anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Naltrexone
Trial phase: Early Phase 1
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 9
Group description: Participants will receive on-going XR-NTX injections in a local community clinic

XR-NTX community location: XR-NTX will be administered at the local health care clinic
Eligibility criteria:
Inclusion Criteria:

Meets criteria for opioid use disorder
Anticipated release date within 30 days
Opioid free
Not currently in methadone or buprenorphine trial
No serious medical or psychiatric condition
Willingness to enroll in the trial

Exclusion Criteria:

Positive study pregnancy test
Abnormal liver function tests (5X upper limits of normal)
Chronic pain conditions that require opioid therapies
Untreated medical or psychiatric disorder
Suicidal ideation
BMI > 40
Intervention: NALTREXONE-HCl
Trial phase: Phase 1 | Phase 2
SMILES: Cl.O=C1CCC2(O)C3Cc4ccc(O)c5c4C2(CCN3CC2CC2)C1O5
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 45
Group description: Patients will be evaluated in clinic 1 month after the phone call evaluation. At this time, patients will begin a 3 month trial of low-dose naltrexone (Naltrexone HCL powder compounded to provide 4.5mg once per day orally).

Patients will be evaluated in clinic 3 months after beginning treatment with naltrexone.

Naltrexone HCl (Bulk) Powder: For the NDPH Persistent group, patient will take naltrexone, 4.5 mg, po 1 time/day for three months-Naltrexone will be compounded from Naltrexone HCL powder
Eligibility criteria:
Inclusion Criteria:

1) Patients meeting clinical International Classification of Headache Disorders (ICHD-3 )classification for NDPH 2) Age 10-17 years, all sexes, races, and ethnicities 3) English speaking 4) Able to wean off headache prophylactic medication 2 weeks prior to start of Naltrexone trial (patient will still be able to use abortive medication throughout the duration of the study) 5) On stable psychotropic medication for mild anxiety and/or mood disturbance for 2 weeks

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Exclusion Criteria:

1) Children and adolescents with significant chronic medical illness: Central Nervous systen (secondary headache disorder other than mild traumatic brain injury); Cardiac, Pulmonary other than stable asthma, Metabolic, Renal, Hepatic 2) Significant psychiatric disorder, such as major depression, somatization disorder, and psychosis 3) Pregnancy 4) Intellectual delay or cognitive limitations precluding completion of questionnaires or following instructions.

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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: Accepts Healthy Volunteers
Participants at risk: 17
Group description: Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours
Eligibility criteria:
Inclusion Criteria:

Patients undergoing laparoscopic gastric bypass at Mayo Clinic in Arizona
BMI is ≥ 35 kg/m2
Consent is able to be obtained as per Mayo Clinic policy

Exclusion Criteria:

Intolerance to ketamine
History of schizophrenia, schizoaffective disorder, or other psychiatric diagnosis with psychotic features
Presence of unstable cardiovascular disease (presence of acute coronary syndrome, unstable angina, hypertension emergency, acute transient ischemic attack (TIA) or stroke)
Presence of acute elevation of intracranial or intraocular pressure
Presence of seizure disorder
History of substance abuse or addiction
Creatinine greater than 1.5 mg/dL
End-stage liver disease
Pregnancy
Patients with chronic pain and/or chronic opioid therapy will not be excluded to more closely replicate the study patient population of interest. However, patients taking greater than 50 morphine equivalents (ME) per day for greater than 1 month prior to surgery will be excluded.
Intervention: Humalog
Trial phase: Phase 1
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)NC(CCCCN)C(=O)N3CCCC3C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 80
Group description: T1DM participants received a single, SC dose of insulin lispro (Humalog®).
Eligibility criteria:
Inclusion Criteria:

Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
Have a body mass index (BMI) of 18.5 to 35.0 kilogram per meter square (kg/m²)
Have a glycated hemoglobin (HbA1c) less than (<)9.0 percent (%)
Have had no episodes of severe hypoglycaemia in the last 6 months

Exclusion Criteria:

- Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
Intervention: Novolog mix 70/30
Trial phase: Phase 1
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)NC(CC(=O)O)C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 80
Group description: T1DM participants received a single, SC dose of insulin aspart (Fiasp®).
Eligibility criteria:
Inclusion Criteria:

Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
Have a body mass index (BMI) of 18.5 to 35.0 kilogram per meter square (kg/m²)
Have a glycated hemoglobin (HbA1c) less than (<)9.0 percent (%)
Have had no episodes of severe hypoglycaemia in the last 6 months

Exclusion Criteria:

- Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
Intervention: Novolog mix 70/30
Trial phase: Phase 1
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)NC(CC(=O)O)C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 80
Group description: T1DM participants received a single, SC dose of insulin aspart (NovoRapid®).
Eligibility criteria:
Inclusion Criteria:

Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
Have a body mass index (BMI) of 18.5 to 35.0 kilogram per meter square (kg/m²)
Have a glycated hemoglobin (HbA1c) less than (<)9.0 percent (%)
Have had no episodes of severe hypoglycaemia in the last 6 months

Exclusion Criteria:

- Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
Intervention: Brimonidine Tartrate
Trial phase: Phase 3
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12.O=C(O)C(O)C(O)C(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 337
Group description: Brimonidine Tartrate Ophthalmic Suspension
Eligibility criteria:
Inclusion Criteria:

Be male or female, of 2 years of age or older
Have open-angle glaucoma or ocular hypertension in both the eyes
Be able and willing to follow study instructions and complete all required visits.

Exclusion Criteria:

Females who are pregnant/lactating.
Have uncontrolled systemic disease which might interfere with the study
Any known allergy or sensitivity to the study medications or their components
Any other clinically relevant abnormality
Intervention: Brimonidine Tartrate
Trial phase: Phase 3
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12.O=C(O)C(O)C(O)C(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 341
Group description: Brimonidine Tartrate Ophthalmic Solution: Three Times Brimonidine Tartrate Ophthalmic Solution
Eligibility criteria:
Inclusion Criteria:

Be male or female, of 2 years of age or older
Have open-angle glaucoma or ocular hypertension in both the eyes
Be able and willing to follow study instructions and complete all required visits.

Exclusion Criteria:

Females who are pregnant/lactating.
Have uncontrolled systemic disease which might interfere with the study
Any known allergy or sensitivity to the study medications or their components
Any other clinically relevant abnormality
Intervention: LENABASUM
Trial phase: Phase 2
SMILES: [H][C@@]12CC(C(=O)O)=CC[C@@]1([H])C(C)(C)Oc1cc(C(C)(C)CCCCCC)cc(O)c12
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 165
Group description: Lenabasum 20 mg: Subjects will receive lenabasum 20 mg twice daily.
Eligibility criteria:
Inclusion Criteria:

≥ 12 years of age at the time Informed Consent/ Assent is signed.
Weight ≥ 40 kg.
FEV1 ≥ 40% predicted and < 100% predicted in the last 12 months.
Physician-initiated treatment with an IV antibiotic 2 or 3 times in the last 12 months for a new PEx or physician-initiated treatment with an IV antibiotic 1 time in the last 12 months plus physician-initiated treatment with oral antibiotic(s) 1 or more times in the past 12 months for a new PEX.

Exclusion Criteria:

Severe or unstable CF at screening or Visit 1.

Any of the following values for laboratory tests at screening:

A positive pregnancy test.
Hemoglobin < 10 g/dL in males and < 9 g/dL in females.
Neutrophils < 1.0 x 10^9 /L.
Platelets < 75 x 10^9/L.
Creatinine clearance < 50 mL/min according to Modification of Diet in Renal Disease (MDRD) Study equation.
Serum transaminases > 2.5 x upper limit of normal.
Any medical condition or concurrent medical therapies at screening or Visit 1 that may put the subject at greater safety risk, influence response to study drug or interfere with study assessments.
Intervention: LENABASUM
Trial phase: Phase 2
SMILES: [H][C@@]12CC(C(=O)O)=CC[C@@]1([H])C(C)(C)Oc1cc(C(C)(C)CCCCCC)cc(O)c12
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 89
Group description: Lenabasum 5 mg: Subjects will receive lenabasum 5 mg twice daily.
Eligibility criteria:
Inclusion Criteria:

≥ 12 years of age at the time Informed Consent/ Assent is signed.
Weight ≥ 40 kg.
FEV1 ≥ 40% predicted and < 100% predicted in the last 12 months.
Physician-initiated treatment with an IV antibiotic 2 or 3 times in the last 12 months for a new PEx or physician-initiated treatment with an IV antibiotic 1 time in the last 12 months plus physician-initiated treatment with oral antibiotic(s) 1 or more times in the past 12 months for a new PEX.

Exclusion Criteria:

Severe or unstable CF at screening or Visit 1.

Any of the following values for laboratory tests at screening:

A positive pregnancy test.
Hemoglobin < 10 g/dL in males and < 9 g/dL in females.
Neutrophils < 1.0 x 10^9 /L.
Platelets < 75 x 10^9/L.
Creatinine clearance < 50 mL/min according to Modification of Diet in Renal Disease (MDRD) Study equation.
Serum transaminases > 2.5 x upper limit of normal.
Any medical condition or concurrent medical therapies at screening or Visit 1 that may put the subject at greater safety risk, influence response to study drug or interfere with study assessments.
Intervention: Vancomycin
Trial phase: Phase 2
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: After 3 months, initial experimental group will be switched to placebo for 3 months.

Vancomycin: Oral vancomycin 250mg capsules

Placebo: Placebo Pills distributed by Research Pharmacy labeled "placebo."
Eligibility criteria:
Inclusion Criteria:

Patients with stable chronic kidney disease on hemodialysis with a fistula or an AV graft.

Exclusion Criteria:

Antibiotics received within the last 3 months;
recent diarrhea
known allergy to vancomycin
history of C. difficile infection
elevation of white blood cell count or fever within one week of enrollment.
Intervention: Tetrabenazine
Trial phase: Phase 2 | Phase 3
ATC code: N07XX06 | N07XX16
SMILES: COc1cc2c(cc1OC)C1CC(=O)C(CC(C)C)CN1CC2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 58
Group description: Participants received TEV-50717 as oral tablets at a starting dose of 6 mg/day, with the dose titrated weekly for 7 weeks to an optimal level. The target maximum daily dose was determined by body weight and CYP2D6 impairment status at baseline. Maximum total daily dose for participants ≥40 kg was 48 mg/day (24 mg BID), 30 to <40 kg was 42 mg/day (21 mg BID), and 20 to <30 kg was 30 mg/day (15 mg BID). For those considered CYP2D6 impaired, maximum daily dose for participants ≥40 kg was 36 mg/day, 30 to <40 kg was 24 mg/day, and 20 to <30 kg was 18 mg/day. Total daily doses of ≥12 mg/day was divided into a BID administration. Depending on the dose, TEV-50717 tablets and/or placebo tablets were taken to maintain the blind. Participants then received TEV-50717 at the optimal level as maintenance therapy daily for 5 weeks.
Eligibility criteria:
Inclusion Criteria:

Participant is 6 to 16 years of age, inclusive.
Participant weighs at least 44 pounds (20 kilograms [kg]).
The participant's active tics are causing distress or impairment.
Participant is able to swallow study medication whole.
Participant is in good general health.

Women/girls of childbearing potential whose male partners are of childbearing potential must use contraception for the duration of the study.

Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

Participant has a neurologic disorder other than TS that could obscure the evaluation of tics.
Participant has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder.
Participant has clinically significant depression at screening or baseline.
Participant has a history of suicidal intent or related behaviors within 2 years of screening.
Participant has a history of a previous actual, interrupted, or aborted suicide attempt.
Participant has a first-degree relative who has completed suicide.
Participant has received comprehensive behavioral intervention for tics (CBIT) for TS or cognitive behavioral therapy (CBT) for obsessive-compulsive disorder (OCD) within 4 weeks of screening.
Participant has an unstable or serious medical illness at screening or baseline.

Participant is pregnant or breastfeeding.

Additional criteria apply, please contact the investigator for more information.
Intervention: Vancocin HCL
Trial phase: Phase 4
SMILES: CNC(CC(C)C)C(=O)NC1C(=O)NC(CC(N)=O)C(=O)NC2C(=O)NC3C(=O)NC(C(=O)NC(C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)C(O)c3ccc(c(Cl)c3)Oc3cc2cc(c3OC2OC(CO)C(O)C(O)C2OC2CC(C)(N)C(O)C(C)O2)Oc2ccc(cc2Cl)C1O.Cl
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision

Administration of Vancomycin: Intravenous Vancomycin Administration
Eligibility criteria:
Inclusion Criteria:

Neurosurgery patients between the ages of 31 days up to 18 years
Receiving a single dose of vancomycin administered prior to surgery for cerebrospinal fluid (CSF) shunt placement or revision.
Orthopedic surgical patients between the ages of 31 days up to 18 years
Receiving a single dose of vancomycin administered prior to surgery for definitive spinal fusion.

Exclusion Criteria:

Patients already receiving vancomycin for treatment of an active infection,
Patients who have a Creatinine ≥1.2,
Patients who's creatinine clearance less than 50,
Known chronic renal failure and are on dialysis,
Patients with a known allergy to vancomycin, not including Red Man Syndrome.
Intervention: Simvastatin
Trial phase: Phase 2
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Patients receive simvastatin PO daily for 2-4 weeks in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Simvastatin: Given PO
Eligibility criteria:
Inclusion Criteria:

Provision of informed consent prior to any study specific procedures
Histologic confirmation of invasive breast cancer with any measures of ER, PR and HER2neu
Clinical stage I or II breast cancer for which there will be at least a 2 week period of time between diagnosis and definitive surgery
Performance status (Eastern Cooperative Oncology Group [ECOG] 0-1)
Not currently pregnant during the study; participants will be informed that the use of contraceptive pills is contraindicated because it may interfere with the study drug and it may be harmful to the woman who has been diagnosed with breast cancer

Exclusion Criteria:

Plans for administration of neoadjuvant chemotherapy or hormonal therapy
Insufficient tissue on diagnostic core breast biopsy for analysis
Previous or concurrent malignancy (with the exception of non-melanomatous skin cancer)
Severe gastrointestinal disorder
Current use of statins or fibrates for any time during the 3 months prior to the study
Proven hypersensitivity to statins
White blood cell (WBC) < 3,500/mm^3
Platelet (Plt) < 120,000/mm^3
Hemoglobin (HgB) < 10 g/dL
Aspartate aminotransferase (AST) > 45 U/L
Alanine aminotransferase (ALT) > 45 U/L
Creatinine > 1.5 mg/dL
Bilirubin > 1.15 mg/dL
Creatine kinase measurement (CPK) > or = 250 mg/dL
Central nervous system (CNS) diseases and major psychiatric diseases or inability to comply to the protocol procedures
Active infections
Cardiac failure, class I-IV
Current anticoagulant or antiplatelet aggregation therapy
Mitral and/or tricuspid valvopathy or valvular prosthesis; angina; severe arterial hypertension; chronic and/or paroxysmal atrial fibrillation; previous myocardial infarction
Current lactation
Intervention: Nitric Oxide
Trial phase: Phase 2 | Phase 3
ATC code: R07AX01
SMILES: [N]=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 18
Group description: 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time

Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass

INOmax: All patients will have the INOmax device connected to the oxygenator
Eligibility criteria:
Inclusion Criteria:

Infants less than one year of age
Undergoing cardiac surgery with the use of cardiopulmonary bypass

Exclusion Criteria:

Prior surgery requiring CPB within the same hospitalization
Pre-operative need for extracorporeal membrane oxygenation or mechanical circulatory support
Known hypersensitivity to nitric oxide
Known hemostatic or thrombotic disorder that results in an altered transfusion/anticoagulation protocol
Intervention: Ketorolac
Trial phase: Phase 4
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 70
Group description: 400mg of Ibuprofen

NSAID: Ibuprofen 400mg for post-operative pain
Eligibility criteria:
Inclusion Criteria:

Patients 18-70 years old undergoing septorhinoplasty or rhinoplasty for either obstructive or aesthetic reasons. All approaches to rhinoplasty and surgical techniques utilized will be included. This will include patients that undergo additional procedures during the rhinoplasty including osteotomies, turbinate reduction, septoplasty, nasal valve repair and ear cartilage graft.

Exclusion Criteria:

Patients who undergo a rhinoplasty requiring a rib cartilage graft for the procedure as this is known to cause significant pleuritic chest pain.
Patients receiving functional endoscopic sinus surgery concurrently with the rhinoplasty will be excluded.
Patients with known history of gastrointestinal bleeds, peptic ulcer disease or who have other comorbidities that prevent them from taking NSAIDs.
Patients with a history of radiation, active head and neck malignancy or other pain disorders such as various rheumatologic diseases will be excluded to decrease confounding factors in the control of pain.