382 matching studies

Sponsor Condition of Interest
Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)
University of South Florida Granulomatosis With Polyangiitis (Wegener's) Granulomatosis With Polyangiitis Wegener's Granulomatosis ANCA-Associated Vasculitis
Multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of abatacept to achieve sustained glucocorticoid-free remission in patients with relapsing non-severe granulomatosis with polyangiitis (Wegener's) (GPA) . Participants will be randomized... expand

Multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of abatacept to achieve sustained glucocorticoid-free remission in patients with relapsing non-severe granulomatosis with polyangiitis (Wegener's) (GPA) . Participants will be randomized 1:1 to receive either abatacept 125 mg or placebo administered by subcutaneous injection once a week. Participants will continue on study treatment for a minimum of 12 months unless they experience a disease relapse or disease flare. Participants who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 6 will have the option of entering an open-label trial period whereby they would receive open-label abatacept.

Type: Interventional

Start Date: Apr 2015

open study

Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain
University of Kansas Medical Center Pain, Postoperative Burns
Donor site pain study comparing post-operative donor site pain and opioid consumption after use of Lidocaine or Liposomal Bupivicaine for split thickness skin graft harvesting in patients with less than 20% TBSA burn wounds and less than %5 Deep partial or full thickness burn... expand

Donor site pain study comparing post-operative donor site pain and opioid consumption after use of Lidocaine or Liposomal Bupivicaine for split thickness skin graft harvesting in patients with less than 20% TBSA burn wounds and less than %5 Deep partial or full thickness burn wounds.

Type: Interventional

Start Date: Mar 2019

open study

Word Learning in Children With Autism
University of Kansas Autistic Disorders Spectrum
The project highlights one of the primary areas of research within the KIDDRC— language and communication. The focus is on language and communication in children with autism and minimal verbal skills (less than 20 spoken words). Remaining nonverbal past the age of 5 years has... expand

The project highlights one of the primary areas of research within the KIDDRC— language and communication. The focus is on language and communication in children with autism and minimal verbal skills (less than 20 spoken words). Remaining nonverbal past the age of 5 years has been considered a poor prognostic indicator for future language developments, yet few interventions have been developed to address this problem. The Specific Aims for this project are (1) to further investigate a multimodal intervention for school-age children with minimal verbal skills—defined as less than 20 words spontaneously spoken, signed, or selected via graphic symbol selection—and (2) to identify significant covariates associated with differential responding to the intervention. The research addresses an unmet need to promote spoken word production in children who remain essentially nonverbal well past the ages associated with speech acquisition. The project is also innovative because: a) it investigates a multimodal intervention based on principles of phonotactic probability and neighborhood density in combination with augmentative and alternative communication (AAC), and b) it investigates novel predictors of treatment response that are obtained through cutting-edge technologies. This intervention will have better success than past interventions because the intervention will provide increased input through speech, digitized speech and visual images and additional speech sound practice for words that are comprised of high frequency sounds in the child's repertoire. Extant speech sounds in each participant's repertoire will be identified using LENA™ digitized recordings. Vocabulary words will then be selected based on a child's speech sound repertoire and principles of word learning—words with high probability speech sound sequences will be selected and taught with either multimodal intervention or a treatment as usual condition. Responses to these interventions will be evaluated using a Sequential Multiple Assignment Randomized Trials (SMART) design. Different outcomes may be associated with individual and environmental predictors identified in our previous research. Individual predictors include verbal comprehension, imitation skills, adaptive behavior, nonverbal speech sound repertoire, and communication complexity. Communication complexity will be measured with the Communication Complexity Scale (CCS), developed by the Principal Investigator. Environmental predictors include language input to the child as measured with LENA™ recording devices. Results will determine if the multimodal intervention is more successful than treatment as usual for teaching word productions.

Type: Interventional

Start Date: Nov 2016

open study

A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Patients With Motor Fluctuations
Impax Laboratories, LLC Parkinson's Disease (Disorder)
To evaluate the safety and efficacy of IPX203 (carbidopa and levodopa) extended-release capsules (IPX203 ER CD-LD) in comparison to immediate release (IR) CD-LD in the treatment of CD-LD-experienced subjects with Parkinson's disease (PD) who have motor fluctuations. expand

To evaluate the safety and efficacy of IPX203 (carbidopa and levodopa) extended-release capsules (IPX203 ER CD-LD) in comparison to immediate release (IR) CD-LD in the treatment of CD-LD-experienced subjects with Parkinson's disease (PD) who have motor fluctuations.

Type: Interventional

Start Date: Nov 2018

open study

Treating Pain With Acceptance and Commitment Therapy Trial
University of New Mexico Acceptance and Commitment Therapy Chronic Pain Opioid Use
The long-term goal is to define best practices for diminishing the risk of high opioid doses used to treat chronic non-cancer pain (CNCP) patients while optimizing pain outcomes and functional levels of activity, emotional functioning, and quality of life. The short-term goal... expand

The long-term goal is to define best practices for diminishing the risk of high opioid doses used to treat chronic non-cancer pain (CNCP) patients while optimizing pain outcomes and functional levels of activity, emotional functioning, and quality of life. The short-term goal is to assess the feasibility of multiple Clinical and Translational Research Award (CTSA) sites working together to perform and study the effects of a cognitive behavioral therapy intervention in a future randomized controlled trial (RCT) among CNCP patients in rural primary care practices in each CTSA state.

Type: Interventional

Start Date: Jan 2019

open study

Comparing PA Compliance During and After Decompensation in HFP
Theranova, L.L.C. Congestive Heart Failure Decompensated Heart Failure
Pulmonary Artery Compliance measurements will be obtained with the Respirix device in patients with congestive heart failure decompensation. Echocardiogram, weight measurements, and BNP will also be gathered as independent measures of decompensation in the clinic. Pulmonary Artery... expand

Pulmonary Artery Compliance measurements will be obtained with the Respirix device in patients with congestive heart failure decompensation. Echocardiogram, weight measurements, and BNP will also be gathered as independent measures of decompensation in the clinic. Pulmonary Artery Compliance measurements will be made daily during the hospital stay. Patients can continue using the device at home for the next 3 weeks. Each patient will serve as their own control and relative changes from their baseline will be recorded for each parameter.

Type: Interventional

Start Date: Jun 2019

open study

mHealth Titration and Management
Amalgam Rx, Inc. Diabetes Mellitus, Type 2 Diabetic Complication
The principal objective of this application is to improve glycemic control of diabetic patients treated with basal insulin through use of an innovative, FDA-cleared smartphone-based insulin titration application connected to Bluetooth enabled glucose meters. iSage Rx (isageapp.com)... expand

The principal objective of this application is to improve glycemic control of diabetic patients treated with basal insulin through use of an innovative, FDA-cleared smartphone-based insulin titration application connected to Bluetooth enabled glucose meters. iSage Rx (isageapp.com) allows providers to prescribe basal insulin treatment plans to patients and manages basal insulin doses utilizing clinically proven algorithms. In this pilot study, we hypothesize that this user-friendly application and seamless data capture will improve glycemic control (achieve HgbA1c <7%) and reduce the frequency and severity of hypoglycemia. Exploratory measures will include healthcare resource utilization and patient and provider satisfaction. The basal insulin titration algorithms used in iSage have had thousands of user-years' experience in FDA-mandated, closely supervised clinical trials, both for long-acting insulins (e.g., Lantus, Levemir) that have been available for a long time and for the newer ultra-long-acting ones (e.g., Tresiba, Toujeo). However, the effectiveness of iSage with a connected glucose meter has not been studied in a "real world" clinical environment. Broad use of such an application and connected devices will, we believe, prove to be cost-effective, favor early and appropriate prescription of insulin, reduce provider effort, shorten time to achieve glycemic goals, and simplify the transition to basal insulin therapy.

Type: Interventional

Start Date: Jan 2019

open study

Ultra-hypofractionated Radiation in Prostate Cancer
University of Kansas Medical Center Early Stage Prostate Cancer
The primary objective of this study is to demonstrate that ultra-hypofractionation of prostate cancer does not increase urinary toxicity as defined by the EPIC-26 GU domain patient reported outcome. expand

The primary objective of this study is to demonstrate that ultra-hypofractionation of prostate cancer does not increase urinary toxicity as defined by the EPIC-26 GU domain patient reported outcome.

Type: Interventional

Start Date: Mar 2018

open study

Physical Activity Across the Curriculum (PAAC 3):Teacher vs. Remotely Delivered Classroom Physical Activity...
University of Kansas Medical Center Physical Activity
The study is designed to compare two methods of delivering short (~10 min) physical activity breaks that will occur during the regular school day for 3 years. Schools will be randomized to deliver physical activity breaks led by either the regular classroom teacher or by a remote... expand

The study is designed to compare two methods of delivering short (~10 min) physical activity breaks that will occur during the regular school day for 3 years. Schools will be randomized to deliver physical activity breaks led by either the regular classroom teacher or by a remote instructor through a video in the classroom. Both delivery methods will promote a variety of whole body movements using large muscle groups. The schools will not be able to choose which group (regular teacher or remote instructor) they will be part of.

Type: Interventional

Start Date: Mar 2018

open study

A Phase 1 Study of Engineered Donor Grafts (OrcaGraft) in Recipients Undergoing Allogeneic Transplantation...
Orca Biosystems, Inc. Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndromes Acute Leukemia
This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft") in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies. expand

This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft") in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.

Type: Interventional

Start Date: Apr 2019

open study

Exosomes in Rectal Cancer
University of Kansas Medical Center Rectal Cancer
The primary aims of this study is to characterize exosomal biomarker levels in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation therapy. Compare rates of exosomal expression before during and after chemoradiation therapy with pathologic response... expand

The primary aims of this study is to characterize exosomal biomarker levels in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation therapy. Compare rates of exosomal expression before during and after chemoradiation therapy with pathologic response rates at the time of APR or LAR. The researchers will also examine the functionality of these exosomes in malignant colonic organoids and mouse models of colorectal cancer.

Type: Observational [Patient Registry]

Start Date: Feb 2018

open study

Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With TRD
Massachusetts General Hospital Treatment Resistant Major Depressive Disorder
This is a multi-site, randomized, open-label, effectiveness trial comparing three treatment arms for Major Depressive Disorder (MDD) patients with TRD who are currently on ongoing, stable and adequate antidepressant therapy (ADT). Adequate ADT is defined as a therapeutically... expand

This is a multi-site, randomized, open-label, effectiveness trial comparing three treatment arms for Major Depressive Disorder (MDD) patients with TRD who are currently on ongoing, stable and adequate antidepressant therapy (ADT). Adequate ADT is defined as a therapeutically sufficient dose for a sufficient treatment period, which would be expected to be effective as listed in the MGH Antidepressant Treatment Response Questionnaire (ATRQ). Patients will be randomized in a 1:1:1 fashion to one of three open-label treatment arms: a) aripiprazole augmentation, b) rTMS augmentation, and c) switching to venlafaxine XR or Duloxetine.

Type: Interventional

Start Date: May 2017

open study

Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors
University of Kansas Medical Center Stroke
By doing this study, researchers hope to learn the effects of aerobic exercise on heart, lung, and bone health in people who cannot walk after a stroke. expand

By doing this study, researchers hope to learn the effects of aerobic exercise on heart, lung, and bone health in people who cannot walk after a stroke.

Type: Interventional

Start Date: Mar 2018

open study

Remote Delivery of Weight Management for Adults With IDD
University of Kansas Medical Center Obesity
The purpose of this study is to compare different weight loss programs in people with IDD to see which program works better. expand

The purpose of this study is to compare different weight loss programs in people with IDD to see which program works better.

Type: Interventional

Start Date: Feb 2018

open study

Trial to Evaluate Safety and Tolerability of GP-2250 in Combination With Gemcitabine
Geistlich Pharma AG Pancreatic Cancer, Adult
This trial will consist of 2 parts. Phase 1 will use a Bayesian Optimal Interval (BOIN) dose escalation design of GP-2250 as intravenous single-dose monotherapy, followed by combination therapy with gemcitabine in subjects with advanced pancreatic cancer. A Simon Two-Stage Design... expand

This trial will consist of 2 parts. Phase 1 will use a Bayesian Optimal Interval (BOIN) dose escalation design of GP-2250 as intravenous single-dose monotherapy, followed by combination therapy with gemcitabine in subjects with advanced pancreatic cancer. A Simon Two-Stage Design (Phase 2) will follow this to assess preliminary clinical activity of GP-2250 in combination with gemcitabine at the recommended Phase 2 dose (RP2D) in subjects with advanced pancreatic cancer previously treated with FOLFIRINOX but never exposed to therapeutic gemcitabine

Type: Interventional

Start Date: Jan 2019

open study

Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy
University of Kansas Medical Center Obesity Prostate Cancer
The purpose of this study is to test how a weight management program affects substances in the blood called biomarkers that can show the presence or severity of cancer, compared to a standardized diet and exercise educational flyer. expand

The purpose of this study is to test how a weight management program affects substances in the blood called biomarkers that can show the presence or severity of cancer, compared to a standardized diet and exercise educational flyer.

Type: Interventional

Start Date: Aug 2017

open study

Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane...
University of Kansas Medical Center Tympanic Membrane Perforation
By doing this study, researchers hope to find out if platelet rich plasma (PRP) can heal holes in the eardrum as an alternative to surgery. expand

By doing this study, researchers hope to find out if platelet rich plasma (PRP) can heal holes in the eardrum as an alternative to surgery.

Type: Interventional

Start Date: May 2018

open study

A Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351
Jazz Pharmaceuticals Hematologic Malignancy Acute Myeloid Leukemia Acute Lymphocytic Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndromes
This study evaluates the pharmacokinetics and safety of CPX-351 in patients with moderate or severe renal impairment. expand

This study evaluates the pharmacokinetics and safety of CPX-351 in patients with moderate or severe renal impairment.

Type: Interventional

Start Date: Nov 2018

open study

A Phase II Study of Lonsurf (TAS-102) in Metastatic Platinum and Checkpoint Inhibitor-resistant Bladder...
Rahul Parikh Bladder Cancer
This study evaluates the clinical benefit of TAS-102 in participants with metastatic urothelial carcinoma who are resistant to cisplatin or carboplatin front-line and checkpoint inhibitors as second line therapy. All participants will receive TAS-102 in oral form twice per day... expand

This study evaluates the clinical benefit of TAS-102 in participants with metastatic urothelial carcinoma who are resistant to cisplatin or carboplatin front-line and checkpoint inhibitors as second line therapy. All participants will receive TAS-102 in oral form twice per day on Days 1-5 and Days 8-12 of each 28 day cycle.

Type: Interventional

Start Date: Jan 2019

open study

Promotion of Physical Activity in Adolescents With Intellectual and Developmental Disabilities
University of Kansas Adolescent Behavior Intellectual Disability Down Syndrome Physical Activity
The objective of this study is to compare the effect of two strategies to increase MVPA in adolescents with intellectual and developmental disabilities (IDD): a single level intervention delivered to the adolescent only, and a multi-level intervention delivered to both the adolescent... expand

The objective of this study is to compare the effect of two strategies to increase MVPA in adolescents with intellectual and developmental disabilities (IDD): a single level intervention delivered to the adolescent only, and a multi-level intervention delivered to both the adolescent and a parent .

Type: Interventional

Start Date: Jan 2019

open study

The Altered Immune Response to Exercise in Patients With Fibromyalgia Before and After a Mind-body Intervention
University of Kansas Medical Center Fibromyalgia
The purpose of this study is to compare two different exercise programs to see if there are differences after exercise in fibromyalgia (FM) symptoms and responses from the immune system. expand

The purpose of this study is to compare two different exercise programs to see if there are differences after exercise in fibromyalgia (FM) symptoms and responses from the immune system.

Type: Interventional

Start Date: Feb 2018

open study

Duration of Medication Therapy and Outcomes After Holmium Laser Prostate Surgery for Patients With Benign...
University of Kansas Medical Center Benign Prostatic Hyperplasia
To determine if the prior prolonged use of medication, as a treatment for benign prostatic hyperplasia, reduces the efficacy of Holmium laser enucleation of the prostate (HoLEP) for patients with benign prostatic hyperplasia (BPH). expand

To determine if the prior prolonged use of medication, as a treatment for benign prostatic hyperplasia, reduces the efficacy of Holmium laser enucleation of the prostate (HoLEP) for patients with benign prostatic hyperplasia (BPH).

Type: Observational

Start Date: Nov 2018

open study

Study of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception
Health Decisions Healthy Men Male Contraception
The long term objective is to develop a gel to be used as a male contraceptive. expand

The long term objective is to develop a gel to be used as a male contraceptive.

Type: Interventional

Start Date: Oct 2018

open study

Evaluation of the Long Term Safety, Tolerability and Efficacy of Two Dosing Regimens of Olokizumab (OKZ),...
R-Pharm Rheumatoid Arthritis
The purpose of the study is to evaluate how safe, how effective and how well tolerated, the study drug Olokizumab is, in the long-term, in patients with Rheumatoid Arthritis (RA) who have previously taken part in and completed 24 weeks of blinded treatment in one of the core... expand

The purpose of the study is to evaluate how safe, how effective and how well tolerated, the study drug Olokizumab is, in the long-term, in patients with Rheumatoid Arthritis (RA) who have previously taken part in and completed 24 weeks of blinded treatment in one of the core studies - CREDO 1, 2 or 3.

Type: Interventional

Start Date: Jul 2017

open study

Effect of Extensively Hydrolyzed Liquid Human Milk Fortifier on Growth and Tolerance in Moderately Premature...
Vishal Pandey, M.D. Complication of Prematurity
The purpose of this study is for the researchers to examine the safety and efficacy of liquid human milk fortifier (HMF) in moderately preterm infants compared to powdered human milk fortifier. expand

The purpose of this study is for the researchers to examine the safety and efficacy of liquid human milk fortifier (HMF) in moderately preterm infants compared to powdered human milk fortifier.

Type: Interventional

Start Date: Jul 2015

open study