anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Prasugrel
Trial phase: Phase 4
ATC code: B01AC22
SMILES: CC(=O)Oc1cc2c(s1)CCN(C(C(=O)C1CC1)c1ccccc1F)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Patients will be randomly (1:1) assigned to receive FDA approved doses of either prasugrel (60 mg loading dose - 10 mg/day maintenance dose) or ticagrelor (180 mg loading dose - 90 mg b.i.d maintenance dose).

Prasugrel: Maintenance dose will be maintained for 10±3 days.
Eligibility criteria:
Inclusion criteria:

Patients with CAD [defined as the presence of at least a 50% stenosis in a major epicardial vessel or major branch, or any prior coronary revascularization (PCI or coronary bypass graft surgery)] on treatment with either aspirin (81mg/day) or aspirin and clopidogrel (75m/day) for at least 30 days as per standard of care
Participated in UFJ 2016-14 study with genetic buccal swab test and have at least one CYP 2C19 LOF allele (CYP2C19*2 and CYP2C19*3)
Women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study.

Exclusion criteria:

Known allergies to prasugrel or ticagrelor
Weight <60kg
Considered at high risk for bleeding
Currently active bleeding
History of ischemic or hemorrhagic stroke or transient ischemic attack, or intracranial hemorrhage
Known severe hepatic dysfunction
On treatment with oral anticoagulant therapy (Vitamin K antagonists, dabigatran, apixaban, rivaroxaban)
Platelet count <80x106/mL
Hemoglobin <10 g/dL.
Creatinine Clearance <30 mL/minute
Patients with sick sinus syndrome (SSS) or high degree AV block without pacemaker protection.
Current treatment with drugs interfering with CYP3A4 metabolism (to avoid interaction with ticagrelor): CYP3A Inhibitors (ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin ) and CYP3A Inducers (rifampin, phenytoin, carbamazepine, and phenobarbital)
Pregnant or breastfeeding females
Intervention: Ticagrelor
Trial phase: Phase 4
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Patients will be randomly (1:1) assigned to receive FDA approved doses of either prasugrel (60 mg loading dose - 10 mg/day maintenance dose) or ticagrelor (180 mg loading dose - 90 mg b.i.d maintenance dose).

Ticagrelor: Maintenance dose will be maintained for 10±3 days.
Eligibility criteria:
Inclusion criteria:

Patients with CAD [defined as the presence of at least a 50% stenosis in a major epicardial vessel or major branch, or any prior coronary revascularization (PCI or coronary bypass graft surgery)] on treatment with either aspirin (81mg/day) or aspirin and clopidogrel (75m/day) for at least 30 days as per standard of care
Participated in UFJ 2016-14 study with genetic buccal swab test and have at least one CYP 2C19 LOF allele (CYP2C19*2 and CYP2C19*3)
Women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study.

Exclusion criteria:

Known allergies to prasugrel or ticagrelor
Weight <60kg
Considered at high risk for bleeding
Currently active bleeding
History of ischemic or hemorrhagic stroke or transient ischemic attack, or intracranial hemorrhage
Known severe hepatic dysfunction
On treatment with oral anticoagulant therapy (Vitamin K antagonists, dabigatran, apixaban, rivaroxaban)
Platelet count <80x106/mL
Hemoglobin <10 g/dL.
Creatinine Clearance <30 mL/minute
Patients with sick sinus syndrome (SSS) or high degree AV block without pacemaker protection.
Current treatment with drugs interfering with CYP3A4 metabolism (to avoid interaction with ticagrelor): CYP3A Inhibitors (ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin ) and CYP3A Inducers (rifampin, phenytoin, carbamazepine, and phenobarbital)
Pregnant or breastfeeding females
Intervention: Acetazolamide
Trial phase: Phase 4
ATC code: G01AE10 | S01EC01
SMILES: CC(=O)Nc1nnc(S(N)(=O)=O)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: One (1) dose of 250mg of Acetazolamide

Acetazolamide: Administration of Acetazolamide
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age
Able to consent
English speaking
Trekking directly to Everest Base Camp

Exclusion Criteria:

Age less than 18 years
Non-English speaking
Pregnant
Already had a diagnosis of acute mountain sickness, high-altitude cerebral edema, or high-altitude pulmonary edema
Been on a high-altitude trek 2 weeks prior to this study
Has taken acetazolamide 1 week prior to start of trek
Has a sulfa allergy
Has any type of acute or chronic pulmonary conditions
Intervention: Buprenorphine
Trial phase: Phase 2
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: 47
Group description: This is the main and only arm of the study. All patients in this arm will undergo the steps outlined in the protocol to convert to buprenorphine treatment.

buprenorphine: Patients in this study will receive dosages to be determined by a physician that are specific to each patient.
Eligibility criteria:
Inclusion Criteria:

Sickle Cell Disease, any genotype
On disease modifying therapy (either chronic transfusions or hydroxyurea)
On chronic daily full agonist opioid therapy with doses ranging from 90 to 400 morphine equivalents
Have greater than 5 acute care visits in the last 6 months or have daily pain of 7 or higher on the Visual Analog Scale despite chronic opioid therapy.
Able to provide consent
Has medical insurance

Exclusion Criteria:

Acute vaso-occlusive crisis on day of or day prior to buprenorphine initiation
Use of methadone as long acting opioid (due to prolonged half-life and limited data in other populations)
Use of illicit drugs as documented by urine toxicology screen (except for THC)
Pregnancy
Acute or severe bronchial asthma
Hypersensitivity to buprenorphine or any component of the product
Medical disorder, condition, or history that in the investigator's judgement would impair the patient's ability to participate or complete this study or render the patient to be inappropriate for enrollment.
Intervention: Taurodeoxycholic acid
Trial phase: Phase 1
SMILES: CC(CCC(=O)NCCS(=O)(=O)O)C1CCC2C3CCC4CC(O)CCC4(C)C3CC(O)C12C
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: single dose of HY209 0.5% gel

total 6 subjects assigned.
Eligibility criteria:
Inclusion Criteria:

Healthy male aged from 20 to 50 at screening test
Weight 45kg ~ 90kg with BMI 17kg/m2 ~ 27kg/m2
No skin diseases, no skin damages(scars, tattoo, etc), no hairy skin

Exclusion Criteria:

Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to generic drugs (aspirin, antibiotics, etc.)
Those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic diseases, mental diseases, especially hemorrhagic diseases (hemophilia, von Willebrand disease, etc.), cardiovascular diseases (coronary artery disease, Congestive heart failure, arrhythmia, cerebrovascular disease, etc.) or who have a history of those diseases
Those who had clinical symptoms suspected of acute infectious disease within 2 weeks before the scheduled date of the first administration, or whose temperature measured by the screening test (eardrum) was 38.0 ° C or higher
Those who have taken any prescription drugs, herbal medicines, crude drugs within 2 weeks before the scheduled date of administration of the medicines for clinical trials , or over-the-counter medicines or vitamin preparations within 1 week.
Those who have a history of substance abuse, or positive urine screening tests (cannabinoid, opiates, amphetamine, cocaine, barbiturate, benzodiazepine)
Those who have a history of smoking within 3 months (However, if they quit smoking three months before the first scheduled medication, they are eligible for selection)
Those who have been found to be positive in serological tests (HBs antigen, hepatitis C virus antibody and HIV antibody)
Those who drink continuously (above 21 units / week, 1 unit = 10 g of pure alcohol)
Those who have been taking medicines by participating in other clinical trials or bioequivalence studies within 3 months prior to the date of first dosing
Those who have been bleeding, blood drawings or blood donation of 400mL or more within 8 weeks before the scheduled date of administration of the drug for clinical trials

Those who have vital signs measured at sitting position after the break for more than 3 minutes,

Low blood pressure (systolic blood pressure <90 mmHg, diastolic blood pressure <50 mmHg)
High blood pressure (systolic blood pressure greater than 150 mmHg, diastolic blood pressure greater than 100 mmHg)
Test subjects who are deemed unsuitable for participating in clinical trials due to clinical laboratory tests, ECG results, or other reasons
Intervention: Taurodeoxycholic acid
Trial phase: Phase 1
SMILES: CC(CCC(=O)NCCS(=O)(=O)O)C1CCC2C3CCC4CC(O)CCC4(C)C3CC(O)C12C
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: multiple dose of HY209 0.1% gel

total 6 subjects assigned.
Eligibility criteria:
Inclusion Criteria:

Healthy male aged from 20 to 50 at screening test
Weight 45kg ~ 90kg with BMI 17kg/m2 ~ 27kg/m2
No skin diseases, no skin damages(scars, tattoo, etc), no hairy skin

Exclusion Criteria:

Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to generic drugs (aspirin, antibiotics, etc.)
Those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic diseases, mental diseases, especially hemorrhagic diseases (hemophilia, von Willebrand disease, etc.), cardiovascular diseases (coronary artery disease, Congestive heart failure, arrhythmia, cerebrovascular disease, etc.) or who have a history of those diseases
Those who had clinical symptoms suspected of acute infectious disease within 2 weeks before the scheduled date of the first administration, or whose temperature measured by the screening test (eardrum) was 38.0 ° C or higher
Those who have taken any prescription drugs, herbal medicines, crude drugs within 2 weeks before the scheduled date of administration of the medicines for clinical trials , or over-the-counter medicines or vitamin preparations within 1 week.
Those who have a history of substance abuse, or positive urine screening tests (cannabinoid, opiates, amphetamine, cocaine, barbiturate, benzodiazepine)
Those who have a history of smoking within 3 months (However, if they quit smoking three months before the first scheduled medication, they are eligible for selection)
Those who have been found to be positive in serological tests (HBs antigen, hepatitis C virus antibody and HIV antibody)
Those who drink continuously (above 21 units / week, 1 unit = 10 g of pure alcohol)
Those who have been taking medicines by participating in other clinical trials or bioequivalence studies within 3 months prior to the date of first dosing
Those who have been bleeding, blood drawings or blood donation of 400mL or more within 8 weeks before the scheduled date of administration of the drug for clinical trials

Those who have vital signs measured at sitting position after the break for more than 3 minutes,

Low blood pressure (systolic blood pressure <90 mmHg, diastolic blood pressure <50 mmHg)
High blood pressure (systolic blood pressure greater than 150 mmHg, diastolic blood pressure greater than 100 mmHg)
Test subjects who are deemed unsuitable for participating in clinical trials due to clinical laboratory tests, ECG results, or other reasons
Intervention: Estradiol
Trial phase: Phase 4
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 59
Group description: Estrace: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum.

Estradiol: 17β-estradiol vaginal cream
Eligibility criteria:
Inclusion Criteria:

females >18 years old with at least one prior prenatal care appointment affiliated with The Ohio State University Wexner Medical Center; nulliparous; 1-2 days status post >37 weeks and 0 day vaginal delivery with at least a second degree perineal laceration; English-speaking and able to provide informed consent.

Exclusion Criteria:

allergies to estradiol cream or its constituents; a vaginal delivery associated with a intrauterine fetal demise or neonatal death; inability to complete questionnaires in English or comply with study protocol; and inability to apply vaginal cream independently. The following medical conditions and diagnoses are also exempted: undiagnosed abnormal vaginal bleeding, known or suspected estrogen-dependent neoplasia, active or history of deep venous thrombosis or pulmonary embolism, active arterial thromboembolic disease, known liver dysfunction or disease, known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.
Intervention: Ifidancitinib
Trial phase: Phase 2
SMILES: COc1cc(Nc2ncc(C)c(Nc3ccc4oc(=O)[nH]c4c3)n2)cc(C)c1F
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 31
Group description: This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.

Upon completion of the first 26 weeks of treatment, subjects will have the option to consent to continue on study medication for an additional 26 weeks of treatment.

Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.
Eligibility criteria:
Inclusion Criteria:

Male subjects and non-pregnant, non-nursing female subjects 18-50 years of age with a clinical diagnosis of androgenetic alopecia.

Subjects willing to agree to have a small circle of hair clipped to approx. 1mm in length on their balding spot.

Subjects willing to agree to have a permanent dot tattoo applied to their scalp to mark the center of the identified target area.

Subjects must agree to maintain the same hair style and hair care regimen during the study.

Exclusion Criteria:

Females who are nursing, pregnant, or planning to become pregnant for the duration of the study and up to 30 days after the last application of study medication.

Clinical diagnosis of alopecia areata or other non AGA forms of alopecia. Scalp hair loss on the treatment area, due to disease, injury or medical therapy.

Active skin disease of the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments or efficacy or safety.
Intervention: Lta4H-IN-1
Trial phase: Phase 2
SMILES: NC(CC(=O)O)Cn1nnc(-c2ccc(Oc3ncc(Cl)cc3F)cc2)n1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 26
Group description: LYS006, 20 mg, orally, twice daily (BID), for 12 weeks
Eligibility criteria:
Inclusion criteria:

Male and female subjects aged 18 to 45 years of age inclusive, and otherwise in good health as determined by medical history, physical examination, vital signs, ECGs and laboratory tests at screening.
Body weight between 50 and 120 kg, both inclusive, at screening.
Patients with papulo-pustular acne vulgaris (inflammatory acne) presenting with 20 to 100 facial inflammatory lesions (papules, pustules and nodules) at baseline, no more than 2 facial inflammatory nodules or cysts at screening and baseline, and a minimun number of 10 non-inflammatory facial lesions (open and closed comedones).
Patients who are candidates for systemic treatment and for whom in the opinion of the investigator, an appropriate previous treatment with topical anti-acne medication failed, or was not well tolerated, or is not indicated (e.g., due to large body surface area affected, e.g., on the back)
Patients with Grade 3 (moderate) or Grade 4 (severe) IGA score assessed by the investigator at screening and baseline.

Exclusion criteria:

Appropriate wash out periods are required for investigational drugs, any oral/systemic treatment for acne, systemic or lesional injected (for acne) corticosteroids or systemic immunomodulators, any systemic hormonal treatments, previous treatment with biologics, oral retinoids (in particular isotretinoin) and any topical anti-acne treatment.
Previous surgical, physical (such as ThermaClear™), light (including blue or UV light, photodynamic therapy or laser therapy within 4 weeks prior to baseline
Use of facial medium depth chemical peels (excluding home regimens) within 3 months prior to baseline.
Any other forms of acne
Any severe, progressive or uncontrolled medical or psychiatric condition or other factors at randomization that in the judgment of the investigator prevents the patient from participating in the study.
Active systemic infections (other than common cold) during the 2 weeks prior to baseline.
History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result at screening.
Chronic infection with Hepatitis B or Hepatitis C virus.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human chorionic gonadotropin (HCG) laboratory test.
Sexually active males or women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of study treatment.
Intervention: Lta4H-IN-1
Trial phase: Phase 2
SMILES: NC(CC(=O)O)Cn1nnc(-c2ccc(Oc3ncc(Cl)cc3F)cc2)n1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 11
Group description: LYS006, 2 mg, orally, BID, for 12 weeks
Eligibility criteria:
Inclusion criteria:

Male and female subjects aged 18 to 45 years of age inclusive, and otherwise in good health as determined by medical history, physical examination, vital signs, ECGs and laboratory tests at screening.
Body weight between 50 and 120 kg, both inclusive, at screening.
Patients with papulo-pustular acne vulgaris (inflammatory acne) presenting with 20 to 100 facial inflammatory lesions (papules, pustules and nodules) at baseline, no more than 2 facial inflammatory nodules or cysts at screening and baseline, and a minimun number of 10 non-inflammatory facial lesions (open and closed comedones).
Patients who are candidates for systemic treatment and for whom in the opinion of the investigator, an appropriate previous treatment with topical anti-acne medication failed, or was not well tolerated, or is not indicated (e.g., due to large body surface area affected, e.g., on the back)
Patients with Grade 3 (moderate) or Grade 4 (severe) IGA score assessed by the investigator at screening and baseline.

Exclusion criteria:

Appropriate wash out periods are required for investigational drugs, any oral/systemic treatment for acne, systemic or lesional injected (for acne) corticosteroids or systemic immunomodulators, any systemic hormonal treatments, previous treatment with biologics, oral retinoids (in particular isotretinoin) and any topical anti-acne treatment.
Previous surgical, physical (such as ThermaClear™), light (including blue or UV light, photodynamic therapy or laser therapy within 4 weeks prior to baseline
Use of facial medium depth chemical peels (excluding home regimens) within 3 months prior to baseline.
Any other forms of acne
Any severe, progressive or uncontrolled medical or psychiatric condition or other factors at randomization that in the judgment of the investigator prevents the patient from participating in the study.
Active systemic infections (other than common cold) during the 2 weeks prior to baseline.
History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result at screening.
Chronic infection with Hepatitis B or Hepatitis C virus.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human chorionic gonadotropin (HCG) laboratory test.
Sexually active males or women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of study treatment.
Intervention: Acetylcysteine
Trial phase: Phase 2
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 13
Group description: Will receive continuous intravenous NAC therapy (6.25 mg/kg/hour of 10 mg/ml solution, or 0.625 ml/kg/hour, to give 150 mg/kg/day), starting within 24 hours of completion of KP and lasting for a total of 7 days

N-Acetyl cysteine: Intravenous NAC therapy (6.25 mg/kg/hour of 10 mg/ml solution, or 0.625 ml/kg/hour, to give 150 mg/kg/day), starting within 24 hours of completion of KP and lasting for a total of 7 days
Eligibility criteria:
Inclusion Criteria:

Age less than or equal to 90 days at time of KP (standard age range in which KPs are performed)
BA diagnosis made by intraoperative cholangiography and KP performed at Texas Children's Hospital, Texas Medical Center Campus
Legal guardian(s) sign consent after understanding risks and investigational nature of study

Exclusion Criteria:

Decompensated liver disease (INR >1.3) despite parenteral Vitamin K administration)
KP not performed for any reason (i.e., normal intraoperative cholangiography, or liver found to be too diseased intraoperatively to proceed with KP)
Active respiratory infection
Renal impairment, as defined by having an eGFR < 60 mL/min/1.73m2 or creatinine clearance < 60 mL/min (https://www.niddk.nih.gov/health-information/communication-programs/nkdep/laboratory-evaluation/glomerular-filtration-rate-calculators/children-conventional-units)
Presence of severe concurrent illnesses, such as pulmonary (i.e., bronchopulmonary dysplasia), neurological, cardiovascular, metabolic, endocrine, and renal disorders, which may be congenital or acquired, that would interfere with the conduct and results of the study