anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
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 | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: metformin dose 3 x 500 mg

Metformin: for group A: 12 weeks metformin treatment in a final dose 3 x 500 mg

for group B: 3 weeks metformin treatment in a dose 3 x 500 mg, next: 3 weeks metformin treatment in a final dose 3 x 1000mg, next: 3 weeks metformin treatment in a dose 3 x 500 mg.
Eligibility criteria:
Inclusion Criteria for treated groups ( A or B):

age: 40-65 years;
pre-diabetic status based on fasting plasma glucose (FPG) and / or OGTT;
without metformin before;
without ischemic heart disease in history;
without a stroke in a history;
without PAOD (peripheral arterial occlusive disease) in a history;
without active cancer in a history

Exclusion Criteria for treated groups (A or B):

age <40 or >65;
diabetes;
taking metformin before study;
active cancer;
history of macro-angiopathy (ischemic heart disease, stroke or TIA, PAOD);
serious gastrointestinal disease that may affect metformin tolerance;
renal failure with GFR<45 ml/min/1.73m2;
alanin transaminase > 3 x ULN

Inclusion criteria for healthy volunteers:

age: 40-65 years;
no carbo-hydrates disturbances (based on fasting plasma glucose (FPG) and/or OGTT);
without metformin before;
without ischemic heart disease in history;
without a stroke in a history;
without PAOD (peripheral arterial occlusive disease) in a history;
without active cancer in a history
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 | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 21
Group description: metformin dose 3 x 1000 mg

Metformin: for group A: 12 weeks metformin treatment in a final dose 3 x 500 mg

for group B: 3 weeks metformin treatment in a dose 3 x 500 mg, next: 3 weeks metformin treatment in a final dose 3 x 1000mg, next: 3 weeks metformin treatment in a dose 3 x 500 mg.
Eligibility criteria:
Inclusion Criteria for treated groups ( A or B):

age: 40-65 years;
pre-diabetic status based on fasting plasma glucose (FPG) and / or OGTT;
without metformin before;
without ischemic heart disease in history;
without a stroke in a history;
without PAOD (peripheral arterial occlusive disease) in a history;
without active cancer in a history

Exclusion Criteria for treated groups (A or B):

age <40 or >65;
diabetes;
taking metformin before study;
active cancer;
history of macro-angiopathy (ischemic heart disease, stroke or TIA, PAOD);
serious gastrointestinal disease that may affect metformin tolerance;
renal failure with GFR<45 ml/min/1.73m2;
alanin transaminase > 3 x ULN

Inclusion criteria for healthy volunteers:

age: 40-65 years;
no carbo-hydrates disturbances (based on fasting plasma glucose (FPG) and/or OGTT);
without metformin before;
without ischemic heart disease in history;
without a stroke in a history;
without PAOD (peripheral arterial occlusive disease) in a history;
without active cancer in a history
Intervention: Metformin
Trial phase: 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: Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.

Metformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Patients both sexes
Age between 30 and 60 years
Mild to moderate physical activity
Stable body weight for at least 12 weeks prior to the study
BMI 25.0 - 34.9 kg/m2
Diabetes mellitus type 2 of recent diagnosis without pharmacological treatment, with one of the following criteria (fasting blood glucose levels >126 mg/dl; or postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose >200 mg/dl
Informed consent signed

Exclusion Criteria:

Women with confirmed or suspected pregnancy
Women under lactation and/or puerperium
Previous treatment for glucose
Fasting glucose ≥250 mg/dL
Known uncontrolled renal, hepatic, heart or thyroid diseased
Hypersensibility to ingredients of intervention
Known allergies to bee stings or their derived products
Triglycerides ≥500 mg/dL
Total cholesterol ≥240 mg/dL
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: 27
Group description: Patients were administered intravenous acetaminophen (1 g IV) twice.
Eligibility criteria:
Inclusion Criteria:

Patients with a diagnosis of bilateral moyamoya disease scheduled for bilateral external-carotid to internal-carotid bypass surgery to be done in two stages.

Exclusion Criteria:

Allergy or history of reaction to acetaminophen. Patients with liver disease. Anyone not able to provide informed consent.
Intervention: Metformin
Trial phase: 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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Metformin 500mg tablet by mouth, every 6 to 8 hours for one year

Metformin: Oral metformin (up to 2gm) were given in divided doses
Eligibility criteria:
Inclusion Criteria:

Age ≥ 60 years
Stable CAD

Prediabetes (one of the following criteria should be met)

Fasting plasma glucose: 100-126 mg/dL
HbA1C: 5.7-6.4
Frailty (Short Physical Performance Battery: Score <9)
Able to return for follow-up
Written informed consent

Exclusion criteria:

Pre-existing or new-onset diabetes
Any active malignancy, hematological disorder, post organ transplant, immunocompromised
Cancer requiring treatment in the past 3 years (other than non-melanoma skin cancer)
Dementia [mini mental state examination (MMSE <20)]
Disability (need for assistance in >2 of any six activities on Katz activities of daily living (ADL)46
Prior stroke with disability
Acute coronary syndrome <3months or participating in cardiac rehabilitation
Severe Parkinson's
Hepatic insufficiency and/or chronic liver disease (cirrhosis)
Chronic kidney disease (GFR < 45 mL/min)
Taking metformin for any indication
Acute alcohol intoxication
Known hypersensitivity to metformin hydrochloride
Acute/chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
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: 70
Group description: Norco (hydrocodone 5mg- acetaminophen 325mg)

Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)
Eligibility criteria:
Inclusion Criteria:

Patients 18-70 years old undergoing septorhinoplasty or rhinoplasty for either obstructive or aesthetic reasons. All approaches to rhinoplasty and surgical techniques utilized will be included. This will include patients that undergo additional procedures during the rhinoplasty including osteotomies, turbinate reduction, septoplasty, nasal valve repair and ear cartilage graft.

Exclusion Criteria:

Patients who undergo a rhinoplasty requiring a rib cartilage graft for the procedure as this is known to cause significant pleuritic chest pain.
Patients receiving functional endoscopic sinus surgery concurrently with the rhinoplasty will be excluded.
Patients with known history of gastrointestinal bleeds, peptic ulcer disease or who have other comorbidities that prevent them from taking NSAIDs.
Patients with a history of radiation, active head and neck malignancy or other pain disorders such as various rheumatologic diseases will be excluded to decrease confounding factors in the control of pain.
Intervention: Flumazenil
Trial phase: Phase 1 | Phase 2
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: 36
Group description: Flumazenil 1mg in 10cc normal saline was given intravenously (iv) over 5-10 minutes. 10 cc of normal saline placebo was given intravenously (iv) over 5-10 minutes. A detailed 90 minute clinical assessment was conducted before and after treatment administration for each visit.
Eligibility criteria:
Inclusion Criteria:

Parkinson's disease (PD): PD diagnosis will follow the UK Parkinson's Disease Society Brain Bank Research Center (UKPDSBRC) clinical diagnostic criteria for PD.
Hoehn and Yahr stages 2-4
Absence of dementia confirmed by cognitive testing.
Abnormal 11C-Dihydrotetrabenazine ([11C]-DTBZ) PET study to demonstrate nigrostriatal dopaminergic denervation.

Exclusion Criteria:

PD with Dementia (PDD) or dementia with Lewy bodies (DLB).
Other disorders which may resemble PD, such as vascular dementia, normal pressure hydrocephalus, multiple system atrophy, corticobasal ganglionic degeneration, or toxic causes of parkinsonism. Prototypical cases have distinctive clinical profiles, like early and severe dysautonomia or appendicular apraxia, which may differentiate them from idiopathic PD. The use of the UKPDSBRC clinical diagnostic criteria for PD will mitigate the inclusion of subjects with atypical parkinsonism.
Subjects on benzodiazepine, GABA-ergic medications (baclofen, tizanidine), neuroleptic, anticholinergic (trihexyphenidyl, benztropine), or cholinesterase inhibitor drugs.
Evidence of a mass lesion on structural brain imaging (MRI).
Participants in whom MRI is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, chest, or cochlear implant.
Severe claustrophobia precluding MR or PET imaging.
Subjects limited by participation in research procedures involving ionizing radiation.
Pregnancy (urine or serum pregnancy test within 48 hours of each PET session) or breastfeeding.
History of seizures
Significant anxiety or history of panic disorder.
History of recent suicide attempt or overdose of tricyclic antidepressants or other medications
Any other medical history determined by investigators to preclude safe participation.
Allergy to flumazenil
Significant liver disease
History of alcohol or other substance abuse within past two years.
History of regular benzodiazepine use within past year
Intervention: Escitalopram Oxalate
Trial phase: Phase 4
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21.O=C(O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: The intervention will consist of initiating a chronic care management plan in the epilepsy clinic and an initial prescription from the epileptologist for escitalopram 10mg daily. Escitalopram dose may be titrated up to a maximum of 20mg daily in 5-10mg increments every 2 weeks for treatment effect, or titrated down to 5mg if needed for adverse effects. If a participant is unable to tolerate escitalopram, then venlafaxine XR 37.5mg will be substituted, to be titrated in a similar manner biweekly based on side effects and anxiety and depression symptoms (with 37.5-75mg increment dose changes and maximum dose of 225mg daily).
Eligibility criteria:
Inclusion Criteria:

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Age 18 or older
Ability to take oral medication and the willing to adhere to the intervention regimen
Minimum of 1 prior clinic visit at the Comprehensive Epilepsy Center
Ability to complete questionnaires independently
Diagnosis of epilepsy: EEG with documented seizure or epileptiform discharges OR non-epileptiform EEG and seizure remission with antiseizure drug OR treating epileptologist's leading clinical impression is epilepsy
(Neurological Disorders Depression Inventory for epilepsy, NDDI-E score greater than 15 and/or Generalized Anxiety Disorder-7, GAD-7 score greater than or equal to 10

Exclusion Criteria:

Pregnancy or lactation
Known allergic reactions to escitalopram or venlafaxine
Comorbid psychogenic nonepileptic seizures
Prior psychiatric hospitalization
Prior suicide attempt
History of manic or psychotic symptoms (past manic episode (SCID-I), or psychotic symptom screen positive)
Current treatment by a psychiatrist or counselor/therapist
Active suicidality at the time of screening
Current treatment with buspirone or an SSRI/SNRI/atypical antidepressant (specifically bupropion, fluoxetine, levomilnacipran, citalopram, milnacipran, desvenlafaxine, mirtazapine, duloxetine, paroxetine, escitalopram, sertraline, fluvoxamine, venlafaxine, vilazodone, vortioxetine)
Intervention: Metformin
Trial phase: Early Phase 1
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 | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Patients given Metformin prior to surgery
Eligibility criteria:
Inclusion Criteria:

Invasive malignant solid tumor of thoracic origin (e.g., lung, esophageal, thymus, mesothelioma, chest wall, mediastinum, trachea, pleura) with the intent to treat or biopsy by surgery as standard of care. Tumor must be ≥2 centimeters (cm).
Patients with multicentric disease are eligible. Samples from all available tumors are requested for research purposes.
Patients with Type 2 diabetes mellitus being treated with metformin (any dose) for a clinical indication at the time of study enrollment are eligible, and will continue metformin treatment as clinically indicated during the presurgical study period. Their dose of metformin will NOT be changed.
Patients not on metformin at the time of study entry must be willing to take metformin extended release (Glucophage® XR, 750 mg QD for 4 days, then 750 mg BID for 3-6 days) for a total of 7-10 days prior to surgery.
Patients do not require a diagnosis of diabetes to be enrolled in the study.
All patients must be willing to keep a drug diary indicating the dates and times of metformin administration.

Patients must meet the following clinical laboratory criteria:

Absolute neutrophil count (ANC) greater than or equal to 1,500/mm3 and platelet count greater than or equal to 75,000/mm3.
Total bilirubin less than or equal to 1.5x the upper limit of the normal range (ULN).
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3x ULN.
Estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73m2 or estimated creatinine clearance (eCrCL) > 60 mL/min
Ability to give informed consent.
Patients must be willing to provide 20 milliliters (mL) of blood for research use.
Patient must be willing to provide consent for use of archived tissue for research.

Exclusion Criteria:

History of diabetes that is currently being treated without metformin.
Patients who, at the time of study entry, are not taking metformin for a clinical indication, and who will need a radiographic analysis with an iodinated contrast agent during the metformin study treatment period.
This criterion does not apply to patients taking clinically indicated metformin at the time of study entry.
History of liver disease as defined with liver function tests (LFTs) above those in the inclusion
Known hypersensitivity to metformin.
History of reactive hypoglycemia.
Active or history of lactic acidosis, metabolic acidosis, or diabetic ketoacidosis.
Intervention: Acetaminophen
Trial phase: Phase 1 | 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: 21
Group description: Standard of care - acetaminophen 650mg every 4 hours PO/NG/FT (per oral, nasogastric tube, feeding tube) for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.
Eligibility criteria:
Inclusion Criteria:

age ≥18 years old
weight ≥ 40 kg
one reading of body temperature ≥ 38.3 ºC
diagnosis of subarachnoid hemorrhage, intracerebral hemorrhage, traumatic brain injury, subdural hematoma, or ischemic stroke
admission to the Intensive Care Unit at UCSF Medical Center or Zuckerberg San Francisco General Hospital.

Exclusion Criteria:

bromocriptine or acetaminophen hypersensitivity or allergy
known contraindication to bromocriptine- known ergot alkaloid hypersensitivity, known history of syncopal migraine
contraindication to nasogastric tube or swallowing pills
current diagnosis of acute liver failure, acute liver injury, or prior diagnosis of cirrhosis. acute presentation (< 26 weeks), evidence of coagulation abnormality: international normalized ratio (INR) ≥ 2; evidence of liver damage: alanine aminotransferase (ALT) of 10 x normal value; and any degree of mental status alteration
currently being treated with intra or extravascular therapeutic hypothermia - or where therapeutic hypothermia treatment is anticipated during study period
hyperthermic syndromes: heat stroke, evidence of thyrotoxicosis, malignant hyperthermia, neuroleptic malignant syndrome, or other drug-induced hyperthermia
administration of acetaminophen or acetaminophen containing medications within 9 hours prior to fever presentation
administration of non-steroidal anti-inflammatory drugs (NSAIDs) within 6 hours prior to fever presentation or aspirin > 300mg less than 1 hour prior to fever presentation.
pregnancy
extracorporeal blood circuit therapies: replacement therapy, extracorporeal life support (ventricular assist device, extracorporeal membrane oxygenation) during study period
anticipated ICU stay < 48 hours'
creatinine clearance ≤ 30
severe cardiovascular disease (especially unstable angina or severe valvular disease)
patients already taking bromocriptine for other indications
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: 100
Group description: Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group.

Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN
Eligibility criteria:
Inclusion Criteria:

ASA class I-II
Patients indicated and scheduled for arthroscopic hip surgery

Exclusion Criteria:

Contraindication to acetaminophen or oxycodone/acetaminophen (e.g. hypersensitivity, history of GI or bleeding disorder)
Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
Younger than 18 years of age or older than 65
Any patient considered a vulnerable subject
Patients on pain medication prior to surgery
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: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment

Acetaminophen: Acetaminophen gel capsule
Eligibility criteria:
Inclusion Criteria:

-Orthodontic patient presenting for orthodontic treatment

Exclusion Criteria:

History of taking an analgesic in the past six hours
Hypersensitivity to ibuprofen or acetaminophen
Aspirin-sensitive asthma
Renal or liver impairment
History of GI bleeding or ulcers
Cardiovascular disease, recent myocardial infarction, heart failure, or coronary artery bypass graft surgery
Currently taking antibiotics or other medications for a chronic systemic disease
Bleeding disorder
Pregnant or nursing
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: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 71
Group description: Patients allocated to receive IV acetaminophen

Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen

none
Eligibility criteria:
Inclusion Criteria:

Any patient age 4-16 years with sickle cell disease who presents the Pediatric ER with acute sickle cell pain crisis with a pain of 6/10 or higher

Exclusion Criteria:

Patient with fever (38C or 100.4F)
Patient less than age 4 years
Patient greater than age 16 years
Patient with hypersensitivity/allergy to either morphine, NSAIDs, or acetaminophen
Patient received acetaminophen within the past 4 hours
Patient with known liver disease or renal disease
Patient not requiring IV morphine (pain score 5/10 or less)
Patient enrolled in the study within the past 72 hours