anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Droperidol
Trial phase: Not Applicable
ATC code: N05AD08
SMILES: O=C(CCCN1CC=C(n2c(=O)[nH]c3ccccc32)CC1)c1ccc(F)cc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 19
Group description: Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
Eligibility criteria:
Inclusion Criteria:

18 years old to 65 years old, diagnosis of primary headache

Exclusion Criteria:

Allergy to study medications, pregnant, breast-feeding, prisoners, non-english speaking, not eligible to receive droperidol based on ED protocol (see below), patients in whom head trauma, infection, vascular disorders, and disorders of facial or cranial structures are suspected

ED Droperidol Protocol

Droperidol must NOT be used in patients with any of the following:

Known or suspected QT prolongation, including congenital long QT syndrome
Cardiac Disease [cardiomyopathy, congestive heart failure, hypertension, ischemic heart disease, myocardial infarction, bradycardia (< 50 bpm)]

History of the following:

Renal failure
Cerebrovascular disease
Diabetes or hypoglycemia
Alcoholism/alcohol abuse
Pituitary insufficiency
Hypothyroidism
Hypothermia
Anorexia
Advanced age (>65 yrs)
Use of the following medications: digoxin, benzodiazepine, diuretics, IV opiates, or other medications known to prolong the QTc interval.
Intervention: Mexiletine
Trial phase: Phase 2
ATC code: C01BB02
SMILES: Cc1cccc(C)c1OCC(C)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Adverse Events for Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
Eligibility criteria:
Inclusion Criteria:

A diagnosis of DM1, confirmed by DM1 genetic mutation
Ability to walk 30 feet (assistance with cane and/or leg bracing permitted)
Presence of grip myotonia

Exclusion Criteria:

Congenital DM1
Treatment with Mexiletine within past 8 weeks
Second or third degree heart block, atrial flutter, atrial fibrillation, ventricular arrhythmias, or is receiving medication for treatment of a cardiac arrhythmia
Receiving another antimyotonia drug
Liver or kidney disease requiring ongoing treatment
Has a seizure disorder
Is pregnant or lactating
Had severe depression within 3 months or a history of suicide ideation
Has any one of the following medical conditions: uncontrolled diabetes mellitus, congestive heart failure, symptomatic cardiomyopathy, symptomatic coronary artery disease, cancer (other than skin cancer) less than five years previously, multiple sclerosis, or other serious medical illness.
Drug or alcohol abuse within 3 months
Coexistence of another neuromuscular disease
Is unable to give informed consent
Severe arthritis or other medical condition (besides DM1) that would significantly impact ambulation
Intervention: Omarigliptin
Trial phase: Phase 1
SMILES: CS(=O)(=O)n1cc2c(n1)CN([C@H]1CO[C@H](c3cc(F)ccc3F)[C@@H](N)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
Eligibility criteria:
Inclusion Criteria:

Impaired Renal Function Subjects:

Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control
Diagnosis of renal insufficiency based on estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) equation

Healthy Subjects:

Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control;
In general good health

Exclusion Criteria:

Impaired Renal Function Subjects:

Is mentally or legally incapacitated
Has rapidly fluctuating renal function or has demonstrated or suspected renal artery stenosis
History of significant endocrine (other than Type 2 diabetes), gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
History of stroke, chronic seizures or major neurological disease
Uncontrolled Type 2 diabetes or history of Type 1 diabetes or ketoacidosis
History of cancer (Some exceptions apply)
Regular user of barbiturates or sleep aides
Consumes excessive amounts of alcohol (more than 2 drinks/day)
Consumes excessive amounts of caffeinated beverages (more than 6/day)
Has had major surgery or has lost or donated 1 unit of blood within 4 weeks
Has a history of significant multiple and/or severe allergies
Current or history of illicit drug abuse
Nursing mothers

Healthy Subjects:

Is mentally or legally incapacitated;
Has a history of stroke, chronic seizures, or major neurological disorder
Renal impairment
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
Hypoglycemia, glucose intolerance, Type 1 or Type 2 diabetes, or ketoacidosis
History of cancer (Some exceptions apply)
Regular user of barbiturates or sleep aides
Consumes excessive amounts of alcohol (more than 2 drinks/day)
Consumes excessive amounts of caffeinated beverages (more than 6/day)
Has had major surgery or has lost or donated 1 unit of blood within 4 weeks
Has a history of significant multiple and/or severe allergies
Current or history of illicit drug abuse
Nursing mothers
Intervention: Omarigliptin
Trial phase: Phase 1
SMILES: CS(=O)(=O)n1cc2c(n1)CN([C@H]1CO[C@H](c3cc(F)ccc3F)[C@@H](N)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
Eligibility criteria:
Inclusion Criteria:

Impaired Renal Function Subjects:

Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control
Diagnosis of renal insufficiency based on estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) equation

Healthy Subjects:

Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control;
In general good health

Exclusion Criteria:

Impaired Renal Function Subjects:

Is mentally or legally incapacitated
Has rapidly fluctuating renal function or has demonstrated or suspected renal artery stenosis
History of significant endocrine (other than Type 2 diabetes), gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
History of stroke, chronic seizures or major neurological disease
Uncontrolled Type 2 diabetes or history of Type 1 diabetes or ketoacidosis
History of cancer (Some exceptions apply)
Regular user of barbiturates or sleep aides
Consumes excessive amounts of alcohol (more than 2 drinks/day)
Consumes excessive amounts of caffeinated beverages (more than 6/day)
Has had major surgery or has lost or donated 1 unit of blood within 4 weeks
Has a history of significant multiple and/or severe allergies
Current or history of illicit drug abuse
Nursing mothers

Healthy Subjects:

Is mentally or legally incapacitated;
Has a history of stroke, chronic seizures, or major neurological disorder
Renal impairment
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
Hypoglycemia, glucose intolerance, Type 1 or Type 2 diabetes, or ketoacidosis
History of cancer (Some exceptions apply)
Regular user of barbiturates or sleep aides
Consumes excessive amounts of alcohol (more than 2 drinks/day)
Consumes excessive amounts of caffeinated beverages (more than 6/day)
Has had major surgery or has lost or donated 1 unit of blood within 4 weeks
Has a history of significant multiple and/or severe allergies
Current or history of illicit drug abuse
Nursing mothers
Intervention: Omarigliptin
Trial phase: Phase 1
SMILES: CS(=O)(=O)n1cc2c(n1)CN([C@H]1CO[C@H](c3cc(F)ccc3F)[C@@H](N)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
Eligibility criteria:
Inclusion Criteria:

Impaired Renal Function Subjects:

Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control
Diagnosis of renal insufficiency based on estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) equation

Healthy Subjects:

Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control;
In general good health

Exclusion Criteria:

Impaired Renal Function Subjects:

Is mentally or legally incapacitated
Has rapidly fluctuating renal function or has demonstrated or suspected renal artery stenosis
History of significant endocrine (other than Type 2 diabetes), gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
History of stroke, chronic seizures or major neurological disease
Uncontrolled Type 2 diabetes or history of Type 1 diabetes or ketoacidosis
History of cancer (Some exceptions apply)
Regular user of barbiturates or sleep aides
Consumes excessive amounts of alcohol (more than 2 drinks/day)
Consumes excessive amounts of caffeinated beverages (more than 6/day)
Has had major surgery or has lost or donated 1 unit of blood within 4 weeks
Has a history of significant multiple and/or severe allergies
Current or history of illicit drug abuse
Nursing mothers

Healthy Subjects:

Is mentally or legally incapacitated;
Has a history of stroke, chronic seizures, or major neurological disorder
Renal impairment
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
Hypoglycemia, glucose intolerance, Type 1 or Type 2 diabetes, or ketoacidosis
History of cancer (Some exceptions apply)
Regular user of barbiturates or sleep aides
Consumes excessive amounts of alcohol (more than 2 drinks/day)
Consumes excessive amounts of caffeinated beverages (more than 6/day)
Has had major surgery or has lost or donated 1 unit of blood within 4 weeks
Has a history of significant multiple and/or severe allergies
Current or history of illicit drug abuse
Nursing mothers
Intervention: Omarigliptin
Trial phase: Phase 1
SMILES: CS(=O)(=O)n1cc2c(n1)CN([C@H]1CO[C@H](c3cc(F)ccc3F)[C@@H](N)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
Eligibility criteria:
Inclusion Criteria:

Impaired Renal Function Subjects:

Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control
Diagnosis of renal insufficiency based on estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) equation

Healthy Subjects:

Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control;
In general good health

Exclusion Criteria:

Impaired Renal Function Subjects:

Is mentally or legally incapacitated
Has rapidly fluctuating renal function or has demonstrated or suspected renal artery stenosis
History of significant endocrine (other than Type 2 diabetes), gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
History of stroke, chronic seizures or major neurological disease
Uncontrolled Type 2 diabetes or history of Type 1 diabetes or ketoacidosis
History of cancer (Some exceptions apply)
Regular user of barbiturates or sleep aides
Consumes excessive amounts of alcohol (more than 2 drinks/day)
Consumes excessive amounts of caffeinated beverages (more than 6/day)
Has had major surgery or has lost or donated 1 unit of blood within 4 weeks
Has a history of significant multiple and/or severe allergies
Current or history of illicit drug abuse
Nursing mothers

Healthy Subjects:

Is mentally or legally incapacitated;
Has a history of stroke, chronic seizures, or major neurological disorder
Renal impairment
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
Hypoglycemia, glucose intolerance, Type 1 or Type 2 diabetes, or ketoacidosis
History of cancer (Some exceptions apply)
Regular user of barbiturates or sleep aides
Consumes excessive amounts of alcohol (more than 2 drinks/day)
Consumes excessive amounts of caffeinated beverages (more than 6/day)
Has had major surgery or has lost or donated 1 unit of blood within 4 weeks
Has a history of significant multiple and/or severe allergies
Current or history of illicit drug abuse
Nursing mothers
Intervention: Omarigliptin
Trial phase: Phase 1
SMILES: CS(=O)(=O)n1cc2c(n1)CN([C@H]1CO[C@H](c3cc(F)ccc3F)[C@@H](N)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
Eligibility criteria:
Inclusion Criteria:

Impaired Renal Function Subjects:

Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control
Diagnosis of renal insufficiency based on estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) equation

Healthy Subjects:

Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control;
In general good health

Exclusion Criteria:

Impaired Renal Function Subjects:

Is mentally or legally incapacitated
Has rapidly fluctuating renal function or has demonstrated or suspected renal artery stenosis
History of significant endocrine (other than Type 2 diabetes), gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
History of stroke, chronic seizures or major neurological disease
Uncontrolled Type 2 diabetes or history of Type 1 diabetes or ketoacidosis
History of cancer (Some exceptions apply)
Regular user of barbiturates or sleep aides
Consumes excessive amounts of alcohol (more than 2 drinks/day)
Consumes excessive amounts of caffeinated beverages (more than 6/day)
Has had major surgery or has lost or donated 1 unit of blood within 4 weeks
Has a history of significant multiple and/or severe allergies
Current or history of illicit drug abuse
Nursing mothers

Healthy Subjects:

Is mentally or legally incapacitated;
Has a history of stroke, chronic seizures, or major neurological disorder
Renal impairment
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
Hypoglycemia, glucose intolerance, Type 1 or Type 2 diabetes, or ketoacidosis
History of cancer (Some exceptions apply)
Regular user of barbiturates or sleep aides
Consumes excessive amounts of alcohol (more than 2 drinks/day)
Consumes excessive amounts of caffeinated beverages (more than 6/day)
Has had major surgery or has lost or donated 1 unit of blood within 4 weeks
Has a history of significant multiple and/or severe allergies
Current or history of illicit drug abuse
Nursing mothers
Intervention: Omarigliptin
Trial phase: Phase 1
SMILES: CS(=O)(=O)n1cc2c(n1)CN([C@H]1CO[C@H](c3cc(F)ccc3F)[C@@H](N)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
Eligibility criteria:
Inclusion Criteria:

Impaired Renal Function Subjects:

Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control
Diagnosis of renal insufficiency based on estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) equation

Healthy Subjects:

Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control;
In general good health

Exclusion Criteria:

Impaired Renal Function Subjects:

Is mentally or legally incapacitated
Has rapidly fluctuating renal function or has demonstrated or suspected renal artery stenosis
History of significant endocrine (other than Type 2 diabetes), gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
History of stroke, chronic seizures or major neurological disease
Uncontrolled Type 2 diabetes or history of Type 1 diabetes or ketoacidosis
History of cancer (Some exceptions apply)
Regular user of barbiturates or sleep aides
Consumes excessive amounts of alcohol (more than 2 drinks/day)
Consumes excessive amounts of caffeinated beverages (more than 6/day)
Has had major surgery or has lost or donated 1 unit of blood within 4 weeks
Has a history of significant multiple and/or severe allergies
Current or history of illicit drug abuse
Nursing mothers

Healthy Subjects:

Is mentally or legally incapacitated;
Has a history of stroke, chronic seizures, or major neurological disorder
Renal impairment
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
Hypoglycemia, glucose intolerance, Type 1 or Type 2 diabetes, or ketoacidosis
History of cancer (Some exceptions apply)
Regular user of barbiturates or sleep aides
Consumes excessive amounts of alcohol (more than 2 drinks/day)
Consumes excessive amounts of caffeinated beverages (more than 6/day)
Has had major surgery or has lost or donated 1 unit of blood within 4 weeks
Has a history of significant multiple and/or severe allergies
Current or history of illicit drug abuse
Nursing mothers
Intervention: Omarigliptin
Trial phase: Phase 1
SMILES: CS(=O)(=O)n1cc2c(n1)CN([C@H]1CO[C@H](c3cc(F)ccc3F)[C@@H](N)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
Eligibility criteria:
Inclusion Criteria:

Impaired Renal Function Subjects:

Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control
Diagnosis of renal insufficiency based on estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) equation

Healthy Subjects:

Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control;
In general good health

Exclusion Criteria:

Impaired Renal Function Subjects:

Is mentally or legally incapacitated
Has rapidly fluctuating renal function or has demonstrated or suspected renal artery stenosis
History of significant endocrine (other than Type 2 diabetes), gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
History of stroke, chronic seizures or major neurological disease
Uncontrolled Type 2 diabetes or history of Type 1 diabetes or ketoacidosis
History of cancer (Some exceptions apply)
Regular user of barbiturates or sleep aides
Consumes excessive amounts of alcohol (more than 2 drinks/day)
Consumes excessive amounts of caffeinated beverages (more than 6/day)
Has had major surgery or has lost or donated 1 unit of blood within 4 weeks
Has a history of significant multiple and/or severe allergies
Current or history of illicit drug abuse
Nursing mothers

Healthy Subjects:

Is mentally or legally incapacitated;
Has a history of stroke, chronic seizures, or major neurological disorder
Renal impairment
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
Hypoglycemia, glucose intolerance, Type 1 or Type 2 diabetes, or ketoacidosis
History of cancer (Some exceptions apply)
Regular user of barbiturates or sleep aides
Consumes excessive amounts of alcohol (more than 2 drinks/day)
Consumes excessive amounts of caffeinated beverages (more than 6/day)
Has had major surgery or has lost or donated 1 unit of blood within 4 weeks
Has a history of significant multiple and/or severe allergies
Current or history of illicit drug abuse
Nursing mothers
Intervention: Buprenorphine
Trial phase: Phase 3
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
Eligibility criteria:
Inclusion Criteria:

Age 21 and older
Major depressive disorder
Non-responder to at least 2 FDA-approved antidepressants prescribed at a therapeutic dose, each for at least 6 weeks, or is a depression non-responder from an ongoing study of late-life depression at our research clinic.
For women of child-bearing age, must have negative pregnancy test and agree not to get pregnant while participating.

Exclusion Criteria:

Concomitant use of strong or moderate CYP3A4 inhibitor.
Refusal to stop all opioids.
Refusal to discontinue all alcohol.
Refusal to discontinue benzodiazepines other than the equivalent of lorazepam 2 mg/day prescribed at a stable dose for at least the past 2 weeks.
Hepatic impairment (AST/ALT > 1.5 times upper normal).
Lung disease requiring supplemental oxygen (CPAP for sleep apnea is acceptable).
Estimated creatinine clearance <30 mL/min.
Inability to provide informed consent.
Depressive symptoms not severe enough (i.e., MADRS < 10) at the baseline assessment.
Dementia, as defined by MMSE < 24 and clinical evidence of dementia
Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms.
Abuse of or dependence on alcohol or other substances within the past 3 months.
Meets criteria for history of abuse or dependence upon opioids.
High risk for suicide.
Contraindication to buprenorphine.
Inability to communicate in English.
Non-correctable clinically significant sensory impairment.
Unstable medical illness.
Subjects taking psychotropic medications that cannot be safely tapered and discontinued prior to study initiation.