anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Cholic Acid
Trial phase: Phase 1 | Phase 2
ATC code: A05AA03
SMILES: [H][C@@]1(O)CC[C@@]2(C)[C@@]([H])(C1)C[C@@]([H])(O)[C@@]1([H])[C@]3([H])CC[C@]([H])([C@]([H])(C)CCC(=O)O)[C@@]3(C)[C@@]([H])(O)C[C@]21[H]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Participants will be treated with cholic acid 10 mg/kg body weight.

Cholic Acid: Participants will be treated with cholic acid for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Ages 2-25 years.
Participants (or their parents/legally-authorized representative) must provide signed informed consent.
Assent must be obtained from those participants ages 7-17 years who are intellectually capable of understanding this study.
Diagnosis of SLOS based on clinical features and biochemical + genetic confirmation.
Participants are capable of traveling to the STAIR study site.
Fasting plasma cholesterol ≤125 mg/dL during the Qualification Phase must be established before starting cholic acid therapy.
Clinically stable at the time of enrollment
Participants must be on a constant dietary cholesterol intake for at least 3-months prior to treatment with cholic acid.
Participants must agree to make no changes in cholesterol supplementation during the STAIR study.
SLOS participants who are taking antioxidants will be included. Participants must agree to make no changes in the antioxidant dose during this study.
For females of childbearing age (who have begun menstruating), a negative pregnancy test must be documented at the start of the study (week 0/ baseline) and at the end of cholic acid administration (week 8).

Exclusion Criteria:

Participants are unable to provide signed informed consent and/or verbal assent.
Participants have an unstable clinical condition that would prevent completion of the study. Medically unstable participants would include those with severe liver disease, complex birth defects such as severe heart disease or renal dysplasia, those with severe respiratory compromise requiring tracheostomy, or those who are not likely to survive longer than 1 year.
Participants are taking drugs, nutraceuticals, probiotics or other compounds that are known or suspected to affect sterol metabolism.
Participants have transaminase elevations (>3-fold above the reference range) at baseline.
Intervention: Fluoxetine
Trial phase: Phase 2
ATC code: N06AB03 | N06CA03
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Fluoxetine 20 MG Oral Tablet

Fluoxetine 20 MG Oral Tablet: Once-daily dosing for 90 days
Eligibility criteria:
Inclusion Criteria:

Participant is 18 years of age or older
Participant has experienced a CT-confirmed ischemic stroke w/in 21 days of enrollment

Exclusion Criteria:

NIH Stroke Scale Score >20 points
Unconscious at presentation
Hemorrhagic conversion of ischemic infarct
transient ischemic symptoms <24h,
Current antidepressant or psychoactive drug use (e.g. SSRI, monoxidase amine inhibitor, benzodiazepine).
Current pregnancy.
History of recent head trauma.
Baseline motor deficits from other etiologies including prior stroke.
Dysphagia preventing the swallowing of a pill.
Hyponatremia (<125 mmol/L), hepatic impairment as defined by a serum alanine aminotransferase (ALT) of >120 U/L.
Renal impairment as defined by a creatinine >180 micromol/L or GFR <30mL/min/1.73m2.
Patients who are moribund for other reasons and unlikely to survive to 90 days will also be excluded from participation.
Contraindication to MRI (e.g. piercings/tattoos, electronic/metallic implants, claustrophobia)
Contraindication to lumbar puncture (e.g. infection at site of needle insertion, evidence of elevated ICP, coagulopathy/thrombocytopenia or use of therapeutic anticoagulation, or a history of LP complications).
Intervention: Sirolimus
Trial phase: Phase 1
ATC code: L01EG04 | L04AA10 | S01XA23
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 21
Group description: Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit.

Rapamycin: Immunosuppressive drug
Eligibility criteria:
Inclusion Criteria:

Must be treatment-seekers
Meet criteria for alcohol use disorder
Must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments
Must use one of the following methods of birth control: oral contraceptives, barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse
Must live within a 50-mile radius of our research program and have reliable transportation,
Must consent to remain abstinent from alcohol and all non-prescription drugs prior to medication administration and testing sessions
Must consent to fast for a two-hour period prior to medication administration
Must consent to random assignment to the rapamycin vs. placebo conditions.

Exclusion Criteria:

Cannot be undergoing other alcohol cessation treatment
Cannot be pregnant, nursing, or of childbearing potential and not using birth control
Cannot have evidence of or a history of significant endocrine, cardiovascular, pulmonary, renal, or neurological disease
Cannot have significant liver impairment
Cannot have an existing infection or immune system disorder
Cannot have a history of or current psychotic disorder, severe major depression, or bipolar affective disorder
Cannot currently take anti-arrythmic agents, psychostimulants, or any other agents known to interfere with heart rate and skin conductance monitoring
Cannot have known or suspected hypersensitivity to macrolide compounds (such as rapamycin/sirolimus)
Cannot currently take medications that could adversely interact with the study medication, including but not limited to significant inhibitors of CYP2D6 or CYP3A4 (voriconazole, fluconazole, itraconazole, erythromycin, clarithromycin, diltiazem, verapamil, etc.), or significant inducers of CYP3A4, such as anticonvulsants (carbamazepine, phenobarbital, phenytoin, etc.) and antibiotics (rifabutin, rifapentine, etc.)
Cannot have a history of thrombocytopenia, idiopathic thrombocytopenia purpura (ITP) or have a platelet count of less than 100,000 cells per mm3
Cannot have any unhealed wounds
Cannot have any planned surgeries within the next month, including surgical dental procedures
Cannot have a history of complicated alcohol withdrawal symptoms (including, but not limited to, symptoms such as seizures, hallucinations, and high blood pressure)
Intervention: Naropin
Trial phase: Phase 2 | Phase 3
SMILES: CCC[NH+]1CCCCC1C(=O)Nc1c(C)cccc1C.O.[Cl-]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 15
Group description: FICB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the groin.

Ropivacaine Hcl 0.5% Inj Vil 20Ml: Anesthetic agent used in peripheral nerve block
Eligibility criteria:
Inclusion Criteria:

ASA grade I-III
Undergoing elective orthopedic surgical procedures involving the hip and upper thigh

Exclusion Criteria:

Local anesthetic allergy
Skin or localized infection at the site of catheter insertion
Patient or parent refusal
Intervention: Naropin
Trial phase: Phase 2 | Phase 3
SMILES: CCC[NH+]1CCCCC1C(=O)Nc1c(C)cccc1C.O.[Cl-]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 15
Group description: LPB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the back.

Ropivacaine Hcl 0.5% Inj Vil 20Ml: Anesthetic agent used in peripheral nerve block
Eligibility criteria:
Inclusion Criteria:

ASA grade I-III
Undergoing elective orthopedic surgical procedures involving the hip and upper thigh

Exclusion Criteria:

Local anesthetic allergy
Skin or localized infection at the site of catheter insertion
Patient or parent refusal
Intervention: Fluorescein Sodium
Trial phase: Not Applicable
SMILES: O=C([O-])c1ccccc1-c1c2ccc(=O)cc-2oc2cc([O-])ccc12.[Na+].[Na+]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 2
Group description: This study will employ the use of sodium fluorescein and an FDA approved operative microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast.

Sodium Fluorescein: Patients enrolled in this study will receive 3 mg/kg sodium fluorescein following induction of anesthesia by administration into a peripheral venous line over 10 seconds

Microscopic Resection: Resection will proceed with the use of a surgical microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast.
Eligibility criteria:
Inclusion Criteria:

Age 31 days through 21 years on date of surgery
Undergoing resection of a central nervous system tumor at Children's Hospital Colorado
Parent/legal guardian (or adult subject) willing and able to complete the informed consent process

Exclusion Criteria:

Tumor in functionally eloquent cortex that precludes maximal surgical resection
Severe renal dysfunction
Preoperative serum creatinine level > than normal range and GFR < 30.
Severe liver dysfunction
History of asthma or pulmonary spasm
Known allergy to sodium fluorescein or any other contrast dye
Previous administration of sodium fluorescein within the last 72 hours
Pregnant or nursing mother
Other unspecified reasons that, in the opinion of the investigator, make the subject unsuitable for enrollment.
Intervention: Imiquimod
Trial phase: Phase 2
ATC code: D06BB10
SMILES: CC(C)Cn1cnc2c(N)nc3ccccc3c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: 5% Imiquimod cream once daily to keloid area 5-times a week for 6 weeks, starting 1-week prior to keloid excision

Imiquimod 5% cream: Imiquimod 5% Cream application to keloid skin area 5-times per week for 6 weeks, starting 1-week before keloid excision
Eligibility criteria:
Inclusion Criteria:

Age 18 or greater
Men and women who present clinically with keloids requesting excision
Any number of keloids
Keloid no larger than 5cm in diameter at the base
Clinical findings consistent with keloid formation
Location of keloid in low-risk areas - areas other than above the neck, hands, feet, or groin
Able and willing to give informed consent

Exclusion Criteria:

Age < 18
Hypersensitivity to Imiquimod or to any of the excipients (methylhydroxybenzoate, propylhydroxybenzoate, cetyl alcohol, and stearyl alcohol)
Involvement in a trial of another experimental intervention within 30 days
Life threatening disease
Use of immunosuppressive medications such as oral corticosteroids
Bleeding disorders
Not available for follow-up for 10 weeks
Pregnant, intention to become pregnant during treatment phase of trial, or breastfeeding
Intervention: Minocycline hydrochloride
Trial phase: Phase 4
SMILES: CN(C)c1ccc(O)c2c1CC1CC3C(N(C)C)C(=O)C(C(N)=O)=C(O)C3(O)C(=O)C1=C2O.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 70
Group description: The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit.

minocycline HCl microspheres: Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.
Eligibility criteria:
Inclusion Criteria:

Male and Female
At least 18 years of age
ADA Class III-IV Chronic Periodontitis
Scaling and Root Planing (SRP) or localized SRP
A minimum of eight sites with pockets ≥5mm with bleeding on probing (any quadrant)

Exclusion Criteria:

Unable to comply with study protocol
Completed treatment of Scaling and Root Planing (SRP) and/or localized SRP within the last 6 months
Cigarette use within the last year
≥2 weeks of antibiotic use in the past three months. Or antibiotic use in the last six weeks.
Pregnant, planning to become pregnant, or unsure of pregnancy status (self- reported)
Diagnosed cardiac conditions (cardiovascular disease (CVD) or atherosclerotic vascular disease (ASVD) including coronary heart disease, cerebrovascular disease, and peripheral artery disease, myocardial infarction, stroke, stable or unstable angina, transient ischemic attack, or coronary or other arterial revascularization
Have any uncontrolled medical condition or immunocompromised that may impact the study (uncontrolled diabetes HbA1c > 7, HIV, etc.)
Tetracycline allergy
Any medication that may impact periodontal conditions (Phenytoin, calcium antagonists, cyclosporin, warfarin, or NSAIDS)
Intervention: Topiramate
Trial phase: Not Applicable
ATC code: A08AA51 | N03AX11
SMILES: [H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.

Topamax: An antiepileptic agent used for migraine prophylaxis.
Eligibility criteria:
Inclusion Criteria:

Chronic migraine diagnosis according to International Classification of Headache-2 Disorders (ICHD)
w/o pregnancy or breastfeeding.
w/o acute or chronic psychiatric disorders.
w/o nephrolithiasis.
w/o medication of anticoagulant and antiaggregant.
w/o allergy to topiramate or bupivacaine.
w/o prophylaxis within the last three months with any of; propranolol, nebivolol, topiramate, valproate, venlafaxine, duloxetine, amitriptyline, flunarizine.
w/o previous history of peripheral nerve block, botulinum toxin or acupuncture.
w/o history of multiple sclerosis, movement disorders, epilepsy, stroke, and tumor.

J-w/o chronic systemic diseases including hypertension, cardiac insufficiency, diabetes, pulmonary disease, kidney disease, liver disease, and peripheral arterial disease.

Exclusion Criteria:

Lost to follow up within the pretreatment period during the detoxification therapy after the detoxification therapy
could not tolerate the peripheral nerve block or topiramate
Intervention: Silver
Trial phase: Phase 3
ATC code: D08AL30
SMILES: [Ag]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Patients will use Theraworx foam and a compression wrap

Theraworx: Theraworx foam applied to skin and/or compression wrap
Eligibility criteria:
Inclusion Criteria:

Thumb CMC arthritis
greater than or equal to age 18
Interested in non-operative treatment of thumb arthritis

Exclusion Criteria:

Recent corticosteroid injection into the thumb joint
Non-English speaking
skin lesions or rashes on the thumb
current use of topical anti-inflammatory medications
concomitant thumb/wrist diagnoses that would impact the results (as determined by the PI)
known allergy to magnesium
Intervention: Silver
Trial phase: Phase 3
ATC code: D08AL30
SMILES: [Ag]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Patients will use Theraworx foam without compression wrap

Theraworx: Theraworx foam applied to skin and/or compression wrap
Eligibility criteria:
Inclusion Criteria:

Thumb CMC arthritis
greater than or equal to age 18
Interested in non-operative treatment of thumb arthritis

Exclusion Criteria:

Recent corticosteroid injection into the thumb joint
Non-English speaking
skin lesions or rashes on the thumb
current use of topical anti-inflammatory medications
concomitant thumb/wrist diagnoses that would impact the results (as determined by the PI)
known allergy to magnesium
Intervention: Emixustat
Trial phase: Phase 3
SMILES: NCC[C@@H](O)c1cccc(OCC2CCCCC2)c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 127
Group description: 10 mg

Emixustat: Once daily oral tablet taken for 24 months
Eligibility criteria:
Inclusion Criteria:

A clinical diagnosis of macular atrophy secondary to Stargardt disease (STGD)
Macular atrophy measured to fall within a defined size range
Two mutations of the ABCA4 gene. If only one mutation, a typical STGD appearance of the retina.
Visual acuity in the study eye of at least 20/320

Exclusion Criteria:

Macular atrophy secondary to a disease other than STGD
Mutations of genes, other than ABCA4, that are associated with retinal degeneration
Surgery in the study eye in the past 3 months
Prior participation in a gene therapy or stem cell clinical trial for STGD
Recent participation in a clinical trial for STGD evaluating a complement inhibitor or vitamin A derivative
Use of certain medications in the past 4 weeks that might interfere with emixustat
An abnormal electrocardiogram (ECG)
Certain abnormalities on laboratory blood testing
Female subjects who are pregnant or nursing
Intervention: Spironolactone
Trial phase: Phase 1
ATC code: C03DA01
SMILES: [H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C
Sex: Male
Age groups: Child
Healthy volunteers: No
Participants at risk: 1
Group description: Twelve subjects will be prescribed a standard clinical dose of spironolactone of 1 mg/kg/day. The spironolactone will be provided as suspension.

Spironolactone: Spironolactone will be prescribed for 6 months, after which the family and primary care physician will determine to either remain on spironolactone or transfer to prednisolone.
Eligibility criteria:
Inclusion Criteria:

Duchenne muscular dystrophy (DMD) patients ≥4 to ≤7 years of age
Clinical features of DMD that include proximal predominant weakness and/or gait disturbance
Presence of a truncating mutation of the DMD gene in the patient or an affected male relative OR a muscle biopsy that demonstrates <5% dystrophin in the patient or an affected male relative
Normal left ventricular ejection fraction by screening echocardiogram
Ability to cooperate for testing
No prior treatment with glucocorticoids or vamorolone
No concomitant experimental therapies

Exclusion Criteria:

Subject amenable to or currently being treated with eteplirsen, casimersen, or viltolarsen
Hyperkalemia at screening
History of or ongoing renal failure (elevated creatinine, oliguria, anuria)
Hypersensitivity to spironolactone (rash, respiratory distress, arrhythmia, numbness or tingling of extremities)
Current treatment with an ACEi
Severe peptic ulcer disease or recent gastrointestinal perforations
Intervention: Acetaminophen
Trial phase: Phase 2
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-Acetaminophen Cap 5-500

Hydrocodone-Acetaminophen: Traditionally used narcotic pain protocol
Eligibility criteria:
Inclusion Criteria:

All adult patients over age 18 and scheduled for a primary or revision rotator cuff repair

Exclusion Criteria:

Exclusion criteria will include patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. Secondary exclusion criterion is an intact rotator cuff
Intervention: Acetaminophen
Trial phase: Phase 3
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Participants received acetaminophen 650 mg capsule by mouth, single dose at any study visits, one hour before the initiation of the exercise test.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of relapsing-remitting MS
self-reported heat-sensitivity to exercise
Expanded Disability Status Scale (EDSS) total score ≤ 6.0
exacerbation-free (and no use of corticosteroids) for 6 weeks prior
BMI ≤ 40

Exclusion Criteria:

prior history of significant head injury, stroke, or other neurological disease/disorder
current daily use of antipyretics or pain medication
currently in a major depressive episode
vascular disease of the legs, uncontrolled high blood pressure
uncontrolled diabetes mellitus or problem with blood sugar levels
contraindications to aspirin use (history of confirmed peptic ulcer, gastrointestinal or severe gynecological bleeding)
tarry stool or known fecal occult blood
uncontrolled syndrome of asthma, rhinitis, or nasal polyps
contraindications to acetaminophen use (severe active hepatic disease, Hepatitis C Virus)
Intervention: Sirolimus
Trial phase: Phase 2 | Phase 3
ATC code: L01EG04 | L04AA10 | S01XA23
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Rapamycin cream topical, 0.5% w/w, applied once daily before bed on affected area for 26 weeks

rapamycin: Apply to the affected area once a day, approximately half an hour before retiring for bed in the evening, for 26 weeks
Eligibility criteria:
Inclusion Criteria:

Male and female patients aged ≥ 6 years and ≤ 65 years on the day informed consent is obtained
Patients diagnosed with TSC based on the clinical diagnostic criteria of International Tuberous Sclerosis Complex Consensus Conference 2012 and presenting visible facial angiofibroma
An FA severity score of 2 or 3 on the IGA scale
Patients or their legal representatives capable of understanding the explanation of the clinical trial and who give written informed consent for participation
Patients or their legal representatives able to maintain patient diaries following the instructions of the investigator or sub-investigator

Exclusion Criteria:

Patients who cannot carry out the treatment plan or follow-up assessment
Patients with serious skin lesions such as erosions or ulcers
Patients with known hypersensitivity to any component of the study product
Patients who have received rapamycin/sirolimus, everolimus, or temsirolimus within 3 months of enrolment
Patients who received laser therapy or surgical therapy within 6 months prior to trial enrolment
Patients who participated in any other clinical trial within 3 months prior to the day of enrolment
Patients judged unsuitable for this clinical trial by the investigator or sub-investigator
Pregnant or lactating females
Sexually active females of childbearing potential not using adequate contraception and sexually active males not using adequate contraception
Patients with immune dysfunction or receiving any form of immunosuppression
Patients with severe FA, with a score of 4 on the IGA scale
Patients with an FA severity score of less than 2 on the IGA scale