anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: H-His-Gly-Glu-Gly-aThr-Phe-aThr-Ser-Asp-Val-Ser-Ser-Tyr-Leu-Glu-Gly-Gln-D-Ala-D-Ala-Lys-Glu-Phe-aIle-D-Ala-Trp-Leu-Val-Lys-Gly-Arg-NH2
Trial phase: Phase 4
ATC code: A10BJ04
SMILES: CCC(C)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CCC(=O)O)NC(=O)C(CCCCN)NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(N)=O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)CNC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(C)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(C)C)C(=O)NC(C(=O)NC(CCCCN)C(=O)NCC(=O)NC(CCCNC(=N)N)C(N)=O)C(C)C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: The participants in this arm, self-administered, albiglutide liquid drug product 50 mg at a volume of 1 mL, as a single dose subcutaneous injection in the abdomen, thigh or upper arm region, once weekly, for 26-weeks. It was administered on the same day each week, anytime during the day without regards to meals. The first dose was self-administered by the participant in the supervision from clinic staff. All further doses of study treatment were self-administered by the participant.
Eligibility criteria:
Inclusion Criteria:

Subjects who have completed the 26 week Treatment Phase of Study 200952
Male or female
Able and willing to provide informed consent.

Exclusion Criteria:

Subject meets one or more of the withdrawal stopping criteria at Visit 1 (Week 26)
Intervention: Ferumoxides
Trial phase: Phase 4
SMILES: [Fe+2].[Fe+3].[Fe+3].[O-2].[O-2].[O-2].[O-2]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 17
Group description: Ferumoxytol, 4mg/kg of body weight, one time infusion of several minutes

ferumoxytol: ferumoxytol as an MRI contrast agent infused over several minutes
Eligibility criteria:
Inclusion Criteria:

Male or female pediatric patients of all ethnicities (age newborn to 6 years) with known or suspected CHD with inconclusive echocardiographic exams and are referred for cardiovascular MRI for further evaluation of cardiac anatomy and function.
Written informed consent obtained from subject's legal representative/guardian(s) and ability for subject to comply with the requirements of the study

Exclusion Criteria:

Standard clinical contraindications to MRI, including subjects with cochlear implants and implanted cardiac devices
Subjects with past or current diagnosis of iron overload due to hereditary hemochromatosis or other causes (for subjects receiving Feraheme injection only).
Subjects with known hypersensitivity or allergy to iron oxide particles.
Subjects with renal insufficiency defined as estimated glomerular filtration rate (eGFR) < 40 mL/min/1.73m2 (for subjects receiving Ablavar injection only).
Subjects who are critically ill at the time of MRI and for whom the period of general anesthesia and separation from the critical care nursery or intensive care unit poses added risk as deemed by referring cardiologists, cardiac surgeons or the managing radiologist (for Part II only).
Other medical conditions, in the judgment of the clinician investigator, that would increase the risks to the child related to participation in the study.
Intervention: Tranexamic acid
Trial phase: Not Applicable
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: 1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery

Tranexamic Acid
Eligibility criteria:
Inclusion Criteria:

Subjects undergoing burn excision surgery for standard of care purposes (to include: greater than or equal to 350 cm2 of full thickness or deep partial thickness burns)
Male or female > 18 years of age
Subject or subject's medical decision maker agrees to participate in this study and provides informed consent

Exclusion Criteria:

Subjects with a history of hypercoagulopathy, deep vein thrombosis (DVT), pulmonary embolism
Baseline creatinine level greater than 2.83 mg/dL
Subjects with known hypersensitivity to tranexamic acid
Patients with acquired defective color vision
Patients with subarachnoid hemorrhage
Children
Pregnant women
Prisoners
Intervention: Entresto
Trial phase: Phase 4
SMILES: CCCCC(=O)N(Cc1ccc(-c2ccccc2-c2nnn[n-]2)cc1)C(C(=O)[O-])C(C)C.CCCCC(=O)N(Cc1ccc(-c2ccccc2-c2nnn[n-]2)cc1)C(C(=O)[O-])C(C)C.CCOC(=O)C(C)CC(Cc1ccc(-c2ccccc2)cc1)NC(=O)CCC(=O)[O-].CCOC(=O)C(C)CC(Cc1ccc(-c2ccccc2)cc1)NC(=O)CCC(=O)[O-].O.O.O.O.O.[Na+].[Na+].[Na+].[Na+].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: REMODEL is a prospective, single-arm longitudinal study investigating the structural, neurohormonal and functional effects of sacubitril/valsartan. Patients with New York Heart Association (NYHA) Class II-III HFrEF who were on optimal guideline directed medical therapy for at least three months with an LVEF between 20-40% who otherwise met inclusion and exclusion criteria similar to that of the Paradigm Trial were eligible for enrollment.
Eligibility criteria:
Inclusion Criteria:

Males and females aged ≥18 years

Congestive Heart Failure (CHF) New York Heart Association (NYHA) class II-IV with 25%≤ Left Ventricular Ejection Fraction (LVEF) ≤40% (ECHO within last 6 months)

NT-proBNP ≥ 600 pg/mL OR
NT-proBNP ≥ 400 pg/mL and a hospitalization for heart failure within the last 12 months
Stable and optimized on an angiotensin-converting-enzyme inhibitor (ACEI) equivalent to enalapril ≥ 10 twice a day (BID) for at least 4 weeks
Stable and optimized on a beta-blocker for at least 4 weeks
Optimized dosing of aldosterone antagonist at stable dose for at least 4 weeks

Exclusion Criteria:

History of angioedema
estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2 at screening
Serum potassium > 5.2 mmol/L at screening
Symptomatic hypotension as defined by Investigator, systolic blood pressure (SBP) < 100 mmHg at screening
Current acute decompensated heart failure
History of severe pulmonary disease
Active malignancy
Requirement for treatment with both angiotensin-converting-enzyme inhibitor (ACEI) and angiotensin receptor blockers (ARB)
Intervention: Pilocarpine
Trial phase: Not Applicable
ATC code: N07AX01 | S01EB01 | S01EB51
SMILES: CC[C@@H]1C(=O)OC[C@@H]1Cc1cncn1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Subjects with open-angle glaucoma, ocular hypertension or pseudoexfoliation glaucoma.

Pilocarpine: Pilocarpine will be administered 4 times in addition to latanoprost.
Eligibility criteria:
Inclusion Criteria:

Current confirmed diagnosis of:

open angle glaucoma, or
ocular hypertension including pigment dispersion glaucoma, and
pseudoexfoliation glaucoma.
Current use of topical latanoprost once a day in both eyes for at least 6 weeks
any race/ethnicity

Exclusion Criteria:

Females who are currently pregnant or planning to become pregnant during the study period
Diagnosis of any other form of glaucoma other than open-angle
Intraocular pressure readings of <14mmHg in either eye when measured during routine office visit in the past 12 months.
Schaffer angle grade < 2 in either eye by gonioscopy
Intraocular surgery within 6 months or laser within 3 months
History of retinal tear or detachment in either eye
Active iritis in either eye as determined by most recent eye examination
Patients who smoke or have irregular daily sleep patterns
Patients who have started or changed glucocorticoids therapy in the last 3 months
Patients who are currently using medical or recreational marijuana
Any use of a non-FDA approved medication for glaucoma in the last 3 months
Intervention: Olanzapine
Trial phase: Phase 2
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 71
Group description: 10-mg dose of olanzapine by mouth prior to anesthetic induction
Eligibility criteria:
Inclusion Criteria:

Adults age ≥ 18 and ≤ 50 years old
Patient scheduled to undergo ambulatory surgery under general anesthesia
Willing and able to provide informed consent

Exclusion Criteria:

Unable to swallow pills
Current use of typical or atypical anti-psychotic medications
History of allergy to olanzapine
Pregnancy/Lactation (subjects of child-bearing potential will have a urine pregnancy test performed the day of surgery)
History of QTc > 450ms or torsades de pointes
Current use of antihypertensive medication
Diabetes Mellitus

Clinically significant cardiovascular disease defined as follows:

Myocardial infarction or unstable angina within 6 months prior to the day of planned surgery.
History of serious ventricular arrhythmia (i.e.: ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications, except for atrial fibrillation that is well controlled on anti-arrhythmic medication.
New York Heart Association (NYHA) Class II or higher congestive heart failure.
Postural hypotension or vasovagal syncope within 6 months of planned surgery.
Hypotension on day of surgery, defined as a systolic blood pressure < 90mm Hg or a diastolic pressure < 60mm Hg.
Seizure disorder
Clinically active prolactinoma
Hepatic disease
Poorly controlled diabetes
Pre-operative blood glucose > 250 mg/dL
Narrow angle glaucoma
Parkinson's disease
Lewy body dementia
Intervention: Metronidazole
Trial phase: Not Applicable
ATC code: A01AB17 | A02BD01 | A02BD02 | A02BD03 | A02BD08 | A02BD11 | A02BD13 | A02BD15 | D06BX01 | G01AF01 | G01AF20 | J01RA03 | J01RA04 | J01RA10 | J01RA14 | J01XD01 | P01AB01 | P01AB51 | P01AB52
SMILES: Cc1ncc([N+](=O)[O-])n1CCO
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 41
Group description: Patients receivingMetronidazole for preprocedure antibiotic
Eligibility criteria:
Inclusion Criteria:

Women in good general health.
English speaking.
Age 18 or over.
Seeking non-urgent surgical termination of pregnancy.
Gestational age of 5 0/7 to 13 6/7 weeks, confirmed by sonogram.

Exclusion Criteria:

Less than 18 years of age.
Early pregnancy failure or fetal demise.
Poor general health that would prevent one from tolerating the medication or surgical procedure.
Intolerance, allergy, or contraindication to any of the study medications.
Inability to tolerate oral intake due to current nausea or vomiting.
Diagnosis of hyperemesis gravidarum with current pregnancy.
Need of an urgent surgical abortion.
Gestational age outside of 5-13 6/7 weeks by sonogram.
Intervention: Azithromycin
Trial phase: Not Applicable
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 46
Group description: Patients receiving Azithromycin for preprocedure antibiotic
Eligibility criteria:
Inclusion Criteria:

Women in good general health.
English speaking.
Age 18 or over.
Seeking non-urgent surgical termination of pregnancy.
Gestational age of 5 0/7 to 13 6/7 weeks, confirmed by sonogram.

Exclusion Criteria:

Less than 18 years of age.
Early pregnancy failure or fetal demise.
Poor general health that would prevent one from tolerating the medication or surgical procedure.
Intolerance, allergy, or contraindication to any of the study medications.
Inability to tolerate oral intake due to current nausea or vomiting.
Diagnosis of hyperemesis gravidarum with current pregnancy.
Need of an urgent surgical abortion.
Gestational age outside of 5-13 6/7 weeks by sonogram.
Intervention: Doxycycline
Trial phase: Not Applicable
ATC code: A01AB22 | J01AA02 | J01AA20
SMILES: [H][C@@]12C(=C(O)[C@]3(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]3([H])[C@H]1O)C(=O)c1c(O)cccc1[C@@H]2C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 42
Group description: Patients receiving Doxycycline for preprocedure antibiotic
Eligibility criteria:
Inclusion Criteria:

Women in good general health.
English speaking.
Age 18 or over.
Seeking non-urgent surgical termination of pregnancy.
Gestational age of 5 0/7 to 13 6/7 weeks, confirmed by sonogram.

Exclusion Criteria:

Less than 18 years of age.
Early pregnancy failure or fetal demise.
Poor general health that would prevent one from tolerating the medication or surgical procedure.
Intolerance, allergy, or contraindication to any of the study medications.
Inability to tolerate oral intake due to current nausea or vomiting.
Diagnosis of hyperemesis gravidarum with current pregnancy.
Need of an urgent surgical abortion.
Gestational age outside of 5-13 6/7 weeks by sonogram.
Intervention: Cetirizine
Trial phase: Phase 3
ATC code: R06AE07 | R06AE09 | S01GX12
SMILES: O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 343
Group description: 1 drop in each eye 3 times daily for up to 6 weeks

AC-170 0.24%
Eligibility criteria:
Inclusion Criteria:

at least 2 years of age
be able to self-administer eye drops or have a parent/legal guardian available for this purpose
if less than 18 years old have a history or family history of atopic disease (including allergic conjunctivitis)
have ocular health within normal limits

Exclusion Criteria:

known contraindications or sensitivities to the study medication or its components
any ocular condition that, in the opinion of the investigator, could affect the subjects safety trial parameters
use of disallowed medication during the period indicated prior to the enrollment or during the study
be pregnant, nursing, or planning a pregnancy
Intervention: Baricitinib
Trial phase: Phase 1
ATC code: L04AA37
SMILES: CCS(=O)(=O)N1CC(CC#N)(n2cc(-c3ncnc4[nH]ccc34)cn2)C1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: 2mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
Eligibility criteria:
Inclusion Criteria:

Are overtly healthy Chinese males agreed to use methods of birth control or are postmenopausal Chinese females, as determined by medical history and physical examination
Have a body mass index of 19.0 to 24.0 kilograms per meter squared (kg/m²), inclusive, at screening.
Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.

Exclusion Criteria:

Have a history of adverse drug reactions or "drug allergy" to more than 3 types of systemically administered medications.
Have an abnormality in the 12-lead electrocardiogram (ECG).
Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
Have a history of stomach or intestinal surgery.
Current or recent history (<30 days prior to screening of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection.
Have an absolute neutrophil count (ANC) less than 2000 cell/microliter (μL) (2 x 109/liter [L]).
Have current herpes zoster or simplex within 90 days prior to the first dose,
Have evidence of active or latent tuberculosis (TB)
Have used or intend to use over-the-counter, prescription medication, or Chinese herbal preparation within 14 days prior to dosing and during the study.
Have consumed grapefruit, grapefruit juice, or grapefruit products within 7 days prior to the first dose or are unwilling to abide by the grapefruit restrictions during the study.
Intervention: Baricitinib
Trial phase: Phase 1
ATC code: L04AA37
SMILES: CCS(=O)(=O)N1CC(CC#N)(n2cc(-c3ncnc4[nH]ccc34)cn2)C1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 9
Group description: 4mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
Eligibility criteria:
Inclusion Criteria:

Are overtly healthy Chinese males agreed to use methods of birth control or are postmenopausal Chinese females, as determined by medical history and physical examination
Have a body mass index of 19.0 to 24.0 kilograms per meter squared (kg/m²), inclusive, at screening.
Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.

Exclusion Criteria:

Have a history of adverse drug reactions or "drug allergy" to more than 3 types of systemically administered medications.
Have an abnormality in the 12-lead electrocardiogram (ECG).
Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
Have a history of stomach or intestinal surgery.
Current or recent history (<30 days prior to screening of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection.
Have an absolute neutrophil count (ANC) less than 2000 cell/microliter (μL) (2 x 109/liter [L]).
Have current herpes zoster or simplex within 90 days prior to the first dose,
Have evidence of active or latent tuberculosis (TB)
Have used or intend to use over-the-counter, prescription medication, or Chinese herbal preparation within 14 days prior to dosing and during the study.
Have consumed grapefruit, grapefruit juice, or grapefruit products within 7 days prior to the first dose or are unwilling to abide by the grapefruit restrictions during the study.
Intervention: Baricitinib
Trial phase: Phase 1
ATC code: L04AA37
SMILES: CCS(=O)(=O)N1CC(CC#N)(n2cc(-c3ncnc4[nH]ccc34)cn2)C1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: 10mg baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days).
Eligibility criteria:
Inclusion Criteria:

Are overtly healthy Chinese males agreed to use methods of birth control or are postmenopausal Chinese females, as determined by medical history and physical examination
Have a body mass index of 19.0 to 24.0 kilograms per meter squared (kg/m²), inclusive, at screening.
Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.

Exclusion Criteria:

Have a history of adverse drug reactions or "drug allergy" to more than 3 types of systemically administered medications.
Have an abnormality in the 12-lead electrocardiogram (ECG).
Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
Have a history of stomach or intestinal surgery.
Current or recent history (<30 days prior to screening of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection.
Have an absolute neutrophil count (ANC) less than 2000 cell/microliter (μL) (2 x 109/liter [L]).
Have current herpes zoster or simplex within 90 days prior to the first dose,
Have evidence of active or latent tuberculosis (TB)
Have used or intend to use over-the-counter, prescription medication, or Chinese herbal preparation within 14 days prior to dosing and during the study.
Have consumed grapefruit, grapefruit juice, or grapefruit products within 7 days prior to the first dose or are unwilling to abide by the grapefruit restrictions during the study.
Intervention: Ataluren
Trial phase: Phase 2
ATC code: M09AX03
SMILES: O=C(O)c1cccc(-c2noc(-c3ccccc3F)n2)c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 15
Group description: ataluren: Powder formulation
Eligibility criteria:
Inclusion Criteria:

Age ≥ 2 years old and ≤ 12 years old, male or female, at Week 0 (at time informed consent/assent is signed)

Documentation of a diagnosis of Dravet syndrome or CDKL5 deficiency resulting from a nonsense mutation in 1 allele, as evidenced by medical records, genetic testing, and the following clinical feature:

a. Failure to control seizures despite appropriate trial of 2 or more AEDs at therapeutic doses

Between 1 to 3 baseline AEDs at stable doses for a minimum for 4 weeks prior to the Baseline visit

a. Vagus nerve stimulator (VNS), ketogenic diet, and modified Atkins diet do not count towards this limit but must be unchanged for 3 months prior to enrollment (Baseline).

VNS must be on stable settings for a minimum of 3 months prior to the Baseline visit
If on ketogenic or modified Atkins diet, must be on stable ratio for a minimum of 3 months prior to the Baseline visit
Written consent obtained from the patient or patient's legal representative must be obtained prior to performing any study procedures
Minimum of 6 convulsive or drop seizures with duration > 3 seconds over the 4 weeks of diary screening prior to randomization and ≥ 6 convulsive or drop seizures with duration > 3 seconds during the 4 weeks from Screening to Baseline.

Exclusion Criteria:

Patient is < 2 years old or ≥ 12 years old
Epilepsies associated with genetic disorders other than Dravet syndrome or CDKL5 deficiency
Patient has Dravet or CDKL5 genetic mutations that are NOT nonsense mutations
Felbatol has been initiated within the past 12 months prior to the Screening Visit
Patients who are currently or have participated in clinical trials in the 30 days prior to enrollment (Baseline Visit)
Prior or ongoing medical condition (eg, concomitant illness, psychiatric condition), medical history, physical findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the patient, makes it unlikely that the course of study drug administration or follow-up would be completed, or could impair the assessment of study results.
Ongoing intravenous administration of aminoglycosides or vancomycin.