anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Letrozole
Trial phase: Phase 4
ATC code: L02BG04
SMILES: N#Cc1ccc(C(c2ccc(C#N)cc2)n2cncn2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
Eligibility criteria:
Inclusion criteria:

Postmenopausal women with primary invasive breast cancer, histologically confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive
Clinical Stage T1c (Size ≥ 1.5 cm), T2, T3, T4a, b, c, N0 or N1, M0 (TNM Classification). According to the modified RECIST criteria, tumors of size ≥ 1.5 cm are considered measurable by mammography and can be determined as target lesions).
Tumor measurable by mammography, sonography and clinical examination.
Adequate bone marrow, renal and hepatic function
Good health status (ECOG Performance status of 0, 1 or 2)

Exclusion criteria:

Prior treatment with letrozole or bisphosphonates. Prior and concomitant anti-breast-cancer treatments such as chemotherapy, immunotherapy / biological response modifiers (BRM's), endocrine therapy other than letrozole (including steroids), and radiotherapy. Patients who have received hormone replacement therapy (HRT) will NOT be excluded, provided that HRT is discontinued at least 2 weeks prior to entry into the study.
Patients with unstable angina, or uncontrolled cardiac disease (e.g. Class III and IV New York Heart Association's Functional Classification, see Appendix 9) or uncontrolled endocrine disorders.
Evidence of inflammatory breast cancer or distant metastasis.
Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures. Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants).
History of diseases with influence on bone metabolism, such as Paget's disease, Osteogenesis Imperfecta, and primary or secondary hyperthyroidism within the 12 months prior to study entry

Other protocol-defined inclusion/exclusion criteria may apply
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: 34
Group description: Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
Eligibility criteria:
Inclusion Criteria:

Male and female outpatients ≥ 18 years,
Eastern Cooperative Oncology Group performance status below 1, with histologically confirmed as gastric adenocarcinoma with inoperable and/or metastatic disease.
Patients must have at least one target lesion with a minimum lesion size as per the Response Evaluation Criteria in Solid Tumors criteria (at least 1 unidimensional measurable lesion ≥ 20 mm in diameter by conventional CT or MRI scan, or ≥ 10 mm in diameter by spiral CT scan).
Creatinine clearance ≥ 60ml/min (estimated creatinine clearance must be calculated at baseline for all patients.)
Adequate major organ function : - Hematopoietic function: white blood cell >4,000/mm3 or absolute neutrophil count > 2,000/mm3, Platelet count ≥ 100,000/mm3,- Hepatic function: Bilirubin < 1.5 X upper normal limit, aspartate aminotransferase/alanine aminotransferase levels <2.5 X upper normal limit, alkaline phosphatase < 5 x upper normal limit (except in case of bone metastasis without any liver disease) - Renal function: Creatinine <1 x upper normal limit or creatinine clearance ≥ 60ml/min.

Exclusion Criteria:

Patients must not have previously received systemic treatment (cytotoxic chemotherapy or active/passive immunotherapy) for advanced or metastatic disease.
Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment.

The following laboratory values: - neutrophils ≤1.5 X 109 /L, platelet count<100 X 109 /L- serum bilirubin ≥ 1.5 X upper normal limit, aspartate aminotransferase

, alanine aminotransferase > 2.5 X upper normal limit or > 5 X upper normal limit in the case of liver metastases- Alkaline phosphatase > 2.5 X upper normal limit or 5 X upper normal limit in the case of liver metastases or > 10 X upper normal limit in the case of bone disease.

Prior therapy with Taxotere or Epirubicin is excluded.
Intervention: ADEFOVIR DIPIVOXIL
Trial phase: Phase 3
ATC code: J05AF08
SMILES: CC(C)(C)C(=O)OCOP(=O)(COCCn1cnc2c(N)ncnc21)OCOC(=O)C(C)(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
Eligibility criteria:
Inclusion Criteria:

Documented compensated chronic hepatitis B defined by a clinical history compatible with chronic hepatitis B.
Previous or current lamivudine treatment
HBV DNA > 6 log10 copies/mL
Evidence of viral breakthrough

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Patient is pregnant or breastfeeding.
Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV.
Patient has received any anti-HBV treatment for HBV infection other than lamivudine in the 12 months before Screening for this study.

Other protocol-defined exclusion criteria may apply.
Intervention: Citicoline
Trial phase: Not Applicable
ATC code: N06BX06
SMILES: C[N+](C)(C)CCOP(=O)([O-])OP(=O)(O)OC[C@H]1O[C@@H](n2ccc(N)nc2=O)[C@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 32
Group description: Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
Eligibility criteria:
Inclusion Criteria:

Men and women ages 18-70 years

Meeting criteria for a current major depressive episode (bipolar I,II, not otherwise specified (NOS)

, depressed phase) or major depressive disorder on the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID) with a duration of at least 4 weeks

Meeting criteria for amphetamine abuse or dependence with use within 14 days prior to baseline
No psychotropic medication changes within 14 days prior to study entry

Exclusion Criteria:

Pregnant or nursing women
Current citicoline therapy
Active suicidal or homicidal ideation with plan and intent
Dementia, mental retardation or other severe cognitive impairment that might interfere with the informed consent process
Currently incarcerated at a prison or jail
Severe or life threatening medical condition (e.g. terminal cancer, congestive heart failure)
Intervention: PCO-371
Trial phase: Early Phase 1
SMILES: Cc1cc(N2C(=O)NC(=O)C2(C)C)cc(C)c1CCS(=O)(=O)N1CCC2(CC1)N=C(c1ccc(OC(F)(F)F)cc1)NC2=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: PTH (1-34) 2 picomoles (pmols)/kg/hr
Eligibility criteria:
Inclusion Criteria:

Healthy Caucasian, Hispanic or Asian subjects
Males and Females
Non-smoker
Ages 24 - 35 years old
Subjects will be recruited either from the employee pool of the University of Pittsburgh or the University of Pittsburgh Medical Center (UPMC), or the general population living in the vicinity.
Participation in this study by an employee or a potential employee at the University of Pittsburgh or UPMC has no effect on their employment or potential employment.
Participants in the study will be required to discontinue all vitamins and health food supplements two weeks prior to the study.

Exclusion Criteria:

Cardiac, hypertensive, vascular, renal (serum creatinine of >1.5), pulmonary, endocrine, musculoskeletal, hepatic, hematologic or malignant or rheumatologic disease
Body Mass Index (BMI) > 30,
Anemia (hematocrit less than 36% in women, less than 40% in men),
Pregnancy (all women will have a urine pregnancy test performed immediately before starting the study and must not be pregnant)
Significant alcohol or drug abuse or
Baseline hypotension (systolic blood pressure less than 90 mm/Hg).
Subjects will be excluded for abnormal levels of any of the screening labs including: ionized and total serum calcium, phosphorus, creatinine, albumin, 25-hydroxyvitamin D, and PTH. Pregnancy
Subjects taking any chronic medications except oral contraceptives and stable doses of thyroid hormone, or those who have received any investigational drug in past 90 days will be excluded from the study.
Subjects may not participate in this study more than once.
Any subject who has previously received PTH or PTHrP, a related peptide, may not participate in this study.

Minority Inclusion/Exclusion Statement: We will not include African-Americans because this group has been demonstrated by a number of investigators to display resistance to PTH, and may create wider statistical variation and a need for larger numbers of study subjects per group.
Intervention: PCO-371
Trial phase: Early Phase 1
SMILES: Cc1cc(N2C(=O)NC(=O)C2(C)C)cc(C)c1CCS(=O)(=O)N1CCC2(CC1)N=C(c1ccc(OC(F)(F)F)cc1)NC2=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: PTH (1-34) 4 picomoles (pmols)/kg/hr
Eligibility criteria:
Inclusion Criteria:

Healthy Caucasian, Hispanic or Asian subjects
Males and Females
Non-smoker
Ages 24 - 35 years old
Subjects will be recruited either from the employee pool of the University of Pittsburgh or the University of Pittsburgh Medical Center (UPMC), or the general population living in the vicinity.
Participation in this study by an employee or a potential employee at the University of Pittsburgh or UPMC has no effect on their employment or potential employment.
Participants in the study will be required to discontinue all vitamins and health food supplements two weeks prior to the study.

Exclusion Criteria:

Cardiac, hypertensive, vascular, renal (serum creatinine of >1.5), pulmonary, endocrine, musculoskeletal, hepatic, hematologic or malignant or rheumatologic disease
Body Mass Index (BMI) > 30,
Anemia (hematocrit less than 36% in women, less than 40% in men),
Pregnancy (all women will have a urine pregnancy test performed immediately before starting the study and must not be pregnant)
Significant alcohol or drug abuse or
Baseline hypotension (systolic blood pressure less than 90 mm/Hg).
Subjects will be excluded for abnormal levels of any of the screening labs including: ionized and total serum calcium, phosphorus, creatinine, albumin, 25-hydroxyvitamin D, and PTH. Pregnancy
Subjects taking any chronic medications except oral contraceptives and stable doses of thyroid hormone, or those who have received any investigational drug in past 90 days will be excluded from the study.
Subjects may not participate in this study more than once.
Any subject who has previously received PTH or PTHrP, a related peptide, may not participate in this study.

Minority Inclusion/Exclusion Statement: We will not include African-Americans because this group has been demonstrated by a number of investigators to display resistance to PTH, and may create wider statistical variation and a need for larger numbers of study subjects per group.
Intervention: Humalog
Trial phase: Phase 4
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: 239
Group description: Insulin lispro mid mixture (MM) up to three times a day (TID)
Eligibility criteria:
Inclusion Criteria:

Have type 2 diabetes
Have been receiving oral antihyperglycemic medications (OAM) without insulin including at least two of the following at maximally tolerated doses, AND meet the minimum dosing criteria shown: Metformin 1500 mg/day, Sulfonylurea 1/2 the maximum daily dose, according to package insert, Thiazolidinedione (TZD) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. The OAMs also must be used in accordance with the product label
Have a hemoglobin A1c greater than or equal to 7.5% and less than or equal to 12.0%.

Exclusion Criteria:

Are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label.
Are taking any other glucose-lowering agents not mentioned in Inclusion Criterion.
Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks or for a total of 30 days or more in the last 24 weeks.
Have a body mass index greater than 40 kg/m2.
Have had more than one episode of severe hypoglycemia in the last24 weeks
Are pregnant, intend to be pregnant during the course of the study or are breastfeeding
Have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease
Intervention: Basaglar
Trial phase: Phase 4
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)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NCC(=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: 240
Group description: Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
Eligibility criteria:
Inclusion Criteria:

Have type 2 diabetes
Have been receiving oral antihyperglycemic medications (OAM) without insulin including at least two of the following at maximally tolerated doses, AND meet the minimum dosing criteria shown: Metformin 1500 mg/day, Sulfonylurea 1/2 the maximum daily dose, according to package insert, Thiazolidinedione (TZD) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. The OAMs also must be used in accordance with the product label
Have a hemoglobin A1c greater than or equal to 7.5% and less than or equal to 12.0%.

Exclusion Criteria:

Are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label.
Are taking any other glucose-lowering agents not mentioned in Inclusion Criterion.
Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks or for a total of 30 days or more in the last 24 weeks.
Have a body mass index greater than 40 kg/m2.
Have had more than one episode of severe hypoglycemia in the last24 weeks
Are pregnant, intend to be pregnant during the course of the study or are breastfeeding
Have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease
Intervention: Naltrexone
Trial phase: Phase 2
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval. PET scan will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up compared to the baseline level of FDG uptake.
Eligibility criteria:
Inclusion Criteria:

Metastatic, hormone-receptor positive breast cancer
Disease that has progressed despite previous systemic hormonal therapy. Hormone therapy must be terminated at least 2 weeks prior to study enrollment.
Prior chemotherapy, immunotherapy, or biological therapy is allowed if at least 3 weeks since last treatment. Patient must recover from the acute toxic effects of the treatment prior to study enrollment.
Measurable disease as defined by solid tumor response (RECIST) criteria or non-measurable bone disease that is Positron-emission tomography (PET) avid
Karnofsky performance status >70%
Female, age 18 years or older

Adequate organ function within 14 days of study enrollment including the following:

Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 10^9/L, platelets >75 x 10^9/L, and hemoglobin > 8 g/dL
Hepatic: bilirubin ≤ 2 times the upper limit of normal (× ULN), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2 × ULN. (AST and ALT ≤ 5 × ULN is acceptable if liver has tumor involvement)
Renal: creatinine ≤ 2 times the upper limit of normal
Women of childbearing potential are required to use an effective method of contraception (ie, a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 3 months after the last dose of study drug.
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion criteria:

Brain metastases unless stable for 1 month or more following radiation therapy.
Pregnant or lactating women. PET-CT is not approved during pregnancy. A negative urine or serum pregnancy test is required for all females of child bearing potential within 7 days prior to study entry. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Use of any short-acting or long-acting opioid medication (including morphine, meperidine, oxycodone, hydromorphone, hydrocodone, fentanyl, tramadol) within 10 days prior to study enrollment
Pain uncontrolled with the use of non-narcotic drugs (acetaminophen or non-steroidal medications)
History of sensitivity to naltrexone
Acute hepatitis or liver failure
Immunosuppressive therapy for patients with autoimmune diseases, organ transplant, or other indications
Intervention: Thalidomide
Trial phase: Phase 2
ATC code: L04AX02
SMILES: O=C1CCC(N2C(=O)c3ccccc3C2=O)C(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: 100 mg capsules orally, once a day for 14 days
Eligibility criteria:
Inclusion Criteria:

Have weight loss of > 5% within the last 6 months
Present with anorexia, fatigue and one of the following: anxiety, depression or sleep disturbances, during the preceding 24 hours, with an average intensity of each symptom >/= 3 on a scale of 0 to 10, in which 0=no symptom, and 10= the worst possible symptom.
Describe the symptoms as being present every day for a minimum of 2 weeks.
Have no clinical evidence of cognitive failure
Must be 18 years or older.
Expect to live at least >/= 4 weeks
Must have negative serum pregnancy test within 24 hours of study enrollment in women of childbearing potential. FDA criteria for the status of not of childbearing potential, hysterectomy, or menopausal for 24 consecutive months.
Understand and sign written informed consent.
Have no concurrent steroids with the exception of steroids used concurrently with chemotherapy as part of a regimen or to reduce nausea.
Willing and able to comply with S.T.E.P.S.[System for Thalidomide Education and Prescribing Safety]
Patient's Absolute neutrophil count (ANC) at time of study enrollment is >/= 750 mm (to be drawn within 14 days prior to registration)
May be on chemotherapy if at a stable dose. Targeted therapies or hormone therapies are permitted once patient has completed two weeks of treatment.

Exclusion Criteria:

Have major contraindication to thalidomide, i.e. hypersensitivity.
Present with National Cancer Institute (NCI) Common Toxicity Criteria Grade 3 or more peripheral neuropathy.
Are not able to complete the baseline assessment forms.
Are pregnant or lactating.
Patients with clinical history of seizures
Patients with an ANC of </= 750 at time of study enrollment will be excluded (to be drawn within 14 days prior to registration).
Patients with a history of Acquired Immune Deficiency Syndrome (AIDS), systemic lupus erythematous, or renal failure as defined by a serum creatinine of > 2.0 mg/dl at baseline will be excluded (to be drawn within 29 days prior to registration).
Patients on Revlimid (lenalidomide).
Patients on investigational chemotherapy/agents.
Intervention: Montelukast
Trial phase: Not Applicable
ATC code: R03DC03 | R03DC53
SMILES: CC(C)(O)c1ccccc1CC[C@@H](SCC1(CC(=O)O)CC1)c1cccc(/C=C/c2ccc3ccc(Cl)cc3n2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: This is all patients who received montelukast, whether in the first or second intervention period
Eligibility criteria:
Inclusion Criteria:

-Current hypertension (blood pressure > 140/90 mmHg) or current use of anti-hypertensive medications AND

Exclusion Criteria:

Current use of lipid-lowering medications
Current use of montelukast
Poorly controlled hypertension, where systolic blood pressure is greater than 160 or diastolic blood pressure is greater than 100
Use of steroid drugs, non-steroidal anti-inflammatory drugs or other anti-inflammatory medications in the two weeks prior to enrollment. (low dose aspirin ( < 325 mg) is OK, but indication must be cardiovascular)
Current recreational drug use
Other cardiovascular disease or previous cardiovascular event. These include:
history of angina pectoris
history of heart failure
presence of a cardiac pacemaker
history of myocardial infarction
previous revascularization procedure
history cerebrovascular disease including stroke and transient ischemic attack
Pregnancy or lactation
Diabetes mellitus
Lactose intolerance
Contraindications to montelukast therapy
Alcoholism
Known hepatic disease
Existing chronic obstructive pulmonary disease, asthma, allergic rhinitis
Active chronic immune, infectious, neoplastic or inflammatory diseases requiring therapy (such as active Hepatitis B, Hepatitis C, human immunodeficiency virus (HIV))
Immunosuppressant therapy or known immunosuppression due to disease high density lipoprotein (HDL) < 40 mg/dL (although this would be a risk factor for heart disease, because of preliminary data which indicates that montelukast may lower HDL levels, we will exclude patients with abnormally low HDL from study)
Other criteria at investigator discretion that are deemed to make the subject a poor candidate for the study