anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Salmeterol Xinafoate
Trial phase: Phase 3
SMILES: O=C(O)c1ccc2ccccc2c1O.OCc1cc(C(O)CNCCCCCCOCCCCc2ccccc2)ccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study.

LIPO-202
Eligibility criteria:
Inclusion Criteria:

Healthy male or non-pregnant female subjects who completed Study LIPO-202-CL-18 or LIPO-202-CL-19
Capable of providing written consent
Willing to comply with the study procedures and schedule

Exclusion Criteria:

Female subjects who are pregnant or are not using adequate birth control methods
Plan on starting a weight loss or exercise program during the study
Plan to enroll in another investigational drug or device study
Unlikely or unable to adhere to the study visit schedule
Intervention: Celecoxib
Trial phase: Phase 2
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Celecoxib 200mg PO QD for 6 months

Celecoxib: We will perform a pilot clinical trial to investigate the safety and tolerability of celecoxib therapy as a single agent for patients with LAM. LAM subjects who are not taking everolimus or rapamycin will be treated with celecoxib at 200mg PO QD for 6 months. They will be monitored for respiratory function and angiomyolipoma size. At the end of the 6 month period, celecoxib will be discontinued, and subjects will be monitored for another 6 months.
Eligibility criteria:
Inclusion Criteria:

Female of age 18 to 69
Ability to give informed consent
Definite diagnosis of LAM Typical cystic change on CT scan of the chest plus one of the following i) biopsy or cytology of any tissue demonstrating LAM, ii) angiomyolipoma, chylothorax, clinical or genetic diagnosis of tuberous sclerosis, iii) serum VEGF-D > 800pg/ml
post-bronchodilator forced expiratory volume in one second ≥ 70% of predicted and DLCO ≥ 70% predicted during baseline visit.
Women of childbearing potential must agree to use two forms of barrier contraception after screening visit, for the duration of study participation and for 30 days after last dose.

Exclusion Criteria:

History of intolerance to non-steroidal anti-inflammatory drugs (NSAIDs)
History of current regular use (daily most days of the week) of NSAIDs
History of use of rapamycin or everolimus
Uncontrolled intercurrent illness
Pregnant, breast feeding or planning to become pregnant in the next 2 years
Significant hematological (platelet count <100.000/µl or hepatic abnormalities (Liver function tests >2 times normal).
Use of an investigational drug within 30 days of study start
Inability to attend scheduled clinic visits
Inability to give informed consent
Inability to perform spirometry
Creatinine > 1.0 mg/dl or eGFR < 60 ml/min
Pneumothorax within past 8 weeks
History of malignancy in the last 2 years other than basal cell skin cancer
Use of estrogen containing medication within 30 days of enrolment
Currently taking doxycycline, metformin, lupron or simvastatin
Unable to undergo MRI
History of seizure within the last year
History of hepatitis or known active hepatitis B or C, or HIV positive serology
Angiomyolipoma of diameter > 4 cm
History of vascular disease, including myocardial infarction or stroke
History of ulcers or GI bleeding
Allergy to sulfonamides, unless subject has previously used Celocoxib without any adverse reactions.
Age older than 70
Intervention: Remifentanil
Trial phase: Phase 4
ATC code: N01AH06
SMILES: CCC(=O)N(c1ccccc1)C1(C(=O)OC)CCN(CCC(=O)OC)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 44
Group description: Following an intravenous bolus dose of 0.5 µg/kg remifentanil administered just before the induction of anaesthesia, patients will receive an intravenous infusion of remifentanil at a dose of 0.25-0.5 µg/kg/min throughout the surgery. The rate of infusion will be adjusted to maintain a mean blood pressure within %70-80 of the baseline value. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated.
Eligibility criteria:
Inclusion Criteria:

diagnosis of rhinosinusitis
indication for functional endoscopic sinus surgery

Exclusion Criteria:

American Society of Anesthesiologists risk score > 2
undertreated hypertension
Haemoglobin A1c test level > 7.5
pregnancy
concurrent surgery
history of drug abuse
history of or new diagnosis of allergy to any of the study drugs
history of post-operative nausea and vomiting
Intervention: Propofol
Trial phase: Not Applicable
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 38
Group description: All subjects will be treated with an intravenous propofol infusion at the following escalating rate schedule:

20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes

Propofol: Intravenous propofol infusion at 20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes.
Eligibility criteria:
Inclusion Criteria:

Patients with a diagnosis of migraine headache per ICHD - 3 (International Classification of Headache Disorders)
The subjects will have a history of migraine headaches with a presentation consistent with presentations of their headaches in the past with no indication for further investigation for secondary causes of his/her headache
Documented pain score greater than or equal to 6 on a 0-10 Numeric Pain Rating Scale
Current migraine has a greater than 24 hours duration with a current pain score of 6 or greater on a 0-10 Numeric Pain Rating Scale
Subjects will be scheduled for DHE infusion therapy for treatment of migraines per standard medical care
Patients age 7-18 years old
Gender: both male and female
Appropriate fasting interval as per ASA guidelines

Exclusion Criteria:

No long acting triptan therapy within 24 hours
No shorter acting triptan therapy within 6 hours
No ergot alkaloid derivatives within the last 24 hours
No opioid within 2 hours
No NSAID or acetaminophen within 1 hour of infusion
Use of sedative medications within 6 hours of infusion, including opioids, benzodiazepines, barbiturates
Headache not consistent with subject's headache history needing further work-up
Headache duration less than 24 hours
Subjects in which an intravenous line could not be secured
Subjects with history of significant reflux or hiatal hernia
Subjects with history of significant cardio pulmonary disorders
Patient not fasting as per ASA guidelines
Intervention: Promega
Trial phase: Phase 2
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)O.CCCC=CCC=CCC=CCC=CCC=CCCCC(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 21
Group description: Infants in this group will receive lipid supplementation with omega-3 fatty acids.

Omegaven: Infants will receive nutritional supplementation with omega-3 fatty acids (omegaven).
Eligibility criteria:
Inclusion Criteria:

Infants born less than or equal to 30 weeks gestation or less than 1500 g at birth

Exclusion Criteria:

Patients with liver disease as tested by liver function tests (LFTs)
≤ 500 grams birthweight
Intervention: Amantadine
Trial phase: Phase 2
ATC code: N04BB01
SMILES: NC12CC3CC(CC(C3)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: 100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.

Amantadine: 100mg BID for 7 days at 0600 and 1200
Eligibility criteria:
Inclusion Criteria:

Non traumatic cardiac arrest
Age 18 and older
Defibrillation and/or chest compressions by healthcare providers
Return of spontaneous circulation

Exclusion Criteria:

Written do not attempt resuscitation (DNAR) reported to providers before randomization
Known prisoner or pregnancy
Lack of motor response to pain and absent N20 response on somatosensory evoked potentials prior to randomization
Initial CT demonstrating brain edema (defined as grey white ratio <1.2)
Presence of malignant pattern on EEG at time of randomization
Next of kin unwilling to provide supportive care for at least one week after enrollment
Presently using other dopaminergic agent
Intervention: Clopidogrel
Trial phase: Phase 4
ATC code: B01AC04
SMILES: [H][C@@](C(=O)OC)(c1ccccc1Cl)N1CCc2sccc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: 300mg load followed by 75mg daily.

Clopidogrel: Standard ADP receptor blockade
Eligibility criteria:
Inclusion Criteria:

Valvular heart disease and a clinical indication for TAVR
Age of 18 years or older
Capable of informed consent
Planned transfemoral TAVR

Exclusion Criteria:

Prior history of stroke, transient ischemic attack (TIA), or intracranial hemorrhage
Established bleeding diathesis or thrombocytopenia (<150k/dl)
End-stage renal disease
Severe hepatic impairment or liver cirrhosis
Pregnancy
Current infection
History of autoimmune disease
Established allergy to contrast agents, thienopyridines, aspirin, or ticagrelor
History of solid organ transplantation
Atrial Fibrillation, DVT, PE or other indication for long term anti-coagulation
Plan for direct aortic access or trans-apical TAVR
Enrollment in another clinical trial
Recent (< 12 months) or active excessive bleeding
Intervention: Ticagrelor
Trial phase: Phase 4
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: 180mg load followed by 90mg twice daily for 30 days.

Ticagrelor: High potency ADP receptor blockade
Eligibility criteria:
Inclusion Criteria:

Valvular heart disease and a clinical indication for TAVR
Age of 18 years or older
Capable of informed consent
Planned transfemoral TAVR

Exclusion Criteria:

Prior history of stroke, transient ischemic attack (TIA), or intracranial hemorrhage
Established bleeding diathesis or thrombocytopenia (<150k/dl)
End-stage renal disease
Severe hepatic impairment or liver cirrhosis
Pregnancy
Current infection
History of autoimmune disease
Established allergy to contrast agents, thienopyridines, aspirin, or ticagrelor
History of solid organ transplantation
Atrial Fibrillation, DVT, PE or other indication for long term anti-coagulation
Plan for direct aortic access or trans-apical TAVR
Enrollment in another clinical trial
Recent (< 12 months) or active excessive bleeding
Intervention: Tamsulosin
Trial phase: Phase 3
ATC code: G01AE10 | G04CA02 | G04CA52 | G04CA53 | G04CA54
SMILES: CCOc1ccccc1OCCN[C@H](C)Cc1ccc(OC)c(S(N)(=O)=O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 76
Group description: Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.

Outline of schedule:

Day 1-7: tamsulosin 0.4mg in the evening
Day 8: surgery; tamsulosin 0.4mg in the evening if the subject has not yet completed the bladder management protocol
Day 9-14: tamsulosin 0.4mg in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual <200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function.
Eligibility criteria:
Inclusion Criteria:

English-speaking
Able to provide informed consent
Scheduled to undergo an elective, complex intra-abdominal operation with a planned postoperative inpatient stay of at least 1 night

Exclusion Criteria:

Less than age 18
Allergy or contraindication to tamsulosin
Serious sulfa allergy
Current use of alpha blocker (alfuzosin, doxazosin, prazosin, silodosin, terazosin, verapamil, tamsulosin) or oral alpha agonist (midodrine), or initiation of one of these medications during the intervention phase of the study will result in subject withdrawal from the study
Current warfarin use
Pre-existing indwelling urinary catheter, suprapubic catheter, or urostomy
End stage renal disease or dialysis-dependence
Sitting systolic blood pressure in the upper extremity of less than 100mm Hg at time of eligibility screening
Presence of orthostatic hypotension at the time of eligibility screening (orthostatic hypotension is defined as a drop in systolic blood pressure of 20mm Hg from sitting to standing, or drop in diastolic BP of 10 mm Hg from sitting to standing after 2-3 minutes of standing after being in a sitting position)
Anticipated inability to take oral medications on post-operative day #0
Anticipated requirement for indwelling urinary catheter beyond post-operative day #2
Non-English speaking
Pregnant or breast-feeding
Unwillingness to answer all 7 questions on the IPSS (International Prostate Symptom Score) survey
Lacking capacity to provide informed consent
Intervention: Doconexent
Trial phase: Phase 3
SMILES: CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCC(=O)O
Sex: Female
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 190
Group description: DHA: 600 mg DHA capsule
Eligibility criteria:
Inclusion Criteria:

Pregnant females 16.0-35.0 years of age (inclusive) at 8-20 weeks gestation at enrollment (date/ultrasound)
Agree to consume study capsules from enrollment until delivery
Agree to return to the study center for delivery
BMI < 40
No serious illnesses (e.g., cancer, diabetes, lupus, hepatitis, sexually transmitted diseases, not HIV positive)
Available by telephone

Exclusion Criteria:

Less than 16 or greater than 35 years of age
BMI < 40
Serious illness such as cancer, lupus, hepatitis, sexually transmitted disease or HIV positive
Expecting multiple infants
Diabetes or gestational diabetes at baseline
Elevated blood pressure due to any cause
Not planning to return to the study center for delivery
Gestational age at baseline < 8 weeks or >20 weeks
Unable or unwilling to agree to consume capsules until delivery
Unable to provide informed consent in English
Intervention: Gallium Ga-68 gozetotide
Trial phase: Phase 1 | Phase 2
ATC code: V09IX14
SMILES: O=C([O-])CCc1ccc(O)c(CN(CCN(CC(=O)[O-])Cc2cc(CCC(=O)NCCCCCC(=O)NCCCC[C@H](NC(=O)N[C@@H](CCC(=O)O)C(=O)O)C(=O)O)ccc2O)CC(=O)[O-])c1.[68Ga+3]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
Eligibility criteria:
Inclusion Criteria:

Provides written informed consent
Known diagnosis of prostate cancer
Patient has suspected recurrence based on biochemical data (prostate specific antigen [PSA] > 2 ng/mL)
Able to remain still for duration of each imaging procedure (about one hour)

Exclusion Criteria:

Unable to provide informed consent
Inability to lie still for the entire imaging time
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
Intervention: Mefloquine
Trial phase: Phase 2
ATC code: P01BC02 | P01BF02
SMILES: OC(c1cc(C(F)(F)F)nc2c(C(F)(F)F)cccc12)C1CCCCN1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 101
Group description: Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.

Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Healthy male or female volunteers who provided informed consent (a healthy volunteer was defined as one who was free of ailments that might cause difficulty in evaluating drug efficacy or adverse experiences).
Subjects aged 18-55 years.
Subjects planning to reside in the study area for the entire study duration of approximately 70 weeks

Exclusion Criteria:

Subjects with positive parasitaemia following halofantrine treatment for radical cure.
Subjects with any medical condition which, in the opinion of the investigator, made the subject unsuitable to enter the study.
Subjects with personal or family history of seizures.
Female subjects with a positive serum beta-HCG5 (tested during screening and within 48 hours of first drug administration and approximately monthly thereafter).
Women who were pregnant or lactating or who in the opinion of the investigator were at risk of becoming pregnant.
Subjects with clinically significant abnormalities (to include but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistries and haematology values. Subjects who had demonstrated hypersensitivity to any of the study drugs especially to any other 8-aminoquinolines.
Subjects unwilling to report for drug administration or blood drawing during the 70 week duration of the study.
Subjects with G6PD deficiency.
Subjects with laboratory guideline values for exclusion: haemoglobin <10 gm/dL, platelets <80,000/mm3, WBC <3000ul3, creatinine or ALT more than twice the upper limit of normal for age.
Subjects with an abnormal ECG, particularly an extended QTc interval > 0.42 seconds.
Subjects taking any other anti-malarial product, or who had taken an antimalarial drug other than halofantrine within the previous two weeks.
Subjects who had received an investigational drug (a new chemical entity not registered for use) within 30 days or 5 half-lives whichever was the longer.
Subjects with a history of psychiatric disorder.
Intervention: Sevoflurane
Trial phase: Not Applicable
ATC code: N01AB08
SMILES: FCOC(C(F)(F)F)C(F)(F)F
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 39
Group description: In the LC group, the trachea was extubated as soon as cough or purposeful movement appeared when end-tidal sevoflurane concentration was less than 0.5%. Patients were excluded in this group if cough or purposeful movement appeared when end-tidal sevoflurane concentration was more than 0.5%.
Eligibility criteria:
Inclusion Criteria:

Age 2-7 years
ASA I - II
Estimated surgery time < 2 hours
Sevoflurane induction and maintenance along with caudal block or Axillary Block

Exclusion Criteria:

Craniofacial anomalies
Difficult exposure of the vocal cordS
Obesity
Asthma
Invalid caudal block or axillary block
Intervention: Sevoflurane
Trial phase: Not Applicable
ATC code: N01AB08
SMILES: FCOC(C(F)(F)F)C(F)(F)F
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 53
Group description: In the HC group, when end-tidal sevoflurane concentration was more than 0.5%, the trachea was extubated as soon as cough or purposeful movement appeared. If there was still no cough or purposeful movement when end-tidal sevoflurane concentration had decreased to 0.5%, the trachea was extubated at this concentration.
Eligibility criteria:
Inclusion Criteria:

Age 2-7 years
ASA I - II
Estimated surgery time < 2 hours
Sevoflurane induction and maintenance along with caudal block or Axillary Block

Exclusion Criteria:

Craniofacial anomalies
Difficult exposure of the vocal cordS
Obesity
Asthma
Invalid caudal block or axillary block
Intervention: Empagliflozin and Linagliptin
Trial phase: Phase 3
ATC code: A10BD19
SMILES: CC#CCn1c(N2CCCC(N)C2)nc2c1c(=O)n(Cc1nc(C)c3ccccc3n1)c(=O)n2C.COC1OC(c2ccc(Cl)c(Cc3ccc(OC4CCOC4)cc3)c2)C(O)C(O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 116
Group description: Patients who received empagliflozin 25 mg during open-label stabilisation period were randomized to receive a FDC tablet of empagliflozin 25 mg and linagliptin 5 mg along with a matching placebo of empagliflozin 25 mg, orally with water, once daily for 52-weeks of double-blind treatment period.
Eligibility criteria:
Inclusion criteria:

Diagnosis of type 2 diabetes prior to informed consent

Male and female patients on diet and exercise regimen for at least 12 weeks prior to informed consent who are:

drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent or,
pre-treated with one oral antidiabetic drug (for sulfonylurea, with up to half of the maximum approved dose) on stable dosage for at least 12 weeks prior to the informed consent (for thiazolidinedione, therapy has to be unchanged for at least 18 weeks prior to the informed consent). Individual antidiabetic drug will have to be discontinued at Visit 1.

haemoglobin A1c (HbA1c) at Visit 1 (screening)

for patients without antidiabetic therapy : HbA1c >=8.0 to =<10.5%
for patients with one oral antidiabetic drug : HbA1c >=7.5 to =<10.5%
HbA1c >=7.5 to =<10.0% at Visit 4 for randomisation into the double blind treatment period

Exclusion criteria:

Uncontrolled hyperglycaemia with a glucose level >270 mg/dL (>15.0 mmol/L) during the open label stabilisation period and placebo run in period
Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2 (modification of diet in renal disease (MDRD) formula)
Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent
Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)
Intervention: Empagliflozin and Linagliptin
Trial phase: Phase 3
ATC code: A10BD19
SMILES: CC#CCn1c(N2CCCC(N)C2)nc2c1c(=O)n(Cc1nc(C)c3ccccc3n1)c(=O)n2C.COC1OC(c2ccc(Cl)c(Cc3ccc(OC4CCOC4)cc3)c2)C(O)C(O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 107
Group description: Patients who received empagliflozin 10 mg during open-label stabilisation period were randomized to receive a fixed dose combination (FDC) tablet of empagliflozin 10 mg and linagliptin 5 mg along with a matching placebo of empagliflozin 10 mg, orally with water, once daily for 24-weeks of double-blind treatment period.
Eligibility criteria:
Inclusion criteria:

Diagnosis of type 2 diabetes prior to informed consent

Male and female patients on diet and exercise regimen for at least 12 weeks prior to informed consent who are:

drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent or,
pre-treated with one oral antidiabetic drug (for sulfonylurea, with up to half of the maximum approved dose) on stable dosage for at least 12 weeks prior to the informed consent (for thiazolidinedione, therapy has to be unchanged for at least 18 weeks prior to the informed consent). Individual antidiabetic drug will have to be discontinued at Visit 1.

haemoglobin A1c (HbA1c) at Visit 1 (screening)

for patients without antidiabetic therapy : HbA1c >=8.0 to =<10.5%
for patients with one oral antidiabetic drug : HbA1c >=7.5 to =<10.5%
HbA1c >=7.5 to =<10.0% at Visit 4 for randomisation into the double blind treatment period

Exclusion criteria:

Uncontrolled hyperglycaemia with a glucose level >270 mg/dL (>15.0 mmol/L) during the open label stabilisation period and placebo run in period
Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2 (modification of diet in renal disease (MDRD) formula)
Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent
Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)