anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Duloxetine
Trial phase: Phase 4
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Duloxetine + clinical management

Duloxetine: Duloxetine up to 120 mg/day + Clinical Management
Eligibility criteria:
Inclusion Criteria:

Age >/= 60
Current episode of MDD per SCID DSM-IV criteria
Must score >/= 16 on the CES-D assessment
Serum sodium >/=130 mEq/ml
CLBP of at least moderate severity for more days than not for >/= 3 months
MADRS score >/= 15
Sufficiently medically stable to be able to participate in a depression treatment protocol
Willingness and ability to speak English Access to translators is limited. It would be unsafe to treat an older adult who does not speak English with an antidepressant and not be able to effectively communicate with them about their progress and any side effects. We provide a 24/7 on-call service for all subjects enrolled in this study. The on-call clinicians and physicians are not bilingual, and if a problem arose, it may be impossible to effectively interpret and manage the emergent situation. Finally, many of the assessments used in the study are self-reports. At the present time, we do not have the ability to translate these instruments into other languages. If the subject cannot read and understand English, this would interfere with their ability to complete the self-report assessments
Willingness to discontinue other antidepressants and anxiolytics, except for lorazepam up to 2 mg/day
Mini Mental State Exam > 20
Willingness to provide informed consent
Corrected visual ability that enables reading of newspaper headlines and hearing capacity that is adequate to respond to a raised conversational voice.

Exclusion Criteria:

Meet DSM-IV criteria for dementia
History of bipolar, schizophrenia, schizoaffective, or other psychotic disorder
Alcohol or other drug abuse (including abuse of prescription medications) within the past 6 months
History of treatment non-adherence in other protocols run by the Mid-Life or Late-Life Centers
Acute pain superimposed on chronic pain. For example, subjects who report "red flags" which suggest a herniated disk, vertebral fracture, infection, cauda equina syndrome, or other medical emergency will be excluded
Wheelchair bound
History of documented non-response to duloxetine
Concurrent use of thioridazine
Active suicidal ideation with plan
Uncontrolled narrow angle glaucoma
Intervention: Fluorouracil
Trial phase: Phase 4
ATC code: L01BC02 | L01BC52
SMILES: O=c1[nH]cc(F)c(=O)[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions

Fluorouracil 0.5%: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions
Eligibility criteria:
Inclusion Criteria:

Any male or female 50 years of age or older with moderate to severe actinic keratoses of the face and anterior scalp diagnosed by a dermatologist will be eligible for participation.

Exclusion Criteria:

Age less than 50.
Known allergy or sensitivity to topical Carac® in the subject.
Inability to complete all study-related visits.
Introduction of any other prescription medication, topical or systemic, for actinic keratosis while participating in the study.
Subjects should not receive surgical or cryotherapy while participating in the study.
Pregnant women, women who are breast feeding, or women of child bearing potential who are not practicing two acceptable methods of birth control
Intervention: Pregabalin
Trial phase: Phase 2
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
Eligibility criteria:
Inclusion Criteria:

- Fibromyalgia diagnosed according to 1990 American College of Rheumatology criteria

Exclusion Criteria:

Unstable medical or psychological conditions that would compromise the subject's safety or put the subject at greater risk during study participation
Other painful conditions that may confound the diagnosis or assessment of fibromyalgia
Treatment with other drugs for fibromyalgia with 14 days of study start or during the study
Intervention: Budesonide
Trial phase: Phase 3
ATC code: A07EA06 | D07AC09 | R01AD05 | R03AK07 | R03AK12 | R03AL11 | R03BA02
SMILES: CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C)C4C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 94
Group description: 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
Eligibility criteria:
Inclusion Criteria:

Completed 12 weeks of treatment in the MAP0010-CL-P301 study.
Patient, parent, and guardian (as appropriate) are willing for child to undergo all study procedures and willing to sign the informed consent and assent, as appropriate.

Exclusion Criteria:

Less than 80% compliance with either study treatment and/or other study procedures (e.g., completion of symptom e-diary) in the MAP0010-CL-P301 Study.
Intervention: Budesonide
Trial phase: Phase 3
ATC code: A07EA06 | D07AC09 | R01AD05 | R03AK07 | R03AK12 | R03AL11 | R03BA02
SMILES: CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C)C4C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 98
Group description: 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
Eligibility criteria:
Inclusion Criteria:

Completed 12 weeks of treatment in the MAP0010-CL-P301 study.
Patient, parent, and guardian (as appropriate) are willing for child to undergo all study procedures and willing to sign the informed consent and assent, as appropriate.

Exclusion Criteria:

Less than 80% compliance with either study treatment and/or other study procedures (e.g., completion of symptom e-diary) in the MAP0010-CL-P301 Study.
Intervention: Celecoxib
Trial phase: Phase 2
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).
Eligibility criteria:
Key Inclusion Criteria:

Patients who will be receiving at least 5000 centigray (cGy) radiation therapy to at least 2 of 14 pre-defined areas in the oral cavity.
Women of childbearing potential must agree to use a medically accepted form of contraception during the course of the study. Women of childbearing potential must have a documented negative pregnancy test within fourteen days of enrollment in the study.
Patient's willing and able to provide written informed consent for the study.

Key Exclusion Criteria:

Patients with known hypersensitivity to celecoxib or other COX-2 inhibitors.
Patients who have experienced asthma, urticaria, or allergic-type reactions after taking salicylates (e.g. aspirin) or Non-steroidal anti-inflammatory drugs (NSAIDs).
Patients who have demonstrated allergic-type reactions to sulfonamides.
Patients with a history of gastric, esophageal, pyloric channel or duodenal ulcer disease or gastrointestinal bleeding.
Patients with a history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) or pancreatic disease.
Patients with severe hepatic impairment.
Patients with advanced renal disease.
Patients with a significant bleeding disorder.
Patients under the age of 18 or over the age of 75.
Women who are pregnant or nursing.
Patients with a history of thromboembolic events including myocardial infarction, pulmonary embolism, deep venous thrombosis, transient ischemic attack and ischemic cerebrovascular accident (stroke).
Patients who have had coronary angioplasty, coronary artery bypass surgery or another cardiac revascularization procedure.
Patients with a history of a cardiac arrhythmia requiring anti-arrhythmic therapy, angina pectoris or congestive heart failure.
Intervention: Hydrochlorothiazide
Trial phase: Phase 4
ATC code: C03AA03 | C03AB03 | C03AX01 | C03EA01 | C09BX03 | C09DX01 | C09DX03 | C09DX06 | C09DX07 | C09DX08 | C09XA52 | C09XA54 | G01AE10
SMILES: NS(=O)(=O)c1cc2c(cc1Cl)NCNS2(=O)=O
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 128
Group description: At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
Eligibility criteria:
Inclusion Criteria:

Age 70 years or older.
Patients with hypertension prior to being randomized into study.
Patients must have an office cuff MSSBP ≥ 140 and ≤ 200 mmHg systolic.
Have the ability to communicate and comply with all study requirements.
Provide written informed consent to participate in the study prior to any screening or study procedures.

Exclusion Criteria:

Use of other investigational drugs within 30 days of enrollment.
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
Office blood pressure measured by office machine cuff with a mean of (3) MSDBP ≥ 120 mmHg at anytime during the screening / washout period.
Patients taking 3 or more antihypertensive drugs and MSSBP ≥ 160 mmHg at the time of Visit 1.
Other protocol-defined exclusion criteria may apply
Intervention: Valsartan
Trial phase: Phase 4
ATC code: C09CA03 | C09DA03 | C09DB01 | C09DB08 | C09DX01 | C09DX02 | C09DX04 | C09DX05 | C10BX10
SMILES: CCCCC(=O)N(Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1)[C@H](C(=O)O)C(C)C
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 128
Group description: At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
Eligibility criteria:
Inclusion Criteria:

Age 70 years or older.
Patients with hypertension prior to being randomized into study.
Patients must have an office cuff MSSBP ≥ 140 and ≤ 200 mmHg systolic.
Have the ability to communicate and comply with all study requirements.
Provide written informed consent to participate in the study prior to any screening or study procedures.

Exclusion Criteria:

Use of other investigational drugs within 30 days of enrollment.
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
Office blood pressure measured by office machine cuff with a mean of (3) MSDBP ≥ 120 mmHg at anytime during the screening / washout period.
Patients taking 3 or more antihypertensive drugs and MSSBP ≥ 160 mmHg at the time of Visit 1.
Other protocol-defined exclusion criteria may apply
Intervention: Saxagliptin
Trial phase: Phase 3
ATC code: A10BD10 | A10BD21 | A10BD25 | A10BH03
SMILES: N#CC1CC2CC2N1C(=O)C(N)C12CC3CC(CC(O)(C3)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 284
Group description: Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosed with Type 2 diabetes
Patients should be drug naïve ie, not received medical treatment for diabetes,
HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization)

Exclusion Criteria:

Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes),
Type 1 diabetes,history of ketoacidosis or hyperosmolar non-ketonic koma
Intervention: LOTEPREDNOL ETABONATE
Trial phase: Phase 3
ATC code: S01BA14
SMILES: [H][C@@]12CC[C@](OC(=O)OCC)(C(=O)OCCl)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 204
Group description: Loteprednol Etabonate Ophthalmic Ointment 0.5%
Eligibility criteria:
Inclusion Criteria:

Subjects at least 18 years of age
Subjects who have the ability to understand and sign an informed consent form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
Subjects who are candidate for routine, uncomplicated cataract surgery.
Subjects who are not of childbearing potential or subjects who have a negative urine pregnancy test result at screening.
Subjects must be willing and able to comply with all treatment and follow- up procedures.

Exclusion Criteria:

Subjects who have known hypersensitivity or contraindication to the study drug or its components.
Subjects who have a history or presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or compound the result of the study.
Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
Subjects with elevated intraocular pressure (>/= 21 mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.
Subjects who have had ocular surgery in the study eye within 3 months or in the fellow eye within 2 weeks prior to the screening visit.
Women who are pregnant or breast feeding.
Subjects who have participated in an investigational drug or device study within the last 30 days.
Subjects previously randomized in this study.
Intervention: Prednisolone
Trial phase: Phase 2
ATC code: A01AC04 | A01AC54 | A07EA01 | C05AA04 | D07AA03 | D07BA01 | D07CA03 | D07XA02 | H02AB06 | R01AD02 | R01AD52 | S01BA04 | S01BB02 | S01CA02 | S01CB02 | S02BA03 | S02CA01 | S03BA02 | S03CA02 | V03AB05
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)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: Tobramycin prednisolone acetate combination

T-PRED: sterile ophthalmic solution at the first time point

Pred Forte: sterile ophthalmic solution at the first time point
Eligibility criteria:
Inclusion Criteria:

18 years of age

Exclusion Criteria:

No active or adverse disease
Intervention: PREDNISOLONE ACETATE
Trial phase: Phase 2
SMILES: CC(=O)OCC(=O)C1(O)CCC2C3CCC4=CC(=O)C=CC4(C)C3C(O)CC21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: Prednisolone acetate

T-PRED: sterile ophthalmic solution at the second time point

Pred Forte: sterile ophthalmic solution at the second time point
Eligibility criteria:
Inclusion Criteria:

18 years of age

Exclusion Criteria:

No active or adverse disease
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: 60
Group description: switched to Kaletra + Isentress
Eligibility criteria:
Inclusion Criteria:

HIV-1-infected individuals receiving HAART regimen (if on PI-based regimen, must be 1st PI-containing HAART).
They must have been on and tolerating current HAART regimen for > 6-months.
Plasma HIV-1 viral load < 50 copies/ml at study entry.
Men and women age > 18 years (sex is defined as sex at birth).

Laboratory values obtained within 30 days prior to study entry:

Hemoglobin > 9.4 g/dl
Creatinine < 2 mg/dl
AST (SGOT) < 2 x ULN
ALT (SGPT) < 2 x ULN
Ability and willingness of subject or legal guardian/representative to give written informed consent.
No CD4 T-cell counts requirement

Exclusion Criteria:

Subjects with a history of previous intolerance to or virological failure to LPV/r
Concomitant drugs (including alternative therapies) that may affect PI or RAL plasma concentrations (inducers or inhibitors of the CYP 3A4 or UDP-glucuronosyltransferase iso-enzymes).
A known history of noncompliance with medications or a known history of noncompliance with scheduled physician and clinic visits.
Investigational ARV drug.
Pregnancy/Breast feeding.
HBV-coinfected patients receiving nucleoside analogue for both HIV and HBV suppression.
Active drug or alcohol use or dependence which, in the Investigator's opinion, may interfere with adherence to study requirements or endanger subject's health while on the study.
Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to the screening visit.
Intervention: Erbitux
Trial phase: Phase 2
SMILES: C=C1N(CCCCCC(=O)O)c2ccccc2C1(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: 400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
Eligibility criteria:
Inclusion Criteria:

Informed consent form signed prior to study entry
Age between 18-69 years old
Pathology approved to be nasopharyngeal carcinoma (types WHO Ⅱ-Ⅲ)
Stage Ⅲ, Ⅳa, Ⅳb according to UICC (International Union Against Cancer) 2002 6th edition criteria
Primary tumor measurable
KPS score ≥80
Expected life span ≥6 months
Adequate bone marrow function: White Blood Cell≥4×109/L，Hemoglobin≥100g/L，Platelet≥100×109/L
Adequate liver function: ALAT/ASAT<1.5 × upper limit of normal (ULN), bilirubin <1.5×ULN
Adequate renal function: Creatinine Clearance < 1.5×ULN

Exclusion Criteria:

Evidence of distant metastatic disease
Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy)
Previous radiotherapy for the primary tumor or lymph nodes
Previous exposure to epidermal growth factor-targeted therapy
Prior chemotherapy or immunotherapy for the primary tumor
Other previous malignancy within 5 years, except non-melanoma skin cancer or pre-invasive carcinoma of the cervix
Any investigational agent prior to the 1st study medication
Participation in another clinical study within the 30 days prior to Inclusion in this study.
Peripheral neuropathy > grade 1
Known grade 3 or 4 allergic reaction to any of the study treatment
History of severe pulmonary or cardiac disease
Creatinine Clearance < 30ml/min
Know drug abuse / alcohol abuse
Legal incapacity or limited legal capacity
Active systemic infection
Medical or psychiatric illness, which in the investigators' opinions, would not permit the subject to complete or fully and completely understand the risks and potential complications of the study
Concurrent chronic systemic immune therapy or hormone therapy not indicated in the study protocol
Pregnancy (confirmed by serum or urine β-HCG) or lactation period
Severe intercurrent illness, e.g. uncontrolled hypertension, cardiac failure
Intervention: Atorvastatin
Trial phase: Phase 4
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Patients with Ischemic Cardiomyopathy receiving Lipitor.
Eligibility criteria:
Inclusion Criteria:

Ischemic Cardiomyopathy (as defined above) with ejection fraction < 35%
Non-ischemic Cardiomyopathy with ejection fraction < 35%
NCEP ATPIII indication for therapy with a statin drug
No statin therapy within previous 6 months of study enrollment
Prescribed stable doses of standard heart failure therapies including beta blocking agents, angiotensin converting enzyme inhibitors or angiotensin receptor blockers, and diuretic agents as required

Exclusion Criteria:

Pregnant or lactating
Myocardial infarction within 6 months preceding study enrollment
Primary valvular heart disease
Surgical or catheter based revascularization within the preceding 6 months
Documented viral or inflammatory myocarditis or cardiomyopathy
Peripartum cardiomyopathy
Infiltrative cardiomyopathies
Chemotherapy associated cardiomyopathy
Without indication for statin therapy
Contraindication to statin therapy including hepatic dysfunction, history of rhabdomyolysis or prior intolerance of statin therapy
Contraindication to magnetic resonance imaging
Intervention: Daptomycin
Trial phase: Phase 3
ATC code: J01XX09
SMILES: CCCCCCCCCC(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(N)=O)C(=O)NC(CC(=O)O)C(=O)NC1C(=O)NCC(=O)NC(CCCN)C(=O)NC(CC(=O)O)C(=O)NC(C)C(=O)NC(CC(=O)O)C(=O)NCC(=O)NC(CO)C(=O)NC(C(C)CC(=O)O)C(=O)NC(CC(=O)c2ccccc2N)C(=O)OC1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
Eligibility criteria:
Inclusion Criteria:

Hospitalized patients, awaiting scheduled elective coronary artery bypass graft (CABG) surgery without valve replacement surgery
Age > 18 years and < 75 years
BMI between 18.5 and 35.0 kg/meters-squared
Crcl > 50 ml/minute calculated based on Cockcroft Gault equation
No known active or suspected infection(s)
Ability to complete the informed consent process
Negative pregnancy test (for women of childbearing age)

Exclusion Criteria:

History of allergic reaction to daptomycin or components of daptomycin
Receipt of daptomycin within 7 days prior to the surgery
Elevated CPK levels (defined as > 3 times the upper limits of known normal)
History of myopathy or complaints consistent with myopathy
Current or planned use of mycophenolate mofetil, mycophenolic acid, or tobramycin during the subjects' current hospitalization (all of which are known to interact with daptomycin)
Inability to complete the informed consent process because of problems with mental capacity
Pregnancy and/or breast feeding