anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Naropin
Trial phase: Phase 4
SMILES: CCC[NH+]1CCCCC1C(=O)Nc1c(C)cccc1C.O.[Cl-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 55
Group description: This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
Eligibility criteria:
Inclusion Criteria:

Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
Patients presenting for unilateral primary total knee replacement.
No focal neurologic deficit of the surgical lower extremity.
Cognitively intact with the ability to sign informed consent

Exclusion Criteria:

Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
History of long term use of daily opioids (>1 months) with oral morphine equivalent (OME) >5mg/day.
Body mass index (BMI) > 40 kg/m2
Allergies to medications used in this study such as: fentanyl, hydromorphone, ketorolac, ibuprofen, acetaminophen, local anesthetics, oxycodone, OxyContin, tramadol, ondansetron, droperidol, or dexamethasone, celecoxib

Major systemic medical problems such as:

Severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2
Cardiovascular disorders defined as congestive heart failure (CHF) New York Heart Association (NYHA) class III-IV
Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), fatty liver, chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver.
Impaired cognitive function or inability to understand the study protocol
Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy in the operative extremity, coagulopathy [platelets < 100,000, International Normalized Ratio (INR) >1.5], refusal, etc.).
Previous contralateral knee replacement managed with regional or periarticular injection
Unable to follow-up at the 3 month interval at Mayo Clinic in Rochester, Minnesota
Pregnancy or breast feeding (women of child-bearing potential, must have a negative pregnancy test)
Intervention: Tadalafil
Trial phase: Phase 4
ATC code: C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51
SMILES: [H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 210
Group description: 2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
Eligibility criteria:
Inclusion Criteria:

Have a history of erectile dysfunction for at least 3 months.
Are sexually active and willing to remain sexually active with the same female partner during the study.
Are willing to have 4 or more attempts of sexual intercourse with female partner between screening and first treatment start day.
Are willing to stay away from any other medicines that the participants were already taking for erectile dysfunction during this study period.

Exclusion Criteria:

Have erectile dysfunction, which is caused by any other primary sexual disorder.
Have certain problems with kidneys, liver, heart, blood sugar levels, eyes, or central nervous system (study doctor will discuss with participants).
Have a penis deformity or penile implant that in the opinion of the participants' doctor is significant.
Have human immunodeficiency virus (HIV) infection.
Are using certain kinds of medicines, which are not allowed in this study.
Are allergic to tadalafil.
Are planning to father a baby or are in a relationship with a pregnant partner.
Are participating or discontinued participation in the past 30 days from any another clinical trial, which is not compatible with this trial.
Have participated or discontinued from any other tadalafil clinical trial.
Have a history of drug, alcohol, or substance abuse within the past 6 months.
Intervention: Tadalafil
Trial phase: Phase 4
ATC code: C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51
SMILES: [H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 421
Group description: 5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
Eligibility criteria:
Inclusion Criteria:

Have a history of erectile dysfunction for at least 3 months.
Are sexually active and willing to remain sexually active with the same female partner during the study.
Are willing to have 4 or more attempts of sexual intercourse with female partner between screening and first treatment start day.
Are willing to stay away from any other medicines that the participants were already taking for erectile dysfunction during this study period.

Exclusion Criteria:

Have erectile dysfunction, which is caused by any other primary sexual disorder.
Have certain problems with kidneys, liver, heart, blood sugar levels, eyes, or central nervous system (study doctor will discuss with participants).
Have a penis deformity or penile implant that in the opinion of the participants' doctor is significant.
Have human immunodeficiency virus (HIV) infection.
Are using certain kinds of medicines, which are not allowed in this study.
Are allergic to tadalafil.
Are planning to father a baby or are in a relationship with a pregnant partner.
Are participating or discontinued participation in the past 30 days from any another clinical trial, which is not compatible with this trial.
Have participated or discontinued from any other tadalafil clinical trial.
Have a history of drug, alcohol, or substance abuse within the past 6 months.
Intervention: Fingolimod
Trial phase: Phase 4
ATC code: L04AA27
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Fingolimod 0.5mg/day tablets taken orally
Eligibility criteria:
Inclusion Criteria:

Patients participating in study FTY720D2406 who experienced a serious cardiovascular event during their fingolimod treatment initiation or re-initiation which led to overnight monitoring or met seriousness criteria.
Patients still on fingolimod after the this first dose serious event

Exclusion Criteria:

-Treatment with any investigational drug unless it is received as part of a Novartis sponsored MS study lasting less than 1 month
Intervention: Milrinone
Trial phase: Phase 2
ATC code: C01CE02
SMILES: Cc1[nH]c(=O)c(C#N)cc1-c1ccncc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 38
Group description: Patients who received milrinone
Eligibility criteria:
Inclusion Criteria:

Provision of informed consent prior to any study specific procedures
Female and male children between 1 and 12 months of age
Non-restrictive VSD (corrective surgery)
Complete AVSD (biventricular repair)
Tetralogy of Fallot

Exclusion Criteria:

Unbalanced AtrioVentricular Septal Defect or AVSD with cyanosis
Age less than one month and more than one year
Acute operation that is unscheduled operation during the first 24 hours after presentation to the department for thoracic surgery
Mild, moderate, or severe kidney dysfunction and known anatomical anomalies of kidneys
Liver impairment or disease
Ongoing infection
Use of nephrotoxic drugs (like ibuprofen, angiotensin-converting-enzyme inhibitors, gentamicin, vancomycin) preoperative or postoperative until first post operative day. Contrast agents whithin 24 hours before operation.
Use of inhibitors of membrane transport proteins (cimetidine, cetirizine, trimethoprim, probenecid, rifampin and gemfibrosil).
Allergy to Levosimendan or substance included in the preparation or previous use of Levosimendan.
Severe arrhythmias needing pace-maker treatment prior to the operation
Severe cardiac dysfunction needing for treatment with extracorporeal membrane oxygenation (ECMO) prior to the operation.
Preoperative need for mechanical ventilation and/or inotropic agents.
Re-operation (open heart surgery). Earlier surgical closure of the arterial duct does not count as an exclusion criteria.
Prematurity: Gestational age < 30 weeks, irrespective of postpartum age. Gestational age 30-34 weeks if patient is included at postpartum age under 3 months.
Intervention: Spironolactone
Trial phase: Phase 2
ATC code: C03DA01
SMILES: [H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 182
Group description: Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours

Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.
Eligibility criteria:
Inclusion Criteria:

Male or female patient ≥21 years old
Admitted to hospital for AHF with at least 1 symptom (dyspnea, orthopnea, or fatigue) and 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography) of congestion
Patient must be randomized within 24 hours of first IV diuretic dose administered for the current episode of decompensation (regardless of where the diuretic was given e.g. office, ED, ambulance, hospital etc.)
Estimated GFR of ≥30 mL/min/1.73m2 determined by the MDRD equation
Serum K+ ≤5.0 mmol/L at enrollment
NT-proBNP ≥1000 pg/mL or BNP ≥250 pg/mL, measured within 24h from randomization
Not on MRA or on low-dose spironolactone (12.5 mg or 25 mg daily) at baseline

Exclusion Criteria:

Taking eplerenone or >25 mg spironolactone at baseline
eGFR < 30 ml/min/1.73m2
Serum K+ >5.0 mmol/L. If a repeat measurement within the enrollment window is <5.0, the patient can be considered for inclusion.
Systolic blood pressure <90 mmHg
Hemodynamically significant arrhythmias or defibrillator shock within 1 week
Acute coronary syndrome currently suspected or within the past 4 weeks
Severe liver disease (ALT or AST >3 x normal, alkaline phosphatase or bilirubin >2x normal)
Active infection (current use of oral or IV antimicrobial agents)
Active gastrointestinal bleeding
Active malignancy other than non-melanoma skin cancers
Current or planned mechanical circulatory support within 30 days
Post cardiac transplant or listed for transplant and expected to receive one within 30 days
Current inotrope use
Complex congenital heart disease
Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade
Previous adverse reaction to MRAs
Enrollment in another randomized clinical trial during index hospitalization
Intervention: Spironolactone
Trial phase: Phase 2
ATC code: C03DA01
SMILES: [H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: 50 mg capsule of Spironolactone administered orally 1 per day for 8 weeks

Spironolactone
Eligibility criteria:
Inclusion Criteria:

Age 30 to 80 years old;
Systolic blood pressures between 110 to 150 mmHg and/or diastolic blood pressure between 80-99 mmHg;
Ability to give informed consent.

Exclusion Criteria:

Pregnancy;
Intolerance to study protocols;
Acute cardiovascular events within the previous 6 months;
Impaired renal function [estimated glomerular filtration rate (GFR) < 45 ml/min/1.73m^2];
Current or recent treatment with systemic glucocorticoid therapy (within 1 month of enrollment);
Current use of anti-hypertensive medication (except calcium channel blockers and beta blockers);
Diabetes mellitus requiring medical therapy;
Morbid obesity (BMI > 45);
Prior adverse reaction to a thiazide or spironolactone;
Claustrophobia preventing the patient from having an MRI or other contraindications to MRI;
Impaired hepatic function (aspartate amino transaminase and/or alanine amino transaminase > 1.5x upper limit of normal range);
Current illicit drug use;

Sexually active women of childbearing potential** who are unwilling to practice adequate contraception during the study [adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (IUD); bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly].

Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
Intervention: Fluoxetine
Trial phase: Phase 4
ATC code: N06AB03 | N06CA03
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Fluoxetine up to 20 mg orally daily for 12 weeks. Flexible dosing between a minimum of 10 mg daily and 20 mg daily as tolerated.

Fluoxetine: Antidepressant
Eligibility criteria:
Inclusion Criteria:

age 30-70 yrs;
have patent and non-infected arteriovenous fistula or graft;
are receiving maintenance HD 3 times per week lasting for 3-4 hours;
serum albumin of ≥ 3.2 g/dl, serum phosphate of <6.5 mg/dl, and serum hemoglobin of ≥9 mg/dl in consecutive two blood tests as per the National Kidney Foundation Disease Outcomes Quality Initiative (NKF KDOQI) guidelines [subjects failing screening due to blood test will be allowed to be re-screened in 30 days];
receiving stable or maintenance dose of iron or erythropoietin-stimulating agents, statins, angiotension receptor blockers and/or angiotension converting enzyme inhibitors, phosphate binders, vitamin D receptor analogs as these agents may influence cytokines proposed in the study;
meet the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for MDD;
have a Ham-D score > 17

Exclusion Criteria:

meet DSM-IV criteria for Bipolar Disorder or other psychotic disorder in the month prior to screening;
are taking antidepressants, anti-anxiety medications, or hypnotics (including Zyban for smoking cessation);
having failed to respond to or tolerate bupropion or fluoxetine in the past
allergic to fluoxetine or bupropion
known history of HIV/AIDS; No testing will be conducted for screening purposes
known history of alcohol or drug abuse or dependence within the month prior to screening based on clinical records;
history of myocardial infarction or heart failure within one month of screening or a history of seizures or stroke at any point;
history of chronic liver disease and diagnosis of hepatic encephalopathy based on clinical records;
currently diagnosed with cancer or receiving any cancer treatment;
history of any infection within the last 2 weeks ;
currently taking any antibiotics, anti-inflammatory, and immune-modulator agents;
recorded noncompliance with dialysis schedules; and
currently participating in clinical or behavioral intervention studies.
recorded noncompliance with dialysis schedules; and
currently participating in clinical or behavioral intervention studies
Intervention: Fentanyl
Trial phase: Phase 3
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.

Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).
Eligibility criteria:
Inclusion Criteria:

Subject capable of giving consent
Age 18-65
Total burn surface area greater than or equal to 5%
Opioid tolerant
BMI less than or equal to 35

Exclusion Criteria:

Subjects with cognitive or psychiatric impairment that would preclude study participation or compliance with protocol
Allergy to fentanyl, morphine, naloxone
Pregnancy, intent to become pregnant or lactating
Evidence of burn injury to oral mucosa
Active illicit drug use or illicit drug abuse history
Intervention: Sodium fluoride and triclosan
Trial phase: Phase 2
SMILES: Oc1cc(Cl)ccc1Oc1ccc(Cl)cc1Cl.[F-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 162
Group description: 1450 ppm sodium fluoride/triclosan toothpaste Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
Eligibility criteria:
Inclusion Criteria

Subjects, ages 18-70, inclusive.
Availability for the six-month duration of the clinical research study.
Good General health.
Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
Signed Informed Consent Form.

Exclusion Criteria

Presence of orthodontic bands.
Presence of partial removable dentures.
Tumor(s) of the soft or hard tissues of the oral cavity.
Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
Five or more carious lesions requiring immediate restorative treatment.
Antibiotic use any time during the one-month period prior to entry into the study.
Participation in any other clinical study or test panel within the one month prior to entry into the study.
Dental prophylaxis during the past two weeks prior to baseline examinations.
History of allergies to oral care/personal care consumer products or their ingredients.
On any prescription medicines that might interfere with the study outcome.
An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
History of alcohol or drug abuse.
Pregnant or lactating subjects.
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 515
Group description: Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.

Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.
Eligibility criteria:
Inclusion Criteria:

18 years of age and older
Able to provide written consent
Able to read and write in English
Weighing over 50 kg
Will undergo total hip or total knee joint replacement

Exclusion Criteria:

Non-verbal patients
Unable to use numeric pain scale
Allergic to the test article
Documented hepatic impairment or failure
Current illicit drug use
Requires traumatic or emergent surgery
Pregnant women
Women who are breastfeeding
Prisoners
Cognitively impaired requiring Legally Authorized Representative (LAR) or Power of Attorney (POA)
Unable to swallow oral capsules
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 515
Group description: Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.

IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.
Eligibility criteria:
Inclusion Criteria:

18 years of age and older
Able to provide written consent
Able to read and write in English
Weighing over 50 kg
Will undergo total hip or total knee joint replacement

Exclusion Criteria:

Non-verbal patients
Unable to use numeric pain scale
Allergic to the test article
Documented hepatic impairment or failure
Current illicit drug use
Requires traumatic or emergent surgery
Pregnant women
Women who are breastfeeding
Prisoners
Cognitively impaired requiring Legally Authorized Representative (LAR) or Power of Attorney (POA)
Unable to swallow oral capsules