anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Metformin Hydrochloride
Trial phase: Phase 2
SMILES: CN(C)C(=N)N=C(N)N.Cl
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.
Eligibility criteria:
Inclusion Criteria:

Male > 18 years of age
Biopsy confirmed adenocarcinoma of the prostate
Able to swallow and retain oral medication
Hemoglobin A1C <7.0%
Able and willing to participate in the full 12 months of the study
Able to understand instructions related to study procedures
Able to read and write English

Exclusion Criteria:

Metastatic Prostate Cancer
Prostate Specific Antigen Doubling Time < 6 months
Prior Chemotherapy, hormonal therapy, oral glucocorticoid therapy, Gonadotropin-releasing hormone analogue therapy
Current or previous use of 5α-reductase inhibitors, antiandrogen drugs, metformin, oral or injectable diabetes drug
Diagnosis of Type 1 Diabetes Mellitus
Known hypersensitivity to metformin
any condition associated with increased risk of metformin associated lactic acidosis
participation in any investigational or marketed drug trial within 30 days prior to screening or during study period
any unstable, serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening
history of megaloblastic anemia
abnormal liver function test (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase or serum creatinine above upper limit of normal)
history of other malignancies, with the exception of adequately treated non-melanoma skin cancer, stage 1 melanoma, non-muscle invasive bladder cancer, or other solid tumors curatively treated with no evidence of disease for at least 5 years
history or current evidence of substance abuse within 12 months of screening
history of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or post an additional risk to the subject
Intervention: Metformin Hydrochloride
Trial phase: Phase 2
SMILES: CN(C)C(=N)N=C(N)N.Cl
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.
Eligibility criteria:
Inclusion Criteria:

Male > 18 years of age
Biopsy confirmed adenocarcinoma of the prostate
Able to swallow and retain oral medication
Hemoglobin A1C <7.0%
Able and willing to participate in the full 12 months of the study
Able to understand instructions related to study procedures
Able to read and write English

Exclusion Criteria:

Metastatic Prostate Cancer
Prostate Specific Antigen Doubling Time < 6 months
Prior Chemotherapy, hormonal therapy, oral glucocorticoid therapy, Gonadotropin-releasing hormone analogue therapy
Current or previous use of 5α-reductase inhibitors, antiandrogen drugs, metformin, oral or injectable diabetes drug
Diagnosis of Type 1 Diabetes Mellitus
Known hypersensitivity to metformin
any condition associated with increased risk of metformin associated lactic acidosis
participation in any investigational or marketed drug trial within 30 days prior to screening or during study period
any unstable, serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening
history of megaloblastic anemia
abnormal liver function test (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase or serum creatinine above upper limit of normal)
history of other malignancies, with the exception of adequately treated non-melanoma skin cancer, stage 1 melanoma, non-muscle invasive bladder cancer, or other solid tumors curatively treated with no evidence of disease for at least 5 years
history or current evidence of substance abuse within 12 months of screening
history of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or post an additional risk to the subject
Intervention: Sodium Nitrite
Trial phase: Phase 2
ATC code: V03AB08
SMILES: O=N[O-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: 64 nmol/min/kg sodium nitrite
Eligibility criteria:
Inclusion Criteria:

Informed consent obtained from a patient or legal representative before enrollment;
Admission to hospital following subarachnoid hemorrhage;
Aneurysm confirmed by digital subtraction angiography or CT-angiography after admission;
Development of the clinical symptoms and /or signs of cerebral vasospasm and CT-angiography results warranting cerebral angiography.

Exclusion Criteria:

Rupture of a fusiform, traumatic, or mycotic aneurysm;
Pregnancy (confirmed by a serum human chorionic gonadotropin pregnancy test) or breast feeding;
Methemoglobin > 2%
History of sickle cell disease, thalassemia, or other hemoglobinopathy;
Anemia with hemoglobin level less than 6 g/dL;
Significant acute or chronic concomitant diseases (including renal, hepatic, cardiovascular, pulmonary, or oncologic disease, sepsis, pulmonary edema, pulmonary embolism) that would be inconsistent with survival for at least 6 months;
History of allergy to nitrites or allergy to other substances that could interfere with nitrite metabolism, within 30 days before screening;
History of red blood cell glucose-6-phosphate dehydrogenase (G6PD)deficiency;
Treatment with allopurinol, a medication that could interfere with nitrite metabolism, within 30 days before screening;
Other investigational drug within the past 30 days;
other cerebral injury within the past 30 days including previous subarachnoid hemorrhage, stroke, transient ischemic attacks (TIA), concussion, head trauma, cranial surgery, radiation therapy to the head.
Intervention: Carvedilol
Trial phase: Phase 2
ATC code: C07AG02 | C07FX06
SMILES: COc1ccccc1OCCNCC(O)COc1cccc2[nH]c3ccccc3c12
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.

Carvedilol
Eligibility criteria:
Inclusion Criteria:

Female
Age ≥ 18 years
Non-metastatic histologically confirmed primary invasive breast carcinoma
Pathologically confirmed HER2-positive breast cancer
Scheduled to receive anthracycline chemotherapy followed by anti-HER2 therapy at MSKCC
Able and willing to provide informed consent
Willing and able to comply with the requirements of the protocol
Able to swallow capsules

For Aim 2, all patients must meet the following criteria:

Meet all inclusion criteria above

LVEF > 50%
Abnormal global longitudinal strain (<19%, or a % decrease of ≥ 11% from baseline) prior to initiation of planned anti-HER2 therapy
Heart rate ≥ 50 beats per minute
Sitting systolic blood pressure > 90 mmHg

Exclusion Criteria:

Patients are to be excluded from randomization for Aim 2 of this study if they meet any of the following criteria:
Current treatment with ACE-inhibitors or beta blockers
Allergies or inability to tolerate beta blockers previously due to bradycardia, hypotension, or AV block.
Known history of NCI CTCAE (Version 4.0) Grade ≥ 2 symptomatic CHF, myocardial infarction within 12 months prior to randomization, significant symptoms (Grade ≥ 3) relating to left ventricular dysfunction, significant (moderate or severe) valvular disease, or significant cardiac arrhythmia (Grade ≥ 3)
Pre-menopausal women without a negative serum or urine pregnancy test within 4 weeks of starting treatment
Enrollment in a therapeutic intervention trial in the Breast Medicine service
Intervention: Colchicine
Trial phase: Phase 3
ATC code: M04AC01
SMILES: COc1cc2c(c(OC)c1OC)-c1ccc(OC)c(=O)cc1[C@@H](NC(C)=O)CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
Eligibility criteria:
Inclusion Criteria:

All consecutive adult patients (age > 40) undergoing standard (non-minimally invasive) coronary artery bypass surgery and/or aortic valve surgery will be approached for enrollment.
All patients must be able to provide informed consent and comply with the 3 month follow-up.
For women of reproductive capability, contraception is necessary and required.

Exclusion Criteria:

Epidermal growth factor receptor (eGFR) < 30 mL/min/1.73 m^2, serum creatinine > 2.5 mg/dL or requiring dialysis
Known permanent or current atrial fibrillation (history of paroxysmal atrial fibrillation allowed if in sinus rhythm at present)
Allergy to colchicine or already treated with colchicine.
Known blood dyscrasia (acute or chronic leukemia, pancytopenia, aplastic anemia, leukopenia)
Known serious gastrointestinal disease
Known severe liver disease (cirrhosis, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2x the upper limit of normal, Model End Stage Liver Disease (MELD) score > 20)
Women of childbearing potential not using contraception.
Patients with HIV or AIDS as the use of protease inhibitors can result in serious colchicine toxicity.
Patients who are treated with strong CYP3A4 inhibitors (clarithromycin/erythromycin, chloramphenicol, ketoconazole/itraconazole, and nefazodone).
There is a risk of rhabdomyolysis with the use of digoxin and colchicine, we will exclude patients who require ongoing treatment with digoxin.
Inability or unwillingness of the individual to give written informed consent.
Intervention: Selonsertib
Trial phase: Phase 2
SMILES: Cc1cc(F)c(C(=O)Nc2cccc(-c3nncn3C(C)C)n2)cc1-n1cnc(C2CC2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 81
Group description: Selonsertib 2 mg tablet once daily for 48 weeks
Eligibility criteria:
Key Inclusion Criteria:

Adult male or females with prior diagnosis of Diabetic Kidney Disease
Type 2 diabetes mellitus diagnosis for at least 6 months
eGFR (MDRD) at screening ≥ 15 mL/min/1.73m^2 to < 60 mL/min/1.73m^2

Urine albumin to creatinine ratio (UACR) as follows:

Stage/Stratum 3a: eGFR range 45 to < 60 mL/min; UACR ≥ 600 mg/g
Stage/Stratum 3b: eGFR range 30 to < 45 mL/min; UACR ≥ 300 mg/g
Stage/Stratum 4: eGFR range 15 to < 30 mL/min; UACR ≥ 150 mg/g

Receiving angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin receptor blockers (ARB) at a minimum dose deemed appropriate for the individual by the investigator and be at a stable dose for the last three months

Individuals not on ACEi/ARB may be screened if there is documented intolerance to ACE inhibitor and/or ARB

Key Exclusion Criteria:

Type 1 diabetes mellitus
HbA1c > 9.5%
Non-diabetic kidney disease
UACR > 5000 mg/g on any measurement during screening
End stage renal disease (ESRD; receiving peritoneal dialysis, hemodialysis, or status post renal transplantation) or anticipated to occur within the treatment period
Unstable cardiovascular disease
Pregnant or lactating females

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Apixaban
Trial phase: Phase 3
ATC code: B01AF02
SMILES: COc1ccc(-n2nc(C(N)=O)c3c2C(=O)N(c2ccc(N4CCCCC4=O)cc2)CC3)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Active drug Apixaban 2.5mg taken by mouth twice a day

Apixaban: Drug is taken by mouth twice a day for 6 months
Eligibility criteria:
Inclusion Criteria:

documented HgbSS, SC or HgbS-beta0 thalassemia,
age ≥18 years old and ≤80,
seen in outpatient clinic ≥2 times in past year
seen for an acute care visit (hospitalization, emergency department, or day hospital visit) for pain >2 times in the past year.

Exclusion Criteria:

Hospitalization or day hospital visit for pain crisis within the past 2 weeks
Patients with ≥10 acute care visits within the past year will be excluded
Creatinine >3.0 mg/dL
creatinine ≥1.5 mg/dL AND weight ≤60 kg
chronic use of antiplatelet or anticoagulation medication
Patients with known vasculopathy or Moya-Moya
platelet count <100 X 109/L
AST or ALT >3 times normal
chronic red blood cell transfusions (scheduled transfusions)
packed red blood cell transfusion within the past 2 months
Use of CYP3A4 and P-gp inhibitor medications
Intervention: Gefitinib
Trial phase: Phase 2
ATC code: L01EB01 | L01XE02
SMILES: COc1cc2ncnc(Nc3ccc(F)c(Cl)c3)c2cc1OCCCN1CCOCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Gefitinib once daily followed by MEDI4736 - analyses not done due to low n
Eligibility criteria:
Inclusion Criteria:

Provision of archived tumor tissue sample and mandatory tissue biopsy
Patients must have either histologically or cytologically documented NSCLC who present with locally advanced or metastatic stage IIIB-IV disease
Life expectancy ≥12 weeks
Patients must have measurable disease and at least 1 lesion not previously irradiated
World Health Organization (WHO) performance status of 0 or 1

Exclusion Criteria:

Mixed small cell and NSCLC histology
Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
Intervention: Terconazole
Trial phase: Phase 4
ATC code: G01AG02
SMILES: CC(C)N1CCN(c2ccc(OC[C@@H]3CO[C@@](Cn4cncn4)(c4ccc(Cl)cc4Cl)O3)cc2)CC1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 140
Group description: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days

Terconazole Vaginal Suppository: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
Eligibility criteria:
Inclusion Criteria:

Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum VVC Composite Signs/Symptoms score of 7
Subject completes the informed consent process
Subject agrees to take study medication when scheduled
Subject complies with all clinical trial instructions. Commits to all follow-up visits
Subject agrees to abstain from sexual intercourse from the time of randomization through the first seven days immediately following treatment

Exclusion Criteria:

had any other sexually transmitted disease or gynaecological abnormality requiring treatment
had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods
had used antifungal medication in the week before entry; or
were expected to menstruate within seven days of the start of treatment
infected more than one candida species
Intervention: Fluconazole
Trial phase: Phase 4
ATC code: D01AC15 | J01RA07 | J02AC01
SMILES: OC(Cn1cncn1)(Cn1cncn1)c1ccc(F)cc1F
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 140
Group description: Orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.

Fluconazole: orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
Eligibility criteria:
Inclusion Criteria:

Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum VVC Composite Signs/Symptoms score of 7
Subject completes the informed consent process
Subject agrees to take study medication when scheduled
Subject complies with all clinical trial instructions. Commits to all follow-up visits
Subject agrees to abstain from sexual intercourse from the time of randomization through the first seven days immediately following treatment

Exclusion Criteria:

had any other sexually transmitted disease or gynaecological abnormality requiring treatment
had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods
had used antifungal medication in the week before entry; or
were expected to menstruate within seven days of the start of treatment
infected more than one candida species
Intervention: Voriconazole
Trial phase: Phase 3
ATC code: J02AC03
SMILES: C[C@@H](c1ncncc1F)[C@](O)(Cn1cncn1)c1ccc(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Eligibility criteria:
Inclusion Criteria:

Body weight >=45 kg
Can be treated by taking tablet orally or intravenous (IV) formulation via central vein
Female has a negative pregnancy test
Female of non-childbearing potential; or if of childbearing potential, agrees to use proper combination of barrier method of birth control
Met screening criteria for either Invasive aspergillosis, chronic pulmonary aspergillosis, zygomycosis or fusariosis.

Exclusion Criteria:

Has a fungal infection other than Aspergillus any species (spp.) Zygomycetes (including Mucor spp.) and Fusarium spp. infection
Has allergic bronchopulmonary aspergillosis, allergic sinusitis of aspergillosis, or aspergillosis of the eye
Has long-term inactive aspergilloma not expected to respond to investigational product
Is not expected to survive study duration
Has an underlying disease, complication and systemic condition which makes it difficult to evaluate effect of study drug
Has received, or continues to receive any systemic antifungal therapy, and cannot discontinue this treatment; but if fungal infection does not improve, can switch to study drug
Is expected to need prohibited medications
Has received posaconazole, has received voriconazole for this infection in the past and has deep-seated fungal infection that has not responded to this treatment, has intolerance for azole antifungal treatments, or is receiving antifungal combination therapy for chronic pulmonary aspergillosis
Has known hypersensitivity to any medication
Has history of either Torsade de Pointes, myocardial infarction within previous 90 days, has congenital or acquired long QT interval syndrome, or unstable cardiac arrhythmia
Has significant liver dysfunction
Has liver cirrhosis or cholestasis
Has renal insufficiency
Has a known hereditary problem of either galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Has acute symptomatic pancreatitis within 6 months of study entry or chronic pancreatitis
Has an active skin lesion consistent with squamous cell carcinoma or melanoma, or within prior 5 years a history of malignant melanoma
Has known or suspected Gilbert's disease
Female is pregnant, or nursing, or intends to become pregnant within 14 days after end of study.
Intervention: Voriconazole
Trial phase: Phase 3
ATC code: J02AC03
SMILES: C[C@@H](c1ncncc1F)[C@](O)(Cn1cncn1)c1ccc(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Participants with aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Eligibility criteria:
Inclusion Criteria:

Body weight >=45 kg
Can be treated by taking tablet orally or intravenous (IV) formulation via central vein
Female has a negative pregnancy test
Female of non-childbearing potential; or if of childbearing potential, agrees to use proper combination of barrier method of birth control
Met screening criteria for either Invasive aspergillosis, chronic pulmonary aspergillosis, zygomycosis or fusariosis.

Exclusion Criteria:

Has a fungal infection other than Aspergillus any species (spp.) Zygomycetes (including Mucor spp.) and Fusarium spp. infection
Has allergic bronchopulmonary aspergillosis, allergic sinusitis of aspergillosis, or aspergillosis of the eye
Has long-term inactive aspergilloma not expected to respond to investigational product
Is not expected to survive study duration
Has an underlying disease, complication and systemic condition which makes it difficult to evaluate effect of study drug
Has received, or continues to receive any systemic antifungal therapy, and cannot discontinue this treatment; but if fungal infection does not improve, can switch to study drug
Is expected to need prohibited medications
Has received posaconazole, has received voriconazole for this infection in the past and has deep-seated fungal infection that has not responded to this treatment, has intolerance for azole antifungal treatments, or is receiving antifungal combination therapy for chronic pulmonary aspergillosis
Has known hypersensitivity to any medication
Has history of either Torsade de Pointes, myocardial infarction within previous 90 days, has congenital or acquired long QT interval syndrome, or unstable cardiac arrhythmia
Has significant liver dysfunction
Has liver cirrhosis or cholestasis
Has renal insufficiency
Has a known hereditary problem of either galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Has acute symptomatic pancreatitis within 6 months of study entry or chronic pancreatitis
Has an active skin lesion consistent with squamous cell carcinoma or melanoma, or within prior 5 years a history of malignant melanoma
Has known or suspected Gilbert's disease
Female is pregnant, or nursing, or intends to become pregnant within 14 days after end of study.
Intervention: Clotrimazole
Trial phase: Phase 4
ATC code: A01AB18 | D01AC01 | G01AF02 | G01AF20
SMILES: Clc1ccccc1C(c1ccccc1)(c1ccccc1)n1ccnc1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 115
Group description: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)

Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
Eligibility criteria:
Inclusion Criteria:

Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum VVC Composite Signs/Symptoms score of 7
Subject completes the informed consent process
Subject agrees to take study medication when scheduled
Subject complies with all clinical trial instructions. Commits to all follow-up visits

Exclusion Criteria:

had any other sexually transmitted disease or gynaecological abnormality requiring treatment
had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods
were pregnant
had used antifungal medication in the week before entry
were expected to menstruate within seven days of the start of treatment
infected more than one candida species
Intervention: Fluconazole
Trial phase: Phase 4
ATC code: D01AC15 | J01RA07 | J02AC01
SMILES: OC(Cn1cncn1)(Cn1cncn1)c1ccc(F)cc1F
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 113
Group description: 2 doses of 150 mg oral Fluconazole (at day1 and day4)

Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)
Eligibility criteria:
Inclusion Criteria:

Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum VVC Composite Signs/Symptoms score of 7
Subject completes the informed consent process
Subject agrees to take study medication when scheduled
Subject complies with all clinical trial instructions. Commits to all follow-up visits

Exclusion Criteria:

had any other sexually transmitted disease or gynaecological abnormality requiring treatment
had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods
were pregnant
had used antifungal medication in the week before entry
were expected to menstruate within seven days of the start of treatment
infected more than one candida species