anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ledipasvir
Trial phase: Phase 3
ATC code: J05AP51
SMILES: COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 215
Group description: LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Age > 18, with chronic genotype 1 HCV infection
HCV treatment-naive
HCV RNA > 10,000 IU/mL at screening
Screening laboratory values within defined thresholds
Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

Pregnant or nursing female or male with pregnant female partner
Presence of cirrhosis
Coinfection with HIV or hepatitis B virus (HBV)
Current or prior history of clinical hepatic decompensation
Chronic use of systemic immunosuppressive agents
History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
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: 66
Group description: Prescribe Omeprazole.

Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast).
Eligibility criteria:
Inclusion Criteria:

met the ROME III criteria for FD;
education level no lower than high school;
Hospital Anxiety and Depression Scale (HADS) score > 8 respectively;
absence of abnormalities in physical examination, laboratory tests (including a routine blood test, blood glucose, and liver function examination), abdominal ultrasonography and upper GI endoscopy within 6 months;
absence of H. pylori infection

Exclusion Criteria:

known allergy to omeprazole, flupenthixol or melitracen;
any evidence of organic digestive diseases;
reflux-related symptoms only (e.g., retrosternal pain, burning and regurgitation) or predominantly reflux-related symptoms;
severe psychological symptoms that affected life and work;
pregnancy or breastfeeding;
recent myocardial infarction or cardiac arrhythmias;
previous gastric surgery;
use of PPIs, psychoactive drugs or other drugs that might affect gastric function within 6 months
Intervention: Dabigatran
Trial phase: Not Applicable
SMILES: Cn1c(CNc2ccc(C(=N)N)cc2)nc2cc(C(=O)N(CCC(=O)O)c3ccccn3)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Dabigatran 150mg tablets
Eligibility criteria:
Inclusion Criteria:

Patients with known CAD
On maintenance treatment with aspirin (81 to 325mg per day) and clopidogrel (75 mg per day) for at least for at least 4-weeks as per standard of care.
Age between 18 and 80 years old.

Exclusion Criteria:

Transient ischemic attack or ischemic stroke in the past 6 months.
Prior hemorrhagic stroke (irrespective of timing).
Known allergies to dabigatran.
On treatment with Coumadin derivate or have an indication to be on Coumadin treatment (atrial fibrillation, prosthetic valve, DVT/pulmonary embolism).
Platelet count <80x106/mL
Active bleeding or hemodynamic instability.
Creatinine clearance <30 mL/minute.
Baseline ALT >2.5 times the upper limit of normal.
Hemoglobin < 10 gm/dL
Pregnant females*. *Women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study.
Intervention: Prasugrel
Trial phase: Not Applicable
ATC code: B01AC22
SMILES: CC(=O)Oc1cc2c(s1)CCN(C(C(=O)C1CC1)c1ccccc1F)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: Prasugrel 60mg loading dose and 10 mg maintenance dose
Eligibility criteria:
Inclusion Criteria:

Patients with known coronary artery disease
On maintenance treatment with aspirin (81 mg per day) and clopidogrel (75 mg per day) for at least 1-month as per standard of care.
Age between 18 and 74 years old.

Exclusion Criteria:

History of stroke, transient ischemic attack or intracranial bleeding.
Known allergies to aspirin, prasugrel, ticagrelor, or clopidogrel.
Weight <60kg
On treatment with oral anticoagulation (coumarin derivate, dabigatran).
Hemoglobin<10 gm/dL
Platelet count <80x106/mL
Active bleeding or hemodynamic instability.
Creatinine Clearance <30 mL/minute.
Baseline ALT >2.5 times the upper limit of normal.
Patients with sick sinus syndrome (SSS) or high degree AV block without pacemaker protection.
Drugs interfering with 2C19 metabolism (to avoid interaction with clopidogrel): , fluconazole (Diflucan), ketoconazole (Nizoral), voriconazole (VFEND), etravirine (Intelence), felbamate (Felbatol), fluoxetine (Prozac, Serafem, Symbyax), fluvoxamine (Luvox), and ticlopidine (Ticlid).
Drugs interfering CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromizycin.
Pregnant females*. *Women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study.
Intervention: Ticagrelor
Trial phase: Not Applicable
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: Ticagrelor 180mg loading dose and 90mg bid maintenance dose
Eligibility criteria:
Inclusion Criteria:

Patients with known coronary artery disease
On maintenance treatment with aspirin (81 mg per day) and clopidogrel (75 mg per day) for at least 1-month as per standard of care.
Age between 18 and 74 years old.

Exclusion Criteria:

History of stroke, transient ischemic attack or intracranial bleeding.
Known allergies to aspirin, prasugrel, ticagrelor, or clopidogrel.
Weight <60kg
On treatment with oral anticoagulation (coumarin derivate, dabigatran).
Hemoglobin<10 gm/dL
Platelet count <80x106/mL
Active bleeding or hemodynamic instability.
Creatinine Clearance <30 mL/minute.
Baseline ALT >2.5 times the upper limit of normal.
Patients with sick sinus syndrome (SSS) or high degree AV block without pacemaker protection.
Drugs interfering with 2C19 metabolism (to avoid interaction with clopidogrel): , fluconazole (Diflucan), ketoconazole (Nizoral), voriconazole (VFEND), etravirine (Intelence), felbamate (Felbatol), fluoxetine (Prozac, Serafem, Symbyax), fluvoxamine (Luvox), and ticlopidine (Ticlid).
Drugs interfering CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromizycin.
Pregnant females*. *Women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study.
Intervention: Duloxetine
Trial phase: Phase 4
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.

At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.

Administration will be as a single a.m. dose.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of dysthymic disorder (SCID and DSM-IV)
Age 60 - 95
Mini-Mental State Score ≥ 24
24-item Hamilton Rating Scale for Depression score 12-25
Willing and capable of giving informed consent

Exclusion Criteria:

Current major depressive episode (SCID and DSM-IV)
Alcohol or substance dependence during the last year (SCID and DSM-IV)
Bipolar disorder, schizophrenia and other psychotic disorders(SCID and DSM-IV)
Clinical stroke, dementia, Huntington's disease, epilepsy or other major neurological disease
Acute unstable medical conditions
Active suicidal ideation or plan
Non-response to duloxetine (minimum 90 mg/day for 6 weeks) during the past year
A positive urine drug screen for substances of abuse or dependence
Sensitivity with intolerability to duloxetine
Use of other medications that may interact with duloxetine, including inhibitors of cytochrome P450 1A2 (CYP1A2) and cytochrome P450 2D6 (CYP2D6), e.g., quinolone antibiotics and type 1-C anti-arrhythmics. Several antidepressant medications, including most SSRIs, are inhibitors of CYP2D6 but these medications are not permitted during this antidepressant treatment trial.
Patients with hypertension (BP >140/90 mm Hg on 2 consecutive measurements). For patients with treated hypertension and BP >140/90, written approval must be obtained from patient's internist allowing them to participate in this study.
Known liver damage or disease
Intervention: BECLOMETHASONE DIPROPIONATE
Trial phase: Phase 4
ATC code: A07EA07 | D07AC15 | D07CC04 | R01AD01 | R03AK08 | R03AK13 | R03AL09 | R03BA01
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 39
Group description: QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment

QNASL
Eligibility criteria:
Inclusion Criteria:

Males and females between 18 and 55 years of age.
Two year history of seasonal allergic rhinitis.
Positive skin test to grass and/or tree antigen.

Exclusion Criteria:

Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
Pregnant or lactating women.
Subjects treated with systemic steroids during the previous 30 days.
Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 30 days.
Subjects treated with oral antihistamine/decongestants during the previous seven days.
Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days.
Subjects treated with immunotherapy and are escalating their dose.
Subjects on chronic anti-asthma medications.
Subjects with polyps in the nose or a significantly displaced septum.
Upper respiratory infection within 14 days prior to study start.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.

Liposomal Injection Bupivacaine (Exparel)
Eligibility criteria:
Inclusion Criteria:

adult men and women
scheduled for abdominoplasty

Exclusion Criteria:

pregnant women
patients with allergy to amide-type local anesthetics
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.

Standard bupivicaine
Eligibility criteria:
Inclusion Criteria:

adult men and women
scheduled for abdominoplasty

Exclusion Criteria:

pregnant women
patients with allergy to amide-type local anesthetics
Intervention: LOTEPREDNOL ETABONATE
Trial phase: Phase 4
ATC code: S01BA14
SMILES: [H][C@@]12CC[C@](OC(=O)OCC)(C(=O)OCCl)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 167
Group description: Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months

loteprednol etabonate 0.5% gel
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age
Male or female patient who had endothelial keratoplasty procedure within the past 1 to 7 weeks
Patient is able and willing to administer eye drops
Patient is able to comprehend and has signed the Informed Consent form.
Patient is likely to complete the one-year course of the study

Exclusion Criteria:

A history of a previous rejection episode in the study eye
A patient exhibiting intraocular inflammation
A patient with a known sensitivity to any of the ingredients in the study medications
A patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
A patient with abnormal eyelid function.
A patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis.
Presence of any ocular disease that would interfere with the evaluation of the study treatment. However, patients with a history of cystoid macular edema, age-related macular degeneration, controlled glaucoma, corneal neovascularization, and other non-interfering comorbidities may be enrolled.
A patient with a history of non-compliance with using prescribed medication.
A patient who is concurrently involved in or participated in another randomized clinical trial within 30 days prior to enrollment in this study.
Patients who are pregnant or planning to become pregnant within the duration of the study
Intervention: PREDNISOLONE ACETATE
Trial phase: Phase 4
SMILES: CC(=O)OCC(=O)C1(O)CCC2C3CCC4=CC(=O)C=CC4(C)C3C(O)CC21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 167
Group description: Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months

prednisolone acetate 1%
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age
Male or female patient who had endothelial keratoplasty procedure within the past 1 to 7 weeks
Patient is able and willing to administer eye drops
Patient is able to comprehend and has signed the Informed Consent form.
Patient is likely to complete the one-year course of the study

Exclusion Criteria:

A history of a previous rejection episode in the study eye
A patient exhibiting intraocular inflammation
A patient with a known sensitivity to any of the ingredients in the study medications
A patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
A patient with abnormal eyelid function.
A patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis.
Presence of any ocular disease that would interfere with the evaluation of the study treatment. However, patients with a history of cystoid macular edema, age-related macular degeneration, controlled glaucoma, corneal neovascularization, and other non-interfering comorbidities may be enrolled.
A patient with a history of non-compliance with using prescribed medication.
A patient who is concurrently involved in or participated in another randomized clinical trial within 30 days prior to enrollment in this study.
Patients who are pregnant or planning to become pregnant within the duration of the study
Intervention: Zosyn
Trial phase: Phase 3
SMILES: CC1(Cn2ccnn2)C(C(=O)O)N2C(=O)CC2S1(=O)=O.CCN1CCN(C(=O)NC(C(=O)NC2C(=O)N3C2SC(C)(C)C3C(=O)[O-])c2ccccc2)C(=O)C1=O.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: 4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
Eligibility criteria:
Key Inclusion Criteria:

Participant has received mechanical ventilation for > 48 hours
Acute Physiology and Chronic Health Evaluation (APACHE) II score of 11-35
Presence of a new or progressive infiltrate on chest x-ray
Presence of clinical criteria consistent with VAP

Key Exclusion Criteria:

History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics
Known end stage renal disease or requirement for dialysis
Intervention: Aprepitant
Trial phase: Not Applicable
ATC code: A04AD12
SMILES: C[C@@H](O[C@H]1OCCN(Cc2n[nH]c(=O)[nH]2)[C@H]1c1ccc(F)cc1)c1cc(C(F)(F)F)cc(C(F)(F)F)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: aprepitant 125 mg taken orally
Eligibility criteria:
Inclusion Criteria:

male or female patient 50 years of age or older
a diagnosis of COPD; former smoker with a history of greater than or equal to 10 pack-years
a clinical diagnosis of chronic bronchitis (productive cough on most days for a minimum of three months per year for at least two successive years)
a post-bronchodilator forced expiratory volume in one second (FEV1) greater than or equal to 30% predicted and less than or equal to 80% predicted
a post-bronchodilator FEV1/forced vital capacity (FVC) ratio less than 70%; and clinically stable COPD.

Exclusion Criteria:

current smoker
pregnant women
current or previous (within the past two weeks) use or of a narcotic medication
any patient who has a concomitant disease that might interfere with study procedures or evaluation including lactose intolerance
use of a drug that may cause possible drug interaction with aprepitant [including cilostazol, dofetilide, ergot alkaloids, oral or non-oral contraceptives, progestins, ranolazine, reboxetine, warfarin, ziprasidone, anxiolytic medications, anti-depressive medications, cholesterol lowering drugs (e.g., atorvastatin, simvastatin), theophylline, antifungal antibiotics, and macrolide antibiotics]
use of a contraindicated medication including astemizole, cisapride, pimozide, and terfenadine;
use of angiotensin converting enzyme inhibitor
Intervention: Capsaicin
Trial phase: Phase 1 | Phase 2
ATC code: M02AB01 | M02AB02 | N01BX04
SMILES: COc1cc(CNC(=O)CCCC/C=C/C(C)C)ccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 25
Group description: Single treatment consisting of healthy adults.

Healthy adults received capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. The participant received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants had a minute in between each presentation and water will be available at all times.
Eligibility criteria:
Inclusion Criteria:

Healthy adults between the ages of 18-80 years.
Ability to provide informed consent.

Exclusion Criteria:

No history of smoking within the last 5 years as this reduces the sensitivity to capsaicin
No history of neurological disease (i.e. Parkinson's disease, stroke, traumatic brain injury, etc.)
No known allergy to capsaicin
No history of respiratory disease (i.e. asthma, chronic obstructive pulmonary disease, or respiratory infection within the last 5 weeks.)
Intervention: Bivalirudin
Trial phase: Phase 3
ATC code: B01AE06
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(=O)O)NC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H]1CCCN1C(=O)[C@H](N)Cc1ccccc1)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 510
Group description: GFF MDI 14.4/9.6 mcg administered as two puffs BID
Eligibility criteria:
Key Inclusion Criteria:

Male or female subjects at least 40 years of age and no older than 80 at Visit 1.
Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
Subjects with FEV1/FVC ratio of <0.70 and FEV1 <80% predicted normal and ≥750 mL if FEV1 <30% of predicted normal value.
Subjects willing and, in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol

Key Exclusion Criteria:

Significant diseases other than COPD, i.e. disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study
Current diagnosis of asthma or alpha-1 antitrypsin deficiency
Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea
Hospitalized due to poorly controlled COPD within 3 months prior to screening or during the Screening Period
Poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to screening or during the Screening Period
Lower respiratory tract infections that required antibiotics within 6 weeks prior to screening or during the Screening Period
Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of enrollment.
Recent history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft within the past three months
Congestive heart failure (CHF NYHA Class III/IV)
Clinically significant abnormal 12-lead ECG
Abnormal liver function tests defined as AST, ALT, or total bilirubin ≥ 1.5 times upper limit of normal at Visit 1 and on repeat testing
Cancer not in complete remission for at least five years
History of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, lactose/milk protein or any component of the MDI

Other protocol-defined inclusion/exclusion criteria may apply