anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Opicapone
Trial phase: Phase 1
ATC code: N04BX04
SMILES: Cc1c(Cl)c(C)[n+]([O-])c(Cl)c1-c1noc(-c2cc(O)c(O)c([N+](=O)[O-])c2)n1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: BIA 9-1067 (OPC, Opicapone) 5 mg

BIA 9-1067
Eligibility criteria:
Inclusion Criteria:

A signed and dated informed consent form before any study-specific screening procedure is performed.
Aged between 18 and 45 years, inclusive.
Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead electrocardiogram (ECG).
Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Exclusion Criteria:

Any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease.
Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1.
History of drug abuse within 1 year before study day 1.
History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° [10%] wine = 12 g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g
Have previously received BIA 9-1067.
Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA [3,4-methylenedioxy-methamphetamine; ecstasy]).
History of any clinically important drug allergy.
Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (IMP) administration.
Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 before study day 1.
Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before IMP administration.
Donation of blood (ie 450 ml) within 90 days before study day 1.
Intervention: Opicapone
Trial phase: Phase 1
ATC code: N04BX04
SMILES: Cc1c(Cl)c(C)[n+]([O-])c(Cl)c1-c1noc(-c2cc(O)c(O)c([N+](=O)[O-])c2)n1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: BIA 9-1067 (OPC, Opicapone) 10 mg

BIA 9-1067
Eligibility criteria:
Inclusion Criteria:

A signed and dated informed consent form before any study-specific screening procedure is performed.
Aged between 18 and 45 years, inclusive.
Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead electrocardiogram (ECG).
Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Exclusion Criteria:

Any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease.
Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1.
History of drug abuse within 1 year before study day 1.
History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° [10%] wine = 12 g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g
Have previously received BIA 9-1067.
Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA [3,4-methylenedioxy-methamphetamine; ecstasy]).
History of any clinically important drug allergy.
Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (IMP) administration.
Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 before study day 1.
Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before IMP administration.
Donation of blood (ie 450 ml) within 90 days before study day 1.
Intervention: Opicapone
Trial phase: Phase 1
ATC code: N04BX04
SMILES: Cc1c(Cl)c(C)[n+]([O-])c(Cl)c1-c1noc(-c2cc(O)c(O)c([N+](=O)[O-])c2)n1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: BIA 9-1067 (OPC, Opicapone) 20 mg

BIA 9-1067
Eligibility criteria:
Inclusion Criteria:

A signed and dated informed consent form before any study-specific screening procedure is performed.
Aged between 18 and 45 years, inclusive.
Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead electrocardiogram (ECG).
Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Exclusion Criteria:

Any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease.
Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1.
History of drug abuse within 1 year before study day 1.
History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° [10%] wine = 12 g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g
Have previously received BIA 9-1067.
Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA [3,4-methylenedioxy-methamphetamine; ecstasy]).
History of any clinically important drug allergy.
Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (IMP) administration.
Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 before study day 1.
Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before IMP administration.
Donation of blood (ie 450 ml) within 90 days before study day 1.
Intervention: Opicapone
Trial phase: Phase 1
ATC code: N04BX04
SMILES: Cc1c(Cl)c(C)[n+]([O-])c(Cl)c1-c1noc(-c2cc(O)c(O)c([N+](=O)[O-])c2)n1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: BIA 9-1067 (OPC, Opicapone) 30 mg

BIA 9-1067
Eligibility criteria:
Inclusion Criteria:

A signed and dated informed consent form before any study-specific screening procedure is performed.
Aged between 18 and 45 years, inclusive.
Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead electrocardiogram (ECG).
Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Exclusion Criteria:

Any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease.
Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1.
History of drug abuse within 1 year before study day 1.
History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° [10%] wine = 12 g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g
Have previously received BIA 9-1067.
Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA [3,4-methylenedioxy-methamphetamine; ecstasy]).
History of any clinically important drug allergy.
Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (IMP) administration.
Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 before study day 1.
Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before IMP administration.
Donation of blood (ie 450 ml) within 90 days before study day 1.
Intervention: Edoxaban
Trial phase: Phase 3
ATC code: B01AF03
SMILES: CN1CCc2nc(C(=O)N[C@@H]3C[C@@H](C(=O)N(C)C)CC[C@@H]3NC(=O)C(=O)Nc3ccc(Cl)cn3)sc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1067
Group description: Participants randomized to receive Edoxaban
Eligibility criteria:
Inclusion Criteria:

Has signed informed consent
Is older than minimum legal adult age (country specific)
Has had ongoing AF lasting at least 48 hrs but <= 12 months (with or without valvular heart disease)
Has treatment plan that includes for electrical cardioversion
Has NVAF or other specific valvular heart diseases (eg, mitral valve prolapse, mitral valve regurgitation, and aortic valve disease)

Exclusion Criteria:

Has AF that is transient or reversible
Has contraindicated condition, ie, conditions considered to be formal indication for conventional anticoagulation
Has a history of left atrial appendage (LAA) closure
Has a known thrombus in LAA, the left atrial, left ventricle or aorta - or an intracardial mass
Has had myocardial infarction (MI), stroke, acute coronary syndrome (ACS), or percutaneous coronary intervention (PCI) within the past 30 days
Has any contraindication to anticoagulant agents
Has had protocol-defined signs of bleeding or conditions associated with high risk of bleeding that would preclude participation
Is receiving, or plans to receive during the study period, dual antiplatelet therapy (DAPT) or invasive procedures (other than routine endoscopy) in which bleeding would be anticipated
Has received prohibited concomitant medication or therapy
Has had protocol-defined signs of bleeding or high
Has inadequate liver, kidney, and blood test results
Received any investigational drug or device within the past 30 days or plans to during the study period
Has reproductive potential and does not agree to take proper contraceptive measures
Has active cancer requiring chemotherapy/radiation/major surgery within the next 3 months
Has significant active concurrent medical illness or infection or life expectancy less than 6 months
In the opinion of the investigator, is unlikely to comply with the protocol or complete the study, has had drug or alcohol dependence within the past year, or has any other condition that might place the participant at increased risk of harm
Is a participant in the United States after January 2015 with creatinine clearance (CrCL) greater than 95 mL/minute
Intervention: Adapalene
Trial phase: Phase 3
ATC code: D10AD03 | D10AD53
SMILES: COc1ccc(-c2ccc3cc(C(=O)O)ccc3c2)cc1C12CC3CC(CC(C3)C1)C2
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 101
Group description: Adapalene 01% Gel

CD0271
Eligibility criteria:
Inclusion Criteria:

Men and women at the age of 12 or older at the Screening visit.
Those with clinical diagnosis of acne vulgaris with more than 20 noninflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).

Exclusion Criteria:

Those with more than two nodular acne lesions or any cysts.
Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.
Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment.
Intervention: BENZOYL PEROXIDE
Trial phase: Phase 3
ATC code: D10AE01 | D10AE51
SMILES: O=C(OOC(=O)c1ccccc1)c1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 104
Group description: Benzoyl Peroxide 2.5% Gel

CD1579
Eligibility criteria:
Inclusion Criteria:

Men and women at the age of 12 or older at the Screening visit.
Those with clinical diagnosis of acne vulgaris with more than 20 noninflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).

Exclusion Criteria:

Those with more than two nodular acne lesions or any cysts.
Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.
Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment.
Intervention: BENZOYL PEROXIDE
Trial phase: Phase 2
ATC code: D10AE01 | D10AE51
SMILES: O=C(OOC(=O)c1ccccc1)c1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: Benzoyl Peroxide 2.5%

CD1579 2.5%
Eligibility criteria:
Inclusion Criteria:

Men and women at the age of 12 or older at the Screening visit.
Those with clinical diagnosis of acne vulgaris with more than 20 noninflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).

Exclusion Criteria:

Those with more than two nodular acne lesions or any cysts.
Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.
Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment
Intervention: BENZOYL PEROXIDE
Trial phase: Phase 2
ATC code: D10AE01 | D10AE51
SMILES: O=C(OOC(=O)c1ccccc1)c1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 78
Group description: Benzoyl Peroxide 5%

CD1579 5%
Eligibility criteria:
Inclusion Criteria:

Men and women at the age of 12 or older at the Screening visit.
Those with clinical diagnosis of acne vulgaris with more than 20 noninflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).

Exclusion Criteria:

Those with more than two nodular acne lesions or any cysts.
Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.
Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment
Intervention: Lovenox
Trial phase: Phase 3
SMILES: CC(=O)NC1C(O)OC(COS(=O)(=O)O)C(OC2OC(C(=O)O)C(OC3OC(CO)C(OC4OC(C(=O)O)C(O)C(O)C4OS(=O)(=O)O)C(OS(=O)(=O)O)C3NS(=O)(=O)O)C(O)C2OS(=O)(=O)O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 524
Group description: Participants received dalteparin daily
Eligibility criteria:
Inclusion Criteria:

Male or female subjects with age ≥ 18 years or the otherwise legal lower age according to the country of residence;
Confirmed acute lower extremity proximal DVT or PE for which long term treatment with low molecular weight heparin (LMWH) is indicated;
Cancer, other than basal-cell or squamous-cell carcinoma of the skin;
Able to provide written informed consent.

Exclusion Criteria:

Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current (index) episode of DVT and/or PE;
Treatment with therapeutic doses of an anticoagulant other than that used for pretreatment of the current (index) VTE episode prior to randomization;
Active bleeding or high risk for bleeding contraindicating treatment with LMWH or edoxaban;
Any other contraindication listed in the local labeling of dalteparin, enoxaparin, or edoxaban;
Intervention: SINAPULTIDE
Trial phase: Phase 2
SMILES: CC(C)C[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](N)CCCCN)C(=O)N[C@@H](CCCCN)C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 8
Group description: 100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
Eligibility criteria:
Inclusion Criteria:

Informed consent from a legally authorized representative
Gestational age 29 to 34 completed weeks (34 weeks 6 days) post menstrual age (PMA)
Successful implementation of controlled nCPAP within 90 minutes after birth
Spontaneous breathing
Chest radiograph consistent with RDS
Need for moderate levels of supplemental oxygen and nCPAP to maintain oxygen saturation of 88% to 95% for at least 30 minutes within the first 21 hours after birth

Exclusion Criteria:

Heart rate that cannot be stabilized above 100 beats/minute within 5 minutes of birth
Recurrent episodes of apnea occurring after the initial newborn resuscitation period (ie, 10 minutes after birth) requiring intermittent positive pressure breaths using inflating pressures above the set CPAP pressure administered manually or mechanically through any patient interface
A 5 minute Apgar score < 5
Major congenital malformation(s) and cranial/facial abnormalities that preclude nCPAP, diagnosed antenatally or immediately after birth
Other diseases or conditions potentially interfering with cardiopulmonary function (eg, hydrops fetalis or congenital infection such as TORCH)
Known or suspected chromosomal abnormality or syndrome
Prolong rupture of membranes (PROM) > 2 weeks
Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis
Need for endotracheal intubation and mechanical ventilation
Has been administered: another investigational agent or exposure to an investigational medical device, any other surfactant agent, steroid treatment after birth
Intervention: SINAPULTIDE
Trial phase: Phase 2
SMILES: CC(C)C[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](N)CCCCN)C(=O)N[C@@H](CCCCN)C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 8
Group description: 150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
Eligibility criteria:
Inclusion Criteria:

Informed consent from a legally authorized representative
Gestational age 29 to 34 completed weeks (34 weeks 6 days) post menstrual age (PMA)
Successful implementation of controlled nCPAP within 90 minutes after birth
Spontaneous breathing
Chest radiograph consistent with RDS
Need for moderate levels of supplemental oxygen and nCPAP to maintain oxygen saturation of 88% to 95% for at least 30 minutes within the first 21 hours after birth

Exclusion Criteria:

Heart rate that cannot be stabilized above 100 beats/minute within 5 minutes of birth
Recurrent episodes of apnea occurring after the initial newborn resuscitation period (ie, 10 minutes after birth) requiring intermittent positive pressure breaths using inflating pressures above the set CPAP pressure administered manually or mechanically through any patient interface
A 5 minute Apgar score < 5
Major congenital malformation(s) and cranial/facial abnormalities that preclude nCPAP, diagnosed antenatally or immediately after birth
Other diseases or conditions potentially interfering with cardiopulmonary function (eg, hydrops fetalis or congenital infection such as TORCH)
Known or suspected chromosomal abnormality or syndrome
Prolong rupture of membranes (PROM) > 2 weeks
Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis
Need for endotracheal intubation and mechanical ventilation
Has been administered: another investigational agent or exposure to an investigational medical device, any other surfactant agent, steroid treatment after birth
Intervention: Bupivacaine hydrochloride
Trial phase: Phase 4
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C.Cl
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: TAP block with plain bupivacaine

Plain bupivacaine: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV .

First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine.

24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h,prn
Eligibility criteria:
Inclusion Criteria:

Female
ASA physical status 1-3
Scheduled for open abdominal hysterectomy
Age 18-80 years old
Able to participate personally or by legal representative in informed consent in English or Spanish

Exclusion Criteria:

History of relevant drug allergy
Age less than 18 or greater than 80 years
Chronic opioid use or drug abuse
Significant psychiatric disturbance
Inability to understand the study protocol
Refusal to provide written consent