anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Cetirizine Hydrochloride
Trial phase: Phase 4
SMILES: Cl.Cl.O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 301
Group description: 5 mg levocetirizine dihydrochloride tablet once daily
Eligibility criteria:
Inclusion Criteria:

Subjects with a history of SAR symptoms
A positive skin prick test at least one grass allergen
Moderate - severe SAR symptoms at baseline
Women of childbearing potential must use a medically acceptable form of contraception
80% compliance on run in study medication and 80% compliance on completing the diary

Exclusion Criteria:

The presence of any clinically significant comorbid disease which may interfere with the study assessments
The presence of renal disease
Pregnant or breastfeeding
Subject is currently participating in another clinical trial
Known hypersensitivity to piperazines or any of the excipients
Intake of medications prohibited before the start of the trial
Subjects who started or changed the dose of immunotherapy
Rhinitis medicamentosa
Subjects with a recent history (within the last 2 years) of drug or alcohol abuse.
Intervention: Ramelteon
Trial phase: Phase 4
ATC code: N05CH02
SMILES: CCC(=O)NCC[C@@H]1CCc2ccc3c(c21)CCO3
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
Eligibility criteria:
Inclusion Criteria:

Diagnosis of ADHD and insomnia-
19-65 years of age
In good general health
Negative pregnancy test

Exclusion Criteria:

Current primary psychiatric diagnosis other than ADHD
Positive urine drug screen for any sedative hypnotic or drugs of abuse
Unstable medical condition
HIV positive
Seizure disorder
Known hypersensitivity to Ramelteon
Intervention: Pruvanserin
Trial phase: Phase 2
SMILES: N#Cc1c[nH]c2c(C(=O)N3CCN(CCc4ccc(F)cc4)CC3)cccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
Eligibility criteria:
Inclusion Criteria:

Anal HSIL confirmed by biopsy no more than 30 days prior to entry
Anal HSIL deemed not amenable to therapy or participant declines routine ablative therapy
HIV positive
Stable HIV treatment regimen for at least 8 weeks prior to entry
At least 18 years of age
Women of childbearing potential must use contraception
Platelet count above 70,000/mm3 within 30 days prior to entry
ANC greater or equal to 1000/mm3 within 30 days prior to entry
Creatinine less then or equal to 1.5 times ULN within 30 days prior to entry
AST and ALT less than or equal to 3 times ULN within 30 days prior to entry

Exclusion Criteria:

Prior history of invasive anal, cervical, vaginal, or vulvar cancer
Pregnancy or lactation and breast-feeding
Must not participate in a conception process including sperm donation
Medical or psychiatric illness that precludes ability to give informed consent or is likely to interfere with ability to comply with protocol
Known allergy to any topical cream components
Patients with lesions clinically suspicious per HRA examiner for early progression (less than one year) to anal cancer
Intervention: Teriflunomide
Trial phase: Phase 3
ATC code: L04AA31
SMILES: C/C(O)=C(\C#N)C(=O)Nc1ccc(C(F)(F)F)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 145
Group description: Core treatment period: Teriflunomide 7 mg tablet once daily orally.

Extension treatment period: Teriflunomide 7 mg tablet once daily orally.
Eligibility criteria:
Inclusion Criteria:

First acute or subacute, well-defined neurological event consistent with demyelination (that is, optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes)
Onset of MS symptoms occurring within 90 days of randomization
A screening MRI scan with 2 or more T2 lesions at least 3 millimeter (mm) in diameter that are characteristic of MS

Exclusion Criteria:

Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease
Significantly impaired bone marrow function
Pregnancy or nursing
Alcohol or drug abuse
Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment
Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Intervention: Teriflunomide
Trial phase: Phase 3
ATC code: L04AA31
SMILES: C/C(O)=C(\C#N)C(=O)Nc1ccc(C(F)(F)F)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 150
Group description: Core treatment period: Teriflunomide 14 mg tablet once daily orally.

Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Eligibility criteria:
Inclusion Criteria:

First acute or subacute, well-defined neurological event consistent with demyelination (that is, optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes)
Onset of MS symptoms occurring within 90 days of randomization
A screening MRI scan with 2 or more T2 lesions at least 3 millimeter (mm) in diameter that are characteristic of MS

Exclusion Criteria:

Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease
Significantly impaired bone marrow function
Pregnancy or nursing
Alcohol or drug abuse
Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment
Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Intervention: Rivastigmine
Trial phase: Phase 4
ATC code: N06DA03
SMILES: CCN(C)C(=O)Oc1cccc([C@H](C)N(C)C)c1
Sex: All
Age groups: Adult | Older Adult
Participants at risk: 218
Group description: During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
Eligibility criteria:
Inclusion Criteria:

Males, and females of at least 50 years old with a primary caregiver
Probable Alzheimer's disease
Mini-Mental State Examination (MMSE) score of ≥ 10 and ≤ 26
Patients initiating therapy for the first time with a Cholinesterase (ChE) inhibitor (patients prescribed both rivastigmine and memantine are allowed) or patients who failed to benefit from previous ChE inhibitor treatment
Residing with someone in the community throughout the study or, if living alone, in contact with the responsible caregiver everyday

Exclusion Criteria:

Patients not treated according to the product monograph for capsules
Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application)
History of allergy to topical products containing any of the constituents of the patches

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Besifloxacin
Trial phase: Phase 2
ATC code: S01AE08
SMILES: N[C@@H]1CCCCN(c2c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c2Cl)C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 137
Group description: 0.6% ISV-403
Eligibility criteria:
Inclusion Criteria:

Must be at least one year of age.
Must have signature of subject or legally authorized representative (if subject is under 18 years of age) on the informed Consent Form.
Must have signature of subject on the Assent Form if subject is 6 to 17 years of age.
Must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one eye. A minimum score of 1 should be present for discharge and a minimum score of 1 for either bulbar or palpebral conjunctival injection.
Must have pinholed visual acuity equal to or better than 20/200 in both eyes. Age appropriate visual acuity testing was to be performed. Every effort was made to obtain a visual acuity measurement in children. If visual acuity was unobtainable in children, it was at the investigator's discretion to meet inclusion criteria.
Must be willing to discontinue contact lens wear for the duration of the study.
Must be willing to avoid disallowed medications during the study period.
Must understand the scope of the study including completion of diary, be willing to follow instructions, and be able to make all required study visits.
If a subject was a female of childbearing potential, she must utilize reliable contraceptive methods and have a negative pregnancy test.

Exclusion Criteria:

Any uncontrolled systemic disease or debilitating disease.
Use of topical ophthalmic solutions including tear substitutes within two hours before and during the study.
Use of any ophthalmic topical anti-inflammatory agents within 48 hours before and during the study.
Subjects likely to require antimicrobial therapy with any active respiratory tract infection, urinary tract infection, skin/soft tissue infection, or otitis media.
Pregnant or nursing females.
Known hypersensitivity to SS734 or to any of the ingredients in the study medications.
Known hypersensitivity to fluoroquinolones or to any of the ingredients in the study medications.
Ocular surgery (including laser surgery) in either eye within the past six weeks.
Subjects with suspected viral or allergic conjunctivitis (i.e., severe itching or acute follicular conjunctivitis), or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication.
Subjects with suspected iritis (i.e., smaller pupil, pain, and photophobia in infected eye).
History of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome.
Use of any antibiotic within 72 hours of enrollment.
Any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis
Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this study.
Subjects who were immune compromised.
Intervention: Gadobutrol
Trial phase: Phase 3
ATC code: V08CA09
SMILES: O=C([O-])CN1CCN(CC(=O)[O-])CCN(C(CO)C(O)CO)CCN(CC(=O)[O-])CC1.[Gd+3]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 343
Group description: Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
Eligibility criteria:
Inclusion Criteria:

Patients referred for contrast enhanced MRI of the CNS based on symptoms or previous procedures.

Exclusion Criteria:

Patients with acute renal insufficiency
Patients with severe renal disease
Patients with any contraindication to magnetic resonance imaging.
Intervention: Dihydroergotamine
Trial phase: Phase 3
ATC code: N02CA01 | N02CA51
SMILES: [H][C@@]12Cc3c[nH]c4cccc(c34)[C@@]1([H])C[C@@H](C(=O)N[C@]1(C)O[C@]3(O)N(C1=O)[C@@H](Cc1ccccc1)C(=O)N1CCC[C@]13[H])CN2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 410
Group description: MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
Eligibility criteria:
Major Inclusion Criteria:

Male or female between 18 and 65 years of age.
History of episodic, acute migraine (with or without aura) with onset prior to 50

Major Exclusion Criteria:

Known allergy or sensitivity or contraindication to study drugs or their formulations
History of chronic pulmonary disease, coronary artery disease (CAD), liver disease, kidney disease, seizures, stroke, or major psychiatric condition.
Any condition that, in the opinion of the Investigator, would make the subject unsuitable for study participation
Intervention: Sertraline
Trial phase: Phase 4
ATC code: N06AB06
SMILES: CN[C@H]1CC[C@@H](c2ccc(Cl)c(Cl)c2)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: sertraline: 50 mg up to 100 mg daily for 6 months
Eligibility criteria:
Inclusion Criteria:

All patients (men, women) who are African American or Hispanic over the age of 21 who have been diagnosed with type 2 diabetes and have a HbA1c of greater than 8.0%. Subjects with neuropathic pain will be included in the study. Their pain will be assessed via a validated pain scale. Their primary care providers will treat their pain as necessary.

Exclusion Criteria:

Pregnant women, patients on dialysis, patients with liver disease or liver enzymes elevated three times above normal, patients with blood pressure greater than 160 systolic or 95 diastolic on two consecutive visits, patients with history of severe depression (as determined by hospitalization or the HAM-D survey) or suicide attempts, patients on therapy for depression, patients already taking SSRI's, and patients with psychotic features or bipolar disease.
Intervention: Celecoxib
Trial phase: Phase 4
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized).
Eligibility criteria:
Inclusion Criteria:

healthy men and women

Exclusion Criteria:

history of heart disease
have had heart surgery
high blood pressure
diabetes
cancer
any other disease such as kidney or neurological diseases
taking medications such as aspirin or medicines for your heart or blood pressure
have asthma or are allergic to sulfa drugs
body mass index greater than 30
use tobacco
pregnant
women using oral contraceptives or hormone replacement therapy
Intervention: rhEPO
Trial phase: Phase 4
SMILES: COC1C(O)CC(=O)OC(C)CC=CC=CC(OC2CC(C)(O)C(O)C(C)O2)C(C)CC(CCO)C1OC1OC(C)C(OC2CC(C)(O)C(O)C(C)O2)C(N(C)C)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
Eligibility criteria:
Inclusion Criteria:

Patients age 30-75
Patients undergoing vascular clipping post SAH
Aneurysmal SAH as determined by history or clinical evaluation
WFNS Score I and II
Hb ≤ 12 g/dL within 36 hours prior to first dose of study drug
Patients who receive Study drug and undergo surgical clipping of the aneurysm within 36 hours of the SAH event

Exclusion Criteria:

Non-aneurysmal SAH
WFNS Score III and higher
Patients presenting with previous history of SAH
Terminal, brain-dead, comfort care patients
Patients not undergoing vascular clipping
Hb > 12 g/dL
Patients receiving blood transfusion prior to surgery
Patients who currently receive Procrit or an EPO product
Patients undergoing surgical clipping of the aneurysm greater than 36 hours after the SAH event
Pregnancy or lactating
Renal insufficiency (must present and maintain normal creatinine levels)
Uncontrolled hypertension (systolic > 150 mmHg)
Active or known seizure history within one year of SAH event
Known history of thrombotic vascular events (PE, DVT, AMI, stroke)
Allergy or sensitivity to mammalian derived products
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
Eligibility criteria:
Inclusion Criteria:

Patients age 30-75
Patients undergoing vascular clipping post SAH
Aneurysmal SAH as determined by history or clinical evaluation
WFNS Score I and II
Hb ≤ 12 g/dL within 36 hours prior to first dose of study drug
Patients who receive Study drug and undergo surgical clipping of the aneurysm within 36 hours of the SAH event

Exclusion Criteria:

Non-aneurysmal SAH
WFNS Score III and higher
Patients presenting with previous history of SAH
Terminal, brain-dead, comfort care patients
Patients not undergoing vascular clipping
Hb > 12 g/dL
Patients receiving blood transfusion prior to surgery
Patients who currently receive Procrit or an EPO product
Patients undergoing surgical clipping of the aneurysm greater than 36 hours after the SAH event
Pregnancy or lactating
Renal insufficiency (must present and maintain normal creatinine levels)
Uncontrolled hypertension (systolic > 150 mmHg)
Active or known seizure history within one year of SAH event
Known history of thrombotic vascular events (PE, DVT, AMI, stroke)
Allergy or sensitivity to mammalian derived products
Intervention: Teneligliptin
Trial phase: Phase 2
ATC code: A10BH08
SMILES: [H][C@@]1(N2CCN(c3cc(C)nn3-c3ccccc3)CC2)CN[C@]([H])(C(=O)N2CCSC2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 84
Group description: Teneligliptin 10 mg, orally, once daily
Eligibility criteria:
Inclusion Criteria:

Patients who are 20 - 75 years old
Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
Patients whose HbA1c is 6.5 - 9.5%
Patients who were not administered drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.

Exclusion Criteria:

Patients with type 1 diabetes, diabetes mellitus caused by pancreas failure, or secondary diabetes (Cushing disease, acromegaly, etc)
Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
Patients with serious diabetic complications
Patients who are habitual excessive alcohol consumption.
Patients with severe hepatic disorder or severe renal disorder.
Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Intervention: Teneligliptin
Trial phase: Phase 2
ATC code: A10BH08
SMILES: [H][C@@]1(N2CCN(c3cc(C)nn3-c3ccccc3)CC2)CN[C@]([H])(C(=O)N2CCSC2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: Teneligliptin 20 mg, orally, once daily
Eligibility criteria:
Inclusion Criteria:

Patients who are 20 - 75 years old
Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
Patients whose HbA1c is 6.5 - 9.5%
Patients who were not administered drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.

Exclusion Criteria:

Patients with type 1 diabetes, diabetes mellitus caused by pancreas failure, or secondary diabetes (Cushing disease, acromegaly, etc)
Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
Patients with serious diabetic complications
Patients who are habitual excessive alcohol consumption.
Patients with severe hepatic disorder or severe renal disorder.
Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Intervention: Teneligliptin
Trial phase: Phase 2
ATC code: A10BH08
SMILES: [H][C@@]1(N2CCN(c3cc(C)nn3-c3ccccc3)CC2)CN[C@]([H])(C(=O)N2CCSC2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 81
Group description: Teneligliptin 40 mg, orally, once daily
Eligibility criteria:
Inclusion Criteria:

Patients who are 20 - 75 years old
Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
Patients whose HbA1c is 6.5 - 9.5%
Patients who were not administered drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.

Exclusion Criteria:

Patients with type 1 diabetes, diabetes mellitus caused by pancreas failure, or secondary diabetes (Cushing disease, acromegaly, etc)
Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
Patients with serious diabetic complications
Patients who are habitual excessive alcohol consumption.
Patients with severe hepatic disorder or severe renal disorder.
Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Intervention: Atomoxetine
Trial phase: Phase 4
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Patients are given the drug Atomoxetine and Cognitive Remediation training.

Atomoxetine: 40mg 2po qam
Eligibility criteria:
Inclusion Criteria:

DSM-IV diagnosis of schizophrenia or schizoaffective disorder.
Males and females.
Ages 18-60 years old.
All races and ethnicities.

Exclusion Criteria:

Diagnosis of an organic brain disease.
Diagnosis of DSM-IV alcohol or substance abuse within the last month or DSM-IV alcohol or substance dependence within the last 3 months.
Meet criteria for primary negative symptoms, established by clinical judgment.
Current or past history of clozapine treatment for antipsychotic non-response.
Patients hospitalized in a psychiatric hospital within the previous 30 days.
Patients with an unstable medical condition, as determined by the Investigator
Colorblindness
Concurrent treatment with electroconvulsive therapy or psychotherapy.
Pregnant women.

Must be able to read, speak, and understand English.

We do not have the resources necessary to properly study non-English speaking patients in this study. The computer software used for cognitive remediation and some clinical assessments are only available in English. The need to provide such resources in foreign languages would be prohibitive to the successful completion of the study.