Clinical trials: Biomarker
Device Latency
Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
- Trial name
- OSMITTER (NCT02404532)
- Testing
- MIND1 System
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Quality of Life
Effect of Colon Delivered Vitamin C on Gut Microbiota and Related Health Biomarkers in Healthy Older Adults
Recent studies have shown that many vitamins, if consumed in high daily dosages or delivered to the colon, can modulate the gut microbiota and their metabolites.
- Trial name
- NCT05598619
- Testing
- Vitamin C
- Where
- Ireland
- Volunteers
- 264 people, healthy volunteers welcome
- Sponsor
- dsm-firmenich Switzerland AG
Relapse Remitting Multiple Sclerosis
Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.
This study evaluates the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes.
- Trial name
- AGNOS (NCT05084638)
- Testing
- Ofatumumab
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Healthy Adult Women of Child Bearing Age
Impact of a MVM to Support Biomarkers Associated With Conception and Pregnancy in Healthy Women.
The goal of this clinical trial is to investigate the effects multivitamin (MVM) on blood biomarkers that are associated with healthy pregnancy and conception in adult women.
- Trial name
- NCT06505408
- Testing
- Multivitamin
- Where
- Ireland
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Perelel Inc.
Healthy
Immune Health Biomarkers and Fecal Microbiota in Filipino Breastfed Infants
This will be a prospective observational study aiming to investigate immune health biomarkers and fecal microbiota in 48-60 Filipino breastfed infants from birth to 12 months of age.
- Trial name
- NCT06708559
- Testing
- Breast-fed infants
- Where
- Philippines
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Smoking, Smoking Cessation
BRP1802 Smoking Abstinence Study
A single-center study designed to evaluate changes in short-term biomarkers of potential harm (BoPH) in healthy adult cigarette smokers of two age groups (Group A: 24-34 years; Group B: 35-60 years) during 14 days of smoking…
- Conditions
- Smoking, Smoking Cessation, Tobacco Use
- Trial name
- NCT04979013
- Testing
- Smoking Abstinence
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- RAI Services Company
Diabetes, Diabetes Mellitus, Type 1
Evaluation of Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period
This study is conducted in the United States of America (USA). The aim of this study is to assess longitudinal variation of immune biomarkers in subjects with type 1 diabetes (T1D), type 2 diabetes (T2D) and healthy, non-diabetic…
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Healthy
- Trial name
- NCT01900834
- Testing
- No treatment given
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Drug-drug Interaction Study
A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin
The goal of this clinical study was to determine the effect of the test drug ceftobiprole (a drug approved for the treatment of bacterial infections) on the elimination of pitavastatin (a drug approved for the treatment of…
- Trial name
- NCT06808646
- Testing
- pitavastatin, pitavastatin single dose combined with ceftobiprole
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Alzheimer Disease, Dementia
Exploratory Clinical Study and Validation of Blood Biomarkers for Alzheimer's Disease
This is a 24-month, monocentric, exploratory and observational clinical study aimed at developing and validating a blood-based diagnostic test for Alzheimer's disease (AD).
- Conditions
- Alzheimer Disease, Dementia, Neurodegenerative Disorders, Cognitive Decline
- Trial name
- ADKIT (NCT07294586)
- Where
- France
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Amoneta Diagnostics SAS
Assessment of Mechanistic Blood Biomarkers in Healthy Humans
A Study of CAT-1004 Biomarkers in Healthy Subjects
This study is being conducted to assess mechanistic blood biomarkers of CAT-1004 in healthy humans.
- Trial name
- NCT01670773
- Testing
- CAT-1004, Salsalate + DHA
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Catabasis Pharmaceuticals
Alzheimer's Disease (AD), Neurodegenerative Disease
A Biomarker-chip Assay in Preserved Red Blood Cells for the Diagnosis of Alzheimer's Disease
The ADCHIP study (ST0067) is a non-interventional, monocentric, prospective study conducted by Amoneta Diagnostics and the Leenaards Memory Center (Lausanne, Switzerland).
- Conditions
- Alzheimer's Disease (AD), Neurodegenerative Disease, Dementia, Frontotemporal Dementia (FTD)
- Trial name
- ADCHIP (NCT07307872)
- Where
- Switzerland
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Amoneta Diagnostics SAS
Alzheimer s Disease, Mild Cognitive Impairment (MCI)
Crownlands Observing Progression With Neurons Study
The CROWN-I Study is an observational study to learn about molecular features of Alzheimer's disease (AD) and mild cognitive impairment (MCI).
- Trial name
- CROWN-I (NCT07611396)
- Where
- United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Crownlands
Bowel Cancer, Bowel Disease
Exploratory Study of Rectal Mucus for Diagnosing Disease
The identification of patients with colorectal cancer is challenging as they present with a variable symptom profile and require invasive tests (colonoscopy) for diagnosis (through histological analysis of biopsies) and…
- Conditions
- Bowel Cancer, Bowel Disease, Genomic, Epigenetic Disorder
- Trial name
- ORI-EGI-02 (NCT04659590)
- Where
- 4 sites in United Kingdom
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Origin Sciences
Schizophrenia
Event-Related Potential (ERP) Biomarkers in Subjects With Schizophrenia and Healthy Volunteer Subjects
This is an observational, non-interventional study that will recruit Healthy Volunteers (HV) and subjects with clinically confirmed Schizophrenia (SZ).
- Trial name
- NCT04025502
- Testing
- Event-Related Potentials (ERP) and Electroencephalogram (EEG) testing with the COGNISION® System
- Where
- 4 sites in United States
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- ERP Biomarker Qualification Consortium
Healthy
A Methodology Study in Healthy Subjects to Evaluate the Effect of AZD8309 After Nasal Administration of Lipopolysaccharide (LPS)
The purpose of this methodology study is to evaluate the effect of AZD8309 on cells and inflammatory biomarkers in nasal lavage and blood after nasal challenge with lipopolysaccharide (LPS)
- Trial name
- NCT00860821
- Testing
- AZD8309
- Where
- Sweden
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Breast Cancer
Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood & Primary Tumor in ER+/HER2- MBC
Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.
- Trial name
- NCT04480814
- Testing
- PIK3CA kit
- Where
- 4 sites in Greece
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pharmassist Ltd
Cutaneous Warts
First-in-Human Study of CLS003 ICVT in Subjects With Cutaneous Warts
This phase I/IIa study has an open-label, First-in-Human (FIH), single center design to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of topically applied CLS003 in healthy subjects with…
- Trial name
- NCT02106260
- Testing
- CLS003
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Maruho Co., Ltd.
Autistic Disorder
Proteomic Biomarker Tests in Blood Samples from Children with Autism Spectrum Disorder (ASD)
Behavioral testing is the gold standard for diagnosing autism spectrum disorder (ASD). These tests, including ADOS and ADI-R, are subjective, require trained staff to administer, are time-consuming, and can only be administered…
- Trial name
- NCT02168868
- Testing
- Blood draw, Stool Sample Collection, Urine Sample Collection
- Where
- Israel
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Benjamin Gesundheit
Device Latency
Substudy of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
The purpose of this study was to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
- Trial name
- OSMITTER (NCT02091882)
- Testing
- Combination product of Aripiprazole + IEM + Sensor + MIND1 Application
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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