anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: 1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.

Sham treatment: preservative-free normal saline
Eligibility criteria:
Inclusion Criteria:

Member of the Army on active duty status
Personal access to Internet
Anticipated stable assignment to installation for at least 2 months
Stable dosing for ≥3 months, if receiving psychotropic medications
Prior to enrollment, offered PTSD treatment using A-level modality (as defined by U.S. Army Medical Command (MEDCOM) policy 14-094; 18 Dec 2014).
PTSD Checklist - Civilian (PCL-C) score of 32 or greater at screening
Acceptable clinically indicated preoperative laboratory studies, per standard site-specific protocols

Exclusion Criteria:

Prior Stellate Ganglion Block (SGB)
Allergy to amide local anesthetics (e.g., ropivacaine, bupivacaine)
Pregnancy (evaluated by urine test pre-procedure)
Current anticoagulant use
History of a bleeding disorder
Infection or mass at injection site
Myocardial infarction within 6 months of procedure
Phrenic or laryngeal nerve palsy (hoarseness)
History of glaucoma
History of schizophrenia, other psychotic disorder, bipolar disorder, or personality disorder (axis 2)
Moderate or severe traumatic brain injury
Symptoms of moderate to severe substance use disorder in past 30 days
Suicidal ideation in the past 2 months, documented by the M.I.N.I.-Plus Suicidality Items
Any ongoing other major life stressor or condition not listed here that the site Investigator believes clearly would place the participant at risk for injury or a poor outcome
Intervention: Dexmedetomidine Hydrochloride
Trial phase: Phase 4
SMILES: Cc1cccc(C(C)c2cnc[nH]2)c1C.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Dexmedetomidine Hydrochloride: 30 patients received a loading dose of 1 μg/kg dexmedetomidine (Precedex; Hospira, Precedex 200 mcg/2 ml, Hospira. Inc, Lake Forest, USA) diluted in 100 ml 0.9% saline infused over 10 min immediately postoperative, followed by continuous infusion of 0.2- 0.7 μg/kg/h
Eligibility criteria:
Inclusion Criteria:

elective cardiac surgery under general anesthesia
at least 60 yr old
ASA physical status I and II
70-100 kg body weight
height 160-180 cm.

Exclusion Criteria:

Patients with impaired kidney or liver functions
history of cardiac or central nervous system disease
uncontrolled medical disease (diabetes mellitus and hypertension)
coagulation defect
history of drug or alcohol abuse
history of chronic pain or daily intake of analgesics
history of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h before surgery
allergy to the used medications
or patient's refusal
Intervention: Nitric Oxide
Trial phase: Phase 2
ATC code: R07AX01
SMILES: [N]=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: 20 ppm iNO delivered via mechanical ventilator connected to the iNO ventilator delivery system (iNOvent). Drug will be started as soon as possible after return of spontaneous circulation (ROSC) but no later than 4h after ROSC. Study drug will be dosed for 12h then tapered off over 1h.

Nitric Oxide: An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
Eligibility criteria:
Inclusion Criteria:

Intubated and comatose adult (>18 yo) resuscitated from out-of-hospital cardiac arrest (OHCA)*

*Cardiac arrest within an emergency department or outpatient medical center will be included). OHCA includes Emergency Medical Service (EMS) witnessed cardiac arrest.

Return of spontaneous circulation (ROSC) within 40 min of CPR initiation
Full Outline of Unresponsiveness (FOUR) Brainstem score ≥ 2 (i.e. patient must have pupil OR corneal reflex at the time of ED presentation or within 1h if sedation/neuromuscular blockade clouds the picture)

Exclusion Criteria:

Traumatic etiology of OHCA
Prisoner
Known pregnancy (beta-human chorionic gonadotropin screening is NOT REQUIRED for enrollment in women of appropriate age)
Hemodynamic instability defined as >1 recurrent arrest prior to enrollment OR inability to maintain mean arterial blood pressure (MAP) > 65 using vasopressors and inotropes (ie actively up titrating medications or giving fluid bolus)
Head CT grey-white ratio < 1.2; Head CT is NOT REQUIRED prior to enrollment
Fixed and dilated pupils without another explanation
Known intracranial hemorrhage or acute cerebral infarction; Head CT is NOT REQUIRED prior to enrollment
Malignant EEG upon presentation defined as: myoclonic status epilepticus, non-convulsive status epilepticus, generalized periodic epileptiform discharges. EEG screening is NOT REQUIRED prior to enrollment
ROSC >3h from time of ED arrival (treatment allocation must be within 4h so anything that will prevent this is reason for exclusion)
Alert and interactive patient with minimal evidence of neurologic injury
Plan to extubate within 12 hours

Post-cardiac arrest service (PCAS) physician opinion that patient will die with >95% likelihood. This may be based on:

Multiple medical comorbidities
Late discovery of don not resuscitate (DNR) or advanced directive
Terminal diagnosis (other than OHCA; may have caused OHCA)
Clinical judgement based on current exam and data
Patient is known to be taking phosphodiesterase type 5 (PDE5) inhibitors, soluble guanylyl cyclase (sGC) stimulator, or has a known diagnosis of Chronic thromboembolic pulmonary hypertension (CTEPH), pulmonary hypertension (PAH), or erectile dysfunction
Known enrollment in another acute interventional study.
Intervention: Nitrogen
Trial phase: Phase 2
ATC code: V03AN04
SMILES: N#N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Nitrogen carrier gas delivered by identical system with similar dose/taper.

Nitrogen: Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
Eligibility criteria:
Inclusion Criteria:

Intubated and comatose adult (>18 yo) resuscitated from out-of-hospital cardiac arrest (OHCA)*

*Cardiac arrest within an emergency department or outpatient medical center will be included). OHCA includes Emergency Medical Service (EMS) witnessed cardiac arrest.

Return of spontaneous circulation (ROSC) within 40 min of CPR initiation
Full Outline of Unresponsiveness (FOUR) Brainstem score ≥ 2 (i.e. patient must have pupil OR corneal reflex at the time of ED presentation or within 1h if sedation/neuromuscular blockade clouds the picture)

Exclusion Criteria:

Traumatic etiology of OHCA
Prisoner
Known pregnancy (beta-human chorionic gonadotropin screening is NOT REQUIRED for enrollment in women of appropriate age)
Hemodynamic instability defined as >1 recurrent arrest prior to enrollment OR inability to maintain mean arterial blood pressure (MAP) > 65 using vasopressors and inotropes (ie actively up titrating medications or giving fluid bolus)
Head CT grey-white ratio < 1.2; Head CT is NOT REQUIRED prior to enrollment
Fixed and dilated pupils without another explanation
Known intracranial hemorrhage or acute cerebral infarction; Head CT is NOT REQUIRED prior to enrollment
Malignant EEG upon presentation defined as: myoclonic status epilepticus, non-convulsive status epilepticus, generalized periodic epileptiform discharges. EEG screening is NOT REQUIRED prior to enrollment
ROSC >3h from time of ED arrival (treatment allocation must be within 4h so anything that will prevent this is reason for exclusion)
Alert and interactive patient with minimal evidence of neurologic injury
Plan to extubate within 12 hours

Post-cardiac arrest service (PCAS) physician opinion that patient will die with >95% likelihood. This may be based on:

Multiple medical comorbidities
Late discovery of don not resuscitate (DNR) or advanced directive
Terminal diagnosis (other than OHCA; may have caused OHCA)
Clinical judgement based on current exam and data
Patient is known to be taking phosphodiesterase type 5 (PDE5) inhibitors, soluble guanylyl cyclase (sGC) stimulator, or has a known diagnosis of Chronic thromboembolic pulmonary hypertension (CTEPH), pulmonary hypertension (PAH), or erectile dysfunction
Known enrollment in another acute interventional study.
Intervention: Leucine
Trial phase: Phase 2
SMILES: CC(C)CC(N)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 4
Group description: AE was reported with a start date within the two week period subject was taking 4 gm L-leucine by mouth twice daily
Eligibility criteria:
Inclusion Criteria:

Current primary diagnosis of nonpsychotic major depressive disorder.
Stable antidepressant dose of no more than one antidepressant medication for 4 weeks and no anticipated changes during the study period.
Stable doses of all concomitant medications for over 6 weeks.
No more than two failed antidepressant trials of adequate dose and duration, as defined by ATRQ, in the current episode.

Exclusion Criteria:

Psychiatric co-morbidity posing safety risk.
Pregnant or breastfeeding or plan to become pregnant over the ensuing 2 months following study entry or are sexually active and not using adequate contraception
Exclusionary psychiatric conditions (such as substance dependence in the last 6 months, substance abuse in the last 2 months, or lifetime history of psychotic disorders.
Unstable or terminal general medical condition (GMC).
Concomitant medications that interact with L-leucine (e.g. sildenafil).
Vagus nerve stimulation, ECT, or rTMS, or other somatic antidepressant treatment during current episode
Inadequately controlled hypothyroidism.
Therapy that is depression specific, such as CBT or Interpersonal Psychotherapy of Depression.
Hypersensitivity to L-leucine
Have Maple Syrup Urine Disease.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 86
Group description: Single injection of Exparel

Exparel: Patients will receive an injection of 30ml of volume to each abdominal side with a total of 60 ml for bilateral TAP blocks.
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for elective colorectal surgery with Dr. Linda Farkas

Exclusion Criteria:

Patients under 18 years of age
Patient over 90 years of age
Pregnancy
Prisoners
Patients unable to provide consent
Patients on systemic anticoagulation therapy
Patients with an allergy to local anesthetics
Intervention: Ropivacaine
Trial phase: Phase 4
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 86
Group description: Injection of Ropivicaine (Naropin) bolus and placement of Ropivicaine catheters

Ropivacaine: Patients will receive 30ml of ropivicaine. Peripheral nerve catheters will be placed approximately 3-5cm into the TAP space and secured to the skin with tegaderm tape. Infusions will be ordered with CADD pumps and will be initiated at a rate of 8ml/hr of 0.2% ropivicaine on the inpatient floor.
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for elective colorectal surgery with Dr. Linda Farkas

Exclusion Criteria:

Patients under 18 years of age
Patient over 90 years of age
Pregnancy
Prisoners
Patients unable to provide consent
Patients on systemic anticoagulation therapy
Patients with an allergy to local anesthetics
Intervention: Modafinil
Trial phase: Phase 2
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: 12
Group description: 24 weeks of modafinil 50 mg oral daily

modafinil 50mg: 1 capsule oral daily
Eligibility criteria:
Inclusion Criteria:

Diagnosis of idiopathic PD on UK brain bank criteria.
Presence of FOG based on objective assessment by the movement disorders neurologist.
FOG-Q score > 8.
Stable PD therapy (including medications and stimulation) for a period of 3 months prior to trial enrollment.
Age ≥ 50 years.

Exclusion Criteria:

Patients on antidopaminergic medications for a period of less than 1 year from date of enrollment.
Patients who may require adjustment of their PD medications over the 6 month period of the trial.
History of allergic reactions to Modafinil or armodafinil.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, mitral valve prolapse, left ventricular hypertrophy, chronic obstructive pulmonary disease or psychiatric illness/social situations that would limit compliance with study requirements.
Individuals who are pregnant or breastfeeding
Non-english speaking individuals who are unable to complete the questionnaires and other assessments in English and/or follow instructions in English.
Intervention: Relugolix
Trial phase: Phase 3
ATC code: H01CC54 | L02BX04
SMILES: CONC(=O)Nc1ccc(-c2sc3c(c2CN(C)C)c(=O)n(-c2ccc(OC)nn2)c(=O)n3Cc2c(F)cccc2F)cc1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 622
Group description: Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Eligibility criteria:
Key Inclusion Criteria:

Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.

Is a candidate for, in the opinion of the investigator, at least 1 year of continuous androgen deprivation therapy for the management of androgen-sensitive advanced prostate cancer with 1 of the following clinical disease state presentations:

Evidence of biochemical (PSA) or clinical relapse following local primary intervention with curative intent, such as surgery, radiation therapy, cryotherapy, or high-frequency ultrasound and not a candidate for salvage treatment by surgery; or
Newly diagnosed androgen-sensitive metastatic disease; or
Advanced localized disease unlikely to be cured by local primary intervention with either surgery or radiation with curative intent.
Has a serum testosterone at the Screening visit of ≥ 150 ng/dL (5.2 nanomoles [nmol]/liter [L]).
Has a serum PSA concentration at the Screening visit of > 2.0 ng/milliliter (mL) (2.0 microgram [μg]/L), or, when applicable, post radical prostatectomy of > 0.2 ng/mL (0.2 μg/L) or post radiotherapy, cryotherapy, or high frequency ultrasound > 2.0 ng/mL (2.0 μg/L) above the post interventional nadir.
Has an Eastern Cooperative Oncology Group performance status of 0 or 1 at initial screening and at baseline.

Key Exclusion Criteria:

In the investigator's opinion, is likely to require chemotherapy or surgical therapy for symptomatic disease management within 2 months of initiating androgen deprivation therapy.
Previously received gonadotropin-releasing hormone analog or other form of androgen deprivation therapy (estrogen or antiandrogen) for > 18 months total duration. If androgen deprivation therapy was received for ≤ 18 months total duration, then that therapy must have been completed at least 3 months prior to baseline. If the dosing interval of the depot is longer than 3 months, then the prior androgen deprivation therapy must have been completed at least as long as the dosing interval of the depot.
Previous systemic cytotoxic treatment for prostate cancer (for example, taxane-based regimen).
Metastases to brain per prior clinical evaluation.
Participants with myocardial infarction, unstable symptomatic ischemic heart disease, cerebrovascular events, or any significant cardiac condition within the prior 6 months.
Active conduction system abnormalities.
Uncontrolled hypertension.
Intervention: Leuprolide
Trial phase: Phase 3
ATC code: L02AE02 | L02AE51
SMILES: CCNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC(C)C)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1c[nH]cn1)NC(=O)[C@@H]1CCC(=O)N1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 308
Group description: Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan, and Taiwan), every 3 months by subcutaneous injection.
Eligibility criteria:
Key Inclusion Criteria:

Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.

Is a candidate for, in the opinion of the investigator, at least 1 year of continuous androgen deprivation therapy for the management of androgen-sensitive advanced prostate cancer with 1 of the following clinical disease state presentations:

Evidence of biochemical (PSA) or clinical relapse following local primary intervention with curative intent, such as surgery, radiation therapy, cryotherapy, or high-frequency ultrasound and not a candidate for salvage treatment by surgery; or
Newly diagnosed androgen-sensitive metastatic disease; or
Advanced localized disease unlikely to be cured by local primary intervention with either surgery or radiation with curative intent.
Has a serum testosterone at the Screening visit of ≥ 150 ng/dL (5.2 nanomoles [nmol]/liter [L]).
Has a serum PSA concentration at the Screening visit of > 2.0 ng/milliliter (mL) (2.0 microgram [μg]/L), or, when applicable, post radical prostatectomy of > 0.2 ng/mL (0.2 μg/L) or post radiotherapy, cryotherapy, or high frequency ultrasound > 2.0 ng/mL (2.0 μg/L) above the post interventional nadir.
Has an Eastern Cooperative Oncology Group performance status of 0 or 1 at initial screening and at baseline.

Key Exclusion Criteria:

In the investigator's opinion, is likely to require chemotherapy or surgical therapy for symptomatic disease management within 2 months of initiating androgen deprivation therapy.
Previously received gonadotropin-releasing hormone analog or other form of androgen deprivation therapy (estrogen or antiandrogen) for > 18 months total duration. If androgen deprivation therapy was received for ≤ 18 months total duration, then that therapy must have been completed at least 3 months prior to baseline. If the dosing interval of the depot is longer than 3 months, then the prior androgen deprivation therapy must have been completed at least as long as the dosing interval of the depot.
Previous systemic cytotoxic treatment for prostate cancer (for example, taxane-based regimen).
Metastases to brain per prior clinical evaluation.
Participants with myocardial infarction, unstable symptomatic ischemic heart disease, cerebrovascular events, or any significant cardiac condition within the prior 6 months.
Active conduction system abnormalities.
Uncontrolled hypertension.
Intervention: NITROUS OXIDE
Trial phase: Phase 4
ATC code: N01AX13 | N01AX63
SMILES: [N-]=[N+]=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 19
Group description: Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method.

Nitrous Oxide: Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method. Which ever method is used will be recorded. When using the titration method, starting at 20%, nitrous oxide will be added in 10% increments every 60 seconds until the ideal level of sedation has been met (not to exceed 70% nitrous oxide). Using the rapid infusion method, after the proper flow rate has been achieved with oxygen, the flowmeter will be increased to obtain 50% concentration of nitrous oxide. After 2-3 minutes if the patient does not have adequate sedation, nitrous oxide concentration will be increased to 70%.
Eligibility criteria:
Inclusion Criteria:

Patients ≥2 years of age and <18 years of age, and
Parent/legal guardian age ≥18 years of age to <80 years of age
Patients with an American Society of Anesthesiologists (ASA) Physical Status Classification System level 1, 2, and 3

Patients requiring anxiolysis and mild sedation for minor procedures

Minor procedures will include simple lacerations less than 4 cm
Lumbar punctures
Minor incision
Drainage of abscesses that do not require extensive debridement

Must receive the standard of care dosing for either nitrous oxide or intranasal midazolam.

Nitrous oxide up to 70% nitrous concentration will be allowed
Intranasal Midazolam 0.4mg/kg with a max dose of 10mg

Exclusion Criteria:

Nasal injury, nasal obstruction or significant congestion
Laceration that involves the nose and ears or come into contact with the scavenger device or nitrous oxide tubing
Allergy to benzodiazepines
Benzodiazepine dosing for any reason 24 hours prior to procedure
Excessive Epistaxis
Facial or nasal deformity
Copious mucous
Recent (less than 1 week) tympanic membrane graft or middle ear surgery
Recent bleomycin therapy
Patients known to be pregnant at time of enrollment
Patients with severe behavior problems, personality disorders or other mind-altering conditions as determined by administering provider.

Closed space situations such as:

pneumothorax,
air embolus,
pneumocephalus, or
craniotomy in the last 3 weeks,
intraocular surgery with retained gas,
pulmonary bullae,
severe emphysema, or
bowel obstruction.

Patients with significant co-morbidities:

severe pulmonary disease,
cardiac disease,
hematologic diseases associated with B12 deficiency,
sickle cell disease.
Patients with acute otitis media and/or sinusitis
History of paradoxical reaction to nitrous oxide
Known Methicillin-resistant Staphylococcus aureus (MRSA+) patients
Co-administration of additional sedation or analgesic medications