Clinical Research Directory

Decentralized Clinical Trial of Effectiveness of EnergyPoints App in Cancer Survivors

The purpose of the study is to evaluate whether EnergyPoints, a mobile phone health app that guides the participant to do self-acupressure, can decrease fatigue and improve sleep. Acupressure consists of applying physical pressure with fingers or a device to small locations on the body called acupoints. * The investigators will conduct this clinical trial remotely, allowing participants to use the app wherever they are. Participation will involve using the app daily while wearing a fitness tracker (a Fitbit) on the wrist, answering questions on the app and online, as well as completing a questionnaire and participating in an online interview at the end of the study. Participants will be assigned by chance to one of two groups. In both groups, participants will have a 1 week baseline week (Week 0) to get used to the Fitbit. Participants in the Immediate Group will start the 6 week trial of EnergyPoints immediately (Week 1). Participants in the Wait-List Group will be on a wait-list for 6 weeks during which time they will wear the Fitbit and answer online questions daily and weekly. At the end of the waiting period (week 7), these participants will begin the 6 week trial of EnergyPoints. * The risks to participating are minimal. There is a small risk of bruising or getting sore at a point where participants apply pressure. As with any mobile app, there is the possibility that electronic information could be viewed by third parties not involved in the study. The investigators cannot promise any benefits from participating in the study. However, it is possible that using acupressure might improve fatigue or sleep. Participants may use any other approaches to improve fatigue and sleep while in the study. A pilot study will be conducted first with 8 participants and 1 week periods (1 week baseline, 1 week waitlist, and 1 week intervention followed by an End of Study Questionnaire and Exit Interview

Assessing the Effects of Cool Roofs on Indoor Environments and Health in Colima, Mexico

Ambient air temperatures in Mexico have broken record highs in 2024. Solutions are needed to build heat resilience in communities and adapt to increasing heat from climate change. Sunlight-reflecting cool roof coatings may passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions in the northern zone of Mexico are susceptible to increased heat exposure. Heat exposure can instigate and worsen numerous physical, mental and social health conditions. The worst adverse health effects are experienced in communities that are least able to adapt to heat exposure. By reducing indoor temperatures, cool roof use can promote physical, mental and social wellbeing in household occupants. The long-term research goal of the investigators is to identify viable passive housing adaptation technologies with proven health benefits to reduce the burden of heat stress in communities affected by heat in Mexico. To meet this goal, the investigators will conduct a cluster-randomized controlled trial to establish the effects of cool roof use on health, indoor environment and economic outcomes in Colima, Mexico.

Assessing the Effects of Cool Roofs on Indoor Environments and Health

Ambient air temperatures in Asian, Latin American, African, and Pacific climate hotspots have broken record highs in 2024, driven by man-made climate change. Solutions are needed to reduce heat exposure in communities. Sunlight-reflecting cool roof coatings passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions globally - for example in informal settlements, slums, and low-socioeconomic households - are especially vulnerable to increased indoor heat exposure. Heat exposure can instigate and worsen numerous physical, mental and social health conditions. The worst adverse health effects are being experienced in communities least able to adapt to heat exposure. By reducing indoor temperatures, cool roof use can promote physical, mental and social wellbeing in occupants. The long-term research goal is to identify viable passive housing adaptation technologies with proven health and environmental benefits to reduce the burden of heat stress in communities affected by heat globally. To meet this goal, the investigators will conduct a cluster-randomized controlled trial to establish the effects of cool roof use on health, indoor environment and economic outcomes in five urban climate hotspots: Ouagadougou, Burkina Faso; Colima, Mexico; Ahmedabad, India; Niue; and Tavua, Fiji.

Psychometric Validation of the MQOL-FR and Descriptive Assessment of Quality of Life in Patients With Meningiomas

This non-interventional study aims to validate the French version of a meningioma-specific quality-of-life questionnaire (MQOL-FR) and to describe health-related quality of life in adults diagnosed with an intracranial meningioma. Participants will be invited to complete online questionnaires through a secure REDCap link. After reading the study information and recording their non-opposition, participants will complete: (1) MQOL-FR (meningioma-specific), (2) EQ-5D-5L (generic health-related quality of life), and (3) FACT-Br (brain tumor-specific quality of life). The questionnaire session takes approximately 30-45 minutes and can be completed in more than one sitting using a REDCap access code. There is no additional visit and no change in usual care. The study will recruit adults (≥18 years) with a meningioma diagnosis based on imaging and/or confirmed by surgery, through the GHU Paris-Sainte-Anne neurosurgery clinic and through patient/community networks. The goal is to obtain 100 fully completed MQOL-FR questionnaires suitable for psychometric analyses.

Psychological Well-Being, Depression, and Health-Related Quality of Life in Adults With Type 2 Diabetes: A Cross-Sectional Study

This prospective cross-sectional observational study aims to explore the relationships among psychological well-being, depression, and quality of life in patients with type 2 diabetes attending the outpatient metabolic clinic at National Taiwan University Hospital. The study will collect data using standardized instruments, including the EQ-5D Health-Related Quality of Life Questionnaire, the PHQ-9 Depression Scale, and the Shalom Scale of Psychological Well-Being, along with demographic and clinical variables such as age, sex, education, body mass index, HbA1c, disease duration, and psychosocial support indicators. Descriptive statistics, Pearson correlation analyses, ANOVA, and multiple linear regression modeling will be performed to identify factors associated with psychological well-being. The findings are expected to provide evidence-based insights to inform tailored interventions and improve the mental health and quality of life of patients with type 2 diabetes.

Effects of Conservative Management on Relieving Storage Urinary Symptoms and Poor Sleep in Women With Diabetes

Women with type 2 diabetes (n=90) experiencing ≥1 storage lower urinary tract symptoms and poor sleep health will be recruited from the outpatient departments or wards/units of the selected hospitals/clinics. Our study aims to examine the effects of conservative management incorporating urologic health promotion and sleep health promotion on relieving storage lower urinary tract symptoms and poor sleep, and on improving urologic health self-management behaviors and health-related quality of life. Women who agree to participate will be randomly assigned into the intervention group A, intervention group B, or comparison group. The intervention group A receives a 4-month conservative management with sleep hygiene related adjustments, pelvic floor muscle training, and urologic health promotion. The intervention group B receives a 4-month conservative management with brief behavioral treatment for insomnia (BBTI), pelvic floor muscle training, and urologic health promotion. The comparison group receives information related to pelvic floor muscle training and urologic health promotion, and receives a brief conservative management related to sleep hygiene adjustments after the completion of data collection. Information related to intervention effects is obtained by a questionnaire, a wristwatch-like actigraphy, and physical activity/diet/voiding/sleep logs from all participants at 4 data collection points: baseline, and 2-, 4-, 6-month follow-ups. Our study hypothesis is that the intervention effects on relieving storage lower urinary tract symptoms and poor sleep, and on improving urologic health self-management behaviors and health-related quality of life in the intervention group A or B are superior to the changes revealed in the comparison group.

The Impact of Supervision by a Health Care Professional on Quality of Life Questionnaire

Effect of supervision on scoring and completion on Quality of Life Questionnaire

Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity

This multicentre two-phased RCT aims to evaluate implementation potential, cost-effectiveness, effectiveness, and the role of exercise intensity of a home-based exercise and physical activity intervention to improve de novo kidney transplant recipients' physical fitness, cardiovascular health, gut microbiome characteristics, and health-related quality of life. The first phase of this study comprehends a six-month exercise training intervention. Patients will be randomized into (i) a sham intervention consisting of low-intensity balance and stretching exercises (LIT), (ii) a moderate-intensity aerobic and strength training intervention (MIT), or (iii) a moderate- and high-intensity aerobic and strength training intervention (MHIT). The second phase of this study comprehends a physical activity maintenance intervention provided to MIT and MHIT but not LIT. A total of 147 de novo kidney transplant recipients will be recruited from two independent Belgian transplant centres i.e. UZ Leuven and UZ Ghent.

Incremental PD With Single Icodextrin Exchange

Objectives: To investigate the efficacy and safety of single daily icodextrin exchange for initiation of incremental peritoneal dialysis (PD). Subjects: Seventy-two incident PD patients. Methods: A single-center randomized controlled trial. Primary outcome: Change in residual kidney function in 48 weeks after recruitment.