anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sevoflurane
Trial phase: Not Applicable
ATC code: N01AB08
SMILES: FCOC(C(F)(F)F)C(F)(F)F
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 67
Group description: Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
Eligibility criteria:
Inclusion Criteria:

Female patients aged between 30 and 65 years old scheduled for thyroidectomy or breast surgery for cancer

Exclusion Criteria:

Drug intake which may affect liver function
Severe cardiovascular or respiratory disease
Hepatic or renal dysfunction
Pregnancy
Alcohol and drug abuse
Body Mass Index (BMI) > 35
Intervention: Propofol
Trial phase: Not Applicable
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 67
Group description: Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.

The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated.
Eligibility criteria:
Inclusion Criteria:

Female patients aged between 30 and 65 years old scheduled for thyroidectomy or breast surgery for cancer

Exclusion Criteria:

Drug intake which may affect liver function
Severe cardiovascular or respiratory disease
Hepatic or renal dysfunction
Pregnancy
Alcohol and drug abuse
Body Mass Index (BMI) > 35
Intervention: Orvepitant
Trial phase: Phase 2
SMILES: Cc1cc(F)ccc1[C@H]1C[C@@H](N2CCN3C(=O)CC[C@H]3C2)CCN1C(=O)N(C)[C@H](C)c1cc(C(F)(F)F)cc(C(F)(F)F)c1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 69
Group description: Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Aged 18-64 years, inclusive.
A primary diagnosis of noncombat-related Post traumatic Stress Disorder (PTSD)
Subjects with symptom severity considered to be at least moderate to severe.

Exclusion Criteria:

Subjects whose symptoms are better accounted for by a diagnosis other than Post traumatic Stress Disorder (PTSD), subjects diagnosed with dementia; subjects diagnosed with a current/recent eating disorder such as anorexia nervosa or bulimia; subjects with a diagnosed history of schizophrenia, schizoaffective disorder, or Bipolar Disorder.
Subjects who have a history of failing to respond to adequate treatment for PTSD with an antidepressant/anti-anxiety drug, i..e, failure to improve following administration of at least two other antidepressants/anti-anxiety drugs, each given for at least 4 weeks.
Intervention: Bimatoprost
Trial phase: Phase 2
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
Eligibility criteria:
Inclusion Criteria:

Ocular hypertension or primary open-angle glaucoma in each eye
Patient requires IOP lowering medication in each eye

Exclusion Criteria:

Ocular hyperemia or other ocular surface findings in either eye
Active ocular disease
Current or anticipated use of any topical ocular medication (including artificial tears) during the study
Intraocular surgery within past six months or unilateral cataract surgery.
Functionally significant visual field loss
Anticipated wearing of contact lenses during study
Use of other medications that affect IOP such as glaucoma treating medications, within 2 months of screening visit
Intervention: Rizatriptan
Trial phase: Phase 3
ATC code: N02CC04
SMILES: CN(C)CCc1c[nH]c2ccc(Cn3cncn3)cc12
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 462
Group description: Participants who took any rizatriptan during the study (Stage 1 or 2)
Eligibility criteria:
Inclusion Criteria:

Patient weighs at least 20 kg (44 pounds)
Patient has had a history of migraine with or without aura > 6 months with >= 1 to <= 8 moderate or severe migraine attacks per month in the 2 months prior to screening Visit 1
Patient has a history of migraine defined by International Headache Society (IHS) migraine definitions
Patient is willing to stay awake for at least 2 hours after administration of the first dose of study medication
Patient has not experienced satisfactory relief from migraine pain with nonsteroidal anti-inflammatory drugs (NSAIDs) or N-acetyl-p-aminophenol (APAP) treatment
The parent or guardian and patient agree to the patient's participation in the study as indicated by parental/guardian signature on the consent form and

patient assent

- For patients taking migraine prophylactic medication, treatment regimen is stable and has been taken for at least 3 months prior to Visit 1.

Exclusion Criteria:

Patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of study participation
Patient has a history of mild migraine attacks or migraines that resolve in less than 2 hours
Patient has basilar or hemiplegic migraine headaches
Patient has >15 headache-days per month OR has taken medication for acute

headache on more than 10 days per month in any of the 3 months prior to screening

Patient has uncontrolled high blood pressure, uncontrolled diabetes, human immunodeficiency virus (HIV), any

cancer, or any other significant disease

Patient has a history or clinical evidence of cardiovascular problems or stroke
Patient has either demonstrated hypersensitivity to or experienced a serious

adverse event in response to rizatriptan

Patient did not experience satisfactory relief from migraine pain to prior treatment with 2 or more adequate courses of 5-hydroxytryptamine 1 (5HT1) agonists
Patient has a recent history (within the past year) or current evidence of drug or alcohol abuse or is a "recreational user" of illicit drugs
Patient is currently taking monoamine oxidase inhibitors, methysergide, selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) or propranolol, and is unable to tolerate withdrawal of these medications for the intervals required
Patient is currently participating or has participated in a study with an

investigational compound or device within 30 days of screening

- Patient is legally or mentally incapacitated.
Intervention: Propofol
Trial phase: Phase 4
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min

propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists rating of I-III
good renal and liver function

Exclusion Criteria:

renal and hepatic insufficiency
uncontrolled diabetes
uncontrolled hypertension
severe cardiac disease Class III or IV
heart blocks
chronic use of sedatives, narcotics, alcohol or illicit drugs
allergy to either propofol or dexmedetomidine
pregnancy or inability to tolerate technique of the study drugs
Intervention: Aripiprazole
Trial phase: Phase 3
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 85
Group description: Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
Eligibility criteria:
Inclusion Criteria:

Subjects with a confirmed Axis I Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia who must have completed Otsuka study 31-03-241 (NCT00102518) treatment of adolescent subjects with schizophrenia

Exclusion Criteria:

Patients with a co-morbid serious, uncontrolled systemic illness
Patients with a significant risk of committing suicide
Intervention: Lovaza
Trial phase: Phase 2
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)OCC.CCC=CCC=CCC=CCC=CCC=CCCCC(=O)OCC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Lovaza 1 gram by mouth twice a day x 24 weeks
Eligibility criteria:
Inclusion Criteria:

HIV+
Ages 18-70
HIV-1 RNA <400 copies/ml.
On stable ART (antiretroviral therapy) regimen for 12 weeks with no intent of modifying regimen, and cumulative ART before study entry of 12 mos.

Exclusion Criteria:

Active infection
Inflammation or malignancy
Uncontrolled diabetes or hypothyroidism
LDL (low density lipoprotein) cholesterol >160 and triglyceride levels >750
Framingham risk score <6.
Intervention: Ketorolac Tromethamine
Trial phase: Phase 4
SMILES: NC(CO)(CO)CO.O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 126
Group description: Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
Eligibility criteria:
Inclusion Criteria:

Subjects must be 18 years of age or older.
Scheduled for cataract surgery by phacoemulsification.
Subject must be willing to comply with all study requirements and be willing to give informed consent.

Exclusion Criteria:

Any subject that has a history of uveitis or active iritis.
Subject can have no previous eye surgery, with the exception of refractive surgery, but not within 6 months.
No ocular use of prostaglandins within 2 weeks of surgery.
Use of oral, injectable or topical ophthalmic steroids, nonsteroidal anti-inflammatory (NSAIDS) or immunosuppressants within 14 days prior to surgery.
Contraindications to NSAIDS.
Active ocular infection.
Intervention: Nepafenac
Trial phase: Phase 4
ATC code: S01BC10
SMILES: NC(=O)Cc1cccc(C(=O)c2ccccc2)c1N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 126
Group description: One day before surgery 1 drop BID, then 3 doses pre op day of surgery
Eligibility criteria:
Inclusion Criteria:

Subjects must be 18 years of age or older.
Scheduled for cataract surgery by phacoemulsification.
Subject must be willing to comply with all study requirements and be willing to give informed consent.

Exclusion Criteria:

Any subject that has a history of uveitis or active iritis.
Subject can have no previous eye surgery, with the exception of refractive surgery, but not within 6 months.
No ocular use of prostaglandins within 2 weeks of surgery.
Use of oral, injectable or topical ophthalmic steroids, nonsteroidal anti-inflammatory (NSAIDS) or immunosuppressants within 14 days prior to surgery.
Contraindications to NSAIDS.
Active ocular infection.
Intervention: Baclofen
Trial phase: Phase 4
ATC code: M03BX01
SMILES: NCC(CC(=O)O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 75
Group description: The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.

Baclofen: Baclofen 50mg per day for 12 weeks
Eligibility criteria:
Inclusion Criteria:

ICD-10 diagnosis of alcohol dependence (World Health Organization, 1993);
Seeking treatment with the aim to stop alcohol consumption;
Age ranging from 18 to 60 years;
Last alcohol intake reported in the 24 h preceding observation;
Presence of a referred family member;
Written informed consent provision.

Exclusion Criteria:.

Serious hepatic, kidney, lung, neurological and cardiovascular, diseases);
Suicide risk, acute psychosis, severe depression, organic brain syndromes;
Dependence on psychoactive substances other than nicotine.
Intervention: Rizatriptan
Trial phase: Phase 3
ATC code: N02CC04
SMILES: CN(C)CCc1c[nH]c2ccc(Cn3cncn3)cc12
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 606
Group description: Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
Eligibility criteria:
Inclusion Criteria:

Patient is between 12 and 17 years of age inclusive at screening Visit 1
Patient weighs at least 20 kg (44 pounds)
Patient has had a history of unilateral or bilateral migraine headache with or without aura >6 months with ≥1 to ≤8 mild, moderate or severe migraine attacks per month in the 2 months prior to screening Visit 1
Patient has a history of migraine defined by International Headache Society (IHS) migraine definitions
The parent or guardian and patient agree to the patient's participation in the study as indicated by parental/guardian signature on the consent form and patient assent
For patients taking migraine prophylactic medication, treatment regimen is stable and has been taken for at least 3 months prior to Visit 1

Exclusion Criteria:

Patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of study participation
Patient has a history of mild migraine attacks or migraines that resolve in less than 2 hours
Patient has basilar or hemiplegic migraine headaches
Patient has >15 headache-days per month OR has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening
Patient has uncontrolled high blood pressure, uncontrolled diabetes, human immunodeficiency virus (HIV), any cancer, or any other significant disease
Patient has a history cardiovascular problems or stroke
Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to rizatriptan
Patient has demonstrated hypersensitivity to or experienced a serious adverse event in response to 3 or more classes of drugs (over-the-counter and prescription)
Patient did not experience satisfactory relief from migraine pain to prior treatment with 2 or more adequate courses of 5-hydroxytryptamine 1 (5HT1) agonists
Patient has a recent history (within the past year) or current evidence of drug or alcohol abuse or is a "recreational user" of illicit drugs
Patient is currently taking monoamine oxidase inhibitors, methysergide, or propranolol, and is unable to tolerate withdrawal of these medications for the intervals required
Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of screening
Patient is legally or mentally incapacitated
Intervention: Simvastatin
Trial phase: Phase 2
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: 31
Group description: Once daily oral dose of 40 mg simvastatin for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Male or female subjects ≥18 years of age
Previously untreated LDL cholesterol ≥100 mg/dL and ≤180 mg/dL.
Provide written informed consent.

Exclusion Criteria:

Subjects with a medical condition requiring chronic pharmacological treatment
On direct questioning and physical examination have evidence of any clinically significant chronic disease, including known or suspected human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection.
On direct questioning and physical examination have a medical history or evidence of abuse of drugs.
Medical history of gastrointestinal bleeding or gastric or duodenal ulcer.
Systolic pressure ≥140 mmHg or diastolic pressure >89 mmHg requiring hypotensive medication.
Presence of secondary dyslipidemia.
Previous use of cholesterol lowering medication.
Previous coronary artery bypass graft (CABG).
Previous percutaneous transluminal coronary angioplasty (PTCA) with a drug-eluting stent.
Presence of severe congestive heart failure (New York Heart Classification [NYHC] III IV).
Presence of untreated or uncontrolled thyroid disease.
Past or current medical history of asthma or aspirin induced asthma
Previous hypersensitivity to ACE inhibitors (eg angioedema or cough).
Previous hypersensitivity to ARBs.
History of unstable angina.
Serum creatinine >2 mg/dL.
Creatine phosphokinase (CPK) ≥5 x the upper limit of normal (ULN).
Hemoglobin ≤12 g/dL (120 g/L) for male subjects or ≤10 g/dL (100 g/L) for female subjects.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 x ULN.
Total bilirubin ≥1.5 x ULN.
Serum triglyceride concentration ≥400 mg/dL.
Subjects not using effective contraception methods (intra uterine device [IUD] and condom or diaphragm with spermicide and condom) during the study and for at least one month thereafter.
Pregnant, lactating, breastfeeding, or intends to become pregnant during the course of the study (females only). All women must have a negative urine pregnancy test at the Screening Visit, be surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or have a postmenopausal status (no menses) for at least one year.
Contraindications to or known or suspected hypersensitivity to aspirin, simvastatin or ramipril or their excipients.
Presence of mental illness limiting the capacity for self-care.
Presence of major systemic illnesses: renal disease, liver disease, neurological or psychiatric disease.
Participation, in the 30 days preceding enrolment into the study, in any other clinical study in which investigational or marketed drugs were employed.
Intervention: Anastrozole
Trial phase: Not Applicable
ATC code: L02BG03
SMILES: CC(C)(C#N)c1cc(Cn2cncn2)cc(C(C)(C)C#N)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: 1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery.

Anastrozole: 1mg PO daily for two weeks prior to scheduled surgery
Eligibility criteria:
Inclusion Criteria:

Histologically-confirmed operable ER+ and/or PR+ invasive breast cancer or ductal carcinoma in situ (DCIS), who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment
Postmenopausal status defined as cessation of menses for >1 year or FSH > 20 mIU/mL (within the past month)
Age ≥ 21 years
No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry
Signed informed consent

Exclusion Criteria:

Treatment with other investigational drugs within 6 months of study entry
Other serious intercurrent medical illness
Intervention: Tetracaine
Trial phase: Phase 4
ATC code: C05AD02 | D04AB06 | N01BA03 | N01BA53 | S01HA03
SMILES: CCCCNc1ccc(C(=O)OCCN(C)C)cc1
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
Eligibility criteria:
Inclusion Criteria:

early labor (>=2cm but =<6cm cervical dilation)
at least 12 years of age
have an assigned ASA physical status 1 or 2
singleton pregnancy

Exclusion Criteria:

contraindications to neuraxial anesthesia
with allergies to drugs used in the study
have an assigned ASA status 3 or 4
advanced labor (> 6cm cervical dilation)
less than 12 years of age
Patients with the potential for distorted epidural anatomy, such as Harrington rods or prior back surgery, will also be excluded.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
Eligibility criteria:
Inclusion Criteria:

early labor (>=2cm but =<6cm cervical dilation)
at least 12 years of age
have an assigned ASA physical status 1 or 2
singleton pregnancy

Exclusion Criteria:

contraindications to neuraxial anesthesia
with allergies to drugs used in the study
have an assigned ASA status 3 or 4
advanced labor (> 6cm cervical dilation)
less than 12 years of age
Patients with the potential for distorted epidural anatomy, such as Harrington rods or prior back surgery, will also be excluded.
Intervention: Digoxin
Trial phase: Phase 4
ATC code: C01AA05
SMILES: [H][C@]12CC[C@]3([H])[C@]([H])(C[C@@H](O)[C@]4(C)[C@@H](C5=CC(=O)OC5)CC[C@@]43O)[C@@]1(C)CC[C@H](O[C@H]1C[C@H](O)[C@H](O[C@H]3C[C@H](O)[C@H](O[C@H]4C[C@H](O)[C@H](O)[C@@H](C)O4)[C@@H](C)O3)[C@@H](C)O1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 131
Group description: This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
Eligibility criteria:
Inclusion Criteria:

Age > 21 years
Diagnosis of heart failure secondary to left ventricular dysfunction
Receiving chronic digoxin therapy or digoxin therapy is being initiated

Exclusion Criteria:

Pregnant
Unstable renal function, defined as either a rise in serum creatinine by > 0.5mg/dl from baseline or a decrease in creatinine clearance by 25% or more within two to four weeks of study entry.
End-stage renal disease requiring hemodialysis
Concomitant therapy with drugs known to interact with digoxin (e.g., amiodarone, quinidine, verapamil, macrolide antibiotics)