anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Everolimus
Trial phase: Phase 3
ATC code: L01EG02 | L04AA18
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(OCCO)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 322
Group description: Everolimus (Afinitor) 10 mg tablet once daily.

Everolimus (Afinitor) tablets
Eligibility criteria:
Select Inclusion Criteria:

Documented histological or cytological diagnosis of renal cell cancer with a clear-cell component.
Measurable disease as determined by the investigator.
Must have received at least one VEGFR-targeting TKI (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib).
Recovery from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
Adequate organ and marrow function.
Sexually active fertile subjects(male and female)must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment.
Female subjects of childbearing potential must not be pregnant at screening.

Select Exclusion Criteria:

Prior treatment with everolimus, or any other specific or selective TORC1/PI3K/AKT inhibitor (eg, temsirolimus), or cabozantinib.
Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization.
Receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before randomization.
Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization. Systemic treatment with radionuclides within 6 weeks before randomization. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization.
Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors.
Chronic treatment with corticosteroids or other immunosuppressive agents.
Serious illness other than cancer.
Major surgery within 3 months before randomization. Complete wound healing from major surgery must have occurred 1 month before randomization and from minor surgery at least 10 days before randomization.
Pregnant or lactating females.
Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low grade tumors.
Intervention: Malathion
Trial phase: Phase 4
ATC code: P03AX03
SMILES: CCOC(=O)CC(SP(=S)(OC)OC)C(=O)OCC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.

Sodium polystyrene sulfonate (ACTIVE): Participants were solicited for adverse events at each study visit (i.e. Days 1, 2 and 9) by systematic regular investigator assessment.
Eligibility criteria:
Inclusion Criteria:

Provision of written informed consent.
Over 18 years of age.
Mean i-STAT potassium values between 5.0 - 6.5 mmol/l inclusive, at screening (Study Day 0).
Previous participation in Clinical ZS-002 or ZS-003 protocol(s). However, subjects cannot be enrolled in this study until at least 30 days have elapsed from their last dose in study ZS-003.
Ability to have repeated blood draws or effective venous catheterization.
Women of childbearing potential must be using two forms of medically acceptable contraception (at least one barrier method) and have a negative pregnancy test at screening.

Women who are surgically sterile or those who are post-menopausal for at least 2 years are not considered to be of child-bearing potential.

Exclusion Criteria:

Pseudohyperkalemia signs and symptoms, such as excessive fist clenching hemolyzed blood specimen, severe leukocytosis or thrombocytosis.
Subjects treated with lactulose, Xifaxan or other non-absorbed antibiotics for hyperammonemia within the last 7 days.
Subjects treated with resins (such as Sevelamer acetate), calcium acetate, calcium carbonate, or lanthanum carbonate, within the last 7 days.
Subjects treated with Sodium Polystyrene Sulfonate (SPS; e.g. Kayexalate®) or ZS (microporous, fractionated, protonated zirconium silicate) within the last 30 days.
Subjects with a life expectancy of less than 3 months.
Subjects who are HIV positive.
Subjects who are severely physically or mentally incapacitated and who in the opinion of investigator are unable to perform the subjects' tasks associated with the protocol.
Women who are pregnant, lactating, or planning to become pregnant.
Subjects with diabetic ketoacidosis.
Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated.
Known hypersensitivity or previous anaphylaxis to ZS or to components thereof.
Previous treatment with SPS.
Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry.
Subjects with cardiac arrhythmias that require immediate treatment.
Subjects on insulin where a stable dose has not yet been established.*
Subjects on dialysis. * Subjects on stable insulin or insulin analogues can be enrolled. Subjects who have been on the same insulin dose and regimen for > 14 days are considered stable. Whenever possible, all blood draws collected prior to meals should be collected prior to insulin/insulin analogue treatment.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 41
Group description: Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.

Normal Saline Solution
Eligibility criteria:
Inclusion Criteria:

18-80 years of age.
Male or female.
Degenerative joint disease of hip joint.
Primary uncemented total hip arthroplasty.
Willingness to participate in the study, follow up at regular intervals

Exclusion Criteria:

Known allergy to tranexamic acid
History of any acquired disturbances of color vision
Preoperative anemia on basis of pre-operative lab work up (a hemoglobin value of <11 g/dL in females and <12 g/dL in males)
History of previous myocardial infarction
History of arterial or venous thromboembolic disease
History of fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy in the past and/or as identified by a preoperative platelet count of <150,000/mm3, an international normalized ratio of >1.5, or a prolonged partial thromboplastin time
Pregnancy (h/o any missed menstrual periods in a women of reproductive age group)
Breastfeeding
Refusal of blood products
Preoperative use of anticoagulant therapy within five days before surgery
Medical issues that may pose complications for surgery and would disqualify patient for surgery regardless of clinical trial (e.g. renal and hepatic failure)
Major comorbidities (e.g. severe ischemic heart disease )
Severe pulmonary disease
Preoperative blood donation
Participation in another clinical trial involving pharmaceutical drugs
Intervention: Tranexamic acid
Trial phase: Phase 2
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 41
Group description: Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline plus 1.5 g (100 mg/mL)Tranexamic Acid is applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.

Tranexamic Acid: Tranexamic Acid 1.5 g (100 mg/mL)in 100cc normal saline is applied topically to the wound for 5 minutes time then suctioned and the skin closed. The control group receives just normal saline and no drug.
Eligibility criteria:
Inclusion Criteria:

18-80 years of age.
Male or female.
Degenerative joint disease of hip joint.
Primary uncemented total hip arthroplasty.
Willingness to participate in the study, follow up at regular intervals

Exclusion Criteria:

Known allergy to tranexamic acid
History of any acquired disturbances of color vision
Preoperative anemia on basis of pre-operative lab work up (a hemoglobin value of <11 g/dL in females and <12 g/dL in males)
History of previous myocardial infarction
History of arterial or venous thromboembolic disease
History of fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy in the past and/or as identified by a preoperative platelet count of <150,000/mm3, an international normalized ratio of >1.5, or a prolonged partial thromboplastin time
Pregnancy (h/o any missed menstrual periods in a women of reproductive age group)
Breastfeeding
Refusal of blood products
Preoperative use of anticoagulant therapy within five days before surgery
Medical issues that may pose complications for surgery and would disqualify patient for surgery regardless of clinical trial (e.g. renal and hepatic failure)
Major comorbidities (e.g. severe ischemic heart disease )
Severe pulmonary disease
Preoperative blood donation
Participation in another clinical trial involving pharmaceutical drugs
Intervention: Eovist
Trial phase: Phase 2
SMILES: CCOc1ccc(CC(CN(CCN(CC(=O)[O-])CC(=O)[O-])CC(=O)[O-])N(CC(=O)[O-])CC(=O)[O-])cc1.[Gd+3].[Na+].[Na+]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.

Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
Eligibility criteria:
INCLUSION CRITERIA:

2.1.1.1 Subject is greater than or equal to 18 years old.

2.1.1.2 Subjects with clinically localized prostate cancer (outside pathology is acceptable) must have image guided biopsy confirmed prostate cancer and sufficient tissue available (obtained before or after 20 weeks of Eovist injection) for organic anion-transporting polypeptide 1B3 (OATP1B3) expression.

2.1.1.3 Subjects with advanced disease who have failed hormone therapy and who have sufficient tissue (obtained before or after 20 weeks of Eovist injection) from a soft tissue lesion (measuring greater than or equal to 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for OATP1B3 expression.

or

2.1.1.4 Subjects, for whom tissue is not available, must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.

2.1.1.5 Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

2.1.1.6 Serum creatinine within 3 weeks prior to Eovist MRI less than or equal to 1.8mg/dl and estimated glomerular filtration rate (eGFR) must be greater than 30 ml/min/1.73m(2).

2.1.1.7 Patients must have normal liver function as defined below:

total bilirubin less than 2 times normal institutional limits or greater than 3.0 mg/dl in patients with Gilberts syndrome
Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) less than or equal to 3 times institutional upper limit of normal

2.1.1.8 Ability of subject to sign a written informed consent document

EXCLUSION CRITERIA:

2.1.2.1 Subjects with known hypersensitivity and allergy to gadolinium contrast agents

2.1.2.2 Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results

2.1.2.3 Subjects with severe claustrophobia unresponsive to oral anxiolytics

2.1.2.4 Subjects with contraindications to magnetic resonance imaging (MRI)

2.1.2.5 Subjects weighing greater than 136 kg (weight limit for scanner table)

2.1.2.6 Subjects with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI

2.1.2.7 Subjects with other medical conditions deemed by the principle investigator (or associates) to make the subject ineligible for protocol procedures

2.1.2.8 Subjects who will have a delay in clinically indicated radiation therapy due to the interval between Eovist MRI imaging and biopsy
Intervention: Dabigatran
Trial phase: Phase 2 | Phase 3
SMILES: Cn1c(CNc2ccc(C(=N)N)cc2)nc2cc(C(=O)N(CCC(=O)O)c3ccccn3)ccc21
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Dabigatran 110 mg BID

Dabigatran: Group 1 - Dabigatran 110 mg
Eligibility criteria:
Inclusion Criteria:

Age from 18 to 64 years at entry
Patients with mitral and/or aorthic valve bioprosthesis for at least 3 months postoperatively
There is 12-lead electrocardiogram documented AF on the day of screening or randomization; or a 24-hour Holter electrocardiogram recording showing AF episodes postoperatively
Brain computed tomography scan without hemorrhage or findings of acute cerebral infarction on the last 2 days of screening
Exclusion of atrial thrombus or valve prosthesis thrombosis by transesophageal echocardiograph on the last 2 days of screening
Written, informed consent

Exclusion Criteria:

Previous hemorrhagic stroke
Ischemic stroke in the last 6 months
Severe renal impairment (creatinine clearance rates < 30 ml/min)
Active liver disease (any etiology)
Concomitant use of any antiplatelet (aspirin, clopidogrel, prasugrel, ticagrelor, ticlopidine, etc)
Increased risk of bleeding (congenital or acquired)
Uncontrolled hypertension
Gastrointestinal hemorrhage within the past year
Anemia (hemoglobin level <10 g/dL) or thrombocytopenia (platelet count < 100 × 109/L)
Active infective endocarditis
Pregnant or lactating women
Intervention: Warfarin
Trial phase: Phase 2 | Phase 3
ATC code: B01AA03
SMILES: CC(=O)CC(c1ccccc1)c1c(O)c2ccccc2oc1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Warfarin adjusted-dose

Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)
Eligibility criteria:
Inclusion Criteria:

Age from 18 to 64 years at entry
Patients with mitral and/or aorthic valve bioprosthesis for at least 3 months postoperatively
There is 12-lead electrocardiogram documented AF on the day of screening or randomization; or a 24-hour Holter electrocardiogram recording showing AF episodes postoperatively
Brain computed tomography scan without hemorrhage or findings of acute cerebral infarction on the last 2 days of screening
Exclusion of atrial thrombus or valve prosthesis thrombosis by transesophageal echocardiograph on the last 2 days of screening
Written, informed consent

Exclusion Criteria:

Previous hemorrhagic stroke
Ischemic stroke in the last 6 months
Severe renal impairment (creatinine clearance rates < 30 ml/min)
Active liver disease (any etiology)
Concomitant use of any antiplatelet (aspirin, clopidogrel, prasugrel, ticagrelor, ticlopidine, etc)
Increased risk of bleeding (congenital or acquired)
Uncontrolled hypertension
Gastrointestinal hemorrhage within the past year
Anemia (hemoglobin level <10 g/dL) or thrombocytopenia (platelet count < 100 × 109/L)
Active infective endocarditis
Pregnant or lactating women
Intervention: Lapatinib
Trial phase: Phase 2
ATC code: L01EH01 | L01XE07
SMILES: CS(=O)(=O)CCNCc1ccc(-c2ccc3ncnc(Nc4ccc(OCc5cccc(F)c5)c(Cl)c4)c3c2)o1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.

lapatinib ditosylate: Given PO

radiation therapy: Undergo radiation therapy

laboratory biomarker analysis: Correlative studies
Eligibility criteria:
Inclusion Criteria:

Patients with histologically or cytologically confirmed locally advanced breast cancer that is refractory to chemotherapy or other therapeutic agents or with a history of breast cancer with new evidence of a local recurrence (defined as a chest wall or breast recurrence and/or nodal recurrence); the diagnosis will be made based on clinical and pathologic features
Patients must be >18 years of age.
Karnofsky Performance Status (KPS) score > 70

Patts must have normal organ function as defined below:

total bilirubin < 1.5 x institutional upper limit of normal
AST(SGOT)/ALT(SGPT) < 2.5 x institutional upper limit of normal
creatinine < 1.5 x institutional upper limit of normal
Patients must have left-ventricular ejection fraction > 50% at baseline.

Exclusion Criteria:

Patients who have contraindications to radiotherapy, such as scleroderma, dermatomyositis, or severe cutaneous manifestations of systemic lupus erythematosus (SLE)
History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, or psychiatric illness/social situations that would limit compliance with study requirements
Women who are pregnant or lactating, as well as women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the duration of the study
Intervention: Betamethasone
Trial phase: Phase 4
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 52
Group description: intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively

Dexamethasone
Eligibility criteria:
Inclusion Criteria:

English Speaking
Non-laboring women
Scheduled Elective Cesarean section under spinal anesthesia
American Society of Anesthesiologists I-II physical status

Exclusion Criteria:

Contraindications to spinal anesthesia
allergy to study medication
patients with allergy to morphine
patients with uncontrolled hypertension
history of peptic ulcer disease
liver cirrhosis
diabetes mellitus
glaucoma
known IV drug abusers
patients with chronic pain or on long term opioids
patients administered steroids in the past week
women with fetuses having known congenital abnormalities
psychiatric illness such that they are unable to comprehend or participate in study questions
patients on antiviral medications or live virus vaccines would also be excluded.
Intervention: Linolenic Acid
Trial phase: Phase 2
SMILES: CCC=CCC=CCC=CCCCCCCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Patients receive omega-3 fatty acid PO daily for 7-14 days.

omega-3 fatty acid: Given PO

laboratory biomarker analysis: Correlative studies
Eligibility criteria:
Inclusion Criteria:

Newly diagnosed stage I to III breast cancer and carcinoma in situ (including lobular carcinoma in situ [LCIS] and ductal carcinoma in situ [DCIS])
Breast surgery (lumpectomy or mastectomy) is planned for at least 7 days from the day of enrollment
Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved written informed consent document
Tumor measures at least 1 centimeter on imaging or physical exam

Exclusion Criteria:

Any patient with surgery scheduled < 7days after biopsy
Patients who are unable to refrain from the use of any NSAID or full-dose acetylsalicylic acid (ASA)-containing NSAID while taking study drug
Patients who will receive neoadjuvant chemotherapy are not eligible
Patients who are currently taking omega-3 fatty acids, as they are unable to be randomized to placebo
Patients who have previously taken omega-3 fatty acid within 1 month prior to study enrollment
Patients with an allergy or known hypersensitivity to fish
Intervention: Chlorhexidine
Trial phase: Not Applicable
ATC code: A01AB03 | B05CA02 | D08AC02 | D08AC52 | D09AA12 | R02AA05 | S01AX09 | S02AA09 | S03AA04
SMILES: N=C(NCCCCCCNC(=N)NC(=N)Nc1ccc(Cl)cc1)NC(=N)Nc1ccc(Cl)cc1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 474
Group description: Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery

Chlorhexidine: Chlorhexidine skin preparation solution prior to cesarean delivery
Eligibility criteria:
Inclusion Criteria:

Gestational age > 37 weeks 0/7 days
Non-emergency indication for cesarean

Exclusion Criteria:

Urogenital tract infection within 2 weeks prior to surgery
Chronic oral or injectable steroid use (> 2 weeks)
Emergency cesarean delivery
Participation in another research study
Intervention: Citalopram
Trial phase: Phase 4
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 257
Group description: Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of major depressive disorder according to the American Psychiatric Association's Diagnostic and Statistical Manual-IV, Text Revision (DSM-IV-TR) diagnostic criteria
Minimum scores of 9 on Sheehan Disability Scale
Minimum scores of 14 on Hamilton Anxiety Scale

Exclusion Criteria:

History of primary or comorbid diagnoses of schizophrenia, schizoaffective disorder, bipolar disorder, or dementia
Presence of unstable serious illness and/or has a clinically significant renal or hepatic impairment, seizure disorders or any other disease which may be detrimental to the participant or the study
Participant who have continuously taken psychoactive substances, antidepressants, anxiolytics, Monoamine oxidase inhibitors, psychoactive herbal remedies, lithium, electroconvulsive therapy, carbamazepine in the past 2 weeks before the baseline visit
Diagnosis of major depressive disorder who currently require treatment systematically within past 2 months from baseline
Receiving pharmacological treatment, which is disallowed in the current approved Chinese summary of product characteristics for escitalopram
Intervention: Ticagrelor
Trial phase: Phase 4
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2001
Group description: 90 mg/tablet, 1 tablet bid
Eligibility criteria:
Inclusion Criteria:

1. Female or male aged at least 18 years 2.Index event of non-ST or ST segment elevation ACS 3.A patient who is considered as ethnic Chinese

Exclusion Criteria:

1. With coagulation disorder 2.Index event is an acute complication of PCI 3.Patient has planned for an urgent coronary artery bypass graft (CABG) within 7days from the enrolment 4.Oral anticoagulation therapy within 30 days prior to enrolment or cannot be stopped 5.Increased risk of bradycardic events 6. Concomitant oral or intravenous therapy (see examples below) with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers 7.Increased risk of bradycardic events (eg, no pacemaker and known sick sinus syndrome, second degree A-V block, third degree A-V block or previous documented syncope suspected to be due to bradycardia unless treated with a pacemaker). 8.Known clinically important thrombocytopenia 9.Known clinically important anaemia