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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 |
Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis
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National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Participants
Rheumatoid Arthritis (RA) Prevention
The purpose of this study is to determine if hydroxychloroquine (HCQ) is safe and effective
for the prevention of future onset of rheumatoid arthritis (RA) in individuals who have
elevations of an autoantibody, anti-cyclic citrullinated peptide (anti-CCP3).
The following recruitment... expand
The purpose of this study is to determine if hydroxychloroquine (HCQ) is safe and effective for the prevention of future onset of rheumatoid arthritis (RA) in individuals who have elevations of an autoantibody, anti-cyclic citrullinated peptide (anti-CCP3). The following recruitment strategies will be employed towards identifying healthy subjects with elevated anti-cyclic citrullinated peptide (anti-CCP3) levels: -Pre-screening: - first degree relatives of patients with rheumatoid arthritis (RA); - subjects at health-fairs; and - identification of subjects with elevated anti-CCP3 levels in the absence of inflammatory arthritis in rheumatology clinics. Type: Interventional Start Date: Mar 2016 |
Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine...
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National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB
LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender
women who have sex with men (MSM and TGW).
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This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW). Type: Interventional Start Date: Dec 2016 |
Randomized Controlled Trial of Treatment of Male Partners of Women With BV
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University of Alabama at Birmingham
Recurrent Bacterial Vaginosis
Male partners of womoen with recurrent bacteria vaginosis are randomized to treatment with
metronidazole or placebo to compare the rates of recurrent BV in the women
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Male partners of womoen with recurrent bacteria vaginosis are randomized to treatment with metronidazole or placebo to compare the rates of recurrent BV in the women Type: Interventional Start Date: Feb 2015 |
Seqirus 2017 H7N9 With/Without MF59 (R) in Healthy Males and Non-pregnant Females, 18-64 Years of Age.
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National Institute of Allergy and Infectious Diseases (NIAID)
Avian Influenza
Influenza Immunisation
This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant
females, 18-64 years of age. This clinical trial is designed to assess the safety,
reactogenicity, and immunogenicity of a pre-pandemic 2017 monovalent inactivated influenza
A/H7N9 virus vaccine... expand
This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant females, 18-64 years of age. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of a pre-pandemic 2017 monovalent inactivated influenza A/H7N9 virus vaccine (2017 H7N9 IIV) manufactured by Seqirus Inc (Seqirus) administered at different dosages (3.75 microgram mcg, 7.5 mcg and 15 mcg of hemagglutinin (HA) per dose) given with MF59 (R) adjuvant manufactured by Seqirus Inc., or without adjuvant (15 mcg of HA per dose). Phosphate buffered saline (PBS) diluent manufactured by Patheon Manufacturing Services LLC will be used to achieve certain targeted doses. Approximately 371 subjects who are in good health and meet all eligibility criteria will be randomized into one of 4 study groups. The study will be conducted at up to 7 Vaccine and Treatment Unit (VTEU) sites and will last approximately 17 months, with subject participation duration of approximately 13 months. The Primary Objectives of the study are: 1) To assess the safety and reactogenicity following receipt of two doses of 2017 H7N9 IIV administered intramuscularly (IM) at different dosages approximately 21 days apart given with or without MF59 (R) adjuvant; 2) To assess the serum hemagglutinin inhibition (HAI) and neutralizing (Neut) antibody responses approximately 21 days following receipt of two doses of 2017 H7N9 IIV administered IM at different dosages approximately 21 days apart with or without MF59 (R) adjuvant. Type: Interventional Start Date: Nov 2018 |
Losartan Effects on Emphysema Progression
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JHSPH Center for Clinical Trials
Emphysema
A randomized, parallel, placebo controlled trial to evaluate the effect of 100mg/day losartan
on the progression of emphysema as measured by quantitative HRCT compared to placebo
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A randomized, parallel, placebo controlled trial to evaluate the effect of 100mg/day losartan on the progression of emphysema as measured by quantitative HRCT compared to placebo Type: Interventional Start Date: May 2017 |
A Study of the ReCor Medical Paradise System in Clinical Hypertension
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ReCor Medical, Inc.
Hypertension
Vascular Diseases
RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO)
designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation
System in two distinct populations of hypertensive subjects.
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RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO) designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects. Type: Interventional Start Date: Mar 2016 |
Neuromodulation for Accidental Bowel Leakage
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NICHD Pelvic Floor Disorders Network
Fecal Incontinence
This study is a multi-center, randomized clinical trial of women with refractory accidental
bowel leakage (ABL) symptoms who have failed to achieve satisfactory symptom control from 2
first-line treatments for ABL: supervised pelvic muscle training (PMT) and constipating
medication.... expand
This study is a multi-center, randomized clinical trial of women with refractory accidental bowel leakage (ABL) symptoms who have failed to achieve satisfactory symptom control from 2 first-line treatments for ABL: supervised pelvic muscle training (PMT) and constipating medication. The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to a validated sham to determine if PTNS is effective for the treatment of fecal incontinence (FI) in women. The investigators will test the null hypothesis that change from baseline in St. Mark's (Vaizey) score after 12 weeks of stimulation is not significantly different in women with symptomatic ABL receiving PTNS treatments compared to women receiving sham PTNS treatments. Type: Interventional Start Date: Feb 2018 |
Skeletal Muscle Dysfunction in Rheumatoid Arthritis (RA)
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University of Alabama at Birmingham
Rheumatoid Arthritis
Insulin Resistance
Muscle strength helps determine a person's quality of life and functional independence.
Patients with rheumatoid arthritis often suffer from muscle weakness and a pre-diabetic
condition called insulin resistance.
By doing this study, the investigators hope to learn why patients... expand
Muscle strength helps determine a person's quality of life and functional independence. Patients with rheumatoid arthritis often suffer from muscle weakness and a pre-diabetic condition called insulin resistance. By doing this study, the investigators hope to learn why patients with rheumatoid arthritis (RA) suffer from muscle weakness. Type: Interventional Start Date: Sep 2015 |
Study to Identify Clinical, Imaging and Biologic Markers of Parkinson Disease Progression
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Ken Marek, MD
Parkinson Disease
This is a observational, multi-center study to assess progression of clinical features,
imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy
controls (HC) and in PD patient subtypes.
The primary objective of this study is to identify clinical,... expand
This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy controls (HC) and in PD patient subtypes. The primary objective of this study is to identify clinical, imaging and biologic markers of PD progression for use in clinical trials of disease-modifying therapies. Type: Interventional Start Date: Jun 2010 |
A Study of Baricitinib (LY3009104) in Adult Participants With Moderate to Severe Atopic Dermatitis
Eli Lilly and Company
Atopic Dermatitis
The purpose of this study is to evaluate the efficacy and safety of baricitinib in adult
participants with moderate to severe atopic dermatitis.
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The purpose of this study is to evaluate the efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis. Type: Interventional Start Date: Feb 2018 |
Comparing Use of a Digital Health System of Pelvic Floor Exercise Program to Kegel Exercises in Stress...
Renovia, Inc.
Stress Urinary Incontinence
Mixed Urinary Incontinence
A randomized controlled trial for patients with stress urinary incontinence or
stress-dominant mixed incontinence. Subjects will be randomized to 8-weeks of home kegel
exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health
system that includes... expand
A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence. Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone. Type: Interventional Start Date: Oct 2018 |
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With...
Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
This study will evaluate the safety and pharmacokinetics (PK) of lumacaftor (LUM) and
ivacaftor (IVA) in subjects 1 to less than 2 years of age with cystic fibrosis (CF),
homozygous for F508del (F/F).
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This study will evaluate the safety and pharmacokinetics (PK) of lumacaftor (LUM) and ivacaftor (IVA) in subjects 1 to less than 2 years of age with cystic fibrosis (CF), homozygous for F508del (F/F). Type: Interventional Start Date: Aug 2018 |
High Resolution Micro OCT Imaging
University of Alabama at Birmingham
Cystic Fibrosis
COPD
PCD - Primary Ciliary Dyskinesia
The purpose of this study is to learn about using the imaging to make images of the lungs and
nose with the long-term goal of the research leading to potential treatments and new
therapies for patients with cystic fibrosis.
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The purpose of this study is to learn about using the imaging to make images of the lungs and nose with the long-term goal of the research leading to potential treatments and new therapies for patients with cystic fibrosis. Type: Observational Start Date: Apr 2016 |
A Study In Adults With Moderate To Severe Dermatomyositis
Pfizer
Dermatomyositis
A Study looking at Investigational drug and Placebo administered to adult Patients with
moderate to severe Dermatomyositis
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A Study looking at Investigational drug and Placebo administered to adult Patients with moderate to severe Dermatomyositis Type: Interventional Start Date: Jan 2018 |
Lipoic Acid for Progressive Multiple Sclerosis (MS)
VA Office of Research and Development
Multiple Sclerosis
The purpose of the study is to determine if lipoic acid can preserve mobility and protect the
brain in progressive forms of multiple sclerosis.
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The purpose of the study is to determine if lipoic acid can preserve mobility and protect the brain in progressive forms of multiple sclerosis. Type: Interventional Start Date: Jul 2018 |
Study of IMGN632 in Patients With Relapse/Refractory AML, BPDCN, ALL, Other CD123+ Hem Malignancies
ImmunoGen, Inc.
Acute Lymphocytic Leukaemia
Blastic Plasmacytoid Dendritic Cell Neoplasm
Myeloproliferative Neoplasm
Acute Myeloid Leukemia
This is an open-label, multi-center, Phase 1 study to determine the MTD and assess the
safety, tolerability, PK, immunogenicity, and preliminary anti-leukemia activity of IMGN632
when administered as monotherapy to patients with CD123+ disease.
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This is an open-label, multi-center, Phase 1 study to determine the MTD and assess the safety, tolerability, PK, immunogenicity, and preliminary anti-leukemia activity of IMGN632 when administered as monotherapy to patients with CD123+ disease. Type: Interventional Start Date: Jan 2018 |
Transthyretin-Associated Amyloidoses Outcome Survey (THAOS)
Pfizer
Transthyretin Mutations
Transthyretin Amyloidosis
THAOS is a global, multi-center, longitudinal observational survey open to all patients with
transthyretin-associated amyloidoses (ATTR), including ATTR-PN (polyneuropathy), ATTR-CM
(cardiomyopathy) and wild-type ATTR-CM. It is open-ended with a minimum duration of 10 years.... expand
THAOS is a global, multi-center, longitudinal observational survey open to all patients with transthyretin-associated amyloidoses (ATTR), including ATTR-PN (polyneuropathy), ATTR-CM (cardiomyopathy) and wild-type ATTR-CM. It is open-ended with a minimum duration of 10 years. Patients will be followed as long as they are able to participate. The principal aims of this outcome survey are to better understand and characterize the natural history of the disease by studying a large and heterogenous patient population. Survey data may be used to develop new treatment guidelines and recommendations, and to inform and educate clinicians about the management of this disease. Type: Observational Start Date: Jul 2007 |
Effect of TTFields (150 kHz) in Non-small Cell Lung Cancer (NSCLC) Patients With 1-10 Brain Metastases...
NovoCure Ltd.
Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
The study is a prospective, randomized controlled phase III trial, to test the efficacy,
safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic
radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to
supportive treatment... expand
The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays. Type: Interventional Start Date: Jul 2016 |
Olaparib In Metastatic Breast Cancer
Dana-Farber Cancer Institute
Metastatic Breast Cancer
Invasive Breast Cancer
Somatic Mutation Breast Cancer (BRCA1)
Somatic Mutation Breast Cancer (BRCA2)
CHEK2 Gene Mutation
This research study is for patients with metastatic breast cancer.
- Metastatic means that the cancer has spread beyond the breast. In addition, through
genetic testing of the blood or tumor, an altered gene has been found that suggests the
tumor may not be able... expand
This research study is for patients with metastatic breast cancer. - Metastatic means that the cancer has spread beyond the breast. In addition, through genetic testing of the blood or tumor, an altered gene has been found that suggests the tumor may not be able to repair its genetic material (DNA) when it becomes damaged. - This aspect of the cancer may cause it to be more sensitive - that is, more effectively killed by certain types of drugs such as the study agent being evaluated in this trial, Olaparib. - Olaparib is a type of drug known as a PARP inhibitor. Some types of breast cancer and ovarian cancer share some basic features that make them sensitive to similar treatments. Information from those other research studies suggests that this drug may help to treat metastatic breast cancer. - This study will evaluate whether olaparib is effective in breast cancer patients whose tumor has a mutation in one of the other genes that function with BRCA1 and BRCA2 to repair damaged DNA .This mutation may have been inherited from a parent, or may have developed only in the tumor. - This study will also evaluate whether olaparib is effective in breast cancer patients whose tumor has a mutation in BRCA1 or BRCA2 that was acquired by the tumor, but not inherited. Type: Interventional Start Date: Apr 2018 |
A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human...
Hoffmann-La Roche
Breast Neoplasms
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several
immunotherapy-based combination treatments in participants with locally advanced or
metastatic HR-positive, HER2-negative breast cancer who have progressed during or following
treatment with... expand
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several immunotherapy-based combination treatments in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer who have progressed during or following treatment with a cyclin-dependent kinase (CDK) 4/6 inhibitor in the first- or second-line setting, such as palbociclib, ribociclib, or abemaciclib. The study will be performed in two stages. During Stage 1, participants will be randomized to fulvestrant (control) or an atezolizumab-containing doublet or triplet combination. Those who experience disease progression, loss of clinical benefit, or unacceptable toxicity may be eligible to receive a new triplet combination treatment in Stage 2 until loss of clinical benefit or unacceptable toxicity. New treatment arms may be added and/or existing treatment arms may be closed during the course of the study on the basis of ongoing clinical efficacy and safety as well as the current treatments available. Type: Interventional Start Date: Sep 2017 |
Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
Duke University
Rheumatic Joint Disease
Continuation of the CARRA Registry as described in the protocol will support data collection
on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis
for future CARRA studies. In particular, this observational registry will be used to answer... expand
Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including safety questions. Type: Observational [Patient Registry] Start Date: Jul 2015 |
Preventive Human Papilomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients
National Cancer Institute (NCI)
Kidney Transplantation
This trial studies whether the nonavalent human papillomavirus vaccine given to adult women
prior to kidney transplantation can help the body build and maintain an effective immune
response during the post-transplant period when they receive immunosuppressive drugs to
prevent... expand
This trial studies whether the nonavalent human papillomavirus vaccine given to adult women prior to kidney transplantation can help the body build and maintain an effective immune response during the post-transplant period when they receive immunosuppressive drugs to prevent transplant rejection. This study will help inform our scientific understanding about vaccine-induced immune responses among immunosuppressed individuals. Type: Interventional Start Date: Jun 2017 |
A Study of Brentuximab Vedotin in Adults Age 60 and Above With Newly Diagnosed Hodgkin Lymphoma (HL)
Seattle Genetics, Inc.
Hodgkin Disease
This is an open-label, multicenter, phase 2 clinical trial designed to evaluate the efficacy
and safety of brentuximab vedotin as a single-agent (Part A) and in combination with
dacarbazine (Part B), bendamustine (Part C), or nivolumab (Part D) in front-line therapy of
HL in... expand
This is an open-label, multicenter, phase 2 clinical trial designed to evaluate the efficacy and safety of brentuximab vedotin as a single-agent (Part A) and in combination with dacarbazine (Part B), bendamustine (Part C), or nivolumab (Part D) in front-line therapy of HL in adults age 60 and above. Type: Interventional Start Date: Oct 2012 |
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
NICHD Neonatal Research Network
Infant, Newborn
Infant, Small for Gestational Age
Infant, Extremely Low Birth Weight
The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26
months of donor human milk as compared to preterm infant formula as the in-hospital diet for
infants whose mothers choose not to provide breast milk or are able to provide only a minimal... expand
The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26 months of donor human milk as compared to preterm infant formula as the in-hospital diet for infants whose mothers choose not to provide breast milk or are able to provide only a minimal amount. Infants will be randomized to receive donor breast milk or formula during their hospital stay. Infant's will be followed until they reach 22-26 months of age. Type: Interventional Start Date: Aug 2012 |