anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Rifaximin
Trial phase: Phase 3
ATC code: A07AA11 | D06AX11
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c5c(nc6cc(C)ccn65)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 247
Group description: Participants received a xifaxan 200 mg tablet 3 times daily orally for 3 days.
Eligibility criteria:
Inclusion Criteria:

Adult male or nonpregnant female aged ≥18 years non-indigenous travelers (for example; visiting students/faculty or international tourists) affected by naturally acquired acute diarrhea. Diarrhea is defined as the passage of at least 3 unformed stools in a 24-hour period. Stools are classified as formed (retains shape), soft (assumes shape of container), or watery (can be poured). When using this classification, both soft and watery stools are unformed and abnormal.
At least 3 unformed stools recorded within the 24 hours immediately preceding randomization.

At least 1 of the following signs and symptoms of enteric infection:

abdominal pain or cramps
nausea
vomiting
fecal urgency
excessive gas/flatulence
tenesmus
Women of child-bearing potential have a negative pregnancy test prior to beginning therapy and agree to use effective contraceptive methods during the study.

Exclusion Criteria:

Pregnant, breast feeding, or planning a pregnancy.
Immediately prior to randomization, acute diarrhea for >72 hours.

Presence of:

fever (≥100 degrees fahrenheit [°F] or ≥37.8 degrees celsius [°C]), or
hematochezia (blood in stool), or
clinical findings suggesting moderate or severe dehydration.
Active, uncontrolled, or clinically significant diseases or disorders of the heart, lung, kidney, gastrointestinal (GI) tract (other than infectious diarrhea in travelers), or central nervous system.

Administration of any of the following:

any antimicrobial agents with an expected activity against enteric bacterial pathogens within 7 days preceding randomization
more than 2 doses of a symptomatic antidiarrheal compound such as antimotility agents, absorbent agents, and antisecretory agents within 8 hours preceding randomization
Use of any drug such as aspirin or ibuprofen (Advil), which can cause GI bleeding. Acetaminophen (Tylenol) or paracetamol is acceptable.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.

Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.
Eligibility criteria:
Inclusion Criteria:

All patients over 18 years of age
Isolated thoracoscopic procedure for therapeutic or diagnostic purposes

Exclusion Criteria:

Previous ipsilateral thoracic surgery
Need for operative pleurectomy or pleurodesis
Chronic use of pain medication -narcotics or nonsteroidal antiinflammatory drugs (NSAIDs), sedatives, or hypnotics
Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or acetaminophen
Liver dysfunction (INR > 1.5, albumin < 2.8g/dl, bilirubin > 2mg/dl)
Renal dysfunction (eGFR < 60ml/min/1.73m2)
History of peptic ulcerative disease
Severe chronic obstructive pulmonary disease (COPD) requiring continuous oxygen supplementation
Inability to consent
Pregnancy
Need for conversion from a Video-Assisted Thoracic Surgery procedure to a thoracotomy
Patient is discharged from the hospital with a chest tube in place
Patient fails to comply with post-operative instructions
Intervention: Ferrous Sulfate
Trial phase: Phase 2
ATC code: B03AA07
SMILES: O=S(=O)([O-])[O-].[Fe+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Ferrous Sulfate 325mg (oral) tabs morning and evening

Ferrous sulfate: Oral iron, 325 mg tabs taken morning and evening

In this arm participants also received intravenous normal saline as part of a double blind, double dummy design
Eligibility criteria:
Inclusion Criteria:

Diagnosis of RLS based on questionnaire and confirmed by Hopkins telephone Diagnostic Interview conducted by investigators or clinicians part of the study.
Iron deficiency anemia defined as ID either ferritin <20 mcg/l, Tsat <19%, anemia Hgb <13 for both males and females.
Willingness to use contraceptive to avoid pregnancy: Women have to be surgically sterile, post-menopausal, or use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: intrauterine devices or hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices, or injections with prolonged release).
Willingness to participate and signing the informed consent form.

Exclusion Criteria:

Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis)
Decompensated liver cirrhosis or active hepatitis (ALAT > 3 times upper limit of normal)
Serum ferritin > 500 ng/mL or transferrin saturation >40%
Active acute or chronic infections (assessed by clinical judgement that may be indicated by White Blood Cells (WBC) and C-Reactive Protein (CRP) when these are available)
Rheumatoid arthritis with symptoms or signs of active inflammation
Pregnant and nursing women
History of multiple allergies
Known hypersensitivity to parenteral or oral iron or any excipients in the drug products
Previous IV iron treatment for RLS
Other iron treatment or blood transfusion within 4 weeks prior to the screening or treatment visit
Planned elective surgery during the study
Current (past 4 weeks) use of drugs that treat RLS, e.g. opioids, alpha-2-delta anti-depressants, dopaminergics (dopamine promoters, dopamine antagonists/blockers)
Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion og the study or place the subject at potential risk from being in the study, e.g. a malignancy, uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus.
Intervention: Ferumoxides
Trial phase: Phase 2
SMILES: [Fe+2].[Fe+3].[Fe+3].[O-2].[O-2].[O-2].[O-2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Ferumoxytol intravenous (IV) 1020 mg - 2 vials of 510 mg (IV push, 2-3 mins) each given 2-7 days apart

Ferumoxytol intravenous: IV iron, 2 vials of 510 mg given 2-7 days apart

In this arm participants received oral vitamin C as part of a double blind, double dummy design
Eligibility criteria:
Inclusion Criteria:

Diagnosis of RLS based on questionnaire and confirmed by Hopkins telephone Diagnostic Interview conducted by investigators or clinicians part of the study.
Iron deficiency anemia defined as ID either ferritin <20 mcg/l, Tsat <19%, anemia Hgb <13 for both males and females.
Willingness to use contraceptive to avoid pregnancy: Women have to be surgically sterile, post-menopausal, or use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: intrauterine devices or hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices, or injections with prolonged release).
Willingness to participate and signing the informed consent form.

Exclusion Criteria:

Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis)
Decompensated liver cirrhosis or active hepatitis (ALAT > 3 times upper limit of normal)
Serum ferritin > 500 ng/mL or transferrin saturation >40%
Active acute or chronic infections (assessed by clinical judgement that may be indicated by White Blood Cells (WBC) and C-Reactive Protein (CRP) when these are available)
Rheumatoid arthritis with symptoms or signs of active inflammation
Pregnant and nursing women
History of multiple allergies
Known hypersensitivity to parenteral or oral iron or any excipients in the drug products
Previous IV iron treatment for RLS
Other iron treatment or blood transfusion within 4 weeks prior to the screening or treatment visit
Planned elective surgery during the study
Current (past 4 weeks) use of drugs that treat RLS, e.g. opioids, alpha-2-delta anti-depressants, dopaminergics (dopamine promoters, dopamine antagonists/blockers)
Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion og the study or place the subject at potential risk from being in the study, e.g. a malignancy, uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus.
Intervention: Ropivacaine
Trial phase: Not Applicable
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).

0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18
Undergoing distal or midshaft osteotomy for bunion correction, 1st MTP Fusion, or cheilectomy

Exclusion Criteria:

Age less than 18
Unable to read/write English
Dementia, history of dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
Weight <70 kg
Allergy to local anesthetics
History of long-acting opioid use or opioid tolerance (any patient receiving at least 30 mg of oxycodone or equivalent per day (e.g., 6 tabs of Percocet 5/325 mg) regularly for approximately 7 days or more OR who require increased analgesic doses for a period long enough to develop tolerance to the effects of the opioid including analgesia and sedation)
Any history of opioid misuse, illicit or prescription
Prior MTP joint correction on the surgical limb
Midfoot and hindfoot procedures performed concurrently, on the same day
Pregnant or breastfeeding
Intervention: Atomoxetine
Trial phase: Phase 2
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 57
Group description: Atomoxetine 40mg PO to be given the night before the study tilt, and the morning of the study tilt test.

Atomoxetine: 40mg PO the night before and the morning of the study tilt table test.
Eligibility criteria:
Inclusion Criteria:

1 or more syncopal spells in the year preceding enrolment
More than -2 points on the Calgary Syncope Symptom Score
Age ≥18 years with informed consent

Exclusion Criteria:

Other causes of syncope, such as ventricular tachycardia, complete heart block, orthostatic hypotension or hypersensitive carotid sinus syndrome
Inability to give informed consent
important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia.
hypertrophic cardiomyopathy
a permanent pacemaker
a seizure disorder
hypertension defined as >150/90 mm Hg
pregnancy
glaucoma
medications with known effects on blood pressure
Known hypersensitivity to atomoxetine and derivatives
Intervention: SODIUM BICARBONATE
Trial phase: Phase 4
ATC code: B05CB04 | B05XA02
SMILES: O=C([O-])O.[Na+]
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 45
Group description: All participants will receive 2 doses of 1950mg Sodium Bicarbonate

sodium bicarbonate: All participants will receive 2 doses of 1950mg sodium bicarbonate
Eligibility criteria:
Inclusion Criteria:

Adults (aged 18-45 years) with type 1 diabetes
Participants must be able to be fasting prior to study visit and give informed consent.

Exclusion Criteria:

Non-type 1 diabetes
History of eGFR <60 ml/min/1.73m2 or microalbuminuria or greater
History of hypocalcemia or at risk of hypocalcemia
Taking allopurinol or uric acid altering medications
Ketogenic diet
Ketonuria
Taking phosphorus binders (e.g. sevelamer)
Pregnant or breastfeeding
Taking the following medications which may interact with sodium bicarbonate (e.g. phentermine, pseudoephedrine, antifungal medication, cephalosporin antibiotics [e.g. Keflex], tetracycline antibiotics [e.g. doxycycline], steroids or lithium)
Taking SGLT-2 inhibitors
Taking blood pressure medications
Intervention: Valganciclovir Hydrochloride
Trial phase: Phase 4
SMILES: CC(C)C(N)C(=O)OCC(CO)OCn1cnc2c(=O)[nH]c(N)nc21.Cl
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 13
Group description: Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.

prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.
Eligibility criteria:
Inclusion Criteria:

children and adolescents 0-18 years old
Solid Organ Transplantation admitted after transplantation
Treatment with prophylactic Valganciclovir
Glomerular Filtration Rate (GFR) >= 60 mL/min/1.73 m2

Exclusion Criteria:

Treatment with ganciclovir IV
Glomerular Filtration Rate (GFR) < 60 mL/min/1.73 m2
Imipenem treatment
Cluster organ transplanted -
Intervention: Sertraline
Trial phase: Phase 4
ATC code: N06AB06
SMILES: CN[C@H]1CC[C@@H](c2ccc(Cl)c(Cl)c2)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Subjects will receive a fixed dose of 150 mg sertraline per day. Sertraline dose will be gradually increased by giving sertraline subjects capsules filled with 50 mg for the first three days and then capsules filled with 100 mg for 4 days before beginning the 150 mg per day in the second week. After completing the study Visit 12, subjects will be given an additional two week supply of medicine to gradually taper down so as to minimize any withdrawal discomfort.

Subjects in the Sertraline arm also will receive COPE therapy (Concurrent Treatment with Prolonged Exposure)which involves 12 sessions of manualized cognitive and behavioral therapy including exposure therapy for PTSD.

Sertraline: A Randomized Controlled Trial Design will randomize subjects to one of two arms. Sertraline is the active medication treatment arm.
Eligibility criteria:
Inclusion Criteria:

21-65 year old Veterans with PTSD who regularly drink more than 5 standard drinks of alcohol in a day
who experienced a trauma during deployment and
who regularly drink more than 5 standard drinks alcohol and
are interested in coming in once per week for 12 weeks of dual diagnosis individual therapy and
are willing to participate in a placebo-controlled trial which could include receipt of sertraline (Zoloft).

Exclusion Criteria:

if their PTSD Symptoms are adequately controlled by other medication regimens;
they require inpatient alcohol detoxification; or currently receive naltrexone, disulfiram, acamprosate, or ondansetron treatment for alcohol dependence; or
currently have an unstable medical illness; or
have a bipolar or psychotic disorder; or
currently are taking and are unwilling to discontinue taking any SSRI, SNRI, MAO inhibitor, tricyclic antidepressant, or anticonvulsant.
Intervention: Victoza
Trial phase: Phase 3
ATC code: A10BJ02
SMILES: CCCCCCCCCCCCCCCC(=O)NC(CCC(=O)NCCCCC(NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(N)=O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1ccccc1)C(=O)NC(C(=O)NC(C)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(C)C)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)O)C(C)C)C(C)CC)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 233
Group description: Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
Eligibility criteria:
Inclusion Criteria:

Male or female Japanese subjects at least 20 years of age at the time of informed consent
Type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior to screening
HbA1c 7.5-10.0% [58 mmol/mol-86 mmol/mol] (both inclusive)
Subjects on stable therapy with one OAD (oral antidiabetic drug) (stable therapy is defined as unchanged medication and unchanged dose) for for at least 60 days before screening according to approved Japanese labelling

Exclusion Criteria:

Treatment with insulin within 12 weeks prior to screening
Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before screening
Screening calcitonin equal or above 50 ng/l
History of pancreatitis (acute or chronic)
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
Subjects presently classified as being in New York Heart Association (NYHA) Class IV
Within the past 180 days any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
Diagnosis of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, polyps and in-situ carcinomas)
Any condition which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
Intervention: Victoza
Trial phase: Phase 3
ATC code: A10BJ02
SMILES: CCCCCCCCCCCCCCCC(=O)NC(CCC(=O)NCCCCC(NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(N)=O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1ccccc1)C(=O)NC(C(=O)NC(C)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(C)C)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)O)C(C)C)C(C)CC)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 233
Group description: Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
Eligibility criteria:
Inclusion Criteria:

Male or female Japanese subjects at least 20 years of age at the time of informed consent
Type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior to screening
HbA1c 7.5-10.0% [58 mmol/mol-86 mmol/mol] (both inclusive)
Subjects on stable therapy with one OAD (oral antidiabetic drug) (stable therapy is defined as unchanged medication and unchanged dose) for for at least 60 days before screening according to approved Japanese labelling

Exclusion Criteria:

Treatment with insulin within 12 weeks prior to screening
Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before screening
Screening calcitonin equal or above 50 ng/l
History of pancreatitis (acute or chronic)
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
Subjects presently classified as being in New York Heart Association (NYHA) Class IV
Within the past 180 days any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
Diagnosis of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, polyps and in-situ carcinomas)
Any condition which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
Intervention: Omeprazole
Trial phase: Phase 4
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: Double-dose PPI [Omeprazole 20 mg BID (twice a day)]
Eligibility criteria:
Key Inclusion Criteria:

Patient seeks consultation for lack of satisfactory symptom response to once daily PPIs.
Age≥ 21 years old.
Abnormal distal esophageal pH determined by total % time pH <4 or DeMeester Score. Testing to be completed off GERD medications for at least 7 days, with the exception of antacids, which may be taken up until the morning of assessment.
Suitable surgical candidate (i.e. is able to undergo general anesthesia and laparoscopic surgery).
Patient has provided written informed consent for participation in the randomized study.

Key Exclusion Criteria:

Currently taking double-dose PPIs (twice daily dosing).
Hiatal hernia >3cm as determined by endoscopy.
Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences.
Esophagitis Grade C or D (Los Angeles classification).
Body mass index >35.
Diagnosed with an esophageal motility disorder LES.
Esophageal stricture or gross esophageal anatomic abnormalities
History of/or known Barrett's esophagus.
Suspected or known allergies to titanium, stainless steel, nickel or ferrous materials.
Intervention: Rivaroxaban
Trial phase: Phase 4
ATC code: B01AF01
SMILES: O=C(NC[C@H]1CN(c2ccc(N3CCOCC3=O)cc2)C(=O)O1)c1ccc(Cl)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: For the first 3 weeks, patients will receive rivaroxaban 15mg twice-daily; thereafter they will take rivaroxaban 20mg once-daily as per the drug label. Rivaroxaban will be initiated immediately following completion of alterplase infusion, and heparin will be discontinued at the time of rivaroxaban administration.

rivaroxaban: Immediately following completion of alteplase infusion, patients will receive rivaroxaban 15 mg oral bid for 21 days followed by 20 mg oral daily.
Eligibility criteria:
Inclusion Criteria:

Provisions of informed consent prior to any study specific procedure
Diagnosis of acute PE
Evidence of RV strain as defined by one of the following:
1. an RV-to-LV diameter ratio>0.9
2. elevated troponin
3. elevated BNP
Plan for CDT for PE.

Exclusion Criteria:

Arterial hypotension and cardiogenic shock at the time of enrollment. Arterial hypotension defined as a systolic arterial pressure <90mm Hg or a drop in systolic arterial pressure of at least 40 mm Hg for at least 15 minutes with tissue hypoperfusion and/or hypoxia)
Hypersensitivity or other reaction to rivaroxaban
Other indication for VKA than PE
Creatinine clearance <30 ml/min
Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALT > 3 x ULN
Life expectancy <3 months