anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lipoic acid
Trial phase: Phase 1 | Phase 2
ATC code: A16AX01
SMILES: O=C(O)CCCCC1CCSS1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
Eligibility criteria:
Inclusion Criteria:

55 years or older
Non-demented: Montreal Cognitive Assessment > 26 and Clinical Dementia Rating = 0
Diagnosis of Essential Hypertension with systolic 90-160 mm Hg and diastolic 60-90 mm Hg
Stable dose of antihypertensive medication 4 month prior to study enrollment
Stable dose of lipid lowering medication - dose must be stable for 4 months prior to study enrollment
Low Omega-3 fatty acid Status: Omega-3 index, < 4% of total fatty acid of combined docosahexaenoic acid and eicosapentanoic acid
Geriatric Depression Scale < 5
General health status that will not interfere with the participant's ability to complete the study.
Screening laboratory values within normal limits or, if abnormal, deemed clinically insignificant by the investigator
Sufficient English language skills to complete all testing

Exclusion Criteria:

Alzheimer's, Dementia or other neurodegenerative disease.
Health conditions such as cancer diagnosed < 5 years prior to enrollment (prostate cancer gleason grade < 3 and non metastatic skin cancers are acceptable), liver disease, history of ventricular fibrillation or ventricular tachycardia, major psychiatric disorder, central nervous system diseases (e.g. brain tumor, seizure disorder)
Insulin dependent diabetes or uncontrolled diabetes (diabetes controlled on medications other than insulin are acceptable)
Fish intake of one 6 ounce serving > once a week less than 4 months prior to enrollment
Omega-3 fatty acid supplement intake (e.g. fish oil capsules, cod liver oil) less than 4 months prior to enrollment
Lipoic Acid supplementation less than 1 month prior to enrollment
Taking systemic corticosteroids, neuroleptics, antiparkinsonian agents, and/or narcotic analgesics. Low dose sinemet and dopamine agonist taken once a day for restless leg syndrome is not an exclusion.
Contraindications to MRI, including: subjects with intrathecal pumps, stimulators, pacemakers, aneurysm clips, non-removable hearing aids, or metal fragments in the eyes. Other exclusion criteria include the inability to lie flat on the back for 40 minutes at a time or a self-reported history of claustrophobia. Subjects with a history of hip replacement and those with well-documented, verifiable, MRI-safe cardiac stents will not be excluded from the study.
Enrollment in another treatment study
Intervention: Vemurafenib
Trial phase: Phase 2
ATC code: G01AE10 | L01EC01 | L01XE15
SMILES: CCCS(=O)(=O)Nc1ccc(F)c(C(=O)c2c[nH]c3ncc(-c4ccc(Cl)cc4)cc23)c1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Vemurafenib 960 mg orally, twice a day
Eligibility criteria:
Inclusion Criteria:

Biopsy proven metastatic melanoma with the B-raf V600E or V600K mutations.
Untreated brain metastases
At least one cerebral metastasis that is not amenable to stereotactic radiosurgery (SRS) or surgical resection based on size or location OR four or more lesions
Patients may be symptomatic at the time of enrollment, but after any necessary local therapy and/or corticosteroids, the patient should be asymptomatic when vemurafenib is initiated.
Age >18
Adequate organ function
ECOG performance status < 3
No prior therapies with selective inhibitors of mutated BRAF; other prior therapies must have been administered at least 4 weeks before administration of vemurafenib
Life expectancy of at least 3 months
Understanding and willingness to consent
The use of corticosteroids to control cerebral edema or treat symptoms will be allowed
A history of whole brain radiotherapy for brain metastases is allowed, but any stable lesion that was present at the time of WBRT will NOT be considered evaluable. A minimum of 1 week break will be required between prior WBRT and initiation of vemurafenib therapy.

Exclusion Criteria:

Presence of leptomeningeal disease based on positive CSF cytology.
History or presence of clinically significant ventricular or atrial dysrhythmias ≥ Grade 2 (NCI CTCAE, v4.0), Corrected QT (QTc) interval >450 ms at baseline or history of congenital long QT syndrome
Uncontrolled medical illness, such as uncontrolled infection, congestive heart failure and MI within 2 months.
Second active, untreated malignancy, which is likely to result in the patient's demise prior to death from uncontrolled melanoma CNS metastases. This will be determined on a case by case basis by the PIs.
Unwillingness to undergo monitoring for a secondary malignancy including clinical dermatologic examinations and head and neck examinations and serial CT scans.
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: 32
Group description: Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Older than 18 years old
Patients who haven't received steroids injection or medical treatment 1 month before the study
Patients with knee osteoarthritis grade I and II (Kellgren-Lawrence scale)
Indistinct gender
Patients who accept to participate in the study with previous signed informed consent

Exclusion Criteria:

Patients with knee osteoarthritis grade III and IV (Kellgren-Lawrence scale)
Patients with prosthesis
Pregnancy
Patients with rheumatic diseases
Patients with diabetes, hepatic diseases, coagulopathy, cardiovascular diseases, immunosuppression, infections
Patients taking anticoagulants
Patients with concentrations of hemoglobin under 11 g/dL and platelets under 150,000/uL
Intervention: Methadone
Trial phase: Phase 2
ATC code: N02AC52 | N07BC02
SMILES: CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 63
Group description: This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.

Methadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia
Eligibility criteria:
Inclusion Criteria:

Patients older than 12, and younger than 19 years of age undergoing posterior spinal fusion for idiopathic scoliosis
American Society of Anesthesiologist (ASA) physical status I or II
Parents/Guardian willing and able to authorize informed consent
Patients willing and able to authorize assent

Exclusion Criteria:

Patients presenting with neuromuscular scoliosis
Patients deemed at increased risk of adverse reactions due to the presence of pre-existing severe organ system dysfunction, including debilitating lung disease, severe obstructive sleep apnea, severe congenital or acquired heart disease, and/or severe renal impairment
Patients who are both being currently treated for a psychological disorder and have a history of hospitalization for said disorder
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: 52
Group description: IV Acetaminophen administered on admission to PACU

IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care
Eligibility criteria:
Inclusion Criteria:

Subject is undergoing pre-scheduled laparoscopic cholecystectomy;
American Society of Anesthesiology patient classification status I-II

Exclusion Criteria:

Regular preoperative use of or opioids,
Subjects admitted after surgery for postoperative complications other than postoperative pain or PONV.
Subjects converted to open laparoscopic cholecystectomy
Known allergy/hypersensitivity to acetaminophen
Use of opioids prior to commencement of the study (<7 days)
Patients with chronic pain conditions or disease requiring pain control
Abnormal liver function
Known or suspected alcohol, drug or opiate abuse or dependence
Patients with a BMI of greater than 35
Other physical, mental or medical conditions that could effect participation.
Abnormal renal function; serum creatinine>2gm/dl
Intervention: Metformin
Trial phase: Phase 1 | Phase 2
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 77
Group description: 60 enrolled participants were to be randomized to metformin.

metformin: Metformin will be given at a dose of 850 mg orally once daily for 1 month with titration up to 850 mg orally twice daily for the remainder of the study.

77 participants were allocated to the metformin group.
Eligibility criteria:
Inclusion Criteria:

The investigators will enroll 120 sedentary, weight-stable, ambulatory Veterans aged 65 years and older with prediabetes identified with fasting glucose values 100 mg/dL or greater but under 126 mg/dL with no use of diabetes medications.
Participants must demonstrate that they are able to ambulate 400 meters without assistance.

Exclusion Criteria:

Chronic medical conditions affecting muscle mass or function like active non-skin cancer and hypogonadism
Medications affecting muscle mass or function like glucocorticoids and androgen/antiandrogens
Contraindications to metformin such as renal dysfunction defined as creatinine >= 1.5 mg/dL for men or >=1.4 mg/dL for women or estimated glomerular filtration rate (eGFR)<60 mL/min; liver dysfunction defined as alanine aminotransferase (ALT)>48 U/L, aspart aminotransferase (AST)>41 U/L or alkaline phosphatase (AlkPhos)>141 U/L; B12 deficiency defined as B12 level <180 pg/dL; congestive heart failure; known hypersensitivity to metformin; excessive alcohol intake (average of 2 or more alcoholic beverages/day over a month)

For the muscle biopsy substudy, additional exclusion criteria include:

Conditions that include bleeding risk such as the use of warfarin, clopidogrel/ticlopidine, aggrenox, dabigatran or anagrelide; laboratory results showing platelets<150 billion/L or international normalized ratio (INR)>1.2 or activated partial thromboplastin time (aPTT)>36 seconds
Allergy to lidocaine
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: 31
Group description: Methadone (1 mg/mL) administered orally every 4 hours. The following is a dosing guide:

NAS Score Methadone 8-12 0.05 mg/kg/dose >=13 0.1 mg/kg/dose

Maximum dose of methadone will be 0.2 mg/kg/dose. (NeoFax)
Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 4 hours, until NAS scores are consistently <8 for 48 hours.
If the maximum dose of methadone is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.

Methadone, Morphine: To compare the duration of opiate medication treatment for babies on methadone versus those on morphine.
Eligibility criteria:
Inclusion Criteria:

i. Evidence of opioid withdrawal clinically defined by at least 2 NAS scores > 8 in an 8 hour time period, AND

ii. Gestation => 35 weeks at entry defined by best obstetrical and physical exam criteria, AND

iii. Medically stable condition in the opinion of the attending neonatologist, other than opiate withdrawal, AND

iv. Mother on opiate replacement treatment therapy - methadone or buprenorphine.

Exclusion Criteria:

i. Gestation < 35 weeks at entry defined by best obstetrical and physical exam criteria.

ii. Hypoglycemia, hypomagnesaemia, or hypocalcemia until corrected,

iii. Serious medical illness such as sepsis, pneumonia, thyroid dysfunction, meningitis, intracranial hemorrhage, perinatal depression, or respiratory failure requiring admission to the NICU.

iv. Evidence of major congenital anomalies or genetic syndromes that impact the neonatal course

v. Mother consistently taking prescribed benzodiazepine at the time of delivery
Intervention: Metformin
Trial phase: Phase 3
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Metformin will be given at a dose of 1000 mg twice a day orally for three months to assess changes in insulin resistance compared to placebo.

Metformin
Eligibility criteria:
Inclusion Criteria:

Adolescents 12-21 years of age with type 1 diabetes (defined as having positive antibodies as well as insulin requirement)
Willing to consent for participation in study
Body Mass Index (BMI) >5% on growth charts

Exclusion Criteria:

Current use of medications known to affect insulin sensitivity: oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, metformin or thiazolidinediones.
Currently pregnant or breastfeeding women
Use of a thiazolidinedione within 12 weeks
Severe illness or Diabetic Ketoacidosis within 60 days
Macroalbuminuria
Hemoglobin A1c > 12%
Weight > 136.4 kg or < 42 kg, BMI < 5%
Creatinine > 1.2
Hemoglobin < 9
Major psychiatric or developmental disorder limiting informed consent
Implanted metal devices
Inability to tolerate ≥500mg twice a day of metformin
Intervention: metformin XR
Trial phase: Phase 3
SMILES: CN=C(N)N(C)C(=N)N.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 237
Group description: Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
Eligibility criteria:
Inclusion Criteria:

Must have type 2 diabetes mellitus with inadequate glycemic control on diet and exercise
Not on antihyperglycemic agent therapy (at least 12 weeks before screening) and have a screening visit fingerstick glycated hemoglobin (HbA1c) of more than or equal to 7 percent and less than or equal to 12.5 percent
Have a screening visit HbA1c of more than or equal to 7.5 percent and less than or equal to 12 percent as determined by the central laboratory
Must have a fasting plasma glucose of less than or equal to 300 mg/dL (16.7 mmol/L) prior to randomization
Must have a fasting fingerstick glucose of greater than 120 mg/dL (6.7 mmol/L) performed at home or at the study center prior to randomization

Exclusion Criteria:

History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
Fasting C-peptide less than 0.70 ng/mL (0.23 nmol/L) in participants for whom the investigator cannot reasonably exclude T1DM based upon clinical evaluation
Repeated (2 or more over a 1 week period) fasting self-monitored blood glucose measurements more than 300 mg/dL (16.7 mmol/L) prior to randomization, despite reinforcement of diet and exercise counseling
History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Has history of, or currently active, illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
Intervention: Canagliflozin
Trial phase: Phase 3
ATC code: A10BD16 | A10BK02
SMILES: [H][C@@]1(c2ccc(C)c(Cc3ccc(-c4ccc(F)cc4)s3)c2)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 238
Group description: Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
Eligibility criteria:
Inclusion Criteria:

Must have type 2 diabetes mellitus with inadequate glycemic control on diet and exercise
Not on antihyperglycemic agent therapy (at least 12 weeks before screening) and have a screening visit fingerstick glycated hemoglobin (HbA1c) of more than or equal to 7 percent and less than or equal to 12.5 percent
Have a screening visit HbA1c of more than or equal to 7.5 percent and less than or equal to 12 percent as determined by the central laboratory
Must have a fasting plasma glucose of less than or equal to 300 mg/dL (16.7 mmol/L) prior to randomization
Must have a fasting fingerstick glucose of greater than 120 mg/dL (6.7 mmol/L) performed at home or at the study center prior to randomization

Exclusion Criteria:

History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
Fasting C-peptide less than 0.70 ng/mL (0.23 nmol/L) in participants for whom the investigator cannot reasonably exclude T1DM based upon clinical evaluation
Repeated (2 or more over a 1 week period) fasting self-monitored blood glucose measurements more than 300 mg/dL (16.7 mmol/L) prior to randomization, despite reinforcement of diet and exercise counseling
History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Has history of, or currently active, illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
Intervention: Metformin
Trial phase: Phase 4
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Metformin: Six week intervention: Study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, 500/1000 for one week, and then 1000mg twice daily for the remainder of the 6 week intervention. If uptitration is not tolerated, max dose will be max tolerated dose of at least 500 mg twice daily.
Eligibility criteria:
Inclusion Criteria:

Age 20-59 years of age,
Type 1 diabetes based on antibody-positivity, rapid persistent conversion to insulin requirement after diagnosis, absent C-peptide, or DKA at diagnosis, or a clinical course consistent with T1D,
HbA1c 6.0 - 9.5, and
Willing and able to commit to two 6 week-long periods of blinded medication followed by hyperinsulinemic euglycemic clamp, vascular testing, and muscle biopsies.

Exclusion Criteria:

Any comorbid condition associated with:

inflammation,
insulin Resistance, or

dyslipidemia including:

cancer,
heart failure,
active or end stage liver disease,
kidney disease, or
rheumatological disease;
Tobacco use;
Pregnancy or women who are breastfeeding;
Steroid use;
Scheduled strenuous physical activity >3 days a week;
Angina, known CAD, or any other cardiovascular or pulmonary disease;
A history of COPD or asthma;
Presence of systolic blood pressure >190 at rest or >250 with exercise, or diastolic pressure >95 at rest or >105 with exercise;
Untreated thyroid disease;
Proteinuria (urine protein >200 mg/dl) or a creatinine > 1.5 mg/dl (males) or 1.4 mg/dL (females), suggestive of severe renal disease;
Severe Proliferative retinopathy;
Niacin treatment;
Administration of experimental agent for T1D within 30 days prior to screening;
Recent (prior 6 months) or current metformin or thiazolidenedione use;
Hypoglycemia unawareness or recurrent severe hypoglycemia (no symptoms of hypoglycemia with FSBS<40 and episodes of this severity >1 per week);
Weight instability (weight change >5% in last 6 months);
History of any organ transplant, including islet cell transplant;
Current or prior infection with HIV, hepatitis B or hepatitis C or hepatic -insufficiency (AST or ALT > 2x the upper limits of normal);
Any condition, medical or otherwise that would, in the opinion of the investigator, prevent complete participation in the study, or that would pose a significant hazard to the subject;
History of substance abuse within the 12 months prior to screening.
Intervention: Hydrocortisone
Trial phase: Phase 4
ATC code: A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.

Hydrocortisone: Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.
Eligibility criteria:
Inclusion Criteria:

All patients undergoing unilateral or bilateral total knee replacement
Age 50-90

Exclusion Criteria:

All patients on steroid therapy regardless of dose or duration of treatment or those requiring stress-dose steroids preoperatively
Patients who are smokers
Patients under 50 years of age
Patients over 90 years of age
Patients with diabetes
Patients with a prior history of corticosteroid intolerance
Patients with previous complications of steroid use
Intervention: Naropin
Trial phase: Not Applicable
SMILES: CCC[NH+]1CCCCC1C(=O)Nc1c(C)cccc1C.O.[Cl-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
Eligibility criteria:
Inclusion Criteria:

Patients who are scheduled for repair of their pectus excavatum with minimally invasive (MIRPE) placement of steel or titanium braces at Mayo Clinic Arizona
Must be able to take oral medications preoperatively and postoperatively.

Exclusion Criteria:

American Society of Anesthesiology class IV or higher
Allergic to Ropivacaine or other local anesthetics
NSAID allergy
Specific epidural contraindication
Currently using opioids, sedatives, or hypnotics
Are pregnant as verified by preoperative pregnancy testing
Inability to place an epidural, patient refusal for epidural, or failure of an epidural to be properly placed or maintain proper placement for adequate pain control.
Intervention: Acetaminophen
Trial phase: Phase 2
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: 30
Group description: Acetaminophen 1 gm
Eligibility criteria:
Inclusion Criteria:

Adult patients who presented to the emergency department with pain (a verbal numeric pain score greater than 0 on a scale of 0 to 10 from none to greatest) secondary to an acute musculoskeletal injury of less than 24 hours of duration when one of the study investigators was present were eligible for enrollment

Exclusion Criteria:

Patients who had taken an opioid containing analgesic as well as those with a prior history of allergy or contraindications to ibuprofen or acetaminophen.