Clinical trials: Biological Markers
Fluid Over-load
B-type Natriuretic Peptide as a Surrogate Marker Guiding Post-operative Fluid Off-loading
The long-range goal of this proposal is to decrease morbidity and mortality related to pulmonary edema and congestive heart failure (CHF) in post-operative patients.
- Trial name
- NCT01584518
- Testing
- Furosemide
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Creighton University
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
Non-Small Cell Lung Cancer
Phase II Umbrella Study of Novel Anti-cancer Agents in Participants With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy
This is an open-label, multi-centre, umbrella Phase II study in participants with metastatic NSCLC who have progressed on an anti-PD-1/PD-L1 containing therapy.
- Trial name
- HUDSON (NCT03334617)
- Testing
- Durvalumab, Danvatirsen, Ceralasertib
- Where
- 45 sites in United States, Austria and 6 more
- Volunteers
- 528 people
- Sponsor
- AstraZeneca
Biomarkers
Changes in Biomarkers Associated With Use of Electronic Cigarettes
The objective of this clinical trial was to compare the effects of e-cigarettes with and without nicotine on patterns of combustible cigarette use and biomarkers of exposure to tobacco toxicants among African American smokers.
- Trial name
- NCT03084315
- Testing
- E-Cig Zero Nicotine, E-Cig 24mg Nicotine
- Where
- United States
- Volunteers
- 234 people
- Sponsor
- University of Minnesota
Type 2 Diabetes Mellitus
Role of Canagliflozin on CD34+ Cells in Patients With Type 2 Diabetes
The investigators hypothesize that Cana may be able to improve number and function of CD34+ endothelial progenitor cells. The investigators also propose that this expected cardiovascular benefit is independent of HbA1C reduction.
- Trial name
- NCT02964585
- Testing
- Canagliflozin
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- George Washington University
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
Coronary Atherosclerosis, Coronary Artery Calcification
Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH)
1. Statement of Problem According to the National Fire Protection Association (NFPA), 43.7% of all firefighters that died on the job experienced sudden cardiac death. The job also affords an incredible amount of stress.
- Conditions
- Coronary Atherosclerosis, Coronary Artery Calcification, Coronary Stenosis
- Trial name
- NCT00860847
- Testing
- Aged garlic extract and Coenzyme Q10
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Depression
Imaging Biomarkers for TMS Treatment of Depression
The purpose of this research is to learn more about how rTMS works to reduce the symptoms of depression. This information can be used to improve the effectiveness of the treatment.
- Trial name
- NCT01900314
- Testing
- repetitive Transcranial Magnetic Stimulation (rTMS)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Michigan
Osteosarcoma, Nephrotoxicity
Preventing Nephrotoxicity and Ototoxicity From Osteosarcoma Therapy
Osteosarcoma is the most common type of bone cancer in children, adolescents and young adults. Treatment with surgery and a combination of three conventional chemotherapy drugs can cure nearly two-thirds patients with…
- Conditions
- Osteosarcoma, Nephrotoxicity, Ototoxicity
- Trial name
- NCT01848457
- Testing
- Pantoprazole, High-dose methotrexate infusion duration
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Children's Hospital of Philadelphia
Coronary Heart Disease
Stress Management and Biomarkers of Risk in Cardiac Rehabilitation
The purpose of this study is to assess the extent to which combining exercise and stress management training (SMT) is more effective at improving biomarkers in vulnerable cardiac patients compared to exercise-based cardiac…
- Trial name
- ENHANCED (NCT00981253)
- Testing
- SMT-enhanced Cardiac Rehabilitation, Standard Cardiac Rehabilitation
- Where
- 2 sites in United States
- Volunteers
- 164 people
- Sponsor
- Duke University
Type 1 Diabetes Mellitus
Feasibility Study of Closed Loop Control in Type 1 Diabetes Using Heart Rate Monitoring as an Exercise Marker
The purpose of this study is to see if the Artificial Pancreas Platform (AP Platform = Cell Phone + Closed Loop Control) can successfully control blood sugar in people with type 1 diabetes mellitus on insulin pump therapy in a…
- Trial name
- NCT01582139
- Testing
- Heart rate informed SSM+HMM
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Virginia
Dermatitis, Atopic
Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis
This study is being conducted to characterize the mechanism of action of crisaborole ointment 2%, by evaluation of efficacy and changes in key skin biomarkers in atopic dermatitis (AD) lesions treated with crisaborole ointment 2%…
- Trial name
- NCT03233529
- Testing
- Crisaborole ointment 2% BID
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Pfizer
Breast Cancer
PET-MR for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer
The purpose of this study is: To validate the efficacy of multiparametric MRI, FDG-PET, RGD-PET, and PET-MR fusion imaging in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced breast cancer…
- Trial name
- NCT01190566
- Where
- South Korea
- Volunteers
- 57 people
- Sponsor
- Seoul National University Hospital
Early Alzheimer's Disease
An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects
This study is being conducted to evaluate the safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype.
- Trial name
- APOLLOE4 (NCT04770220)
- Testing
- Experimental: ALZ-801
- Where
- 95 sites in United States, Canada and 7 more
- Volunteers
- 325 people
- Sponsor
- Alzheon Inc.
Mild Cognitive Impairment
Candesartan's Effects on Alzheimer's Disease And Related Biomarkers
This study is intended to investigate the safety of candesartan, a blood pressure medication, in non-hypertensive individuals who have mild cognitive impairment (MCI) due to Alzheimer's disease and its effect on disease…
- Trial name
- CEDAR (NCT02646982)
- Testing
- Candesartan
- Where
- 2 sites in United States
- Volunteers
- 77 people
- Sponsor
- Emory University
Squamous Cell Lung Cancer
Necitumumab in the Neoadjuvant Setting With Gemcitabine in Surgically Resectable - 14X-US-I001
This will be a single-arm study to primarily evaluate the feasibility of administering necitumumab added to gemcitabine and cisplatin as neoadjuvant treatment in treatment-naïve patients with stage IB (tumor size >4cm), II or…
- Trial name
- NCT03574818
- Testing
- Necitumumab-Gemcitabine-Cisplatin, Evaluation to determine if patient is a candidate to proceeed with surgical resection or not
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Montefiore Medical Center
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
Atopic Dermatitis (AD)
Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)
The primary objective of the study was to assess the efficacy of Dupilumab, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).
- Trial name
- NCT01979016
- Testing
- Dupilumab, Background treatment
- Where
- 4 sites in United States, Canada
- Volunteers
- 54 people
- Sponsor
- Regeneron Pharmaceuticals