anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Citalopram
Trial phase: Phase 4
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 239
Group description: Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Eligibility criteria:
Inclusion Criteria:

Have received treatment with an SSRI (escitalopram, sertraline, paroxetine, or citalopram) for major depressive disorder
Females of child-bearing potential to test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control
Apathy Evaluation Scale - Clinician Rated Version (AES-C) total score >30 at screening and randomization.
Montgomery-Asberg Depression Rating Scale (MADRS) total score ≤15 and Item 1 (apparent sadness) score of <2 at screening and randomization.
Have a level of understanding sufficient to provide informed consent and to communicate with the investigators, study coordinator, and site personnel.

Exclusion Criteria:

Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device
Have previously completed or withdrawn from this study or any other study investigating duloxetine.
Have had previous lack of response to an adequate trial of duloxetine within the past 12 months or escitalopram at any time.
Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), diagnosis of mania, bipolar disorder, treatment resistant depression or psychosis; or current suicide risk
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision(DSM-IV-TR),substance abuse or dependence within the 6 months
Presence of an Axis II disorder
Monoamine oxidase inhibitor (MAOI) treatment within 14 days prior to randomization or the potential need to use an MAOI during the study
Positive urine drug screen for any substance of abuse or excluded medication.
Are pregnant or breast-feeding.
Serious medical illness, requires hospitalization during the study
Have uncontrolled narrow-angle glaucoma.
Have acute liver injury or severe cirrhosis
Abnormal thyroid stimulating hormone (TSH) concentration
Amphetamines, dopaminergic medications or modafinil within 14 days prior to randomization or potential need to use such medications during the study or within 14 days of discontinuation of study drug.
Intervention: Ritonavir
Trial phase: Phase 1
ATC code: J05AE03 | J05AE30 | J05AP52 | J05AP53 | J05AR10 | J05AR23 | J05AR26
SMILES: CC(C)c1nc(CN(C)C(=O)N[C@H](C(=O)N[C@@H](Cc2ccccc2)C[C@H](O)[C@H](Cc2ccccc2)NC(=O)OCc2cncs2)C(C)C)cs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: All participants were given three sequential doses of lopinavir/ritonavir: lopinavir/ritonavir 400/100mg twice daily (2 heat-stable 200/50mg tablets BID), lopinavir/ritonavir 200/150mg twice daily (1 heat-stable 200/50mg tablet BID plus 1 ritonavir 100mg capsule BID), lopinavir/ritonavir 200/50mg twice daily (1 heat-stable 200/50mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period.
Eligibility criteria:
Inclusion Criteria:

Subjects must meet all of the following inclusion criteria within 28 days prior to the baseline visit:

The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
Male or non-pregnant, non-lactating females
Between 18 to 65 years, inclusive
Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive.
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month after the study

Exclusion Criteria:

Any significant acute or chronic medical illness
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
Positive blood screen for hepatitis B core and/or C antibodies and/or hepatitis B surface antigen
Positive blood screen for HIV-1 and/or 2 antibodies
Current or recent (within 3 months) gastrointestinal disease
Clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study
Exposure to any investigational drug or placebo within 3 months of first dose of study drug
Consumption of grapefruit, or Seville oranges or any grapefruit or Seville orange containing product within one week of first dose of study drug and for the duration of the study
Use of any other drugs, including over-the-counter medications and herbal preparations, within two weeks prior to first dose of study drug, unless approved/prescribed by the Principal Investigator as known not to interact with study drugs.
Females of childbearing potential without the use of effective non-hormonal birth control methods, or not willing to continue practising these birth control methods for at least 30 days after the end of the treatment period
Previous allergy to any of the constituents of the pharmaceuticals administered in this trial
Intervention: Dutasteride
Trial phase: Phase 2
ATC code: G04CA52 | G04CB02
SMILES: [H][C@@]12CC[C@@]3([H])NC(=O)C=C[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1([H])C(=O)Nc1cc(C(F)(F)F)ccc1C(F)(F)F
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
Eligibility criteria:
Inclusion Criteria:

40-85 year old males
Patient is newly diagnosed with clinical Stage T1a-T2c prostate cancer based on transrectal guided extended prostate biopsy of at least 10 cores.
Patient elects to undergo 3D mapping biopsy at our center as part of prostate cancer management.
Patient will read, understand and sign the informed consent agreement
Patients must have a life expectancy of at least one year.
Gleason score ≤ 7 (low to moderate risk 2-7) 7= 3+4
Percentage positive core rate < 50% based on sextant or extended biopsy technique.
Prostate Volume (PV) >15 grams.
Negative imaging studies ( if available) during the staging period such as Bone scan, MRI and CT scan if PSA> 10 ng.dl before initiation of the study drug

Exclusion Criteria:

Any 5α-reductase inhibitors medications within the past 12 months before enrollment.
Known hypersensitivity to dutasteride, or other 5α-reductase inhibitors.
Anticipated blood donation within the next 90 days.
Serum PSA levels of >20ng/dl.
Clinical evidence of metastatic prostate cancer.
Two documented urinary tract infections in the past year
CHF, MI (within 6 months) or other symptomatic CVS disease
Other serious diseases (hematological, hepatic, renal, respiratory or psychiatric)
Enrollment in other studies for any disease in the past 30 days
Significant urinary incontinence
Diagnosis of cancer that in not considered cured, except BCC of skin
Prior transurethral resection of the prostate with a large tissue defect.
History of abdominoperineal resection for rectal cancer, rectal stenosis, or other major rectal pathology
Previous or concurrent radiotherapy, hormonal therapy or chemotherapy
Intervention: Fusidate Sodium
Trial phase: Phase 4
SMILES: CC(=O)OC1CC2(C)C(CC(O)C3C4(C)CCC(O)C(C)C4CCC32C)C1=C(CCC=C(C)C)C(=O)[O-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 40
Group description: Fucidin® cream 20 mg/g 3 times daily for 10 days
Eligibility criteria:
Inclusion Criteria:

Patients with a clinical diagnosis of impetigo,
Patients aged 2-11 years,
Patients of either sex,
Patients whose parent(s) has(ve) provided written consent, AND
Patients with a severity score of 1 for at least one of the following signs: pustules/infected bullae, erythema and infiltration/induration.

Exclusion Criteria:

Patients with other active inflammatory dermatitis at the area of impetigo,
Patients with a temperature above 38.5 C rectally (or equivalent), OR
Patients who have been administered topical or systemic Fucidin® or other antibacterial agents within the previous 4 weeks.
Intervention: Fusidate Sodium
Trial phase: Phase 4
SMILES: CC(=O)OC1CC2(C)C(CC(O)C3C4(C)CCC(O)C(C)C4CCC32C)C1=C(CCC=C(C)C)C(=O)[O-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 16
Group description: Fucidin® cream vehicle 3 times daily for 10 days
Eligibility criteria:
Inclusion Criteria:

Patients with a clinical diagnosis of impetigo,
Patients aged 2-11 years,
Patients of either sex,
Patients whose parent(s) has(ve) provided written consent, AND
Patients with a severity score of 1 for at least one of the following signs: pustules/infected bullae, erythema and infiltration/induration.

Exclusion Criteria:

Patients with other active inflammatory dermatitis at the area of impetigo,
Patients with a temperature above 38.5 C rectally (or equivalent), OR
Patients who have been administered topical or systemic Fucidin® or other antibacterial agents within the previous 4 weeks.
Intervention: Mifepristone
Trial phase: Not Applicable
ATC code: G03XB01 | G03XB51
SMILES: [H][C@@]12CC[C@@](O)(C#CC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted

Mifepristone 200 mg : mifepristone would be given the day before the procedure

All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique.
Eligibility criteria:
Inclusion Criteria:

women aged 18-45 having pregnancy termination at 14-16 weeks

Exclusion Criteria:

multiple gestation, pre-existing infection, contraindication to osmotic dilators, unable to obtain proper consent
Intervention: Sapropterin
Trial phase: Not Applicable
ATC code: A16AX07
SMILES: CC(O)C(O)C1CNc2nc(N)[nH]c(=O)c2N1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 6
Group description: All subjects will received KUVAN therapy 20 mg/kg/day for four months.
Eligibility criteria:
Inclusion Criteria:

Males or females over the age of 18 years
Subject must be able to give independent informed consent
Girls must have a negative urine pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.
Subject must have a confirmed diagnosis of PKU
Subjects with Phenylalanine (Phe) levels over 10 mg/dL
Subjects naïve to KUVAN therapy or has not received KUVAN in the 6 months before screening

Exclusion Criteria:

Pregnancy
Cognitive deficits resulting from physical trauma (e.g. subject with history of severe birth trauma).
Neurologic comorbidities including a history of a stroke or a seizure disorder.
Laboratory abnormalities that indicate clinically significant hepatic disease Aspartate aminotransferase (AST)> 2.0 times the upper limit of normal, Alanine transaminase (ALT) > 2.0 times the upper limit of normal, Prothrombin Time (PT) > 2.0 times the upper limit of normal, Partial Thromboplastin Time(PTT) > 2.0 times the upper limit of normal
Subjects using medications such as steroids, insulin and glucagons that may interfere with the results of PET scan.
Subjects using medications that inhibit folate metabolism such as methotrexate
Subjects using medications known to affect nitric oxide-mediated vasorelaxation.
Subjects using Levodopa
Treatment with KUVAN in the past 6 months before study entry.
Treatment with any investigational product in the last 90 days before study entry
Intervention: NIACIN
Trial phase: Not Applicable
ATC code: C04AC01 | C10AD02 | C10AD52 | C10BA01
SMILES: O=C(O)c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Subjects in this arm will be given 12 weeks of extended release niacin
Eligibility criteria:
Inclusion Criteria:

Age ≥18 years
Documented HIV infection
Subjects must have taken HAART 6 months prior to study entry and must be on stable HAART (no dose change to antiretroviral medications) for at least 30 days immediately prior to study entry
HDL < 40 mg/dL • LDL < 130 mg/dL
All subjects with reproductive potential should utilize adequate contraception for the duration of this study and for at least 12 weeks following permanent discontinuation of study treatment. Acceptable methods include male condom, female condom, diaphragm, or intra-uterine device (IUD)

Exclusion Criteria:

Known cardiac disease
Arrhythmia
History of angina
Uncontrolled hypertension
Pregnancy
Breast-feeding
Medication known to influence vasodilatation such as nitrates, metformin, pioglitazone, and rosiglitazone
Heavy use of vitamin supplements
Diagnosis of diabetes mellitus
Treatment with lipid-lowering drugs within 6 weeks prior to study
Hemoglobin <9.0 mg/dL
Absolute neutrophil count <750 cells/mm3
Platelet count <75,000 platelets/ mm3
Alanine aminotransferase (ALT or SGOT)/ aspartate aminotransferase (AST or SGPT) / alkaline phosphatase > 2.5 x upper limit of normal (ULN)
Creatinine >1.5 x ULN
Individuals with an infection or other medical illness requiring hospitalization within 14 days prior to study entry
Individuals who have active alcohol or drug abuse which, in the investigator's opinion, is sufficient to prevent adequate compliance with study therapy and evaluations
Prior history of hypersensitivity reaction to niacin or any other component of the study drug
Intervention: Rosuvastatin
Trial phase: Phase 2 | Phase 3
ATC code: A10BH52 | C10AA07 | C10BA06 | C10BA09 | C10BX05 | C10BX07 | C10BX09 | C10BX10 | C10BX13 | C10BX14 | C10BX16 | C10BX17 | G01AE10
SMILES: CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1/C=C/[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: rosuvastatin 10 mg qd increased to 20 mg qd as tolerated

rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years
Eligibility criteria:
Inclusion Criteria:

HIV infection
Age > 18 years old
On stable antiretroviral therapy for > 6 months with no plans to change therapy during the treatment phase of the study
Plasma HIV RNA < 50 copies/mL
Karnofsky performance score > 70 within 30 days prior to study entry
Ability to understand and sign informed consent

Following laboratory values obtained within 30 days prior to randomization:

Absolute neutrophil count (ANC) > 750/mm3
Hemoglobin >/= 8.0 g/dL
Platelets >/= 50,000/mm3
ALT (SGPT) and AST (SGOT) < 2.5 x ULN
Fasting glucose < 126 mg/dL
TSH < 3.0 mIU/L
HDL-C < 50 mg/dL in men, < 55 mg/dL in women
Direct LDL-C </= 130 mg/dL
Calculated creatinine clearance > 50 mL/min
Willing to be treated with rosuvastatin or be on an observational arm for a minimum of 3 months
Female subject must not participate in a conception process (active attempt to become pregnant) or be post-menopausal. If participating in sexual activity that could lead to pregnancy, the subject must use contraception while receiving study medication and 30 days after stopping the medication

Exclusion criteria

History of past cardiovascular event
Acute illnesses or active AIDS-defining opportunistic infection (OI) within 30 days prior to entry
Other chronic illness including diabetes, autoimmune diseases, and endocrinopathies
Serology positive for hepatitis B surface antigen or hepatitis C antibody
Signs and symptoms of liver failure
Receipt of supraphysiologic glucocorticoid therapy within 3 months prior to study entry
Use of lipid lowering agents within 30 days prior to study entry
Receipt of an HIV vaccine or investigational agents
Pregnancy or breast-feeding
Presence of any active malignancy within the last 5 years
Severe Hypertension (Systolic >/= 180 or Diastolic >/= 110 mm Hg)
Use of oral postmenopausal hormone replacement therapy
Known hypersensitivity to rosuvastatin
Active drug or alcohol dependence
Any acute illness within 30 days prior to study entry that, in the opinion of the site investigator, would interfere with participation in the study.
Use of lopinavir/ritonavir (Kaletra) as part of current HIV antiretroviral regimen
Intervention: Allopurinol
Trial phase: Phase 2
ATC code: M04AA01 | M04AA51
SMILES: Oc1ncnc2[nH]ncc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 128
Group description: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.

allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
Eligibility criteria:
Inclusion Criteria:

NYHA class II-IV heart failure due to ischemic or non-ischemic cardiomyopathy.
Left ventricular ejection fraction ≤ 40% by echocardiography- Heart failure symptoms for 3 months despite standard treatment.
Serum uric acid level ≥ 9.5 mg/dl.
At least one of the following additional markers of increased risk: Hospitalization, ER visit or urgent clinic visit for heart failure requiring IV diuretics within the previous 12 months; Left ventricular ejection fraction ≤ 25; B-type natriuretic peptide level > 250 pg/ml

Exclusion Criteria:

Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis, biopsy-proven myocarditis, severe stenotic valvular disease, or complex congenital heart disease.
Acute coronary syndrome, PCI or CABG within 3 months.
Current ventricular assist device or ventricular assist device or heart transplant likely within the next 6 months.
Uncontrolled hypertension (i.e., SBP > 170 mm Hg or DBP > 110 mm Hg)
Serum creatinine > 3 mg/dL or estimated GFR < 20 ml/min.
Evidence of active hepatitis with ALT and AST greater than 3x normal.
Any condition other than HF which could limit the ability to perform a 6-minute walk test
Any diseases other than HF which are likely to alter the patient's global perception of status or quality of life over a period of 6 months.
Receiving treatment with allopurinol currently or within 30 days, or having symptomatic hyperuricemia which requires treatment with allopurinol.
Intervention: Healon
Trial phase: Phase 4
SMILES: CC(=O)NC1C(O)OC(CO)C(O)C1OC1OC(C(=O)O)C(OC2OC(CO)C(O)C(OC3OC(C(=O)O)C(O)C(O)C3O)C2NC(C)=O)C(O)C1O.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: sodium hyaluronate 0.18% (VISMED® Multi)
Eligibility criteria:
Inclusion Criteria:

Have been using artificial tears for at least 3 months prior to study inclusion
Have been using preservative free artificial tears at least three times daily (TIB) for at least 2 weeks immediately prior to study inclusion
Having moderate to severe symptoms suggestive of dry eye

Exclusion Criteria:

Current enrollment in an investigational drug or device study or participation in such a study within 3 months prior to entry into this study
Moderate to severe blepharitis
History or active signs of ocular trauma, ocular infection, or ocular inflammation within the last 3 months
History or active signs of ocular allergic disease or ocular herpes within the last year
History or active signs of severe or serious ocular conditions such as inflammatory corneal ulcers, recurrent erosions, and uveitis at any time.
Intervention: Maraviroc
Trial phase: Phase 2
ATC code: J05AX09
SMILES: Cc1nnc(C(C)C)n1[C@@H]1C[C@H]2CC[C@@H](C1)N2CC[C@H](NC(=O)C1CCC(F)(F)CC1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
Eligibility criteria:
Inclusion Criteria:

HIV-1 infection as documented by ELISA and confirmed by either Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA by RT-PCR or bDNA at any time prior to study entry.
Receipt of ARV medication uninterrupted for > 1 year leading up to the screening period with demonstrated HIV RNA < 50 copies/ml for a period of 1 year."
Willingness for both males and females of childbearing potential to utilize 2 effective contraception methods (2 separate forms, one of which must be an effective barrier method), be non-heterosexually active or have a an exclusive vasectomized partner from screening throughout the duration of the study treatment and for 30 days following the last dose of study drugs.
Age >18 years.
Ability and willingness to provide written informed consent

The following laboratory parameters documented within 30 days prior to study entry:

Hemoglobin >8.0
Absolute neutrophil count >500
Platelet count >40,000
AST (SGOT) and ALT (SGPT) <5 x ULN
Creatinine <1.5 x ULN
Lipase <2.0 x ULN
Estimated creatinine clearance > 60 mL/min.
HIV DNA within peripheral blood mononuclear cells > 100 copies/mL
Not currently receiving Maraviroc as part of ARV regimen

Exclusion Criteria:

Past or present HIV opportunistic infection of the brain, learning disability, head injury with prolonged loss of consciousness or cognitive sequelae, or other non-HIV risk factor that may impact cognitive performance.
Any factor that precludes MRI scan including presence of metal or exposure to metal work (e.g., metal grinder/worker) and claustrophobia
History of seizure disorder
History of myocardial infarction, angina, congestive heart failure, peripheral vascular disease, angioplasty or cardiac surgery
Current malignancy or history of past malignancies excluding basal cell CA
Any immunomodulator, HIV vaccine, or investigational therapy within 30 days of study entry.
Any vaccination within 30 days of study entry.
Requirement for acute therapy for other AIDS-defining illness or other serious medical illnesses (in the opinion of the site investigator) within 14 days prior to study entry.
Other chronic illnesses including diabetes, autoimmune diseases, and endocrinopathies, except subjects on stable physiologic replacement therapy for low testosterone or thyroid levels
Known hypersensitivity to Maraviroc
Any condition which, in the opinion of the investigator, would compromise the subject's ability to participate in the study
Current active substance or alcohol dependence
Pregnancy or breast-feeding, intent to become pregnant during the course of the study.
Intervention: Oseltamivir
Trial phase: Phase 1
ATC code: J05AH02
SMILES: CCOC(=O)C1=C[C@@H](OC(CC)CC)[C@H](NC(C)=O)[C@@H](N)C1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 40
Group description: Participants aged 91 to <365 days received oral suspension of oseltamivir 3 milligram (mg)/kilogram (kg) twice a day for 5 days
Eligibility criteria:
Inclusion Criteria:

infants </=12 months of age
laboratory confirmed diagnosis of influenza within 96 hours prior to first dose
influenza symptoms for </=96 hours prior to first dose

Exclusion Criteria:

preterm infants less than 40 weeks (corrected for gestational age)
weight less than 5th percentile for age (corrected for gestational age)
concurrent gastrointestinal conditions that preclude enteric absorption of the drug
bronchopulmonary dysplasia/chronic lung disease on assisted ventilation at time of enrollment
active or uncontrolled respiratory, cardiac, hepatic, CNS or renal disease at baseline
symptomatic inborn errors of metabolism