anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ketorolac
Trial phase: Phase 1
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.

PRO-156: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.
Eligibility criteria:
Inclusion Criteria:

Healthy male and female.
Age between 18 and 40 years old at screening visit.
Signed informed consent

Exclusion Criteria:

Patient with one blind eye.
Any ocular or systemic condition.
Visual acuity of 20/100 in any eye.
Use of ocular or systemic medication.
Contraindications or sensitivity to any component of the study treatment.
Contact lens users.
Ocular surgery within the past 3 months..
Pregnant, nursing or childbearing potential women who were not using effective contraception.
Participation in any studies of investigational drugs within 90 days previous to the inclusion.
Intervention: OMACETAXINE MEPESUCCINATE
Trial phase: Phase 2
ATC code: L01XX40
SMILES: [H][C@]12c3cc4c(cc3CCN3CCC[C@@]31C=C(OC)[C@@]2([H])OC(=O)[C@@](O)(CCCC(C)(C)O)CC(=O)OC)OCO4
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Omacetaxine: Omacetaxine 1.25 mg/m² sub-cutaneously twice daily for 5 consecutive days every 28 (± 8) days for 3 cycles.

Patients in continuous remission after 3 cycles of consolidation will receive maintenance omacetaxine 1.25 mg/m² twice daily for 3 days, every 28 days for up to 6 cycles
Eligibility criteria:
Inclusion Criteria:

Diagnosis of AML including de novo, secondary, or with an antecedent hematologic disorder (AHD) according to the World Health Organization (WHO) criteria.
Age ≥ 55 years.
Patient eligible for standard induction chemotherapy based on Eastern Cooperative Oncology Group (ECOG) performance status and vital organ function at the discretion of the treating physician.
Patients who received 1-2 cycles of hypomethylating therapy (decitabine azacitidine) are eligible.
Provide signed written informed consent.
Be able to comply with study procedures and follow-up examinations.
Be non-fertile or agree to use birth control during the study through the end of last treatment visit.

Adequate renal and hepatic function at the time of second registration:

Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); and
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN; and
Serum creatinine ≤ 1.2 x ULN.
ECOG performance ≤ 2 at the time of second registration.
Patients with a history of carcinoma in remission, on no therapy or on hormonal therapy for the adjuvant treatment of breast carcinoma or prostate carcinoma are included in the study.

Exclusion Criteria:

Diagnosis of acute promyelocytic leukemia (APL, French-American-British [FAB] classification M3 or WHO classification of APL with t (15;17)(q22;q12), (PML/retinoic acid receptor alpha [RARa] and variants).
Prior treatment with omacetaxine.
Relapsed or refractory AML.
Investigational agent received within 30 days prior to the first dose of study drug. If received any investigational agent prior to this time point, drug-related toxicities must have recovered to Grade 2 or less prior to first dose of study drug.
Psychiatric disorders that would interfere with consent, study participation, or follow-up.
Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo the proposed therapy. This includes uncontrolled hypertension and uncontrolled diabetes, as cases of life threatening hyperglycemia have been reported (using continuous infusion at higher doses of omacetaxine).
Active carcinoma requiring systemic chemotherapy or radiation therapy.
Intervention: Naltrexone
Trial phase: Phase 4
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Naltrexone

Naltrexone: Adults with ADHD
Eligibility criteria:
Inclusion Criteria

Male and female outpatients 18-55 years of age.
Diagnosis of ADHD, by DSM-IV by clinical evaluation by an expert clinician.
Subjects treated for anxiety disorders and depression who are on a stable medication regimen for at least one month, and who have a disorder-specific CGI-Severity score ≤ 3 (mildly ill) and who have a score on the Hamilton-Depression and Hamilton-Anxiety rating scales below 15 (mild range).

Exclusion Criteria

Any clinically unstable psychiatric conditions including any history of psychosis or mania, suicidality, sociopathy, criminality, or delinquency.
Current (last 3 months) substance use disorders (alcohol or drugs),
Medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study including cardiovascular disease, current untreated hypertension, history of renal or hepatic impairment, or a condition that will or may require treatment with opioid analgesics.
Clinically significant abnormal baseline laboratory LFT's, which is defined as LFT's greater than the ULN.
Mental retardation (IQ < 80).
Organic brain disorders including delirium, dementia, seizures, stroke, neurosurgery, and head trauma with loss of consciousness.
Pregnant or nursing females.
Subjects with current adequate treatment for ADHD.
Current treatment with medication for ADHD.
Any other concomitant medication with primarily central nervous system activity other than specified in the protocol (a stable and effective treatment regimen of an SSRI or benzodiazepine is permitted per clinical review.)
A Clinical Global Impression (CGI) of 7 (among the most extremely ill patients) at the screening visit is exclusionary, and any subject who presents a CGI-S of 7 at any point during the study will be removed from participation.
Subjects presenting with a CGI-Severity score of 6 (severely ill) at two consecutive visits after week 2 will be dropped from the study (i.e. A subject with a CGI of 6 at his/her week 3 visit and at week 4 visit will be dropped from the study at the week 4 visit). Subjects who are dropped for severe or worsening symptoms after exposure to the study medication will receive free follow up care as described in the detailed protocol and protocol summary.
Non-English speaking subjects
Intervention: Finerenone
Trial phase: Phase 2
ATC code: C03DA05
SMILES: CCOc1ncc(C)c2c1[C@H](c1ccc(C#N)cc1OC)C(C(N)=O)=C(C)N2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 96
Group description: 1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days
Eligibility criteria:
Inclusion Criteria:

Men and women aged 18 years and older.The lower age limit may be higher if legally required in the participating country
Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active.

Subjects with type 2 diabetes mellitus fulfilling at least 1 of the following criteria

are on oral antidiabetics and / or insulin,
have a documented fasting glucose >/= 7.0 mmol/L in the medical history,
have a 2 hour plasma glucose >/=11.1 mmol/L during an oral glucose tolerance test in the medical history, or
have a glycated hemoglobin (HbA1c) >/=6.5% [National Glycohemoglobin Standardization Program (NGSP) / Diabetes Control and Complications Trial (DCCT)] in the medical history or at the run-in visit

Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on at least 1 of the following criteria:

Persistent very high albuminuria defined as urinary albumin-to-creatine ratio (UACR) of >/=300 mg/g ( >/= 34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) >/=30 mL/min/1.73 m² but < 90 mL/min/1.73m² (Chronic Kidney Disease Epidemiology Collaboration, CKD EPI) (mL = milliliter; min = minute; m2 = square meter; g = gram; mmol = millimole) or
Persistent high albuminuria defined as UACR of >/=30 mg/g but <300 mg/g in (>/=3.4mg/mmol but <34 mg/mmol) in 2 out of 3 first morning void samples and eGFR >/=30 mL/min/1.73 m² but < 90 mL/min/1.73m²
Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) for at least 3 months without any adjustments to this therapy for at least 4 weeks prior to the screening visit
Serum potassium </= 4.8 mmol/L at both the run-in visit and the screening visit

Exclusion Criteria:

Non-diabetic renal disease
Glycated hemoglobin (HbA1c) >12% at the run-in visit or the screening visit
UACR >3000 mg/g (339mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit
Hypertension with mean sitting systolic blood pressure (SBP) >/=180 mmHg or mean sitting diastolic blood pressure (DBP) >/=110 mmHg at the run-in visit or mean supine SBP >/=160 mmHg or mean sitting DBP >/=100 mmHg at the screening visit
Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit
Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic
Dialysis for acute renal failure within the previous 6 months prior to the run-in visit
Intervention: Finerenone
Trial phase: Phase 2
ATC code: C03DA05
SMILES: CCOc1ncc(C)c2c1[C@H](c1ccc(C#N)cc1OC)C(C(N)=O)=C(C)N2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: 2.5 mg BAY94-8862 tablet once daily in the morning for 90 days
Eligibility criteria:
Inclusion Criteria:

Men and women aged 18 years and older.The lower age limit may be higher if legally required in the participating country
Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active.

Subjects with type 2 diabetes mellitus fulfilling at least 1 of the following criteria

are on oral antidiabetics and / or insulin,
have a documented fasting glucose >/= 7.0 mmol/L in the medical history,
have a 2 hour plasma glucose >/=11.1 mmol/L during an oral glucose tolerance test in the medical history, or
have a glycated hemoglobin (HbA1c) >/=6.5% [National Glycohemoglobin Standardization Program (NGSP) / Diabetes Control and Complications Trial (DCCT)] in the medical history or at the run-in visit

Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on at least 1 of the following criteria:

Persistent very high albuminuria defined as urinary albumin-to-creatine ratio (UACR) of >/=300 mg/g ( >/= 34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) >/=30 mL/min/1.73 m² but < 90 mL/min/1.73m² (Chronic Kidney Disease Epidemiology Collaboration, CKD EPI) (mL = milliliter; min = minute; m2 = square meter; g = gram; mmol = millimole) or
Persistent high albuminuria defined as UACR of >/=30 mg/g but <300 mg/g in (>/=3.4mg/mmol but <34 mg/mmol) in 2 out of 3 first morning void samples and eGFR >/=30 mL/min/1.73 m² but < 90 mL/min/1.73m²
Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) for at least 3 months without any adjustments to this therapy for at least 4 weeks prior to the screening visit
Serum potassium </= 4.8 mmol/L at both the run-in visit and the screening visit

Exclusion Criteria:

Non-diabetic renal disease
Glycated hemoglobin (HbA1c) >12% at the run-in visit or the screening visit
UACR >3000 mg/g (339mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit
Hypertension with mean sitting systolic blood pressure (SBP) >/=180 mmHg or mean sitting diastolic blood pressure (DBP) >/=110 mmHg at the run-in visit or mean supine SBP >/=160 mmHg or mean sitting DBP >/=100 mmHg at the screening visit
Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit
Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic
Dialysis for acute renal failure within the previous 6 months prior to the run-in visit
Intervention: Finerenone
Trial phase: Phase 2
ATC code: C03DA05
SMILES: CCOc1ncc(C)c2c1[C@H](c1ccc(C#N)cc1OC)C(C(N)=O)=C(C)N2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: 5 mg BAY94-8862 tablet once daily in the morning for 90 days
Eligibility criteria:
Inclusion Criteria:

Men and women aged 18 years and older.The lower age limit may be higher if legally required in the participating country
Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active.

Subjects with type 2 diabetes mellitus fulfilling at least 1 of the following criteria

are on oral antidiabetics and / or insulin,
have a documented fasting glucose >/= 7.0 mmol/L in the medical history,
have a 2 hour plasma glucose >/=11.1 mmol/L during an oral glucose tolerance test in the medical history, or
have a glycated hemoglobin (HbA1c) >/=6.5% [National Glycohemoglobin Standardization Program (NGSP) / Diabetes Control and Complications Trial (DCCT)] in the medical history or at the run-in visit

Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on at least 1 of the following criteria:

Persistent very high albuminuria defined as urinary albumin-to-creatine ratio (UACR) of >/=300 mg/g ( >/= 34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) >/=30 mL/min/1.73 m² but < 90 mL/min/1.73m² (Chronic Kidney Disease Epidemiology Collaboration, CKD EPI) (mL = milliliter; min = minute; m2 = square meter; g = gram; mmol = millimole) or
Persistent high albuminuria defined as UACR of >/=30 mg/g but <300 mg/g in (>/=3.4mg/mmol but <34 mg/mmol) in 2 out of 3 first morning void samples and eGFR >/=30 mL/min/1.73 m² but < 90 mL/min/1.73m²
Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) for at least 3 months without any adjustments to this therapy for at least 4 weeks prior to the screening visit
Serum potassium </= 4.8 mmol/L at both the run-in visit and the screening visit

Exclusion Criteria:

Non-diabetic renal disease
Glycated hemoglobin (HbA1c) >12% at the run-in visit or the screening visit
UACR >3000 mg/g (339mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit
Hypertension with mean sitting systolic blood pressure (SBP) >/=180 mmHg or mean sitting diastolic blood pressure (DBP) >/=110 mmHg at the run-in visit or mean supine SBP >/=160 mmHg or mean sitting DBP >/=100 mmHg at the screening visit
Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit
Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic
Dialysis for acute renal failure within the previous 6 months prior to the run-in visit
Intervention: Finerenone
Trial phase: Phase 2
ATC code: C03DA05
SMILES: CCOc1ncc(C)c2c1[C@H](c1ccc(C#N)cc1OC)C(C(N)=O)=C(C)N2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 97
Group description: 7.5 mg BAY94-8862 tablet once daily in the morning for 90 days
Eligibility criteria:
Inclusion Criteria:

Men and women aged 18 years and older.The lower age limit may be higher if legally required in the participating country
Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active.

Subjects with type 2 diabetes mellitus fulfilling at least 1 of the following criteria

are on oral antidiabetics and / or insulin,
have a documented fasting glucose >/= 7.0 mmol/L in the medical history,
have a 2 hour plasma glucose >/=11.1 mmol/L during an oral glucose tolerance test in the medical history, or
have a glycated hemoglobin (HbA1c) >/=6.5% [National Glycohemoglobin Standardization Program (NGSP) / Diabetes Control and Complications Trial (DCCT)] in the medical history or at the run-in visit

Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on at least 1 of the following criteria:

Persistent very high albuminuria defined as urinary albumin-to-creatine ratio (UACR) of >/=300 mg/g ( >/= 34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) >/=30 mL/min/1.73 m² but < 90 mL/min/1.73m² (Chronic Kidney Disease Epidemiology Collaboration, CKD EPI) (mL = milliliter; min = minute; m2 = square meter; g = gram; mmol = millimole) or
Persistent high albuminuria defined as UACR of >/=30 mg/g but <300 mg/g in (>/=3.4mg/mmol but <34 mg/mmol) in 2 out of 3 first morning void samples and eGFR >/=30 mL/min/1.73 m² but < 90 mL/min/1.73m²
Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) for at least 3 months without any adjustments to this therapy for at least 4 weeks prior to the screening visit
Serum potassium </= 4.8 mmol/L at both the run-in visit and the screening visit

Exclusion Criteria:

Non-diabetic renal disease
Glycated hemoglobin (HbA1c) >12% at the run-in visit or the screening visit
UACR >3000 mg/g (339mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit
Hypertension with mean sitting systolic blood pressure (SBP) >/=180 mmHg or mean sitting diastolic blood pressure (DBP) >/=110 mmHg at the run-in visit or mean supine SBP >/=160 mmHg or mean sitting DBP >/=100 mmHg at the screening visit
Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit
Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic
Dialysis for acute renal failure within the previous 6 months prior to the run-in visit
Intervention: Finerenone
Trial phase: Phase 2
ATC code: C03DA05
SMILES: CCOc1ncc(C)c2c1[C@H](c1ccc(C#N)cc1OC)C(C(N)=O)=C(C)N2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 119
Group description: 20 mg BAY94-8862 tablet once daily in the morning for 90 days
Eligibility criteria:
Inclusion Criteria:

Men and women aged 18 years and older.The lower age limit may be higher if legally required in the participating country
Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active.

Subjects with type 2 diabetes mellitus fulfilling at least 1 of the following criteria

are on oral antidiabetics and / or insulin,
have a documented fasting glucose >/= 7.0 mmol/L in the medical history,
have a 2 hour plasma glucose >/=11.1 mmol/L during an oral glucose tolerance test in the medical history, or
have a glycated hemoglobin (HbA1c) >/=6.5% [National Glycohemoglobin Standardization Program (NGSP) / Diabetes Control and Complications Trial (DCCT)] in the medical history or at the run-in visit

Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on at least 1 of the following criteria:

Persistent very high albuminuria defined as urinary albumin-to-creatine ratio (UACR) of >/=300 mg/g ( >/= 34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) >/=30 mL/min/1.73 m² but < 90 mL/min/1.73m² (Chronic Kidney Disease Epidemiology Collaboration, CKD EPI) (mL = milliliter; min = minute; m2 = square meter; g = gram; mmol = millimole) or
Persistent high albuminuria defined as UACR of >/=30 mg/g but <300 mg/g in (>/=3.4mg/mmol but <34 mg/mmol) in 2 out of 3 first morning void samples and eGFR >/=30 mL/min/1.73 m² but < 90 mL/min/1.73m²
Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) for at least 3 months without any adjustments to this therapy for at least 4 weeks prior to the screening visit
Serum potassium </= 4.8 mmol/L at both the run-in visit and the screening visit

Exclusion Criteria:

Non-diabetic renal disease
Glycated hemoglobin (HbA1c) >12% at the run-in visit or the screening visit
UACR >3000 mg/g (339mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit
Hypertension with mean sitting systolic blood pressure (SBP) >/=180 mmHg or mean sitting diastolic blood pressure (DBP) >/=110 mmHg at the run-in visit or mean supine SBP >/=160 mmHg or mean sitting DBP >/=100 mmHg at the screening visit
Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit
Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic
Dialysis for acute renal failure within the previous 6 months prior to the run-in visit
Intervention: Caffeine Citrate
Trial phase: Phase 3
SMILES: Cn1c(=O)c2c(ncn2C)n(C)c1=O.O=C(O)CC(O)(CC(=O)O)C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 42
Group description: Caffeine citrate 6 mg/kg/day

Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age.
Eligibility criteria:
Inclusion Criteria:

Gestational age of 25 + 0 to 32 + 0 weeks PMA at birth, and 34 + 0 to 375 + 6 weeks PMA at randomization
Prior treatment with caffeine based on routine clinical indications, and clinical caffeine now discontinued ≥5 days before randomization
Previously tolerated clinical treatment with caffeine
Breathing room air (no current supplemental O2 treatment; may have previously required respiratory support)
Parental consent to enroll in pilot study

Exclusion Criteria:

Congenital syndrome or other medical diagnosis associated with known risk for neurodevelopmental abnormality, including intraventricular hemorrhage Grade 3 or greater, cyanotic congenital heart disease, confirmed central nervous system infection, or fetal alcohol syndrome
Currently receiving supplemental oxygen, ventilatory support, or nasal airflow therapy
Clinical decision to restart caffeine prior to completing 5 days of continuous physiologic monitoring after clinical caffeine stopped
Anticipated inability to meet protocol requirements