anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Citalopram
Trial phase: Phase 4
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 65
Group description: Open treatment with 20mg of citalopram, increased to 40mg if depression has not remitted at week 4.

Citalopram
Eligibility criteria:
Inclusion Criteria:

Men and women aged 24-75 years
Diagnosed with Diagnostic and Statistical Manual of Mental Disorders (DSM) IV Major Depressive Disorder, nonpsychotic
24-item Hamilton Rating Scale for Depression (HRSD) score ≥ 16
Willing to and capable of providing informed consent and complying with study procedures
Subjects are right-handed
Using appropriate contraceptive method if woman of child-bearing age

Exclusion Criteria:

Current comorbid Axis I DSM IV disorder other than Nicotine Dependence, Adjustment Disorder, Panic Disorder, Generalized Anxiety Disorder, or Social Phobia
Diagnosis of substance abuse or dependence (excluding Nicotine Dependence) within the past 12 months
History of psychosis or psychotic disorder, mania or bipolar disorder
Subject is considered to be at significant risk of suicide based on current mental status and recent history
History of allergic or adverse reaction to citalopram, or nonresponse to adequate trial of citalopram (at least 4 weeks at dose of 40mg) or escitalopram (at least 4 weeks at dose of 20mg)
Subject is considered based on history to be unlikely to respond to the single agent citalopram (i.e., subjects with treatment resistant depression)
Current treatment with psychotherapy
Clinical Global Impression (CGI)-Severity score of 7 at baseline Clinical Interview
Current or recent (within the past 4 weeks) treatment with any of the following: antidepressants, antipsychotics, mood stabilizers, isoniazid, glucocorticoids, opiates, centrally active antihypertensive drugs (e.g. clonidine, reserpine)
Subject has metal in body or prior history working with metal fragments (e.g., as a machinist), tattoos, or unable to tolerate the scanning procedures (i.e., severe obesity, claustrophobia)
Acute, severe, or unstable medical illness
Intervention: Letrozole
Trial phase: Phase 2
ATC code: L02BG04
SMILES: N#Cc1ccc(C(c2ccc(C#N)cc2)n2cncn2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Letrozole 2.5 mg alone once daily
Eligibility criteria:
Inclusion Criteria:

Female patient is ≥ 18 years old at the time of informed consent, with newly diagnosed resectable breast cancer, who received no prior therapy for breast cancer

Patient is postmenopausal. Postmenopausal status is defined either by:

Prior bilateral oophorectomy
Age ≥60
Age <60 and amenorrhea for 12 or more months and FSH (Follicle Stimulating Hormone) and estradiol in the postmenopausal range.
Patient has a histologically (and/or cytologically) confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.
Patient has a grade II or grade III invasive breast cancer
Patient has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer defined as a negative in situ hybridization test or an Immunohistochemistry (IHC) status of 0, 1+ or 2+ (if IHC 2+, a negative in situ hybridization (respectively FISH/CISH/SISH) test is required) by local laboratory testing
Patient has at least one breast lesion with a diameter of ≥1.0 cm by the most accurate imaging modality used.
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

Patient has received any prior therapy for breast cancer.
Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated, basal cell skin cancer or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.

Patient has active cardiac disease or a history of cardiac dysfunction including any of the following:

History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to study entry
History of documented congestive heart failure (New York Heart Association functional classification III-IV)
Documented cardiomyopathy
Patient has a Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)
History of ventricular, supraventricular, nodal arrhythmias, or any other cardiac arrhythmias, Long QT Syndrome or conduction abnormality in the previous 12 months.
Family history of QTc prolongation or of unexplainable sudden death at <50 years of age.
On screening 12 lead ECG, any of the following cardiac parameters: bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval >109 msec, or QTcF >450 msec.
Systolic blood pressure >160 mmHg or <90 mmHg.
Patient is currently receiving any of the following medications (see

Appendix 1 for details):

That are known strong inducers or inhibitors of CYP3A4.
That have a narrow therapeutic window and are predominantly metabolized through CYP3A4.
That have a known risk to prolong the QT interval or induce Torsades de Pointes.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Augmentin
Trial phase: Phase 4
SMILES: CC1(C)SC2C(NC(=O)C(N)c3ccc(O)cc3)C(=O)N2C1C(=O)O.O=C([O-])C1C(=CCO)OC2CC(=O)N21.[K+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery.
Eligibility criteria:
Inclusion Criteria:

- Patients eligible for surgery would be patients with chronic rhinosinusitis (defined by the AAOHNS 2007 consensus statement by Rosenfeld et al) and have been determined by their surgeons to have persistent symptoms after maximal medical therapy. Maximal medical therapy is defined as a course of broad spectrum or culture-directed antibiotics used in conjunction with a nasal steroid.

Exclusion Criteria:

Penicillin, cephalosporin, amoxicillin/clavulanate allergy
Cystic Fibrosis
Immunodeficiency
Presence of any foreign body (ie.absorbable and non-absorbable packing) after surgery
Odontogenic causes of sinusitis
Fungal ball
Infected mucocele
Complication of sinusitis (meningitis, orbital complication, cellulitis, brain abscess)
Non endoscopic sinus surgery (Caldwell luc, external approaches, etc)
Age <18
Pregnant women
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: EXPAREL 266 mg diluted with saline to a volume of 40 mL

EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.
Eligibility criteria:
Inclusion Criteria:

Females, 18-75 years of age inclusive.
American Society of Anesthesiologist (ASA) physical status 1-3.
Undergoing open total abdominal hysterectomy (i.e., laparoscopic procedures are not sufficient) without any concurrent surgical procedure(s).
Physically and mentally able to participate in the study and complete all study assessments.
Able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP.

Exclusion Criteria:

Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP.
Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.
Any subject, who in the opinion of the Investigator, is on chronic pain medicine.
Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: EXPAREL 266 mg diluted with saline to a volume of 60 mL

EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.
Eligibility criteria:
Inclusion Criteria:

Females, 18-75 years of age inclusive.
American Society of Anesthesiologist (ASA) physical status 1-3.
Undergoing open total abdominal hysterectomy (i.e., laparoscopic procedures are not sufficient) without any concurrent surgical procedure(s).
Physically and mentally able to participate in the study and complete all study assessments.
Able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP.

Exclusion Criteria:

Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP.
Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.
Any subject, who in the opinion of the Investigator, is on chronic pain medicine.
Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
Intervention: Azithromycin
Trial phase: Phase 2
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 8
Group description: All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
Eligibility criteria:
Inclusion Criteria:

Male or female patient, aged 12 to 17 years.
Requires outpatient treatment for acute pharyngitis/tonsillitis infection.
Appropriate to treat with oral azithromycin as an alternative to intramuscular penicillin, in the opinion of the investigator.
Positive rapid antigen detection test.

Exclusion Criteria:

History of clinically significant eye disorder that would interfere with protocol test procedures.
Hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide antibiotic.
Increased risk of QT prolongation.
Pregnant or breastfeeding.
Intervention: Nebivolol
Trial phase: Phase 4
ATC code: C07AB12 | C07BB12 | C07FB12 | C09DX05
SMILES: OC(CNCC(O)C1CCc2cc(F)ccc2O1)C1CCc2cc(F)ccc2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.

Nebivolol
Eligibility criteria:
Inclusion Criteria:

Stage 1 hypertension
40-75 years
Weight stable (+/-2 kg)
Sedentary to recreationally active
Willing to be randomized to one of three arms
Verbal and written consent
Approval by medical director

Exclusion Criteria:

Blood pressure outside stated range
Diabetes or taking diabetes medications
Total cholesterol >6.2 mmol/L; triglycerides >4.5 mmol/L
Past or current ischemic heart disease, stroke, respiratory disease, endocrine or metabolic disease, neurological disease, or hematological-oncological disease
Medications (including but not limited to antihypertensives, statins or other with anti-inflammatory actions) or antioxidant vitamins or supplements
Known allergy or hypersensitivity to nebivolol or any of its components
Inability to perform regular physical activity or participate in other components of lifestyle modification
Pregnant or planning to become pregnant
Intervention: Cyclobenzaprine
Trial phase: Phase 2
ATC code: M03BX08
SMILES: CN(C)CCC=C1c2ccccc2C=Cc2ccccc21
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Female gender, age ≥ 18, postmenopausal.
Histologically proven stage 0-III invasive carcinoma of the breast
Initiating or have been receiving a standard dose of aromatase inhibitor therapy (letrozole 2.5mg once daily or exemestane 25mg once daily or anastrozole 1mg once daily) for up to a total of 48 months of AI therapy.
Trouble sleeping during the past week. (After signing the informed consent document, subjects must also have a global PSQI score of ≥5)
ECOG performance status 0-2 (see Appendix A).

Exclusion Criteria:

Known hypersensitivity to cyclobenzaprine or any of the inactive ingredients
Diagnosis of sleep apnea that is currently interfering with sleep or requiring CPAP, restless leg syndrome that is currently interfering with sleep or requiring medication, or Epworth sleepiness scale >10.
Subjects with a history of hypothyroidism must have been on a stable dose of thyroid replacement medicine for at least 3 months prior to enrollment
Treatment with steroids within 1 month
Treatment with monoamine oxidase inhibitors (MAO-I) within 14 days of enrollment.
Concurrent treatment with bupropion, MAO inhibitors, phenothiazines (including thioridazine), selegiline, tramadol, or medications known to prolong the QT interval (www.azcert.org/medical-pros/drug-lists/drug-lists.cfm)
Currently primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder
Known moderate or severe hepatic impairment
History of congestive heart failure or cardiac arrhythmia (other than atrial fibrillation); myocardial infarction within the past 6 months
Uncontrolled narrow-angle glaucoma
Pregnant or breast feeding
Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation
Intervention: Trospium chloride
Trial phase: Phase 4
SMILES: O=C(OC1CC2CCC(C1)[N+]21CCCC1)C(O)(c1ccccc1)c1ccccc1.[Cl-]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 28
Group description: Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).

Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit.
Eligibility criteria:
Inclusion Criteria:

Female 50 or older
Diagnosis of OAB (ICS definition)
English literacy
Ability to swallow oral medication
Cognitive ability to give consent

Exclusion Criteria:

Dementia/Depression/Delirium
Current anticholinergic use (requires 2 week washout period)
Current cholinesterase
Urinary or gastric retention
Severe decreased gastrointestinal motility
Uncontrolled narrow-angle glaucoma
Myasthenia gravis
Diagnosis fo renal impairment (creatinine clearance <30 mL/min)
Intervention: Prazosin
Trial phase: Not Applicable
ATC code: C02CA01 | C02LE01
SMILES: COc1cc2nc(N3CCN(C(=O)c4ccco4)CC3)nc(N)c2cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 71
Group description: group will receive the study medication prazosin ( 1 mg PO) 6 hours prior to catheter discontinuation (24 hours postoperatively)

Prazosin given 6 hours prior to catheter removal in the 24 hour group: Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively)
Eligibility criteria:
Inclusion Criteria:

Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
Males or females, >18 years of age inclusive at the time of study screening;
American Society of Anesthesiologists (ASA) Class I-III;
Infraperitoneal colorectal surgery (open and/or laparoscopic);
Elective Surgery

Exclusion Criteria:

Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures;
Children <18;
No perioperative antibiotics;
Past or current urinary tract malignancy;
Urinary catheter inserted before surgery;
Chronic kidney insufficiency with Creatinine> 2
Diagnosis of benign prostatic hyperplasia
Chronic urinary infections
Neurogenic bladder
History of enterovesical fistula
Pregnancy
Prior surgery of the lower urinary tract
Epidural
Perioperative ureteral stents

After randomization:

Catheter pulled out inadvertently;
Postoperative complications requiring prolonged monitoring of urine output
Postoperative complications requiring early reoperation
Intervention: Estradiol
Trial phase: Phase 2
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: ESTRING® (estradiol vaginal ring) is a slightly opaque ring with a whitish core containing a drug reservoir of 2 mg estradiol. Estradiol, silicone polymers and barium sulfate are combined to form the ring. When placed in the vagina, ESTRING releases estradiol, approximately 7.5 mcg per 24 hours, in a consistent stable manner over 90 days.
Eligibility criteria:
Inclusion Criteria:

Stage I-III estrogen receptor positive breast cancer (positive for estrogen receptor (ER)) with positivity defined as immunohistochemical staining in ≥ 10% of cells) on adjuvant hormonal therapy with aromatase inhibitors (anastrozole, letrozole or exemestane)
Adults over 18 years of age with a life expectancy of at least 3 months
Attained menopause as defined by World Health Organization Criteria (defined as permanent cessation of menstruation resulting from the loss of ovarian follicular activity. This is recognized to occur after 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause.)
Persistent genitourinary symptoms causing discomfort for more than 2 weeks prior to the visit with the physician.
Tried at least 1 prior pharmacological/ non-pharmacological treatment for their genitourinary symptoms
Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to any study specific procedures
Be willing and able to comply with the treatment plan, scheduled clinic visits, laboratory tests and other study procedures

Exclusion Criteria:

Patients with metastatic breast cancer
Have a concurrent active non-breast malignancy except for non-melanoma skin cancer
Patients with vaginal stenosis
Patients unable to apply Estring
Intervention: Zosyn
Trial phase: Not Applicable
SMILES: CC1(Cn2ccnn2)C(C(=O)O)N2C(=O)CC2S1(=O)=O.CCN1CCN(C(=O)NC(C(=O)NC2C(=O)N3C2SC(C)(C)C3C(=O)[O-])c2ccccc2)C(=O)C1=O.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.

Piperacillin/Tazobactam Standard Dose to High Dose: Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Patients will be switched to higher dose after receiving the standard dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
Eligibility criteria:
Inclusion Criteria:

BMI greater than or equal to 30 kg/m2
Weight at least 105 kg
Age 18-89 years of age
Prescribed piperacillin/tazobactam at standard doses for suspected or confirmed infection(s)
English or Spanish speaking
Central line access

Exclusion Criteria:

Do not meet specified inclusion criteria
Hepatic impairment classified by Child-Pugh Class B or greater
Documented pre-existing seizure disorder
Documented pre-existing hematologic disorder
Pregnancy
Documented allergy or contraindication to beta-lactams or tazobactam
Intervention: Desflurane
Trial phase: Phase 4
ATC code: N01AB07
SMILES: FC(F)OC(F)C(F)(F)F
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 62
Group description: 1.5 MAC desflurane until extubation

Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane
Eligibility criteria:
Inclusion Criteria:

Age 20-60
patients undergoing elective surgery take more than an hour
Under general anesthesia using an LMA
ASA I,II

Exclusion Criteria:

Patients on CNS depressants
Chronic opioid use
Corticosteroid
Pregnant patients
Full stomach
Morbidly obese (BMI >35kg/m2)
Hepatitis B
Hepatitis C
Coronary artery disease
Liver disease
Renal disease
Seizure disorder

Dropout criteria:

Need for reintubation due to breath holding
high ETCO2 during self ventilation (ETCO2>50)
Surgeon or patient request
Intervention: Ledipasvir
Trial phase: Phase 2
ATC code: J05AP51
SMILES: COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Body mass index (BMI) greater than or equal to 18 kg/m^2.
HCV RNA greater than or equal to 1000 IU/mL at screening.
Documented acquisition of nosocomial genotype 1 HCV infection within 36 months from the screening visit.
Screening laboratory values within predefined thresholds.
Use of two effective contraception methods if female of childbearing potential or sexually active male.
Healthy according to medical history and physical examination with the exception of HCV diagnosis.

Exclusion Criteria:

Unstable cardiac disease including subjects with active angina pectoris and/or hospitalization for a cardiac condition within 24 weeks prior to screening.
Prior exposure to an HCV NS5a inhibitor.
Pregnant or nursing female.
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
History of solid organ transplantation.
Current or prior history of clinical hepatic decompensation.
History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
Known hypersensitivity to LDV, SOF, or formulation excipients.