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Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) Protocol
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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 |
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 |
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 |
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 |
Therapy in Amyotrophic Lateral Sclerosis (TAME)
University of Kansas Medical Center
Amyotrophic Lateral Sclerosis
Frontal Temporal Dementia
The purpose of this study is to determine if memantine at 20 mg BID when used in conjunction
with riluzole, can slow down the disease progression of patients with ALS including
potentially improving their neuropsychiatric changes, as well as determine if serum
biomarkers can... expand
The purpose of this study is to determine if memantine at 20 mg BID when used in conjunction with riluzole, can slow down the disease progression of patients with ALS including potentially improving their neuropsychiatric changes, as well as determine if serum biomarkers can be used both as a diagnostic and a prognostic marker in patients with ALS. Funding Source: FDA-OPD Type: Interventional Start Date: Nov 2018 |
QP ExCELs: MultiPole Pacing (MPP) Sub-Study
Biotronik, Inc.
Heart Failure
The objective of this MultiPole Pacing (MPP) sub-study of the QP ExCELs study is to
demonstrate that the MPP feature is effective by converting a percentage of cardiac
resynchronization therapy (CRT) non-responders to responders. The MPP sub-study is a
single-arm, multi-center,... expand
The objective of this MultiPole Pacing (MPP) sub-study of the QP ExCELs study is to demonstrate that the MPP feature is effective by converting a percentage of cardiac resynchronization therapy (CRT) non-responders to responders. The MPP sub-study is a single-arm, multi-center, prospective trial within the ongoing QP ExCELs study (NCT02290028). Type: Interventional Start Date: May 2017 |
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Thomas G. Brott, M.D.
Carotid Stenosis
Carotid revascularization for primary prevention of stroke (CREST-2) is two independent
multicenter, randomized controlled trials of carotid revascularization and intensive medical
management versus medical management alone in patients with asymptomatic high-grade carotid
stenosis.... expand
Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed. Type: Interventional Start Date: Dec 2014 |
Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients
Orbus Therapeutics, Inc.
Anaplastic Astrocytoma
Recurrent Anaplastic Astrocytoma
The purpose of this study is to compare the efficacy and safety of eflornithine in
combination with lomustine, compared to lomustine taken alone, in treating patients whose
anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.
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The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy. Type: Interventional Start Date: Jul 2016 |
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 |
aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation
AtriCure, Inc.
Atrial Fibrillation
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the
safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left
Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI)... expand
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation. This study will be conducted in two stages: - Limited Early Stage (Stage 1): up to 250 subjects at up to 65 sites. (COMPLETED, transitioned to Stage 2) - Pivotal Stage/ Phase III (Stage 2): up to 600 subjects at up to 65 sites. (ENROLLING) All subjects from both stages will be included in the primary analysis. Type: Interventional Start Date: Sep 2015 |
Extracorporeal Photopheresis for Medicare Recipients of Lung Allografts
Washington University School of Medicine
Bronchiolitis Obliterans Syndrome (BOS)
The primary aims of this study is to determine the efficacy and tolerability of
Extracorporeal Photopheresis (ECP) for the treatment of either refractory (240) or newly
diagnosed (739) Bronchiolitis Obliterans Syndrome (BOS) in patients after lung
transplantation.In compliance... expand
The primary aims of this study is to determine the efficacy and tolerability of Extracorporeal Photopheresis (ECP) for the treatment of either refractory (240) or newly diagnosed (739) Bronchiolitis Obliterans Syndrome (BOS) in patients after lung transplantation.In compliance with the Centers for Medicare and Medicaid Services' (CMS) Coverage with Evidence Development (CED) decision, the study will collect specified demographic, comorbidity, treatment, and outcome data exclusively for Medicare beneficiaries who are treated with Extracorporeal Photopheresis for either refractory or New Bronchiolitis Obliterans Syndrome . Type: Interventional Start Date: Jan 2015 |
Behavioral Effects of Drugs (Inpatient): 40 [Methamphetamine, Methylphenidate, Duloxetine]
Craig Rush
Methamphetamine Use Disorder
This study will evaluate the behavioral effects of methamphetamine during maintenance on
placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using
sophisticated human laboratory methods.
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This study will evaluate the behavioral effects of methamphetamine during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods. Type: Interventional Start Date: Sep 2019 |
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 |
Inflammatory Markers in Trauma Patient Outcomes
Arun Aneja
Polytrauma
It is unknown whether early modulation of inflammatory cytokines is associated with improved
patient outcomes, reduced narcotic requirements in orthopaedic patient population, and
improved patient subjective pain after hospital discharge. Preliminary animal and clinical
studies... expand
It is unknown whether early modulation of inflammatory cytokines is associated with improved patient outcomes, reduced narcotic requirements in orthopaedic patient population, and improved patient subjective pain after hospital discharge. Preliminary animal and clinical studies have shown correlation between elevated blood cytokine concentrations during the acute phase of trauma and the development of post-traumatic complications. Early administration of nonsteroidal anti-inflammatory drug (NSAID) in animals significantly reduced inflammatory profiles, improved pulmonary edema, and enhanced arteriole vasoconstriction in response to hemorrhage. The ability to modify post-traumatic physiologic response via short-term administration of a non-steroidal anti-inflammatory drug (NSAID) may lead to improved patient outcome. In addition, given the current landscape for opioid epidemic in the United States, alternative non-opioid pain management during acute trauma has the potential to reduce opioid consumption and represents a pivotal component of multimodal analgesia strategy. By doing this study, the investigators hope to learn how to provide the best care for all patients in the state of Kentucky. Patient participation in this research will last about 1 year. Type: Interventional Start Date: Feb 2019 |
A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
This study will evaluate the long-term safety and tolerability of elexacaftor (ELX, VX-445)
in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA).
expand
This study will evaluate the long-term safety and tolerability of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA). Type: Interventional Start Date: Aug 2019 |
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 |
A Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function
David Nichols, MD
Cystic Fibrosis
This is a prospective, multi-center observational study. The study is designed to measure the
clinical effectiveness of elexacaftor, tezacaftor and ivacaftor triple combination therapy
(TCT) in people with one or more copies of the F508del mutation, study the effects of TCT
across... expand
This is a prospective, multi-center observational study. The study is designed to measure the clinical effectiveness of elexacaftor, tezacaftor and ivacaftor triple combination therapy (TCT) in people with one or more copies of the F508del mutation, study the effects of TCT across a number of CF disease manifestations, and collect specimens for future research. Subjects in the study will have one "before TCT" visit within 30 days before initiation of the therapy and five "after TCT" visits over a 24-month follow-up period. Most participating sites will be divided into sub-study groups; each sub-study group will have specific non-optional procedures conducted in addition to the "Core" procedures. Finally there are four optional procedures (pH pill, transient elastography, and nasal cell procurement) that will be offered to subjects at certain sites. The duration of participation for each subject is 25 months. NOTE: FDA is currently reviewing the New Drug Application (NDA) for the TCT. Study will not begin unless and until FDA approval is granted. Type: Observational Start Date: Oct 2019 |
Depression, Trauma, and Health: Efficacy of an mHealth App for Symptom Self-Management in College Students
University of Kentucky
Depression
The study is designed to examine the efficacy of a mobile application heart rate variability
biofeedback exercise on heart rate variability and depression.
The main objective of this study is to assess the Breather app manufactured by Happify, Inc.,
as a tool for improving levels... expand
The study is designed to examine the efficacy of a mobile application heart rate variability biofeedback exercise on heart rate variability and depression. The main objective of this study is to assess the Breather app manufactured by Happify, Inc., as a tool for improving levels of depression and heart rate variability in college students.Happify™ Breather is a mobile app that provides users with HRV biofeedback aimed at improving mental health and wellness. Breather uses HRV sensors to help users control breathing, leading to calm and relaxation. The more relaxed users are, the more visually reinforcing scene elements will appear in the underwater environment of the game. Breather uses an optical sensor in a smartphone camera. During app use, users are cued by the app to breathe at 6 cycles/minute using a breath pacer. When the smartphone camera flash is illuminated, color signal changes are measured from the fingertip pressed to the camera lens. The study population is college students who score in the clinical range on the PHQ-9. Secondary outcomes include anxiety, somatoform symptoms, and app adherence. Type: Interventional Start Date: Nov 2019 |
Treatments Against RA and Effect on FDG-PET/CT
Brigham and Women's Hospital
Arthritis, Rheumatoid
In a randomized controlled clinical trial, investigators will compare the effects on
[18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from
two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate
responders... expand
In a randomized controlled clinical trial, investigators will compare the effects on [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate responders (MTX-IRs). Two common RA treatments will be compared: triple therapy (sulfasalazine, methotrexate, and hydroxychloroquine) versus tumor necrosis factor (TNF) inhibitor (etanercept or adalimumab, plus background methotrexate for all subjects and hydroxychloroquine for subjects who were taking this at screening). Type: Interventional Start Date: Jul 2016 |
Effect of All-Stim 2 Quadriceps Treatments on Limb Muscle Strength In Mechanically Ventilated Patients
Gerald Supinski
Weakness
Patients that are on mechanical ventilators in medical intensive care units (MICU) have
extremely weak leg muscles. Currently there is no treatment to prevent or reverse this
weakness. Treatments with a thigh muscle stimulator, called an All Stim 2, can improve leg
muscle strength... expand
Patients that are on mechanical ventilators in medical intensive care units (MICU) have extremely weak leg muscles. Currently there is no treatment to prevent or reverse this weakness. Treatments with a thigh muscle stimulator, called an All Stim 2, can improve leg muscle strength and help patients regain leg function after knee surgery. The purpose of the present study is to determine if treatments with the All Stim 2 device can also improve leg muscle strength in patients on mechanical ventilation. Type: Interventional Start Date: Dec 2014 |
A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone...
Bristol-Myers Squibb
Non Small Cell Lung Cancer
The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and
chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus
ipilimumab's safety and effectiveness in treating resectable NSCLC.
This study has multiple primary endpoints.... expand
The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC. This study has multiple primary endpoints. The first primary completion date of Pathological Complete Response is anticipated to be reached April 2020. The completion date for all primary outcome measures is expected May 2023. Type: Interventional Start Date: Jan 2017 |
Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate)
Craig Rush
Alcohol Use Disorder
This study will evaluate the behavioral effects of alcohol during maintenance on placebo,
duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated
human laboratory methods.
expand
This study will evaluate the behavioral effects of alcohol during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods. Type: Interventional Start Date: Sep 2018 |
AMPLATZER PFO Occluder Post Approval Study
Abbott Medical Devices
Stroke
Patent Foramen Ovale
The purpose of this single arm, multi-center study is to confirm the safety and effectiveness
of the AMPLATZER™ PFO Occluder in the post Approval Setting.
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The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting. Type: Interventional Start Date: Jan 2018 |
Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures
BONESUPPORT AB
Tibial Fracture
The purpose of this study is to demonstrate the safety and effectiveness of CERAMENT™|G used
in conjunction with standard-of-care treatment compared to standard-of-care treatment alone
in the care of subjects with open fractures of the tibial diaphysis.
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The purpose of this study is to demonstrate the safety and effectiveness of CERAMENT™|G used in conjunction with standard-of-care treatment compared to standard-of-care treatment alone in the care of subjects with open fractures of the tibial diaphysis. Type: Interventional Start Date: Feb 2017 |
A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del...
Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
This study will evaluate the efficacy, safety and pharmacodynamics of elexacaftor (ELX,
VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with
cystic fibrosis (CF) who are heterozygous for F508del and a gating or residual function
mutation... expand
This study will evaluate the efficacy, safety and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a gating or residual function mutation (F/G and F/RF genotypes). Type: Interventional Start Date: Aug 2019 |