478 matching studies

Sponsor Condition of Interest
LTA Pilot Study of Glucarpidase in Patients With Central Nervous System Lymphoma - ARM A
Memorial Sloan Kettering Cancer Center Central Nervous System Lymphoma
The purpose of this study is to test the effects of a drug called Voraxaze when it's routinely given in combination with methotrexate and rituximab, the standard treatment for CNSL. expand

The purpose of this study is to test the effects of a drug called Voraxaze when it's routinely given in combination with methotrexate and rituximab, the standard treatment for CNSL.

Type: Interventional

Start Date: Nov 2018

open study

Binocular Dig Rush Game Treatment for Amblyopia
Jaeb Center for Health Research Amblyopia
To compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to <13 years of age. expand

To compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to <13 years of age.

Type: Interventional

Start Date: Mar 2017

open study

Study of ANAVEX2-73 in Patients With Rett Syndrome
Anavex Life Sciences Corp. Rett Syndrome
Phase 2 safety, tolerability and efficacy study is designed as a double-blind, randomized, placebo-controlled study. 7-week placebo-controlled study of ANAVEX2-73 oral solution for the treatment of patients with RTT 18 years or older. A voluntary option will be offered for all... expand

Phase 2 safety, tolerability and efficacy study is designed as a double-blind, randomized, placebo-controlled study. 7-week placebo-controlled study of ANAVEX2-73 oral solution for the treatment of patients with RTT 18 years or older. A voluntary option will be offered for all patients who meet the exposure criteria for ANAVEX2-73 to continue a 12-week open label extension.

Type: Interventional

Start Date: Feb 2019

open study

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in...
Novartis Pharmaceuticals Early Breast Cancer
A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer expand

A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer

Type: Interventional

Start Date: Dec 2018

open study

A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
United Therapeutics PAH Pulmonary Hypertension Pulmonary Arterial Hypertension Hypertension Connective Tissue Diseases
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH. expand

Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.

Type: Interventional

Start Date: Aug 2018

open study

Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
Arena Pharmaceuticals Ulcerative Colitis
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis. expand

The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.

Type: Interventional

Start Date: Jun 2019

open study

Evaluation of the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and Surgeon-Modified...
University of Alabama at Birmingham Juxtarenal Aortic Aneurysm Suprarenal Aortic Aneurysm Thoracoabdominal Aortic Aneurysm Penetrating Aortic Ulcer
This is a single-center study to evaluate the safety and effectiveness of three investigational devices, the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and the Surgeon-Modified Endografts in the treatment of aortic pathologies involving the visceral... expand

This is a single-center study to evaluate the safety and effectiveness of three investigational devices, the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and the Surgeon-Modified Endografts in the treatment of aortic pathologies involving the visceral vessels. The three investigational devices offer an endovascular approach to treat complex aortic pathologies that cannot be treated with commercially available devices. This customized, endovascular approach has the potential to decrease hospital length of stay, pulmonary complications, and in-hospital mortality.

Type: Interventional

Start Date: Jun 2014

open study

A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding...
AbbVie Uterine Fibroids
The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women. expand

The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women.

Type: Interventional

Start Date: Apr 2019

open study

Alvelestat (MPH996) for the Treatment of ALpha-1 ANTitrypsin Deficiency
University of Alabama at Birmingham Alpha-1 Antitrypsin Deficiency (AATD) Pi*ZZ, Pi*SZ, or Pi*Null Phenotype Emphysema or COPD
This is a Phase 2, multicenter, double-blind, randomized (1:1), placebo-controlled, 12-week, proof-of-concept study to evaluate the safety and tolerability as well as the mechanistic effect of oral administration of alvelestat (MPH996) in subjects with confirmed alpha-1 (Alpha-1... expand

This is a Phase 2, multicenter, double-blind, randomized (1:1), placebo-controlled, 12-week, proof-of-concept study to evaluate the safety and tolerability as well as the mechanistic effect of oral administration of alvelestat (MPH996) in subjects with confirmed alpha-1 (Alpha-1 ZZ genotype (Pi*ZZ), Alpha-1 SZ genotype (Pi*SZ), or Alpha -1 Null phenotype (Pi*Null phenotype)) antitrypsin deficiency (AATD)-related emphysema.

Type: Interventional

Start Date: Apr 2019

open study

TRILUMINATE Pivotal Trial
Abbott Medical Devices Tricuspid Regurgitation
The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality with tricuspid... expand

The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).

Type: Interventional

Start Date: Aug 2019

open study

A Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function
David Nichols, MD Cystic Fibrosis
This is a prospective, multi-center observational study. The study is designed to measure the clinical effectiveness of elexacaftor, tezacaftor and ivacaftor triple combination therapy (TCT) in people with one or more copies of the F508del mutation, study the effects of TCT across... expand

This is a prospective, multi-center observational study. The study is designed to measure the clinical effectiveness of elexacaftor, tezacaftor and ivacaftor triple combination therapy (TCT) in people with one or more copies of the F508del mutation, study the effects of TCT across a number of CF disease manifestations, and collect specimens for future research. Subjects in the study will have one "before TCT" visit within 30 days before initiation of the therapy and five "after TCT" visits over a 24-month follow-up period. Most participating sites will be divided into sub-study groups; each sub-study group will have specific non-optional procedures conducted in addition to the "Core" procedures. Finally there are four optional procedures (pH pill, transient elastography, and nasal cell procurement) that will be offered to subjects at certain sites. The duration of participation for each subject is 25 months. NOTE: FDA is currently reviewing the New Drug Application (NDA) for the TCT. Study will not begin unless and until FDA approval is granted.

Type: Observational

Start Date: Oct 2019

open study

A Study of LY3434172, a PD-1 and PD-L1 Bispecific Antibody, in Advanced Cancer
Eli Lilly and Company Advanced Cancer
The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3434172, a PD-1/PD-L1 bispecific antibody, in participants with advanced solid tumors. expand

The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3434172, a PD-1/PD-L1 bispecific antibody, in participants with advanced solid tumors.

Type: Interventional

Start Date: May 2019

open study

Acute Kidney Injury in Patients With Sickle Cell Disease
University of Alabama at Birmingham Sickle Cell Disease Kidney Injury Kidney Diseases Kidney Disease, Chronic
Patients with sickle cell disease may be at risk for acute kidney injury (AKI)during sickle cell crisis (pain or acute chest syndrome). This study will evaluate the role of hemolysis during SCD crisis on the development of AKI and the role for monitoring urine biomarkers during... expand

Patients with sickle cell disease may be at risk for acute kidney injury (AKI)during sickle cell crisis (pain or acute chest syndrome). This study will evaluate the role of hemolysis during SCD crisis on the development of AKI and the role for monitoring urine biomarkers during an admission for crisis and during well clinic follow-up.

Type: Observational

Start Date: Jan 2017

open study

Neuroinflammation After Myocardial Infarction - Imaging Substudy
University of Alabama at Birmingham Myocardial Infarction
The purpose of the study is to see if positron emission tomography and magnetic resonance imaging (PET/MRI) with an investigational drug called [18F]DPA-714 will show inflammation in the brain after a heart attack. This study may help physicians and researchers better understand... expand

The purpose of the study is to see if positron emission tomography and magnetic resonance imaging (PET/MRI) with an investigational drug called [18F]DPA-714 will show inflammation in the brain after a heart attack. This study may help physicians and researchers better understand the role of brain inflammation in heart disease and develop new treatments to protect the brain.

Type: Interventional

Start Date: Jul 2019

open study

Bougie or Stylet In Patients Undergoing Intubation Emergently (BOUGIE)
Vanderbilt University Medical Center Acute Respiratory Failure
Complications are common during tracheal intubations performed outside of the operating room. Successful intubation on the first attempt has been associated with a lower rate of procedural complications, but the proportion of critically ill patients intubated on the first attempt... expand

Complications are common during tracheal intubations performed outside of the operating room. Successful intubation on the first attempt has been associated with a lower rate of procedural complications, but the proportion of critically ill patients intubated on the first attempt during tracheal intubations outside of the operating room is less than 90%. The bougie, a thin semi-rigid tube that can be placed into the trachea, allowing a Seldinger-like technique of intubating a patient's airway, has been traditionally reserved for difficult or failed airways. However, a recent single center trial of adult patients intubated in an emergency department demonstrated that use of the bougie on the first attempt improved intubation success, compared to use of a traditional stylet. Theinvestigators propose a multi-center randomized trial to compare first-attempt bougie use versus endotracheal tube with stylet use for tracheal intubation of critically ill adults in the ED and ICU.

Type: Interventional

Start Date: Apr 2019

open study

A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients...
Hoffmann-La Roche Huntingtons Disease
This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (RG6042) compared with placebo in patients with manifest Huntington's disease (HD). expand

This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (RG6042) compared with placebo in patients with manifest Huntington's disease (HD).

Type: Interventional

Start Date: Jan 2019

open study

A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors
Bristol-Myers Squibb Colorectal Cancer Pancreatic Cancer
This study will evaluate the safety profile, tolerability, PK, PD, and preliminary efficacy of BMS-813160 alone or in combination with either chemotherapy or nivolumab in participants with metastatic colorectal and pancreatic cancers. expand

This study will evaluate the safety profile, tolerability, PK, PD, and preliminary efficacy of BMS-813160 alone or in combination with either chemotherapy or nivolumab in participants with metastatic colorectal and pancreatic cancers.

Type: Interventional

Start Date: Aug 2017

open study

Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
ACADIA Pharmaceuticals Inc. Schizophrenia
To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia expand

To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia

Type: Interventional

Start Date: Dec 2016

open study

Use of a Patient Preferences Shared Decision-Making Encounter Tool in Clinical Practice for Patients...
Carevive Systems, Inc. Diffuse Large B Cell Lymphoma Follicular Lymphoma
The goal of this project is to test the feasibility of a Patient Preferences in Shared Decision-Making encounter tool (PPSDM) in the clinical context of Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL). This project will evaluate the feasibility of a shared... expand

The goal of this project is to test the feasibility of a Patient Preferences in Shared Decision-Making encounter tool (PPSDM) in the clinical context of Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL). This project will evaluate the feasibility of a shared decision-making (SDM) model that employs an "encounter tool"1 to facilitate SDM at the point of a treatment decision for patients with DLBCL and FL.

Type: Interventional

Start Date: Jan 2009

open study

Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern
EngageTherapeutics, Inc. Epilepsy
This is a multi-center, double-blind, randomized, parallel group, dose-ranging study to investigate the efficacy and clinical usability of STAP-001 in adult (18 years of age and older) subjects with epilepsy with a predictable seizure pattern. These subjects have an established... expand

This is a multi-center, double-blind, randomized, parallel group, dose-ranging study to investigate the efficacy and clinical usability of STAP-001 in adult (18 years of age and older) subjects with epilepsy with a predictable seizure pattern. These subjects have an established diagnosis of focal or generalized epilepsy with a documented history of predictable seizure episodes. This is an in-patient study. The subjects will be admitted to a Clinical Research Unit (CRU) or Epilepsy Monitoring Unit (EMU) for study participation. The duration of the stay in the in-patient unit will be 2-8 days. One seizure event per subject will be treated with study medication. The duration and timing of the seizure event and occurrence of subsequent seizures will be assessed by the Staff Caregiver(s)1 through clinical observation and confirmed with video electroencephalogram (EEG).

Type: Interventional

Start Date: Mar 2018

open study

Effects of Individual Intervention for Men in Focused Deterrence Program
University of Alabama at Birmingham Violence
This project will implement and evaluate a community-based intervention to improve individual outcomes in violence-related injuries and homicide. Young African American men participating in a focused deterrence program (the Birmingham Violence Reduction Initiative, BVRI) will be... expand

This project will implement and evaluate a community-based intervention to improve individual outcomes in violence-related injuries and homicide. Young African American men participating in a focused deterrence program (the Birmingham Violence Reduction Initiative, BVRI) will be randomized to receive an additional individual intervention based on the cognitive-behavioral Reasoning and Rehabilitation program.

Type: Interventional

Start Date: Mar 2018

open study

PF-06651600 for the Treatment of Alopecia Areata
Pfizer Alopecia Areata
This is a global Phase 2b/3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients... expand

This is a global Phase 2b/3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 5 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

Type: Interventional

Start Date: Dec 2018

open study

Integrating Geriatric Assessment for Older Patients Diagnosed With Acute Myelogenous Leukemia
Carevive Systems, Inc. Acute Myeloid Leukemia
Despite the suggestions that GA and frailty indices could be used to guide therapy selection, the ability to effectively incorporate the use of GA in older patients diagnosed with AML in a real-world clinic environment has not yet been established. Thus, in this study, the investigators... expand

Despite the suggestions that GA and frailty indices could be used to guide therapy selection, the ability to effectively incorporate the use of GA in older patients diagnosed with AML in a real-world clinic environment has not yet been established. Thus, in this study, the investigators seek to describe the feasibility of using this shorter GA tool, the mGA, administered via patient self-report on a touchscreen computer, as well as the real-time use and utility by clinicians and the correlation of mGA results on treatment decision-making.

Type: Interventional

Start Date: Apr 2019

open study

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors,...
National Cancer Institute (NCI) Advanced Malignant Solid Neoplasm Bladder Carcinoma Breast Carcinoma Cervical Carcinoma Colon Carcinoma
This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests... expand

This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.

Type: Interventional

Start Date: Aug 2015

open study

Tenecteplase in Stroke Patients Between 4 and 24 Hours
Genentech, Inc. THROMBOLYSIS
This study will evaluate the efficacy and safety of tenecteplase compared with placebo in patients with acute ischemic stroke (AIS). All patients will receive standard-of-care therapy according to American Heart Association / American Stroke Association clinical guidelines (2018).... expand

This study will evaluate the efficacy and safety of tenecteplase compared with placebo in patients with acute ischemic stroke (AIS). All patients will receive standard-of-care therapy according to American Heart Association / American Stroke Association clinical guidelines (2018). To determine eligibility for randomization, all patients will undergo multimodal CT or MRI at baseline. Only patients with a vessel occlusion (ICA or MCA) and penumbral tissue will be randomized. The primary analysis is to compare the efficacy of tenecteplase versus placebo in all patients at Day 90.

Type: Interventional

Start Date: Mar 2019

open study