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The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related neuroinflammatory conditions. Participants in the United States aged 2 years and older will provide self-reported health data, biometrics, and symptom diaries through the MyDataHelps™ app (branded as unhide® for this study). The goal is to create comprehensive longitudinal profiles to facilitate research into disease subtypes, causes, diagnostics, and potential treatments, as well as to identify potential participants for future optional studies. "Healthy" individuals without brain inflammation are also eligible to participate. The digital health research platform used in this study was originally developed and designed by Solve M.E and was called SolveTogether. The Brain Inflammation Collaborative (BIC) expanded upon Solve M.E.'s work to include related diagnoses, pediatric participants, enhance symptom tracking, and more. BIC and Solve M.E. combined Solve Together and unhide®, to create The unhide® Solve Together Unified Platform in 2025.
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
Yes |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational [Patient Registry] |
| Eligible Ages | 2 Years and Over |
| Gender | All |
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04806620 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Brain Inflammation Collaborative |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Megan L Fitzgerald, PhD |
| Principal Investigator Affiliation | Brain Inflammation Collaborative |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Recruiting |
| Countries | United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Post-Acute COVID-19 Syndrome, ME/CFS, Rheumatic Arthritis, Juvenile Rheumatoid Arthritis (JRA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), Autoimmune Encephalitis, Bipolar Disorder (BPD), Celiac Disease, Celiac Disease in Children, Chronic Lyme Disease, Post-treatment Lyme Disease Syndrome, Crohn's Disease, Dysautonomia, Anorexia Nervosa, Bulimia Nervosa, ARFID, Avoidant / Restrictive Food Intake Disorder, Ehlers Danlos Syndrome, Endometriosis, Fibromyalgia (FM), Long COVID, Lupus, Major Depression, Migraines, Mast Cell Activation Syndrome, Multiple Sclerosis, Myalgic Encephalomyelitis (ME), Myasthenia Gravis, Generalized, Myasthenia Gravis in Children, Narcolepsy, Obsessive Compulsive Disorder (OCD), PANDAS, Pediatric Acute-onset Neuropsychiatric Syndrome (PANS), POTS - Postural Orthostatic Tachycardia Syndrome, General Anxiety Disorder, Social Anxiety Disorder, PTSD - Post Traumatic Stress Disorder, Psoriasis, Traumatic Brain Injury, Tourette's Syndrome, Inflammatory Bowel Disease (IBD), Autoimmune Diseases, Neurological Diseases or Conditions, Psychiatric Disorder, Sjogren's Syndrome, Ulcerative Colitis and Crohn's Disease |
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
