437 matching studies

Sponsor Condition of Interest
Pharmacogenomic Modulators of Impaired Exercise Adaptation in Statin Users
University of Kansas Medical Center HMG-CoA Reductase Inhibitor Toxicity
HMG-CoA reductase inhibitors (statins) have beneficial effects (prevent stroke, heart attack) but also some bad ones (block some good effects of exercise). Individuals have genetic variations in proteins that metabolize/transport statins. We hypothesize that these variations... expand

HMG-CoA reductase inhibitors (statins) have beneficial effects (prevent stroke, heart attack) but also some bad ones (block some good effects of exercise). Individuals have genetic variations in proteins that metabolize/transport statins. We hypothesize that these variations modulate the relationship between statin use and lack of benefit from exercise. We will test this by having statin-users do supervised exercise for 6 weeks, measuring the cardiorespiratory fitness before/after and correlating this to genetic variations present in the patient.

Type: Interventional

Start Date: Nov 2020

open study

A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants...
Eli Lilly and Company Type 2 Diabetes Mellitus
The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk. expand

The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.

Type: Interventional

Start Date: May 2020

open study

Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ...
Alliance for Clinical Trials in Oncology Atypical Ductal Breast Hyperplasia BRCA1 Mutation Carrier BRCA2 Mutation Carrier Ductal Breast Carcinoma in Situ Lobular Breast Carcinoma in Situ
This randomized phase III trial studies metformin hydrochloride to see how well it works compared to placebo in preventing breast cancer in patients with atypical hyperplasia or in situ breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming.... expand

This randomized phase III trial studies metformin hydrochloride to see how well it works compared to placebo in preventing breast cancer in patients with atypical hyperplasia or in situ breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of metformin hydrochloride may prevent breast cancer.

Type: Interventional

Start Date: Feb 2015

open study

Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial...
Merck Sharp & Dohme Corp. Carcinoma, Hepatocellular
The purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses... expand

The purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS).

Type: Interventional

Start Date: May 2020

open study

A Dyadic Approach for a Remote Physical Activity Intervention in Adults With AD and Their Caregivers
University of Kansas Alzheimer Disease
The objective of this study is to compare the effectiveness of 2 intervention delivery strategies for increasing moderate physical activity (MPA), real-time group video conferencing (RGV) vs. enhanced usual care (EUC), in community dwelling adults with Alzheimer's diseases... expand

The objective of this study is to compare the effectiveness of 2 intervention delivery strategies for increasing moderate physical activity (MPA), real-time group video conferencing (RGV) vs. enhanced usual care (EUC), in community dwelling adults with Alzheimer's diseases (AD) and their caregiver (dyads) over 18 mos. (6 mos. active, 6 mos. maintenance, 6 mos. no contact). The primary outcome is to compare total MPA (min/wk.), assessed using ActiGraph, in adults with AD from baseline to 6 mos. Secondary aims for the Adults with AD are to compare MPA (min/wk), sedentary time (min/wk.), percentage meeting 150 min/wk. goal, functional fitness, activities of daily living (basic/instrumental), quality of life, residential transitions, and cognitive function across 18 months between RGV and EUC. Secondary aims for the caregivers are to compare total MPA (min/wk.), sedentary time (min/wk.), functional fitness, quality of life, caregiver burden across 18 months between RGV and EUC. Additionally, as an exploratory aim, this study will evaluate the influence of process variables/participant characteristics on MPA in adults with AD and their caregiver across 6, 12 & 18 mos.: age, sex, BMI, attendance (exercise/support sessions), use of recorded videos, PA self-monitoring, peer interactions during group sessions, caregiver support, type and quality of dyadic relationship, and number of caregivers.

Type: Interventional

Start Date: Jul 2020

open study

Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute...
Alliance for Clinical Trials in Oncology B Acute Lymphoblastic Leukemia
This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab ozogamicin,... expand

This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.

Type: Interventional

Start Date: Jun 2017

open study

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe...
Medtronic Cardiovascular Mitral Valve Regurgitation
Multi-center, global, prospective, non-randomize, interventional, pre-market trial. All subjects enrolled with receive the study device expand

Multi-center, global, prospective, non-randomize, interventional, pre-market trial. All subjects enrolled with receive the study device

Type: Interventional

Start Date: Oct 2017

open study

Study of AG-881 in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation...
Agios Pharmaceuticals, Inc. Grade 2 Glioma Residual Glioma Recurrent Glioma
Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of AG-881 to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment.... expand

Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of AG-881 to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization. Approximately 366 participants are planned to be randomized 1:1 to receive orally administered AG-881 40 mg QD or placebo.

Type: Interventional

Start Date: Jan 2020

open study

Study of LAU-7b in the Treatment of Cystic Fibrosis in Adults
Laurent Pharmaceuticals Inc. Cystic Fibrosis
An International Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of LAU-7b administered once-daily for 6 months for the treatment of CF. expand

An International Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of LAU-7b administered once-daily for 6 months for the treatment of CF.

Type: Interventional

Start Date: Oct 2018

open study

A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON
Reata Pharmaceuticals, Inc. Autosomal Dominant Polycystic Kidney ADPKD
This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD. Approximately 300 patients will be enrolled. expand

This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD. Approximately 300 patients will be enrolled.

Type: Interventional

Start Date: May 2019

open study

P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)
Poseida Therapeutics, Inc. Multiple Myeloma
Phase 1 of the study is comprised of an open-label, single ascending dose (SAD), multiple cohort study; a multiple dose cycle administration cohort study; and a combination administration study of P-BCMA-101 autologous T stem cell memory (Tscm) CAR-T cells in patients with... expand

Phase 1 of the study is comprised of an open-label, single ascending dose (SAD), multiple cohort study; a multiple dose cycle administration cohort study; and a combination administration study of P-BCMA-101 autologous T stem cell memory (Tscm) CAR-T cells in patients with relapsed / refractory MM. Followed by a Phase 2, open-label, efficacy and safety study. Rimiducid may be administered as indicated.

Type: Interventional

Start Date: Sep 2017

open study

Testing the Addition of an Anti-cancer Drug, M6620, to the Usual Treatments (Carboplatin and Gemcitabine)...
National Cancer Institute (NCI) Lung Non-Small Cell Squamous Carcinoma Stage IV Lung Cancer AJCC v8
This phase Ib/II trial studies the best dose of carboplatin when given together with M6620, gemcitabine and avelumab and to see how well it works in treating patients with stage IV squamous cell non-small cell lung cancer. M6620 may stop the growth of tumor cells by blocking... expand

This phase Ib/II trial studies the best dose of carboplatin when given together with M6620, gemcitabine and avelumab and to see how well it works in treating patients with stage IV squamous cell non-small cell lung cancer. M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving M6620 together with carboplatin, gemcitabine, and avelumab may work better in treating patients with squamous cell non-small cell lung cancer compared to carboplatin, gemcitabine, and avelumab alone.

Type: Interventional

Start Date: Jun 2020

open study

Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment...
Biosense Webster, Inc. Atrial Fibrillation
The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation. expand

The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.

Type: Interventional

Start Date: Oct 2018

open study

Kindergarten Children Acquiring Words Through Storybook Reading
University of Kansas Language Development Disorders
Children with Specific Language Impairment (SLI) are slower to learn new words than their peers, placing them at risk for academic failure. In this study, we are improving a storybook reading treatment to help Kindergarten children with SLI learn new words. In this study, we... expand

Children with Specific Language Impairment (SLI) are slower to learn new words than their peers, placing them at risk for academic failure. In this study, we are improving a storybook reading treatment to help Kindergarten children with SLI learn new words. In this study, we compare three versions of book reading that vary in how often children are tested on, meaning asked to talk about, the words they are learning in the book: low vs. mid vs. high testing. We then examine which version of the treatment leads to better learning of the words during treatment and remembering of the words after treatment. We also seek to understand individual differences in treatment outcomes by examining pre-treatment predictors as well as progress during and after treatment.

Type: Interventional

Start Date: Jul 2018

open study

Phase II Study of Bendamustine and Rituximab Plus Venetoclax in Untreated Mantle Cell Lymphoma Over 60...
PrECOG, LLC. Mantle Cell Lymphoma
Eligible untreated patients will receive single arm venetoclax, bendamustine and rituximab as induction therapy. After 6 cycles, maintenance rituximab may be administered per physician discretion. Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell... expand

Eligible untreated patients will receive single arm venetoclax, bendamustine and rituximab as induction therapy. After 6 cycles, maintenance rituximab may be administered per physician discretion. Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with mantle cell lymphoma. Venetoclax may make the cancer cells sensitive to chemotherapy. This may help to slow down the growth of cancer or may cause cancer cells to die. The purpose of this study is to see if venetoclax in combination with bendamustine and rituximab chemotherapy is effective in treating people who have mantle cell lymphoma and to examine the side effects, good and bad, associated with this combination.

Type: Interventional

Start Date: Jan 2020

open study

Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults
Vanderbilt University Medical Center COVID-19 Coronavirus SARS-CoV-2
The purpose of this study is to test the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting. The effect of convalescent plasma will be compared to placebo on clinical outcomes, measured using the... expand

The purpose of this study is to test the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting. The effect of convalescent plasma will be compared to placebo on clinical outcomes, measured using the COVID-19 7-point Ordinal Clinical Progression Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.

Type: Interventional

Start Date: Apr 2020

open study

A Study of NKTR-262 in Combination With Bempegaldesleukin (NKTR-214) and With Bempegaldesleukin Plus...
Nektar Therapeutics Melanoma Merkel Cell Carcinoma Triple Negative Breast Cancer Head and Neck Squamous Cell Carcinoma Renal Cell Carcinoma
Patients will receive intra-tumoral (IT) NKTR-262 in 3-week treatment cycles. During the Phase 1 dose escalation portion of the trial, NKTR-262 will be combined with systemic administration of bempegaldesleukin. After determination of the recommended Phase 2 dose (RP2D) of... expand

Patients will receive intra-tumoral (IT) NKTR-262 in 3-week treatment cycles. During the Phase 1 dose escalation portion of the trial, NKTR-262 will be combined with systemic administration of bempegaldesleukin. After determination of the recommended Phase 2 dose (RP2D) of NKTR-262, between 6 and 18 patients may be enrolled at the RP2D to further characterize the safety and tolerability profile of the combination of NKTR 262 plus bempegaldesleukin (doublet) or NKTR 262 plus bempegaldesleukin in combination with nivolumab (triplet) in Cohorts A and B, respectively. In the Phase 2 dose expansion portion, patients will be treated with doublet or triplet in the relapsed/refractory setting and earlier lines of therapy.

Type: Interventional

Start Date: Mar 2018

open study

mHealth Insulin Titration and Management (iSage)
University of Kansas Medical Center Type 2 Diabetes Mellitus
The purpose of this study is to determine the benefits of using the iSage app for basal insulin titration and support. By doing this study the investigators hope to learn whether the app improves the participant's ability to follow his/her healthcare provider's instructions... expand

The purpose of this study is to determine the benefits of using the iSage app for basal insulin titration and support. By doing this study the investigators hope to learn whether the app improves the participant's ability to follow his/her healthcare provider's instructions to adjust his/her insulin doses.

Type: Interventional

Start Date: Aug 2018

open study

A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab...
Hoffmann-La Roche B-cell Non-Hodgkin Lymphoma
This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP)... expand

This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (DLBCL).

Type: Interventional

Start Date: Feb 2019

open study

A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
Eli Lilly and Company Crohn's Disease
The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease. expand

The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.

Type: Interventional

Start Date: Jul 2019

open study

Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric (7-17 Years) With Major Depressive...
Allergan Major Depressive Disorder
The objective of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran compared with placebo in pediatric outpatients (7-17 years) with major depressive disorder (MDD) expand

The objective of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran compared with placebo in pediatric outpatients (7-17 years) with major depressive disorder (MDD)

Type: Interventional

Start Date: Jul 2018

open study

Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults
Duke University Cognitive Impairment, Mild Dementia Cardiovascular Diseases
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... expand

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.

Type: Interventional

Start Date: Sep 2020

open study

A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced...
Deciphera Pharmaceuticals LLC Locally Advanced or Metastatic Solid Tumor
This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with paclitaxel designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in patients with advanced or metastatic solid tumors. expand

This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with paclitaxel designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in patients with advanced or metastatic solid tumors.

Type: Interventional

Start Date: Sep 2018

open study

Cabozantinib in Combination With Durvalumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal...
Anwaar Saeed Gastric Cancer Esophageal Adenocarcinoma Hepatocellular Carcinoma Colorectal Cancer
The investigators propose to evaluate cabozantinib in combination with durvalumab in patients with advanced gastroesophageal cancer and other gastrointestinal (GI) malignancies. Finding effective novel therapies for patients with advanced gastric cancer and other GI malignancies... expand

The investigators propose to evaluate cabozantinib in combination with durvalumab in patients with advanced gastroesophageal cancer and other gastrointestinal (GI) malignancies. Finding effective novel therapies for patients with advanced gastric cancer and other GI malignancies is an area of great unmet need. The investigators believe that modulating the tumor microenvironment with biologic agents like cabozantinib will have synergistic effect when combined with checkpoint-based immunotherapeutics like durvalumab in this patient population. This is a phase I/II, open label, multi-cohort trial looking at safety, tolerability and efficacy endpoints.

Type: Interventional

Start Date: Sep 2018

open study

Breast Cancer WEight Loss Study (BWEL Study)
Alliance for Clinical Trials in Oncology Breast Carcinoma
This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk... expand

This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.

Type: Interventional

Start Date: Aug 2016

open study