anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lubiprostone
Trial phase: Phase 4
ATC code: A06AX03
SMILES: [H][C@@]12CC(=O)[C@H](CCCCCCC(=O)O)[C@@]1([H])CC[C@](O)(C(F)(F)CCCC)O2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 65
Group description: Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
Eligibility criteria:
Inclusion Criteria:

Less than 18 years of age
Weight of at least 12 kg and capable of swallowing a capsule
Able to refrain from use of medications known to treat or associated with constipation symptoms
Stable fiber therapy or ADHD therapy if using such medications
Patient/Caregiver able to complete daily diary
Patient able to use recommended rectal and/or oral rescue medications if needed

Exclusion Criteria:

Constipation is associated with some medical, anatomic, physical, organic, or other condition
Hirschsprung's Disease or Nonretentive Fecal Incontinence
Untreated fecal impactions or impactions requiring digital manipulation
Open gastrointestinal/abdominal surgery or laparoscopic surgery at the investigator discretion
Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, or unexplained weight loss
Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests at the investigator discretion
If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study
Sexually active males and females must utilize acceptable birth control methods
Prior use of lubiprostone, Amitiza, SPI-0211, or RU-0211
Intervention: Lubiprostone
Trial phase: Phase 4
ATC code: A06AX03
SMILES: [H][C@@]12CC(=O)[C@H](CCCCCCC(=O)O)[C@@]1([H])CC[C@](O)(C(F)(F)CCCC)O2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 32
Group description: Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
Eligibility criteria:
Inclusion Criteria:

Less than 18 years of age
Weight of at least 12 kg and capable of swallowing a capsule
Able to refrain from use of medications known to treat or associated with constipation symptoms
Stable fiber therapy or ADHD therapy if using such medications
Patient/Caregiver able to complete daily diary
Patient able to use recommended rectal and/or oral rescue medications if needed

Exclusion Criteria:

Constipation is associated with some medical, anatomic, physical, organic, or other condition
Hirschsprung's Disease or Nonretentive Fecal Incontinence
Untreated fecal impactions or impactions requiring digital manipulation
Open gastrointestinal/abdominal surgery or laparoscopic surgery at the investigator discretion
Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, or unexplained weight loss
Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests at the investigator discretion
If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study
Sexually active males and females must utilize acceptable birth control methods
Prior use of lubiprostone, Amitiza, SPI-0211, or RU-0211
Intervention: Moxifloxacin
Trial phase: Phase 3
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: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 225
Group description: Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
Eligibility criteria:
Inclusion Criteria:

Diagnosis of uncomplicated PID based on the absence of pelvic or tubo-ovarian abscess at pelvic ultrasound and/or laparoscopic examination.

Exclusion Criteria:

Subjects with impaired liver and renal function; known hypersensitivity to study drugs, related compounds or any of the excipients.
Intervention: IFN alpha-IFNAR-IN-1
Trial phase: Phase 2
SMILES: CNCc1ccccc1Sc1cccc2ccccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: 500 IU Interferon-alpha lozenges for oral dissolution
Eligibility criteria:
Inclusion Criteria:

Must have tested positive for HIV.
Must have two or more warts inside the mouth.
Must be receiving a standard course of anti-retroviral therapy (HAART).

Exclusion Criteria:

Must not be receiving oral or injected steroids.
Must not be taking other drugs for treatment of oral warts.
Must not have other active HIV-related opportunistic infections.
Intervention: rhEPO
Trial phase: Phase 3
SMILES: COC1C(O)CC(=O)OC(C)CC=CC=CC(OC2CC(C)(O)C(O)C(C)O2)C(C)CC(CCO)C1OC1OC(C)C(OC2CC(C)(O)C(O)C(C)O2)C(N(C)C)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.

Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.
Eligibility criteria:
Inclusion Criteria:

adult patients, >=18 years of age;
chronic kidney disease stage IV not requiring dialysis;
expected to initiate dialysis within 18 months;
15<=Glomerular Filtration Rate (GFR)<=29.

Exclusion Criteria:

failing renal allograft in place;
acute or chronic bleeding within 8 weeks prior to screening;
transfusion of red blood cells within 8 weeks prior to screening;
poorly controlled hypertension;
immunosuppressive therapy in the 12 weeks prior to screening.
Intervention: Viani
Trial phase: Phase 4
SMILES: CCC(=O)OC1(C(=O)SCF)C(C)CC2C3CC(F)C4=CC(=O)C=CC4(C)C3(F)C(O)CC21C.OCc1cc(C(O)CNCCCCCCOCCCCc2ccccc2)ccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Eligible participants received a starting dose of 50/100 mcg Seretide (combination of Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
Eligibility criteria:
Inclusion Criteria:

Willing to give informed consent.
Males or females aged 18-70.
Able to understand and complete dairy cards.
Mild persistent asthma according to GINA. In addition, at randomisation subjects were required to have: 1. Day time symptoms more than once a week but not every day. 2. Night-time symptoms not more than once a week. 3. FEV1 >80% predicted 4. PC20 <8mg/mL

Exclusion Criteria:

Change to regular asthma medication in 4-weeks prior to visit 1.
Use of oral, depot or parenteral corticosteroids within 8 weeks of visit 1.
Lower respiratory tract within 4 weeks of Visit 1
Received investigational study drug within 4 weeks of visit
Smoking history of >10 pack years of more.
Serious uncontrolled disease.
Medical conditions or medications known to affect the assessments or endpoints.
Evidence of alcohol or drug abuse.
Known pregnancy or planned pregnancy.
Known or suspected hypersensitivity to inhaled corticosteroids, beta-agonists or lactose.
Previous enrollment in the study
Intervention: Pravastatin
Trial phase: Phase 3
ATC code: C10AA03 | C10BA03 | C10BA11 | C10BA12 | C10BX02
SMILES: [H][C@@]12C(=C[C@@H](O)C[C@@H]1OC(=O)[C@@H](C)CC)C=C[C@H](C)[C@@H]2CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 110
Group description: Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years)
Eligibility criteria:
Inclusion Criteria:

Age 8-22 years
Autosomal dominant polycystic kidney disease
Normal kidney function

Exclusion Criteria:

Abnormal kidney function
Past allergic history to medications used in study
Liver disease
Muscle disease/dystrophy
Pregnancy, planned pregnancy, or lactation within study period
Inability to cooperate with or clinical contraindication for magnetic resonance imaging
Intervention: Plasma kallikrein
Trial phase: Phase 3
ATC code: B06AC03
SMILES: CCC(C)C1NC(=O)C(Cc2ccccc2)NC(=O)C(CCC(=O)O)NC(=O)C(CCC(=O)O)NC(=O)C2CSSCC3NC(=O)C(CCC(=O)O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CO)NC(=O)C(CCC(=O)O)NC(=O)C(Cc4ccccc4)NC(=O)C(CCCNC(=N)N)NC(=O)C(CC(N)=O)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CSSCC(NC(=O)C4CCCN4C(=O)CNC(=O)C(CC(=O)O)NC(=O)C(CC(=O)O)NC(=O)C(C)NC(=O)C(CCCCN)NC(=O)C(Cc4ccccc4)NC(=O)C(C)NC(=O)C(NC(=O)C(Cc4ccccc4)NC(=O)C(CO)NC(=O)C(Cc4cnc[nH]4)NC(=O)C(CCSC)NC(=O)C(C)NC(=O)C(N)CCC(=O)O)CSSCC(C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NC(CC(=O)O)C(=O)O)C(C)O)NC(=O)C(CCSC)NC(=O)C(CCCCN)NC(=O)C(CCCCN)NC3=O)C(=O)NC(CCCNC(=N)N)C(=O)NC(C)C(=O)NC(C)C(=O)NC(Cc3cnc[nH]3)C(=O)N3CCCC3C(=O)NC(CCCNC(=N)N)C(=O)NC(Cc3c[nH]c4ccccc34)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(CC(N)=O)C(=O)NC(C(C)CC)C(=O)NC(Cc3ccccc3)C(=O)NC(C(C)O)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCC(N)=O)C(=O)N2)NC(=O)CNC(=O)CNC(=O)C(Cc2ccc(O)cc2)NC1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 147
Group description: DX-88 (ecallantide)
Eligibility criteria:
Inclusion Criteria:

10 years of age or older
Documented diagnosis of HAE (Type I or II)
Willing and able to give informed consent
Acute HAE attack at time of presentation

Exclusion Criteria:

Receipt of an investigational drug or device, within 30 days prior to study treatment, other than DX-88 (ecallantide)
Pregnancy or breastfeeding
Receipt of non-investigational C1-INH or DX-88 within 72 hours of treatment
Patients eligible for current, ongoing clinical trial in which DX 88 (ecallantide) is offered
Intervention: Quetiapine
Trial phase: Phase 4
ATC code: N05AH04
SMILES: OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 72
Group description: Quetiapine

Quetiapine: Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary upto a maximum dose of Quetiapine 600mg PO QD
Eligibility criteria:
Inclusion Criteria:

English or Spanish speaking patients
Provision of written informed consent-English and Spanish
Males and females age 18 to 60 years. Females who are pregnant by inspection should not be included.
Provision at diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV) criteria for Axis I documented who present in an agitated state. PANSS-EC score should be >15.
Ability, in the treating physician's opinion, to co-operate with taking oral medication

Exclusion Criteria:

Pregnant females who will thus receive routine care in the treating physician's opinion
Unstable medical illness
Withdrawal stage from any illicit drugs
Psychosis that prohibits participation in trial
Females of childbearing age where pregnancy cannot be confirmed or denied by screening
Patients who required continued intervention or prolonged restraint
Intervention: Valsartan
Trial phase: Phase 3
ATC code: C09CA03 | C09DA03 | C09DB01 | C09DB08 | C09DX01 | C09DX02 | C09DX04 | C09DX05 | C10BX10
SMILES: CCCCC(=O)N(Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1)[C@H](C(=O)O)C(C)C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 66
Group description: Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg escalated to 2 mg/kg or 4 mg/kg based on MSSBP control after 2 weeks up to 18 weeks.
Eligibility criteria:
Inclusion criteria

Participants who qualified and entered the core study.
Participants who participated in the core study, completed Period 1 and were re-randomized in Period 2 and continued for at least 3 days in Period 2.

Exclusion criteria

Participants who did not complete Period 1 of the core study.
Participants who were re-randomized in Period 2 of core study but did not continue for => 3 days in Period 2 of the core study.
Participants who experienced any adverse events considered serious or drug related in the core study.
Participants excluded from the core study.
Intervention: Brimonidine
Trial phase: Phase 4
ATC code: D11AX21 | S01EA05 | S01GA07
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Brimonidine 0.1%
Eligibility criteria:
Inclusion Criteria:

patients with open-angle glaucoma or ocular hypertension

Exclusion Criteria:

allergy to brimonidine
inability to complete 24 hour stay for monitoring
Intervention: Ziprasidone
Trial phase: Phase 4
ATC code: N05AE04
SMILES: O=C1Cc2cc(CCN3CCN(c4nsc5ccccc45)CC3)c(Cl)cc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Open label change to ziprasidone
Eligibility criteria:
Inclusion Criteria:

Schizophrenia or schizoaffective
Capacity to give consent
Stable, on the same medication for a month but only partial response or with unacceptable side effects 18-65 years of age

Exclusion Criteria:

Repeated non-compliance
Current depot medication
Active medical conditions
QTc >500msec
Previous non-response
Previous treatment with ziprasidone
Intervention: Ciclesonide
Trial phase: Phase 4
ATC code: R01AD13 | R03BA08
SMILES: [H][C@@]12C[C@@]3([H])O[C@@H](C4CCCCC4)O[C@@]3(C(=O)COC(=O)C(C)C)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Ciclesonide 300 mcg intranasally via aqueous nasal spray
Eligibility criteria:
Main Inclusion Criteria:

Written informed consent and HIPAA
Body weight as indicate by a Body Mass Index (BMI) between ≥ 18 and ≤ 28 kg/m², and a body weight >50 kg
General good health
Ability to use oral inhaler

Main Exclusion Criteria:

Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women
Participation in any investigational drug trial within the 30 days before Screening Visit and thereafter
History or current clinically relevant allergies or idiosyncrasy to drugs or food
History of allergic reactions to any corticosteroids including ciclesonide or any excipients of the formulations
Any contraindication to nasally administered corticosteroids
History of a respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, flu, severe acute respiratory syndrome (SARS)] within the 30 days before Screening Visit, or development of a respiratory infection during the Screening Period
History or current evidence of any other relevant allergic, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, metabolic, neurological, psychiatric, or other disease within the last 2 years
Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding Screening Visit
Intervention: Ciclesonide
Trial phase: Phase 4
ATC code: R01AD13 | R03BA08
SMILES: [H][C@@]12C[C@@]3([H])O[C@@H](C4CCCCC4)O[C@@]3(C(=O)COC(=O)C(C)C)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Ciclesonide 300 mcg intranasally via HFA nasal aerosol
Eligibility criteria:
Main Inclusion Criteria:

Written informed consent and HIPAA
Body weight as indicate by a Body Mass Index (BMI) between ≥ 18 and ≤ 28 kg/m², and a body weight >50 kg
General good health
Ability to use oral inhaler

Main Exclusion Criteria:

Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women
Participation in any investigational drug trial within the 30 days before Screening Visit and thereafter
History or current clinically relevant allergies or idiosyncrasy to drugs or food
History of allergic reactions to any corticosteroids including ciclesonide or any excipients of the formulations
Any contraindication to nasally administered corticosteroids
History of a respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, flu, severe acute respiratory syndrome (SARS)] within the 30 days before Screening Visit, or development of a respiratory infection during the Screening Period
History or current evidence of any other relevant allergic, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, metabolic, neurological, psychiatric, or other disease within the last 2 years
Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding Screening Visit
Intervention: Ciclesonide
Trial phase: Phase 4
ATC code: R01AD13 | R03BA08
SMILES: [H][C@@]12C[C@@]3([H])O[C@@H](C4CCCCC4)O[C@@]3(C(=O)COC(=O)C(C)C)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Ciclesonide 320 mcg orally inhaled via HFA MDI
Eligibility criteria:
Main Inclusion Criteria:

Written informed consent and HIPAA
Body weight as indicate by a Body Mass Index (BMI) between ≥ 18 and ≤ 28 kg/m², and a body weight >50 kg
General good health
Ability to use oral inhaler

Main Exclusion Criteria:

Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women
Participation in any investigational drug trial within the 30 days before Screening Visit and thereafter
History or current clinically relevant allergies or idiosyncrasy to drugs or food
History of allergic reactions to any corticosteroids including ciclesonide or any excipients of the formulations
Any contraindication to nasally administered corticosteroids
History of a respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, flu, severe acute respiratory syndrome (SARS)] within the 30 days before Screening Visit, or development of a respiratory infection during the Screening Period
History or current evidence of any other relevant allergic, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, metabolic, neurological, psychiatric, or other disease within the last 2 years
Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding Screening Visit
Intervention: Docetaxel
Trial phase: Phase 2
ATC code: L01CD02
SMILES: CC(=O)OC12COC1CC(O)C1(C)C(=O)C(O)C3=C(C)C(OC(=O)C(O)C(NC(=O)OC(C)(C)C)c4ccccc4)CC(O)(C(OC(=O)c4ccccc4)C21)C3(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Docetaxel Alone
Eligibility criteria:
Inclusion Criteria:

Histologically/cytologically documented SCCHN, excluding nasopharyngeal carcinoma. Squamous cell carcinomas of unknown primary are allowed. Primary salivary gland tumors and tumor of the nasal cavity and paranasal sinuses are not included.
18 years of age or older.
Evaluable or uni-dimensionally measurable local-regional and/or metastatic disease that is not amendable to primary surgical resection or radiotherapy.
Life expectancy of at least 3 months.
ECOG performance status of 0-2.
Negative pregnancy test for women of childbearing potential.
Adequate bone marrow function.

Exclusion Criteria:

Evidence of sever or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial.
Clinically significant cardiac event such as myocardial infarction, NYHA classification of heart disease grade II or higher within 3 months of study entry, or presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia.
History of arrhythmia which is symptomatic or requires treatment or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is not excluded.
Previous history of QTc prolongation as a result from other medication that required discontinuation of that medication.
Congenital long QT syndrome, or 1st degree relative with unexplained sudden death under 40 years of age.
Presence of left bundle branch block.
QTc with Bazett's correction that is unmeasurable or > 480 msec on screening ECG.
Any concomitant medication that may cause QTC prolongation, induce Torsades de Pointes or induce CYP3A4 function.
Hypertension not controlled by medical therapy.
Currently active diarrhea that may affect the ability of the patient to absorb Zactima.
Pregnant or breast-feeding women.
Previous or concurrent malignancies of other histologies within the last 5 years, with the exception of cervical carcinoma in-situ and adequately treated basal cell or squamous cell carcinoma of the skin.
Receipt of any investigational agents within 30 days prior to commencing study treatment.
Prior treatment with docetaxel.
Last dose of prior chemotherapy discontinued less than 3 weeks before start of study therapy.
Last dose of radiation therapy within the last 4 weeks before the start of study therapy, except palliative radiotherapy.
Major surgery within 4 weeks, or incompletely healed surgical incision.
Intervention: Terbinafine
Trial phase: Phase 3
ATC code: D01AE15 | D01BA02
SMILES: CN(C/C=C/C#CC(C)(C)C)Cc1cccc2ccccc12
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 493
Group description: 10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
Eligibility criteria:
Inclusion Criteria:

Male and females 12 - 75 years of age
Fungal toenail infection of one or both of the large (great) toenails
The nail infection must be due to a dermatophyte, (mixed infections [dermatophyte and non-dermatophyte] are not allowed)
The target toenail area must have at least 25% to no more than 75% disease involvement without spikes.

Exclusion Criteria:

Target foot must not have severe plantar (moccasin) tinea pedis that would require systemic therapy. Mild to moderate tinea pedis (athlete's foot) infection should be treated with terbinafine prior to baseline or at any time during the trial. Other topical treatments for athlete's foot may be recommended at the discretion of the investigator.
Subjects must not have abnormalities of the nail that could prevent a normal appearing nail if clearing of infection is achieved
No administration of systemic antifungal medications within 6 months prior to screening visit
No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit
Patients with the target toenail involving the matrix (lunula) or having less than 2mm clear (unaffected) nail plate length beyond the proximal fold.
Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail.
No professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit
Known pregnancy or lactation at time of enrollment

Other protocol-defined inclusion/exclusion criteria may apply