anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Roflumilast
Trial phase: Phase 3
ATC code: R03DX07
SMILES: O=C(Nc1c(Cl)cncc1Cl)c1ccc(OC(F)F)c(OCC2CC2)c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 286
Group description: Participants apply roflumilast cream 0.3% topically once daily for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Participants legally competent to sign and give informed consent and if appropriate assent as required by local laws
Males and females ages 2 years and older (inclusive)
Clinical diagnosis of psoriasis vulgaris of at least 6 months duration (3 months for children) as determined by the Investigator
Females of childbearing potential (FOCBP) must have a negative pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.
In good health as judged by the Investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis.
Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion Criteria:

Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
Previous treatment with ARQ-151 or its active ingredient
Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of investigational product
Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation
Intervention: Velpatasvir
Trial phase: Phase 3
ATC code: J05AP55 | J05AP56
SMILES: COC[C@H]1C[C@@H](c2nc(-c3ccc4c(c3)COc3cc5c(ccc6nc([C@@H]7CC[C@H](C)N7C(=O)[C@@H](NC(=O)OC)C(C)C)[nH]c65)cc3-4)c[nH]2)N(C(=O)[C@H](NC(=O)OC)c2ccccc2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Participants with chronic HCV infection (genotype 1 or 2), who were treatment-naive or treatment-experienced with IFN-based treatments received SOF/VEL 400/100 mg FDC tablet orally once daily for 12 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Chronic HCV infected males and non-pregnant/non-lactating females
Treatment-naive or treatment-experienced individuals
Non-cirrhosis or compensated cirrhosis at screening

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Velpatasvir
Trial phase: Phase 3
ATC code: J05AP55 | J05AP56
SMILES: COC[C@H]1C[C@@H](c2nc(-c3ccc4c(c3)COc3cc5c(ccc6nc([C@@H]7CC[C@H](C)N7C(=O)[C@@H](NC(=O)OC)C(C)C)[nH]c65)cc3-4)c[nH]2)N(C(=O)[C@H](NC(=O)OC)c2ccccc2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Participants with chronic HCV infection (genotype 1 or 2), who were treatment-experienced with NS5A-DAA based treatments of at least a 4 weeks duration received SOF/VEL/VOX 400/100/100 mg FDC tablet orally once daily for 12 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Chronic HCV infected males and non-pregnant/non-lactating females
Treatment-naive or treatment-experienced individuals
Non-cirrhosis or compensated cirrhosis at screening

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Losartan
Trial phase: Phase 1 | Phase 2
ATC code: C09CA01 | C09DA01 | C09DB06
SMILES: CCCCc1nc(Cl)c(CO)n1Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 1
Group description: 12.5mg Losartan capsules, oral administration, twice daily (25mg total per day), taken for 30 consecutive days starting on the evening of the second post-surgery day.

Losartan: Losartan will be administered to improve the quality of hip cartilage repair following arthroscopic microfracture. Losartan is a known anti-fibrotic agent via blocking of TGF-B1.
Eligibility criteria:
Inclusion Criteria:

Underwent primary hip arthroscopy
Underwent baseline quantitative MRI at The Steadman Clinic (TSC)
Single, localized, grade 3 or 4 cartilage lesion of the acetabulum or femoral head treated with Bone Marrow Stimulation (BMS; i.e. microfracture)
Aged 18-60 at time of surgery
Tonnis grade 1 or less

Exclusion Criteria:

Two or more cartilage lesions of grade 3 or 4
Less than 2 mm of minimal hip joint space
Osteoarthritis or diffuse change of cartilage
Non-English speaking
Prior hip surgery on operative hip
Pre-existing bony deformity caused by previous fracture(s)
Synovial chondromatosis
Pigmented Villonodular Synovitis (PVNS)
Dysplasia (center edge angle <20 degrees)
History of Avascular Necrosis (AVN), Perthes disease, or slipped capital femoral epiphysis (SCFE)
Inflammatory arthritis or other arthritis caused by autoimmune disease
Patients allergic to any active or inactive ingredient of losartan
Patients taking medication with known losartan interaction, including phenobarbital, rifampin, and fluconazole.
Subjects that are currently taking losartan
Intervention: Lidocaine
Trial phase: Phase 2
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Patients receiving lidocaine

Lidocaine: Lidocaine injection into shoulder
Eligibility criteria:
Inclusion Criteria:

1.18-90

2. Proximal Humerus Fracture

3. Decreased range of motion at 6 wk follow-up

4. Likely to be available for follow up for 26 wks

Exclusion Criteria:

Known drug allergy to kenalog or lidocaine
Unable to complete functional outcome
Pregnant Women
Intervention: Kenalog
Trial phase: Phase 2
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Patients receiving Kenalog

kenalog: Cortisone injection into shoulder
Eligibility criteria:
Inclusion Criteria:

1.18-90

2. Proximal Humerus Fracture

3. Decreased range of motion at 6 wk follow-up

4. Likely to be available for follow up for 26 wks

Exclusion Criteria:

Known drug allergy to kenalog or lidocaine
Unable to complete functional outcome
Pregnant Women
Intervention: Ceftriaxone
Trial phase: Phase 4
ATC code: J01DD04 | J01DD54
SMILES: CON=C(C(=O)NC1C(=O)N2C(C(=O)O)=C(CSc3nc(=O)c(=O)[nH]n3C)CSC12)c1csc(N)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: 1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization

Ceftriaxone: Antibiotic
Eligibility criteria:
Inclusion Criteria:

MELD-Na >= 18
Cirrhosis as defined by liver biopsy or a composite assessment of available results from imaging, elastography, prior records, and laboratory studies

Exclusion Criteria:

Inability to obtain consent (from subject or next of kin/legal authorized representative (LAR)
Allergy to cephalosporins
Pregnancy (due to limited prospective data regarding safety of ceftriaxone)
Existing indication for new antibiotics, e.g. upper gastrointestinal hemorrhage or apparent infection
Use of major immunosuppressive medications (e.g. prednisone 20 mg/day or greater, immunosuppression for solid organ transplant)
H/o recurrent C difficile infection within the past year (>2) or requiring fecal microbiota transplant (FMT)
Enrollment in the study protocol during a previous admission
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Normal saline (50cc) once daily for up to one week or until end of hospitalization

Normal saline: 50cc intravenous once daily
Eligibility criteria:
Inclusion Criteria:

MELD-Na >= 18
Cirrhosis as defined by liver biopsy or a composite assessment of available results from imaging, elastography, prior records, and laboratory studies

Exclusion Criteria:

Inability to obtain consent (from subject or next of kin/legal authorized representative (LAR)
Allergy to cephalosporins
Pregnancy (due to limited prospective data regarding safety of ceftriaxone)
Existing indication for new antibiotics, e.g. upper gastrointestinal hemorrhage or apparent infection
Use of major immunosuppressive medications (e.g. prednisone 20 mg/day or greater, immunosuppression for solid organ transplant)
H/o recurrent C difficile infection within the past year (>2) or requiring fecal microbiota transplant (FMT)
Enrollment in the study protocol during a previous admission
Intervention: Ketamine
Trial phase: Phase 2
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure).

Ketamine: Intraoperative ketamine and post operative 48 hour ketamine infusion with a standardized general anesthesia protocol.
Eligibility criteria:
Inclusion Criteria

Patients undergoing lumbar, thoracic or cervical spine surgery of at least one level, and no more than 6 levels.
Patients with chronic back pain (>3 months)
Anaesthetic risk assessment (ASA) 1-3
Opiate-dependent with daily opiate use for at least 2 months and regimented daily narcotic dose twice a day/bis in die (BID) or greater or use of a regimented opioid pump

Exclusion Criteria

Intolerance or known allergy to ketamine
History of increased intraocular pressure (> 22mmHg)
Uncontrolled hypertension (systolic blood pressure greater than or equal to 180, diastolic blood pressure greater than equal to 100)
Increased intracranial pressure
History of psychosis
Pregnancy
Patients with significant liver disease {signs and symptoms of liver injury, such as discolored skin and eyes that appear yellowish, abdominal pain and swelling, Itchy skin that doesn't seem to go away, dark urine color, pale stool color, bloody or tar-colored stool, chronic fatigue, nausea, loss of appetite, with or without elevated Liver Function Tests (LFTs): aspartate aminotransferase (AST) > 120 IU/ml, alkaline phosphatase (AP) >130 IU/ml, and alanine aminotransferase (ALT) >40 IU/ml}
Patients with exposure to Cytochrome P450, family 3, subfamily A (CYP3A) and / or Cytochrome P450 Family 2 Subfamily B Member 6 (CYP2B6) inhibitors, including the herbs and the over-the-counter compounds (list of drugs can be found at http://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/druginteractionslabeling/ucm093664.htm)
Intervention: Betamethasone
Trial phase: Phase 4
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 3
Group description: Participants will be given dexamethasone (0.6mg/kg/dose) in a single oral dose in addition to the standard of care for bronchiolitis (supplemental oxygen, antipyretics, suctioning etc.)
Eligibility criteria:
Inclusion Criteria:

Less than or equal to 24 months
First episode of wheezing or first clinical diagnosis of bronchiolitis
Admitted to the general pediatric service at UPMC Children's Hospital of Pittsburgh
Ability of a parent or guardian to understand and comply with the study procedures
Signed written informed consent by parent or guardian

Exclusion Criteria:

Preterm birth < 35 weeks
Presence of underlying cardiopulmonary, neuromuscular, or other complex disease
Admission to the pediatric intensive care unit
Co-infection with influenza infection or concomitant bacterial infection (such as pneumonia or AOM)
History of allergy or reaction to steroids
History of an underlying chronic medical condition -including chronic heart disease, chronic lung disease (except asthma),congenital anomalies of the airways or lung, cystic fibrosis, chronic renal disease including nephrotic syndrome, protein losing enteropathy of any cause, severe malnutrition, neurocognitive disorders, metabolic disorders (including phenylketonuria), or genetic disorders (note: genetic syndromes such as Down syndrome and Edwards Syndrome are excluded; however, children with genetic disorders (e.g., hemophilia) but who do not have a genetic syndrome may not satisfy this particular exclusion criterion; it is important that children with such genetic disorders do not have symptoms and/or comorbidities that would pose additional risk to them nor jeopardize the adequacy of study assessments.")
History of a condition that compromises the immune system - human immunodeficiency virus infection, primary immunodeficiency, anatomic or functional asplenia; receipt of a hematopoietic stem cell or solid organ transplant at any time; receipt of immunosuppressive therapy including chemotherapeutic agents, biologic agents, antimetabolites or radiation therapy during the past 12 months; or daily use of systemic corticosteroids for more than 7 consecutive days during the past 14 days.
Any other condition that in the judgment of the investigator precludes participation because it could affect the safety of the subject
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 118
Group description: Approximately 96 subjects treated with 5 ml of saline than crossover to treatment arm

Saline solution: Placebo
Eligibility criteria:
Inclusion Criteria:

Subjects between ≥ 18 and ≤ 85 years old.
Subjects who signed written, IRB approved, informed consent form.
Subjects scheduled for urological or gynecological surgical procedures in which the patency of the ureter must be assessed by the surgeon during the procedure

Exclusion Criteria:

Subjects with stage 4 or 5 Chronic Kidney Failure as evidenced by a GFR <30 mL/min/1.73m2 (using the MDRD) or need for dialysis in the near future, or having only 1 kidney.
Subjects with known severe hypersensitivity reactions to IC or other dyes including contrast agents.
Known history of drug or alcohol abuse within 6 months prior to the time of screening visit.
Subjects, as assessed by the Investigator, with conditions/concomitant diseases precluding their safe participation in this study (e.g. major systemic diseases).
Unable to meet specific protocol requirements (e.g., scheduled visits) or subject is uncooperative or has a condition that could lead to non-compliance with the study procedures.
Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol;
Subjects with life expectancy < 6 months;
Requirement for concomitant treatment that could bias primary evaluation.
Subjects who are pregnant or breast-feeding.
Intervention: Enalapril
Trial phase: Phase 4
ATC code: C09AA02 | C09BA02 | C09BB02 | C09BB06
SMILES: CCOC(=O)[C@H](CCc1ccccc1)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 94
Group description: This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive.

Enalapril: Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
Eligibility criteria:
Inclusion Criteria:

diagnosis of any hypertensive disorder of pregnancy/postpartum period or chronic hypertension
provider wanting to initiate antihypertensive in the postpartum period
the patient is not currently on >1 antihypertensive
plans to receive postpartum care at the hospital or affiliated clinic

Exclusion Criteria:

sustained pulse <60 or >120 BPM over four hours
allergy to any of the antihypertensives
creatinine greater than or equal to 1.5
strict contraindication to any of the antihypertensives
history of failed treatment with any of the antihypertensives
Intervention: Cannabidiol
Trial phase: Phase 1 | Phase 2
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 3
Group description: Epidiolex 100 mg/mL oral solution: 8 mL of Epidiolex (800 mg of cannabidiol) + 16 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses)
Eligibility criteria:
Inclusion Criteria:

Medically cleared to take study medication
Are not pregnant or breast feeding
Willing to comply with the study protocol
Provides urine that tests positive for methadone
Maintained on 80-120 mg of daily methadone with no dose changes in the past 2 weeks (verified through a medical release with the participant's provider)

Exclusion Criteria:

Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for alcohol/substance use disorder other than opioid use disorder
Previous adverse reaction to a cannabinoid product
Self-report any illicit drug use or cannabinoid use in the past 7 days
Presence of any clinically significant medical/psychiatric illness judged by the investigators to put subject at elevated risk for experiencing an adverse events
Past year suicidal behavior as assessed via the Columbia Suicide Severity Rating Scale
History of seizure disorder

Past 14 day use of any of the following contraindicated medications:

Clobazam, Valproate
Moderate or strong inhibitors of CYP3A4 or CYPC19 (with the exception of methadone, as outlined in the Protection Against CBD Risks section).
Strong CYP3A4 or CYP2C19 inducers
UGT1A9, UGT2B7, CYP1A2, CYP2C8, CYP2C9 and CYP2C19 substrates (with the exclusion of caffeine).
Central nervous system (CNS) depressants that are contraindicated with Epidiolex
Breathalyzer that tests positive for alcohol prior to session admission
Self-reported consumption of grapefruit juice within 24 hours of session admission
Have a history of clinically significant cardiac arrhythmias or vasospastic disease
Have circumstances that the study investigators believe are contraindicated with study participation and/or would interfere with study participation (e.g., impending jail).
Moderate-severe hepatic impairment as indicated by ALT or AST levels > 3x ULN and/or Bilirubin levels >2x ULN as evidenced by a blood test.
Intervention: Pafolacianine
Trial phase: Phase 3
ATC code: V04CX10
SMILES: CC1(C)C(=CC=C2CCCC(C=CC3=[N+](CCCCS(=O)(=O)O)c4ccc(S(=O)(=O)[O-])cc4C3(C)C)=C2Oc2ccc(CC(NC(=O)c3ccc(NCc4cnc5nc(N)[nH]c(=O)c5n4)cc3)C(=O)O)cc2)N(CCCCS(=O)(=O)O)c2ccc(S(=O)(=O)O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging.

OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL
Eligibility criteria:
Inclusion Criteria:

Male and Female subjects 18 years of age and older
Have a primary diagnosis, or a high clinical suspicion, of cancer in the lung warranting surgery based on CT/PET or other imaging
Are scheduled to undergo surgical thoracoscopy for diagnostic wedge resection followed by anatomic lung resection
Female subjects of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion
Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments

Exclusion Criteria:

Previous exposure to OTL38
Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
History of anaphylactic reactions to folate, including synthetic folic acid (pteroylmonoglutamic acid) and contrast agents containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation.
History of allergy to any of the components of OTL38, including folic acid
A positive serum pregnancy test at Screening or a positive urine pregnancy test on the day of surgery or day of admission for female subjects of childbearing potential
Clinically significant abnormalities on electrocardiogram (ECG) at screening.
Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol and follow-up schedule
Impaired renal function defined as eGFR< 50 mL/min/1.73m2
Impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >2x ULN for total bilirubin except in subjects with Gilbert's syndrome.
Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of study drug
Known sensitivity to fluorescent light
Intervention: Ketorolac
Trial phase: Phase 3
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 48
Group description: Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery.

Ketorolac: Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac.
Eligibility criteria:
Inclusion Criteria:

Patients between 18 and 89 years of age
Patients undergoing primary arthroscopic meniscus surgery

Exclusion Criteria:

Patients age less than 18 or greater than 89 years
Illiterate or non-English speaking patients
Patients with contraindications to ketorolac
History of drug or alcohol abuse
Chronic use of analgesic or psychotropic drugs
Intervention: Ketorolac
Trial phase: Phase 3
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: Patients receive IV ketorolac followed by ketorolac 10 mg every 6 hours for 3 days following ACL reconstruction surgery. Patients are additionally discharged with oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for additional pain control

Ketorolac: Oral ketorolac for pain control following ACL reconstruction surgery
Eligibility criteria:
Inclusion Criteria:

Patients between 18 and 89 years old
Patients undergoing primary anterior cruciate ligament (ACL) reconstruction surgery

Exclusion Criteria:

Patients below age 18 or above age 89
Illiterate or non-English speaking individuals
Patients with contraindications to Ketorolac
History of chronic alcohol or drug abuse
Chronic use of psychotropic or analgesic drugs
Known peptic ulcer disease or bleeding diasthesis
Renal dysfunction (estimated glomerular filtration rate < 50 mL/min/1.73m2)
Breastfeeding women
Pregnant women