anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Emricasan
Trial phase: Phase 2
SMILES: C[C@H](NC(=O)C(=O)Nc1ccccc1C(C)(C)C)C(=O)N[C@@H](CC(=O)O)C(=O)COc1c(F)c(F)cc(F)c1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Dosed twice daily

IDN-6556
Eligibility criteria:
Inclusion Criteria:

Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
Subjects with a clinical, radiological and/or histological diagnosis of cirrhosis
Subjects having not required hospital admission within 4 weeks of screening for a complication of cirrhosis
Subjects with an acute deterioration of liver function

Subjects who meet one of the following criteria:

Subjects with renal failure (defined as creatinine ≥ 2.0 to ≤ 3.4 mg/dL)
Subjects with other single organ failure with i. Renal impairment (defined as an increase in creatinine of > 0.3 mg/dL from either an established prior Baseline level or if applicable, upon admission to hospital if prior level is unavailable; for inclusion, the creatinine level must be raised above normal levels), and/or ii. Hepatic encephalopathy grade I or II
Subjects with two organ failures
If a subject received steroids for alcohol-induced acute liver failure, he/she must be unresponsive to steroid therapy. Responsiveness is based on investigator discretion.
Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to one month after the last dose of study drug

Exclusion Criteria:

Known infection with HIV
Subjects with cirrhosis who develop decompensation at any time in the postoperative period following partial hepatectomy
Subjects with evidence of uncontrolled infection defined as persistent bacterial culture positivity despite adequate antibiotic therapy
Subjects with clinical evidence of disseminated intravascular coagulation
Subjects with chronic and/or pre-existing kidney disease defined as eGFR (estimated glomerular filtration rate) of less than 30 mL/min for 3 months or longer
Subjects who are hypotensive (defined as mean arterial pressure <70 mmHg) or require the use of inotropic support
Subjects with evidence of significant and/or uncontrolled bleeding
Subjects requiring mechanical ventilation
Subjects with active or history of malignancies other than hepatocellular carcinoma (HCC) within Milan criteria or curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for five or more years
Subjects previously exposed to IDN-6556
History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of > 480 milliseconds (msec)
Intervention: Sildenafil
Trial phase: Not Applicable
ATC code: G01AE10 | G04BE03
SMILES: CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: 20 mg of oral sildenafil, single dose at baseline

Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug.
Eligibility criteria:
Inclusion Criteria:

Adult patients over age 18 years of age who are able to consent
Diagnosis of diffuse parenchymal lung disease with concomitant pulmonary hypertension

Exclusion Criteria:

None
Intervention: Salicylhydroxamic Acid
Trial phase: Phase 3
SMILES: O=C(NO)c1ccccc1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 87
Group description: Sham: Simulated single, intratympanic injection:

One sham injection into each ear during surgery.
Eligibility criteria:
Inclusion Criteria includes, but is not limited to:

Subject is a male or female aged 6 months to 17 years, inclusive
Subject has a clinical diagnosis of bilateral middle ear effusion requiring tympanostomy tube placement
Subject's caregiver is willing to comply with the protocol and attend all study visits

Exclusion Criteria includes, but is not limited to:

Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with tympanostomy tube placement
Subject has a history of sensorineural hearing loss
Subject has a history of chronic or recurrent bacterial infections other than otitis media that likely will require treatment with antibiotics during the course of the study
Intervention: Trifluridine
Trial phase: Phase 3
ATC code: L01BC59 | S01AD02
SMILES: O=c1[nH]c(=O)n([C@H]2C[C@H](O)[C@@H](CO)O2)cc1C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 271
Group description: TAS-102: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
Eligibility criteria:
Inclusion Criteria:

Has provided written informed consent
Has adenocarcinoma of the colon or rectum
Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Is able to take medication orally
Has adequate organ function (bone marrow, kidney and liver)
Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
Intervention: Levetiracetam
Trial phase: Phase 3
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 150
Group description: Administer 60 mg/Kg levetiracetam intravenously up to a maximum dose of 4500 mg ( 75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 4500 levetiracetam over 10 minutes.

Levetiracetam
Eligibility criteria:
Inclusion Criteria: Patient witnessed to seize for greater than 5 minute duration prior to treatment with study drug; Patient received adequate dose of benzodiazepines. The last dose of a benzo was administered in the 5-30 minutes prior to study drug administration. The doses may be divided.; continued or recurring seizure in the Emergency Department; Age 2 years or older

Exclusion Criteria:Known pregnancy; Prisoner; Opt-out identification; Treatment with a second line anticonvulsant (FOS, PHT, VPA, LEV, phenobarbital or other agents defined in the MoP) for this episode of SE; Treatment with sedatives with anticonvulsant properties other than benzodiazepines (propofol, etomidate, ketamine or other agents defined in the MoP); Endotracheal intubation; Acute traumatic brain injury; Known metabolic disorder; Known liver disease; Known severe renal impairment; Known allergy or other known contraindication to FOS, PHT, LEV, or VPA; Hypoglycemia < 50 mg/dL; Hyperglycemia > 400 mg/dL; Cardiac arrest and post-anoxic seizures
Intervention: Ornithine phenylacetate
Trial phase: Phase 2
SMILES: NCCCC(N)C(=O)O.O=C(O)Cc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 114
Group description: Participants receive ornithine phenylacetate up to 5 days via continuous IV infusion in addition to SOC
Eligibility criteria:
Inclusion Criteria:

Hospitalized with an acute episode of hepatic encephalopathy as complication of cirrhosis
Elevated venous ammonia

Exclusion Criteria:

Renal failure with serum creatinine > 3 mg/dL or need for dialysis
Molecular Adsorbent Recirculation System utilized
Pregnancy or breastfeeding
Intervention: Diphenhydramine
Trial phase: Phase 4
ATC code: D04AA32 | D04AA33 | R06AA02 | R06AA52
SMILES: CN(C)CCOC(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives
Eligibility criteria:
Inclusion Criteria:

Patients aged 18-64 years undergoing screening, surveillance, diagnostic and therapeutic colonoscopy
Patient on chronic opioids defined as at least 5 mg of morphine or its equivalent at least 3 days per week for more than 3 months

Exclusion Criteria:

Inability to execute informed consent
Allergy to Diphenhydramine, fentanyl or midazolam
Known or suspected pregnancy
Endoscopic procedure without sedation
Patient scheduled to have other endoscopic procedures on the same day
Prior alimentary tract surgery
Severe cardiopulmonary disease (ASA IV)
Monoamine Oxidase Inhibitors (MOI) use within 2 weeks of procedure
Intervention: Dexmedetomidine
Trial phase: Phase 3
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 148
Group description: continuous infusion of 0.4 mcg/kg/hr

Dexmedetomidine
Eligibility criteria:
Inclusion Criteria:

Adult patients ( ≥ 21 years old) scheduled for Thoracic Surgery

Exclusion Criteria:

2nd or 3rd degree heart block as assessed by preoperative EKG
Use of dexmedetomidine within 28 days prior to day of surgery
Use of long acting opioids pre-operatively 28 days prior to day of surgery
Current or past diagnosis of a Major Psychiatric disorder precluding adequate outcome responses such as Schizophrenia, dementia, delirium etc. as recorded in the Pre-Operative Record.
Documentation of congestive heart failure and Ejection fraction < 30% if recorded in the Pre-Operative Record.
Planned use of an epidural for surgery or post-operative pain relief
Contraindication to use of NSAID, Acetaminophen or IV opioids.
Any known hypersensitivity to dexmedetomidine
Pregnant or breastfeeding
Abnormal liver function tests as related to the MSK guidelines for use of IV Acetaminophen

Yes or NO?; Is ALT greater than 2 x Upper Limit of Normal (> 75 U/L)?

Abnormal renal function tests as related to contraindications to use of IV Ketorolac

Yes or No?; Is Serum Creatinine < 1.5 mg/dl?
Intervention: Levetiracetam
Trial phase: Phase 4
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
Eligibility criteria:
Inclusion Criteria:

Adult (≥18 years)
Presence of intracranial aneurysm (without rupture)
Treating surgeon has recommended surgical repair of the aneurysm.

Exclusion Criteria:

History of seizures within last 10 years
History of epilepsy
History of prior stroke
Currently prescribed medication with anti-epileptic activity (keppra,dilantin, tegretol, lamictal, topamax, etc.)
Brain tumor
Pregnant or nursing woman
Known levetiracetam allergy
Intervention: Iron sucrose
Trial phase: Phase 1 | Phase 2
ATC code: B03AB02 | V03AE05
SMILES: O.O.O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Iron infusion: 5 mg/kg of intravenous iron sucrose supplied as Venofer (TM) with a maximum dose of 200mg. Iron sucrose will be diluted to 1 mg of elemental iron in 1 mL of NaCl 0.9% with a maximum volume of 210 mL.
Eligibility criteria:
Inclusion criteria

aged 12-21 years
chronic (>3 months)symptoms of orthostatic intolerance (including but not limited to lightheadedness, syncope, headache, fatigue, weakness, sweating, nausea and palpitations)
symptomatic orthostatic heart rate increase of greater than or equal to 40 beats per minute during a 10 minute 70 degree head up tilt study
presence of non-anemic iron deficiency, defined as serum ferritin level less than or equal to 20 ug/L with normal hemoglobin

Exclusion criteria

orthostatic hypotension within 3 minutes of 70 degree head up tilt
pregnant or lactating females
presence of other organ failure or systemic illness that can affect autonomic function
concurrent medication therapy with anticholinergic, alpha-adrenergic antagonists, beta-adrenergic antagonists unless medication is held for five half-lives prior to study
laboratory evidence of anemia or iron overload
personal history of hematochromatosis or first degree relative with hematochromatosis
known sensitivity to Venofer (TM) or other intravenous iron preparations
Intervention: Fluorescein
Trial phase: Early Phase 1
ATC code: S01JA01 | S01JA51
SMILES: O=C1OC2(c3ccc(O)cc3Oc3cc(O)ccc32)c2ccccc21
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: All research participants will receive fluorescein injection through existing intravenous line during the operative procedure. This will consist of one ampule (5 cc) injected intravenously 5- 10 minutes prior to ligation of the uterine arteries.

Fluorescein
Eligibility criteria:
Inclusion Criteria:

Documented endometrial cancer and scheduled for hysterectomy as part of their treatment.
No known allergy to fluorescein dye
Ability to understand and sign informed consent
18 years of age or older

Exclusion Criteria:

Prior hysterectomy
Known sensitivity to fluorescein dye
Intervention: Cycloserine
Trial phase: Phase 4
ATC code: J04AB01
SMILES: N[C@@H]1CONC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Participants will receive a weekly dose of 50 mg placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits).

Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
Eligibility criteria:
Inclusion Criteria:

Age 18-68
Diagnosis of schizophrenia, schizoaffective disorder, or delusional disorder
Treated with any antipsychotic except clozapine for at least 8 weeks or antipsychotic naive for lifetime
Willing to participate in CBT
Sufficient proficiency in English to complete assessments
Score of at least 3 on the SAPS at two assessments, four weeks apart

Exclusion Criteria:

Current treatment with clozapine
SSRI treatment
Active alcohol or other substance abuse within six weeks
Unstable medical illness
Pregnant or nursing
Anemia
Renal insufficiency
Intervention: Lisinopril
Trial phase: Not Applicable
ATC code: C09AA03 | C09BA03 | C09BB03 | C10BX07
SMILES: NCCCC[C@H](N[C@@H](CCc1ccccc1)C(=O)O)C(=O)N1CCC[C@H]1C(=O)O
Sex: Male
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Lisinopril
Eligibility criteria:
Inclusion Criteria:

Duchenne muscular dystrophy patients of all ages
Null mutation of the dystrophin gene or muscle with <5% dystrophin
Doppler echocardiogram with ejection fraction (EF) <55% within 30 days of enrollment
Ability to cooperate for testing
Glucocorticoid treatment acceptable including daily or weekend administration of prednisone or deflazacort

Exclusion Criteria:

Patients with EF 55% or greater
Patients with EF <40% after washout
Patients taking >5 mg lisinopril, or >25 mg losartan or >5 mg enalapril
Skeletal deformities or pulmonary anatomical variants that preclude consistent measures of Doppler echocardiography
Intervention: Levetiracetam
Trial phase: Phase 2
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 23
Group description: Oral Levetiracetam administered by NG tube.

Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days
Eligibility criteria:
Inclusion Criteria:

Comatose with Blantyre Comas Score ≤ 2
P. falciparum parasitemia via thick blood film or rapid diagnostic test
Active seizure in past 24 hours

Exclusion Criteria:

Serum creatinine > 2mg/dL
Pre-admission/concomitant treatment with antiretroviral medications for HIV (ARVs), antituberculous treatments(ATTs), or chronic use of any other enzyme-inducing medications
Intervention: Thiamine
Trial phase: Phase 2
ATC code: A11DA01
SMILES: Cc1ncc(C[n+]2csc(CCO)c2C)c(N)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: 200mg intravenous thiamine in 50ml 5% dextrose, single dose

Thiamine: 200 mg IV thiamine
Eligibility criteria:
Inclusion Criteria:

Adult patients (age > 18 yrs) admitted to an ICU
Mechanically ventilated for an acute illness, with stable respiratory status (no changes in ventilator settings in the 3 hours prior to enrollment)
Cardiac index >2.4L/min/m2 as measured by Noninvasive Cardiac Output Monitor(NICOM) by Cheetah Medical or, if being used clinically, by PA catheter or Vigileo device.
Upper central venous line in place

Exclusion Criteria:

Unstable ventilator settings during measurement of VO2
Temperature >100.5
FIO2>60%
Endotracheal cuff leak, chest tube, or other evident source of air leak
Positive end expiratory pressure > 12cmH2O
Intravenous thiamine supplementation within 2 weeks of enrollment, or oral supplementation more than that found in a multivitamin.
Protected populations (pregnant woman, prisoners, cognitively impaired)
Intervention: Thiamine
Trial phase: Phase 2
ATC code: A11DA01
SMILES: Cc1ncc(C[n+]2csc(CCO)c2C)c(N)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: 50ml intravenous 5% dextrose, single dose

Thiamine: 200 mg IV thiamine
Eligibility criteria:
Inclusion Criteria:

Adult patients (age > 18 yrs) admitted to an ICU
Mechanically ventilated for an acute illness, with stable respiratory status (no changes in ventilator settings in the 3 hours prior to enrollment)
Cardiac index >2.4L/min/m2 as measured by Noninvasive Cardiac Output Monitor(NICOM) by Cheetah Medical or, if being used clinically, by PA catheter or Vigileo device.
Upper central venous line in place

Exclusion Criteria:

Unstable ventilator settings during measurement of VO2
Temperature >100.5
FIO2>60%
Endotracheal cuff leak, chest tube, or other evident source of air leak
Positive end expiratory pressure > 12cmH2O
Intravenous thiamine supplementation within 2 weeks of enrollment, or oral supplementation more than that found in a multivitamin.
Protected populations (pregnant woman, prisoners, cognitively impaired)
Intervention: Travoprost
Trial phase: Phase 4
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of normal tension glaucoma.
Must sign an Informed Consent form.
IOP within protocol-specified range.
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

Pregnant and lactating women, or women who intend to become pregnant during the study period.
Advanced and serious glaucoma, as specified in protocol.
Complicated chronic or recurrent uveitis, scleritis or corneal herpes.
History of ocular trauma, intraocular surgery or laser surgery for the included eye.
Ocular-infection and severe ocular complication.
Best-corrected visual acuity (BCVA) worse than 0.2 decimal.
Difficulty in conducting applanation tonometry for the included eye as determined by the doctor.
Severe or serious hypersensitivity to prostaglandin analogues or any ingredients used in the study.
Use of IOP lowering ophthalmic solutions other than TRAVATAN Z® or oral carbonic anhydrase inhibitor (Diamox, etc.) during the study period.
Use of any adrenocorticosteroids during the study period.
Use of IOP lowering ophthalmic solution within the past 30 days.
Regarded by doctor as not suitable for study participation.
Other protocol-specified exclusion criteria may apply.
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 394
Group description: Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.

Dexmedetomidine: Dexmedetomidine
Eligibility criteria:
Inclusion Criteria:

18-85 years old;
Scheduled for cardiac surgery with bypass (CABG, valve, or combined);
Able to provide a written informed consent;
Hemodynamically stable (heart rate>= 55).

Exclusion Criteria:

Sick sinus syndrome or Wolff-Parkinson-White syndrome
Atrio-ventricular block
Hypersensitivity or known allergy to dexmedetomidine
Hepatic disease, e.g. twice the normal level of liver enzymes
Atrial fibrillation within 1 preoperative month;
Permanent pacemaker;
Use of amiodarone or dexmedetomidine within the last 30 days;
Patients with an ejection fraction under 30% or who had severe heart failure
Myocardial infarction in the previ¬ous 7 days;
Body mass index =< 40 (BMI= mass (kg) / height (m)2);
Those taking clonidine within last 48 hours.
Intervention: Misoprostol
Trial phase: Phase 3
ATC code: A02BB01 | G02AD06 | M01AE56
SMILES: CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 151
Group description: 800 micrograms of vaginal misoprostol alone

Misoprostol
Eligibility criteria:
Inclusion Criteria:

between 5 and 12 completed weeks gestation
18 years or older
hemodynamically stable
confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation (ultrasound examination demonstrates a fetal pole without cardiac activity measuring between 5.3 and 40 mm or an abnormal growth pattern diagnostic of early pregnancy failure)
willing and able to give informed consent

Exclusion Criteria:

diagnosis of incomplete or inevitable abortion (absent gestational sac and/or active bleeding, open cervical os)
contraindication to mifepristone (chronic corticosteroid administration, adrenal disease)
contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, or known allergy to prostaglandin)
cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure)
most recent hemoglobin <9.5 g/dL
diagnosis of porphyria
known clotting defect or receiving anticoagulants
pregnancy with an intrauterine device (IUD) in place
breastfeeding during the first 7 days of study participation
unwilling to comply with the study protocol and visit schedule
any evidence of viable pregnancy
possibility of ectopic pregnancy
known or suspected pelvic infection
concurrent participation in any other interventional trial