anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Rosuvastatin
Trial phase: Phase 4
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: 32
Group description: Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
Eligibility criteria:
Inclusion Criteria:

atorvastatin 10 mg monotherapy for 4 weeks or longer before the start of the 4-week washout and low density lipoprotein-cholesterol (LDL-C) levels that had not reached the following lipid management target values during treatment: Category I (low-risk group) with no other risk factors - LDL-C <160 mg/dL; Category II (mid-risk group) with 1-2 risk factors other than LDL-C levels - LDL-C <140 mg/dL; Category III (high-risk group) with 3 or more other risk factors - LDL-C <120 mg/dL; and for participants with history of coronary artery disease - LDL-C <100 mg/dL.
outpatient men or women, age 20 years and older

Exclusion Criteria:

fasted triglyceride level at the start of washout or treatment period exceeding 400 mg/dL.
homozygous familial hypercholesterolemia.
creatine phosphokinase (CPK) >2 times the upper limit of normal (X ULN) at start of washout or treatment period.
glycosylated hemoglobin (HbA1c) >=8％ at start of washout or treatment period.
severe hepatic function disorder, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2X ULN at start of washout or treatment period.
hypersensitivity to ezetimibe, atorvastatin, or rosuvastatin tablets.
pregnant or lactating
discontinued use of atorvastatin 10 mg for less than 4 weeks at start of treatment period (however, if participant had taken atorvastatin 10 mg before the test conducted at the start of the observation period, a period of discontinuation of 27 days is allowed.)
cyclosporine treatment
hyperlipidemia associated with hypothyroidism, obstructive gall bladder or biliary disease, chronic renal failure, and/or pancreatitis.
hyperlipidemia associated with drug administration that causes adverse serum lipid effects.
participation in a clinical study within 4 weeks of washout
cancer or cancer history within previous 5 years, except for successfully treated basal cell carcinoma of the skin.
Intervention: Itraconazole
Trial phase: Phase 4
ATC code: J02AC02
SMILES: CCC(C)n1ncn(-c2ccc(N3CCN(c4ccc(OCC5COC(Cn6cncn6)(c6ccc(Cl)cc6Cl)O5)cc4)CC3)cc2)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 130
Group description: Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
Eligibility criteria:
Inclusion Criteria:

Onychomycosis participants whose etiologic agent is identified by potassium hydroxide (KOH) smear and bacterial identification test
Participants with Scoring Clinical Index for Onychomycosis (SCIO) greater than or equal to 9
Participants who are healthy in general in following items: medical and medication history, physical examination before administration time, vital signs (blood pressure and pulse) and clinical laboratory tests (clinical test results [liver function and renal function] are within 2 times the normal range)
Female participants of child-bearing age who use acceptable contraceptives
Participants who can understand features of clinical study and signed informed consent form

Exclusion Criteria:

Participants with psoriasis (scaly skin rash)
Diabetic participants who take an anti-diabetic drug
Pregnant or breast feeding female participants
Participants with clinical evidence of arterial insufficiency or peripheral vascular disease and medical history of decreased ventricular function like congestive heart failure (heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body)
Participants who applied a topical antifungal agent (nail lacquer) on target nail within 1 month before the study medication administration and who took an oral antifungal agent within 3 month before the study medication administration
Intervention: Anastrozole
Trial phase: Phase 2
ATC code: L02BG03
SMILES: CC(C)(C#N)c1cc(Cn2cncn2)cc(C(C)(C)C#N)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.

anastrozole: Given orally
Eligibility criteria:
DISEASE CHARACTERISTICS:

Histologically confirmed invasive breast cancer, meeting 1 of the following criteria:

SBR grade I-II disease (patients < 65 years of age)
SBR grade I-III disease (patients > 65 years of age)
T2 (2-5 cm), T3, or T4B, and N0-1 disease
No metastatic disease
Breast lesion not amenable to breast-conserving resection
No inflammatory breast cancer
No prior breast cancer

Hormone receptor status:

Estrogen receptor- and/or progesterone receptor-positive

PATIENT CHARACTERISTICS:

Postmenopausal
No other cancer within the past 5 years except for adequately treated skin carcinoma or carcinoma in situ of the cervix
No contraindication to anti-hormonal treatment
No psychological, familial, social, or geographical reasons that would preclude follow up

PRIOR CONCURRENT THERAPY:

At least 8 days since prior hormone replacement therapy
No concurrent anti-vitamin K treatment
Intervention: ASPIRIN
Trial phase: Phase 1 | Phase 2
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 100
Group description: PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.

acetylsalicylic acid: 325mg once a day for 7 days
Eligibility criteria:
Inclusion Criteria:

Subject is ≥50 to ≤75 years of age.
Subject is healthy.
Subject has a BMI between 20 and 32
If female and of child bearing potential, subject has a negative pregnancy test and is not nursing.

Exclusion Criteria:

Subject has abnormal screening/baseline laboratory parameters or endoscopic observations deemed clinically significant by the Investigator.
Subject has an active Helicobacter pylori infection.
Subject has a prior GI ulcer, bleeding, obstruction or perforation.
Subject has taken aspirin or any aspirin containing product within the last 4 weeks, or a non-aspirin NSAID product within 2 weeks.
Subject has taken any of the following medications within 2 weeks prior to enrollment: Any anti-platelet agents, anti-coagulants or selective serotonin reuptake inhibitors.
Subject has used an investigational agent within the past 30 days.
Subject has hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID.
Intervention: ASPIRIN
Trial phase: Phase 1 | Phase 2
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 104
Group description: Immediate release 325mg aspirin

acetylsalicylic acid: 325mg once a day for 7 days
Eligibility criteria:
Inclusion Criteria:

Subject is ≥50 to ≤75 years of age.
Subject is healthy.
Subject has a BMI between 20 and 32
If female and of child bearing potential, subject has a negative pregnancy test and is not nursing.

Exclusion Criteria:

Subject has abnormal screening/baseline laboratory parameters or endoscopic observations deemed clinically significant by the Investigator.
Subject has an active Helicobacter pylori infection.
Subject has a prior GI ulcer, bleeding, obstruction or perforation.
Subject has taken aspirin or any aspirin containing product within the last 4 weeks, or a non-aspirin NSAID product within 2 weeks.
Subject has taken any of the following medications within 2 weeks prior to enrollment: Any anti-platelet agents, anti-coagulants or selective serotonin reuptake inhibitors.
Subject has used an investigational agent within the past 30 days.
Subject has hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID.
Intervention: Sodium Nitrite
Trial phase: Phase 2
ATC code: V03AB08
SMILES: O=N[O-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Sodium nitrite : 14 day continuous infusion of one of 3 escalating doses of sodium nitrite: 32 nmol/min/kg, 48 nmol/min/kg, or 64 nmol/min/kg
Eligibility criteria:
Inclusion Criteria:

Ruptured cerebral aneurysm

Exclusion Criteria:

Pregnancy, sickle cell disease, G6PD deficiency, anticoagulant therapy
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Nitrite : 14 day continuous infusion of a vehicle control infusion
Eligibility criteria:
Inclusion Criteria:

Ruptured cerebral aneurysm

Exclusion Criteria:

Pregnancy, sickle cell disease, G6PD deficiency, anticoagulant therapy
Intervention: Zosyn
Trial phase: Phase 1
SMILES: CC1(Cn2ccnn2)C(C(=O)O)N2C(=O)CC2S1(=O)=O.CCN1CCN(C(=O)NC(C(=O)NC2C(=O)N3C2SC(C)(C)C3C(=O)[O-])c2ccccc2)C(=O)C1=O.[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 32
Group description: Open label -- 6 interval doses

piperacillin-tazobactam : 6 doses intravenously at the following doses:

Infants <32 weeks gestation at birth < 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6

Infants ≥32 weeks gestation at birth < 14 days PNA 100 mg/kg Q6

≥ 14 days PNA 100 mg/kg Q6
Eligibility criteria:
Inclusion Criteria:

Written permission from parent or legal guardian
< 61 days of age
Likely to survive beyond the first 48 hours after enrollment
Sufficient intravascular access (either peripheral or central) to receive study drug.

AND ONE OF THE FOLLOWING

Suspected systemic infection
Receiving piperacillin-tazobactam as part of standard of care

Exclusion Criteria:

History of allergic reactions to any penicillin, cephalosporins, or beta-lactamase inhibitors
Urine output < 0.5 mL/hr/kg over the prior 24 hours
Serum creatinine > 1.2 mg/dL
Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study
Intervention: MK-0941 mesylate
Trial phase: Phase 1
SMILES: CCS(=O)(=O)c1ccc(Oc2cc(OC(C)CO)cc(C(=O)Nc3ccn(C)n3)c2)cn1.CS(=O)(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
Eligibility criteria:
Inclusion Criteria:

Subject has a BMI < 42 kg/m2
Subject is taking >1500 mg metformin per day for at least 8 weeks
Subject has HbA1c value of 7.0% and < 11% at screening
Subject is willing to follow AHA weight maintaining diet and exercise program
Subject is a nonsmoker for at least 6 months

Exclusion Criteria:

Subject has type 1 diabetes
Subject has a history of stroke or chronic seizure
Subject has a history of neoplastic disease
Subject has a history of gastrointestinal, cardiovascular, blood, liver kidney, respiratory, immunological or genitourinary disorders or diseases
Subject is currently taking 2 or more diabetes medications
Subject has glaucoma or is blind
If female, subject is pregnant or breastfeeding
Subject consumes > 3 alcoholic beverages per day
Subject has had major surgery or has donated blood in the last 4 weeks
Intervention: TEPROTIDE
Trial phase: Phase 2
SMILES: CCC(C)C(NC(=O)C(CCC(N)=O)NC(=O)C1CCCN1C(=O)C(CCCN=C(N)N)NC(=O)C1CCCN1C(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C1CCC(=O)N1)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day
Eligibility criteria:
Inclusion Criteria:

Age > 60 years
BP 120/80 or higher *(bps will be checked weekly first 4 weeks to ensure < 130/80 - IF bp remains > 130/80 we will administer other bp meds per JNC VII guidelines)
CKD stage 3 (GFR 30 - 59 ml/min) for CKD group; no CKD for control group

Exclusion Criteria:

Known significant CVD (history of Myocardial infarction (MI), recurrent stroke, or New York Heart Association (NYHA) class III or greater).
Serum potassium > 5.2 meq/L
Known allergy or hypersensitivity to ACE inhibitor or ARB
Female of childbearing age not practicing contraception
Current treatment with an Angiotensin Converting Enzyme Inhibitors (ACE-I) or Angiotensin-Receptor Blockers (ARB) (Note: can participate if on ACE-I after 6 week washout period)
History of ACE-I induced angioedema
History of angioedema, hereditary or idiopathic

Persons lacking consent capacity

500 mg/dL proteinuria on 2 consecutive spot urine protein/creat ratios
Intervention: TEPROTIDE
Trial phase: Phase 2
SMILES: CCC(C)C(NC(=O)C(CCC(N)=O)NC(=O)C1CCCN1C(=O)C(CCCN=C(N)N)NC(=O)C1CCCN1C(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C1CCC(=O)N1)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 14
Group description: Placebo

angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day
Eligibility criteria:
Inclusion Criteria:

Age > 60 years
BP 120/80 or higher *(bps will be checked weekly first 4 weeks to ensure < 130/80 - IF bp remains > 130/80 we will administer other bp meds per JNC VII guidelines)
CKD stage 3 (GFR 30 - 59 ml/min) for CKD group; no CKD for control group

Exclusion Criteria:

Known significant CVD (history of Myocardial infarction (MI), recurrent stroke, or New York Heart Association (NYHA) class III or greater).
Serum potassium > 5.2 meq/L
Known allergy or hypersensitivity to ACE inhibitor or ARB
Female of childbearing age not practicing contraception
Current treatment with an Angiotensin Converting Enzyme Inhibitors (ACE-I) or Angiotensin-Receptor Blockers (ARB) (Note: can participate if on ACE-I after 6 week washout period)
History of ACE-I induced angioedema
History of angioedema, hereditary or idiopathic

Persons lacking consent capacity

500 mg/dL proteinuria on 2 consecutive spot urine protein/creat ratios
Intervention: Moxifloxacin Hydrochloride
Trial phase: Phase 4
SMILES: COc1c(N2CC3CCCNC3C2)c(F)cc2c(=O)c(C(=O)O)cn(C3CC3)c12.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 66
Group description: Moxifloxacin 0.5% HCL ophthalmic solution
Eligibility criteria:
Inclusion Criteria:

Male or Female
At least 50 years of age
In good general health

Exclusion Criteria:

Any ocular surgery or use of topical antibiotics or antiseptics in either eye within the last 3 months
Use of topical steroids, or non-steroidal anti inflammatory drugs in either eye within 30 days of Baseline (or anticipated during the study)
Use of lid scrubs within 7 days of Baseline in either eye (or anticipated use during the study)
Intervention: Gatifloxacin
Trial phase: Phase 4
ATC code: J01MA16 | S01AE06
SMILES: COc1c(N2CCNC(C)C2)c(F)cc2c(=O)c(C(=O)O)cn(C3CC3)c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 66
Group description: Gatifloxacin 0.3% ophthalmic solution
Eligibility criteria:
Inclusion Criteria:

Male or Female
At least 50 years of age
In good general health

Exclusion Criteria:

Any ocular surgery or use of topical antibiotics or antiseptics in either eye within the last 3 months
Use of topical steroids, or non-steroidal anti inflammatory drugs in either eye within 30 days of Baseline (or anticipated during the study)
Use of lid scrubs within 7 days of Baseline in either eye (or anticipated use during the study)
Intervention: Elacestrant
Trial phase: Phase 2
ATC code: L02BA04
SMILES: CCNCCc1ccc(CN(CC)c2cc(OC)ccc2[C@@H]2CCc3cc(O)ccc3C2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Oral once a day for 28 days
Eligibility criteria:
Inclusion Criteria:

Have documented evidence of a minimum of 7 moderate to severe hot flashes per day, or 50 per week.
Be in good general health as determined by medical history, physical examination, and inclusion procedures and is without evidence of any clinically significant abnormalities.
Have a normal pelvic assessment with no clinically significant signs on examination and pelvic ultrasound.
Have a normal mammogram at the time of study screening.

Exclusion Criteria:

A history of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic, immunologic or metabolic diseases to a degree that would compromise patient safety or interfere with the interpretation of study data. A history of active presence of thrombophlebitis, thrombosis, thromboembolic disorders.
A history of active presence of stroke, transient ischemic attack (TIA), heart attack or ischemic heart disease.
Unexplained vaginal bleeding within the 3 months prior to study entry.
Intervention: Elacestrant
Trial phase: Phase 2
ATC code: L02BA04
SMILES: CCNCCc1ccc(CN(CC)c2cc(OC)ccc2[C@@H]2CCc3cc(O)ccc3C2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Oral once a day for 28 days
Eligibility criteria:
Inclusion Criteria:

Have documented evidence of a minimum of 7 moderate to severe hot flashes per day, or 50 per week.
Be in good general health as determined by medical history, physical examination, and inclusion procedures and is without evidence of any clinically significant abnormalities.
Have a normal pelvic assessment with no clinically significant signs on examination and pelvic ultrasound.
Have a normal mammogram at the time of study screening.

Exclusion Criteria:

A history of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic, immunologic or metabolic diseases to a degree that would compromise patient safety or interfere with the interpretation of study data. A history of active presence of thrombophlebitis, thrombosis, thromboembolic disorders.
A history of active presence of stroke, transient ischemic attack (TIA), heart attack or ischemic heart disease.
Unexplained vaginal bleeding within the 3 months prior to study entry.
Intervention: Elacestrant
Trial phase: Phase 2
ATC code: L02BA04
SMILES: CCNCCc1ccc(CN(CC)c2cc(OC)ccc2[C@@H]2CCc3cc(O)ccc3C2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Oral once a day for 28 days
Eligibility criteria:
Inclusion Criteria:

Have documented evidence of a minimum of 7 moderate to severe hot flashes per day, or 50 per week.
Be in good general health as determined by medical history, physical examination, and inclusion procedures and is without evidence of any clinically significant abnormalities.
Have a normal pelvic assessment with no clinically significant signs on examination and pelvic ultrasound.
Have a normal mammogram at the time of study screening.

Exclusion Criteria:

A history of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic, immunologic or metabolic diseases to a degree that would compromise patient safety or interfere with the interpretation of study data. A history of active presence of thrombophlebitis, thrombosis, thromboembolic disorders.
A history of active presence of stroke, transient ischemic attack (TIA), heart attack or ischemic heart disease.
Unexplained vaginal bleeding within the 3 months prior to study entry.
Intervention: Calcitriol
Trial phase: Not Applicable
ATC code: A11CC04 | D05AX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 117
Group description: Subjects with low vitamin D levels and pre-diabetes
Eligibility criteria:
Inclusion Criteria:

Age greater than 40.
Impaired fasting glucose (FPG level greater than 100 and less than 126 mg/dl); and/or
Impaired glucose tolerance (2-h plasma glucose concentration after 75 gram glucose load greater than 140 and less than 200 mg/dl)
Serum 25-OHD less than 30 ng/ml
Able and willing to provide informed consent

Exclusion Criteria:

FPG greater than 126 mg/dl or 2-hour-OGTT plasma glucose greater than 200 mg/dl
Major psychiatric disorder on medication (excluding successfully treated depression)
Diagnosed diabetes mellitus
HIV/AIDS
Major hematological, hepatic (AST/ALT levels greater than or equal to 2 times normal) or renal eGFR less than 60 ml/min) disorder
History of carcinoma, except skin basal cell or squamous cell skin carcinomas
Heart failure, unstable angina or history of a myocardial infarction
Alcohol or substance abuse
Current treatment with glucocorticoids
Current treatment with diabetes medications, including metformin
Cushing's syndrome
Primary hyperparathyroidism
Nephrolithiasis
Pregnancy or breast-feeding
Regular visits to a tanning salon (unlikely in this minority population)
Intervention: Ertapenem
Trial phase: Phase 4
ATC code: J01DH03
SMILES: [H][C@@]1(SC2=C(C(=O)O)N3C(=O)[C@]([H])([C@@H](C)O)[C@@]3([H])[C@H]2C)CN[C@]([H])(C(=O)Nc2cccc(C(=O)O)c2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Subjects will receive ertapenem while receiving CVVHD

ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained.
Eligibility criteria:
Inclusion Criteria:

Hospitalized in ICU
Receiving Continuous hemodialysis
Prescribed ertapenem
Informed consent granted

Exclusion Criteria:

< 18 years of age
Allergy to ertapenem or other carbapenem antibiotic
Severe, life-threatening reaction to penicillin or cephalosporins
Patients experiencing or with history of CNS disorders (eg: seizure, stroke)
Patients experiencing CNS infection
Inability to complete 24 hours of CVVHD
Concurrent use of other extracorporeal therapies such as extracorporeal membrane oxygenation, plasmapheresis or intermittent hemodialysis
Inability to obtain informed consent
Pregnant and/or breastfeeding women