anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ruxolitinib
Trial phase: Phase 3
ATC code: D11AH09 | L01EJ01 | L01XE18
SMILES: N#CC[C@H](C1CCCC1)n1cc(-c2ncnc3[nH]ccc23)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 161
Group description: All patients will receive ruxolitinib at a starting dose of 10 mg twice daily which could be titrated to most appropriate dose. Dose was not to exceed 25 mg bid nor be less than 5 mg once a day
Eligibility criteria:
Inclusion Criteria:

•Confirmed diagnosis of PV according to the 2008 World Health Organization criteria, palpable spleen, Resistant to or intolerant of hydroxyurea, ECOG performance status of 0, 1 or 2; did not have access to a comparable or satisfactory alternative treatment

Exclusion Criteria:

•Inadequate liver or renal function, Significant bacterial, fungal, parasitic, or viral infection requiring treatment, Active malignancy within the past 5 years, except treated cervical intraepithelial neoplasia, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin, with no evidence for recurrence in the past 3 years., Women who were pregnant or nursing.
Intervention: Retosiban
Trial phase: Phase 3
SMILES: CC[C@H](C)[C@@H]1C(=O)N[C@H](C2Cc3ccccc3C2)C(=O)N1[C@@H](C(=O)N1CCOCC1)c1coc(C)n1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 49
Group description: All infants and children born to women who received retosiban (6 mg IV loading dose of retosiban over 5 minutes followed by a 6 mg per hour continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg per hour continuous infusion for remainder of 48-hour treatment period) in 200719 study or 200721 study. Current study did not require any medical interventions or study visits to an investigational site.
Eligibility criteria:
Inclusion Criteria:

Mother is randomly assigned and dosed (retosiban or comparator) in 1 of the Phase III SPTL retosiban clinical studies.
Infant is alive at 28 days post EDD.
Written informed consent is obtained from the parent(s) or legal guardian(s) of the infant. The parent/legal guardian of subjects aged 12 to 17 years must also provide written agreement for the infant to participate in the study where required by applicable regulatory and country or state requirements.

Exclusion Criteria:

There are no formal exclusion criteria for participation.
Intervention: Metoprolol Succinate
Trial phase: Not Applicable
SMILES: COCCc1ccc(OCC(O)CNC(C)C)cc1.COCCc1ccc(OCC(O)CNC(C)C)cc1.O=C(O)CCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 462
Group description: The parent study will integrate covariates to predict metoprolol effectiveness for SBP decline of 10%. All patients will receive metoprolol. The following covariates will be used to predict metoprolol effectiveness: clinical variables (Age, sex, race/ethnicity, co-medications, and BMI) CYP2D6 genotype, CYP2D6 phenotype, and metabolomic factors.

metoprolol succinate

Genotyping: CYP2D6 only clinically pertinent pathway of metoprolol metabolism and polymorphisms have been associated with altered levels of metoprolol. ADRB1 is the drug target and polymorphism in this receptor has been associated with variable drug response. Genotyping will occur after the treatment phase is complete.

CYP2D6 Phenotyping: Phenotype can be discordant from what is predicted by genotype. CYP2D6 henotyping using dextromethorphan will be used. Investigators will be blind to the patient blood pressure outcome for this intervention.
Eligibility criteria:
Inclusion Criteria:

Subjects between age >30 years and < 80 years
Subjects have diagnosis of uncontrolled essential hypertension.

Exclusion Criteria:

end stage liver disease,
end stage renal disease,
pregnant females,
American Society of Anesthesiologists (ASA) classification of >3,
wards of the state, prisoners,
decisionally challenged,
HR<60 bpm,
AV block>240 msec,
active reactive airway disease,
illicit drug abuse in the preceding 30 days,
hypersensitivity to metoprolol or its derivatives
severe peripheral arterial circulatory disorders.

Subjects will have a screening physical exam performed by Dr. Monte prior to enrollment in the study.
Intervention: Polidocanol
Trial phase: Phase 1 | Phase 2
ATC code: C05BB02
SMILES: CCCCCCCCCCCCOCCOCCOCCOCCOCCOCCOCCOCCOCCO
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 37
Group description: Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg.

Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Eligibility criteria:
Inclusion Criteria:

Infants admitted to the NICU at Hutzel Women's Hospital (HWH)/Children's Hospital of Michigan (CHM)
Gestational age of 240/7-366/7 weeks
Postnatal age ≤ 24 hours
Clinical diagnosis of RDS based on (i) presence of at least two of the four classic symptoms (need of supplemental oxygen, tachypnea, intercostal retractions or grunting), and (ii) exclusion of other causes of respiratory failure and (iii) Clinician intent to administer surfactant if infant requires intubation
Respiratory support with NIV (CPAP or NIPPV or HFNC) with FiO2 ≥25% or PEEP ≥ 4 cmH20 or HFNC rate ≥ 2 LPM for ≤8 hours
Written informed consent from parent/guardian

Exclusion Criteria:

Previous receipt of surfactant
Infants with respiratory distress who are unstable and require immediate intubation
Active air leak syndrome (e.g. pneumothorax, pneumomediastinum)
Lethal congenital malformations; death anticipated within first 3 days of life; decision to withhold support
Serious abdominal, cardiac, airway or respiratory malformations including tracheal esophageal fistula, intestinal atresia, omphalocele, gastroschisis, pulmonary hypoplasia, or diaphragmatic hernia
Neuromuscular disorder resulting in respiratory compromise
Intervention: Polidocanol
Trial phase: Phase 1 | Phase 2
ATC code: C05BB02
SMILES: CCCCCCCCCCCCOCCOCCOCCOCCOCCOCCOCCOCCOCCO
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 38
Group description: Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg.

Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Eligibility criteria:
Inclusion Criteria:

Infants admitted to the NICU at Hutzel Women's Hospital (HWH)/Children's Hospital of Michigan (CHM)
Gestational age of 240/7-366/7 weeks
Postnatal age ≤ 24 hours
Clinical diagnosis of RDS based on (i) presence of at least two of the four classic symptoms (need of supplemental oxygen, tachypnea, intercostal retractions or grunting), and (ii) exclusion of other causes of respiratory failure and (iii) Clinician intent to administer surfactant if infant requires intubation
Respiratory support with NIV (CPAP or NIPPV or HFNC) with FiO2 ≥25% or PEEP ≥ 4 cmH20 or HFNC rate ≥ 2 LPM for ≤8 hours
Written informed consent from parent/guardian

Exclusion Criteria:

Previous receipt of surfactant
Infants with respiratory distress who are unstable and require immediate intubation
Active air leak syndrome (e.g. pneumothorax, pneumomediastinum)
Lethal congenital malformations; death anticipated within first 3 days of life; decision to withhold support
Serious abdominal, cardiac, airway or respiratory malformations including tracheal esophageal fistula, intestinal atresia, omphalocele, gastroschisis, pulmonary hypoplasia, or diaphragmatic hernia
Neuromuscular disorder resulting in respiratory compromise
Intervention: Polidocanol
Trial phase: Phase 1 | Phase 2
ATC code: C05BB02
SMILES: CCCCCCCCCCCCOCCOCCOCCOCCOCCOCCOCCOCCOCCO
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 35
Group description: Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg.

Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Eligibility criteria:
Inclusion Criteria:

Infants admitted to the NICU at Hutzel Women's Hospital (HWH)/Children's Hospital of Michigan (CHM)
Gestational age of 240/7-366/7 weeks
Postnatal age ≤ 24 hours
Clinical diagnosis of RDS based on (i) presence of at least two of the four classic symptoms (need of supplemental oxygen, tachypnea, intercostal retractions or grunting), and (ii) exclusion of other causes of respiratory failure and (iii) Clinician intent to administer surfactant if infant requires intubation
Respiratory support with NIV (CPAP or NIPPV or HFNC) with FiO2 ≥25% or PEEP ≥ 4 cmH20 or HFNC rate ≥ 2 LPM for ≤8 hours
Written informed consent from parent/guardian

Exclusion Criteria:

Previous receipt of surfactant
Infants with respiratory distress who are unstable and require immediate intubation
Active air leak syndrome (e.g. pneumothorax, pneumomediastinum)
Lethal congenital malformations; death anticipated within first 3 days of life; decision to withhold support
Serious abdominal, cardiac, airway or respiratory malformations including tracheal esophageal fistula, intestinal atresia, omphalocele, gastroschisis, pulmonary hypoplasia, or diaphragmatic hernia
Neuromuscular disorder resulting in respiratory compromise
Intervention: Polidocanol
Trial phase: Phase 1 | Phase 2
ATC code: C05BB02
SMILES: CCCCCCCCCCCCOCCOCCOCCOCCOCCOCCOCCOCCOCCO
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 39
Group description: Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg.

Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Eligibility criteria:
Inclusion Criteria:

Infants admitted to the NICU at Hutzel Women's Hospital (HWH)/Children's Hospital of Michigan (CHM)
Gestational age of 240/7-366/7 weeks
Postnatal age ≤ 24 hours
Clinical diagnosis of RDS based on (i) presence of at least two of the four classic symptoms (need of supplemental oxygen, tachypnea, intercostal retractions or grunting), and (ii) exclusion of other causes of respiratory failure and (iii) Clinician intent to administer surfactant if infant requires intubation
Respiratory support with NIV (CPAP or NIPPV or HFNC) with FiO2 ≥25% or PEEP ≥ 4 cmH20 or HFNC rate ≥ 2 LPM for ≤8 hours
Written informed consent from parent/guardian

Exclusion Criteria:

Previous receipt of surfactant
Infants with respiratory distress who are unstable and require immediate intubation
Active air leak syndrome (e.g. pneumothorax, pneumomediastinum)
Lethal congenital malformations; death anticipated within first 3 days of life; decision to withhold support
Serious abdominal, cardiac, airway or respiratory malformations including tracheal esophageal fistula, intestinal atresia, omphalocele, gastroschisis, pulmonary hypoplasia, or diaphragmatic hernia
Neuromuscular disorder resulting in respiratory compromise
Intervention: Codeine
Trial phase: Not Applicable
ATC code: N02AA59 | N02AA79 | N02AJ06 | N02AJ07 | N02AJ08 | R05DA04
SMILES: [H][C@@]12C=C[C@H](O)[C@@H]3Oc4c(OC)ccc5c4[C@@]31CCN(C)[C@@H]2C5
Sex: Female
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 70
Group description: Participants received oral 30 mg of oral codeine (up to two doses).
Eligibility criteria:
Inclusion Criteria:

Pregnant women age 16 or older, admitted to the hospital or treated in the triage unit at 14 weeks gestation or greater, with subjective symptoms of persistent headache despite 650-1000 mg acetaminophen taken more than one hour before administration of study medication.

Exclusion Criteria:

Treatment with another headache-aborting medication other than acetaminophen within 24 hours Allergy to metoclopramide, diphenhydramine, or codeine Systolic blood pressure >/= 140 Diastolic blood pressure >/= 90 History of brain tumor Active diagnosis of hyperemesis Acute asthma exacerbation at time of presentation Active labor
Intervention: Propofol
Trial phase: Phase 4
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 14
Group description: Ketamine dose will be 0 mg/kg. Propofol dose for the first patient will be 4 mg/kg. Doses for the subsequent patients will increase or decrease by 1.6 mg/kg using the Dixon Up and Down method.

Propofol
Eligibility criteria:
Inclusion Criteria:

Age 3-13 years
Receiving general anesthesia for upper endoscopy

Exclusion Criteria:

Known or possible difficult airway
BMI > 35
Weight < 10 kg
Sedative premedication required
Known contraindication to ketamine or propofol
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 114
Group description: Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
Eligibility criteria:
Inclusion Criteria:

Adults greater than 18 years of age
Planning for outpatient surgical treatment of stress urinary incontinence with placement of a retropubic suburethral sling under general anesthesia

Exclusion Criteria:

Pregnant or nursing
Allergy to bupivacaine
History of drug/alcohol abuse
Severe cardiovascular, hepatic, renal disease, or neurological impairment
Long-acting opioid within 3 days or any opioid use within 24 hours before surgery
Contraindication to: acetaminophen, oxycodone, and/or non-steroidal anti-inflammatory drugs (NSAID)
Administration of an investigational drug within 30 days before study
Chronic pain syndromes
Daily NSAID/opioid use
Patients having concomitant procedures or not undergoing general anesthesia
Intervention: Ibuprofen
Trial phase: Phase 4
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 18
Group description: Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.
Eligibility criteria:
Inclusion Criteria:

≥4 and ≤17 years old
Meeting criteria for tonsillectomy based on AAO-HNS clinical guidelines: Adenotonsillectomy is indicated for patients with recurrent adenotonsillitis and sleep disordered breathing. Both groups in this study will have surgery for the same preoperative indications

Exclusion Criteria:

<4 or >17 years old
Known bleeding diathesis (or family history of bleeding diathesis)
Known allergy to any study medication
participant/caregiver inability to understand or complete the required study documentation (pain scales, medication logs)
Intervention: Remimazolam
Trial phase: Phase 3
ATC code: N05CD14
SMILES: COC(=O)CC[C@@H]1N=C(c2ccccn2)c2cc(Br)ccc2-n2c(C)cnc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 303
Group description: Remimazolam iv 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.
Eligibility criteria:
Inclusion Criteria:

Male and female patients, aged ≥18 years, scheduled to undergo a diagnostic or therapeutic flexible bronchoscopy in the bronchoscopy suite (therapeutic bronchoscopies could include eg, lavage, biopsies, brushings, and foreign body extraction).
American Society of Anesthesiologists Physical Status Score (ASA PS) 1 through 3.
Body mass index (BMI) ≤ 45.
Peripheral blood oxygen saturation (measured by pulse oximetry: SpO2) ≥ 90% in ambient air or with no more than 2 L/min of oxygen support.
For all female patients, negative result of urine pregnancy test. Additionally, for women of child bearing potential only, use of birth control during the study period (from the time of consent until all specified observations were completed).
Patients voluntarily signed and dated an informed consent form that was approved by an IRB prior to the conduct of any study procedure, including screening procedures.
Patient was willing and able to comply with study requirements and available for a follow up phone call on Day Day 4 (+3/ 1 days) after the bronchoscopy.

Exclusion Criteria:

Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition such that these agents were contraindicated.
Bronchoscopy outside the bronchoscopy unit (eg, intensive care unit).
Patients on mechanical ventilation.
Tracheal stenosis.
Planned laser bronchoscopy, rigid scope bronchoscopy.
Use of unstable doses of benzodiazepines and opioids for any indication, eg, insomnia, anxiety, or spasticity. An unstable dose means dose changes of more than 50% of the previous dose within 30 days prior to Day of procedure.
Female patients with a positive pregnancy test at Screening or Baseline and lactating female patients.
Patients with positive drugs of abuse screen (unless explained by concomitant medication) or a positive ethanol test at baseline.
Patient with a history of drug or ethanol abuse within the past two years.
Patients in receipt of any investigational drug or use of investigational device within 30 days or less than 7 t½ (whichever was longer) before the start of the study or scheduled to receive one during the study period.
Participation in any previous clinical study with remimazolam.
Patients with an inability to communicate well in English with the investigator or deemed unsuitable according to the investigator (in each case providing a reason).
Intervention: Midazolam
Trial phase: Phase 3
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 69
Group description: Midazolam iv 1.75 mg* for sedation induction and 1.0 mg* for sedation maintenance. *1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill.
Eligibility criteria:
Inclusion Criteria:

Male and female patients, aged ≥18 years, scheduled to undergo a diagnostic or therapeutic flexible bronchoscopy in the bronchoscopy suite (therapeutic bronchoscopies could include eg, lavage, biopsies, brushings, and foreign body extraction).
American Society of Anesthesiologists Physical Status Score (ASA PS) 1 through 3.
Body mass index (BMI) ≤ 45.
Peripheral blood oxygen saturation (measured by pulse oximetry: SpO2) ≥ 90% in ambient air or with no more than 2 L/min of oxygen support.
For all female patients, negative result of urine pregnancy test. Additionally, for women of child bearing potential only, use of birth control during the study period (from the time of consent until all specified observations were completed).
Patients voluntarily signed and dated an informed consent form that was approved by an IRB prior to the conduct of any study procedure, including screening procedures.
Patient was willing and able to comply with study requirements and available for a follow up phone call on Day Day 4 (+3/ 1 days) after the bronchoscopy.

Exclusion Criteria:

Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition such that these agents were contraindicated.
Bronchoscopy outside the bronchoscopy unit (eg, intensive care unit).
Patients on mechanical ventilation.
Tracheal stenosis.
Planned laser bronchoscopy, rigid scope bronchoscopy.
Use of unstable doses of benzodiazepines and opioids for any indication, eg, insomnia, anxiety, or spasticity. An unstable dose means dose changes of more than 50% of the previous dose within 30 days prior to Day of procedure.
Female patients with a positive pregnancy test at Screening or Baseline and lactating female patients.
Patients with positive drugs of abuse screen (unless explained by concomitant medication) or a positive ethanol test at baseline.
Patient with a history of drug or ethanol abuse within the past two years.
Patients in receipt of any investigational drug or use of investigational device within 30 days or less than 7 t½ (whichever was longer) before the start of the study or scheduled to receive one during the study period.
Participation in any previous clinical study with remimazolam.
Patients with an inability to communicate well in English with the investigator or deemed unsuitable according to the investigator (in each case providing a reason).
Intervention: Magnesium Sulfate
Trial phase: Phase 1 | Phase 2
ATC code: A06AD04 | A12CC02 | B05XA05 | D11AX05 | V04CC02
SMILES: O=S(=O)([O-])[O-].[Mg+2]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 34
Group description: In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.

Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)
Eligibility criteria:
Phase 1: Healthy Volunteers

Inclusion Criteria:

18 years of age or older
Provide informed consent
Agree to comply with study procedures
Deemed medically stable by their healthcare provider, including normal range blood pressure.
Have been clinically identified to be able to receive standard IV saline fluid

Exclusion Criteria:

Women with a history of heart disease of cardiac complications.
Women with a history of complications with an IV.

Phase 2: Pre-eclamptic Women

Inclusion Criteria:

18 years of age or older
Provide informed consent
Agree to comply with study procedures
Have systolic blood pressure P140mm Hg or a diastolic blood pressure P100mm Hg and proteinuria P1+.
Be pregnant or are <24 hours postpartum.
Diagnosed with pre-eclampsia and deemed to benefit from treatment with MGSO4 by healthcare providers

Exclusion Criteria:

Have systolic blood pressure P140mm Hg or a diastolic blood pressure P100mm Hg and proteinuria P1+.
Be pregnant or are <24 hours postpartum.