anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tadalafil
Trial phase: Phase 3
ATC code: C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51
SMILES: [H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
Eligibility criteria:
Inclusion Criteria

Present with benign prostatic hyperplasia
Provide signed informed consent at the screening
Agree not to use other treatment for Benign Prostatic Hyperplasia, Erectile Dysfunction or Overactive Bladder (including herbal treatments) during the study

Exclusion Criteria

Have prostatic cancer or are being treated for cancer.
Any condition that may negatively influence the transrectal ultrasound.
Are being treated for heart disease with any drug that is called a nitrate (for example, nitroglycerin).
Any evidence of moderate to severe cardiac disease
Have had any of the following in the past 90 days: chest pain (called unstable angina or angina) that requires treatment, heart attack also known as myocardial infarction, heart bypass surgery (called coronary artery bypass graft surgery), had a procedure to open up blood vessels in the heart know as angioplasty or stent placement (percutaneous coronary intervention), positive cardiac stress test without effective cardiac intervention.
Have very high or very low blood pressure.
Have uncontrolled diabetes.
Have certain problems with your kidneys, liver, or nervous system.
Intervention: Vortioxetine
Trial phase: Phase 3
ATC code: N06AX26
SMILES: Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1073
Group description: Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
Eligibility criteria:
Inclusion Criteria:

Has completed either study LuAA21004_315 ( NCT01153009), LuAA21004_316 (NCT01163266), or LuAA21004_317 (NCT01179516) immediately prior to enrollment in the extension study (ie, the baseline visit is the same visit as the Week 8 [Lu AA21004_317] or Week 10 [Lu AA21004_315 or Lu AA21004_316] assessment of the preceding protocol).
Suffers from a recurrent major depressive episode) as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.3x) at entry into the prior study.
Twelve-month continuation treatment with Lu AA21004 is indicated for the treatment of this participant according to the opinion of the investigator.
Females of childbearing potential who are sexually active with a nonsterilized male partner agree to routinely use adequate contraception throughout the duration of the study.

Exclusion Criteria:

Has Major Depressive Disorder for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia, or any psychotic disorder) have been diagnosed during the prior study.
In the investigator's clinical judgment, has a significant risk of suicide and/or a score of ≥5 points on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale (MADRS).
In the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
Has a clinically significant moderate or severe ongoing adverse event related to study medication from the prior study.
Has used/uses disallowed concomitant medication.
Intervention: Latanoprost
Trial phase: Phase 4
ATC code: S01EE01 | S01EE51
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 150
Group description: Latanoprost

One drop in the conjunctival sac of each eye in the evening
Eligibility criteria:
Inclusion Criteria:

Written informed consent.

Association of the 4 following criteria:

- Bilateral primary open angle glaucoma or bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day),
- With local intolerance signs.

Exclusion Criteria:

Presence of severe objective ocular sign.
Any ocular hypertension other than primary ocular hypertension or primary chronic open angle glaucoma (such as congenital, angle closure glaucoma, secondary glaucoma).
Absolute defect in the ten degrees central point of the visual field.
Best far corrected visual acuity ≤ 1/10.
Intervention: Tobramycin
Trial phase: Phase 3
ATC code: J01GB01 | S01AA12
SMILES: NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 286
Group description: Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
Eligibility criteria:
Inclusion Criteria:

Age ≥ one day of life and ≤ 18 years
Purulent bacterial conjunctivitis
Intervention: Latanoprost
Trial phase: Phase 3
ATC code: S01EE01 | S01EE51
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 213
Group description: One drop of T2345

T2345: One drop of T2345 at 9.00pm.
Eligibility criteria:
Inclusion Criteria:

Adult patients diagnosed with glaucoma

Exclusion Criteria:

Under 18.
Intervention: Hydrocortisone
Trial phase: Not Applicable
ATC code: A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 2
Group description: Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
Eligibility criteria:
Inclusion Criteria:

Infant born at gestational age less than 34 weeks
Birth weight less than 2500 grams
Diagnosis of stage II or III NEC made by attending neonatologist, neonatology fellow, or pediatric hospitalist
Legally authorized representative is able to provide written informed consent prior to the performance of an protocol-specified evaluations or procedures
Consent can be obtained and study drug can be administered within 6 hours of diagnosis

Exclusion Criteria:

congenital gastrointestinal anomaly
subject is already receiving parenteral steroid therapy or subject has received parenteral steroids within one week prior to study entry
subject has received indomethacin therapy within 48 hours prior to being diagnosed with NEC
Intervention: Methotrexate
Trial phase: Phase 2
ATC code: L01BA01 | L04AX03
SMILES: CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Sirolimus: Oral bolus on day 1, then daily oral dose days 2-28. Dose will be altered to maintain a sirolimus trough level between ≥ 8 and ≤ 13. Trough levels will be checked weekly.

Methotrexate: Oral 20 mg/m2/week on Days 2, 9, 16, 23.

One cycle is 28 days

Sirolimus and Methotrexate: Single Arm Efficacy Trial:

Sirolimus: Oral bolus on day 1, then daily oral dose days 2-28. Dose will be altered to maintain a sirolimus trough level between ≥ 8 and ≤ 13. Trough levels will be checked weekly.

Methotrexate: Oral 20 mg/m2/week on Days 2, 9, 16, 23.

One cycle is 28 days.
Eligibility criteria:
Inclusion Criteria:

Patients </= 25 years of age, at time of enrollment, with second or greater relapse of ALL or NHL. For ALL must have histologic diagnosis with >10% blasts in the marrow and for lymphoblastic lymphoma or peripheral T-cell lymphoma must have radiologic or physical evidence of recurrence.
Lansky > 50% or Karnofsky > 50%
Negative Pregnancy Test
Creatinine clearance or radioisotope GFR > 70ml/min/m2 OR serum creatinine based on age /gender
Pulse ox >94%
Total Bilirubin <1.5 x normal for age
ALT < 5 x normal for age
Albumin > 2g/dL
Shortening fraction by echo > 28% OR ejection fraction > 50% by gated radionuclide study

Exclusion Criteria:

Patient has known allergies to sirolimus,FK-506 or mTOR inhibitors
Patient is taking other investigational anti-neoplastic drugs
Patient received no myelosuppressive chemo within 14 days
< 14 days have elapsed since local palliative XRT (small port) < 28 days since prior craniospinal XRT or 50% radiation of pelvis <28 days if other substantial BM radiation
Hematopoietic growth factors within 7 days of entry (except erythropoietin.)
Patient has taken any biologic agents within 14 days
Post BMT/SCT - evidence of active GVHD, at least > 3 months must have elapsed
Patient has uncontrolled infection (if patients with fungal disease, stable for < 14 days and patients with bacteremia without negative blood culture
Existing non-hematologic toxicities > grade 2

Use of steroids or hydroxyurea is permitted upto 14 days prior to entry.
Intervention: Vortioxetine
Trial phase: Phase 3
ATC code: N06AX26
SMILES: Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 155
Group description: Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Suffers from a major depressive episode recurrent as the primary diagnosis according to the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits.
Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.

Exclusion Criteria:

Has previously participated in a Lu AA21004 clinical study.

Has 1 or more the following:

Any current psychiatric disorder other than Major Depressive Disorder as defined in the DSM-IV
Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder defined in the DSM-IV-TR.
Diagnosis of alcohol or other substance disorder (except nicotine and caffeine) as defined in the DSM-IV-TR that has not been in sustained full remission for at least years prior to screening (participant must also have negative urine drug screen prior to Baseline).
Presence or history of a clinically significant neurological disorder (including epilepsy)
Neurodegenerative disorder.
Any Axis II disorder that might compromise the study.
Has a thyroid stimulating hormone value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.
Has clinically significant abnormal vital signs as determined by the investigator.
Has an abnormal Electrocardiogram.
Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.
Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication.
Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance. For the purposes of this protocol the following conditions are considered unstable due to the potential impact on assessment of MDD response: pain disorder, chronic fatigue syndrome, fibromyalgia, and obstructive sleep apnea.
Has a significant risk of suicide according to the investigator's opinion.
Intervention: Vortioxetine
Trial phase: Phase 3
ATC code: N06AX26
SMILES: Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 150
Group description: Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
Eligibility criteria:
Inclusion Criteria:

Suffers from a major depressive episode recurrent as the primary diagnosis according to the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits.
Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.

Exclusion Criteria:

Has previously participated in a Lu AA21004 clinical study.

Has 1 or more the following:

Any current psychiatric disorder other than Major Depressive Disorder as defined in the DSM-IV
Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder defined in the DSM-IV-TR.
Diagnosis of alcohol or other substance disorder (except nicotine and caffeine) as defined in the DSM-IV-TR that has not been in sustained full remission for at least years prior to screening (participant must also have negative urine drug screen prior to Baseline).
Presence or history of a clinically significant neurological disorder (including epilepsy)
Neurodegenerative disorder.
Any Axis II disorder that might compromise the study.
Has a thyroid stimulating hormone value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.
Has clinically significant abnormal vital signs as determined by the investigator.
Has an abnormal Electrocardiogram.
Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.
Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication.
Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance. For the purposes of this protocol the following conditions are considered unstable due to the potential impact on assessment of MDD response: pain disorder, chronic fatigue syndrome, fibromyalgia, and obstructive sleep apnea.
Has a significant risk of suicide according to the investigator's opinion.
Intervention: Combigan
Trial phase: Phase 4
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12.CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 59
Group description: COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
Eligibility criteria:
Inclusion Criteria:

Diagnosed with glaucoma or ocular hypertension.
Visual Acuity 20/100 or better in both eyes

Exclusion Criteria:

Any active ocular disease
History of any intraocular surgery or glaucoma laser surgery within 3 months
Contraindication to pupil dilation
Use of topical, periorbital, intravitreal, or systemic steroid within 3 months
Intervention: Mardepodect
Trial phase: Phase 2
SMILES: Cn1cc(-c2ccncc2)c(-c2ccc(OCc3ccc4ccccc4n3)cc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of schizophrenia with acute exacerbation of illness
The current acute exacerbation of schizophrenia must be less than 4 weeks duration prior to the initial evaluation.

Exclusion Criteria:

Subjects with evidence or history of clinically significant uncontrolled medical illness
Subjects with a current diagnosis of schizoaffective disorder, major depression, bipolar disorder, or obsessive compulsive disorder.
Subjects who meet Diagnostic and Statistical Manual-IV (DSM-IV)defined diagnostic criteria for psychoactive substance dependence (excluding nicotine dependence) within 12 months of screening or DSM-IV defined substance abuse within 3 months prior to screening.
Intervention: Mardepodect
Trial phase: Phase 2
SMILES: Cn1cc(-c2ccncc2)c(-c2ccc(OCc3ccc4ccccc4n3)cc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of schizophrenia with acute exacerbation of illness
The current acute exacerbation of schizophrenia must be less than 4 weeks duration prior to the initial evaluation.

Exclusion Criteria:

Subjects with evidence or history of clinically significant uncontrolled medical illness
Subjects with a current diagnosis of schizoaffective disorder, major depression, bipolar disorder, or obsessive compulsive disorder.
Subjects who meet Diagnostic and Statistical Manual-IV (DSM-IV)defined diagnostic criteria for psychoactive substance dependence (excluding nicotine dependence) within 12 months of screening or DSM-IV defined substance abuse within 3 months prior to screening.
Intervention: Metformin
Trial phase: Not Applicable
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Metformin: metformin 500- 2500 mg/day.
Eligibility criteria:
Inclusion Criteria:

Patients will be 18-70 years of age;
Currently hospitalized or an outpatient at MPC;
BMI ≥ 35 or excessive recent weight gain ( > than 10 lb weight gain in the past 3 months);
Patients will have a diagnosis of schizophrenia or schizoaffective disorder or bipolar disorder.

Exclusion Criteria:

Age below 18 or over 70;
Patient is currently already treated with metformin.
Intervention: Ivabradine
Trial phase: Phase 3
ATC code: C01EB17 | C07FX05 | C07FX06
SMILES: COc1cc2c(cc1OC)CC(=O)N(CCCN(C)C[C@H]1Cc3cc(OC)c(OC)cc31)CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 121
Group description: up to 7.5 mg b.i.d.
Eligibility criteria:
Inclusion Criteria:

heart failure II-III
ischemic origin
stable medications from at least 3 months
> 3 months from an acute ischemic syndrome or revascularization procedure
naive on heart rate reducing agents

Exclusion Criteria:

bradycardia
hypersensitivity or contraindications to study drugs
exercise tolerance at 6 minute walking test <100 m or >400 m
Intervention: Cuprous ion
Trial phase: Phase 3
SMILES: [Cu+]
Sex: Male
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: 65 IU/kg of rFVIIIFc via IV injection every 7 days
Eligibility criteria:
Inclusion Criteria:

Male, ≥12 years of age with weight at least 40 kg
Diagnosed with severe hemophilia A, defined as <1 IU/dL (<1%) endogenous Factor VIII)
History of at least 150 documented prior exposure days to any Factor VIII product
Platelet count ≥100,000 cells/μL

Exclusion Criteria:

History of Factor VIII inhibitors
Kidney and liver dysfunction
Diagnosed with other coagulation disorder(s) in addition to hemophilia A
Prior history of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration
Intervention: Cuprous ion
Trial phase: Phase 3
SMILES: [Cu+]
Sex: Male
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Initial single dose of 50 IU/kg of rFVIIIFc via IV injection followed by 10 to 50 IU/kg rFVIIIFc, as required to treat a bleeding episode
Eligibility criteria:
Inclusion Criteria:

Male, ≥12 years of age with weight at least 40 kg
Diagnosed with severe hemophilia A, defined as <1 IU/dL (<1%) endogenous Factor VIII)
History of at least 150 documented prior exposure days to any Factor VIII product
Platelet count ≥100,000 cells/μL

Exclusion Criteria:

History of Factor VIII inhibitors
Kidney and liver dysfunction
Diagnosed with other coagulation disorder(s) in addition to hemophilia A
Prior history of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration