Crohn Disease
Healing After Anti-TNF Therapy in Children Newly Diagnosed With Crohn’s Disease
This study investigates which clinical and biological factors are associated with intestinal healing after guided anti-tumor necrosis factor therapy in children with newly diagnosed Crohn’s disease.
Registry title: Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease
21 recruiting U.S. sites ↓Study at a glance
- Age
- 6 Years–17 Years
- Treatment
- Anti-TNF therapy
- Design
- Not provided
- Central study contact
- Dena E Hopkins, MPH, CCRP860-545-8125CAMEO_CCC@connecticutchildrens.org
- Sponsor
- Connecticut Children's Medical Center
Research question
Which clinical, imaging, genetic, immune, microbial, and gene-expression factors are associated with complete intestinal healing after optimized anti-TNF therapy in children with newly diagnosed Crohn’s disease?
Participant snapshot
Who the study is looking for
- The study is initially looking for children ages 6 through 17 who are suspected of having Crohn’s disease.
- Initial enrollment occurs around the diagnostic evaluation, before Crohn’s disease has necessarily been confirmed.
- Continuing into phase 2 requires confirmed Crohn’s disease involving the terminal ileum or colon and participation in phase 1.
- Phase 2 participants must start adalimumab or infliximab as their first therapy or within 180 days of diagnosis.
Participation overview
What participation may involve
Enrollment has two phases: an initial diagnostic observation phase, followed by at least 52 weeks of guided anti-TNF therapy and follow-up for children who meet the phase 2 requirements. What participation may involve: - Participants undergo diagnostic assessment and biological sampling during phase 1. - Phase 2 participants receive adalimumab or infliximab guided by the ROADMAB clinical decision-support tool. - Blood and stool inflammation markers and genetic and intestinal biological factors are assessed before, during, and after one year of therapy. - Ileocolonoscopy and magnetic resonance enterography are compared before anti-TNF treatment and approximately one year later to assess healing. Phase 1 may involve up to six months of observation; participants who start anti-TNF therapy must be able to remain in follow-up for at least 52 additional weeks.
Study interventions
What participants may receive or do
- Anti-TNF therapy: Children continuing into phase 2 receive adalimumab or infliximab, medicines that block tumor necrosis factor, with treatment guided by the ROADMAB clinical decision-support tool.
Study design
How the comparison works
This is a phase 4, prospective, open-label study in which all phase 2 participants are followed in one anti-TNF treatment group. The registry reports allocation as not applicable, so participants are not randomly assigned among study groups. The study is open label with no masking, meaning the treatment assignment is not concealed. The registry describes a single treatment group and does not list a separate comparison group.
Reported activities
Procedures and tests
- Diagnostic ileocolonoscopy, with video available for central review
- Follow-up ileocolonoscopy at approximately 52 weeks to assess endoscopic healing
- Magnetic resonance enterography near the initial diagnostic evaluation
- Follow-up magnetic resonance enterography at approximately 52 weeks to assess healing through the bowel wall
- Blood testing for inflammation markers and anti-TNF therapeutic drug monitoring
- Stool testing, including fecal calprotectin measurement
- Collection or analysis of genomic DNA and gene-expression information
- Ileal and rectal biopsies, with specified exceptions when ileal intubation is not possible
- Clinical disease-activity assessment using the weighted Pediatric Crohn’s Disease Activity Index
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Phase 1 requires an age of at least 6 and under 18 at enrollment.
- Phase 1 is for children with a suspected diagnosis of Crohn’s disease.
- A parent or guardian must consent, and the child must assent.
- The family must be able to remain in follow-up for up to six months of observation and at least 52 weeks after a possible anti-TNF start.
- Phase 2 requires participation in phase 1 and fulfillment of all phase 1 eligibility criteria.
- Phase 2 requires Crohn’s disease visible in the terminal ileum or colon on endoscopy or magnetic resonance enterography.
- Magnetic resonance enterography must generally occur within six weeks of ileocolonoscopy and no more than four weeks after initial treatment starts.
- Phase 2 requires starting adalimumab or infliximab as first therapy or within 180 days of diagnosis, with or without an immunomodulator.
- Phase 2 generally requires ileal and rectal biopsies, with detailed exceptions when ileal biopsies cannot be obtained because of inflammatory or structural changes.
Possible reasons someone may not be able to join
- A child is excluded from phase 1 if Crohn’s disease is diagnosed after abdominal resection surgery or appendectomy at the initial presentation.
- Phase 1 excludes children whom the investigator judges to have a greater than 50% likelihood of needing bowel resection within three months of diagnosis.
- Phase 1 excludes prior immunomodulator treatment within one year or anti-TNF treatment within two years for another medical condition.
- Pregnancy is an exclusion criterion for phase 1.
- Poorly controlled medical conditions, such as diabetes or congestive heart failure, exclude participation in phase 1.
- Inability to undergo magnetic resonance enterography, including because of claustrophobia, excludes participation.
- Phase 2 excludes Crohn’s disease limited to the mouth and face or limited to the esophagus, stomach, duodenum, or jejunum.
- Severe complex fistulizing perianal disease or perianal disease requiring or likely to require ongoing surgery excludes phase 2, although seton placement or abscess drainage alone is not exclusionary.
- Phase 2 excludes initial inflammatory bowel disease treatment with a non-anti-TNF biologic or small-molecule therapy.
- Phase 2 excludes treatment with an anti-TNF medicine other than adalimumab or infliximab.
- A child is excluded from phase 2 if bowel resection occurred within three months of diagnosis.
Important unknowns
What the record does not make clear
- The registry describes major assessments but does not provide the number, timing, length, or format of study visits.
- The registry allows anti-TNF therapy with or without an immunomodulator and lists several possible initial therapies, but it does not state how each child’s background treatment is selected or managed.
- Several prior-treatment timing restrictions are reported, but the registry does not provide a complete medication washout or transition plan.
- The registry does not explain what rescue treatment is available if symptoms worsen or anti-TNF therapy is not working.
- The registry does not say which study-related or clinical-care costs are covered or billed to insurance.
- The registry does not report whether participants receive payment or reimbursement.
- The registry does not describe transportation, lodging, meals, or other travel support.
- The study is recruiting overall, but site statuses vary and the registry does not specify whether each site is enrolling both phases.
Before contacting the site
Questions for the study team
- What is the complete visit and procedure schedule for phase 1 and phase 2?
- Which tests and samples are for research only, and which are part of usual clinical care?
- How does the ROADMAB clinical decision-support tool affect anti-TNF dosing, testing, or treatment changes?
- What happens if Crohn’s disease worsens or the anti-TNF medicine is not working?
- Which costs are covered, what may be billed to insurance, and is compensation or travel support available?
- Is the nearest listed site currently enrolling children into phase 1, phase 2, or both?
Before changing care
Questions for your gastroenterologist
- How stable is my child’s Crohn’s disease, and would the study’s assessment schedule be clinically appropriate?
- How might participation affect the timing or choice of approved treatment alternatives?
- Should any current medicines continue or change while the research team evaluates participation?
- What risks or practical concerns do the endoscopies, magnetic resonance enterography, biopsies, and repeated sampling raise in my child’s clinical situation?
- How would you coordinate treatment decisions and urgent care with the research team if symptoms worsen?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
Crohn's disease (CD) is a condition that causes inflammation (swelling, redness) of the lining and wall of the small intestine, large intestine, or both. CD may be associated with abdominal cramps/pain, diarrhea, blood in the stool, weight loss, or delayed growth in children. While the exact cause of CD is not certain it is thought that the immune system located in the intestine reacts abnormally to the large number of bacteria contained there. The investigators think that diet, exposure to antibiotics early in life, and having a family history of CD puts people at increased risk for developing CD. In order to decrease the inflammation doctors use what is called biologic therapy with anti-TNF molecules that can be given through an intravenous or shots. TNF is a chemical made by white blood cells that is involved in inflammation. When this type of treatment is given early after diagnosis it is more effective than when it is given later. The investigators have learned that it is important to give the optimum (ideal) amount of this medicine guided by certain blood tests. The investigators also know that not everyone responds to this therapy but do not understand the reasons for this variability between people. The CAMEO study has been started to help understand what factors are important in determining whether a child with CD completely heals the inflammation after anti-TNF therapy. The investigators will do that by measuring certain markers of inflammation in the blood and stool and by looking at a person's genes (DNA) and how inflammation is controlled in the intestine. These inflammation tests will be done before, during, and after one year of anti-TNF therapy. The investigators will determine how much healing has taken place by comparing the results of the colonoscopy and a special type of MRI that are both done before anti-TNF and then again one year later. The goal in treating CD is to heal both the lining and the wall of the intestine. Children ages 6-17 years who are thought to have CD and are about to undergo their diagnostic colonoscopy are eligible to be enrolled. If they are found to indeed have CD and start an anti-TNF medicine within 6 months they can continue in the study. There are no increased risks of participating in this study beyond those normally associated with having CD and its treatment. By better understanding why the bowel does or does not heal, doctors will be better able to provide personalized care.
Study Sites: Approximately 27 pediatric clinical centers in North America Study Period: Planned enrollment period - 3 years Planned duration of the study: 5 years Primary Study Objective: Identify clinical, radiologic, genomic, immune, microbial and transcriptomic factors associated with complete intestinal healing (CH) in the context of optimized anti-TNF therapy in children with newly diagnosed CD Secondary Study Objective: Identify clinical, radiologic, genomic, immune, microbial and transcriptomic factors associated with endoscopic healing only, transmural healing by MRE only, endoscopic response only, transmural response only, clinical remission, fecal calprotectin normalization, in the context of optimized anti-TNF therapy in children with newly diagnosed CD Study Design: Prospective multicenter open label single arm clinical trial with 2-phase enrollment Sample Size: Phase 1: 900; Phase 2: 550
Study design and administration
- Organization
- Connecticut Children's Medical Center
- Organization class
- Other
- Organization study ID
- 22-066
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Na
- Intervention model
- Single Group
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Child
Study arms
Other
Anti-tumor necrosis factor (TNF)
Patients newly diagnosed with pediatric-onset Crohn's disease starting anti-TNF therapy within 6 months of diagnosis
Interventions: Drug: Anti-TNF therapy
Interventions
Drug
Anti-TNF therapy
Use of anti-TNF therapy for children and adolescents with newly diagnosed Crohn's disease guided by a clinical decision support tool
Eligibility
6 Years–17 Years
All
Not accepted
Inclusion criteria (17)
- Age ≥ 6 years and \< 18 years at enrollmentRegistry-derived · unreviewed
- Suspected diagnosis of CDRegistry-derived · unreviewed
- Stool culture if performed that is negative for routine enteric pathogens (Salmonella, Shigella, Campylobacter, E. coli 0157:H7) and Clostridium difficile toxin in patients presenting with diarrhea. If history of C. difficile then a minimum of 6 weeks duration from treatment start and negative repeat stool for C. difficile toxin.Registry-derived · unreviewed
- Parent/guardian consent and patient assentRegistry-derived · unreviewed
- Ability to remain in follow-up for up to 6 months of initial observation followed by a minimum of 52 weeks after possible start of anti-TNF therapyRegistry-derived · unreviewed
- Met all eligibility criteria for Phase 1 and participated in Phase 1Registry-derived · unreviewed
- Diagnosed with macroscopic CD involving the terminal ileum and/or colon by endoscopic evaluation and/or MRERegistry-derived · unreviewed
- MRE imaging within 6 weeks of ileocolonoscopy and no more than 4 weeks after starting initial therapy (TT). A limited 'research protocol' MRE is acceptable in participants who have undergone a clinical CTE during their initial diagnostic evaluation; see Manual of Procedures for details.Registry-derived · unreviewed
- Received at least one of the following as initial therapy upon diagnosis:Registry-derived · unreviewed
- CorticosteroidsRegistry-derived · unreviewed
- ImmunomodulatorRegistry-derived · unreviewed
- Aminosalicylic acids (5-ASA)Registry-derived · unreviewed
- Defined nutritional therapyRegistry-derived · unreviewed
- Anti-TNF (adalimumab or infliximab)Registry-derived · unreviewed
- Commenced adalimumab or infliximab anti-TNF therapy guided by ROADMAB™ CDST as first therapy or within 180 days of diagnosis (TD), with or without concomitant immunomodulatorRegistry-derived · unreviewed
- 6 a. Had ileal and rectal biopsies, OR b. Ileal biopsies are not obtained secondary to inflammatory or structural changes at the ileocecal valve or distal ileum that prevent ileal intubation. To be acceptable for Phase 2, the following additional criteria must be met: b1. Gross inflammation or obvious narrowing at the IC valve or distal ileum as documented by the video colonoscopy, AND b2. MRE documentation of TI inflammation with or without narrowing, OR c. Ileal biopsies are not obtained secondary to inflammatory or structural changes due to colonic CD.Registry-derived · unreviewed
- 7\. Parent/guardian consent and patient assent 8. Ability to remain in follow-up for a minimum of 52 weeks after start of anti-TNF therapyRegistry-derived · unreviewed
Exclusion criteria (21)
- Diagnosis of CD following abdominal resectional surgery/appendectomy at initial presentationRegistry-derived · unreviewed
- Investigator judgment that patient has high likelihood (\>50%) of needing bowel resection within 3 months of diagnosis (i.e., presentation with perforation, bowel obstruction from stricture)Registry-derived · unreviewed
- Use of any oral CS for non-gastrointestinal indication within the four weeks prior to diagnostic assessment and biosampling (e.g., asthma)Registry-derived · unreviewed
- Use of any investigational drug within the past four weeks prior to diagnostic assessment and samplingRegistry-derived · unreviewed
- PregnancyRegistry-derived · unreviewed
- Patients with poorly controlled medical conditions (e.g. diabetes, congestive heart failure)Registry-derived · unreviewed
- Previous treatment with immunomodulators within one year of enrollment or anti-TNF therapy within two years of enrollment for other medical conditions (e.g., juvenile idiopathic arthritis)Registry-derived · unreviewed
- Previous treatment with non-anti TNF biologics or small molecules for non-IBD indications in the past 6 months, with the exception of dupilumab (Dupixent) for asthma, eczema, or eosinophilic esophagitisRegistry-derived · unreviewed
- Inability to have MRE because of claustrophobia or other reasonsRegistry-derived · unreviewed
- Diagnosis of CD using video capsule endoscopy only with normal ileocolonoscopy and normal MRERegistry-derived · unreviewed
- Orofacial CD onlyRegistry-derived · unreviewed
- Esophageal, gastric, duodenal, and/or jejunal CD onlyRegistry-derived · unreviewed
- Severe complex fistulizing perianal disease +/- abscess, or perianal disease requiring surgical intervention or likely to require on-going surgical intervention possibly including diversion. The placement of a seton is not exclusionary. Incision and drainage of a perirectal abscess is also not exclusionary.Registry-derived · unreviewed
- Perianal CD only with no evidence of luminal diseaseRegistry-derived · unreviewed
- Internal fistulizing disease at diagnosisRegistry-derived · unreviewed
- Initial IBD treatment with non-anti-TNF biologic or small molecule therapyRegistry-derived · unreviewed
- Received any anti-TNF agent other than adalimumab or infliximabRegistry-derived · unreviewed
- Investigator judgment that patient unlikely to return for clinical, endoscopic or MRE follow-upRegistry-derived · unreviewed
- Inability to have MRE because of claustrophobia or other reasonsRegistry-derived · unreviewed
- Video of baseline endoscopy not available for central reading, unless otherwise approved by the Clinical Coordinating Center (Adequate photo documentation required)Registry-derived · unreviewed
- Underwent bowel resection within 3 months of diagnosis (TD)Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Complete healing (CH)
Time frame: 52 weeks from anti-TNF start
The achievement of complete healing (CH) 52 weeks after initiation of anti-TNF therapy guided by ROADMAB™ (therapeutic drug monitoring) as evidenced by a composite of all of the following four features below: 1. Endoscopic healing (EH) determined by centrally read ileocolonoscopy (total SES-CD score \<3) 2. Transmural healing (TH) determined by centrally read MRE (no segmental MaRIAs score of ≥1) 3. Corticosteroid free for a minimum of 4 weeks 4. The absence of either intestinal resection or the addition of a nutritional, biological or small molecule therapeutic agent other than anti-TNF± concomitant IM
Secondary outcome
Endoscopic mucosal healing only
Time frame: 52 weeks
Following approximately 52 weeks of anti-TNF therapy guided by the ROADMAB™ Clinical Decision Support Tool (CDST), with a minimum of 4 weeks of being corticosteroid free, and in the absence of either intestinal resection or the addition of a biological or small molecule therapeutic agent other than anti-TNF± concomitant IM: Endoscopic mucosal healing only (total Simple Endoscopic Score - Crohn's Disease (SES-CD) \<3)
Secondary outcome
Transmural healing only
Time frame: 52 weeks
Following approximately 52 weeks of anti-TNF therapy guided by the ROADMAB™ Clinical Decision Support Tool (CDST), with a minimum of 4 weeks of being corticosteroid free, and in the absence of either intestinal resection or the addition of a biological or small molecule therapeutic agent other than anti-TNF± concomitant IM: Transmural healing only (no segmental simplified magnetic resonance index of activity (MaRIAs) score ≥1)
Secondary outcome
Clinical remission
Time frame: 52 weeks
Following approximately 52 weeks of anti-TNF therapy guided by the ROADMAB™ Clinical Decision Support Tool (CDST), with a minimum of 4 weeks of being corticosteroid free, and in the absence of either intestinal resection or the addition of a biological or small molecule therapeutic agent other than anti-TNF± concomitant IM: Clinical remission (weighted Pediatric Crohn's Disease Activity Index (wPCDAI) \< 12.5)
Secondary outcome
Fecal calprotectin
Time frame: 52 weeks
Following approximately 52 weeks of anti-TNF therapy guided by the ROADMAB™ Clinical Decision Support Tool (CDST), with a minimum of 4 weeks of being corticosteroid free, and in the absence of either intestinal resection or the addition of a biological or small molecule therapeutic agent other than anti-TNF± concomitant IM: Fecal calprotectin \<250 ug/g
Secondary outcome
Endoscopic response
Time frame: 52 weeks
Following approximately 52 weeks of anti-TNF therapy guided by the ROADMAB™ Clinical Decision Support Tool (CDST), with a minimum of 4 weeks of being corticosteroid free, and in the absence of either intestinal resection or the addition of a biological or small molecule therapeutic agent other than anti-TNF± concomitant IM: Endoscopic response: 50% reduction in SES-CD
Secondary outcome
Transmural response
Time frame: 52 weeks
Following approximately 52 weeks of anti-TNF therapy guided by the ROADMAB™ Clinical Decision Support Tool (CDST), with a minimum of 4 weeks of being corticosteroid free, and in the absence of either intestinal resection or the addition of a biological or small molecule therapeutic agent other than anti-TNF± concomitant IM: Transmural response: 50% reduction in MaRIAs
Recruiting locations in the United States
Phoenix Children's Hospital
RecruitingPhoenix, Arizona, 85016, United States
Samantha Zeno602-933-3689szeno@phoenixchildrens.com
Elizabeth Hilow, MD
Paula Tizzard, MD
Cedars-Sinai
RecruitingLos Angeles, California, 90048, United States
Yvette Gonzales310-423-7100Yvette.Gonzales@cshs.org
Shervin Rabizadeh, MD, MBA
David Ziring, MD
UCSF Benioff Children's Hospitals
RecruitingSan Francisco, California, 94158, United States
Becca Trombler415-502-3190Becca.trombler@ucsf.edu
Sofia Verstraete, MD, MAS
Melvin Heyman, MD, MPH
Connecticut Children's Medical Center
RecruitingHartford, Connecticut, 06106, United States
Dena Hopkins860-545-8125dhopkins01@connecticutchildrens.org
Victoria Grossi, DO
Jeffrey S Hyams, MD
Emory University
RecruitingAtlanta, Georgia, 30328, United States
Jen Davis404-727-4542jenascia.davis@emory.edu
B. Joanna Niklinska-Schirtz, MD
Subra Kugathasan, MD
Riley Hospital for Children at Indiana University Health
RecruitingIndianapolis, Indiana, 46202, United States
Lydia Bhatt317-278-1421lydware@iu.edu
Marian Pfefferkorn, MD
Steven Steiner, MD
The Johns Hopkins Children's Medical Center
RecruitingBaltimore, Maryland, 21287, United States
Alyssa Cavezza410-955-8769acavezz1@jh.edu
Maria Oliva-Hemker, MD
Anthony Guerrerio, MD, PhD
Boston Children's Hospital
RecruitingBoston, Massachusetts, 02115, United States
Richelle Bearup, MPH617-919-4973richelle.bearup@childrens.harvard.edu
Jodie Ouahed, MD, MMSc
Scott Snapper, MD, PhD
University of Michigan
RecruitingAnn Arbor, Michigan, 48109, United States
Lauren Manning734-763-9650lbadish@med.umich.edu
G. Jennifer Lee, MD
Jeremy Adler, MD, MSc
Goryeb Children's Hospital/Morristown Medical Center/Atlantic Children's Health
RecruitingMorristown, New Jersey, 07960, United States
Annette Langseder, RN, BSN973-971-4321Annette.langseder@atlantichealth.org
Oren Koslowe, MD
Peter Wilmot, MD
Cohen Children's Medical Center of NY
RecruitingLake Success, New York, 11042, United States
Jillian Charyn516-472-3691jcharyn@northwell.edu
James Markowitz, MD
Benjamin Sahn, MD
Columbia University Medical Center
RecruitingNew York, New York, 10032, United States
Sally Dorfzaun212-305-5903sg2837@cumc.columbia.edu
Neal LeLeiko, MD, PhD
Joseph Picoraro, MD
Levine Children's
RecruitingCharlotte, North Carolina, 28203, United States
Megan Care704-381-8840Megan.Care@advocatehealth.org
Tiffany Linville, MD
Nathan Fleishman, MD
Cincinnati Children's Hospital Medical Center
RecruitingCincinnati, Ohio, 45229, United States
Kathleen Lake513-636-1412Kathleen.Lake@cchmc.org
Jasbir Dhaliwal, MD
Lee Denson, MD
UH/Rainbow Babies and Children's Hospital
RecruitingCleveland, Ohio, 44106, United States
Hannah Thome216-844-1765hannah.thome2@uhhospitals.org
Denise Young, MD
Thomas Sferra, MD
Nationwide Children's Hospital
RecruitingColumbus, Ohio, 43205, United States
Ling Fan, MPH614-722-3412Ling.fan@nationwidechildrens.org
Brendan Boyle, MD, MPH
Hilary Michel, MD
Children's Hospital of Philadelphia
RecruitingPhiladelphia, Pennsylvania, 19146, United States
Lindsey Albenberg, DO267-426-7791
Lindsey Albenberg, DO
Robert Baldassano, MD
UPMC Children's Hospital of Pittsburgh
RecruitingPittsburgh, Pennsylvania, 15224, United States
Susan Richey, RN412-692-6337richeys@upmc.edu
Whitney Sunseri, MD
Rhode Island Hospital
RecruitingProvidence, Rhode Island, 02903, United States
Linda Ineus401-444-8306lineus@brownhealth.org
Jason Shapiro, MD
Shova Subedi, MD
Seattle Children's Hospital
RecruitingSeattle, Washington, 98105, United States
Mason Nuding206-987-0055Mason.Nuding@seattlechildrens.org
Hengqi (Betty) Zheng, MD
David Suskind, MD
Medical College of Wisconsin
RecruitingMilwaukee, Wisconsin, 53226, United States
Rachel Unteutschrunteutsch@mcw.edu
Joshua Noe, MD
Jose Cabrera, MD
Abdul Elkadri, MD
This study also lists 4 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Mar 23, 2023
- Primary completion
- Jul 1, 2028
- Overall completion
- Jul 1, 2029
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.