anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Oseltamivir
Trial phase: Phase 1
ATC code: J05AH02
SMILES: CCOC(=O)C1=C[C@@H](OC(CC)CC)[C@H](NC(C)=O)[C@@H](N)C1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 5
Group description: Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
Eligibility criteria:
Inclusion Criteria:

infants </=12 months of age
laboratory confirmed diagnosis of influenza within 96 hours prior to first dose
influenza symptoms for </=96 hours prior to first dose

Exclusion Criteria:

preterm infants less than 40 weeks (corrected for gestational age)
weight less than 5th percentile for age (corrected for gestational age)
concurrent gastrointestinal conditions that preclude enteric absorption of the drug
bronchopulmonary dysplasia/chronic lung disease on assisted ventilation at time of enrollment
active or uncontrolled respiratory, cardiac, hepatic, CNS or renal disease at baseline
symptomatic inborn errors of metabolism
Intervention: Ezetimibe
Trial phase: Phase 4
ATC code: C10AX09 | C10BA02 | C10BA05 | C10BA06 | C10BA10 | C10BA11 | C10BA12
SMILES: [H][C@]1(CC[C@H](O)c2ccc(F)cc2)C(=O)N(c2ccc(F)cc2)[C@]1([H])c1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Participants take Ezetimibe 10mg daily for 3 months. N= 6
Eligibility criteria:
Inclusion Criteria:

Participants who meet 3 or more of the 5 criteria specified in the ATPIII guidelines will be recruited.

The 5 criteria are:

abdominal obesity (men>40 inches, women >35 inches);
TG> 150mg/dL;
low HDL-C (men < 40mg/dL, women < 50 mg/dL);
high blood pressure (>or=130/>or=85 mmHg);
fasting glucose > or = 110mg/dL.
People with different ethnic backgrounds will be included.

Exclusion Criteria:

symptomatic coronary artery disease
peripheral vascular disease
cerebral ischemia (stroke)
smoking
hypothyroidism
kidney diseases
consumption of antioxidation supplements/drugs or use of lipid-lowering drugs in the last 3 months
women who are pregnant, nursing, or planning to become pregnant
Intervention: Simvastatin
Trial phase: Phase 4
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Participants take Simvastatin 20mg daily for 3 months. N=6
Eligibility criteria:
Inclusion Criteria:

Participants who meet 3 or more of the 5 criteria specified in the ATPIII guidelines will be recruited.

The 5 criteria are:

abdominal obesity (men>40 inches, women >35 inches);
TG> 150mg/dL;
low HDL-C (men < 40mg/dL, women < 50 mg/dL);
high blood pressure (>or=130/>or=85 mmHg);
fasting glucose > or = 110mg/dL.
People with different ethnic backgrounds will be included.

Exclusion Criteria:

symptomatic coronary artery disease
peripheral vascular disease
cerebral ischemia (stroke)
smoking
hypothyroidism
kidney diseases
consumption of antioxidation supplements/drugs or use of lipid-lowering drugs in the last 3 months
women who are pregnant, nursing, or planning to become pregnant
Intervention: Vytorin
Trial phase: Phase 4
ATC code: C10BA02
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21.O=C1C(CCC(O)c2ccc(F)cc2)C(c2ccc(O)cc2)N1c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Participants take Vytorin 20/10mg daily for 3 months. N=6
Eligibility criteria:
Inclusion Criteria:

Participants who meet 3 or more of the 5 criteria specified in the ATPIII guidelines will be recruited.

The 5 criteria are:

abdominal obesity (men>40 inches, women >35 inches);
TG> 150mg/dL;
low HDL-C (men < 40mg/dL, women < 50 mg/dL);
high blood pressure (>or=130/>or=85 mmHg);
fasting glucose > or = 110mg/dL.
People with different ethnic backgrounds will be included.

Exclusion Criteria:

symptomatic coronary artery disease
peripheral vascular disease
cerebral ischemia (stroke)
smoking
hypothyroidism
kidney diseases
consumption of antioxidation supplements/drugs or use of lipid-lowering drugs in the last 3 months
women who are pregnant, nursing, or planning to become pregnant
Intervention: PF-04447943
Trial phase: Phase 1
SMILES: C[C@@H]1CN(Cc2ncccn2)C[C@H]1c1nc2c(cnn2C2CCOCC2)c(=O)[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: PF-04447943 25 mg tablet orally, twice daily from Day 1 through Day 6 and once in morning on Day 7 along with donepezil 10 mg tablet orally once daily for 7 days.
Eligibility criteria:
Inclusion Criteria:

Subjects must have Alzheimer's dementia with a Mini Mental State Examination score between 18-26, inclusive.
Subjects must have a reliable caregiver.
Subjects must be on Aricept
Memantine is allowed if subjects are on a stable dose
Subjects must be in reasonably good health, based on medical history, physical examination, vital signs, and ECG, with no serious or unstable disease within the past 3 months.

Exclusion Criteria:

Subjects with clinically significant heart disease cannot participate.
Subjects with a past or current history of seizures cannot participate.
Intervention: Brimonidine Tartrate
Trial phase: Phase 2
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12.O=C(O)C(O)C(O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: 0.5% Topical Gel
Eligibility criteria:
Inclusion Criteria:

Male or female who is at least 18 years of age.
Clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea.
CEA (clinician's erythema assessment) score greater than or equal to 3 at Screening and on Treatment visit at baseline.
PSA (patient self assessment) score of greater than or equal to 3 at Screening and on Treatment visit at baseline.
Presence of 2 or fewer inflammatory facial lesions.

Exclusion Criteria:

History of Raynaud's Syndrome, glaucoma, orthostatic hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, or depression.
History of refractive surgery such as photorefractive keratectomy.
The subject is being treated with monoamine oxidase (MAO) inhibitor, anti-depressants, barbiturates, opiates, sedatives, systemic anesthetics, alpha-agonists, beta blockers, antihypertensive agents, cardiac glycosides, or systemic anticoagulants.
The subject is currently enrolled in an investigational drug or device study or participated in such a study in the past 3 months prior to enrollment and is still in the exclusion period on the day of the Treatment visit.
Intervention: Brimonidine Tartrate
Trial phase: Phase 2
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12.O=C(O)C(O)C(O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: 0.18% Topical Gel
Eligibility criteria:
Inclusion Criteria:

Male or female who is at least 18 years of age.
Clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea.
CEA (clinician's erythema assessment) score greater than or equal to 3 at Screening and on Treatment visit at baseline.
PSA (patient self assessment) score of greater than or equal to 3 at Screening and on Treatment visit at baseline.
Presence of 2 or fewer inflammatory facial lesions.

Exclusion Criteria:

History of Raynaud's Syndrome, glaucoma, orthostatic hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, or depression.
History of refractive surgery such as photorefractive keratectomy.
The subject is being treated with monoamine oxidase (MAO) inhibitor, anti-depressants, barbiturates, opiates, sedatives, systemic anesthetics, alpha-agonists, beta blockers, antihypertensive agents, cardiac glycosides, or systemic anticoagulants.
The subject is currently enrolled in an investigational drug or device study or participated in such a study in the past 3 months prior to enrollment and is still in the exclusion period on the day of the Treatment visit.
Intervention: Brimonidine Tartrate
Trial phase: Phase 2
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12.O=C(O)C(O)C(O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: 0.07% Topical Gel
Eligibility criteria:
Inclusion Criteria:

Male or female who is at least 18 years of age.
Clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea.
CEA (clinician's erythema assessment) score greater than or equal to 3 at Screening and on Treatment visit at baseline.
PSA (patient self assessment) score of greater than or equal to 3 at Screening and on Treatment visit at baseline.
Presence of 2 or fewer inflammatory facial lesions.

Exclusion Criteria:

History of Raynaud's Syndrome, glaucoma, orthostatic hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, or depression.
History of refractive surgery such as photorefractive keratectomy.
The subject is being treated with monoamine oxidase (MAO) inhibitor, anti-depressants, barbiturates, opiates, sedatives, systemic anesthetics, alpha-agonists, beta blockers, antihypertensive agents, cardiac glycosides, or systemic anticoagulants.
The subject is currently enrolled in an investigational drug or device study or participated in such a study in the past 3 months prior to enrollment and is still in the exclusion period on the day of the Treatment visit.
Intervention: Tetomilast
Trial phase: Phase 2 | Phase 3
SMILES: CCOc1ccc(-c2nc(-c3cccc(C(=O)O)n3)cs2)cc1OCC
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 65
Group description: Oral administration of OPC-6535 25 mg once daily for 8 weeks (started from 12.5 mg for the first week and the dose was titrated to 25 mg from the second week)
Eligibility criteria:
Inclusion Criteria:

Primary lesion in either small intestine or large intestine
C-reactive protein (CRP) level above the upper limit of the normal range
Patients who have been receiving a 5-ASA formulation (oral mesalazine) at a fixed dose of 2.25 g/day or higher (not exceeding the approved dose) and at a fixed dosing regimen
Patients who have not received enteral nutrition or who have been receiving enteral nutrition at a fixed intake of 1200 kcal/day or less

Exclusion Criteria:

Patients with an uncontrolled external fistula (including anal fistula)
Patients with a history of total proctocolectomy or subtotal colectomy
Patients with short bowel syndrome
Patients with an artificial anus
Patients with serious infectious disease (intra-abdominal abscess, etc)
Patients with malignant tumor
Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the trial period
Intervention: Tetomilast
Trial phase: Phase 2 | Phase 3
SMILES: CCOc1ccc(-c2nc(-c3cccc(C(=O)O)n3)cs2)cc1OCC
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 63
Group description: Oral administration of OPC-6535 50mg once daily for 8 weeks (started from 12.5 mg for the first week and the dose was titrated to 25 mg from the second week, with further titration to 50 mg from the third week)
Eligibility criteria:
Inclusion Criteria:

Primary lesion in either small intestine or large intestine
C-reactive protein (CRP) level above the upper limit of the normal range
Patients who have been receiving a 5-ASA formulation (oral mesalazine) at a fixed dose of 2.25 g/day or higher (not exceeding the approved dose) and at a fixed dosing regimen
Patients who have not received enteral nutrition or who have been receiving enteral nutrition at a fixed intake of 1200 kcal/day or less

Exclusion Criteria:

Patients with an uncontrolled external fistula (including anal fistula)
Patients with a history of total proctocolectomy or subtotal colectomy
Patients with short bowel syndrome
Patients with an artificial anus
Patients with serious infectious disease (intra-abdominal abscess, etc)
Patients with malignant tumor
Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the trial period
Intervention: Bosentan
Trial phase: Not Applicable
ATC code: C02KX01 | G01AE10
SMILES: COc1ccccc1Oc1c(NS(=O)(=O)c2ccc(C(C)(C)C)cc2)nc(-c2ncccn2)nc1OCCO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
Eligibility criteria:
Inclusion Criteria:

At least 12 years of age
Single ventricle congenital heart disease
Require cardiac magnetic resonance imaging (MRI) for clinical purposes.

Exclusion Criteria:

< 12 years of age
Pregnancy or women who may become pregnant (sexually active and unwilling to use birth control)
Patients taking cyclosporin or glyburide
Patients with baseline liver dysfunction (aspartate aminotransferase or alanine aminotransferase > 3 times upper limit of normal)
Contraindications to MRI (including pacemakers)
Use of Bosentan within one month prior to enrollment
Intervention: Maxacalcitol
Trial phase: Phase 2
SMILES: [H]C(=C1\C[C@@]([H])(O)C[C@]([H])(O)C1=C)/C([H])=C1\CCC[C@]2(C)[C@@]([H])([C@]([H])(C)OCCC(C)(C)O)CC[C@@]12[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: 5 or 10 mcg with incremental of 2.5 mcg
Eligibility criteria:
Inclusion Criteria:

Chronic kidney disease (CKD) patients with iPTH >=300 pg/mL, adjusted calcium >=8.4 to <10.2 mg/dL, and phosphorus <=6.5 mg/dL
Patients receiving dialysis 3 times weekly for at least 3 months before informed consent was obtained and scheduled to receive the same hemodialysis during the study period
Patients using dialysate with constant concentration of calcium for 4 weeks before informed consent was obtained and receiving phosphate binder with constant dose regimen for 2 weeks before informed consent was obtained

Exclusion Criteria:

Patients taking drugs that affect iPTH, calcium, or bone metabolism
Patients with a history of allergic reaction or significant sensitivity to vitamin D
Patients who received parathyroidectomy or ethanol infusion within 1 year before informed consent was obtained
Patients with malignancy or with clinically significant hepatic disease (liver function tests more than 3 times the upper limit of normal) or with refractory hepatic disease

Patients with cardiovascular disease designated as New York Heart Association Class III or IV or with any of the following cardiovascular or cerebrovascular diseases within 6 months before informed consent was obtained:

Acute coronary syndrome (myocardial infarction or unstable angina) or acute cerebral vascular disease (cerebral infarction or cerebral hemorrhage)
Coronary arterial revascularization (such as coronary artery bypass grafting, percutaneous transluminal coronary angioplasty)
Cerebral arterial revascularization (such as cerebral aneurysm clipping, cerebral aneurysm embolization, carotid artery endarterectomy)
Arteriosclerosis obliterans with rest pain (Fontaine classification III or more severe)
Patients with severe hypertension (defined as mean resting blood pressure taken with the patient in a supine position before dialysis and at 6 dialyses sessions before informed consent was obtained: systolic >= 180 mmHg and diastolic >= 110 mmHg)
Patients with uncontrolled diabetes mellitus (defined as mean glycosylated hemoglobin >=8% for 3 months before informed consent was obtained)
Patients with a history of drug or alcohol abuse within 6 months before informed consent was obtained
Patients who require chronic use of cytochrome P450 (CYP3A) inhibitors or inducers
Patients who are taking products that contain aluminum 2 weeks before informed consent was obtained
Patients who have taken paricalcitol in the past
Intervention: Fosaprepitant Dimeglumine
Trial phase: Phase 1
SMILES: CC(OC1OCCN(Cc2nn(P(=O)(O)O)c(=O)[nH]2)C1c1ccc(F)cc1)c1cc(C(F)(F)F)cc(C(F)(F)F)c1.CNCC(O)C(O)C(O)C(O)CO.CNCC(O)C(O)C(O)C(O)CO
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: MK-0517, non-PS80 formulation, administered with a single IV administration
Eligibility criteria:
Inclusion Criteria:

Subject is neither grossly overweight nor underweight for his/her height and body build
Subject is in good health -Subject is a nonsmoker
Subject is willing to avoid excessive alcohol consumption for the duration of the study
Subject is willing to avoid strenuous physical activity (i.e. unaccustomed weight lifting, running, bicycling) for the duration of the study
Subject agrees to refrain from consumption of grapefruit (and grapefruit products) before and during the study

Exclusion Criteria:

Subject has a history of multiple and/or severe allergies to drugs or food
Subject has donated blood or taken an investigational drug in another clinical trial within the last 4 weeks
Subject has an infection, including Human immunodeficiency virus (HIV) infection
Subject is a regular user of any illicit drug
Subject consumes excessive amounts of alcohol
Subject drinks excessive amounts of coffee, tea, cola or other caffeinated beverages
Subject currently uses on a regular basis, any prescription or non prescription medications
Intervention: Alfentanil
Trial phase: Not Applicable
ATC code: N01AH02
SMILES: CCC(=O)N(c1ccccc1)C1(COC)CCN(CCn2nnn(CC)c2=O)CC1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.

Alfentanil : 15 mcg/kg IM
Eligibility criteria:
Inclusion Criteria:

Age 18-55
No active medical conditions
BMI between 20-30
Able and willing to perform/tolerate pain procedures
Able to communicate in English

Exclusion Criteria:

Lifetime substance use disorder, except for alcohol abuse/dependence in remission
Use of opiates in last 3 months
Ongoing marijuana use
Acute or chronic pain
Neurologic or psychiatric condition known to influence cold pressor testing (peripheral neuropathy, major depression, or schizophrenia)
Current use of prescribed or over the counter pain medications
Previous adverse reaction to opiate medications or diphenhydramine
Use of tobacco or caffeine on study days
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: lidocaine injection group

lidocaine: 1cc 1%
Eligibility criteria:
Inclusion Criteria:

Subjects are to have identifiable painful myofascial trigger points in the masseter, temporalis, and medial and lateral pterygoid muscles.
Subjects will be examined by the principle investigators to determine if the individual is a suitable candidate for the study, based on active trigger points and willingness to participate in the study

Exclusion Criteria:

Pregnant woman will be excluded from participation as potential risk is noted in product label indications. Individuals over the age of 65 will be excluded per product label indications that reflect lack of data in individuals over age 65.
Intervention: Risperidone
Trial phase: Phase 4
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
Eligibility criteria:
Inclusion Criteria: - Participants who will understand the objectives and necessary procedures of the study and have signed the informed consent form which specified that they were willing to participate in the study - Participants with schizophrenia or schizoaffective disorder requiring long-term antipsychotic drug therapy - Participants with pre-morbid global assessment of functioning score of 71 or higher at Screening - Participants who do not present clinically significant abnormality in biochemistry and electrocardiography - Participants who will be compliant with the study requirements (that is, filling in the questionnaire by themselves) and who are capable of actually performing and willing to implementing them

Exclusion Criteria: - Participants who had taken clozapine for the past three months - Participants with mental retardation (Intelligence Quotient less than 70 at the screening) - Participants with history of or currently with a serious disease (cardiovascular, respiratory, neurological [including seizures or significant cerebrovascular], renal, hepatic, hematologic, endocrine, immunologic or other systemic disease) including clinically relevant abnormal level - Participants who have an allergic or hypersensitive reaction to risperidone or who are unresponsive to risperidone - Pregnant or lactating female participants
Intervention: Warfarin
Trial phase: Phase 4
ATC code: B01AA03
SMILES: CC(=O)CC(c1ccccc1)c1c(O)c2ccccc2oc1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
Eligibility criteria:
Inclusion Criteria:

Prescribed warfarin for any indication, so long as they are naïve to the drug at enrollment and are expected to receive therapy for at least 12 weeks

Exclusion Criteria:

Recent cardiothoracic surgery as indication for warfarin.
Intervention: Welchol
Trial phase: Phase 2 | Phase 3
SMILES: C=CCN.C=CCNCCCCCCCCCC.C=CCNCCCCCC[N+](C)(C)C.Cl.ClCC1CO1.[Cl-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: 3.75 grams of colesevelam HCl taken at evening meal
Eligibility criteria:
Inclusion Criteria:

Male or female subjects ≥18 and ≤75 years of age
Clinical diagnosis of type 2 diabetes
Currently treated with metformin, a sulfonylurea, or combination metformin/sulfonylurea; stable dose for ≥3 months
HbA1c of 7.0-9.0% inclusive
If taking lipid lowering medications, stable dose for >30 days

Exclusion Criteria:

Taken oral or injected prednisone or cortisone medications in the previous 30 days. (Topical or inhaled steroids will not be considered excluded medications.)
Current use of insulin or TZD's, or incretins
LDL <70 mg/dL
Serum triglycerides >500 mg/dL
History of hypertriglyceridemia-induced pancreatitis
History of gastrointestinal disorder such as dysphagia, swallowing disorder, intestinal motility disorder or prior bowel obstruction
History or presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
Unable to follow the study protocol
Unable to speak, read and write in English
Pregnant, planning to become pregnant, breast feeding
Intervention: Celecoxib
Trial phase: Phase 4
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 76
Group description: Celecoxib 100 mg tablet twice a day with meal for 2 weeks
Eligibility criteria:
Inclusion Criteria:

Healthy Volunteers

Exclusion Criteria:

Endoscopic evidence of ulceration, erosion or active bleeding etc. in the esophagus, stomach, pylorus and/or duodenum prior to treatment endoscopy
A history of gastrointestinal ulcer
Any use of celecoxib, nonsteroidal anti-inflammatory drugs (including aspirin), anti-ulcer medication, antacids, systemic steroids or antibiotics within four weeks prior to the first dose of study medication