anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ropivacaine
Trial phase: Not Applicable
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: 0.2% ropivacaine

ropivacaine
Eligibility criteria:
Inclusion Criteria:

All patients scheduled for shoulder arthroscopy
ASA physical status between I-III
Mentally competent and able to give consent for enrollment in the study -

Exclusion Criteria:

Patients who are coagulopathic or currently on anticoagulation medication (except for ASA (acetylsalicylic acid) or NSAIDS)
Patients with severe pulmonary disease such as asthma or COPD or substantial smoking history suggestive of COPD
Patients with allergy to local anesthetics or other study drugs
Patients with chronic opiate use
Patients with known dysfunction of diaphragm, intercostal muscles, or other neuromuscular disorders affecting respiration
Inability to speak or understand English language
Intervention: Ropivacaine
Trial phase: Not Applicable
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: 0.1% ropivacaine

ropivacaine
Eligibility criteria:
Inclusion Criteria:

All patients scheduled for shoulder arthroscopy
ASA physical status between I-III
Mentally competent and able to give consent for enrollment in the study -

Exclusion Criteria:

Patients who are coagulopathic or currently on anticoagulation medication (except for ASA (acetylsalicylic acid) or NSAIDS)
Patients with severe pulmonary disease such as asthma or COPD or substantial smoking history suggestive of COPD
Patients with allergy to local anesthetics or other study drugs
Patients with chronic opiate use
Patients with known dysfunction of diaphragm, intercostal muscles, or other neuromuscular disorders affecting respiration
Inability to speak or understand English language
Intervention: Ketorolac Tromethamine
Trial phase: Not Applicable
SMILES: NC(CO)(CO)CO.O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 112
Group description: participant receives 0 mg of Ketorolac

Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
Eligibility criteria:
Population: Patients scheduled for outpatient knee arthroscopy under general anesthesia with ASA physical status I-III ages 18-65 years old. All subjects will receive informed consent. Subjects will not be eligible to participate if they cannot provide informed consent. Non-English speaking patients will not be included due to the limited time and availability of translators.

Inclusion Criteria:

Ability to consent and desire to participate in study
Outpatient knee arthroscopy with Dr. C. David Geier
ASA physical status I-III
18-65 years old
Over 50 kg (110 pounds)
General anesthesia

Exclusion Criteria

Any contraindication to receiving a non-steroidal antiinflammatory medication (including but not limited to allergy to any non-steroidal antiinflammatory medications including aspirin; chronic renal insufficiency; history of gastric ulcers, gastritis, peptic ulcers or gastrointestinal bleeding; severe volume depletion; presence of cerebrovascular bleeding or high risk of bleeding)
Allergy to propofol, fentanyl or hydromorphone.
Any chronic painful conditions requiring opioid use for over the last 6 months
Emergency surgery
Altered mental status (not oriented to place, person or time)
Pregnant or lactating patients
Patient is taking non-steroidal antiinflammatory medications (including aspirin)1 at home and took that medication on day of surgery.
Non-English speaking
Patient refusal to study
Patient refusal or not a candidate for general anesthesia with Laryngeal Mask Airway (LMA)
Intervention: Ketorolac Tromethamine
Trial phase: Not Applicable
SMILES: NC(CO)(CO)CO.O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 112
Group description: participant receives 7.5 mg of Ketorolac

Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
Eligibility criteria:
Population: Patients scheduled for outpatient knee arthroscopy under general anesthesia with ASA physical status I-III ages 18-65 years old. All subjects will receive informed consent. Subjects will not be eligible to participate if they cannot provide informed consent. Non-English speaking patients will not be included due to the limited time and availability of translators.

Inclusion Criteria:

Ability to consent and desire to participate in study
Outpatient knee arthroscopy with Dr. C. David Geier
ASA physical status I-III
18-65 years old
Over 50 kg (110 pounds)
General anesthesia

Exclusion Criteria

Any contraindication to receiving a non-steroidal antiinflammatory medication (including but not limited to allergy to any non-steroidal antiinflammatory medications including aspirin; chronic renal insufficiency; history of gastric ulcers, gastritis, peptic ulcers or gastrointestinal bleeding; severe volume depletion; presence of cerebrovascular bleeding or high risk of bleeding)
Allergy to propofol, fentanyl or hydromorphone.
Any chronic painful conditions requiring opioid use for over the last 6 months
Emergency surgery
Altered mental status (not oriented to place, person or time)
Pregnant or lactating patients
Patient is taking non-steroidal antiinflammatory medications (including aspirin)1 at home and took that medication on day of surgery.
Non-English speaking
Patient refusal to study
Patient refusal or not a candidate for general anesthesia with Laryngeal Mask Airway (LMA)
Intervention: Ketorolac Tromethamine
Trial phase: Not Applicable
SMILES: NC(CO)(CO)CO.O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 112
Group description: participant receives 15 mg of Ketorolac

Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
Eligibility criteria:
Population: Patients scheduled for outpatient knee arthroscopy under general anesthesia with ASA physical status I-III ages 18-65 years old. All subjects will receive informed consent. Subjects will not be eligible to participate if they cannot provide informed consent. Non-English speaking patients will not be included due to the limited time and availability of translators.

Inclusion Criteria:

Ability to consent and desire to participate in study
Outpatient knee arthroscopy with Dr. C. David Geier
ASA physical status I-III
18-65 years old
Over 50 kg (110 pounds)
General anesthesia

Exclusion Criteria

Any contraindication to receiving a non-steroidal antiinflammatory medication (including but not limited to allergy to any non-steroidal antiinflammatory medications including aspirin; chronic renal insufficiency; history of gastric ulcers, gastritis, peptic ulcers or gastrointestinal bleeding; severe volume depletion; presence of cerebrovascular bleeding or high risk of bleeding)
Allergy to propofol, fentanyl or hydromorphone.
Any chronic painful conditions requiring opioid use for over the last 6 months
Emergency surgery
Altered mental status (not oriented to place, person or time)
Pregnant or lactating patients
Patient is taking non-steroidal antiinflammatory medications (including aspirin)1 at home and took that medication on day of surgery.
Non-English speaking
Patient refusal to study
Patient refusal or not a candidate for general anesthesia with Laryngeal Mask Airway (LMA)
Intervention: Ketorolac Tromethamine
Trial phase: Not Applicable
SMILES: NC(CO)(CO)CO.O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 112
Group description: participant receives 30mg of Ketorolac

Ketorolac Dose: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
Eligibility criteria:
Population: Patients scheduled for outpatient knee arthroscopy under general anesthesia with ASA physical status I-III ages 18-65 years old. All subjects will receive informed consent. Subjects will not be eligible to participate if they cannot provide informed consent. Non-English speaking patients will not be included due to the limited time and availability of translators.

Inclusion Criteria:

Ability to consent and desire to participate in study
Outpatient knee arthroscopy with Dr. C. David Geier
ASA physical status I-III
18-65 years old
Over 50 kg (110 pounds)
General anesthesia

Exclusion Criteria

Any contraindication to receiving a non-steroidal antiinflammatory medication (including but not limited to allergy to any non-steroidal antiinflammatory medications including aspirin; chronic renal insufficiency; history of gastric ulcers, gastritis, peptic ulcers or gastrointestinal bleeding; severe volume depletion; presence of cerebrovascular bleeding or high risk of bleeding)
Allergy to propofol, fentanyl or hydromorphone.
Any chronic painful conditions requiring opioid use for over the last 6 months
Emergency surgery
Altered mental status (not oriented to place, person or time)
Pregnant or lactating patients
Patient is taking non-steroidal antiinflammatory medications (including aspirin)1 at home and took that medication on day of surgery.
Non-English speaking
Patient refusal to study
Patient refusal or not a candidate for general anesthesia with Laryngeal Mask Airway (LMA)
Intervention: FLUTICASONE PROPIONATE
Trial phase: Not Applicable
ATC code: D07AC17 | R01AD08 | R01AD58 | R03BA05
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 93
Group description: Fluticasone propionate nasal spray

Glucocorticoid: Fluticasone propionate nasal spray 200 μg/d for 3 months
Eligibility criteria:
Inclusion Criteria:

Meeting the CRS diagnostic criteria including CRSsNP and CRSwNP based on the EP3OS definition
Age ≥16 and ≤70 years
Chinese of either sex
Failure to conventional medical therapies according to EP3OS recommendation

Exclusion Criteria:

Pregnant or breast-feeding women
Cystic fibrosis
Congenital ciliary dyskinesia
Sinonasal fungal disease
Systemic vasculitis
Granulomatous disease
Tumor
Immunodeficiency
Allergic to clarithromycin or topical corticosteroid
With an upper respiratory tract infection within 4 weeks of entering the study
With serious metabolic, cardiovascular, autoimmune, neurology, blood, digestive, cerebrovascular, respiratory system disease, or any disease interfering with the evaluation of results or affecting subjects' safety such as glaucoma and tuberculosis
With emotional or mental problems
Have received immunotherapy within the previous 3 months
Have had a history of local or systemic medications, such as glucocorticoids and macrolides within 4 weeks
Have had an acute asthmatic within the 4 weeks before entering the study
Intervention: Saxagliptin
Trial phase: Phase 4
ATC code: A10BD10 | A10BD21 | A10BD25 | A10BH03
SMILES: N#CC1CC2CC2N1C(=O)C(N)C12CC3CC(CC(O)(C3)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: saxagliptin 2.5-5 mg daily
Eligibility criteria:
Inclusion Criteria:

Patients with T2DM and HbA1C ≤7.5% on ≤1 non-insulin hypoglycemic agent or HbA1C ≤7.0% on ≤2 non-insulin hypoglycemic agents admitted to the hospital for a non-critical illness.
Written informed consent.

Exclusion Criteria:

Admitted to or expected to require admission to ICU
Patients with a history of diabetic ketoacidosis or hyperosmolar state
HbA1c >7.5% at the time of admission or within 3 months before admission
Insulin requiring before admission
Unable to take oral food or medications
Systemic steroid use
Pregnancy or breastfeeding
Women of Child-Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 4 weeks after the last dose of study drug.
History of pancreatitis or active gallbladder disease
End stage renal disease on dialysis
Hypersensitivity to saxagliptin or another contraindication to DPP4 inhibitors
Subject unable to give informed consent
Intervention: Tolvaptan
Trial phase: Phase 4
ATC code: C03XA01
SMILES: Cc1ccccc1C(=O)Nc1ccc(C(=O)N2CCCC(O)c3cc(Cl)ccc32)c(C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone)

Tolvaptan
Eligibility criteria:
Inclusion Criteria:

Acute HF with signs or symptoms of volume overload [i.e. elevated jugular venous pulsation (JVP), rales, edema]
Serum sodium < 135 mEq/L at time of or within first 48 hours of hospitalization
Randomized within 48 hours of presentation to hospital
≥ 18 years of age
Informed consent

Exclusion Criteria:

Severe symptomatic hyponatremia requiring acute treatment
Severe renal impairment upon admission (creatinine clearance < 20 mL/min)
Renal replacement therapy dependent, or requiring upon admission
Acute coronary syndrome on admission
Requires or has a mechanical circulatory support device
Evidence of cardiogenic shock requiring intravenous vasopressors
Pregnancy
Patient requiring concomitant use of strong CYP3A4 inhibitors (clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin)
Intervention: Furosemide
Trial phase: Phase 4
ATC code: C03CA01 | C03CB01 | C03EB01 | G01AE10
SMILES: NS(=O)(=O)c1cc(C(=O)O)c(NCc2ccco2)cc1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone)

Furosemide
Eligibility criteria:
Inclusion Criteria:

Acute HF with signs or symptoms of volume overload [i.e. elevated jugular venous pulsation (JVP), rales, edema]
Serum sodium < 135 mEq/L at time of or within first 48 hours of hospitalization
Randomized within 48 hours of presentation to hospital
≥ 18 years of age
Informed consent

Exclusion Criteria:

Severe symptomatic hyponatremia requiring acute treatment
Severe renal impairment upon admission (creatinine clearance < 20 mL/min)
Renal replacement therapy dependent, or requiring upon admission
Acute coronary syndrome on admission
Requires or has a mechanical circulatory support device
Evidence of cardiogenic shock requiring intravenous vasopressors
Pregnancy
Patient requiring concomitant use of strong CYP3A4 inhibitors (clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin)
Intervention: Sivelestat
Trial phase: Phase 3
SMILES: CC(C)(C)C(=O)Oc1ccc(S(=O)(=O)Nc2ccccc2C(=O)NCC(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 252
Group description: Participants received open-label adalimumab 40 mg by subcutaneous injection every other week for 40 weeks.
Eligibility criteria:
Inclusion Criteria:

- Subject successfully enrolled in and completed Study M14-115 (NCT02185014), including the Week 12 ileocolonoscopy.

Exclusion Criteria:

If the Week 12 (Study M14-115; NCT02185014) colonoscopy shows evidence of dysplasia or malignancy.
Subject is not in compliance with prior and concomitant medication requirements throughout M14-115 (NCT02185014).
Subject who developed active Tuberculosis (TB) during M14-115 (NCT02185014), or subject who is non compliant with prophylaxis for latent tuberculosis (TB) initiated per M14-115 (NCT02185014) procedures.
Intervention: Mirtazapine
Trial phase: Phase 2
ATC code: N06AX11
SMILES: CN1CCN2c3ncccc3Cc3ccccc3C2C1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.

Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.

Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.
Eligibility criteria:
Inclusion Criteria:

DSM-IV-TR diagnosis of current alcohol dependence, confirmed by the Mini International Neuropsychiatric Interview (MINI)
DSM-IV-TR diagnosis of current major depressive disorder, confirmed by the Mini International Neuropsychiatric Interview (MINI)

Exclusion Criteria:

Any person who meets criteria for alcohol-induced depression
Any psychotic disorder bipolar disorder, mental retardation, impaired cognitive functioning, or use of any psychotropic medication in the previous month
Current Diagnostic and Statistical Manual (DSM-IV) criteria for dependence on substances other than alcohol, cannabis, nicotine, or caffeine
Significant neurological conditions or medical conditions
Persistent elevation of liver function enzymes indicating active liver disease (elevated t. bilirubin or elevation to three-time normal range of liver enzymes, SGOT, SGPT, or g-GTP)
The presence of renal function impairment defined as serum creatinine >2x upper limit of normal
Pregnancy, inability or unwillingness to use contraceptive methods
Use of any antidepressant medication in the prior two months, or any lifetime use of mirtazapine
Inability to read or understand study forms and agree to informed consent
Intervention: Clopidogrel
Trial phase: Phase 1
ATC code: B01AC04
SMILES: [H][C@@](C(=O)OC)(c1ccccc1Cl)N1CCc2sccc2C1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 81
Group description: Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
Eligibility criteria:
Inclusion Criteria:

Healthy male and female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venepuncture.

Females must have a negative pregnancy test at screening and on each admission to the clinical unit, must not be lactating and

• if of non child-bearing potential, confirmed at screening by fulfilling one of the following criteria:

Post-menopausal defined as amenorrhoea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle-stimulating hormone (FSH) levels in the post-menopausal range.

Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.

• if of child-bearing potential and are sexually active must use, with their partner, 2 approved methods of highly effective contraception from the time of IMP administration until 3 months after the last dose of IMP.

Have a body mass index between 18,5 and 29.9 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
Be able to understand, read and speak the German language.

Exclusion criteria

History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the potential subject at risk because of participation in the study, or influence the results or the potential subject's ability to participate in the study.
Current smokers or those who have smoked or used nicotine products within the previous 3 months.
History of haemophilia, von Willebrand's disease, lupus anticoagulant, or other diseases/syndromes that can either alter or increase the propensity for bleeding.
A personal history of vascular abnormalities including aneurysms; a personal history of severe haemorrhage, haematemesis, melena, haemoptysis, severe epistaxis, severe thrombocytopenia, intracranial haemorrhage; or rectal bleeding within 1 year prior to screening; or history suggestive of peptic ulcer disease; or at the discretion of the Investigator.
Use of aspirin, ibuprofen, NSAIDS, or any other drug known to increase the propensity for bleeding for 2 weeks before randomisation.
Intervention: Clopidogrel
Trial phase: Phase 1
ATC code: B01AC04
SMILES: [H][C@@](C(=O)OC)(c1ccccc1Cl)N1CCc2sccc2C1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 80
Group description: Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
Eligibility criteria:
Inclusion Criteria:

Healthy male and female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venepuncture.

Females must have a negative pregnancy test at screening and on each admission to the clinical unit, must not be lactating and

• if of non child-bearing potential, confirmed at screening by fulfilling one of the following criteria:

Post-menopausal defined as amenorrhoea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle-stimulating hormone (FSH) levels in the post-menopausal range.

Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.

• if of child-bearing potential and are sexually active must use, with their partner, 2 approved methods of highly effective contraception from the time of IMP administration until 3 months after the last dose of IMP.

Have a body mass index between 18,5 and 29.9 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
Be able to understand, read and speak the German language.

Exclusion criteria

History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the potential subject at risk because of participation in the study, or influence the results or the potential subject's ability to participate in the study.
Current smokers or those who have smoked or used nicotine products within the previous 3 months.
History of haemophilia, von Willebrand's disease, lupus anticoagulant, or other diseases/syndromes that can either alter or increase the propensity for bleeding.
A personal history of vascular abnormalities including aneurysms; a personal history of severe haemorrhage, haematemesis, melena, haemoptysis, severe epistaxis, severe thrombocytopenia, intracranial haemorrhage; or rectal bleeding within 1 year prior to screening; or history suggestive of peptic ulcer disease; or at the discretion of the Investigator.
Use of aspirin, ibuprofen, NSAIDS, or any other drug known to increase the propensity for bleeding for 2 weeks before randomisation.