anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ferumoxides
Trial phase: Phase 3
SMILES: [Fe+2].[Fe+3].[Fe+3].[O-2].[O-2].[O-2].[O-2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 997
Group description: Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
Eligibility criteria:
Key Inclusion Criteria include:

Participants with IDA and in whom IV iron treatment is indicated and defined as:

Participants with documented hemoglobin <12.0 g per deciliter (dL) for females and <14.0 g/dL for males within 60 days of dosing And
Participants with documented transferrin saturation (TSAT) ≤20% or Ferritin ≤100 nanograms (ng) per mL within 60 days of dosing
Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate (as per oral iron history questionnaire)
All participants (male and female) of childbearing potential who are sexually active who agree to routinely use adequate contraception from randomization throughout the duration of the study

Key Exclusion Criteria include:

Known hypersensitivity reaction to any component of ferumoxytol or FCM
History of allergy to an IV iron
History of multiple drug allergies
Participants with dialysis-dependent chronic kidney disease
Hemoglobin ≤7.0 g/dL
Female participants who are pregnant, intend to become pregnant, are breastfeeding, have a positive serum/urine pregnancy test or not willing to use effective contraceptive precautions during the study (including females of childbearing potential who are partners of male participants)
Intervention: Fosfomycin
Trial phase: Phase 3
ATC code: J01XX01 | S02AA17
SMILES: C[C@@H]1O[C@@H]1P(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1000
Group description: Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.
Eligibility criteria:
Key Inclusion Criteria include:

Participants with IDA and in whom IV iron treatment is indicated and defined as:

Participants with documented hemoglobin <12.0 g per deciliter (dL) for females and <14.0 g/dL for males within 60 days of dosing And
Participants with documented transferrin saturation (TSAT) ≤20% or Ferritin ≤100 nanograms (ng) per mL within 60 days of dosing
Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate (as per oral iron history questionnaire)
All participants (male and female) of childbearing potential who are sexually active who agree to routinely use adequate contraception from randomization throughout the duration of the study

Key Exclusion Criteria include:

Known hypersensitivity reaction to any component of ferumoxytol or FCM
History of allergy to an IV iron
History of multiple drug allergies
Participants with dialysis-dependent chronic kidney disease
Hemoglobin ≤7.0 g/dL
Female participants who are pregnant, intend to become pregnant, are breastfeeding, have a positive serum/urine pregnancy test or not willing to use effective contraceptive precautions during the study (including females of childbearing potential who are partners of male participants)
Intervention: Minocycline
Trial phase: Phase 4
ATC code: A01AB23 | D10AF07 | J01AA08 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)ccc(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Oral extended release minocycline - up to 2mg/kg once a day for 30 days.

Minocycline: Oral extended release minocycline
Eligibility criteria:
Inclusion Criteria:

Otherwise healthy male and female subjects 14 to 40 years of age
Moderate to severe inflammatory facial acne vulgaris (EGSA score of 3-5)
Subjects not using oral or topical antibiotic products for at least 30 days prior to study entry and willing to refrain from use of oral and topical antibiotics for the duration of study participation
Subjects not currently using and willing to refrain from use of other topical acne products for the duration of study participation

Exclusion Criteria:

Mild, non-inflammatory or nodular acne vulgaris
Have current or previous skin cancer
Have a history of skin disease or presence of skin condition the PI believes would interfere with the study
Females who report that they are pregnant, planning a pregnancy during the study period or breastfeeding
Have conditions or factors that the PI believes may affect the response of the skin or the interpretation of the results
Participation in any clinical study within the previous 30 days or plan concurrent participation in other studies
Intervention: Mitomycin
Trial phase: Phase 3
ATC code: L01DC03
SMILES: [H][C@]12N[C@@]1([H])CN1C3=C(C(=O)C(N)=C(C)C3=O)[C@@H](COC(N)=O)[C@]12OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Mitomycin C 40 mg in 40 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.

Mitomycin C: Cancer chemotherapeutic agent
Eligibility criteria:
Inclusion Criteria:

sign an informed consent for the study
be scheduled for a TURBT for suspected non-muscle invasive bladder tumor.

Exclusion Criteria:

patients unable to consent for themselves
individuals under 18 years old
pregnant women
prisoners
patients with known allergy or intolerance to the mitomycin C or Gemcitabine
any other sound medical, psychiatric and/or social reason as determined by the investigator.
Intervention: Gemcitabine
Trial phase: Phase 3
ATC code: L01BC05
SMILES: Nc1ccn([C@@H]2O[C@H](CO)[C@@H](O)C2(F)F)c(=O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.

Gemcitabine: Cancer chemotherapeutic agent
Eligibility criteria:
Inclusion Criteria:

sign an informed consent for the study
be scheduled for a TURBT for suspected non-muscle invasive bladder tumor.

Exclusion Criteria:

patients unable to consent for themselves
individuals under 18 years old
pregnant women
prisoners
patients with known allergy or intolerance to the mitomycin C or Gemcitabine
any other sound medical, psychiatric and/or social reason as determined by the investigator.
Intervention: Warfarin
Trial phase: Not Applicable
ATC code: B01AA03
SMILES: CC(=O)CC(c1ccccc1)c1c(O)c2ccccc2oc1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm

TAVR Warfarin and clopidogrel: Begin Warfarin and clopidogrel (75 mg/day) treatment within 1-3 days postop for 12 weeks with a target INR of 2-3 When warfarin is discontinued, begin aspirin (81 mg/day) and continue aspirin/clopidogrel for 12 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely
Eligibility criteria:
Inclusion Criteria:

Scheduled for SAVR or TAVR

Age > 18 years
Able and willing to give informed consent
Able and willing to return for follow up

Exclusion Criteria:

Contraindications to warfarin, Plavix or aspirin
Pre-existing medical indication for warfarin, Plavix or aspirin
History of previous cardiac surgery
History of previous coronary artery stenting
Requirement for concomitant coronary artery bypass grafting or mitral valve surgery or surgical treatment of an ascending aortic aneurysm
Contraindications to contrast-enhanced MDCT including anaphylactic iodine allergy, uncontrolled atrial fibrillation, renal dysfunction (GFR < 60 ml/min).
Intervention: ASPIRIN
Trial phase: Not Applicable
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Aspirin arm (81mg/day)

SAVR Aspirin: Aspirin (81 mg/day) to begin within 1-3 postoperative days according to the patient's clinical status and continue indefinitely per standard of care.
Eligibility criteria:
Inclusion Criteria:

Scheduled for SAVR or TAVR

Age > 18 years
Able and willing to give informed consent
Able and willing to return for follow up

Exclusion Criteria:

Contraindications to warfarin, Plavix or aspirin
Pre-existing medical indication for warfarin, Plavix or aspirin
History of previous cardiac surgery
History of previous coronary artery stenting
Requirement for concomitant coronary artery bypass grafting or mitral valve surgery or surgical treatment of an ascending aortic aneurysm
Contraindications to contrast-enhanced MDCT including anaphylactic iodine allergy, uncontrolled atrial fibrillation, renal dysfunction (GFR < 60 ml/min).
Intervention: Budesonide
Trial phase: Phase 4
ATC code: A07EA06 | D07AC09 | R01AD05 | R03AK07 | R03AK12 | R03AL11 | R03BA02
SMILES: CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C)C4C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: The study intervention will be budesonide powder (0.5 mg/capsule). Subjects will be required to dissolve the contents of two capsules into the 8-ounce (240 ml) NeilMed Sinus Rinse Regular Bottle along with the saline rinse. All subjects will be instructed to irrigate both right and left nasal cavity with one-half of the contents of the nasal rinse once daily for 30 days..

Each study bottle will contain 60 capsules of Budesonide and will be assigned with a number from 1-80.

Budesonide: Participants will undergo 30-day treatment course that includes budesonide powder added to saline rinse.
Eligibility criteria:
Inclusion Criteria:

Twelve (12) weeks or longer of two or more of the following signs and symptom consistent with chronic rhinosinusitis (CRS)

• mucopurulent drainage (anterior, posterior, or both), nasal obstruction (congestion),facial pain-pressure-fullness, and decreased sense of smell

AND inflammation documented by one or more of the following findings:

purulent (not clear) mucus or edema in the middle meatus or ethmoid region,
polyps in nasal cavity or the middle meatus, and/or
radiographic imaging showing inflammation of the paranasal sinuses

Exclusion Criteria:

Unable to speak English
History of comorbid ciliary dyskinesia, cystic fibrosis or any other mucociliary condition
Dependence on prolonged corticosteroid therapy for comorbid conditions, such as asthma and chronic obstructive pulmonary disease.
History of oral or systematic antibiotic use in the past 2 weeks
History of nasal or sinus surgery within past 6 weeks
History of cerebrospinal fluid leak
History of allergy to budesonide or other topical steroids
Pregnant or breast feeding
Current infection or history of one of the following infections: Tuberculosis (TB) lung infection, or Herpes infection of the eye.
Baseline SNOT-22 total scores below 9 were excluded due to the inability to achieve a minimally clinically improved difference
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 34
Group description: Patients will receive an equivalent volume of normal saline intravenously.

Normal Saline: Patients will receive normal saline intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration.
Eligibility criteria:
Inclusion Criteria:

18-65 years of age
Chief complaint of headache
International Classification of Headache Disorder classification of migraine or probable migraine with or without aura
Has decision making capacity
Consent
Provider determination of non-emergent cause

Exclusion Criteria:

Over the age of 50 with first time headache
Known adverse reaction or tolerance to study medication
Headache due to trauma
New onset, focal, abnormal, neurologic findings
New onset seizures
History of metastatic cancer or neoplasm
Active psychotic symptoms
Altered mental status
Provider intends to preform lumbar puncture
Pregnancy
Breast feeding
Previous enrollment in study
Fever > 100.3 F
Physiologic instability (blood pressure < 90/50 or >170/100, heart rate <50 or >120, chronic respiratory, renal or hepatic failure)
Suspected cardiac pain
Intervention: Ketamine
Trial phase: Not Applicable
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 34
Group description: Patients will receive 0.2mg/kg ketamine intravenously over one minute.

Ketamine: Patients in this arm will receive 0.2mg/kg ketamine intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration.
Eligibility criteria:
Inclusion Criteria:

18-65 years of age
Chief complaint of headache
International Classification of Headache Disorder classification of migraine or probable migraine with or without aura
Has decision making capacity
Consent
Provider determination of non-emergent cause

Exclusion Criteria:

Over the age of 50 with first time headache
Known adverse reaction or tolerance to study medication
Headache due to trauma
New onset, focal, abnormal, neurologic findings
New onset seizures
History of metastatic cancer or neoplasm
Active psychotic symptoms
Altered mental status
Provider intends to preform lumbar puncture
Pregnancy
Breast feeding
Previous enrollment in study
Fever > 100.3 F
Physiologic instability (blood pressure < 90/50 or >170/100, heart rate <50 or >120, chronic respiratory, renal or hepatic failure)
Suspected cardiac pain
Intervention: Citrulline
Trial phase: Phase 1
SMILES: NC(=O)NCCC[C@H](N)C(=O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Intravenous citrulline at a bolus dose over 5 minutes and then a continuous rate for the next 23 hours.

Intravenous citrulline: Intravenous citrulline at a bolus dose of 20 mg/kg over 5 minutes and then continuous at a rate of 7 mg/kg/hour for the next 23 hours for the first 7 participants, and depending on safety and pharmacokinetic profile, increase or decrease the continuous rate to 9 or 5 mg/kg/hour for the next 7 participants.
Eligibility criteria:
Inclusion Criteria:

Sickle cell disease genotypes (HbSS, HbS/β0-thalassemia, HbS/β+-thalassemia, HbSC)
Ages 6 to 50 years old
Patients with sickle cell disease aged 6 to 50 years old Presence of sickle cell pain crisis defined by the presence of pain requiring hospitalization and parental opioid therapy
Presence of acute chest syndrome defined by the presence of a new CXR infiltrate and any one of the following respiratory symptoms of fever, shortness of breath, wheezing, chest pain, cough or new onset hypoxia.

Exclusion Criteria:

Presence of any other complication related to sickle cell disease requiring hospitalization such as splenic sequestration, hepatic sequestration, stroke, avascular necrosis of the hip/shoulder, acute priapism, etc.
Severe anemia (hemoglobin < 5g/dL)
History of red blood cell transfusion within the last 30 days
Systemic steroid therapy within the last 48 hours
Pregnant (as confirmed by a negative urine pregnancy test) or lactating female
Alanine/aspartate transferase >2x upper limit of normal laboratory range for age.

Subject has the following serum creatinine:

Age 6 to 13 years > 0.9 mg/dL
Age 14-17 years 1.0 mg/dL
Age 18 years >1.5mg/dL
Patients with an inability to give consent will be excluded
Intervention: ASPIRIN
Trial phase: Not Applicable
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7434
Group description: aspirin 81mg

aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
Eligibility criteria:
Inclusion Criteria:

Known atherosclerotic cardiovascular disease (ASCVD), defined by a history of prior myocardial infarction, prior coronary angiography showing ≥75% stenosis of at least one epicardial coronary vessel, or prior coronary revascularization procedures (either PCI or CABG), or history of chronic heart disease, CAD, ASCVD
Age ≥ 18 years
No known safety concerns or side effects considered to be related to aspirin, including
No history of significant allergy to aspirin such as anaphylaxis, urticaria, or significant gastrointestinal intolerances
No history of significant GI bleed within the past 12 months
Significant bleeding disorders that preclude the use of aspirin
Access to the Internet. In the event that the CDRNs are notified that a cohort of patients without internet access can be included, then patient agreement will be obtained during the consent process to provide follow-up information by telephone contact with the DCRI Call Center.
Not currently treated with an oral anticoagulant - either warfarin or a novel anticoagulant (dabigatran, rivaroxaban, apixaban, edoxaban) - and not planned to be treated in the future with an oral anticoagulant for existing indications such as atrial fibrillation, deep venous thrombosis, or pulmonary embolism.
Not currently treated with ticagrelor and not planned to be treated in the future with ticagrelor.
Female patients who are not pregnant or nursing an infant
Estimated risk of a major cardiovascular event (MACE) > 8% over next 3 years as defined by the presence of at least one or more of the following enrichment factors:
Age > 65 years
Serum creatinine > 1.5 mg/dL
Diabetes mellitus (Type 1 or Type 2)
3-vessel coronary artery disease
Cerebrovascular disease and/or peripheral arterial disease
Left ventricular ejection fraction (LVEF) < 50%
Current cigarette smoker
Chronic systolic or diastolic heart failure
SBP > 140 (within past 12 mos)
LDL > 130 (within past 12 mos)

Exclusion Criteria:

There will be no exclusions for any upper age limit, comorbid conditions, or concomitant medications other than oral anticoagulants and ticagrelor that are used at the time of randomization, or are planned to be used during the study follow-up.
Patients and sites interested in participating must be part of the listed health systems collaborators.
Intervention: ASPIRIN
Trial phase: Not Applicable
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7330
Group description: aspirin 325mg

aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
Eligibility criteria:
Inclusion Criteria:

Known atherosclerotic cardiovascular disease (ASCVD), defined by a history of prior myocardial infarction, prior coronary angiography showing ≥75% stenosis of at least one epicardial coronary vessel, or prior coronary revascularization procedures (either PCI or CABG), or history of chronic heart disease, CAD, ASCVD
Age ≥ 18 years
No known safety concerns or side effects considered to be related to aspirin, including
No history of significant allergy to aspirin such as anaphylaxis, urticaria, or significant gastrointestinal intolerances
No history of significant GI bleed within the past 12 months
Significant bleeding disorders that preclude the use of aspirin
Access to the Internet. In the event that the CDRNs are notified that a cohort of patients without internet access can be included, then patient agreement will be obtained during the consent process to provide follow-up information by telephone contact with the DCRI Call Center.
Not currently treated with an oral anticoagulant - either warfarin or a novel anticoagulant (dabigatran, rivaroxaban, apixaban, edoxaban) - and not planned to be treated in the future with an oral anticoagulant for existing indications such as atrial fibrillation, deep venous thrombosis, or pulmonary embolism.
Not currently treated with ticagrelor and not planned to be treated in the future with ticagrelor.
Female patients who are not pregnant or nursing an infant
Estimated risk of a major cardiovascular event (MACE) > 8% over next 3 years as defined by the presence of at least one or more of the following enrichment factors:
Age > 65 years
Serum creatinine > 1.5 mg/dL
Diabetes mellitus (Type 1 or Type 2)
3-vessel coronary artery disease
Cerebrovascular disease and/or peripheral arterial disease
Left ventricular ejection fraction (LVEF) < 50%
Current cigarette smoker
Chronic systolic or diastolic heart failure
SBP > 140 (within past 12 mos)
LDL > 130 (within past 12 mos)

Exclusion Criteria:

There will be no exclusions for any upper age limit, comorbid conditions, or concomitant medications other than oral anticoagulants and ticagrelor that are used at the time of randomization, or are planned to be used during the study follow-up.
Patients and sites interested in participating must be part of the listed health systems collaborators.
Intervention: BENZOYL PEROXIDE
Trial phase: Not Applicable
ATC code: D10AE01 | D10AE51
SMILES: O=C(OOC(=O)c1ccccc1)c1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 103
Group description: Applied BPO treatment once daily
Eligibility criteria:
Inclusion Criteria:

Has mild to moderate acne
Has 10 - 100 pimples, 10 - 50 inflamed red pimples, up to 2 raised bumps and no cysts
In general good health
Must avoid excessive sun exposure and any light treatments or any professional or aesthetic spa-like procedures
Must not be pregnant, nursing or intend to become pregnant during the study
Must agree to practice a medically acceptable form of birth control.
Must be able to read, speak, write and understand English

Exclusion Criteria:

Allergies or sensitivities to product ingredients or to light
Has severe acne or pre-existing dermatological facial condition
Has an uncontrolled disease or immune deficient disorder
Is pregnant, breast-feeding or intending to become pregnant
Has been taking prescription drug medication for acne or antibiotics for the past 6 months
Intervention: Dapagliflozin
Trial phase: Phase 4
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.

Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Patients both sexes
Age between 30 and 60 years
Diagnosis of prediabetes according ADA criteria (fasting blood glucose levels between 100-126 mg/dl; postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose between 140-199 mg/dl; or glycosylated hemoglobin between 5.7-6.4%)
Informed consent signed

Exclusion Criteria:

Women with confirmed or suspected pregnancy
Women under lactation and/or puerperium
Hypersensibility to ingredients of intervention
Physical impossibility for taking pills
Known uncontrolled renal, hepatic, heart or thyroid diseased
Diabetes diagnosis
Previous treatment for glucose
Body Mass Index ≥35 kg/m2
Triglycerides ≥500 mg/dL
Total cholesterol ≥240 mg/dL
Low density lipoprotein (c-LDL) ≥190 mg/dL
Blood Pressure ≥140/90 mmHg