anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Cabergoline
Trial phase: Phase 2
ATC code: G02CB03 | N04BC06
SMILES: [H][C@@]12Cc3c[nH]c4cccc(c34)[C@@]1([H])C[C@@H](C(=O)N(CCCN(C)C)C(=O)NCC)CN2CC=C
Sex: Female
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 5
Group description: cabergoline 0.5 mg PO twice weekly x 6 months

Cabergoline
Eligibility criteria:
Inclusion Criteria:

Surgically confirmed endometriosis
Age between 15-40 y, and premenopausal
Pelvic pain score ≥3 on a Visual Analog Scaleover the last month

Exclusion Criteria:

Use of other concurrent hormone medications (such as birth control pills)
Impaired liver function (ALT > 2x normal) or liver disease (cirrhosis, hepatitis)
Pregnancy
Breast cancer
Active thromboembolic disease
Uncontrolled hypertension, history of cardiac valve disorder, history of fibrotic disorders
Intervention: Merotocin
Trial phase: Phase 2
SMILES: CCC(C)C1NC(=O)C(Cc2ccc(O)cc2)NC(=O)CCCSCC(C(=O)N(CC(=O)NC(CC(C)C)C(=O)NCC(N)=O)Cc2ccc(F)cc2)NC(=O)C(CC(N)=O)NC(=O)C(CCC(N)=O)NC1=O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Merotocin: Merotocin nasal spray 400 μg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
Eligibility criteria:
Inclusion Criteria:

Delivered at the hospital system associated with the trial center
Delivered preterm singleton gestational age 24 weeks + 0 days to 34 weeks + 2 days
Willing to express milk at least 5 times every 24 hours during the observation period and 6 to 8 times every 24 hours during the treatment and post-treatment follow up
Produced < 200 mL milk in 24 hours prior to randomization
Delivered 96 to 192 (+4) hours prior to randomization

Exclusion Criteria:

Pre-pregnancy body mass index (BMI) > 50 kg/m^2
Mastitis
History of breast trauma, breast surgery, nipple piercing
Prolactin-releasing pituitary tumor, history of Sheehan's syndrome, pituitary surgery/radiation therapy
Pre-pregnancy insulin-dependent diabetes mellitus, polycystic ovarian syndrome. Note: gestational diabetes is allowed (also when requiring the use of insulin for treatment)
Unstable thyroid disease
Moderate or severe renal or hepatic impairment
Mental illness
Significant nasal congestion or mucous production
Use of anti-psychotic drugs within past 12 months
Intervention: Chlordiazepoxide
Trial phase: Not Applicable
ATC code: N05BA02
SMILES: CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 150
Group description: administration of 0.9% normal saline 10ml

Control: administration of normal saline
Eligibility criteria:
Inclusion Criteria:

ASA Physical status I or II female scheduled for breast conserving surgery of modified radical mastectomy.

Exclusion Criteria:

uncontrolled cardiovascular disease
history of chronic pain
smoker
previous history of steroid administraion
neoajuvant chemotherapy
Intervention: Dexmedetomidine
Trial phase: Not Applicable
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 150
Group description: administration of 0.5ug/kg of dexmedetomidine (5ml)

Dexmedetomidine: administration of dexmedetomidine only
Eligibility criteria:
Inclusion Criteria:

ASA Physical status I or II female scheduled for breast conserving surgery of modified radical mastectomy.

Exclusion Criteria:

uncontrolled cardiovascular disease
history of chronic pain
smoker
previous history of steroid administraion
neoajuvant chemotherapy
Intervention: DIMETHYL FUMARATE
Trial phase: Phase 3
ATC code: L04AX07
SMILES: [H]/C(C(=O)OC)=C(/[H])C(=O)OC
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 20
Group description: Participants will receive 120 mg capsule(s) taken orally.
Eligibility criteria:
Key Inclusion Criteria:

Ability of parents, legal guardians, and/or subjects to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. Subjects will provide assent in addition to the parental or guardian consent, as appropriate, per local regulations.
Subjects who completed, as per protocol, the previous BG00012 clinical study 109MS202 (NCT02410200) and remain on BG00012 treatment.

Key Exclusion Criteria:

Unwillingness or inability to comply with study requirements, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
Any significant changes in medical history occurring after enrollment in the parent Study 109MS202 (NCT02410200), including laboratory test abnormalities or current clinically significant conditions that in the opinion of the Investigator would have excluded the subject's participation from the parent study. The Investigator must re-review the subject's medical fitness for participation and consider any factors that would preclude treatment.
Subjects from Study 109MS202 (NCT02410200) who could not tolerate study treatment.

NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Intervention: Ringer's lactate
Trial phase: Not Applicable
SMILES: CC(O)C(=O)O.[Ca+2].[Cl-].[Cl-].[Cl-].[Cl-].[K+].[Na+].[Na]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 276
Group description: Patients in this arm will receive 1500mL of Lactated Ringer's solution

Lactated Ringer's: IV Fluid (crystalloid) used for preload prior to epidural adminstration
Eligibility criteria:
Inclusion Criteria:

Singleton pregnancy with gestational age ≥ 35 weeks
Admission for delivery
Age 18 or older
Desires neuraxial analgesia in labor
No exclusion criteria
Maternal pulse pressure < 45 mmHg on admission (verified by repeat blood pressure)
Category 1 FHT on admission/prior to epidural placement
Epidural placement within 6 hours of admission to Labor and Delivery

Exclusion Criteria:

Multiple gestation
Intrauterine growth restriction
Hypertensive disorders (gestational hypertension, chronic hypertension, and preeclampsia/eclampsia)
Gestational or pregestational diabetes mellitus
Substance abuse
Intrauterine fetal demise
Congenital or chromosomal fetal abnormalities
Category II or III FHR tracing on admission to L&D (pre-epidural)
Contraindication to neuraxial aesthesia (e.g. thrombocytopenia)
Maternal cardiomyopathy, congenital heart disease, active pulmonary edema or any other underlying maternal cardiopulmonary condition that increases the risk of pulmonary edema
Maternal renal insufficiency (serum creatinine > 1.0)
Maternal hypotension (as defined in secondary outcomes below) prior to epidural placement
Intervention: GDC-0810
Trial phase: Phase 2
SMILES: CC/C(=C(/c1ccc(/C=C/C(=O)O)cc1)c1ccc2[nH]ncc2c1)c1ccc(F)cc1Cl
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Participants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women with histologically or cytologically confirmed invasive, ER+/HER- (defined by local guidelines) metastatic or inoperable, locally advance breast cancer
Participants for whom endocrine therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study
Participants must have measurable disease by RECIST v1.1 or non-measurable, evaluable disease with atleast one evaluable bone lesion by RECIST v1.1 based on radiologic scans within 28 days of Day 1 of Cycle 1
Participants with radiologic/objective evidence of breast cancer recurrence or progression while on or within 6 months after the end of adjuvant treatment with an AI, or progression while on or within 1 month after the end of prior AI treatment for locally advanced or metastatic breast cancer

Exclusion Criteria:

HER2-positive disease
Prior treatment with fulvestrant
Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen or >2 endocrine therapies for advanced or metastatic disease
Intervention: Regadenoson
Trial phase: Phase 4
ATC code: C01EB21
SMILES: CNC(=O)c1cnn(-c2nc(N)c3ncn([C@@H]4O[C@H](CO)[C@@H](O)[C@H]4O)c3n2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 55
Group description: No cardiovascular abnormalities or diabetes. Estimated glomerular filtration rate (eGFR) >60.

Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism.

regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants
Eligibility criteria:
ALL

Inclusion Criteria:

estimated glomerular filtration rate (eGFR) > 60 ml/min
preserved left ventricular ejection fraction (>= 50%) on echocardiography

Exclusion Criteria:

coronary artery disease
diabetes mellitus
contraindications to cardiac magnetic resonance imaging (CMR)
weight >350 lbs
inability to lie flat for imaging
anemia
contraindications to regadenoson or aminophylline

HEALTHY

Inclusion criteria:

normal cardiac structure and function on echocardiography
BP < 140/90

Exclusion criteria:

known cardiovascular disease, cardiac risk factors or use of cardiac medications

HYPERTENSIVE

Inclusion criteria:

history of BP >140/90
1 or more antihypertensive medications
LV ejection fraction (LVEF) at least 50%
current BP < 160/90

Exclusion criteria:

known cardiovascular disease or risk factors aside from hypertension or use of cardiac medications

HFpEF

Inclusion criteria:

physician-confirmed diagnosis of HF
symptomatic HF
LVEF at least 50%
elevated LV filling pressure by catheterization, echocardiographic criteria or B-type-natriuretic peptide > 100
current BP < 160/90

Exclusion criteria:

prior history of LVEF below 50%
acute decompensated HF
moderate or greater valvular disease
significant cardiac arrhythmias
pericardial disease
congenital heart disease
primary pulmonary hypertension
Intervention: Regadenoson
Trial phase: Phase 4
ATC code: C01EB21
SMILES: CNC(=O)c1cnn(-c2nc(N)c3ncn([C@@H]4O[C@H](CO)[C@@H](O)[C@H]4O)c3n2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 55
Group description: No history of coronary artery disease or diabetes. Estimated glomerular filtration rate (eGFR) >60.

Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism.

regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants
Eligibility criteria:
ALL

Inclusion Criteria:

estimated glomerular filtration rate (eGFR) > 60 ml/min
preserved left ventricular ejection fraction (>= 50%) on echocardiography

Exclusion Criteria:

coronary artery disease
diabetes mellitus
contraindications to cardiac magnetic resonance imaging (CMR)
weight >350 lbs
inability to lie flat for imaging
anemia
contraindications to regadenoson or aminophylline

HEALTHY

Inclusion criteria:

normal cardiac structure and function on echocardiography
BP < 140/90

Exclusion criteria:

known cardiovascular disease, cardiac risk factors or use of cardiac medications

HYPERTENSIVE

Inclusion criteria:

history of BP >140/90
1 or more antihypertensive medications
LV ejection fraction (LVEF) at least 50%
current BP < 160/90

Exclusion criteria:

known cardiovascular disease or risk factors aside from hypertension or use of cardiac medications

HFpEF

Inclusion criteria:

physician-confirmed diagnosis of HF
symptomatic HF
LVEF at least 50%
elevated LV filling pressure by catheterization, echocardiographic criteria or B-type-natriuretic peptide > 100
current BP < 160/90

Exclusion criteria:

prior history of LVEF below 50%
acute decompensated HF
moderate or greater valvular disease
significant cardiac arrhythmias
pericardial disease
congenital heart disease
primary pulmonary hypertension
Intervention: Aprocitentan
Trial phase: Phase 2
ATC code: C02KN01
SMILES: NS(=O)(=O)Nc1ncnc(OCCOc2ncc(Br)cn2)c1-c1ccc(Br)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 82
Group description: Participants received aprocitentan 5 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Eligibility criteria:
Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure
No contra-indication to stop (according to label) anti-hypertensive treatment(s) at screening

Mild-to-moderate essential hypertension with or without ongoing anti-hypertensive treatment(s):

-- Mean (of 5 measurements) sitting diastolic blood pressure (SiDBP) ≥ 90 to < 110 mmHg measured by office blood pressure measurements (OBPM).

Women of childbearing potential must have a negative pregnancy test and use of reliable methods of contraception

Exclusion Criteria:

Severe hypertension (grade 3): mean sitting systolic/diastolic BP (SiSBP/SiDBP; measured by OBPM) ≥ 180/110 mmHg, respectively.
Secondary hypertension
Known hypertensive retinopathy greater than Keith-Wagener Grade 2
Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within 12 months prior to randomization
Unstable angina within 6 months prior to randomization
Heart failure New York Heart Association class III and IV
Valvular defects (such as severe aortic or mitral valve disease) and/or hemodynamically relevant rhythm disturbances
Clinical evidence of cerebrovascular insufficiency or a cerebrovascular accident within 6 months prior to randomization.
Subjects working night shifts
Body mass index < 20 kg/m2 or > 40 kg/m2
Treatment with any medication which may affect BP (e.g., treatment of psychiatric diseases, ophthalmic preparations)
Treatment with strong cytochrome P450 3A4 (CYP3A4) isoenzyme inhibitors or inducers
Treatment with guanethidine and/or mineralocorticoid receptor antagonists within 1 month prior to Screening (Visit 1)
Treatment with another investigational treatment within 1 month prior to Screening (Visit 1)
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Intervention: Aprocitentan
Trial phase: Phase 2
ATC code: C02KN01
SMILES: NS(=O)(=O)Nc1ncnc(OCCOc2ncc(Br)cn2)c1-c1ccc(Br)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 82
Group description: Participants received aprocitentan 10 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Eligibility criteria:
Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure
No contra-indication to stop (according to label) anti-hypertensive treatment(s) at screening

Mild-to-moderate essential hypertension with or without ongoing anti-hypertensive treatment(s):

-- Mean (of 5 measurements) sitting diastolic blood pressure (SiDBP) ≥ 90 to < 110 mmHg measured by office blood pressure measurements (OBPM).

Women of childbearing potential must have a negative pregnancy test and use of reliable methods of contraception

Exclusion Criteria:

Severe hypertension (grade 3): mean sitting systolic/diastolic BP (SiSBP/SiDBP; measured by OBPM) ≥ 180/110 mmHg, respectively.
Secondary hypertension
Known hypertensive retinopathy greater than Keith-Wagener Grade 2
Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within 12 months prior to randomization
Unstable angina within 6 months prior to randomization
Heart failure New York Heart Association class III and IV
Valvular defects (such as severe aortic or mitral valve disease) and/or hemodynamically relevant rhythm disturbances
Clinical evidence of cerebrovascular insufficiency or a cerebrovascular accident within 6 months prior to randomization.
Subjects working night shifts
Body mass index < 20 kg/m2 or > 40 kg/m2
Treatment with any medication which may affect BP (e.g., treatment of psychiatric diseases, ophthalmic preparations)
Treatment with strong cytochrome P450 3A4 (CYP3A4) isoenzyme inhibitors or inducers
Treatment with guanethidine and/or mineralocorticoid receptor antagonists within 1 month prior to Screening (Visit 1)
Treatment with another investigational treatment within 1 month prior to Screening (Visit 1)
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Intervention: Aprocitentan
Trial phase: Phase 2
ATC code: C02KN01
SMILES: NS(=O)(=O)Nc1ncnc(OCCOc2ncc(Br)cn2)c1-c1ccc(Br)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 82
Group description: Participants received aprocitentan 25 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Eligibility criteria:
Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure
No contra-indication to stop (according to label) anti-hypertensive treatment(s) at screening

Mild-to-moderate essential hypertension with or without ongoing anti-hypertensive treatment(s):

-- Mean (of 5 measurements) sitting diastolic blood pressure (SiDBP) ≥ 90 to < 110 mmHg measured by office blood pressure measurements (OBPM).

Women of childbearing potential must have a negative pregnancy test and use of reliable methods of contraception

Exclusion Criteria:

Severe hypertension (grade 3): mean sitting systolic/diastolic BP (SiSBP/SiDBP; measured by OBPM) ≥ 180/110 mmHg, respectively.
Secondary hypertension
Known hypertensive retinopathy greater than Keith-Wagener Grade 2
Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within 12 months prior to randomization
Unstable angina within 6 months prior to randomization
Heart failure New York Heart Association class III and IV
Valvular defects (such as severe aortic or mitral valve disease) and/or hemodynamically relevant rhythm disturbances
Clinical evidence of cerebrovascular insufficiency or a cerebrovascular accident within 6 months prior to randomization.
Subjects working night shifts
Body mass index < 20 kg/m2 or > 40 kg/m2
Treatment with any medication which may affect BP (e.g., treatment of psychiatric diseases, ophthalmic preparations)
Treatment with strong cytochrome P450 3A4 (CYP3A4) isoenzyme inhibitors or inducers
Treatment with guanethidine and/or mineralocorticoid receptor antagonists within 1 month prior to Screening (Visit 1)
Treatment with another investigational treatment within 1 month prior to Screening (Visit 1)
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Intervention: Aprocitentan
Trial phase: Phase 2
ATC code: C02KN01
SMILES: NS(=O)(=O)Nc1ncnc(OCCOc2ncc(Br)cn2)c1-c1ccc(Br)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 81
Group description: Participants received aprocitentan 50 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Eligibility criteria:
Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure
No contra-indication to stop (according to label) anti-hypertensive treatment(s) at screening

Mild-to-moderate essential hypertension with or without ongoing anti-hypertensive treatment(s):

-- Mean (of 5 measurements) sitting diastolic blood pressure (SiDBP) ≥ 90 to < 110 mmHg measured by office blood pressure measurements (OBPM).

Women of childbearing potential must have a negative pregnancy test and use of reliable methods of contraception

Exclusion Criteria:

Severe hypertension (grade 3): mean sitting systolic/diastolic BP (SiSBP/SiDBP; measured by OBPM) ≥ 180/110 mmHg, respectively.
Secondary hypertension
Known hypertensive retinopathy greater than Keith-Wagener Grade 2
Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within 12 months prior to randomization
Unstable angina within 6 months prior to randomization
Heart failure New York Heart Association class III and IV
Valvular defects (such as severe aortic or mitral valve disease) and/or hemodynamically relevant rhythm disturbances
Clinical evidence of cerebrovascular insufficiency or a cerebrovascular accident within 6 months prior to randomization.
Subjects working night shifts
Body mass index < 20 kg/m2 or > 40 kg/m2
Treatment with any medication which may affect BP (e.g., treatment of psychiatric diseases, ophthalmic preparations)
Treatment with strong cytochrome P450 3A4 (CYP3A4) isoenzyme inhibitors or inducers
Treatment with guanethidine and/or mineralocorticoid receptor antagonists within 1 month prior to Screening (Visit 1)
Treatment with another investigational treatment within 1 month prior to Screening (Visit 1)
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol