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Characterizing SARS-CoV-2-specific Immunity in Individuals Who Have Recovered From COVID-19
HIV Vaccine Trials Network
SARS-CoV-2
COVID-19
The purpose of this study is to learn more about infection with and recovery from the virus
called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some people know this
virus by the name "coronavirus." It can cause the disease called COVID-19.
The information... expand
The purpose of this study is to learn more about infection with and recovery from the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some people know this virus by the name "coronavirus." It can cause the disease called COVID-19. The information gained from the study will be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines and treatments by allowing researchers to determine the difference between the body's immune response to natural SARS-CoV-2 infection and immunization with a SARS-CoV-2 vaccine. Type: Observational Start Date: May 2020 |
Personality and Cancer Care Study
Tulane University
Cancer
This randomized clinical trial will test whether giving an individualized personality
feedback report to adults with a history of cancer can improve their self-awareness,
confidence in managing their illness, and mood.
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This randomized clinical trial will test whether giving an individualized personality feedback report to adults with a history of cancer can improve their self-awareness, confidence in managing their illness, and mood. Type: Interventional Start Date: Nov 2020 |
Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices...
Galectin Therapeutics Inc.
Prevention of Esophageal Varices
NASH - Nonalcoholic Steatohepatitis
Cirrhosis
This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter,
parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability
of belapectin compared with placebo in patients with nonalcoholic steatohepatitis (NASH)
cirrhosis... expand
This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients with nonalcoholic steatohepatitis (NASH) cirrhosis and clinical signs of portal hypertension but without esophageal varices at baseline. Type: Interventional Start Date: Jun 2020 |
Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
CareDx
Kidney Transplant Rejection
This is an observational study to evaluate safety and efficacy outcomes in renal transplant
recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a
non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is
intended... expand
This is an observational study to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making regarding the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment. Amendment 1 (A1): Is an observational study to develop and validate the clinical use of KidneyCare®. Type: Observational Start Date: Jan 2018 |
Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis
GID BIO, Inc.
Osteoarthritis, Knee
This study is a pivotal study to evaluate the efficacy and safety of a single injection of
autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of
pain with concomitant improvement in function associated with osteoarthritis of the knee
joint.... expand
This study is a pivotal study to evaluate the efficacy and safety of a single injection of autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of pain with concomitant improvement in function associated with osteoarthritis of the knee joint. Type: Interventional Start Date: Oct 2020 |
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Remdesivir (GS-5734™) in...
Gilead Sciences
COVID-19
The primary objectives of this study are to evaluate the safety, tolerability, and
pharmacokinetics (PK) of remdesivir (RDV) in participants with laboratory-confirmed
coronavirus disease 2019 (COVID-19) aged 0 days to < 18 years.
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The primary objectives of this study are to evaluate the safety, tolerability, and pharmacokinetics (PK) of remdesivir (RDV) in participants with laboratory-confirmed coronavirus disease 2019 (COVID-19) aged 0 days to < 18 years. Type: Interventional Start Date: Jul 2020 |
Pneumonia in the ImmunoCompromised - Use of the Karius Test for the Detection of Undiagnosed Pathogens
Karius, Inc.
Pneumonia, Bacterial
Pneumonia, Viral
Pneumonia Fungal
Pneumonia Cavitary
Immunocompromised Host
Given the need for a more sensitive pathogen detection test in patients with
immunocompromised pneumonia, this study will evaluate the performance of the Karius Test, a
novel NGS blood test for the diagnosis of infectious diseases. We will compare the
performance of the Karius... expand
Given the need for a more sensitive pathogen detection test in patients with immunocompromised pneumonia, this study will evaluate the performance of the Karius Test, a novel NGS blood test for the diagnosis of infectious diseases. We will compare the performance of the Karius Test to the results of microbiologic tests obtained as part of usual care for immunocompromised patients undergoing evaluation for suspected pneumonia. Type: Observational Start Date: Nov 2019 |
A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing...
Seagen Inc.
Hodgkin Lymphoma
Peripheral T Cell Lymphoma
Anaplastic Large Cell Lymphoma
This study will look at whether brentuximab vedotin works and is safe in the re-treatment
setting. To be in this study, patients must have already received brentuximab vedotin as
treatment and have cancer that progressed (got worse) after stopping treatment.
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This study will look at whether brentuximab vedotin works and is safe in the re-treatment setting. To be in this study, patients must have already received brentuximab vedotin as treatment and have cancer that progressed (got worse) after stopping treatment. Type: Interventional Start Date: Oct 2019 |
Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage
Delta-Fly Pharma, Inc.
Leukemia, Myeloid, Acute
Phase III, multicenter, randomized study with two arms (1:1 ratio) enrolling patients with
AML relapsed/refractory after 2, 3, or 4 prior induction regimens:
Experimental arm: DFP-10917 14-day continuous intravenous (IV) infusion at a dose of 6
mg/m²/day followed by a 14-day... expand
Phase III, multicenter, randomized study with two arms (1:1 ratio) enrolling patients with AML relapsed/refractory after 2, 3, or 4 prior induction regimens: Experimental arm: DFP-10917 14-day continuous intravenous (IV) infusion at a dose of 6 mg/m²/day followed by a 14-day resting period per 28-day cycles. Control arm: Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine, Venetoclax Combination Regimens) or Intensive Reinduction (High and Intermediate Dose Cytarabine Regimens), depending on the patient's prior induction treatment. Type: Interventional Start Date: Nov 2019 |
Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Anti-tumor Activity of a Thorium-227...
Bayer
Metastatic Castration Resistant Prostate Cancer (mCRPC)
The study medication (BAY 2315497 Injection) is a thorium-227 labeled immuno-conjugate,
specific for the prostate-specific membrane antigen (PSMA), which will be evaluated in
patients with metastatic castration resistant prostate cancer. In this study, this
investigational... expand
The study medication (BAY 2315497 Injection) is a thorium-227 labeled immuno-conjugate, specific for the prostate-specific membrane antigen (PSMA), which will be evaluated in patients with metastatic castration resistant prostate cancer. In this study, this investigational medication will be administered to patients for the first time. The primary objective of the study is to define the safety and tolerability profile and Maximal Tolerated Dose (MTD) of BAY 2315497 Injection. The secondary objectives are to determine the recommended dose for further clinical development and to investigate how the study drug is distributed and cleared from the body. Type: Interventional Start Date: Dec 2018 |
A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse...
AbbVie
Hypogonadism
Cardiovascular Diseases
This is a blinded and placebo-controlled study of topical testosterone replacement therapy
(TRT) in symptomatic hypogonadal men with increased risk for cardiovascular (CV) disease.
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This is a blinded and placebo-controlled study of topical testosterone replacement therapy (TRT) in symptomatic hypogonadal men with increased risk for cardiovascular (CV) disease. Type: Interventional Start Date: May 2018 |
Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients...
National Cancer Institute (NCI)
High Grade Fallopian Tube Serous Adenocarcinoma
High Grade Ovarian Serous Adenocarcinoma
Ovarian Seromucinous Carcinoma
Primary Peritoneal High Grade Serous Adenocarcinoma
Recurrent Fallopian Tube Carcinoma
This phase II/III trial studies how well pegylated liposomal doxorubicin hydrochloride with
atezolizumab and/or bevacizumab work in treating patients with ovarian, fallopian tube, or
primary peritoneal cancer that has come back (recurrent). Chemotherapy drugs, such as
pegylated... expand
This phase II/III trial studies how well pegylated liposomal doxorubicin hydrochloride with atezolizumab and/or bevacizumab work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent). Chemotherapy drugs, such as pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab and bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known which combination will work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer. Type: Interventional Start Date: May 2017 |
Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-angle Glaucoma or Ocular...
Allergan
Glaucoma, Open-Angle
Ocular Hypertension
This study evaluates the duration of intraocular pressure (IOP)-lowering effect and safety of
as needed administrations of Bimatoprost sustained release (SR) in participants with
open-angle glaucoma (OAG) or ocular hypertension (OHT) who are not adequately managed with
topical... expand
This study evaluates the duration of intraocular pressure (IOP)-lowering effect and safety of as needed administrations of Bimatoprost sustained release (SR) in participants with open-angle glaucoma (OAG) or ocular hypertension (OHT) who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy. Type: Interventional Start Date: Feb 2019 |
DM-CHOC-PEN Plus Radiation for Brain Tumors
DEKK-TEC, Inc.
Advanced Cancer
4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) is a polychlorinated pyridyl
cholesterol carbonate that is lipophilic, electrically neural, crosses the blood brain
barrier (BBB), ability to localize in intracranial tumor tissue, lacks neurotoxicity and not
transported... expand
4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) is a polychlorinated pyridyl cholesterol carbonate that is lipophilic, electrically neural, crosses the blood brain barrier (BBB), ability to localize in intracranial tumor tissue, lacks neurotoxicity and not transported out of the brain via Pgp (p-glycoprotein) (1). DM-CHOC-PEN has completed Phase I/II trials in humans with primary and secondary tumors involving the brain with success. Complete remissions in both primary astrocytoma and metastatic lung and leukemia malignancies. This trial is open for adult subjects with advanced cancer - brain involvement is required. Type: Interventional Start Date: Feb 2016 |
Impact of Fever Prevention in Brain Injured Patients
C. R. Bard
Fever
Ischemic Stroke
Intracerebral Hemorrhage
Subarachnoid Hemorrhage
This study will assess the impact of fever prevention on fever burden and short- and
long-term neurologic outcomes in brain injured patients. Half of the subjects will undergo
fever prevention using a targeted temperature management system and half of the subjects will
be... expand
This study will assess the impact of fever prevention on fever burden and short- and long-term neurologic outcomes in brain injured patients. Half of the subjects will undergo fever prevention using a targeted temperature management system and half of the subjects will be treated for fever should it develop. Type: Interventional Start Date: Jan 2017 |
Integrated Cancer Repository for Cancer Research
University of Nebraska
Pancreatic Cancer
Thyroid Cancer
Lung Cancer
Esophageal Cancer
Thymus Cancer
The iCaRe2 is a multi-institutional resource created and maintained by the Fred & Pamela
Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal
data and biospecimens on consented adult cancer patients, high-risk individuals, and normal
controls.... expand
The iCaRe2 is a multi-institutional resource created and maintained by the Fred & Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies. Type: Observational [Patient Registry] Start Date: Nov 2013 |
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.
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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 |
Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
Icahn School of Medicine at Mount Sinai
NAS
This study examines the effects of 6 different music therapy interventions on outcomes for
neonates diagnosed with Neonatal Abstinence Syndrome.
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This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome. Type: Interventional Start Date: Nov 2017 |
Impact of CMS Reimbursement Policy Supporting Care Coordination in Louisiana
Tulane University
Diabetes Mellitus, Type 2
Chronic Disease
Investigators propose to use a natural experiment design to examine the impacts of the new
CPT code (99490) for chronic care management on health outcomes. The Investigators will
collaborate with partners in the Louisiana Clinical Data Research Network (LaCDRN) who serve
more... expand
Investigators propose to use a natural experiment design to examine the impacts of the new CPT code (99490) for chronic care management on health outcomes. The Investigators will collaborate with partners in the Louisiana Clinical Data Research Network (LaCDRN) who serve more than 90,000 patients with type 2 diabetes mellitus in Louisiana to examine impacts of the CMS reimbursed care coordination. Now, LaCDRN is renamed as Research Action for Health Network (REACHnet). Patient and stakeholder engagement will be planned and implemented across all phases of this natural experiment. This project will examine outcome differences created by the policy change in a natural experiment framework. The analyses will utilize the RE-AIM framework to identify the critical elements of the programs that will enhance the reach, effectiveness, adoption, implementation, and maintenance of these strategies in the diverse LaCDRN diabetes populations. PCORI Proposal COVID-19- Related Enhancement for Existing Research: The proposed enhancement will contribute timely information to address two important implications of the coronavirus pandemic: 1. Disparities in continuity of care and 2. Health systems' responsiveness in terms of telehealth delivery for high risk populations. The enhancement builds upon our current project by further examining effects of CMS payment innovations to expand remotely delivered care. Our proposed study is a rapid assessment of telehealth services, using an existing "learning health system" infrastructure to provide timely, actionable evidence to inform telehealth service provision during the pandemic and recovery. Type: Observational Start Date: Jan 2017 |
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 |
Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women
Harvard School of Public Health
Antiretroviral Toxicity
SMARTT will estimate the incidence of conditions and diagnoses potentially related to in
utero exposure to antiretroviral therapy and/or exposure in the first two months of life
among children born of HIV-infected mothers.
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SMARTT will estimate the incidence of conditions and diagnoses potentially related to in utero exposure to antiretroviral therapy and/or exposure in the first two months of life among children born of HIV-infected mothers. Type: Observational Start Date: Mar 2007 |
S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration
Southwest Oncology Group
Multiple Myeloma
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step
2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2
(first randomization). Patients are randomized between Lenalidomide for 2 years and
Lenalidomide... expand
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years. Type: Interventional Start Date: Jun 2019 |
Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management...
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Neonatal Opiate Withdrawal Syndrome
The overall objective is to determine if the ESC care approach will reduce the time until
infants being managed for NOWS are medically ready for discharge.
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The overall objective is to determine if the ESC care approach will reduce the time until infants being managed for NOWS are medically ready for discharge. Type: Interventional Start Date: Sep 2020 |
Prospective Global Registry for the Study of Chronic Total Occlusion Intervention
Minneapolis Heart Institute Foundation
Coronary Artery Disease
Percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is increasingly
being performed in patients with advanced coronary artery disease, but there is limited
information on the techniques utilized and the procedural outcomes. The goal of this
multicenter,... expand
Percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is increasingly being performed in patients with advanced coronary artery disease, but there is limited information on the techniques utilized and the procedural outcomes. The goal of this multicenter, investigator initiated registry is to collect information on treatment strategies and outcomes of consecutive patients undergoing CTO PCI among various participating centers. The information collected will be used to determine the frequency of CTO PCI performed at the participating sites and examine the procedural strategies utilized, and the procedural (both immediate and during follow-up) outcomes. Type: Observational [Patient Registry] Start Date: Jan 2012 |
Optimization for Regorafenib in HCC
SC Liver Research Consortium, LLC
Hepatocellular Carcinoma
This is a randomized, two arm, phase II study of 1st Cycle dose optimization for regorafenib
treatment compared to standard dose of regorafenib treatment in HCC patients for whom the
physician is intending to treat with regorafenib and who failed any 1st line systemic
treatment.... expand
This is a randomized, two arm, phase II study of 1st Cycle dose optimization for regorafenib treatment compared to standard dose of regorafenib treatment in HCC patients for whom the physician is intending to treat with regorafenib and who failed any 1st line systemic treatment. Type: Interventional Start Date: Dec 2020 |