Clinical Research Directory

MBSR and NLP, Postpartum Breastfeeding and Depression

The postnatal period is a risky period in which mothers experience regressive and progressive changes and rapid biopsychosocial changes. Since this process affects not only the mother but also the family, mothers are under intense stress due to adaptation to the changes that occur in this period.

Remote Ischaemic Conditioning for Fatigue After Stroke 2 (RICFAST 2)

Post-stroke fatigue is an overwhelming tiredness or lack of energy that does not get better with rest. It affects around half of people who have had a stroke. It can hold back recovery, make it harder to take part in everyday and social activities or to return to work, and reduce quality of life. There are currently no proven treatments for it. Remote ischaemic conditioning (RIC) is a simple treatment that people can do at home using a blood pressure cuff on the upper arm. The cuff is inflated for 5 minutes and then let down for 5 minutes, and this is repeated 4 times, taking about 40 minutes in all. RIC briefly and safely reduces blood flow to the arm before letting it return. Research suggests this may help the body's cells produce energy more efficiently, improve blood flow and reduce inflammation. In our earlier small study (RICFAST), RIC done 3 times a week for 6 weeks was safe and well tolerated, and there were early signs that it might reduce fatigue. This study (RICFAST 2) will find out: * whether people with post-stroke fatigue can safely and comfortably do RIC at home more often (5 times a week) or for longer (12 weeks) * whether enough people can be recruited to a study like this * whether doing RIC more often or for longer might reduce fatigue more, and for longer, than the usual schedule or a comparison treatment * how RIC might work in the body Who can take part? Adults who had a stroke between 3 months and 3 years ago and who have had troublesome fatigue for at least 6 weeks. People are being identified through stroke services, GP practices and community organisations in Sheffield, Doncaster, Rotherham and Barnsley (South Yorkshire, England). What does the study involve? 60 people will take part. Each person will be put into one of four groups by chance (randomisation), with 15 people in each group. The groups differ in the pressure the cuff is inflated to (called "Pressure 1" and "Pressure 2"), and in how often and for how long the treatment is done: * Group A (comparison group): cuff inflated to Pressure 1, 3 times a week for 6 weeks * Group B: cuff inflated to Pressure 2, 3 times a week for 6 weeks * Group C: cuff inflated to Pressure 2, 5 times a week for 6 weeks * Group D: cuff inflated to Pressure 2, 3 times a week for 12 weeks All the treatments cause a feeling of pressure in the upper arm. So that the results are fair, participants will not be told which cuff pressure is expected to have an effect. Everyone will continue with their usual care. Participants will be shown how to use the cuff at home, can do the treatment at any time of day, and will keep a simple treatment log and symptom diary. The research team will phone or video call each week to check how things are going. Each participant will also wear a wrist activity tracker (Fitbit) throughout the study to record their steps, activity and sleep. Questionnaires and tests of fatigue, mood, independence in daily activities, quality of life and walking will be done at the start of the study and 6 weeks, 12 weeks and 24 weeks (about 6 months) after starting treatment. The first three assessments take place at Sheffield Teaching Hospitals, and the 24-week assessment can be done remotely. Travel expenses are paid. Thirty participants from Groups A, B and C will be invited to have extra tests before treatment and after 6 weeks: an exercise test on a bike, a magnetic resonance (MRI) scan of the lower leg muscles to measure how much energy is stored in the muscle, and a blood test for markers of inflammation. Some participants will also be invited to an interview about their experience of doing the treatment at home. What do investigators expect to find? Investigators expect that people in all groups will be able to do the treatment at home, and that RIC done more often or for longer will lead to bigger and longer-lasting improvements in fatigue. The findings will be used to design a larger trial to test whether RIC is an effective treatment for post-stroke fatigue.

Electrical Muscle Stimulation Versus Resistive Training On Physical Measures, And Fatigue In Hemodialysis Patients

The purpose of this randomized controlled trial is to compare the effects of intradialytic neuromuscular electrical stimulation (NMES) and intradialytic resistance exercise with usual care on physical function, dialysis adequacy, and fatigue in patients receiving maintenance hemodialysis. The study aims to evaluate whether these intradialytic rehabilitation interventions provide additional benefits compared with usual dialysis care.

Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis

Fatigue is the most common symptom reported by end-stage kidney disease patients on maintenance hemodialysis. Unfortunately, there currently is no medical management for this overwhelming feeling of tiredness. As a result, patients continue to suffer with poor quality of life and impaired daily activities. The purpose of this pilot trial is to find out if bupropion (a medicine commonly prescribed for stopping smoking, seasonal mood disorder, and depression) may help lessen fatigue in hemodialysis patients. In this study, hemodialysis participants will receive bupropion tablet orally three times a week during routine dialysis procedure for consecutive 8 weeks. Study participants will complete a battery of questionnaires to self-report fatigue, cognition, and quality of life. The study team will collect biological specimens. All these procedures will be performed at the dialysis clinic during routine dialysis procedure.

Chronic Fatigue in the Internal Medicine Outpatient Clinic: a Mixed-methods Quantitative and Qualitative Study

With this study, the investigators aim to answer the following research questions: 1. In what percentage of cases does the diagnostic process conducted during a fatigue consultation at the internal medicine outpatient clinic contribute to a somatic diagnosis? 2. What are the experiences of patients presenting with fatigue at the internal medicine outpatient clinic when a consultation, including diagnostic testing, does not lead to a diagnosis? To address question (1), the investigators will conduct a retrospective data analysis using information from HiX, an electronic health record (EHR) system. To answer question (2), the investigators will conduct a prospective qualitative study through interviews.

Effects of Swimming and Tennis on Mental Health, Fatigue, and Sleep in Young Women

This study compared the effects of swimming and tennis on mental health, fatigue, and sleep quality in young women who were not regularly physically active. A total of 34 women aged 18-25 years were randomly assigned to either a swimming group or a tennis group. Both groups participated in supervised exercise sessions lasting 45 minutes, three times per week, for eight weeks. Participants completed questionnaires before and after the exercise programs to assess anxiety, depressive symptoms, psychological well-being, perceived stress, fatigue, and sleep quality. Thirty participants completed the study and were included in the final analysis. The purpose of this study was to determine whether swimming and tennis had different effects on psychological health, fatigue, and sleep quality in physically inactive young women.

Cycling During Dialysis: A Feasibility and Safety Study

People who receive hemodialysis sit for about 4 hours, three times a week, and often feel tired and weak. Exercise can help, but many patients find it hard to exercise on their own. Cycling on a stationary bike during dialysis has been shown to be safe in other hospitals, but it is not yet offered at Sunnybrook. This study will find out if a supervised cycling program during dialysis is practical and safe at Sunnybrook Health Sciences Centre (Bayview Campus). Twelve adults who have dialysis on Mondays, Wednesdays and Fridays will cycle on a bedside exercise bike during their dialysis sessions, three times a week for 3 months. Trained nurses and a physiotherapist will set up the bike and watch every session, including checking heart rate, blood pressure and oxygen levels. We will look at how many patients join and stay in the study, how many cycling sessions they complete, and whether any safety problems happen. We will also look at changes in tiredness, walking ability, quality of life, and how well dialysis cleans the blood. At the end, patients and nurses will give feedback on the program. The results will help decide if cycling can be added to regular dialysis care and will help plan a larger study.

Individualized Music Listening in Acute Leukemia Patients With Fatigue

The objective of this study is to assess the efficacy of employing music therapy in alleviating fatigue and medical laboratory values among patients with acute myeloid leukemia.

The Effects of an App-based Acupressure on Alleviating Fatigue, Pruritus, and Sleep Quality Among Hemodialysis Patients

Objectives: To evaluate the effectiveness of an app-based self-guided acupressure intervention in alleviating fatigue and pruritus, and in improving sleep quality among hemodialysis patients. Design and subjects: The parallel randomized controlled trial will be employed in one hospital. Block randomization in a 1:1 ratio will be used to assign the patients to the intervention and control groups. It is estimated that 50 to 100 participants receiving hemodialysis will be recruited. Instrument: The demographic and health-related information questionnaire, the Post-dialysis Fatigue, 5-D Itch, and Pittsburgh Sleep Quality Index will be used in this study. Interventions: The intervention group will use an app-based self-guided acupressure program to do the acupressure by themselves once daily for 4 weeks. Participants in the control group will receive usual care and no other intervention. Data analysis: Both intention-to-treat and per-protocol analysis approaches will be performed. Generalized Estimating Equations analysis will be used to assess the effectiveness of the interventions. Sensitivity analysis will be conducted to assess the impact of missing data on the treatment effect if necessary. Expected outcomes: Participants in the intervention group will know how to do the self-guided acupressure by themselves. If the intervention is effective, the App can be introduced to the hemodialysis patients who need it.

A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being

This study evaluates the effects of Primal Harvest's Primal Meno+ supplement on symptoms of menopause and overall well-being in females aged 40-60 who are currently menopausal and experiencing at least two menopausal symptoms. Over a 12-week period, 40 participants will take one capsule of the test product daily with their first meal of the day. Participants will complete self-reported questionnaires at Baseline, Week 4, Week 8, and Week 12 to assess menopausal symptoms (including hot flashes, night sweats, sleep quality, stress resilience, and emotional well-being) and overall health and well-being. This is a single-arm, open-label, virtual trial with no randomization or blinding.

Laser Acupuncture for Fatigue in Hemodialysis Patients

The goal of this clinical trial is to learn if laser acupuncture (low-level laser therapy) works to treat fatigue and improve quality of life in adults with end-stage renal disease (ESRD) undergoing hemodialysis. It will also learn about how laser acupuncture affects blood circulation and autonomic nervous system balance. The main questions it aims to answer are: 1. Does laser acupuncture reduce the severity of fatigue and its interference with daily life? 2. Can laser acupuncture improve related symptoms such as insomnia, poor appetite, and skin itching? 3. How does laser acupuncture affect objective markers like microcirculation and heart rate variability? Researchers will compare laser acupuncture to a sham treatment (a look-alike procedure using a device that does not emit a laser) to see if laser acupuncture works to treat fatigue. Participants will: 1. Receive laser acupuncture or a sham treatment during their regular hemodialysis sessions 3 times a week for 4 weeks. 2. Have their fatigue and life quality assessed through questionnaires on the first day, at 4 weeks, and at 8 weeks. 3. Undergo non-invasive tests to measure microcirculation, heart rate variability, and pulse waves, and have photos of their tongue taken for Chinese medicine assessment.

Does Fatigue Coaching Improve Functioning and Fatigue in Resident Night Shifts

Emergency Medicine (EM) requires 24/7 staff coverage resulting in healthcare workers' circadian rhythm disruptions that impair clinical and cognitive performance, physical recovery, and contribute to burnout. Multiple well-being surveys continue to highlight EM's challenges with sleep impairment due to the nature of the specialty. Despite evidence that lifestyle strategies effectively optimize performance and recovery, EM residents have variable lifestyle choices to prepare for overnight shifts. This prospective randomized controlled trial will examine whether a pre-shift personalized fatigue-mitigation lifestyle coaching (PFMLC) for EM residents on overnight shifts minimizes the effects of circadian rhythm disruptions on performance and recovery compared to those who receive one-time passive information on lifestyle practices. All participants will receive lifestyle strategy materials on fatigue mitigation to improve performance. Residents' self-reported and biometric data will inform PFMLC in the active arm. Performance and recovery from night shifts will be assessed by changes in sleep, heart rate variability, readiness/recovery, alertness, cognitive performance, and mental health using Fitbit and validated measures.

A Study to Evaluate the Effects of a Beef Liver Supplement on Energy, Mood, and Mental Clarity

This is a randomized, triple-blind, placebo-controlled clinical trial evaluating the effects of the Ancestral Supplements Grass Fed Beef Liver oral supplement on energy, mood, and mental clarity over 12 weeks. One hundred male and female participants aged 18-50 who report concerns regarding energy levels, mood, and mental clarity will be enrolled and randomized equally into an intervention arm (beef liver supplement) or a placebo arm. Participants will take their assigned product once daily and complete self-reported questionnaires at Baseline, Week 4, Week 8, and Week 12. Blood testing (iron panel) will be conducted at Baseline and Week 12 at a local Quest Diagnostics Clinic. The primary objective is to evaluate the product's effects on energy and mood; the secondary objective is to assess participants' perceptions of the product's effects on energy, mood, and mental clarity, including happiness, anxiety, well-being, brain fog, and concentration.

Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

To find out if combining psychoeducational interventions (such as education, counseling, and self-managed therapies) with an open-label placebo can help to improve your quality of life better than either the psychoeducational interventions or the placebo alone.

Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia

This pilot clinical trial studies the side effects and best dose of metformin hydrochloride and ritonavir in treating patients with multiple myeloma or chronic lymphocytic leukemia that has returned after a period of improvement or has not responded to treatment. Metformin hydrochloride and ritonavir may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Cohort of Repeat Donor Experiences (CORE) Study

The Plasma Protein Therapeutics Association (PPTA) sponsors the Cohort of Repeat Donor Experiences (CORE) Study. This is a prospective, observational cohort study that will follow Source Plasma donors for up to 2 years during the main study (launching in October 2026) ) and up to 3 months during the pilot inconducted April - September 2026. This study aims to confirm a lack of negative health effects Source Plasma donors may experience as a result of frequent plasmapheresis. The study will use data obtained through self-report surveys for the duration of the study along with periodic whole blood sample collections to test for CRP, ferritin, and IgG.

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.

Home-Based High-Intensity Interval Training in Systemic Lupus Erythematosus

Systemic lupus erythematosus, or SLE, is a chronic autoimmune disease that can cause persistent fatigue, muscle pain, reduced physical function, and impaired quality of life, even when the disease is otherwise clinically stable. The biological mechanisms contributing to these symptoms are not fully understood. Abnormal energy production within skeletal muscle and increased fat accumulation within the muscle may contribute to fatigue and reduced physical performance in people with SLE. This pilot study will evaluate the effects of a 16-week personalized, home-based exercise program in 20 adults with stable SLE and clinically significant fatigue. The program will include three exercise sessions per week: bodyweight high-intensity interval training, strength training, and walking-based interval training. Sessions will be adapted to each participant's fitness, mobility, symptoms, and exercise tolerance. Some sessions will be supervised remotely by video, while others will be completed independently using personalized recorded instructions. Participants will undergo assessments before and after the 16-week program. These assessments will examine skeletal muscle mitochondrial function, fat accumulation within the thigh muscles, physical performance, fatigue, quality of life, and blood-based markers of mitochondrial function and inflammation. The study will help determine whether a personalized home-based exercise program can improve muscle health and physical function in people with SLE and will provide information needed to design larger future studies.

Patient-Centered Assessment of Symptoms and Outcomes

Background: The cause of fatigue is not well understood. It can be felt differently by different people. Some people think there are different types of fatigue, with different causes. Researchers think a therapy to treat one type of fatigue in one condition should be able to treat that type of fatigue in other conditions. Objective: To understand the types of fatigue. Eligibility: Adults 18 and older who have felt fatigue for more than a month, and non-fatigued adults Design: Participants will be screened with a physical exam, their medical history, a vision test, and blood and urine tests. Participants will begin to track the foods they eat. This study will involve up to 10 visits. Each visit will last no more than 4 hours. In Stage 1, participants will have an interview, fill out questionnaires, and play computer games. They will take walking and handgrip tests. They will give blood, urine, and saliva samples. They will wear a wrist monitor at home for 7 days and write down their activities. They will be put into a group: fatigue or non-fatigued control. In Stage 2, participants will answer questionnaires and give a blood sample. They will have heart tests. They may take exercise and lung function tests that include wearing a nose clip. They may have an optional brain MRI: They may wear an electrode cap on their head during the scan to measure brain activity. They will lie on table that slides into a cylinder. They may perform tasks in the scanner. After the study, participants might be contacted about other studies.

Effect of Aerobic Exercise Training on Cardiorespiratory Function in Patients With Traumatic Brain Injury

Background: \- Many people who have traumatic brain injury (TBI) have low levels of physical fitness. Low physical fitness causes severe fatigue that reduces the ability to perform routine daily activities, and may also cause increased depression, anxiety, or sadness. Aerobic exercise, such as treadmill walking or running, improves physical fitness in most people and may also decrease fatigue and improve mood. However, more information is needed to determine if exercise improves these conditions in people who have TBI. Objectives: \- To examine the effect of an aerobic treadmill walking exercise program on physical fitness, fatigue, and mood in people with TBI. Eligibility: \- Individuals between 21 and 45 years of age who had a nonpenetrating traumatic brain injury at least 6 months before participating; able to understand oral and written English language, give informed consent and sign a consent form; are physically inactive (including activities related to both job and recreation); and are able to stand and walk on a treadmill safely without help. Design: * This study requires 4 testing visits and 36 exercise visits over 14 weeks. * The first and third testing visits will last about 4 hours and the second and final testing visits will take about 2 hours. * Testing visits will consist of a medical history and physical examination, completion of questionnaires (about fatigue, daily physical activity, sleep quality, mood, and overall quality of life), tests of thinking and a treadmill exercise test. * Participants will have treadmill exercise training 3 days per week for 12 weeks. Each session includes a check-in, warm-up, treadmill walking at the training heart rate, and cool-down. Thirty-two of the sessions will last for about 1 hour, and four of the sessions will include questionnaires to fill out and will last about one-and-a-half hours. * After completing the exercise training program, participants will have a final testing visit to complete the questionnaires (about fatigue, daily physical activity, sleep quality, mood, and overall quality of life), tests of thinking and a treadmill exercise test.

The Effect of Remotely Delivered Pilates on Physical , and Psychological Outcomes in Individuals With Multiple Sclerosis

Objectives Objective 1: To determine the effects of a 16-week remotely delivered Pilates intervention on walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS. Objective 2: To examine the impact of a 16-week remotely delivered Pilates intervention on depression \& anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS. Aim Aim 1: To assess whether the 16-week remotely delivered Pilates intervention significantly improves walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS Aim 2: To investigate whether the 16-week remotely delivered Pilates intervention significantly improves depression \& anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS. Hypothesis Hypothesis 1: The 16-week remotely delivered Pilates intervention will significantly improve walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS. Hypothesis 2: Participants receiving the 16-week remotely delivered Pilates intervention will demonstrate significantly greater improvements in depression \& anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS.

The Precision Mito- Mito Map COMPASS Study

Mito Map is a research tool that produces an Energy Score from information provided by a participant. This remote observational study has an initial enrollment target of 400 adults across seven prespecified cohorts: healthy comparison participants; broad mitochondrial disease; POLG-related disease; post-infectious or autonomic illness; Lyme disease or post-treatment Lyme disease syndrome; cancer or cancer-survivorship related fatigue; and other neuromuscular or persistent energy-limiting conditions. The broad mitochondrial cohort has an initial target of 100 participants, and each other cohort has an initial target of 50 participants. These are planning targets rather than caps. Participants complete a baseline assessment and repeated assessments about every two weeks for 12 weeks. Routine activity is designed to take about 5-10 minutes per week, although screening, consent, baseline setup, troubleshooting, or safety follow-up may take longer. Assessments include the Energy Score and protocolized home measures of physical function such as grip strength and five-times sit-to-stand performance, with an approved alternative when grip testing is unsuitable. Participants assigned to grip testing receive a study-provided hand-grip dynamometer at no cost. Optional compatible wearable data may be collected continuously when authorized and technically available. The study does not assign treatment, and research scores will not be used to make clinical decisions. The primary hypothesis is that, within the same participant, higher-than-usual Energy Score values will be associated with better-than-usual objective functional performance at matched assessments. Cohort comparisons, including POLG-specific analyses, are exploratory. A separately consented subset may use a study-provided Flic button to create timestamped symptom, context, or intervention markers with optional follow-up confirmation. The device module is not continuously monitored, does not assign treatment, and is not an emergency service.

Effects of Physical and Cognitive Fatigue on Reaction Time and Depth Perception in Adolescents

This study investigates how physical fatigue, cognitive fatigue, and a combination of both affect reaction time and depth perception in adolescents. Sixty healthy adolescents will participate in four experimental conditions: a control condition, a physical fatigue condition, a cognitive fatigue condition, and a combined fatigue condition. Physical fatigue will be induced using a modified shuttle run protocol, while cognitive fatigue will be induced using computerized Stroop and mental arithmetic tasks. Reaction time will be assessed using the BlazePod system, and depth perception will be evaluated using the Titmus Fly Stereotest before and after each condition. Heart rate, perceived exertion, and mental fatigue will also be measured to verify the effectiveness of the fatigue protocols. The findings may improve understanding of how different types of fatigue influence perceptual and motor performance in adolescents and may contribute to the development of safer and more effective training and sport participation strategies.

The Effect of Acupressure on the Sleep Quality and Fatigue

This research aims to determine the effect of acupressure applied to nurses actively working in internal clinics on sleep quality and fatigue during the COVID-19 pandemic process. This research hypothesizes that acupressure improves sleep quality and reduces fatigue.