475 matching studies

Sponsor Condition of Interest
A Study To Evaluate PF-06730512 In Adults With Primary Focal Segmental Glomerulosclerosis
Pfizer Focal Segmental Glomerulosclerosis (FSGS)
The purpose of this Phase 2 adaptive study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06730512 following multiple intravenous infusion in adult subjects with primary FSGS. expand

The purpose of this Phase 2 adaptive study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06730512 following multiple intravenous infusion in adult subjects with primary FSGS.

Type: Interventional

Start Date: Oct 2018

open study

A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)
AbbVie Parkinson's Disease (PD)
The purpose of this study is to assess the safety and tolerability of ABBV-951 in subjects with Parkinson's disease (PD). expand

The purpose of this study is to assess the safety and tolerability of ABBV-951 in subjects with Parkinson's disease (PD).

Type: Interventional

Start Date: Apr 2019

open study

Pembrolizumab in Treating Patients With Stage III-IV High-Risk Melanoma Before and After Surgery
National Cancer Institute (NCI) Acral Lentiginous Melanoma Clinical Stage III Cutaneous Melanoma AJCC v8 Clinical Stage IV Cutaneous Melanoma AJCC v8 Mucosal Melanoma Pathologic Stage III Cutaneous Melanoma AJCC v8
This phase II trial studies how pembrolizumab works before and after surgery in treating patients with stage III-IV high-risk melanoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with... expand

This phase II trial studies how pembrolizumab works before and after surgery in treating patients with stage III-IV high-risk melanoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab before and after surgery may work better in treating melanoma.

Type: Interventional

Start Date: Dec 2018

open study

Functionally Validated Structural Endpoints for Early AMD
Cynthia Owsley Age-related Macular Degeneration Aging
Delayed rod-mediated dark adaptation (RMDA), or delayed recovery of vision in a dark environment, is a functional biomarker (i.e., risk factor) for early age-related macular degeneration (AMD). This research plan is designed to elucidate the structural (anatomical) basis of this... expand

Delayed rod-mediated dark adaptation (RMDA), or delayed recovery of vision in a dark environment, is a functional biomarker (i.e., risk factor) for early age-related macular degeneration (AMD). This research plan is designed to elucidate the structural (anatomical) basis of this visual deficit using cellular- and subcellular level imaging of the retina and its supporting tissues in living people. An accurate map and timeline of structure-function relationships in persons tested for night vision will result in functionally validated structural endpoints for early AMD trials, as well as define major biologic effects for development into future treatments.

Type: Observational

Start Date: Oct 2019

open study

Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2)
Celsion Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer
This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone. expand

This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.

Type: Interventional

Start Date: Sep 2018

open study

Treg Therapy in Subclinical Inflammation in Kidney Transplantation
National Institute of Allergy and Infectious Diseases (NIAID) Kidney Transplant Adult Living Donor Kidney Transplant Recipients Renal Transplant Living Kidney Donor
The purpose of this study is: - To see if polyTregs can reduce inflammation in a transplanted kidney. - To find out what effects, good or bad, polyTregs will have in the kidney recipient. - To find out what effects, good or bad, taking everolimus after polyTregs will... expand

The purpose of this study is: - To see if polyTregs can reduce inflammation in a transplanted kidney. - To find out what effects, good or bad, polyTregs will have in the kidney recipient. - To find out what effects, good or bad, taking everolimus after polyTregs will have in the kidney recipient.

Type: Interventional

Start Date: May 2016

open study

Cesarean Section Via Enhanced Recovery
University of Alabama at Birmingham Cesarean Section
Enhanced Recovery After Surgery (ERAS) protocols have been proven to be very successful in specific patient populations. An example is with ERAS for colorectal surgery. ERAS protocols in this patient population have been shown to reduce overall morbidity and hospital length of... expand

Enhanced Recovery After Surgery (ERAS) protocols have been proven to be very successful in specific patient populations. An example is with ERAS for colorectal surgery. ERAS protocols in this patient population have been shown to reduce overall morbidity and hospital length of stay (LOS). At the University of Alabama at Birmingham (UAB), the institution has had successful implementation of ERAS protocols for several surgical specialties including colorectal, breast, spine, gynecology, and gynecology-oncology. However, the institution currently does not have a protocol in place for the most commonly performed surgical procedure - cesarean delivery. At UAB, the institution performs approximately 1,000 cesarean deliveries per year. The investigators believe that an ERAS protocol will be beneficial for these patients. Currently, there is very little data published on ERAS protocols. Although this patient population is ideal for an ERAS protocol, there are several barriers that have to be overcome. The data published show promising results for ERAS protocols with cesarean delivery. A larger tertiary care center showed earlier discharge with lower re-admission rates with an ERAS pathway. Currently, the investigators have created a multidisciplinary group at UAB to establish an ERAS protocol for patients undergoing cesarean delivery. This group includes anesthesiologists, obstetricians, nursing, neonatology, pharmacy, and informatics. Once the investigators have implemented this protocol, the investigators would like to perform a retrospective analysis to determine if there are any significant changes in our desired outcomes the investigators will study. Our goal is to demonstrate significantly improved outcomes in the investigators' measured endpoints. The investigators believe that this information will be very useful because although there is a national interest in creating ERAS protocols for cesarean deliveries, there currently is very little published on the subject. The investigators would like to publish the investigators' results and protocol as a resource for other institutions to adopt.

Type: Observational

Start Date: Jan 2019

open study

LCI-HEM-SCD-ST3P-UP-001: The Sickle Cell Trevor Thompson Transition Project (ST3P-UP Study)
Ifeyinwa (Ify) Osunkwo MD MPH Sickle Cell Disease
This multi-center study will compare the effectiveness of adding virtual peer mentoring (PM) to a structured education-based (STE) transition program for emerging adults with sickle cell disease to determine its effect on decreasing the number of acute care visits per year, improving... expand

This multi-center study will compare the effectiveness of adding virtual peer mentoring (PM) to a structured education-based (STE) transition program for emerging adults with sickle cell disease to determine its effect on decreasing the number of acute care visits per year, improving patient-reported outcomes, and reducing healthcare utilization among emerging adults with sickle cell disease (EA-SCD)

Type: Interventional

Start Date: Jan 2018

open study

Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS
Astex Pharmaceuticals, Inc. Myelodysplastic Syndromes
Multicenter, open-label study of various ASTX727 LD doses and schedules to assess safety, pharmacodynamics, pharmacokinetics, and hematologic response in subjects with IPSS risk category of low-risk or Intermediate-1 MDS. This study will be conducted in two phases. In phase 1... expand

Multicenter, open-label study of various ASTX727 LD doses and schedules to assess safety, pharmacodynamics, pharmacokinetics, and hematologic response in subjects with IPSS risk category of low-risk or Intermediate-1 MDS. This study will be conducted in two phases. In phase 1 subjects will be randomized into 3 cohorts in a 28-day cycles. Phase 2, 80 new subjects will be randomized in a 1:1 ratio into 2 doses/schedules.

Type: Interventional

Start Date: Jul 2018

open study

Southeastern Collaboration to Improve Blood Pressure Control
University of Alabama at Birmingham Hypertension
The central objective of this proposal is to rigorously compare two strategies designed to improve BP control in primary care practices serving rural Southeastern African Americans with low socioeconomic status (SES) living in the "Black Belt". The Agency for Healthcare Research... expand

The central objective of this proposal is to rigorously compare two strategies designed to improve BP control in primary care practices serving rural Southeastern African Americans with low socioeconomic status (SES) living in the "Black Belt". The Agency for Healthcare Research and Quality (AHRQ) Disparities Report identifies individuals with rural residence, minority ethnicity, and low SES as being at high risk for poor health outcomes. The "Black Belt" region stretches from eastern Texas in an arc to Maryland and includes residents with all 3 of these characteristics - the proverbial triple threat. This traditionally agricultural region is characterized by steep poverty, low educational attainment, scarce resources, and mostly African American residents. The Black Belt is in the heart of the Stroke Belt, a geographic area long recognized to have the highest cardiovascular disease (CVD) mortality in the US. The AHRQ Disparities Report also cites that the Southeast has lower quality of care than the rest of the US, thus effective strategies to optimize CVD prevention in general and hypertension (HTN) control specifically are urgently needed here. In year 1 (AIM 1) we're engaging community members (community members who have experience being community peer advisors or have high blood pressure) to develop the study interventions and protocols. In years 2-5, the investigators will test these interventions.

Type: Interventional

Start Date: May 2017

open study

Study of CB-839 (Telaglenastat) in Combination With Talazoparib in Patients With Solid Tumors
Calithera Biosciences, Inc Solid Tumor Clear Cell Renal Cell Carcinoma TNBC - Triple-Negative Breast Cancer Colorectal Cancer CRC
This is a Phase 1b/2 study to determine the recommended phase 2 dose (RP2D), safety and tolerability, pharmacokinetics (PK) and clinical activity of the glutaminase inhibitor CB-839 with the PARP inhibitor talazoparib in participants with advanced/metastatic solid tumors. expand

This is a Phase 1b/2 study to determine the recommended phase 2 dose (RP2D), safety and tolerability, pharmacokinetics (PK) and clinical activity of the glutaminase inhibitor CB-839 with the PARP inhibitor talazoparib in participants with advanced/metastatic solid tumors.

Type: Interventional

Start Date: Mar 2019

open study

A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT...
Pfizer Respiratory Tract Infection
This Phase 2b study will evaluate the safety, tolerability, and immunogenicity of an RSV vaccine in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, and investigate safety and characteristics... expand

This Phase 2b study will evaluate the safety, tolerability, and immunogenicity of an RSV vaccine in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, and investigate safety and characteristics of antibodies in their infants.

Type: Interventional

Start Date: Aug 2019

open study

Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects
Actelion Congenital Heart Disease
The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing. expand

The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.

Type: Interventional

Start Date: Aug 2017

open study

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

KRT-232 in Subjects With PMF, Post-PV MF, or Post-ET MF Who Have Failed a JAK Inhibitor
Kartos Therapeutics, Inc. Primary Myelofibrosis (PMF) Post-Polycythemia Vera MF (Post-PV-MF) Post-Essential Thrombocythemia MF (Post-ET-MF)
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF. This study is a global, open-label... expand

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF. This study is a global, open-label Phase 2 study to determine the efficacy and safety of KRT-232 in patients with primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF who have failed previous treatment with JAK inhibitor (Part A), or Ruxolitinib (Part B). In Part A of the study, patients will be randomly assigned to 2 different doses and 3 different dosing schedules of KRT-232. In Part B of the study, patients will be treated at the recommended dose and schedule from Part A.

Type: Interventional

Start Date: Jan 2019

open study

A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
Vertex Pharmaceuticals Incorporated Cystic Fibrosis
This study will evaluate the long-term safety and tolerability of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA). expand

This study will evaluate the long-term safety and tolerability of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA).

Type: Interventional

Start Date: Aug 2019

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 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

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

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

Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer...
Alliance for Clinical Trials in Oncology Node Positive HER2 Negative Breast Cancer
This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces... expand

This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.

Type: Interventional

Start Date: Dec 2016

open study

A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab...
Hoffmann-La Roche B-cell Non-Hodgkin Lymphoma
This study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of mosunetuzumab in combination with polatuzumab vedotin in participants with diffuse large B-cell lymphoma (DLBCL) and in participants with follicular lymphoma (FL). It will consist of a dose finding... expand

This study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of mosunetuzumab in combination with polatuzumab vedotin in participants with diffuse large B-cell lymphoma (DLBCL) and in participants with follicular lymphoma (FL). It will consist of a dose finding portion followed by an expansion phase for second line or later (2L+) participants with relapsed or refractory (R/R) DLBCL and 2L+ R/R FL.

Type: Interventional

Start Date: Sep 2018

open study

A Study to Evaluate the Long-term Safety and Tolerability of Lucerastat in Adult Subjects With Fabry...
Idorsia Pharmaceuticals Ltd. Fabry Disease
A study to determine the long-term safety and tolerability of oral lucerastat in adult subjects with Fabry disease expand

A study to determine the long-term safety and tolerability of oral lucerastat in adult subjects with Fabry disease

Type: Interventional

Start Date: Dec 2018

open study

Ketone Supplementation in Adolescents Post-Concussion
University of Alabama at Birmingham Concussion, Mild Concussion, Severe Concussion, Brain Concussive Injury Sport Injury
Adolescent brains undergo rapid and significant changes in structural architecture and functional organization during development. A concussive injury during this developmental period can have substantial physiological and cognitive ramifications. If not adequately managed, adolescent... expand

Adolescent brains undergo rapid and significant changes in structural architecture and functional organization during development. A concussive injury during this developmental period can have substantial physiological and cognitive ramifications. If not adequately managed, adolescent concussions can have profound long-term effects. The purpose of this study is to determine whether ketone supplementation after a concussion will reduce long-term consequences and improve short-term functional status and outcomes in adolescents who have suffered a concussion.

Type: Interventional

Start Date: Jan 2020

open study