anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Dimethylcurcumin
Trial phase: Phase 2
SMILES: COc1ccc(/C=C/C(=O)/C=C(O)/C=C/c2ccc(OC)c(OC)c2)cc1OC
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 181
Group description: ASC-J9: Cream for twice daily topical application to the face
Eligibility criteria:
Key Inclusion Criteria:

At least 12 years of age at the time of enrollment

Facial acne, with:

20-60 inflammatory facial lesions (papules/pustules/nodules/cysts);
20-100 noninflammatory facial lesions (open and closed comedones);
No more than 2 nodules/cysts on the face (defined as an inflammatory lesion greater than or equal to 5 mm in diameter);
Investigator's Global Assessment (IGA) acne score of 3 or 4.

Key Exclusion Criteria:

Females who are pregnant or breast-feeding
Skin diseases other than acne vulgaris
Use of other topical or systemic treatments for acne
Other significant medical conditions or clinically significant abnormal laboratory test results.
Intervention: Zidovudine
Trial phase: Phase 2
ATC code: J05AF01 | J05AR01 | J05AR04 | J05AR05
SMILES: Cc1cn([C@H]2C[C@H](N=[N+]=[N-])[C@@H](CO)O2)c(=O)[nH]c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: interleukin-2 therapy during lymphocyte recovery

Interleukin-2: Famotine 20mg IV push daily just prior to the aldesleukin (IL-2) IL-2 18 million IU/m2 in 50 mL 5% D5 or NS IVPB over 15 - 30 minutes daily for 5 days
Eligibility criteria:
Inclusion Criteria:

Confirmed hematopathology diagnosis of AML receiving marrow suppressive treatment
Total WBC recovery of 500 mm3 prior to IL-2 treatment
Platelet count of at least 20,000 mm3 prior to starting IL-2 treatment
Active infection controlled prior to starting IL-2 treatment
Stable systolic blood pressure > 90mm Hg prior to starting IL-2 treatment
O2 saturation >90% prior to starting treatment
Stable cardiopulmonary status prior to starting IL-2 treatment
Serum creatinine < or equal to 2.0 mg/dl
Total bilirubin and AST <3x upper limits normal

Exclusion Criteria:

Acute Promyelocytic Leukemia
Active thrombocytopenic bleeding
Cardiac ejection fraction below 45%
Pregnancy and/or lactation
Intervention: Injectafer
Trial phase: Phase 2
SMILES: O.O=C([O-])C(O)C(O)C(OC1OC(CO)C(OC2OC(CO)C(OC3OC(CO)C(O)C(O)C3O)C(O)C2O)C(O)C1O)C(O)CO.[Fe+3].[O-2].[OH-]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Intravenous iron

Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I) or 750 mg dose at 100 mg/minute (Cohort II)
Eligibility criteria:
Inclusion Criteria:

Female subjects 18-50 years of age and able to give informed consent.
If post-partum, at least 10 days post delivery at Day 0.
Screening Visit local laboratory Hgb < or = to 10 g/dL or < or = to 12 g/dL with symptoms (dizziness and/or fatigue).
Screening Visit ferritin < or = to 100 ng/mL or < or = to 300 when TSAT is < or = to 30%.
Documented unsatisfactory response or intolerance to oral iron.

Exclusion Criteria:

Previous participation in a ferric carboxymaltose (FCM) clinical trial.
Known hypersensitivity reaction to any component of ferric carboxymaltose, Venofer, or Dexferrum.
History of drug allergy or any history of rheumatoid arthritis or other autoimmune diseases.
Current anemia not attributed to iron deficiency.
During the 10 day period prior to screening has been treated with antibiotics.
During the 30 day period prior to screening or during the study period has or will be treated with erythropoiesis stimulating agents.
Active malignancy within 5 years. Basal or squamous cell skin cancer is not exclusionary.
During the 30 day period prior to screening or during the study period has or will require a surgical procedure that necessitates general anesthesia.
Current (acute or chronic) infection other than viral upper respiratory tract infection.
AST or ALT at screening greater than 1.5 times the upper limit of normal.
Known positive hepatitis B with evidence of active hepatitis.
Known positive HIV-1/HIV-2 antibodies (anti-HIV).
Patient has an active diagnosis of asthma and is currently using an anti- asthmatic therapy.
Received an investigational drug within 30 days of screening.
Alcohol or drug abuse within the past 6 months.
Hemochromatosis or other iron storage disorders.
Systolic blood pressure > or = to 180 or < 80 mmHg or diastolic blood pressure > or = to 100 or < 40 mmHg at screening or Day 0.
Chronic kidney disease.
Chronic inflammatory condition including but not limited to Lupus and Rheumatoid Arthritis.
Pre-term delivery < 32 weeks.
Emergent C-section delivery.
Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of NYHA Class III or IV congestive heart failure.
Any other laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator puts the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
Night shift workers.
Breastfeeding planned on or after Day 0.
Pregnant or sexually-active female subjects who are of childbearing potential and who don't use an acceptable form of contraception.
Intervention: Tiotropium
Trial phase: Phase 3
ATC code: R03AL06 | R03AL10 | R03BB04 | R03BB54
SMILES: [H][C@]1(OC(=O)C(O)(c2cccs2)c2cccs2)C[C@@]2([H])[C@]3([H])O[C@]3([H])[C@@]([H])(C1)[N+]2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 532
Group description: Tiotropium: Tiotropium bromide 18 mcg once daily for one year of treatment.
Eligibility criteria:
Inclusion Criteria:

Black (self-identified, with at least one biological parent identified as Black)
Male and female subjects, ages 18-75
Ability to provide informed consent
Clinical history consistent with asthma for > 1 year.
Ability to perform pulmonary function tests
FEV1 > 40% of predicted
Receiving inhaled corticosteroids (ICS)/LABA combination therapy, or ICS moderate dose monotherapy and baseline ACQ>1.25
Non-smoker for past year (total lifetime smoking history < 10 pack-years)

Exclusion Criteria:

Use of greater than the equivalent of 1000 mcg inhaled fluticasone daily
Chronic use of oral corticosteroids or Anti IgE for asthma
Lung disease other than asthma or diagnosis of vocal cord dysfunction.
Significant medical illness (other than asthma) that is not stable.
Pregnancy or lactation or an unwillingness to maintain effective birth control.
History of a significant exacerbation of asthma or respiratory tract infection in the prior 4 weeks
History of life-threatening asthma requiring treatment with intubation and mechanical ventilation within 5 years.
Hypo sensitization therapy other than an established maintenance regimen.
Use of inhaled anticholinergic therapy (ipratropium, tiotropium) in prior month
Known contraindication to inhaled tiotropium e.g. narrow angle glaucoma, history of bladder neck obstruction or significant symptoms related to prostatic hypertrophy.
Inability to speak and read English.
Intervention: Simenepag isopropyl
Trial phase: Phase 2
SMILES: CCCCC[C@H](O)c1ccc(N2C(=O)CC[C@@H]2COCc2ccc(C(=O)OC(C)C)s2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 65
Group description: AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of primary open-angle glaucoma or ocular hypertension in each eye
Requires bilateral treatment with an IOP-lowering medication
Best corrected visual acuity of 20/100 or better in each eye

Exclusion Criteria:

Use of oral, intramuscular, intravenous or topical ophthalmic corticosteroids within 2 months
Inability to fast for up to 10 hours
Prior refractive laser surgery (eg, LASIK, radial keratectomy, photorefractive keratectomy)
Intraocular surgery or IOP-lowering laser surgery (eg, laser trabeculoplasty) within 6 months
Current or anticipated use of artificial tears or any ocular medications aside from study medications during study
Anticipated wearing of contact lenses during study
Intervention: Bimatoprost
Trial phase: Phase 2
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of primary open-angle glaucoma or ocular hypertension in each eye
Requires bilateral treatment with an IOP-lowering medication
Best corrected visual acuity of 20/100 or better in each eye

Exclusion Criteria:

Use of oral, intramuscular, intravenous or topical ophthalmic corticosteroids within 2 months
Inability to fast for up to 10 hours
Prior refractive laser surgery (eg, LASIK, radial keratectomy, photorefractive keratectomy)
Intraocular surgery or IOP-lowering laser surgery (eg, laser trabeculoplasty) within 6 months
Current or anticipated use of artificial tears or any ocular medications aside from study medications during study
Anticipated wearing of contact lenses during study
Intervention: Pentoxifylline
Trial phase: Early Phase 1
ATC code: C04AD03 | R03DA20
SMILES: CC(=O)CCCCn1c(=O)c2c(ncn2C)n(C)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
Eligibility criteria:
Inclusion Criteria:

Predicted Severe Acute Pancreatitis
Enrollment within 72 hours of diagnosis
Ability to give informed consent
Age >17 years

Exclusion Criteria:

Moderate or severe congestive heart failure
History of seizure disorder or demyelinating disease
Nursing mothers
Pregnancy
History of prior tuberculosis or risk factors for tuberculosis
Evidence of immunosuppression (malignancy, chronic renal failure, chemotherapy within 60 days, ongoing steroid treatment*, and HIV)- (*the exception of prednisone use will be allowed to participate).
Evidence of chronic pancreatitis from history and examination (however, "acute on chronic pancreatitis" diagnosis is allowed)
Evidence of active or pending hemorrhage.
Paralytic ileus with vomiting
Intervention: Aripiprazole
Trial phase: Phase 3
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Medication

Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days
Eligibility criteria:
Inclusion Criteria:

Age 21 - 40 (to focus on an age group still on a trajectory of increasing alcohol consumption).
Meets the DSM IV criteria for current alcohol dependence including criterion 3 and/or 4 "loss of control over drinking" or "the inability to cut-down or stop drinking".
Currently not engaged in, and does not want treatment for, alcohol related problems.
Able to read and understand questionnaires and informed consent.
Lives within 50 miles of the study site.
Able to maintain abstinence for two days (without the aid of detoxification medications) as determined by self report and breathalyzer measurements.

Inclusion for fMRI (functional magnetic resonance imaging) Imaging:

Does not have metal objects in the head/neck.
Does not have a history of claustrophobia leading to significant clinical anxiety symptoms.

Exclusion Criteria:

Currently meets DSM IV criteria for any other psychoactive substance dependence disorder.
Any psychoactive substance use (except marijuana and nicotine) within the last 30 days by self-report and urine drug screen. For marijuana, no use within the last seven days by verbal report and negative (or decreasing) urine THC (tetrahydrocannabinol) levels.
Meets DSM IV criteria for current axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, dissociate disorders and eating disorders, any other psychotic disorder or organic mental disorder.
Has current suicidal ideation or homicidal ideation.
Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications and medications for ADHD (attention deficit hyperactivity disorder .
Currently taking medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, topiramate).
Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problems that would impair participation or limit medication ingestion.
Past history of alcohol related medical illness such as gastrointestinal bleeding, pancreatitis, peptic ulcer, hepatic cirrhosis or alcoholic hepatitis.
Hepatocellular disease indicated by elevations of SGPT (ALT) or SGOT (AST) greater than 2.5 times normal at screening.
Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
Has current charges pending for a violent crime (not including DUI (Driving Under Intoxication) related offenses).
Does not have a stable living situation.
Intervention: Lidocaine
Trial phase: Not Applicable
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 72
Group description: Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement.

2% lidocaine gel: 120mg lidocaine x 1
Eligibility criteria:
Inclusion Criteria:

plans for IUD insertion for contraception or abnormal uterine bleeding;
18 to 49 years of age;
reached more than 6 weeks postpartum or 2 weeks postabortion if recently pregnant;
no prior IUD use;
not taken analgesics or anxiolytics in the previous 24 hours;
not taken misoprostol prior to IUD insertion;
the ability and are willing to give informed consent;
speaks English or Spanish.

Exclusion Criteria:

any contraindication to IUD placement;
allergy to lidocaine or sensitivities to components of the lidocaine or placebo gel;
chronic narcotic/benzodiazepine/barbiturate use within the past year.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 17
Group description: 5 mL of 7% saline was inhaled once over a 20 minute period.

7% saline: 5mL 7% saline inhaled once over 20 minutes
Eligibility criteria:
Inclusion Criteria:

Males and females
Age 7-12 years old
Diagnosis of cystic fibrosis by sweat chloride > 60 meq/L, or presence of two CFTR mutations known to cause CF
Routinely treated with the short-acting bronchodilator albuterol
FEV1 > 90% of predicted values

Exclusion Criteria:

FEV1 < 90% of predicted values
Routine use of hypertonic saline, mannitol, or amiloride
Allergic bronchopulmonary aspergillosis (ABPA)
Sputum colonization with Burkholderia cepacia or multiple antibiotic resistant organisms
Evidence of a pulmonary exacerbation within past two weeks
Treated with intravenous or oral antibiotics in the past two weeks for a pulmonary exacerbation

Presence of an acute respiratory illness characterized by:

Coughing above baseline values
Wheezing
Respiratory distress
Hemoptysis
Cannot perform the inhalation maneuvers that are required for drug inhalation or radioaerosol administration
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 17
Group description: 5mL 0.12% saline inhaled once during 20 minutes

0.12% saline: 5mL of 0.12% saline inhaled once over 20 minutes
Eligibility criteria:
Inclusion Criteria:

Males and females
Age 7-12 years old
Diagnosis of cystic fibrosis by sweat chloride > 60 meq/L, or presence of two CFTR mutations known to cause CF
Routinely treated with the short-acting bronchodilator albuterol
FEV1 > 90% of predicted values

Exclusion Criteria:

FEV1 < 90% of predicted values
Routine use of hypertonic saline, mannitol, or amiloride
Allergic bronchopulmonary aspergillosis (ABPA)
Sputum colonization with Burkholderia cepacia or multiple antibiotic resistant organisms
Evidence of a pulmonary exacerbation within past two weeks
Treated with intravenous or oral antibiotics in the past two weeks for a pulmonary exacerbation

Presence of an acute respiratory illness characterized by:

Coughing above baseline values
Wheezing
Respiratory distress
Hemoptysis
Cannot perform the inhalation maneuvers that are required for drug inhalation or radioaerosol administration
Intervention: Raltegravir
Trial phase: Not Applicable
ATC code: J05AJ01 | J05AR16 | J05AX08
SMILES: Cc1nnc(C(=O)NC(C)(C)c2nc(C(=O)NCc3ccc(F)cc3)c(O)c(=O)n2C)o1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Raltegravir: raltegravir 400 mg PO twice daily
Eligibility criteria:
Inclusion Criteria:

Men and women aged 18-65 years;
Integrase inhibitor-naive subjects with clinical indication to initiate RAL under the supervision of their HIV care provider;
Baseline detectable HIV-1 RNA levels ≥ 5000 copies/mL in plasma and ≥ 500 copies/mL in CSF;
Absolute T-cell CD4+ subset between 200-500/mm3
Individual willing to undergo serial lumbar punctures as outlined in study evaluations;
Subject able to give informed consent to all study procedures (if cognitively impaired, the individual must pass an evaluation to ensure adequate comprehension of the consent document and procedures);
Susceptibility to all study drugs on Monogram Biosciences PhenoSense GT assay.

Exclusion Criteria:

Contraindication to lumbar puncture, such as current coagulopathy, thrombocytopenia (platelets below 50,000/µL), or use of anticoagulants;
Cognitive, psychiatric, or substance use disorders or any other medical conditions that would interfere with study participation, in the opinion of the investigator;
Major opportunistic infections (e.g., pneumonia, tuberculosis) within 30 days;
Use of prescribed drugs with known substantial interactions with the study drugs;
Positive HCV serology;
HIV-associated dementia/Global Deterioration Scale ≥4;
Pregnancy;
Serum creatinine higher than 2.0 mg/dL;
Total bilirubin or alanine or aspartate transaminases more than 3 times the upper limit of normal
Intervention: Novolog mix 70/30
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(CC(=O)O)C(=O)NC(CCCCN)C(=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: 20
Group description: Insulin Aspart 30: Patients received biphasic insulin aspart 30 before breakfast and before lunch.
Eligibility criteria:
Inclusion Criteria:

Type-II Diabetes
BMI > 27 kg/m2
age 35 to 75 years
HbA1c < 8.5%
informed consent
treatment with pre-mixed insulin
stabile dose of insulin for at least 4 weeks

Exclusion Criteria:

Type-I Diabetes mellitus
HbA1c > 8.5 %
Serum Creatinine > 1.7 mg/dl
Alaninaminotranferase or Aspartataminotransferase > 3x Upper Limit of Normal
treatment with sulfonylurea or gliptins
treatment with glitazones
manifest clinical infections
treatment with glucocorticoids or antipsychotic drugs
psychiatric diseases
alcohol abuse
myocardial infarction or stroke within the previous 3 months
surgery within the previous 3 months
Intervention: Novolog mix 70/30
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(CC(=O)O)C(=O)NC(CCCCN)C(=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: 20
Group description: Insulin Aspart: Patients received insulin aspart before breakfast and before lunch.
Eligibility criteria:
Inclusion Criteria:

Type-II Diabetes
BMI > 27 kg/m2
age 35 to 75 years
HbA1c < 8.5%
informed consent
treatment with pre-mixed insulin
stabile dose of insulin for at least 4 weeks

Exclusion Criteria:

Type-I Diabetes mellitus
HbA1c > 8.5 %
Serum Creatinine > 1.7 mg/dl
Alaninaminotranferase or Aspartataminotransferase > 3x Upper Limit of Normal
treatment with sulfonylurea or gliptins
treatment with glitazones
manifest clinical infections
treatment with glucocorticoids or antipsychotic drugs
psychiatric diseases
alcohol abuse
myocardial infarction or stroke within the previous 3 months
surgery within the previous 3 months