129 matching studies

Sponsor Condition of Interest
Piloting Pathways With Lung Cancer Patients
Laurie McLouth Metastatic Lung Cancer
The purpose of this research is to determine the feasibility of a new supportive intervention, called Pathways, for patients with metastatic lung cancer. expand

The purpose of this research is to determine the feasibility of a new supportive intervention, called Pathways, for patients with metastatic lung cancer.

Type: Interventional

Start Date: Jan 2020

open study

Platform-based Mild Cognitive Impairment (MCI) Trial
Allison Gibson Mild Cognitive Impairment
The process of receiving a diagnosis of mild cognitive impairment (MCI) is recognized to induce behavioral responses that can be either adaptive or maladaptive. Five specific areas of concern have been identified, including: 1) failure to plan for future decline, decreased compliance... expand

The process of receiving a diagnosis of mild cognitive impairment (MCI) is recognized to induce behavioral responses that can be either adaptive or maladaptive. Five specific areas of concern have been identified, including: 1) failure to plan for future decline, decreased compliance and interaction with medical care providers, 3) decreased confidence and reduced social engagement, 4) increased physical limitations and 5) decreased medication compliance. In this pilot study, participants with MCI and their study partners will participate in behavioral interventions (primarily training workshops and classes) targeting each of these five areas of potential maladaptive behaviors.

Type: Interventional

Start Date: Nov 2019

open study

Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain
Henrietta Bada Neonatal Abstinence Syndrome
The long term goals of our research are to establish the best pharmacological treatment for NAS and determine how pharmacologic treatment of NAS affects long-term developmental outcomes. The objective of this application is to evaluate the effectiveness of clonidine as a treatment... expand

The long term goals of our research are to establish the best pharmacological treatment for NAS and determine how pharmacologic treatment of NAS affects long-term developmental outcomes. The objective of this application is to evaluate the effectiveness of clonidine as a treatment for neonates with NAS, in a randomized clinical trial. Our central hypothesis is that clonidine will effectively treat drug withdrawal manifestations in neonates.

Type: Interventional

Start Date: Dec 2017

open study

A Causative Role for Amylin in Diabetic Peripheral Neuropathy
John Slevin Type2 Diabetes Peripheral Neuropathy
Three pieces of information lead to the basis for this study: 1. Individuals with Type-2 diabetes commonly develop peripheral neuropathy. 2. Increased production of the hormone amylin occurs in individuals who have Type-2 diabetes. 3. Aggregations of amylin... expand

Three pieces of information lead to the basis for this study: 1. Individuals with Type-2 diabetes commonly develop peripheral neuropathy. 2. Increased production of the hormone amylin occurs in individuals who have Type-2 diabetes. 3. Aggregations of amylin was found in the peripheral vasculature of rats that overexpressed human amylin. The purpose of this study is to determine whether a correlation exists between the amount of amylin present in the upper extremities of human subjects with Type-2 diabetes and the extent to which symptoms of peripheral neuropathy are expressed in those subjects. The investigators will be testing this by initially collecting blood and skin biopsy samples from subjects, followed by measuring patient sensation and pain responses to heat, cold, and pressure in the upper extremities.

Type: Observational

Start Date: Feb 2018

open study

Study Evaluating Efficacy and Safety of CPI-613 in Combination With HD Cytarabine and Mitoxantrone Compared...
Rafael Pharmaceuticals Inc. Relapsed/Refractory Acute Myeloid Leukemia
A Phase III study to evaluate the safety and efficacy of CPI-613® (devimistat) in combination with High Dose Cytarabine and Mitoxantrone in comparison with high dose Cytarabine and Mitoxantrone and control sub-groups: combination of Mitoxantrone, Etoposide and Cytarabine (MEC)... expand

A Phase III study to evaluate the safety and efficacy of CPI-613® (devimistat) in combination with High Dose Cytarabine and Mitoxantrone in comparison with high dose Cytarabine and Mitoxantrone and control sub-groups: combination of Mitoxantrone, Etoposide and Cytarabine (MEC) and combination of Fludarabine, Cytarabine, and Filgrastim (FLAG) in older patients with relapsed/refractory Acute Myeloid Leukemia. CPI-613® (devimistat) targets the altered energy metabolism and processes for production of ATP and essential bio-intermediates unique to and characteristic of most cancer cell types. The addition of CPI-613® (devimistat) to high dose cytarabine and mitoxantrone (CHAM) will improve the complete remission (CR) rate in patients 50 years or older with relapsed or refractory AML when compared to HAM alone or other control sub groups.

Type: Interventional

Start Date: Nov 2018

open study

Platelet Bioenergetics in TBI
Kevin Hatton Brain Injuries, Traumatic
This is a prospective study enrolling 5 patients with a diagnosis of traumatic brain injury (TBI) without polytrauma and 5 patients with TBI with polytrauma admitted to the University of Kentucky (UK) Chandler Medical Center to evaluate differences in platelet bioenergetics in... expand

This is a prospective study enrolling 5 patients with a diagnosis of traumatic brain injury (TBI) without polytrauma and 5 patients with TBI with polytrauma admitted to the University of Kentucky (UK) Chandler Medical Center to evaluate differences in platelet bioenergetics in the populations. Additionally, five healthy subjects will be recruited to the control group.

Type: Observational

Start Date: Feb 2020

open study

Behavioral Parent Training for Families With Deaf and Hard of Hearing Preschoolers
Christina Studts Deafness Hearing Loss Parenting Child Behavior
Children who are deaf and hard of hearing (DHH) rarely receive behavioral interventions to prevent the long-term costly outcomes of behavior problems. This project will systematically adapt an evidence-based parent training intervention to increase its acceptability and relevance... expand

Children who are deaf and hard of hearing (DHH) rarely receive behavioral interventions to prevent the long-term costly outcomes of behavior problems. This project will systematically adapt an evidence-based parent training intervention to increase its acceptability and relevance for parents of young DHH children. Effectiveness of the adapted intervention and its implementation in "real world" hearing healthcare clinics will be assessed.

Type: Interventional

Start Date: Jan 2020

open study

Hyperbaric Oxygen Brain Injury Treatment Trial
Hennepin Healthcare Research Institute Traumatic Brain Injury
The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial. expand

The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial.

Type: Interventional

Start Date: Jun 2018

open study

The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding US Study
Ethicon, Inc. Controlling Mild to Moderate Bleeding During Surgery
The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery... expand

The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in pediatric population.

Type: Interventional

Start Date: Mar 2018

open study

Kentucky Communities and Researchers Engaging to Halt the Opioid Epidemic (CARE2HOPE)
University of Kentucky Substance Use HIV Infections HCV Infection Sexually Transmitted Infections (Not HIV or Hepatitis) Overdose, Drug
This study will test the effects of an intervention to reduce substance use and related harms among people leaving rural jails. This study will compare people in a re-entry health linkage intervention with people who will get overdose education in jail. Everyone will take part in... expand

This study will test the effects of an intervention to reduce substance use and related harms among people leaving rural jails. This study will compare people in a re-entry health linkage intervention with people who will get overdose education in jail. Everyone will take part in follow-up surveys after release. Participants will be assigned to one of the two groups by chance based on when they are released from jail and when their county is randomly chosen to start the project.By doing this study, the investigators hope to learn if providing linkage to health services along with HIV, hepatitis C, and overdose education to people leaving rural jails will reduce substance use and related harms.

Type: Interventional

Start Date: Nov 2019

open study

Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery...
Cerus Corporation Anemia
The objective of this study is to evaluate the efficacy and safety of RBC transfusion for support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment following transfusion of red blood cells (RBCs) treated with the INTERCEPT Blood... expand

The objective of this study is to evaluate the efficacy and safety of RBC transfusion for support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment following transfusion of red blood cells (RBCs) treated with the INTERCEPT Blood System (IBS) for Red Blood Cells compared to patients transfused with conventional RBCs.

Type: Interventional

Start Date: Dec 2018

open study

Selective Surgical Staging for the Treatment of Endometrial Cancer Based on Intraoperative Consultation
Frederick R. Ueland, M.D. Endometrial Cancer
Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical staging for endometrial cancer increases operative time and surgical morbidity, but appears to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic approach... expand

Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical staging for endometrial cancer increases operative time and surgical morbidity, but appears to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic approach has not been reproduced, and the investigators propose to validate their algorithm at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the investigators are well-suited to perform this investigation. A surgical approach that is tailored to the patient's cancer biology is rational, supported by the recent literature, and medically compelling since the co-morbidities of many obese, low-risk EC patients put them at significantly increased perioperative risk for complete lymphadenectomy.

Type: Interventional

Start Date: Jan 2016

open study

Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Type1 Diabetes Mellitus
The study is a 2-arm, double blinded, multicenter, 2:1 randomized, placebo controlled clinical trial. Subjects will receive hydroxychloroquine or placebo and close monitoring for progression of T1D. expand

The study is a 2-arm, double blinded, multicenter, 2:1 randomized, placebo controlled clinical trial. Subjects will receive hydroxychloroquine or placebo and close monitoring for progression of T1D.

Type: Interventional

Start Date: Aug 2018

open study

Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Children's Hospital of Philadelphia Failed or Difficult Intubation, Sequela Intubation; Difficult Intubation Complication
Advanced airway interventions are common high risk, high stakes events for children in intensive care units (ICU) and emergency departments (ED), with risk for life and health threatening consequences. expand

Advanced airway interventions are common high risk, high stakes events for children in intensive care units (ICU) and emergency departments (ED), with risk for life and health threatening consequences.

Type: Observational

Start Date: Mar 2010

open study

MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.
Carolyn M Hettrich Other Instability, Shoulder Dislocations Subluxations Recurrent Dislocation of Shoulder Region
This project will be a multi-center, prospective longitudinal cohort for all patients undergoing primary shoulder instability surgery, excluding isolated SLAP repairs. We will be looking for risk factors for recurrent instability, revision surgery, and poor outcomes. Patients... expand

This project will be a multi-center, prospective longitudinal cohort for all patients undergoing primary shoulder instability surgery, excluding isolated SLAP repairs. We will be looking for risk factors for recurrent instability, revision surgery, and poor outcomes. Patients will be asked to complete the RAND-36, ASES, Shoulder Activity, EQ-5D and WOSI outcome measures, as well as demographic and socioeconomic information. Surgeons will complete a form after surgery with information on radiographic findings, physical exam, surgical findings, and the repair. Patients will wear a sling post-operatively, and follow standardized rehabilitation protocols, including physical therapy. Patients will be sent outcome questionnaires at 2, 6, 10, and 20 years after surgery.

Type: Observational [Patient Registry]

Start Date: Aug 2012

open study

Treatment of Partial-Thickness Rotator Cuff Tears
Smith & Nephew, Inc. Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness
Demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (>50%) partial-thickness tears because REGENETEN preserves more of the native tendon footprint resulting in less postoperative pain and faster recovery. expand

Demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (>50%) partial-thickness tears because REGENETEN preserves more of the native tendon footprint resulting in less postoperative pain and faster recovery.

Type: Interventional

Start Date: Dec 2018

open study

Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis
Massachusetts General Hospital Septic Shock
Multicenter, prospective, phase 3 randomized non-blinded interventional trial of fluid treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. The aim of the study is to determine the impact of a restrictive fluids strategy (vasopressors first... expand

Multicenter, prospective, phase 3 randomized non-blinded interventional trial of fluid treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. The aim of the study is to determine the impact of a restrictive fluids strategy (vasopressors first followed by rescue fluids) as compared to a liberal fluid strategy (fluids first followed by rescue vasopressors) on 90-day in-hospital mortality in patients with sepsis-induced hypotension.

Type: Interventional

Start Date: Mar 2018

open study

Community Agriculture Nutritional Enterprises (CANE) Meal Program
Dawn Brewer Diet, Healthy Life Style, Healthy
Previous adult participants of the Tanglewood to Table walking program will be recruited to enroll in the CANE Meal Program. This program will encourage participants to pick up a healthy meal from the CANE Kitchen each week for five weeks. The meal will consist of at least one... expand

Previous adult participants of the Tanglewood to Table walking program will be recruited to enroll in the CANE Meal Program. This program will encourage participants to pick up a healthy meal from the CANE Kitchen each week for five weeks. The meal will consist of at least one serving of fruit or vegetables. At each meal, educational materials will be distributed, including the recipe for healthy meals and nutrition handouts that are linked to the recipes. Additional information about the ways the nutrients in the meal may help protect from the negative effects of environmental pollutants will be included. Surveys, blood pressure, height, weight, waist circumference and carotenoid status will be assessed before and after the program.

Type: Interventional

Start Date: Jan 2020

open study

TVB 2640 for Resectable Colon Cancer Other Resectable Cancers; a Window Trial.
Mark Evers Colon Cancer
Primary Objective • To evaluate the pharmacodynamic effects on metabolic endpoints (malonyl carnitine and tripalmitin levels) following short-term treatment with TVB-2640 in patients with resectable cancers Secondary Objectives - To determine if short-term treatment... expand

Primary Objective • To evaluate the pharmacodynamic effects on metabolic endpoints (malonyl carnitine and tripalmitin levels) following short-term treatment with TVB-2640 in patients with resectable cancers Secondary Objectives - To determine if short-term treatment with TVB-2640 decreases cancer cell proliferation. - To examine other biological endpoints and determine if TVB-2640 inhibits cell survival signaling and lipid biogenesis. - To perform comprehensive metabolomic analysis in tumor tissues to identify metabolic alterations induced by TVB-2640 treatment. - To correlate FASN levels in tumor with metabolic and biological endpoints to determine if FASN inhibition has more pronounced effects in patients with increased expression.

Type: Interventional

Start Date: Jan 2017

open study

Addressing Neuromuscular Deficits for Improved Outcomes in Ankle Rehabilitation
Phillip Gribble Ankle Sprains
The purpose of this project is to compare a novel sensorimotor ankle rehabilitation training (SMART) protocol for Lateral ankle sprains (LASs) against a standard of care (SOC) protocol to determine if it is more successful at producing successful one-year outcomes and lower rates... expand

The purpose of this project is to compare a novel sensorimotor ankle rehabilitation training (SMART) protocol for Lateral ankle sprains (LASs) against a standard of care (SOC) protocol to determine if it is more successful at producing successful one-year outcomes and lower rates of re-injury and improved health. This will address the identified needs for evidence-support and reintegration strategies to improve understanding of the management of patient rehabilitation strategies throughout the rehabilitation process following neuromusculoskeletal injury. The project will validate an innovative rehabilitation approach while providing metrics of success using a variety of clinical and innovative markers.

Type: Interventional

Start Date: Nov 2019

open study

COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve...
Edwards Lifesciences Complex Congenital Heart Defect Dysfunctional RVOT Conduits or Previously Implanted Valve in the Pulmonic Position
The purpose of this study is to evaluate the hypothesis that valve dysfunction of the Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) System is within the performance goal of 25% in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or... expand

The purpose of this study is to evaluate the hypothesis that valve dysfunction of the Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) System is within the performance goal of 25% in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.

Type: Interventional

Start Date: Jul 2016

open study

Cocaine Use Reduction and Health
William Stoops Cocaine Use Disorder
Reduced drug use is a clinically meaningful target for treatment development, but few studies have evaluated the positive impacts produced by this behavioral change, preventing adoption of this endpoint in clinical trials. The proposed research will fill that critical knowledge... expand

Reduced drug use is a clinically meaningful target for treatment development, but few studies have evaluated the positive impacts produced by this behavioral change, preventing adoption of this endpoint in clinical trials. The proposed research will fill that critical knowledge gap by demonstrating the biopsychosocial benefits of reduced cocaine use. These data will be used to change current accepted cocaine treatment endpoints and accelerate identification of therapies for cocaine use disorder.

Type: Interventional

Start Date: Sep 2017

open study

Dietary Intervention in Persons With Metabolic Syndrome
Martha Biddle Metabolic Syndrome
Individuals diagnosed with metabolic syndrome are at a two-fold risk for developing cardiovascular disease. The investigators must identify strategies that can abort the development of cardiovascular disease. Inflammation and oxidative stress responsible for the pathogenesis... expand

Individuals diagnosed with metabolic syndrome are at a two-fold risk for developing cardiovascular disease. The investigators must identify strategies that can abort the development of cardiovascular disease. Inflammation and oxidative stress responsible for the pathogenesis of metabolic syndrome and CVD can be influenced by dietary changes. Strategic and novel interventions that include changing dietary patterns to include more antioxidant rich fruit and vegetables are pragmatic for primary prevention of CVD. Antioxidant rich fruits and vegetables, especially those with carotenoids (lycopene, lutein, zeaxanthin, alpha-carotene, and beta-carotene) have been efficacious in reducing the risk of CVD by decreasing inflammation and oxidative stress. The purpose of this study is to test the effect of a dietary antioxidant intervention on biomarkers of inflammation and oxidative stress in persons diagnosed with metabolic syndrome. The sample will be randomized into one of two groups. Group one (intervention) will drink an 11.5 ounce serving of V8 100% vegetable juice once per day for 30 days. The second group (control) will continue to consume their normal diet. We will measure biomarkers of inflammation (C-reactive protein) and oxidative stress (malondialdehyde) in the two groups at baseline and the end of the 30-day intervention.

Type: Interventional

Start Date: Dec 2018

open study

A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
Vertex Pharmaceuticals Incorporated Cystic Fibrosis
This study will evaluate the long-term safety and tolerability of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA). expand

This study will evaluate the long-term safety and tolerability of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA).

Type: Interventional

Start Date: Aug 2019

open study

Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Reducing Tobacco Use Among Opioid...
Kristin Ashford Smoking Cessation
This study tests an intervention for tobacco cessation (named B-EPIC) in an established community medication assisted treatment (MAT) clinic for pregnant and postpartum women with opioid dependence. Half of the participants will receive the intervention for tobacco cessation,... expand

This study tests an intervention for tobacco cessation (named B-EPIC) in an established community medication assisted treatment (MAT) clinic for pregnant and postpartum women with opioid dependence. Half of the participants will receive the intervention for tobacco cessation, which is standard cessation counseling from the provider plus additional cessation support from a Certified Tobacco Treatment Specialist (CTTS). The other half of participants will receive standard tobacco cessation from their provider. The project will also determine the economic impact of the B-EPIC intervention on healthcare expenditures.

Type: Interventional

Start Date: Dec 2018

open study