470 matching studies

Sponsor Condition of Interest
Safety and Efficacy of OT-82 in Participants With Relapsed or Refractory Lymphoma
Oncotartis, Inc. Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, T-Cell Lymphoma, Follicular
This research study will test OT-82, which is an investigational ("research" or "experimental" ) drug. The study has two stages (Stage 1 and Stage 2). The purpose of Stage 1 is to determine the safety and tolerability and the maximum tolerated dose (MTD) or the maximum tested... expand

This research study will test OT-82, which is an investigational ("research" or "experimental" ) drug. The study has two stages (Stage 1 and Stage 2). The purpose of Stage 1 is to determine the safety and tolerability and the maximum tolerated dose (MTD) or the maximum tested dose of OT-82 administered orally to participants. The purpose of Stage 2 is to determine the preliminary efficacy of OT-82 in relapsed or refractory lymphoma at the MTD or the maximum tested dose. Both parts of the study will also evaluate the pharmacokinetics (absorption, distribution, metabolism, elimination) of OT-82. OT-82 treatment slowed the growth, reduced the size, or in some cases cured certain cancers in animal studies. It is hoped that participants with relapsed or refractory lymphoma treated with OT - 82 in this study will experience slowing tumor growth and/or reduction of tumor size.

Type: Interventional

Start Date: Jul 2019

open study

Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine
University of Alabama at Birmingham Headache Pregnancy Related Occipital Nerve Block
This is an open label randomized controlled trial evaluating response to bupivacaine occipital nerve block compared to Tylenol/Caffeine cocktail in treatment of pregnant patients seeking care of headache. expand

This is an open label randomized controlled trial evaluating response to bupivacaine occipital nerve block compared to Tylenol/Caffeine cocktail in treatment of pregnant patients seeking care of headache.

Type: Interventional

Start Date: Feb 2020

open study

Robotic-assisted and Laparoscopic Right Colectomy Study - Intracorporeal vs. Extracorporeal Anastomoses
Intuitive Surgical Benign Right Colon Disease Malignant Right Colon Disease
To compare intracorporeal and extracorporeal anastomoses for robotic-assisted and laparoscopic right colectomies expand

To compare intracorporeal and extracorporeal anastomoses for robotic-assisted and laparoscopic right colectomies

Type: Observational

Start Date: Feb 2018

open study

Novel Biomarkers of Preeclampsia, Aquaporin, Fatty Acid, and S110B
University of Alabama at Birmingham Preeclampsia
This is a research study designed to help identify preeclampsia in pregnant women earlier, and possibly lead to better treatment for women preeclampsia. expand

This is a research study designed to help identify preeclampsia in pregnant women earlier, and possibly lead to better treatment for women preeclampsia.

Type: Observational

Start Date: May 2017

open study

Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors
University of Alabama at Birmingham Breast Cancer Gut Microbiome Exercise Fatigue
The primary goal of this project is to determine the effects of exercise on the gut microbiome in breast cancer survivors and determine how these changes may relate to psychosocial symptoms such as fatigue. expand

The primary goal of this project is to determine the effects of exercise on the gut microbiome in breast cancer survivors and determine how these changes may relate to psychosocial symptoms such as fatigue.

Type: Interventional

Start Date: Jan 2020

open study

Comparing NicoBloc to Nicotine Lozenges
University of Alabama at Birmingham Smoking Cessation Nicotine Dependence
To examine the feasibility, acceptability, and preliminary impact of using NicoBloc compared to nicotine lozenges expand

To examine the feasibility, acceptability, and preliminary impact of using NicoBloc compared to nicotine lozenges

Type: Interventional

Start Date: Mar 2019

open study

Panitumumab IRDye800 Optical Imaging Study
Eben Rosenthal Head and Neck Cancer
Phase I trial to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent. expand

Phase I trial to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent.

Type: Interventional

Start Date: Aug 2016

open study

Trikafta in Cystic Fibrosis Patients
Emory University Cystic Fibrosis
Cystic Fibrosis (CF) is a life threatening genetic disorder resulting from mutations found in the gene known as the cystic fibrosis transmembrane conductance regulator (CFTR). This clinical study will enroll 22 participants without the F508del mutation, carrying partial function... expand

Cystic Fibrosis (CF) is a life threatening genetic disorder resulting from mutations found in the gene known as the cystic fibrosis transmembrane conductance regulator (CFTR). This clinical study will enroll 22 participants without the F508del mutation, carrying partial function mutations not approved for Trikafta, and who are not expected to be approved for CFTR modulator treatment in the immediate future. Each participant will be given Trikafta for approximately four weeks. The study researchers will monitor clinical endpoints that include forced expiratory volume (FEV1), sweat chloride, and nasal potential difference. Additionally, the researchers will obtain skin biopsy material from each subject so that induced pluripotent stem (iPS) cells can be modified into airway cell monolayers and tested for response to Trikafta. In this way, the study will evaluate an emerging and readily accessible in vitro endpoint as a predictor of clinical response. This study will serve as a pilot/test case for other clinical protocols relevant to patients with rare CFTR variants who do not currently receive modulator therapies. It is hypothesized that a robust correlation will be established between in vitro Trikafta responsiveness of iPS cells and in vivo benefit (FEV1) to patients, and will provide a new tool for utilizing iPS to identify patient populations most suitable for cystic fibrosis modulator therapy.

Type: Interventional

Start Date: Sep 2019

open study

Treatment Outcomes of CBT for PNES
University of Alabama at Birmingham Convulsion, Non-Epileptic
This research study is examining the effects of a cognitive behavioral intervention (an intervention focused on changing behaviors and thoughts) for psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no medical explanation). Participants... expand

This research study is examining the effects of a cognitive behavioral intervention (an intervention focused on changing behaviors and thoughts) for psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no medical explanation). Participants engage in 8 individual therapy sessions consisting of either cognitive behavioral therapy or supportive therapy. Healthy control participants also complete pre-questionnaires.

Type: Interventional

Start Date: Jun 2016

open study

High Resolution Micro OCT Imaging
University of Alabama at Birmingham Cystic Fibrosis COPD PCD - Primary Ciliary Dyskinesia
The purpose of this study is to learn about using the imaging to make images of the lungs and nose with the long-term goal of the research leading to potential treatments and new therapies for patients with cystic fibrosis. expand

The purpose of this study is to learn about using the imaging to make images of the lungs and nose with the long-term goal of the research leading to potential treatments and new therapies for patients with cystic fibrosis.

Type: Observational

Start Date: Apr 2016

open study

CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes
Nicole Hamblett Cystic Fibrosis
This is a multicenter, cross-sectional, cohort study which will collect contemporary sweat chloride (SC) values from approximately 5000 Cystic Fibrosis (CF) patients prescribed and currently receiving commercially approved Cystic Fibrosis transmembrane conductance regulator (CFTR)... expand

This is a multicenter, cross-sectional, cohort study which will collect contemporary sweat chloride (SC) values from approximately 5000 Cystic Fibrosis (CF) patients prescribed and currently receiving commercially approved Cystic Fibrosis transmembrane conductance regulator (CFTR) modulator therapies.

Type: Observational

Start Date: Jan 2018

open study

Heart Failure Optimization Study
Zoll Medical Corporation Sudden Cardiac Death Sudden Cardiac Arrest Heart Failure Heart Failure Low Output
This study is designed as a multi-center prospective observational study of newly diagnosed Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF) recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy (GDMT) is achieved.... expand

This study is designed as a multi-center prospective observational study of newly diagnosed Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF) recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy (GDMT) is achieved. Although the study doesn't start until day 90, all eligible, consenting patients will be entered into a registry at the start of wearable cardioverter defibrillator (WCD) use. The pre-study registry will allow us to collect early (90 day) outcomes and data in those patients who are likely to be eligible for the study at day 90, or are eligible, but refuse the study at day 90.

Type: Observational

Start Date: Mar 2017

open study

Factors That Impact the Relationship Between Pulmonary Status and Susceptibility to Electronic Cigarette...
University of Alabama at Birmingham Electronic Cigarette Use Pulmonary Disease
The purpose of the study is to explores various psycho-social, physiological, cognitive, behavioral, and environmental factors that may affect the association between pulmonary status and Susceptibility to Electronic Cigarette Use expand

The purpose of the study is to explores various psycho-social, physiological, cognitive, behavioral, and environmental factors that may affect the association between pulmonary status and Susceptibility to Electronic Cigarette Use

Type: Observational

Start Date: Jan 2020

open study

Study of Intravenous ATYR1923 for Pulmonary Sarcoidosis
aTyr Pharma, Inc. Pulmonary Sarcoidosis
This randomized, double-blind, placebo-controlled, study will evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK), and preliminary efficacy of multiple ascending doses of IV ATYR1923 in patients with pulmonary sarcoidosis undergoing a protocol-guided oral... expand

This randomized, double-blind, placebo-controlled, study will evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK), and preliminary efficacy of multiple ascending doses of IV ATYR1923 in patients with pulmonary sarcoidosis undergoing a protocol-guided oral corticosteroid (OCS) tapering regimen.This study will consist of 3 staggered multiple dose cohorts. Each eligible participant will participate in only one cohort during the study. Within each cohort, 12 participants will be randomized 2:1 to ATYR1923 (N=8) or placebo (N=4).

Type: Interventional

Start Date: Jan 2019

open study

Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk...
Daiichi Sankyo, Inc. Cardiac Disease
A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care). All children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing... expand

A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care). All children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots. The study will find out if edoxaban is safer and more effective than the standard of care.

Type: Interventional

Start Date: May 2018

open study

Using Interactive Virtual Presence to Remotely Assist Parents With Child Restraint Installations
University of Alabama at Birmingham Car Seat Installation
Motor vehicle crashes cause the death of an American child every 3 hours, more than any other cause. When installed correctly, car seats reduce risk of serious injury and death to infants and young children. Unfortunately, a large portion of child restraints is installed incorrectly.... expand

Motor vehicle crashes cause the death of an American child every 3 hours, more than any other cause. When installed correctly, car seats reduce risk of serious injury and death to infants and young children. Unfortunately, a large portion of child restraints is installed incorrectly. A network of trained technicians work across the country to assist parents in achieving correct use of child restraints through scheduled "car seat checks," where technicians work with parents to install restraints in their vehicles. Car seat checks are effective in reducing errors in child restraint installations. However, the services are highly underutilized. The present study evaluates use of interactive virtual presence technology (also called interactive merged reality) to remotely assist parents to install child restraints correctly into their vehicles. Building from small pilot studies on the topic, the investigators will conduct a randomized non-inferiority trial to evaluate whether parents who install child restraints while communicating with a remote expert technician via interactive virtual presence achieve installations and learning that are not inferior in their safety to parents who install restraints live with a remote technician onsite. The investigators will recruit 1476 parents at 7 locations nationwide and randomly assign consenting parents to install their child restraint either via interactive virtual presence or with a live technician. The correctness of installation safety will be assessed using objective checklists, both following installation and again four months later. The investigators aim to demonstrate that child restraint installation is accurate (>90% correct) when conducted remotely via interactive virtual presence, that such installations are not inferior to the accuracy of installation with a live on-site expert, and that parents learn and retain information about correct child restraint installation.

Type: Interventional

Start Date: Jan 2020

open study

A Phase 1/2 Study to Evaluate SNDX- 6352 in Subjects With Active cGVHD
Syndax Pharmaceuticals Chronic Graft-versus-host-disease
This is a Phase 1/2, Open-label, Dose Escalation study to investigate SNDX-6352 in subjects with active cGVHD. expand

This is a Phase 1/2, Open-label, Dose Escalation study to investigate SNDX-6352 in subjects with active cGVHD.

Type: Interventional

Start Date: Nov 2018

open study

The Inotrope Evaluation and Research Patient Registry
Coram Clinical Trials Heart Failure
The INTERPRET Inotrope Evaluation and Research Patient Registry is a longitudinal, observational study designed to look at the demographics and outcomes of heart failure patients on inotropic therapy administered in the home or infusion suite setting. The data gathered in this... expand

The INTERPRET Inotrope Evaluation and Research Patient Registry is a longitudinal, observational study designed to look at the demographics and outcomes of heart failure patients on inotropic therapy administered in the home or infusion suite setting. The data gathered in this registry will provide information on how a patient's quality of life and symptoms change over time while on inotrope therapy, and help healthcare providers to have a better understanding of the benefits and risks associated with bridge-to-treatment and palliative care.

Type: Observational [Patient Registry]

Start Date: Aug 2014

open study

Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With...
National Cancer Institute (NCI) Ann Arbor Stage III Hodgkin Lymphoma Ann Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma Ann Arbor Stage III Mixed Cellularity Classic Hodgkin Lymphoma Ann Arbor Stage III Nodular Sclerosis Classic Hodgkin Lymphoma Ann Arbor Stage IIIA Hodgkin Lymphoma
This randomized phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab,... expand

This randomized phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.

Type: Interventional

Start Date: Jul 2019

open study

Metabolic Health in Individuals With Spinal Cord Injury (SCI)
University of Alabama at Birmingham Spinal Cord Injuries Skeletal Muscle Atrophy Metabolic Disease
Individuals with spinal cord injury (SCI) live longer than before and live to an age where metabolic disorders become highly prevalent. Due to loss of mobility and severe skeletal muscle atrophy, obesity, glucose intolerance, and peripheral insulin resistance develop soon after... expand

Individuals with spinal cord injury (SCI) live longer than before and live to an age where metabolic disorders become highly prevalent. Due to loss of mobility and severe skeletal muscle atrophy, obesity, glucose intolerance, and peripheral insulin resistance develop soon after the onset of SCI. These abnormalities are thought to contribute to the increased diabetes disease risk and accelerated aging process in the SCI population. As a result of these trends, overall burden of complications, economic impact and reduced quality of life are increasing. Until there are effective treatments for SCI, it is imperative to develop effective interventions to mitigate metabolic disorders that develop in individuals with SCI. The proposed research project examines the impact of early utilization of a novel neuromuscular electrical stimulation (NMES) program on skeletal muscle metabolism and overall metabolic health in individuals with sub-acute, complete SCI.

Type: Interventional

Start Date: Jan 2018

open study

Study of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic...
Tracon Pharmaceuticals Inc. Solid Tumor Metastatic Cancer
This is a multicenter, open label, Phase 1 dose escalation study of TJ004309 in combination with standard dose atezolizumab in patients with advanced or metastatic cancer in patients who are refractory to or intolerant to all available therapy. expand

This is a multicenter, open label, Phase 1 dose escalation study of TJ004309 in combination with standard dose atezolizumab in patients with advanced or metastatic cancer in patients who are refractory to or intolerant to all available therapy.

Type: Interventional

Start Date: Jul 2019

open study

Pain Management in Head and Neck Surgery Patients
University of Alabama at Birmingham Pain Management
Our study aims to see if the addition of a scheduled non-opioid pain regimen will decrease the use and risk of opioid pain medications as well as improve pain control in head and neck surgery patients. Participants will be randomized to one of two pain regimens (opioid medication... expand

Our study aims to see if the addition of a scheduled non-opioid pain regimen will decrease the use and risk of opioid pain medications as well as improve pain control in head and neck surgery patients. Participants will be randomized to one of two pain regimens (opioid medication regimen vs combination regimen of opioid and non-opioid medications).

Type: Interventional

Start Date: Nov 2017

open study

Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People...
University of Pittsburgh Chronic Pain
Due to its prevalence and impact on quality of life and overall health, the National Academy of Medicine has called chronic pain a "public health crisis." Therefore, this proposal is relevant to public health because it seeks to improve chronic pain treatment in accordance with... expand

Due to its prevalence and impact on quality of life and overall health, the National Academy of Medicine has called chronic pain a "public health crisis." Therefore, this proposal is relevant to public health because it seeks to improve chronic pain treatment in accordance with the approach recommended by the Department of Health and Human Services National Pain Strategy: to develop and test Pain Self-Management interventions tailored to the needs of vulnerable populations, particularly people living with HIV (PLWH). Chronic pain is an important and understudied comorbidity among PLWH; therefore, this proposal is responsive to the NIH's HIV Research Priorities, which identify comorbidities as a high priority research topic.

Type: Interventional

Start Date: Aug 2019

open study

The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents,...
Children's Hospital Los Angeles B-cell Acute Lymphoblastic Leukemia
This study will evaluate the use of non- TBI (total body irradiation) conditioning for B-ALL patients with low risk of relapse as defined by absence of NGS-MRD (next generation sequencing minimal residual disease) before receiving a hematopoietic cell transplant (HCT). Patients... expand

This study will evaluate the use of non- TBI (total body irradiation) conditioning for B-ALL patients with low risk of relapse as defined by absence of NGS-MRD (next generation sequencing minimal residual disease) before receiving a hematopoietic cell transplant (HCT). Patients diagnosed with B-ALL who are candidates for HCT will be screened by NGS-MRD on a test of bone marrow done before the HCT. Subjects who are pre-HCT NGS-MRD negative will be eligible to receive a non-TBI conditioning regimen as part of the treatment cohort of the study. Subjects who are pre-HCT NGS-MRD positive will be treated as per treating center standard and will be followed in an observational cohort (HCT center standard of care).

Type: Interventional

Start Date: Aug 2018

open study

Trial of Hu5F9-G4 in Combination With Rituximab in Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Gilead Sciences Lymphoma, Non-Hodgkin Lymphoma, Large B-Cell, Diffuse Indolent Lymphoma
This Phase 1b/2 trial will evaluate Hu5F9-G4 (magrolimab) in combination with rituximab and magrolimab or in combination with R-GemOx. Magrolimab is a monoclonal antibody which is designed to block a protein called CD47, which is widely expressed on human cancer cells. Blocking... expand

This Phase 1b/2 trial will evaluate Hu5F9-G4 (magrolimab) in combination with rituximab and magrolimab or in combination with R-GemOx. Magrolimab is a monoclonal antibody which is designed to block a protein called CD47, which is widely expressed on human cancer cells. Blocking CD47 with magrolimab may enable the body's immune system to find and destroy the cancer cells. Rituximab is a monoclonal antibody drug that is used for treatment of non-Hodgkin's lymphoma and other types of cancer. Gemcitabine and Oxaliplatin are chemotherapy commonly used with rituximab in treating NHL. The major aims of the trial are: (Phase 1b) to investigate the safety and tolerability of sequential dose cohorts and to determine a recommended Phase 2 dose for Hu5F9-G4 in combination with rituximab, and (Phase 2) to evaluate the efficacy of Hu5F9-G4 in combination with rituximab in patients with indolent lymphoma or diffuse large B-cell lymphoma as measured by the overall response rate.

Type: Interventional

Start Date: Nov 2016

open study