anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Pregabalin
Trial phase: Phase 4
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 125
Group description: Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.

Pregabalin: Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.

Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
Eligibility criteria:
Inclusion Criteria:

ASA classification 1-2 undergoing abdominal hysterectomy with/without salpingo-oophorectomy under spinal anesthesia with intrathecal morphine
Patient can use patient-controlled analgesia (IV PCA)

Exclusion Criteria:

History of drug allergy to gabapentinoid and related drug
History of regular analgesic drug use, psychiatric drug usage, drug abuse, alcohol addiction or chronic pain patient
Renal disease (Creatinine Clearance < 60), Liver disease, Seizure disorder and Psychiatric disorder
Intervention: Solusprin
Trial phase: Phase 3
SMILES: CC(=O)Oc1ccccc1C(=O)O.NCCCCC(N)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: 100mg Acetylsalicylic Acid

Acetylsalicylic acid lysinate: 100mg intravenously administered Acetylsalicylic Acid lysinate per day
Eligibility criteria:
Inclusion Criteria:

patients admitted to an intensive care unit
>18 years of age

Exclusion Criteria:

known allergy of intolerance to acetylsalicylic acid
recent surgery or planned surgery
active bleeding
known coagulation disorders
discretion of the physician
terminal illness (anticipated life expectancy <3months; e.g. due to cancer)
platelet count <20 000
recent ulcera
recent gastrointestinal bleeding
pregnancy
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: 0.9% sodium-chloride solution

0.9% sodium-chloride solution: Placebo, intravenously administered, daily
Eligibility criteria:
Inclusion Criteria:

patients admitted to an intensive care unit
>18 years of age

Exclusion Criteria:

known allergy of intolerance to acetylsalicylic acid
recent surgery or planned surgery
active bleeding
known coagulation disorders
discretion of the physician
terminal illness (anticipated life expectancy <3months; e.g. due to cancer)
platelet count <20 000
recent ulcera
recent gastrointestinal bleeding
pregnancy
Intervention: Itraconazole
Trial phase: Phase 2 | Phase 3
ATC code: J02AC02
SMILES: CCC(C)n1ncn(-c2ccc(N3CCN(c4ccc(OCC5COC(Cn6cncn6)(c6ccc(Cl)cc6Cl)O5)cc4)CC3)cc2)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 58
Group description: Two 100mg capsules by mouth twice a day for 24 weeks

Itraconazole
Eligibility criteria:
Inclusion Criteria:

Meet criteria for diagnosis of CRS with nasal polyps undergoing medically indicated sinus surgery

Exclusion Criteria:

cystic fibrosis
aspirin exacerbated respiratory disease
uncontrolled or unstable chronic diseases such as uncontrolled diabetes
active or history of cancer
HIV positive
history of liver or kidney disease
history of disease with effects on immune system
pregnant
allergy to triazole antifungals
Intervention: Diethylstilbestrol
Trial phase: Phase 4
ATC code: G03CB02 | G03CC05 | L02AA01 | L02AA04
SMILES: CC/C(=C(/CC)c1ccc(O)cc1)c1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: Prednizone pills. 4 day course 2 x 20mg per day.

Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.
Eligibility criteria:
Inclusion Criteria:

Age 18-80 males and females
Presence of phonotraumatic lesion deemed to be etiologic for the complaint of dysphonia
Voice therapy deemed to be the primary (or at least initial) treatment to address the dysphonia.
Willingness to be an active participant in voice therapy.

Exclusion Criteria:

Use of any glucocorticoids (oral, inhaled, or intravenous) within 3 months of the initial evaluation
Known allergy or hypersensitivity to oral steroids
Active infection
Diabetes Mellitus
Prior history of radiation to the neck
Recent myocardial infarction
Recent gastrointestinal surgery with bowel anastamosis (3 months)
Active peptic ulcer
Pregnancy
Severe depression or history of psycosis
History of recent laryngeal surgery (within 12 months)
Intervention: Diclofenac
Trial phase: Phase 4
ATC code: D11AX18 | M01AB05 | M01AB55 | M02AA15 | S01BC03 | S01CC01
SMILES: O=C(O)Cc1ccccc1Nc1c(Cl)cccc1Cl
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 51
Group description: 5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.

diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.
Eligibility criteria:
Inclusion Criteria:

Male and female subjects between 2-12 years of age.
Subjects must be post-op, having mild or moderate acute pain.

Other inclusions apply.

Exclusion Criteria:

Subject has a known history of allergic reaction, hypersensitivity to diclofenac, aspirin, acetaminophen, or reaction to the non-active ingredients of the study medication.
Subject has been taking analgesics for 48-72 hours prior to Screening.
Subject has a history of any GI event greater than 6 months before Screening.
Subject is currently receiving any medication that is contraindicated for use concomitantly with diclofenac or acetaminophen.
Subject is requiring treatment for pre-existing hypertension.

Other exclusions apply.
Intervention: Voglibose
Trial phase: Phase 4
ATC code: A10BF03
SMILES: OCC(CO)N[C@H]1C[C@](O)(CO)[C@@H](O)[C@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 197
Group description: One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
Eligibility criteria:
Inclusion Criteria:

Patients on diet therapy and exercise therapy for 3 to 6 months prior to the start of screening, with baseline (fasting ) plasma glucose < 126 mg/dL and 2-hour plasma glucose of 140 to 199 mg/dL (revised WHO criteria) during a 75 g oral glucose tolerance test (OGTT) in the screening period

Patients meeting any of 1 through 4 below:

1) Comorbid hypertension or high normal blood pressure
2) Comorbid dyslipidemia
3) Comorbid obesity
4) Patients with up to a second-degree family history of type 2 diabetes mellitus
Patients with HbA1c < 6.5% in the screening period
Male or female patients at least 20 years of age at the time informed consent was obtained
Treatment category: Outpatient

Exclusion Criteria:

Patients previously diagnosed with diabetes mellitus.
Patients with apparent impaired glucose metabolism or with a disease or condition potentially involving impaired glucose metabolism.
Patients with serious hepatic impairment.
Patients with serious renal impairment.
Patients with serious cardiac, cerebrovascular, pancreatic, hematologic, or other disease.
Patients with a history of intestinal obstruction or a history of laparotomy within 6 months (24 weeks) before the start of screening.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Patients will receive a TAP block with liposomal bupivacaine

liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine
Eligibility criteria:
Inclusion Criteria:

presenting for donor nephrectomy

Exclusion Criteria:

non english speaking
chronic pain condition
taking chronic opioids
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Patients will receive a TAP block with bupivacaine

bupivacaine: patients will receive a tap with bupivacaine
Eligibility criteria:
Inclusion Criteria:

presenting for donor nephrectomy

Exclusion Criteria:

non english speaking
chronic pain condition
taking chronic opioids
Intervention: Clopidogrel
Trial phase: Phase 4
ATC code: B01AC04
SMILES: [H][C@@](C(=O)OC)(c1ccccc1Cl)N1CCc2sccc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily

Clopidogrel: Swiching from ticagrelor to clopidogrel
Eligibility criteria:
Inclusion Criteria

Patients with angiographically documented CAD
On therapy with aspirin(<100mg/day) and clopidogrel (75mg/day) for at least 30 days per standard of care
Age between 18 and 80 years old

Exclusion Criteria

History of intracranial bleeding
Severe hepatic impairment (ALT >2.5 times the upper limit of normal)
Active bleeding or propensity to bleed or blood dycrasia
Platelet count <80x106/mL
Hemoglobin <10g/dL
Hemodynamic instability
Estimated glomerular filtration rate (eGFR) <30 mL/min
On treatment with oral anticoagulants
Patients with sick sinus syndrome (SSS) or II or III degree AV block without pacemaker protection
Drugs interfering CYP3A4 metabolism (to avoid interaction with ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromicin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromizycin
Pregnant females [women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study].
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: 20
Group description: Patients will be randomized (1:1:1:1) into one of the four following groups: A) clopidogrel 600 mg LD 24 hours after last MD of ticagrelor, followed by 75mg daily MD; B) clopidogrel 600 mg LD 12 hours after last MD of ticagrelor, followed by 75mg daily MD; C) clopidogrel 75mg daily MD 24 hours after last MD of ticagrelor; D) continue ticagrelor MD 90mg twice daily

Ticagrelor: Continue treatment with ticagrelor
Eligibility criteria:
Inclusion Criteria

Patients with angiographically documented CAD
On therapy with aspirin(<100mg/day) and clopidogrel (75mg/day) for at least 30 days per standard of care
Age between 18 and 80 years old

Exclusion Criteria

History of intracranial bleeding
Severe hepatic impairment (ALT >2.5 times the upper limit of normal)
Active bleeding or propensity to bleed or blood dycrasia
Platelet count <80x106/mL
Hemoglobin <10g/dL
Hemodynamic instability
Estimated glomerular filtration rate (eGFR) <30 mL/min
On treatment with oral anticoagulants
Patients with sick sinus syndrome (SSS) or II or III degree AV block without pacemaker protection
Drugs interfering CYP3A4 metabolism (to avoid interaction with ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromicin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromizycin
Pregnant females [women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study].
Intervention: Capsaicin
Trial phase: Phase 4
ATC code: M02AB01 | M02AB02 | N01BX04
SMILES: COc1cc(CNC(=O)CCCC/C=C/C(C)C)ccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Capsaicin: via nasal spray
Eligibility criteria:
Inclusion Criteria:

idiopathic rhinitis patients with at least 2 persistent (> 12w) rhinological symptoms (nasal discharge, sneezing, nasal congestion) for an average of at least 1 h per day,
idiopathic rhinitis patients with a total nasal symptoms score (TNS) of 5 or more on a visual analogue scale (VAS).
Age > 18 and < 65 years.
Written informed consent.
Willingness to adhere to visit schedules.
Adequate contraceptive precautions in female patients with childbearing potential.

Exclusion Criteria:

Patients with concomitant allergic rhinitis, demonstrated by positive skin prick test (Hal reagents) and/or immunoglobins E in blood. *
Patients with structural abnormalities: nasal polyps, severe septal deviation (septum reaching concha inferior or lateral nasal wall), septal perforation, hypertrophy of the inferior turbinates.
Patients with local allergic rhinitis (LAR) or entopy.
Systemic steroid treatment less than 4 weeks before the inclusion in the study, nasal steroid spray less than 4 weeks before the inclusion, oral leukotriene antagonists or long-acting antihistamines less than 2 weeks before the inclusion.
Inability of the patient to stop taking medication affecting nasal function like ß-blockers.
History of prolonged use or abuse of decongestant nasal spray like xylometazoline spray and/or use or abuse of decongestive oral medication.
Evidence of infectious rhinitis/rhinosinusitis or common cold within 4 weeks prior to inclusion.
Pregnancy or lactation. **
Any disorder of which might compromise the ability of a patient to give truly informed consent for participation in this study.
Enrollment in other investigational drug trial(s) or receiving other investigational agent(s) for any other medical condition.
Contra-indications for the use of local anesthesia (cocaine 5%).
Smoking or occupational exposure to irritants (like hypochlorite, persulfates, isocyanates).
Nasal malignancies or severe comorbidity like granulomatosis or vasculitis.
Intervention: Milnacipran Hydrochloride
Trial phase: Phase 4
SMILES: CCN(CC)C(=O)C1(c2ccccc2)CC1CN.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 644
Group description: FETZIMA® (levomilnacipran extended release [ER]) taken orally during flexible dose titration up to 40, 80 or 120 mg once daily in 8-week run-in period followed by fixed dose of 40, 80 or 120 mg once daily in 12-week stabilization period.
Eligibility criteria:
Inclusion Criteria

Currently meet the DMS-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) criteria for Major Depressive Disorder (MDD)
The participant must have an ongoing major depressive episode of at least 8 weeks and no more than 18 months
The participant must have at least 3 lifetime episodes of MDD (including the current episode)

Exclusion Criteria:

Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control
Participants who are considered a suicide risk
History of non-response to 2 or more antidepressants (after adequate treatment)
Participants who have a history of meeting DMS-5 criteria for manic, hypomanic, or mixed episode, obsessive-compulsive disorder, schizophrenia or other psychotic disorder
Panic disorder
Intervention: Milnacipran Hydrochloride
Trial phase: Phase 4
SMILES: CCN(CC)C(=O)C1(c2ccccc2)CC1CN.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 165
Group description: FETZIMA® (levomilnacipran ER) taken orally at fixed dose of 40, 80 or 120 mg once daily for 26 weeks during double-blind treatment period.
Eligibility criteria:
Inclusion Criteria

Currently meet the DMS-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) criteria for Major Depressive Disorder (MDD)
The participant must have an ongoing major depressive episode of at least 8 weeks and no more than 18 months
The participant must have at least 3 lifetime episodes of MDD (including the current episode)

Exclusion Criteria:

Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control
Participants who are considered a suicide risk
History of non-response to 2 or more antidepressants (after adequate treatment)
Participants who have a history of meeting DMS-5 criteria for manic, hypomanic, or mixed episode, obsessive-compulsive disorder, schizophrenia or other psychotic disorder
Panic disorder
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 88
Group description: 1% Lidocaine alone.
Eligibility criteria:
Inclusion Criteria:

21 Years of age
Any patient scheduled for a breast biopsy at Duke Breast Interventional Imaging

Exclusion Criteria:

Less than 21 Years of age
Allergic to Lidocaine or Sodium Bicarbonate
Not mentally capable of consenting
Intervention: Lanreotide
Trial phase: Phase 2 | Phase 3
ATC code: H01CB03
SMILES: CC(C)C1NC(=O)C(CCCCN)NC(=O)C(Cc2c[nH]c3ccccc23)NC(=O)C(Cc2ccc(O)cc2)NC(=O)C(NC(=O)C(N)Cc2ccc3ccccc3c2)CSSCC(C(=O)NC(C(N)=O)C(C)O)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Patients will receive lanreotide 120 mg every 28 days until disease progression
Eligibility criteria:
Inclusion Criteria:

Metastatic (synchronous or metachronous) or locally advanced, non-resectable, well-differentiated duodeno-pancreatic neuroendocrine tumour, of grade 1 or 2 (WHO 2010 classification; Ki-67 ≤ 20%)
Progressive before first-line treatment
Histologically confirmed (either on primary tumour or metastases)
Pathological diagnosis validated by the NET consulting pathologist
Documented stable disease or objective response after first-line treatment, within 4 weeks (28 days) prior to randomisation
The first-line treatment will consist of either a chemotherapy or biotherapy (everolimus or sunitinib) as referred to TNCD or ENETS guidelines. Treatment must have been administered for 3 to 6 months for chemotherapy and for 6 months for biotherapy
Non-functional tumour or gastrinoma controlled by PPIs
Age > or = 18 years
WHO 0, 1 or 2
Effective contraception for male or female patients of childbearing age, defined as: oral contraceptives, intra-uterine devices, barrier contraceptive methods along with a spermicide gel, or surgical sterilisation. Female patients should use this contraception throughout the treatment period and for 6 months after the last treatment administration. Male patients should use contraception throughout the treatment period and for 3 months after the last treatment administration.
Signed informed consent prior to initiation of any study-specific procedures or treatment.

Exclusion Criteria:

History of haematological malignancy or other cancer, except those treated for more than 5 years and considered as cured, carcinoma in situ of the cervix and treated skin cancer (excluding melanoma)
Poorly differentiated neuroendocrine carcinoma or NET grade 3 ENETS (Ki-67 > 20%)
If primary resected, bone metastasis exclusively
Pre-treatment by somatostatin long-acting analogue
Total bilirubin ≥ 60 µmol/L
Uncontrolled diabetes
Contraindication to product used in the study or its components
Tumour arising in the context of a genetic disease
Pregnancy or lactation
Patients unable to undergo medical follow-up due to geographical, social, psychological or legal reasons
Concomitant participation in another clinical trial investigating a treatment during the treatment phase and within 30 days prior to the start of the study treatment.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: these patients receive a subcostal TAP with liposomal bupivacaine

liposomal bupivacaine
Eligibility criteria:
Inclusion Criteria:

those who present for elective robotic assisted hysterectomy

Exclusion Criteria:

non english speaking
chronic pain
on opioids greater than 1 weeks
chronic anticoagulation
allergy to local anesthetics
use of spinal or epidural for surgery
lack of patient cooperation
contraindication to regional anesthesia
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: These patients receive a subcostal TAP with bupivacaine

Bupivacaine
Eligibility criteria:
Inclusion Criteria:

those who present for elective robotic assisted hysterectomy

Exclusion Criteria:

non english speaking
chronic pain
on opioids greater than 1 weeks
chronic anticoagulation
allergy to local anesthetics
use of spinal or epidural for surgery
lack of patient cooperation
contraindication to regional anesthesia
Intervention: Pitavastatin
Trial phase: Not Applicable
ATC code: C10AA08
SMILES: O=C(O)C[C@H](O)C[C@H](O)/C=C/c1c(C2CC2)nc2ccccc2c1-c1ccc(F)cc1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: pitavastatin 4mg daily by mouth for 6 months

pitavastatin
Eligibility criteria:
Inclusion Criteria:

Men age 40-65yo
BMI ≥ 27kg/m2 and waist circumference ≥102cm, high probability risk factors for NAFLD
At least one of the following indicating insulin resistance: Fasting glucose ≥100mg/dL and <126mg/dL, HOMA-IR >2.0, and/or 2 hour glucose ≥140mg/dL and <200mg/dL following standard glucose tolerance test.
10-year cardiovascular disease risk ≥5% by American Heart Association(AHA)/American College of Cardiology (ACC) Pooled Cohort Equations CV Risk Calculator or LDL ≥ 100mg/dL
No use of any statin within 1 year of study entry and not being actively considered for statin therapy by a treating provider.

Exclusion Criteria:

Diagnosis of diabetes or use of anti-diabetic medications.
Use of erythromycin, rifampin, cyclosporin, colchicine, or gemfibrozil.
Use of statin therapy within 1 year prior to study entry as above. Use of any other lipid-modifying therapy (including fish oil, fibrates, niacin, gemfibrozil) within 6 months of study entry.
Contraindication to statin therapy.
Creatinine > upper limit of normal or known renal disease
AST or ALT > 3 times the upper limit of normal
hemoglobin < 10g/dL
Contraindication to undergoing a magnetic resonance scan.
Atherosclerotic cardiovascular disease or low-density lipoprotein cholesterol (LDL-C) ≥ 190mg/dL.
Triglyceride ≥500mg/dL