anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Levetiracetam
Trial phase: Phase 3
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Formulation: Tablet
Strength: LEV 250 mg, LEV 500 mg
Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.
Frequency: Twice daily
Eligibility criteria:
Inclusion Criteria:

Subject is male or female and aged ≥ 16 years at Visit 1
Subjects with newly or recently diagnosed Epilepsy having experienced unprovoked Partial Seizures (IA, IB, IC), that are classifiable according to the International League Against Epilepsy (ILAE) classification of Epileptic Seizures
Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year prior to Visit 1, of which, at least 1 unprovoked seizure occurred in the 3 months prior to Visit 1
Minimum body weight of 40 kg at Visit 1

Exclusion Criteria:

Subject has a history or presence of seizure types other than partial (IA, IB, IC)
Subject has an experience of any type of brain surgery in the consecutive 2 years prior to Visit 1
Subject has a history or presence of known Pseudo-Seizures
Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) within the 6 months prior to Visit 1. However, acute and sub-acute seizure treatments are accepted for a maximum use of 2 weeks, if the treatments are stopped for the week prior to Visit 1
Subject has a known clinically significant acute or chronic illness, such as but not restricted to: cardiac, renal, hepatic dysfunction, endocrinological, or psychiatric illness, and that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol
Intervention: Levetiracetam
Trial phase: Phase 3
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Formulation: Tablet
Strength: LEV 250 mg, LEV 500 mg
Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.
Frequency: Twice daily
Eligibility criteria:
Inclusion Criteria:

Subject is male or female and aged ≥ 16 years at Visit 1
Subjects with newly or recently diagnosed Epilepsy having experienced unprovoked Partial Seizures (IA, IB, IC), that are classifiable according to the International League Against Epilepsy (ILAE) classification of Epileptic Seizures
Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year prior to Visit 1, of which, at least 1 unprovoked seizure occurred in the 3 months prior to Visit 1
Minimum body weight of 40 kg at Visit 1

Exclusion Criteria:

Subject has a history or presence of seizure types other than partial (IA, IB, IC)
Subject has an experience of any type of brain surgery in the consecutive 2 years prior to Visit 1
Subject has a history or presence of known Pseudo-Seizures
Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) within the 6 months prior to Visit 1. However, acute and sub-acute seizure treatments are accepted for a maximum use of 2 weeks, if the treatments are stopped for the week prior to Visit 1
Subject has a known clinically significant acute or chronic illness, such as but not restricted to: cardiac, renal, hepatic dysfunction, endocrinological, or psychiatric illness, and that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol
Intervention: Bisoprolol
Trial phase: Phase 4
ATC code: C07AB07 | C07BB07 | C07FB07 | C07FX04 | C09BX02 | C09BX04 | C09BX05
SMILES: CC(C)NCC(O)COc1ccc(COCCOC(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 93
Group description: Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects aged: >=18 years and =<70 years old
EH who are suitable for mono-therapy, either mild to moderate EH patients who have not been treated with anti-hypertension drugs, or mild EH subjects who have taken anti-hypertension drug.
Clinic resting Heart Rate >=70 beats per minute (bpm)
Patients who have signed informed consent

Exclusion Criteria:

Subjects with contraindications according to the China Summary of Product Characteristics (SmPCs) of both bisoprolol and metoprolol SR, such as acute heart failure, second or third degree atrioventricular block (without a pacemaker), sick sinus syndrome, symptomatic bradycardia or symptomatic hypotension, severe bronchial asthma or severe chronic obstructive pulmonary disease, metabolic acidosis, etc.
Moderate EH patients who have used anti-hypertension drugs
Secondary hypertension
Subjects with history of coronary heart disease
Chronic or acute heart failure
Cerebrovascular events within 6 months before screening
Impaired hepatic or renal function (according to local lab standard)
Other protocol defined exclusion criteria could apply
Intervention: Diclofenac sodium
Trial phase: Not Applicable
SMILES: O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Pennsaid (20-40 drops; 2-4 times daily for 2 weeks).
Eligibility criteria:
Inclusion Criteria:

Subject will be between 18 and 80 years of age.
Subject has not been on Pennsaid or other topical non-steroid anti-inflammatory drugs for at least one month.
Subject agrees to make no change in his/her current pain medications during the entire study period. This requirement will ensure that valid comparisons of primary and secondary measures can be made before and after the study.
Subject has a VAS pain score of 4 or above at the beginning of the study.
Subject has had a neuropathic pain condition such as those listed above for at least three months. This requirement is to avoid clinical uncertainty from an unstable pain condition and to minimize the study variation.
Female subjects of childbearing age must have a negative urine pregnancy test at the initial visit.

Exclusion Criteria:

Subject has documented severe liver or renal disease that will affect the elimination of Pennsaid or is subject to the adverse effect of Pennsaid on these organs. (Renal dysfunction is defined as eGFR < 60. Hepatic dysfunction is defined as LFTs ≥ 3X ULN.)
Subject has pending litigation related to the neuropathic pain condition.
Subject has active skin lesion or open wound at the site of Pennsaid application (e.g., active shingles with skin lesions).
Subject is pregnant or lactating.
Subject has scar tissue or sensory deficit at the site of QST.
Subject is allergic to diclofenac or has cross-sensitivity to other non-steroid anti-inflammatory drugs.
Subject has a positive urine (illicit) drug test.
Subjects who experience asthma, urticaria or an allergic type reaction when taking aspirin or NSAIDs.
Subjects undergoing coronary artery bypass surgery.
Subject with a known history of cardiovascular disease, ulcer, gastrointestinal bleed or impaired renal function.
Subjects currently using NSAIDS.
Intervention: Valganciclovir
Trial phase: Phase 4
ATC code: J05AB14
SMILES: CC(C)C(N)C(=O)OCC(CO)OCn1cnc2c(=O)[nH]c(N)nc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant

Valganciclovir: Valcyte per package insert guidelines for 200 days post transplant
Eligibility criteria:
Inclusion Criteria:

Male and female patients ≥ 18 years of age.
Male or female patients who CMV seronegative receiving a kidney, pancreas or liver from a seropositive donor.
Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to receiving transplant or study inclusion.
The patient has given written informed consent to participate in the study.

Exclusion Criteria:

Solid organ transplant recipient is CMV seropositive at the time of transplant.
Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
Patients with thrombocytopenia (<25,000/mm3 ), with an absolute neutrophil count of < 1,000/mm3); and/or leucopoenia (< 2,000/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.
Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.
Patient has a known hypersensitivity to valganciclovir, tacrolimus, mycophenolate mofetil, rabbit anti-thymocyte globulin, CMV hyperimmune globulin, basiliximab or corticosteroids.
Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication.
Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.
Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.
Inability to cooperate or communicate with the investigator.
Intervention: Albenatide
Trial phase: Phase 2
SMILES: NC(=O)C(N)CCCCNCCCCNC(=O)COCCOCCNC(=O)CCN1C(=O)CC(SCC(N)C(=O)O)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
Eligibility criteria:
Inclusion Criteria:

Men or women 18 to 70 years of age, inclusive
Body mass index of 27 to 45 kg/m2
Diagnosed with T2DM for at least 6 months before screening
Stable daily dose of metformin monotherapy of ≥1000 mg for at least 3 months before screening
FPG ≤240 mg/dL at screening
HbA1c ≥7.0% and ≤11% at screening
A 12-lead electrocardiogram recording without clinically significant arrhythmia, left bundle-branch block, or corrected QT interval

Exclusion Criteria:

Pregnant or breastfeeding women
Use of a weight control treatment, including over-the-counter medications (includes herbal supplements), or a significant change in body weight (at least ±10%) in the 3 months before screening
Treatment with any oral antidiabetic agent other than metformin within the 3 months before screening
Treatment with insulin for longer than 1 week within the 3 months before screening or any treatment with insulin within the 2 weeks before screening
Previous treatment with a glucagon-like peptide 1 (GLP-1) analog or other incretin therapy
Receipt of any experimental drug in a clinical trial within 30 days before administration of study drug or receipt of any investigational antidiabetic product within 3 months before screening
Intervention: Albenatide
Trial phase: Phase 2
SMILES: NC(=O)C(N)CCCCNCCCCNC(=O)COCCOCCNC(=O)CCN1C(=O)CC(SCC(N)C(=O)O)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
Eligibility criteria:
Inclusion Criteria:

Men or women 18 to 70 years of age, inclusive
Body mass index of 27 to 45 kg/m2
Diagnosed with T2DM for at least 6 months before screening
Stable daily dose of metformin monotherapy of ≥1000 mg for at least 3 months before screening
FPG ≤240 mg/dL at screening
HbA1c ≥7.0% and ≤11% at screening
A 12-lead electrocardiogram recording without clinically significant arrhythmia, left bundle-branch block, or corrected QT interval

Exclusion Criteria:

Pregnant or breastfeeding women
Use of a weight control treatment, including over-the-counter medications (includes herbal supplements), or a significant change in body weight (at least ±10%) in the 3 months before screening
Treatment with any oral antidiabetic agent other than metformin within the 3 months before screening
Treatment with insulin for longer than 1 week within the 3 months before screening or any treatment with insulin within the 2 weeks before screening
Previous treatment with a glucagon-like peptide 1 (GLP-1) analog or other incretin therapy
Receipt of any experimental drug in a clinical trial within 30 days before administration of study drug or receipt of any investigational antidiabetic product within 3 months before screening
Intervention: Albenatide
Trial phase: Phase 2
SMILES: NC(=O)C(N)CCCCNCCCCNC(=O)COCCOCCNC(=O)CCN1C(=O)CC(SCC(N)C(=O)O)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection
Eligibility criteria:
Inclusion Criteria:

Men or women 18 to 70 years of age, inclusive
Body mass index of 27 to 45 kg/m2
Diagnosed with T2DM for at least 6 months before screening
Stable daily dose of metformin monotherapy of ≥1000 mg for at least 3 months before screening
FPG ≤240 mg/dL at screening
HbA1c ≥7.0% and ≤11% at screening
A 12-lead electrocardiogram recording without clinically significant arrhythmia, left bundle-branch block, or corrected QT interval

Exclusion Criteria:

Pregnant or breastfeeding women
Use of a weight control treatment, including over-the-counter medications (includes herbal supplements), or a significant change in body weight (at least ±10%) in the 3 months before screening
Treatment with any oral antidiabetic agent other than metformin within the 3 months before screening
Treatment with insulin for longer than 1 week within the 3 months before screening or any treatment with insulin within the 2 weeks before screening
Previous treatment with a glucagon-like peptide 1 (GLP-1) analog or other incretin therapy
Receipt of any experimental drug in a clinical trial within 30 days before administration of study drug or receipt of any investigational antidiabetic product within 3 months before screening
Intervention: Albenatide
Trial phase: Phase 2
SMILES: NC(=O)C(N)CCCCNCCCCNC(=O)COCCOCCNC(=O)CCN1C(=O)CC(SCC(N)C(=O)O)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
Eligibility criteria:
Inclusion Criteria:

Men or women 18 to 70 years of age, inclusive
Body mass index of 27 to 45 kg/m2
Diagnosed with T2DM for at least 6 months before screening
Stable daily dose of metformin monotherapy of ≥1000 mg for at least 3 months before screening
FPG ≤240 mg/dL at screening
HbA1c ≥7.0% and ≤11% at screening
A 12-lead electrocardiogram recording without clinically significant arrhythmia, left bundle-branch block, or corrected QT interval

Exclusion Criteria:

Pregnant or breastfeeding women
Use of a weight control treatment, including over-the-counter medications (includes herbal supplements), or a significant change in body weight (at least ±10%) in the 3 months before screening
Treatment with any oral antidiabetic agent other than metformin within the 3 months before screening
Treatment with insulin for longer than 1 week within the 3 months before screening or any treatment with insulin within the 2 weeks before screening
Previous treatment with a glucagon-like peptide 1 (GLP-1) analog or other incretin therapy
Receipt of any experimental drug in a clinical trial within 30 days before administration of study drug or receipt of any investigational antidiabetic product within 3 months before screening
Intervention: Azarga
Trial phase: Phase 4
SMILES: CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1.CCNC1CN(CCCOC)S(=O)(=O)c2sc(S(N)(=O)=O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
Eligibility criteria:
Inclusion Criteria:

18 years of age or older.
Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
Be on a stable intraocular pressure (IOP) lowering regimen within 30 days of the Screening Visit.
IOP considered safe in both eyes in such a way that should assure clinical stability of vision and optic nerve throughout the study period.
Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
IOP between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Presence of other primary or secondary glaucoma not listed in inclusion criteria #2.
History of ocular herpes simplex.
Abnormality preventing reliable applanation tonometry.
Corneal dystrophies.
Concurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to the Screening Visit.
Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
Progressive retinal or optic nerve disease from any cause.
Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study.
Pregnant or lactating.
Other protocol-defined exclusion criteria may apply.
Intervention: Azarga
Trial phase: Phase 4
SMILES: CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1.CCNC1CN(CCCOC)S(=O)(=O)c2sc(S(N)(=O)=O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
On a stable IOP (intra-ocular pressure) lowering regimen within 30 days of Screening Visit.
IOP considered safe in both eyes in order to assure clinical stability of vision and optic nerve throughout the study period.
Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
IOP between 19 and 35 mmHG in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Presence of other primary or secondary glaucoma.
History of ocular herpes simplex.
Any abnormality preventing reliable applanation tonometry.
Corneal dystrophies.
Concurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to Screening Visit.
Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the opinion of the investigator.
Progressive retinal or optic nerve disease from any cause.
Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
Pregnant or lactating.
Other protocol-defined exclusion criteria may apply.
Intervention: (2-Bromo-4-imidazol-1-ylphenyl)methanamine
Trial phase: Phase 4
SMILES: NCc1ccc(-n2ccnc2)cc1Br
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1829
Group description: 70 units/kg body weight intravenous

unfractionated heparin: 70 units/kg body weight intravenous
Eligibility criteria:
Inclusion Criteria:

All patients presenting with a suspected myocardial infarction event with PPCI as the proposed index reperfusion strategy will be included in the trial

Exclusion Criteria:

≤ 18 years of age
Known intolerance, hypersensitivity or contraindication to any trial medication
Active bleeding at presentation
Artificial ventilation, reduced conscious level or other factors precluding the administration of oral antiplatelet therapy
Previous enrolment in this trial
Intervention: Cycloserine
Trial phase: Phase 2
ATC code: J04AB01
SMILES: N[C@@H]1CONC1=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 52
Group description: active drug condition

d-cycloserine: 50 mg d-cycloserine
Eligibility criteria:
Inclusion Criteria:

18-60 years of age (> 60 due to age-related effects on cognitive functioning)
Satisfy DSM-IV criteria for cocaine dependence (primarily crack)
Able to complete all study measures
Currently seeking treatment for cocaine dependence

Exclusion Criteria:

Meets DSM-IV criteria for dependence on a drug other than cocaine or nicotine (may meet abuse criteria for other drugs)
Pregnant, breast feeding, or planning to become pregnant within 3 months
If female, do not agree to use an effective means of birth control during the course of treatment (via phone screen)
History of seizure disorder, severe hepatic impairment, porphyria, serious head trauma, dementia, or significant cognitive impairment
Diagnosis of current major psychiatric disorder besides substance dependence or abuse
Reported use of DCS in the past year
Illiteracy, as will be determined during in-person screening
Concurrently prescribed or using ethionamide or isoniazid (both used to treat tuberculosis)
Positive urine result for opioids at screening interview
Intervention: Dexmedetomidine
Trial phase: Phase 3
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 200
Group description: Dexmedetomidine

Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery
Eligibility criteria:
Inclusion Criteria:

children undergoing tonsillectomy with and without adenoidectomy and myringotomy and tube insertion
ASA 1,2,3
females who have started menses but have a negative urine pregnancy test

Exclusion Criteria:

patients with known dysrhythmias,
not recovering in the ICU
developmental delay,
autism communication disorder
bleeding disorder
PI discretion