166 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... 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

Transcranial Direct Current Stimulation for Post-stroke Motor Recovery
Duke University Stroke, Ischemic Motor Activity Upper Extremity Paralysis
This research study is to find out if brain stimulation at different dosage level combined with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation technique is called transcranial direct current stimulation (tDCS). The treatment uses direct... expand

This research study is to find out if brain stimulation at different dosage level combined with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation technique is called transcranial direct current stimulation (tDCS). The treatment uses direct currents to stimulate specific parts of the brain affected by stroke. The adjunctive rehabilitation therapy is called "modified Constraint-Induced Movement Therapy" (mCIMT). During this therapy the subject will wear a mitt on the hand of the arm that was not affected by a stroke and force to use the weak arm. The study will test 3 different doses of brain stimulation in combination with mCIMT to find out the most promising one.

Type: Interventional

Start Date: Sep 2019

open study

Sodium Watchers Program - Hypertension
Misook L. Chung Hypertension
Hypertensive adults are a vulnerable population at high risk of developing cardiovascular disease. Despite the many interventions tested to reduce hypertension, it remains a major risk factor that is not appropriately managed in the population. Prior dietary interventions... expand

Hypertensive adults are a vulnerable population at high risk of developing cardiovascular disease. Despite the many interventions tested to reduce hypertension, it remains a major risk factor that is not appropriately managed in the population. Prior dietary interventions were successful on reduction of sodium intake, but the changes were not maintained after the end of the intervention. We propose that changing patients' salt taste preference and including family members will produce long-term changes in sodium intake and blood pressure. The Sodium Watchers Program (SWaP) proposed in this study is designed to improve adherence to a sodium restricted diet through education and self-care strategies for gradual taste adaptation to low salt foods. The purpose of this pilot is to test short-term effects of the SWaP intervention on adherence to the sodium restricted diet, blood pressure, salt taste preference, and dietary patterns in hypertensive adults. A total of 30 hypertensive adults will be randomly assigned to the intervention (n=20) or control group (n=10). The intervention group will receive 16-weeks of education and booster sessions remotely using a video conferencing program on mini-iPads. All participants will collect a 24-hour urine specimen for sodium excretion and complete assessments of blood pressure, salt taste preference testing using salt concentration solutions, and dietary pattern using VioScreen Food Frequency Questionnaire at baseline and post intervention at 4-months. Data will be analyzed using repeated measures analysis of variance.

Type: Interventional

Start Date: Sep 2019

open study

Novel Agents for Treatment of High-risk COVID-19 Positive Patients
Susanne Arnold COVID Sars-CoV2
This is a multi-arm, phase II trial for rapid efficacy and toxicity assessment of multiple therapies immediately after COVID19 positive testing in high-risk individuals. Therapies include stand-alone or combination treatment with hydroxychloroquine, azithromycin, ivermectin,... expand

This is a multi-arm, phase II trial for rapid efficacy and toxicity assessment of multiple therapies immediately after COVID19 positive testing in high-risk individuals. Therapies include stand-alone or combination treatment with hydroxychloroquine, azithromycin, ivermectin, or camostat mesilate, artemesia annua. The hypothesis of this study is that the addition of agents that inhibit viral entry or replication of SARS-CoV-2 virus replication in will be devoid of additional moderate to severe toxicities, will prevent clinical deterioration, and will improve viral clearance in high risk individuals.

Type: Interventional

Start Date: May 2020

open study

A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants
Janssen Vaccines & Prevention B.V. Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol
The study will enroll up to 60,000 participants in order to evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult participants. expand

The study will enroll up to 60,000 participants in order to evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult participants.

Type: Interventional

Start Date: Sep 2020

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

Prazosin for Agitation in Alzheimer's Disease
Alzheimer's Disease Cooperative Study (ADCS) Alzheimer's Disease Disruptive Behavior
The study evaluates the effects of Prazosin on agitation in adults with Alzheimer's disease. Two thirds of the participants will participate in the medication portion, while one third will participate in the placebo portion expand

The study evaluates the effects of Prazosin on agitation in adults with Alzheimer's disease. Two thirds of the participants will participate in the medication portion, while one third will participate in the placebo portion

Type: Interventional

Start Date: Oct 2018

open study

Abemaciclib and Letrozole to Treat Endometrial Cancer
Gynecologic Oncology Group Endometrial Cancer
This is a phase II single arm trial to evaluate the objective response rate of abemaciclib and letrozole in advanced stage, persistent or recurrent endometrioid endometrial cancer. Treatment will continue until either unacceptable toxicity, progression of disease, or investigator/patient... expand

This is a phase II single arm trial to evaluate the objective response rate of abemaciclib and letrozole in advanced stage, persistent or recurrent endometrioid endometrial cancer. Treatment will continue until either unacceptable toxicity, progression of disease, or investigator/patient request for withdrawal.

Type: Interventional

Start Date: Oct 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... 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. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor.

Type: Observational

Start Date: Mar 2017

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,... 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 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... 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

Randomized Controlled Trial for Ankle Fracture Pain Control
University of Massachusetts, Worcester Ankle Fractures
This project is a multicenter, three armed, prospective randomized control trial studying the effectiveness of a long-acting local anesthetic "cocktail" in patients undergoing operative fixation of ankle fractures. expand

This project is a multicenter, three armed, prospective randomized control trial studying the effectiveness of a long-acting local anesthetic "cocktail" in patients undergoing operative fixation of ankle fractures.

Type: Interventional

Start Date: Jan 2020

open study

Study With Afuresertib and Paclitaxel in Platinum Resistant Ovarian
Laekna Limited Platinum-resistant Ovarian Cancer
Afuresertib is an AKT inhibitor, a new class of agents under development that may provide physicians with a new clinical option to control platinum resistant ovarian cancer (PROC) progression. Afuresertib plus chemotherapy has demonstrated anti-tumor efficacy and an acceptable... expand

Afuresertib is an AKT inhibitor, a new class of agents under development that may provide physicians with a new clinical option to control platinum resistant ovarian cancer (PROC) progression. Afuresertib plus chemotherapy has demonstrated anti-tumor efficacy and an acceptable safety profile in patients with PROC in a published Phase I/II study. Therefore, the combination of afuresertib plus weekly paclitaxel could represent a clinically meaningful step forward in the clinical management of these difficult-to-treat patients with PROC.

Type: Interventional

Start Date: Jun 2020

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

Phase I Trial HIPEC With Nal-irinotecan
Stony Brook University Peritoneal Cancer Pseudomyxoma Peritonei Mucinous Adenocarcinoma Mucinous Tumor Colorectal Cancer
The purpose of this study is to assess the effectiveness and safety of intraperitoneal administration of heated nanoliposomal Irinotecan in cytoreductive surgery (CRS), which is surgery designed to remove as much of the cancer as possible, and heated intraperitoneal chemotherapy... expand

The purpose of this study is to assess the effectiveness and safety of intraperitoneal administration of heated nanoliposomal Irinotecan in cytoreductive surgery (CRS), which is surgery designed to remove as much of the cancer as possible, and heated intraperitoneal chemotherapy (HIPEC) procedures.

Type: Interventional

Start Date: Oct 2019

open study

COVID-19: Povidone-Iodine Intranasal Prophylaxis in Front-line Healthcare Personnel and Inpatients
Alexandra Kejner COVID-19 SARS-CoV 2
Povidone-iodine (PVP-I) is a broad-spectrum antiseptic with activity against bacteria, fungi, and viruses. It has been previously used in both intranasal preparations against Methicillin Resistant Staphylococcus Aureus (MRSA) as well as oral preparations in in-vitro studies of... expand

Povidone-iodine (PVP-I) is a broad-spectrum antiseptic with activity against bacteria, fungi, and viruses. It has been previously used in both intranasal preparations against Methicillin Resistant Staphylococcus Aureus (MRSA) as well as oral preparations in in-vitro studies of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV), Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV), influenza H1N1, and rotavirus with good efficacy. This study will evaluate the efficacy of PVP-I as prophylaxis in Coronavirus Disease 2019 (COVID19)-negative front-line health care workers, hospital patients, and community members.

Type: Interventional

Start Date: Apr 2020

open study

A Prospective Clinical Study of Phenylketonuria (PKU)
BioMarin Pharmaceutical Phenylketonurias
This is a study for adults and children ≥ 14 years old who have Phenylketonuria (PKU) with uncontrolled plasma Phe levels. No clinical intervention or study drug is provided by BioMarin in this study. expand

This is a study for adults and children ≥ 14 years old who have Phenylketonuria (PKU) with uncontrolled plasma Phe levels. No clinical intervention or study drug is provided by BioMarin in this study.

Type: Observational

Start Date: Oct 2019

open study

Renin and Renal Biomarker Response to Angiotensin II
Alexander Flannery Septic Shock Acute Kidney Injury
Septic shock continues to exert a large economic burden around the world. Several developments have occurred that lead to the current study. First, angiotensin II is the newest FDA approved vasopressor agent indicated for use in vasodilatory shock. Several subgroups from the... expand

Septic shock continues to exert a large economic burden around the world. Several developments have occurred that lead to the current study. First, angiotensin II is the newest FDA approved vasopressor agent indicated for use in vasodilatory shock. Several subgroups from the approval trial have indicated that angiotensin II may confer a survival benefit in certain conditions, including those patients requiring continuous renal replacement therapy, those with altered angiotensin I: angiotensin II ratios, and most recently, those with elevated renin levels (which may serve as a surrogate for dysfunctional angiotensin 1: angiotensin II ratios). This open-label, sequential period pilot study will evaluate angiotensin II and biomarker response (renin) in the treatment of septic shock.

Type: Interventional

Start Date: Oct 2020

open study

CERAMENT™| Bone Void Filler Device Registry
BONESUPPORT AB Orthopedic Disorder
A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use. expand

A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.

Type: Observational [Patient Registry]

Start Date: Mar 2020

open study

A Study of Suboptimally Controlled Participants Previously Taking Injectable Disease-modifying Drugs...
EMD Serono Research & Development Institute, Inc. Multiple Sclerosis
To evaluate the effectiveness and safety of cladribine tablets in participants with RMS including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (aSPMS),who transition to cladribine tablets after suboptimal response to any... expand

To evaluate the effectiveness and safety of cladribine tablets in participants with RMS including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (aSPMS),who transition to cladribine tablets after suboptimal response to any injectable DMD approved in the United States (US) for RMS in a real-world setting.

Type: Observational

Start Date: May 2019

open study

Next Generation Sequencing-Based Stratification of Front Line Treatment of HighGrade Neuroendocrine Carcinoma
Aman Chauhan Large-Cell Neuroendocrine Carcinoma
PRECISION-NEC is a single-center, open-label, pilot feasibility study of molecularly defined subtypes of metastatic high-grade neuroendocrine carcinoma (HG-NEC). The hypothesis is that HG-NEC (excluding small cell carcinoma) can be segregated based on mutational analysis and... expand

PRECISION-NEC is a single-center, open-label, pilot feasibility study of molecularly defined subtypes of metastatic high-grade neuroendocrine carcinoma (HG-NEC). The hypothesis is that HG-NEC (excluding small cell carcinoma) can be segregated based on mutational analysis and that next generation sequencing (NGS)-based assignment of therapy is feasible and will potentially improve the outcomes.

Type: Interventional

Start Date: Nov 2020

open study

Topical Naloxone to Diagnose Ocular Pain
Seema Capoor Dry Eye Syndromes Neuropathic Pain
Chronic ocular neuropathic pain may be misdiagnosed as dry eye disease. Our study aims to identify a population with previous monocular trauma and dry eye symptoms and differentiate neuropathic from dry eye pain using topical corneal naloxone hydrochloride. expand

Chronic ocular neuropathic pain may be misdiagnosed as dry eye disease. Our study aims to identify a population with previous monocular trauma and dry eye symptoms and differentiate neuropathic from dry eye pain using topical corneal naloxone hydrochloride.

Type: Interventional

Start Date: Oct 2020

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