anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tredaptive
Trial phase: Phase 4
SMILES: CS(=O)(=O)c1cc(F)cc2c3c(n(Cc4ccc(Cl)cc4)c12)C(CC(=O)O)CC3.O=C(O)c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
Eligibility criteria:
Inclusion Criteria:

Male subjects or postmenopausal female subjects aged between 19-70 years
High risk patients (PROCAM risk ≥20%) on a stable statin-therapy, but at least simvastatin 20 mg/d
HDL-cholesterol ≤50 mg/dl and /or triglycerides 150-400 mg/dl and/or LDL-cholesterol 70 - 150 mg/dl
Lipoprotein (a) < 30 mg/dl
Patients may have normal glucose metabolism (normal HOMA), be insulin resistant (abnormal HOMA), have impaired fasting glucose or impaired glucose tolerance but not diabetes mellitus.
Without niacin therapy for at least 6 months
Dosage of any concomitant medication has been stable for at least 3 weeks
If female, postmenopausal (absence of menstruation for at least 12 months or absence of menstruation > 6 months with FSH > 40 ng/ml respectively oestrogen < 20 pg/ml)

Exclusion Criteria:

Subjects with additional causes for hyperlipoproteinemia
Diabetes mellitus or antidiabetic medication
Subject has history of cardiovascular ischemia in previous 3 months or acute myocardial infarction or unstable angina
History of psychiatric disorder or cognitive impairment that would interfere with participation in the study
History of alcoholism
Contraindication against niacin and/or laropiprant
Subject has participated in an investigational study within 30 days prior to study initiation
Fasting triglycerides >400 mg/dl
Life-threatening disease (e.g. cancer)
Renal insufficiency (GFR ≤ 30 ml/min )
Major hepatic impairment
Known allergic reaction/intolerance against niacin and/or laropiprant
Active peptic ulcer disease
Intervention: Diquafosol tetrasodium
Trial phase: Phase 3
SMILES: O=c1ccn(C2OC(COP(=O)([O-])OP(=O)([O-])OP(=O)([O-])OP(=O)([O-])OCC3OC(n4ccc(=O)[nH]c4=O)C(O)C3O)C(O)C2O)c(=O)[nH]1.[Na+].[Na+].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Participants at risk: 144
Group description: 3% DE-089 ophthalmic solution
Eligibility criteria:
Inclusion Criteria:

Those who show:

Keratoconjunctival disorder confirmed with vital dye staining
Abnormal Schirmer score results

Exclusion Criteria:

Eye disease that needs therapy other than that for dry eye
Those who need to wear contact lenses during the clinical study
Intervention: Healon
Trial phase: Phase 3
SMILES: CC(=O)NC1C(O)OC(CO)C(O)C1OC1OC(C(=O)O)C(OC2OC(CO)C(O)C(OC3OC(C(=O)O)C(O)C(O)C3O)C2NC(C)=O)C(O)C1O.[Na+]
Sex: All
Age groups: Adult | Older Adult
Participants at risk: 143
Group description: 0.1% sodium hyaluronate ophthalmic solution
Eligibility criteria:
Inclusion Criteria:

Those who show:

Keratoconjunctival disorder confirmed with vital dye staining
Abnormal Schirmer score results

Exclusion Criteria:

Eye disease that needs therapy other than that for dry eye
Those who need to wear contact lenses during the clinical study
Intervention: SODIUM FLUORIDE
Trial phase: Phase 2
ATC code: A01AA01 | A01AA51 | A12CD01 | V09IX06
SMILES: [F-].[Na+]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
Eligibility criteria:
INCLUSION CRITERIA:

Participants must have a clinical course consistent with prostate cancer and have available documentation of prostate adenocarcinoma from either the National Cancer Institute (NCI) or from an outside pathology laboratory.

Participant must have:

- A history of PSA of > 10ng/mL or a history of PSA doubling time of less than or equal to 6 months, and no known bone metastatic involvement on standard of care imaging (Tc-99m MDP bone scan, CT etc)

OR

- Any PSA level and known bone metastatic disease on standard of care imaging (Tc-99m MDP bone scan, CT etc).

Ability to provide informed consent. All subjects must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.

EXCLUSION CRITERIA:

Participants with severe claustrophobia unresponsive to oral anxiolytics.

Subjects weighing greater than 350 lbs (weight limit for scanner table), or unable to fit within the imaging gantry.

Subjects with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.
Intervention: Humalog
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(CCCCN)C(=O)N3CCCC3C(=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: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 107
Group description: insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
Eligibility criteria:
Inclusion Criteria:

Mothers with gestational diabetes who had at least twice plasma glucose at fasting > 5.4 mmol/L and/or 1 hour postprandial value > 7.7 mmol/L at 24 to 32 gestational weeks

Exclusion Criteria:

Fasting glucose > 7.0 mmol/L or 1 hour postprandial plasma glucose > 11.0 mmol/L or Glycosylated hemoglobin A1c (HbA1c) > 7.0%
Renal, hepatic or cardiac failure
Pregestational use of metformin
Pregnancy with multiple fetuses
Intervention: Ethanol
Trial phase: Phase 2 | Phase 3
ATC code: D08AX08 | V03AB16 | V03AZ01
SMILES: CCO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18510
Group description: Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.

Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.
Eligibility criteria:
Inclusion Criteria:

Pregnant women in the 2nd or 3rd trimester
Age 15 years and above
Pregnant women who plan to stay in the study area (catchment area of the health facility) for delivery and one month post partum
Willingness to provide cord care as per the protocol of their cluster
Willingness to provide informed consent

Exclusion Criteria:

Pregnant women who are not willing to provide cord care as per the protocol of their cluster
Pregnant women who are not willing to provide informed consent
Pregnant women in the 1st trimester
Pregnant women under age 15 years
Intervention: Rosuvastatin
Trial phase: Phase 1
ATC code: A10BH52 | C10AA07 | C10BA06 | C10BA09 | C10BX05 | C10BX07 | C10BX09 | C10BX10 | C10BX13 | C10BX14 | C10BX16 | C10BX17 | G01AE10
SMILES: CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1/C=C/[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
Eligibility criteria:
Inclusion Criteria:

Subjects must be between 18 and 80 years old.
Subjects must be willing and able to give informed consent
A woman of child-bearing potential who is currently sexually active must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for up to 30 days after enrollment.
Subjects must have symptoms of acute coronary syndrome as defined by 2 of the 3: (a) history of cardiac-ischemia-related symptoms of at least 10 minutes duration ≤ 8 hours prior to randomized treatment assignment (b) concurrent biomarker evidence of cardiac ischemia, as defined by troponin I or T greater that upper limit of normal (ULN) or creatine kinase-myocardial band (CK-MB) greater than ULN. (c) concurrent electrocardiographic evidence of cardiac ischemia, as defined by new of presumably new ST-segment depression (≥1 mm) or transient (<30 min) ST-segment elevation (≥ 1mm) in at least two contiguous leads.
Subjects must be statin naive or currently only on low dose statin (Simvastatin 20mg, Pravastatin 40mg, or Atorvastatin 10mg)

Exclusion Criteria:

Age <18 years
Age > 80 years
Use of Crestor in the past 30 days
GFR (estimated) <30 ml/min
Hemodialysis
History of liver failure
Unexplained liver function abnormalities
Current or planned use of cyclosporine or gemfibrozil
Sepsis
Hypotension
Dehydration
Trauma
Severe metabolic, endocrine or electrolyte abnormality
Recent (within the last 2 weeks) or planned (in the next month) major surgery
HIV/AIDS with current of planned use of HIV protease inhibitors
Intervention: Propofol
Trial phase: Phase 3
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 80
Group description: Non-obese children categorized as those with a body mass index(BMI)between 25-84th percentile

Propofol: This arm of patients(non-obese)will act as the control group for the obese children. Each non-obese child/subject will receive a predetermined dose of propofol from a range of 1.0mg/kg to 4.25mg/kg depending on the response of the previous patient to their assigned dose( biased coin design)
Eligibility criteria:
Inclusion Criteria:

Children between the ages of 3 and 17 years who fall into the categories of non-obese(BMI percentile between 25-84th percentile) or obese(>95th percentile)
American Society of Anesthesiology(ASA) classification 1 or 2-

Exclusion Criteria:

Patients classified as ASA (American Society of Anesthesiology) Class 3 or greater.
Patients with documented kidney or liver disease or those presenting for open surgery on the liver or kidney.
Patients who will NOT be receiving propofol for induction as part of their anesthetic regimen.
Patients who are currently on anti-convulsant medication or receiving drugs with sedative effects.
Patients currently being treated for attention deficit disorder.
Patients who are diagnosed with failure to thrive or those with a BMI less than 25th percentile.
Patients who are hemodynamically unstable.
Patients with egg allergy.
Patients with low levels of albumin -
Intervention: Propofol
Trial phase: Phase 3
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 80
Group description: Obese children are categorized as those with a body mass index >95th percentile

Propofol: Each Obese child/subject in this group will receive a predetermined dose of propofol ranging from 1.0mg/kg to 4.25mg/kg to induce loss of consciousness depending on the response (presence or absence of lash reflex) of the preceding patient to his/her assigned dose (biased coin design)
Eligibility criteria:
Inclusion Criteria:

Children between the ages of 3 and 17 years who fall into the categories of non-obese(BMI percentile between 25-84th percentile) or obese(>95th percentile)
American Society of Anesthesiology(ASA) classification 1 or 2-

Exclusion Criteria:

Patients classified as ASA (American Society of Anesthesiology) Class 3 or greater.
Patients with documented kidney or liver disease or those presenting for open surgery on the liver or kidney.
Patients who will NOT be receiving propofol for induction as part of their anesthetic regimen.
Patients who are currently on anti-convulsant medication or receiving drugs with sedative effects.
Patients currently being treated for attention deficit disorder.
Patients who are diagnosed with failure to thrive or those with a BMI less than 25th percentile.
Patients who are hemodynamically unstable.
Patients with egg allergy.
Patients with low levels of albumin -
Intervention: Morphine
Trial phase: Phase 2
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 48
Group description: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.

ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
Eligibility criteria:
Inclusion Criteria: All subjects who underwent:

knee arthroscopy + synovectomy
knee arthroscopy + partial or complete meniscectomy
knee arthroscopy + chondroplasty
knee arthroscopy + microfracture
knee arthroscopy + autologous osteoarticular transplantation

Exclusion Criteria:

A surgical procedure that required an incision other then an arthroscopic portal
A surgical procedure within the same joint within ninety days
A acute or chronic knee infection
Any diagnosis of complex regional pain syndrome
A known allergy to one of the study drugs
A documented history of narcotic use
A score of less than two standard deviation on the SF-12 mental component
Any major systemic or cardiac illness (heart failure, uncontrolled angina, bifascicular blocks, renal insufficiency, or liver disease)
Under the age of eighteen years
Intervention: Ganfort
Trial phase: Phase 4
SMILES: CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1.CCNC(=O)CCCC=CCC1C(O)CC(O)C1C=CC(O)CCc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of primary open-angle glaucoma that has never been treated
Visual Acuity 20/60 or better in each eye

Exclusion Criteria:

Eye surgery within 3 months
Any refractive eye surgery
Contraindication to beta-adrenoceptor antagonist therapy (eg, chronic obstructive pulmonary disease [COPD], bronchial asthma, sinus bradycardia, heart block, history of severe myocardial infarction [heart attack])
Eye inflammation or eye infection within 3 months
Eye trauma within 6 months
Oral, injectable, or topical ophthalmic steroids within 21 days or anticipated use during study
Intervention: ETHINYL ESTRADIOL
Trial phase: Phase 1
ATC code: G03AA07 | G03CA01 | L02AA03
SMILES: C#C[C@]1(O)CC[C@H]2[C@@H]3CCc4cc(O)ccc4[C@H]3CC[C@@]21C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 34
Group description: Ortho-Cyclen® is a comparator drug intervention

Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.
Eligibility criteria:
Inclusion Criteria:

Healthy women, ages 18-45
Body mass index (BMI) ≥18 and ≤32, and weight ≥ 110 lbs.
Willing to use a non-hormonal method of contraception if at risk of pregnancy, OR have already undergone previous bilateral tubal ligation or hysterectomy
Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior until completion of each treatment period

Exclusion Criteria:

Known or suspected pregnancy;
Lactating women
Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
Use of other contraceptive methods than study medication
Smokers
Intervention: Varenicline
Trial phase: Phase 4
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 249
Group description: Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
Eligibility criteria:
Inclusion Criteria:

Smokers aged 18 years or above and wanting to stop smoking
Smokers who have smoked an average of at least 10 cigarettes per day over the last 4 weeks
Smokers who have tried before to stop smoking at least once with varenicline, and who took varenicline for at least 2 weeks
The last attempt to stop smoking must be at least 3 months before entering the study

Exclusion Criteria:

Individuals who have not tolerated varenicline well previously, or who have a current or prior medical or psychiatric history that would make entry into the trial inadvisable
Individuals who have previously participated in clinical trials of varenicline
Individuals who have been participating in another smoking cessation trial within the last 3 months, or other drug trial within the last 30 days
Intervention: Citalopram
Trial phase: Phase 4
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
Eligibility criteria:
Inclusion Criteria:

Patients will be 20 males or females above the age of 18 with a current major depressive episode, as defined by DSM-IV and assessed on the MINI, of at least 4 weeks duration.
All subjects must have epilepsy, defined as the recurrence of seizures that are unprovoked and unpredictable, requiring treatment with an anti-epileptic medication under the care of a neurologist.
Subjects must be stabilized on their antiepileptic drug (AED) regimen for the previous 2 months.
If a vagus nerve stimulator is in place, the settings must be unchanged for the previous 2 months.
Patients must be ages 18 - 75 and have a 24 item Hamilton Depression Rating Scale Score (HAM-D) at intake >/= 20.
Subjects must be fluent in English and have the capacity to understand the nature of the study and sign the written informed consent.

Exclusion Criteria:

Axis II diagnosis of antisocial, schizotypal or severe borderline personality disorder(defined as patients who are high risk for being unable to complete the study due to hospitalization, suicide attempts, significant self-mutilation, or other self-injurious or destructive behavior).
History of psychosis, mania or hypomania.
Subjects with more than 10 seizures per month that involve impairment of consciousness, such as complex partial or generalized seizures.
Subjects unable to count seizures accurately, or do not have a someone in their home who can count seizures accurately .
Unstable medical or neurological disorder (other than epilepsy).
Epilepsies related to a progressive neurologic disease such as a brain tumor.
Substance abuse including ETOH within the past 6 months.
Need for concurrent psychotropic drugs with the exception of AEDs or zolpidem for sleep.
Concurrent or recent (within 3 months) entry into a new psychotherapy.
Actively or acutely suicidal.
Failure to respond to escitalopram or to two or more other adequate antidepressant trials in the past year.
Pregnancy or lactation.

Females of child bearing potential who do not practice adequate contraception.

-
Intervention: Roxadustat
Trial phase: Phase 2
ATC code: B03XA05
SMILES: Cc1nc(C(=O)NCC(=O)O)c(O)c2ccc(Oc3ccccc3)cc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
Eligibility criteria:
Inclusion Criteria:

Age 18 to 75 years
Chronic kidney disease, not receiving dialysis
Body weight 45 to 140 kg

Exclusion Criteria:

Any clinically significant infection or evidence of an underlying infection
Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
History of chronic liver disease
New York Heart Association Class III or IV congestive heart failure
Myocardial infarction or acute coronary syndrome within 12 weeks prior to randomization
History of malignancy
Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
History of myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia
History of hemosiderosis, hemochromatosis or polycystic kidney disease
Active hemolysis or diagnosis of hemolytic syndrome
Uncontrolled or symptomatic secondary hyperparathyroidism
Seizure disorder or receiving anti-epilepsy medication
Known bone marrow fibrosis
Any prior or scheduled organ transplant
Prior treatment with roxadustat or any hypoxia-inducible factor prolyl hydroxylase inhibitor
History of alcohol or drug abuse
Intervention: Aminophylline
Trial phase: Not Applicable
ATC code: R03DA05 | R03DA20 | R03DA55 | R03DB05
SMILES: Cn1c(=O)c2[nH]cnc2n(C)c1=O.Cn1c(=O)c2[nH]cnc2n(C)c1=O.NCCN
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 72
Group description: Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours

Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours
Eligibility criteria:
Inclusion Criteria:

Less than 18 years old, undergoing cardiac surgery with bypass
neonates must be at least 36 weeks gestational age

Exclusion Criteria:

History of arrythmia or seizure, on extracorporeal membrane oxygenation (ECMO) support, already taking aminophylline/theophylline, liver failure, sepsis, on renal replacement therapy