anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tolvaptan
Trial phase: Phase 4
ATC code: C03XA01
SMILES: Cc1ccccc1C(=O)Nc1ccc(C(=O)N2CCCC(O)c3cc(Cl)ccc32)c(C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Augmentation of current dose of loop diuretic + 30 mg of oral tolvaptan daily

Tolvaptan: Study will test the addition of tolvaptan to augmentation of loop diuretic as standard of care for outpatients presenting with worsening heart failure.
Eligibility criteria:
Inclusion Criteria:

≥ 18 years of age

Presenting to clinic with worsening heart failure due congestion (fluid overload) Patient reported worsening fluid overload based on perception of edema and/or weight gain With at least one of the following symptoms

Worsening dyspnea on exertion or fatigue
Worsening orthopnea or paroxysmal nocturnal dyspnea (PND)
Perception of abdominal and/or lower extremity edema
Early satiety and/or decreased appetite And at least one of the following signs
Lower extremity edema
Ascites
Elevated jugular venous distension (JVD)
Pulmonary rales
Daily oral dose of loop diuretic
Prior history of heart failure with this diagnosis for at least 1 month with preserved or reduced left ventricular ejection fraction
Signed informed consent

Exclusion Criteria:

Patients with symptomatic hyponatremia will be excluded from the study.
Patients with severe hyponatremia, defined as serum sodium < 125 milliequivalents per Liter (mEq/L) at the time of screening, will be excluded regardless of whether they are symptomatic or not.
Patients with the following predisposing factors for osmotic demyelinating syndrome (ODS), assessed by the study investigator judgment, will be excluded: chronic alcoholism at the time of study, severe liver disease, marked malnutrition, and risk for chronic hypoxia.
Patients currently undergoing renal replacement therapy
Planned hospitalization for acute heart failure
History of primary significant liver disease or acute hepatic failure, as defined by the investigator
Hemodynamically significant arrhythmias
Acute coronary syndrome (ACS) or acute myocardial infarction within 4 weeks prior to study entry
Active myocarditis
Hypertrophic obstructive, restrictive, or constrictive cardiomyopathy
Severe stenotic valvular disease amendable to surgical treatment
Complex congenital heart disease
Constrictive pericarditis
Clinical evidence of digoxin toxicity

History of adverse reaction or clinical contraindication to tolvaptan

Concomitant use of strong cytochrome P450 3A4 (CYP3A4) inhibitors
Inability of patient to sense and/or respond to thirst
History of hypersensitivity to tolvaptan
Patient is anuric
Enrollment or planned enrollment in another randomized clinical trial during the study period
Pregnant or breast-feeding
Inability to comply with planned study procedures
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 44
Group description: Infused into the bladder to allow for visualization of bladder walls and urine jets.

Normal saline: Used to distend the bladder for cystoscopic evaluation
Eligibility criteria:
Inclusion Criteria:

adult
undergoing a cystoscopy or as part of their planned procedure

Exclusion Criteria:

Chronic kidney disease
known prior surgical removal of kidney or ureteral obstruction
Current ureteral stent placed
Allergy to any of the interventions
Intervention: Desmopressin
Trial phase: Not Applicable
ATC code: H01BA02
SMILES: N=C(N)NCCC[C@@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H]1CSSCCC(=O)N[C@@H](Cc2ccc(O)cc2)C(=O)N[C@@H](Cc2ccccc2)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N1)C(=O)NCC(N)=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 44
Group description: Infused into the bladder to allow for visualization of bladder walls and colored urine jets.

Dextrose 10%: Used to distend the bladder for cystoscopic evaluation
Eligibility criteria:
Inclusion Criteria:

adult
undergoing a cystoscopy or as part of their planned procedure

Exclusion Criteria:

Chronic kidney disease
known prior surgical removal of kidney or ureteral obstruction
Current ureteral stent placed
Allergy to any of the interventions
Intervention: Phenazopyridine
Trial phase: Not Applicable
ATC code: G04BX06
SMILES: Nc1ccc(/N=N/c2ccccc2)c(N)n1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 44
Group description: Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy.

Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy
Eligibility criteria:
Inclusion Criteria:

adult
undergoing a cystoscopy or as part of their planned procedure

Exclusion Criteria:

Chronic kidney disease
known prior surgical removal of kidney or ureteral obstruction
Current ureteral stent placed
Allergy to any of the interventions
Intervention: Intralipid
Trial phase: Phase 4
SMILES: CCCCCC=CCC=CCCCCCCCC(=O)O.CCCCCCCCC=CCCCCCCCC(=O)OC(COC(=O)CCCCCCCCCCCCCCC)COP(=O)(O)OCC[N+](C)(C)C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 1
Group description: Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion
Eligibility criteria:
Inclusion Criteria:

Patients and/or their legal representative must be able to understand the study and voluntarily sign the ICF
Patients age <18 years
Patients who are able to adhere to protocol requirements
Patients who are expected to require PN for at least 7 days
Premature infants (<36 weeks of gestation) require at least 80% PN to meet nutrition requirements at study entry; full term infants and children require at least 70% PN to meet nutrition requirements at study entry

Exclusion Criteria:

Patients who are not expected to survive hospitalization or with a severe illness with foreseeable intercurrent events that could jeopardize the patient's participation in the study
Patients with a known hypersensitivity to lipid emulsion, egg or soybean proteins, or any of the active substances, excipients, or components of the container
Patients with a diagnosis of shock, renal failure requiring dialysis, or severe metabolic acidosis (eg, pH <7.10, serum bicarbonate level ≤15 mEq/L , and/or an Anion Gap >16 mEq/L)
Patients with hemodynamic instability as judged by the Investigator
Patients with uncorrected metabolic disorders (eg, diabetes) or liver disease including cholestasis
Patients with severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (triglyceride >400 mg/dL)
Patients who are unable to tolerate the necessary laboratory monitoring
Patients who have a new and active infection (as assessed by the investigator) at time of initiation of study treatment
Patients who are enrolled in another clinical trial involving an investigational agent
Patients who were treated with IV lipids within 48 hours of randomization into the study
Intervention: Dextromethorphan
Trial phase: Phase 2
ATC code: N07XX59 | R05DA09
SMILES: COc1ccc2c(c1)C13CCCCC1C(C2)N(C)CC3
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 88
Group description: Participants who received AVP-786 in Stage 1 or Stage 2 (up to a target dose of AVP-786-34/4.9 milligrams twice a day [d6-DM 34 mg/Q 4.9 mg BID]).
Eligibility criteria:
Inclusion Criteria:

Patients who meet DSM-IV-TR diagnostic criteria for schizophrenia using the M.I.N.I. version 6.0.
Patients must meet PANSS criteria
Patients currently receiving atypical antipsychotics are eligible provided they are on a stable dose

Exclusion Criteria:

Patients with current major depressive disorder (MDD)
Patients with extrapyramidal syndrome secondary to their ongoing antipsychotic medication
Patients currently using anticholinergic medications
Recent in-patient hospitalization
Intervention: Gefapixant
Trial phase: Phase 2
ATC code: G01AE10 | R05DB29
SMILES: COc1cc(C(C)C)c(Oc2cnc(N)nc2N)cc1S(N)(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
Eligibility criteria:
Inclusion Criteria:

Idiopathic pulmonary fibrosis diagnosis based upon the American Thoracic Society (ATS)/ European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/ Latin American Thoracic Society (ALAT) IPF 2011 guideline
Life expectancy of greater than 6 months
Stable medical condition (IPF) for at least 4 weeks
Women of child-bearing potential must use 2 forms of an acceptable birth control method from Screening through the Follow-Up Visit
Male subjects and their partners of child-bearing potential must use 2 methods of acceptable birth control, 1 of which must be a barrier method, and make no donation of sperm from Screening until 3 months after the last dose of study drug
Written informed consent
Willing and able to comply with all aspects of the protocol

Exclusion Criteria:

Current smoker (i.e., within the last 30 days)
Initiation of treatment with an antihypertensive agent within 4 weeks prior to the day of dosing (Day 1) or during the study
History of upper respiratory tract infection within 4 weeks of the day of dosing (Day 1)
Requiring concomitant therapy with prohibited medications
Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2
History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including subjects with <3 excised basal cell carcinomas)
History of a diagnosis of drug or alcohol dependency or abuse within approximately the last 3 years
Any condition possibly affecting drug absorption (e.g., gastrectomy, gastroplasty, fundoplication, any type of bariatric surgery, vagotomy, or bowel resection)
Recent history of stroke or transient ischemic attack (within 6 months prior to Screening) not due to trauma, repaired vascular malformation, or aneurysm
Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP) >90 mm Hg
QTc interval >450 milliseconds in males, >470 milliseconds in females
Breastfeeding
Treatment with an investigational drug or biologic within 30 days preceding the first dose of study medication or plans to take another investigational drug or biologic within 30 days of study completion
Blood donation within 56 days or plasma donation within 7 days prior to dosing
Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the subject inappropriate for entry into this trial
Intervention: Ropivacaine
Trial phase: Not Applicable
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 113
Group description: Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.

Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine.
Eligibility criteria:
Inclusion Criteria:

All patients (age> 18years old) undergoing primary unilateral total knee arthroplasty (TKA) with a clinical diagnosis of osteoarthritis

Exclusion Criteria:

Patients planned for uni-compartmental/bilateral or revision knee surgery patients
Patients with a diagnosis of rheumatoid arthritis (RA)
Patients with coagulation or anatomical defects e.g. preventing the use of spinal anaesthesia
Known allergies to any medications within the trial
Patients who were unable to give written informed consent
Patients requiring pre-operative catheterisation for urinary outflow dysfunction
Known neurological incident that would limit or make impossible early ambulation following surgery
Intervention: Naltrexone
Trial phase: Phase 4
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 123
Group description: Monthly XR-NTX (380 mg) Subjects randomized to XR-NTX will receive one intramuscular gluteal injection (in accordance with the FDA approved label/package insert) of 380 mg of NTX for extended-release injectable suspension at study entry (in the hospital) and 1, and 2 months later (outpatient in the primary care clinic), alternating buttocks.

Extended-release injectable naltrexone (XR-NTX): injectable naltrexone
Eligibility criteria:
Inclusion Criteria:

Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 alcohol use disorder (AUD) (assessed using Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS))
≥1 heavy drinking episodes (≥5 standard drinks [4 for women] in a day) in 30 days prior to hospitalization*
Inpatient on a hospital general medical service
Adult (age 18 years or greater)
Ability to speak English (fluency)
≥2 contact persons*

Exclusion Criteria:

Pregnancy (urine testing if childbearing potential)
Currently breast-feeding
Urine expanded panel drug test (dipstick) positive for opiates, semi-synthetic or synthetic opioids
Opioid use (self-report and verification in medical record) in past 7 days for long-acting opioids
Opioid use in past 24 hours for short-acting opioids
Discharge prescription for opioids
Future need for opioids for an anticipated painful event or surgery
Known hypersensitivity to NTX
Acute severe psychiatric illness (currently suicidal or psychotic)
Cognitive dysfunction that precludes informed consent or research assistant (RA) assessment that subject cannot understand interview questions
Alanine aminotransferase or aspartate aminotransferase >5 times the upper limit of normal
Acute hepatitis
Liver failure
Known severe thrombocytopenia (<50,000)
Coagulopathy
Coagulation disorder
Body habitus that precludes intramuscular injection
Plans to leave the Boston area in less than one year
Enrollment in a research study which involves taking a pharmaceutical agent that is expected to interact with naltrexone

[*criteria not changed since study start; change reflects correction of typo]
Intervention: Modafinil
Trial phase: Phase 3
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 67
Group description: A single oral dose of Nuvigil 150 mg in preoperative area

NUVIGIL: Patient will receive Nuvigil before the surgery
Eligibility criteria:
Inclusion Criteria:

Patient presented for surgery under general anesthesia
Documented OSA
Patients with BMI above 35

Exclusion Criteria:

Coronary Artery Disease or Myocardial infarcts
Mitral valve prolapse
Cyclosporine, contraceptive drugs
Known allergic reaction to Modafinil or any of its products
Intervention: Theophylline
Trial phase: Phase 2
ATC code: R03DA04 | R03DA20 | R03DA54 | R03DA74 | R03DB04
SMILES: Cn1c(=O)c2[nH]cnc2n(C)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: 20 μg intranasal theophylline (theophylline methylpropyl paraben in a 0.4-mL saline solution) once daily (in the morning) into each naris for a total of 6 weeks

Theophylline: The study medication will be provided by Foundation Care.
Eligibility criteria:
Inclusion Criteria:

ESRD requiring chronic outpatient hemodialysis
Able to provide written consent
Defects in smell identification and/or smell threshold detection as measured by "Scratch-and-sniff" University of Pennsylvania Smell Identification Test (UPSIT) and Smell Threshold Test

Exclusion Criteria:

Prior allergic reaction to theophylline
Patients currently treated with theophylline for clinical indication
Pregnancy or lactation
ESRD patients on peritoneal dialysis
Patients hospitalized at the time of study enrollment
Intervention: Bupivacaine
Trial phase: Phase 3
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: 84
Group description: Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle.

Liposomal Bupivacaine with Bupivacaine: Pain medications injected locally during surgery around affected ankle.
Eligibility criteria:
Inclusion Criteria:

Patients at least 18 years old.
Male or Female
All racial and ethnic groups
Fractures and fracture/dislocations of the ankle
Patients who opt for surgical treatment of their fractures.
Patients who consent to be randomized.
Patients who are willing to follow-up for a minimum of 52 weeks.

Exclusion Criteria:

Patients younger than 18 years old
Patients who are on chronic opioids
Patients who abuse opioids
Patients who are unwilling to follow-up for a minimum of 52 weeks
Neurologic condition that could interfere with pain sensation
Intervention: Ataciguat
Trial phase: Phase 2
SMILES: O=C(Nc1ccc(S(=O)(=O)N2CCOCC2)cc1)c1cc(Cl)ccc1NS(=O)(=O)c1ccc(Cl)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: 200mg taken daily for 6 months

Ataciguat (HMR1766)
Eligibility criteria:
Inclusion Criteria

Age > 50 years
Male or female sex
Aortic valve area greater than 1.0 cm2 but less than 2.0 cm2
Aortic valve calcium levels greater than 300 AU from chest CT
Ejection fraction >50%

Exclusion Criteria

Orthostatic intolerance or symptomatic hypotension prior to study or during study visits
Positive pregnancy test during screening visit
Nitrate use or α-antagonist medication use within 24 hours
Systolic blood pressure <110 mm Hg
Mean systemic arterial pressure <75 mm Hg
Severe mitral or aortic regurgitation
Retinal or optic nerve problems
Recent (≤30 days) acute coronary syndrome
Oxygen saturation <90% on room air
Congenital valve disease
Hepatic dysfunction/elevated liver enzymes
Prescription of drugs known to alter NO-sGC-cGMP signaling (sildenafil, nitrates, etc.)
Prescription of Warfarin (Coumadin) for chronic anticoagulation
Concomitant participation in other trials at Mayo Clinic or elsewhere
Use of phenytoin or related compounds for any indication
Chronic midazolam treatment for any indication
Use of monoamine oxidase inhibitors for any indication
Use of anti-diabetic drugs in the sulfonylurea family
Intervention: Lubiprostone
Trial phase: Phase 3
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: No
Participants at risk: 229
Group description: Lubiprostone (24 mcg capsule bid)
Eligibility criteria:
Inclusion Criteria:

Male or female subjects at least 18 years of age
Constipated, defined by the following adapted ROME II definition:

A. Fewer than 3 spontaneous defecations per week and at least one of the following symptoms for at least 12 weeks (which need not be consecutive) in the preceding 12 months:

Straining during > 25% of defecations
Lumpy or hard stools in > 25% of defecations
Sensation of incomplete evacuation for > 25% of defecations

B. Loose stools are rarely present without the use of laxatives

C. There are insufficient criteria for IBS - loose (mushy) or watery stool in the absence of laxative use for more than 25% of bowel movements

Criteria A, B and C must be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.

Otherwise in good health, as determined by physical exam and medical history
If female, and of child-bearing potential, is using an acceptable form of birth control
Negative urine pregnancy test at screening, if applicable
In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
Subjects who have had major surgery 30 days before Visit 1; appendectomy or cholecystectomy 60 days before Visit 1; abdominal, pelvic, or retroperitoneal surgery 6 months before Visit 1; bariatric surgery or surgery to remove a segment of the GI tract at any time before Visit 1
Subjects with hypothyroidism that is being treated and for which the dose of thyroid hormone has not been stable for at least 6 weeks at the time of Visit 1
Subjects taking laxatives, enemas or prokinetic agents that refuse to discontinue these treatments from Visit 1 until after completion of Visit 5
Subjects who are pregnant or lactating, or intend to become pregnant during the study
Subjects of childbearing potential who refuse a pregnancy test
Subjects who are allergic to any study medication component
Subjects taking narcotic analgesics or other medications known to cause constipation
Subjects with clinically significant cardiac abnormalities identified at the Visit 1 ECG
Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
Subjects with an active history of drug or alcohol abuse
Subjects have been hospitalized for a psychiatric condition or have made a suicide attempt during the 2 years before Visit 1
Subjects who withdraw consent at any time prior to completion of Visit 1 procedures
Subjects with known or suspected moderate to severe hepatic insufficiency (Child Pugh Classes B and C)
Intervention: Betamethasone
Trial phase: Phase 2
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: All subjects exposed to Dexamethasone ophthalmic solution
Eligibility criteria:
Inclusion Criteria:

Provide written informed consent.
Diagnosis of non-infectious AAU in at least 1 eye.
Anterior chamber cell score of 2+ or 3+ as per Standardization of Uveitis Nomenclature (SUN) in at least one eye.
Able to communicate well with the Investigator, to understand and comply with the requirements of the study.
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

Women of child-bearing potential unwilling to use effective contraception methods as defined in the protocol.
AC cell score of 4+ (SUN) or hypopyon.
Onset of anterior uveitis more than 2 weeks prior to enrollment in the study.
Presence of intermediate-, posterior-, or panuveitis in either eye.
Administration of stable doses >10 mg daily systemic prednisone or corticosteroids as described in the protocol.
Recurrent corneal abrasion or ulceration in either eye (past or present).
Tuberculosis (past or present).
Other protocol-specified exclusion criteria may apply.