anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Haloperidol
Trial phase: Phase 3
ATC code: N05AD01
SMILES: O=C(CCCN1CCC(O)(c2ccc(Cl)cc2)CC1)c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 192
Group description: Haloperidol

Haloperidol: Haloperidol, up to 10mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 5mg/mL. Patient will only receive IV while in the ICU.
Eligibility criteria:
Inclusion Criteria:

adult patients (≥18 years old)
in a medical and/or surgical ICU
on mechanical ventilation or non-invasive positive pressure ventilation (NIPPV), and/or requiring vasopressors due to shock
delirious (according to the CAM-ICU)

Exclusion Criteria:

Rapidly resolving organ failure criteria, indicated by planned immediate discontinuation of mechanical ventilation, NIPPV, and/or vasopressors at the time of screening for study enrollment
Pregnancy or breastfeeding (negative pregnancy test required prior to enrollment of female patients of childbearing age)
Severe dementia or neurodegenerative disease, defined as either impairment that prevents the patient from living independently at baseline or IQCODE >4.5, measured using a patient's qualified surrogate, mental illness requiring long-term institutionalization, acquired or congenital mental retardation, Parkinson's disease, Huntington's disease, and/or coma or another severe deficit due to structural brain disease such as stroke, intracranial hemorrhage, cranial trauma, intracranial malignancy, anoxic brain injury, or cerebral edema.
History of torsades de pointes, documented baseline QT prolongation (congenital long QT syndrome), or QTc >500 ms at screening due to refractory electrolyte abnormalities, other drugs, or thyroid disease
Ongoing maintenance therapy with typical or atypical antipsychotics
History of neuroleptic malignant syndrome (NMS), haloperidol allergy, or ziprasidone allergy
Expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family or the medical team (e.g., likely withdrawal of life support measures within 24 hours of screening)
Inability to obtain informed consent from an authorized representative within 72 hours of meeting all inclusion criteria, i.e., developing qualifying organ dysfunction criteria.
Intervention: Fingolimod
Trial phase: Phase 4
ATC code: L04AA27
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 783
Group description: Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
Eligibility criteria:
Inclusion Criteria:

Relapsing forms of MS
Expanded Disability Status Scale (EDSS) 0-5.5
Continuous treatment with MS DMT for a minimum of 6 months
Fingolimod naive

Exclusion Criteria:

Immune system diseases other than MS
Active macular edema
History of selected prior infections and criteria for immunizations
History of selected immune system treatments and/or medications
Selected cardiovascular, pulmonary, or hepatic conditions
Selected abnormal laboratory values
Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria applied
Intervention: Metformin
Trial phase: Phase 2 | Phase 3
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: 191
Group description: metformin 500mg twice daily during 4 months

Metformin: Metformin 500mg twice daily during 4 months
Eligibility criteria:
Inclusion Criteria:

The diagnosis acute MI defined by chest pain suggestive for myocardial ischemia for at least 30 minutes, the time from onset of the symptoms less than 12 hours before hospital admission, and an ECG recording with ST- segment elevation of more than 0.1 mV in 2 or more leads.
Successful primary PCI (post-procedural TIMI 2/3);
At least one stent sized ≥ 3.0 mm;
Eligible for 3T CMR imaging;
Verbal followed by written informed consent.

Exclusion Criteria:

rescue PCI after thrombolytic therapy;
need for emergency coronary artery bypass grafting;
creatinin >177 μmol/L measured pre-PCI;
Younger than 18 years;
Mechanical ventilation;
Diabetes;
Prior myocardial infarction;
Contra-indication to metformin (see safety);
The existence of a life-threatening disease with a life-expectancy of less than 6 months.
Intervention: Combigan
Trial phase: Phase 3
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12.CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 95
Group description: Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
Eligibility criteria:
Inclusion Criteria:

Ocular hypertension or primary open-angle glaucoma in each eye
Requires treatment with IOP-lowering medication in both eyes

Exclusion Criteria:

Required chronic use of ocular medications during the study other than study medication
Use of any corticosteroids within 30 days
History of any traumatic eye surgeries
Cataract surgery in the past 6 months
Anticipated wearing of contact lenses during the study
Intervention: Dasatinib
Trial phase: Phase 1 | Phase 2
ATC code: L01EA02 | L01XE06
SMILES: Cc1nc(Nc2ncc(C(=O)Nc3c(C)cccc3Cl)s2)cc(N2CCN(CCO)CC2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Participants received dasatinib, 100/140 mg once daily (QD) (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
Eligibility criteria:
Key Inclusion Criteria

Age ≥18 years
Diagnosis of chronic myeloid leukemia (CML) and cytogenetic positive for the Philadelphia chromosome (Ph+), documented Ph+ cells on bone marrow assessment (BMA) ≤6 weeks prior to treatment
Either chronic-phase CML, with <15% blasts in peripheral blood and bone marrow, or advanced-phase CML, including Ph+ acute lymphoblastic leukemia (ALL) (> 5% blasts) or hematologic progression with ≥15% blasts not in complete cytogenetic remission
Resistance or suboptimal response to imatinib, dasatinib, or nilotinib and no known T315I/A Abl-kinase mutation.

Key Exclusion Criteria

Known Abl-kinase T315I or T315A mutation
CCyR at baseline
Any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
Uncontrolled or significant cardiovascular disease
Grade 3 or higher peripheral blood counts
Serum calcium or phosphate below the lower limit of normal
Baseline hypomagnesemia and amylase or lipase at least Grade 1 or higher
Reduced renal function, defined as serum creatinine level >3*upper limit of normal

Prior therapies for CML or Ph+ ALL permitted, with the following restriction:

Therapy permitted with corticosteroids, hydroxyurea, or anagrelide prior to starting treatment and during the first 4 weeks on study
6 months or longer after stem cell transplantation
28 days or longer after any investigational agent
7 days or longer after any standard chemotherapy agent
Concomitant use of medications with a known risk of causing Torsades de Pointes
Concomitant use of strong inhibitors of the CYP3A4 isoenzyme
Intervention: Finasteride
Trial phase: Phase 1 | Phase 2
ATC code: D11AX10 | G04CA51 | G04CA55 | G04CB01 | G04CB51
SMILES: [H][C@@]12CC[C@@]3([H])NC(=O)C=C[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(=O)NC(C)(C)C)CC[C@@]21[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
Eligibility criteria:
INCLUSION CRITERIA:

Participant previously participated in NCT00837252 (NIH protocol 09-EI-0075), Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy, and demonstrated clinical improvement, as indicated by a reduction in subretinal fluid as measured on OCT.

Participant has subretinal fluid present in the macula that has a volume of at least 0.1 microliter causing visual change (such as reduced acuity, metamorphopsia or microperimetry deficits) and warrants treatment.

Participant must understand and sign the protocol's informed consent document.

Participant agrees to take the appropriate precautions to ensure that persons who are pregnant, nursing or of childbearing potential do not handle the finasteride tablets. [All of the NCT00837252 (NIH protocol 09-EI-0075) participants were male given the male predilection of this disease.]

EXCLUSION CRITERIA:

Participant has abnormal liver function testing (LFT) as defined by elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels that are greater than twice the respective upper limits of normal (ULN) (i.e., ALT greater than 82 U/L and/or AST greater than 68 U/L). If a participant has ALT or AST levels greater than twice the ULN, the participant can be enrolled only if cleared by hepatology.

Participant is on steroid medication (oral, topical or inhaled).
Intervention: Topiramate
Trial phase: Phase 4
ATC code: A08AA51 | N03AX11
SMILES: [H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 166
Group description: 25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
Eligibility criteria:
Inclusion Criteria:

Male or female subjects from 16 to 80 years, inclusive. Subjects under 20 years may only be included where legally permitted and ethically accepted
Subjects with refractory epilepsy with partial onset seizure classifiable according to the International League Against Epilepsy (ILAE).
Subjects having at least 2 partial onset seizures whether or not secondarily generalized during the 8 weeks historical baseline preceding V1 according to ILAE classification
Subjects having at least 1 partial onset seizures whether or not secondarily generalized per 4 weeks preceding V2 according to ILAE classification
Subjects with each interval of partial onset seizures less than 6 weeks during entire 12 weeks (8 weeks preceding V1 and 4 weeks preceding V2)
Subjects being uncontrolled while treated by 1 to 3 permitted concomitant AEDs.
Permitted concomitant AEDs having been stable and at optimal dosage for the subject from at least 4 week before V1 and during 4 weeks preceding V2 and expected to be kept stable during the Treatment Period.

Exclusion Criteria:

Subjects presenting any generalized epilepsies classified as type II according to the ILAE classification (ref to publication from 1981)
Subjects suffering from epilepsies and syndromes undetermined whether focal or generalized (classification III according to the ILAE classification)
Subjects suffering from special syndromes (classification IV according to the ILAE classification)
History or occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before V2.
Presence of exclusively type IA non-motor seizures.
History or presence of status epilepticus within last 3 months preceding V1 or during Baseline
History or presence of known pseudo-seizures
Subjects who are currently on vigabatrin. (Subjects who received vigabatrin in the past and have a normal visual field test are allowed.)
Subject taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1: antipsychotics drugs, and psychostimulant (amphetamine derivatives)
Intervention: Methotrexate
Trial phase: Phase 3
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 | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
Eligibility criteria:
Inclusion Criteria:

Non-infectious anterior, intermediate, posterior or panuveitis
Active uveitis within the last 60 days (defined by the presence of any of the following according to SUN criteria: ≥ 1+ anterior chamber cells, anterior vitreous cells, vitreous haze, active retinal or choroidal lesions)
Prednisone dose ≥ 15 mg/day
History of corticosteroid taper failure (inability to taper to prednisone 10 mg or less) or obvious chronic disease necessitating corticosteroid-sparing immunosuppressive treatment

Exclusion Criteria:

Any infectious cause of uveitis
Tuberculosis: Evidence of active TB (PPD and CXR required - latent TB patients are still eligible)
Positive for Hepatitis: HBsAg and/or Hep C antibody
Positive for Syphilis: RPR/VDRL and/or FTA-ABS
Abnormal CBC (<2500 WBC or <75,000 Plts or <10 Hgb)
Abnormal liver and/or kidney tests (ALT/AST >2x normal or CR>1.5)
Pregnancy or breast-feeding (blood or urine pregnancy test for all females, excluding those who are post-menopausal)
Chronic hypotony (IOP < 5 mm Hg for > 3 months)
Prior use of any immunosuppressive drug for the treatment of uveitis in the past 6 months
Prior failed treatment with methotrexate or mycophenolate mofetil
Periocular or intravitreal corticosteroid injection in the past 3 months
Fluocinolone acetonide implant surgery in either eye in < 3 years
Intraocular surgery in < 30 days, or any ocular surgery scheduled during the 6-month study period
VA of hand motions or worse in better eye
< 16 years of age at enrollment
Intervention: Sirolimus
Trial phase: Phase 1
ATC code: L01EG04 | L04AA10 | S01XA23
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
Eligibility criteria:
Inclusion Criteria:

Male or female, above 18 years of age and Body Mass Index (BMI) of 18.0 to 25.0 kg/m2, inclusive;
Subjects must have received a primary or secondary renal allograft for at least 2 months prior to Screening;
Subjects must be currently taking Rapamune tablets for prophylaxis of renal rejection. The dosages of any medications must be stable for at least 2 weeks prior to screening and continue with no change until completion of the last PK sample collection.

Exclusion Criteria:

Acute rejection or vascular rejection episode in the 4 weeks prior to Screening; or patients dependent on dialysis; or inadequate renal function (in the opinion of the investigator);
Recipients of multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant);
Current use of strong inducers or inhibitors of CYP3A4 within 2 weeks prior to collection of the first PK sample and until collection of the final PK sample;
Any clinically significant medical or psychiatric condition or laboratory abnormality, in the judgment of the investigator.
Intervention: Rabeprazole
Trial phase: Not Applicable
ATC code: A02BC04 | A02BC54 | A02BD12 | A02BD13 | M01AA05 | M02AA03
SMILES: COCCCOc1ccnc(CS(=O)c2nc3ccccc3[nH]2)c1C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5

Rabeprazole : rabeprazole po daily x 5 days
Eligibility criteria:
Inclusion Criteria:

Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam;
BMI between 18.5 - 35 kg/m2;
Taking no medications 2 weeks before and during the study enrollment, including drugs of abuse, prescription or OTC medications (except acetaminophen);
Subjects must be able to maintain adequate birth control during the study independent of hormonal contraceptive use;
Be able to provide written informed consent and comply with requirements of the study;
Avoid eating grapefruit and drinking grapefruit juice from 7 days before the first study day until completion of the entire study;
Abstinence from alcoholic beverages, caffeinated beverages and orange juice from 6pm the night before a study day until completion of that study day;
Fast from food and beverages at least 8 hours prior to the study day;
Be able to read, speak and understand English

Exclusion Criteria:

Subjects with a history of gastrointestinal disease including gastroesophageal reflux disease, gastritis, peptic ulcer disease or dyspepsia.
Subjects with a fasting gastric pH of > 4 (i.e. hypochlorhydria)
Subjects with history of dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills.
Subjects on prescription or chronic over-the counter medications (including hormonal contraceptives);
Subjects with known allergy to study interventions;
Subjects who smoke tobacco;
Subjects with ongoing alcohol or illegal drug use;
Subjects who are pregnant, lactating or attempting to conceive;
Subjects unable to maintain adequate birth control during the study;
Subjects unable to follow protocol instructions or protocol criteria.
Intervention: Metformin
Trial phase: Phase 4
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: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 110
Group description: metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
Eligibility criteria:
Inclusion Criteria:

Mothers with gestational diabetes who had at least twice plasma glucose at fasting > 5.4 mmol/L and/or 1 hour postprandial value > 7.7 mmol/L at 24 to 32 gestational weeks

Exclusion Criteria:

Fasting glucose > 7.0 mmol/L or 1 hour postprandial plasma glucose > 11.0 mmol/L or Glycosylated hemoglobin A1c (HbA1c) > 7.0%
Renal, hepatic or cardiac failure
Pregestational use of metformin
Pregnancy with multiple fetuses
Intervention: Combigan
Trial phase: Phase 3
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12.CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 98
Group description: Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Ocular hypertension or primary open-angle glaucoma in each eye
Requires treatment with IOP-lowering medication in both eyes

Exclusion Criteria:

Required chronic use of ocular medications during the study other than study medication
Use of any corticosteroids within 30 days
History of any prior eye surgery, except for uncomplicated eye surgery performed more than 6 months before the Screening visit
Anticipated wearing of contact lenses during the study
Intervention: Tretinoin
Trial phase: Phase 3
ATC code: D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02
SMILES: CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 401
Group description: active cream

Tretinoin: Topical skin
Eligibility criteria:
A subject will be eligible to participate if they meet all of the following inclusion criteria:

Normal, healthy male and female children and adults.
Age 12 to 40 years.
Written and verbal informed consent must be obtained. Subjects age 12 to 17 (inclusive) must sign an assent for the study and a parent or a legal guardian must sign the informed consent (per FDA letter 8.21.07).
Women of child-bearing potential must be non-pregnant and non-nursing, and must be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study, adequate contraception is defined as regular use of any two of the following: oral, injectable contraceptives, condoms, spermicides, diaphragm, IUD, implantable and contraceptive patches. (oral contraceptives if used for at least three months and injectable contraceptives if used for at least 6 months)- prior to enrollment in the study, or abstinence.
Have at least 20 inflammatory (papules and pustules) and 25 non-inflammatory (open and closed comedones) lesions with a maximum of 2 nodulocystic lesions on the face (per FDA letter 8.21.07).
Global severity score from 2-4
Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period.
Considered reliable and capable of understanding their responsibility and role in the study.

Exclusion Criteria

A subject will be eligible to participate if they meet none of the following exclusion criteria:

Subjects with active cystic acne as evidenced by more than 2 facial nodules.
More than 40 papules and/or pustules (inflammatory lesions)
More than 60 open and or closed comedones/milia (non-inflammatory lesions)
Overall severity grade of less than 2 or greater than 4,
History of allergy or hypersensitivity to tretinoin.
Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease
Use of systemic retinoid treatment within six months prior to study initiation.
Oral contraceptives should not be started or changed within 3 months prior to study initiation or planned to change during the study.
Pregnant or breast-feeding.
Participation in a clinical study for acne within 4 months preceding study initiation.