anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Levosimendan
Trial phase: Phase 4
ATC code: C01CX08
SMILES: C[C@@H]1CC(=O)NN=C1c1ccc(NN=C(C#N)C#N)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.

Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min.
Eligibility criteria:
Inclusion Criteria:

informed consent of the study signed
severe heart failure in stable clinical condition (NYHA class III, peak VO2 <12 ml / kg / min) in optimized medical therapy. The clinical stability is defined by the stability of the therapy, the weight and urine output for 3 days

Exclusion Criteria:

unstable patients from a clinical point of view, not in optimized therapy
patients unable to perform a CPET (Cardiopulmonary Exercise Test) .
are excluded from the protocol also patients with absolute contraindications to CPET (acute myocardial infarction, severe aortic stenosis, myocarditis or pericarditis, active, acute thromboembolism, sepsis,unstable angina, uncontrolled arrhythmia.
age < 18 years.
Intervention: DARIGABAT
Trial phase: Phase 2
SMILES: CCn1cnc2c(-c3ccc(F)c(-c4ccc(S(=O)(=O)CC)cc4OC)c3)cnnc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
Eligibility criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Intervention: Naproxen
Trial phase: Phase 2
ATC code: G02CC02 | M01AE02 | M01AE52 | M01AE56 | M02AA12
SMILES: COc1ccc2cc([C@H](C)C(=O)O)ccc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Eligibility criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Intervention: Loperamide
Trial phase: Phase 3
ATC code: A07DA03 | A07DA53
SMILES: CN(C)C(=O)C(CCN1CCC(O)(c2ccc(Cl)cc2)CC1)(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered

Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge
Eligibility criteria:
Inclusion Criteria:

Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
Males or females, age 18 and older at the time of study screening;
American Society of Anesthesiologists (ASA) Class I-III (Appendix III) undergoing elective surgery

Exclusion Criteria:

Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures
American Society of Anesthesiologists (ASA) Class IV or V; emergency surgeries
Children <18
Pregnant patients
Patients who have intra-abdominal sepsis or partial or intermittent bowel obstruction or enteritis
Patients who are on long term steroids, opioids or antidiarrheals pre operatively
Patients who are administered pro kinetics eg. Metoclopramide
Patients with recurrent disease in their small bowel - Crohn's disease, or previous irradiated pelvis resulting in irradiation bowel disease
End ileostomies
Intervention: Donepezil
Trial phase: Phase 4
ATC code: N06DA02 | N06DA52 | N06DA53
SMILES: COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Sleep data with Donepezil given

Donepezil: Donepezil 10mg before sleep
Eligibility criteria:
Inclusion Criteria:

Ages 18-70 years
sleep study (with apnea hypopnea index>5)
Diagnosis of obstructive sleep apnea

Exclusion Criteria:

Any known unstable cardiac (apart from treated hypertension), pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, or hepatic disease.
Susceptible to stomach ulcers.
Pregnant women or Nursing mothers
Using positive airway pressure (PAP) therapy over one week or longer
Body weight <55kg
History of hypersensitivity to Afrin, Lidocaine and/or Donepezil
History of bleeding diathesis and/or gastrointestinal bleeding.
Use of any medications that may affect sleep or breathing.
A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
Substantial cigarette (>5/day), alcohol (>3oz/day) or use of illicit drugs.
More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day.
Deprived from sleep in the recent one week
Desaturations to below 70% lasting greater than 10 seconds in duration per event in the sleep study (without Oxygen).
Intervention: Ranolazine
Trial phase: Phase 2
ATC code: C01EB18
SMILES: COc1ccccc1OCC(O)CN1CCN(CC(=O)Nc2c(C)cccc2C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Ranolazine 500 mg tablets

500mg tablet two times per day for 7 days then,
500mg tablet (1000mg) two times per day for 15 weeks

Ranolazine: Ranolazine 500mg tablet

500mg tablet two times per day for 7 days then,
500mg tablet (1000mg) two times per day for 15 weeks
Eligibility criteria:
Inclusion Criteria:

Adult patients >= 18 years of age referred for cardiac catheterization for evaluation of cardiac symptoms ( angina, fatigue, or shortness of breath)
At least 1 indeterminate stenosis (20-80%),
Fractional flow reserve (FFR) <=0.8 and PCI deferred

Exclusion Criteria:

Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) during the index procedure or anticipated within the next month
acute coronary syndrome or cardiogenic shock
QTc > 500 milliseconds
use of strong inhibitors of CTP3A (i.e. ketoconazole, itraconazole, clarithromycin,nefazodone, nelfinavir, ritonavir, indinavir and saquinavir)
use of inducers of CYP3A (i.e. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort)
liver cirrhosis
sever renal insufficiency (i.e. creatinine clearance < 30mL/min/1.73 m2)
Intervention: Nitroglycerin
Trial phase: Phase 4
ATC code: C01DA02 | C01DA52 | C05AE01
SMILES: O=[N+]([O-])OCC(CO[N+](=O)[O-])O[N+](=O)[O-]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: Subjects will receive IV nitroglycerin at the time of Hysterotomy. Infusion will be stopped once neonate is delivered

intravenous nitroglycerin: Infusion at started at time of hysterotomy and stopped at neonate delivery
Eligibility criteria:
Inclusion Criteria: women 37weeks or greater gestation diagnosed with second stage arrest of descent undergoing cesarean delivery -

Exclusion Criteria: elective, active phase arrest cesarean delivery, successful operative vaginal delivery

-
Intervention: Betamethasone
Trial phase: Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 127
Group description: Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.

Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine

Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.

Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.

In its approved indication there use limitations for immunocompromised
Eligibility criteria:
Inclusion Criteria:

Patients must be diagnosed with at least one of the following: trigger finger, de quervain's tenosynovitis, or tennis elbow (lateral epicondylitis)
Patients age 18 years of age or older from all racial/ethnic types
Patient who are both males and females
Study participants will include any New York University employee or students as these individuals also can get hand and upper extremity pathology. It will be specifically reiterated to them that their academic status or grades, or employment will not be affected by their decision to participate in this study. Record of the participation cannot be linked to an academic record.

Exclusion Criteria:

Patients had previous steroid injection at the site in question within 90 days of enrollment
Patients with a history of gastric ulcers, renal impairment, allergy/hypersensitivity to non-steroidal anti-inflammatory (NSAID) or lidocaine derivative medications, immunocompromised patients (HIV/AIDs) and pregnant females
Intervention: Ketorolac
Trial phase: Phase 3
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 118
Group description: Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine.

Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.

Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Eligibility criteria:
Inclusion Criteria:

Patients must be diagnosed with at least one of the following: trigger finger, de quervain's tenosynovitis, or tennis elbow (lateral epicondylitis)
Patients age 18 years of age or older from all racial/ethnic types
Patient who are both males and females
Study participants will include any New York University employee or students as these individuals also can get hand and upper extremity pathology. It will be specifically reiterated to them that their academic status or grades, or employment will not be affected by their decision to participate in this study. Record of the participation cannot be linked to an academic record.

Exclusion Criteria:

Patients had previous steroid injection at the site in question within 90 days of enrollment
Patients with a history of gastric ulcers, renal impairment, allergy/hypersensitivity to non-steroidal anti-inflammatory (NSAID) or lidocaine derivative medications, immunocompromised patients (HIV/AIDs) and pregnant females
Intervention: Betamethasone
Trial phase: Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.

Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
Eligibility criteria:
Inclusion Criteria:

The subjects included in the study are patients undergoing an anterior cervical spine procedure.

Exclusion Criteria:

Patients with greater than ASA grade II will be excluded. Patients with non-degenerative conditions, such as trauma, tumors, infection, radiation, and diabetes will be excluded. Patients with posterior procedures will be excluded. Patients with clinical pre-operative dysphagia, indicated by a score of 3 or higher on the EAT-10 questionnaire,19 will also be excluded. Patients who are pregnant will be excluded from this study.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 70
Group description: Patients will receive nebulized hypertonic (3%) saline along with standard 2.5 mg albuterol treatments once every 6 hours for 24 hour, with allowance for PRN (as needed use).

Dyspnea will be assessed prior to treatment and at completion of the 24 hour period using the Modified Borg Dyspnea Scale.
Eligibility criteria:
Inclusion Criteria:

Patients at least 18 years of age
Admitted to Doctors Hospital with a clinical diagnosis of COPD
Documented obstruction on spirometry from prior records available at the time of the study.

Exclusion Criteria:

Patients younger than 18 years of age
Spirometry data not available
History of smoking less than twenty pack-years
Possibility of other primary cause of the patient's change in dyspnea or cough (e.g. pneumonia, congestive heart failure with pulmonary edema, myocardial infarction)
Patient is found to have a different primary cause after initial enrollment
Non-English speaking subjects
Intervention: Eritoran
Trial phase: Phase 2
SMILES: CCCCCC/C=C\CCCCCCCCCC(=O)N[C@H]1[C@H](OC[C@H]2O[C@H](OP(=O)(O)O)[C@H](NC(=O)CC(=O)CCCCCCCCCCC)[C@@H](OCCCCCCCCCC)[C@@H]2O)O[C@H](COC)[C@@H](OP(=O)(O)O)[C@@H]1OCC[C@@H](CCCCCCC)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: Obese subjects - IV administration of Eritoran 12 mg every 12 hours
Eligibility criteria:
Inclusion Criteria:

Subjects capable of giving informed consent.
lean (BMI <26 kg/m2) with normal glucose-tolerant subjects without a family history of type 2 DM
obese (BMI 30-37 kg/m2) with normal glucose-tolerant subjects
Type 2 DM subjects base on ADA criteria, who have HbA1c <8.5% and control with diet or sulfonylureas.
Both genders. (50% males)
Age = 18-65 years. Older subjects are excluded because aging is a pro-inflammatory state.
All ethnic groups
Premenopausal women in the follicular phase, non-lactating, and with a negative pregnancy test. Postmenopausal women on stable dose of or not exposed to hormone replacement for >=6 months.
Lab: Hematocrit >=34%, serum creatinine <=1.4 mg/dL, normal electrolytes, urinalysis, and coagulation tests. Liver function tests up to 2x normal range.
Stable body weight (+/-1%) for >=3 months.
One or less sessions of strenuous exercise/wk for last 6 months.

Exclusion Criteria:

Current treatment with drugs known to affect glucose and lipid homeostasis. Subjects on a stable dose of statin (>3 months) are eligible.
Non-steroidal anti-inflammatory drugs or systemic steroid use for more than 1 week within 3 months.
Current treatment with anticoagulants (warfarin). Aspirin (up to 325 mg) and clopidogrel will be permitted if these can be held for seven days prior to the biopsies.
History of heart disease (New York Heart Classification greater than class II; more than non-specific ST-T wave changes on the ECG), peripheral vascular disease, pulmonary disease, smokers.
Poorly controlled blood pressure (systolic BP>160, diastolic BP>90 mmHg).
Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease.
Intervention: Eritoran
Trial phase: Phase 2
SMILES: CCCCCC/C=C\CCCCCCCCCC(=O)N[C@H]1[C@H](OC[C@H]2O[C@H](OP(=O)(O)O)[C@H](NC(=O)CC(=O)CCCCCCCCCCC)[C@@H](OCCCCCCCCCC)[C@@H]2O)O[C@H](COC)[C@@H](OP(=O)(O)O)[C@@H]1OCC[C@@H](CCCCCCC)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 3
Group description: T2DM subjects - IV administration of Eritoran 12 mg every 12 hours
Eligibility criteria:
Inclusion Criteria:

Subjects capable of giving informed consent.
lean (BMI <26 kg/m2) with normal glucose-tolerant subjects without a family history of type 2 DM
obese (BMI 30-37 kg/m2) with normal glucose-tolerant subjects
Type 2 DM subjects base on ADA criteria, who have HbA1c <8.5% and control with diet or sulfonylureas.
Both genders. (50% males)
Age = 18-65 years. Older subjects are excluded because aging is a pro-inflammatory state.
All ethnic groups
Premenopausal women in the follicular phase, non-lactating, and with a negative pregnancy test. Postmenopausal women on stable dose of or not exposed to hormone replacement for >=6 months.
Lab: Hematocrit >=34%, serum creatinine <=1.4 mg/dL, normal electrolytes, urinalysis, and coagulation tests. Liver function tests up to 2x normal range.
Stable body weight (+/-1%) for >=3 months.
One or less sessions of strenuous exercise/wk for last 6 months.

Exclusion Criteria:

Current treatment with drugs known to affect glucose and lipid homeostasis. Subjects on a stable dose of statin (>3 months) are eligible.
Non-steroidal anti-inflammatory drugs or systemic steroid use for more than 1 week within 3 months.
Current treatment with anticoagulants (warfarin). Aspirin (up to 325 mg) and clopidogrel will be permitted if these can be held for seven days prior to the biopsies.
History of heart disease (New York Heart Classification greater than class II; more than non-specific ST-T wave changes on the ECG), peripheral vascular disease, pulmonary disease, smokers.
Poorly controlled blood pressure (systolic BP>160, diastolic BP>90 mmHg).
Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease.
Intervention: Oteseconazole
Trial phase: Phase 2
ATC code: J02AC06
SMILES: O[C@@](Cn1cnnn1)(c1ccc(F)cc1F)C(F)(F)c1ccc(-c2ccc(OCC(F)(F)F)cc2)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: Loading doses of VT-1161 300mg once daily for 2 weeks, then 300mg once weekly for 10 weeks, followed by placebo for 12 weeks
Eligibility criteria:
Key Inclusion Criteria:

Distal subungual onychomycosis of the great toenail, affecting at least ≥25 to ≤75% of nail.

Positive culture for dermatophytes and positive KOH.

Nail ≤ 3 mm thick at the distal end.

At least ≥ 2 mm of the proximal end of the great toenail must be free of infection.

Subjects must be able to swallow tablets.

Women of childbearing potential and males must use acceptable birth control methods throughout the study.

Key Exclusion Criteria:

Presence of subungual hematoma or melanonychia.

Presence of dermatophytoma/nail streaks and severe onychorrhexis.

Significant dystrophy or anatomic abnormalities of the great toenail.

Presence of any other infections of the foot.

Evidence of clinically significant major organ disease.

Poorly controlled diabetes mellitus.

Onychomycosis involving more than 8 toe nails.

Recent use of systemic antifungal therapy.

Recent of any topical antifungal nail therapy.

Recent use of systemic corticosteroid therapy.

Recent use of immunosuppressive medication.

History of prolonged QT intervals.

Known human immunodeficiency virus (HIV) infection.

Known significant renal or hepatic impairment.

Known history of intolerance or hypersensitivity to azole antifungal drugs.
Intervention: Oteseconazole
Trial phase: Phase 2
ATC code: J02AC06
SMILES: O[C@@](Cn1cnnn1)(c1ccc(F)cc1F)C(F)(F)c1ccc(-c2ccc(OCC(F)(F)F)cc2)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: Loading doses of VT-1161 300mg once daily for 2 weeks, then 300mg once weekly for 22 weeks
Eligibility criteria:
Key Inclusion Criteria:

Distal subungual onychomycosis of the great toenail, affecting at least ≥25 to ≤75% of nail.

Positive culture for dermatophytes and positive KOH.

Nail ≤ 3 mm thick at the distal end.

At least ≥ 2 mm of the proximal end of the great toenail must be free of infection.

Subjects must be able to swallow tablets.

Women of childbearing potential and males must use acceptable birth control methods throughout the study.

Key Exclusion Criteria:

Presence of subungual hematoma or melanonychia.

Presence of dermatophytoma/nail streaks and severe onychorrhexis.

Significant dystrophy or anatomic abnormalities of the great toenail.

Presence of any other infections of the foot.

Evidence of clinically significant major organ disease.

Poorly controlled diabetes mellitus.

Onychomycosis involving more than 8 toe nails.

Recent use of systemic antifungal therapy.

Recent of any topical antifungal nail therapy.

Recent use of systemic corticosteroid therapy.

Recent use of immunosuppressive medication.

History of prolonged QT intervals.

Known human immunodeficiency virus (HIV) infection.

Known significant renal or hepatic impairment.

Known history of intolerance or hypersensitivity to azole antifungal drugs.
Intervention: Oteseconazole
Trial phase: Phase 2
ATC code: J02AC06
SMILES: O[C@@](Cn1cnnn1)(c1ccc(F)cc1F)C(F)(F)c1ccc(-c2ccc(OCC(F)(F)F)cc2)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 52
Group description: Loading doses of VT-1161 600mg once daily for 2 weeks, then 600mg once weekly for 10 weeks, followed by placebo for 12 weeks
Eligibility criteria:
Key Inclusion Criteria:

Distal subungual onychomycosis of the great toenail, affecting at least ≥25 to ≤75% of nail.

Positive culture for dermatophytes and positive KOH.

Nail ≤ 3 mm thick at the distal end.

At least ≥ 2 mm of the proximal end of the great toenail must be free of infection.

Subjects must be able to swallow tablets.

Women of childbearing potential and males must use acceptable birth control methods throughout the study.

Key Exclusion Criteria:

Presence of subungual hematoma or melanonychia.

Presence of dermatophytoma/nail streaks and severe onychorrhexis.

Significant dystrophy or anatomic abnormalities of the great toenail.

Presence of any other infections of the foot.

Evidence of clinically significant major organ disease.

Poorly controlled diabetes mellitus.

Onychomycosis involving more than 8 toe nails.

Recent use of systemic antifungal therapy.

Recent of any topical antifungal nail therapy.

Recent use of systemic corticosteroid therapy.

Recent use of immunosuppressive medication.

History of prolonged QT intervals.

Known human immunodeficiency virus (HIV) infection.

Known significant renal or hepatic impairment.

Known history of intolerance or hypersensitivity to azole antifungal drugs.