anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Gabapentin
Trial phase: Not Applicable
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
Eligibility criteria:
Inclusion Criteria:

Male or female patients >18 years of age referred to IUMC for first-time ERCP procedure.

Exclusion Criteria:

Pregnant women
age <18 years
Incarcerated individuals
Patients currently taking or having taken gabapentin or pregabalin within the last 3 months
Patients unable to give informed consent
Patients not able to fill out visual analog scales for pain, nausea and anxiety or unable to fill out survey regarding procedural satisfaction.
High risk patients for anesthesia: home oxygen, class III or IV heart failure, sleep apnea (on CPAP/BiPAP at home), or ASA class > 3.
Patients undergoing general anesthesia for their ERCP procedure
Patients receiving propofol sedation for their ERCP procedure
Intervention: Brimonidine
Trial phase: Early Phase 1
ATC code: D11AX21 | S01EA05 | S01GA07
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Eyedrops for lowering intraocular pressure

Brimonidine: One drop of brimonidine in each eye three times a day for six weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects must be 19 years of age or older
Subjects must exhibit a history of untreated IOPs between 21 and 35 mmHg (inclusive)

Exclusion Criteria:

Age less than nineteen years old
Women who are pregnant, lactating or of childbearing potential who are not using birth control measures.
Aphakia or pseudophakia
Best corrected visual acuity worse than 20/60 in either eye
Chronic or recurrent severe ocular inflammatory disease
Ocular infection or inflammation within (3) months of screening visit.
History of clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment.
Any abnormality preventing reliable tonometry of either eye.
Previous exposure to: beta-adrenergic antagonists, topical prostaglandin analogues within six (6) weeks of the baseline visit; α-adrenergic agonists within two (2) weeks of the baseline visit; and cholinergic agonists and carbonic anhydrase inhibitors within five (5) days of the treatment initiation visit.
History of any severe ocular pathology (including severe dry eye) that would prelude the administration of a topical beta blocker, carbonic anhydrase inhibitor, or a topical prostaglandin.
Any eye with a cup-to-disc ratio greater than 0.8.
History of intraocular surgery
History of ocular laser surgery
History of severe or serious hypersensitivity to brimonidine or its vehicle.
History of severe, unstable, or uncontrolled cardiovascular, hepatic or renal disease.
History of bronchial asthma or chronic obstructive pulmonary disease (COPD).
Less than one month (prior to baseline) stable dosing regimen of any non-glaucoma medication that would affect IOP.
Gonioscopy angle < 2.
Inability to be dosed with treatment medication
Inability to discontinue contact lens wear.
Therapy with any investigational agent within 30 days of screening.
Use of any additional topical or systemic adjunctive ocular hypotensive medications during the study.
History of open angle glaucoma (either primary open angle glaucoma or other cause of open angle glaucoma) or narrow angle glaucoma.
Intervention: PROPYLENE GLYCOL
Trial phase: Early Phase 1
SMILES: CC(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Lubricated eye drops

Artificial tears: Lubricating drops added three times a day for six weeks
Eligibility criteria:
Inclusion Criteria:

Subjects must be 19 years of age or older
Subjects must exhibit a history of untreated IOPs between 21 and 35 mmHg (inclusive)

Exclusion Criteria:

Age less than nineteen years old
Women who are pregnant, lactating or of childbearing potential who are not using birth control measures.
Aphakia or pseudophakia
Best corrected visual acuity worse than 20/60 in either eye
Chronic or recurrent severe ocular inflammatory disease
Ocular infection or inflammation within (3) months of screening visit.
History of clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment.
Any abnormality preventing reliable tonometry of either eye.
Previous exposure to: beta-adrenergic antagonists, topical prostaglandin analogues within six (6) weeks of the baseline visit; α-adrenergic agonists within two (2) weeks of the baseline visit; and cholinergic agonists and carbonic anhydrase inhibitors within five (5) days of the treatment initiation visit.
History of any severe ocular pathology (including severe dry eye) that would prelude the administration of a topical beta blocker, carbonic anhydrase inhibitor, or a topical prostaglandin.
Any eye with a cup-to-disc ratio greater than 0.8.
History of intraocular surgery
History of ocular laser surgery
History of severe or serious hypersensitivity to brimonidine or its vehicle.
History of severe, unstable, or uncontrolled cardiovascular, hepatic or renal disease.
History of bronchial asthma or chronic obstructive pulmonary disease (COPD).
Less than one month (prior to baseline) stable dosing regimen of any non-glaucoma medication that would affect IOP.
Gonioscopy angle < 2.
Inability to be dosed with treatment medication
Inability to discontinue contact lens wear.
Therapy with any investigational agent within 30 days of screening.
Use of any additional topical or systemic adjunctive ocular hypotensive medications during the study.
History of open angle glaucoma (either primary open angle glaucoma or other cause of open angle glaucoma) or narrow angle glaucoma.
Intervention: Silodosin
Trial phase: Phase 2
ATC code: G04CA04
SMILES: C[C@H](Cc1cc2c(c(C(N)=O)c1)N(CCCO)CC2)NCCOc1ccccc1OCC(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 119
Group description: silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age or older
Male or a non-pregnant, non-lactating female using adequate means of birth control, if not menopausal
Have radiopaque unilateral ureteral calculus ≥4mm and ≤10mm in any location of the ureter

Exclusion Criteria:

Multiple ureteral calculi, or a solitary kidney, or refractory renal colic, or a non-opaque calculus, or active urinary tract infection, or severe hydronephrosis
History of previous ureteral surgery or ureteral stricture on affected side
History of any of the following conditions: myasthenia gravis, myopathy, spina bifida, spinal cord injury, autonomic nervous system disorder, fibromyalgia, breast cancer
Moderate to severe renal impairment or severe liver insufficiency
History of significant postural hypotension
Is receiving medication(s) which preclude safe participation in the study or that may produce a confounding effect on the variables under study
History of allergy to alpha-blockers or oxycodone
Intervention: Doxazosin
Trial phase: Phase 2
ATC code: C02CA04 | G04CA55
SMILES: COc1cc2nc(N3CCN(C(=O)C4COc5ccccc5O4)CC3)nc(N)c2cc1OC
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 96
Group description: Doxazosin 8 mg/day
Eligibility criteria:
Inclusion Criteria: (1) Signed informed consent form (2) Subject understands the risk and benefits and agrees to visit frequency and procedures (3) Male or female (4) Any race or ethnic origin (5)Diagnosis of cocaine-dependence according to DSM-IV criteria (6) between the ages of 18 and 64 (7)Must be current users of cocaine with self-reported use of cocaine at least once weekly for at least one month preceding study entry, cocaine-positive urine screen and score over 3 which is the cut-off for diagnosis of cocaine dependence as assessed with the Severity of Dependence Scale (Kaye & Darke 2002; Gossop, et al 1995; Gossop, et al. 1997) (8)Women of childbearing age are eligible to be included in the study if they have a negative pregnancy test at screening, agree to adequate contraception to prevent pregnancy, to have monthly pregnancy tests, and they understand the risk of fetal toxicity due to medication.

Exclusion Criteria: (1)Current diagnosis of other drug , especially alcohol or benzodiazepine dependence or abuse (other than cocaine or tobacco) (2) Significant medical conditions (e.g., major cardiovascular, renal, endocrine, hepatic disorders) such as abnormal liver function (with laboratory findings of SGOT or SGPT greater than three times normal), hypotension or hypertension, a current cardiac condition, and those having a high risk of cardiovascular disease, seizure disorders, or another significant underlying medical condition which would contraindicate Doxazosin treatment (3)Lifetime schizophrenia, bipolar disorder, or other psychotic disorders (4) Actively considering plans of suicidality or homicidality (5) Current use of a prescribed psychotropic medication that cannot be discontinued (6) Women planning to become pregnant or breastfeed during the study, or refuse to use a reliable form of birth control or refuse monthly pregnancy testing (7) Subjects who are prescribed any anti-hypertension drugs, except thiazides, will be excluded because these medications may interact with Doxazosin's brain effects in reducing cocaine abuse.
Intervention: Insulin
Trial phase: Not Applicable
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(N)=O)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: 20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of probable AD
Age over 21
Clinical Dementia Rating of 0.5 or 1.0
Mini Mental State Exam Score>15

Exclusion Criteria:

preexisting diabetes
significant neurological disease that might affect cognition, other than AD, including stroke, Parkinson's disease, multiple sclerosis
severe head injury with loss of consciousness > 30 minutes or with permanent neurological sequelae
significant medical illness or organ failure, such as uncontrolled hypertension or cardiovascular disease, chronic obstructive pulmonary disease, liver disease, or kidney disease
current use of anti-psychotic or anti-convulsant medications
current or previous use of hypoglycemic agents or insulin
MRI contraindications
claustrophobia
pregnancy
Intervention: Ferrous Sulfate
Trial phase: Phase 3
ATC code: B03AA07
SMILES: O=S(=O)([O-])[O-].[Fe+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 112
Group description: oral iron sulphate twice a day

iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks
Eligibility criteria:
Inclusion Criteria:

Men and women, aged more than 18 years.
Subjects diagnosed with cancer (non-myeloid malignancies) receiving chemotherapy at least 1 day prior to screening and who are going to receive at least two more chemotherapy cycles.
Hb < 12 g/dL (7.4 mmol/L).
TfS <50%.
Serum Ferritin <800 ng/ml.
An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
Willingness to participate after informed consent (including HIPAA, if applicable).

Exclusion Criteria:

Anemia caused primarily by other factors than CIA.
IV or oral iron treatment within 4 weeks prior to screening visit.
Erythropoietin treatment within 4 weeks prior to screening visit.
Blood transfusion within 4 weeks prior to screening visit.
Imminent expectation of blood transfusion on part of treating physician.
Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulfate).
Known hypersensitivity to any excipients in the investigational drug products.
Subjects with a history of multiple allergies.
Decompensated liver cirrhosis or active hepatitis (alanine aminotransferase (ALAT) > 3 times upper normal limit).
Active acute or chronic infections (assessed by clinical judgement and if deemed necessary by investigator supplied with white blood cells (WBC) and C-reactive protein (CRP)).
Rheumatoid arthritis with symptoms or signs of active joint inflammation.
Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches).
Planned elective surgery during the study.
Participation in any other clinical study (except chemotherapy protocol) within 3 months prior to screening.
Known intolerance to oral iron treatment.
Untreated B12 or folate deficiency.
Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
Intervention: Duloxetine
Trial phase: Phase 2
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Duloxetine 30 mg, 60 mg
Eligibility criteria:
Inclusion Criteria:

Provision of signed, written, and dated Informed Consent
Documented primary clinical diagnosis of Major Depressive Disorder

Exclusion Criteria:

Patients with a secondary psychiatric disorder including bipolar disorder, psychotic disorders (i.e. schizophrenia, schizoaffective disorder, depression with psychotic features), GAD and social anxiety disorder
Patients whose current episode of depression started less than 4 weeks before enrollment
History of inadequate response of antidepressants during current depressive episode
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 83
Group description: Saline: Saline Control
Eligibility criteria:
Inclusion Criteria:

singleton pregnancy,
at least 36 weeks gestational age,
active labor (≤ 5 cm dilation) requesting neuraxial analgesia,
ASA I or II,
not currently taking pain medications.

Exclusion Criteria:

multiple gestation,
preterm labor,
systemic opioids in the past 4 hours,
chronic pain syndromes,
chronic opioid use,
contraindications to regional anesthesia,
allergies to opioids,
significant co existing medical problems,
severe pregnancy induced hypertension,
sedatives,
magnesium therapy,
diabetes type 1.
Intervention: Morphine
Trial phase: Not Applicable
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 83
Group description: Morphine: Active dosage
Eligibility criteria:
Inclusion Criteria:

singleton pregnancy,
at least 36 weeks gestational age,
active labor (≤ 5 cm dilation) requesting neuraxial analgesia,
ASA I or II,
not currently taking pain medications.

Exclusion Criteria:

multiple gestation,
preterm labor,
systemic opioids in the past 4 hours,
chronic pain syndromes,
chronic opioid use,
contraindications to regional anesthesia,
allergies to opioids,
significant co existing medical problems,
severe pregnancy induced hypertension,
sedatives,
magnesium therapy,
diabetes type 1.
Intervention: Lopinavir and ritonavir
Trial phase: Phase 3
ATC code: J05AR10
SMILES: CC(C)c1nc(CN(C)C(=O)NC(C(=O)NC(Cc2ccccc2)CC(O)C(Cc2ccccc2)NC(=O)OCc2cncs2)C(C)C)cs1.Cc1cccc(C)c1OCC(=O)NC(Cc1ccccc1)C(O)CC(Cc1ccccc1)NC(=O)C(C(C)C)N1CCCNC1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 148
Group description: Participants are assigned to remain on their current LPV/r-based antiretroviral regimen. Ritonavir-boosted lopinavir syrup was given twice per day at 230 mg/m^2 per dose. Children able to swallow tablets were given 1 tablet twice per day (200 mg lopinavir/50 mg ritonavir) if body surface area was less than 0.9m^2 or 2 tablets twice per day if body surface area was 0.9m^2 or higher
Eligibility criteria:
Inclusion Criteria:

HIV-infected child 3 to 5 years of age at time of screening for this trial if enrolled from outside or any age if enrolled from control arm of Neverest II.
Reliable history or documented exposure to NVP used as part of PMTCT
Initiated antiretroviral therapy with LPV/r at age less than 36 months
Receiving LPV/r-based ART for at least 12 months
At least one viral load measurement less than 50 copies/ml conducted as part of screening for the study
ALT measurement grade I or less (DAIDS Toxicity Tables 2004) (Appendix A). These may be repeated until ALTs normalize if necessary.

Exclusion criteria:

Prior treatment with any NNRTI drug as part of a therapeutic regimen
Substitution of other NRTI drugs (instead of 3TC and D4T which are the standard first line regimen) will be allowed.
Intervention: Rufinamide
Trial phase: Phase 3
ATC code: N03AF03
SMILES: NC(=O)c1cn(Cc2c(F)cccc2F)nn1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
Eligibility criteria:
Inclusion criteria

Participants who are diagnosed as Lennox-Gastaut syndrome with tonic/atonic seizures and atypical absence seizures (A history of atypical absence seizures will also be incorporated).
Participants who had a slow spike-and-wave pattern in an electroencephalogram within 6 months prior to the enrollment for the Observation Period.
Participants who had at least a total of 90 seizures in the 28 days prior to the enrollment for the Observation Period.
Participants who have been on 1 - 3 anti-epileptic drugs from 28 days prior to the enrollment for the Observation Period and have not changed the type of the anti-epileptic drugs.
Participants who have not changed the type nor the dose or administration of the anti-epileptic drugs they are taking in the Observation Period.

Exclusion criteria;

Participants who had a history of generalized tonic-clonic status epilepticus within baseline.
Participants who received drug therapy at least 4 times to be rescued from status epilepticus within baseline.
Participants who had a history of hypoxia which needed emergency resuscitation within 12 months prior to the Treatment Period.
Participants who were on a ketogenic diet or have received adrenocorticotropic hormone (ACTH) therapy or Vitamin B6 therapy within 6 months prior to the Treatment Period.
Participants who had a history of suicide attempt within the 1 year prior to the Treatment Period.
Participants who had a history of or has an allergy to triazole compound.
Participants who have clinically significant electrocardiogram abnormalities at baseline.
Participants who are pregnant, who may be pregnant, who are lactating or who wish to be pregnant.
Intervention: Raltegravir
Trial phase: Phase 4
ATC code: J05AJ01 | J05AR16 | J05AX08
SMILES: Cc1nnc(C(=O)NC(C)(C)c2nc(C(=O)NCc3ccc(F)cc3)c(O)c(=O)n2C)o1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily

Raltegravir: Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily
Eligibility criteria:
Inclusion Criteria:

HIV infected patients, age >18 years, meet Vietnam guideline to begin ART (CD4 count < 350 cells/mm3 and/or WHO stage III or IV disease)
Hepatitis C infection as documented by positive HCV antibodies and a detectable serum HCV RNA level
AST and ALT ≤ 2 x ULN (≤ 80 U/L)
Estimated creatinine clearance ≥ 60 mL/min

Exclusion Criteria:

Any prior ART
Positive Hepatitis B surface antigen
Clinical evidence of de-compensated cirrhosis (ascites, encephalopathy, esophageal bleeding)
Requirement for acute therapy for other AIDS-defining illness within 14 days prior to study entry
Currently on rifampicin therapy
In the first trimester of pregnancy, intent to become pregnant, or breast feeding during the study period
Intervention: Timolol
Trial phase: Early Phase 1
ATC code: C07AA06 | C07BA06 | C07DA06 | S01ED01 | S01ED51
SMILES: [H][C@](O)(CNC(C)(C)C)COc1nsnc1N1CCOCC1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 5
Group description: Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.

topical 0.5% Timolol: topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily
Eligibility criteria:
Inclusion Criteria:

Infants 1 month to 8 months of age with infantile hemangioma (IH) that are 3 cm or less on the scalp, trunk, or extremities.

Exclusion Criteria:

Subjects with facial, genital, perianal, hand, finger, feet, or toe IH
Subjects with PHACES (plaque-like hemangioma on the face awaiting imaging) syndrome (proven) or suspected PHACES .
Subjects with IH measuring more than 3cm in size or ulcerated.
Children with a history of hypersensitivity to beta blockers.
Children with a personal history of asthma.
Children with known renal impairment.
Children with known cardiac conditions that may predispose to heart block
Personal history of hypoglycemia
Children on medications that may interact with beta blockers