anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Bisacodyl
Trial phase: Not Applicable
ATC code: A06AB02 | A06AB52 | A06AG02
SMILES: CC(=O)Oc1ccc(C(c2ccc(OC(C)=O)cc2)c2ccccn2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 72
Group description: Docusate, Miralax, Metamucil wafers, Bisacodyl suppository

Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID
Eligibility criteria:
Inclusion Criteria:

Planning to be admitted to the hospital to undergo minimally-invasive urogynecologic surgery at Strong Memorial Hospital.

Procedures may include:

robot-assisted laparoscopic sacrocolpopexy
sacrospinous ligament suspension
uterosacral ligament suspension/paravaginal defect repair
colpocleisis
cystocele repair

Additional procedures may include:

hysterectomy
adnexectomy
culdoplasty
minimally invasive sling procedure (TVT or TOT)
periurethral collagen injections
enterocele repair

Exclusion Criteria:

Planning to undergo laparotomy.
Undergoing rectocele or perineocele repair as part of surgery.
Taking Miralax, laxatives, enemas, or suppositories daily, at the time of enrollment.
Presence of a colostomy.
Chronic kidney disease
Insulin-dependent diabetes mellitus
Known cardiac disease
Gastric ulcers
Difficulty swallowing or esophageal stricture
Persistent nausea and vomiting
Signs and symptoms consistent with bowel obstruction
Intervention: Norethindrone and ethinyl estradiol
Trial phase: Phase 3
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3CCC21C.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
Eligibility criteria:
Inclusion Criteria:

Adult patients with child bearing potential, 18-44 years of age.
Rheumatoid arthritis (RA) for over 6 months duration.
On oral contraceptive without interruption for at least 3 months with normal cycle control.
Treatment with disease-modifying anth-rheumatic drugs (DMARD) for at least 12 weeks prior to study start.
Body weight < 150 kg.

Exclusion Criteria:

Functional class IV rheumatoid arthritis (American College of Rheumatology [ACR] classification).
History of amenorrhea (unrelated to pregnancy).
History or current inflammatory joint disease other than RA.
Rheumatic autoimmune disease other than RA.
Intervention: Nebivolol Hydrochloride
Trial phase: Not Applicable
SMILES: Cl.OC(CNCC(O)C1CCc2cc(F)ccc2O1)C1CCc2cc(F)ccc2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Nebivolol 5 mg capsule

Nebivolol 5 mg: Nebivolol 5mg single oral dose
Eligibility criteria:
Inclusion Criteria:

Male or female and aged 18 years or over.
Clinical diagnosis of orthostatic hypotension associated with Primary Autonomic Failure (Parkinson Disease, Multiple System Atrophy and Pure Autonomic Failure).
A documented fall in systolic blood pressure of at least 20 mmHg, or in diastolic blood pressure of at least 10 mmHg, within 3 minutes after standing.
Supine hypertension, defined as a systolic blood pressure >150 mm Hg or diastolic blood pressure > 90 mm Hg.
Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care.

Exclusion Criteria:

Have changed dose, frequency and or type of prescribed medication, within two weeks of study start.
Women of childbearing potential who are not using a medically accepted contraception.
Have, in the investigator's opinion, any significant cardiac, systemic, hepatic, or renal illness.
Diabetes mellitus or insipidus.
In the investigator's opinion, have clinically significant abnormalities on clinical examination or laboratory testing.
In the investigator's opinion, are unable to adequately co-operate because of individual or family situation.
In the investigator's opinion, are suffering from a mental disorder that interferes with the diagnosis and/or with the conduct of the study, e.g. schizophrenia, major depression, dementia.
Are not able or willing to comply with the study requirements for the duration of the study.
Persons on drugs with beta-blocking potential (e.g., amiodarone), persons taking scheduled or as needed nitrates and persons on drugs with alpha-blocking potential (e.g. tamsulosin).
Intervention: Hydrochlorothiazide
Trial phase: Not Applicable
ATC code: C03AA03 | C03AB03 | C03AX01 | C03EA01 | C09BX03 | C09DX01 | C09DX03 | C09DX06 | C09DX07 | C09DX08 | C09XA52 | C09XA54 | G01AE10
SMILES: NS(=O)(=O)c1cc2c(cc1Cl)NCNS2(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Metoprolol tartrate 50 mg single oral dose

metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose
Eligibility criteria:
Inclusion Criteria:

Male or female and aged 18 years or over.
Clinical diagnosis of orthostatic hypotension associated with Primary Autonomic Failure (Parkinson Disease, Multiple System Atrophy and Pure Autonomic Failure).
A documented fall in systolic blood pressure of at least 20 mmHg, or in diastolic blood pressure of at least 10 mmHg, within 3 minutes after standing.
Supine hypertension, defined as a systolic blood pressure >150 mm Hg or diastolic blood pressure > 90 mm Hg.
Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care.

Exclusion Criteria:

Have changed dose, frequency and or type of prescribed medication, within two weeks of study start.
Women of childbearing potential who are not using a medically accepted contraception.
Have, in the investigator's opinion, any significant cardiac, systemic, hepatic, or renal illness.
Diabetes mellitus or insipidus.
In the investigator's opinion, have clinically significant abnormalities on clinical examination or laboratory testing.
In the investigator's opinion, are unable to adequately co-operate because of individual or family situation.
In the investigator's opinion, are suffering from a mental disorder that interferes with the diagnosis and/or with the conduct of the study, e.g. schizophrenia, major depression, dementia.
Are not able or willing to comply with the study requirements for the duration of the study.
Persons on drugs with beta-blocking potential (e.g., amiodarone), persons taking scheduled or as needed nitrates and persons on drugs with alpha-blocking potential (e.g. tamsulosin).
Intervention: Raltegravir
Trial phase: Not Applicable
ATC code: J05AJ01 | J05AR16 | J05AX08
SMILES: Cc1nnc(C(=O)NC(C)(C)c2nc(C(=O)NCc3ccc(F)cc3)c(O)c(=O)n2C)o1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Single arm study:

Tenofovir containing nucleoside backbone changed over to raltegravir in all patients
Eligibility criteria:
Inclusion Criteria:

Documented HIV infection
Ability to comply to protocol requirements
On stable HAART for minimum of 12 weeks
Evidence of TDF induced proteinuria
No evidence of prior Protease inhibitor failure
Treatment-naïve to integrase inhibitors
VL<200 x 12 weeks (minimum of 2 viral load measurements)

Exclusion Criteria:

Active Hepatitis B infection
Proteinuria predating tenofovir use
PRAMs on historic GT or PT
Life expectancy less than 6 months
Subjects with any ongoing AIDS defining illness
Any condition which could compromise the safety of study subject
Grade 3 or 4 lab abnormalities (excl. grade 3 bilirubin elevations)
Intervention: Lansoprazole
Trial phase: Phase 1
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 12
Group description: Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
Eligibility criteria:
Inclusion Criteria:

Must have a body weight within the 5th through 95th percentile by age, inclusive, as determined by the National Center for Health Statistics .
Females of childbearing potential must not be nursing, must have a negative serum pregnancy test at the Screening Visit and on Day -1, and if sexually active agree to routinely use adequate contraception from Screening and throughout the duration of the study.
Subjects who take prescription or non-prescription proton pump inhibitors (PPI), histamine receptor antagonists (except cimetidine), sucralfate, or antacids on a regular or as required basis must agree to discontinue usage on Day -1 and agree to discontinue use throughout the study.
Must have a history of GERD symptoms for at least 2 months prior to Screening or is currently symptomatic, as determined by the investigator.
Must be able to swallow study drug capsule or must be able to ingest study drug granules sprinkled on 1 tablespoon of applesauce.

Exclusion Criteria:

Has evidence of current cardiovascular, central nervous system, pulmonary, endocrine disease, hepatic, hematopoietic, renal, or metabolic dysfunction, serious allergy, asthma, or allergic skin rash.
Has a known hypersensitivity to any PPI or any component of the formulation of dexlansoprazole capsules.
Is taking any other prescription (except birth control) or nonprescription medication (including cimetidine), vitamins, or dietary supplements within 10 days prior to Day 1, or has taken herbal over-the-counter medications within 28 days prior to Day 1.
Has a positive test result for hepatitis B surface antigen or hepatitis C virus antibody.
Has donated or lost greater than 10% of the total blood volume, undergone plasmapheresis, or has had a transfusion of any blood product within 90 days prior to the first dose of study drug.
Has a history of alcohol abuse or illegal drug use or drug abuse in the past, or tests positive for alcohol or drugs of abuse at the initial Screening Visit or Day -1 or is unwilling to agree to abstain from alcohol and drugs throughout the study.
Has used a product containing nicotine within 90 days prior to the first dose of study drug or has a positive cotinine screen at the initial Screening Visit or Day -1 or is unwilling to agree to abstain throughout the study.
Is determined to be a Cytochrome P450 2C19 poor metabolizer (ie, genotyped homozygous non-wild-type).
Intervention: Lansoprazole
Trial phase: Phase 1
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 12
Group description: Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
Eligibility criteria:
Inclusion Criteria:

Must have a body weight within the 5th through 95th percentile by age, inclusive, as determined by the National Center for Health Statistics .
Females of childbearing potential must not be nursing, must have a negative serum pregnancy test at the Screening Visit and on Day -1, and if sexually active agree to routinely use adequate contraception from Screening and throughout the duration of the study.
Subjects who take prescription or non-prescription proton pump inhibitors (PPI), histamine receptor antagonists (except cimetidine), sucralfate, or antacids on a regular or as required basis must agree to discontinue usage on Day -1 and agree to discontinue use throughout the study.
Must have a history of GERD symptoms for at least 2 months prior to Screening or is currently symptomatic, as determined by the investigator.
Must be able to swallow study drug capsule or must be able to ingest study drug granules sprinkled on 1 tablespoon of applesauce.

Exclusion Criteria:

Has evidence of current cardiovascular, central nervous system, pulmonary, endocrine disease, hepatic, hematopoietic, renal, or metabolic dysfunction, serious allergy, asthma, or allergic skin rash.
Has a known hypersensitivity to any PPI or any component of the formulation of dexlansoprazole capsules.
Is taking any other prescription (except birth control) or nonprescription medication (including cimetidine), vitamins, or dietary supplements within 10 days prior to Day 1, or has taken herbal over-the-counter medications within 28 days prior to Day 1.
Has a positive test result for hepatitis B surface antigen or hepatitis C virus antibody.
Has donated or lost greater than 10% of the total blood volume, undergone plasmapheresis, or has had a transfusion of any blood product within 90 days prior to the first dose of study drug.
Has a history of alcohol abuse or illegal drug use or drug abuse in the past, or tests positive for alcohol or drugs of abuse at the initial Screening Visit or Day -1 or is unwilling to agree to abstain from alcohol and drugs throughout the study.
Has used a product containing nicotine within 90 days prior to the first dose of study drug or has a positive cotinine screen at the initial Screening Visit or Day -1 or is unwilling to agree to abstain throughout the study.
Is determined to be a Cytochrome P450 2C19 poor metabolizer (ie, genotyped homozygous non-wild-type).
Intervention: Propofol
Trial phase: Not Applicable
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Is an alkylphenol, is primarily indicated for use as a general anesthetic and has minimal analgesic properties.

Propofol: For propofol, the current study will employ the Marsh parameters, with an initial effect site target concentration of 1.0 mcg/ml, a level likely to produce only mild sedation. Though our patient population is expected to be predominantly obese, a previous pharmacokinetic study has validated that constant infusions utilizing the dosing scheme of mcg-1•kg-1•min will yield similar effect site concentrations.25 The effect site target will be increased in increments approximately every five minutes until the pharmacodynamic targets defined in the study are attained.
Eligibility criteria:
Inclusion Criteria:

Patients with mild or no Sleep disorder breathing
Patients with moderate to severe Sleep disorder breathing

Exclusion Criteria:

No unstable medical conditions
Anatomic pathology of airway
Pregnancy or nursing
Inability to fit an anesthesia facemask
Excessive alcohol or drug abuse
Bleeding abnormalities
Claustrophobia
Intervention: Basaglar
Trial phase: Phase 3
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NCC(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 261
Group description: Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
Eligibility criteria:
Inclusion Criteria:

For MAIN period (NN5401-3590):
Diagnosis of type 2 diabetes mellitus for at least 6 months
Insulin naïve subjects
Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start
Glycosylated haemoglobin (HbA1c) between 7.5 - 11.0% (both inclusive)
Body Mass Index (BMI) no higher than 40.0 kg/m^2
For EXTENSION period (NN5401-3726):
Informed consent obtained before any trial-related activities
Must have completed the 26-week treatment period (visit 28) in trial NN5401-3590

Exclusion Criteria:

For MAIN period (NN5401-3590):
Treatment with glucagon like peptide-1 (GLP-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start
Cardiovascular disease diagnosed within 6 months before trial start
For EXTENSION period (NN5401-3726):
Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, Monoamine oxidase (MAO) inhibitors
Anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Intervention: Caspofungin
Trial phase: Phase 2
ATC code: J02AX04
SMILES: CCC(C)CC(C)CCCCCCCCC(=O)NC1CC(O)C(NCCN)NC(=O)C2C(O)CCN2C(=O)C(C(O)CCN)NC(=O)C(C(O)C(O)c2ccc(O)cc2)NC(=O)C2CC(O)CN2C(=O)C(C(C)O)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
Eligibility criteria:
Inclusion Criteria:

Hospitalization for a minimum of 3 days in an ICU and expectation to stay in the ICU for at least another 48 hours
Meets the following high-risk criteria: Requires mechanical ventilation at the time of study entry; and has a central venous catheter in place at the time of study entry; and is receiving broad spectrum antibiotics at the time of study entry; AND meets at least one of the following criteria: Required parenteral nutrition during the current ICU admission; or required renal dialysis during the current ICU admission; or had major surgery during or within the 7 days before the current ICU admission; or was diagnosed with pancreatitis during or within the 7 days before the current ICU admission; or required systemic steroids or other immunosuppressive agents during or within the 7 days before the current ICU admission
Meets at least one of the following criteria of suspected infection at the time of study entry or within the 24 hours before study entry: Temperature ≥38° C or ≤36° C (oral equivalent); or hypotension (systolic blood pressure of <90 mm Hg) or significant drop in blood pressure (40 mm Hg) from the participant's normal baseline; or elevated white blood cell count of ≥12,000/mm^3
Candida is growing in at least one non-sterile culture site collected during the current ICU admission
Female of childbearing potential has a negative serum or urine pregnancy test before enrollment

Exclusion Criteria:

Females pregnant or breast feeding
History of allergy, hypersensitivity, or any serious reaction to caspofungin or another member of the echinocandin class (e.g., micafungin, anidulafungin)
Neutropenia or expected to develop neutropenia during study therapy
Diagnosis of acquired immune deficiency syndrome (AIDS), aplastic anemia, or chronic granulomatous disease
Diagnosis of moderate or severe hepatic insufficiency
Patient not expected to survive at least 24 hours
Received systemic (IV or oral) antifungal therapy within 10 days before study entry
Active diagnosis of proven or probable invasive fungal infection (IFI)
Currently on or has received an investigational agent within 10 days before study entry
Any condition or concomitant illness which might confuse the study results or pose additional risk in administering the study therapy
Intervention: Sitagliptin
Trial phase: Phase 3
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 228
Group description: Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes (diagnosed clinically) for at least 6 months
Ongoing treatment with 1 or 2 of the following OADs (metformin, insulin secretagogue (sulphonylurea or glinides) or pioglitazone) in any combination with unchanged dosing for at least 3 months prior to Visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination)1500 mg or maximum tolerated dose (at least 1000 mg daily) -Insulin secretagogue (sulfonylurea or glinide): minimum half of the maximal daily dose according to local labelling -Pioglitazone: minimum half of the maximal daily dose according to local labelling or maximum tolerated dose
Body Mass Index (BMI) below or equal to 40.0 kg/m^2
HbA1c 7.5-11.0 % (both inclusive) by central laboratory analysis

Exclusion Criteria:

Use within the last 3 months prior to Visit 1 of: exenatide, liraglutide, rosiglitazone or acarbose
Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
Cancer and medical history hereof (except basal cell skin cancer or squamous cell skin cancer)
Intervention: Guaifenesin
Trial phase: Phase 2
ATC code: R05CA03
SMILES: COc1ccccc1OCC(O)CO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 188
Group description: 2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
Eligibility criteria:
Inclusion Criteria:

common cold symptoms
meet symptom severity
females of child-bearing potential must have negative pregnancy test and use effective birth control

Exclusion Criteria:

chronic respiratory conditions
significant heart, kidney, liver, or lung disease, uncontrolled hypertension or diabetes, cystic fibrosis, thyroid disorder
pregnant or lactating
known malignancy
participation in any other clinical trial within 30 days of baseline
related to another enrolled patient or persons involved directly or indirectly with the conduct of this study