anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Esmolol
Trial phase: Phase 2
ATC code: C07AB09
SMILES: COC(=O)CCc1ccc(OCC(O)CNC(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Patients receiving esmolol when intra-operative MAP > 80 mmHg.

Esmolol: Infusion - 0.1mg/kg/min

• Maximum Dose - after 30 minutes, 0.3mg/kg/min
Eligibility criteria:
Inclusion Criteria:

History of CRS with or without nasal polyps
Undergoing FESS for CRS
American Society of Anesthesiologists (ASA) physical status 1 (healthy) or 2 (patient with mild systemic disease).

Exclusion Criteria:

Pregnancy
Asthma
COPD
Bradycardia
Heart failure
End stage renal disease
Cerebrovascular accident
Diabetes mellitus
Preoperative use of NSAIDs, aspirin, or beta-blockers
Body mass index (BMI) greater than 40 kg/m2.
Intervention: Labetalol
Trial phase: Phase 2
ATC code: C07AG01 | C07BG01 | C07CG01
SMILES: CC(CCc1ccccc1)NCC(O)c1ccc(O)c(C(N)=O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Patients receiving labetalol when intra-operative MAP > 80 mmHg

Labetalol: Aliquots of 20mg of Labetol

• Maximum Dose - 300mg total for case
Eligibility criteria:
Inclusion Criteria:

History of CRS with or without nasal polyps
Undergoing FESS for CRS
American Society of Anesthesiologists (ASA) physical status 1 (healthy) or 2 (patient with mild systemic disease).

Exclusion Criteria:

Pregnancy
Asthma
COPD
Bradycardia
Heart failure
End stage renal disease
Cerebrovascular accident
Diabetes mellitus
Preoperative use of NSAIDs, aspirin, or beta-blockers
Body mass index (BMI) greater than 40 kg/m2.
Intervention: Gemcitabine
Trial phase: Phase 2
ATC code: L01BC05
SMILES: Nc1ccn([C@@H]2O[C@H](CO)[C@@H](O)C2(F)F)c(=O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Participants receive gemcitabine IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity

Gemcitabine: Given IV

Nivolumab: Given IV
Eligibility criteria:
Inclusion Criteria:

Patients must have histologically or cytologically confirmed incurable SCLC and have had prior treatment with platinum-based chemotherapy. High-grade neuroendocrine tumors that are suspected to be of bronchopulmonary origin can be enrolled if they have had prior treatment with a SCLC chemotherapy regimen (e.g. platinum plus etoposide).
Patients should not be demonstrating end-organ damage due to rapid progression of disease based on the most recent assessment of the treating physician.
Patients must have radiographically measurable metastatic disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Absolute neutrophil count >= 1,500/mcL.
Platelets >= 100,000/mcL.
Chemotherapy agents are known to be teratogenic, therefore women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document.

Exclusion Criteria:

Patients who have previously received either gemcitabine or an immune checkpoint inhibitor can be enrolled.
Emergent need for palliative radiation.
Patients may not be receiving any other investigational agents for the treatment of nonsmall cell lung cancer.
History of allergic reaction to gemcitabine.
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects with chemotherapy. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy, breastfeeding should be discontinued.
Intervention: Promega
Trial phase: Phase 3
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)O.CCCC=CCC=CCC=CCC=CCC=CCCCC(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Omegaven treatment group
Eligibility criteria:
Inclusion Criteria:

Greater than 14 days old
Has parenteral nutrition associated cholestasis defined as at least 2 consecutive direct bilirubin >2 mg/dL with anatomical or functional short gut (OR >4 mg/dL if intact intestine) obtained at least 1 week apart with a ratio of direct: total bilirubin > 0.4
Patient is parenteral nutrition dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require parenteral nutrition for at least 3 more weeks
Patient has not responded to other therapeutic approaches for parenteral nutrition-associated liver disease such as : cycling of parenteral nutrition, avoiding overfeeding, reduction/removal of copper and manganese from parenteral nutrition, advancement of enteral feeding, and use of Ursodiol
Patient has been on at least 2 weeks of SMOFLIPIDs with no improvement or worsening of direct bilirubin levels
Signed patient informed consent
The patient is expected to have a reasonable possibility of survival
No other known etiology of cholestasis other than parenteral nutrition-associated liver disease at the time of Omegaven® initiation

Exclusion Criteria:

Known causes of cholestasis other than parenteral nutrition-associated liver disease including but not limited to Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 antitrypsin deficiency are present, prior to Omegaven® initiation
Known fish or egg allergy

Any of the contraindications to use of Omegaven®:

Active new infection at the time of initiation of Omegaven®
Hemodynamic instability
Recent use of medications with associated risk of bleeding, including NSAIDs
Active coagulopathy or bleeding
Platelet counts persistently under 30,000 despite transfusions
Unstable hyperglycemia
Impaired lipid metabolism (triglycerides >1000 mg/dL) while on 1 g/kg/day or less of Intralipid
History of severe hemorrhagic disorders (ie. hemophilia, Von Willebrand disease, etc.)
Unstable diabetes mellitus
Collapse and shock
Stroke/ Embolism
Cardiac infarction within the last 3 months
Undefined coma status
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: 104
Group description: Administered utilizing ultrasound guidance by an anesthesiologist. Study patients received 10ml (133 mg) of liposomal bupivacaine mixed with 7.5ml of 0.5% plain bupivacaine and 7.5ml of 0.25% bupivacaine. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.

Liposomal Bupivacaine: Interscalene Nerve Blocks
Eligibility criteria:
Inclusion Criteria

All adult patients (>18 years of age)
Patients undergoing standard or reverse total shoulder arthroplasty for the primary diagnoses of glenohumeral arthritis or cuff tear arthropathy
Cognitively intact with the ability to give informed consent as outlined by our institutional review board.
Patients must be capable of participating in the post-operative electronic survey and / or able to maintain a written diary of events

Exclusion Criteria

Non-elective cases
Infection, tumor, trauma
Weight < 50 kg
Patients with any contraindications to regional anesthesia including allergy or hypersensitivity to amide-type local anesthetics
Patients with allergy to any component of medication regimen e.g. amide- type local anesthetics, oxycodone, hydromorphone, fentanyl
Chronic pain patients with history of chronic opioid use (defined as 20 mg morphine equivalent / day for greater than 30 days pre-operatively
Concurrent painful physical condition that may require analgesic treatment that is not related to the shoulder surgery (chronic peripheral neuropathy, radiculopathy, or other neurologic disorder)
Severe hepatic disease defined by clinical evidence of liver disease with abnormal liver function tests.
Pregnancy
Respiratory disease that contraindicates interscalene nerve block (elevated contralateral hemidiaphragm, contralateral pneumonectomy, or severe COPD with FEV1 < 50% predicted, and 02 dependence)
Intervention: Bupivacaine hydrochloride
Trial phase: Phase 4
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 104
Group description: Peripheral nerve blocks were performed with ultrasound guidance by an anesthesiologist. Standard bupivacaine hydrochloride was utilized. 25 ml of 0.5% bupivacaine for peripheral nerve block was utilized. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.

Bupivacaine Hydrochloride: Interscalene Nerve Blocks
Eligibility criteria:
Inclusion Criteria

All adult patients (>18 years of age)
Patients undergoing standard or reverse total shoulder arthroplasty for the primary diagnoses of glenohumeral arthritis or cuff tear arthropathy
Cognitively intact with the ability to give informed consent as outlined by our institutional review board.
Patients must be capable of participating in the post-operative electronic survey and / or able to maintain a written diary of events

Exclusion Criteria

Non-elective cases
Infection, tumor, trauma
Weight < 50 kg
Patients with any contraindications to regional anesthesia including allergy or hypersensitivity to amide-type local anesthetics
Patients with allergy to any component of medication regimen e.g. amide- type local anesthetics, oxycodone, hydromorphone, fentanyl
Chronic pain patients with history of chronic opioid use (defined as 20 mg morphine equivalent / day for greater than 30 days pre-operatively
Concurrent painful physical condition that may require analgesic treatment that is not related to the shoulder surgery (chronic peripheral neuropathy, radiculopathy, or other neurologic disorder)
Severe hepatic disease defined by clinical evidence of liver disease with abnormal liver function tests.
Pregnancy
Respiratory disease that contraindicates interscalene nerve block (elevated contralateral hemidiaphragm, contralateral pneumonectomy, or severe COPD with FEV1 < 50% predicted, and 02 dependence)
Intervention: Tiopronin
Trial phase: Phase 2
ATC code: G04BX16
SMILES: CC(S)C(=O)NCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Phase 1: No medication, Phase 2: 500mg PO daily x 7 days (total 500mg), Phase 3: 500mg PO BID x 7 days (total 1g), Phase 4: 1g PO BID x 7 days (total 2g)
Eligibility criteria:
Inclusion Criteria:

Patients with a confirmed laboratory diagnosis of cystinuria who meet the following criteria: (1) stone analysis demonstrating cystine as a component, or (2) increased urinary cystine excretion (>250mg/24hrs in adults).
A medical regimen that includes Tiopronin.
Willing to use a medically accepted form of birth control, if female and of child bearing- potential
Ability to reliably urinate in a collection vessel and measure urine volume.
Ability to give informed consent.
Documentation of a stable complete blood count (CBC) and urinalysis (UA) in the six month period prior to the date of enrollment.
Enrollment in Rare Kidney Stone Consortium (RKSC) Protocol 6401 (Cystinuria Registry)

Exclusion Criteria:

Women who are pregnant, breastfeeding, or trying to become pregnant
Patients with renal colic
Patients who are scheduled to undergo a surgical procedure
Inability to give informed consent
Intervention: Betamethasone
Trial phase: Phase 3
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: 73
Group description: OTO-104: Single intratympanic injection of 12 mg dexamethasone
Eligibility criteria:
Inclusion Criteria:

Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
Subject has experienced active vertigo during the lead-in period.
Subject has documented asymmetric sensorineural hearing loss.
Subject agrees to maintain their current treatments for Meniere's disease while on-study.

Exclusion Criteria:

Subject is pregnant or lactating.
Subject has a history of immunodeficiency disease.
Subject has a history of significant middle ear or inner ear surgery, or endolymphatic sac surgery in the affected ear.
Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
Subject has a history of vestibular migraine.
Subject has used an investigational drug or device in the 3 months prior to screening.
Subject has previously been randomized to a clinical study of OTO-104.
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Participants will receive SPG blocks with lidocaine.

Lidocaine: Nasal application using the Sphenocath device- cleared by FDA
Eligibility criteria:
Inclusion Criteria:

Age 18 years or more at time of consent
Current patients in the UCSF Headache Center eligible to receive SPG blocks for migraine and would otherwise receive treatment clinically
Ability to provide consent for the research study

Exclusion Criteria

Pregnant or breast feeding within 4 weeks of enrollment
Inability to communicate with the study team
Patients who cannot read and understand English
Deemed unsuitable for enrollment in study by the investigator
Allergy to local anesthetics or saline
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: 10
Group description: Participants will receive SPG blocks with bupivacaine

Bupivacaine: Nasal application using the Sphenocath device- cleared by FDA
Eligibility criteria:
Inclusion Criteria:

Age 18 years or more at time of consent
Current patients in the UCSF Headache Center eligible to receive SPG blocks for migraine and would otherwise receive treatment clinically
Ability to provide consent for the research study

Exclusion Criteria

Pregnant or breast feeding within 4 weeks of enrollment
Inability to communicate with the study team
Patients who cannot read and understand English
Deemed unsuitable for enrollment in study by the investigator
Allergy to local anesthetics or saline
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: 10
Group description: Participants will receive SPG blocks with ropivacaine

Ropivacaine: Nasal application using the Sphenocath device- cleared by FDA
Eligibility criteria:
Inclusion Criteria:

Age 18 years or more at time of consent
Current patients in the UCSF Headache Center eligible to receive SPG blocks for migraine and would otherwise receive treatment clinically
Ability to provide consent for the research study

Exclusion Criteria

Pregnant or breast feeding within 4 weeks of enrollment
Inability to communicate with the study team
Patients who cannot read and understand English
Deemed unsuitable for enrollment in study by the investigator
Allergy to local anesthetics or saline
Intervention: Raltegravir
Trial phase: Phase 4
ATC code: J05AJ01 | J05AR16 | J05AX08
SMILES: Cc1nnc(C(=O)NC(C)(C)c2nc(C(=O)NCc3ccc(F)cc3)c(O)c(=O)n2C)o1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Participants received a single oral dose of raltegravir 1200 mg (600 mg tablet X 2) in a fasted state on Day 0 and were followed up to 2 weeks
Eligibility criteria:
Inclusion Criteria:

Japanese male in good health
Body mass index (BMI) between 18.5 and 32.0 kg/m^2
Nonsmoker and has not used nicotine-containing products for over 3 months at the time of screening test.

Exclusion Criteria:

History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or neurological (including cerebrovascular stroke and epilepsy) abnormalities or diseases
Significant emotional problem at the time of screening test or suspected to occur during the conduct of the study, or has a history of clinically significant psychiatric disorder within the last 5 years
History of malignancy
History of clinically significant allergies to multiple antigens or severe allergies (e.g., food, drug, and latex [natural rubber] allergies), or has had an anaphylactic reaction or significant intolerability (e.g., systemic allergic reaction) to prescription or non-prescription drugs or food
Positive for hepatitis B virus surface antigen, hepatitis C virus antibodies, syphilis, or HIV antigen or antibody on the screening test
Had surgery or donated or lost blood within 4 weeks prior to the screening test
Participated in another study (clinical trial) within 4 months prior to the screening test
Consumes greater than 3 glasses of alcoholic beverages (definition of 1 glass: 354 mL for beer, 118 mL for wine, 29.5 mL for distilled spirits) per day
Consumes greater than 6 servings (definition of 1 serving: equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day
Regular user of cannabis, any illicit drugs, or has a history of drug or alcohol abuse within 2 years at the time of the screening test. Participants must have a negative predose urine drug screen
Unable to consent to refrain from the consumption of citrus beverages and foods (e.g., grapefruits) beginning 2 weeks prior to administration of the study drug until the end of post-study examination, and the consumption of all fruit beverages and foods for 24 hours predose and after dosing
Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is study site or Sponsor staff directly involved with this study.
Intervention: Rapastinel
Trial phase: Phase 3
SMILES: CC(O)C(N)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(C(N)=O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 230
Group description: Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
Eligibility criteria:
Inclusion Criteria:

Completion of lead-in study
Adequate therapeutic benefit in the lead-in study to justify continuation of treatment with rapastinel in the judgement of the investigator

Exclusion Criteria:

Suicide risk, as determined by meeting any of the following criteria:

A suicide attempt within the past year
Significant risk, as judged by the investigator, based on the psychiatric interview or information collected in the Columbia- Suicide Severity Rating Scale (C-SSRS) at any visit in the lead-in study
Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 score ≥ 5 at any visit during participation in the lead-in study where MADRS was conducted.
At imminent risk of injuring self or others or causing significant damage to property, as judged by the investigator
Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during participation
Females of childbearing potential and male partners of females of childbearing potential, not using a reliable means of contraception
Intervention: Vitamin E
Trial phase: Phase 2
SMILES: Cc1c(C)c2c(c(C)c1O)CC[C@@](C)(CCC[C@H](C)CCC[C@H](C)CCCC(C)C)O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Vitamin E 800 IU/daily for 24 weeks

Vitamin E: Vitamin E 800 IU/daily
Eligibility criteria:
Inclusion Criteria:

males and females ≥18 years with biopsy-proven NASH within 6 months prior to enrollment
histological diagnosis of NASH will be confirmed by an experienced liver pathologist before study entry
HIV infection
stable dose of anti-diabetic agents and ART in the 3 months preceding enrollment and expected by the physician treating diabetes and HIV to remain on stable medications during the study
willingness to participate in the study
ability to understand and give informed consent for participation

Exclusion Criteria:

Presence of other chronic liver diseases (hepatitis B or C, autoimmune hepatitis, cholestatic liver disease, Wilson disease, hemochromatosis, etc.)
average alcohol consumption >3 drinks/day for men or >2 drinks/day for women in the 6 months prior to enrollment.
Alcohol Use Disorder Identification Test (AUDIT) score of ≥8
evidence of cirrhosis on histology or imaging
ongoing use of medications known to cause hepatic steatosis (e.g., corticosteroids, amiodarone, methotrexate, tetracycline, tamoxifen, estrogens at doses greater than those used for birth control, anabolic steroids, or valproic acid)
prior bariatric surgery
severe co-morbidities (e.g., advanced cardiac, renal, pulmonary, or psychiatric illness)
allergy to vitamin E
use of vitamin E or multivitamins containing vitamin E in the three months preceding enrollment
use of drugs with potential effect on NASH such as ursodeoxycholic acid, S-adenosylmethionine (SAM-e), betaine, pentoxifylline, or milk thistle in the three months prior to enrollment.
changing doses of statins (simvastatin, pravastatin, atorvastatin, fluvastatin, lovastatin, rosuvastatin) or fibrates (clofibrate, fenofibrate) in the three months prior enrollment.
illicit substance abuse within the past twelve months
breast feeding, pregnancy, inability or unwillingness to practice contraception for the duration of the study
contraindications for the MRI procedure (e.g., prostheses, severe claustrophobia)
poorly controlled diabetes with A1C >8.5 within in the last six months
use of total parenteral nutrition in the 6 months preceding liver biopsy or enrollment
Intervention: Phenobarbital
Trial phase: Phase 2
ATC code: N03AA02 | N05CB01
SMILES: CCC1(c2ccccc2)C(=O)NC(=O)NC1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Phenobarbital loading dose 20mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital continued throughout the infants hospitalization.

Phenobarbital: Phenobarbital loading dose 20 mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital dose will be adjusted to obtain desired trough of 25 to 30 mcg/mL. Levels will be obtained on Day 6 then weekly thereafter. Phenobarbital will be tapered over 4 weeks upon discharge from the hospital. The standardized taper is based the patient specific dose at the time of discharge.
Eligibility criteria:
Inclusion Criteria:

Infants greater than or equal to 35 weeks gestation age
Admitted to the neonatal intensive care unit
Failed monotherapy with morphine sulfate therapy

Exclusion Criteria:

Neonatal abstinence syndrome due to iatrogenic causes
Unable to take oral medications at any point during their treatment
Infants in the custody of the Department of Child Protective Services with no legal guardian identified at the time of enrollment