anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sugammadex
Trial phase: Phase 2
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
Eligibility criteria:
Inclusion Criteria:

Participants of American Society of Anesthesiologists (ASA) class 1 - 3;
Participants at least 20 years but under 65 years of age;
Caucasian participants ;
Participants scheduled for elective surgery requiring muscle relaxation in supine position and under sevoflurane anesthesia, in need of administration of a neuromuscular blocking agent (NMBA), with an anticipated duration of about 1.5- 3 hours;
Participants who had given written informed consent. This was obtained before the investigator or the sub-investigator performed any procedures or assessments for the screening, and after the participant was informed about the nature and purpose of the study, the study procedures, and the risks and restrictions of the study.

Exclusion criteria:

Participants in whom a difficult intubation because of anatomical malformations was expected;
Participants known or suspected to have neuromuscular disorders impairing neuromuscular blockade (NMB) and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic dysfunction.
Participants known or suspected to have a (family) history of malignant hyperthermia;
Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
Participants receiving medication expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration;
Female participants who were pregnant;
Female participants of childbearing potential not using birth control or using only oral contraception as birth control;
Participants who were breast-feeding;
Participants who had already participated in CT 19.4.209B, or in another trial with sugammadex;
Participants who had participated in another clinical trial, not preapproved by Organon, within 6 months of entering into CT 19.4.209B.
Intervention: Sugammadex
Trial phase: Phase 2
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
Eligibility criteria:
Inclusion Criteria:

Participants of American Society of Anesthesiologists (ASA) class 1 - 3;
Participants at least 20 years but under 65 years of age;
Caucasian participants ;
Participants scheduled for elective surgery requiring muscle relaxation in supine position and under sevoflurane anesthesia, in need of administration of a neuromuscular blocking agent (NMBA), with an anticipated duration of about 1.5- 3 hours;
Participants who had given written informed consent. This was obtained before the investigator or the sub-investigator performed any procedures or assessments for the screening, and after the participant was informed about the nature and purpose of the study, the study procedures, and the risks and restrictions of the study.

Exclusion criteria:

Participants in whom a difficult intubation because of anatomical malformations was expected;
Participants known or suspected to have neuromuscular disorders impairing neuromuscular blockade (NMB) and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic dysfunction.
Participants known or suspected to have a (family) history of malignant hyperthermia;
Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
Participants receiving medication expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration;
Female participants who were pregnant;
Female participants of childbearing potential not using birth control or using only oral contraception as birth control;
Participants who were breast-feeding;
Participants who had already participated in CT 19.4.209B, or in another trial with sugammadex;
Participants who had participated in another clinical trial, not preapproved by Organon, within 6 months of entering into CT 19.4.209B.
Intervention: Qsymia
Trial phase: Phase 3
ATC code: A08AA51
SMILES: CC(C)(N)Cc1ccccc1.CC1(C)OC2COC3(COS(N)(=O)=O)OC(C)(C)OC3C2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 498
Group description: 7.5 mg/46 mg phentermine/topiramate
Eligibility criteria:
Inclusion Criteria:

Informed Consent
BMI ≥ 27 (no lower BMI limit for Type 2 diabetics)
70 years of age or less

Have 2 or more of the following obesity-related co-morbid conditions:

Systolic blood pressure 140-160 mmHg (130-160 if diabetic);
Diastolic blood pressure 90-100 mmHg (85-100 if diabetic);
Requirement for 2 or more medications to achieve control (<140/90 mmHg)
Triglyceride level between 200-400 mg/dL or requirement for 2 or more medications to achieve control (<200 mg/dL)

At lease one of the following metabolic criteria:

Fasting blood glucose level > 100 mg/dL
Glucose level > 140 mg/dL
Diagnosis of type 2 diabetes
Waist circumference ≥ 102 cm for men or ≥88 cm for women

Exclusion Criteria:

Stroke/MI/unstable cardiovascular disease within 6 months
Clinically significant renal, hepatic or psychiatric disease
Unstable thyroid disease or replacement therapy
Nephrolithiasis
Obesity of known genetic or endocrine origin
Participation in a formal weight loss program or lifestyle intervention
Glaucoma or intraocular pressure
Pregnancy or breastfeeding
Drug or Alcohol abuse
Smoking cessation within previous 3 months or plans to quit smoking during study
Eating disorders
Cholelithiasis within past 6 months
Excluded medications
Type 1 diabetes or use of any antidiabetic medication other than metformin
Previous bariatric surgery
Bipolar disorder or psychosis
Steroid hormone therapy
Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg
Creatinine clearance < 60 mL/minute
Intervention: Qsymia
Trial phase: Phase 3
ATC code: A08AA51
SMILES: CC(C)(N)Cc1ccccc1.CC1(C)OC2COC3(COS(N)(=O)=O)OC(C)(C)OC3C2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 994
Group description: 15 mg/92 mg phentermine/topiramate
Eligibility criteria:
Inclusion Criteria:

Informed Consent
BMI ≥ 27 (no lower BMI limit for Type 2 diabetics)
70 years of age or less

Have 2 or more of the following obesity-related co-morbid conditions:

Systolic blood pressure 140-160 mmHg (130-160 if diabetic);
Diastolic blood pressure 90-100 mmHg (85-100 if diabetic);
Requirement for 2 or more medications to achieve control (<140/90 mmHg)
Triglyceride level between 200-400 mg/dL or requirement for 2 or more medications to achieve control (<200 mg/dL)

At lease one of the following metabolic criteria:

Fasting blood glucose level > 100 mg/dL
Glucose level > 140 mg/dL
Diagnosis of type 2 diabetes
Waist circumference ≥ 102 cm for men or ≥88 cm for women

Exclusion Criteria:

Stroke/MI/unstable cardiovascular disease within 6 months
Clinically significant renal, hepatic or psychiatric disease
Unstable thyroid disease or replacement therapy
Nephrolithiasis
Obesity of known genetic or endocrine origin
Participation in a formal weight loss program or lifestyle intervention
Glaucoma or intraocular pressure
Pregnancy or breastfeeding
Drug or Alcohol abuse
Smoking cessation within previous 3 months or plans to quit smoking during study
Eating disorders
Cholelithiasis within past 6 months
Excluded medications
Type 1 diabetes or use of any antidiabetic medication other than metformin
Previous bariatric surgery
Bipolar disorder or psychosis
Steroid hormone therapy
Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg
Creatinine clearance < 60 mL/minute
Intervention: Qsymia
Trial phase: Phase 3
ATC code: A08AA51
SMILES: CC(C)(N)Cc1ccccc1.CC1(C)OC2COC3(COS(N)(=O)=O)OC(C)(C)OC3C2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 240
Group description: PHEN/TPM 3.75/23
Eligibility criteria:
Inclusion Criteria:

Body mass index (BMI) ≥ 35 kg/m2
Informed consent
70 years of age or less
Triglyceride level ≤ 200 mg/dL with treatment of 0 or 1 medications
Blood pressure of ≤ 140/90 mmHg with treatment of 0-2 medications for hypertension
Fasting blood glucose level of ≤ 110 mg/dL

Exclusion Criteria:

Stroke/myocardial infarction (MI)/unstable cardiovascular disease within 6 months
Clinically significant renal, hepatic or psychiatric disease
Unstable thyroid disease or replacement therapy
Nephrolithiasis
Obesity of known genetic or endocrine origin
Participation in a formal weight loss program or lifestyle intervention
History of glaucoma or intraocular pressure
Pregnancy or breastfeeding
Alcohol abuse
Smoking cessation within previous 3 months or plans to quit smoking during study
Eating disorders
Cholelithiasis within past 6 months
Excluded medications
Type 2 diabetes
Previous bariatric surgery
History of bipolar disorder or psychosis
Intervention: Qsymia
Trial phase: Phase 3
ATC code: A08AA51
SMILES: CC(C)(N)Cc1ccccc1.CC1(C)OC2COC3(COS(N)(=O)=O)OC(C)(C)OC3C2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 511
Group description: PHEN/TPM 15/92
Eligibility criteria:
Inclusion Criteria:

Body mass index (BMI) ≥ 35 kg/m2
Informed consent
70 years of age or less
Triglyceride level ≤ 200 mg/dL with treatment of 0 or 1 medications
Blood pressure of ≤ 140/90 mmHg with treatment of 0-2 medications for hypertension
Fasting blood glucose level of ≤ 110 mg/dL

Exclusion Criteria:

Stroke/myocardial infarction (MI)/unstable cardiovascular disease within 6 months
Clinically significant renal, hepatic or psychiatric disease
Unstable thyroid disease or replacement therapy
Nephrolithiasis
Obesity of known genetic or endocrine origin
Participation in a formal weight loss program or lifestyle intervention
History of glaucoma or intraocular pressure
Pregnancy or breastfeeding
Alcohol abuse
Smoking cessation within previous 3 months or plans to quit smoking during study
Eating disorders
Cholelithiasis within past 6 months
Excluded medications
Type 2 diabetes
Previous bariatric surgery
History of bipolar disorder or psychosis
Intervention: Ambrisentan
Trial phase: Phase 3
ATC code: C02KX02 | C02KX52
SMILES: COC(c1ccccc1)(c1ccccc1)[C@H](Oc1nc(C)cc(C)n1)C(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
Eligibility criteria:
Inclusion Criteria:

Subjects who complete the 24-week administration of the Phase II/III study (Study No.AMB107816)
Subjects who are assessed that the long-term extension administration of GSK1325760A is appropriate in the judgement of the investigator or subinvestigator
Subjects who request the long-term extension administration of GSK1325760A, and agree to newly sign the informed consent form

Exclusion Criteria:

Subjects who have been withdrawn from the Phase II/III study.
Female subjects who wish to become pregnant.
Treatment with other PAH medication is needed.
A worsening of 2 or more levels of the WHO Functional Classification (see Appendix 2.1) comparing with the baseline of Phase II/III study (Study No.AMB107816).
Worsening of right ventricular failure (e.g. as indicated by increased jugular venous pressure, new/worsened hepatomegaly, ascites, or peripheral edema) during Phase II/III study (Study No.AMB107816).
Rapidly progressing cardiac, hepatic or renal failure during Phase II/III study (Study No.AMB107816).
Participation to the long-term extension study is considered as inappropriate in the judgment of the investigator or subinvestigator.
Intervention: Varenicline
Trial phase: Phase 2
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Subjects randomized to receive active drug (varenicline) will have the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
Eligibility criteria:
Inclusion Criteria:

Age 18-64
Regular ten cigarette per day smoker for one year
Nicotine Dependency Score greater than or equal to four
DSM-IV Diagnosis of Schizophrenia or Schizoaffective disorder
Psychiatric medication regimen unchanged for at least 90 days
Psychiatric medication dosage unchanged for at least 30 days

Exclusion Criteria:

Psychiatric hospitalization in last 6 months
Meets criteria for current Major Depressive Disorder or has a score of greater than 10 on the Calgary Depression Scale (see withdrawal criteria)
Suicide or homicide ideation with a plan in the last six months
Life time history of suicide attempt
Has had a diagnosis of Schizophrenia or Schizoaffective disorder for less than three years
Current treatment with Bupropion SR
DSM-IV diagnosis of alcohol or substance dependence within last 6 months*
DSM-IV diagnosis of alcohol or substance abuse within three months *
Pregnancy or lactation in females (+HCG)
Use of tobacco product other than cigarettes
Use of nicotine replacements
Unstable or serious medical condition in last 6 months
Regular use of cimetidine (OTC or Rx) *Substance abuse/dependency exclusions do not apply to abuse of or dependence on nicotine.
Intervention: Oseltamivir
Trial phase: Not Applicable
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 | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 194
Group description: Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:

for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)
Eligibility criteria:
Inclusion criteria:

Outpatient or inpatient encounter for acute respiratory illness less than 5 days (120 hours) duration.
Acute respiratory illness with feverishness OR cough.
Access to the internet or telephone at home. This is required because symptom severity reports will be submitted twice daily using either a secure web-based form or automated telephone entry. All phones in the Marshfield area have touchtone service, allowing automated data entry.

Exclusion criteria:

Institutional resident (including assisted living or skilled nursing facility).
Self-reported chronic liver or kidney disease. These conditions are listed as precautions in the oseltamivir manufacturer package insert (www.rocheusa.com/products/tamiflu/pi.pdf).
Pregnancy or breast-feeding. Oseltamivir is classified as pregnancy category C, and it is excreted in breast milk. The package insert states that the drug should be used only if the potential benefit justifies the potential risk to the fetus or breast-fed infant.
Prior hypersensitivity reaction to oseltamivir.
Dementia, impaired communication, or other reason for inability to provide informed consent.
Immunocompromised status, including HIV infection, neutropenia, systemic corticosteroid use, or use of other immunosuppressive drugs in the past 30 days. The manufacturer states that the efficacy of oseltamivir has not been established in immunocompromised patients.
Patient received 1 or more doses of influenza antiviral agents (oseltamivir, zanamivir, amantadine, rimantadine) or a prescription for one of these drugs prior to randomization.
Intervention: Telapristone acetate
Trial phase: Phase 2
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Proellex 25 mg: 1 capsule daily for 4 months
Eligibility criteria:
Inclusion Criteria:

Premenopausal women aged 18-48 inclusive
Endometriosis documented by laparoscopic or surgical assessment within the past ten (10) years
Clinical symptoms of endometriosis for at least the past three (3) months
Endometriosis symptoms
Must be sexually active unless sexually inactive for endometriosis-related dyspareunia
Must have a regular or steady menstrual cycle lasting from 24 to 36 days and a detectable ovulation during the baseline period using an ovulation monitoring kit (for timing of endometrial biopsy)
Other inclusion criteria may apply

Exclusion Criteria:

Six (6) months or more without a menstrual period, or
Prior hysterectomy or
Prior bilateral oophorectomy
Diagnosis of osteopenia
Present history or condition that causes non-endometriosis-related dyspareunia
Presence of excessive bleeding or menorrhagia
Abnormal screening endometrial biopsy
Other exclusion criteria may apply
Intervention: Minocycline
Trial phase: Not Applicable
ATC code: A01AB23 | D10AF07 | J01AA08 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)ccc(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
Eligibility criteria:
Inclusion Criteria:

Age over 18 years
planned CABG or valvular surgery with cardiopulmonary bypass
Serum creatinine available (within 30 days)
Estimated GFR 15-90ml/min using the abbreviated MDRD formula (CKD stages 2-4)

Exclusion Criteria:

Emergent or urgent surgery (to be performed within the next 36 hours)
End stage renal disease, or GFR < 15ml/min (CKD stage 5)
Estimated GFR>90ml/min (CKD stage 1 or no CKD)
Ongoing infection by positive blood, urine or sputum cultures or pneumonia on CXR
Allergy to minocycline or tetracyclines
inability to take oral medications
use of preoperative vasopressor agents at therapeutic doses
Pregnant or lactating females
Advanced liver disease by history or exam(cirrhosis, ascitis, jaundice)
Rising creatinine meeting the definition of acute kidney injury prior to surgery
Neurologic signs or symptoms or history of increased intracranial pressure
current participation in another research study involving an investigational drug or device
Intervention: Tenofovir Disoproxil Fumarate(TDF)
Trial phase: Phase 3
SMILES: CC(C)OC(=O)OCOP(=O)(COCC(C)n1cnc2c(N)ncnc21)OCOC(=O)OC(C)C.O=C(O)C=CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1584
Group description: TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
Eligibility criteria:
Inclusion Criteria for HIV-1 uninfected partner:

Partner within an HIV-1 discordant heterosexual relationship
One partner meets study eligibility for HIV-1 uninfected study participant and the other partner meets study eligibility criteria for HIV-1 infected participant
Plan to remain in the relationship for the duration of the study period
Adequate renal, hepatic & hematologic function
Negative Hepatitis B surface antigen test
Willing and able to provide written informed consent & locator information

Exclusion Criteria for HIV-1 uninfected partner:

Current pregnancy, or planning to become pregnant during the study period
Currently breastfeeding
Concurrent enrollment in another HIV-1 vaccine or prevention trial
Receiving ongoing antiretroviral therapy
Repeated positive urine dipstick tests for glycosuria or proteinuria
Active and serious infections
History of pathological bone fractures not related to trauma

Inclusion Criteria for HIV-1 infected partner:

Partner within an HIV-1 discordant heterosexual relationship
One partner meets study eligibility for HIV-1 uninfected study participant and the other partner meets study eligibility criteria for HIV-1 infected participant
HIV-1 infected based on positive EIA
No history of any clinical AIDS-defining diagnoses
Plan to remain in the relationship for the duration of the study period
Willing and able to provide written informed consent & locator information

Exclusion Criteria for HIV-1 infected partner:

Current use of antiretroviral therapy
Concurrent enrollment in another HIV-1 treatment trial
Intervention: Montelukast
Trial phase: Phase 4
ATC code: R03DC03 | R03DC53
SMILES: CC(C)(O)c1ccccc1CC[C@@H](SCC1(CC(=O)O)CC1)c1cccc(/C=C/c2ccc3ccc(Cl)cc3n2)c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 20
Group description: Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
Eligibility criteria:
Inclusion Criteria:

Mild to moderate atopic dermatitis involving greater than or equal to 5% of body surface
Total severity score of 2 or greater for any 3 of the 4 signs and symptoms calculated by study doctor (erythema, papulation, or lichenification)
Positive skin or (radioallergosorbent) RAST tests by ImmunoCap to food or environmental allergens
GI symptoms total score of 2 by caregiver on GSRS scale revised for pediatrics

Exclusion Criteria:

Participants with intolerance or allergy to montelukast.
History of anaphylaxis requiring hospitalization.
No underlying renal or liver disease.
Participants with a diagnosis of severe asthma.
Participants diagnosed with primary immune deficiency.
Participants using sublingual immunotherapy.
Immunotherapy must be a maintenance dose for a minimum of 30 days.
If on gastrointestinal medication, 30 day stable dose before visit 1 and maintained throughout the study.
Intervention: Omeprazole
Trial phase: Phase 4
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: 40 mg daily for 14 weeks
Eligibility criteria:
Inclusion Criteria:

Subject is age ≥ 18 years
Patient meets the criteria for laparoscopic gastric bypass surgery
Females only: Patient is willing to take a urine pregnancy test

Exclusion Criteria:

Subject allergic to omeprazole or famotidine
Patient receiving antifungal (i.e. ketoconazole or itraconazole)
Hepatic insufficiency
History of Crohns disease
History of Zollinger-Ellison disease
Patient received an investigational drug within 30 days of enrollment
Patient currently enrolled in another research project
Females Only: Pregnancy or plan on becoming pregnant during the next 14 weeks