anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Losartan Potassium
Trial phase: Phase 4
SMILES: CCCCc1nc(Cl)c(CO)n1Cc1ccc(-c2ccccc2-c2nnn[n-]2)cc1.[K+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 469
Group description: Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
Eligibility criteria:
Inclusion Criteria:

Males or females aged > 18 years who are not institutionalized and have signed informed consent.
Mean cuff seated diastolic blood pressure (BP) must be > 95 mmHg and < 115 mmHg and a mean cuff seated systolic BP must be < 180 mmHg when measured at two consecutive qualification study visits during the placebo run-in phase.
The difference in mean cuff seated diastolic BP must be < 7 mmHg between two consecutive qualification study visits during the placebo run-in phase.

Exclusion Criteria:

Subjects with type 2 diabetes mellitus with an HbA1c ≥ 9.5% at Screening.
Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of olmesartan medoxomil and losartan potassium, including cardiovascular, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic (with the exception of non-insulin, dependent type 2 diabetes mellitus with HbA1c < 9.5% at Screening), hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases.
Subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or heart failure within the last 12 months.
Subjects with any history of New York Heart Association Class III or IV congestive heart failure (CHF). A history of New York Heart Association Class I or II CHF may be exclusionary at the discretion of the Investigator.
Subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year.
Subjects with clinically significant cardiac conduction defects, including second or third degree atrioventricular (AV) block, left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication.
Intervention: Erlotinib
Trial phase: Phase 4
ATC code: L01EB02 | L01XE03
SMILES: C#Cc1cccc(Nc2ncnc3cc(OCCOC)c(OCCOC)cc23)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6586
Group description: Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
Eligibility criteria:
Inclusion Criteria:

Adults greater than or equal to (≥) 18 years of age
Histologically or cytologically documented inoperable, locally advanced, metastatic, or recurrent NSCLC
Previous treatment with no more than 2 prior chemotherapy regimens

Exclusion Criteria:

Previous systemic anti-cancer therapy with human epidermal growth factor receptor 1 (HER1)/epidermal growth factor receptor (EGFR) inhibitors
Inability to take oral medication
Any other malignancies within 5 years
Intervention: Ibuprofen
Trial phase: Not Applicable
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 102
Group description: Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals.
Eligibility criteria:
Inclusion Criteria:

Females ages >= 18 years
4 consecutive monthly menstrual cycles
Self-assessment of dysmenorrhea
Non-pregnant status
Agrees to use adequate birth control during the trial
Consents to use tampons through the test of cure assessment
Provides informed consent for participating in the trial

Exclusion Criteria:

Prohibited use of pain medication 4 hours prior to treatment and during the first 2 hours after treatment with study medication
Positive pregnancy test
Unwilling or unable to comply with protocol
Allergic to ibuprofen
Intervention: Clevidipine
Trial phase: Phase 4
ATC code: C08CA16
SMILES: CCCC(=O)OCOC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1c1cccc(Cl)c1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: 21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
Eligibility criteria:
Inclusion Criteria:

Age 21 or older
Able to give consent
No significant laboratory abnormalities
Undergoing elective surgery for tumor resection or epilepsy focus resection

Exclusion Criteria:

Patients with acute cardiac ischemia, renal or liver dysfunction, unstable hemodynamic, advanced heart block, or pregnancy defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and in patients with severe aortic stenosis will be excluded.
Known or suspected allergy to study drug or study drug components,patients with allergies to soybeans, soy products, eggs, or egg products; Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment in this study.
Intervention: GTS-21
Trial phase: Phase 1
SMILES: [H]/C(=C1/CCCN=C1c1cccnc1)c1ccc(OC)cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.

Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined
Eligibility criteria:
Inclusion Criteria:

Healthy volunteers: males and females who are incapable of pregnancy

Exclusion Criteria:

Medical illnesses requiring acute treatment
History of seizures
Substance abuse including nicotine
Intervention: Lubiprostone
Trial phase: Phase 4
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: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 101
Group description: 106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
Eligibility criteria:
Inclusion Criteria:

adult patients referred to our clinic for average or increased risk screening for colorectal cancer

Exclusion Criteria:

elevated serum creatinine (Men >1.4mg/dL, Women >1.3mg/dL)
previous diagnosis of congestive heart failure
history of bowel obstruction
history of solid organ transplant
current pregnancy
lactating mother
participants allergic to either polyethylene glycol (Miralax), lubiprostone (Amitiza), or bisacodyl (Dulcolax)
Intervention: Bisacodyl
Trial phase: Phase 4
ATC code: A06AB02 | A06AB52 | A06AG02
SMILES: CC(=O)Oc1ccc(C(c2ccc(OC(C)=O)cc2)c2ccccn2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 101
Group description: 107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
Eligibility criteria:
Inclusion Criteria:

adult patients referred to our clinic for average or increased risk screening for colorectal cancer

Exclusion Criteria:

elevated serum creatinine (Men >1.4mg/dL, Women >1.3mg/dL)
previous diagnosis of congestive heart failure
history of bowel obstruction
history of solid organ transplant
current pregnancy
lactating mother
participants allergic to either polyethylene glycol (Miralax), lubiprostone (Amitiza), or bisacodyl (Dulcolax)
Intervention: Sodium Sulfate
Trial phase: Phase 4
ATC code: A06AD13 | A12CA02
SMILES: O=S(=O)([O-])[O-].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 101
Group description: 106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
Eligibility criteria:
Inclusion Criteria:

adult patients referred to our clinic for average or increased risk screening for colorectal cancer

Exclusion Criteria:

elevated serum creatinine (Men >1.4mg/dL, Women >1.3mg/dL)
previous diagnosis of congestive heart failure
history of bowel obstruction
history of solid organ transplant
current pregnancy
lactating mother
participants allergic to either polyethylene glycol (Miralax), lubiprostone (Amitiza), or bisacodyl (Dulcolax)
Intervention: Lubiprostone
Trial phase: Phase 4
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: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 26
Group description: Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
Eligibility criteria:
Inclusion criteria:

Healthy subjects
Body mass index (BMI): 18 to 32.
Negative pregnancy test for women of childbearing potential.
Absence of gastrointestinal symptoms (abridged Bowel Disease Questionnaire).
Signed informed consent.

Exclusion criteria:

Subjects with body mass index (BMI) of less than 18 or more than 32.
Structural or metabolic diseases/conditions that affect the gastrointestinal (GI)system, or functional gastrointestinal disorders. For screening, the Bowel Disease Questionnaire will be used to exclude subjects with irritable bowel syndrome.
Use of drugs or agents within the past 2 weeks that alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants.

NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection, and birth control pills or depot injections are permissible.

Use of drugs or agents within the 2 weeks prior to screening that may add drowsiness and central nervous system (CNS) depression such as barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, antihistamines, muscle relaxants, other CNS depressants.
Female subjects who are pregnant or breast feeding.
Females must be either surgically sterilized, postmenopausal (>12 months since last menses) or, if of childbearing potential, using reliable methods of contraception as determined by the physician (single-barrier methods alone and rhythm methods are not acceptable).
Clinical evidence (including physical exam and ECG) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study. Any candidate participants with such disorder mentioned will be referred to their general physician.
The Hospital Anxiety and Depression Scale (HADS) will be used to exclude subjects with significant affective disorders, as well as to determine anxiety and depression scores at the start of the study. Any candidate participants with such disorder mentioned will be referred to their general physician.
Symptoms of a significant clinical illness in the two weeks prior to screening.
Participation in another clinical study within the 30 days prior to screening.
Subjects who are considered by the investigator to be alcoholics not in remission or known substance abusers.
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: 506
Group description: Normal Saline: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) used at ERCP (standard of care).
Eligibility criteria:
Inclusion Criteria:

Patients included are >18 years old, referred to Endoscopy Clinic for an ERCP for any well established indication such as: biliary strictures, benign and malignant hepato-pancreato-biliary tumors, chronic pancreatitis, and suspected sphincter of Oddi dysfunction

Exclusion Criteria:

Known sensitivity to lidocaine or contrast agent
History of seizure disorder
History of cardiac arrhythmia (tachyarrhythmia, bradyarrhythmia, cardiac conduction defects, prolonged QT syndrome)
History of congestive heart failure
Active acute pancreatitis before procedure
Planned biliary stent removal without pancreatogram
Pregnancy
Incarcerated individuals
Less than 18 years of age
Previous sphincterotomy
Inability to give informed consent
Intervention: Metoprolol Succinate
Trial phase: Phase 3
SMILES: COCCc1ccc(OCC(O)CNC(C)C)cc1.COCCc1ccc(OCC(O)CNC(C)C)cc1.O=C(O)CCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 76
Group description: Beta Blockers alone

beta blockers: metoprolol 25mg by mouth every 6 hours
Eligibility criteria:
Inclusion Criteria:

adults (18 years of age or older)
all comers for elective or urgent open heart surgery ( CABG, Valve repair or replacement, Combined CABG/Valves, CABG/other, Other)

Exclusion Criteria:

patients who refuse to participate
patients with a history of atrial fibrillation or atrial flutter
pediatric patients (under 18 years of age)
Emergency surgery
patients with contraindications to study medications
patients with untreated thyroid disease, hepatic failure, pregnancy
Intervention: Cholecalciferol
Trial phase: Phase 2
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 83
Group description: 4,000 IU vitamin D3 daily for one year

vitamin D3: 4,000 IU daily for one year
Eligibility criteria:
Inclusion Criteria:

Male Veterans (> 18 years of age) recently diagnosed with low-risk PCa (histologically documented adenocarcinoma of the prostate)
A serum PSA value of up to 10.0 ng/ml, and a Gleason score of six or less (three or less in either architectural pattern)

For the purpose of eligibility, these additional criteria will be verified: *serum creatinine 2.0 mg/dL

serum phosphate (measured as phosphorus) > 2.3 and < 4.8 mg/dL
serum calcium > 8.5 and < 10.5 mg/dL

Exclusion Criteria:

Subjects with any concurrent malignancy, except non-melanoma skin cancer
Subjects with a history of sarcoidosis
Subjects with a history of high-dose (1,000 IU per day) vitamin D supplementation
Subjects with a history of hypercalcemia
Subjects who use lithium as a medication
Intervention: Thalidomide
Trial phase: Phase 2
ATC code: L04AX02
SMILES: O=C1CCC(N2C(=O)c3ccccc3C2=O)C(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Patients with primary sclerosing cholangitis (PSC) who met with enrollment criteria were treated with 400 mg in the evening for a duration of 6 months
Eligibility criteria:
Inclusion Criteria:

Previous diagnosis of primary sclerosing cholangitis as defined by: serum alkaline phosphatase level greater than or equal to 1.5 times the upper limit of normal, negative serum antimitochondrial antibody test, cholangiography diagnostic of PSC without other etiology for biliary obstruction, and liver histology consistent with or diagnostic of PSC
Patients must give written informed consent.
Patients must be willing and able to comply with the most recent version of the FDA-mandated System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.®) program.

Exclusion Criteria:

Pregnant and/or lactating female
Inability or unwillingness to practice contraceptive measures for the prevention of pregnancy
History of hypersensitivity reaction to thalidomide
Inability to provide consent
Findings suggestive of liver disease of other etiology such as primary biliary cirrhosis, chronic alcoholic liver disease, chronic hepatitis B and C infection, hemochromatosis, Wilson's disease, alpha-1-antitrypsin deficiency, autoimmune hepatitis, and cryptogenic liver disease
Anticipated need for liver transplantation in one year from decompensated chronic liver disease or recurrent variceal bleeding, spontaneous hepatic encephalopathy, or refractory ascites
Treatment with tacrolimus, cyclosporine, sirolimus, ursodeoxycholic acid, corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil, budesonide, pentoxifylline, nicotine, silymarin, vitamin E or pirfenidone in the preceding three months
History of peripheral neuropathy
Use of medications with significant drug-drug interactions with thalidomide
History of Human Immunodeficiency Virus (HIV) positive status or Acquired Immunodeficiency Syndrome (AIDS)
History of coexistent advanced malignancy
History of coexistent severe cardiovascular disease
History of coexistent severe renal disease
History of current excessive or recent (within 6 months) alcohol use
Any condition that, in the opinion of the investigators, would interfere with the patient's ability to complete the study safely or successfully
History of thrombolytic events. Combination use with corticosteroids increases risk of deep vein thrombosis.
Intervention: Danazol
Trial phase: Phase 2
ATC code: G03XA01
SMILES: C#CC1(O)CCC2C3CCC4=Cc5oncc5CC4(C)C3CCC21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Everyone will receive Danazol with plasma exchange and corticosteroids

Danazol: Danazol 600 mg PO will be initiated with plasma exchange and corticosteroids at the time of enrollment.
Eligibility criteria:
Inclusion Criteria:

TTP with platelets less than 100,000 and microangiopathic hemolytic anemia
Age greater than 18 and less than 60
LDH > 2x upper limit of normal
PT and PTT normal
Patients must give signed informed consent
Pre-menopausal woman must have negative pregnancy test.
TTP not related to underlying cancer, treatment of cancer or transplantation.
TTP not associated with drugs.

Exclusion Criteria:

LFTs AST/ALT > 2x upper limit of normal
Hepatitis B and Hepatitis C infection.
HIV with active opportunistic infections
Acute or chronic Disseminated Intravascular Coagulation (DIC), defined as D-dimer 8ug/ml and fibrinogen<100 mg/dl
TTP related to drugs, malignancy and transplantation.
Pregnancy
Concurrent other investigational drug use during this study.
Porphyria.
Intervention: Celecoxib
Trial phase: Phase 1 | Phase 2
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: oral cancer patients receiving Celecoxib prior to surgery
Eligibility criteria:
Inclusion Criteria:

locoregional OSCC (T stage II-IV) of the oral cavity, oropharynx, larynx, or hypopharynx without evidence of distant metastases
greater than or equal to 18 years of age
the OSCC treatment plan includes surgical resection
performance status of 0 or 1
recovered from any prior surgery
must be willing to use appropriate contraception if of child-bearing potential
give signed informed consent prior to the initiation of therapy

Exclusion Criteria:

prior immunotherapy
chemotherapy or radiation therapy within three weeks
concurrent NSAID treatments while undergoing treatment
women pregnant or lactating
HIV positive
have an active infection requiring antibiotic therapy, or concomitant malignancies
history of idiopathic urinary calcium stone disease, chronic hypercalcemia, or gastrointestinal malabsorptive conditions
Intervention: Calcitriol
Trial phase: Phase 1 | Phase 2
ATC code: A11CC04 | D05AX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: oral cancer patients receiving Calcitriol prior to surgery
Eligibility criteria:
Inclusion Criteria:

locoregional OSCC (T stage II-IV) of the oral cavity, oropharynx, larynx, or hypopharynx without evidence of distant metastases
greater than or equal to 18 years of age
the OSCC treatment plan includes surgical resection
performance status of 0 or 1
recovered from any prior surgery
must be willing to use appropriate contraception if of child-bearing potential
give signed informed consent prior to the initiation of therapy

Exclusion Criteria:

prior immunotherapy
chemotherapy or radiation therapy within three weeks
concurrent NSAID treatments while undergoing treatment
women pregnant or lactating
HIV positive
have an active infection requiring antibiotic therapy, or concomitant malignancies
history of idiopathic urinary calcium stone disease, chronic hypercalcemia, or gastrointestinal malabsorptive conditions
Intervention: Gabapentin
Trial phase: Not Applicable
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Neurontin

Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days
Eligibility criteria:
Inclusion Criteria:

18 years of age or older
Undergoing PRK in at least one eye

Exclusion Criteria:

Serious medical problems within the last 6 months including myocardial infarction (heart attack), congestive heart failure, stroke, deep vein thrombosis, pulmonary embolism, and other conditions, etc.
Serious kidney disease as evidenced by the need for dialysis or kidney transplant.
History of seizure or other neurologic disorders.
Patients intending to become pregnant or who are pregnant or nursing over the projected course of treatment.
Currently taking gabapentin or pregabalin for other medical purposes.
Known allergic reaction to gabapentin or pregabalin from previous use.
Plans to move out of the area within 8 weeks after the surgery.
Intervention: Pregabalin
Trial phase: Not Applicable
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Lyrica

pregabalin: 50 mg PO TID
Eligibility criteria:
Inclusion Criteria:

18 years of age or older
Undergoing PRK in at least one eye

Exclusion Criteria:

Serious medical problems within the last 6 months including myocardial infarction (heart attack), congestive heart failure, stroke, deep vein thrombosis, pulmonary embolism, and other conditions, etc.
Serious kidney disease as evidenced by the need for dialysis or kidney transplant.
History of seizure or other neurologic disorders.
Patients intending to become pregnant or who are pregnant or nursing over the projected course of treatment.
Currently taking gabapentin or pregabalin for other medical purposes.
Known allergic reaction to gabapentin or pregabalin from previous use.
Plans to move out of the area within 8 weeks after the surgery.