475 matching studies

Sponsor Condition of Interest
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

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

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

Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD)
University of Alabama at Birmingham Chronic Obstructive Pulmonary Disease
Using various types of inhalers is the treatment cornerstone for COPD patients to control their symptoms. Many inhaler devices require minimum inspiratory effort to activate the device, COPD patients commonly use such devices. Those devices deliver the medications only when the... expand

Using various types of inhalers is the treatment cornerstone for COPD patients to control their symptoms. Many inhaler devices require minimum inspiratory effort to activate the device, COPD patients commonly use such devices. Those devices deliver the medications only when the patient forcefully inhales so the drug can reach the lungs, thus exerting their therapeutic action. The effect of appropriate use of the inhalers in patients with COPD is not well studied, and the impact of demonstrating that a patient can inhale forcefully enough to activate a device on its' effect on symptoms is also lacking in the medical literature. The purpose of this study is to find out: 1. the frequency of COPD patients demonstrating an appropriate use of inhalers that have flow-triggered systems, 2. whether the appropriate use of inhalers impacts the Quality of Life and Shortness of Breath of COPD patients, and 3. the impact of appropriate use of inhalers on FEV1 in COPD patients.

Type: Interventional

Start Date: Sep 2019

open study

Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting...
Alliance for Clinical Trials in Oncology Malignant Neoplasm
This randomized phase III trial studies how well olanzapine with or without fosaprepitant work in preventing chemotherapy induced nausea and vomiting in cancer patients receiving chemotherapy that causes vomiting. Olanzapine and fosaprepitant dimeglumine may help control nausea... expand

This randomized phase III trial studies how well olanzapine with or without fosaprepitant work in preventing chemotherapy induced nausea and vomiting in cancer patients receiving chemotherapy that causes vomiting. Olanzapine and fosaprepitant dimeglumine may help control nausea and vomiting in patients during chemotherapy. Olanzapine is usually given in combination with other drugs, including fosaprepitant dimeglumine. It is not yet known if olanzapine when given with other drugs, is still effective without using fosaprepitant dimeglumine for controlling nausea and vomiting.

Type: Interventional

Start Date: Oct 2018

open study

Improving Family Quality of Life Through Training to Reduce Care-Resistant Behaviors by People With AD...
University of Alabama at Birmingham Dementia Traumatic Brain Injury
To reduce care resistant behaviors (CRB) among people with dementia residing in nursing homes, to a distance-learning education, training, and coaching program for family caregivers of people with dementia or TBI; assess the efficacy of the intervention for reducing frequency... expand

To reduce care resistant behaviors (CRB) among people with dementia residing in nursing homes, to a distance-learning education, training, and coaching program for family caregivers of people with dementia or TBI; assess the efficacy of the intervention for reducing frequency or severity of CRB-triggered symptoms of agitation, aggression, and irritability; assess the efficacy of the intervention for improving quality of life of patients, caregivers, and families; and determine how patient and caregiver characteristics influence the effectiveness of the intervention. 5. Evaluate how the intervention affects the health care costs of people with dementia or TBI.

Type: Interventional

Start Date: Feb 2017

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

Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer
Alliance for Clinical Trials in Oncology Malignant Neoplasm
This phase III trial studies how well dexamethasone works in reducing everolimus-induced oral stomatitis in patients with cancer. Dexamethasone may help to reduce the everolimus-induced oral stomatitis so as to improve quality of life in cancer patients. expand

This phase III trial studies how well dexamethasone works in reducing everolimus-induced oral stomatitis in patients with cancer. Dexamethasone may help to reduce the everolimus-induced oral stomatitis so as to improve quality of life in cancer patients.

Type: Interventional

Start Date: Feb 2019

open study

Treatments Against RA and Effect on FDG-PET/CT
Brigham and Women's Hospital Arthritis, Rheumatoid
In a randomized controlled clinical trial, investigators will compare the effects on [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate responders... expand

In a randomized controlled clinical trial, investigators will compare the effects on [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate responders (MTX-IRs). Two common RA treatments will be compared: triple therapy (sulfasalazine, methotrexate, and hydroxychloroquine) versus tumor necrosis factor (TNF) inhibitor (etanercept or adalimumab, plus background methotrexate for all subjects and hydroxychloroquine for subjects who were taking this at screening).

Type: Interventional

Start Date: Jul 2016

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

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

Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa
ChemoCentryx Hidradenitis Suppurativa Acne Inversa
Phase 2 study of Avacopan in Subjects with Moderate to Severe Hidradenitis Suppurativa expand

Phase 2 study of Avacopan in Subjects with Moderate to Severe Hidradenitis Suppurativa

Type: Interventional

Start Date: Dec 2018

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

Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic...
Bausch Health Americas, Inc. Hepatic Encephalopathy
The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy. expand

The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.

Type: Interventional

Start Date: Apr 2013

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

A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression
Janssen Research & Development, LLC Depressive Disorder, Treatment-Resistant
The purpose of this study is to assess the safety and tolerability of esketamine nasal spray in participants with treatment-resistant depression (TRD). expand

The purpose of this study is to assess the safety and tolerability of esketamine nasal spray in participants with treatment-resistant depression (TRD).

Type: Interventional

Start Date: Jun 2016

open study

REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects
Boston Scientific Corporation Aortic Valve Stenosis
REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects expand

REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects

Type: Interventional

Start Date: Jan 2019

open study

Efficacy and Safety of Lucerastat Oral Monotherapy in Adult Subjects With Fabry Disease
Idorsia Pharmaceuticals Ltd. Fabry Disease
This study aimed to determine the efficacy and safety of lucerastat oral monotherapy in adult subjects with Fabry disease. expand

This study aimed to determine the efficacy and safety of lucerastat oral monotherapy in adult subjects with Fabry disease.

Type: Interventional

Start Date: Jun 2018

open study

Treatment of Macrophage Activation Syndrome (MAS) With Anakinra
University of Alabama at Birmingham Macrophage Activation Syndrome
The primary purpose of this study is to determine whether giving injections of anakinra is a safe and well tolerated treatment to give as an adjunct to standard prescribed treatment for patients who are admitted to the hospital with signs of severe inflammation (macrophage activation... expand

The primary purpose of this study is to determine whether giving injections of anakinra is a safe and well tolerated treatment to give as an adjunct to standard prescribed treatment for patients who are admitted to the hospital with signs of severe inflammation (macrophage activation syndrome) that is potentially life-threatening. Anakinra is a commercially available product (Kineret™) approved for the treatment of rheumatoid arthritis; it is a replica of a naturally occurring protein called Il-1 receptor antagonist (IL-1ra), made by humans to inhibit and regulate the action of interleukin-1 (IL-1). IL-1 is a mediator of inflammation that when generated in excess amounts by immune system cells can result in severe dysfunction of multiple organs that can be life-threatening. The specific primary objectives of the study are to determine if giving anakinra results in no increased infection complications or mortality. Additional data will be collected to determine whether anakinra administration results in any other unanticipated side effects in this setting, and the effects of anakinra administration on inflammation markers, the overall dose of steroids required to treat the inflammation, and the length of hospital stay.

Type: Interventional

Start Date: May 2016

open study

Preventing Cardiovascular Collapse With Administration of Fluid Resuscitation During Induction and Intubation
Vanderbilt University Medical Center Acute Respiratory Failure Intubation Complication Hypotension on Induction
Complications are common during tracheal intubation of critically ill patients. Nearly one in five patients undergoing intubation in the intensive care unit experiences cardiovascular collapse, defined as severe hypotension, vasopressor administration, cardiac arrest or death.... expand

Complications are common during tracheal intubation of critically ill patients. Nearly one in five patients undergoing intubation in the intensive care unit experiences cardiovascular collapse, defined as severe hypotension, vasopressor administration, cardiac arrest or death. Cardiovascular collapse during intubation is associated with increased resource utilization and decreased survival. Administration of 500 mL of intravenous crystalloid solution beginning prior to induction may prevent cardiovascular collapse. The only prior trial examining fluid bolus administration during intubation found no effect on cardiovascular collapse or clinical outcomes overall, but a hypothesis-generating subgroup analysis suggested potential benefit to fluid bolus administration among patients receiving positive pressure ventilation between induction and laryngoscopy. Therefore, we propose a randomized trial comparing fluid bolus administration versus none with regard to cardiovascular collapse among critically adults undergoing intubation with positive pressure ventilation between induction and laryngoscopy.

Type: Interventional

Start Date: Feb 2019

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

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