Clinical trials: Proof of Concept
Microbiome Dysbiosis, Gut Health
Colon-delivered Riboflavin and Gut Microbiota Composition
Recent studies suggest B-vitamins such as riboflavin to possess prebiotic-like effects. However, there is still a lack of understanding of the exact host health benefits vs. conventional systemically available vitamin forms.
- Trial name
- CONCOL (NCT07093463)
- Testing
- Colon-delivered riboflavin, Conventional riboflavin, Microcrystalline Cellulose
- Where
- Germany
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- dsm-firmenich Switzerland AG
Infertility
Automation of Gamete Preparation, Intracytoplasmic Sperm Injection (ICSI), Embryo Culture, and Vitrification
Patients suffering from infertility may seek assisted conception treatment. In a full treatment cycle, the sperm and eggs (gametes) from the intended parents will be looked after by skilled laboratory staff (embryologists) who…
- Trial name
- NCT06074835
- Testing
- Gamete preparation, ICSI, embryo culture and vitrification robot assistant, Routine Manual ICSI Workflow
- Where
- Mexico
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Conceivable Life Sciences
Healthy Volunteer
A Human Tick Kill Study to Investigate the Safety, Tolerability, and Whole Blood Concentration of TP-05
This is a Phase 2a, randomized, double-blind, proof-of-concept, single-center study evaluating the safety, tolerability, and whole blood concentration of TP-05 (lotilaner) in the killing of ticks after they have attached to human…
- Trial name
- NCT05387083
- Testing
- Low Dose TP-05, High Dose TP-05
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Tarsus Pharmaceuticals, Inc.
Pain, Delayed Onset Muscle Soreness
An Investigator Initiated, Within-Subject, Proof of Concept Study to Assess the Efficacy and Safety of Voltaren Gel in Subjects With DOMS
The purpose of this study is to evaluate analgesic efficacy of Topical Voltaren Gel (diclofenac sodium gel) 1% applied QID compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness.
- Trial name
- NCT02087748
- Testing
- 1% diclofenac sodium gel
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Lotus Clinical Research, LLC
Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)
Proof-of-concept of a Robotic Knee Exoskeleton in Healthy Subjects and Hemiparetic Patients During Gait.
Hemiparetic gait is characterized by strong asymmetries that could severely affect the quality of life of stroke survivors. This asymmetry is due to motor deficits in the paretic leg and the resulting compensations in the…
- Trial name
- NCT05138185
- Testing
- Exoskeleton assisted gait on a treadmill
- Where
- Spain
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Spanish National Research Council
Malaria, Vivax
Serological Screen and Treat Trial for Plasmodium Vivax
This is a clinical trial to evaluate an experimental serological diagnostic technique intended to identify people at high risk of having dormant malaria parasites in their liver.
- Trial name
- SSAT (NCT04223674)
- Testing
- Serological screen and treat
- Where
- Indonesia
- Volunteers
- 1,133 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
Healthy
A Proof of Concept Study to Investigate the Use and Relevance of a Digital Platform for Infant Crying and Fussing
Primary: The rating by the primary caregivers on the use and relevance of data provided by the Language ENvironment Analysis (LENA) recorder and their level of engagement due to the content on the Cool mobile app.
- Trial name
- COOL (NCT03729960)
- Testing
- LENA recorder
- Where
- Singapore
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Cardiovascular Diseases
Search of Biomarkers of Mineralocorticoid Receiver Activity : the Value of Neutrophil Gelatinase Associated Lipocalin (NGAL)in Serum or Urine in Human
Aldosterone and its target the mineralocorticoid receptor are implied in development of cardiovascular disease such as arterial high blood pressure or cardiac failure.
- Trial name
- NCT02129621
- Testing
- Urinary and blood lipococalin levels determination, Spironolactone
- Where
- 3 sites in France
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Central Hospital, Nancy, France
Endometriosis, Diagnosis
Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers
This study is testing a way to diagnose endometriosis using a uterine tissue biopsy (similar to a pap smear) as opposed to undergoing laparoscopy surgery.
- Trial name
- NCT05698212
- Testing
- MetriDx
- Where
- 3 sites in United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Hera Biotech, Inc.
Mild Cognitive Impairment, Mild Dementia
Brain Health & the Microbiome
The GW SMHS supports research in complementary and integrative approaches to treatment of sickness and disease and for health promotion.
- Conditions
- Mild Cognitive Impairment, Mild Dementia, Alzheimer Disease 1
- Trial name
- bMicrobiome (NCT06039267)
- Testing
- Gut Microbiome Testing
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- George Washington University
Low Back Pain
Ultrasound Imaging Measurements of the Thoracolumbar Fascia
In this prospective study, eligible subjects with chronic non specific low back pain and asymptomatic volunteers will undergo a research dynamic ultrasound exam of the lower back before and after a massage technique.
- Trial name
- NCT04716101
- Testing
- Massage therapy technique
- Where
- Canada
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
Alzheimer Disease
Proof-of-concept Study of New Imaging Diagnostic in Patients With Suspected Alzheimer's Disease
This study is a Phase 1, first-in-human, multi-center study to establish safety of ADx-001 in healthy volunteers, and safety and proof of concept in patients with confirmed amyloid plaques in the brain (confirmed by amyloid…
- Trial name
- NCT05453539
- Testing
- DSPE-DOTA-Gd Liposomal Injection
- Where
- 2 sites in Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Alzeca Biosciences, Inc.
Bowel Preparation
Safety and Tolerability Study of an Edible Colon Preparation
The purpose of this study is to learn about a new bowel preparation that uses food to clean the colon. In order to learn about this new food preparation, some people in this study will get the food preparation, and others will…
- Trial name
- NCT02402270
- Testing
- NuLYTELY® (PEG 3350), ECP-019, MoviPrep® (PEG 3350)
- Where
- 2 sites in United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- ColonaryConcepts LLC
Healthy, Muscle Disuse Atrophy
The Effects of Protein Supplementation With or Without Urolithin A During Single-leg Immobilization
There are times in life when people cannot use their muscles, such as during illness or injury. Muscle and mitochondria (the 'energy factory' in cells) health decline very quickly when people cannot use their muscles, but certain…
- Trial name
- NCT05814705
- Testing
- Protein supplement, Protein supplement with Urolithin A
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- McMaster University
Idiopathic Pulmonary Fibrosis
Evaluation of the Value of 18F-Fluoromisonidazole (18F-FMISO) Positron Emission Tomography Hypoxia Imaging in Idiopathic Pulmonary Fibrosis
Idiopathic pulmonary fibrosis (IPF) is a rare, chronic, lethal disease of unknown etiology and with a variable course. There is currently no test in routine care that can assess both the anatomical and functional damage of the…
- Trial name
- FIPOXY (NCT05331729)
- Testing
- FMISO-PET Protocol
- Where
- France
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire Dijon
Nondaily Smoking
A Proof-of-concept RCT of Version 3.0 of the Smoking Cessation Smartphone App "Smiling Instead of Smoking" (SiS)
This is the third study in a series of 3 studies to develop a smartphone app to support nondaily smokers in quitting smoking, as funded by the American Cancer Society grant #RSG CPPB - 130323 (project dates: 07/01/2017 …
- Trial name
- NCT04672239
- Testing
- Smartphone app "Smiling instead of Smoking" (SiS) Version 3, Smartphone app "QuitGuide" (QG), Brochure "Clearing the Air" (CTA)
- Where
- United States
- Volunteers
- 229 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Cancer Survivors, Healthy Participant
A Study to Evaluate the Effects of the Combination of GI-102 With GIB-7 on Biomarkers of Aging in Healthy Adults and Cancer Survivors
This Phase 2a clinical study (GIANTS-1) aims to evaluate a novel dual-combination strategy using GI-102 and GIB-7 to address key pathological features of aging, including immunosenescence (the aging of the immune system)…
- Conditions
- Cancer Survivors, Healthy Participant, Elderly
- Trial name
- GIANTS-1 (NCT07363057)
- Testing
- GI-102 in combination with GIB-7
- Where
- 2 sites in Australia
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- GI Innovation, Inc.
No Disease or Condition is Being Studied, Metabolism
The Effects of Gyngerlean Supplementation on Energy Expenditure
The goal of this randomized controlled study is to asses the effects of a ginger containing supplement on energy expenditure and substrate utilization in healthy men.
- Trial name
- NCT06805201
- Testing
- Gyngerlean
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Nova Southeastern University
Schizophrenia
Evaluation Study of New Compounds With Potential Use in Schizophrenia
Different compounds that might modify the glucose regulation in the central nervous system will be evaluated in healthy volunteers.
- Trial name
- EICAS (NCT00916201)
- Testing
- URB597, intranasal Insulin, Cannabidiol CR
- Where
- Germany
- Volunteers
- healthy volunteers welcome
- Sponsor
- Central Institute of Mental Health, Mannheim
Aging
Revitalize Cognition: Near Infrared Stimulation in Older Adults
Changes in mood and cognition are common in older adulthood. Some studies have suggested that transcranial application of near-infrared (NIR) light may have enhancing effects on cognitive and mood status in young adults and…
- Trial name
- NCT02582593
- Testing
- MedX 1116 Rehab Console
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- University of Florida