143 matching studies

Study is registered in ResearchMatch
Sponsor Condition of Interest
Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) Protocol
University of Southern California Mild Cognitive Impairment (MCI) Alzheimer's Disease (AD)
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD. ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been combined public/private... expand

Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD. ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD). The overall goal of the study is to continue to discover, optimize, standardize, and validate clinical trial measures and biomarkers used in AD research.

Type: Observational

Start Date: Oct 2016

open study

Dietary Intervention in Persons With Metabolic Syndrome
Martha Biddle Metabolic Syndrome
Individuals diagnosed with metabolic syndrome are at a two-fold risk for developing cardiovascular disease. The investigators must identify strategies that can abort the development of cardiovascular disease. Inflammation and oxidative stress responsible for the pathogenesis... expand

Individuals diagnosed with metabolic syndrome are at a two-fold risk for developing cardiovascular disease. The investigators must identify strategies that can abort the development of cardiovascular disease. Inflammation and oxidative stress responsible for the pathogenesis of metabolic syndrome and CVD can be influenced by dietary changes. Strategic and novel interventions that include changing dietary patterns to include more antioxidant rich fruit and vegetables are pragmatic for primary prevention of CVD. Antioxidant rich fruits and vegetables, especially those with carotenoids (lycopene, lutein, zeaxanthin, alpha-carotene, and beta-carotene) have been efficacious in reducing the risk of CVD by decreasing inflammation and oxidative stress. The purpose of this study is to test the effect of a dietary antioxidant intervention on biomarkers of inflammation and oxidative stress in persons diagnosed with metabolic syndrome. The sample will be randomized into one of two groups. Group one (intervention) will drink an 11.5 ounce serving of V8 100% vegetable juice once per day for 30 days. The second group (control) will continue to consume their normal diet. We will measure biomarkers of inflammation (C-reactive protein) and oxidative stress (malondialdehyde) in the two groups at baseline and the end of the 30-day intervention.

Type: Interventional

Start Date: Dec 2018

open study

Hyperbaric Oxygen Brain Injury Treatment Trial
Hennepin Healthcare Research Institute Traumatic Brain Injury
The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial. expand

The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial.

Type: Interventional

Start Date: Jun 2018

open study

Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary...
Biotronik, Inc. Coronary Artery Disease Atherosclerosis, Coronary Myocardial Ischemia Ischemic Heart Disease Acute Coronary Syndrome
The objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device Exemption pivotal trial, as a condition of the... expand

The objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device Exemption pivotal trial, as a condition of the US Food and Drug Administration (FDA) approval (P170030).

Type: Observational

Start Date: Jan 2020

open study

MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Vertos Medical, Inc. Lumbar Spinal Stenosis
This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group... expand

This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure.

Type: Observational

Start Date: Mar 2017

open study

A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant...
Amplyx Pharmaceuticals BK Virus Infection
This clinical research study will test the safety and efficacy of the investigational medication MAU868, compared to a placebo, in patients who have had a kidney transplant who have active BK virus. expand

This clinical research study will test the safety and efficacy of the investigational medication MAU868, compared to a placebo, in patients who have had a kidney transplant who have active BK virus.

Type: Interventional

Start Date: Aug 2020

open study

A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory...
Astellas Pharma Global Development, Inc. Acute Myeloid Leukemia (AML) Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
The purpose of this study is to determine the safety and tolerability of gilteritinib given in combination with atezolizumab in participants with relapsed or treatment refractory FMS-like tyrosine kinase 3 (FLT3) mutated AML and to determine the composite complete remission (CRc)... expand

The purpose of this study is to determine the safety and tolerability of gilteritinib given in combination with atezolizumab in participants with relapsed or treatment refractory FMS-like tyrosine kinase 3 (FLT3) mutated AML and to determine the composite complete remission (CRc) rate for participants who either discontinued the study or completed 2 cycles of gilteritinib given in combination with atezolizumab. This study will also evaluate pharmacokinetics (PK), response to treatment, remission and survival. Adverse events (AEs), clinical laboratory results, vital signs, electrocardiograms (ECGs), and Eastern Cooperative Oncology Group (ECOG) performance status scores will also be assessed.

Type: Interventional

Start Date: Jun 2019

open study

Nab-Paclitaxel and Gemcitabine for Recurrent/Refractory Sarcoma
H. Lee Moffitt Cancer Center and Research Institute Osteosarcoma Ewing Sarcoma Rhabdomyosarcoma Soft Tissue Sarcoma
The purpose of this study is to see if nab-paclitaxel combined with gemcitabine prevents the formation or growth of tumors in participants with relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma and other soft tissue sarcoma and to measure the length of time... expand

The purpose of this study is to see if nab-paclitaxel combined with gemcitabine prevents the formation or growth of tumors in participants with relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma and other soft tissue sarcoma and to measure the length of time during and after treatment that their disease does not get worse. Researchers also want to find out if nab-paclitaxel combined with gemcitabine is safe and tolerable.

Type: Interventional

Start Date: Oct 2016

open study

A Study to Evaluate the Safety and Tolerability of QR-1123 in Subjects With Autosomal Dominant Retinitis...
ProQR Therapeutics Autosomal Dominant Retinitis Pigmentosa Eye Diseases Eye Diseases, Hereditary Retinal Dystrophies Retinal Disease
This study evaluates the safety, tolerability and efficacy of QR-1123 injection in the eye (intravitreal; IVT) injections (one eye/unilateral) in subjects receiving a single dose or repeat doses. Single injections will be assessed in an open label way, and repeat injections will... expand

This study evaluates the safety, tolerability and efficacy of QR-1123 injection in the eye (intravitreal; IVT) injections (one eye/unilateral) in subjects receiving a single dose or repeat doses. Single injections will be assessed in an open label way, and repeat injections will be assessed in a double-masked, randomized, sham-controlled fashion.

Type: Interventional

Start Date: Oct 2019

open study

Neuroblastoma Maintenance Therapy Trial
Giselle SaulnierSholler Neuroblastoma
Difluoromethylornithine (DFMO) will be used in an open label, single agent, multicenter, study for patients with neuroblastoma in remission. In this study subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 750 mg/m2 ± 250 mg/m2 BID (strata 1, 2,... expand

Difluoromethylornithine (DFMO) will be used in an open label, single agent, multicenter, study for patients with neuroblastoma in remission. In this study subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 750 mg/m2 ± 250 mg/m2 BID (strata 1, 2, 3, and 4) OR 2500 mg/m2 BID (stratum 1B) on each day of study. This study will focus on the use of DFMO in high risk neuroblastoma patients that are in remission as a strategy to prevent recurrence.

Type: Interventional

Start Date: Feb 2016

open study

A Study of VB-111 With Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian...
Vascular Biogenics Ltd. operating as VBL Therapeutics Recurrent Platinum Resistant Ovarian Cancer
The purpose of this phase 3, randomized, multicenter study is to compare VB-111 and paclitaxel to placebo and paclitaxel in adult patients with Recurrent Platinum-Resistant Ovarian Cancer. expand

The purpose of this phase 3, randomized, multicenter study is to compare VB-111 and paclitaxel to placebo and paclitaxel in adult patients with Recurrent Platinum-Resistant Ovarian Cancer.

Type: Interventional

Start Date: Dec 2017

open study

The International Spontaneous Coronary Artery Dissection "iSCAD" Registry
SCAD Alliance Spontaneous Coronary Artery Dissection
The aim of "iSCAD," the International Spontaneous Coronary Artery Dissection (SCAD) Registry, is to serve as an internationally collaborative, multicenter registry coordinated by an experienced and centralized coordinating center in an effort to increase the pace of participant... expand

The aim of "iSCAD," the International Spontaneous Coronary Artery Dissection (SCAD) Registry, is to serve as an internationally collaborative, multicenter registry coordinated by an experienced and centralized coordinating center in an effort to increase the pace of participant recruitment, and thereby increase statistical power of studies related to SCAD. The ultimate goal of iSCAD Registry is to facilitate the development of best practices and clinical guidelines for preventing SCAD or its recurrence. This observational study will be prospective and retrospective in its recruitment and will collect clinical information to better understand the natural history and prognosis for SCAD.

Type: Observational [Patient Registry]

Start Date: Mar 2019

open study

A Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A Inhalation Solution...
Breath Therapeutics Inc. Bronchiolitis Obliterans Chronic Rejection of Lung Transplant Lung Transplant Rejection Lung Transplant; Complications Lung Transplant Failure and Rejection
This is a Phase III randomized, controlled clinical trial of L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with BOS following double lung transplant. Patients will receive either L-CsA (10 mg) via the PARI Investigational eFlow® Device twice... expand

This is a Phase III randomized, controlled clinical trial of L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with BOS following double lung transplant. Patients will receive either L-CsA (10 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-2.

Type: Interventional

Start Date: Mar 2019

open study

Re-entry XR-NTX for Rural Women With Opioid Use Disorder
Michele Staton Opioid Dependence
The overall aim of this R34 proposal is to examine the feasibility, acceptability, and short-term outcomes associated with an innovative service delivery model to increase adherence to extended-release naltrexone (XR-NTX) during the transition from jail to the community for rural... expand

The overall aim of this R34 proposal is to examine the feasibility, acceptability, and short-term outcomes associated with an innovative service delivery model to increase adherence to extended-release naltrexone (XR-NTX) during the transition from jail to the community for rural women with opioid use disorder (OUD). The significance of this study is grounded in the public health emergency associated with the opioid epidemic in rural Appalachia, the increased vulnerability of rural women with OUD, and the dearth of available and accessible evidence-based treatment in the region. This study has potential to make a significant contribution to the OUD treatment field by advancing knowledge on innovative service delivery models to increase access to evidence-based treatment to reduce the prevalence of opioid use disorders and related health disparities among hard-to-reach, high-risk, underserved populations.

Type: Interventional

Start Date: Sep 2019

open study

Social Media HIV Prevention Intervention for High Risk Rural Women
University of Kentucky HIV/AIDS
The overall aim of this R34 application is to adapt and feasibility test an evidence-based HIV prevention education for high-risk, underserved rural women in Appalachia. This study has potential to make a significant contribution to science by advancing knowledge on the use of... expand

The overall aim of this R34 application is to adapt and feasibility test an evidence-based HIV prevention education for high-risk, underserved rural women in Appalachia. This study has potential to make a significant contribution to science by advancing knowledge on the use of social media to increase access to prevention interventions to reduce high-risk substance use and related health disparities among rural women during a time of emerging and significant public health risk in Appalachia. Successfully accomplishing study aims will respond to a critical and unmet need to increase access to prevention interventions using social media, as well as advance knowledge about the high-risk drug use behaviors among vulnerable populations.

Type: Interventional

Start Date: May 2019

open study

A Clinical Trial Investigating the Efficacy, Safety and Tolerability of Continuous Subcutaneous ND0612...
NeuroDerm Ltd. Parkinson's Disease
This is a multi-center, randomized, double blind, active controlled clinical Study. Following a screening period, eligible subjects will be enrolled to an open-label oral IR LD/CD adjustment period; then an open-label ND0612 conversion period; then after optimization periods... expand

This is a multi-center, randomized, double blind, active controlled clinical Study. Following a screening period, eligible subjects will be enrolled to an open-label oral IR LD/CD adjustment period; then an open-label ND0612 conversion period; then after optimization periods subjects will be randomized to receive either ND0612 or its matching Placebo with IR LD/CD. Subjects can continue to an optional open-label extension period for one year; To contact US site near you should go to: www.BouNDless-Study.com

Type: Interventional

Start Date: Aug 2019

open study

A Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A Inhalation Solution...
Breath Therapeutics Inc. Bronchiolitis Obliterans Chronic Rejection of Lung Transplant Lung Transplant Rejection Lung Transplant; Complications Lung Transplant Failure and Rejection
This is a Phase III randomized, controlled clinical trial of L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with BOS following single lung transplant. Patients will receive either L-CsA (5 mg) via the PARI Investigational eFlow® Device twice... expand

This is a Phase III randomized, controlled clinical trial of L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with BOS following single lung transplant. Patients will receive either L-CsA (5 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-1.

Type: Interventional

Start Date: Mar 2019

open study

MIND: Artemis in the Removal of Intracerebral Hemorrhage
Penumbra Inc. Cerebral Hemorrhage Brain Hemorrhage Cerebral Parenchymal Hemorrhage Intracerebral Hemorrhage
The primary objective of this multicenter randomized controlled study is to compare the safety and efficacy of minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device to best medical management for the treatment of intracerebral hemorrhage (ICH). expand

The primary objective of this multicenter randomized controlled study is to compare the safety and efficacy of minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device to best medical management for the treatment of intracerebral hemorrhage (ICH).

Type: Interventional

Start Date: Feb 2018

open study

Impact of Discontinuing Chronic Therapies in People With Cystic Fibrosis on Highly Effective CFTR Modulator...
David Nichols, MD Cystic Fibrosis
Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating CF, it is still largely unknown whether or not other chronic therapies can be safely stopped. The SIMPLIFY study is being done to test whether or... expand

Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating CF, it is still largely unknown whether or not other chronic therapies can be safely stopped. The SIMPLIFY study is being done to test whether or not it is safe to stop taking inhaled hypertonic saline or Pulmozyme® (dornase alfa) in those people that are also taking Trikafta™. Trikafta (elexacaftor/tezacaftor/ivacaftor) is a combination CFTR modulator therapy that was approved by the Food and Drug Administration for people with CF who have at least one F508del mutation. The three drugs that make up Trikafta work together to allow many more chloride ions to move into and out of the cells, improving the balance of salt and water in the lungs. These changes result in better clearance of mucus from the lungs and improvements in lung function. Inhaled hypertonic saline and Pulmozyme (dornase alfa) also improve clearance of mucus from the lungs to support lung function and have been available to people with CF for many years. Both therapies are considered to be relatively burdensome and it is not known whether either therapy can improve or maintain lung function above what is already gained through Trikafta use. The goal of the SIMPLIFY study is to get information about whether or not it is safe to stop either inhaled hypertonic saline or Pulmozyme (dornase alfa) by testing if there is a change in lung function in subjects with cystic fibrosis (CF) who are assigned to stop their chronic medication (either hypertonic saline or Pulmozyme) as compared to those who are assigned to keep taking their medication while continuing to take Trikafta.

Type: Interventional

Start Date: Aug 2020

open study

Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis
Massachusetts General Hospital Septic Shock
Multicenter, prospective, phase 3 randomized non-blinded interventional trial of fluid treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. The aim of the study is to determine the impact of a restrictive fluids strategy (vasopressors first... expand

Multicenter, prospective, phase 3 randomized non-blinded interventional trial of fluid treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. The aim of the study is to determine the impact of a restrictive fluids strategy (vasopressors first followed by rescue fluids) as compared to a liberal fluid strategy (fluids first followed by rescue vasopressors) on 90-day in-hospital mortality in patients with sepsis-induced hypotension.

Type: Interventional

Start Date: Mar 2018

open study

HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections...
Inflammatix Respiratory Tract Infections Urinary Tract Infections Intra-Abdominal Infections Skin and Soft Tissue Infection Sepsis
This study will analyze gene expression and other laboratory data from biological samples collected from participants with suspected respiratory, urinary, intra-abdominal, and/or skin & soft tissue infections; or suspected sepsis of any cause. expand

This study will analyze gene expression and other laboratory data from biological samples collected from participants with suspected respiratory, urinary, intra-abdominal, and/or skin & soft tissue infections; or suspected sepsis of any cause.

Type: Observational

Start Date: Feb 2020

open study

Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia
PrECOG, LLC. Acute Myeloid Leukemia
Eligible untreated patients with FLT3 acute myeloid leukemia (AML) between the ages of 18 and 65 will be randomized to receive gilteritinib or midostaurin during induction and consolidation. Patients will also receive standard chemotherapy of daunorubicin and cytarabine during... expand

Eligible untreated patients with FLT3 acute myeloid leukemia (AML) between the ages of 18 and 65 will be randomized to receive gilteritinib or midostaurin during induction and consolidation. Patients will also receive standard chemotherapy of daunorubicin and cytarabine during induction and high-dose cytarabine during consolidation. Gilteritinib, is an oral drug that works by stopping the leukemia cells from making the FLT3 protein. This may help stop the leukemia cells from growing faster and thus may help make chemotherapy more effective. Gilteritinib has been approved by the Food and Drug Administration (FDA) for patients who have relapsed or refractory AML with a FLT3 mutation but is not approved by the FDA for newly diagnosed FLT3 AML, and its use in this setting is considered investigational. Midostaurin is an oral drug that works by blocking several proteins on cancer cells, including FLT3 that can help leukemia cells grow. Blocking this pathway can cause death to the leukemic cells. Midostaurin is approved by the FDA for the treatment of FLT3 AML. The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin in patients receiving standard combination chemotherapy for FLT3 AML.

Type: Interventional

Start Date: Dec 2019

open study

Rate of Progression in EYS Related Retinal Degeneration
Jaeb Center for Health Research Retinitis Pigmentosa Eye Diseases
The overall goal of this project funded by the Foundation Fighting Blindness is to characterize the natural history of disease progression in patients with EYS mutations in order to accelerate the development of outcome measures for clinical trials. expand

The overall goal of this project funded by the Foundation Fighting Blindness is to characterize the natural history of disease progression in patients with EYS mutations in order to accelerate the development of outcome measures for clinical trials.

Type: Observational

Start Date: Feb 2020

open study

Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
University of Florida Coronary Artery Disease
The Ischemia-IMT (Ischemia-Intensive Medical Treatment Reduces Events in Women with Non-Obstructive CAD), subtitle: Women's Ischemia Trial to Reduce Events in Non-Obstructive CAD (WARRIOR) trial is a multicenter, prospective, randomized, blinded outcome evaluation (PROBE design)... expand

The Ischemia-IMT (Ischemia-Intensive Medical Treatment Reduces Events in Women with Non-Obstructive CAD), subtitle: Women's Ischemia Trial to Reduce Events in Non-Obstructive CAD (WARRIOR) trial is a multicenter, prospective, randomized, blinded outcome evaluation (PROBE design) evaluating intensive statin/ACE-I (or ARB)/aspirin treatment (IMT) vs. usual care (UC) in 4,422 symptomatic women patients with symptoms and/or signs of ischemia but no obstructive CAD. The hypothesis is that IMT will reduce major adverse coronary events (MACE) 20% vs. UC. The primary outcome is first occurrence of MACE as death, nonfatal MI, nonfatal stroke/transient ischemic attack (TIA) or hospitalization for heart failure or angina. Secondary outcomes include quality of life, time to "return to duty"/work, health resource consumption, angina, cardiovascular (CV) death and primary outcome components. Events will be adjudicated by an experienced Clinical Events Committee (CEC). Follow-up will be 3-years using 50 sites: primarily VA and Active Duty Military Hospitals/Clinics and a National Patient-Centered Clinical Research Network (PCORnet) clinical data research network (CDRN)(OneFlorida Consortium). This study is being conducted to determine whether intensive medication treatment to modify risk factors and vascular function in women patients with coronary arteries showing no flow limit obstruction but with cardiac symptoms (i.e., chest pain, shortness of breath) will reduce the patient's likelihood of dying, having a heart attack, stroke/TIA or being hospitalized for cardiac reasons. The results will provide evidence data necessary to inform future guidelines regarding how best to treat this growing population of patients, and ultimately improve the patient's cardiac health and quality of life and reduce health-care costs.

Type: Interventional

Start Date: Feb 2018

open study

Improving Hand Recovery With Neuromodulation in Tetraplegia
University of Kentucky Spinal Cord Injuries Tetraplegia, Unspecified, Incomplete, Chronic
This study will examine a form of non-invasive brain stimulation applied with intensive therapy of the arm and hand. The goal of the study is to determine if arm and hand function can be improved in people with incomplete cervical spinal cord injury (neck spinal cord injury,... expand

This study will examine a form of non-invasive brain stimulation applied with intensive therapy of the arm and hand. The goal of the study is to determine if arm and hand function can be improved in people with incomplete cervical spinal cord injury (neck spinal cord injury, tetraplegia). Participants will be assigned to receive either active or inactive non-invasive brain stimulation.

Type: Interventional

Start Date: Jul 2019

open study