anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Revefenacin
Trial phase: Phase 2
ATC code: R03BB08
SMILES: CN(CCN1CCC(OC(=O)Nc2ccccc2-c2ccccc2)CC1)C(=O)c1ccc(CN2CCC(C(N)=O)CC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 71
Group description: TD-4208

TD-4208
Eligibility criteria:
Inclusion Criteria:

Subject is a male or female subject 40 years of age or older
Subject must have a negative pregnancy test, and must be prepared to use effective contraception if of child-bearing potential
Subject is capable of performing reproducible spirometry maneuvers
Subject has post-bronchodilator FEV1/FVC ratio <0.7
Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the GOLD Guidelines)
Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal
Subject has a current or past smoking history of at least 10 pack-years.

Exclusion Criteria:

Subject has a significant respiratory disease or disorder other than COPD that would affect the interpretation of data from this study
Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergic or beta-agonist agents
Subject suffers from any medical condition that would preclude the use of inhaled anticholinergic agents
Subject has been hospitalized for COPD or pneumonia within 12 weeks
Subject requires long-term oxygen therapy (>15 hours a day)
Intervention: Revefenacin
Trial phase: Phase 2
ATC code: R03BB08
SMILES: CN(CCN1CCC(OC(=O)Nc2ccccc2-c2ccccc2)CC1)C(=O)c1ccc(CN2CCC(C(N)=O)CC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: TD-4208

TD-4208
Eligibility criteria:
Inclusion Criteria:

Subject is a male or female subject 40 years of age or older
Subject must have a negative pregnancy test, and must be prepared to use effective contraception if of child-bearing potential
Subject is capable of performing reproducible spirometry maneuvers
Subject has post-bronchodilator FEV1/FVC ratio <0.7
Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the GOLD Guidelines)
Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal
Subject has a current or past smoking history of at least 10 pack-years.

Exclusion Criteria:

Subject has a significant respiratory disease or disorder other than COPD that would affect the interpretation of data from this study
Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergic or beta-agonist agents
Subject suffers from any medical condition that would preclude the use of inhaled anticholinergic agents
Subject has been hospitalized for COPD or pneumonia within 12 weeks
Subject requires long-term oxygen therapy (>15 hours a day)
Intervention: Imatinib Mesylate
Trial phase: Phase 3
SMILES: CS(=O)(=O)O.Cc1ccc(NC(=O)c2ccc(CN3CCN(C)CC3)cc2)cc1Nc1nccc(-c2cccnc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: QTI571
Eligibility criteria:
Inclusion Criteria:

patient is receiving QTI571 for the treatment of Pulmonary Arterial Hypertension (PAH) and is currectly enrolled in a long-term extension study (CQTI571A2301E1) in Japan.
Patient is currently benifitting form the treatment with QTI571 in the opinion of the investigator.

Exclusion Criteria:

Patient has been permanently discontinued from QTI571 study treatment in the parent study.
Concomitant use of oral vitamin K antagonist medication.
Intervention: Lubiprostone
Trial phase: Phase 3
ATC code: A06AX03
SMILES: [H][C@@]12CC(=O)[C@H](CCCCCCC(=O)O)[C@@]1([H])CC[C@](O)(C(F)(F)CCCC)O2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 400
Group description: Participants receive lubiprostone BID for up to 12 weeks
Eligibility criteria:
Inclusion Criteria:

Medically-confirmed diagnosis of Functional Constipation per Rome III Diagnostic Criteria for Childhood Functional Constipation
At least 6 years of age but less than 18 years of age at the time of randomisation
Only stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors are allowed if subject is taking antidepressants

Exclusion Criteria:

Any gastrointestinal (GI) condition, other than constipation and/or irritable bowel syndrome (IBS), affecting GI motility or defecation
Untreated faecal impaction at the time of screening
Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication
Intervention: Rivaroxaban
Trial phase: Phase 2
ATC code: B01AF01
SMILES: O=C(NC[C@H]1CN(c2ccc(N3CCOCC3=O)cc2)C(=O)O1)c1ccc(Cl)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 98
Group description: Safety population : 98 (patients)

Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.

Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.

The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety.
Eligibility criteria:
Inclusion Criteria: All of below

Acute ischemic stroke or TIA presumed to be cardioembolic origin (within 5 days from stroke onset) with mild severity: infarct size on DWI less than 1/3 of MCA territory, 1/2 of ACA territory, 1/2 of PCA territory, and 1/2 of one cerebellar hemisphere
Atrial fibrillation including paroxysmal atrial fibrillation: atrial fibrillation must be documented by ECG evidence (e.g., 12-lead ECG, rhythm strip, Holter, pacemaker interrogation) within 30 days before randomization. This could be obtained from a notation in the subject's record (e.g., medical chart, hospital discharge summary).
Age ≥19 years
Informed consent

Exclusion Criteria: Any of below

Chronic renal failure (GFR less than 30ml/min) or severe hepatic impairment
Significant hemorrhagic transformation (parenchymal hematoma type I or II by the ECASS definition)
Stroke mechanism of presumed small vessel occlusion: single small subcortical infarct in the perforating artery territory
Large hemispheric or cerebellar infarction; larger than 1/3 of MCA territory, 1/2 of ACA territory, 1/2 of PCA territory, and 1/2 of one cerebellar hemisphere
Mechanical valve requiring warfarin therapy
Active internal bleeding

Prior history of symptomatic intracranial bleeding

: patients with asymptomatic bleedings or microbleedings on MRI are eligible for inclusion

Major surgery or major trauma within 30 days that might be associated with increased bleeding risk
Clinically significant gastrointestinal bleeding within 6 months

Intravenous tissue plasminogen activator use or mechanical embolectomy within 48 hours plus 'significant hemorrhagic transformation as described above (exclusion criteria 2)' or 'large hemispheric infarction or cerebellar infarction as described above (exclusion criteria 4)'

: patients achieving successful reperfusion without hemorrhage nor large infarction are eligible for enrollment

Severe anemia: hemoglobin <10 g/dL
Bleeding diathesis; thrombocytopenia (<90,000/µL, prolonged PT (INR>1.7)
Sustained uncontrolled hypertension: SBP >180 mmHg or DBP >100 mmHg
Severe devastating illness, such terminal cancer, hepatic failure; therefore, the participants have a life expectancy less than 6 months.
Planned invasive procedure with potential for uncontrolled bleeding, including major surgery
Intervention: Tranexamic acid
Trial phase: Phase 2 | Phase 3
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.

Tranexamic Acid: Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution.
Eligibility criteria:
Inclusion Criteria:

Patients undergoing scheduled primary reverse total shoulder arthroplasty performed by J. Michael Wiater, MD.
Patients age 18 and older

Exclusion Criteria:

Pregnant* or breast-feeding women
Allergy to tranexamic acid
Acquired disturbances of color vision
Use of estrogen containing medications (i.e. oral contraceptive pills)
Hormone replacement therapy
Preoperative anemia [Hemoglobin (Hb) < 11g/dL in females, Hb < 12 g/dL in males]
Refusal of blood products

Preoperative use of anticoagulant therapy within 5 days prior to surgery

Coumadin
Heparin
Low molecular weight heparin
Factor Xa inhibitors
Thrombin inhibitors
Coagulopathy
Thrombophilia
Antithrombin deficiency
Factor V Leiden
Antiphospholipid Syndrome
Protein C and S deficiency
History of heparin induced thrombocytopenia
Sickle cell anemia
Myeloproliferative disorders
Platelet < 150,00 mm3
International Normalized Ratio (INR) > 1.4
Partial Thromboplastin Time (PTT) > 1.4 times normal
A history of arterial or venous thromboembolism
Cerebral Vascular Accident
Deep Vein Thrombosis
Pulmonary Embolism
Subarachnoid hemorrhage
Active intravascular clotting
Major comorbidities
Coronary artery disease (New York Heart Association Class III or IV)
Previous MI
Severe pulmonary disease (FEV <50% normal)
Plasma creatinine > 115 μmol/L in males, > 100 μmol/L in females, or hepatic failure)

34. Participation in another clinical trial 35. *All women of child bearing potential must have a negative serum or urine pregnancy test.
Intervention: Estradiol
Trial phase: Not Applicable
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 50
Group description: Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
Eligibility criteria:
Inclusion Criteria:

Infants <6 months old
Successfully weaned off cardiopulmonary bypass after cardiac surgery

Exclusion Criteria:

Requirement of extra corporeal membrane oxygenation in the operating room
Known immune deficiency
Current Do Not Resuscitate or limitation of care order
Current enrollment in another interventional clinical study
Refusal of parental consent
Intervention: Lorcaserin hydrochloride
Trial phase: Phase 2
SMILES: CC1CNCCc2ccc(Cl)cc21.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 201
Group description: APD356-lorcaserin hydrochloride 10 mg twice daily
Eligibility criteria:
Inclusion Criteria:

Males or females aged 18-65 years, inclusive
≥10 cigarettes per day with no period of abstinence longer than 3 months in the past year and who are motivated to quit smoking
Able to give signed informed consent

Eligible female patients will be:

non-pregnant
non-lactating
agree to use an acceptable method of effective contraception during the study
Eligible male patients agree to use contraception when sexually active with a female partner who is not using an acceptable method of birth control
Body weight of ≥50 kg (110 pounds), inclusive
Considered to be in stable health in the opinion of the investigator

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study.

Prior or current use of lorcaserin HCl
Prior participation in any study of a nicotine vaccination
Use of other therapies for smoking cessation is not allowed within 3 months of screening through study exit
Use of tobacco products other than cigarettes
Prior use of fenfluramine or dexfenfluramine
Serious or unstable medical condition or clinically significant new illness within the 6 months prior to screening
Previous participation in any clinical study within 6 weeks prior to the screening visit
History of severe allergies, severe drug or excipient allergy or hypersensitivity
History of significant cardiovascular condition
History of other significant medical conditions
Significant risk of suicide
Anticipated use of any agents that are associated with valvulopathy and/or pulmonary hypertension
Positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
Recent history of alcohol or drug/solvent abuse
Concurrent participation in the study by more than one member of the same household
Not suitable to participate in the study in the opinion of the investigator
Intervention: Lorcaserin hydrochloride
Trial phase: Phase 2
SMILES: CC1CNCCc2ccc(Cl)cc21.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 202
Group description: APD356-lorcaserin hydrochloride 10 mg once daily
Eligibility criteria:
Inclusion Criteria:

Males or females aged 18-65 years, inclusive
≥10 cigarettes per day with no period of abstinence longer than 3 months in the past year and who are motivated to quit smoking
Able to give signed informed consent

Eligible female patients will be:

non-pregnant
non-lactating
agree to use an acceptable method of effective contraception during the study
Eligible male patients agree to use contraception when sexually active with a female partner who is not using an acceptable method of birth control
Body weight of ≥50 kg (110 pounds), inclusive
Considered to be in stable health in the opinion of the investigator

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study.

Prior or current use of lorcaserin HCl
Prior participation in any study of a nicotine vaccination
Use of other therapies for smoking cessation is not allowed within 3 months of screening through study exit
Use of tobacco products other than cigarettes
Prior use of fenfluramine or dexfenfluramine
Serious or unstable medical condition or clinically significant new illness within the 6 months prior to screening
Previous participation in any clinical study within 6 weeks prior to the screening visit
History of severe allergies, severe drug or excipient allergy or hypersensitivity
History of significant cardiovascular condition
History of other significant medical conditions
Significant risk of suicide
Anticipated use of any agents that are associated with valvulopathy and/or pulmonary hypertension
Positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
Recent history of alcohol or drug/solvent abuse
Concurrent participation in the study by more than one member of the same household
Not suitable to participate in the study in the opinion of the investigator
Intervention: Methylprednisolone
Trial phase: Phase 2
ATC code: D07AA01 | D07CA02 | D10AA02 | H02AB04 | H02BX01 | S01CA08 | S03CA07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@@]21C
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
Eligibility criteria:
Inclusion Criteria:

Women who are not doing other therapies for pain (physical therapy, chiropractic management, pool)
Women between age 21 and 50 who plan to deliver at Loyola or Gottlieb
Pain Numeric Rating Scale (NRS) on average of greater than or equal to 5/10 at Visit 1
Pain must be between the upper level of the iliac crests and the gluteal folds in conjunction with or separately from pain in the pubic symphysis and influenced by position and locomotion
2/4 positive physical examination tests on the symptomatic side including the P4 test, the LDL test, pubic symphysis palpation and the acute straight leg rise (ASLR)

Exclusion Criteria:

Women presenting with PGP in the first or third trimester (<13 weeks gestation or >28 weeks gestation)
Women with pubic symphysis (anterior) pain alone
Women who do not plan to deliver a baby at Loyola or Gottlieb
Pain above the upper level of the iliac crest
History of lumbar or pelvic fracture, neoplasm, inflammatory disease, active urogenital infection or active gastrointestinal illness, current physical therapy or other therapies for PGP, or previous surgery of the lumbar spine, pelvic girdle, hip joint or femur
History or signs of radiculopathy or other systemic neurologic disease
Women with diabetes or gestational diabetes
Intervention: Hematoporphyrin
Trial phase: Phase 2
SMILES: CC1=C(CCC(=O)O)c2cc3nc(cc4[nH]c(cc5[nH]c(cc1n2)c(C)c5C(C)O)c(C)c4C(C)O)C(C)=C3CCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 62
Group description: HP

IDP-118 Monad HP Lotion: Active Comparator
Eligibility criteria:
Key Inclusion Criteria:

Male or female, of any race, at least 18 years of age (inclusive).
Freely provides both verbal and written informed consent.
Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this calculation.
Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or 4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment, if psoriasis is present).

Key Exclusion Criteria:

Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.
Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator.
Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.
Is pregnant, nursing an infant, or planning a pregnancy during the study period.
Has received treatment with any investigational drug or device within 60 days or 5 drug half lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.
Intervention: Dulera
Trial phase: Phase 4
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl.COc1ccc(CC(C)NCC(O)c2ccc(O)c(NC=O)c2)cc1.COc1ccc(CC(C)NCC(O)c2ccc(O)c(NC=O)c2)cc1.O.O.O=C(O)C=CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Adherence Monitoring Dulera; Identification of adherence barrier(s); Motivational Interviewing Adherence Strategies to promote adherence

Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older.
Eligibility criteria:
Inclusion Criteria:

Physician diagnosis of asthma of moderate severity
Subjects ≥ 18 years of age
Currently receiving an inhaled corticosteroid medication and being prescribed Dulera 100/5 as part of standard of care based upon asthma severity and dosing guidelines
Asthma Control Questionnaire (ACQ) result > 1.0 at entry
Demonstration of correct inhalation technique for use of meter-dosed inhalers (MDIs)
History of reversible airway obstruction documented by treating physician Exclusion Criteria: intermittent asthma; emphysema, chronic obstructive pulmonary disease; chronic bronchitis; cystic fibrosis; medication that may have a drug interaction with Dulera

Exclusion Criteria

Intermittent asthma (asthma exacerbations or symptoms < 3 days/week)
Diagnosis of emphysema in prior year
Diagnosis at any time of: chronic obstructive pulmonary disease (COPD), chronic bronchitis, cystic fibrosis, bronchiectasis, Churg Strauss, Wegener's, sarcoidosis, pulmonary hypertension or lung cancer
On any medication documented to have a drug interaction with Dulera
Intervention: Dulera
Trial phase: Phase 4
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl.COc1ccc(CC(C)NCC(O)c2ccc(O)c(NC=O)c2)cc1.COc1ccc(CC(C)NCC(O)c2ccc(O)c(NC=O)c2)cc1.O.O.O=C(O)C=CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Dulera standard of asthma care

Dulera: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older.
Eligibility criteria:
Inclusion Criteria:

Physician diagnosis of asthma of moderate severity
Subjects ≥ 18 years of age
Currently receiving an inhaled corticosteroid medication and being prescribed Dulera 100/5 as part of standard of care based upon asthma severity and dosing guidelines
Asthma Control Questionnaire (ACQ) result > 1.0 at entry
Demonstration of correct inhalation technique for use of meter-dosed inhalers (MDIs)
History of reversible airway obstruction documented by treating physician Exclusion Criteria: intermittent asthma; emphysema, chronic obstructive pulmonary disease; chronic bronchitis; cystic fibrosis; medication that may have a drug interaction with Dulera

Exclusion Criteria

Intermittent asthma (asthma exacerbations or symptoms < 3 days/week)
Diagnosis of emphysema in prior year
Diagnosis at any time of: chronic obstructive pulmonary disease (COPD), chronic bronchitis, cystic fibrosis, bronchiectasis, Churg Strauss, Wegener's, sarcoidosis, pulmonary hypertension or lung cancer
On any medication documented to have a drug interaction with Dulera
Intervention: SODIUM BICARBONATE
Trial phase: Phase 2
ATC code: B05CB04 | B05XA02
SMILES: O=C([O-])O.[Na+]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 51
Group description: At the start of the surgery, the patient will receive NaHCO3 as a continuous infusion of D5% 1/3NS + 100 meq/L NaHCO3 + 20 meq/L KCl at maintenance IVF (solution contains ~154 meq of sodium which is equivalent to normal saline). The NaHCO3 infusion will continue for the first 24 hours after the discontinuation of CPB. After 24 hours of receiving the NaHCO3 infusion, the IVF administered to the patient will be the standard solutions used in the PICU at CCMC.

Sodium Bicarbonate
Eligibility criteria:
Inclusion Criteria:

Subjects age ≤18 years
Subjects scheduled for cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

Subjects with abnormal creatinine clearance (<90 ml/min/1.7m2) as measured by the Schwartz formula
Subjects with known cystic kidney disease or posterior ureteral valves (subjects with solitary kidney, single multicystic/dysplastic kidney, hydronephrosis will not be excluded if renal function is preserved)
Subjects with known metabolic disorder
Premature infants born <30 weeks gestation and <30 days old due to risk of intraventricular hemorrhage

Subjects in severe cardiogenic shock post-operative requiring extra-corporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD) will be withdrawn from the study.