anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Itraconazole
Trial phase: Phase 4
ATC code: J02AC02
SMILES: CCC(C)n1ncn(-c2ccc(N3CCN(c4ccc(OCC5COC(Cn6cncn6)(c6ccc(Cl)cc6Cl)O5)cc4)CC3)cc2)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Probable or proven invasive pulmonary infectious participants (IPFI) - Hospitalized participants (at least hospitalized treatment and observation could be ensured during the intravenous injection period) - The participants (or legal representatives) have signed the informed consent forms.

Exclusion Criteria:

Currently taking taboo drugs, such as terfenadine, astemizole, cisapride and HMG CoA reductase inhibitors (for example simvastatin, lovastatin, oral or intravenous midazolam or triazolam) - History of allergy or intolerance to imidazoles or pyrrole drugs (for example fluconazole, itraconazole, ketoconazole, miconazole, clotrimazole) - Pregnant and breast feeding women, or women of child bearing age not taking effective contraception measures - Participants with pure oral, urinary tract, and vaginal candidiasis (yeast infection) - Participants with fungal meningitis (inflammation of the meninges), active liver disease, renal insufficiency with the serum creatinine clearance rate less than 30 milliliter per minute (ml/min), and current abnormal cardiac function such as congestive heart failure (condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body), or participants with history of congestive heart failure
Intervention: Ketamine
Trial phase: Phase 4
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 62
Group description: Subjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI).

Ketamine: Subjects will receive ketamine for sedation prior to rapid sequence intubation.
Eligibility criteria:
Inclusion Criteria:

18 years of age
Undergoing rapid sequence intubation (RSI) in the Emergency Department

Exclusion Criteria:

Known contraindication to ketamine or etomidate
Patient has a condition in which an increase in heart rate or blood pressure would be hazardous, as judged by the treating physician
Patient is known or suspected of having increased intracranial pressure, based on the history and physical examination performed by the treating physician.
Females of child-bearing age, defined as 18-50 years, who do not have a documented pregnancy test in this institution confirming that they are not pregnant or who do not have a confirmed surgical procedure preventing pregnancy, i.e., tubal ligation, hysterectomy. The timing of the pregnancy test at which the investigative team will consider a subject to be non-pregnant is a documented negative test during current hospitalization or upon direct transfer from outside institution during current illness.
Patient declines participation in the trial by wearing a bracelet marked "KvE declined"
Prisoner
Intervention: Etomidate
Trial phase: Phase 4
ATC code: N01AX07
SMILES: CCOC(=O)c1cncn1[C@H](C)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 67
Group description: Subjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI).

Etomidate: Subjects will receive etomidate for sedation prior to rapid sequence intubation.
Eligibility criteria:
Inclusion Criteria:

18 years of age
Undergoing rapid sequence intubation (RSI) in the Emergency Department

Exclusion Criteria:

Known contraindication to ketamine or etomidate
Patient has a condition in which an increase in heart rate or blood pressure would be hazardous, as judged by the treating physician
Patient is known or suspected of having increased intracranial pressure, based on the history and physical examination performed by the treating physician.
Females of child-bearing age, defined as 18-50 years, who do not have a documented pregnancy test in this institution confirming that they are not pregnant or who do not have a confirmed surgical procedure preventing pregnancy, i.e., tubal ligation, hysterectomy. The timing of the pregnancy test at which the investigative team will consider a subject to be non-pregnant is a documented negative test during current hospitalization or upon direct transfer from outside institution during current illness.
Patient declines participation in the trial by wearing a bracelet marked "KvE declined"
Prisoner
Intervention: Morphine
Trial phase: Not Applicable
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 16
Group description: Parent/Nurse Controlled Analgesia will be the method of morphine delivery.

Morphine: Morphine will be used to control pain post-surgery.
Eligibility criteria:
Inclusion Criteria:

Surgery Location:

Abdominal or Thoracic
First surgery only

Age:

Born ≥ 34-44 weeks post-menstrual age
Weight: Weight at birth or current weight ≥2 kg Intubated or extubated

Prior opioid exposure:

< 2 days of continuous exposure
if history of > 2 day continuous exposure, must be off continuous drip for a week
Intermittent exposure ≤ 2 days prior to surgery Neonates exposed to chronic opioids in utero *In utero exposure to Selective Seretonin Reuptake Inhibitors and illicit drugs will be screened for and annotated.

At least 1 parent is English-speaking

Exclusion Criteria:

Surgery Type:

Cardiac, Patent Ductus Arteriosus Ligation; Omphalocele (if intubated pre-operatively)

Diagnoses:

• Necrotizing Enterocolitis; Diaphragmatic hernia (unless thoracoscopically repaired); Chemically or physiologically paralyzed Receiving vasopressors Receiving acetaminophen or a benzodiazepine (lorazepam or midazolam) ≤ 24 h before surgery Patients with any of the following: Epidural; Oscillating ventilator
Intervention: Morphine
Trial phase: Not Applicable
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 9
Group description: Continuous Opioid Infusion will be the method used to deliver morphine to group 2

Morphine: Morphine will be used to control pain post-surgery.
Eligibility criteria:
Inclusion Criteria:

Surgery Location:

Abdominal or Thoracic
First surgery only

Age:

Born ≥ 34-44 weeks post-menstrual age
Weight: Weight at birth or current weight ≥2 kg Intubated or extubated

Prior opioid exposure:

< 2 days of continuous exposure
if history of > 2 day continuous exposure, must be off continuous drip for a week
Intermittent exposure ≤ 2 days prior to surgery Neonates exposed to chronic opioids in utero *In utero exposure to Selective Seretonin Reuptake Inhibitors and illicit drugs will be screened for and annotated.

At least 1 parent is English-speaking

Exclusion Criteria:

Surgery Type:

Cardiac, Patent Ductus Arteriosus Ligation; Omphalocele (if intubated pre-operatively)

Diagnoses:

• Necrotizing Enterocolitis; Diaphragmatic hernia (unless thoracoscopically repaired); Chemically or physiologically paralyzed Receiving vasopressors Receiving acetaminophen or a benzodiazepine (lorazepam or midazolam) ≤ 24 h before surgery Patients with any of the following: Epidural; Oscillating ventilator
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: 20
Group description: Single loading doses of Ticagrelor (180 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (ticagrelor 90 mg twice daily + ASA 81 mg once daily).
Eligibility criteria:
Inclusion Criteria:

Diagnosed with type-2 diabetes being treated with oral or parenteral hypoglycemic therapy or both.
Have not had thienopyridine therapy for at least 30 days before the study.
Are of legal age (at least 18 years of age but less than 75 years of age) and competent mental condition to provide written informed consent.
For women of child-bearing potential only test negative for pregnancy at the time of enrollment.

Exclusion Criteria:

Have a defined need for thienopyridine therapy.
Subjects within ≤30 days of coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI).
Known glycosylated hemoglobin (HbA1c) ≥10 mg/dL within last 3 months prior to study entry.
Have received fibrinolytic therapy <48 hours prior to randomization.
Have active internal bleeding or history of bleeding diathesis.
Have clinical findings that are, in the judgment of the investigator, associated with an increased risk of bleeding.
Have history of ischemic or hemorrhagic stroke, transient ischemic attack (TIA) or intracranial neoplasm, arteriovenous malformation, or aneurysm.
Have an International Normalized Ratio (INR) known to be >1.5 within 1 week of study entry.
Have a known platelet count of <100,000/mm3 within 1 week of study entry.
Have known anemia (hemoglobin [Hgb] <10 gm/dL) within 1 week of study entry.
Are receiving or will receive oral anticoagulation or other antiplatelet therapy (other than ASA) that cannot be safely discontinued for the duration of the trial.
Are receiving daily treatment with non-steroidal anti-inflammatory drugs (NSAIDS) that cannot be discontinued.
Have a concomitant medical illness that in the opinion of the investigator may interfere with or prevent completion in this study.
Have known severe hepatic dysfunction (e.g., cirrhosis or portal hypertension).
Have a history of intolerance or allergy to ASA or approved thienopyridines (ticlopidine or clopidogrel).
Intervention: Isoflurophate
Trial phase: Phase 3
ATC code: S01EB07
SMILES: CC(C)OP(=O)(F)OC(C)C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 193
Group description: 75-100 mg/kg/day seven days per week

Deferiprone: Deferiprone 80 mg/mL oral solution
Eligibility criteria:
Inclusion Criteria:

Patients of both genders aged from 1 month up to less than 18 years at the time of enrolment
Patients affected by any hereditary haemoglobinopathy requiring chronic transfusion therapy and chelation, including but not limited to thalassemia syndromes and sickle cell disease
Patients on current treatment with deferoxamine (DFO) or DFX or DFP in a chronic transfusion program receiving at least 150 mL/kg/year of packed red blood cells (corresponding approximately to 12 transfusions);
For patients naïve to chelation treatment: patients that have received at least 150 mL/kg of packed red blood cells (corresponding to approximately 12 transfusions) in a chronic transfusion program and with serum ferritin levels ≥ 800 ng/mL;
Until availability of results from the PK Study (Study DEEP-1, EudraCT n. 2012-000658-67) for patients aged from 1 month to less than 6 years: known intolerance or contraindication to DFO;
Written informed consent and patient's informed assent, relating to his/her comprehension abilities and level of maturity

Exclusion Criteria:

Patients with intolerance or known contraindication to either DFP or DFX
Patients receiving DFX at a dose > 40 mg/kg/day or DFP at a dose > 100 mg/kg/day at screening
Platelet count <100.000/mm3 during the run-in phase
Absolute neutrophils count <1.500/mm3 during the run-in phase
Hb levels lower than 8g/dL during the run-in phase
Evidence of abnormal liver function
Iron overload from causes other than transfusional haemosiderosis
Severe heart dysfunction secondary to iron overload
Serum creatinine level > ULN (Upper Limit of Normal) for age during the run-in phase
History of significant medical or psychiatric disorder
The patient has received another investigational drug within 30 days prior to this clinical trial
Fever and other signs/symptoms of infection in the 10 days before baseline assessment
Concomitant use of trivalent cation-dependent medicinal products such as aluminium-based antacids
Positive test for β-HCG (Human chorionic gonadotropin) and lactating female patients
Intervention: Deferasirox
Trial phase: Phase 3
ATC code: V03AC03
SMILES: O=C(O)c1ccc(-n2nc(-c3ccccc3O)nc2-c2ccccc2O)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 197
Group description: 20 to 40 mg/kg/day seven days per week

Deferasirox: Deferasirox is used at the following dosage strengths: 125 mg, 250 mg and 500 mg
Eligibility criteria:
Inclusion Criteria:

Patients of both genders aged from 1 month up to less than 18 years at the time of enrolment
Patients affected by any hereditary haemoglobinopathy requiring chronic transfusion therapy and chelation, including but not limited to thalassemia syndromes and sickle cell disease
Patients on current treatment with deferoxamine (DFO) or DFX or DFP in a chronic transfusion program receiving at least 150 mL/kg/year of packed red blood cells (corresponding approximately to 12 transfusions);
For patients naïve to chelation treatment: patients that have received at least 150 mL/kg of packed red blood cells (corresponding to approximately 12 transfusions) in a chronic transfusion program and with serum ferritin levels ≥ 800 ng/mL;
Until availability of results from the PK Study (Study DEEP-1, EudraCT n. 2012-000658-67) for patients aged from 1 month to less than 6 years: known intolerance or contraindication to DFO;
Written informed consent and patient's informed assent, relating to his/her comprehension abilities and level of maturity

Exclusion Criteria:

Patients with intolerance or known contraindication to either DFP or DFX
Patients receiving DFX at a dose > 40 mg/kg/day or DFP at a dose > 100 mg/kg/day at screening
Platelet count <100.000/mm3 during the run-in phase
Absolute neutrophils count <1.500/mm3 during the run-in phase
Hb levels lower than 8g/dL during the run-in phase
Evidence of abnormal liver function
Iron overload from causes other than transfusional haemosiderosis
Severe heart dysfunction secondary to iron overload
Serum creatinine level > ULN (Upper Limit of Normal) for age during the run-in phase
History of significant medical or psychiatric disorder
The patient has received another investigational drug within 30 days prior to this clinical trial
Fever and other signs/symptoms of infection in the 10 days before baseline assessment
Concomitant use of trivalent cation-dependent medicinal products such as aluminium-based antacids
Positive test for β-HCG (Human chorionic gonadotropin) and lactating female patients
Intervention: Methylphenidate
Trial phase: Phase 4
ATC code: N06BA04 | N06BA11 | N06BA15
SMILES: COC(=O)C(c1ccccc1)C1CCCCN1
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: There were no adverse events reported.
Eligibility criteria:
Inclusion Criteria:

65- 95 years of age
Ability to ambulate (may use walking aid)
Male or Female
Clinical diagnosis of Dementia
Identified as fall risk by nursing staff

Exclusion Criteria:

Clinically significant musculoskeletal, cardiovascular or respiratory diseases.
Clinically significant vestibular disorder
History of significant head trauma
Any medically unstable condition, as determined by the PI that would expose patient to potential harm.

Patients taking medications that may interact with MPH, as determined by manufacture's package insert.

Including but not limited to: Warfarin, anticonvulsants, MAOIs, alpha2-agonists, tri-cyclic antidepressants.

Legally Blind
History of seizures,
Poorly controlled hypertension, cardiac arrhythmia or cardiovascular disease, heart failure.
Known or suspected allergy to MPH or similar compounds
Glaucoma
Motor tics
History of significant agitation or anxiety
Family history of Tourette's syndrome
History of significant anxiety
History of significant agitation
History of significant tension.
Intervention: Cetirizine
Trial phase: Phase 4
ATC code: R06AE07 | R06AE09 | S01GX12
SMILES: O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 3
Group description: zyrtec 10mg, oral, one time

Cetirizine
Eligibility criteria:
Inclusion Criteria:

Children age 6-18yrs on opioids who develop pruritus and are willing to participate in the study

Exclusion Criteria:

Children with history of chronic urticaria
Children with other chronic pruritic condition like eczema, contact dermatitis, psoriasis
Children with known hypersensitivity to cetirizine/zyrtec
Children on H1 antihistamine like diphenhydramine, hydroxyzine, cetirizine, loratadine, fexofenadine, chlorpheniramine within the last 7days prior to randomization
Children who have received Ondansetron within 24hrs prior to randomization
Children who are on Tricyclic antidepressants
Children who are unwilling or unable to swallow the capsule.
Children with chronic liver or kidney disease
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: 25
Group description: LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
Eligibility criteria:
Inclusion Criteria:

Chronic genotype 1, 2, 3, or 6 HCV infection
Cirrhosis determination; a liver biopsy may be required
Screening laboratory values within defined thresholds
Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

Pregnant or nursing female or male with pregnant female partner
Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
Chronic use of systemic immunosuppressive agents
History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
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: 25
Group description: LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
Eligibility criteria:
Inclusion Criteria:

Chronic genotype 1, 2, 3, or 6 HCV infection
Cirrhosis determination; a liver biopsy may be required
Screening laboratory values within defined thresholds
Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

Pregnant or nursing female or male with pregnant female partner
Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
Chronic use of systemic immunosuppressive agents
History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
Intervention: OXYTOCIN
Trial phase: Not Applicable
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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: intranasal administration

Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET.
Eligibility criteria:
Inclusion Criteria:

Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
Subjects must meet DSM-IV criteria for current marijuana dependence (within the past three months). While individuals may also meet criteria for abuse of other substances, they must identify marijuana as their primary substance of abuse and must not meet criteria for dependence on any other substance (except nicotine) within the last 60 days.
Subjects must consent to remain abstinent from alcohol for 24 hours and other drugs of abuse (except nicotine and marijuana) for three days immediately prior to study procedures. Subjects must abstain from marijuana for 24 hours prior to testing. By restricting marijuana use as proposed, subjects should not be under the acute effects of marijuana.
Subjects must consent to random assignment.

Exclusion Criteria:

Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect physiological/subjective responses.
Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with subjective measurements.
Subjects who pose a current suicidal or homicidal risk.
Subjects taking any psychotropic medications, including SRI's or other antidepressants, opiates or opiate antagonists because these may affect test response. Individuals who take stimulants for treatment of ADHD will be allowed to participate.
Subjects with any acute illness or fever. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.
Subjects who are unwilling or unable to maintain abstinence from alcohol and marijuana for 24 hours and other drugs of abuse (except nicotine) for three days prior to study procedures.
Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or marijuana) within the past 60 days.
Subjects who, in the investigator's opinion, would be unable to comply with study procedures or assessments.