anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Maraviroc
Trial phase: Phase 3
ATC code: J05AX09
SMILES: Cc1nnc(C(C)C)n1[C@@H]1C[C@H]2CC[C@@H](C1)N2CC[C@H](NC(=O)C1CCC(F)(F)CC1)c1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1032
Group description: Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
Eligibility criteria:
Inclusion Criteria:

Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA greater than or equal to 1000 copies/ml, at screening
Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay
Minimum age must be 16 years or minimum adult age as determined by local regulatory authorities or directed by local law.

Exclusion Criteria:

Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trial or having previously prematurely discontinued Maraviroc in trials
Intervention: Integrilin
Trial phase: Phase 3
ATC code: B01AC16
SMILES: NC(=O)C1CSSCCC(=O)NC(CCCCN=C(N)N)C(=O)NCC(=O)NC(CC(=O)O)C(=O)NC(Cc2c[nH]c3ccccc23)C(=O)N2CCCC2C(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 226
Group description: Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
Eligibility criteria:
Inclusion Criteria:

Women must be postmenopausal (i.e.12 months without menstrual period), or surgically sterile, i.e. women of child bearing potential are not allowed to be included into the study. In cases of doubt a pregnancy test should be performed. (NB -post menopausal women currently receiving hormone replacement are permissible)

Acute myocardial infarction < 12 h defined as:

Angina or equivalent symptoms > 20 min and
ST elevation in 2 contiguous ECG leads (= 2 mm precordial lead, = 1 mm limb lead). This ECG recording serves as baseline ECG, i.e. ECG I.
Planned primary percutaneous coronary intervention
The subject has given written informed, dated consent to participate in the study

Exclusion Criteria:

Subjects not able to give informed consent
Left Bundle Branch Block
Thrombolytic therapy within 24 hours before randomization
Oral anticoagulation with International Normalized Ratio (INR) > 2
Known platelets < 100.000/µl or known hemorrhagic diathesis
Stroke or Transient Ischemic Attack (TIA) within the past 6 months or any permanent residual neurological defect
Evidence of an active gastrointestinal or urogenital bleeding
Major surgery within 6 weeks
History of allergic reaction to abciximab or eptifibatide or any component used in the study (including contrast media)
Known severe renal (creatinine clearance <30ml/min) or hepatic insufficiency as well as Alanine transaminase (ALT)/aspartate transaminase (AST) elevations = 3xUpper limit normal (ULN); isolated AST-elevation is not considered an exclusion criteria from study participation
Severe concomitant disease with life expectation < 1 year
Subject has participated in any study using an investigational drug or device within 30 days or within 5 half-lives of the investigational drug (whichever is longer) of entry into this study.
Subjects who will be inaccessible due to geographic or social factors during treatment or follow-up
In France, a subject is neither affiliated with nor a beneficiary of a social security category.
Intervention: Cholecalciferol
Trial phase: Not Applicable
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: This is vitamin D3 or Cholecalciferol
Eligibility criteria:
Inclusion Criteria:

Age 18-85
CKD stage 3-4 (GFR 15-59 ml/min/1.73 m2 body surface area, calculated by using the MDRD Study equation GFR Calculator)
serum 25(OH)D concentrations ≤ 30 ng/mL, and serum PTH levels >70 pg/mL documented within the last six months

Exclusion Criteria:

History of liver failure (serum AST or ALT > 3-fold the upper limit of normal)
requiring dialysis at any stage of the study
history of intestinal malabsorption or chronic diarrhea
serum calcium level (corrected for serum albumin) > 10.5 mg/dL
calcium x phosphorus product >70
treatment with more than 1000 IU of vitamin D per day, or current treatment with a vitamin D analogue or calcimimetic
an anti-epileptic medication and other medications which can affect vitamin D metabolism (e.g., phenobarbital, phenytoin, rifampicin)
Intervention: Novolog mix 70/30
Trial phase: Not Applicable
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(CC(=O)O)C(=O)NC(CCCCN)C(=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: 4
Group description: insulin Aspart versus insulin Lispro : Subjects will be randomly assigned to one of the two insulins by the statistician working in the study via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients.

Period 1: four weeks using insulin aspart in the pump, followed by Period 2: four weeks using insulin lispro in the pump, or vice versa depending on randomization.
Eligibility criteria:
Inclusion Criteria:

Type 1 diabetes treated with CSII at least 3 months.
Males and females, > 18 years but < 75 years old.
Hemoglobin A1c ≤ 8.0 % at measurement taken at week 0 (screening visit).
Duration of diabetes ≥ 12 months.
Willingness to perform self-blood glucose monitoring several times/day.

Exclusion Criteria:

Previous insulin precipitation in pump infusion catheters.
Daily insulin requirements > 25% of pump reservoir capacity. (This would preclude the subject from using the pump infusion system for more than 3 days).
Use of an insulin pump that does not have a downloadable record of basal and bolus doses.
Known or suspected allergy to trial products.
Pregnancy, breast-feeding, intention to become pregnant or inadequate contraception measures.
Known or suspected alcohol or drug abuse.
Impaired renal function with creatinine ≥ 1.7 mg/dl.
Pronounced catheter site scarring.
Chronic use of drugs that may influence glycemic control (e.g. steroids).
Any other significant concomitant disease that would interfere with participation in and completion of the trial.
Intervention: Paricalcitol
Trial phase: Not Applicable
ATC code: H05BX02
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1C[C@@H](O)C[C@H](O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: 1 mcg paricalcitol
Eligibility criteria:
Inclusion Criteria:

Patients with chronic kidney disease with estimated GFR of 30 mL/minute or more.
Patients receiving stable dose of ACE inhibitor or Angiotensin receptor blockers for at least one month.
Patients not currently hypertensive more than 180/110 mmHg by clinic blood pressure.
Hemoglobulin A1C< 11%

Exclusion Criteria:

Patients taking vitamin D analogs
Calcium> 10 mg/dL
Phosphorus>6 mg/dL
Patients with anticipated need of dialysis in the next 6 weeks
Patients unstable in the opinion of the investigator
Patients who have emergent need for starting IV iron
Patients who will be started on statins within the next 6 weeks
Patients currently taking PDE5 inhibitors
Patients allergic to radiocontrast, Zemplar or who can not take nitroglycerin
Patients known to be HIV positive
Patients who can not give informed consent
Intervention: Paricalcitol
Trial phase: Not Applicable
ATC code: H05BX02
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1C[C@@H](O)C[C@H](O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: 2 mcg paricalcitol
Eligibility criteria:
Inclusion Criteria:

Patients with chronic kidney disease with estimated GFR of 30 mL/minute or more.
Patients receiving stable dose of ACE inhibitor or Angiotensin receptor blockers for at least one month.
Patients not currently hypertensive more than 180/110 mmHg by clinic blood pressure.
Hemoglobulin A1C< 11%

Exclusion Criteria:

Patients taking vitamin D analogs
Calcium> 10 mg/dL
Phosphorus>6 mg/dL
Patients with anticipated need of dialysis in the next 6 weeks
Patients unstable in the opinion of the investigator
Patients who have emergent need for starting IV iron
Patients who will be started on statins within the next 6 weeks
Patients currently taking PDE5 inhibitors
Patients allergic to radiocontrast, Zemplar or who can not take nitroglycerin
Patients known to be HIV positive
Patients who can not give informed consent
Intervention: VALACYCLOVIR
Trial phase: Phase 2
ATC code: J05AB11
SMILES: CC(C)[C@H](N)C(=O)OCCOCn1cnc2c(=O)nc(N)[nH]c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
Eligibility criteria:
Inclusion Criteria:

Be between the ages of 18-65
Have a diagnosis of Bipolar I or II disorder (as defined by DSM-IV)
Be in active treatment with an outpatient psychiatrist
Test positive for HSV1
Demonstrate cognitive impairment on the RBANS as defined by a total score of less than 85 (i.e. greater than one standard deviation below normal).

Exclusion Criteria:

Either pregnant or nursing
Have been diagnosed with any serious, unstable illnesses including HIV infection or other immunodeficiency condition, hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease and hypertension), endocrinologic, neurologic, immunologic, or hematologic disease. Illnesses that are currently well controlled and being treated are not grounds for exclusion.
Have a history of hypersensitivity or intolerance to valacyclovir or acyclovir
Meet criteria for DSM-IV substance abuse (except nicotine and caffeine) within the past 90 days
Had Electroconvulsive Therapy (ECT) within three months prior to randomization
Judged to be at serious suicidal risk; inability to provide informed consent.
Intervention: Methylphenidate Hydrochloride
Trial phase: Phase 3
SMILES: COC(=O)C(c1ccccc1)C1CCCCN1.Cl
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 150
Group description: Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
Eligibility criteria:
Inclusion Criteria:

Children aged 6-12
Diagnosis of Attention-Deficit Hyperactivity Disorder (ADHD)
Current medication with either 20 mg or 40 mg immediate release methylphenidate

Exclusion Criteria:

Concomitant psychiatric disorders requiring pharmacological treatment
Concomitant severe somatic disorders
Eating disorders
Addiction disorders
Very high or low body weight according to age
Known hypersensitivity to methylphenidate
Contraindications for methylphenidate

Other protocol-defined inclusion/exclusion criteria applied to the study.
Intervention: Methylphenidate Hydrochloride
Trial phase: Phase 3
SMILES: COC(=O)C(c1ccccc1)C1CCCCN1.Cl
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 150
Group description: Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
Eligibility criteria:
Inclusion Criteria:

Children aged 6-12
Diagnosis of Attention-Deficit Hyperactivity Disorder (ADHD)
Current medication with either 20 mg or 40 mg immediate release methylphenidate

Exclusion Criteria:

Concomitant psychiatric disorders requiring pharmacological treatment
Concomitant severe somatic disorders
Eating disorders
Addiction disorders
Very high or low body weight according to age
Known hypersensitivity to methylphenidate
Contraindications for methylphenidate

Other protocol-defined inclusion/exclusion criteria applied to the study.
Intervention: Paroxetine
Trial phase: Phase 4
ATC code: N06AB05
SMILES: Fc1ccc([C@@H]2CCNC[C@H]2COc2ccc3c(c2)OCO3)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Participants will receive paroxetine for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Currently suffering from a major depressive episode (unipolar only)
History of a past suicide attempt or score greater than 2 on the Hamilton Depression Rating Scale (HDRS) item #3 (suicide) at in-person screening interview. Patients with suicidal plan or intent will only be enrolled as inpatients if independent inpatient treatment team agrees.
Patients 60 years of age and older must score at least 25 on MMSE at screening.
Patients 60 years of age and older must have a normal ECG within the past year.

Exclusion Criteria:

Any of the following conditions: bipolar disorder; current psychotic symptoms; bulimia or anorexia that is current or within the past year, or current purging at least twice a week for three months; already taking selective serotonin reuptake inhibitors (SSRIs) or bupropion for other indications (such as anxiety disorders)
Primary disorder is an anxiety disorder (e.g., panic disorder, general anxiety disorder, obsessive compulsive disorder, social anxiety disorder), with secondary depression
Drug or alcohol dependence within 6 months prior to study entry (current drug or alcohol abuse may be permitted if study officials determine that the abuse is of lesser importance than the major depressive episode)
Systolic blood pressure greater than or equal to 140 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg
Significant active physical illness, particularly those that may affect the brain or serotonergic system (e.g., blood dyscrasias lymphomas, hypersplenism, endocrinopathies, kidney failure, severe chronic obstructive lung disease, autonomic neuropathies, active malignancy)
Active medical problems
Requires antipsychotic medication
History of hypomania or mania while taking antidepressants
Any condition that may make the use of an SSRI or bupropion medically inadvisable
Currently using Zyban
Failure to respond to adequate trials of three SSRIs, paroxetine, or bupropion within 2 years prior to study entry (failure to respond to therapeutic trial defined as at least 2/3 maximal daily dose [PDR] for at least 6 weeks)
Pregnant, breastfeeding, or plans to become pregnant during the course of study participation
Currently on effective treatment, requires adjunctive antipsychotic or mood stabilizing medication, or is unlikely to respond to single agent treatment for depression
Patients with ferrous metal implants in their bodies, or a history of claustrophobia that precludes MRI, will be excluded.
Patients assessed as being unlikely to tolerate the maximum 2-week delay to start of treatment.
Intervention: Bupropion
Trial phase: Phase 4
ATC code: A08AA62 | N06AX12
SMILES: CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Participants will receive bupropion for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Currently suffering from a major depressive episode (unipolar only)
History of a past suicide attempt or score greater than 2 on the Hamilton Depression Rating Scale (HDRS) item #3 (suicide) at in-person screening interview. Patients with suicidal plan or intent will only be enrolled as inpatients if independent inpatient treatment team agrees.
Patients 60 years of age and older must score at least 25 on MMSE at screening.
Patients 60 years of age and older must have a normal ECG within the past year.

Exclusion Criteria:

Any of the following conditions: bipolar disorder; current psychotic symptoms; bulimia or anorexia that is current or within the past year, or current purging at least twice a week for three months; already taking selective serotonin reuptake inhibitors (SSRIs) or bupropion for other indications (such as anxiety disorders)
Primary disorder is an anxiety disorder (e.g., panic disorder, general anxiety disorder, obsessive compulsive disorder, social anxiety disorder), with secondary depression
Drug or alcohol dependence within 6 months prior to study entry (current drug or alcohol abuse may be permitted if study officials determine that the abuse is of lesser importance than the major depressive episode)
Systolic blood pressure greater than or equal to 140 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg
Significant active physical illness, particularly those that may affect the brain or serotonergic system (e.g., blood dyscrasias lymphomas, hypersplenism, endocrinopathies, kidney failure, severe chronic obstructive lung disease, autonomic neuropathies, active malignancy)
Active medical problems
Requires antipsychotic medication
History of hypomania or mania while taking antidepressants
Any condition that may make the use of an SSRI or bupropion medically inadvisable
Currently using Zyban
Failure to respond to adequate trials of three SSRIs, paroxetine, or bupropion within 2 years prior to study entry (failure to respond to therapeutic trial defined as at least 2/3 maximal daily dose [PDR] for at least 6 weeks)
Pregnant, breastfeeding, or plans to become pregnant during the course of study participation
Currently on effective treatment, requires adjunctive antipsychotic or mood stabilizing medication, or is unlikely to respond to single agent treatment for depression
Patients with ferrous metal implants in their bodies, or a history of claustrophobia that precludes MRI, will be excluded.
Patients assessed as being unlikely to tolerate the maximum 2-week delay to start of treatment.
Intervention: Goserelin
Trial phase: Phase 3
ATC code: L02AE03
SMILES: CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1cnc[nH]1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O
Sex: Female
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 1
Group description: 3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
Eligibility criteria:
Inclusion Criteria:

Female patients older than 15 years and younger than 46 years.
Primary breast cancer (Stage I, II, or III).
Pathologically confirmed invasive breast carcinoma.
Negative hormone-receptor status. (Negative defined as ER- and PR- staining in less than 10% of tumor cells, or tumors with less than or equal to 3 fm/mg cytosol protein on ligand-binding or enzyme-linked immunoassay).

Premenopausal, verified before chemotherapy is begun as satisfying both:

Cyclic vaginal bleeding.
Follicle-stimulating hormone (FSH) is less than or equal to 15 IU/L. If patients are taking oral contraceptives, FSH must be measured 1-2 weeks after discontinuation. If FSH is greater than 15 and the patient has regular menses, gynecologic consultation will be required for a decision on premenopausal status.
Candidates for neoadjuvant and/or adjuvant chemotherapy for primary breast cancer.
Treatment with at least four (4) cycles of chemotherapy as planned.
Zubrod performance score of 0 or 1.
Must consent to preservation of their ovarian function and indicate their awareness of the investigational nature of this study, in keeping with institutional policy.
Willingness to use barrier contraception if sexually active.

Exclusion Criteria:

Pregnancy. Women must have a negative serum pregnancy test before initiation of injection.
Hypersensitivity to any GnRH analog.
Previous receipt of systemic chemotherapy.
To receive at least 4 cycles of neoadjuvant and/or adjuvant chemotherapy with CMF.
Stage IV breast cancer.
Prothrombin time (PT) and partial prothrombin time (PTT) with INR > 1.5
Platelets < 50,000/mm^3
Intervention: Leuprolide Acetate
Trial phase: Phase 2
SMILES: CC(=O)O.CCNC(=O)C1CCCN1C(=O)C(CCCN=C(N)N)NC(=O)C(CC(C)C)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(Cc1cnc[nH]1)NC(=O)C1CCC(=O)N1
Sex: Female
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 59
Group description: Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
Eligibility criteria:
Inclusion Criteria:

Hematopoietic stem cell transplantation candidate.
Post-menarche female less than 40 years old.
Premenopausal before the start of transplantation, or the start of oral contraceptive pills.
Follicle-stimulating hormone (FSH) less than or equal to 20 IU/L and Luteinizing hormone (LH) less than or equal to 20 IU/L within 1 weeks of initiation of injection or the ovarian status is determined by Gynecology Oncology Service.
Agree to stop any oral contraceptive pills for a period of 3-6 months starting 1 year post-transplant

Exclusion Criteria:

Breast cancer
Ovarian cancer
Pregnancy
Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs
Intervention: Febuxostat
Trial phase: Phase 3
ATC code: M04AA03
SMILES: Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 757
Group description: Febuxostat 40 mg, orally, once daily for up to 6 months.
Eligibility criteria:
Inclusion Criteria:

Has one or more of the American Rheumatism Association criteria for the diagnosis of gout.
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Must have a serum urate level greater than or equal to 8.0 milligram per deciliter (mg/dL).

Exclusion Criteria:

Have a severe, unstable, or life threatening medical condition that would likely prevent them from completing this study.
Has a known body reaction to febuxostat, allopurinol, naproxen, any other non-steroidal anti-inflammatory drug (NSAID), aspirin, lansoprazole, colchicine, or any components in their formulation.
History of xanthinuria.
Alcohol consumption greater than 14/week.
History of significant concomitant illness.
Active liver or peptic ulcer disease.
Has rheumatoid arthritis requiring treatment.
Has estimated creatinine clearance less than 30 milliliter per minute (mL/min) calculated using the Cockcroft-Gault formula corrected for ideal body weight.
Requires therapy with any other urate-lowering drug other than the study drug; long-term use of NSAIDs and COX-2 inhibitors; salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; intravenous (IV) colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole;trimethoprim.