anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Efavirenz
Trial phase: Phase 4
ATC code: J05AG03 | J05AR06 | J05AR11
SMILES: O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
Eligibility criteria:
Inclusion Criteria:

HIV-1 infection
The absence of exclusionary resistance mutations on a genotypic resistance assay
Antiretroviral (ARV) drug-naïve
Screening HIV-1 RNA >1000 copies/mL
Screening CD4+ T-cell count < 200 cells/ml

Laboratory values obtained within 30 days prior to study entry.

Absolute neutrophil count (ANC) >500/mm3
Hemoglobin >8.0 g/dL
Platelet count >40,000/mm3
AST (SGOT), ALT (SGPT), and alkaline phosphatase <5 x ULN
Total bilirubin <2.5 x ULN
Calculated creatinine clearance ≥60 mL/min (by Cockcroft-Gault equation)
For women of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to initiating study medications.
Contraception requirements
Men and women age >18 years and < 60 years.
Ability and willingness of subject or legal guardian/representative to give written informed consent.

Exclusion Criteria:

Currently breast-feeding.
Use of immunomodulators, vaccines, growth hormone, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry.
Known allergy/sensitivity to study drugs, pneumococcal polysaccharide vaccine, tetanus-diphtheria vaccine
Receipt of pneumococcal polysaccharide vaccine or tetanus-diphtheria vaccine in the past 5 years.
Active drug or alcohol use or dependence
Serious illness requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 14 days prior to study entry.
Requirement for any current medications that are prohibited with any study treatment.
Evidence of any major resistance-associated mutation on any genotype or evidence of significant resistance on any phenotype performed at any time prior to study entry
Current or anticipated imprisonment or involuntary incarceration in a medical facility for psychiatric or physical (e.g., infectious disease) illness
History of, or current bipolar disorder, major depression, schizophrenia or other psychotic disorders
Intervention: Methotrexate
Trial phase: Not Applicable
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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.

Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.
Eligibility criteria:
Inclusion Criteria:

Adult patients (18 years and older) with clinically significant macular edema (CSME) with visual acuity less than 20/60 to Hand motion in the study eye.
Patients should have persistent CSME three months after laser therapy or three months after intraocular injection of Avastin or triamcinolone. These interventions could be multiple or combined.
Optical coherence tomography (OCT) scan demonstrating more than 275 microns retinal thickness in central subfield of study eye.
Ability to understand study instructions, interventions and potential complications.
History of reasonably controlled Diabetes mellitus (DM), ≤ 8.5HbA1c that has been evaluated in the last 3 months.
Ability to undergo contraceptive protection during and 3 months after intraocular injections.
Clear demonstration (in female patients) of commitment to avoid pregnancy and a negative urine pregnancy test at baseline for women of childbearing potential.
Clear understanding of teratogenic potential of MTX.

Exclusion Criteria:

History of allergy to MTX.
An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition.
An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, epiretinal membrane, etc.).
An eye treated for Glaucoma
Eyes that underwent vitrectomy
History of intraocular malignancies.
Intraocular surgery with the prior 3 months.
Recent significant change in diabetic medications.
Insulin usage less than a year.
Life threatening co morbidities such as cancer under therapy.
Use of oral, intravenous, periocular or intraocular corticosteroids (steroids) in prior 3 months.
Liver function that exceeds three times the upper limit of normal at baseline, or within 6 weeks of that appointment.
Pregnant females.
Vitreous hemorrhage (active) in study eye
Anticipation of the need for laser pan retinal photocoagulation in the next 6 months.
Media opacities
Herpetic disease of cornea
Corneal dystrophy with significant corneal edema.
Any major surgery within the last 30 days
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 | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Metformin: Metformin 500 mg od for 1 week, bd for 1 week, 1g mane 500 mg nocte 1 week, 1g bd there after. Total of 6 months treatment
Eligibility criteria:
Inclusion Criteria:

Cohort 1 - metformin treatment

Type 2 diabetes diagnosed more than 6 weeks prior to visit 1
GP considers adequate diet and lifestyle advice given
Age >35 and < 80
Age of diabetes diagnosis >35
White European
HbA1c >7% & <=9%
eGFR>=50 ml/min
ALT <= 2.5*ULN
Contactable by telephone

Cohort 2 - 2nd line treatment

Type 2 diabetes
Treated with metformin for more than 3 months; or metformin intolerant
Age >35 and < 80
Age of diabetes diagnosis >35
White European
HbA1c >7% & <=9%
eGFR>=50 ml/min
ALT <= 2.5*ULN
No previous history of heart failure; No patients with documented evidence of left ventricular systolic dysfunction OR with symptoms and signs consistent with a clinical diagnosis of heart failure
No treatment with Gemfibrozil or Rifampicin (CYP2C8 inhibitor or inducer respectively); or with Miconazole or phenylbutazone (increased hypoglycemic effect of gliclazide).
No diagnosis of osteoporosis
Contactable by telephone

Exclusion Criteria:

Cohort 1

Type 1 diabetes
HbA1c >9% or <=7%
eGFR<50 ml/min
ALT > 2.5*ULN
Alcohol consumption in excess of 50 units per week
Pregnancy, lactation or a female planning to conceive within the study period
Any other significant medical reason for exclusion as determined by the investigator

Cohort 2

Type 1 diabetes
HbA1c >9% or <=7%
eGFR< 50 ml/min
ALT > 2.5*ULN
Previous history of heart failure OR documented evidence of left ventricular systolic dysfunction OR symptoms and signs consistent with a clinical diagnosis of heart failure
Ongoing treatment with Gemfibrozil or Rifampicin (CYP2C8 inhibitor or inducer respectively); or with Miconazole or phenylbutazone (increased hypoglycemic effect of gliclazide).
Previous diagnosis of osteoporosis
Pregnancy, lactation or a female planning to conceive within the study period
Any other significant medical reason for exclusion as determined by the investigator
Intervention: Boron
Trial phase: Not Applicable
SMILES: [B]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 62
Group description: An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.

Group B: An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
Eligibility criteria:
Inclusion Criteria:

Age 18-60
Healthy nulliparous or multiparous women
Term (>36 week gestation)
Singleton pregnancy
Spontaneous labor or with spontaneous rupture of membranes
Receive oxytocin
Request neuraxial analgesia

Exclusion Criteria:

Under 18 years of age
Presence of any systemic disease (e.g., diabetes mellitus, hypertension, preeclampsia)
Use of chronic analgesic medications
Prior administration of systemic opioid labor analgesia
Non-vertex presentation
Induction of labor
Contraindication to neuraxial analgesia.
Intervention: Lenalidomide
Trial phase: Phase 2
ATC code: L04AX04
SMILES: Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Participants received lenalidomide 5mg orally daily for 57 +/- 3 days
Eligibility criteria:
Inclusion Criteria:

Describe fatigue as being present every day for most of day for a minimum of 2 weeks and rate fatigue greater than or equal to 4 on a 0-10 scale, in which 0= no fatigue and 10=worst possible fatigue as assessed by MD Anderson symptom Inventory(MDASI).
Have diagnoses of CLL and started on a new cytotoxic therapy or breast cancer receiving new cytotoxic or radiation therapy
Patients will be eligible to participate in this study if they rate sleep disturbance greater than or equal to 4 on a 0-10 scale, in which 0= disturbed sleep is not present and 10 = disturbed sleep as bad as you can imagine as assessed by MDASI.
Have a MDAS of 13 or less.
Able to understand the description of the study and give written informed consent.

Exclusion Criteria:

Patients who are unable to complete the assessment measures or refuse to participate
Patients with known history of brain metastasis.
Patients with known history of sleep apnea.
Intervention: Sirolimus
Trial phase: Phase 2
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: Child | Adult
Healthy volunteers: No
Participants at risk: 63
Group description: This includes all study participants.
Eligibility criteria:
Inclusion Criteria:

Pediatric patients' ages (0 - 21 years) with lymphoid malignancies considered for allogeneic bone marrow transplant from HLA-identical sibling donor, single antigen mismatched related or unrelated donor marrow /peripheral blood stem cell (PBSC) or cord blood available for marrow donation.

First remission:

if remission not achieved by day28
high risk cytogenetic features, including t(9;22) or t(4;11) Second or third remission
Signed informed consent.

Exclusion Criteria:

1. Organ criteria:

Cardiac: ECHO shortening fraction <27%
Renal: Creatinine clearance <60 ml/min/1.73 m2
Hepatic: Bilirubin >1.5 mg/dl, transaminases <3x normal
Infection: active viral, fungal or bacterial infection including HIV.
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: No
Participants at risk: 119
Group description: One drop self administered in the study eye(s) once daily at night for 12 weeks
Eligibility criteria:
Inclusion Criteria:

18 years or older.
Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
Intraocular pressure (IOP) controlled with BAK (benzalkonium chloride) preserved IOP-lowering medication for 1 year, with last 6 months on XALATAN® monotherapy.
Best corrected visual acuity of -0.6 logMAR or better in each eye.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Treatment with BAK preserved artificial tears within 30 days of Visit 1.
Known or suspected Sjogren's disease.
Uncontrolled IOP.
History or evidence of infectious or inflammatory ocular conditions.
Progressive retinal or optic nerve disease.
Ocular laser surgery within 3 months of Visit 1.
Keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface within 1 year of Visit 1.
Current use of punctal plugs or punctal cautery.
Use of systemic medications that has not been stable for 30 days prior to Visit 1.
Use of contact lens within 30 days of Visit 1.
Other protocol-defined exclusion criteria may apply.
Intervention: Lenalidomide
Trial phase: Phase 2
ATC code: L04AX04
SMILES: Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 48
Group description: single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.

Lenalidomide: single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
Eligibility criteria:
Inclusion Criteria:

Age > 65 years
Age < 65 but not eligible to high-dose chemotherapy and autologous stem cell transplantation
Biopsy-proven DLBCL relapsed to previous combination chemotherapy regimen ± rituximab
PR (Partial Response) or CR (Complete Response) to second-line chemotherapy (ICE or DHAP/DHAOx or MINE regimen) + rituximab
ECOG (Eastern Cooperative Oncology Group) performance status score < 4
Female of childbearing potential (FCBP) must demonstrate to practice a proper contraception to avoid any pregnancy risk during the study and at least 28 days after the discontinuation of the study
Male subjects must agree to practice a proper contraception during any sexual contact with females childbearing potential

Exclusion Criteria:

CNS (Central Nervous System) involvement
Prior ASCT
TTP (Time To Progression) <6 months after first-line therapy
Use of experimental drugs during second-line salvage chemotherapy
Severe concomitant illnesses / medical conditions (e.g. impaired respiratory and/or cardiac function, uncontrolled diabetes mellitus )
Active infectious disease
HIV, HBV (Hepatitis B Virus) or HCV (Hepatitis C Virus) - positivity
Impaired liver function (Bilirubin >2 x upper normal limit; ALT (alanine aminotransferase) /AST (aspartate aminotransferase) /GGT (γ-glutamyltransferase) > 3 x upper normal limit) at one month from salvage chemotherapy conclusion
Impaired renal function (creatinine clearance <50 ml/min) at one month from salvage chemotherapy conclusion
Absolute neutrophil count (ANC) <1000/microL
Platelet count <75.000 /mm3
Hemoglobin <9 g/dL
Non-co-operative behaviour or non-compliance
Psychiatric diseases or conditions that might impair the ability to give informed consent
Pregnant or lactating females
Intervention: Fesoterodine
Trial phase: Phase 4
ATC code: G04BD11
SMILES: CC(C)C(=O)Oc1ccc(CO)cc1[C@H](CCN(C(C)C)C(C)C)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 331
Group description: Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
Eligibility criteria:
Inclusion Criteria:

Male or female >18 years old
OAB for >3 months

Exclusion Criteria:

Patients with conditions that would contraindicate for fesoterodine use
Patients with significant hepatic and renal disease or other significant unstable diseases.
OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
Intervention: Sitaxentan
Trial phase: Phase 2
ATC code: C02KX03
SMILES: Cc1cc2c(cc1CC(=O)c1sccc1S(=O)(=O)Nc1onc(C)c1Cl)OCO2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Participants received Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in either first, second or third intervention period.
Eligibility criteria:
Inclusion Criteria:

Has stage 1-5 chronic kidney disease (CKD) as defined by the Kidney Disease Outcomes Quality Initiative (K/DOQI) with proteinuria, including any of the following aetiologies: immunoglobulin (IgA) nephropathy, polycystic kidney disease (PCKD), congenital abnormalities, reflux nephropathy, focal segmental glomerulosclerosis, minimal change nephropathy, and membranous nephropathy.

Exclusion Criteria:

Required peritoneal dialysis or haemodialysis.
Has kidney disease due to diabetes mellitus, vasculitis, systemic lupus erythematosus, or known renovascular disease; antiglomerular basement membrane disease; or is on immunosuppressive medication.
Intervention: Combigan
Trial phase: Phase 4
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12.CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 73
Group description: Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
Eligibility criteria:
Inclusion Criteria:

Be at least 18 years of age;
Give written informed consent;
Be in good general health as determined by your doctor;
Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension;
If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills);
Understand the study instructions, and be able to follow the study instructions; and
Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits.

Exclusion Criteria:

Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation;
Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Screening Visit
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: No
Participants at risk: 75
Group description: Latanoprost 0.005% ophthalmic solution
Eligibility criteria:
Inclusion Criteria:

Be at least 18 years of age;
Give written informed consent;
Be in good general health as determined by your doctor;
Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension;
If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills);
Understand the study instructions, and be able to follow the study instructions; and
Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits.

Exclusion Criteria:

Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation;
Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Screening Visit
Intervention: Combigan
Trial phase: Phase 4
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12.CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
Eligibility criteria:
Inclusion Criteria:

Age: 30 years or older.
Primary open-angle glaucoma (POAG) or ocular hypertensive in at least one eye.
Best corrected visual acuity at least 20/40 in at least one eye.

Exclusion Criteria:

History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
History or signs of intraocular trauma.
Any abnormality preventing reliable applanation tonometry.
Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.
Intervention: RIFAMPIN
Trial phase: Phase 2
ATC code: J04AB02 | J04AM02 | J04AM05 | J04AM06 | J04AM07 | J04BA50 | J04BA51
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c(C=NN5CCN(C)CC5)c(O)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 48
Group description: Rifampin 600mg daily

Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Suspected pulmonary tuberculosis with acid-fast bacilli in a stained smear of expectorated sputum. Patients having extra-pulmonary manifestations of tuberculosis, in addition to smear-positive pulmonary disease, are eligible for enrollment.
No prior history of tuberculosis disease or tuberculosis treatment
No treatment with fluoroquinolones in the 2 months preceding initiation of study drugs.
Age > 18 years
Weight ≥ 50 kg and ≤ 80 kg
Karnofsky score of at least 60 (requires occasional assistance but is able to care for most of his/her needs; see Appendix)
Signed informed consent
Ability to adhere with study follow-up
Women with child-bearing potential must agree to practice an adequate (barrier) method of birth control or to abstain from heterosexual intercourse during study therapy.
HIV negative, or HIV-positive with CD4 > 200 cells/cu mm

Laboratory parameters done at, or 14 days prior to, screening (with results available for review by study personnel):

Serum alanine aminotransferase (ALT) activity ≤ 2 times the upper limit of normal
Serum total bilirubin level ≤ 2 times the upper limit of normal
Serum creatinine level less than or equal to the upper limit of normal
Hemoglobin level of at least 7.0 g/dL
Platelet count of at least 100,000/mm3
Negative pregnancy test (women of childbearing potential)

Exclusion Criteria:

Pregnant or breast-feeding
Known intolerance or allergy to any of the study drugs
Concomitant disorders or conditions for which isoniazid (INH), rifamycins, pyrazinamide (PZA), or ethambutol (EMB) are contraindicated. These include severe hepatic damage, acute liver disease of any cause, and acute uncontrolled gouty arthritis.
Current or planned therapy, during the intensive phase of TB therapy with cyclosporine or tacrolimus, or HIV antiretroviral (ARV) therapy, which have unacceptable interactions with rifamycins.
Any medical or psychosocial condition, which, in the view of the study investigator, makes study participation inadvisable.
Pulmonary silicosis
Central nervous system TB