anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: ASPIRIN
Trial phase: Phase 4
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: Aspirin 81mg at baseline
Eligibility criteria:
Inclusion Criteria:

Women at least 19 years old
Taking 81 mg aspirin daily, non-enteric coated, for at least one month for the primary prevention of cardiovascular disease.
Able and willing to provide informed consent

Exclusion Criteria:

Pregnancy or breastfeeding
Known CHD
Currently taking clopidogrel or ticlopidine
Use of heparin, warfarin, or glycoprotein IIb/IIIa inhibitors within previous 96 hours
Allergy or hypersensitivity to salicylates
Use of other OTC or prescription analgesics or anti-inflammatory medication in the past two weeks
Currently participating in another investigational drug or device study
Intervention: Vancomycin
Trial phase: Not Applicable
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 121
Group description: Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
Eligibility criteria:
Inclusion Criteria:

Adults aged 18 years or older undergoing elective thoracic surgery at Brigham & Women's Hospital. The majority of these patients will be undergoing lung resection for either the evaluation of a lung mass, or for the removal of a known malignancy. Some participants may be undergoing biopsy or removal of a mediastinal mass.
Undergoing thoracic surgery procedure expected to require tube thoracostomy.
Ability to give informed consent

Exclusion Criteria:

Patients undergoing the following complex thoracic surgical procedures:

Pneumonectomy
Decortication
Chemical pleurodesis
Pleurectomy
Lung volume reduction
Esophagectomy

Patients with the following conditions:

Prior diagnosis of empyema or lung abscess.
Cystic fibrosis
Known or suspected pneumonia pre-operatively.
Known hypersensitivity to beta-lactam antibiotics and vancomycin
Current or recent antibiotic use within one week of surgery.
Anticipated requirement for postoperative antibiotic in addition to 48 hours of cefazolin or vancomycin.
Renal insufficiency with estimated creatinine clearance <60 ml/minute.
Intervention: Aliskiren
Trial phase: Phase 4
ATC code: C09DX02 | C09XA02 | C09XA52 | C09XA53 | C09XA54
SMILES: COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Aliskiren 150-300 mg once daily
Eligibility criteria:
Inclusion Criteria:

Diagnosis of type 2 diabetes
Diagnosis of coronary artery disease
Currently receiving therapy with an ACE-Inhibitor or Angiotensin Receptor Blocker
Currently receiving antiplatelet therapy and statin therapy
Baseline blood pressure > 100/75 mm Hg
BMI 25-35 kg/m2

Exclusion Criteria:

Concurrent calcium channel blocker therapy
Documented peripheral edema
Hyperkalemia
Serum creatinine > 2.0
Diagnosed with proteinuria
Diagnosed with liver dysfunction or serious rheumatological disorder
Intervention: Amlodipine
Trial phase: Phase 4
ATC code: C07FB07 | C07FB12 | C07FB13 | C08CA01 | C08CA17 | C08CA51 | C08GA02 | C09BB03 | C09BB04 | C09BB07 | C09BB13 | C09BX01 | C09BX03 | C09BX04 | C09DB01 | C09DB02 | C09DB04 | C09DB05 | C09DB06 | C09DB07 | C09DB09 | C09DX01 | C09DX03 | C09DX06 | C09DX07 | C09DX08 | C09XA53 | C09XA54 | C10BX03 | C10BX07 | C10BX09 | C10BX11 | C10BX14 | C10BX18 | C10BX19
SMILES: CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1c1ccccc1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: 5-10 mg amlodipine once daily
Eligibility criteria:
Inclusion Criteria:

Diagnosis of type 2 diabetes
Diagnosis of coronary artery disease
Currently receiving therapy with an ACE-Inhibitor or Angiotensin Receptor Blocker
Currently receiving antiplatelet therapy and statin therapy
Baseline blood pressure > 100/75 mm Hg
BMI 25-35 kg/m2

Exclusion Criteria:

Concurrent calcium channel blocker therapy
Documented peripheral edema
Hyperkalemia
Serum creatinine > 2.0
Diagnosed with proteinuria
Diagnosed with liver dysfunction or serious rheumatological disorder
Intervention: Olopatadine
Trial phase: Phase 4
ATC code: R01AC08 | S01GX09
SMILES: CN(C)CC/C=C1/c2ccccc2COc2ccc(CC(=O)O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: Olopatadine 0.1% in one eye in either the first or second period
Eligibility criteria:
Inclusion Criteria:

Age/Gender: males and females aged >20 to < 65 years (at the time of obtaining consent).
Positive cases in whom blood specific IgE antibody quantification against cedar pollen showed class 2-6 in a health checkup conducted within the past 3 years.
Cases who were diagnosed as patients with seasonal allergic conjunctivitis and were judged eligible as subjects of the said study by the investigator or co-investigator from the results of medical examination conducted on the day of the study or prior to it.
Cases who gave consent on study participation of their own free will in writing, with understanding the contents of the said study.

Exclusion Criteria:

Cases with an ocular disease that requires treatment other than allergic conjunctivitis.
Cases with an inflammatory ocular disease in the external/anterior part of the eye that may affect drug efficacy evaluation.
Cases with a respiratory disease such as bronchial asthma other than allergic rhinitis.
Cases with past history of anaphylaxis.
Cases with past history of hypersensitivity to olopatadine hydrochloride/tranilast.
Cases undergoing immunotherapy (hyposensitization therapy; modulated therapy).
Patients who are pregnant, lactating women, or may be pregnant, or cases wishing to be pregnant during the study period.
Other cases who are judged ineligible for participation in the main study by the doctor in charge of the study.
Intervention: Tranilast
Trial phase: Phase 4
SMILES: COc1ccc(/C=C/C(=O)Nc2ccccc2C(=O)O)cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: Tranilast 0.5% in one eye in either the first or second period
Eligibility criteria:
Inclusion Criteria:

Age/Gender: males and females aged >20 to < 65 years (at the time of obtaining consent).
Positive cases in whom blood specific IgE antibody quantification against cedar pollen showed class 2-6 in a health checkup conducted within the past 3 years.
Cases who were diagnosed as patients with seasonal allergic conjunctivitis and were judged eligible as subjects of the said study by the investigator or co-investigator from the results of medical examination conducted on the day of the study or prior to it.
Cases who gave consent on study participation of their own free will in writing, with understanding the contents of the said study.

Exclusion Criteria:

Cases with an ocular disease that requires treatment other than allergic conjunctivitis.
Cases with an inflammatory ocular disease in the external/anterior part of the eye that may affect drug efficacy evaluation.
Cases with a respiratory disease such as bronchial asthma other than allergic rhinitis.
Cases with past history of anaphylaxis.
Cases with past history of hypersensitivity to olopatadine hydrochloride/tranilast.
Cases undergoing immunotherapy (hyposensitization therapy; modulated therapy).
Patients who are pregnant, lactating women, or may be pregnant, or cases wishing to be pregnant during the study period.
Other cases who are judged ineligible for participation in the main study by the doctor in charge of the study.
Intervention: Aprepitant
Trial phase: Phase 1
ATC code: A04AD12
SMILES: C[C@@H](O[C@H]1OCCN(Cc2n[nH]c(=O)[nH]2)[C@H]1c1ccc(F)cc1)c1cc(C(F)(F)F)cc(C(F)(F)F)c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 46
Group description: In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
Eligibility criteria:
Inclusion Criteria:

Participant is scheduled to have surgery requiring a 48 hour (Part I) or 24 hour (Part II) hospital stay
Participant is scheduled to receive general anesthesia
Participant is scheduled to receive opioids (e.g. morphine or fentanyl)
Female participants of childbearing potential must have negative pregnancy test prior to drug administration
A female participant who is of reproductive potential must agree to remain abstinent or use a barrier form of contraception for at least 14 days prior to, throughout, and for at least one month following the last dose of study medication
Participant weighs 6 kg or more

Exclusion Criteria:

Participant is undergoing surgery for a life-threatening condition
Participant is pregnant or breast feeding
Participant has vomited within 24 hours prior to surgery
Participant has a known history of QT prolongation or is currently taking other medicinal products that lead to QT prolongation
Participant has an active infection (e.g., pneumonia), congestive heart failure, bradyarrythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction), evidence of any clinically significant respiratory, metabolic, hepatic, renal dysfunction, or a history of any illness, including morbid obesity, that might pose unwarranted risk
Intervention: Simvastatin
Trial phase: Phase 4
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: Simvastatin 40 mg daily

simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.
Eligibility criteria:
Inclusion Criteria:

Men and women greater than or equal to 21 years of age

Diagnosis of metabolic syndrome. We defined the presence of metabolic syndrome based on the US National Cholesterol Education Program's Adult Treatment Panel III guidelines. Specifically, metabolic syndrome will be diagnosed and documented when 3 of the following 5 characteristics will be present:

abdominal obesity, given as waist circumference for men > 102 cm, and for women > 88 cm
triglycerides > 150 mg/dL
HDL cholesterol < 40 mg/dL for men, and < 50 mg/dL for women
blood pressure > 130/85 mm Hg
fasting glucose > 100 mg/dL

Exclusion Criteria:

Patients will be excluded for a history of bleeding diathesis
drug or alcohol abuse
prothrombin time greater than 1.5 times control
platelet count < 100,000/mm3
hematocrit < 25%
creatinine > 4.0 mg/dl
surgery or angioplasty performed within 3 months or planned for the future
history of gastrointestinal or other bleeding
history of drug-induced disorders
trauma, cancer, rheumatic diseases, coronary artery disease or stroke
Patients participating in other investigational drug trials within one month of completion will be also excluded
Patients treated with intravenous platelet glycoprotein IIb/IIIa inhibitors or thienopyridines, within past 6 months
Patients treated with statins or aspirin within past four weeks
Intervention: Vytorin
Trial phase: Phase 4
ATC code: C10BA02
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21.O=C1C(CCC(O)c2ccc(F)cc2)C(c2ccc(O)cc2)N1c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.

ezetimibe/simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.
Eligibility criteria:
Inclusion Criteria:

Men and women greater than or equal to 21 years of age

Diagnosis of metabolic syndrome. We defined the presence of metabolic syndrome based on the US National Cholesterol Education Program's Adult Treatment Panel III guidelines. Specifically, metabolic syndrome will be diagnosed and documented when 3 of the following 5 characteristics will be present:

abdominal obesity, given as waist circumference for men > 102 cm, and for women > 88 cm
triglycerides > 150 mg/dL
HDL cholesterol < 40 mg/dL for men, and < 50 mg/dL for women
blood pressure > 130/85 mm Hg
fasting glucose > 100 mg/dL

Exclusion Criteria:

Patients will be excluded for a history of bleeding diathesis
drug or alcohol abuse
prothrombin time greater than 1.5 times control
platelet count < 100,000/mm3
hematocrit < 25%
creatinine > 4.0 mg/dl
surgery or angioplasty performed within 3 months or planned for the future
history of gastrointestinal or other bleeding
history of drug-induced disorders
trauma, cancer, rheumatic diseases, coronary artery disease or stroke
Patients participating in other investigational drug trials within one month of completion will be also excluded
Patients treated with intravenous platelet glycoprotein IIb/IIIa inhibitors or thienopyridines, within past 6 months
Patients treated with statins or aspirin within past four weeks
Intervention: Fluocinonide
Trial phase: Phase 4
ATC code: C05AA11 | D07AC08 | D07CC05
SMILES: [H][C@@]12C[C@@]3([H])OC(C)(C)O[C@@]3(C(=O)COC(C)=O)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: glucocorticoid cream

Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosis of AD according to Hanifin-Rajka criteria (see Appendix B)
Age 12 years or older
Must have an Investigator's Global Assessment (IGA) Score of Moderate, Severe, or Very Severe (See Appendix C)
Must have failed to achieve adequate disease despite adequate topical or systemic therapy
Must be a candidate, according to the principal investigator and standard of care, for a super-potent topical steroid course. Subjects that are candidates for super-potent topical steroids are defined as subjects whose disease is not adequately controlled with medium-potency topical steroids or systemic therapy, including phototherapy.

Exclusion Criteria:

Active skin infection
Hypersensitivity to any ingredients in Vanos cream
Previous use of super-potent topical steroids within 2 weeks of starting study (Class I steroid).
Intervention: Colchicine
Trial phase: Phase 2
ATC code: M04AC01
SMILES: COc1cc2c(c(OC)c1OC)-c1ccc(OC)c(=O)cc1[C@@H](NC(C)=O)CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Extension study: Group D
Eligibility criteria:
Core study

Inclusion Criteria:

Signed written informed consent before any study procedure is performed.
History of at least 2 gout flares in the year prior to Screening (Visit 1, based on patient history), thus, candidates for initiating uric acid lowering therapy.
Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of arthritis of primary gout.
Body Mass Index (BMI) ≤ 40 kg/m^2.
Willingness to initiate allopurinol therapy as urate lowering agent for their gout therapy or having initiated allopurinol therapy within ≤ 1 month before Screening (Visit 1) or willing to re-initiate allopurinol therapy if this was stopped > 2 months before Screening (Visit 1) for reasons different to toxicity/ intolerance or lack of efficacy.

Exclusion Criteria:

Acute gout flare within 2 weeks of Screening (Visit 1) and during the Screening period.
History of allergy or contraindication to colchicine or allopurinol.
History of intolerance to allopurinol or to oral colchicine in appropriate dose for prophylactic use.
History of bone marrow suppression.
Absolute or relative contraindication to both naproxen and oral prednisolone/ prednisone.

Extension study

Inclusion criteria:

Patients who completed the core study. A patient is defined as completing the core study if he/she completed the study up to and including the last visit (Visit 9).
Patients who have signed a written informed consent before any trial procedure is performed.

Exclusion Criteria:

Patients for whom continuation in the extension study is not considered appropriate by the treating physician.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine).

Other protocol-defined inclusion/exclusion criteria applied to the study.
Intervention: Penciclovir
Trial phase: Phase 4
ATC code: D06BB06 | J05AB13
SMILES: Nc1nc(=O)c2ncn(CCC(CO)CO)c2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 126
Group description: Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
Eligibility criteria:
Inclusion Criteria:

Be known to be a cold sore sufferer and presenting a prodromal stage with pain
Sign the written informed consent form prior to enrolment in the trial;
Be aged 18 to 75 years;

Exclusion Criteria:

If female, are pregnant, planning pregnancy or lactating;
Have a known hypersensitivity to penciclovir or any ingredients of the vehicle;
Have already ongoing classical cold sore lesions at the baseline visit;
Have taken any cold sore product, analgesic or NSAID in the 24 hours before the baseline visit;
Have applied a cosmetic lip balm on their lips in the 12 hours before the baseline thermographic assessment;
Are known to be immunosuppressed (acquired, congenital or therapeutic);
Have been involved in any investigational protocol within the 30 days prior to the trial;
Have evidence or history of drug or alcohol abuse;
Intervention: Indomethacin
Trial phase: Phase 4
ATC code: C01EB03 | M01AB01 | M01AB51 | M02AA23 | S01BC01 | S01CC02
SMILES: COc1ccc2c(c1)c(CC(=O)O)c(C)n2C(=O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 295
Group description: 2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
Eligibility criteria:
Inclusion Criteria:

Included patients are those undergoing ERCP and have one of the following:

Clinical suspicion of sphincter of Oddi dysfunction
History of post-ERCP pancreatitis (at least one episode)
Pancreatic sphincterotomy
Pre-cut (access) sphincterotomy
> 8 cannulation attempts
Pneumatic dilation of intact biliary sphincter
Ampullectomy

or at least 2 of the following:

Age < 50 years old & female gender
History of recurrent pancreatitis (at least 2 episodes)
≥3 pancreatic injections, with at least one injection to tail
Pancreatic acinarization
Pancreatic brush cytology

Exclusion Criteria:

Unwillingness or inability to consent for the study
Age < 18 years
Intrauterine pregnancy
Breast feeding mother
Standard contraindications to ERCP
Allergy to Aspirin or NSAIDs
Renal failure (Cr > 1.4)
Active or recent (within 4 weeks) gastrointestinal hemorrhage
Acute pancreatitis (lipase peak) within 72 hours
Known chronic calcific pancreatitis
Pancreatic head malignancy
Procedure performed on major papilla/ventral panc duct in pt with pancreas divisum (no manipulation of minor papilla)
ERCP for biliary stent removal or exchange without anticipated pancreatogram
Subjects with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
Anticipated inability to follow protocol
Endoscopist discretion: low risk (<10%) of post-ERCP pancreatitis
Intervention: Solifenacin Succinate
Trial phase: Phase 3
SMILES: O=C(O)CCC(=O)O.O=C(OC1CN2CCC1CC2)N1CCc2ccccc2C1c1ccccc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Vesicare alone in treatment of incontinence
Eligibility criteria:
Inclusion Criteria:

Female patients > 18 years of age
OAB symptoms for > 3 months
Symptoms defined as greater than 3 episodes/week of an uncontrolled urge to void causing incontinence.
May or may not be accompanied by urinary frequency
May be accompanied by stress urinary incontinence where stress incontinence does not predominate

Exclusion Criteria:

Male Patients
Underlying cortical or spinal cord pathology including SCI, MS, or
Parkinson's Disease
Urinary retention with post-void residual > 150cc
Current treatment or treatment within the last 3 months with anticholinergic medications
Patients not able to complete the questionaires or voiding diaries in English
Pregnancy
Active urinary tract infections
Bladder Cancer or unevaluated hematuria
Known diagnosis of narrow angle glaucoma
Severe constipation
History of reduced renal function (CrCl<30ml/min)
History of liver disease
Current treatment with cytochrome P450 inhibitor medications
Intervention: Hydrochlorothiazide
Trial phase: Not Applicable
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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Hydrochlorothiazide 50 mg will be administered by mouth once.

Hydrochlorothiazide: 50 mg one time
Eligibility criteria:
Inclusion Criteria:

Institutional Review Board (IRB) approved written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) Authorization as per national regulations, must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
Subject is between the ages of 21 and 60.
Female subjects of child bearing potential must have a negative urine pregnancy test at the screening visit (Study Visit 1) and must agree to maintain effective birth control during the study.
Subjects who are referred to Dr. Ellison for evaluation of normotensive hypokalemia of unknown etiology

Exclusion Criteria:

Subject has known allergy to thiazide or sulfonamide medications
Subject is pregnant or lactating.

Subject has major systemic illnesses that affect potassium regulation through pathology or pharmacologic treatment. This category includes:

Hypertension
Requiring regular pharmacological control
History of blood pressure greater than 140mmHg systolic and 90mmHg diastolic
Congestive heart failure
Cirrhosis of the liver
Subject has documented kidney disease resulting in anuria, proteinuria or abnormal urinalysis, or requiring dialysis for treatment.