anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: ASPIRIN
Trial phase: Phase 4
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 166
Group description: aspirin 100mg tablet by mouth daily for 12 months

Aspirin
Eligibility criteria:
Inclusion Criteria:

Patients able to provide written informed consent
Provision of informed consent prior to any study specific procedures
Female and male patients aged 18-80 years
Indication for CABG surgery

Exclusion Criteria:

Cardiogenic shock, haemodynamic instability
Need for urgent revascularization within 5 days from presentation
Single vessel disease
Two vessel disease with normal left ventricular function (> 50%)
Need for concomitant other cardiac surgery (e.g. valve replacement)
Need for dual antiplatelet treatment for the patients undergoing CABG after acute coronary syndrome(ACS)
Contraindication for aspirin and ticagrelor use(e.g. known allergy)
History of bleeding diathesis within 3 months prior presentation
History of significant GI bleed within 1 year prior presentation
History of peptic ulcer without GI bleeding in past 3 years
History of intracranial hemorrhage
History of moderate to severe liver impairment
Patient requires dialysis
Patient with an increased risk of bradycardic events (as patients without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree arteriolar-venular block or bradycardic-related syncope)
Need vitamin K antagonist therapy after bypass surgery eg. persistent atrial fibrillation, mechanical valves
Known, clinically important thrombocytopenia(i.e. < 100*109/L)
Known, clinically important anaemia (i.e. <100g/L)
Participation in another investigational drug or device study in the last 30 days
Pregnancy or lactation(for premenopausal women 2 methods of reliable contraception, one of which must barrier method, are required)
Concomitant oral or intravenous therapy with strong cytochrome P450 3A4(CYP3A4) inhibitors, CYP3A4 substrates with narrow therapeutic indices, or strong CYP3A4 inducers which cannot be stopped for the course of the study (strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, over 1 litre daily of grapefruit juice. Substrates with narrow therapeutic index: cyclosporine, quinidine. Strong inducers: rifampin, phenytoin, carbamazepine. )
Any other condition such as active cancer
Life expectancy less than 12 months that may result in protocol non-compliance or a risk for being lost to follow up
Indication for major surgery(e.g. cancer treatment, carotid surgery, cerebral surgery, major vascular surgery)
Intervention: Ticagrelor
Trial phase: Phase 4
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 166
Group description: ticagrelor 90mg tablet by mouth twice daily for 12 months

Ticagrelor
Eligibility criteria:
Inclusion Criteria:

Patients able to provide written informed consent
Provision of informed consent prior to any study specific procedures
Female and male patients aged 18-80 years
Indication for CABG surgery

Exclusion Criteria:

Cardiogenic shock, haemodynamic instability
Need for urgent revascularization within 5 days from presentation
Single vessel disease
Two vessel disease with normal left ventricular function (> 50%)
Need for concomitant other cardiac surgery (e.g. valve replacement)
Need for dual antiplatelet treatment for the patients undergoing CABG after acute coronary syndrome(ACS)
Contraindication for aspirin and ticagrelor use(e.g. known allergy)
History of bleeding diathesis within 3 months prior presentation
History of significant GI bleed within 1 year prior presentation
History of peptic ulcer without GI bleeding in past 3 years
History of intracranial hemorrhage
History of moderate to severe liver impairment
Patient requires dialysis
Patient with an increased risk of bradycardic events (as patients without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree arteriolar-venular block or bradycardic-related syncope)
Need vitamin K antagonist therapy after bypass surgery eg. persistent atrial fibrillation, mechanical valves
Known, clinically important thrombocytopenia(i.e. < 100*109/L)
Known, clinically important anaemia (i.e. <100g/L)
Participation in another investigational drug or device study in the last 30 days
Pregnancy or lactation(for premenopausal women 2 methods of reliable contraception, one of which must barrier method, are required)
Concomitant oral or intravenous therapy with strong cytochrome P450 3A4(CYP3A4) inhibitors, CYP3A4 substrates with narrow therapeutic indices, or strong CYP3A4 inducers which cannot be stopped for the course of the study (strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, over 1 litre daily of grapefruit juice. Substrates with narrow therapeutic index: cyclosporine, quinidine. Strong inducers: rifampin, phenytoin, carbamazepine. )
Any other condition such as active cancer
Life expectancy less than 12 months that may result in protocol non-compliance or a risk for being lost to follow up
Indication for major surgery(e.g. cancer treatment, carotid surgery, cerebral surgery, major vascular surgery)
Intervention: Velpatasvir
Trial phase: Phase 3
ATC code: J05AP55 | J05AP56
SMILES: COC[C@H]1C[C@@H](c2nc(-c3ccc4c(c3)COc3cc5c(ccc6nc([C@@H]7CC[C@H](C)N7C(=O)[C@@H](NC(=O)OC)C(C)C)[nH]c65)cc3-4)c[nH]2)N(C(=O)[C@H](NC(=O)OC)c2ccccc2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 624
Group description: SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Willing and able to provide written informed consent
HCV RNA ≥ 10^4 IU/mL at screening
HCV genotype 1, 2, 4, 5, 6, or indeterminate assessed at screening by the central laboratory
Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
Classification as treatment naive or treatment experienced
Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Exclusion Criteria:

Current or prior history of clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
Screening ECG with clinically significant abnormalities
Laboratory results outside of acceptable ranges at Screening
Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Intervention: Velpatasvir
Trial phase: Phase 3
ATC code: J05AP55 | J05AP56
SMILES: COC[C@H]1C[C@@H](c2nc(-c3ccc4c(c3)COc3cc5c(ccc6nc([C@@H]7CC[C@H](C)N7C(=O)[C@@H](NC(=O)OC)C(C)C)[nH]c65)cc3-4)c[nH]2)N(C(=O)[C@H](NC(=O)OC)c2ccccc2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 277
Group description: SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Willing and able to provide written informed consent
HCV RNA ≥ 10^4 IU/mL
HCV genotype 3
Chronic HCV infection (≥ 6 months)
Females of childbearing potential must have a negative serum pregnancy test
Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Exclusion Criteria:

Current or prior history of clinically-significant illness (other than HCV) that may interfere with subject treatment, assessment or compliance with the protocol
Screening ECG with clinically significant abnormalities
Laboratory results outside of acceptable ranges at Screening
Pregnant or nursing female or male with pregnant female partner
Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Intervention: Ledipasvir
Trial phase: Phase 2
ATC code: J05AP51
SMILES: COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
Eligibility criteria:
Key Inclusion Criteria:

Willing and able to provide written informed consent
Chronic HCV infection
Cirrhosis determination (liver biopsy may be required)
Screening laboratory values within specified limits
Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Specific genotype, prior medical history, or concurrent disease as required by the specific study group

Key Exclusion Criteria:

History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Pregnant or nursing female, or male with pregnant female partner
Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
Use of any prohibited concomitant medications

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Ledipasvir
Trial phase: Phase 2
ATC code: J05AP51
SMILES: COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
Eligibility criteria:
Key Inclusion Criteria:

Willing and able to provide written informed consent
Chronic HCV infection
Cirrhosis determination (liver biopsy may be required)
Screening laboratory values within specified limits
Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Specific genotype, prior medical history, or concurrent disease as required by the specific study group

Key Exclusion Criteria:

History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Pregnant or nursing female, or male with pregnant female partner
Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
Use of any prohibited concomitant medications

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Phenylephrine
Trial phase: Phase 4
ATC code: C01CA06 | R01AA04 | R01AB01 | R01BA03 | R01BA53 | S01FB01 | S01FB51 | S01GA05 | S01GA55
SMILES: CNC[C@H](O)c1cccc(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock

Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock
Eligibility criteria:
Inclusion Criteria:

Adults 18 years of age or greater
Intention to treat with vasopressor for diagnosis of septic shock
Exclusion criteria not met

Exclusion Criteria:

Emergent indication for surgery
Patient possesses a terminal condition for which patient or medical decision maker has decided to de-escalate medical care (patients with Do Not Resuscitate order but for whom standard care is continued will not be excluded)
Known allergy to phenylephrine or norepinephrine
Treated with vasopressor >12 hours for current episode of shock
Preference of specific vasopressor agent by patient's provider
Pregnancy
Intervention: Norepinephrine
Trial phase: Phase 4
ATC code: C01CA03
SMILES: NC[C@H](O)c1ccc(O)c(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock

Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock
Eligibility criteria:
Inclusion Criteria:

Adults 18 years of age or greater
Intention to treat with vasopressor for diagnosis of septic shock
Exclusion criteria not met

Exclusion Criteria:

Emergent indication for surgery
Patient possesses a terminal condition for which patient or medical decision maker has decided to de-escalate medical care (patients with Do Not Resuscitate order but for whom standard care is continued will not be excluded)
Known allergy to phenylephrine or norepinephrine
Treated with vasopressor >12 hours for current episode of shock
Preference of specific vasopressor agent by patient's provider
Pregnancy
Intervention: OXYTOCIN
Trial phase: Phase 1 | Phase 2
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 6
Group description: 4IU of oxytocin every other day

oxytocin: Intranasal administration
Eligibility criteria:
Inclusion Criteria:

Infants with PWS genetically confirmed
Aged less than 5 months

Exclusion Criteria:

Infants presenting hepatic insufficiency
Infants presenting renal insufficiency
Infants with abnormal ECG
Intervention: Hydromorphone
Trial phase: Not Applicable
ATC code: N02AA03 | N02AA53 | N02AG04
SMILES: [H][C@@]12CCC(=O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: Healthy adult volunteers will receive 2 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion.

2 mg hydromorphone: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.
Eligibility criteria:
Inclusion Criteria:

Healthy adult volunteers

Exclusion Criteria:

any current medical condition requiring medication or abnormal electrocardiogram
current or past medical condition considered to be a contraindication for the study conditions
any current Axis I psychiatric disorder (APA, 1994) including Substance Use Disorder, or Anxiety Disorder or Major Depression in the past year, any history of psychosis
less than high school education
lack of fluency in English
night shift work
Pregnancy, lactation or plans to become pregnant.
Use of hormonal contraception.
Daily cigarette smokers i.e., >7 cigarettes per week
Intervention: Hydromorphone
Trial phase: Not Applicable
ATC code: N02AA03 | N02AA53 | N02AG04
SMILES: [H][C@@]12CCC(=O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: Healthy adult volunteers will receive 4 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion

4 mg hydromorphone: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.
Eligibility criteria:
Inclusion Criteria:

Healthy adult volunteers

Exclusion Criteria:

any current medical condition requiring medication or abnormal electrocardiogram
current or past medical condition considered to be a contraindication for the study conditions
any current Axis I psychiatric disorder (APA, 1994) including Substance Use Disorder, or Anxiety Disorder or Major Depression in the past year, any history of psychosis
less than high school education
lack of fluency in English
night shift work
Pregnancy, lactation or plans to become pregnant.
Use of hormonal contraception.
Daily cigarette smokers i.e., >7 cigarettes per week
Intervention: Proflavine
Trial phase: Not Applicable
SMILES: Nc1ccc2cc3ccc(N)cc3nc2c1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Before participant's cold knife cone biopsy (CKC), topical application of 0.01% proflavine solution applied to cervix. HRME probe applied to cervix and high-resolution images obtained. Participant undergoes cervical biopsies of any abnormal areas noted with colposcopy and/or HRME. Immediately following the CKC, the removed surgical specimen evaluated. Proflavine reapplied to surgical specimen and repeat evaluation with HRME performed and high-resolution images obtained.

Proflavine: 0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging.

High-Resolution Microendoscopy (HRME) Imaging: in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization.
Eligibility criteria:
Inclusion Criteria:

Any woman with a confirmed preoperative diagnosis of cervical AIS, including co-existing squamous CIN and/or microinvasive cancer
Women undergoing cold knife cone (CKC) of the cervix at MD Anderson
Negative pregnancy test for women of child-bearing potential
Women who are >/= 21 years of age and < 65 years of age
Ability to understand and the willingness to provide informed consent and sign a written Informed Consent Document (ICD)

Exclusion Criteria:

Women < 21 years of age and >/= 65 years of age
Women with a known allergy to proflavine or acriflavine
Women who are pregnant or nursing
Patients unable or unwilling to provide informed consent or sign a written Informed Consent Document (ICD)
Intervention: Acetylcysteine
Trial phase: Phase 1 | Phase 2
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: N-acetyl cysteine IV infusion given as a 150 mg/kg loading dose over the first hour and then follow that with a 50 mg/kg maintenance dose infused over the next 4 hours during a controlled hyperinsulinemic hypoglycemic insulin clamp

N-acetyl cysteine: N-acetyl cysteine (or saline) IV infusion given as a 150 mg/kg loading dose over the first hour and then follow that with a 50 mg/kg maintenance dose infused over the next 4 hours during a controlled hyperinsulinemic hypoglycemic insulin clamp
Eligibility criteria:
Inclusion Criteria:

Healthy controls
Age 18 - 65 years
Baseline hemoglobin A1C <6.0%

Exclusion Criteria:

History of stroke, seizures (other than those related to hypoglycemia), arrhythmias, active cardiac disease (all of which could be associated with adverse cardiac or neurological events during hypoglycemia)
Pregnancy or plan to become pregnant during the study period
Diagnosis of asthma (increases risk of hypersensitivity reactions to NAC)
Use of anti-oxidants or drugs that can alter glucose metabolism
Concomitant medical problems that may prevent the subject from successfully completing the protocol
Unwillingness to avoid exercise during the 7 days before each part of the study
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: The control group will receive a 20 ml normal saline placebo infusion over 10 minutes

Normal Saline: the control group will receive a 20 ml normal saline placebo infusion over 10 minutes
Eligibility criteria:
Inclusion Criteria:

Patient age 10 - 17 years
Patients undergoing multilevel thoraco-lumbar spine surgery with instrumentation and fusion

Exclusion Criteria:

Preoperative methadone therapy
Inability to use the PCA
Allergy to methadone or morphine
Morbid obesity with a body mass index >36.0 kg/m2
Patients with chronic renal failure defined by serum creatinine >2.0 mg/dL
Liver failure defined as a history of cirrhosis or fulminant hepatic failure
Preoperative congenital heart disease or arrhythmias
Patient refusal to participate in study
Pregnancy (It is standard of care for all post menarche female patients to undergo a urine pregnancy test prior to surgery).
Intervention: SODIUM FLUORIDE
Trial phase: Phase 2
ATC code: A01AA01 | A01AA51 | A12CD01 | V09IX06
SMILES: [F-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 123
Group description: Toothpaste containing 1100 ppm fluoride as sodium fluoride
Eligibility criteria:
Inclusion Criteria:

Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/dental examination.
A minimum of 20 permanent gradable teeth
Moderate gingivitis present at the screening visit in the opinion of the investigator
A total of 20 bleeding sites or greater at baseline visit
Positive response to bleeding on brushing present at the screening visit

Exclusion Criteria:

Pregnant or breast feeding women
Tobacco chewers
Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the participant unlikely to fully complete the study or any that increases the risk to the participants or undermines the data validity.
Recent history (within the last year) of alcohol or other substance abuse
Participants requiring prophylactic antibiotic treatment prior to dental therapy
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
Have current active caries or any medical conditions which may directly influence gingival bleeding
Use of concomitant or any systemic medication that, in the opinion of the investigator, might interfere with the outcome of the study or have an effect on gingival conditions within 14 days of gingival examinations
Excessive calculus present that interferes with the probing examination for Gingival Bleeding Index
Participation in another clinical study or receipt of an investigational drug or oral care product within 30 days of the screening visit
An employee of the sponsor or the study site or members or their immediate family.