anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Hydrocortisone
Trial phase: Phase 2
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: 31
Group description: Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
Eligibility criteria:
Inclusion Criteria:

Patient in the Memorial Hermann Children's Hospital (MHCH) neonatal intensive care unit with a birth weight ≤ 1000 grams.
Ventilator-dependent between 10 and 21 days of age.
Respiratory index score (RIS: mean airway pressure x fraction of inspired oxygen) of ≥ 2.0 that is increasing or stable for the previous 24 hours or a RIS ≥ 3.0 if improvement noted in the past 24 hours.

Exclusion Criteria:

Prior postnatal steroid treatment.
Evidence of sepsis or necrotizing enterocolitis.
Known major congenital anomalies of the cardiopulmonary or central nervous system.
Infants being treated with indomethacin or those likely to require treatment in the next 7 days as judged by the treating physician.
Inability or unwillingness of parent or legal guardian/representative to give written informed consent.
Gestational age < 23 weeks.
Intervention: Galantamine
Trial phase: Phase 4
ATC code: N06DA04
SMILES: [H][C@]12C[C@@H](O)C=C[C@]13CCN(C)Cc1ccc(OC)c(c13)O2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 42
Group description: galantamine, 24mgs, p.o., qday

galantamine: see arm/group description
Eligibility criteria:
Inclusion Criteria:

DSM-IV diagnosis of either schizophrenia or schizoaffective disorder.
Males and females
Age: 18 and 60
Caucasian or Non-Caucasian
Subjects will be currently treated with one of the following new generation antipsychotics: olanzapine, risperidone, quetiapine, ziprasidone, or aripiprazole.
Subjects will meet a priori criteria for cognitive impairment severity. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will be used to determine the level of cognitive impairment. Patients will meet entry criteria if they have a RBANS total score of 90 or less (one standard deviation below the normal control mean).

Exclusion Criteria:

History of an organic brain disease
History of DSM-IV alcohol or substance abuse (within the last month), or DSM-IV alcohol or substance dependence (within the last six months).
Pregnant women and women taking oral contraceptives (because of the theoretical risk of breakthrough ovulation).
Current treatment with galantamine or other acetylcholinesterase inhibitor (e.g. donepezil)
History of a second or third degree atrioventricular (AV) block.
Persons with chronic medical conditions, which are unstable.
Intervention: Galantamine
Trial phase: Phase 4
ATC code: N06DA04
SMILES: [H][C@]12C[C@@H](O)C=C[C@]13CCN(C)Cc1ccc(OC)c(c13)O2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 44
Group description: placebo, 3 tablets, p.o., qday

galantamine: see arm/group description
Eligibility criteria:
Inclusion Criteria:

DSM-IV diagnosis of either schizophrenia or schizoaffective disorder.
Males and females
Age: 18 and 60
Caucasian or Non-Caucasian
Subjects will be currently treated with one of the following new generation antipsychotics: olanzapine, risperidone, quetiapine, ziprasidone, or aripiprazole.
Subjects will meet a priori criteria for cognitive impairment severity. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will be used to determine the level of cognitive impairment. Patients will meet entry criteria if they have a RBANS total score of 90 or less (one standard deviation below the normal control mean).

Exclusion Criteria:

History of an organic brain disease
History of DSM-IV alcohol or substance abuse (within the last month), or DSM-IV alcohol or substance dependence (within the last six months).
Pregnant women and women taking oral contraceptives (because of the theoretical risk of breakthrough ovulation).
Current treatment with galantamine or other acetylcholinesterase inhibitor (e.g. donepezil)
History of a second or third degree atrioventricular (AV) block.
Persons with chronic medical conditions, which are unstable.
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: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
Eligibility criteria:
Inclusion Criteria:

Previous participation in the Study Of Pharmacogenetics In Ethnically Diverse Populations (SOPHIE) study.
Between the ages of 18 and 40.
Possess a specific OCT1 genotype.

Exclusion Criteria:

Taking any medications other than vitamins
Individuals with anemia (hemoglobin < 12 g/dL), an elevation in liver enzymes to higher than double the respective normal value, or elevated creatinine concentrations (males ≥ 1.5 mg/dL, females ≥ 1.4 mg/dL)
Pregnant at time of study.
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: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin
Eligibility criteria:
Inclusion Criteria:

Subjects have previously participated in the Study Of Pharmacogenetics In Ethnically Diverse Populations (SOPHIE) study.
18-40 years old
Possess a pre-specified genotype for OCT2

Exclusion Criteria:

Taking any regular medications other than vitamins.
Individuals with anemia (hemoglobin < 12 g/dL), an elevation in liver enzymes to higher than double the respective normal value, or elevated creatinine concentrations (males ≥ 1.5 mg/dL, females ≥ 1.4 mg/dL)
Pregnant or breastfeeding
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: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin
Eligibility criteria:
Inclusion Criteria:

Subjects have previously participated in the Study Of Pharmacogenetics In Ethnically Diverse Populations (SOPHIE) study.
18-40 years old
Possess a pre-specified genotype for OCT2

Exclusion Criteria:

Taking any regular medications other than vitamins.
Individuals with anemia (hemoglobin < 12 g/dL), an elevation in liver enzymes to higher than double the respective normal value, or elevated creatinine concentrations (males ≥ 1.5 mg/dL, females ≥ 1.4 mg/dL)
Pregnant or breastfeeding
Intervention: Sirolimus
Trial phase: Phase 2 | Phase 3
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: 49
Group description: Thymoglobulin induction, sirolimus and no maintenance corticosteroid.

Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid
Eligibility criteria:
Inclusion Criteria:

African American recipient race
Solitary cadaveric or living donor renal transplantation
Age ≥18years at the time of transplantation
Negative pregnancy serum test in females with childbearing potential

Exclusion Criteria:

Age < 18 years at the time of transplantation
Multi-organ transplant recipient
Currently taking steroids
White Blood Cell Count < 3,000
Platelet count < 100,000
Triglycerides >400mg/dL
Cholesterol > 350 mg/dL
Unwillingness to comply with study procedures
Allergic reaction to sirolimus Allergy to polyclonal antilymphocyte drugs (Thymoglobulin)
Intervention: Imiquimod
Trial phase: Phase 3
ATC code: D06BB10
SMILES: CC(C)Cn1cnc2c(N)nc3ccccc3c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 169
Group description: Aldara (imiquimod) cream 5%
Eligibility criteria:
Inclusion Criteria:

Have at least 1 previously untreated superficial basal cell carcinoma tumor
Minimum tumor size 0.5 cm2 and maximum diameter of 2.0 cm

Exclusion Criteria:

Evidence of clinically significant, unstable medical conditions
Cannot have recent use of topical steroids or retinoids in the treatment area.
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: Accepts Healthy Volunteers
Participants at risk: 17
Group description: All participants will be taking Latanoprost; This study compares efficacy within age groups.

Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks
Eligibility criteria:
Inclusion Criteria:

diagnosis of open angle glaucoma,
pseudoexfoliation glaucoma, pigmentary glaucoma or ocular hypertension in one or both eyes;
IOP above their target pressure as determined by a glaucoma specialist;
willingness to participate in the study.

Exclusion Criteria:

hypersensitivity to any of the components of the treatment medication;
previous use of topical prostaglandins;
documented ocular infection or intraocular inflammation within the past year;
previous filtering surgery or complicated cataract surgery;
active corneal disease;
presence of cystoid macular edema;
laser trabeculoplasty or any other ocular laser procedure within the past three months.
Intervention: Galantamine
Trial phase: Phase 4
ATC code: N06DA04
SMILES: [H][C@]12C[C@@H](O)C=C[C@]13CCN(C)Cc1ccc(OC)c(c13)O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Galantamine for 12 weeks

Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study.
Eligibility criteria:
Inclusion Criteria:

Admitted to a rehabilitation hospital with primary diagnosis of ischemic stroke (cardiovascular accident)
Stroke was within 30 days of being admitted
Medically stable
Presence of memory and/or attentional impairments and evidence that these impairments were not present or were less severe prior to the stroke (assessed via interview with family)
Approval by individual's attending physician at the rehabilitation hospital

Exclusion Criteria:

Aphasia or cognitive (or behavioral) impairments severe enough to prevent valid neuropsychiatric assessment
Currently experiencing a major depressive episode (unless treated and in partial remission, assessed using the Primary Care Evaluation of Mental Disorders)
Current psychosis or mania
History of substance or alcohol abuse or dependence within three months of study entry
Currently taking a cholinomimetic drug
Medical condition with known sensitivity to donepezil (e.g., slower than normal heart rate, supraventricular cardiac conduction defects, severe asthma or obstructive pulmonary disease, active upper gastrointestinal bleed, or gastric/duodenal ulcer if not on acid-blocking agent)
Informed that taking donepezil is medically inadvisable
Current use of any anticholinergic medication (e.g., for bladder spasm)
Intervention: Cilostazol
Trial phase: Phase 4
ATC code: B01AC23
SMILES: O=C1CCc2cc(OCCCCc3nnnn3C3CCCCC3)ccc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1337
Group description: cilostazol, oral tablet, 100 mg cilostazol
Eligibility criteria:
Inclusion Criteria:

Patients with stable medical conditions for 182 days (26 weeks) after occurrence of cerebral infarction
Patients in whom the infarct-related foci was detected by X-ray CT scan or MRI
Patients aged 20 to 80 years (inclusive) at time of consent
Patients with none of the following cardiac diseases that may be associated with cardiogenic cerebral embolism: mitral stenosis, prosthetic heart valve, endocarditis, myocardial infarction within 6 weeks after occurrence, ventricular aneurysm, endocardial thrombosis, mitral valve prolapse (patients less than 45 years of age in whom no other cause was identified), atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy, and patent foramen ovale
Patients without asymptomatic cerebral infarction
Patients who have neither undergone nor are scheduled to undergo percutaneous transluminal angioplasty or revascularization for the treatment of cerebral infarction
Patients without severe disturbances/impairments following occurrence of cerebral

Exclusion Criteria:

Patients with hemorrhage or bleeding tendency (hemophilia, capillary fragility, intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary tract, hemoptysis, and hemorrhage in the vitreous body)
Pregnant, possibly pregnant, or nursing women
Patients with ischemic heart failure
Patients with peptic ulcer
Patients with severer blood disorders
Patients with severe hepatic or renal
Patients with malignant neoplasm or patients who have received any therapy for malignant neoplasm within 5 years prior to entering the study
Patients with a history of hypersensitivity to salicylic acid formulations or ingredients of cilostazol tablets
Patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory analgesic agents) or a history of aspirin asthma
Patients who are being treated with ticlopidine hydrochloride
Patients who are participating in another study for an investigational drug
Patients who are otherwise judged inappropriate for inclusion in the study by the investigators
Intervention: Fluoxetine
Trial phase: Phase 4
ATC code: N06AB03 | N06CA03
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 25
Group description: Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.

Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score.
Eligibility criteria:
Inclusion Criteria:

Male or female children and adolescents aged 16 and younger
BDD or its delusional variant present currently and for at least 6 months prior to the study
Ability to communicate meaningfully with the investigators and competent to provide written assent

Exclusion Criteria:

Presence of Schizophrenia or Bipolar Disorder
Recent suicide attempt or suicidal ideations that warrant hospitalizations
Previous allergic reaction to fluoxetine
History of a seizure disorder
Intervention: LITHIUM CARBONATE
Trial phase: Phase 2
SMILES: O=C([O-])[O-].[Li+].[Li+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
Eligibility criteria:
INCLUSION CRITERIA

Patients older than 16 years with well-differentiated papillary or follicular thyroid cancer stage I or II, according to the NTCTCS classification at time of surgery
Patients younger than 45 years with any size of primary papillary or follicular tumor

Patients older than 45 years with:

primary papillary tumor less than 4 cm or
primary follicular tumor less than 1 cm

EXCLUSION CRITERIA

Patients with postsurgical thyroid remnant more than 5 g
Patients with distant metastases

Patients above 45 years of age having:

known cervical lymph nodes metastases
microscopic multifocal follicular cancer
microscopic extraglandular invasion of follicular cancer
gross extraglandular invasion of papillary or follicular cancer
Patients with confirmed histological subtypes of well-differentiated thyroid cancer such as Hurtle cell carcinoma, insular and tall cell variants of papillary cancer.
Pregnant or lactating women
Patients with renal impairment defined as repeat serum creatinine concentrations above 1.5 mg/dl on thyroid hormone
Patients on chronic lithium therapy for psychiatric illness
Patients with current unstable cardiovascular conditions
Patients with severe chronic medical conditions (liver failure, severe debilitation, dehydration, sodium depletion, any other cancer requiring therapy, etc)
Intervention: Dasatinib
Trial phase: 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: 68
Group description: Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily
Eligibility criteria:
Inclusion Criteria:

Patients >/= 18 years old who meet the following eligibility criteria
Patients must have one of the following hematopoietic malignancies: C-kit positive (10% or more BM or PB MNC positive by flow) acute myeloid leukemia (AML excluding acute promyelocytic leukemia) or myelodysplastic syndrome (MDS) of the following types: Refractory-relapse AML-MDS including those who fail to achieve Complete Response (CR) after the first cycle of induction; Second or subsequent AML-MDS refractory-relapse; Newly diagnosed AML-MDS patients over 60 years of age with karyotype other than t(15:17), inv16, t(8:21), who do not want chemotherapy.
(Con't from # 2) Patients with MDS who do not want chemotherapy as initial treatment, or who are not eligible for the treatments of higher priority.
Agnogenic myeloid metaplasia - myelofibrosis (MMM)
Hypereosinophilic syndrome (HES)
Polycythemia vera (PV)
Mastocytosis
Serum bilirubin less than 2mg%, serum creatinine less than 2mg% unless abnormality is considered due to hematologic malignancy by investigator.
Eastern Cooperative Oncology Group (ECOG) Performance Status < 3
Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
Women of pregnancy potential must practice an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. Prior to study enrollment, women of childbearing potential (WOCBP) (defined as not post-menopausal for 12 months or no previous surgical sterilization) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
Continued from #11: In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.Women and men must continue birth control for the duration of the trial and at least 3 months after the last dose of study drug.
Inclusion of women and minorities: As per NIH policy, women and members of minorities will be included in this protocol as they are referred in the relevant populations. There are no exclusions of women or minorities based on the study objectives.
New York Heart Association (NYHA) Class < 3
Ph negative MPD including chronic myelomonocytic leukemia (CMML).

Exclusion Criteria:

Pregnant or breast-feeding women are excluded.
All WOCBP MUST have a negative pregnancy test prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study.
Intervention: Oxycodone
Trial phase: Phase 3
ATC code: N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19
SMILES: COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 250
Group description: Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Eligibility criteria:
Inclusion Criteria:

Adult patients with chronic noncancer pain severe enough to require continuous opioid therapy (a score of at least 5 in "pain right now" on a 11 point numeric rating scale) who have never received an opioid or are currently treated with a weak opioid, and who experience insufficient pain control.

Exclusion Criteria:

Patients who have been treated with strong opioids (including hydromorphone and oxycodone) within the last 4 weeks prior to study inclusion or who will probably undergo any treatment (e.g. neurological techniques, surgery) within the next 6 months, which may abruptly alter degree or nature of pain experienced
patients with a history of disease(s), current illness, or therapy which would preclude them from participation in the study
and patients who are pregnant or nursing.