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99 Feasibility Trials Near You
Power is an online platform that helps thousands of Feasibility patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerDietary Intervention for Breast Cancer Risk Reduction
Columbus, Ohio
This clinical trial tests whether a new dietary pattern that consists of foods that lower the blood insulin response can reduce breast cancer risk in high-risk women. In a large group of patients, this new dietary pattern was associated with reduced risk of multiple cancers and reduced risk of long-term weight gain. Parts of this new dietary pattern are quite different from typical dietary recommendations, and much education is needed. Overall, compared to the typical American diet, this new dietary pattern is moderately low in total fat and saturated fat, low in protein from animal foods but high in protein from plant sources, high in fruits and vegetables, high in whole grains, and high in dietary fiber. We will determine if a low-insulinemic dietary pattern intervention is feasible and effective in reducing breast cancer risk in high-risk women.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:45+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Breast Cancer, BMI, Diabetes, Others
30 Participants Needed
Positive Psychosocial Intervention for Dementia
Fairborn, Ohio
The goal of this clinical trial is to test the feasibility of the Individualized Positive Psychosocial Interaction (IPPI) with 108 nursing home residents living with dementia and distress or depressive symptoms. The main questions it aims to answer are: •is it feasible to deliver the IPPI and track impact through data collected in the electronic medical records. Care partners will engage eligible residents in 2 brief preference-based IPPIs per week over the course of 6 months.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
135 Participants Needed
Gabapentin for Spinal Cord Injury Neurorecovery
Cleveland, Ohio
The objective of the proposed study is to conduct the first ever prospective, dose-exploration trial to test the feasibility of early administration of gabapentin as an intervention for neurorecovery. This research project falls under the Intervention Development stage of research as the primary goal is to assess the feasibility of conducting a well-designed intervention efficacy study in the future.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Moderate/severe TBI, Others
Must Not Be Taking:Gabapentinoids
42 Participants Needed
Music Therapy for Sickle Cell Disease
Cleveland, Ohio
This is a multi-site, multi-visit feasibility RCT of music therapy (MT) among adolescent and adult patients (aged 14 and older) with sickle cell disease (SCD).
Subjects will be randomized into one of three groups, either (1) 6 visits of in- person MT (InMT:); (2) 1 visit of in-person MT and 5 visits of virtual MT (HybMT); or (3) 1 visit of in-person health education and 5 visits of virtual health education (HybHE).
Cohorts of 15 participants (10 at site 1 and 5 site 2) will be recruited each quarter for 6 quarters to reach 90 participants. Cohorts will maintain a semi-structured recruitment, consenting, assessment, and intervention schedule.
The primary objective of the study is to examine the feasibility of study. This is defined by 6 metrics: (1) completeness of data collection, (2) participant screening, (3) participant recruitment, (4) participant retention, (5) Individual attendance and (6) Home practice. A final determination of "feasibility" for the study will be met if any 4 of the 6 metrics described above are met.
This study will also include a secondary objective of conducting qualitative interviews to assess feasibility of implementation.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:14+
Key Eligibility Criteria
Disqualifiers:Visual, Hearing, Cognitive Impairment, Others
90 Participants Needed
Genital Nerve Stimulation for Spinal Cord Injury
Cleveland, Ohio
The purpose of this study is to test whether electrical stimulation of the skin in the pelvic area (near the genitals) can reduce the reflexes that cause bowel accidents in people with spinal cord injuries. Current bowel treatments either involve diet and medications or surgery. This study will evaluate whether electrical stimulation can be an alternate option for bowel management.
Researchers will:
* Use an FDA approved Transcutaneous Electrical Nerve Stimulation (TENS) device off-label
* Compare a target stimulation level to a placebo stimulation level
Participants will:
* Use electrical stimulation on the skin in the pelvic area for 6-8 hours each day for 4 weeks at home
* Visit the research center 3 times to participate in exams and answer questions
* Keep a daily diary of their bowel symptoms and stimulation times
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Cardiac Pacemaker, Others
12 Participants Needed
Educational Website for Reproductive Coercion
Ann Arbor, Michigan
The goal of this clinical trial is to evaluate the feasibility and acceptability of "BRIDGES" (Building Reproductive Decision-Making, Empowerment, \& Support), a new patient-directed educational website (bridges4support.org). BRIDGES aims to improve family planning (FP) patients' understanding of reproductive coercion (RC) and harm-reduction strategies, as well as their ability to discuss RC-related issues with healthcare providers if they so choose. Designed to be integrated into routine FP clinical care and pre-visit materials, this brief (5-10 minute) educational website includes 1) education on reproductive coercion and (un)healthy relationships, 2) harm-reduction and safety planning strategies, and 3) patient activation messages to encourage patients to actively engage with their healthcare provider. Four study clinics were selected from Planned Parenthood of Michigan (PPMI) clinics based on patient volume and number of clinics. Two of the four chosen clinics will be randomly assigned to receive BRIDGES, with 40 participants per clinic, and the other two clinics will be randomly assigned to receive the standard of care, also with 40 participants per clinic. Control clinics will receive the standard of care, which includes the typical support and counseling provided at these centers for FP patients, and the intervention clinics will receive BRIDGES plus standard of care. Research staff will recruit FP patients ages 18-29 (N=160) through patient portal messages. Participants will complete online, self-directed Qualtrics surveys at three time points: pre-appointment, post-appointment, and 3-months. Survey data will be used to assess differences in patient knowledge, self-efficacy, and behavior between patients attending intervention clinics and patients attending control FP clinics (i.e., receiving standard-of-care FP services). Feasibility, implementation, and pilot outcome data will be used to further refine the intervention towards the goal of conducting a future larger-scale study of BRIDGES within FP clinics.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:18 - 29
Sex:Female
Key Eligibility Criteria
Disqualifiers:Previous Exposure, No Valid Email
160 Participants Needed
Exercise Programs for Knee Arthritis
Pittsburgh, Pennsylvania
This pilot randomize trial tests the feasibility of administering two different exercise programs in people with knee osteoarthritis. One group receives the exercise program administered as usual, and the other group received the exercise program with resting intervals.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:45 - 79
Key Eligibility Criteria
Disqualifiers:Cardiovascular Disease, Hypertension, Inflammatory Disorders, Others
20 Participants Needed
TEA Device Usability and Safety Study
Ann Arbor, Michigan
This project is being completed to test the usability and safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device.
This is a pilot study that will lead to future projects for cancer patients that may experience chemotherapy-induced symptoms.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Implanted Devices, Concurrent Study, Compliance Issues, Others
20 Participants Needed
Ketamine for Chronic Lower Back Pain and Depression
Ann Arbor, Michigan
This is a pilot study to evaluate the feasibility, acceptability, and safety of ketamine infusions followed by a brief behavioral intervention in Veterans with chronic low back pain and depression.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Psychotic Disorders, Uncontrolled Hypertension, Cardiac Condition, Others
44 Participants Needed
Microeconomic Intervention for HIV Prevention
Highland Park, Michigan
The aim is the current study is to establish feasibility and acceptability of the SeCuRE intervention to improve HIV prevention and care continua outcomes. To meet this aim, the study has the following objectives:
1. To deliver a two-armed pilot RCT of the SeCuRE intervention with 40 transgender women of color.
2. The determine acceptability of the intervention with transgender women of color.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Non-transgender, Non-person Of Color, Others
40 Participants Needed
Nutritional Support for Esophageal Cancer
London, Ontario
Patients diagnosed with esophageal cancer have difficulty eating, as the food pipe becomes obstructed by the cancer. This may impair the ability for the patient to receive appropriate calorie intake, especially during administration of chemotherapy and radiation therapy given prior to surgical resection.
A strategy is to place a feeding tube directly in the stomach or in the small bowel to have an access to the patient's gastrointestinal tract during administration of chemo radiation therapy. However, these feeding tubes may lead to adverse events, including dislodgement, infection, the tube may be plugged, etc. If these complications were to happen, patients may have their treatment delayed, may have to come to the emergency department or even be admitted. In some cases, patients may need to have a surgery performed to treat the complication. Most centres in Canada have moved away from placement of these feeding tubes due to the high incidence of complications associated with the feeding tubes placement, and due to the high efficacy from the chemoradiation therapy in shrinking the tumour, allowing for the patient to swallow.
In London, the preference from the Medical and Radiation Oncologists was to have these feeding tubes placed to avoid delay in treating the patients. There is therefore significant controversy as to what is the best approach in this patient population. Our goal is to run a feasibility randomized controlled trial studying this question.
No Placebo Group
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
26 Participants Needed
TXA for Bleeding in Liver Surgery
London, Ontario
This is a Phase III multicentre randomized controlled trial (RCT) to evaluate the impact of tranexamic acid (TXA) on perioperative blood transfusion in patients undergoing liver resection. The rationale for this study includes: (1) experimental evidence supporting the use of TXA in other surgical populations; (2) lack of evidence in patients undergoing liver resection; (3) clinical uncertainty and extensive support amongst hepatobiliary surgeons, anaesthesiologists, and hematologists for this proposed trial; (4) a feasible and efficient study design; and (5) the importance of the question: incidence of blood transfusion in patients undergoing liver resection is high, and the consequences serious. The sample size for this study is 1230 participants.Participants enrolled in the prior Vanguard study will proceed directly into the RCT.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Severe Anemia, Thrombosis, Renal Insufficiency, Seizure Disorder, Others
Must Not Be Taking:Anticoagulants, Thrombin Inhibitors
1386 Participants Needed
Helping Hand Program for Osteoarthritis
London, Ontario
The goal of this study is to to examine the feasibility of a full-scale trial on Helping Hand, a new Joint Protection Program for Hand Osteoarthritis and to examine the acceptability of the new Joint Protection Program.
This study will not assess the effectiveness of the program, as it is not designed or powered to do so. Instead, the information gathered will be used to refine the trial design and ensure the future full-scale trial that will assess the effectiveness of the program is robust and successful. The acceptability of the new Joint Protection Program will be assessed through a survey that will be administered to the intervention group at the end of the trial, which will be based on a standardized acceptability framework
Participants will:
Gain access to an online Joint Protection Program or continue to receive usual care for 12 weeks Visit the clinic or complete online assessments once every 4 weeks Keep a diary of their symptoms and the number of times they used other interventions to manage their symptoms (i.e. painkillers)
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Neurological Disorders, Dementia, Cognitive Conditions, Others
60 Participants Needed
Brain Stimulation + FES Cycling for Spinal Cord Injury
London, Ontario
This trial tests if combining brain and muscle electrical stimulation helps people with partial spinal cord injuries walk better by improving muscle strength and coordination. Functional electrical stimulation (FES) has been used to assist walking and improve muscle strength in individuals with spinal cord injuries.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Orthopedic, Neurological, Implanted Devices, Others
14 Participants Needed
Splenic Stimulation for Rheumatoid Arthritis
Altoona, Pennsylvania
This study will evaluate the safety, tolerability, and effects of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, external components and accessories. The study will consist of 4 study periods, including a Randomized Control Trial period (Period 1), an Open Label period (Period 2), a Treat-to-target period (Period 3), and a Long-term Follow-up period (Period 4). Participants eligible for implant will have active rheumatoid arthritis (RA) and have an inadequate response or intolerance to at least two biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) or JAK inhibitors (JAKis). A sufficient number of participants will be enrolled so that approximately 28 participants will undergo device implantation.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:22 - 75
Key Eligibility Criteria
Disqualifiers:Psychiatric Disease, Substance Abuse, Tuberculosis, HIV, Others
Must Be Taking:Conventional DMARDs
28 Participants Needed
Denosumab for Broken Bones in Dialysis Patients
Woodstock, Ontario
PREFERRED-1 is a pilot study designed to determine the feasibility of a large randomized, pragmatic, open-label, comparative-effectiveness trial of denosumab for the prevention of fragility fractures in people receiving hemodialysis. The pilot study will enroll at least 60 patients from across at least 6 different hemodialysis centres in Ontario, Canada. Patients on outpatient maintenance hemodialysis at high risk of fragility fracture, will be randomized 1:1 to a denosumab care pathway vs. usual care.
Primary outcomes include recruitment feasibility and treatment adherence. Secondary outcomes include safety and participant satisfaction with our protocol and processes.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:40+
Key Eligibility Criteria
Disqualifiers:Kidney Recovery, Palliative Care, Childbearing, Others
Must Not Be Taking:Osteoporosis Medications
60 Participants Needed
Point of Care Testing for Toxoplasmosis
Chicago, Illinois
This is part of a feasibility study to compare the predicate standard FDA cleared test for serum to a point of care test Toxoplasma ICT IgG-IgM BK produced by LD Bio Diagnostic. The specificity and sensitivity in testing serum and whole blood will be compared. This study includes 70 persons either pregnant or non pregnant.
This is being done in accordance with FDA requirements for clearance of a testing device . The investigators will use a standard FDA cleared test in all studies. The FDA has suggested that the investigators submit a pre subQ for a 510K and dual CLIA waiver.
This allows the investigators also to determine feasibility of use of the predicate test in conjunction with the experimental test with volunteers, including men, women, and pregnant women.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy 17-27 Weeks
70 Participants Needed
Empagliflozin for Chronic Kidney Disease
Chicago, Illinois
The goal of this study is to learn if a clinical trial of sodium-glucose co-transporter 2 inhibitors (SGLT2i) is possible in youth with chronic kidney disease (CKD). The investigators also plan to explore whether treatment with SGLT2i (Empagliflozin) helps improve risk factors for worsening kidney and heart disease. The main questions are:
1. Is enrolling 40 youth with CKD into a clinical trial of empagliflozin feasible (ie achievable)?
2. Does taking empagliflozin for 3 months result in positive changes in blood, urine, and heart function tests?
Participants will be randomly selected (like flipping a coin) to either receive empagliflozin or not start treatment with empagliflozin and remain on their usual care.
Study Procedures Include
* For participants randomly selected for treatment, take empagliflozin once daily for 3 months
* Phone calls with researchers every 2 weeks for check-ins
* For participants taking empagliflozin, clinic visits 4 and 8 weeks after starting for check-ups and tests
* All study participants will have clinic visits at the beginning and end (3 months) where researchers will collect information about their health and perform tests
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:12 - 25
Key Eligibility Criteria
Disqualifiers:Heart Disease, Diabetes, Pregnancy, Others
Must Not Be Taking:SGLT2i, Immunosuppressives
40 Participants Needed
Remote Exercise Training for Multiple Sclerosis
Chicago, Illinois
This trial investigates a home-based exercise program for Hispanics/Latinos with multiple sclerosis (MS). The program includes flexibility, aerobic, and resistance exercises guided by experienced coaches. It aims to improve physical function, manage symptoms, and enhance quality of life for this underserved group. The study also examines how factors like income and access to healthcare affect the program's success.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Age, MS Diagnosis, Physical Activity, Others
33 Participants Needed
Retinal Health Sensor Evaluation for Electrode Site Reaction
Chicago, Illinois
The primary purpose of this study is to evaluate the ability of a new contact lens electrode to record a measurable electroretinogram (ERG). ERG sensors in various forms have been in common clinical use for more than 50 years. The ERG sensor that is the subject of this study is the RM Electrode, developed by RetMap, Inc. (project sponsor). The subject of this study is the RM Electrode, a new ERG sensor developed by RetMap, Inc. The RM Electrode is not yet approved by the FDA. The testing described in this study has been requested by the FDA (pre-submission feedback) in support of the 510k application for the RM Electrode. ERG Jet Electrode (Fabrinal, Switzerland) will be used as the predicate device for comparison.
The first Aim of the present study is to compare the functionality of the RM Electrode and the ERG Jet. Following standard ERG test protocols, responses will be recorded from ten healthy (normally-sighted) adult subjects using both electrodes (used in random order). The signal quality of the ERG responses obtained from both contact lens electrodes will be compared. Signal quality will be determined by measuring ERG signal amplitudes and calculating signal-to-noise ratios (SNR). Signal-to-noise ratios will be used to establish substantial equivalence. ERG test results will not be used to determine the effect of the devices on the participants.
The second Aim of the present study is to evaluate the risk of ocular irritation caused by use of the RM Electrode compared to the ERG Jet Electrode. A typical ERG test session lasts 20 minutes. Ten healthy (normally-sighted) adult subjects will wear the RM Electrode on one eye and the ERG Jet Electrode on the other eye, for a total of 60 minutes, in 20-minute sessions with short breaks in between. To determine the effect of the devices on the participants, the eyes will be evaluated for irritation.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Early Phase 1
Key Eligibility Criteria
Disqualifiers:Pregnancy, Retinal Disease, Ocular Surgery, Others
90 Participants Needed
Why Other Patients Applied
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
Chiropractic Care for Back Pain
Hamilton, Ontario
The investigators will conduct a pilot cluster randomized controlled trial (RCT) of chiropractic care added to usual medical care, versus usual medical care alone, for adult patients prescribed opioid therapy for chronic non-cancer spinal pain at four community health centers (CHCs) in Ontario, Canada. These centers provide services to communities and vulnerable populations with high unemployment rates, multiple co-morbidities, and high rates of chronic musculoskeletal disorders that are commonly managed with prescription opioids.
The investigators hypothesize that a full-scale (definitive) cluster RCT on the impact of chiropractic care on prescription opioid use for chronic non-cancer spinal pain will be feasible within the Ontario CHC context.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Chiropractic Care, Opioid Naive, Spinal Neoplasms, Others
Must Be Taking:Opioids
25 Participants Needed
Caffeine for Cardiovascular Disease
Hamilton, Ontario
Caffeine is one of the most widely consumed substances worldwide. This study looks to test and measure the changes in different biomarkers in the blood before and after having caffeine using capillary and venous blood sampling methods. A biomarker is a measurable indicator of biological processes. The primary goal of this clinical trial is to evaluate participant rate and adherence. It will also learn about how caffeine affects different biomarkers that may be related to cardiovascular disease. Finally, it will assess the accuracy of the capillary blood samples compared to the venous blood samples. The main questions it aims to answer are:
* What is the feasibility of recruiting and retaining participants?
* Are the study procedures appropriate to be translated to a larger future study?
Researchers will compare caffeine to a placebo (a look-alike substance that contains no drug) to see if
Participants will:
* Be randomly assigned to the control group or the caffeine group. Individuals in the control group will be taking a placebo pill with no effect and those in the caffeine group will be taking 400mg of caffeine in pill form.
* Be asked to undergo a fast of at least 8 hours overnight before taking two placebo pills or the 400 mg of caffeine via two caffeine pills. They will be required to stay fasted for 6 hours after taking the pill as well. The total time fasted will be at least 14 hours.
* Have blood collected using three different methods before taking the two pills, 3 hours after taking the pills and 6 hours after taking the pills. The 3 methods include intravenous (IV) blood sampling, finger prick and collection on Whatman 903 Protein Saver Card and collection using the TASSO+ device. The TASSO+ blood collection device is a small capillary blood collection device that is designed to be easy to use and able to be used outside of a hospital/lab setting. Whatman 903 Protein Saver Cards are special filter paper with five circles for samples, that are designed for the collection and storage of blood.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Early Phase 1
Key Eligibility Criteria
Disqualifiers:Pregnancy, Diabetes, Hypertension, Heart Disease, Others
Must Not Be Taking:Caffeine-interacting Medications
36 Participants Needed
Kiwifruit Extract for Constipation in Children
Hamilton, Ontario
The goal of this pilot feasibility randomized controlled trial is to determine whether Actazin (kiwifruit extract) is a feasible and effective alternative to polyethylene glycol 3350 (PEG 3350) for maintenance therapy in children with functional constipation (FC). This study will include children aged 4 to 17 years who meet the Rome IV criteria for functional constipation.
The main questions it aims to answer are:
1. Is it feasible to conduct a definitive, multi-centre trial comparing Actazin to PEG 3350 in children with FC?
2. What are the within-group differences in clinical outcomes such as stool frequency, abdominal pain, and laxative use over a 4-week period?
Researchers will compare chewable Actazin tablets with placebo PEG 3350 powder to PEG 3350 powder with placebo Actazin tablets to see if Actazin is a viable non-pharmacologic natural health product alternative for treating FC.
Participants will:
Undergo an initial bowel cleanout using PEG 3350 and bisacodyl. Following, they will be randomized to one of two groups:
1. Actazin chewable tablets (titrate to effect: 600-2400 mg/day) + placebo PEG 3350
2. PEG 3350 (dose based on age and titratable to effect) + placebo Actazin chewable tablets Participants will take the assigned intervention daily for 4 weeks and complete a daily bowel diary recording stool frequency, consistency (Bristol Stool Scale), abdominal pain, and laxative use. They will have weekly follow-ups via phone or electronic survey to assess adherence, medication use, and adverse events.
Additionally, a bi-weekly follow-up will be conducted for an additional 8 weeks to track longer-term outcomes.
Outcomes:
Primary feasibility outcomes include consent rate, adherence to allocated intervention, and 4-week follow-up completion rate.
Secondary clinical outcomes include resolution of FC (Rome IV criteria), weekly stool frequency, abdominal pain episodes, use of rescue laxatives, and treatment palatability.
This study is being conducted at McMaster Children's Hospital and is funded by the Hamilton Academic Health Sciences Organization (HAHSO). Data collection will be managed using the Lumedi™ platform, and safety will be overseen by a Data Safety Monitoring Board (DSMB).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2, 3
Age:4 - 17
Key Eligibility Criteria
Disqualifiers:Celiac, Hirschsprung's, Spina Bifida, Others
Must Not Be Taking:Opioids, Domperidone, Linaclotide, Others
60 Participants Needed
Tecovirimat for Monkeypox
Toronto, Ontario
PLATINUM-CAN is a parallel collaborative trial linked with the sister trial PLATINUM led by Oxford University. PLATINUM-CAN is a multi-centre, randomized, placebo-controlled trial of Tecovirimat in non-hospitalized patients with presumptive or PCR confirmed monkeypox infection. The study will provide evidence on the efficacy and safety of Tecovirimat for laboratory-confirmed monkeypox in outpatients with monkeypox infection and determine the feasibility of conducting interventional monkeypox trials in Canada.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
120 Participants Needed
Ketamine + Cognitive Behavioral Therapy for Neuropathic Pain
Toronto, Ontario
The purpose of the study is to investigate new therapies to alleviate pain on neuropathic chronic pain. At this time, the main purpose is to complete a feasibility or pilot study with 60 participants suffering from neuropathic chronic pain. Participants will be randomized to (1) Ketamine (Hydrochloride) HCL; (2) psychotherapy (using Cognitive Behavioral Therapy); or (3) a combination of Ketamine HL and psychotherapy.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, Hypertension, Others
Must Not Be Taking:Theophylline, Aminophylline, Others
30 Participants Needed
Social-emotional Learning Curriculum for Youth Feasibility
Toronto, Ontario
The goal of this cluster randomized trial is to:
1. primary purpose: to determine the feasibility of a novel social-emotional learning curriculum when implemented in the beyond 3:30 after school program; 2a. secondary purpose: to determine whether the novel social-emotional learning curriculum has positive effects youth social emotional learning skills; 2b. secondary purpose: to determine whether the novel social-emotional learning curriculum has positive effects on youth resilience and overall functioning.
Participants:
1. Beyond 3:30 facilitators
2. Youth aged 11-14 who participate in the beyond 3:30 program
3. Parents of youth who participate in the beyond 3:30 program
The main questions this study aims to answer are:
Primary Objectives:
1. Is the novel social-emotional curriculum feasible within the beyond 3:30 after school program?
2. Is the novel social-emotional curriculum acceptable within the beyond 3:30 after school program?
3. Is the novel social-emotional curriculum appropriate within the beyond 3:30 after school program?
Secondary Objectives: Social-emotional learning skills 1. Have youth social-emotional learning skills improved as a result of participating in the novel social-emotional learning curriculum?
Secondary Objectives: Resilience and overall functioning
1. Have youth resilience abilities and overall functioning improved as a result of participating in the novel social-emotional learning program?
Comparator:
Primary objective: Feasibility - There is no comparison group for the feasibility objectives.
Secondary objective: Social-emotional learning skills
* The investigators will compare the intervention arm \[10 sites within the beyond 3:30 program who will implement the EMPOWER social-emotional learning curriculum\] with the usual programming control arm \[10 sites within the beyond 3:30 program who will implement the usual beyond 3:30 program\]
Secondary objective: Resilience and overall functioning
- The investigators will compare the intervention arm \[10 sites within the beyond 3:30 program who will implement the EMPOWER social-emotional learning curriculum\] with the usual programming control arm \[10 sites within the beyond 3:30 program who will implement the usual beyond 3:30 program\]
Measures:
Primary Objective: Feasibility
After school program staff participants in the intervention arm will be asked to complete:
- 3 feasibility measures (feasibility, acceptability, appropriateness of intervention) every 4-weeks after each social-emotional module they complete teaching.
- weekly fidelity checklists to assess feasibility.
Youth participants in the intervention arm will be asked to complete:
- the intervention appropriateness measure during the post-curriculum data collection time point.
Secondary Objective: Social-emotional learning skills
After school program staff participants in both intervention and usual programming arms will be asked to complete the following measure pre- and post-curriculum implementation:
- social-emotional learning skills measure for each youth aged 11-14 years in their class.
Youth participants in both intervention and usual programming arms will be asked to complete the following measure pre- and post-curriculum implementation:
- social-emotional learning skills measure Parents participants whose youth are in the intervention arm will be asked to participate in an interview.
Secondary objective: Resilience and overall functioning
After school program staff participants in both intervention and usual programming arms will be asked to complete the follow measures pre- and post-curriculum implementation:
- overall functioning measure for each youth aged 11-14 years in their class.
Youth participants in both intervention and usual programming arms will be asked to complete:
* resilience measure
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Age:11+
Key Eligibility Criteria
Disqualifiers:Not Listed
650 Participants Needed
Online Psychology Program for Post-Surgical Pain
Toronto, Ontario
This project will evaluate the feasibility of a new fully self-guided online Acceptance and Commitment Therapy (ACT) program entitled Advancing Online Psychology Tools for the Transitional Pain Service (ADOPT-TPS), developed on an online health application platform called Manage My Pain (MMP). The ACT program is designed to teach mindfulness skills and provide psychoeducation about post-surgical pain. The feasibility of the self-guided online program will be compared to a pre-existing psychologist-guided workshop that delivers the same program. It is anticipated that the self-guided online ACT program will be deemed feasible by participants.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Serious Mental Illness, Dementia, Others
60 Participants Needed
Radiofrequency Ablation for Thyroid Cancer
Toronto, Ontario
The goal of this clinical trial is to test radiofrequency ablation (RFA) in thyroid cancers ≤2 cm in diameter. The main question it aims to answer is:
• What is the feasibility of RFA use for low-risk thyroid cancers (≤2 cm)?
Participants will undergo a set of pre-procedural scans of the target thyroid nodule and undergo the RFA procedure/intervention. Then, participants will partake in three follow-up appointments at 4 weeks, 6 months, and 12 months post-procedure as per standard of care.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Invasive Cancer, Prior Treatment, Others
40 Participants Needed
Resistance Training for Prostate Cancer
Toronto, Ontario
Prostate cancer and its treatment are associated with many long-term adverse effects including cancer-related cognitive impairment. Specifically, androgen deprivation therapy has been shown to negatively impact cognitive function. Combined aerobic and resistance training has been shown to improve cognitive function in men treated with androgen deprivation therapy, but limited research has observed its impact into survivorship. Additionally, existing study designs are limited to supervised, combined aerobic and resistance training interventions. Remotely-delivered resistance training programs could enhance exercise participation by overcoming commonly reported barriers in men living with and beyond prostate cancer such as transportation, distance to facility, and timing of programs. Alongside the needs to address cancer-related cognitive impairments due to androgen deprivation therapy, resistance training may serve to manage functional deficits, losses in bone mineral density and muscle mass and increases in cardiometabolic risk factors. This study will assess the feasibility of an 8-week remotely-delivered resistance training program to improve cognitive function in men living with and beyond prostate cancer who have a history of androgen deprivation therapy treatment.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Male
Key Eligibility Criteria
Disqualifiers:Other Cancer, Recent Fall, Gait Aid, Others
Must Be Taking:Androgen Deprivation Therapy
30 Participants Needed
Lemborexant for Insomnia and Depression
Toronto, Ontario
The goal of this clinical trial is to learn if Lemborexant works to treat residual insomnia in adults with depression that is being treated. It will also learn about how practical, tolerable, and effective Lemborexant is. The main questions it aims to answer are:
* Does Lemborexant help participants improve sleep and reduce insomnia symptoms?
* How practical is it to use Lemborexant (how many participants join, drop out, and follow the study rules)? How do participants feel about using it (based on surveys and interviews)?
Researchers will compare Lemborexant to a placebo (a look-alike substance that contains no drug) to see if Lemborexant works to treat residual insomnia in adequately treated major depressive disorder.
Participants will:
* Take Lemborexant or a placebo every day for 6 weeks (2 weeks at 5 mg then 4 weeks at 10 mg)
* Complete clinical assessments and in-person study visits
* Maintain a digital sleep diary and complete daily and weekly self-report ecological momentary assessments (EMAs)
* Use a wearable device which will be used to collect and monitor physiological data
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, Substance Abuse, Bipolar, Others
Must Not Be Taking:Sleep Aids, Antidepressants
30 Participants Needed
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We started Power when my dad was diagnosed with multiple myeloma, and I struggled to help him access the latest immunotherapy. Hopefully Power makes it simpler for you to explore promising new treatments, during what is probably a difficult time.
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Frequently Asked Questions
How much do Feasibility clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Feasibility clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Feasibility trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Feasibility is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Feasibility medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Feasibility clinical trials?
Most recently, we added Ketamine for Chronic Lower Back Pain and Depression, TEA Device Usability and Safety Study and Helping Hand Program for Osteoarthritis to the Power online platform.
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