anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tretinoin
Trial phase: Phase 3
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: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 404
Group description: Tretinoin: Topical skin
Eligibility criteria:
A subject will be eligible to participate if they meet all of the following inclusion criteria:

Normal, healthy male and female children and adults.
Age 12 to 40 years.
Written and verbal informed consent must be obtained. Subjects age 12 to 17 (inclusive) must sign an assent for the study and a parent or a legal guardian must sign the informed consent (per FDA letter 8.21.07).
Women of child-bearing potential must be non-pregnant and non-nursing, and must be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study, adequate contraception is defined as regular use of any two of the following: oral, injectable contraceptives, condoms, spermicides, diaphragm, IUD, implantable and contraceptive patches. (oral contraceptives if used for at least three months and injectable contraceptives if used for at least 6 months)- prior to enrollment in the study, or abstinence.
Have at least 20 inflammatory (papules and pustules) and 25 non-inflammatory (open and closed comedones) lesions with a maximum of 2 nodulocystic lesions on the face (per FDA letter 8.21.07).
Global severity score from 2-4
Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period.
Considered reliable and capable of understanding their responsibility and role in the study.

Exclusion Criteria

A subject will be eligible to participate if they meet none of the following exclusion criteria:

Subjects with active cystic acne as evidenced by more than 2 facial nodules.
More than 40 papules and/or pustules (inflammatory lesions)
More than 60 open and or closed comedones/milia (non-inflammatory lesions)
Overall severity grade of less than 2 or greater than 4,
History of allergy or hypersensitivity to tretinoin.
Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease
Use of systemic retinoid treatment within six months prior to study initiation.
Oral contraceptives should not be started or changed within 3 months prior to study initiation or planned to change during the study.
Pregnant or breast-feeding.
Participation in a clinical study for acne within 4 months preceding study initiation.
Intervention: Latanoprost
Trial phase: Phase 4
ATC code: S01EE01 | S01EE51
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of primary open-angle glaucoma that has never been treated
Visual Acuity 20/60 or better in each eye

Exclusion Criteria:

Eye surgery within 3 months
Any refractive eye surgery
Contraindication to beta-adrenoceptor antagonist therapy (eg, chronic obstructive pulmonary disease [COPD], bronchial asthma, sinus bradycardia, heart block, history of severe myocardial infarction [heart attack])
Eye inflammation or eye infection within 3 months
Eye trauma within 6 months
Oral, injectable, or topical ophthalmic steroids within 21 days or anticipated use during study
Intervention: Morphine sulfate pentahydrate
Trial phase: Phase 4
SMILES: CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O.O.O.O.O.O=S(=O)(O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 171
Group description: 0.1 mg/kg morphine IM
Eligibility criteria:
Inclusion Criteria:

bilateral myringotomy

Exclusion Criteria:

ASA greater than 2
history of bleeding disorder/thrombocytopenia
history of allergy to morphine or fentanyl
Intervention: Latanoprost
Trial phase: Phase 4
ATC code: S01EE01 | S01EE51
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of ocular hypertension or open-angle glaucoma in at least 1 eye requiring treatment with an anti-glaucoma/ocular hypertensive medication
Best corrected visual acuity score of 20/100 or better in both eyes
Females on birth control pills must be on same type of pill and dose for at least 3 month

Exclusion Criteria:

Use of Lumigan® 0.01%/Lumigan® RC, Lumigan®, Travatan® or Travatan Z® within 6 months
History of or active ocular infection/inflammation (eg, uveitis)
Punctal plug use
Required use of ocular medications during the study other than study medication (intermittent use of certain types artificial tears acceptable)
Intraocular surgery or glaucoma laser surgery in study eye(s) within 3 months
History of corneal refractive laser surgery (eg, LASIK, LASEK) in study eye(s)
Planned contact lens wear during study
Intervention: Tafluprost
Trial phase: Phase 3
ATC code: S01EE05
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/C(F)(F)COc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 93
Group description: One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
Eligibility criteria:
Inclusion Criteria:

Participant has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension
Has been using ocular hypotensive medication on a stable treatment regimen for at least 30 days prior to screening, or is treatment-naive (has never used or has not used ocular hypotensive medication for the last 4 weeks prior to screening)
Able to discontinue all topical and/or systemic ocular hypotensive medication during the washout period (up to 4 weeks pre-study)
Best-corrected early treatment of diabetic retinopathy study (ETDRS) visual acuity of 20/80 or better in each eye
Willing and able to avoid wearing contact lenses from 4 weeks prior to dosing with study medication through 24 hours after final dosing
Willing and able to self-administer or has an able person available on a daily basis to assist with administration of study medications
Participant with reproductive potential must agree to remain abstinent (unless abstinence is not a locally acceptable method of contraception) or use highly effective methods of birth control (hormonal contraceptives, intrauterine device, diaphragm, condoms and vasectomy) within the projected duration of the study
Able to refrigerate study drug at home.

Exclusion Criteria:

Mean IOP >36 mmHg in either eye at screening
Unable to use study medication in the affected eye(s)
History of any inflammatory ocular surface disease or a history of anterior or posterior uveitis in either eye within 6 months prior to screening
History of retinal detachment, proliferative diabetic retinopathy, or any progressive retinal disease
Significant visual field loss or evidence of progressive visual loss within the last year
Intraocular surgery in either eye in the last 4 months
Any glaucoma surgery, refractive surgery, or penetrating keratoplasty in either eye
Currently on two or more anti-glaucoma medications (except Cosopt™ or its generic formulation)
Previously used tafluprost
History of cardiovascular disorder within 6 months of screening
History of bronchial asthma, wheezing, chronic obstructive pulmonary disease (COPD) or other pulmonary disease, abnormal chest x-ray, or has current active pneumonia.
Intervention: Iopromide
Trial phase: Phase 4
ATC code: V08AB05
SMILES: COCC(=O)Nc1c(I)c(C(=O)NCC(O)CO)c(I)c(C(=O)N(C)CC(O)CO)c1I
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 159
Group description: Patients were IV injected with a single dose of iopromide before a coronary CT angiography

iopromide: Single IV injection
Eligibility criteria:
Inclusion Criteria:

Male or female adult patient (having reached legal majority age)
Symptomatic patient suspected for coronary artery disease scheduled for a coronary CT angiography

Exclusion Criteria:

Patient with a heart rate > 65 beats per minute (bpm) and contraindication or intolerance to b-blocker administration
Patient with arrhythmia or non-sinus rhythm
Patient with decompensated heart failure
Patient with evidence of ongoing or active clinical instability (suspected or known acute myocardial infarction, cardiac shock, acute pulmonary oedema)
Patient who has previously undergone coronary artery bypass graft
Patient who has previously undergone percutaneous transluminal coronary stent placement
Patient with artificial heart valve
Patient with known moderate to severe aortic stenosis
Intervention: Nepadutant
Trial phase: Phase 2
SMILES: CC(=O)NC1C(NC(=O)CC2NC(=O)C(CC(C)C)NC(=O)C3CNC(=O)CC(NC2=O)C(=O)NC(Cc2c[nH]c4ccccc24)C(=O)NC(Cc2ccccc2)C(=O)N3)OC(CO)C(O)C1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 40
Group description: Nepadutant oral solution: Oral administration once daily for 7 days
Eligibility criteria:
Inclusion Criteria:

Healthy infants with diagnosis of infant colic according to the following modified Wessel criterion "paroxysm of irritability, fussing or crying that start and stop without obvious cause for >3h/day, >3 days/week for one week"
Age > 4 weeks and < 20 weeks
Infants breast-fed mixed fed or formula fed with a stable dietary regimen
Normal growth
History of no adequate response to conventional treatment alternatives which make the infants in need of medical treatment
Willingness to refrain from use of antimuscarinic drugs, simethicone, dimethicone or antiacids during the study period.

Exclusion Criteria:

Clinical evidence of allergies or other diseases which may cause crying and/or fussiness or may interfere with absorption or clearance of the drug.
Suspect of gastroesophageal reflux disease (GERD)
Suspect of cow milk allergy.
Intervention: Nepadutant
Trial phase: Phase 2
SMILES: CC(=O)NC1C(NC(=O)CC2NC(=O)C(CC(C)C)NC(=O)C3CNC(=O)CC(NC2=O)C(=O)NC(Cc2c[nH]c4ccccc24)C(=O)NC(Cc2ccccc2)C(=O)N3)OC(CO)C(O)C1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 38
Group description: Nepadutant oral solution: Oral administration once daily for 7 days
Eligibility criteria:
Inclusion Criteria:

Healthy infants with diagnosis of infant colic according to the following modified Wessel criterion "paroxysm of irritability, fussing or crying that start and stop without obvious cause for >3h/day, >3 days/week for one week"
Age > 4 weeks and < 20 weeks
Infants breast-fed mixed fed or formula fed with a stable dietary regimen
Normal growth
History of no adequate response to conventional treatment alternatives which make the infants in need of medical treatment
Willingness to refrain from use of antimuscarinic drugs, simethicone, dimethicone or antiacids during the study period.

Exclusion Criteria:

Clinical evidence of allergies or other diseases which may cause crying and/or fussiness or may interfere with absorption or clearance of the drug.
Suspect of gastroesophageal reflux disease (GERD)
Suspect of cow milk allergy.
Intervention: Ivacaftor
Trial phase: Phase 2
ATC code: R07AX02 | R07AX30 | R07AX31 | R07AX32
SMILES: CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
Eligibility criteria:
Inclusion Criteria:

Male or female subjects with confirmed diagnosis of CF
Must have the G551D-CFTR mutation in at least 1 allele
FEV1 >90% of predicted normal for age, gender, and height

Exclusion Criteria:

Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within the 30 days prior to screening
Use of inhaled hypertonic saline treatment within 2 weeks of the Period 1, Day 1 visit
Intervention: Ribavirin
Trial phase: Not Applicable
ATC code: J05AP01
SMILES: NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: This will be a single institution non-randomized study for patients with tonsil and/or base of tongue squamous cell cancer. This is a pilot study to obtain pharmacodynamic data regarding the effects of ribavirin on tonsil squamous cell cancer.

ribavirin: The clinical intervention in this study is ribavirin therapy for approximately 14 days. Ribavirin 800 mg/day is administered in divided doses, 400 mg PO qAM and 400 mg PO qPM.
Eligibility criteria:
Inclusion Criteria:

Prior diagnostic surgical or core needle biopsy, with confirmation of tonsil and/or base of tongue squamous cell carcinoma that is positive for expression of p16 and phosphorylated eIF4E, as determined by the Department of Pathology at MSKCC. The biopsy may be either of the tonsil base of tongue and/or an involved neck node. 2 unstained slides and/or tissue block must be available from the initial diagnostic biopsy
Positive expression p16 and phosphorylated eIF4E is defined as >=30% of tumor cells with cytological and/or nuclear staining
Age ≥ 18 and ≤ 65 years of age
Karnofsky Performance Status ≥ 80
Adequate organ function, as follows:

Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 X 109/L, platelets ≥ 160 X 109/L, hemoglobin ≥ 12 g/dL Hepatic: total bilirubin within 1.5 X upper limit of normal (ULN) ; alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 X ULN (Patients with Gilbert's syndrome as the cause of hyperbilirubinemia may be eligible if total bilirubin ≤ 2.5 X UNL) Renal: Serum creatinine ≤ 1.3 mg/dL. Patients with serum creatinine > 1.3 mg/dL may be eligible if creatinine clearance (CrCl) ≥ 55 mL/min based on the standard Cockroft and Gault formula.

Patients of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. Patients must agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.
Ability to swallow oral medication.
Non-surgical patients: If primary radiation +/- chemotherapy (concurrent or sequential) is planned, patients must agree to undergo research biopsy after completion of ribavirin treatment.

Exclusion Criteria:

Prior chemotherapy or radiation for tonsillar or base of tongue squamous cell cancer
More than 10 pack-years of tobacco use
History of hemolytic anemia or thalassemia
Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment.
Current therapeutic anticoagulation with Coumadin (warfarin)
Current or prior treatment with ribavirin
Known active Hepatitis B or C
Any prior documented history of transient ischemic attack (TIA) or cerebrovascular accident (CVA)
New York Heart Association (NYHA) Grade II or greater congestive heart failure
Clinically significant peripheral vascular disease
History of unstable angina or myocardial infarction (MI) within the last 3 years
Intervention: Fentanyl
Trial phase: Phase 3
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Subject will receive FBT and placebo at a low dose

Fentanyl: Fentanyl buccal tablet 100 mcg once
Eligibility criteria:
Inclusion Criteria:

pain sufficient to warrant medication stronger than acetaminophen (Tylenol) or aspirin
only if Emergency Department provider approves
a negative pregnancy test is required for participation for women of childbearing age

Exclusion Criteria:

If treating provider determines intravenous analgesia is required
allergy to acetaminophen or any opiate/opioid, or lansoprazole patients currently taking phenothiazines, CNS depressants (including alcohol), or if they have taken an monoamine oxidase inhibitor (MAOI) or selective serotonin reuptake inhibitor (SSRI) in the past two weeks
if patient has already been administered an opioid analgesic for their current injury
patients on chronic opioids therapy or a history of opioid abuse
breastfeeding mothers
patients who plan to drive home after their emergency department visit
history of phenylketonuria (due to phenylalanine in the formulation of the lansoprazole solutab)
Intervention: Fentanyl
Trial phase: Phase 3
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Subject will receive the high dose regimen of FBT and a high dose placebo

Fentanyl: Fentanyl buccal tablet 200 mcg once
Eligibility criteria:
Inclusion Criteria:

pain sufficient to warrant medication stronger than acetaminophen (Tylenol) or aspirin
only if Emergency Department provider approves
a negative pregnancy test is required for participation for women of childbearing age

Exclusion Criteria:

If treating provider determines intravenous analgesia is required
allergy to acetaminophen or any opiate/opioid, or lansoprazole patients currently taking phenothiazines, CNS depressants (including alcohol), or if they have taken an monoamine oxidase inhibitor (MAOI) or selective serotonin reuptake inhibitor (SSRI) in the past two weeks
if patient has already been administered an opioid analgesic for their current injury
patients on chronic opioids therapy or a history of opioid abuse
breastfeeding mothers
patients who plan to drive home after their emergency department visit
history of phenylketonuria (due to phenylalanine in the formulation of the lansoprazole solutab)
Intervention: Tadalafil
Trial phase: Phase 4
ATC code: C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51
SMILES: [H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Tadalafil: Active drug will be encapsulated to look identical to the placebo pill. Subjects will take a single oral dose of tadalafil once daily from the time of randomization until the surgical date (~4 weeks). Subjects will begin by taking 20 mg (1 pill) daily for 3 days before having the dose increased to 40 mg (2 pills) once daily. If the increase to 40mg daily is not tolerated, then the dose will be decreased back to 20mg daily.
Eligibility criteria:
Inclusion Criteria:

Patients with severe aortic stenosis (AVA < 1.0 cm2)
Left ventricular hypertrophy
EF ≥ 45%
NYHA functional class ≥ 2
Ambulatory (able to perform a 6 minute walk test)
Normal sinus rhythm
18 years of age and older
Able and willing to comply with all the requirements for the study

Exclusion Criteria:

Need for ongoing nitrate medications
SBP < 110mmHg or MAP < 75mmHg
Moderately severe or severe mitral regurgitation
Moderately severe or severe aortic regurgitation
Creatinine clearance < 30 mL/min
Increased risk of priapism
Retinal or optic nerve problems or unexplained visual disturbance
If a subject requires ongoing use of an alpha antagonist typically used for benign prostatic hyperplasia (BPH) (prazosin, terazosin, doxazosin, or tamsulosin), SBP < 120 mmHg or MAP < 80 mmHg is excluded
Need for ongoing use of a potent CYP3A inhibitor or inducer (ritonavir, ketoconazole, itraconazole, rifampin)
Cirrhosis
Pulmonary fibrosis
Current or recent (≤ 30 days) acute coronary syndrome
O2 sat < 90% on room air
Females that are pregnant or believe they may be pregnant
Any condition which the PI determines will place the subject at increased risk or is likely to yield unreliable data
Unwilling to provide informed consent
Intervention: Tadalafil
Trial phase: Phase 4
ATC code: C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51
SMILES: [H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Tadalafil: Active drug will be encapsulated to look identical to the placebo pill. Subjects will take a single oral dose of tadalafil once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 20 mg (1 pill) daily for 3 days before having the dose increased to 40 mg (2 pills) once daily. If the increase to 40mg daily is not tolerated, then the dose will be decreased back to 20mg daily.
Eligibility criteria:
Inclusion Criteria:

Patients with moderate to severe aortic stenosis (AVA < 1.5 cm2)
Left ventricular hypertrophy
Diastolic dysfunction as evidenced by tissue Doppler e' (average of septal and lateral) ≤ 7 cm/s
EF ≥ 50%
None or minimal symptoms related to aortic stenosis (NYHA ≤ 2)
The subject and treating physician are not planning on a valve replacement procedure to occur during the next 6 months
Ambulatory
Normal sinus rhythm
18 years of age and older
Able and willing to comply with all the requirements for the study

Exclusion Criteria:

Need for ongoing nitrate medications
SBP < 110mmHg or MAP < 75mmHg
Moderately severe or severe mitral regurgitation
Moderately severe or severe aortic regurgitation
Contraindication to MRI
Creatinine clearance < 30 mL/min
Cirrhosis
Pulmonary fibrosis
Increased risk of priapism
Retinal or optic nerve problems or unexplained visual disturbance
If a subject requires ongoing use of an alpha antagonist typically used for benign prostatic hyperplasia (BPH) (prazosin, terazosin, doxazosin, or tamsulosin), SBP < 120 mmHg or MAP < 80 mmHg is excluded
Need for ongoing use of a potent CYP3A inhibitor or inducer (ritonavir, ketoconazole, itraconazole, rifampin)
Current or recent (≤ 30 days) acute coronary syndrome
O2 sat < 90% on room air
Females that are pregnant or believe they may be pregnant
Any condition which the PI determines will place the subject at increased risk or is likely to yield unreliable data
Unwilling to provide informed consent