439 matching studies

Sponsor Condition of Interest
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

A Long-term Safety Study of Intranasal Esketamine 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 intranasal esketamine in participants with treatment-resistant depression (TRD). expand

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

Type: Interventional

Start Date: Jun 2016

open study

A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder
Naurex, Inc, an affiliate of Allergan plc Depressive Disorder, Major
The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to placebo in adult patients with major depressive disorder (MDD) who are at imminent risk of suicide. expand

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to placebo in adult patients with major depressive disorder (MDD) who are at imminent risk of suicide.

Type: Interventional

Start Date: Dec 2017

open study

Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 3
University of Alabama at Birmingham Infant,Premature
To determine if servo-controlled oxygen environment is associated with reduction in (a) bradycardia events, (b) hypoxemic time, (c) bradycardia time, (d) apneic episodes expand

To determine if servo-controlled oxygen environment is associated with reduction in (a) bradycardia events, (b) hypoxemic time, (c) bradycardia time, (d) apneic episodes

Type: Interventional

Start Date: Apr 2018

open study

Obesity and Endogenous Oxalate Synthesis
University of Alabama at Birmingham Obesity Kidney Stone
The goal of this proposal is to determine the contribution and significance of obesity to urinary oxalate excretion and thus calcium oxalate kidney stone disease. Successful completion of the study will provide insight into the link between obesity and kidney stone disease and... expand

The goal of this proposal is to determine the contribution and significance of obesity to urinary oxalate excretion and thus calcium oxalate kidney stone disease. Successful completion of the study will provide insight into the link between obesity and kidney stone disease and should identify future strategies to treat this disease.

Type: Interventional

Start Date: Jan 2013

open study

A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced...
Seattle Genetics, Inc. HER2 Positive Breast Cancer
This study is being done to see if tucatinib works better than placebo to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed... expand

This study is being done to see if tucatinib works better than placebo to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. All patients in the study will get capecitabine and trastuzumab, two drugs that are often used to treat this cancer. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. They will swallow capecitabine pills two times a day during the first two weeks of each cycle. Patients will get trastuzumab injections from the study site staff on the first day of every cycle.

Type: Interventional

Start Date: Jan 2016

open study

Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma
University of Alabama at Birmingham Penile Squamous Cell Carcinoma (PSCC)
Penile squamous cell carcinoma (PSCC) is a highly aggressive and relatively rare disease. Supportive evidence for the value of systemic therapy does not exist for this disease and there are no agents currently approved by regulatory agencies. This study will evaluate the drug... expand

Penile squamous cell carcinoma (PSCC) is a highly aggressive and relatively rare disease. Supportive evidence for the value of systemic therapy does not exist for this disease and there are no agents currently approved by regulatory agencies. This study will evaluate the drug Gilotrif in patients with metastatic progressive PSCC following chemotherapy. Gilotrif has shown supportive evidence in non-small cell lung cancer by inhibiting certain proteins that are also found in PSCC. The drug has the potential for some patients to exhibit a response contributing to a greater quality of life.

Type: Interventional

Start Date: Oct 2015

open study

Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously for Maintenance Treatment of Anemia...
Hoffmann-La Roche Anemia Renal Insufficiency, Chronic
Ascertain the starting dose of Mircera given subcutaneously for the maintenance treatment of anemia in pediatric participants with chronic kidney disease (CKD) on dialysis or not yet on dialysis when switching from stable subcutaneous (SC) maintenance treatment with epoetin alfa,... expand

Ascertain the starting dose of Mircera given subcutaneously for the maintenance treatment of anemia in pediatric participants with chronic kidney disease (CKD) on dialysis or not yet on dialysis when switching from stable subcutaneous (SC) maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa.

Type: Interventional

Start Date: May 2018

open study

A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin,...
Hoffmann-La Roche Diffuse Large B-Cell Lymphoma
This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated diffuse large B-cell lymphoma (DLBCL). expand

This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated diffuse large B-cell lymphoma (DLBCL).

Type: Interventional

Start Date: Nov 2017

open study

A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients With...
United Therapeutics Pulmonary Hypertension Chronic Obstructive Pulmonary Disease
This is a multicenter, randomized, double-blind, placebo-controlled, 30-week, adaptive cross-over study, with a Treatment Period of approximately 26 weeks under the Original Design or, if applicable, a 17-week parallel study, with a Treatment Period of approximately 14 weeks... expand

This is a multicenter, randomized, double-blind, placebo-controlled, 30-week, adaptive cross-over study, with a Treatment Period of approximately 26 weeks under the Original Design or, if applicable, a 17-week parallel study, with a Treatment Period of approximately 14 weeks under the Contingent Design.

Type: Interventional

Start Date: Jun 2018

open study

A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus
Janssen Research & Development, LLC Lupus Erythematosus, Systemic
The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments. expand

The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.

Type: Interventional

Start Date: Apr 2018

open study

The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE
National Institute of Allergy and Infectious Diseases (NIAID) HIV Infections
The purpose of this study is to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA) antiretroviral therapy (ART) and all-oral standard of care... expand

The purpose of this study is to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA) antiretroviral therapy (ART) and all-oral standard of care (SOC).

Type: Interventional

Start Date: Mar 2019

open study

An Investigational Study to Evaluate BMS-986165 in Patients With Systemic Lupus Erythematosus
Bristol-Myers Squibb Systemic Lupus Erythematosus
This study will investigate BMS-986165 to assess its effects in patients with systemic lupus erythematosus (SLE). expand

This study will investigate BMS-986165 to assess its effects in patients with systemic lupus erythematosus (SLE).

Type: Interventional

Start Date: Sep 2017

open study

A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata
Eli Lilly and Company Alopecia Areata
This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata. expand

This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata.

Type: Interventional

Start Date: Sep 2018

open study

Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients...
Merck Sharp & Dohme Corp. CMV Disease
The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated,... expand

The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated, that LET is superior to VGCV, in preventing CMV disease through 52 weeks post-transplant.

Type: Interventional

Start Date: May 2018

open study

Pentoxifylline and Tocopherol (PENTO) in the Treatment of Medication-related Osteonecrosis of the Jaw...
University of Washington Medication-related Osteonecrosis of the Jaw Bisphosphonate-related Osteonecrosis of the Jaw Avascular Necrosis
The overall purpose of this project is to answer the following clinical question: Among Medication-Related Osteonecrosis of the Jaw (MRONJ) patients, do those who are treated with the Pentoxifylline and Tocopherol (PENTO) regimen and standard of care, when compared to those treated... expand

The overall purpose of this project is to answer the following clinical question: Among Medication-Related Osteonecrosis of the Jaw (MRONJ) patients, do those who are treated with the Pentoxifylline and Tocopherol (PENTO) regimen and standard of care, when compared to those treated with standard of care alone, have decreased areas of exposed bone after one year of treatment?

Type: Interventional

Start Date: Apr 2018

open study

A Registry for Patients With Chronic Hypoparathyroidism
Shire Chronic Hypoparathyroidism
This is a prospective, observational disease and drug registry designed to evaluate the safety and effectiveness profile of rhPTH(1-84) under conditions of routine clinical practice and to observe the clinical course of chronic hypoparathyrodism. No treatment is provided as a... expand

This is a prospective, observational disease and drug registry designed to evaluate the safety and effectiveness profile of rhPTH(1-84) under conditions of routine clinical practice and to observe the clinical course of chronic hypoparathyrodism. No treatment is provided as a result of participating in this registry and all decisions on the participant's treatment are determined by his or her physician.

Type: Observational [Patient Registry]

Start Date: Jul 2013

open study

An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab...
Bristol-Myers Squibb Colorectal Cancer Colorectal Tumors Colorectal Carcinoma Colorectal Neoplasm
The purpose of this study is to investigate treatment with Nivolumab in combination with Trametinib with or without Ipilimumab in patients with previously treated cancer of the colon or rectum that has spread. expand

The purpose of this study is to investigate treatment with Nivolumab in combination with Trametinib with or without Ipilimumab in patients with previously treated cancer of the colon or rectum that has spread.

Type: Interventional

Start Date: Jan 2018

open study

Examining Racial and SocioEconomic Disparities (ERASED) in Chronic Low Back Pain Study
University of Alabama at Birmingham Back Pain Lower Back Chronic
It remains unclear whether certain disadvantaged subgroups of society may be at heightened risk for poor chronic low back pain (cLBP) outcomes. The overall aim of this study is to incorporate a socioeconomic framework to characterize racial differences in cLBP severity and disability.... expand

It remains unclear whether certain disadvantaged subgroups of society may be at heightened risk for poor chronic low back pain (cLBP) outcomes. The overall aim of this study is to incorporate a socioeconomic framework to characterize racial differences in cLBP severity and disability. Further, guided by the theory of fundamental causes, we aim to examine racial and socioeconomic status differences in biopsychosocial predictors of cLBP outcomes, particularly endogenous pain modulation.

Type: Observational

Start Date: Oct 2017

open study

Understanding Value in Metastatic Breast Cancer
University of Alabama at Birmingham Metastatic Breast Cancer
The overall objective of this project is to gain knowledge about out-of-pocket (OOP) expenses and lost opportunity costs among metastatic breast cancer (MBC) patients. To achieve this objective, MBC patients will be asked to participate in a short, 37-question survey asking questions... expand

The overall objective of this project is to gain knowledge about out-of-pocket (OOP) expenses and lost opportunity costs among metastatic breast cancer (MBC) patients. To achieve this objective, MBC patients will be asked to participate in a short, 37-question survey asking questions about the financial burden, OOP expenses, and opportunity costs related to their cancer care

Type: Observational

Start Date: Jun 2017

open study

Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 2
University of Alabama at Birmingham Infant,Premature
To determine if late (at or beyond postnatal day 14) mild permissive hypercapnia is associated with reduction in apnea, bradycardia, and hypoxemic episodes and with improved stability of oxygenation. expand

To determine if late (at or beyond postnatal day 14) mild permissive hypercapnia is associated with reduction in apnea, bradycardia, and hypoxemic episodes and with improved stability of oxygenation.

Type: Interventional

Start Date: Apr 2018

open study

RAD 1601: EDGE Radiosurgery for Intractable Essential Tremor and Tremor-Dominant Parkinson's Disease
University of Alabama at Birmingham Essential Tremor Parkinson Disease
To determine the efficacy of frameless Virtual Cone Radiosurgical Thalamotomy for medically refractory tremor resulting from either Essential Tremor or Tremor-Dominant Parkinson's Disease with the Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) in patients who are not candidates... expand

To determine the efficacy of frameless Virtual Cone Radiosurgical Thalamotomy for medically refractory tremor resulting from either Essential Tremor or Tremor-Dominant Parkinson's Disease with the Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) in patients who are not candidates for deep brain stimulation (DBS).

Type: Interventional

Start Date: Dec 2017

open study

Genetically Engineered HSV-1 Phase 1 Study for the Treatment of Recurrent Malignant Glioma
University of Alabama at Birmingham Recurrent Glioblastoma Multiforme Progressive Glioblastoma Multiforme Anaplastic Astrocytoma or Gliosarcoma
To determine the safety and tolerability of the maximum dose for laboratory engineered Herpes Simplex Virus-1 in patients who would not be eligible for surgical resection of recurrent glioma To determine the safety and tolerability of the maximum dose for laboratory engineered... expand

To determine the safety and tolerability of the maximum dose for laboratory engineered Herpes Simplex Virus-1 in patients who would not be eligible for surgical resection of recurrent glioma To determine the safety and tolerability of the maximum dose for laboratory engineered Herpes Simples Virus-1 in patients who would benefit from surgical resection of recurrent glioma

Type: Interventional

Start Date: Sep 2014

open study

Influence of Obesity on Endogenous Oxalate Synthesis
University of Alabama at Birmingham Kidney Stone
There is increasing evidence that obesity is associated with increased urinary oxalate excretion, an important risk factor for calcium oxalate stone formation. By the administration of a controlled low oxalate diet the investigators will estimate endogenous oxalate synthesis... expand

There is increasing evidence that obesity is associated with increased urinary oxalate excretion, an important risk factor for calcium oxalate stone formation. By the administration of a controlled low oxalate diet the investigators will estimate endogenous oxalate synthesis in both non-obese and obese non-kidney-stone forming adults. This study seeks to thusly increase the understanding of the relationships between obesity and endogenous oxalate synthesis to serve as a platform to develop novel therapies for stone prevention.

Type: Interventional

Start Date: May 2019

open study

Low-Dose Atropine for Treatment of Myopia
Jaeb Center for Health Research Myopia
Study Objectives The objectives for this randomized trial are: 1. To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years (Primary Outcome On-Treatment).... expand

Study Objectives The objectives for this randomized trial are: 1. To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years (Primary Outcome On-Treatment). 2. To determine the efficacy of atropine treatment on myopia progression 6 months following cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment). Synopsis of Study Design The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.

Type: Interventional

Start Date: Jun 2018

open study