anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Metformin
Trial phase: Not Applicable
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 19
Group description: 12 weeks of Metformin tablet 850 mg 3 x daily

metformin: A 12 week single blind metformin
Eligibility criteria:
Inclusion Criteria:

Age 18-60

No smoking the past 6 months
Normal screening labs or no clinically significant values-except those listed below

Must have 3 of the following 4 characteristics established by NCEP-AHA-NHLBI

Males waist circumference greater than 40 inches, females greater than 35 inches
Blood pressure greater than 130/85 or on treatment with one or more antihypertensive agent
Fasting plasma triglycerides >150 or HDL <40 (males) <50 (females)
Fasting blood sugar >100 but <126

Subject may participate if on the following drugs, provided the drugs can remain at stable doses throughout the 12 week treatment interval.

Ace inhibitor
ARB
HMG CoA reductase inhibitor
Beta blocker
Calcium channel blockers
Alpha-adrenergic antagonist

Exclusion Criteria:

Smoking presently or in the past 6 months
HbA1c ≥ 6.5
Glucocorticoids-eg: prednisone, dexamethasone
Any known sensitivity or intolerance to Metformin
Any chronic GI disorders such as Irritable Bowel Syndrome or Crohns disease
History of congestive heart failure, ischemic heart disease, severe pulmonary disease, liver or kidney disease.
History of malignant or metabolic disorders including diabetes
Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by PI)
Hypersensitivity to perflutren (contained in Definity)
Pregnant or breastfeeding
Intervention: Doravirine
Trial phase: Phase 1
ATC code: J05AG06 | J05AR24
SMILES: Cn1c(Cn2ccc(C(F)(F)F)c(Oc3cc(Cl)cc(C#N)c3)c2=O)n[nH]c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Participants with severe renal impairment received a single oral dose of 100 mg doravirine
Eligibility criteria:
Inclusion Criteria:

is a non-smoker or moderate smoker
has a body mass index (BMI) ≥ 18.5 and ≤ 40.0 kg/m^2
other than renal impairment, participant is judged to be in good health based on medical history, physical examination, vital signs, and laboratory safety tests
female informed of the risks of pregnancy, agree not to become pregnant while participating in this study. Female of childbearing potential must either be sexually inactive for 14 days prior to dosing and throughout the study, or uses one acceptable birth control method
female of non-childbearing potential must have undergone sterilization procedures at least 6 months prior to dosing.
Participants with severe renal impairment only: has baseline estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2

Exclusion Criteria:

is mentally or legally incapacitated or has significant emotional problems
has a history or presence of clinically significant medical or psychiatric condition or disease
has history or presence of alcoholism or drug abuse within the past 2 years
has history or presence of hypersensitivity or idiosyncratic reaction to the study drug, any inactive ingredients, or related compounds
has history or presence of renal artery stenosis
has had a renal transplant or nephrectomy
has rapidly fluctuating renal function as determined by historical measurements
female is pregnant or lactating
has positive results for the urine or saliva drug and urine or breath alcohol screen at screening or check-in
has positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
is unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to dosing and throughout the study. Certain medications including those to treat kidney disease will be permitted. Other medications may be permitted following consultation with the Sponsor Clinical Monitor.
is unable to refrain from or anticipates the use of inducers of cytochrome P450 3A (CYP3A) or permeability glycoprotein (P-gp) transporters for at least 28 days prior to dosing and throughout the study.
has been on a diet incompatible with the on-study diet, within 28 days prior to dosing, and throughout the study
has donated blood or had significant blood loss within 56 days prior to dosing
has donated plasma within 7 days prior to dosing
has participated in another clinical trial within 28 days prior to dosing
Intervention: Doravirine
Trial phase: Phase 1
ATC code: J05AG06 | J05AR24
SMILES: Cn1c(Cn2ccc(C(F)(F)F)c(Oc3cc(Cl)cc(C#N)c3)c2=O)n[nH]c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine
Eligibility criteria:
Inclusion Criteria:

is a non-smoker or moderate smoker
has a body mass index (BMI) ≥ 18.5 and ≤ 40.0 kg/m^2
other than renal impairment, participant is judged to be in good health based on medical history, physical examination, vital signs, and laboratory safety tests
female informed of the risks of pregnancy, agree not to become pregnant while participating in this study. Female of childbearing potential must either be sexually inactive for 14 days prior to dosing and throughout the study, or uses one acceptable birth control method
female of non-childbearing potential must have undergone sterilization procedures at least 6 months prior to dosing.
Participants with severe renal impairment only: has baseline estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2

Exclusion Criteria:

is mentally or legally incapacitated or has significant emotional problems
has a history or presence of clinically significant medical or psychiatric condition or disease
has history or presence of alcoholism or drug abuse within the past 2 years
has history or presence of hypersensitivity or idiosyncratic reaction to the study drug, any inactive ingredients, or related compounds
has history or presence of renal artery stenosis
has had a renal transplant or nephrectomy
has rapidly fluctuating renal function as determined by historical measurements
female is pregnant or lactating
has positive results for the urine or saliva drug and urine or breath alcohol screen at screening or check-in
has positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
is unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to dosing and throughout the study. Certain medications including those to treat kidney disease will be permitted. Other medications may be permitted following consultation with the Sponsor Clinical Monitor.
is unable to refrain from or anticipates the use of inducers of cytochrome P450 3A (CYP3A) or permeability glycoprotein (P-gp) transporters for at least 28 days prior to dosing and throughout the study.
has been on a diet incompatible with the on-study diet, within 28 days prior to dosing, and throughout the study
has donated blood or had significant blood loss within 56 days prior to dosing
has donated plasma within 7 days prior to dosing
has participated in another clinical trial within 28 days prior to dosing
Intervention: Sirolimus
Trial phase: Phase 2
ATC code: L01EG04 | L04AA10 | S01XA23
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Adverse events are only reported for the treatment group who received the intervention.
Eligibility criteria:
Inclusion Criteria:

Women with confirmed menopausal status. All patients who have NOT had a prior bilateral oophorectomy and/or are younger than age 60, will require menopausal status verified by FSH and estradiol local labs.
Women diagnosed with DCIS/LCIS, Atypical lobular hyperplasia (ALH) or ADH lesions detected by pathology
Women scheduled for mastectomy or lumpectomy after DCIS/LCIS, ALH or ADH diagnosis
Women consented to the UT Health Cancer Center MD Anderson Cancer Center tissue biorepository (HSC20070684H)
Women of child-bearing potential willing to practice 2 forms of contraception, one of which must be a barrier method until at least 30 days after the last dose of rapamycin.
Women of child-bearing potential must have a negative serum pregnancy test at time of enrollment.
Patients must be able to swallow and retain oral medication.
All patients must have given signed informed consent prior to registration on study.

Patients must have normal organ and marrow function as defined below:

Leukocytes ≥ 3,000/uL
Absolute neutrophil count ≥ 1,500/uL
Platelets ≥ 100,000/uL
AST ≤ 2.5 X ULN
ALT ≤ 2.5 X ULN
Total bili ≤ 1.5 X ULN or Direct bili ≤ 1 X ULN

Exclusion Criteria:

Women who are pregnant.
Women who are receiving any other concomitant treatment for their DCIS/LCIS, ALH or ADH
Women who are taking rapamycin for another diagnosis.
Women with an allergy to rapamycin or its derivatives.
Active infection requiring systemic therapy.
Patients who are taking any pills containing herbal (alternative) medicines are NOT eligible for participation. Patients must be off any such medications by the time of registration.
Immunocompromised subjects, including patients with human immunodeficiency virus
Women currently taking strong CYP3A4 inducers or inhibitors. Drugs that cannot be coadministered with rapamycin include but are not limited to: Calcium channel blockers: nicardipine, Antifungal agents: clotrimazole, fluconazole, Antibiotics: troleandomycin, Gastrointestinal prokinetic agents: cisapride, metoclopramide, Other drugs: bromocriptine, cimetidine, danazol, HIV-protease inhibitors (e.g., ritonavir, indinavir), Anticonvulsants: carbamazepine, phenobarbital, phenytoin, Antibiotics: rifapentine. The research team can provide a full list of these medications.

Patients with any of the following conditions or complications are NOT eligible for participation:

GI tract disease resulting in an inability to take oral medication
Malabsorption syndrome
Require IV alimentation
History of prior surgical procedures affecting absorption
Uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)
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: 51
Group description: Oral Acetaminophen 1-hour before surgery

Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision
Eligibility criteria:
Inclusion Criteria:

Adult patients aged 18 years or older
Undergoing elective sinus surgery at Zale Lipshy Hospital

Exclusion Criteria:

Inability of the patient to follow directions or comprehend either English or Spanish language.

Disorders of the liver which would make acetaminophen contraindicated (such as hepatitis, liver failure, prior liver transplant, etc).
Patients with chronic pain manifest by a baseline pain score > 4/10
Chronic opioid use (>2 weeks continuously), or illicit drug abuse
Body weight < 50 kg.
Patients with contraindications to any of the study drugs (such as Malignant Hyperthermia susceptible, celecoxib or sulfa allergy, etc.).
Patients who have taken analgesic medications on the morning of surgery (prior to arrival).
Allergy to acetaminophen
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: 50
Group description: Intravenous Acetaminophen within 1-hour prior to anesthetic emergence

Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence.
Eligibility criteria:
Inclusion Criteria:

Adult patients aged 18 years or older
Undergoing elective sinus surgery at Zale Lipshy Hospital

Exclusion Criteria:

Inability of the patient to follow directions or comprehend either English or Spanish language.

Disorders of the liver which would make acetaminophen contraindicated (such as hepatitis, liver failure, prior liver transplant, etc).
Patients with chronic pain manifest by a baseline pain score > 4/10
Chronic opioid use (>2 weeks continuously), or illicit drug abuse
Body weight < 50 kg.
Patients with contraindications to any of the study drugs (such as Malignant Hyperthermia susceptible, celecoxib or sulfa allergy, etc.).
Patients who have taken analgesic medications on the morning of surgery (prior to arrival).
Allergy to acetaminophen
Intervention: Metformin
Trial phase: Phase 2
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Participants will be started on 500 mg of metformin once daily, with the following scheduled dose titrations:

Increase to 500mg twice daily at week 2
Increase to 1000mg qAM, 500mg qPM at week 4

Increase to 1000mg twice daily at week 6 for the duration of their participation (26 months).

Increased titrations based on tolerability

Metformin: Monitoring of tolerability and symptoms.
Eligibility criteria:
Inclusion Criteria:

Subject has Autosomal Dominant Polycystic Kidney Disease; Subject is fluent in English

Exclusion Criteria:

Subject is not on active military duty; Subject is not currently participating in another clinical trial; Subject's current GFR is not <50 cc/min/1.73m2; Subject does not have diabetes; Subject does not have a systemic disease other than hypertension and PKD; Subject does not have a solitary kidney; Subject does not have an allergy or intolerance to metformin; Subject is not pregnant or lactating or intending to become pregnant within the next three years; Subject does not have an unstable or unclipped cerebral aneurysm; Subject does not have active coronary artery disease; Subject does not have an MRI incompatible device/implant; Subject does not have severe claustrophobia; Subject has not had any solid organ transplant; Subject does not have a Vitamin B12 deficiency; Subject does not currently take any medications that interact with metformin, such as nifedipine, furosemide, cationic drugs (amiloride, ranitidine, triamterene digoxin, procainamide, quinidine, vancomycin, trimethoprim); Subject does not currently take nor has taken (within 2 weeks) the drug tolvaptan (Jynarque or Samsca)
Intervention: Oxycodone Hydrochloride
Trial phase: Phase 4
SMILES: COc1ccc2c3c1OC1C(=O)CCC4(O)C(C2)N(C)CCC314.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Oxycodone Hydrochloride: Oxycodone injection
Eligibility criteria:
Inclusion Criteria:

Adult men and women aged 19 years or more
Patients with cancerous pain who are hospitalized or scheduled for hospitalization at Screening and not planned to be discharged during the study
Patients with mean moderate to severe pain over the past 7 days at Screening as verbally confirmed (NRS 4 or higher)
Subjects who voluntarily signed the Informed Consent Form for the study
Subjects who are capable of understanding details of the study and verbal communication on pain intensity

Exclusion Criteria:

Patients who reached the narcotic analgesic dose corresponding to the followings for cancerous pain treatment immediately prior to Screening (oral morphine dose 195mg/day, oral oxycodone dose 130mg/day, patch fentanyl dose 75μg/hour)
Patients with a medical history of hypersensitivity to an ingredient of oxycodone hydrochloride or morphine sulfate or other narcotic analgesics
Patients who have contraindications and cautions when study drugs administered.
Intervention: Amiodarone
Trial phase: Phase 4
ATC code: C01BD01
SMILES: CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: < 10g oral loading dose of amiodarone
Eligibility criteria:
Inclusion Criteria:

New onset atrial fibrillation
Severe sepsis or septic shock (defined by ≥2 systemic inflammatory response syndrome criteria + infection)

Exclusion Criteria:

Age < 18 years
History of atrial flutter
History of atrial fibrillation
QTc >500 msec at baseline
2nd or 3rd degree AV block
Currently receiving anti-arrhythmic therapy
Untreated thyroid dysfunction
Acute or chronic hepatic failure
Other indication for antiarrhythmic therapy
Recent cardiac surgery in last 30 days
Pregnancy
Intervention: Amiodarone
Trial phase: Phase 4
ATC code: C01BD01
SMILES: CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: 10 g (+/- 20%) oral loading dose of amiodarone
Eligibility criteria:
Inclusion Criteria:

New onset atrial fibrillation
Severe sepsis or septic shock (defined by ≥2 systemic inflammatory response syndrome criteria + infection)

Exclusion Criteria:

Age < 18 years
History of atrial flutter
History of atrial fibrillation
QTc >500 msec at baseline
2nd or 3rd degree AV block
Currently receiving anti-arrhythmic therapy
Untreated thyroid dysfunction
Acute or chronic hepatic failure
Other indication for antiarrhythmic therapy
Recent cardiac surgery in last 30 days
Pregnancy
Intervention: Canagliflozin
Trial phase: Not Applicable
ATC code: A10BD16 | A10BK02
SMILES: [H][C@@]1(c2ccc(C)c(Cc3ccc(-c4ccc(F)cc4)s3)c2)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Subjects will undergo basal interruption with canagliflozin during an overnight stay on the research unit

canagliflozin: basal interruption with canagliflozin
Eligibility criteria:
Inclusion Criteria:

Age 18-45 years
Clinical diagnosis of T1D (type 1 diabetes) (formal antibody and/or genetic testing will not be required)
Duration of T1D ≥ 1 year
HbA1c ≤ 9 %
Treated with continuous subcutaneous insulin infusion (with or without adjunctive treatment with a SGLT2 inhibitor) for at least 3 months
Body weight > 40 kg
Be in good general health without other acute or chronic illness that in the judgment of the investigator could interfere with the study or jeopardize subject safety
Normal hematocrit
Able to give consent
Female subjects of reproductive potential must be abstinent or consistently using appropriate family planning methods.

Exclusion Criteria:

Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment)

Renal impairment, determined as eGFR < 60 ml/minute/1.73m2

History of unstable or rapidly progressing renal disease
Conditions of congenital renal glucosuria
Renal allograft
Recurrent UTI (urinary tract infection)
History of Vesico-ureteral-reflux disease
Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
Use of metformin, thiazolidinedione or GLP1 agonist within 1 month prior to screening visit. For those subjects on canagliflozin or other SGLT2 inhibitors, an alternate study procedure may be utilized as described above
Use of any medications (besides insulin or SGLT2 inhibitor) known to effect blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed as long as not given within 2 weeks of the closed loop admissions. Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites
History of hypoglycemic seizure within last 3 months
History of diabetic ketoacidosis (DKA) requiring medical intervention (ie. emergency room visit and/or hospitalization) within 1 month prior to the screening visit
Allergies or contraindication to the contents of canagliflozin tablets or insulin
Volume depleted subjects. Subjects at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics who cannot carefully monitor their volume status should be excluded from the study
Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
Recurrent GU (genitourinary) infections
Uncircumcised males secondary to increased risk of development of GU infections
History of hypotension, defined as blood pressure (BP) <10th% for age and sex
Intervention: Phenazopyridine hydrochloride
Trial phase: Phase 4
SMILES: Cl.Nc1ccc(N=Nc2ccccc2)c(N)n1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Method of administration: oral
Dose: 200 mg PO with small sip of water
Known adverse events: yellow discoloration of skin or sclera, 1-10% central nervous system effects including headache and dizziness, GI effect of cramping, < 1% acute renal failure, methemoglobinemia, hemolytic anemia, hepatitis, rash, skin pigmentation, vertigo, stomach cramps
Contraindications: to be used in caution in patients with renal impairment Cr Cl < 50ml/minute and in patients who are receiving nitric oxide, prilocaine and sodium nitrite as it can cause methemoglobinemia

Pyridium
Eligibility criteria:
Inclusion Criteria:

- Planned cystoscopy

Exclusion Criteria:

Women who are pregnant

Women with contraindications to pyridium, sodium fluorescein or mannitol:

Intra-operative administration of nitric oxide, prilocaine and sodium nitrite
Anuria
Women with creatinine greater than 1 or Cr Cl < 50ml/minute
Known allergy to pyridium, sodium fluorescein or mannitol.
Women with a known urologic anatomical anomaly
Intervention: Fluorescein Sodium
Trial phase: Phase 4
SMILES: O=C([O-])c1ccccc1-c1c2ccc(=O)cc-2oc2cc([O-])ccc12.[Na+].[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Method of administration: intravenous
Dose: 25 mg
Known adverse events: nausea, vomiting, flushing or rash, hypersensitivity and anaphylactic reactions can occur following injection and immediate treatment with epinephrine should be available, skin and urine discoloration (urine may appear bright yellow for 24-36 hours), extravasation may cause skin sloughing, toxic neuritis and phlebitis, nausea, rare cardiac arrest and seizure,
Contraindications: use with caution in patients with history of hypersensitivity, allergies or asthma

Sodium Fluorescein
Eligibility criteria:
Inclusion Criteria:

- Planned cystoscopy

Exclusion Criteria:

Women who are pregnant

Women with contraindications to pyridium, sodium fluorescein or mannitol:

Intra-operative administration of nitric oxide, prilocaine and sodium nitrite
Anuria
Women with creatinine greater than 1 or Cr Cl < 50ml/minute
Known allergy to pyridium, sodium fluorescein or mannitol.
Women with a known urologic anatomical anomaly