anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sirolimus
Trial phase: Phase 2
ATC code: L01EG04 | L04AA10 | S01XA23
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: 0.1% Rapamycin cream

Rapamycin: Study cream is applied nightly to the affected areas on the face. Low Dose
Eligibility criteria:
Inclusion Criteria:

Subjects must be willing and able to comply with all trial requirements.
Subject has a diagnosis of TSC and has visible facial angiofibromas.
Female subjects of child bearing potential must not be pregnant and must agree to use appropriate contraceptive methods .

Exclusion Criteria:

Subject is currently receiving therapy with Rapamycin.
Subject is receiving any form of immunosuppression or has previously experienced immune dysfunction.
Subject is currently participating in or has participated within the last 30 days in a clinical trial involving an investigational drug.
Subject has a known hypersensitivity to either the vehicle or Rapamycin.
Subject is a pregnant or nursing female.
Subject has other dermatologic conditions that would preclude or prevent adequate assessment of changes to their facial angiofibromas.
Subject has had laser surgery, cryotherapy, or other dermatologic treatment to their facial angiofibromas within the previous 6 months.
Intervention: Sirolimus
Trial phase: Phase 2
ATC code: L01EG04 | L04AA10 | S01XA23
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 57
Group description: 1% Rapamycin cream

Rapamycin: Study cream is applied nightly to the affected areas on the face. High Dose
Eligibility criteria:
Inclusion Criteria:

Subjects must be willing and able to comply with all trial requirements.
Subject has a diagnosis of TSC and has visible facial angiofibromas.
Female subjects of child bearing potential must not be pregnant and must agree to use appropriate contraceptive methods .

Exclusion Criteria:

Subject is currently receiving therapy with Rapamycin.
Subject is receiving any form of immunosuppression or has previously experienced immune dysfunction.
Subject is currently participating in or has participated within the last 30 days in a clinical trial involving an investigational drug.
Subject has a known hypersensitivity to either the vehicle or Rapamycin.
Subject is a pregnant or nursing female.
Subject has other dermatologic conditions that would preclude or prevent adequate assessment of changes to their facial angiofibromas.
Subject has had laser surgery, cryotherapy, or other dermatologic treatment to their facial angiofibromas within the previous 6 months.
Intervention: Acetaminophen
Trial phase: Not Applicable
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.

Acetaminophen: Intravenous Acetaminophen 1,000 mg IV
Eligibility criteria:
Inclusion Criteria:

Morbidly Obese and body mass index (BMI) of 35
Between ages 20-17
Candidates for Laparoscopic Bariatric Surgery

Exclusion Criteria:

know hypersensitivity to acetaminophen or opioids
impairment in liver function
renal dysfunction
mental retardation
Intervention: Nacom
Trial phase: Not Applicable
SMILES: CC(Cc1ccc(O)c(O)c1)(NN)C(=O)O.NC(Cc1ccc(O)c(O)c1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
Eligibility criteria:
Inclusion Criteria:

Idiopathic Parkinson's Disease (PD)
Older than 30 years of age at the time of diagnosis
Hoehn and Yahr stage greater than or equal to 2.5
PD duration greater than 3 years
Stable regimen of PD medications for at least 2 weeks prior to imaging
PD medications include carbidopa-levodopa

Exclusion Criteria:

Patients with a diagnosis of other neurodegenerative conditions
Patients unwilling or unable to give informed consent
Contraindications (cardiac pacemaker, etc.) or inability (e.g., claustrophobia) to undergo MRI scan
Intervention: Naloxone
Trial phase: Not Applicable
ATC code: A06AH04 | N02AA53 | N02AA55 | N02AX51 | V03AB15
SMILES: C=CCN1CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 84
Group description: Naloxone: Naloxone infusion 0.5 mcg/kg/hr
Eligibility criteria:
Inclusion Criteria:

Idiopathic scoliosis requiring spine fusion surgery
Age 10-21 years

Exclusion Criteria:

Inability to understand PCA instructions
Allergy to: morphine, hydromorphone, fentanyl, naloxone, or diphenhydramine
Chronic opioid therapy > 2 months
Non-English speaking
Intervention: Naloxone
Trial phase: Not Applicable
ATC code: A06AH04 | N02AA53 | N02AA55 | N02AX51 | V03AB15
SMILES: C=CCN1CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 84
Group description: Naloxone infusion 2.5 mcg/kg/hr

Naloxone: Naloxone infusion 2.5 mcg/kg/hr
Eligibility criteria:
Inclusion Criteria:

Idiopathic scoliosis requiring spine fusion surgery
Age 10-21 years

Exclusion Criteria:

Inability to understand PCA instructions
Allergy to: morphine, hydromorphone, fentanyl, naloxone, or diphenhydramine
Chronic opioid therapy > 2 months
Non-English speaking
Intervention: Perflutren
Trial phase: Phase 4
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 1
Group description: Albumin (Human) 25% solution for intravenous (IV) infusion in the dosage strength of 250g/L human albumin, supplied in 50 mL type II vial (each vial containing 12.5g human albumin).

The dose will be 0.5 to 1g/kg body weight (2 to 4 mL/kg of 25% albumin). The duration of treatment is based on the subject's response to treatment until hemodynamic stability is achieved. If hemodynamic stability is not achieved within 72 hours of starting the study treatment, the subject will be withdrawn from the study and will be treated according to standard practice and data collected during the study period will be used for the safety evaluation.

Kedbumin 25%: Albumin (Human) 25% solution for intravenous (IV) infusion in the dosage strength of 250g human albumin /L, supplied in 50 mL type II vial (each vial containing 12.5g human albumin).

The dose will be 0.5 to 1g/kg body weight (2 to 4 mL/kg of 25% albumin).
Eligibility criteria:
Inclusion Criteria:

Male or female aged 0 days to 12 years, inclusive:

(0 to 28 days);
(29 days to 23 months);
(2 to 5 years 11 months);
(6 to 12 years).
Subjects undergoing elective cardiac, abdominal, orthopedic, or transplant surgery.
Subjects with a clinical diagnosis of hypovolemia developed within 24 hours from the completion of surgery, as judged by the Investigator.
Admitted to ICU or acute care floor for post-operative recovery and care, in relatively stable condition.
Subject, parent or guardian agrees to comply with the requirements of the protocol.
Subject, parent or guardian has signed an informed consent form (ICF) and a child assent form if appropriate.
Subject, parent or guardian has signed the Health Insurance Portability and Accountability Act (HIPAA) authorization.

Exclusion Criteria:

Intra-operative blood loss > 50 mL/kg.
Severe hypoalbuminemia with serum albumin levels < 1g/dL.
Known intolerance or allergy to albumin and/or plasma proteins.
Preterm neonates, defined as neonates with a gestational age of <37 weeks (this criteria would only affect the 0-28 days group).
Burn and trauma patients.
Renal surgery.
Subjects with acute CNS injury or trauma would be excluded from the study.
Chronic renal insufficiency or acute renal failure (creatinine > 1.5 of normal value or based on age-appropriate renal function parameters), or a history of renal transplantation.
Subjects with hypernatremia, defined as a Na level of ≥ 155 mEq/L.
Severe congestive heart failure (CHF) using one of the following classification systems: Ross Heart Failure Classification, modified Ross Heart Failure Classification, or New York University Pediatric Heart Failure Index (NYU PHFI).
Any concurrent medical, surgical or psychiatric condition that may, in the Investigator's opinion, affect the subject's ability to meet the protocol requirements.
Subject has participated in another interventional clinical study within 30 days prior to study enrollment. Subjects who are participating in another observational study are not excluded.
Intervention: Fingolimod
Trial phase: Phase 4
ATC code: L04AA27
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 230
Group description: Participants received 0.5 mg orally once a day.
Eligibility criteria:
Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed.
Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria (McDonald et al 2001, Polman et al 2005) (Appendix 2).
Patients who explicitly agree to be assigned to a treatment group that may receive or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
Male or female patients aged 18-70 years.
An Expanded Disability Status Scale (EDSS) score of 0-6 inclusive.
Must have received continuous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to the screening visit. Patients must continue with this MS DMT until the randomization visit.
Naïve to treatment with fingolimod.

Exclusion Criteria:

A manifestation of MS other than those defined in the inclusion criteria.
A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.
History of malignancy of any organ system.
Diagnosis of macular edema during Screening Phase.
Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to have positive HIV antibody test.
Patients who have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 2 months prior to baseline.
Patients who have received total lymphoid irradiation or bone marrow transplantation.
History of selected immune system treatments and/or medications.
Any medically unstable condition, as assessed by the investigator.
Selected cardiovascular, or hepatic conditions
Selected abnormal laboratory values.
Patients with any other disease or clinical condition (including neurologic or psychiatric disorders) which may affect patient enrollment into the study and study medication use by the Investigators' opinion.
Participation in any clinical research study evaluating another not approved in Russia investigational drug or therapy within 6 months prior to baseline.
History of hypersensitivity to the study drug or to drugs of similar chemical classes.
Pregnant or nursing (lactating) women.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Methadone
Trial phase: Phase 4
ATC code: N02AC52 | N07BC02
SMILES: CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 164
Group description: Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
Eligibility criteria:
Inclusion Criteria:

All patients presenting for elective cardiac surgery with CPB will be eligible for enrollment.

Exclusion Criteria:

Preoperative renal failure requiring dialysis
Significant hepatic dysfunction (liver function tests > 2 times upper normal limit)
Preoperative ejection fraction < 30%
Pulmonary disease necessitating home oxygen therapy
Preoperative requirement for inotropic agents or intraaortic balloon pump to maintain hemodynamic stability
Allergy to methadone or fentanyl
Preoperative pain, use of preoperative opioids, or recent history of opioid abuse
Intervention: Fentanyl
Trial phase: Phase 4
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 164
Group description: Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
Eligibility criteria:
Inclusion Criteria:

All patients presenting for elective cardiac surgery with CPB will be eligible for enrollment.

Exclusion Criteria:

Preoperative renal failure requiring dialysis
Significant hepatic dysfunction (liver function tests > 2 times upper normal limit)
Preoperative ejection fraction < 30%
Pulmonary disease necessitating home oxygen therapy
Preoperative requirement for inotropic agents or intraaortic balloon pump to maintain hemodynamic stability
Allergy to methadone or fentanyl
Preoperative pain, use of preoperative opioids, or recent history of opioid abuse
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 68
Group description: Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.
Eligibility criteria:
Inclusion Criteria:

(1) subjects who clinically consented to elective sternotomy for coronary artery bypass grafting (CABG), heart valve repair or replacement under general anesthesia, and (2) ages between 18 and 75 years

Exclusion Criteria:

(1) subject refusal, (2) non-English speaking, (3) previous chronic or neuropathic pain, (4) previous chronic use of opioids, (5) history of psychiatric disorder, (6) allergy to acetaminophen, (7) severely impaired liver and kidney function and (8) previous sternotomy
Intervention: Fentanyl
Trial phase: Phase 3
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).

The abscess I&D will be followed according to protocol using topical and local anesthetic.

Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose
Eligibility criteria:
Inclusion Criteria:

Patient is 4 years of age up to their 18th birthday
Patient has a cutaneous abscess for which an I&D is to be performed

Exclusion Criteria:

Patient's parent doesn't speak English or Spanish
Patient has developmental delay or neurological impairment
Patient has altered mental status
Known hypersensitivity to study drugs (fentanyl, morphine sulfate, lidocaine, LMX4®)
The presence of significant blood or mucous in the nares despite blowing nose or suctioning
Severe renal or liver dysfunction, signs of respiratory distress or depression, any respiratory distress, chronic and severe asthma, upper airway obstruction, suspected gastrointestinal obstruction, suspected paralytic ileus
Narcotic analgesia within 4 hours of ED physician evaluation
Need for moderate sedation, deep sedation, or general anesthesia
Need for subspecialty consultation to perform the I&D
Need for I&D of more than 1 skin abscess
Cutaneous abscesses located on the genitals, breasts, face, or neck
Previous enrollment in the study
Patients with chronic pain syndromes (sickle cell disease, cancer, arthritis, inflammatory bowel disease)
Intervention: Amiodarone
Trial phase: Not Applicable
ATC code: C01BD01
SMILES: CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.

Amiodarone: Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.

Cardioversion: Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol.
Eligibility criteria:
Inclusion Criteria:

Subjects who underwent CABG and/or cardiac valve surgery involving cardiopulmonary bypass and develop postoperative atrial fibrillation within 7 days after surgery

Exclusion Criteria:

Subjects who had any form of atrial fibrillation prior to surgery
Subjects who were on antiarrhythmic medications preoperatively, including but not limited to procainamide and amiodarone
Intervention: Methadone
Trial phase: Phase 4
ATC code: N02AC52 | N07BC02
SMILES: CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Methadone 10-60 mg/day divided 2-4 times a day for 6 months
Eligibility criteria:
Inclusion Criteria:

have a well-documented chronic pain disorder due to past back surgery,
have a chronic back pain syndrome,
have evidence of opioid addiction,
prior attempt at abstinence-oriented treatment documented by the referring physician,
be able to understand spoken and written English,
reside in Erie or Niagara counties,
have health insurance or other ability to pay for treatment with the approval from patient's primary physician;
have no prior history of methadone or BUP/NLX maintenance treatment since the last surgery,
not be a member of a vulnerable population, including prisoners

Exclusion Criteria:

homeless, or any patient without a "locator" (no means to participate in the follow-up data collection interviews by phone),
inability to give consent,
those with major co-occurring psychiatric disorders,
EKG showing prolonged QT and/or previous cardiac issues,
are taking a medication that is contraindicated with methadone,
medically unstable,
urine positive for cocaine at initial visit,
pregnant women
Intervention: Acetaminophen
Trial phase: Phase 1
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years
Eligibility criteria:
Inclusion Criteria:

Diagnosed with Parkinsons disease
No levodopa (Sinemet) treatment or prior exposure to levodopa

Exclusion Criteria:

Prior exposure to levodopa
Unable to stand for 1 minute without aid
Sensory deficits on feet
Significant cognitive impairment
Current use of dopamine receptor blocking medications (depakote, lithium, amiodarone, tetrabenazine, metoclopramide, dronabinol)
Current fish oil or lutein supplementation
Allergy to soy
Intervention: Siponimod
Trial phase: Phase 1
ATC code: L04AA42 | L04AE03
SMILES: CCc1cc(/C(C)=N/OCc2ccc(C3CCCCC3)c(C(F)(F)F)c2)ccc1CN1CC(C(=O)O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Treatment with a single oral dose of 0.25 mg BAF312
Eligibility criteria:
Inclusion Criteria:

All subjects:

Male and female Caucasian subjects 18 to 70 years of age
At least 50 kg and body mass index (BMI) within 18-35 kg/m2.
CYP2C9 wild-type (CYP2C9*1 homozygous carriers)

Hepatic impairment:

- Subjects must have either mild, moderate or severe hepatic impairment

Exclusion Criteria:

All subjects

Hepatic impairment due to non-liver disease.
Use of other investigational drugs within certain timelines
Donation or loss of 400 mL or more of blood or plasma within eight (8) weeks prior to initial dosing
History of cardiac rhythm abnormalities or cardiac rhythm abnormalities identified in the 24-h Holter ECG recording including episodes of bradycardia (HR < 50 bpm) during waking hours and/or arrhythmic episodes; subjects with history or presence of ventricular rhythm disturbances (ventricular extra-systoles >100/24h, or higher grade), or supraventricular arrhythmias (other than occasional supraventricular ectopic beats with a maximum of 5 subsequent ectopic beats per event) or subjects with conduction disturbances (higher than AV-block grade 1) or bradycardia or tachycardia.
History of cardiac catheter ablation.
Women of child-bearing potential
History of malignancy of any organ system
Recent and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease)
History or presence of symptomatic postural hypotension or syncope.
Total WBC or lymphocyte counts which falls outside the 1.5-fold local laboratory normal range or platelet count < 30,000/μL at screening or baseline.
Clinically significant infection or recent vaccination with live-attenuated vaccines.
History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.
History or presence of coronary heart disease (stable or unstable), myocardial infarction, myocarditis, cardiomyopathy, heart failure NYHA II - IV.

Hepatic impairment:

History or presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk.
Any surgical or medical condition other than hepatic impairment which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study.
Treatment with certain drugs

Healthy subjects:

History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases.
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, drugs, or which may jeopardize the subject in case of participation in the study.