Beacon Clinical Registry

Consent for this questionnaire

Please read and confirm before continuing.

"I understand that this questionnaire is being used to collect observational real-world outcome data for NCT07521384. The study does not assign treatment. My responses will help document changes in TNF-alpha, overall condition, quality of life, diagnosis-specific function, safety, and tolerability over time."

I confirm that the information provided is accurate to the best of my knowledge.I understand that urgent medical concerns should be directed to the treating physician or emergency services.I understand that validated instruments may require official scoring and licensing.I consent to submit this information for study data collection according to the study consent and privacy authorization.

Submission Metadata

Identify the participant, the form completer, and the response source.

Participant study ID *

Date completed

Person completing this form *

Relationship to participant

Response source *

Diagnosis category *

Treatment cohort *

Date of intranasal therapy

New medical events since prior assessment

New medications, therapies, biologics, vaccines, etc. since prior assessment

Secondary Outcome 1 — TNF-alpha

Serum TNF-alpha at 3-month follow-up. Baseline-vs-3-month is the primary analysis window.

Date collected

Value

Unit

Reference range

Laboratory name

Collected ~3 months after intranasal therapy?

Upload lab report (PDF, image)

Secondary Outcome 2 — Global Impression of Change

Caregiver or participant-reported overall change vs. baseline.

Compared with the participant's condition before intranasal therapy, how would you rate the participant's overall condition today?

Main reason for rating

Free-text description of observed change

Was the change meaningful in daily life?

Which domains were affected?

Secondary Outcome 3 — Health-Related Quality of Life

Select an age-appropriate instrument. Do not reproduce proprietary items here — administer offline and enter scores only.

Instrument used

Version used

Respondent type

Baseline score

3-Month Follow-Up score

Scoring method (e.g. official scoring guide vs. composite)

Upload completed instrument PDF

Secondary Outcome 4 — Diagnosis-Specific Functional Outcome

Validated functional measure appropriate to the diagnosis.

Diagnosis-specific instrument selected

Baseline score

3-Month Follow-Up score

Assessor name & credentials

Date of assessment

Upload completed documentation

Safety & Medical Events

Since the prior assessment, has the participant experienced any of the following?

Concomitant Treatments & Confounders

Did the participant start, stop, or change any of the following since the prior assessment?

Caregiver / Participant Narrative

Open-text observations.

1. What is the most meaningful improvement you have observed since baseline?

2. What is the most concerning change you have observed since baseline?

3. Have there been any new abilities, behaviors, movements, communication attempts, or signs of awareness?

4. Have therapists, nurses, physicians, teachers, or family members noticed changes?

5. Is there anything important the study team should know that was not captured in the structured questions?