anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Prednisolone
Trial phase: Phase 2
ATC code: A01AC04 | A01AC54 | A07EA01 | C05AA04 | D07AA03 | D07BA01 | D07CA03 | D07XA02 | H02AB06 | R01AD02 | R01AD52 | S01BA04 | S01BB02 | S01CA02 | S01CB02 | S02BA03 | S02CA01 | S03BA02 | S03CA02 | V03AB05
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: Male
Age groups: Child
Healthy volunteers: No
Participants at risk: 25
Group description: Oral Prednisolone 5mg/kg/ day on two consecutive days, Friday and Saturday with breakfast

Prednisolone: Prednisolone (5mg per kg )will be taken on two consecutive days, Friday and Saturday mornings each week with breakfast
Eligibility criteria:
Inclusion Criteria:

Appropriate degree of weakness for age, creatine kinase greater than 20 times the upper limit of normal, and genetic mutation known to be causative for Duchenne muscular dystrophy .
Appropriate degree of weakness for age, creatine kinase greater than 20 times the upper limit of normal and genetic or biopsy confirmation of Duchenne muscular dystrophy in a primary relative (e.g. brother or maternal uncle).
De-identified, genetic studies will be reviewed by collaborator Kevin Flanigan, MD prior to enrollment of subjects.
Age at entry: one month through 30 months.

Exclusion Criteria:

Prior treatment with corticosteroids
Intervention: Maraviroc
Trial phase: Phase 1 | Phase 2
ATC code: J05AX09
SMILES: Cc1nnc(C(C)C)n1[C@@H]1C[C@H]2CC[C@@H](C1)N2CC[C@H](NC(=O)C1CCC(F)(F)CC1)c1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Maraviroc administration will start on day -3 and will end on day +30 after stell cell transplant, making the total number of days of drug administration 34 days. Maraviroc will be administered twice daily orally or via enteral tube. Dosing of Maraviroc will be based on body surface area (starting with 100mg twice a day for BSA of 0.2 and up to 300mg twice a day for BSA greater than 1.73).

Maraviroc
Eligibility criteria:
Inclusion Criteria:

Ages 5 years and </= 40 years
All diagnoses
Peripheral blood stem cells, marrow or cord blood
All conditioning regimens
Patient must be planned to receive a calcineurin inhibitor (cyclosporine or tacrolimus) together with steroid, methotrexate or mycophenolate mofetil as GVHD prophylaxis.

Exclusion Criteria:

Documented anaphylaxis to Maraviroc
Ex vivo T-cell (type of white blood cell) depleted grafts
Abnormal Alanine Aminotransferase (ALT) (>/=10X ULN) on day -3. (Assessed at study enrollment and confirmed again prior to the first dose of maraviroc.)
Intervention: Labetalol
Trial phase: Not Applicable
ATC code: C07AG01 | C07BG01 | C07CG01
SMILES: CC(CCc1ccccc1)NCC(O)c1ccc(O)c(C(N)=O)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Labetalol 200mg PO BID starting dose

Labetalol: Titrate up for blood pressure control
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years with the abililty to give informed consent
Intrauterine pregnancy ≥ 32 weeks
Postpartum
Persistent postpartum blood pressures ≥ 160/105 on two or more occasions
Primary obstetrician amenable to starting either study medication in the postpartum period

Exclusion Criteria:

Use of other oral antihypertensives concomitantly
Known AV heart block
HR <60 or >120
Absolute contraindication to nifedipine or labetolol such as allergy
Significant renal disease (Cr >1.5 mg/dL)
Heart failure
Moderate persistent or severe asthma
Preexisting diagnosis of chronic hypertension with medical treatment before delivery
Chronic hypertension
Intervention: Nifedipine
Trial phase: Not Applicable
ATC code: C07FB03 | C08CA05 | C08CA55 | C08GA01
SMILES: COC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1c1ccccc1[N+](=O)[O-]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Nifedpine XL starting at dose 30mg PO daily

Nifedipine: Titrate up to achieve blood pressure control
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years with the abililty to give informed consent
Intrauterine pregnancy ≥ 32 weeks
Postpartum
Persistent postpartum blood pressures ≥ 160/105 on two or more occasions
Primary obstetrician amenable to starting either study medication in the postpartum period

Exclusion Criteria:

Use of other oral antihypertensives concomitantly
Known AV heart block
HR <60 or >120
Absolute contraindication to nifedipine or labetolol such as allergy
Significant renal disease (Cr >1.5 mg/dL)
Heart failure
Moderate persistent or severe asthma
Preexisting diagnosis of chronic hypertension with medical treatment before delivery
Chronic hypertension
Intervention: Midazolam
Trial phase: Phase 4
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 18
Group description: Intranasal Midazolam 0.4 milligram/kilogram

Midazolam: 20 patients enrolled, 18 underwent analysis
Eligibility criteria:
Inclusion Criteria:

Presenting to Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
Laceration <5 cm in total length
Require simple suture laceration repair

Exclusion Criteria:

Allergies/intolerance/contraindication to the study drugs
Lacerations requiring complex (multilayer) repair or total laceration length>5cm
Intervention: FLUOCINOLONE ACETONIDE
Trial phase: Phase 4
ATC code: C05AA10 | D07AC04 | D07BC02 | D07CC02 | S01BA15 | S01CA10 | S02BA08 | S02CA05
SMILES: [H][C@@]12C[C@@]3([H])OC(C)(C)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 206
Group description: All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline. Test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.

Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae.

Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae.

Saline: Approximately 0.2 ml of the saline is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae.
Eligibility criteria:
Inclusion Criteria:

Subjects must be 18 to 79 years inclusive.
Subjects must be able to understand and execute informed consent.
Female subjects must produce a negative pregnancy test.
Subjects must be capable of following directions.
Subjects must be considered reliable .

Exclusion Criteria:

Subjects who are ill of health or taking medication that could influence the purpose, integrity, or outcome of the trial.
Female subjects who are pregnant.
Subjects with a history of adverse reactions to cosmetics, OTC (over the counter) drugs or other personal care products.
Subjects who have used topical or systemic steroids or antihistamines within 7 days prior to trial initiation or plan to use either during the duration of the trial.
Subjects with known allergy to neomycin, bacitracin, gentamicin, paromomycin, spectinomycin, streptomycin or tobramycin.
Subjects with known allergy to corticosteroid.
Subjects with a history of auto-immune disease (e.g. lupus, psoriatic arthritis, rheumatoid arthritis).
Intervention: Calcifediol
Trial phase: Phase 2
ATC code: A11CC06 | H05BX05
SMILES: C=C1CCC(O)CC1=CC=C1CCCC2(C)C1CCC2C(C)CCCC(C)(C)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 22
Group description: Standard vitamin D3 dose as per IOM (Institute of Medicine) recommendations; actual dose will be 5000 IU per week, which is just slightly higher than the IOM recommendation of 600 IU per day. Length of time proposed to be 4 months at 5000 IU D3 per week. End of study measures at 4 months to be HOMA-IR, BMI Z score, 25-OH D level.

Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL.
Eligibility criteria:
Inclusion Criteria:

age 6-17 years
BMI > 95% for age
serum 25-OH D level < or + to 25 ng/mL

Exclusion Criteria:

BMI < 95% for age
serum 25-OH D level > 25 ng/mL
current Vitamin D supplementation > 400 IU/day
anti-convulsant therapy, anti-hypertensive therapy, lipid lowering medication
any medications that affect glucose metabolism (e.g., metformin, insulin)
daily glucocorticoid therapy
diabetes
any disorders of bone or calcium metabolism
hepatic or renal disease
any malabsorptive disorder
baseline serum Calcium > 11 ng/dL (> 2 SD above the mean)
any genetic disorder that predisposes to obesity (e.g., Prader Willi
hypothalamic obesity
Intervention: Calcifediol
Trial phase: Phase 2
ATC code: A11CC06 | H05BX05
SMILES: C=C1CCC(O)CC1=CC=C1CCCC2(C)C1CCC2C(C)CCCC(C)(C)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 18
Group description: Initial D3 dose will be 30,000 IU per week; at 6 week intervals serum D3 levels will be checked, and dose adjustments made to reach target 25-OHD level of between 30-50 ng/mL (inclusive). Once within target, D3 dose will be continued for 4 months, and end of study measurements done (HOMA-IR, BMI Z score, 25-OHD level).

Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL.
Eligibility criteria:
Inclusion Criteria:

age 6-17 years
BMI > 95% for age
serum 25-OH D level < or + to 25 ng/mL

Exclusion Criteria:

BMI < 95% for age
serum 25-OH D level > 25 ng/mL
current Vitamin D supplementation > 400 IU/day
anti-convulsant therapy, anti-hypertensive therapy, lipid lowering medication
any medications that affect glucose metabolism (e.g., metformin, insulin)
daily glucocorticoid therapy
diabetes
any disorders of bone or calcium metabolism
hepatic or renal disease
any malabsorptive disorder
baseline serum Calcium > 11 ng/dL (> 2 SD above the mean)
any genetic disorder that predisposes to obesity (e.g., Prader Willi
hypothalamic obesity
Intervention: Calcifediol
Trial phase: Phase 2
ATC code: A11CC06 | H05BX05
SMILES: C=C1CCC(O)CC1=CC=C1CCCC2(C)C1CCC2C(C)CCCC(C)(C)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 21
Group description: Initial D3 dose will be 60,000 IU/week; at 6 week intervals 25-OHD levels will be done, and dose adjustments made to achieve target level of 40-60 ng/mL (inclusive). Once within target range, De3 dose will be continued for 4 months, and end of study measures obtained (HOMA-IR, BMI Z score, 25-OHD level).

Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL.
Eligibility criteria:
Inclusion Criteria:

age 6-17 years
BMI > 95% for age
serum 25-OH D level < or + to 25 ng/mL

Exclusion Criteria:

BMI < 95% for age
serum 25-OH D level > 25 ng/mL
current Vitamin D supplementation > 400 IU/day
anti-convulsant therapy, anti-hypertensive therapy, lipid lowering medication
any medications that affect glucose metabolism (e.g., metformin, insulin)
daily glucocorticoid therapy
diabetes
any disorders of bone or calcium metabolism
hepatic or renal disease
any malabsorptive disorder
baseline serum Calcium > 11 ng/dL (> 2 SD above the mean)
any genetic disorder that predisposes to obesity (e.g., Prader Willi
hypothalamic obesity
Intervention: Nortriptyline
Trial phase: Not Applicable
ATC code: N06AA10
SMILES: CNCCC=C1c2ccccc2CCc2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Diet modification - nortriptyline and then if necessary topiramate

nortriptyline: The nortriptyline will be given in an escalating fashion, starting at 25 mg PO qhs for 2 weeks, followed by 50 mg PO qhs for 2 weeks, and finally 75 mg PO qhs. Patients will be encouraged to use the lowest effective dose and to self-titrate their medication.
Eligibility criteria:
Inclusion Criteria:

-Men and women aged 18 to 70 with untreated vestibular migraine variant as diagnosed by history.

Exclusion Criteria:

Patients with allergies to nortriptyline or topiramate and their analogs or medication interactions that preclude their use.
Patients under the care of a psychiatrist.
Patients who are pregnant or trying to become pregnant.
Patients taking more than 5 prescription medications.
Patients with cancer.
Patient has a history of immunodeficiency.
Patient has a history of substance abuse within the preceding 6 months prior to screening.
Patient has used an investigational drug or device in the the 3 months prior to screening.
Patient is using marijuana for medical or other uses.
Patient has any other clinically significant illness or medical condition that, in the investigator's opinion, would prohibit the subject from participating in the study.
Patient with traumatic brain injury.
Patients taking Nortriptyline, MAOIs
Patients with liver or kidney dysfunction or glaucoma

Due to know drug interactions, patients taking the following medications will be excluded.

Nortriptyline: monoamine oxidase inhibitors (MAO) such as phenelzine. Patients on oral contraceptives will be asked to use a secondary method as nortriptyline can reduce the effectiveness of oral contraceptives.

Topiramate: acetazolamide (kidney stones), digoxin

Exclude subjects with liver dysfunction, kidney dysfunction and glaucoma (per the risks associated with topiramate).
Intervention: Iloprost
Trial phase: Phase 4
ATC code: B01AC11
SMILES: CC#CCC(C)C(O)C=CC1C(O)CC2CC(=CCCCC(=O)O)CC21
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.

A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.

Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
Eligibility criteria:
Inclusion Criteria:

Clinical evidence of pulmonary hypertension (PH) requiring INO therapy as prescribed by the attending physician.
Indwelling arterial catheter.
Signed informed consent

Exclusion Criteria:

Clinically unstable circulatory condition requiring epinephrine > 0.1 mcg/kg/min or levophed, or already meeting treatment failure criteria (see section 5.3 below)
Known hypersensitivity to prostacyclin compounds
Patients receiving sildenafil or bosentan
Refusal by the attending physician
Intervention: Iloprost
Trial phase: Phase 4
ATC code: B01AC11
SMILES: CC#CCC(C)C(O)C=CC1C(O)CC2CC(=CCCCC(=O)O)CC21
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.

A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.

Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially.
Eligibility criteria:
Inclusion Criteria:

Clinical evidence of pulmonary hypertension (PH) requiring INO therapy as prescribed by the attending physician.
Indwelling arterial catheter.
Signed informed consent

Exclusion Criteria:

Clinically unstable circulatory condition requiring epinephrine > 0.1 mcg/kg/min or levophed, or already meeting treatment failure criteria (see section 5.3 below)
Known hypersensitivity to prostacyclin compounds
Patients receiving sildenafil or bosentan
Refusal by the attending physician
Intervention: Iopamidol
Trial phase: Phase 4
ATC code: V08AB04
SMILES: C[C@H](O)C(=O)Nc1c(I)c(C(=O)NC(CO)CO)c(I)c(C(=O)NC(CO)CO)c1I
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 139
Group description: 50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).

Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
Eligibility criteria:
Inclusion Criteria:

male or non-lactating, non-pregnant females
18 years or older who are able to give written informed consent

Exclusion Criteria:

a chronic underlying liver disease such as cirrhosis, fatty infiltration of the liver or glycogen storage diseases
patients with a prolonged cardiac transit time such as those with a congested heart failure, a history of prior cardiac valve replacement, or restrictive/constrictive pericarditis
patients having undergone any other radiological procedure utilizing iodinated contrast with the 24 hours prior to the CT exam
patients above a certain total body weight (440 lbs.) due to limitation of the scales themselves (determined by manufacturer)
any subjects with a history of hypersensitivity to iodine-containing compounds or renal insufficiency (serum creatinine >1.8)
subjects with implanted electronic devices (pacemakers, defibrillators, insulin pumps, etc.)
Intervention: Iodixanol
Trial phase: Phase 3
ATC code: V08AB09
SMILES: CC(=O)N(CC(O)CN(C(C)=O)c1c(I)c(C(=O)NCC(O)CO)c(I)c(C(=O)NCC(O)CO)c1I)c1c(I)c(C(=O)NCC(O)CO)c(I)c(C(=O)NCC(O)CO)c1I
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Standard protocol is Visipaque 320.

Visipaque 320: Visipaque 320 is standard protocol.
Eligibility criteria:
Inclusion Criteria:

adult patients who are referred for coronary CTA for suspected or known coronary artery disease

Exclusion Criteria:

creatinine greater than 2.0
allergy to contrast media
patients under the age of 18
women who are pregnant or breast feeding
patients with cardiac arrhythmia will also be excluded
Intervention: Iopamidol
Trial phase: Phase 3
ATC code: V08AB04
SMILES: C[C@H](O)C(=O)Nc1c(I)c(C(=O)NC(CO)CO)c(I)c(C(=O)NC(CO)CO)c1I
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Isovue 370 is a contrast agent with increased iodine concentration.

Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration.
Eligibility criteria:
Inclusion Criteria:

adult patients who are referred for coronary CTA for suspected or known coronary artery disease

Exclusion Criteria:

creatinine greater than 2.0
allergy to contrast media
patients under the age of 18
women who are pregnant or breast feeding
patients with cardiac arrhythmia will also be excluded
Intervention: Nalbuphine
Trial phase: Phase 2 | Phase 3
ATC code: N02AF02
SMILES: Oc1ccc2c3c1O[C@H]1[C@@H](O)CC[C@@]4(O)[C@@H](C2)N(CC2CCC2)CC[C@]314
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: nalbuphine HCl ER

nalbuphine HCl ER: nalbuphine HCl ER BID for up to 50 weeks
Eligibility criteria:
Inclusion Criteria:

Subject completed participation in the TR03 study

Exclusion Criteria:

Medical condition or other factors that in the opinion of the Investigator may interfere with the conduct of the study.
Subject is a pregnant or lactating female
Intervention: Moxifloxacin
Trial phase: Phase 1
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: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 14
Group description: Moxifloxacin (400mg x1/day taken orally for 5 days) used alone
Eligibility criteria:
Inclusion Criteria:

Healthy volunteers
Normal digestive transit, with usually one daily stool.
Females participating in the study :

must be either of non-child bearing potential (surgically sterilized at least 3 months prior to inclusion, or postmenopausal or having a negative pregnancy test and be not breastfeeding at screening, and using abstinence or a double contraception method during the treatment period and for additional period of 2 weeks after the end of investigational treatment.

Having given and signed the written study informed consent prior to undertaking any study-related procedure.
Covered by the French Health Insurance system.

Exclusion Criteria:

Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurological, bone and joint, muscular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness.
Contra-indications to fluoroquinolones, or risk factors for adverse events associated to fluoroquinolones.
Subjects with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency should be excluded.
Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should be excluded.
Contra-indications to DAV132, risk of gastrointestinal obstruction, perforation or haemorrhage, recent digestive tract surgery.
Fecal colonisation by Clostridium difficile.
Recent history of hospitalisation (within 3 months prior to inclusion).
Any antibiotic administration within 3 months before inclusion.
Any vaccination within the last 28 days.
Intervention: Metformin Hydrochloride
Trial phase: Phase 2
SMILES: CN(C)C(=N)N=C(N)N.Cl
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.
Eligibility criteria:
Inclusion Criteria:

Male > 18 years of age
Biopsy confirmed adenocarcinoma of the prostate
Able to swallow and retain oral medication
Hemoglobin A1C <7.0%
Able and willing to participate in the full 12 months of the study
Able to understand instructions related to study procedures
Able to read and write English

Exclusion Criteria:

Metastatic Prostate Cancer
Prostate Specific Antigen Doubling Time < 6 months
Prior Chemotherapy, hormonal therapy, oral glucocorticoid therapy, Gonadotropin-releasing hormone analogue therapy
Current or previous use of 5α-reductase inhibitors, antiandrogen drugs, metformin, oral or injectable diabetes drug
Diagnosis of Type 1 Diabetes Mellitus
Known hypersensitivity to metformin
any condition associated with increased risk of metformin associated lactic acidosis
participation in any investigational or marketed drug trial within 30 days prior to screening or during study period
any unstable, serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening
history of megaloblastic anemia
abnormal liver function test (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase or serum creatinine above upper limit of normal)
history of other malignancies, with the exception of adequately treated non-melanoma skin cancer, stage 1 melanoma, non-muscle invasive bladder cancer, or other solid tumors curatively treated with no evidence of disease for at least 5 years
history or current evidence of substance abuse within 12 months of screening
history of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or post an additional risk to the subject