Clinical trials: Biologic Markers
Spinal Muscular Atrophy (SMA)
Spinal Muscular Atrophy (SMA) Biomarkers Study in the Immediate Postnatal Period of Development
Spinal muscular atrophy (SMA) is the leading genetic cause of death of infants. Strong preclinical evidence suggests that effective therapy must be delivered as early as possible to prevent progression of the disease.
- Trial name
- NCT01736553
- Where
- 15 sites in United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Ohio State University
Healthy Volunteers
A Study to Assess Tobacco-related Biomarkers of Exposure in Smokers Using myBlu E-cigarettes
The purpose of this study is to assess changes in exposure to selected harmful and potentially harmful substances related to tobacco/nicotine use when adult smokers switch from their usual brand of combustible cigarettes to the…
- Trial name
- NCT04019626
- Testing
- Continue-smoking, myblu Tobacco 2.5%, myblu Tobacco 4.0%
- Where
- United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Fontem Ventures BV
Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers
A Two-part Single and Multiple Dose Study to Assess the Safety , Pharmacokinetics and Effects of AZD3293 in Healthy Japanese Young and Elderly Volunteers
This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2), to assess the safety, tolerability, pharmacokinetics and…
- Trial name
- NCT02005211
- Testing
- AZD3293
- Where
- Japan
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Infant Nutrition
Baylor Infant Biomarker of Nutrition Study
The study evaluates the the utility of a non-invasive skin measurement as a biomarker of infant food intake during complementary feeding.
- Trial name
- BIBS (NCT03996395)
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
Drug-induced QT Prolongation, Pharmacokinetics
CiPA Phase 1 ECG Biomarker Validation Study
This study will assess whether exposure response analysis of the electrocardiographic QTc and J-Tpeakc intervals in Phase 1 clinical pharmacology studies can be used to confirm that drugs that predominantly block the potassium…
- Conditions
- Drug-induced QT Prolongation, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT03070470
- Testing
- Ranolazine, Verapamil, Lopinavir / Ritonavir
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Food and Drug Administration (FDA)
Healthy
A Pilot Study of the Effects of BCG Immunization on CSF and Blood-based Biomarkers in Older Adults.
A pilot study of the effects of Bacillus Calmette-Guérin (BCG) immunization on cerebrospinal fluid and blood-based biomarkers in older adults.
- Trial name
- NCT04507126
- Testing
- Bacillus Calmette-Guerin (BCG)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Asthma
Biomarkers of Irritant-Induced and Allergic Asthma
Asthma is a heterogeneous disease, and although much is understood about mechanisms of inflammation in allergic asthma, less is known about mechanisms of irritant-induced asthma (IA).
- Trial name
- NCT02740543
- Testing
- Fluticasone propionate HFA 220
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- NYU Langone Health
Human Immunodeficiency Virus
Biomarkers for Event-driven PrEP Adherence
This study aims to recruit 40 participants who will take the combination anti-HIV drug tenofovir+emtricitabine (TDF/FTC) at specified times.
- Trial name
- NCT04298697
- Testing
- Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Emory University
Breast Cancer
Breast Cancer Risk Biomarkers in Postmenopausal Women
This study is designed to gather information on how the prescription drug Lovaza™ which contains omega-3 fatty acids, affects blood and tissue risk biomarkers for breast cancer.
- Trial name
- NCT01252290
- Testing
- Lovaza™
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Carol Fabian, MD
Concussion, Brain
Salivary Biomarkers for Concussion Recovery
The overarching purpose of this proposed research is to determine whether BDNF and/or specific miRNAs can serve as biomarkers for recovery from a concussion during prescribed exercise.
- Trial name
- NCT05379920
- Testing
- High Volume Aerobic Exercise, Low Volume Aerobic Exercise
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- State University of New York at Buffalo
Tobacco Use Disorder
Aspirin and Zileuton and Biomarker Expression in Nasal Tissue of Current Smokers
This randomized phase II trial studies the effects of aspirin and zileuton on genes related to tobacco use in current smokers. Aspirin and zileuton may interfere with genes related to tobacco use and may be useful in preventing…
- Trial name
- NCT02348203
- Testing
- Aspirin, Laboratory Biomarker Analysis, Zileuton
- Where
- 2 sites in United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- National Cancer Institute (NCI)
Mental Disorder, Schizophrenia
A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion
The primary purpose of the study is to evaluate the positive detection accuracy (PDA) and detection latency measures of the D-Tect patch.
- Conditions
- Mental Disorder, Schizophrenia, Major Depressive Disorder, Bipolar I Disorder
- Trial name
- NCT06372210
- Testing
- Abilify MyCite®, D-Tect Patch
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Asthma
A Study to Evaluate the Safety and Use of Human Rhinovirus in Healthy and Asthmatic Participants (MK-0000-218)
The purpose of this study is to establish the safety and tolerability of Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes (U-BIOPRED) human rhinovirus 16 (RV16UB) in healthy and asthmatic participants, and…
- Trial name
- NCT01866306
- Testing
- RV16UB, LABA
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Body Weight Changes
The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet
It is hypothesized that the use of a partial supplement diet, which includes the use of meal replacements, will result in significantly greater weight loss after three and six months compared to an isocaloric diet that does not…
- Trial name
- FORMULA (NCT00138645)
- Testing
- MicroDiet, Healthy Diet
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center
Healthy, Premature Ovarian Failure
Feasibility Study for Development of an Early Test for Ovarian Failure
This purpose of this study is to gain information about normal ovarian function that will be useful in developing a test for early detection of ovarian failure.
- Trial name
- NCT00006156
- Testing
- Control, Drug: FSH
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Alzheimer's Disease, Amnestic Mild Cognitive Impairment
[18F]MK-6240 Positron Emission Tomography (PET) Tracer First-in-Human Validation Study (MK-6240-001)
This 2-part, open-label study was designed to investigate the safety, tolerability, and efficacy of [18F]MK-6240, a Positron Emission Tomography (PET) imaging agent, for the quantification of neurofibrillary tangle (NFT)…
- Trial name
- NCT02562989
- Testing
- [18F]MK-6240, ~185 MBq, [18F]MK-6240, ~160 MBq
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Tobacco Use
A Study to Assess Changes in Cigarette Consumption During a Switch to Very Low Nicotine Cigarettes
This study evaluates the impact of switching from usual brand cigarettes to very low nicotine cigarettes on cigarette consumption, smoking behavior, and biomarkers of exposure.
- Trial name
- NCT03571724
- Testing
- Non-Menthol Very Low Nicotine Cigarettes, Menthol Very Low Nicotine Cigarettes, Subject's UB non-mentholated filtered cigarettes
- Where
- 2 sites in United States
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- 22nd Century Group, Inc.
Validation Studies
d13C Added Sugar Intake Biomarker: Determining Validity in Children
Added sugars (AS) constitute a significant source (~ 16%) of the total daily calories consumed by youth. The role of AS in health is contentious, and the reliance on self-reported dietary data is an often-cited flaw in existing…
- Trial name
- NCT02455388
- Testing
- High added sugar diet, Low added sugar diet
- Where
- United States
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- Virginia Polytechnic Institute and State University
SRP, Minocycline HCl Microspheres
Scaling and Root Planing (SRP) With and Without Minocycline HCl Microspheres, 1 mg
The primary goal of this study is to investigate the qualitative and quantitative effects of scaling and root planing (SRP) with and without minocycline HCL microspheres, 1 mg on periodontal pathogens and overall bacterial load.
- Conditions
- SRP, Minocycline HCl Microspheres, Biomarkers
- Trial name
- NCT03762915
- Testing
- minocycline HCl microspheres
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Nonalcoholic Fatty Liver Disease (NAFLD)
Impact of Fructose on Metabolism, Energy Homeostasis and Magnetic Resonance Biomarkers in Nonalcoholic Fatty Liver Disease
This study will advance several goals of the NIH Action Plan: 1) establish a multidisciplinary team to develop quantitative methodologies and imaging protocols for liver, 2) validate diagnostic criteria and methodologies for…
- Trial name
- NCT01930123
- Testing
- intravenous fructose challenge, Blood Draw
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Manal F Abdelmalek