anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sitagliptin
Trial phase: Phase 4
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Sitagliptin

sitagliptin: sitagliptin 100mg daily
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women (as defined by age >55 years old or amenorrhea for >1years)
Type 2 DM currently not on diabetes-specific medication(s) or treated with monotherapy of metformin or a sulfonylurea. Patients treated with insulin monotherapy will also be eligible if the total daily dose of insulin is <10units.
Hemoglobin A1c (HbA1c) of 6.5-9.0%

Exclusion Criteria:

Use of an incretin mimetic (i.e. exenatide), a DPP-4 inhibitor (i.e. sitagliptin, saxagliptin), a thiazolidinedione, or oral glucocorticoids in the 6 months prior to the study will not be eligible
Known osteoporosis or patients treated with an osteoporosis-specific medication (bisphosphonate, teriparatide) or estrogen (including Selective Estrogen Receptor Modulators (SERMs)) or those who anticipate imminent treatment with one of these medications will be excluded from the study
Chronic kidney disease (calculated GFR <30 ml/min) or a disease known to affect bone turnover (i.e. Paget Disease, Osteogenesis Imperfecta, HIV) will be excluded from the study.
History of pancreatitis
Intervention: Doxycycline
Trial phase: Phase 4
ATC code: A01AB22 | J01AA02 | J01AA20
SMILES: [H][C@@]12C(=C(O)[C@]3(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]3([H])[C@H]1O)C(=O)c1c(O)cccc1[C@@H]2C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 39
Group description: Participants with DM2 receiving doxycycline 100mg BID

Doxycycline : generic doxycycline 100mg twice daily
Eligibility criteria:
Inclusion Criteria:

Ambulatory, medically stable, able to give informed consent, and comply with the protocol.
Obesity with BMI >30 kg/m2.
DM2 for less than 10 years.
7.5% < HA1C < 10%
Taking insulin and/or oral medications (biguanide, sulfonlylurea, etc.)

Exclusion Criteria:

Mental states that would preclude complete understanding of the protocol and compliance.
Chronic illness such as renal failure (with creatinine clearance <80 ml/min for Specific Aim 2).
Women of child-bearing age because of the potential hazard to the fetus (doxycycline may cause permanent discoloration of the teeth and deposition in bone inhibiting growth) and because doxycycline may render oral contraceptives less effective.
Nursing mothers.
Allergy to tetracyclines.
Subjects taking the following drugs: penicillin or it's derivatives, anticoagulant therapy, antacids containing aluminum, calcium, or magnesium, iron-containing preparations, bismuth subsalicylate, barbiturates, carbamazepine, phenytoin or methoxyflurane, thiazolidinediones (TZD)
Intervention: Ezetimibe
Trial phase: Phase 2
ATC code: C10AX09 | C10BA02 | C10BA05 | C10BA06 | C10BA10 | C10BA11 | C10BA12
SMILES: [H][C@]1(CC[C@H](O)c2ccc(F)cc2)C(=O)N(c2ccc(F)cc2)[C@]1([H])c1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Participants received 10 mg ezetimibe orally once a day for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female ≥ 18 to ≤ 75 years of age
Low density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL and < 190 mg/dL
Framingham risk score of 10% or less
Fasting triglycerides < 400 mg/dL

Exclusion Criteria:

History of coronary heart disease
New York Heart Association (NYHA) II - IV heart failure
Uncontrolled cardiac arrhythmia
Uncontrolled hypertension
Intervention: Ovral
Trial phase: Phase 1
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3CCC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna).
Eligibility criteria:
Inclusion Criteria:

Healthy women, ages 18-45
Body mass index (BMI)of ≥18 and less than or equal to 32, and weight ≥ 110 lbs.
Willing to use a non-hormonal method of contraception if of childbearing potential, or have already undergone previous bilateral tubal ligation or hysterectomy
Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior to patch application until completion of each treatment period
Willing to give informed consent to participate in study

Exclusion Criteria:

Known or suspected pregnancy
Breast-feeding or within 1 month after stopping breast-feeding
Smokers
Any disease that may worsen with hormonal treatment
Hypersensitivity to transdermal preparations or sensitivity to surgical/medical tape
Intervention: Ibuprofen
Trial phase: Phase 4
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.

Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.

Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose.
Eligibility criteria:
Inclusion Criteria:

Adults, 18 and over, who will undergo surgery lasting longer than one hour with general anesthesia

Subject is non-lactating and is either:

Not of childbearing potential
Of childbearing potential but is not pregnant at time of baseline as determined by pre-surgical pregnancy testing.
Subject is ASA physical status 1, 2, or 3

Exclusion Criteria:

Cognitively impaired (by history)
Subject requires chronic antipsychotic history
Subject is anticipated to require an additional surgery within 90 days after the intended surgery
Chronic use of steroids or opioids
Subject has received treatment with COX inhibitors within 3 days of study entry
Subject for whom opiates, benzodiazepines, and COX inhibitors are contraindicated
Intervention: Posaconazole
Trial phase: Phase 2
ATC code: J02AC04
SMILES: CC[C@@H]([C@H](C)O)n1ncn(-c2ccc(N3CCN(c4ccc(OC[C@@H]5CO[C@@](Cn6cncn6)(c6ccc(F)cc6F)C5)cc4)CC3)cc2)c1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 32
Group description: POS 400 mg (10 mL) oral suspension twice daily for 60 days
Eligibility criteria:
Inclusion Criteria:

- Must have a positive serology result for Trypanosoma cruzi on any 2 of 3 of the following tests: indirect immunofluorescence, indirect hemagglutination, or enzyme-linked immunoabsorbent assay (ELISA)

Must have a positive qualitative polymerase chain reaction (PCR) for Trypanosoma cruzi
Must have a normal 12-lead electrocardiogram (ECG)
Must have a normal 2-D echocardiogram
Must have no evidence of ventricular tachycardia on 24-hour Holter monitoring
Female participants of childbearing age must be using a medically accepted method of birth control before beginning study drug treatment and must agree to continue its use during the study, or must have been surgically sterilized
Female participants of childbearing potential must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline or within 72 hours before the start of study drug

Exclusion Criteria:

Are breastfeeding, pregnant, or planning to become pregnant
Body weight <60 kg
Have an immunodeficiency or are immunosuppressed
History of megacolon with obstipation or megaesophagus with severe swallowing impairment.
Have previously received treatment with benznidazole or nifurtimox
Known allergy/sensitivity to azoles
Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than 2.5 times the upper limit of normal at Screening
Has serum creatinine >2.5 mg/dL or 200 micromoles at Screening
Has a history of severe alcohol abuse within two years from Screening
Is taking any of the prohibited medication
Intervention: Isoprenaline
Trial phase: Not Applicable
ATC code: C01CA02 | R03AB02 | R03AK02 | R03CB01 | R03CB51
SMILES: CC(C)NCC(O)c1ccc(O)c(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: In this study, serious adverse events were considered clinically significant adverse events. The well known isoproterenol effects on heart rate, rhythm, ST segments, and blood pressure were noted.
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for EP studies for catheter ablation of atrial fibrillation under general anesthesia will participate in the study

Exclusion Criteria:

Patients with neuromuscular disease precluding the use of succinylcholine will be excluded.
Patient or cardiologist refusal
Intervention: Bexagliflozin
Trial phase: Phase 2
ATC code: A10BK08
SMILES: OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(OCCOC4CC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 145
Group description: EGT0001442 capsule, 20 mg, orally once daily
Eligibility criteria:
Inclusion Criteria:

Male or female subjects ≥18 years old
Diagnosed with type 2 diabetes
Body mass index (BMI) ≤ 45 kg/m2
HbA1c between 7 and 10% (inclusive) at screening
FPG <250 mg/dL at screening for subjects not treated with oral anti-diabetic therapies or FPG <240 mg/dL at screening for subjects treated with anti-diabetic therapies
Diabetes currently treated with diet and exercise only or diet and exercise along with one approved oral anti-diabetic agent
If taking anti-diabetic medication, dose and regimen must be stable for past 3 months
If taking anti-hypertensive medication, dose and regimen must be stable for past 3 months
If taking lipid modifying therapy, dose and regimen must be stable for past 3 months
Blood glucose <250 mg/dL based on finger stick blood glucose for all subjects at randomization

Exclusion Criteria:

Hemoglobinopathy that affects HbA1c measurement
Current use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor based therapy)
Genitourinary tract infection within 6 weeks of screening
Greater than 2 episodes of genitourinary tract infection in the past year
History of kidney stones, bladder malfunction or other significant risk factor for urinary tract infections
eGFR, as calculated by the modification of diet in renal disease study equation (MDRD), < 50 mL/min/1.73 m2
Abnormal tests of liver function ALT, AST or bilirubin ≥ 3x ULN
Diagnosis of retinopathy or significant nephropathy (eGFR < 50 mL/min/1.73 m2
Uncontrolled hypertension (systolic blood pressure >160 or diastolic blood pressure >95)
Not willing to use effective birth control, if female with child-bearing potential
Life expectancy < 2 years
New York Heart Association (NYHA) Class 4 heart failure
Sera positive of HCV, HIV, or positive on drug screen
Currently participating in another interventional trial
Previous treatment with EGT0001442 or EGT0001474
Not able to comply with the study scheduled visits
Intervention: Amifampridine Phosphate
Trial phase: Phase 3
SMILES: Nc1ccncc1N.O=P(O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Matching amifampridine phosphate tablets, 10 mg, administered 3-4 times a day for 2 weeks.

Amifampridine Phosphate: 30-80 mg given 3-4 times per day with a maximum single dose of 20 mg (2 x 10 mg tablets).
Eligibility criteria:
Inclusion Criteria: Individuals eligible to participate in this study must meet all of the following inclusion criteria:

≥18 years of age
Confirmed diagnosis of LEMS
Normal respiratory function
Normal swallowing function
If receiving peripherally acting cholinesterase inhibitors a stable dose is required for at least 7 days prior to Screening.
If receiving oral immunosuppressants a stable dose is required for at least 90 days prior to Screening.
Negative pregnancy test for females of childbearing potential
If sexually active, willing to use 2 acceptable methods of contraception
Willing to perform all study procedures as physically possible.
Willing and able to provide written informed consent after the nature of the study has been explained and prior to the start of any research-related procedures.

Exclusion Criteria: Individuals who meet any of the following exclusion criteria are not eligible to participate in the study:

History of epilepsy or seizure.
Known active brain metastasis.
Use of Fampridine (4-aminopyridine), and any form of 3,4-diaminopyridine other than the IP provided, such as amifampridine base or Firdapse, during the study.
Use of medications known to lower the epileptic threshold within 7 days or 5 half-lives.
Use of medications which inhibit neuromuscular junction function within 7 days or 5 half-lives.
Use of IVIG, plasmapheresis (plasma exchange), or immunoadsorption within 90 days
Use of guanidine hydrochloride within 7 days
Use of rituximab within 12 months
History of drug allergy to any pyridine-containing substances or any amifampridine phosphate excipient(s).
Use of any other investigational productwithin 30 days
Treatment with a concomitant medication that prolongs the QT/QTc interval within 7 days or 5 half-lives.
Treatment with sultopride (4-amino-N-[(1-ethylpyrrolidin-2-yl)methyl]-5-ethylsulfonyl-2-methoxybenzamide) within 7 days.
An abnormal electrocardiogram (ECG).
Documented history of arrhythmias.
History of additional risk factors for torsade de pointes.
Breastfeeding or pregnant or planning to become pregnant (self or partner) at any time during the study.
Likely or expected to require treatment for cancer within 3 months (90 days) after entering.
History of severe renal impairment or evidence of severe renal impairment
Any condition that places the patient at high risk of poor treatment compliance or of not completing the study.
History of uncontrolled asthma.
Intervention: Acetazolamide
Trial phase: Not Applicable
ATC code: G01AE10 | S01EC01
SMILES: CC(=O)Nc1nnc(S(N)(=O)=O)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Acetazolamide (active arm)
Eligibility criteria:
Inclusion Criteria (Heart failure patients)

Left ventricular ejection fraction (EF) <50%, or heart failure with preserved EF
Age 18-89

Exclusion Criteria:

severe obstructive respiratory disease
unstable heart failure status
recent use of positive airway pressure therapy
current use of opioids, benzodiazepines
severe kidney disease
severe anemia
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: 26
Group description: Glargine once daily and lispro before meals + supplemental insulin lispro as needed for elevated blo0d glucose using sliding scale Insulin (SSI)
Eligibility criteria:
Inclusion Criteria:

Males or females between the ages of 18 and 80 years admitted to a general medicine and surgery services.
A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone, oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination therapy (excluding Trazodone (TZDs) and DPP4 inhibitors), or low-dose (≤ 0.4 units/kg/day) insulin therapy.
Subjects with a BG >140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 milliequivalent /L or positive serum or urinary ketones).

Exclusion Criteria:

Age < 18 or > 80 years.
Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia).
Subjects with a history of type 1 diabetes (suggested by BMI < 25 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria) [46].
History of TZD treatment (pioglitazone or rosiglitazone) or DPP4 inhibitor (sitagliptin or saxagliptin) during the past 3 months prior to admission.
Acute critical illness or coronary artery bypass graft (CABG) surgery expected to require prolonged admission to a critical care unit (ICU, cardiac care unit , surgical intensive care unit, neuro ICU).
Subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction.
Medical or surgical patients expected to be kept nil per os (NPO) for >24-48 hours after admission or after completion of surgical procedure.
Patients with clinically relevant pancreatic or gallbladder disease.
Patients with congestive heart failure (NYHA class III and IV), acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (serum creatinine ≥ 2.0 mg/dL).
Treatment with oral or injectable corticosteroid.
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Female subjects are pregnant or breast feeding at time of enrollment into the study.
Intervention: TESTOSTERONE CYPIONATE
Trial phase: Phase 1
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](OC(=O)CCC3CCCC3)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 105
Group description: All patients who qualify for the study will receive testosterone cypionate

Testosterone Cypionate: DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.

Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1oxopropoxy)-,

(178)-. Its molecular formula is CvH400a, and the mole
Eligibility criteria:
Inclusion Criteria:

Male Veterans with low total testosterone (<300 ng/dl) as defined by the Endocrine Society, who are between 40-75 years of age.
These patients must be ambulatory; and be willing and able to provide written informed consent.

Exclusion Criteria:

history of prostate cancer, breast cancer
history of testicular disease
untreated sleep apnea
any ongoing illness that, in the opinion of the investigator, could prevent the subject from completing the study
patients with a hematocrit of more than 50% (2010 Endocrine Society Guidelines)
prostate-related findings of a palpable prostate nodule on exam, a serum PSA of 4.0 ng/ml or more, International Prostate Symptom Score >8(9), urinary postvoid residual by ultrasound of >149 ml, or an abnormal transrectal ultrasound
patients who are on androgen replacement therapy, selective androgen receptor modulator, or finasteride

patients currently on medications that affects bone metabolism such as:

estrogen
the selective estrogen receptor modulator (SERM) as raloxifene
use of bisphosphonates (i.e. risedronate, alendronate, zoledronic acid and pamidronate)
within two years of study entry
aromatase inhibitors
GnRH analogs
glucocorticoids of at least 5 mg daily for one month or more
anabolic steroids
dilantin
warfarin
patients with diseases known to interfere with bone metabolism as hyperparathyroidism, untreated hyperthyroidism, osteomalacia, chronic liver disease, renal failure, hypercortisolism, malabsorption and immobilization
those with current alcohol use of more than 3 drinks per day (62).
history of documented coronary artery disease at high risk for recurrence
Subjects with osteoporosis or a BMD T-score of -2.5 in the lumbar spine, total femur or femoral neck as well as those patients with a history of osteoporosis-related fractures (spine, hip or wrist) or vertebral deformities on lateral spine radiographs deemed as fragility fractures by the team principal investigator.
history of documented coronary artery disease at high risk for recurrence, history of deep vein thrombosis and cerebrovascular event.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 80
Group description: Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
Eligibility criteria:
Inclusion Criteria:

Parturients beyond 37 weeks gestation
ASA І or ІІ

Exclusion Criteria:

pregnancy-induced hypertension
chronic hypertension
multiple pregnancy
fetal compromise
diabetes mellitus
polyhydramnios
body weight >100 kg
major systemic disease
anemia (hemoglobin concentration<10 g/dl)
clotting diathesis
Intervention: Phenylephrine
Trial phase: Phase 4
ATC code: C01CA06 | R01AA04 | R01AB01 | R01BA03 | R01BA53 | S01FB01 | S01FB51 | S01GA05 | S01GA55
SMILES: CNC[C@H](O)c1cccc(O)c1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 80
Group description: Phenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery
Eligibility criteria:
Inclusion Criteria:

Parturients beyond 37 weeks gestation
ASA І or ІІ

Exclusion Criteria:

pregnancy-induced hypertension
chronic hypertension
multiple pregnancy
fetal compromise
diabetes mellitus
polyhydramnios
body weight >100 kg
major systemic disease
anemia (hemoglobin concentration<10 g/dl)
clotting diathesis
Intervention: Meclinertant
Trial phase: Phase 4
SMILES: COc1cccc(OC)c1-c1cc(C(=O)NC2(C(=O)O)C3CC4CC(C3)CC2C4)nn1-c1ccnc2cc(Cl)ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Inert powder (in capsule taken orally)
Eligibility criteria:
Inclusion Criteria:

50 years of age or older;
diagnosis of COPD;
current or former smoker of at least 10 pack-years;
post-bronchodilator FEV1 greater than or equal to 30% predicted and less than or equal to 80% predicted; post-bronchodilator ratio < 70%

Exclusion Criteria:

any concomitant disease that might interfere with study procedures;
use of a drug that may cause a possible drug interaction with ketoconazole