Kentucky Clinical
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Kentucky Clinical Trials

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A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.
The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ Mesh in subjects requiring primary ventral, incisional or first-recurrent hernia repair in subjects at high risk for complications. Subjects at high risk [more...]  are defined as having 1 or more of the following co-morbidity conditions: body mass index (BMI) between 30-40 kg/m2, inclusive, active smokers, chronic obstructive pulmonary disease (COPD), diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, low pre-operative serum albumin, advanced age, or renal insufficiency.
Status: Recruiting Start Date: September 2013 Completion Date: 
Using mHealth to Aid Opioid Addicts
The purpose of the proposed study is perform focus groups to identify and prioritize features of the SubAID application (APP). The SubAID APP is smartphone APP being created to support patients self-managing buprenorphine/naloxone (bup/nal) medication. Many people have difficulty [more...]  in managing bup/nal in the prescribed manner. Not taking medicines in their prescribed manner can cause negative health outcomes. Focus group participants will be asked to elaborate on medication-taking patterns that work best for them, pitfalls associated with poor adherence and offer opinions upon what features/functions the SubAID APP should perform to be most helpful to them. The focus group is designed to remain open-ended and allow free discussion regarding each particular topic that the moderator will bring up.
Status: Recruiting Start Date: August 2013 Completion Date: October 2013
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus
This trial is conducted globally. The aim of the trial is to compare the efficacy and safety of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes mellitus.
Status: Recruiting Start Date: September 2013 Completion Date: October 2014
Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 65 Years of Age and Older
The purpose of this placebo controlled study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals H7N1 influenza vaccine in subjects 65 years of age and older. The study will evaluate safety related events and antibody immune responses to [more...]  different formulations of study vaccine.
Status: Recruiting Start Date: September 2013 Completion Date: November 2014
Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent Influenza Virus Vaccine
The aim of this study is to evaluate the safety and immunogenicity of Fluzone® Quadrivalent vaccine in participants aged 6 months to < 9 years at enrollment, divided into 2 age strata (6 months to < 36 months and 3 years to < 9 [more...]  years) Primary Objective: - To describe the safety of the 2013-2014 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices' (ACIP) recommendations, in children 6 months to < 9 years of age. Observational Objectives: - To describe the immunogenicity of the 2013-2014 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in children 6 months to < 9 years of age. - To submit sera from subjects to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
Status: Recruiting Start Date: September 2013 Completion Date: March 2014
A Phase 2 Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
Randomized, double-blind, placebo-controlled, parallel-group, multi-center study followed by open-label phase. To evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly migraine days
Status: Recruiting Start Date: August 2013 Completion Date: July 2015
Phase 2, Randomized, Double Blinded, Study of Nivolumab (BMS-936558) in Combination With Ipilimumab vs Ipilimumab Alone in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
The primary purpose of this study is to compare the objective response rate (ORR) as determined by investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in subjects with unresectable or metastatic melanoma
Status: Recruiting Start Date: August 2013 Completion Date: May 2015
EXPAREL Administered by Infiltration Into the TAP for Prolonged Postsurgical Analgesia in Lower Abdominal Surgeries
The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in Transversus Abdominis Plane (TAP) infiltration in lower abdominal surgical procedures.
Status: Recruiting Start Date: August 2013 Completion Date: 
Promoting Early Diagnosis of Congenital Hearing Loss With Patient Navigators
Hearing loss is the most common sensory congenital disorder and this condition is diagnosable and treatable. Children that are born with hearing loss have to undergo several hearing tests to diagnose the condition and many families are delayed in receiving this [more...]  testing or never obtain the needed testing. This research employs a new method for helping children with hearing loss get timely care by using a patient navigator, who is someone who teaches and provides emotional/ social support for the families of these children. The hypothesis of this study is that a patient navigator will hasten the timing of pediatric audiological testing, improve compliance with scheduled appointments, and expand parental knowledge of pediatric hearing loss.
Status: Recruiting Start Date: July 2013 Completion Date: July 2017
Safety and Efficacy Trial of Dymista Nasal Spray in Children Ages 4 to 11 With Seasonal Allergic Rhinitis (SAR)
The purpose of this study is to determine if Dymista nasal spray is better and safer than placebo in treating children ages 4 to <12 years old who have seasonal allergic rhinitis.
Status: Recruiting Start Date: July 2013 Completion Date: December 2013
A Study of the Pharmacokinetics, Safety, and Preliminary Efficacy of MDT-15 in Subjects With Lumbosacral Radiculopathy
The primary objectives of this clinical trial are to investigate the pharmacokinetics and safety of MDT-15 pellets in escalating sequential doses administered to different cohorts. Preliminary efficacy data will also be collected for assessment.
Status: Recruiting Start Date: July 2013 Completion Date: January 2016
A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa
The objective of this study is to compare the relative efficacy and safety of the test formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par Pharmaceutical Companies, Inc.) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension [more...]  (Alcon) in the treatment of acute bacterial otitis externa.
Status: Recruiting Start Date: July 2013 Completion Date: July 2014
Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia
The purpose of this study is to determine the safety and efficacy of different doses of CAT-2003 in patients with hyperlipidemia when CAT-2003 is taken for 4 weeks. The study will evaluate effects of CAT-2003 on (1) fasting triglycerides and non-HDL-C in patients with [more...]  moderate hypertriglyceridemia and (2) fasting LDL-C levels in combination with a statin in patients with hypercholesterolemia who are on a statin.
Status: Recruiting Start Date: July 2013 Completion Date: December 2013
Refametinib in RAS Mutant Hepatocellular Carcinoma (HCC)
This is a study to investigate the potential clinical benefit of refametinib in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be [more...]  accrued to this study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15 patients at Stage 1 show at least confirmed partial response (PR) according to modified response evaluation criteria in solid tumors (mRECIST) assessed by central image review. Refametinib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib improves the response rate in this RAS mutation patient population.
Status: Recruiting Start Date: September 2013 Completion Date: February 2017
Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS
The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with relapsing forms of MS who are treated with dimethyl fumarate (DMF) after suboptimal response to glatiramer acetate (GA). The secondary [more...]  objectives of this study in this study population are to assess the impact of DMF over a 12-month period on patient-reported outcomes (PROs) and health economic-related outcomes and to evaluate additional clinical outcomes at Month 12.
Status: Recruiting Start Date: July 2013 Completion Date: July 2015
Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis
The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a 13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the effect of daily dosing with UDCA in combination with LUM001 or placebo.
Status: Recruiting Start Date: August 2013 Completion Date: December 2014
Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo
To test the idea that solanezumab will slow the cognitive and functional decline of Alzheimer's Disease (AD) as compared with placebo in participants with mild AD.
Status: Recruiting Start Date: July 2013 Completion Date: December 2016
An Observational Study in Patients With Asthma Initiating Treatment With Xolair (Omalizumab)
This observational study will evaluate the correlation of patient's characteristics with predictive markers of clinical outcome in patient with moderate to severe asthma initiating treatment with Xolair (omalizumab). Data will be collected for 48 weeks.
Status: Recruiting Start Date: June 2013 Completion Date: November 2015
To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca
The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.
Status: Recruiting Start Date: July 2013 Completion Date: July 2014
Longitudinal Study of Outcomes Measures in ALS Trials
A new strength measurement device called Accurate Test of Limb Isometric Strength (ATLIS) was developed to precisely and conveniently measure static limb strength in patients with ALS. The investigators will compare ATLIS data with data from two commonly used ALS outcomes [more...]  measures, the ALS Functional Rating Scale-Revised (ALSFRS-R) and slow vital capacity (SVC) in a prospective, longitudinal study. All three outcomes measures will be performed on 100 subjects collected preferably at bi-monthly clinic visits during the study period.
Status: Recruiting Start Date: July 2013 Completion Date: December 2014
Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment of opioid-induced constipation (OIC)in adults taking opioid therapy for chronic non-cancer pain.
Status: Recruiting Start Date: June 2013 Completion Date: August 2015
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Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Participants often receive the best healthcare available for their condition.

Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. Trials are federally regulated with strict guidelines to protect participants.

Kentucky Clinical Trials Information presented on is not intended to be a substitute for qualified medical advice visit or treatment with a real physician. We are not physicians. Always consult with a medical doctor (MD). is a website dedicated to listing clinical research studies in human subjects, including those specifically related to Kentucky. Clinical research trials and medical trials take place in hundreds of cities across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectiveness of new treatments and drugs. The purpose of the studies is to answer specific human health questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions. Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Many times the participants receive treatment for free, and sometimes they are paid for their time. Participants often receive the best healthcare available possible for their condition. Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. U.S. - based Kentucky studies are federally regulated with strict guidelines to protect patients.

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