anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Etonogestrel
Trial phase: Phase 4
ATC code: G03AC08
SMILES: [H][C@@]12CC[C@@](O)(C#C)[C@@]1(CC)CC(=C)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21[H]
Sex: Female
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.

Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.
Eligibility criteria:
Inclusion Criteria:

1)Age 12-40 years 2)Must deliver at Duke Hospital 3)Must have a working telephone number 4)No contraindications to receiving this method of contraception, which include: known or suspected pregnancy, active liver disease or hepatic tumor, current or past history of thrombosis or thromboembolic disorder, undiagnosed abnormal genital bleeding, known or suspected breast cancer or history of breast cancer, hypersensitivity to any of the components of the device.

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Exclusion Criteria:

Not meeting inclusion criteria
Use of chronic medical therapy that has an adverse interaction with etonogestrel. Medications that will be cause for exclusion from the study include:

1. Non-nucleoside reverse transcriptase inhibitors 2. ritonavir-boosted protease inhibitors 3. Certain anticonvulsants - phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine 4. Rifampin 5. St. John's Wort

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Intervention: Indigo carmine
Trial phase: Phase 1 | Phase 2
ATC code: V04CH02
SMILES: O=C1C(c2[nH]c3ccc(S(=O)(=O)[O-])cc3c2O)=Nc2ccc(S(=O)(=O)[O-])cc21.[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Intraoperative stereotactic injection of Indigo Carmine

Indigo carmine: During resection, a small quantity of a special dye called indigo carmine will be infused at the margins of the tumor using computer-guided stereotactic navigation equipment. This dye will be visible during the tumor resection and it can potentially serve as an additional marker of the tumor margins. A post-operative MRI scan -which is part of the standard care- will accurately measure the extent of tumor resection.
Eligibility criteria:
Inclusion Criteria:

Subjects with gliomas or other tumors that may have ill defined margins during the operative resection.

Exclusion Criteria:

Subjects with a contraindication for brain MRI scan. Subjects who are pregnant, younger than 18 years old or have a contraindication for indigo carmine are excluded as well
Intervention: FLORBETAPIR
Trial phase: Phase 4
ATC code: V09AX05
SMILES: CNc1ccc(C=Cc2ccc(OCCOCCOCCF)nc2)cc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 19
Group description: [18F]Florbetapir and PET imaging
Eligibility criteria:
Eligibility criteria (for all subjects):

Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations
Willingness to comply with study procedures
Willingness to provide written informed consent
Age greater than or equal to 18 and less than or equal to 60 years old at the time of the informed consent
Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception until PET testing is completed
For females, must be of non-childbearing potential or have a negative urine and blood pregnancy test on the day of [18F]Florbetapir PET injection

Inclusion Criteria (Healthy Volunteers):

No history of or signs of acute or chronic neurological or psychiatric illness based on evaluation by a research physician.

Inclusion Criteria (MS Subjects):

Have a diagnosis of relapsing remitting MS according to the 2010 MacDonald Criteria
Have at least 10 demyelinating lesion on brain MRI with the following characteristics:
Hypointense on T2 weighted images with FLAIR

Exclusion Criteria (for all subjects):

The subject has clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological (other than RRMS), immunodeficiency, pulmonary, or other disorder or disease.
Women who are pregnant or actively breastfeeding
The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery)
The subject has participated in another clinical study within the previous 30 days
Renal impairment with a creatine clearance <80mL/minute at screening (creatine clearance estimated by Cockcroft-Gault equation)
The subject is scheduled to have a major surgery or procedure during the time of the study.
Intervention: Solifenacin
Trial phase: Phase 3
ATC code: G04BD08 | G04CA53
SMILES: O=C(O[C@H]1CN2CCC1CC2)N1CCc2ccccc2[C@@H]1c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 147
Group description: Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
Eligibility criteria:
Inclusion Criteria:

Symptoms of Overactive Bladder (OAB) (frequency/urgency) with urinary incontinence for at least 6 months
Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

Exclusion Criteria:

Overactive Bladder caused by neurological condition
Patient has predominance of stress incontinence
Use of anticholinergics or other medications to treat OAB symptoms in the 7 days prior to screening
Previous use of solifenacin
History or evidence of pelvic or urological abnormality
Previous use of any botulinum toxin of any serotype for any urological condition
Previous use of any botulinum toxin of any serotype for any non-urological condition within 12 weeks of randomization
Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
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: 8
Group description: Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
Eligibility criteria:
Inclusion Criteria:

Impaired Hepatic Function Participants:

A diagnosis of:

Chronic (> 6 months) hepatic insufficiency
Stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology
Score on the Child-Pugh Scale of 7 to 9 (moderate hepatic insufficiency)
Estimated creatinine clearance (CLCr) > 60 mL/min or glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m^2

Both Impaired Hepatic Function and Healthy Participants:

In general good health
Continuous non-smokers or moderate smokers for at least 3 months prior to study start
Body Mass Index ≤39 kg/m^2
Females of reproductive potential must have a negative pregnancy test and agree to use acceptable birth control method(s) or remain sexually inactive throughout study
Non-vasectomized male patients must agree to use acceptable birth control method(s) or abstain from sexual intercourse during the trial and for 3 months after the study

Exclusion Criteria:

Healthy Participants:

History or presence of alcoholism within the past 2 years
Presence of hepatitis B virus (HBV) or hepatitis virus C (HVC)

Both Impaired Hepatic Function and Healthy Participants:

History or presence of drug abuse within the past 2 years
History or presence of human immunodeficiency virus (HIV)
History or presence of significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (other than hepatic impairment), endocrine, immunologic, dermatologic, or neurological disease
Use of any medication or substance (including prescription or over the counter, health supplements, natural or herbal supplements) which cannot be

discontinued at least 14 days prior to the study start and throughout the study

Has been on a special diet within 28 days prior to the study start
Blood donation within 56 days or plasma donation within 7 days prior to study start
Participation in another clinical trial within 28 days of study start
Women who are pregnant or nursing
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: 8
Group description: Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
Eligibility criteria:
Inclusion Criteria:

Impaired Hepatic Function Participants:

A diagnosis of:

Chronic (> 6 months) hepatic insufficiency
Stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology
Score on the Child-Pugh Scale of 7 to 9 (moderate hepatic insufficiency)
Estimated creatinine clearance (CLCr) > 60 mL/min or glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m^2

Both Impaired Hepatic Function and Healthy Participants:

In general good health
Continuous non-smokers or moderate smokers for at least 3 months prior to study start
Body Mass Index ≤39 kg/m^2
Females of reproductive potential must have a negative pregnancy test and agree to use acceptable birth control method(s) or remain sexually inactive throughout study
Non-vasectomized male patients must agree to use acceptable birth control method(s) or abstain from sexual intercourse during the trial and for 3 months after the study

Exclusion Criteria:

Healthy Participants:

History or presence of alcoholism within the past 2 years
Presence of hepatitis B virus (HBV) or hepatitis virus C (HVC)

Both Impaired Hepatic Function and Healthy Participants:

History or presence of drug abuse within the past 2 years
History or presence of human immunodeficiency virus (HIV)
History or presence of significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (other than hepatic impairment), endocrine, immunologic, dermatologic, or neurological disease
Use of any medication or substance (including prescription or over the counter, health supplements, natural or herbal supplements) which cannot be

discontinued at least 14 days prior to the study start and throughout the study

Has been on a special diet within 28 days prior to the study start
Blood donation within 56 days or plasma donation within 7 days prior to study start
Participation in another clinical trial within 28 days of study start
Women who are pregnant or nursing
Intervention: Ranolazine
Trial phase: Phase 2
ATC code: C01EB18
SMILES: COc1ccccc1OCC(O)CN1CCN(CC(=O)Nc2c(C)cccc2C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Oral treatment Intervention: Drug: Ranolazine 1000 mg

Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI
Eligibility criteria:
Inclusion Criteria:

Age 18 or older
Patients undergoing Coronary Angiography with possible PCI
Able and willing to give consent
Able to read and write English

Exclusion Criteria:

Current EKG or Biomarker of Acute Myocardial Infarction (MI) or Acute Coronary Syndromes (ACS)
History of Allergy to Ranolazine
Pregnant or Nursing
Currently taking Ranolazine
Intervention: Ledipasvir
Trial phase: Phase 3
ATC code: J05AP51
SMILES: COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 109
Group description: LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Age > 18, with chronic genotype 1 HCV infection
HCV treatment-experienced, including patients who have previously failed a nonstructural protein (NS)3/4A protease inhibitor plus pegylated interferon (PEG)/RBV regimen
HCV RNA > 10,000 IU/mL at screening
Cirrhosis determination; a liver biopsy may be required
Screening laboratory values within defined thresholds
Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

Pregnant or nursing female or male with pregnant female partner
Coinfection with HIV or hepatitis B virus
Current or prior history of clinical hepatic decompensation
Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)
Chronic use of systemic immunosuppressive agents
History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Intervention: Avanafil
Trial phase: Phase 4
ATC code: G04BE10
SMILES: COc1ccc(CNc2nc(N3CCC[C@H]3CO)ncc2C(=O)NCc2ncccn2)cc1Cl
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 90
Group description: 100 mg once daily in the evening
Eligibility criteria:
Inclusion Criteria:

Provide written informed consent
Able to produce semen samples without requiring therapy (PDE5 inhibitors, over-the-counter (OTC) medication, and/or herbal supplements) for erectile dysfunction
Be medically healthy (no clinically significant screening results for medical history, electrocardiogram (ECG), laboratory studies, physical examination, etc.) in the opinion of the investigator
Be willing and able to comply with all study requirements

Exclusion Criteria:

An International Index of Erectile Function (IIEF) erectile function domain score of less than 17;
History of infertility, vasectomy, testicular mass, testicular trauma, testicular abnormality (including size), radiation to the testis, previous pelvic surgery, cryotherapy of the prostate, known sperm defect, or retrograde ejaculation, or cryptorchidism;
Resting heart rate <45 or >90 beats per minute at screening (3 rechecks permitted);
Screening systolic blood pressure <90 or >140 mmHg and/or diastolic blood pressure <50 or >90 mmHg (3 rechecks permitted);
High serum FSH (>18.0 mIU/mL), high serum LH (>18 mIU/mL), or low serum testosterone (< 270 ng/dL, early morning collection) on screening;
AST or ALT >2.0 x ULN or other evidence of significant hepatic impairment;
Prostate specific antigen (PSA) level ≥4 ng/mL at screening;
Individuals who perform rotating shift work during the course of the study.
Intervention: Midazolam
Trial phase: Not Applicable
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: 1.5 mg increments up to 3 times (maximum 4.5 mg)

Midazolam
Eligibility criteria:
Inclusion Criteria:

Patients >18 years-old who are undergoing elective colonoscopy with conscious sedation

Exclusion Criteria:

allergy or prior adverse reactions to diphenhydramine
medical contraindications to use of diphenhydramine (e.g. closed angle glaucoma)
pregnancy
Intervention: Isoflurophate
Trial phase: Phase 4
ATC code: S01EB07
SMILES: CC(C)OP(=O)(F)OC(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.

Deferiprone
Eligibility criteria:
Main Inclusion Criteria:

All subjects:

Adult males or females, 18 - 75 years of age (inclusive);
Body weight ≥ 45 kg;
Body mass index (BMI) range of approximately 18.5-32 kg/m^2 (inclusive);
Absolute neutrophil count (ANC) of >1.5x10^9/L;

Healthy volunteers:

Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, vital signs, physical examination);
eGFR ≥ 90 mL/min/1.73m^2;

Renally impaired subjects:

Considered clinically stable in the opinion of the Investigator;
Subjects with mild renal impairment (eGFR 60-89 mL/min/1.73m^E2) OR moderate renal impairment (eGFR 30-59 mL/min/1.73m^2) OR severe renal impairment (eGFR 15-29 mL/min/1.73m^2).

Main Exclusion Criteria:

History of renal transplant;
Subjects undergoing any method of dialysis;
History or presence of clinically unstable significant respiratory, cardiovascular, pulmonary, hepatic, renal (except for subjects assigned to one of the renally impaired groups), hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease;
Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the PK of the investigational medicinal product (e.g. cholecystectomy, resections of the small or large intestine, febrile conditions, chronic diarrhea, chronic vomiting, endocrine disease, severe infections, acute inflammations, etc.);
Clinically significant abnormalities on 12-lead ECG (e.g., QTcF≥430 ms in males or ≥450 ms in females);
Evidence of liver damage: hepatitis B and C; aspartate aminotransferase (AST), alanine aminotransferase (ALT) that is considered clinically significant by the Investigator;
Participation in another clinical trial within 28 days prior to the study drug administration;
Intervention: Isoflurophate
Trial phase: Phase 4
ATC code: S01EB07
SMILES: CC(C)OP(=O)(F)OC(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.

Deferiprone
Eligibility criteria:
Main Inclusion Criteria:

All subjects:

Adult males or females, 18 - 75 years of age (inclusive);
Body weight ≥ 45 kg;
Body mass index (BMI) range of approximately 18.5-32 kg/m^2 (inclusive);
Absolute neutrophil count (ANC) of >1.5x10^9/L;

Healthy volunteers:

Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, vital signs, physical examination);
eGFR ≥ 90 mL/min/1.73m^2;

Renally impaired subjects:

Considered clinically stable in the opinion of the Investigator;
Subjects with mild renal impairment (eGFR 60-89 mL/min/1.73m^E2) OR moderate renal impairment (eGFR 30-59 mL/min/1.73m^2) OR severe renal impairment (eGFR 15-29 mL/min/1.73m^2).

Main Exclusion Criteria:

History of renal transplant;
Subjects undergoing any method of dialysis;
History or presence of clinically unstable significant respiratory, cardiovascular, pulmonary, hepatic, renal (except for subjects assigned to one of the renally impaired groups), hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease;
Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the PK of the investigational medicinal product (e.g. cholecystectomy, resections of the small or large intestine, febrile conditions, chronic diarrhea, chronic vomiting, endocrine disease, severe infections, acute inflammations, etc.);
Clinically significant abnormalities on 12-lead ECG (e.g., QTcF≥430 ms in males or ≥450 ms in females);
Evidence of liver damage: hepatitis B and C; aspartate aminotransferase (AST), alanine aminotransferase (ALT) that is considered clinically significant by the Investigator;
Participation in another clinical trial within 28 days prior to the study drug administration;
Intervention: Isoflurophate
Trial phase: Phase 4
ATC code: S01EB07
SMILES: CC(C)OP(=O)(F)OC(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.

Deferiprone
Eligibility criteria:
Main Inclusion Criteria:

All subjects:

Adult males or females, 18 - 75 years of age (inclusive);
Body weight ≥ 45 kg;
Body mass index (BMI) range of approximately 18.5-32 kg/m^2 (inclusive);
Absolute neutrophil count (ANC) of >1.5x10^9/L;

Healthy volunteers:

Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, vital signs, physical examination);
eGFR ≥ 90 mL/min/1.73m^2;

Renally impaired subjects:

Considered clinically stable in the opinion of the Investigator;
Subjects with mild renal impairment (eGFR 60-89 mL/min/1.73m^E2) OR moderate renal impairment (eGFR 30-59 mL/min/1.73m^2) OR severe renal impairment (eGFR 15-29 mL/min/1.73m^2).

Main Exclusion Criteria:

History of renal transplant;
Subjects undergoing any method of dialysis;
History or presence of clinically unstable significant respiratory, cardiovascular, pulmonary, hepatic, renal (except for subjects assigned to one of the renally impaired groups), hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease;
Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the PK of the investigational medicinal product (e.g. cholecystectomy, resections of the small or large intestine, febrile conditions, chronic diarrhea, chronic vomiting, endocrine disease, severe infections, acute inflammations, etc.);
Clinically significant abnormalities on 12-lead ECG (e.g., QTcF≥430 ms in males or ≥450 ms in females);
Evidence of liver damage: hepatitis B and C; aspartate aminotransferase (AST), alanine aminotransferase (ALT) that is considered clinically significant by the Investigator;
Participation in another clinical trial within 28 days prior to the study drug administration;
Intervention: Aristospan
Trial phase: Phase 2
SMILES: CC(C)(C)CC(=O)OCC(=O)C12OC(C)(C)OC1CC1C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC12C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.

Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
Eligibility criteria:
Inclusion Criteria:

Female
18-80 years of age
TMJ arthralgia
Masticatory myalgia
TMJ sounds
History of at least 6 weeks use of occlusal appliance therapy

Exclusion Criteria:

Contraindication to sedation including pregnancy or medical history
History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy
History of steroidal injection into TMJ
History of trauma to TMJ
TMJ pain longer than 3 years
History of narcotic drug use on a scheduled basis
Current active infection