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158 Clinical Paid Trials near Kentucky
Power is an online platform that helps thousands of 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 PowerVeraCept IUD for Preventing Pregnancy
Cincinnati, Ohio
To assess the contraceptive efficacy (prevention of pregnancy) of VeraCept
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:< 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Cancer, HIV, Others
Must Not Be Taking:Hormonal Contraceptives
1620 Participants Needed
Injectable Cabotegravir for HIV Prevention
Cincinnati, Ohio
This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Not Listed
4570 Participants Needed
Chemotherapy + Immunotherapy for Acute Lymphoblastic Leukemia
Cincinnati, Ohio
This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:30 - 70
Key Eligibility Criteria
Disqualifiers:Mature B ALL, Active Malignancy, Others
Must Be Taking:Antiretrovirals
488 Participants Needed
Tapinarof Cream for Plaque Psoriasis
Louisville, Kentucky
To compare the safety and efficacy of the test (Tapinarof Cream 1%), placebo (vehicle cream) and reference VTAMA® (Tapinarof Cream 1%) treatments to demonstrate clinical equivalence in patients with plaque psoriasis.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Unstable Psoriasis, Immunosuppression, Others
Must Not Be Taking:Biologics, Systemic Steroids
560 Participants Needed
mRNA-1273.214 Vaccine for COVID-19 in Children
Lexington, Kentucky
This trial tests updated COVID-19 vaccines on young children. The vaccines use mRNA to teach the body to recognize and fight the virus. The study aims to ensure these vaccines are safe and effective for this age group.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:6 - 5
Key Eligibility Criteria
Disqualifiers:SARS-CoV-2 Infection, Immunodeficiency, Others
Must Not Be Taking:Immunosuppressants, Monoclonal Antibodies
1860 Participants Needed
Bupivacaine Injection for Pudendal Neuralgia
Louisville, Kentucky
Chronic pain affecting the pelvic and urogenital area is a major clinical problem and can have a profound impact on quality of life and health care costs. Pelvic pain arising from entrapment or neuropathy of the pudendal nerve is known as pudendal neuralgia, which results in chronic perineal pain. This pain syndrome is difficult to diagnose and patients with pudendal neuralgia may present to providers with refractory chronic pelvic pain. Pudendal nerve infiltration or pudendal nerve block (PNB) serves as a diagnostic tool and treatment modality for patients with this condition. To date, there are no published randomized controlled trials comparing imaging-guided PNB to transvaginal finger-guided PNB. While one can assume that image-guided nerve blocks will provide better accuracy for injection and potentially better efficacy in pain relief as a result, no published data exists comparing the outcomes and efficacy between modalities.
The purpose of this prospective, non-inferiority, randomized controlled trial is to compare the efficacy of pain relief from bilateral transvaginal finger-guided pudendal nerve block versus bilateral fluoroscopy-guided trans gluteal pudendal nerve block for patients with pudendal neuralgia.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Recent Pelvic Surgery, Neurologic Disease, Others
40 Participants Needed
COVID-19 and Flu Vaccines for Pregnant Women
Cincinnati, Ohio
This study is a prospective, randomized clinical trial. During this study, pregnant women will be randomly assigned to receive IIV and mRNA COVID-19 vaccine either simultaneously or sequentially (7-14 days apart). All participants will receive an mRNA COVID-19 vaccine at Visit 1 (Day 1).
Solicited local and systemic symptoms of reactogenicity will be assessed on day of visit for Visits 1 and 2 and daily during the 6 days following each visit using either electronic or paper symptoms diaries, depending on study participant preference. Serious adverse events (SAE) and adverse events of special interest (AESI) will be collected throughout the duration of the study.
Pregnant women will be followed through delivery with comprehensive obstetric and infant outcomes obtained from medical record review for 90 days post-delivery.
Maternal serum samples will be collected for antibody titers relevant to Influenza and COVID-19 prior to vaccination, at Day 29 (both groups), as well as Days 36-43 if in sequential group. When feasible, maternal blood at delivery and cord blood serum will be analyzed for serological analyses of placental influenza and COVID-19 antibody transfer (cord blood: maternal antibody ratio) will be determined.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Sex:Female
Key Eligibility Criteria
Disqualifiers:Immunosuppression, Hepatitis B, Hepatitis C, Others
Must Not Be Taking:Immunosuppressants, Anticancer Chemotherapy
350 Participants Needed
Metaxalone for Lower Back Pain
Wheelersburg, Ohio
The goal of this clinical trial is to learn if a modification to metaxalone 640 mg can reduce low back and leg pain. The participants will be 18 to 80 years old, healthy with newly occurring back or leg pain. The main question aims to compare a group taking active treatment and a group taking a look-alike substance containing no active treatment. All participants will answer questions on Day 1, before treatment, and on 7-day after treatment, about:
* Amount and quality of pain
* Interference with physical activity
* Interference with sleep
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Clinically Significant Conditions, Others
Must Not Be Taking:Skeletal Relaxants, Pain Relievers, Cimetidine, MAO Inhibitors
50 Participants Needed
mRNA COVID-19 Vaccine Safety With Childhood Vaccines
Cincinnati, Ohio
This is a prospective, randomized, open-label clinical trial to evaluate the safety of COVID-19 vaccination and other routine childhood vaccines given simultaneously at Visit 1, as compared to sequential vaccination of COVID-19 vaccine and other vaccines at separate visits (Visits 1 and 2).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:6 - 4
Key Eligibility Criteria
Disqualifiers:Seizures, Allergies, Immunosuppression, Others
Must Be Taking:MRNA COVID-19 Vaccine
344 Participants Needed
Mirabegron + Tadalafil for Prediabetes
Lexington, Kentucky
This trial is testing whether mirabegron, a drug that helps the body use sugar better, can improve blood sugar levels in obese, insulin-resistant people who are prediabetic. Mirabegron is a β3-adrenergic receptor agonist initially approved for treating overactive bladder, with potential benefits for metabolic diseases. The study also looks at whether adding tadalafil, another drug, can make mirabegron work even better. Participants will be treated for several months.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:35 - 65
Key Eligibility Criteria
Disqualifiers:Diabetes, Unstable Conditions, Inflammatory, Others
Must Not Be Taking:Antidiabetics, Steroids, NSAIDs, Anticoagulants
96 Participants Needed
Escitalopram for Anxiety
Cincinnati, Ohio
This double-blind, 12-week study will consist include132 anxious youth who are randomized (1:1) to standard or pharmacogenetically-guided escitalopram dosing. Block randomization (1:1) will be stratified by sex and metabolizer status.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:12 - 17
Key Eligibility Criteria
Disqualifiers:Mood Disorders, Intellectual Disability, Trauma, Others
Must Not Be Taking:SSRIs, Psychiatric Medications
132 Participants Needed
Metronidazole for Postoperative Pain in Endometriosis
Louisville, Kentucky
This trial is testing if taking the antibiotic metronidazole can reduce pain after endometriosis surgery in women aged 18-50. The antibiotic works by killing bacteria to prevent infections, which might help with pain relief.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Breastfeeding, Elevated Creatinine, Others
Must Not Be Taking:Disulfiram
90 Participants Needed
Atorvastatin for Preventing Dementia
Cincinnati, Ohio
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia will demonstrate the benefit of statins for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:75+
Key Eligibility Criteria
Disqualifiers:Cardiovascular Disease, Dementia, ADL Dependence, Others
Must Not Be Taking:Statins
20000 Participants Needed
Sertraline for Anxiety Disorders
Cincinnati, Ohio
A Multicenter, acute, randomized, double-blind, placebo-controlled, flexible-dose trial with the treatment of sertraline.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:8 - 17
Key Eligibility Criteria
Disqualifiers:Mood, Eating, Bipolar, Psychotic, Others
Must Not Be Taking:SSRIs, CNS Drugs
150 Participants Needed
RSV Vaccination + Immunization for Respiratory Syncytial Virus
Cincinnati, Ohio
Respiratory Syncytial Virus (RSV) is the leading cause of lower respiratory tract infections (LRTIs) in infants and young children. It is also a leading cause of mortality in children \<5 years of age worldwide. Until recently, no Food and Drug Administration (FDA)-approved vaccines were available to prevent RSV infection. The only prophylactic product for RSV prevention recommended for infants was the monoclonal antibody palivizumab, but administration was limited to those with extreme prematurity, chronic lung disease, or hemodynamically significant congenital heart disease. However, in 2023, the FDA approved two products designed to prevent RSV lower respiratory tract disease (LRTD) in all infants: an active RSV vaccine based on the prefusion F protein (RSVpreF, ABRYSVO, Pfizer) administered during pregnancy, and a passive, long-acting monoclonal antibody (nirsevimab-alip \[henceforth referred to as nirsevimab\], BEYFORTUS, AstraZeneca) administered to infants at birth or at the start of their first RSV season. Both products were evaluated in Phase 3 pivotal clinical trials and have high efficacy in preventing LRTD caused by RSV in infants. Although there is no established correlate of protection against RSV, antibodies have been associated with protection across multiple studies. The clinical development plan for the products did not include comprehensive evaluations of the magnitude and durability of the immune response, nor were the two products tested in a single trial. This study is a prospective, randomized, open-label Phase 4 study with the primary objective of evaluating the magnitude and durability of RSV-specific neutralizing antibodies in infants through 12 months of life following either maternal RSV vaccination, infant nirsevimab administration, or both products combined.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Psychiatric Disease, Immune Impairment, Others
Must Not Be Taking:Immunosuppressants, Corticosteroids
181 Participants Needed
Diagnostic Imaging for Pancreatitis
Cincinnati, Ohio
This study seeks to understand the performance of MRI to characterize pancreatitis and predict chronic complications (endocrine and exocrine) of pancreatitis. Through multiple aims, the investigators will benchmark MRI against relevant reference standards (e.g. endoscopic pancreatic function tests, laboratory data). The investigators will also characterize repeatability of the imaging findings and will work to develop methods to simplify and automate analysis of the MRI images.
Research interventions depend on the Aim(s) participants enroll in but include: endoscopic pancreatic function testing (added on to clinically indicated upper GI endoscopy), blood tests, stool tests, gene sequencing, and survey completion. All participants will undergo research MRI examinations, a subset of which will include administration of intravenous secretin.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 4
Age:5 - 21
Key Eligibility Criteria
Disqualifiers:Acute Pancreatitis, Pregnancy, Sedation, Others
195 Participants Needed
LP-184 for Solid Tumors
Louisville, Kentucky
The primary objective of this study is to evaluate the safety, tolerability, MTD and RP2D of LP-184 in patients with advanced solid tumors who have relapsed from or are refractory to standard therapy or for whom no standard therapy is available. The secondary objectives are to characterize the PK of LP-184 and its metabolites in plasma and assess clinical activity of LP-184.
Participants will receive LP-184 infusion during Day 1 and Day 8 of each 21-day cycle, for a minimum of two cycles. Patients will be monitored for safety, PK, and clinical activity
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Retinopathy, Hepatitis, HIV, Others
Must Not Be Taking:Antibiotics, Antivirals, Antifungals, Others
175 Participants Needed
INBRX-106 + Pembrolizumab for Lung Cancer
Louisville, Kentucky
This is a Phase 1/2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp \& Dohme LLC, a subsidiary of Merck \& Co., Inc., Rahway, NJ, USA.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Hematologic Malignancies, CNS Metastases, Autoimmune Disease, Others
Must Not Be Taking:OX40 Agonists, Immunosuppressants
333 Participants Needed
225Ac-SSO110 for Small Cell Lung Cancer and Merkel Cell Carcinoma
Louisville, Kentucky
This study aims to determine safety, tolerability, recommended phase 2 dose (RP2D), and preliminary antitumor activity of 225Ac-SSO110 with standard of care (SoC) therapy in patients with somatostatin receptor 2 expressing (SSTR2+) extensive-stage small cell lung cancer (ES-SCLC) and recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Unstable Spinal Cord Compression, Others
Must Be Taking:Immune Checkpoint Inhibitors
50 Participants Needed
MVA-BN-WEV Vaccine for Encephalitis
Versailles, Kentucky
This phase 2 clinical trial will investigate an optimal dose, dosing regimen, and evaluate reactogenicity, safety and immunogenicity in healthy adult participants of the recombinant, multivalent MVA-BN-WEV vaccine. MVA-BN-WEV is intended for active immunization for prevention of disease induced by VEEV and EEEV, in persons aged 18 years and older at high risk of exposure.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 50
Key Eligibility Criteria
Disqualifiers:Pregnancy, Autoimmune, Immunodeficiency, Cancer, Others
Must Not Be Taking:Immunosuppressants, Live Vaccines
400 Participants Needed
Why Other Patients Applied
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"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
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"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
"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
D-MAPPS for Graft-versus-Host Disease
Lexington, Kentucky
A Double-Masked, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of d-MAPPS™ Ophthalmic Solution in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGHVD)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Rheumatoid Arthritis, Lupus, Scleroderma, Others
Must Not Be Taking:Topical Steroids, Tacrolimus, Tetracyclines, Antibiotics
1 Participants Needed
Gene Therapy for Huntington's Disease
Cincinnati, Ohio
The main goal of this study is to evaluate the safety, tolerability, and preliminary efficacy of SPK-10001 in participants with Huntington's Disease.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:25 - 65
Key Eligibility Criteria
Disqualifiers:Deep Brain Stimulation, Gene Therapy, Others
Must Be Taking:Cholinesterase Inhibitors, Antipsychotics
53 Participants Needed
SLS-002 for PTSD
Fort Thomas, Kentucky
This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for Post Traumatic Stress Disorder (PTSD) utilizing an adaptive platform trial (APT) design.
Intervention D - SLS-002 will assess the safety and efficacy of SLS-002 in participants with PTSD.
Please see NCT05422612 for information on the S-21-02 Master Protocol.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Seizures, Hypertension, Cardiovascular Disease, Others
Must Not Be Taking:MAOIs, Opioids, Antipsychotics, Others
200 Participants Needed
Alprazolam + Oxycodone for Drug Interaction
Lexington, Kentucky
This study will examine the effects of doses of opioid/placebo and doses of alprazolam/placebo, alone and in combination. The primary outcomes are pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) and pharmacokinetic outcomes (from blood samples) to determine the interaction effects of these compounds.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Alcohol Dependence, Hypertension, Diabetes, Bipolar, Others
Must Be Taking:Opioids, Sedatives
25 Participants Needed
CVXGA Vaccine for Coronavirus
Cincinnati, Ohio
The purpose of this trial is to assess the safety and relative efficacy of CVXGA (CVXGA50), a KP.2 containing vaccine, compared to COMIRNATY® (COVID-19 Vaccine, mRNA; 2024-2025 Formula), a currently approved COVID-19 vaccine in the prevention of symptomatic, RT-PCR-confirmed SARS-CoV-2 infection. The trial will enroll up to 10016 healthy participants.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Acute Illness, Positive COVID-19, Autoimmune, Others
Must Not Be Taking:Intranasal Medications, Immunosuppressants
10016 Participants Needed
New CAB LA Formulation for HIV Prevention
Cincinnati, Ohio
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a new formulation of Cabotegravir (CAB) dosed every 4-months (Q4M) for pre-exposure prophylaxis (PrEP) in participants at risk of HIV-1 acquisition.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:16+
Key Eligibility Criteria
Disqualifiers:HIV, Hepatitis B, Liver Disease, Others
Must Not Be Taking:Antiretrovirals, Interferon
228 Participants Needed
Amiodarone Patches for Atrial Fibrillation
Louisville, Kentucky
The goal of this clinical trial is to is to test the safety of a new way to deliver a commonly used drug (amiodarone) used in heart surgery by placing a patch containing the drug directly on the heart instead of in an IV (vein). Participating subjects must be 20-85 year old males or females. Up to 80 participants having cardiac surgery at the University of Louisville will be involved in this study.
The main questions this study aims to answer are:
1. Is the patch safe?
2. Does the patch lower the rate of atrial fibrillation (irregular heart rhythm) after cardiac surgery?
Researchers will compare up to 3 different doses of the amiodarone patches (low, medium and high) to the usual treatment (Standard of Care) to see if there are differences (increases or decreases) in heart rhythms after cardiac surgery across study groups.
Participants will be placed in one of 4 study groups:
* Standard of Care (20 participants)
* Low dose patch (20 participants)
* Medium dose patch (20 participants)
* High dose patch (20 participants)
Participants will be monitored closely by their doctor(s) during the study and would:
* Agree to participate after having their doctor, or a member of the team, explain the study in detail and allowing them to ask any questions they would like.
* Sign an Informed Consent Form which will describe the study and tests in full.
* Agree to have their doctor and his/her research team record your medical information, draw blood, and perform electrocardiograms, or EKGs (quick, painless test that measures the electrical activity of the heart) and echocardiograms (image of heart) to monitor their heart.
* Agree to receive training on the portable EKG recorder and to use it at home approximately 30 days and 6 months after their surgery to monitor their heart.
* Agree to return to the hospital approximately 30 days and 6 months after their surgery for a study visit.
Participant involvement will be approximately 7 months total.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:20 - 85
Key Eligibility Criteria
Disqualifiers:Pregnancy, Connective Tissue Diseases, Others
Must Not Be Taking:Corticosteroids, Anti-inflammatories, QT Prolongers, Others
80 Participants Needed
VAX-31 Vaccine for Pneumococcal Prevention
Bardstown, Kentucky
The objective of the study is to evaluate the safety, tolerability, and immunogenicity of 4 injections of VAX-31 (at 3 dose levels) compared to PCV20 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll the remainder of the sample size.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:42 - 89
Key Eligibility Criteria
Disqualifiers:Pneumococcal Disease, Immunodeficiency, Bleeding Disorder, Others
Must Not Be Taking:Immunosuppressants
800 Participants Needed
Lifestyle Intervention for Heart Disease Risk
Cincinnati, Ohio
This research seeks to improve the Midlife Black Women's Stress Reduction and Wellness Intervention (B-SWELL), a program designed to lower heart disease risk in midlife Black women. The B-SWELL leverages stress reduction to facilitate the adoption and adherence to healthier lifestyle behaviors. This research study will use choice to increase engagement and minimize the effect of social determinants of health on research participation among midlife Black women.
A comparative clinical trial will be conducted. Midlife Black women (ages 45-64) who reside in the Greater Cincinnati area will be recruited for participation. Women are eligible if they self-identify as Black/ African American, are between the ages of 45-64, and are willing to commit to the requirements of the study (e.g., attend 8 weekly sessions and 4 phone interviews). Participants will be randomly placed (like the flip of a coin) into either the B-SWELL or WE group. Both the B-SWELL and WE groups are 8-week programs that focus on healthy lifestyle behaviors and heart disease awareness. Women will have the choice to participate in person or virtually. Survey phone interviews will be conducted at baseline, 8-, 12-, and 16-weeks. Data collected will provide information about adherence, healthy lifestyle behaviors, and cardiovascular health. Heart health will be measured using the American Heart Association's Life's Essential 8 metric.
Outcome measures include heart disease awareness, Life's Essential 8 score, stress, self-efficacy, depressive symptoms, and symptoms.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:45 - 64
Sex:Female
Key Eligibility Criteria
Disqualifiers:Incarceration, Terminal Illness, Severe Mental Illness, Others
64 Participants Needed
Niraparib + Temozolomide for Small Cell Lung Cancer
Louisville, Kentucky
Randomized phase 2, multicenter, biomarker directed clinical trial with a safety lead-in to assess the efficacy of Stenoparib plus Temozolomide (TMZ) in relapsed Small Cell Lung Cancer patients. Participants will receive either a combination of oral Stenoparib at the highest tolerated dose with oral Temozolomide 40mg daily or standard of care Lurbinectedin for 21-day cycles. The Dose limiting toxicity period will be 1 cycle of 21 days. This study will explore if the biomarkers the investigators test predict sensitivity to the combination of Stenoparib plus TMZ and therefore leads to a better treatment response. There are two potential tests of biomarkers that can predict who would benefit from the oral combination of Stenoparib with Temozolomide (TMZ), but they have not been evaluated. This study will test for this sensitivity using a biomarker (found in the blood that may be related to how a person reacts to a drug). The study will include 9 participants for the safety evaluation of the Stenoparib+TMZ group and 5 participants for the standard of care Lurbinectedin safety group. We will first determine safety dose for the experiment arm which, will include 3 groups with 3 participants in each group. Three doses of Stenoparib will be evaluated for toxicity. The initial starting dose of Stenoparib will be 200mg po QD. Once the maximum tolerated dose has been determined, participants will be assigned to one of the two groups in the phase 2 portion. Group 1 will be patients that test negative for the biomarker and will receive treatment with Lurbinectedin as per standard of care guidelines. Group 2 will be patients that test positive for the biomarker that will be randomly assigned to either the combination of Stenoparib plus Temozolomide (TMZ) or Lurbinectedin.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Unstable Condition, Acute Infection, Cardiovascular Disease, MDS, AML, Others
Must Not Be Taking:Lurbinectedin, TMZ, Stenoparib
166 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.
Bask GillCEO at Power
Frequently Asked Questions
How much do clinical trials in Kentucky 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 clinical trials in Kentucky 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 trials in Kentucky 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 in Kentucky 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 in Kentucky 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 medical study in Kentucky?
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 clinical trials in Kentucky?
Most recently, we added LevoCept for Birth Control, Niraparib + Temozolomide for Small Cell Lung Cancer and 225Ac-SSO110 for Small Cell Lung Cancer and Merkel Cell Carcinoma to the Power online platform.
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