Clinical Research Directory

Effects of Chiropractic on Chronic Cancer-related Fatigue

The primary aims of the proposed trial are centered around examining the feasibility of conducting a prospective, chiropractic intervention study on a population of cancer survivors living in and around Atlanta, Georgia. This includes evaluating various implementation outcomes including recruitment, adherence, tolerability, retention, acceptability, and data fidelity. The results of this trial will inform the design of a future randomized controlled trial (RCT) that has an increased focus on the efficacy/effectiveness of chiropractic care on chronic cancer-related fatigue (CCRF) and other cancer-related sequelae in cancer survivors.

A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy

This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in treating excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.

Evaluation of NuvastaticTM in Reducing Cancer-Related Fatigue in Colon Cancer Patients Undergoing First-Line Chemotherapy

The goal of this clinical trial is to evaluate whether Nuvastatic can reduce cancer-related fatigue in adult patients with colon cancer undergoing first-line chemotherapy. The main questions it aims to answer are: Does Nuvastatic significantly reduce cancer-related fatigue compared to placebo? Is Nuvastatic safe and well tolerated in this patient population? Researchers will compare Nuvastatic vs placebo to see if Nuvastatic improves fatigue scores and maintains an acceptable safety profile. Participants will: Receive Nuvastatic or placebo sachets (3 times per day) for 3 cycles of 20 days each (total \~60 treatment days). Continue their standard first-line chemotherapy regimen. Provide blood samples for biomarkers (CEA, CA-125) at Screening and End of Treatment. Complete patient diaries and fatigue assessments as per protocol.

Photobiomodulation Effects on Fatigue and Muscle Damage Induced by NMES

Neuromuscular electrical stimulation (NMES) is widely used to improve muscle strength and mitigate atrophy. However, its clinical efficacy is often limited by early neuromuscular fatigue, muscle damage, and discomfort, which reduce patient tolerance and contraction time. Photobiomodulation (PBM) has emerged as a potential therapy to enhance muscle performance and accelerate recovery by minimizing fatigue and damage. Despite its potential, few studies have investigated the effects of PBM applied specifically before an NMES-evoked fatigue protocol. This randomized, double-blind, placebo-controlled trial aims to evaluate the acute effects of PBM on neuromuscular fatigue, muscle damage, and functional outcomes in healthy young subjects. Participants will receive either active PBM (cluster probe: 5 lasers 810nm/200mW; 4 LEDs 660nm/10mW; Total Energy: 249.6 J per limb) or sham treatment 5 minutes before a fatiguing NMES protocol (80 contractions at 20% MVIC, 80 Hz, 1ms pulse width) applied to the quadriceps muscle. Assessments will be performed at baseline, immediately post-intervention, and at 24h, 48h, and 72h post-intervention. Primary outcomes include maximum and evoked isometric strength, mechanical work, and electrical muscle activity. Secondary outcomes include muscle damage (ultrasound echo-intensity), delayed onset muscle soreness (DOMS), functional performance (unilateral vertical jump), and clinical discomfort. The study seeks to determine if PBM can effectively modulate NMES-induced fatigue and muscle damage, potentially optimizing its clinical application.

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.

Comparing Effect of Intradialytic Aerobic Exercise Versus Incentive Spirometer on Fatigue and Sleep Quality Among Hemodialysis Patients.

In order to accomplish the objectives of this investigation, a single-blind experimental comparative design was implemented to evaluate the impact of intradialytic aerobic exercise and Incentive Spirometer on sleep quality and fatigue. Three experimental groups (aerobic exercise and Incentive Spirometer) and one control group were subjected to pre- and post-tests. Is there a difference in the levels of fatigue and sleep quality between hemodialysis patients who receive aerobic exercise and incentive spirometer therapy and those who do not receive it? Researcher will compare the levels of fatigue and sleep quality between hemodialysis patients who receive interventional therapy and those who do not receive it to see if interventional therapy works to relieve the fatigue and improve sleep quality. Participants will take aerobic exercise therapy group applied on the leg muscles for 20 minutes per session, and incentive spirometer group on respiratory muscles * Ask the patient to hold the breath as long as possible (at least five seconds) then exhale slowly. * Session was in the form of 30 times in sets, each set consist of 5-6 repetitions with rest 1 minute between sets , 3 times per week for total three month, during the first hour of each hemodialysis. sessions.

A Trial of a Positive Psychology Intervention for Older Adults (RESET)

The heightened vulnerability to COVID-19 of African American older adults in Detroit, Michigan and other marginalized communities is linked to systemic racism experienced over the life course. Structural inequities also magnify the pandemic's impact on older adults' physical and psychosocial functioning. Many older adults in Detroit, burdened by poor health even before the pandemic, face a downward spiral of increased distress, reduced physical and social activity, and physical deconditioning. RESET (Re-Engaging in Self-care, Enjoying Today) is a self-management and resilience-building intervention led by community health workers (CHWs) at the Detroit Health Department (DHD). The central hypothesis of this study is that RESET, with components that include group telephone calls, a podcast series, and activity trackers, will improve psychosocial and physical functioning at 2 and 8 months. Specific aims are: 1) With input from a Community Advisory Board, modify RESET for group delivery and refine content after testing in a mini-pilot (n=10). 2) Conduct a randomized, controlled trial to assess the impact of RESET (compared to a one-time /telephone wellness check) on PROMIS-29 Psychosocial Score (a weighted combination of distress, fatigue, pain, social participation and sleep) among 456 primarily African American older adults age 50 and over who are at elevated risk of poor functioning. 3) Collect qualitative (interview) data from participants and other stakeholders, and use this data to better understand trial results, as well as to assess community impact and inform a dissemination toolkit.

Micro-choice-based Intervention for Multicausal Fatigue

This proof-of-concept study aims to evaluate the feasibility, acceptability, and potential benefits of a novel multimodal approach: the micro-choice-based intervention.

Lactate Kinetics After Multimodal Exercise and Adjunctive Virtual Reality Exercise in Hospitalized Geriatric Patients

The goal of this clinical trial is to determine whether adding virtual reality exercise to conventional multimodal exercise affects exercise-related lactate kinetics, functional status, frailty, sarcopenia risk, perceived exertion, and health-related quality of life in adults aged 60 years or older who are hospitalized in an acute geriatric ward. The main questions it aims to answer are: 1. are there any difference in post exercise lactate at day 1 and 7 between the two groups? 2. does the lactate concentration reduces after low intensity resistance exercise in subject with high resting lactate? 3. Does virtual reality-assisted multimodal exercise improve functional independence, frailty status, sarcopenia risk, perceived exertion, and health-related quality of life from baseline to Day 7? Researchers will compare participants receiving conventional multimodal exercise plus virtual reality exercise with participants receiving conventional multimodal exercise alone to evaluate the additional effects of the virtual reality intervention. Participants will: * Undergo functional and medical assessments before starting the exercise program. * Receive an individualized conventional multimodal exercise program during hospitalization. * If assigned to the intervention group, perform additional virtual reality exercise using the VRAGMENT program. * Have capillary blood lactate concentrations measured immediately before and after standardized low-intensity resistance exercise on Day 1 and Day 7. * Complete the following assessments at baseline and on Day 7: * Barthel Index to assess functional independence. * Frailty Index-40 (FI-40) to assess frailty. * SARC-F to assess the risk of sarcopenia. * Borg Rating of Perceived Exertion (RPE) Scale to assess perceived exercise intensity. * EQ-5D-5L to assess health-related quality of life. * Have vital signs, exercise tolerance, and adverse events monitored throughout the intervention.

Radicle Women's HealthTM: A Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes Among Women Experiencing Menopausal Symptoms

Radicle Women's HealthTM: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue and related health outcomes among women experiencing menopausal symptoms.

Cancer-related Fatigue and Its Biological Contributors in Adolescent and Young Adult Brain Tumor Survivors: Effects of a Tele-exercise Intervention

The goal of this research study is to learn about the effects of the RISE-YA intervention on cancer-related fatigue in young adults who are brain cancer survivors.

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.

Effects of Taekwondo Match-Simulated Fatigue on Balance Performance in Female Athletes

Taekwondo is a high-intensity combat sport characterized by repeated explosive kicking actions and rapid changes in body position, requiring well-developed postural control to maintain technical performance and reduce injury risk. Although fatigue has been reported to impair balance performance, previous studies have primarily induced fatigue using non-specific laboratory protocols that do not adequately reflect the physiological and neuromuscular demands of taekwondo competition. Consequently, the effects of taekwondo-specific fatigue on static and dynamic balance performance remain insufficiently understood. The primary objective of this study will be to investigate the effects of a taekwondo match-simulated fatigue protocol on static and dynamic balance performance in female taekwondo athletes. Eighteen competitive female taekwondo athletes will participate in this single-group repeated-measures study. Following a familiarization session, participants will complete a standardized taekwondo match-simulated fatigue protocol consisting of three 2-minute rounds separated by 1-minute passive recovery periods, replicating the official Olympic competition format. Static and dynamic balance performance will be assessed before and immediately after the fatigue protocol using the Biodex Balance System (Biodex Medical Systems Inc., Shirley, NY, USA). Balance performance will be evaluated under static and dynamic testing conditions, and the Overall Stability Index, Anteroposterior Stability Index, and Mediolateral Stability Index will be recorded. The findings of this study are expected to improve understanding of the acute effects of sport-specific fatigue on postural control in female taekwondo athletes and may contribute to the development of evidence-based training and injury prevention strategies.

A Clinical Trial to Evaluate the Effects of a Supplement on Cognitive Function and Energy Levels

This study evaluates the effects of Artah's Cellular Hydration electrolyte supplement on cognitive function and energy levels in healthy adults aged 25-60 who experience mild to moderate fatigue, brain fog, or related symptoms. The trial is a single-arm, unblinded, virtual study in which all 50 participants will use the test product daily for 4 weeks. Participants will complete self-reported questionnaires at Baseline, Week 1, Week 2, Week 3, and Week 4, and will undergo cognitive battery testing at Baseline and Week 4. The primary endpoint is change in cognitive performance scores as measured by a standardized cognitive battery. Secondary endpoints include participants' self-reported perceptions of mental clarity, alertness, mood, physical performance, overall energy levels, and frequency of food cravings.

Behavioral and Neural Correlates of Post-Stroke Fatigue

The goal of this phase I/II clinical trial is to determine the behavioral and neural effects of 5-daily transcranial direct current stimulation on post-stroke fatigue. The three aims are: Aim 1: Investigate the behavioral effect of 5 daily sessions of anodal tDCS over the ipsilesional M1 on PSF. Aim 2: Investigate the neurophysiological effect of 5 daily sessions of anodal tDCS over the ipsilesional M1. Aim 3: Determine the relationship between changes in M1 excitability, brain connectivity and changes in PSF. Participants will receive either a real or sham stimulation for 5 consecutive days and fatigue will be assessed before, immediately after and 1-month after the intervention. Fatigue will be assessed using clinical, behavioral, and neurophysiological outcomes.

POSH-Ex: Physiotherapist-Led Telerehabilitation Exercise Programme for Postpartum Sexual Health

Postpartum women frequently experience impairments in sexual function, pelvic floor dysfunction, fatigue, and depressive symptoms, all of which may adversely affect their quality of life during the postpartum period. Although pelvic floor muscle training is recommended as part of postpartum rehabilitation, evidence regarding comprehensive physiotherapist-led exercise programmes specifically targeting postpartum sexual health remains limited. Furthermore, no standardized telerehabilitation programme has yet been evaluated using a randomized controlled trial design. The aim of this randomized controlled trial is to evaluate the effectiveness of the POSH-Ex (Postpartum Sexual Health Exercise) programme, a standardized 12-week physiotherapist-led telerehabilitation intervention designed to improve female sexual function and overall postpartum health after childbirth. Secondary objectives are to evaluate its effects on pelvic floor muscle strength, physical activity, fatigue, depressive symptoms, health-related quality of life, and body composition. A total of 84 postpartum women will be randomly allocated in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will complete supervised online exercise sessions twice weekly for 12 weeks, while participants in the control group will receive usual postpartum care. Outcome assessments will be performed at baseline and immediately after completion of the intervention. The primary outcome is female sexual function assessed using the Female Sexual Function Index (FSFI). Secondary outcomes include pelvic floor muscle strength, physical activity, fatigue, depressive symptoms, health-related quality of life, and body composition. The findings are expected to provide high-quality evidence regarding the effectiveness of a standardized telerehabilitation programme for postpartum rehabilitation and may contribute to the development of evidence-based postpartum rehabilitation programmes and future clinical practice guidelines.

Wellness App for Sleep Disturbance in Hematological Cancer Patients

In a randomized controlled trial (RCT), the investigators will recruit participants to an 8-week "app-based wellness" intervention, followed by a 12-week follow-up period. The investigators will recruit a total of 276 self-declared Chronic Hematological Cancer (CHC) patients who (representative of age, race/ethnicity, and gender) will be on stable CHC pharmacologic therapy (if any), self-identify as sleep disturbed (\>5 on Pittsburgh Sleep Quality Index), do not have a sleep disorder diagnosis, do not take sleep medication/supplements \>3 times per week, and are not currently practicing regular meditation. Aim 1: Test the efficacy of two app-based wellness programs (10 minutes per day) on the primary outcome of self reported sleep disturbance (Insomnia Severity Index (primary) and PROMIS Sleep Disturbance (secondary)) and secondary sleep outcomes including sleep impairment (PROMIS Sleep Impairment Scale) and sleep efficiency measured via sleep diaries and actigraphy. Aim 2: Test the efficacy of two app-based wellness programs (10 minutes per day) on inflammatory markers (i.e., TNF-a, IL-6, IL-8, CRP), fatigue, and emotional distress (i.e., anxiety, depressive symptoms measured with PROMIS®). Aim 3: Explore the sustained effects (i.e., 20 weeks from baseline) of two app-based wellness programs (10 minutes per day) in CHC patients.

A Clinical Trial to Evaluate the Effects of EMF Protection Devices on Sleep and Energy Levels

This study evaluates the effects of a selection of EMF protection devices (Home Harmonizers, Better ZZZs, iCell Chip, Car Harmonizer, Laptop Chip, XL Band, and Device Chips) on sleep quality, sleep quantity, and energy levels in adults aged 30-60 who currently experience sleep difficulties. The trial is a single-arm, unblinded, virtual study conducted over 4 weeks and 4 days (including a 4-day calibration period). Twenty-four participants will use all test products daily and complete self-reported questionnaires at Baseline, Day 2, Day 4, Week 1, Week 2, Week 3, and Week 4. Objective sleep data will be collected via an Oura Generation 3 ring worn throughout the study. Secondary outcomes include participants' perceptions of effects on sleep, energy, focus, and general well-being.

Radicle Energy™ DNB: A Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes

Radicle Energy™ DNB: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on fatigue and related health outcomes

A Study of Oxidative Pathways in MS Fatigue

This is a 4-week randomized, placebo-controlled, parallel group, double-blind, single center trial on effect of N-acetyl cysteine versus placebo on fatigue in patients with progressive MS defined by McDonald criteria. Subjects who enter the treatment phase of study, will be randomly assigned to either N-acetyl cysteine (1250 mg three times a day) or placebo (three times a day) for 4 weeks. There will be 3 in-person study visits (screening, baseline, and week 4) and 2 visits over the phone (week 2, and week 6 which is 2 weeks after completing last study drug dose). Visits will all occur in the morning to maximize consistency of assessments and evaluate main outcomes within 2 hours of morning dose of study medication. Fatigue questionnaires, and research samples will be obtained before neurological examination, or magnetic resonance imaging. Research blood draws will be obtained just after fatigue questionnaire completion. Brain spectroscopy will be obtained less than 2 hours after morning dose of study drug to maximize detection of the biological effect of study medication.

Radicle Women's Health DNS™: A Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Women's Health Outcomes

Radicle Women's Health DNSTM: A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue and related women's health outcomes

Modafinil to Improve Fatiguability

Cancer-related fatigue (CRF) and cancer-related cognitive impairment (CRCI) are among the most commonly reported disabling symptoms experienced by patients with advanced cancer. However, there are currently limited evidence-based pharmacologic interventions available. The investigators will conduct a Vanguard Randomized Clinical Trial (RCT) to estimate the effect of modafinil in managing CRF and CRCI, and to test the feasibility of carrying out the study.

Patient Descriptors Of Cancer-Related Fatigue: A Mixed Methods Pilot Study Of Cancer Survivors

The purpose of this research study is to better understand how cancer-related fatigue affects patients and how it's discussed with providers. This information will be used to develop an educational resource (visual aid poster) that could help individuals and their providers talk about cancer-related fatigue and which may help individuals better manage this symptom.

Transcranial Direct Current Stimulation for Long COVID Brain Fog and Fatigue

Long COVID can cause persistent symptoms such as fatigue, cognitive difficulties commonly described as brain fog, reduced exercise tolerance, and impaired quality of life. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may help modulate brain activity in regions involved in cognition, fatigue, and executive function. The NEUROSTIM-LC study will evaluate the feasibility and potential effects of repeated tDCS sessions in adults with long COVID presenting fatigue and/or brain fog. Participants will receive 30 sessions of tDCS applied over the left dorsolateral prefrontal cortex. Assessments will be performed before and after the intervention to evaluate changes in quality of life, fatigue, cognitive function, brain metabolism, physical performance, autonomic function, sleep quality, psychological symptoms, respiratory function, and blood biomarkers.