anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Imatinib
Trial phase: Phase 3
ATC code: L01EA01 | L01XE01
SMILES: Cc1ccc(NC(=O)c2ccc(CN3CCN(C)CC3)cc2)cc1Nc1nccc(-c2cccnc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
Eligibility criteria:
Inclusion Criteria:

Patients aged 18 years and older
Patients with metastatic or unresectable malignant gastrointestinal stromal tumour which has been histologically confirmed by the detection of CD117 on immunohistochemical staining or genetically confirmed by the detection of mutation in KIT or PDGFRα genes on direct sequencing of tumor DNA.
Prior benefit from 1st line imatinib defined as complete response, partial response, or stable disease at 6 months after the start of 1st line imatinib
Patients whose disease has progressed despite at least both prior imatinib therapy (400mg/day) and then subsequently also failure of prior sunitinib therapy.
ECOG(Eastern Cooperative Oncology Group) performance status 0 ~ 3
Adequate bone marrow function as defined by platelets ≥ 75 x 109/L and neutrophils ≥ 1.5 x 109/L
Adequate renal function, with serum creatinine < 1.5 x upper limit of normal
Adequate hepatic function with serum total bilirubin < 1.5 x upper limit of normal, alanine aminotransferase or aspartate aminotransferase < 2.5 x upper limit of normal in the absence of liver metastases, or < 5 x upper limit of normal in the presence of liver metastases.
Expected life expectancy of greater than 12 weeks in the absence of any intervention
No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other cancer except where treated with curative intent > 5 years previously without evidence of relapse
Written, informed consent to the study

Exclusion Criteria:

Medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol or a history of non- compliance
Last dose of radiotherapy received within 4 weeks before the start of study treatment, excluding palliative radiotherapy
Obstruction of gastrointestinal tract
Active gastrointestinal bleeding
Myocardial infarction within 6 months prior to the study medication, and other clinically significant heart disease (e.g., unstable angina, congestive heart failure or uncontrolled hypertension)
Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol
Female patients who are pregnant or breast-feeding. Female patients must have had a negative pregnancy test within one week before starting imatinib.
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: 7
Group description: Propofol bolus at an initial dose of 1 mg/kg over 1 minute then up to 2 additional 1 mg/kg boluses may be given (total 3 mg/kg) - each over 1 minute interval, wait 30 seconds after bolus completion to reassess sedation level. Once a minimum Ramsey Sedation Score 4 is achieved, an infusion at 125 mcg/kg/min is initiated. It may be titrated to 300 mcg/kg/min. If there is movement or awakening the patient may be rebolused with no more than 2 doses of Propofol at 1 mg/kg over 1 minute, in the same dosing manner as described above, waiting 30 seconds between doses. If adequate sedation is not achieved, 0.5 mg/kg IV pentobarbital may be administered at q1 minute intervals up to a maximum of 2 mg/kg.

Propofol: An initial bolus of 1mg/kg of propofol will be administered over 1 minute. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a propofol infusion of 125 mcg/kg/min is initiated until the MRI is complete.
Eligibility criteria:
Inclusion Criteria:

Patient is 3 - 11 years
Patient is scheduled for MRI at Children's Hospital Boston.
Patient meets criteria to receive either dexmedetomidine or propofol sedation
Patient's guardian provides written consent

Exclusion Criteria:

Patient does not meet established sedation criteria
Patient has history of allergy, intolerance, or reaction to dexmedetomidine or propofol or hypersensitivity
Patient has current, repaired, or risk for Moya-Moya disease
Patient has had a stroke within the past six months
Patient has uncontrolled hypertension
Patient currently uses beta antagonist, alpha 2 agonist or calcium blocker
Known soy, Lecithin, or egg allergy
Intervention: Remifentanil
Trial phase: Phase 4
ATC code: N01AH06
SMILES: CCC(=O)N(c1ccccc1)C1(C(=O)OC)CCN(CCC(=O)OC)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: stopping of propofol and maintenance of remifentanil infusion
Eligibility criteria:
Inclusion Criteria:

Age ≥ 20
Short term ventilator care after surgery in intensive care unit

Exclusion Criteria:

pneumonia
chronic obstructive lung disease
asthma
end stage renal disease
risk factors for aspiration
Intervention: Ganirelix Acetate
Trial phase: Phase 2
SMILES: CC(=O)O.CC(=O)O.CCNC(=NCCCCC(NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(Cc1cccnc1)NC(=O)C(Cc1ccc(Cl)cc1)NC(=O)C(Cc1ccc2ccccc2c1)NC(C)=O)C(=O)NC(CC(C)C)C(=O)NC(CCCCN=C(NCC)NCC)C(=O)N1CCCC1C(=O)NC(C)C(N)=O)NCC
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 109
Group description: Ganirelix acetate (Organon, Roseland, NJ, USA), a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotrophin-releasing hormone (GnRH) to suppress GnRH. (250 μg in 0.5ml normal saline for 16 days).
Eligibility criteria:
Inclusion Criteria:

Healthy, English-speaking non-smoking women age 18- 34 with regular menses

Exclusion Criteria:

Gynecologic:

current or past estrogen-dependent neoplasia,
unexplained vaginal bleeding,
history of uterine fibroids,
current pregnancy,
known or suspected breast or uterine cancer,
partial or complete hysterectomy

Cardiac:

myocardial infarction, ventricle tachycardia or fibrillation,
angina,
valvular disease,
congestive heart failure, orthopnea, paroxysmal nocturnal dyspnea,
current arrhythmias,
prosthetic valves

Pulmonary:

current cigarette smokers, or pipe or cigar smokers,
chronic obstructive pulmonary disease,
adult asthma,
dyspnea on exertion,
current bronchitis, pneumonia, or tuberculosis,
lung carcinoma,
pulmonary embolus, recent

Vascular:

claudication or history of peripheral vascular disease,
abdominal or thoracic aortic aneurysm, or repair of same,
cerebral aneurysm, vascular malformations,
hypertension, systolic or diastolic, or strong family history of hypertension

Gastrointestinal:

GI malignancy,
hepatitis, current,
splenomegaly from any cause,
Cholecystitis,
current diverticulosis or diverticulitis, inflammatory bowel disease, ulcerative colitis, Crohn's Disease,
previous gastrointestinal surgery
Infectious Disease: any intercurrent infection

Hematologic/Oncologic:

receiving chemotherapy or radiation therapy,
any metastatic malignancy,
anemia (hematocrit < 35),
thrombocytopenia or thrombocytosis,
neutropenia,
hematologic malignancy,
bleeding dyscrasia

Neurologic:

history of cerebral vascular accident with any neurologic sequels,
uncontrolled seizures (e.g. more than 1 seizure/year),
transient ischemic attacks,
dementia,
neurologic conditions producing dyscoordination, peripheral neuropathy, or myopathy,
severe migraine headaches

Endocrine:

diabetes mellitus,
any untreated endocrinopathy

Renal:

chronic renal disease,
any history of renal disease or impairment,
current urinary tract infection

Musculoskeletal:

inflammatory arthritis history (e.g., rheumatoid, psoriatic, Reiters),
any history of pathologic fractures, including vertebral compression fractures

Pharmacologic:

any illegal drug use,
alcohol use greater than an average of 4 oz/day over 30 days,
coumadin or heparin use,
current systemic antifungal use
Intervention: Estradiol
Trial phase: Phase 2
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 109
Group description: The same women added 17β-Oestradiol, E2; 0.2 mg day-1 patch (Vivelle; CIBA Pharmaceuticals, Summit, NJ) for days 4-16.
Eligibility criteria:
Inclusion Criteria:

Healthy, English-speaking non-smoking women age 18- 34 with regular menses

Exclusion Criteria:

Gynecologic:

current or past estrogen-dependent neoplasia,
unexplained vaginal bleeding,
history of uterine fibroids,
current pregnancy,
known or suspected breast or uterine cancer,
partial or complete hysterectomy

Cardiac:

myocardial infarction, ventricle tachycardia or fibrillation,
angina,
valvular disease,
congestive heart failure, orthopnea, paroxysmal nocturnal dyspnea,
current arrhythmias,
prosthetic valves

Pulmonary:

current cigarette smokers, or pipe or cigar smokers,
chronic obstructive pulmonary disease,
adult asthma,
dyspnea on exertion,
current bronchitis, pneumonia, or tuberculosis,
lung carcinoma,
pulmonary embolus, recent

Vascular:

claudication or history of peripheral vascular disease,
abdominal or thoracic aortic aneurysm, or repair of same,
cerebral aneurysm, vascular malformations,
hypertension, systolic or diastolic, or strong family history of hypertension

Gastrointestinal:

GI malignancy,
hepatitis, current,
splenomegaly from any cause,
Cholecystitis,
current diverticulosis or diverticulitis, inflammatory bowel disease, ulcerative colitis, Crohn's Disease,
previous gastrointestinal surgery
Infectious Disease: any intercurrent infection

Hematologic/Oncologic:

receiving chemotherapy or radiation therapy,
any metastatic malignancy,
anemia (hematocrit < 35),
thrombocytopenia or thrombocytosis,
neutropenia,
hematologic malignancy,
bleeding dyscrasia

Neurologic:

history of cerebral vascular accident with any neurologic sequels,
uncontrolled seizures (e.g. more than 1 seizure/year),
transient ischemic attacks,
dementia,
neurologic conditions producing dyscoordination, peripheral neuropathy, or myopathy,
severe migraine headaches

Endocrine:

diabetes mellitus,
any untreated endocrinopathy

Renal:

chronic renal disease,
any history of renal disease or impairment,
current urinary tract infection

Musculoskeletal:

inflammatory arthritis history (e.g., rheumatoid, psoriatic, Reiters),
any history of pathologic fractures, including vertebral compression fractures

Pharmacologic:

any illegal drug use,
alcohol use greater than an average of 4 oz/day over 30 days,
coumadin or heparin use,
current systemic antifungal use
Intervention: Progesterone
Trial phase: Phase 2
ATC code: G03DA04 | G03FA04
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(C)=O)CC[C@@]21[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 109
Group description: The same women added progesterone (P4, 200 mg day-1 Prometrium, oral, Solvay Pharmaceuticals, Marietta, GA, USA) on days 13-16.
Eligibility criteria:
Inclusion Criteria:

Healthy, English-speaking non-smoking women age 18- 34 with regular menses

Exclusion Criteria:

Gynecologic:

current or past estrogen-dependent neoplasia,
unexplained vaginal bleeding,
history of uterine fibroids,
current pregnancy,
known or suspected breast or uterine cancer,
partial or complete hysterectomy

Cardiac:

myocardial infarction, ventricle tachycardia or fibrillation,
angina,
valvular disease,
congestive heart failure, orthopnea, paroxysmal nocturnal dyspnea,
current arrhythmias,
prosthetic valves

Pulmonary:

current cigarette smokers, or pipe or cigar smokers,
chronic obstructive pulmonary disease,
adult asthma,
dyspnea on exertion,
current bronchitis, pneumonia, or tuberculosis,
lung carcinoma,
pulmonary embolus, recent

Vascular:

claudication or history of peripheral vascular disease,
abdominal or thoracic aortic aneurysm, or repair of same,
cerebral aneurysm, vascular malformations,
hypertension, systolic or diastolic, or strong family history of hypertension

Gastrointestinal:

GI malignancy,
hepatitis, current,
splenomegaly from any cause,
Cholecystitis,
current diverticulosis or diverticulitis, inflammatory bowel disease, ulcerative colitis, Crohn's Disease,
previous gastrointestinal surgery
Infectious Disease: any intercurrent infection

Hematologic/Oncologic:

receiving chemotherapy or radiation therapy,
any metastatic malignancy,
anemia (hematocrit < 35),
thrombocytopenia or thrombocytosis,
neutropenia,
hematologic malignancy,
bleeding dyscrasia

Neurologic:

history of cerebral vascular accident with any neurologic sequels,
uncontrolled seizures (e.g. more than 1 seizure/year),
transient ischemic attacks,
dementia,
neurologic conditions producing dyscoordination, peripheral neuropathy, or myopathy,
severe migraine headaches

Endocrine:

diabetes mellitus,
any untreated endocrinopathy

Renal:

chronic renal disease,
any history of renal disease or impairment,
current urinary tract infection

Musculoskeletal:

inflammatory arthritis history (e.g., rheumatoid, psoriatic, Reiters),
any history of pathologic fractures, including vertebral compression fractures

Pharmacologic:

any illegal drug use,
alcohol use greater than an average of 4 oz/day over 30 days,
coumadin or heparin use,
current systemic antifungal use
Intervention: Olodaterol
Trial phase: Phase 1
ATC code: R03AC19 | R03AL06
SMILES: COc1ccc(CC(C)(C)NC[C@H](O)c2cc(O)cc3c2OCC(=O)N3)cc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 35
Group description: Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
Eligibility criteria:
Inclusion criteria:

Healthy male and female volunteers
Intervention: Erlotinib
Trial phase: Phase 2
ATC code: L01EB02 | L01XE03
SMILES: C#Cc1cccc(Nc2ncnc3cc(OCCOC)c(OCCOC)cc23)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
Eligibility criteria:
Inclusion Criteria:

Histological documented adenocarcinoma, locally advanced - Stage IIIB, metastatic - Stage IV or recurrent non-squamous NSCLC
Activated EGFR mutation positive status (Exons 19 and 21) for treatment phase
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Life expectancy greater than or equal to (≥) 12 weeks
Evidence of disease with at least one measurable disease evaluation on Response Evaluation Criteria in Solid Tumors (RECIST)
Adequate hematological , liver and renal function

Exclusion Criteria:

Known hypersensitivity to erlotinib or any of its excipients
Squamous non-small cell or small cell tumors or absence of histological report
Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment
Prior exposure to inhibitors of EGFR
Prior chemotherapy or treatment with another systemic anti-cancer agent for the treatment of the participant's current stage of disease
Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions
Radical radiotherapy with curative intent within 28 days prior to enrollment
Any active non-controlled systemic disease
Intervention: Atorvastatin
Trial phase: Phase 3
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 480
Group description: Atorvastatin 20 mg tablet once daily for 6 weeks
Eligibility criteria:
Inclusion Criteria:

Patient is at high cardiovascular risk and meets one of the following conditions: has never taken lipid-lowering therapy or has been off such therapy for at least 6 weeks; or, is currently taking a stable dose of certain lipid-lowering agents
Patient is willing to maintain a cholesterol lowering diet during the study
Female patients receiving non-cyclical hormone therapy have maintained a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen during the study

Exclusion Criteria:

Patient is Asian
Patient routinely has more than 2 alcoholic drinks per day
Female patient is pregnant or breastfeeding
Patient has congestive heart failure
Patient has had a myocardial infarction, coronary bypass surgery, angioplasty, or acute coronary syndrome within 3 months of screening
Patient has uncontrolled cardiac arrhythmias
Patient has had a partial ileal or gastric bypass or other significant intestinal malabsorption
Patient has uncontrolled high blood pressure
Patient has kidney disease
Patient has any disease known to influence blood lipid levels
Patient has any disorders of the blood, digestive system, or nervous system including stroke and degenerative disease that would limit study participation
Patient has poorly controlled or newly diagnosed diabetes
Patient is known to be HIV positive
Patient has a history of cancer in the last 5 years, except certain skin and cervical cancers
Intervention: Atorvastatin
Trial phase: Phase 3
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 124
Group description: Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
Eligibility criteria:
Inclusion Criteria:

Patient is at high cardiovascular risk and meets one of the following conditions: has never taken lipid-lowering therapy or has been off such therapy for at least 6 weeks; or, is currently taking a stable dose of certain lipid-lowering agents
Patient is willing to maintain a cholesterol lowering diet during the study
Female patients receiving non-cyclical hormone therapy have maintained a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen during the study

Exclusion Criteria:

Patient is Asian
Patient routinely has more than 2 alcoholic drinks per day
Female patient is pregnant or breastfeeding
Patient has congestive heart failure
Patient has had a myocardial infarction, coronary bypass surgery, angioplasty, or acute coronary syndrome within 3 months of screening
Patient has uncontrolled cardiac arrhythmias
Patient has had a partial ileal or gastric bypass or other significant intestinal malabsorption
Patient has uncontrolled high blood pressure
Patient has kidney disease
Patient has any disease known to influence blood lipid levels
Patient has any disorders of the blood, digestive system, or nervous system including stroke and degenerative disease that would limit study participation
Patient has poorly controlled or newly diagnosed diabetes
Patient is known to be HIV positive
Patient has a history of cancer in the last 5 years, except certain skin and cervical cancers
Intervention: Glycopyrrolate
Trial phase: Phase 3
ATC code: A03AB02
SMILES: C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days

Period 2: Matching placebo via NEOHALER inhaler device for 21 days

The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.

Salbutamol (albuterol) was used as rescue medication throughout the study.
Eligibility criteria:
Inclusion Criteria:

Patients who signed an Informed Consent Form prior to initiation of any study-related procedure
Patients with moderate to severe stable COPD (clinical diagnosis in compliance with GOLD 2008)
Current or ex-smokers with a smoking history ≥ 10 pack years. (Ten pack-years were defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.).
Patients with a post-bronchodilator FEV1 ≥ 40 and < 70% of the predicted normal, and postbronchodilator FEV1/FVC < 0.7 during screening. (Post referred to the highest post-bronchodilator value after inhalation of 80 μg ipratropium bromide)
Increase in FEV1 from pre- to post-bronchodilator assessment of ≥ 5%

Exclusion Criteria:

Pregnant women or nursing mothers
Women of child-bearing potential
Patients who had a COPD exacerbation (whether hospitalized or not) in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 4
Patients who had a lower respiratory tract infection in the 6 weeks prior to Visit 1
Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia
Patients with resting (5 min) oxygen SaO2 (or SpO2) saturation on room air of < 85%
Patients with a maximum workload (Wmax) value < 20 W (as determined by the incremental cycle endurance test) at Visit 2.
Patients whose exercise endurance time at sub-maximal workload was above 25 min at baseline
Patients with a clinically significant abnormality on the screening or baseline ECG who in the judgment of the investigator would have been at potential risk if enrolled into the study
Patients with a history of long QT syndrome or whose QTc was prolonged (> 450 ms for males and > 470 ms females) at screening (Fredericia's correction)

Other protocol-defined inclusion/exclusion criteria applied
Intervention: Clindamycin
Trial phase: Not Applicable
ATC code: D10AF01 | D10AF51 | G01AA10 | J01FF01
SMILES: [H][C@]1([C@]([H])(NC(=O)[C@@H]2C[C@@H](CCC)CN2C)[C@H](C)Cl)O[C@H](SC)[C@H](O)[C@@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days

clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days
Eligibility criteria:
Inclusion Criteria:

All adult patients (≥ 18 years of age) presenting to the ED with simple hand lacerations. Anatomically, lacerations distal to the radial carpal ligament will be considered "hand" lacerations. "Simple" or "uncomplicated" laceration refers to one that does not involve any special tissue (bone, tendon, blood vessel, or nerve).

Exclusion Criteria:

Immunocompromised patients (cancer, chemotherapy, transplant, HIV/AIDs)
Current or recent (within two weeks) use of any antibiotics
Allergy to clindamycin or cephalexin
Bites (e.g. dog, cat, or human)
Lacerations resulted from crush injury
Lacerations involving bone, tendon, blood vessel, or nerve
Lacerations inflicted more than 12 hours prior to ED visit
Pregnant or breast-feeding women