anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Bexarotene
Trial phase: Early Phase 1
ATC code: L01XF03 | L01XX25
SMILES: C=C(c1ccc(C(=O)O)cc1)c1cc2c(cc1C)C(C)(C)CCC2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Open label - all patients receive intervention

Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2.
Eligibility criteria:
Inclusion Criteria:

Subject must have a histologically/cytologically confirmed diagnosis of papillary, follicular, or anaplastic thyroid cancer (any follicular cell derived thyroid cancer).
Subjects must have evidence of follicular cell-derived thyroid cancer progression. In patients with anatomically stable disease, PET positive lesions will also be eligible given the poor prognostic risk for PET positive thyroid cancer.
Subjects must not be eligible for surgical resection.
Subjects must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Subjects must have laboratory values that fall within certain ranges.
Subjects must be age 18 years or older.
Subjects must provide written informed consent prior to any study procedures being performed.
Females of childbearing potential must have a negative pregnancy test prior to enrollment.
All eligible subjects must be willing to use adequate contraception throughout the duration of the study.
Subjects must be willing to submit a primary tumor tissue sample for immunohistochemical analysis.
Subjects have the option of providing one additional test tube of blood taken at baseline, 6 months and 1 year for banking of plasma for potential future studies (no genetic testing will be conducted). The current planned analysis is for the assessment of a potential peripheral marker for rexinoid responsive cancer - leukemia inhibitory factor (LIF)

Exclusion Criteria:

Subjects with a known history of hyperlipidemia refractory to treatment.
Subjects with a known history of hypertriglyceridemia refractory to treatment.
Subjects with leukopenia below the reference range for the University of Colorado Hospital (UCH) laboratory.
Subjects, who are pregnant, have a desire to become pregnant or are breastfeeding.
Subjects who are unwilling or unable to comply with study medication administration, or study guidelines, as determined by the investigator.
Subjects with any prior history of malignancy with the exception of adequately treated basal cell skin cancer, in situ cervical cancer or other cancer for which the subject has been disease free for 3 years or more.
Subjects without radiographically assessable disease
Intervention: Entecavir
Trial phase: Phase 4
ATC code: J05AF10
SMILES: C=C1[C@H](CO)[C@@H](O)C[C@@H]1n1cnc2c(=O)nc(N)[nH]c21
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 89
Group description: Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
Eligibility criteria:
Inclusion Criteria:

Chronic infection with hepatitis B virus (HBV)(detectable hepatitis B surface antibody (HBsAg) at screening and at least 24 weeks prior to screening, or detectable HBsAg for <24 weeks and negative for immunoglobulin M core antibody)
Documentation of hepatitis B e antigen (HBeAg) positive or negative status
Naive to nucleoside/nucleotide analogues, with the exception of adefovir
Suboptimal response to adefovir treatment
No lamivudine/telbivudine, entecavir, or adefovir resistance-associated substitutions at screening
Male or female gender, aged 16 years and older
Compensated liver function
Serum alanine aminotransferase level <10*upper limit of normal at screening

Exclusion Criteria:

Women who are pregnant or breastfeeding
Evidence of decompensated cirrhosis
Coinfection with HIV, hepatitis C virus, or hepatitis D virus
Recent history of pancreatitis (within 24 weeks prior to the first dose of study medication)
Chronic renal insufficiency, defined as a creatinine clearance <50 mL/min
Current abuse of illegal drugs or alcohol, sufficient in the investigator's opinion to prevent adequate compliance with study therapy or to increase the risk of hepatotoxicity or pancreatitis
Other serious medical conditions that might preclude completion of this study or that require chronic administration of prohibited medications
Serum creatinine level >1.5 mg/dL; hemoglobin level <10.0 g/dL; platelet count <70,000/mm^3; absolute neutrophil count <1500 cells/mm^3; serum alpha fetoprotein level >100 ng/mL
Except adefovir, any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (eg, lamivudine, entecavir), or any other experimental anti-HBV antiviral, or any China Traditional Medicine
Therapy with interferon, thymosin alpha, or other immunostimulators within 24 weeks of randomization
Required chronic administration of medications that cause immunosuppression, that are associated with a high risk of nephrotoxicity or hepatotoxicity, or that affect renal excretion.
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: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1931
Group description: Chlorhexidine cleansing of the cord for seven days
Eligibility criteria:
Inclusion Criteria:

Enrolled in parent chlorhexidine cleansing trial

Exclusion Criteria:

Not enrolled in parent trial
First visited after 48 hours of life
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: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1931
Group description: Chlorhexidine cleansing of the cord for 1 day
Eligibility criteria:
Inclusion Criteria:

Enrolled in parent chlorhexidine cleansing trial

Exclusion Criteria:

Not enrolled in parent trial
First visited after 48 hours of life
Intervention: Azelastine Hydrochloride
Trial phase: Phase 3
SMILES: CN1CCCC(n2nc(Cc3ccc(Cl)cc3)c3ccccc3c2=O)CC1.Cl
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 238
Group description: 0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
Eligibility criteria:
Inclusion Criteria:

Male and female patients 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis
Must be in generally good health
Must meet minimum symptom requirements, as specified in the protocol
Must be willing and able to provide informed consent and to participate in all study procedures
Positive skin test to a prevalent fall allergen

Exclusion Criteria:

On focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation at either the screening visit or randomization visit will disqualify the subject from the study.
Other nasal disease(s)likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
Nasal Surgery or sinus surgery within the previous year
Chronic sinusitis-more than 3 episodes a year
Planned travel outside of the study area during the study period
The use of any investigational drug within 30 days prior to screening. No investigational products are permitted for use during the conduct of the study.
Presence of any hypersensitivity to drugs similar to azelastine and to either sorbital or sucralose (Splenda brand sweetener)
Women who are pregnant or nursing
Women of childbearing potential who are not abstinent or not practicing medically acceptable method of contraception
Respiratory tract infection within 14 days prior to screening
Respiratory tract infections requiring antibiotic treatment 14 days prior to screening
Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not for more often tha twice a week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment
Significant pulmonary disease including COPD
Clinically significant arrythmia or symptomatic cardiac conditions
A known history of alcohol or drug abuse within the last 2 years
Existence of any surgical or medical condition or physical laboratory findings, which in the opinion of the investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug; that might significantly affect the subject's ability to complete this trial; or their safety in this trial
Clinically relevant abnormal physical findings which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures.
Intervention: Integrilin
Trial phase: Phase 2
ATC code: B01AC16
SMILES: NC(=O)C1CSSCCC(=O)NC(CCCCN=C(N)N)C(=O)NCC(=O)NC(CC(=O)O)C(=O)NC(Cc2c[nH]c3ccccc23)C(=O)N2CCCC2C(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Intracoronary injection of eptifibatide
Eligibility criteria:
Inclusion Criteria:

Clinical

Patients (men or women) at least 18 years of age and
Presenting with ischemic chest discomfort >20 minutes and <6 hours of duration suggestive of acute myocardial infarction

AND:

ECG

ST elevation >1mm (>0.1mV) in two contiguous limb leads OR >2mm (>0.2mV) in two contiguous precordial leads

Exclusion Criteria:

CLINICAL

Maximal systolic blood pressure <80 mmHg AFTER initial fluid and/or pressor resuscitation
Uncontrolled hypertension (SBP>180 OR DBP >110) at time of enrollment
Ventricular fibrillation or ventricular tachycardia requiring DC cardioversion
Sinus bradycardia (HR <50/min), third degree or advanced second degree heart block.
Known pregnancy
New or suspected new left bundle branch block

BIOCHEMICAL

Known thrombocytopenia (platelet count <100,000)
Known severe renal insufficiency (creatinine >4.0 mg/dL)

INCREASED BLEEDING RISK

Active or recent (<1 year) bleeding or gastrointestinal hemorrhage
Major surgery <1 month
Known coagulopathy, platelet disorder or history of thrombocytopenia: If a patient is known to be on chronic warfarin therapy, the International Normalized Ratio (INR) must be known to be <1.6 in order for the patient to be included
Known neoplasm
Any history of hemorrhagic cerebrovascular disorder or active intracranial pathology

MEDICATIONS

Administration of a fibrinolytic agent within 7 days
Known allergy or contraindication to eptifibatide OR aspirin OR heparin
Treatment with another GP IIb/IIIa inhibitor within 7 days
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: No
Participants at risk: 31
Group description: Intra-coronary injection of normal saline.
Eligibility criteria:
Inclusion Criteria:

Clinical

Patients (men or women) at least 18 years of age and
Presenting with ischemic chest discomfort >20 minutes and <6 hours of duration suggestive of acute myocardial infarction

AND:

ECG

ST elevation >1mm (>0.1mV) in two contiguous limb leads OR >2mm (>0.2mV) in two contiguous precordial leads

Exclusion Criteria:

CLINICAL

Maximal systolic blood pressure <80 mmHg AFTER initial fluid and/or pressor resuscitation
Uncontrolled hypertension (SBP>180 OR DBP >110) at time of enrollment
Ventricular fibrillation or ventricular tachycardia requiring DC cardioversion
Sinus bradycardia (HR <50/min), third degree or advanced second degree heart block.
Known pregnancy
New or suspected new left bundle branch block

BIOCHEMICAL

Known thrombocytopenia (platelet count <100,000)
Known severe renal insufficiency (creatinine >4.0 mg/dL)

INCREASED BLEEDING RISK

Active or recent (<1 year) bleeding or gastrointestinal hemorrhage
Major surgery <1 month
Known coagulopathy, platelet disorder or history of thrombocytopenia: If a patient is known to be on chronic warfarin therapy, the International Normalized Ratio (INR) must be known to be <1.6 in order for the patient to be included
Known neoplasm
Any history of hemorrhagic cerebrovascular disorder or active intracranial pathology

MEDICATIONS

Administration of a fibrinolytic agent within 7 days
Known allergy or contraindication to eptifibatide OR aspirin OR heparin
Treatment with another GP IIb/IIIa inhibitor within 7 days
Intervention: Losartan
Trial phase: Phase 4
ATC code: C09CA01 | C09DA01 | C09DB06
SMILES: CCCCc1nc(Cl)c(CO)n1Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Losartan 100 mg daily

Losartan: Losartan 100 mg daily
Eligibility criteria:
Inclusion Criteria:

Adults with COPD who are either active or former smokers

Exclusion Criteria:

Clinical requirement or history of intolerance of angiotensin receptor blockers, serious heart, liver, kidney, neurological disease.
Intervention: Ropivacaine
Trial phase: Not Applicable
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation

ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation
Eligibility criteria:
Inclusion Criteria:

Age greater than 18 and less than 75 years
Male
Unilateral inguinal hernia scheduled for elective open repair

Exclusion Criteria:

Incarcerated hernia or urgent procedure
Reoperation (recurrent hernia)
Contraindication to regional anesthesia such as:
Coagulopathy
Infection at the site of needle insertion
Pre-existing chronic pain (at any site) requiring treatment
Contraindication to any study medication (local anesthetic or ketamine)
History of significant Axis I psychiatric disease (major depressive disorder,bipolar disorder, schizophrenia, etc.)
Significant hepatic (ALT or AST > 2 times normal) or renal (serum creatinine > 2 mg/dl) impairment
Intervention: Choline
Trial phase: Phase 4
SMILES: C[N+](C)(C)CCO
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Oral choline

Choline: Oral Choline 20 grams before surgery
Eligibility criteria:
Inclusion Criteria:

open pelvic surgery
able to swallow pills

Exclusion Criteria:

chronic pain
opioid use
pregnancy
lactation
Intervention: Azelastine Hydrochloride
Trial phase: Phase 3
SMILES: CN1CCCC(n2nc(Cc3ccc(Cl)cc3)c3ccccc3c2=O)CC1.Cl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 466
Group description: 0.15% azelastine hydrochloride 1644 mcg
Eligibility criteria:
Inclusion Criteria:

Male and female patients 12 years and older with a compatible history greater than or equal to 1 year of rhinitis due to perennial allergies.
Must be willing and able to provide informed consent and to participate in all study procedures
Must be in generally good health
Positive skin test to a prevalent perennial allergen

Exclusion Criteria:

On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
Use of any investigational drug within 30 days of the first visit
Any nasal surgery or sinus surgery within the previous year
Presence of any hypersensitivity to drugs similar to azelastine or mometasone furoate and to either sorbital or sucralose
Women who are pregnant or nursing
Women who are not using an acceptable method of birth control
Nasal Diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities.
Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with investigator.
Patients with Arrythmia
Patients with know history of alcohol and drug abuse
Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of the study.
Use of medications that could affect the study results
Intervention: Lidocaine
Trial phase: Not Applicable
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery

Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively.
Eligibility criteria:
Inclusion Criteria:

Age greater than 18 years old and less than 75 years years old
Horizontal abdominal incision

Exclusion Criteria:

Emergency or urgent procedure
Preexisting chronic pain (at any site) requiring treatment
Contraindication to any study medication (ketamine or lidocaine)
History of significant Axis I psychiatric disease (major depressive disorder, bipolar disorder, schizophrenia, etc.)
Significant hepatic (ALT or AST > 2 times normal) or renal (serum creatinine > 2 mg/dl) impairment
Seizure disorder requiring medication within past 2 years
Planned spinal or epidural anesthesia or analgesia
Intervention: Ketamine
Trial phase: Not Applicable
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery

Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.
Eligibility criteria:
Inclusion Criteria:

Age greater than 18 years old and less than 75 years years old
Horizontal abdominal incision

Exclusion Criteria:

Emergency or urgent procedure
Preexisting chronic pain (at any site) requiring treatment
Contraindication to any study medication (ketamine or lidocaine)
History of significant Axis I psychiatric disease (major depressive disorder, bipolar disorder, schizophrenia, etc.)
Significant hepatic (ALT or AST > 2 times normal) or renal (serum creatinine > 2 mg/dl) impairment
Seizure disorder requiring medication within past 2 years
Planned spinal or epidural anesthesia or analgesia
Intervention: 1,3,5-Trichlorobenzene
Trial phase: Phase 3
SMILES: Clc1cc(Cl)cc(Cl)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 538
Group description: Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Patients who have completed participation in the Phase III study WA17822 (NCT00106548) in adult rheumatoid arthritis.

Exclusion Criteria:

Treatment with any investigational agent since the last administration of study drug in WA17822.
Treatment with intravenous (IV) gammaglobulin, plasmapheresis, or Prosorba column since the last administration of study drug in WA17822.
Treatment with an anti-tumor necrosis factor or anti-interleukin-1 agent, or a T cell costimulation modulator since the last administration of study drug in WA17822.
Previous treatment with any cell-depleting therapies.
Parenteral, intramuscular, or intra-articular corticosteroids within 6 weeks prior to baseline.
Intervention: Sucroferric oxyhydroxide
Trial phase: Phase 2
ATC code: V03AE05
SMILES: O.O.O.OCC1OC(OC2(CO)OC(CO)C(O)C2O)C(O)C(O)C1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 11
Group description: All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
Eligibility criteria:
Inclusion Criteria:

Age > or = 12 to < or = 16 years
Parent and/or legal guardian able to give informed consent
Subject able to give written assent for participating in the study
NDD-CKD defined as: kidney damage for 3 months or longer, or GFR < 60 for 3 months or longer
Hemoglobin indicative of anemia
Ferritin indicative of iron deficiency anemia
If appropriate, subject must be willing to use an accepted form of birth control from time of screening through the follow-up period

Exclusion Criteria:

Known history of hypersensitivity to any component of Venofer
Parenteral iron within 14 days of the screening visit
Dialysis dependent-CKD
Chronic or serious active infection
Pregnancy or lactation
Subjects with causes of iron deficiency anemia other than CKD
Blood transfusion within the last month or anticipated during the study
Body weight < 55 pounds
Received an investigational drug within 30 days before screening
Intervention: Azacitidine
Trial phase: Phase 2
ATC code: L01BC07
SMILES: Nc1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)c(=O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: 5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.

5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days.
Eligibility criteria:
Inclusion Criteria:

Patients fulfilling the following criteria will be eligible for study entry:

Diagnosis of MDS according to WHO criteria
Intermediate-2 or high risk by IPSS score
Clinically able to receive 5-Azacytidine
Serum bilirubin levels </=1.5 times the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis
Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) levels </=2 x ULN
Serum creatinine levels </=1.5 x ULN
Negative serum pregnancy test prior to 5-Azacytidine treatment for women of childbearing potential
Women and men of childbearing potential agree to use contraception while receiving treatment with 5-Azacytidine
Potentially eligible for allogeneic transplantation
No prior allogeneic transplant
Age 18 to 70, inclusive.

Exclusion Criteria:

Known or suspected hypersensitivity to 5-azacytidine or mannitol
Patients previously treated with 5-azacytidine or deoxyazacytidine
Pregnant or breast feeding
Patients with advanced malignant hepatic tumors
Intervention: Loxapine
Trial phase: Phase 3
ATC code: N05AH01
SMILES: CN1CCN(C2=Nc3ccccc3Oc3ccc(Cl)cc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 104
Group description: Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2

Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2
Eligibility criteria:
Inclusion Criteria:

Male and female adult patients with bipolar 1 disorder and acute agitation

Exclusion Criteria:

Agitation caused primarily by acute intoxication
History of drug or alcohol dependence
Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration