anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 154
Group description: Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo

Acetaminophen: Oral acetaminophen, intravenous placebo
Eligibility criteria:
Inclusion criteria:

Adult
Scheduled for an elective primary THA with a participating surgeon,
Planned for Combined Spinal Epidural anesthesia (CSE) and Patient Controlled Epidural Analgesia (PCEA)
English-speaking
Patients that did not receive pre-operative opioids

Exclusion criteria:

Hepatic or renal insufficiency, as defined by abnormal readings on liver and kidney functioning tests.
Hypersensitivity or contraindication to protocol medication
Contraindication for CSE and PCEA
Incapable to provide consent/answer questions in English
Revision or urgent surgery
Receiving Periarticular Injections
History of opioid use
Patients on disability or worker's compensation
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 154
Group description: Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo

Acetaminophen: Intravenous acetaminophen, oral placebo
Eligibility criteria:
Inclusion criteria:

Adult
Scheduled for an elective primary THA with a participating surgeon,
Planned for Combined Spinal Epidural anesthesia (CSE) and Patient Controlled Epidural Analgesia (PCEA)
English-speaking
Patients that did not receive pre-operative opioids

Exclusion criteria:

Hepatic or renal insufficiency, as defined by abnormal readings on liver and kidney functioning tests.
Hypersensitivity or contraindication to protocol medication
Contraindication for CSE and PCEA
Incapable to provide consent/answer questions in English
Revision or urgent surgery
Receiving Periarticular Injections
History of opioid use
Patients on disability or worker's compensation
Intervention: Emixustat
Trial phase: Phase 2
SMILES: NCC[C@@H](O)c1cccc(OCC2CCCCC2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: lowest dose of once-daily oral emixustat

Emixustat: Once daily, tablet for oral administration
Eligibility criteria:
Inclusion Criteria, including, but not limited to:

Clinical diagnosis of macular atrophy (MA) secondary to Stargardt disease (STGD) in one or both eyes
At least 2 pathogenic mutations of the ABCA4 gene
Early Treatment Diabetic Retinopathy Study BCVA of ≥ 20 letters (approximately ≥ 20/400 Snellen) in the study eye
Adequate clarity of ocular media and adequate pupillary dilation to permit good quality imaging of MA in the study eye
Able and willing to provide written informed consent before undergoing any study-related procedures
Able to reliably administer oral medication by self or with available assistance

Exclusion Criteria, including, but not limited to:

Macular atrophy associated with a condition other than STGD in either eye.
Presence in either eye of an active ocular disease that in the opinion of the Investigator compromises or confounds visual function.
History of any intraocular or ocular surface surgery in either eye within 3 months of screening.
Current or previous participation in an interventional study to treat STGD using gene therapy or stem cell therapy at any time, or participation in an interventional study of a vitamin A derivative ≤3 months prior to screening.
Pre-specified laboratory abnormalities at screening
Presence of other medical or ophthalmic disease, physical examination finding, or clinical laboratory finding that in the opinion of the Investigator may contraindicate the use of an investigational drug and place the subject at risk
Current or history of cancer (except for adequately treated basal cell or squamous cell carcinoma of the skin) within 1 year of screening
History of myocardial infarction, stroke, unstable ischemic heart disease, uncontrolled cardiac arrhythmia, or hospitalization for congestive heart failure within 6 months of screening.
Anticipated hospitalization for a medical/surgical procedure(s) that could result in interruption/premature cessation of study treatment or participation.
Electrocardiogram with a clinically significant abnormal finding
Female subjects who are pregnant or lactating
Female subjects of childbearing potential or male subjects who are not surgically sterile who are not willing to practice a medically accepted method of birth control with their sexual partner from screening through 30 days after the final dose of study drug
Intervention: Emixustat
Trial phase: Phase 2
SMILES: NCC[C@@H](O)c1cccc(OCC2CCCCC2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: middle dose of once-daily oral emixustat

Emixustat: Once daily, tablet for oral administration
Eligibility criteria:
Inclusion Criteria, including, but not limited to:

Clinical diagnosis of macular atrophy (MA) secondary to Stargardt disease (STGD) in one or both eyes
At least 2 pathogenic mutations of the ABCA4 gene
Early Treatment Diabetic Retinopathy Study BCVA of ≥ 20 letters (approximately ≥ 20/400 Snellen) in the study eye
Adequate clarity of ocular media and adequate pupillary dilation to permit good quality imaging of MA in the study eye
Able and willing to provide written informed consent before undergoing any study-related procedures
Able to reliably administer oral medication by self or with available assistance

Exclusion Criteria, including, but not limited to:

Macular atrophy associated with a condition other than STGD in either eye.
Presence in either eye of an active ocular disease that in the opinion of the Investigator compromises or confounds visual function.
History of any intraocular or ocular surface surgery in either eye within 3 months of screening.
Current or previous participation in an interventional study to treat STGD using gene therapy or stem cell therapy at any time, or participation in an interventional study of a vitamin A derivative ≤3 months prior to screening.
Pre-specified laboratory abnormalities at screening
Presence of other medical or ophthalmic disease, physical examination finding, or clinical laboratory finding that in the opinion of the Investigator may contraindicate the use of an investigational drug and place the subject at risk
Current or history of cancer (except for adequately treated basal cell or squamous cell carcinoma of the skin) within 1 year of screening
History of myocardial infarction, stroke, unstable ischemic heart disease, uncontrolled cardiac arrhythmia, or hospitalization for congestive heart failure within 6 months of screening.
Anticipated hospitalization for a medical/surgical procedure(s) that could result in interruption/premature cessation of study treatment or participation.
Electrocardiogram with a clinically significant abnormal finding
Female subjects who are pregnant or lactating
Female subjects of childbearing potential or male subjects who are not surgically sterile who are not willing to practice a medically accepted method of birth control with their sexual partner from screening through 30 days after the final dose of study drug
Intervention: Emixustat
Trial phase: Phase 2
SMILES: NCC[C@@H](O)c1cccc(OCC2CCCCC2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: highest dose of once-daily oral emixustat

Emixustat: Once daily, tablet for oral administration
Eligibility criteria:
Inclusion Criteria, including, but not limited to:

Clinical diagnosis of macular atrophy (MA) secondary to Stargardt disease (STGD) in one or both eyes
At least 2 pathogenic mutations of the ABCA4 gene
Early Treatment Diabetic Retinopathy Study BCVA of ≥ 20 letters (approximately ≥ 20/400 Snellen) in the study eye
Adequate clarity of ocular media and adequate pupillary dilation to permit good quality imaging of MA in the study eye
Able and willing to provide written informed consent before undergoing any study-related procedures
Able to reliably administer oral medication by self or with available assistance

Exclusion Criteria, including, but not limited to:

Macular atrophy associated with a condition other than STGD in either eye.
Presence in either eye of an active ocular disease that in the opinion of the Investigator compromises or confounds visual function.
History of any intraocular or ocular surface surgery in either eye within 3 months of screening.
Current or previous participation in an interventional study to treat STGD using gene therapy or stem cell therapy at any time, or participation in an interventional study of a vitamin A derivative ≤3 months prior to screening.
Pre-specified laboratory abnormalities at screening
Presence of other medical or ophthalmic disease, physical examination finding, or clinical laboratory finding that in the opinion of the Investigator may contraindicate the use of an investigational drug and place the subject at risk
Current or history of cancer (except for adequately treated basal cell or squamous cell carcinoma of the skin) within 1 year of screening
History of myocardial infarction, stroke, unstable ischemic heart disease, uncontrolled cardiac arrhythmia, or hospitalization for congestive heart failure within 6 months of screening.
Anticipated hospitalization for a medical/surgical procedure(s) that could result in interruption/premature cessation of study treatment or participation.
Electrocardiogram with a clinically significant abnormal finding
Female subjects who are pregnant or lactating
Female subjects of childbearing potential or male subjects who are not surgically sterile who are not willing to practice a medically accepted method of birth control with their sexual partner from screening through 30 days after the final dose of study drug
Intervention: Water
Trial phase: Phase 4
SMILES: O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: Drug: Sterile Water

Nature's Tears: Sterile water mist will be administered 1-2 sprays prior to intravenous access
Eligibility criteria:
Inclusion Criteria:

Any outpatient ordered to undergo a Nuclear Medicine Stress Test and is required to have IV access for injection of Radiopharmaceuticals

Exclusion Criteria:

If it is the first time the patient has had an intravenous catheter inserted
Any patient who is or may be pregnant
Any patient who is breast-feeding
Any patient who has taken a narcotic, sedative and/or anti-anxiety medication within 8 hours of intervention time.
Any patient who has a known diagnosis of Raynaud's Syndrome or Carpal Tunnel Syndrome.
Any patient who has an allergy or hypersensitivity to Ethyl Chloride.
Any patient under the age of 18 and/or any patient over the age of 85
Any patient who is illiterate
Any patient who is non-English speaking
Any patient with prior experience with a vapocoolant spray.
Intervention: Fentanyl
Trial phase: Early Phase 1
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 51
Group description: 2 mcg/Kg of fentanyl

Fentanyl: single modal analgesia
Eligibility criteria:
Inclusion Criteria:

Patients who are 24 months through 7 years of age
Patients who weigh <50 kg
Patients who are able to take PO medications
Patients who are ASA Classification I and II
Patients who are found to be a candidate after clinical review of detailed History and Physical Exam, review of Polysomnogram or Pediatric Sleep Questionnaire
Patients who are scheduled for routine adenoidectomy or tonsillectomy with or without adenoidectomy not in conjunction with another invasive or diagnostic procedure
Patients who meet clinical indications for surgery
Family and patient must be proficient in English to understand consent, post-operative instructions, and facilitate the assessment after emergence of anesthesia

Exclusion Criteria:

Children with a history of developmental delay or psychological disorders that may be at higher risk for EA as determined by study physician after review of history and problem list in EMR
Patients with previous hypersensitivity to oral or intravenous acetaminophen, fentanyl or any of its components or ingredients in placebo,
Patients with severe hepatic impairment or severe active hepatic disease
Patients with previous history of Malignant Hyperthermia or susceptibility to volatile anesthetics agents like sevoflurane
Any patient who weighs >50 Kg.
Any patient that requires premedication. Versed may contribute to an increase in EA. Premedication is reserved when parental presence is not feasible or for very anxious children.
Patients unable to take PO (acetaminophen or placebo) will be excluded from the study.
Children with severe symptomatic sleep apnea that require post-operative hospitalization.
Severe symptomatic sleep apnea is defined as a- patients who has a pre-operative polysomnogram and a calculated Apnea-Hypoxia Index greater than 10 b- patients with high scoring in Pediatric Sleep Questionnaire (PSQ)
Patients with severe symptoms and findings in physical exam that require post-operative hospital admission.
Patients and/or families not proficient in English
Participant is currently participating or has within the previous 30 days, participated in another clinical trial/research study
Intervention: Rocuronium
Trial phase: Phase 4
ATC code: M03AC09
SMILES: [H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Comparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents.

Neuromuscular block: Subjects allocated to the neuromuscular block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to PACU or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction.
Eligibility criteria:
Inclusion Criteria:

Patients ≥ 18 years of age
Planned TURBT for unilateral or bilateral posterolateral bladder tumors
Ability to understand and provide informed consent

Exclusion Criteria:

Patient refusal or inability to provide informed consent
True allergy, not sensitivity, to local anesthetics
True allergy, not sensitivity, Propofol
True allergy, not sensitivity, general anesthetic agents
Pregnancy
Severe hepatic impairment
Evidence of infection at or near the proposed needle insertion site
Any sensorimotor deficit of the lower extremity, whether acute or chronic
Inability to walk without assistance
Lower extremity joint replacement surgery in the preceding six months
Intervention: Ivacaftor
Trial phase: Phase 2
ATC code: R07AX02 | R07AX30 | R07AX31 | R07AX32
SMILES: CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Ivacaftor, 150 mg PO every 12 hrs for 84 days

Ivacaftor 150 MG: Ivacaftor is a CFTR potentiator
Eligibility criteria:
Inclusion Criteria:

Male or Female age 40-80
A Clinical diagnosis of COPD as defined by GOLD
At Least a 10 pack year smoking history
Exhibit symptoms of chronic bronchitis as defined by the Medical Research Council
FEV1% predicted ≥ 35% and ≤70% Post Bronchodilator
Clinically stable in the last 4 weeks with no evidence of COPD exacerbation
Weight of 40 kg-120 kg
Willingness to use at least one form of acceptable birth control including abstinence, condom with spermicide, or hormonal contraceptives from time of signing ICF through study follow up visit
Willing to monitor blood glucose if known history of diabetes mellitus requiring insulin or medical therapy
Element of CFTR Dysfunction, as defined by Sweat Chloride > 30 mEq/L)

Exclusion Criteria:

Current Diagnosis of Asthma
Known Diagnosis of Cystic Fibrosis
Use of Continuous Oxygen Therapy of greater than 2 liters per minute - patients on 2 liters of Oxygen or less will be excluded if they have been hospitalized for COPD in the prior year or had more than 2 exacerbations requiring steroids and/or antibiotics in the prior year.
Documented history of drug abuse within the last year
Subjects should not have a pulmonary exacerbation or changes in therapy for pulmonary disease within 28 days before receiving the first dose of study drug.
Cirrhosis or elevated liver transaminases > 3X ULN
GFR < 50 estimated by Cockroft-Gault
Any illness or abnormal lab finding that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject.
Pregnant or Breastfeeding
Subjects taking moderate or strong inhibitors or inducers of CYP3A4, including certain herbal medications and grapefruit juice. (Excluded medications and foods including the drugs and foods listed in the IRB HSP application.)
Uncontrolled Diabetes
Recent (e.g 1year) arterial thrombotic events (peripheral arterial disease, thrombotic stroke)
Clinically significant arrhythmias requiring anti-arrhythmic agent(s) or conduction abnormalities that in the opinion of the investigator that affect patient safety such as the abnormalities listed below (patients with stable coronary artery disease are eligible) : (1) Angina symptoms (2) History of MI (3) Revascularization procedure in the last year prior to screening (4) Clinically significant congestive heart failure (known LVEF <= 45%, cor pulmonale, diastolic heart failure, etc)
Intervention: Vonoprazan
Trial phase: Phase 1
ATC code: A02BC08 | A02BD14 | A02BD15
SMILES: CNCc1cc(-c2ccccc2F)n(S(=O)(=O)c2cccnc2)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
Eligibility criteria:
Inclusion Criteria:

Is a healthy adult male or female Chinese participant.
Is aged 18 to 45 years, inclusive, at the time of signing the informed consent form.
Weighs at least 50 kilogram (kg) and has a body mass index (BMI) between 19 and 26 kilogram per square meter (kg/m^2), inclusive at Screening (Check-In Day -1).
Is willing to abstain from caffeine and alcohol from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18.
Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18.
Is willing to provide a sample for pharmacogenetic analysis (for cytochrome [CYP2C19] genotyping).

Exclusion Criteria:

Has uncontrolled, clinically significant cardiovascular disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
Is lactose intolerant or has a known hypersensitivity to any component of the formulation of TAK-438.
Has poor peripheral venous access.
Has donated or lost 400 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 90 days prior to Day 1; or participant has donated or lost more than 200 mL or more of his or her blood in the last 28 days.
Has a history of symptomatic gastroesophageal reflux disease (GERD), Erosive Esophagitis, duodenal ulcer (DU), gastric ulcer (GU), dyspepsia, Barrett's Esophagus, or Zollinger-Ellison (ZE) syndrome or has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs.
Intervention: Vonoprazan
Trial phase: Phase 1
ATC code: A02BC08 | A02BD14 | A02BD15
SMILES: CNCc1cc(-c2ccccc2F)n(S(=O)(=O)c2cccnc2)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
Eligibility criteria:
Inclusion Criteria:

Is a healthy adult male or female Chinese participant.
Is aged 18 to 45 years, inclusive, at the time of signing the informed consent form.
Weighs at least 50 kilogram (kg) and has a body mass index (BMI) between 19 and 26 kilogram per square meter (kg/m^2), inclusive at Screening (Check-In Day -1).
Is willing to abstain from caffeine and alcohol from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18.
Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18.
Is willing to provide a sample for pharmacogenetic analysis (for cytochrome [CYP2C19] genotyping).

Exclusion Criteria:

Has uncontrolled, clinically significant cardiovascular disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
Is lactose intolerant or has a known hypersensitivity to any component of the formulation of TAK-438.
Has poor peripheral venous access.
Has donated or lost 400 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 90 days prior to Day 1; or participant has donated or lost more than 200 mL or more of his or her blood in the last 28 days.
Has a history of symptomatic gastroesophageal reflux disease (GERD), Erosive Esophagitis, duodenal ulcer (DU), gastric ulcer (GU), dyspepsia, Barrett's Esophagus, or Zollinger-Ellison (ZE) syndrome or has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs.
Intervention: Acetaminophen
Trial phase: Phase 2
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 90
Group description: Oral APAP at 15 mg/kg and placebo of equal volume

APAP: Oral APAP at 15mg/kg dose
Eligibility criteria:
Inclusion Criteria:

ages 3-17 years old presenting to the pediatric ED
treating physician deems patient required ibuprofen Tylenol or both for pain relief

Exclusion Criteria:

documented or suspected pregnancy, (2)
parental refusal,
allergies to NSAIDS or APAP
inability to tolerate oral medications or contraindications to oral medication route
received analgesics within 4 hours prior to ED presentation
inability to use pain scales