anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: VALPROIC ACID
Trial phase: Phase 3
ATC code: N03AG01
SMILES: CCCC(CCC)C(=O)O
Sex: Male
Age groups: Adult
Healthy volunteers: No
Participants at risk: 31
Group description: sodium valproate

Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day
Eligibility criteria:
Inclusion Criteria:

Veterans attending alcohol use disorders rehabilitation treatment within the VA
Presence of a diagnosis of alcohol dependence according to DSM-IV
A history of heavy drinking
Absence of withdrawal symptoms

Exclusion Criteria:

Evidence of other substance abuse different from nicotine or cannabis (DSM-IV criteria) or by 2 consecutive positive urine drug screens
Unstable medical conditions such as severe heart disease, liver or renal failure or evidence of neoplasia.
Liver Enzymes (ALT, AST) serum levels >3 times the upper limit of normal
Unstable psychiatric conditions that requires treatment in a more structured setting (i.e. active SI, worsening psychotic symptoms or acute mania)
Diagnosis of schizophrenia or schizoaffective disorder
Requiring therapy with valproate or naltrexone or has a history of significant side effects from either study drug
Requiring therapy with topiramate, lamotrigine or carbamazepine
Requiring chronic treatment with opioid analgesics for refractory pain
Failed 3 previous intensive alcohol rehabilitation programs in the past 2 years
Females
Intervention: Naltrexone
Trial phase: Phase 3
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: Male
Age groups: Adult
Healthy volunteers: No
Participants at risk: 31
Group description: naltrexone

Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day
Eligibility criteria:
Inclusion Criteria:

Veterans attending alcohol use disorders rehabilitation treatment within the VA
Presence of a diagnosis of alcohol dependence according to DSM-IV
A history of heavy drinking
Absence of withdrawal symptoms

Exclusion Criteria:

Evidence of other substance abuse different from nicotine or cannabis (DSM-IV criteria) or by 2 consecutive positive urine drug screens
Unstable medical conditions such as severe heart disease, liver or renal failure or evidence of neoplasia.
Liver Enzymes (ALT, AST) serum levels >3 times the upper limit of normal
Unstable psychiatric conditions that requires treatment in a more structured setting (i.e. active SI, worsening psychotic symptoms or acute mania)
Diagnosis of schizophrenia or schizoaffective disorder
Requiring therapy with valproate or naltrexone or has a history of significant side effects from either study drug
Requiring therapy with topiramate, lamotrigine or carbamazepine
Requiring chronic treatment with opioid analgesics for refractory pain
Failed 3 previous intensive alcohol rehabilitation programs in the past 2 years
Females
Intervention: Pioglitazone
Trial phase: Phase 2
ATC code: A10BD05 | A10BD06 | A10BD09 | A10BD12 | A10BG03
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
Eligibility criteria:
Inclusion Criteria:

Suspected or biopsy-proven NSCLC
Willingness to provide biopsy tissue for correlative studies
Candidate for pulmonary resection; must be able to schedule >= 14 days and =< 42 days between registration and surgery to allow for treatment with pioglitazone
Ability to understand and the willingness to sign a written informed consent document
Ability and willingness to swallow oral tablets

Ability and willingness to undergo two bronchoscopies (before treatment and at the time of surgery)

For those participants who are undergoing mediastinoscopy as part of their standard-of-care, the pre-treatment bronchoscopy may be performed during the mediastinoscopy; if the participant remains eligible for definitive surgical resection after the mediastinoscopy, the participant may proceed to registration and pioglitazone treatment
Current or former smoker with a >= 10 pack-year smoking history
Women of child-bearing potential and men who agree to use adequate contraception for the duration of study participation; women must not be pregnant or lactating; women of child-bearing potential (women considered not of childbearing potential if they are at least two years postmenopausal and/or surgically sterile) must have used adequate contraception (abstinence; barrier methods such as intrauterine device [IUD], diaphragm with spermicidal gel, condom, or others; and hormonal methods such as birth control pills or others) since her last menses prior to study entry; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately

Exclusion Criteria:

Receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to pioglitazone
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant or lactating woman
Currently treated diabetes
Participants with >= class II New York Heart Association (NYHA) congestive heart failure or history of congestive heart failure
Participants with >= grade 2 (moderate) edema
Participants currently receiving an inhibitor of cytochrome P450 family 2, subfamily C, polypeptide 8 (CYP2C8) (gemfibrozil, ketoconazole, quercetin, trimethoprim), or an inducer of CYP2C8 (cortisol, dexamethasone, phenobarbital, rifampin), or cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) substrate
Prior neoadjuvant therapy for NSCLC
History of bladder cancer or in situ bladder cancer
Intervention: CID 76943386
Trial phase: Phase 3
SMILES: CCC(C)C(NC(=O)C(CO)NC(=O)C(CCCCN)NC(=O)CNC(=O)C(CCCCN)NC(=O)C(CC(=O)O)NC(=O)C(Cc1cnc[nH]1)NC(=O)C(CC(C)C)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc1cnc[nH]1)NC(=O)C(CCC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(C)N)C(C)C)C(=O)NC(CCC(N)=O)C(=O)NC(CC(=O)O)C(=O)NC(CC(C)C)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCC(=O)O)C(=O)NC(CC(C)C)C(=O)NC(CC(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(CC(C)C)C(=O)NC(C)(C)C(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(Cc1cnc[nH]1)C(=O)NC(C(=O)NC(C)C(N)=O)C(C)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 822
Group description: BA058 80 mcg: BA058 80 mcg subcutaneous daily
Eligibility criteria:
Inclusion Criteria:

Healthy ambulatory postmenopausal (≥ 5 years) women from 50 to 85 years of age (inclusive) with a diagnosis of osteoporosis
The women are to have a bone mineral density (BMD) T score ≤ -2.5 and > -5.0 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years. Postmenopausal women older than 65 who meet the above fracture criteria but have a T score ≤ -2.0 and > -5.0 may be enrolled. Women older than 65 who do not meet the fracture criteria may also be enrolled if their T score is ≤ -3.0 and > -5.0
Normal physical exam, vital signs, electrocardiogram (ECG) and medical history
Laboratory tests within the normal range including serum calcium, PTH(1-84), serum phosphorus and alkaline phosphatase

Exclusion Criteria:

History of more than 4 mild or moderate spine fractures or any severe fracture
Abnormality of the spine or hip that would prohibit assessment of bone mineral density (BMD)
Unexplained elevation of serum alkaline phosphatase, history of bone disorders (such as Paget's disease) or a diagnosis of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin)
History of thyroid, parathyroid, or adrenal disorders, or malabsorptive syndromes or any chronic or recurrent diseases or disturbances that would interfere with the interpretation of study data or compromise the safety of the patient
Prior treatment with parathyroid hormone (PTH) or parathyroid hormone-related peptid (PTHrP)
Prior treatment with bisphosphonates, fluoride, or strontium within the past five years or treatment with androgens, anabolic steroids, corticosteroids or selective estrogen receptor modulators within the past 12 months (except hormone replacement therapy)
Prior treatment with an investigational drug within the past 12 months
History of nephrolithiasis or urolithiasis within the past five years, or history of osteosarcoma at any time
Intervention: TERIPARATIDE
Trial phase: Phase 3
ATC code: H05AA02
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@@H](N)CO)C(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@H](C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(=O)O)C(=O)N[C@H](C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](Cc1ccccc1)C(=O)O)C(C)C)C(C)C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 818
Group description: Blinded until after randomization, then open-label

teriparatide: teriparatide 20 mcg subcutaneous daily
Eligibility criteria:
Inclusion Criteria:

Healthy ambulatory postmenopausal (≥ 5 years) women from 50 to 85 years of age (inclusive) with a diagnosis of osteoporosis
The women are to have a bone mineral density (BMD) T score ≤ -2.5 and > -5.0 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years. Postmenopausal women older than 65 who meet the above fracture criteria but have a T score ≤ -2.0 and > -5.0 may be enrolled. Women older than 65 who do not meet the fracture criteria may also be enrolled if their T score is ≤ -3.0 and > -5.0
Normal physical exam, vital signs, electrocardiogram (ECG) and medical history
Laboratory tests within the normal range including serum calcium, PTH(1-84), serum phosphorus and alkaline phosphatase

Exclusion Criteria:

History of more than 4 mild or moderate spine fractures or any severe fracture
Abnormality of the spine or hip that would prohibit assessment of bone mineral density (BMD)
Unexplained elevation of serum alkaline phosphatase, history of bone disorders (such as Paget's disease) or a diagnosis of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin)
History of thyroid, parathyroid, or adrenal disorders, or malabsorptive syndromes or any chronic or recurrent diseases or disturbances that would interfere with the interpretation of study data or compromise the safety of the patient
Prior treatment with parathyroid hormone (PTH) or parathyroid hormone-related peptid (PTHrP)
Prior treatment with bisphosphonates, fluoride, or strontium within the past five years or treatment with androgens, anabolic steroids, corticosteroids or selective estrogen receptor modulators within the past 12 months (except hormone replacement therapy)
Prior treatment with an investigational drug within the past 12 months
History of nephrolithiasis or urolithiasis within the past five years, or history of osteosarcoma at any time
Intervention: Propofol
Trial phase: Phase 4
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
Eligibility criteria:
Inclusion Criteria:

Patients with documented history of OSA by polysomnography who require anesthesia for MRI sleep study or MRI brain imaging study.
Subjects must be 12 months to 25 years of age (inclusive)
Either the subject (if subject's age is 18-25) or the subject's legally authorized representative has given written informed consent to participate in the study

Exclusion Criteria:

The subject has life-threatening medical conditions (American Society of Anesthesiologists Physical Status 4, 5 or 6). The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is. For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III).
The subject is allergic to or has a contraindication to propofol or dexmedetomidine.
The subject has a tracheostomy or other mechanical airway device
The subject is not scheduled to receive anesthesia-sedation care for the MRI
The subject has a history or a family (parent or sibling) history of malignant hyperthermia.
Intervention: Ranolazine
Trial phase: Phase 4
ATC code: C01EB18
SMILES: COc1ccccc1OCC(O)CN1CCN(CC(=O)Nc2c(C)cccc2C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: patients receiving ranolazine
Eligibility criteria:
Inclusion Criteria:

Ischemic cardiomyopathy patients on optimal medical treatment. Optimal medical treatment is defined as the continued symptoms of chest pain or dyspnea despite treatment with 2 antiischemic agents (beta blockers, CCB or nitrates). Unless contraindicated, all cardiomyopathy patients should be treated with a beta blocker and an ACEI/ARB.
Anginal chest pain or dyspnea
Documentation of non treatable or optimally treated coronary artery disease
Ejection Fraction of less than or equal to 40%

Exclusion Criteria:

Less than 18 years of age
Pregnant or breast feeding
Patients with non ischemic cardiomyopathy
Intervention: Afatinib
Trial phase: Phase 3
ATC code: L01EB03 | L01XE13
SMILES: CN(C)C/C=C/C(=O)Nc1cc2c(Nc3ccc(F)c(Cl)c3)ncnc2cc1O[C@H]1CCOC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 411
Group description: Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
Eligibility criteria:
Inclusion criteria:

Histologically or cytologically confirmed loco-regionally advanced head and neck squamous cell carcinoma (HNSCC), stage III to IVb
Unresected tumour prior to chemo-radiotherapy (CRT)
Concomitant CRT completed prior to randomisation
After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and radiographic examinations
Eastern cooperative oncology group (ECOG) performance status 0 or 1

Exclusion criteria:

Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
Patients with smoking history of less than or equal to 10 pack years and with primary tumour site of base of tongue and/or tonsil
Any other malignancy (except for simultaneous HNSCC primaries, appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least five years
Known pre-existing Interstitial Lung Disease (ILD)
Pregnancy or breast feeding
Intervention: Afatinib
Trial phase: Phase 3
ATC code: L01EB03 | L01XE13
SMILES: CN(C)C/C=C/C(=O)Nc1cc2c(Nc3ccc(F)c(Cl)c3)ncnc2cc1O[C@H]1CCOC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 320
Group description: Oral administration of Afatinib (film-coated tablets). Starting dose 40 milligram (mg) once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
Eligibility criteria:
Inclusion criteria:

Histologically or cytologically confirmed R/M HNSCC of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy
Documented progressive disease based on investigator assessment according to Response Evaluation Criteria in Solid Tumours (RECIST) following receipt of at least two cycles of cisplatin or carboplatin administered for R/M disease
Measurable disease according to RECIST
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria:

Progressive disease within three months of completion of curatively intended treatment for locoregionally advanced or metastatic HNSCC
Any other than one previous platinum based systemic regimen given for R/M disease
Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules
Pregnancy or breast feeding
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: The saline arm will receive normal saline through the catheter as a placebo.

Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used.
Eligibility criteria:
Inclusion Criteria:

SICU patient
positive c. diff toxin assay
visualization of pseudomembranes on colonoscopy,
able to give consent or have representative to give consent.

Exclusion Criteria:

Under age 18
pregnant
absence of a colon or surgical discontinuity of bowel
allergy to vancomycin
need for anti-diarrheal medication
need for prolonged antibiotics for other cause
need for probiotics
need for other medications with action against C. diff.
need for surgery, colon perforation
recent IV IG use
toxic megacolon.
Intervention: Vancomycin
Trial phase: Not Applicable
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: The vancomycin arm will receive vancomycin solution through the catheter.

Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline.
Eligibility criteria:
Inclusion Criteria:

SICU patient
positive c. diff toxin assay
visualization of pseudomembranes on colonoscopy,
able to give consent or have representative to give consent.

Exclusion Criteria:

Under age 18
pregnant
absence of a colon or surgical discontinuity of bowel
allergy to vancomycin
need for anti-diarrheal medication
need for prolonged antibiotics for other cause
need for probiotics
need for other medications with action against C. diff.
need for surgery, colon perforation
recent IV IG use
toxic megacolon.
Intervention: Sildenafil Citrate
Trial phase: Phase 3
SMILES: CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12.O=C(O)CC(O)(CC(=O)O)C(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Oral Sildenafil citrate, 50mg, b.i.d.

Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks
Eligibility criteria:
Inclusion Criteria:

Systemic sclerosis according to the classification criteria of the American College of Rheumatology (1980) with no more than 4 years since diagnosis
Early systemic sclerosis as defined by LeRoy and Medsger (2001)
6 or more Raynaud's crisis per week
Written informed consent provided by the subjects prior to initiating study procedures

Exclusion Criteria:

Smoking
Peripheral or central vasculopathy other than Systemic sclerosis
Uncontrolled Diabetes
Liver disease
Pregnant or lactating woman
Current use of cyclosporin, prostanoids, bosentan or any PDE-5 inhibitors (including current Sildenafil use during randomization)
History of stroke, myocardial infarction or life threatening cardiac condition within the last 6 months
History of surgical sympathectomy
Systolic blood pressure < 85mm Hg
History of scleroderma renal crisis
Known hypersensitivity to Sildenafil or any of the excipients
History of Retinitis Pigmentosa
Current use of Nitrates
Intervention: GLYCEROL PHENYLBUTYRATE
Trial phase: Phase 3
ATC code: A16AX09
SMILES: O=C(CCCc1ccccc1)OCC(COC(=O)CCCc1ccccc1)OC(=O)CCCc1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 23
Group description: The first part of this open-label study consisted of a switch-over period during which patients were switched from the current medication (NaPBA) to HPN-100. The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
Eligibility criteria:
Inclusion Criteria:

Male and female subjects 29 days to < 6 years old. If the subject is born prematurely, calculation of the lower age limit begins at the corrected gestational age of 40 weeks.
Signed informed consent by the subject's legally acceptable representative
Suspected or confirmed UCD diagnosis of any subtype, except NAGS deficiency
On stable dose of NaPBA powder for at least 5 days before Day 1
Not receiving sodium benzoate for at least 5 days before Day 1
No concomitant illness which would preclude safe participation as judged by the investigator
Able to receive medication orally
Has not undergone liver transplantation, including hepatocellular transplantation
Judged sufficiently stable and compliant with diet and treatment to be suitable for enrollment

Exclusion Criteria:

Screening ammonia level > 100 μmol/L and signs and symptoms indicative of hyperammonemia; subjects may be rescreened after their ammonia is controlled and they are clinically stable, at the discretion of the investigator
Use of any investigational drug within 30 days of Day 1
Active infection (viral or bacterial) or any other condition that may increase ammonia levels
Any clinical or laboratory abnormality of Grade 3 or greater severity according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03, except Grade 3 elevations in ammonia and liver enzymes, defined as levels 5-20 times ULN (upper limit of normal)in alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma glutamyl transpeptidase (GGT) in a clinically stable subject
Any clinical or laboratory abnormality or medical condition that, at the discretion of the investigator, may put the subject at increased risk by participating in this study
Known hypersensitivity to PAA or PBA
Liver transplant, including hepatocellular transplant
Currently treated with Carbaglu® (carglumic acid)