anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
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: 33
Group description: Rapamycin cream topical, 1.0% 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
Intervention: Ganaxolone
Trial phase: Phase 2
ATC code: N03AX27
SMILES: [H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](C(C)=O)CC[C@@]34[H])[C@@]1(C)CC[C@@](C)(O)C2
Sex: Female
Age groups: Child
Healthy volunteers: No
Participants at risk: 10
Group description: ganaxolone suspension (50 mg/ml) 3x's /day for 17 weeks

Ganaxolone: active drug
Eligibility criteria:
Inclusion Criteria:

Molecular confirmation of a pathogenic or likely pathogenic PCDH19 variant
Failure to control seizures despite 2 or more anti-seizure medications
12 seizures over a 12-week period of primary seizure types prior to screening
On a stable regimen of concomitant AEDs, Ketogenic diets, and modified Atkins diet should be unchanged for 3 months prior to screening)

Exclusion Criteria:

Previous exposure to ganaxolone
> 8 consecutive weeks of seizure freedom during the 12 weeks prior to screening
Concurrent use of strong inducers or inhibitors of CYP3A4/5/7 is not permitted
Use of tetrahydrocannabinol (THC) or non-approved cannabidiol (CBD) is prohibited during the double-blind phase
Exposure to any other investigational drug within 30 days or fewer than 5 half-lives prior to screening
Intervention: CALCIUM CHLORIDE
Trial phase: Phase 1 | Phase 2
ATC code: A11GB01 | A12AA07 | B05XA07 | G04BA03
SMILES: [Ca+2].[Cl-].[Cl-]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Non-participating anesthesiologist prepares the drug solution, which is 1 gram of calcium chloride diluted into a total volume of 60 milliliters normal saline, labeled only with the study ID number. The solution is administered intravenously utilizing an Alaris syringe pump and microbore tubing, with infusion starting immediately at the time of fetal delivery at a rate of 360 milliliters per hour (for a calcium infusion rate of 100 milligrams /minute until the full 1 gram dose is administered).

This is a one-time administration. Patients continue to receive all standard care during the Cesarean including 1 unit oxytocin bolus at the time of fetal delivery + continuous oxytocin infusion at 7.5 units per hour per our institution's protocol.

Calcium Chloride: All included in intervention description.

1 gram of calcium chloride in total 60 milliliters normal saline
Eligibility criteria:
Inclusion Criteria:

Pregnant female subjects at Lucile Packard Children's hospital / Stanford hospital undergoing Cesarean will be screened for inclusion in the study based upon presence of at least 2 risk factors for uterine atony/ postpartum hemorrhage. The risk factors include the following:

intrapartum Cesarean delivery
failed operative vaginal delivery with forceps or vacuum
magnesium infusion
chorioamnionitis
multiple gestation
polyhydramnios
preterm delivery <37 weeks
prior history of postpartum hemorrhage
labor induction or augmentation with oxytocin
advanced maternal age
obesity with body mass index >40

Exclusion Criteria:

a degree of case urgency to which taking time to consent for the study could compromise patient care, determined by anesthesiologist or obstetrician
patient age <18 years or >50 years
renal dysfunction with serum Creatinine > 1.0
abnormal cardiac function or history of arrhythmia
patient taking digoxin
patient currently taking a calcium channel blocker for a cardiovascular indication
Intervention: Fentanyl
Trial phase: Not Applicable
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 44
Group description: Participants receive fentanyl 5 mcg/kg/hr not to exceed 10 mcg/kg/hr (high dose).
Eligibility criteria:
Inclusion Criteria:

Neonates of at least 32 weeks of gestation, infants and children up to 2 years of age admitted to The Children's Hospital for treatment of cyanotic or non-cyanotic heart disease requiring surgical intervention.
Admitting diagnosis of cyanotic or non-cyanotic heart disease

Exclusion Criteria:

Neonates less than 32 weeks of gestational age, and children more than 2 years of age.
Any documented central nervous system malformations.
Any potential subject requiring unexpected postoperative Extracorporeal membrane oxygenation (ECMO) support
Intervention: PF-06700841
Trial phase: Phase 2
SMILES: Cn1cc(Nc2nccc(N3CC4CCC(C3)N4C(=O)C3CC3(F)F)n2)cn1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of Atopic Dermatitis for at least 3 months
Investigator's Global Assessment (IGA) Score of 2 or 3
Eczema Area Severity Index (EASI) score of 3-21
Body Surface Area (BSA) of 2-20%
Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more

Exclusion Criteria:

Other forms of dermatological diseases (other than atopic dermatitis)
Fitzpatrick skin type score greater than 5
Clinically significant abnormal ECG, vital signs, and laboratory values
Infection with HBV, HCV, herpes zoster or tuberculosis
Intervention: PF-06700841
Trial phase: Phase 2
SMILES: Cn1cc(Nc2nccc(N3CC4CCC(C3)N4C(=O)C3CC3(F)F)n2)cn1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of Atopic Dermatitis for at least 3 months
Investigator's Global Assessment (IGA) Score of 2 or 3
Eczema Area Severity Index (EASI) score of 3-21
Body Surface Area (BSA) of 2-20%
Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more

Exclusion Criteria:

Other forms of dermatological diseases (other than atopic dermatitis)
Fitzpatrick skin type score greater than 5
Clinically significant abnormal ECG, vital signs, and laboratory values
Infection with HBV, HCV, herpes zoster or tuberculosis
Intervention: PF-06700841
Trial phase: Phase 2
SMILES: Cn1cc(Nc2nccc(N3CC4CCC(C3)N4C(=O)C3CC3(F)F)n2)cn1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of Atopic Dermatitis for at least 3 months
Investigator's Global Assessment (IGA) Score of 2 or 3
Eczema Area Severity Index (EASI) score of 3-21
Body Surface Area (BSA) of 2-20%
Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more

Exclusion Criteria:

Other forms of dermatological diseases (other than atopic dermatitis)
Fitzpatrick skin type score greater than 5
Clinically significant abnormal ECG, vital signs, and laboratory values
Infection with HBV, HCV, herpes zoster or tuberculosis
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: 19
Group description: Imiquimod 3.75% Cream topically: Approximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen.
Eligibility criteria:
Inclusion Criteria:

Adults at least 18 years old.
Subjects must be in good general health as confirmed by the medical history.
Subjects must be able to read, sign, and understand the informed consent.
Prior to imiquimod therapy, subjects must have at least 4-8 actinic keratoses on the face and/or scalp.
Subject must be willing to forego any other treatments on the face and/or scalp, including tanning bed use and excessive sun exposure while in the study.
Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods and to comply with all study requirements including concomitant medication and other treatment restrictions.
If subject is a female of childbearing potential she must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study.

Exclusion Criteria:

Subjects with a history of melanoma anywhere on the body.
Subjects with an unstable medical condition as deemed by the clinical investigator.
Subjects with non-melanoma skin cancer on the face and/or or scalp.
Subjects with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of AKs.
Subjects who have previously been treated with imiquimod: on the face or scalp in the past 6 months; or outside of the study area within the past 30 days.
Women who are pregnant, lactating, or planning to become pregnant during the study period.
Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc).
Subjects who have active chemical dependency or alcoholism as assessed by the investigator.
Subjects who have known allergies to any excipient in the study cream.
Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device on the study area within 30 days prior to study treatment initiation.

Subjects who have received any of the following within 90 days prior to study treatment initiation:

interferon or interferon inducers
cytotoxic drugs
immunomodulators or immunosuppressive therapies (inhaled/ intranasal steroids are permitted)
oral or parenteral corticosteroids
topical corticosteroids if greater than 2 mg/day
any dermatologic procedures or surgeries on the study area (including any AK treatments)
Subjects who have used any topical prescription medications on the study area within 30 days prior to study treatment initiation.
Intervention: Tobramycin
Trial phase: Phase 4
ATC code: J01GB01 | S01AA12
SMILES: NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: patients will receive hand mixed tobramycin cement

hand mixed tobramycin: hand mixed tobramycin into cement
Eligibility criteria:
Inclusion Criteria:

Age over 18
Total knee arthroplasty for primary osteoarthritis performed by Dr. Rick Wright.

Primary diagnosis of knee osteoarthritis

Exclusion Criteria:
Diminished mental capacity
Vancomycin allergy
Tobramycin allergy
Patient history requiring IV administration of vancomycin or tobramycin perioperatively
Chronic kidney disease stage III and stage IV
Intervention: Tretinoin
Trial phase: Not Applicable
ATC code: D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02
SMILES: CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 25
Group description: Tretinoin 0.05% cream 25g for 1 month, applied on the half side of the face once a day every night

Tretinoin 0.05% cream: Stieva-A Cream 0.05%, 25g, GSK
Eligibility criteria:
Inclusion Criteria:

Age: older than 19
A patient with stable non-segmental vitiligo
A patient with symmetrical vitiligo lesions on face
A patient with the willingness to comply with the study protocol during the study period and capable of complying with it.
A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages.

Exclusion Criteria:

Age: lower than 20
A pregnant or lactating patient
A patient with active or spreading vitiligo
A patient who cannot understand the study or who does not sign the informed consent
Women of childbearing potential not using an effective method of contraception properly
Intervention: Fentanyl
Trial phase: Phase 1
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)

Fentanyl: Fentanyl standard of care
Eligibility criteria:
Inclusion Criteria:

Ages 0 to <18 years at the time of enrollment.
If < 6 months postnatal age, gestational age ≥ 35 weeks.
Admitted to an intensive care unit.
Planned or anticipated mechanically ventilation for ≥2 days.
Require sedation to maintain mechanical ventilation per clinical judgment.
No contraindication to receipt of fentanyl or dexmedetomidine per clinician judgment.
Availability and willingness of the parent/legal guardian to provide written informed consent.

Exclusion Criteria:

Previous participation in this study.
Severe traumatic brain injury as the underlying etiology for critical illness requiring mechanical ventilation or baseline pediatric cerebral performance category (PCPC) >3.
Planned receipt of sedatives other than fentanyl or dexmedetomidine.
Anticipated receipt of neuromuscular blockade for >48 consecutive hours during the study period.
Receipt of fentanyl or dexmedetomidine via continuous infusion for >12 hours in the 24 hours prior to enrollment.
Extracorporeal life support (including renal replacement therapy, extracorporeal membrane oxygenation, ventricular assist device, etc.) at the time of enrollment.
Chronic use of or recent overdose of serotonergic agents (selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase (MAO) inhibitors, cyclic antidepressants)
Known pregnancy
Known liver dysfunction, defined as: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2x the upper limit of normal for age
Known or impending renal failure defined as: anuria > or equal to 12 hours prior to enrollment or requiring renal replacement therapy
High risk children, define as: a. known heart block b. known bradyarrythmia including clinically significant bradycardia (defined as requiring chronotropic agents or cardiac pacing to treat)
Receipt of mechanical ventilation during an admission for cardiac surgery

Note: receipt of drugs other than fentanyl or dexmedetomidine for intubation, and receipt of neuromuscular blockage for intubation, will not be considered exclusionary criteria.
Intervention: Fesoterodine
Trial phase: Phase 4
ATC code: G04BD11
SMILES: CC(C)C(=O)Oc1ccc(CO)cc1[C@H](CCN(C(C)C)C(C)C)c1ccccc1
Sex: Female
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: Subjects (irrespective of preference) will receive a 90-day supply of open label fesoterodine 4 mg per day. Medication will start 1 week after the baseline visit. After 2 weeks of treatment, dose may be increased to 8 mg over the telephone based on symptom report. This dosing regimen is direct alignment with clinical care. Change of prescription to another anti-cholinergic may occur during the study period, if determined necessary by the physician.

Fesoterodine: Fesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder.
Eligibility criteria:
Inclusion Criteria:

adults aged 65 or older, urinary urgency of quite a bit severity or more on the Overactive Bladder Questionnaire-Short Form (OABq-SF), eligible for pharmacologic therapy for overactive bladder

Exclusion Criteria:

predominant stress incontinence (on UDI-6), current/recent use (6 m) or contraindication to anti-cholinergic medication, severe voiding difficulties, men on 5-alpha reductase inhibitors, severe neurologic disease, recent anti-incontinence or prolapse surgery, other urinary tract conditions such as calculus or recurrent UTI.
Intervention: Acetaminophen
Trial phase: Phase 1 | Phase 2
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 17
Group description: Topical 5% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Acetaminophen: Topical acetaminophen gel
Eligibility criteria:
Inclusion Criteria:

Healthy subjects must be between 18 and 50 years of age.
Must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception.
No history of chronic itch or pain.
Must abstain from the use of any systemic or topical anti-histamine, steroid, or pain relief medications from the week prior to the study till the completion of the study.
Must abstain from the use of moisturizers on the arms 24 hours before study visits.

Exclusion Criteria:

Individuals under 18 or over 50 years of age.
Inability to complete the required measures.
The presence of an itchy skin disease.
Diagnosis of diseased that would affect itch or pain perception (e.g. neuropathies).
Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
Use of oral, topical analgesics, or other medications known to interfere with itch or pain perception in the week prior to the study and throughout the study (e.g. antihistamines, anesthetics, opioids, neuroleptics, etc.).
Use of emollients on the arms a week prior to the study and throughout the study.
Known allergies to acetaminophen and cowhage.
Pregnant women. (Women of child bearing potential will undergo an hCG pregnancy test).
Currently incarcerated.
Intervention: Acetaminophen
Trial phase: Phase 1 | Phase 2
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 17
Group description: Topical 2.5% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Acetaminophen: Topical acetaminophen gel
Eligibility criteria:
Inclusion Criteria:

Healthy subjects must be between 18 and 50 years of age.
Must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception.
No history of chronic itch or pain.
Must abstain from the use of any systemic or topical anti-histamine, steroid, or pain relief medications from the week prior to the study till the completion of the study.
Must abstain from the use of moisturizers on the arms 24 hours before study visits.

Exclusion Criteria:

Individuals under 18 or over 50 years of age.
Inability to complete the required measures.
The presence of an itchy skin disease.
Diagnosis of diseased that would affect itch or pain perception (e.g. neuropathies).
Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
Use of oral, topical analgesics, or other medications known to interfere with itch or pain perception in the week prior to the study and throughout the study (e.g. antihistamines, anesthetics, opioids, neuroleptics, etc.).
Use of emollients on the arms a week prior to the study and throughout the study.
Known allergies to acetaminophen and cowhage.
Pregnant women. (Women of child bearing potential will undergo an hCG pregnancy test).
Currently incarcerated.