anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: METHYLPREDNISOLONE ACETATE
Trial phase: Not Applicable
SMILES: CC(=O)OCC(=O)[C@@]1(O)CC[C@H]2[C@@H]3C[C@H](C)C4=CC(=O)C=C[C@]4(C)[C@H]3[C@@H](O)C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Corticosteroid (methylprednisolone acetate)

methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate
Eligibility criteria:
Inclusion Criteria:

Between ages of 18 and 95
Has elected to undergo total knee replacement

Exclusion Criteria:

Allergy to any of the medications used in the protocol
History of kidney disease
Rheumatoid arthritis
Any systemic conditions associated with chronic pain
History of deep knee sepsis in the affected extremity
Unable to understand the questions used to obtain the Knee Society Score
Minors and prisoners will be excluded from the study
Intervention: Moxifloxacin
Trial phase: Phase 4
ATC code: J01MA14 | S01AE07
SMILES: [H][C@@]12CCCN[C@]1([H])CN(c1c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c1OC)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 145
Group description: Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
Eligibility criteria:
Inclusion Criteria:

Age >= 18 years
Clinical diagnosis of acute rhinosinusitis with signs and symptoms present for >/= 5-7 days but < 28 days
Clinical diagnosis will be confirmed by nasal endoscopic examination

Exclusion Criteria:

History of chronic sinusitis defined as greater than four weeks of continuous symptoms (subject with history of sinus surgery may be included; subjects with recurrent acute sinusitis may be included)
Any symptoms that suggest the subject's current illness is allergic rhinitis (e.g. repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis
Known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses
Known immunodeficiency diseases including, but not limited to: neutropenia (neutrophil count < 1000/mm3), human immunodeficiency virus (HIV) infection (Cluster of differentiation 4 (CD4)+ T-cell count of < 200/mm3). Note: HIV testing is not required
Received systemic antibacterial therapy likely to be effective in the treatment of acute bacterial sinusitis for more than 24 hours within 5/6 days of enrollment
Requirement for concomitant systemic antibacterial therapy with agents other than those specified in this protocol
Currently receiving topical nasal corticosteroids, unless they have been on a stable dose for > 4 weeks prior to enrollment
Requirement for concomitant therapy with systemic corticosteroids
Pregnant or breast feeding
Of childbearing potential in whom pregnancy cannot be excluded by a negative pregnancy test and who are not using reliable barrier method of contraception
Received an investigational drug in the past 30 days
Previously enrolled in this study
Unable to take oral medication
History of allergy to quinolone antibiotics or related compounds and beta-lactams
History of tendinopathy associated with quinolones
Known to have congenital or sporadic syndromes of QT interval corrected for rate (QTc) prolongation or receiving concomitant medication reported to increase the QTc interval (e.g. amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine)
Uncorrected hypokalemia
End stage liver cirrhosis (class Child-Pugh C)
Severe renal impairment requiring dialysis
Diagnosis of rapidly fatal illness with a life expectancy of less than 6 months
Intervention: Zileuton
Trial phase: Phase 3
SMILES: CC(c1cc2ccccc2s1)N(O)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Zileuton (Zyflo, 600 mg 4 times a day)
Eligibility criteria:
Inclusion Criteria:

Admitted to the hospital for a COPD exacerbation
FEV1 less than 60% of predicted level
At least 10 pack years of smoking

Exclusion Criteria:

Any uncontrolled systemic disease
Known hypersensitivity to zileuton
Asthma
Lobar pneumonia or pulmonary edema
Interstitial lung disease
Medical condition that is likely to limit survival to less than 30 days at the time of study entry
History of liver disease
Current use of theophylline
Participation in another clinical trial in the COPD Clinical Research Network
Incarceration
Institutionalization
Pregnant
History of a suicide attempt
Prior inpatient admission for a psychiatric disorder
Bipolar disorder

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Intervention: Humalog
Trial phase: Phase 3
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)NC(CCCCN)C(=O)N3CCCC3C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 219
Group description: Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Have type 2 diabetes mellitus for at least 1 year.
Are at least 18 years old.
Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1, at or above the doses defined in the following: Metformin--1500 milligrams per day (mg/day); Sulfonylureas--1/2 the maximum daily dose, according to the local package insert; Dipeptidyl peptidase-intravenous (DPP-IV) inhibitors-- 1/2 the maximum daily dose, according to the local package insert; Thiazolidinediones (TZDs)--30 mg/day pioglitazone or 4 mg/day rosiglitazone.
Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2.
Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kilograms per square meter (kg/m2).

Exclusion Criteria

Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
Have taken any glucose-lowering medications not included in Inclusion Criterion [3] (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1.
Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
Have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dL) (177 micromoles per liter [micromol/L]).
Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [ALT], or aspartate transaminase [AST] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.
Intervention: Nepafenac
Trial phase: Phase 4
ATC code: S01BC10
SMILES: NC(=O)Cc1cccc(C(=O)c2ccccc2)c1N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 82
Group description: 1 drop per study eye three times per day for 30 days plus standard care
Eligibility criteria:
Inclusion Criteria:

over age 50
having cataract surgery at UNC

Exclusion Criteria:

medically controlled diabetes
history of intraocular surgery
abnormal pre-op optical coherence tomography scan
history of ocular inflammation
have age related macular degeneration
Intervention: Amoxicillin clavulanate
Trial phase: Phase 4
SMILES: CC1(C)SC2C(NC(=O)C(N)c3ccc(O)cc3)C(=O)N2C1C(=O)O.O=C(O)C1C(=CCO)OC2CC(=O)N21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 158
Group description: Amoxycillin and clavulanate t.i.d. for 8 days
Eligibility criteria:
Inclusion Criteria:

Acute exacerbations (at least one criterion present: increase of dyspnoea, increase of sputum production and/or increase of purulence) of
patients older than 40 years old,
smokers or ex-smokers of more than 10 pack-years,
with COPD and FEV1 greater than 50%, diagnosed by spirometry and a predicted ratio FEV1/FVC<0.7%.

Exclusion Criteria:

Severe COPD (FEV1<50%)
Pneumonia
Active neoplasm
Tracheotomy
Criteria for hospitalisation
Patients previously being on antibiotics
Immunodepressed patients
History of hypersensitivity to beta-lactams or intolerance to clavulanate
Enrollment in other clinical trials
Patients who refuse to take part in this study
Patients who have not had a spirometry test for the past two years
Intervention: Acyclovir
Trial phase: Phase 4
ATC code: D06BB03 | D06BB53 | J05AB01 | S01AD03
SMILES: Nc1nc2c(ncn2COCCO)c(=O)[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: 800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence

acyclovir: 800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
Eligibility criteria:
Inclusion Criteria:

Age 18 years or older
HSV-2 seropositive by Western blot OR documented culture positive for HSV-2 from anogenital site
2 or more vaginal or anal sex partners in the past 12 months
Not currently in a monogamous sexual relationship of >= 6 months duration
Willing and able to be randomized and comply with the study protocol

Exclusion Criteria:

Pregnancy or intention to become pregnant within the next year
Suppressive therapy with acyclovir, valacyclovir, or famciclovir within 2 weeks of enrollment/randomization
6 or more symptomatic herpes recurrences in the prior 12 months or in the 12 months prior to starting suppressive therapy if on suppressive therapy during the prior 12 months
HIV seropositive or known immunocompromising medical condition. HIV negative test must be performed within 60 days of Visit 1 (enrollment/randomization). For current or former participants in HIV vaccine clinical trials for whom HIV vaccine-induced seropositivity potentially leading to vaccine study unblinding may be a concern, a report from the Seattle HVTU documenting that the participant is HIV uninfected based on HIV testing done within 60 days of Visit 1 will be accepted in lieu of HIV testing done at our clinic.
Intention to move from the Seattle area within the next year
Known allergy, intolerance, or medical contraindication to acyclovir
Inability to understand, speak, and read English
Intervention: Acyclovir
Trial phase: Phase 4
ATC code: D06BB03 | D06BB53 | J05AB01 | S01AD03
SMILES: Nc1nc2c(ncn2COCCO)c(=O)[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: 400 mg acyclovir orally twice daily for 1 year

acyclovir: 400 mg acyclovir orally twice daily for 1 year
Eligibility criteria:
Inclusion Criteria:

Age 18 years or older
HSV-2 seropositive by Western blot OR documented culture positive for HSV-2 from anogenital site
2 or more vaginal or anal sex partners in the past 12 months
Not currently in a monogamous sexual relationship of >= 6 months duration
Willing and able to be randomized and comply with the study protocol

Exclusion Criteria:

Pregnancy or intention to become pregnant within the next year
Suppressive therapy with acyclovir, valacyclovir, or famciclovir within 2 weeks of enrollment/randomization
6 or more symptomatic herpes recurrences in the prior 12 months or in the 12 months prior to starting suppressive therapy if on suppressive therapy during the prior 12 months
HIV seropositive or known immunocompromising medical condition. HIV negative test must be performed within 60 days of Visit 1 (enrollment/randomization). For current or former participants in HIV vaccine clinical trials for whom HIV vaccine-induced seropositivity potentially leading to vaccine study unblinding may be a concern, a report from the Seattle HVTU documenting that the participant is HIV uninfected based on HIV testing done within 60 days of Visit 1 will be accepted in lieu of HIV testing done at our clinic.
Intention to move from the Seattle area within the next year
Known allergy, intolerance, or medical contraindication to acyclovir
Inability to understand, speak, and read English
Intervention: Budesonide
Trial phase: Phase 4
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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 329
Group description: Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Eligibility criteria:
Inclusion Criteria:

>=40 years of age, diagnosed COPD with symptoms >=2 years, pre-bronchodilatory FEV1 <=50% of PN

Exclusion Criteria:

Current respiratory tract disorder other than COPD, history of asthma or rhinitis, significant or unstable cardiovascular disorder
Intervention: Tiotropium
Trial phase: Phase 4
ATC code: R03AL06 | R03AL10 | R03BB04 | R03BB54
SMILES: [H][C@]1(OC(=O)C(O)(c2cccs2)c2cccs2)C[C@@]2([H])[C@]3([H])O[C@]3([H])[C@@]([H])(C1)[N+]2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 330
Group description: Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Eligibility criteria:
Inclusion Criteria:

>=40 years of age, diagnosed COPD with symptoms >=2 years, pre-bronchodilatory FEV1 <=50% of PN

Exclusion Criteria:

Current respiratory tract disorder other than COPD, history of asthma or rhinitis, significant or unstable cardiovascular disorder
Intervention: Vytorin
Trial phase: Phase 3
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: No
Participants at risk: 124
Group description: simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosis of the metabolic syndrome according to 2005 American Heart Association/National Heart, Lung and Blood Institute (AHA/NHLBI) scientific statement
No history of diabetes and 100 <=LDL-C <=250 mg/dl

Exclusion Criteria:

Myocardial Infarction, coronary artery bypass surgery, or angioplasty within 3 months
Congestive heart failure defined by New York Heart Association (NYHA) class III or IV
Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
Uncontrolled hypertension
Unstable angina
Intervention: Atorvastatin
Trial phase: Phase 3
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: 121
Group description: atorvastatin 10 mg; tablet, once daily, 8 Weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosis of the metabolic syndrome according to 2005 American Heart Association/National Heart, Lung and Blood Institute (AHA/NHLBI) scientific statement
No history of diabetes and 100 <=LDL-C <=250 mg/dl

Exclusion Criteria:

Myocardial Infarction, coronary artery bypass surgery, or angioplasty within 3 months
Congestive heart failure defined by New York Heart Association (NYHA) class III or IV
Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
Uncontrolled hypertension
Unstable angina
Intervention: Aplaviroc
Trial phase: Not Applicable
SMILES: [H][C@]1([C@H](O)C2CCCCC2)NC(=O)C2(CCN(Cc3ccc(Oc4ccc(C(=O)O)cc4)cc3)CC2)N(CCCC)C1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 69
Group description: 8 mg/kg intravenously (IV) Over 90 Minutes
Eligibility criteria:
Inclusion Criteria:

All patients with histologic confirmation of DCIS (TisN0M0) that is Her-2/neu 3+ positive by immunohistochemistry (IHC) and/or positive for Her-2 gene amplification by fluorescence in situ hybridization (FISH) will be eligible for the study.
Patients must sign informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.
Those patients with history of other contralateral non-invasive and invasive breast and non-breast malignancies are eligible to participate unless they have previously received a doxorubicin dose of more than 400 mg/m2.
All patients should have adequate bone marrow function, as defined by peripheral granulocyte count of > 1,500/mm3, and platelet count > 100,000 mm3. Patients must have adequate liver function, with bilirubin within normal laboratory values. In addition, patients should have adequate renal function, defined as serum creatinine < 2.0 mg/dl.
Patients with intact primary tumors will be eligible for this study. Patients who have had their diagnostic biopsy at an outside facility but still have measurable disease on presentation will be eligible.
Patients with history of cardiac arrhythmia will be eligible for study after being seen by cardiology and deemed good candidates for participation.
Women of child bearing potential must have a negative urine or serum pregnancy test.

Exclusion Criteria:

Patients with a current known invasive breast cancer are not eligible for this study.
All patients who are Her-2/neu negative will be ineligible for the study.
Patients with history of congestive heart failure will be excluded.
Intervention: Mirtazapine
Trial phase: Phase 2
ATC code: N06AX11
SMILES: CN1CCN2c3ncccc3Cc3ccccc3C2C1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: mirtazapine 30 mg daily for 3 months
Eligibility criteria:
Inclusion Criteria:

HIV-negative by rapid test, or documentation of HIV infection with a laboratory result of a positive HIV test;
male gender;
reports having anal sex with men in the prior 3 months while using methamphetamine;
diagnosed with methamphetamine dependence as determined by SCID;
interested in stopping or reducing methamphetamine use;
at least one methamphetamine-positive urine at screening and run-in period;
no known allergies to mirtazapine;
no current acute illnesses requiring prolonged medical care;
no chronic illnesses that are likely to progress clinically during trial participation;
able and willing to provide informed consent and to be followed over a 3-month period;
age 18-60 years;
baseline CBC, total protein, albumin, glucose, alk phos, creatinine, BUN and electrolytes without clinically significant abnormalities as determined by investigator in conjunction with symptoms, physical exam, and medical history.

Exclusion Criteria:

evidence of current major depression, as determined by SCID;70
history of bipolar disorder or psychosis, as determined by SCID;
taking anti-depressant or other psychotropic medication within the last 30 days, including mirtazapine or a monoamine oxidase (MAO) inhibitor;
currently using or unwilling not to use pseudoephedrine-containing products for trial duration (causes false positive urines for methamphetamine use);
current CD4 count < 200 cells/mm3;
measured moderate or severe liver disease (AST, ALT, and total bilirubin > 3 times upper limit of normal) and/or any symptoms of current liver disease;
impaired renal function (creatinine clearance < 60 ml/min);
currently participating in another research study;
any condition that, in the principal investigator's judgment, interferes with safe study participation or adherence to study procedures.
Intervention: Colestilan
Trial phase: Phase 2
ATC code: V03AE06
SMILES: Cc1ncc[nH]1.ClCC1CO1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
Eligibility criteria:
Inclusion Criteria:

Patients whose fasting blood glucose levels during the observation period are between 130mg/dL and 200mg/dL.
Patients whose HbA1c is 7.0% or above during the observation period.

Exclusion Criteria:

Patients with serious cardiac, hepatic or renal complications.
Patients with serious diabetic complications.
Patients with complete biliary obstruction or ileus.
Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception.
Intervention: Fasudil
Trial phase: Phase 3
ATC code: C04AX32
SMILES: O=S(=O)(c1cccc2cnccc12)N1CCCNCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Placebo was administered 2 hours before a standardized cold challenge.
Eligibility criteria:
Inclusion Criteria:

diagnosis of scleroderma
definite Raynaud's

Exclusion Criteria:

symptomatic orthostatic hypotension
evidence of current malignancy
active ischemic digital ulcer and/or tissue gangrene
history of sympathectomy at any time
upper extremity deep vein thrombosis or lymphedema within 3 months of the study
recent surgical procedure requiring general anesthesia
current alcohol or illicit drug use
use of any investigational drug within 30 days of the study sessions
pregnancy or current breast feeding
subjects felt by the investigators to active disease that would affect their ability to safely participate in the study.
Intervention: Fasudil
Trial phase: Phase 3
ATC code: C04AX32
SMILES: O=S(=O)(c1cccc2cnccc12)N1CCCNCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: 40 mg Fasudil was administered 2 hours before a standardized cold challenge.
Eligibility criteria:
Inclusion Criteria:

diagnosis of scleroderma
definite Raynaud's

Exclusion Criteria:

symptomatic orthostatic hypotension
evidence of current malignancy
active ischemic digital ulcer and/or tissue gangrene
history of sympathectomy at any time
upper extremity deep vein thrombosis or lymphedema within 3 months of the study
recent surgical procedure requiring general anesthesia
current alcohol or illicit drug use
use of any investigational drug within 30 days of the study sessions
pregnancy or current breast feeding
subjects felt by the investigators to active disease that would affect their ability to safely participate in the study.