anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Amlodipine
Trial phase: Not Applicable
ATC code: C07FB07 | C07FB12 | C07FB13 | C08CA01 | C08CA17 | C08CA51 | C08GA02 | C09BB03 | C09BB04 | C09BB07 | C09BB13 | C09BX01 | C09BX03 | C09BX04 | C09DB01 | C09DB02 | C09DB04 | C09DB05 | C09DB06 | C09DB07 | C09DB09 | C09DX01 | C09DX03 | C09DX06 | C09DX07 | C09DX08 | C09XA53 | C09XA54 | C10BX03 | C10BX07 | C10BX09 | C10BX11 | C10BX14 | C10BX18 | C10BX19
SMILES: CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1c1ccccc1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 359
Group description: Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks

Amlodipine: Amlodipine 5mg/day
Eligibility criteria:
Inclusion Criteria:

Grade I or II essential hypertension
The sitting systolic blood pressure is in term of 140-179 mmHg, or sitting diastolic blood pressure is in term of 90-109 mmHg at the both two time points at the beginning of the observation period and at the beginning of a treatment period (Week0)
20 years old or older at the time of the informed consent
Able to give written informed consent before participating in the research
Therapeutic category during the observation period: Ambulatory

Exclusion Criteria:

Secondary hypertension, grade III hypertension (sitting systolic blood pressure greater than or equal to 180 mmHg or sitting diastolic blood pressure greater than or equal to 110 mmHg), malignant hypertension
More than 2 kinds of antihypertensive agents for treatment on the hypertension
History of taking following medicines within 2 weeks before start of the observation period.

When subject with taking any of the following medicine at the time of informed consent is included, stop to take the medicine for determined period after the informed consent.

I. Antihypertensive agents II. Antianginal agents III. Antiarrhythmic agents (except single time use of the lidocaine hydrochloride formulation for anesthesia) IV. Digitalis products

Less than 130 mmHg of mean 24-hour systolic blood pressure and less than 80 mmHg of mean 24-hour diastolic blood pressure at the start of the observation period.
History of following circulatory-related diseases or symptoms within 24 weeks before start of the observation period.

I. Cardiac disease: Myocardial infarction, coronary artery revascularization II. Cerebrovascular-disease: cerebral infarction, cerebral hemorrhage, transient ischemic attack III. Progressive hypertensive retinopathy: hemorrhage, exudation, or papilledema

History or complication with the following circulatory-related diseases; Valvular stenosis, atrial fibrillation, pharmacotherapy-required angina, congestion heart failure, or cardiac arrhythmia, or arteriosclerosis obliterans with symptoms of intermittent claudication et al
Day / night reversal
History of hypersensitivity or allergy to Azilsartan, Amlodipine, or related drugs
Participant in any other clinical research
Pregnant, possible to being pregnant, or lactating woman
Mal-control of blood pressure during informed consent to taking antihypertensive agent
Any those the investigator or other researchers consider as unsuitable
Intervention: Lovenox
Trial phase: Not Applicable
SMILES: CC(=O)NC1C(O)OC(COS(=O)(=O)O)C(OC2OC(C(=O)O)C(OC3OC(CO)C(OC4OC(C(=O)O)C(O)C(O)C4OS(=O)(=O)O)C(OS(=O)(=O)O)C3NS(=O)(=O)O)C(O)C2OS(=O)(=O)O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Patients assigned to enoxaparin.

Enoxaparin: Patients will be receive 6 months of subcutaneous enoxaparin (1 mg/kg BID with a maximum starting dose of 100 mg BID. Patients who weigh more than 100 kg will start at a dose of 100 mg BID; their subsequent dosing will be guided by hematology and may change.
Eligibility criteria:
Any adult patient with active systemic cancer diagnosed with acute ischemic stroke at the main MSKCC campus or at any of MSKCC's New York City outpatient center WCMC, NYPH/CUMC within the prior four weeks would be eligible.

Inclusion Criteria:

18 to 85 years of age.
Active cancer, defined as a pathologic diagnosis of or treatment for any cancer, other than basal-cell or squamous-cell carcinoma of the skin, within the past six months; or patients with known recurrent or metastatic disease within the past six months.
A pathology report issued at the enrolling site confirming the diagnosis of cancer is required for enrollment.
Acute ischemic stroke within the prior four weeks, defined as a new neurologic deficit(s) with MRI evidence of acute ischemia in a referable location, and no clinical or radiologic indication of a non-cerebrovascular mimic, such as a brain metastasis, as the etiology of the deficit(s).

Exclusion Criteria:

Inability to get brain MRI
Known malignant primary brain tumor.
Diagnosis of intracranial hemorrhage within the past 3 months, including intratumoral hemorrhage into brain metastases from a systemic cancer.
Active or serious bleeding within two weeks of enrollment.
Patient condition associated with a high risk of bleeding such as recent surgery or peptic ulcer disease.
Clear indication for anticoagulation (e.g., atrial fibrillation) anticipated during the study period.
Clear indication for antiplatelet agents (e.g., cardiac stents); a patient receiving aspirin for primary prevention prior to index stroke may be enrolled as long as study investigators believe it would be safe for the patient to stop aspirin if the patient was randomized to the enoxaparin arm.
Active bleeding diathesis.
Platelet count of ≤ 70,000/mm3, an international normalized ratio (INR) > 1.6, or a partial thromboplastin time (PTT) > 40 seconds.
Known allergy to heparin or aspirin or a history of heparin induced thrombocytopenia.
Serum creatinine > 2 mg/dl.
AST or ALT > 200 U/L.
Hemoglobin < 8 gm/dl
Symptomatic carotid stenosis.
Active pregnancy.
Life expectancy < 1 month or current hospice care
Unavailability for follow-up.
Intervention: Cortrosyn
Trial phase: Not Applicable
ATC code: H01AA02
SMILES: CSCCC(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(N)CO)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1c[nH]cn1)C(=O)NC(Cc1ccccc1)C(=O)NC(CCCNC(=N)N)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NCC(=O)NC(CCCCN)C(=O)N1CCCC1C(=O)NC(C(=O)NCC(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)N1CCCC1C(=O)NC(C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(Cc1ccc(O)cc1)C(=O)N1CCCC1C(=O)O)C(C)C)C(C)C)C(C)C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: Each participant will be asked to sit in a chair for 30 minutes prior to a blood draw. Then a small dose of cosyntropin is administered intravenous. Blood samples will be drawn again at 30 minutes and 60 minutes after the drug has been given.

Cosyntropin administration: After 30 minutes of rest in the seated position, participants will be given cosyntropin intravenously. Blood samples will be taken 30 minutes pre-drug administration, 30 minutes post and 60 minutes post drug administration.
Eligibility criteria:
Inclusion Criteria:

Subjects will be enrolled in the parent study "Dietary Salt in Postural Tachycardia Syndrome" during the "LOW SALT" phase

Postural Tachycardia Syndrome Diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center Increase in heart rate ≥30 beats/min with position change from supine to standing (10 minutes) Chronic symptoms consistent with POTS that are worse when upright and get better with recumbence

Control Subjects

Healthy, non-obese, non-smokers without orthostatic tachycardia
Selected to match profiles of POTS patients (gender, age)
Not using vasoactive medication
Age between 18-50 years
Male and female subjects are eligible.
Able and willing to provide informed consent

Exclusion Criteria:

Overt cause for postural tachycardia (such as acute dehydration)
Inability to give, or withdrawal of, informed consent
pregnant
Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
Intervention: Tenapanor
Trial phase: Phase 2
ATC code: A06AX08
SMILES: CN1Cc2c(Cl)cc(Cl)cc2[C@H](c2cccc(S(=O)(=O)NCCOCCOCCNC(=O)NCCCCNC(=O)NCCOCCOCCNS(=O)(=O)c3cccc([C@@H]4CN(C)Cc5c(Cl)cc(Cl)cc54)c3)c2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Tenapanor administered in a clinical pharmacology unit

AZD1722 (in-patient): doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting
Eligibility criteria:
Inclusion Criteria:

Males or females aged 18 to 80 years, inclusive;
Body mass index between 18 and 45 kg/m2, inclusive;
Ambulatory (≥ 6 months) maintenance hemodialysis;
Stable dialysis treatment regimen 3x/week for ≥ 2 months prior to screening visit.

Exclusion Criteria:

Currently taking diuretic medication;
Has a urine production of ≥ 200 ml/day (based on a 24-hour measurement starting on Day -1 and completed prior to randomization);
Predialysis systolic BP >200 mmHg or diastolic BP >110 mmHg on two successive occasions during the 2-week run-in period;
Predialysis SBP < 110 mmHg on two successive occasions during the 2-week run-in period
Intervention: Tenapanor
Trial phase: Phase 2
ATC code: A06AX08
SMILES: CN1Cc2c(Cl)cc(Cl)cc2[C@H](c2cccc(S(=O)(=O)NCCOCCOCCNC(=O)NCCCCNC(=O)NCCOCCOCCNS(=O)(=O)c3cccc([C@@H]4CN(C)Cc5c(Cl)cc(Cl)cc54)c3)c2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Tenapanor

AZD1722 (out-patient): doses between 5 and 45 mg BID
Eligibility criteria:
Inclusion Criteria:

Males or females aged 18 to 80 years, inclusive;
Body mass index between 18 and 45 kg/m2, inclusive;
Ambulatory (≥ 6 months) maintenance hemodialysis;
Stable dialysis treatment regimen 3x/week for ≥ 2 months prior to screening visit.

Exclusion Criteria:

Currently taking diuretic medication;
Has a urine production of ≥ 200 ml/day (based on a 24-hour measurement starting on Day -1 and completed prior to randomization);
Predialysis systolic BP >200 mmHg or diastolic BP >110 mmHg on two successive occasions during the 2-week run-in period;
Predialysis SBP < 110 mmHg on two successive occasions during the 2-week run-in period
Intervention: Saxagliptin
Trial phase: Phase 4
ATC code: A10BD10 | A10BD21 | A10BD25 | A10BH03
SMILES: N#CC1CC2CC2N1C(=O)C(N)C12CC3CC(CC(O)(C3)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
Eligibility criteria:
Inclusion Criteria:

Known diagnosis of type 2 diabetes mellitus (T2DM) with glycosylated hemoglobin (HbA1c) between 6.5% and 10%, inclusive.

Stable doses of oral antihyperglycemic agents for at least 2 months
Stable dose of chronic insulin therapy for at least 2 months
HbA1c documented within 3 months before study enrollment
Planned first elective coronary artery bypass graft (CABG) surgery

Exclusion Criteria:

Elevated Creatine Kinase-Myocardial Bands (CK-MB) or troponin level above the 99th percentile at screening
Receiving incretin therapy or having received incretin therapy within the previous 2 months
Type 1 DM or a history of ketoacidosis
Women who are pregnant or breastfeeding
Known end-stage Kidney disease
Known sensitivity or intolerance to saxagliptin or dipeptidyl peptidase-4 (DPP-4) inhibitor
Clinically apparent liver disease
History of pancreatitis
Intervention: Bimatoprost
Trial phase: Phase 3
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 118
Group description: Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
Eligibility criteria:
Inclusion Criteria:

-Adult participants with eyebrow hypotrichosis (inadequate eyebrow growth).

Exclusion Criteria:

Patients with disease, infection, or abnormality of the eyebrow area
Patients with permanent eyebrow loss due to over-grooming
Intervention: FOLIC ACID
Trial phase: Phase 4
ATC code: B03AD01 | B03AD02 | B03AD03 | B03AD04 | B03AD05 | B03AE01 | B03AE02 | B03BB01 | B03BB51 | V04CX02
SMILES: Nc1nc(=O)c2nc(CNc3ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc3)cnc2[nH]1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study

Folic Acid
Eligibility criteria:
Inclusion Criteria:

Patient age between 9-18 years
Diagnosed obesity (BMI more than median plus two of standard deviation for age and sex according to WHO reference 2007)

Exclusion Criteria:

Secondary obesity
Thalassemia disease
Renal and hepatic dysfunction
Drugs: anticonvulsant, estrogen, thiazides, metformin, cholestyramine, methotrexate, fibrates, nicotinic acid
Previous vitamin supplementation 1 month before study
Intervention: Calcitriol
Trial phase: Phase 4
ATC code: A11CC04 | D05AX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 18
Group description: Topical application every 12 hours for 14 consecutive days

Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application
Eligibility criteria:
Inclusion Criteria:

Male or female pediatric subjects, 2 to 12 years of age inclusive at screening
Clinical diagnosis of plaque type psoriasis involving 3% through 35% body surface area at screening and baseline (excluding face and scalp)

Exclusion Criteria:

Subjects with guttate or pustular psoriasis, erythrodermic psoriasis or active infection
Vitamin D deficiency at screening
Subjects with hypercalcemia and out of range urinary calcium/creatinine ratio at screening
Subjects with secondary hyperparathyroidism at screening
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: 7
Group description: Healthy volunteers with normal hepatic function
Eligibility criteria:
Main Inclusion Criteria:

All subjects:

Adult males or females, 18 - 75 years of age (inclusive);
Body weight ≥ 50 kg;
Body mass index (BMI) between 19 and 32 kg/mE2 (inclusive);
Absolute neutrophil count (ANC) of >1.5x10E9/L ;

Healthy volunteers:

Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, vital signs, physical examination);
Matched to hepatically impaired subjects in the study by age (+/- 10 years), sex and weight (+/- 15% BMI).

Hepatically impaired subjects:

Considered clinically stable in the opinion of the Investigator;
Subjects with different degrees of impaired hepatic function as assessed by a Child-Pugh classification score: mild (Class A: 5-6 points) and moderate (Class B: 7-9 points) impaired hepatic function.

Main Exclusion Criteria:

For subjects with hepatic impairment, fluctuating or rapidly deteriorating hepatic function as indicated by clinical and/or laboratory signs of hepatic impairment (e.g. advanced ascites, infection of ascites, fever, or active gastrointestinal bleeding).
Evidence of liver impairment in healthy volunteers: hepatitis B and C; or aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, clotting factors, serum protein that is considered clinically significant by the Investigator;
History or presence of significant clinically unstable respiratory, cardiovascular, pulmonary, hepatic (except for subjects assigned to one of the hepatically impaired groups), renal, hematologic, gastrointestinal, endocrine (except for subjects with hepatic impairment with clinically stable and treated diabetes, hypertension and thyroid disorders), 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. resections of the small or large intestine, febrile conditions, chronic diarrhea, chronic vomiting, clinically unstable endocrine disease, severe infections, acute inflammations, etc.);
Received a pharmacological agent in another clinical trial within 28 days prior to the first dose of the study;
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: 7
Group description: Mild hepatic failure as defined by the Child-Pugh Class C: 5-6 points
Eligibility criteria:
Main Inclusion Criteria:

All subjects:

Adult males or females, 18 - 75 years of age (inclusive);
Body weight ≥ 50 kg;
Body mass index (BMI) between 19 and 32 kg/mE2 (inclusive);
Absolute neutrophil count (ANC) of >1.5x10E9/L ;

Healthy volunteers:

Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, vital signs, physical examination);
Matched to hepatically impaired subjects in the study by age (+/- 10 years), sex and weight (+/- 15% BMI).

Hepatically impaired subjects:

Considered clinically stable in the opinion of the Investigator;
Subjects with different degrees of impaired hepatic function as assessed by a Child-Pugh classification score: mild (Class A: 5-6 points) and moderate (Class B: 7-9 points) impaired hepatic function.

Main Exclusion Criteria:

For subjects with hepatic impairment, fluctuating or rapidly deteriorating hepatic function as indicated by clinical and/or laboratory signs of hepatic impairment (e.g. advanced ascites, infection of ascites, fever, or active gastrointestinal bleeding).
Evidence of liver impairment in healthy volunteers: hepatitis B and C; or aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, clotting factors, serum protein that is considered clinically significant by the Investigator;
History or presence of significant clinically unstable respiratory, cardiovascular, pulmonary, hepatic (except for subjects assigned to one of the hepatically impaired groups), renal, hematologic, gastrointestinal, endocrine (except for subjects with hepatic impairment with clinically stable and treated diabetes, hypertension and thyroid disorders), 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. resections of the small or large intestine, febrile conditions, chronic diarrhea, chronic vomiting, clinically unstable endocrine disease, severe infections, acute inflammations, etc.);
Received a pharmacological agent in another clinical trial within 28 days prior to the first dose of the study;
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: 7
Group description: Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
Eligibility criteria:
Main Inclusion Criteria:

All subjects:

Adult males or females, 18 - 75 years of age (inclusive);
Body weight ≥ 50 kg;
Body mass index (BMI) between 19 and 32 kg/mE2 (inclusive);
Absolute neutrophil count (ANC) of >1.5x10E9/L ;

Healthy volunteers:

Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, vital signs, physical examination);
Matched to hepatically impaired subjects in the study by age (+/- 10 years), sex and weight (+/- 15% BMI).

Hepatically impaired subjects:

Considered clinically stable in the opinion of the Investigator;
Subjects with different degrees of impaired hepatic function as assessed by a Child-Pugh classification score: mild (Class A: 5-6 points) and moderate (Class B: 7-9 points) impaired hepatic function.

Main Exclusion Criteria:

For subjects with hepatic impairment, fluctuating or rapidly deteriorating hepatic function as indicated by clinical and/or laboratory signs of hepatic impairment (e.g. advanced ascites, infection of ascites, fever, or active gastrointestinal bleeding).
Evidence of liver impairment in healthy volunteers: hepatitis B and C; or aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, clotting factors, serum protein that is considered clinically significant by the Investigator;
History or presence of significant clinically unstable respiratory, cardiovascular, pulmonary, hepatic (except for subjects assigned to one of the hepatically impaired groups), renal, hematologic, gastrointestinal, endocrine (except for subjects with hepatic impairment with clinically stable and treated diabetes, hypertension and thyroid disorders), 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. resections of the small or large intestine, febrile conditions, chronic diarrhea, chronic vomiting, clinically unstable endocrine disease, severe infections, acute inflammations, etc.);
Received a pharmacological agent in another clinical trial within 28 days prior to the first dose of the study;
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: Etonogestrel implant placed in the hospital after delivery, before discharge home.

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.

-

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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