anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
Eligibility criteria:
Inclusion Criteria:

Patients scheduled to undergo single-level or double-level laminectomy under general anesthesia
Willingness and ability to sign an informed consent document
No allergies to any of the anesthetic or analgesic medications being used for the study, as outlined in the study protocol
Between 18-80 years of age
American Society of Anesthesiologists (ASA) class I-III adults of either sex

Exclusion Criteria:

Patients who are ASA class IV or higher
Patients with known allergy, hypersensitivity, or contraindication to the use of any of the medications being used for the study, as outlined in the study protocol
Patients who are heavy chronic opioid users, defined for the purposes of this study as any patient who is taking the equivalent of 10mg of oral morphine per day or greater
Pregnant or lactating women
Patients with a history of drug or alcohol abuse within the past 3 months
Patients with any other medical conditions or who are using any medications which may interfere with the conduct of the study (including patients taking clonidine, patients with EKG conduction defects and who are taking calcium channel blockers, patients with clinically significant congestive heart failure (CHF) or bronchospasm, or patients with second- or third-degree heart block, symptomatic sinus bradyarrhythmia, or nonsinus rhythm on preoperative EKG.)
Intervention: Esmolol
Trial phase: Phase 4
ATC code: C07AB09
SMILES: COC(=O)CCc1ccc(OCC(O)CNC(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
Eligibility criteria:
Inclusion Criteria:

Patients scheduled to undergo single-level or double-level laminectomy under general anesthesia
Willingness and ability to sign an informed consent document
No allergies to any of the anesthetic or analgesic medications being used for the study, as outlined in the study protocol
Between 18-80 years of age
American Society of Anesthesiologists (ASA) class I-III adults of either sex

Exclusion Criteria:

Patients who are ASA class IV or higher
Patients with known allergy, hypersensitivity, or contraindication to the use of any of the medications being used for the study, as outlined in the study protocol
Patients who are heavy chronic opioid users, defined for the purposes of this study as any patient who is taking the equivalent of 10mg of oral morphine per day or greater
Pregnant or lactating women
Patients with a history of drug or alcohol abuse within the past 3 months
Patients with any other medical conditions or who are using any medications which may interfere with the conduct of the study (including patients taking clonidine, patients with EKG conduction defects and who are taking calcium channel blockers, patients with clinically significant congestive heart failure (CHF) or bronchospasm, or patients with second- or third-degree heart block, symptomatic sinus bradyarrhythmia, or nonsinus rhythm on preoperative EKG.)
Intervention: Citalopram
Trial phase: Phase 2
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: 101
Group description: Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.

Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.
Eligibility criteria:
Inclusion Criteria:

Diagnosed with Complicated Grief and this is the patient's most important (primary) problem
Ability to give informed consent
Fluent in English
Willingness to have sessions audiotaped
Willingness to undergo random assignment

Exclusion Criteria:

Diagnosis of one or more of the following disorders: Schizophrenia or other psychotic disorder, current (past 6 months) substance abuse, Bipolar Disorder, current manic episode, Dementia
Pregnant or lactating women and women of childbearing potential not using medically accepted forms of contraception
Acute, unstable or severe medical illness such as (but not limited to) stroke, epilepsy, or other neurodegenerative disorders, metastatic or active cancer, hepatic disease, or primary renal disease requiring dialysis
Prior intolerance of citalopram
Pending or active disability claim or lawsuit related to the death
Intervention: Oseltamivir
Trial phase: Phase 1 | Phase 2
ATC code: J05AH02
SMILES: CCOC(=O)C1=C[C@@H](OC(CC)CC)[C@H](NC(C)=O)[C@@H](N)C1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 21
Group description: Oseltamivir 75 mg by mouth every 12 hours for 9 doses

Oseltamivir: Capsule, 75 mg by mouth for 9 doses
Eligibility criteria:
Inclusion Criteria:

males and females, 18 to 50 years of age
non-smoking or light-smoking (≤5 cigarettes per day) volunteers
BMI ≥ 40 kg/m2
female subjects of childbearing potential either surgically sterilized, using an effective method of contraception (diaphragm, cervical cap,condom) or agree to abstain from sex from time of pre-study screening, during entire study period and 1 week following the study period.

Exclusion Criteria:

history of significant hypersensitivity reaction to oseltamivir
history of gastric bypass surgical procedure
history of significant clinical illness requiring pharmacological management
abnormal serum electrolyte or complete blood count requiring further clinical work-up
transaminases (AST or ALT) >2.5 x upper limit of normal
estimated creatinine clearance <50 mL/min (Cockcroft-Gault equation)
positive urine pregnancy test (if female)
abnormal electrocardiogram (ECG) as judged by study physician
unable to tolerate venipuncture and multiple blood draws
clinically significant abnormal physical examination defined as a physical finding requiring further clinical work-up
Intervention: Progesterone
Trial phase: Phase 3
ATC code: G03DA04 | G03FA04
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(C)=O)CC[C@@]21[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 36
Group description: 400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
Eligibility criteria:
Inclusion Criteria:

pregnant women less than 20 weeks' gestation who had at least one prior spontaneous preterm birth of a liveborn baby between 20 & 0/7 weeks' and 36 & 6/7 weeks' gestation.

Exclusion Criteria:

multiple gestations, the presence of major fetal anomalies, progesterone use in the current pregnancy (ongoing or past), the presence of a cervical cerclage, and the presence of a placenta previa.
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: No
Participants at risk: 26
Group description: Placebo Normal Saline Infusion

Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period
Eligibility criteria:
Inclusion Criteria:

ASA I, II,III;
BMI > 35 kg/m2,
Age between 18-70,
Fluent in English,
Patients undergoing laparoscopic gastric bypass,
EKG within 3 months.

Exclusion Criteria:

History of allergy to local anesthetics,
History of chronic opioid use,
Pregnant patients,
History of EKG abnormalities.

Dropout: Conversion to open, patient or surgeon request.
Intervention: Edoxaban
Trial phase: Phase 3
ATC code: B01AF03
SMILES: CN1CCc2nc(C(=O)N[C@@H]3C[C@@H](C(=O)N(C)C)CC[C@@H]3NC(=O)C(=O)Nc3ccc(Cl)cn3)sc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 354
Group description: DU-176b oral tablets, 30 mg., taken once daily for 2 weeks

edoxaban
Eligibility criteria:
Inclusion Criteria:

Patients undergoing unilateral total knee arthroplasty

Exclusion Criteria:

Subjects with risks of hemorrhage
Subjects with thromboembolic risks
Subjects who weigh less than 40 kg
Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant.
Intervention: Monomer of enoxaparin sodium
Trial phase: Phase 3
SMILES: CC(=O)NC1C(OC2C(C(=O)[O-])OC(OC3C4COC(O4)C(NS(=O)(=O)[O-])C3O)C(O)C2O)OC(CO)C(OC2CC(C(=O)[O-])C(OC3OC(COS(=O)(=O)O)C(OC4OC(C(=O)[O-])=CC(O)C4O)C(O)C3NC(C)=O)C(O)C2O)C1C.[Na+].[Na+].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 349
Group description: enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks

enoxaparin sodium
Eligibility criteria:
Inclusion Criteria:

Patients undergoing unilateral total knee arthroplasty

Exclusion Criteria:

Subjects with risks of hemorrhage
Subjects with thromboembolic risks
Subjects who weigh less than 40 kg
Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant.
Intervention: Edoxaban Tosylate
Trial phase: Phase 3
SMILES: CN1CCc2nc(C(=O)NC3CC(C(=O)N(C)C)CCC3NC(=O)C(=O)Nc3ccc(Cl)cn3)sc2C1.Cc1ccc(S(=O)(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 59
Group description: DU-176b oral tablets, 30 mg., taken once daily for 2 weeks

DU-176b (edoxaban)
Eligibility criteria:
Inclusion Criteria:

Subjects who are scheduled to undergo surgery within 10 days for fracture of inner or outer femoral neck (trochanteric and subtrochanteric)

Exclusion Criteria:

Subjects with risks of hemorrhage
Subjects with thrombolic risks
Subjects who weigh less than 40 kg
Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant
Intervention: Monomer of enoxaparin sodium
Trial phase: Phase 3
SMILES: CC(=O)NC1C(OC2C(C(=O)[O-])OC(OC3C4COC(O4)C(NS(=O)(=O)[O-])C3O)C(O)C2O)OC(CO)C(OC2CC(C(=O)[O-])C(OC3OC(COS(=O)(=O)O)C(OC4OC(C(=O)[O-])=CC(O)C4O)C(O)C3NC(C)=O)C(O)C2O)C1C.[Na+].[Na+].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks

Enoxaparin sodium 20mg
Eligibility criteria:
Inclusion Criteria:

Subjects who are scheduled to undergo surgery within 10 days for fracture of inner or outer femoral neck (trochanteric and subtrochanteric)

Exclusion Criteria:

Subjects with risks of hemorrhage
Subjects with thrombolic risks
Subjects who weigh less than 40 kg
Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant
Intervention: Edoxaban
Trial phase: Phase 3
ATC code: B01AF03
SMILES: CN1CCc2nc(C(=O)N[C@@H]3C[C@@H](C(=O)N(C)C)CC[C@@H]3NC(=O)C(=O)Nc3ccc(Cl)cn3)sc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 303
Group description: DU-176b oral tablets, 30 mg., taken once daily for 2 weeks

edoxaban
Eligibility criteria:
Inclusion Criteria:

Patients undergoing unilateral total hip arthroplasty

Exclusion Criteria:

Subjects with risks of hemorrhage
Subjects with thromboembolic risks
Subjects who weigh less than 40 kg
Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant
Intervention: Monomer of enoxaparin sodium
Trial phase: Phase 3
SMILES: CC(=O)NC1C(OC2C(C(=O)[O-])OC(OC3C4COC(O4)C(NS(=O)(=O)[O-])C3O)C(O)C2O)OC(CO)C(OC2CC(C(=O)[O-])C(OC3OC(COS(=O)(=O)O)C(OC4OC(C(=O)[O-])=CC(O)C4O)C(O)C3NC(C)=O)C(O)C2O)C1C.[Na+].[Na+].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 301
Group description: enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks

enoxaparin sodium
Eligibility criteria:
Inclusion Criteria:

Patients undergoing unilateral total hip arthroplasty

Exclusion Criteria:

Subjects with risks of hemorrhage
Subjects with thromboembolic risks
Subjects who weigh less than 40 kg
Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant
Intervention: Warfarin
Trial phase: Phase 3
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: 138
Group description: Subjects assigned to warfarin therapy.

Warfarin: Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0
Eligibility criteria:
Key Inclusion Criteria:

Paroxysmal, persistent or permanent non-valvular AF
Eligible for long-term warfarin therapy
Eligible to come off warfarin therapy

Calculated CHADS2 score of 2 or greater. Also patients with a CHADS2 score of 1 may be included if any of the following apply:

Female age 75 or older
Baseline LVEF ≥ 30 and < 35%
Aged 65-74 and has diabetes or coronary artery disease
Aged 65 or greater and has congestive heart failure

Key Exclusion Criteria:

Contraindicated/allergic to aspirin
Indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment
History of atrial septal repair or has an ASD/PFO device
Implanted mechanical valve prosthesis
NYHA Class IV CHF
Resting heart rate > 110 bpm
Participated previously in the PROTECT AF or CAP Registry studies

Key Echo Exclusion Criteria:

LVEF < 30%
Existing pericardial effusion > 2mm
High risk PFO
Significant mitral valve stenosis
Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
Cardiac tumor
Intervention: Salsalate
Trial phase: Not Applicable
ATC code: N02BA06
SMILES: O=C(Oc1ccccc1C(=O)O)c1ccccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
Eligibility criteria:
Inclusion Criteria:

DSM-IV TR diagnosis of schizophrenia or schizoaffective disorder
Body Mass Index (BMI) greater than or equal to 27 kg/m2
Participant will be judged to be clinically stable
Participants will be treated with the same antipsychotic for at least 90 days and will have received a constant therapeutic dose for at least 20 days prior to study entry. There will not be any restriction on the type of antipsychotic with which the participant is treated.
Participants must be judged competent to participate in the informed consent process and provide voluntary informed consent.

Exclusion Criteria:

Individuals with aspirin allergy.
Individuals with pre-existing tinnitus.
Individual with anemia or thrombocytopenia.
Individuals with ongoing infections.
Individuals with history of autoimmune disease.
Individuals with peptic ulcer disease or gastritis.
Individuals with weight loss greater than 5% over the past 6 months.
Individuals currently taking immunosuppressive drugs including corticosteroids.
Individuals taking anti-diabetic agents.
Individuals taking non-steroidal anti-inflammatory agents (other than low dose aspirin).
Individuals with organic brain disorder; mental retardation; or medical conditions whose pathology or treatment would alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol.
Pregnant females.
Individuals who meet DSM-IV TR criteria for alcohol or substance dependence (except nicotine) within the last 6 months.
Individuals who meet DSM-IV TR criteria for alcohol or substance abuse (except nicotine) within the last month.
Intervention: Sitagliptin
Trial phase: Not Applicable
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 148
Group description: Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
Eligibility criteria:
Inclusion Criteria:

Patients with type 2 diabetes who are oral hypoglycemic agent naive or, α-glucosidase inhibitor or biguanide monotherapy (to be washed out 4 weeks prior to randomization)
Signed informed consent obtained before any trial-related activities
Treatment with diet and exercise for 12 weeks and longer at screening
Age =>60 y.o.
Male and Female
HbA1c 6.9%=< <8.9%

Exclusion Criteria:

Active proliferative retinopathy or maculopathy requiring treatment
Liver dysfunction (>x2 of upper normal limit), moderate or severe renal dysfunction(serum Cr>1.5mg/dL in male, Cr>1.3mg/dL in female, eGFR<30), severe cardiac disease (NYHA III or IV), malignancy or uncontrolled hypertension (treated or untreated) as judged by the Investigator
Mental incapacity (including moderate or severe dementia) precluding adequate understanding and/or cooperation as judged by the Investigator
Recurrent hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
Previous history of severe allergy to pharmaceutical products
Systemic glucocorticoids users or potential users
Suspected type 1 diabetes (including slowly progressive insulin dependent diabetes mellitus) or positive anti-glutamic acid decarboxylase antibody
Any condition that the investigator considers a potential obstacle to trial participation and/or data analysis
Intervention: Glimepiride
Trial phase: Not Applicable
ATC code: A10BB12 | A10BD04 | A10BD06
SMILES: CCC1=C(C)CN(C(=O)NCCc2ccc(S(=O)(=O)NC(=O)N[C@H]3CC[C@H](C)CC3)cc2)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 143
Group description: Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
Eligibility criteria:
Inclusion Criteria:

Patients with type 2 diabetes who are oral hypoglycemic agent naive or, α-glucosidase inhibitor or biguanide monotherapy (to be washed out 4 weeks prior to randomization)
Signed informed consent obtained before any trial-related activities
Treatment with diet and exercise for 12 weeks and longer at screening
Age =>60 y.o.
Male and Female
HbA1c 6.9%=< <8.9%

Exclusion Criteria:

Active proliferative retinopathy or maculopathy requiring treatment
Liver dysfunction (>x2 of upper normal limit), moderate or severe renal dysfunction(serum Cr>1.5mg/dL in male, Cr>1.3mg/dL in female, eGFR<30), severe cardiac disease (NYHA III or IV), malignancy or uncontrolled hypertension (treated or untreated) as judged by the Investigator
Mental incapacity (including moderate or severe dementia) precluding adequate understanding and/or cooperation as judged by the Investigator
Recurrent hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
Previous history of severe allergy to pharmaceutical products
Systemic glucocorticoids users or potential users
Suspected type 1 diabetes (including slowly progressive insulin dependent diabetes mellitus) or positive anti-glutamic acid decarboxylase antibody
Any condition that the investigator considers a potential obstacle to trial participation and/or data analysis
Intervention: OXYTOCIN
Trial phase: Phase 2
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 28
Group description: One dose 24IU (3 sprays/nostril) intranasal oxytocin,
Eligibility criteria:
Inclusion Criteria:

In good physical health
Meet criteria for ASD according to psychiatric interview using the Diagnostic and Statistic Manual, Fourth Edition (DSM-IV)
Must be a history of developmental delay
Must meet full criteria for ASD on the Autism Diagnostic Interview- Revised (ADI-R) on either the social or communication domains and within two points on other domain (only if parent available for interview)
Must meet full criteria for ASD on the Autism Diagnostic Observation Schedule- Generic (ADOS-G) on the social domain. Meeting for ASD on the communication domain and total domain is not necessary
Must have a verbal IQ greater than 75, as measured by the Wechsler Adult Intelligence Scale- Fourth Edition (WAIS- III). Intelligence testing performed at other sites or through another protocol at this site within the past year will also be accepted
Capability of performing experimental tasks (i.e. can read and understand task instructions, cooperate with procedures)
Informed consent and capacity
Female participants must remain on birth control for the duration of the study

Exclusion Criteria:

Participants with any primary psychiatric diagnosis at screening
Participants with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal MRI/structural lesion of the brain
Participants who are pregnant, who gave birth in the last six months, or who are currently breastfeeding
Participants with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being
Participants with evidence or history of malignancy or any significant hematological endocrine, cardiovascular (including rhythm disorder), respiratory, renal, hepatic, gastrointestinal disease, or other major medical conditions
Participants taking psychoactive medication(s) (e.g., stimulants, antidepressants, antipsychotics, antiepileptics, anxiolytics, clondine)
Participants who, in the Investigator's opinion, might not be suitable for the study
Participants who are involved in another study whose procedures could influence performance in the current study
Female participants who do not stay on birth control for the duration of the study
Participants who have a known contraindication to the MRI scan: including sever claustrophobia or any kind of metal implant in the body
Intervention: Pioglitazone
Trial phase: Phase 2
ATC code: A10BD05 | A10BD06 | A10BD09 | A10BD12 | A10BG03
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Pioglitazone

Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months
Eligibility criteria:
Inclusion Criteria:

Heart transplant recipients, years 1-4 post-transplant
Age >= 18 years
Fasting TG/HDL ratio>=3.0 or Fasting TG>=150 mg/dL

Exclusion Criteria:

Diabetes mellitus
Severe liver dysfunction (ALT>=2.5 x upper limit of normal)
Severe renal dysfunction (GFR<30 or Stage IV CKD)
Moderate-severe fluid retention
Clinical or echocardiographic signs of left ventricular dysfunction
Contraindication to coronary angiography and/or IVUS