anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
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: 31
Group description: Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for elective, primary total hip replacement for osteoarthritis
American Society of Anesthesiologists (ASA) Physical Classification I-III
Weight 50 kg or greater
Body mass index 18-40 kg/m2

Exclusion Criteria:

Inability to consent to study
Inability to speak English
Pregnancy
Weight <50 kg
Revision hip replacement or emergency surgery
Contraindications to spinal anesthesia: coagulopathy or bleeding diathesis, local infection, allergy to local anesthetics
Allergies/intolerances/contraindications to any of the multimodal agents: acetaminophen, pregabalin, celecoxib, ketamine, or dexamethasone
Chronic pain from a separate source other than operative hip
Daily opioid equivalent use of 30 mg of morphine or greater at time of consent
History of heart failure
History of drug or alcohol abuse
Rheumatoid arthritis
Uncontrolled anxiety, schizophrenia or other psychiatric disorder that, in the opinion of the investigator, may interfere with the study assessments
Chronic malnutrition, renal or liver impairment
Hypersensitivity to acetaminophen or any of its excipients
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: 29
Group description: Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for elective, primary total hip replacement for osteoarthritis
American Society of Anesthesiologists (ASA) Physical Classification I-III
Weight 50 kg or greater
Body mass index 18-40 kg/m2

Exclusion Criteria:

Inability to consent to study
Inability to speak English
Pregnancy
Weight <50 kg
Revision hip replacement or emergency surgery
Contraindications to spinal anesthesia: coagulopathy or bleeding diathesis, local infection, allergy to local anesthetics
Allergies/intolerances/contraindications to any of the multimodal agents: acetaminophen, pregabalin, celecoxib, ketamine, or dexamethasone
Chronic pain from a separate source other than operative hip
Daily opioid equivalent use of 30 mg of morphine or greater at time of consent
History of heart failure
History of drug or alcohol abuse
Rheumatoid arthritis
Uncontrolled anxiety, schizophrenia or other psychiatric disorder that, in the opinion of the investigator, may interfere with the study assessments
Chronic malnutrition, renal or liver impairment
Hypersensitivity to acetaminophen or any of its excipients
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: Child
Healthy volunteers: No
Participants at risk: 13
Group description: Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours

Methadone: Methadone wean protocol as described in arm description

Adverse events were recorded only for infants of each dyad.
Eligibility criteria:
Inclusion criteria:

Born at University of New Mexico Hospital
Greater than 34 weeks gestation
Primary in-utero drug exposure was opioids other than buprenorphine
Maternal or infant urine drug screen positive for methadone and/or opioids on admission

Exclusion criteria:

Born prior to 34 weeks
Neonatal intensive care unit admission
Serious medical comorbidities
Primary substance exposure in-utero was buprenorphine, or was not opioids
Intervention: Ubiquinol
Trial phase: Phase 3
SMILES: COc1c(O)c(C)c(C/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CCC=C(C)C)c(O)c1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking

Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Eligibility criteria:
Inclusion Criteria:

Male and female Veterans who were deployed in 1990 -1991 Gulf War.
Veterans who currently meet the Kansas Gulf War Study Case Definition for Gulf War Illness.
Veterans who were in good health based on medical history prior to 1990.
Veterans whose severity of illness is moderate to severe, evidenced by scoring less than 30 of 100 on the physical domain of SF36.

Exclusion Criteria:

Veteran has a condition that may interfere with the ability to accurately report symptoms, such as:

severe psychiatric problems
schizophrenia
bipolar disorder
major depression with psychotic or melancholic features
delusional disorders alcohol or drug dependence requiring hospitalization, or regular illegal drug use or other psychiatric condition requiring inpatient stay in the 6 months prior to study entry.
Has dementias of any type
Currently does not have exclusionary conditions that could reasonably be responsible for the symptoms in multi-symptom disorders, as determined by Investigator (based on Reeves et al.2003).
Is pregnant or breastfeeding or plans to become pregnant within the next 6 months.

Medical conditions excluded:

organ failure
defined rheumatologic inflammatory disorders
chronic active infections such as HIV, hepatitis B and C, or transplant
primary sleep disorders

Medications that could potentially impact immune function excluded:

steroids
immune-suppressives
nutraceuticals that are formulated to impact mitochondrial function or oxidative stress
Biologic response modifiers within 3 months of study entry.
Current use of Coumadin (given the vitamin K structural similarity of CoQ10)
Known allergy to CoQ10 and/or inactive ingredients of active and placebo soft gelatin capsules
Willingness to have 12 weeks of washout of current CoQ10, ubiquinol, or ubiquinone supplements will be required between the screening and baseline visits.
Common multivitamin preparations will be allowed if taken without change throughout the protocol.
Intervention: LITHIUM CARBONATE
Trial phase: Phase 4
SMILES: O=C([O-])[O-].[Li+].[Li+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 107
Group description: Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine).

Group (A) Started Lithium (900mg-1500mg)

Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.

First step: Monotherapy with Lithium (900-1500mg) Non responsive patients: 2nd step.

Second step: Randomization for lithium (900mg-1500mg) + valproic acid (1000mg-1500mg) OR lithium (900mg-1500mg) + carbamazepine (600mg-1200mg).

Non responsive patients: 3rd step.

Third step: Crossover lithium (900mg-1500mg) + valproic acid (1000mg-1500mg) X lithium (900mg-1500mg) + carbamazepine (600mg-1200mg).

Non responsive patients: 4th step.

Fourth step: Association with risperidone (1-6mg)

Lithium
Eligibility criteria:
Inclusion Criteria:

ages between 18 and 65;
BD current acute mixed episode;
total capacity to understand and respond to self-applied instruments;
the presence of symptoms in the last 30 days;
abstinence for at least 30 days for drug addicts.

Exclusion Criteria:

presence of Organic Brain Syndrome (OBS);
pregnancy or lactation;
criteria for psychiatric hospitalization.
Intervention: Water
Trial phase: Phase 2
SMILES: O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days.

Water: Delivered as a footbath
Eligibility criteria:
Inclusion Criteria:

Positive clinical findings for moccasin, interdigital or bullous tinea pedis as determined by direct clinical examination
Must have a clinical symptom severity score of at least 20 on a possible 64 point scale
Written informed consent must be obtained from the subject.
Must ≥ 19 years of age, for study sites located in British Columbia. For other locations the subject must be ≥ 18 years of age, unless local laws dictate otherwise.
Must agree to avoid professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit until the conclusion of the trial.
Must agree to take measures to avoid pregnancy during the 31 day study period

Exclusion Criteria:

Has a diagnosis of either psoriasis or eczema, in or immediately around the area under evaluation.
Has a visual diagnosis, by the investigator, of onychomycosis at a level, which in the opinion of the investigator could compromise the integrity of the study.
Use of topical antifungals e.g. (clotrimazole, ketoconazole,miconazole, oxiconazole- (Oxistat®, Glaxo Smith Kline), sulconazole, naftifine (Naftin®, Merz), terconazole, econazole nitrate (Spectazole®, Ortho-McNeil), butoconazole ,Fluconazole, ciclopirox olamine-(Loprox®), tolnaftate, haloprogin), Zeasorb, antibacterials and corticosteroids in the preceding 5 days of screening visit (Day 1) on or immediately around the area under evaluation.
Use of systemic corticosteroids in the preceding 7 days respectively, of screening visit (Day 1)
Use of systemic antifungals in the preceding 7 days of screening visit (Day1) including - (terbinafine - (Lamisil®, Novartis), Itraconazole - (Sporanox®, Janssen), fluconazole- (Diflucan®, Pfizer), ketoconazole, miconazole, griseofulvin (GrisPEG®), butoconazole, terconazole, Potassium iodide)
Has used any investigational drug(s) within 30 days preceding screening visit (Day 1)
Is pregnant or is a nursing mother
Is a woman of child bearing potential who is not using an adequate form of contraception (or abstinence)
Is < 19 years of age, for study sites located in British Columbia. For other locations subject is < 18 years of age, unless local laws dictate otherwise.
Suffers from a condition, which, in the opinion of the medical investigator, would compromise his/her safety and / or the quality of the data. Such conditions may include collagen vascular disease, diabetes mellitus, Cushing's Disease, hematological malignancy, chronic mucocutaneous candidiasis or atopy
Intervention: Vortioxetine
Trial phase: Phase 3
ATC code: N06AX26
SMILES: Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 662
Group description: Participants initiated treatment with vortioxetine 5 mg/day orally for the first 2 days and thereafter they received 10 mg/day vortioxetine. Based on the response and dose-limiting AEs, vortioxetine dose could be up- or down-titrated with 5 mg/day but the maximum dose did not exceed 20 mg/day. The total duration of treatment was 26 weeks.
Eligibility criteria:
Inclusion Criteria:

The participant is a male or female child aged ≥7 and <12 years or adolescent aged ≥12 and ≤18 years in the lead-in study (12709A and 12710A).
The participant must have completed Study 12709A or 12710A (Visit 12, Completion Visit) immediately prior to enrolment into this extension study.
The participant had a primary diagnosis of MDD at entry in study 12709A or 12710A, diagnosed according to DSM-5™.
The participant is indicated for long-term treatment with vortioxetine according to the clinical opinion of the Investigator.
For participants aged ≥7 and ≤17 years at the Baseline visit; the participant is able to understand the Informed Assent Form, and parent(s)/legal representative(s) are able to read and understand the Informed Consent Form.
For participants who turned 18 years during the lead-in study 12710A; the participant has signed the Informed Consent Form.

Exclusion Criteria:

The participant has been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12709A or 12710A.
The participant has an attention-deficit/hyperactivity disorder (ADHD) that requires a pharmacological treatment other than a stimulant medication.

Other protocol-defined inclusion and exclusion criteria may apply
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: Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: No placebo control; Rapamycin 1mg once daily for 8 weeks

Rapamycin: No placebo control in this substudy group
Eligibility criteria:
Inclusion Criteria: age 70-95

participants will be in good health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable.
participants must have adequate cognitive function to be able to give informed consent. This will be established by enrolling participants with CLOX 1 scores of ≥10.

Exclusion Criteria:

unstable ischemic heart disease
clinically significant pulmonary disease
history of immunodeficiency or receiving immunosuppressive therapy
history of a coagulopathy or receiving a medical condition requiring anticoagulation
an estimated glomerular filtration rate of <30ml/min
uncontrolled hypercholesteremia >350mg/dl;
uncontrolled hypertriglyceridemia >500mg/dl
diabetes
history of skin ulcers or poor wound healing
smoking
liver disease
treatment with drugs known to affect cytochrome P450 3A (diltiazem, erythromycin)
Intervention: Perflutren
Trial phase: Phase 4
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: RTMPE with Perflutren Lipid Microsphere (DEFINITY) is a safe and feasible non-invasive technique commonly used to diagnose coronary disease, and offers an attractive alternative for CAV detection.

Perflutren Lipid Microsphere: Definity (injectible suspension ultrasound contrast agent) will be diluted with saline for both Pediatric and Adult subjects. For pediatric subjects under 60kg (kilogram), the dose will be 20 MicroL/kg (MicroLiter/kilogram) diluted to the same concentration used in the adult dosing. Hand Injections will be performed at baseline, Pre-peak, and peak perfusion stages.

RTMPE: Utilizes intravenous administration of biologically-inert microbubbles to assess myocardial perfusion and has demonstrated utility for identifying small vessel coronary artery disease.
Eligibility criteria:
Inclusion:

Cardiac transplant recipients (> or equal to 10 months post transplant)
Clinically followed at Mayo Clinic, Rochester Minnesota

Exclusion:

Standard contraindications to the use of ultrasound contrast and pharmacologic stress
Recent (< 3 months) hospitalization for heart failure, acute coronary syndrome or allograft rejection
Multi-organ transplant Known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts
Hypersensitivity to perflutren
Intervention: Perflutren
Trial phase: Not Applicable
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 85
Group description: Human albumin 5% during surgery.

Human albumin: human albumin 5% during surgery
Eligibility criteria:
Inclusion Criteria:

Age 40 - 85 years old
Scheduled for elective aortic valve replacement with or without coronary artery bypass grafting with or without additional minor surgical procedure.
Written, informed consent for participation in this investigation.

Exclusion Criteria:

Patients with Raynaud's disease or other disease associated with upper extremity vascular insufficiency,
Inability to perform EndoPAT exam (inability to lie still for 15 min, or significant finger deformity),
Patients with renal failure with oliguria or anuria not related to hypovolemia.
Patients receiving dialysis.
Patients with preoperative renal insufficiency (Creatinine > 1.6 mg/dL)
Anticipated deep hypothermic circulatory arrest
Known hypersensitivity or allergy to hydroxyethyl starch or the excipients of hydroxyethyl starch
Clinical conditions with volume overload (e.g., patients in pulmonary edema or congestive heart failure)
Patients with severe hypernatremia or severe hyperchloremia
Patients with intracranial bleeding
Pregnant or breast feeding women
Critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy, (e.g. patients who are hospitalized in the intensive care unit prior to surgery)
Severe liver disease
Pre-existing coagulation or bleeding disorders
Any contraindications to proposed interventions.
Intervention: Spironolactone
Trial phase: Phase 4
ATC code: C03DA01
SMILES: [H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: spironolactone

Spironolactone: spironolactone 25 mg up to 50 mg
Eligibility criteria:
Inclusion Criteria:

liver transplant

Exclusion Criteria:

dual organ transplant
Intervention: Flumazenil
Trial phase: Phase 4
ATC code: V03AB25
SMILES: CCOC(=O)c1ncn2c1CN(C)C(=O)c1cc(F)ccc1-2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: The flumazenil continuous infusion is started at an initial dose of 0.1 mg/hr., and can be titrated up to a maximum of 0.3 mg/hr. Dose titrations may occur every 60 minutes to maintain RASS scores of 0 to +1. The maximum rate is 0.3 mg/hr.

Flumazenil
Eligibility criteria:
Inclusion Criteria:

critically ill adults
RASS score of -3 to 0 after receiving benzodiazepine therapy
CAM-ICU positive
no benzodiazepine therapy within the previous 12 hours

Exclusion Criteria:

contraindications to flumazenil including hypersensitivity
receipt of benzodiazepines for control of potentially life-threatening conditions (e.g., control of intracranial pressure or status epilepticus)
active seizure disorder or on current anti-convulsant therapy for history of seizure disorder. Seizures secondary to alcohol withdrawal will NOT be excluded.
history of traumatic brain injury complicated by seizures
acute episode (within prior 30 days) of severe traumatic brain injury
history of structural lesion (e.g. subarachnoid hemorrhage, cerebrovascular accident, intra-parenchymal hemorrhage) complicated by seizures
acute episode (within prior 14 days) of structural lesion (e.g. subarachnoid hemorrhage, cerebrovascular accident, intra-parenchymal hemorrhage)
brain tumor complicated by seizure
history of anoxic brain injury
third-degree burn with total body surface area (TBSA) burn greater than 20%
chronic benzodiazepine (clonazepam:lorazepam:diazepam approximately 4:8:40 mg per day) for 7 consecutive days with no taper
chronic delirium that is attributable to other causes
anticipated to transfer to lower level of care within 24 hours
admitted for polysubstance overdose as determined by initial drug toxicity screening
recent exposure (prior 7 days) to pro-convulsant medications (identified via medication list, medication reconciliation performed by PI/pharmacy medication reconciliation team, or urine drug screening)
children, incarcerated individuals, and pregnant women
unable to provide consent and the legally authorized representative is unable to provide consent
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: Female
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: Women receiving acetaminophen for primary pain control following vaginal delivery.
Eligibility criteria:
Inclusion Criteria:

vaginal delivery
diagnosis of chronic hypertension, chronic hypertension with superimposed preeclampsia
preeclampsia without severe features
preeclampsia with severe features gestational hypertension without severe range blood pressures
gestational hypertension with severe range blood pressures
singleton pregnancies

Exclusion Criteria:

Cesarean Delivery
no diagnosis of hypertensive disorder
chronic or acute renal disease
allergy to ibuprofen or acetaminophen
lupus
multiple order pregnancies (twins, triplets)
Narcotic addiction/ in treatment for substance abuse/ current prescription drug user/ current use of illegal drugs
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.

Acetaminophen
Eligibility criteria:
Inclusion Criteria:

ability to give informed consent
diagnosis of a "severe" hypertensive disorder of pregnancy:
preeclampsia with severe features
chronic hypertension with superimposed preeclampsia with severe features
HELLP syndrome: hemolysis, elevated liver function tests, low platelets
eclampsia
not yet delivered or less than 6 hours after delivery

Exclusion Criteria:

current incarceration
serum creatinine > 1.0 mg/dL or suspicion of acute kidney injury
AST (aspartate aminotransferase) >200 unit/L
ALT (alanine aminotransferase) > 200 unit/L
known allergy or sensitivity to NSAIDs or acetaminophen
delivery > 6 hours prior to enrollment
chronic kidney disease
chronic liver disease
prior liver transplant
chronic infectious hepatitis
gastritis
gastro-esophageal reflux disease (GERD)
peptic ulcer disease
bleeding disorder
provider feels that participation is not in the best interest of the patient
Intervention: Morphine sulfate pentahydrate
Trial phase: Phase 4
SMILES: CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O.O.O.O.O.O=S(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: ED provider will choose an appropriate dose of intravenous morphine for the patient.

At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.

Intravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine
Eligibility criteria:
Inclusion Criteria:

Subject has severe pain (NRS ≥7)
Subject has anticipated ED stay of ≥1 hour

Exclusion Criteria:

High acuity trauma patients
Patients deemed to critically ill by ED provider
Active psychosis
Pregnancy
History of heart block or bradycardia
Allergy to lidocaine or amide type local anesthetic
History of seizures