with a heart pump are able to attend to a supervised program on a daily basis. The goal of this clinical trial is to determine whether a home-based exercise program helps patients with a heart pump improve their exercise capacity and quality of life, guided by telemedicine tools including a mobile app, smartwatch, and remote medical checkups. The study will also provide information about the safety of this program by monitoring for any issues or symptoms during home activity. The trial aims to answer the following questions: * Does a 12-week remote exercise program improve patients' exercise capacity? This will be measured using the 6-minute walk test and a cardiopulmonary exercise test. * Is it safe for patients to follow this exercise plan at home while being monitored through a mobile app and smartwatch? * Does the program improve quality of life and reduce feelings of anxiety or depression? This will be assessed using widely validated questionnaires, such as the Kansas City Cardiomyopathy Questionnaire. Researchers will compare the remote exercise program to standard care, which usually does not include exercise for patients who are unable to attend the hospital daily. Participants will: * Join the study voluntarily after signing a consent form. * Be randomly assigned, with a 50% chance of being in either the exercise group (following a structured plan with a mobile app) or the usual care group (receiving general written advice), to see which approach works best for recovery. * Follow a 12-week home-based routine if in the exercise group, including warm-up routine, walking or cycling, respiratory exercises, and light strength training, all supported by the mobile app, smartwatch, and professional monitoring. * Visit the hospital three times over six months for medical checkups, including walking and exercise tests, blood analyses, and questionnaires about physical and emotional health.

Digital Literacy Intervention to Address Support, Literacy and Communication in Older Adults

The investigators propose a person-directed, values-based digital literacy intervention to address the community-identified barriers of health literacy, health communication and social support to improve quality of life and specific disease related metrics in the older adult's own home. This intervention will be a way to address the community-identified barriers of health literacy, health communication and social support to improve quality of life and specific disease related metrics in the older adult's own home.

Optimizing Patient-centred Outcomes Using Opioid Minimization Strategies: The OPUS Anesthesia Pilot Trial

Up to 40% of patients experience suboptimal recovery in the days following major surgery, limiting their return to functional independence. Few preventive interventions exist, but intravenous dexmedetomidine and lidocaine administered during general anesthesia represent simple strategies that may significantly impact recovery and other patient-centred outcomes after surgery. The goal of this pilot trial is to determine the feasibility of conducting a phase 3 pragmatic adaptive multicentre trial to evaluate the impact of dexmedetomidine and lidocaine administered during major non-cardiac surgery on patient-centred outcomes.

A Study to Evaluate a Supplement Combination in Supporting Weight Loss, Metabolic Health, and Quality of Life

This consumer-use study evaluates the effects of a combined postbiotic and prebiotic supplement regimen on appetite control, cravings, metabolic health, energy, and quality of life in adults aged 18-65 years with a body mass index (BMI) between 25 and 30. Participants will consume one capsule of resM™ GLP-1 Postbiotic and one scoop of resG prebeet ENERGY Prebiotic daily for 60 days. Data will be collected through daily check-ins, weekly surveys, and quality-of-life questionnaires administered through the Chloe mobile application. The primary objective is to evaluate changes in appetite control and food cravings over 60 days of supplementation.

Effect of Virtual Reality on Caregivers of Palliative Care Patients

Due to advances in medical technology and accessible health services, the prognosis of diseases has improved and the need for care has increased, and primary caregivers have experienced the increased burden of caring for family members for a long time. Because the patient is primarily responsible for continuing patient care in palliative care units and then at home, and especially because they have problems in psychological, social and financial support, caregivers within the family are considered as second-degree patients or occult patients. Studies have shown that caregivers have a significant burden of care, therefore they experience serious depression, anxiety and physical problems, isolate themselves from society, and their quality of life decreases significantly. In recent years, the use of virtual reality, which shows itself in different application areas in the field of health as a safe and useful system, has become widespread. Considering the use of virtual reality in the field of health; It is seen that it is mostly preferred for pain management, physical condition improvement, blood collection, burn treatment, and psychological disorder.

Effects of Comprehensive Community Support Programs on Cognitive Function and Quality of Life in Older Adults

This prospective observational study aims to investigate the effects of a multidomain community-based support program on cognitive function and quality of life in older adults attending the Vefahane Life Center in Istanbul, Türkiye. The study will compare elderly individuals actively participating in community-based social, cognitive, physical, and supportive activities with individuals registered at the center but not actively participating during the study period. Participants will undergo neuropsychological and psychosocial assessments at baseline and after 3 months. The primary outcome is change in global cognitive performance measured by the Mini Mental State Examination (MMSE). Secondary outcomes include memory, executive functions, depression, neuropsychiatric symptoms, and quality of life measures.

Efficacy of a Self-advocacy Serious Game Intervention

Individuals with cancer must overcome multiple, ongoing challenges ("self-advocate") related to their cancer experience to receive patient-centered care. Women with metastatic cancer often face significant challenges managing their quality of life concerns and cancer- and treatment-related symptoms. If they do not self-advocate to manage these concerns, they risk having poor quality of life, high symptom burden, and care that is not patient-centered. Serious games (video games that teach) are effective health interventions that allow users to vicariously engage in situations reflecting their personal experiences, receive meaningful information, and learn personally relevant skills that they can apply in real life. The goal of the current study is to test the efficacy of a novel intervention using a serious game platform to teach self-advocacy skills to women with advanced cancer. The Strong Together intervention consists of a multi-session, interactive serious game application with tailored self-advocacy goal-setting and training. The serious game is based on a self-advocacy conceptual framework and applies behavior change theories and serious game mechanisms to promote skill development and implementation. The game works by immersing users in the experiences of characters who are women with advanced cancer; requiring users to make decisions about how the characters self-advocate; demonstrating the positive and negative consequences of self-advocating or not, respectively; and providing multiple, individualized feedback mechanisms and game features to enforce self-advocacy skill acquisition and transference to real life.

Health Anxiety and Quality of Life Among Faculty of Medicine Students

This cross-sectional analytical study aims to assess the impact of health anxiety on quality of life (QoL) among medical students at the Faculty of Medicine, Sohag University, Egypt. Health anxiety will be measured using the Short Health Anxiety Inventory (SHAI), and quality of life will be assessed using the Short Form-12 Health Survey (SF-12), covering both Physical Component Summary (PCS) and Mental Component Summary (MCS). The study targets third-year (pre-clinical) and fifth-year (clinical) students selected by cluster sampling. Findings will help identify prevalence and determinants of health anxiety and its impact on QoL, informing mental health support strategies for medical students in Upper Egypt.

Robotic Dog Intervention on Emotional Well-Being and Quality of Life

The hematopoietic stem cell transplantation (HSCT) process imposes a substantial psychological burden, leading to impaired emotional well-being due to intensive treatment, isolation, and immunosuppression. Patients often experience social withdrawal, loneliness, and loss of control, which may result in persistent anxiety, depressive symptoms, and reduced quality of life (QoL) if unaddressed. This study aims to evaluate the effectiveness, feasibility, and acceptability of an AI-powered robotic dog in improving emotional well-being and QoL in pediatric patients undergoing HSCT.

Compare Adjuvant Monotherapy With Endocrine or Accelerated Partial Breast Irradiation After Lumpectomy

The aim of this prospective study is to investigate quality of life and oncologic outcomes in low-risk elderly breast cancer patients randomized to adjuvant therapy with accelerated partial breast irradiation (APBI) alone or endocrine therapy alone after lumpectomy. The study population will include women age 65 years and older with low-risk tumor characteristics (tumor size \<2cm, grade 1-2, node-negative). APBI will consist of 5 fractions of radiation therapy delivered every other day to the lumpectomy cavity. Endocrine therapy will be chosen by the treating medical oncologist with an aim of 5 years duration, as tolerated by the patient. Quality of life outcomes will be measured at 1 year following lumpectomy and compared between groups. We hypothesize that the use of APBI may be superior in terms of quality of life when compared to endocrine therapy alone following lumpectomy while providing equivalent rates of disease control and overall survival. In this phase II study, we anticipate enrolling 90 women at N.C. Cancer Hospital in Chapel Hill, NC.

COVID-19 Follow up Intensive Care Studies

Since the SARS-CoV-2 infection is relatively new, the long term attributable burden related to COVID19 has not been investigated yet. To date, in patients with COVID-19 and their family members, there is little information on the functional status, cognitive ability, pattern of return to work, and health related quality of life after the ICU admission. This study aims to describe the psychological wellbeing, physical - and social functioning of COVID-19 ICU survivors and their family members up to 12 months following ICU discharge.

EVOLUTION IN FRAGILITY IN PEOPLE ON THE WAITING LIST FOR A KIDNEY TRANSPLANT

This study looks at how the physical and emotional health of people changes while they wait for a kidney transplant. Waiting for an organ can take a long time. During this period, some patients become "frail." This means they lose strength and are at a higher risk for health problems. The main goal is to follow these patients over time to better understand their needs. Researchers will use a mobile app to collect information directly from patients about how they feel and their quality of life. The study will also include personal interviews to learn about the patients' experiences and any difficulties they face when using technology. The results of this study will help to: * Identify early which patients are losing strength or health. * Improve the support that nurses provide during the transplant waiting period. * Make sure that digital health tools are easy for everyone to use. In short, this work aims to help patients reach the day of their surgery in the best possible condition.

Machine-Based Pilates on Quality of Life and Low Back Pain in Older Adults

Chronic low back pain is one of the most prevalent and debilitating conditions among older adults, often compromising physical function and overall quality of life. Structured physical exercise, particularly the Pilates method, is widely recommended for managing this condition. However, existing literature primarily focuses on younger populations using mat-based group classes. This pilot study utilizes an exploratory mixed-methods design to investigate the feasibility and preliminary outcomes of a 12-week individualized, machine-based Classical Pilates program on quality of life and low back pain in active older adults (aged 55 to 75 years). Participants will complete 24 individual sessions (twice a week). The aim is to assess changes in physical domains of quality of life and perceived low back pain intensity, while gathering qualitative contextual insights on body awareness and psychosocial well-being.

Compliance With PROMs Detection Through Digital Support and Correlation Compared to Standard Outpatient PROMs Detection in Hip Prosthetics (DIG-PROMs-h)

Two methods for detecting outcomes after hip prosthetic surgery are compared: the traditional one using paper questionnaires administered in the outpatient setting (WOMAC Score) VS detection using digital questionnaires created on Google Forms and sent to the patient's smartphone on which the compilation takes place in the extra area outpatient.

Motor Imaging, Neglect, and Upper Extremity Function in Stroke

This study aims to investigate the relationship between motor imagery skills and neglect level, upper extremity motor function, activities of daily living, quality of life, lateralization performance, and mental timer performance in individuals with stroke. Individuals with stroke who meet the inclusion criteria and voluntarily agree to participate will be evaluated. Demographic and clinical information of the participants will be recorded on an assessment form prepared by the researcher. Upper extremity motor functions will be assessed using the Fugl-Meyer Upper Extremity Motor Assessment Scale and the Wolf Motor Function Test; activities of daily living will be assessed using the Modified Barthel Index; and quality of life will be assessed using the Stroke-Specific Quality of Life Scale. Motor imagery skills will be measured using the Kinesthetic and Visual Imagery Questionnaire and a mental timer task; upper extremity lateralization performance will be assessed using the Recognise™ application. Neglect level will be assessed using the Catherine Bergego Scale, the Line Splitting Test, and the Star Erase Test. The data obtained will be statistically analyzed to examine the relationships between motor imagery skills and other clinical variables.

ROBO-PAWS: Robot-Dog-Assisted Walking

Childhood cancers affect approximately 400,000 children and adolescents worldwide each year. Although advances in treatment have significantly improved survival rates, children undergoing cancer treatment continue to experience a wide range of treatment-related symptoms and complications. Among these, fatigue and sleep disturbances are particularly common and may persist throughout treatment and survivorship, negatively affecting psychological well-being, cognitive functioning, and overall quality of life. Reduced physical activity during treatment is strongly associated with worsening fatigue, impaired sleep, and decreased quality of life in pediatric oncology patients. However, treatment side effects, prolonged hospitalization, infection risk, and lack of motivating play-based activities often limit children's participation in physical activity during treatment. Recent evidence suggests that physical activity interventions may help reduce fatigue and improve well-being in children with cancer, yet engaging and age-appropriate non-pharmacological interventions remain limited, especially for younger children. This pilot randomized controlled trial aims to evaluate the feasibility and potential effects of a robot-dog-assisted walking intervention on sleep quality, fatigue, and quality of life among children aged 2-7 years undergoing cancer treatment.

Photobiomodulation in Chronic Fatigue Syndrome

The goal of this clinical trial is to evaluate whether photobiomodulation therapy (low-level laser therapy) can reduce fatigue and improve quality of life in patients with chronic fatigue syndrome (CFS). The study will include adults aged 18-60 years diagnosed with chronic fatigue syndrome. The main questions it aims to answer are: Does photobiomodulation therapy significantly reduce fatigue levels as measured by the Fatigue Severity Scale (FSS) and Multidimensional Fatigue Inventory (MFI-20)? Does photobiomodulation therapy improve pain, functional capacity, sleep quality, and psychological well-being in patients with chronic fatigue syndrome? Researchers will compare the low-level laser therapy group with a placebo (sham laser) group to determine whether photobiomodulation therapy leads to greater improvements in fatigue, pain, and overall quality of life. Participants will: Receive either active low-level laser therapy or placebo treatment three times per week for eight weeks Undergo assessments of fatigue, pain, functional capacity, quality of life, sleep quality, and psychological well-being at baseline and follow-up intervals (3, 6, and 12 months)

The Effect of a Medication Coordinator on the Quality of Patients Medication Treatment

To examine the effect of a Medication Coordinator, who facilitates medication reviews in close collaboration with patients using My Medication Plan to reduce the risk of post-hospital inappropriate medication usage.

Trauma-adapted Yoga in Child & Adolescent Psychiatry.

The goal of this randomized clinical trial is to evaluate the efficacy of trauma-adapted yoga as a complementary intervention to care as usual in child and adolescents psychiatry clinics, in the population of adolescents with the diagnosis of ADHD and/or PTSD. We hypothesize that trauma-adapted yoga (TAY) is an effective non-pharmacological intervention for adolescent with ADHD and/or PTSD. Aims: (1) Validate the impact of TAY on the mental health \& quality of life of adolescents with ADHD and/or PTSD. (2) Investigate the feasibility of online TAY for continued self-care. (3) Explore adolescents' experiences \& parental perspectives on TAY in their treatment. (4) Explore healthcare professionals' experience on the integration of TAY into clinical practice. Within and between group (yoga group vs waiting list) analyses will be performed.

Logotherapy-Based Online Education to Improve Physical Activity in Sedentary Workers

Insufficient physical activity (PA) among individuals with sedentary occupations is associated with an increased risk of chronic disease and reduced health-related quality of life. This study aims to evaluate the effectiveness of an originally developed logotherapy-based distance education program on physical activity, sedentary behavior, and selected aspects of health-related quality of life. A minimum of 200 participants aged 35-60 years with sedentary occupations will be recruited from multiple organizations in Croatia and randomly assigned to an experimental or control group. All participants will complete validated questionnaires assessing physical activity, sedentary behavior, health-related quality of life, self-efficacy, meaning in life, and motivation for exercise at baseline and after the intervention period. The experimental group will participate in an eight-week online education program consisting of weekly 30-minute sessions followed by brief discussions, while the control group will continue their usual lifestyle without intervention. The intervention integrates principles of logotherapy and existential analysis with the Transtheoretical Model of Behavior Change and the CALO-RE behavior change taxonomy. The findings may contribute to the development of more effective, meaning-centered approaches to promoting physical activity and reducing sedentary behavior in adult populations.