anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ibuprofen
Trial phase: Phase 2
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 741
Group description: Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.

Ibuprofen: Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.
Eligibility criteria:
Inclusion Criteria:

Patients ages 2-18 undergoing tonsillectomy with or without adenoidectomy by electrocautery alone for sleep disordered breathing or infectious tonsillitis will be included.
Patients with complex medical conditions and craniofacial abnormalities will be included.
Informed consent and child assent will be required for enrollment

Exclusion Criteria:

Patients with a known personal or family history of a bleeding disorder will be excluded.
Patients with a history of asthma, kidney or liver problems will also be excluded.
Patients with tonsillectomy or adenoidectomy performed using a cold knife technique, microdebrider, coblation or plasma knife.
Patients on NSAIDs for other medical conditions, or those who have taken NSAIDs within 1 week of surgery will be excluded.
Patients with allergy to aspirin or other NSAIDs, acetaminophen, Red Dye #40 or Red Dye #33 will also be excluded.
Pregnancy testing using urine β-subunit of hCG gonadotropin (beta-HCG) will be performed on all children > 13 years of age, or those younger than 13 who are menstruating; this is the testing protocol used at the Children's Hospital of Boston. Patients found to be pregnant will be excluded from participation.
Intervention: Lidocaine
Trial phase: Not Applicable
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: 0.1 ml/kg of 1% Lidocaine

1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure
Eligibility criteria:
Inclusion Criteria:

neonate requiring lumbar puncture
gestational age at birth equal to or greater than 34 weeks

Exclusion Criteria:

on mechanical ventilation
receiving sedation (opioids or benzodiazepines)
suspected congenital spinal anomaly
infants older than 1 week of life
Intervention: Lidocaine
Trial phase: Not Applicable
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure

topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure
Eligibility criteria:
Inclusion Criteria:

neonate requiring lumbar puncture
gestational age at birth equal to or greater than 34 weeks

Exclusion Criteria:

on mechanical ventilation
receiving sedation (opioids or benzodiazepines)
suspected congenital spinal anomaly
infants older than 1 week of life
Intervention: Leuprolide Acetate
Trial phase: Phase 4
SMILES: CC(=O)O.CCNC(=O)C1CCCN1C(=O)C(CCCN=C(N)N)NC(=O)C(CC(C)C)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(Cc1cnc[nH]1)NC(=O)C1CCC(=O)N1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: Induction of oocyte maturation with GnRH agonist

GnRH agonist: GnRH agonist 1mg one dose
Eligibility criteria:
Inclusion Criteria:

Oocyte donors
Ages between 21 and 33
Normal baseline serum FSH < 10mIU/mL

Exclusion Criteria:

Hypothalamic dysfunction
Smokers
Baseline serum FSH ≥ 10mIU/mL
Intervention: delta-(L-alpha-Aminoadipoyl)-L-cysteinyl-glycine
Trial phase: Phase 4
ATC code: G03GA01
SMILES: NC(CCCC(=O)NC(CS)C(=O)NCC(=O)O)C(=O)O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: Induction of oocyte maturation with hCG

hCG: 5,000 IU one dose
Eligibility criteria:
Inclusion Criteria:

Oocyte donors
Ages between 21 and 33
Normal baseline serum FSH < 10mIU/mL

Exclusion Criteria:

Hypothalamic dysfunction
Smokers
Baseline serum FSH ≥ 10mIU/mL
Intervention: Verapamil
Trial phase: Phase 2
ATC code: C08DA01 | C08DA51 | C09BB10
SMILES: COc1ccc(CCN(C)CCCC(C#N)(c2ccc(OC)c(OC)c2)C(C)C)cc1OC
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 2
Group description: open label adjunctive add on of verapamil to existing medications. dosing begins at 1 mg/kg/d and increases weekly to target of 4 mg/kg/d in divided doses (three times/day)

Verapamil: Verapamil will be prepared as a solution. A 50mg/ml oral suspension may be made with immediate release tablets and either a 1:1 mixture of Ora-Sweet and Ora-Plus or a 1:1 mixture of Ora-Sweet SF and Ora-Plus will be used.

Children will start on a 4 weeks titration period:

Week 1: 1mg/kg/day divided BID Week 2: 2mg/kg/day divided BID or TID Week 3: 3mg/kg/day divided BID or TID Week 4: 4mg/kg/day divided TID

In event of adverse events, and in consultation with the family and treating physician, the dosage may be decreased to 2mg/kg/day and remain at that dose for the remainder of the study.
Eligibility criteria:
Inclusion Criteria:

2 to 25 years old
Onset of seizures in first year of life
seizure type usually generalized tonic-clonic, clonic, or hemiclonic, often prolonged (>10 minutes)
myoclonic jerks/myoclonic seizures
history of normal development at seizure onset with subsequent developmental delay or regression which occurs after seizure onset
presence of documented abnormality on the SCN1A gene
medically intractable epilepsy: must have been on at least 2 prior antiepileptic medications without adequate control of epilepsy
subject is capable of giving informed consent (or assent if possible) or has an acceptable surrogate capable of giving informed consent on the subject's behalf

Exclusion Criteria:

use of clonidine, propranolol, carbamazepine, oxcarbazine, stiripentol, lamotrigine, or cyclosporine
Abnormalities of cardiac conduction or rhythm (excluding sinus arrhythmia) on screening EKG
significant use of grapefruit juice
ketogenic diet
pregnancy
Intervention: beta-Hydroxyisovaleric acid
Trial phase: Phase 2
SMILES: CC(C)(O)CC(=O)O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG)

Standard of care ADT + (HMB + arginine + glutamine): 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine.

Take one packet twice daily for 3 months
Eligibility criteria:
Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate
Age 60 years or older

Patients with asymptomatic or minimally symptomatic prostate cancer for which they are about to start androgen deprivation therapy (ADT) per provider recommendation

Asymptomatic or minimally symptomatic (as judged by treating physician) metastases allowed
Men receiving ADT for localized prostate cancer are allowed
Patient able to give informed consent.

Exclusion Criteria:

Patient already on ADT
Patients who are visiting clinic for a second opinion only
Patients with a diagnosis of dementia
Patients with a diagnosis of a neuromuscular disorder (i.e. multiple sclerosis)
Intervention: Vilazodone
Trial phase: Phase 4
ATC code: N06AX24
SMILES: N#Cc1ccc2[nH]cc(CCCCN3CCN(c4ccc5oc(C(N)=O)cc5c4)CC3)c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly received incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
Eligibility criteria:
Inclusion Criteria:

60 years of age or older
The presence of a major depressive disorder diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
A 24-item Hamilton Depression Rating Scale (HAMD) score of 17 or higher at baseline
Mini-Mental State Exam (MMSE) score > 24.

Exclusion Criteria:

Subjects will be excluded if they had any current and/or lifetime history of other psychiatric disorders (except unipolar depression with or without comorbid generalized anxiety disorder), or recent unstable medical or neurological disorders; any disabilities preventing their participation in the study; diagnosis of mild cognitive impairment (MCI)/dementia; those with known allergic reactions to paroxetine or vilazodone.
Intervention: Paroxetine
Trial phase: Phase 4
ATC code: N06AB05
SMILES: Fc1ccc([C@@H]2CCNC[C@H]2COc2ccc3c(c2)OCO3)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly received incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs were adjusted according to individual tolerability and safety.
Eligibility criteria:
Inclusion Criteria:

60 years of age or older
The presence of a major depressive disorder diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
A 24-item Hamilton Depression Rating Scale (HAMD) score of 17 or higher at baseline
Mini-Mental State Exam (MMSE) score > 24.

Exclusion Criteria:

Subjects will be excluded if they had any current and/or lifetime history of other psychiatric disorders (except unipolar depression with or without comorbid generalized anxiety disorder), or recent unstable medical or neurological disorders; any disabilities preventing their participation in the study; diagnosis of mild cognitive impairment (MCI)/dementia; those with known allergic reactions to paroxetine or vilazodone.
Intervention: Saxagliptin
Trial phase: Phase 4
ATC code: A10BD10 | A10BD21 | A10BD25 | A10BH03
SMILES: N#CC1CC2CC2N1C(=O)C(N)C12CC3CC(CC(O)(C3)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1361
Group description: Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
Eligibility criteria:
Inclusion Criteria:

Provision of informed consent prior to any study specific procedures Diagnosed with type 2 diabetes
Men or women who are >18 years of age at time of consenting upon Visit 1
HbA1c >7.5% and ≤11.0% Patients should be drug naive or treated with metformin alone on stable doses of for at least continues 8 weeks prior to Visit 1
Drug naive patients are defined as patients who have not received medical treatment for diabetes (insulin and/or oral hypo)

Exclusion Criteria:

Pregnant or breastfeeding patients
Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
Previous treatment with any DPP-IV inhibitors or GLP-1 analogue
History of administration of any antihyperglycemic therapy (other than metformin) during the 8 weeks prior to Visit 1(12 weeks for previous TZD)
Treatment with systemic glucocorticoids other than replacement therapy
Inhaled, local injected and topical use of glucocorticoids is allowed
Intervention: Venlafaxine
Trial phase: Not Applicable
ATC code: N06AX16
SMILES: COc1ccc(C(CN(C)C)C2(O)CCCCC2)cc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: 225 mg daily over 12 weeks

Venlafaxine: 225 mg daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Dementia due to Alzheimer's disease by Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-IV (TR) criteria (90), with a Mini-Mental State Exam (MMSE) (82) score of 10-26 inclusive;
Depression as defined by the National Institute of Mental Health (NIMH) Consensus Criteria,
Clinical Dementia Rating Scale of 1 "mild" or 2 "moderate". Ratings of 3 "severe" will be excluded because many of the instruments lack validity in the presence of severe cognitive impairment, particularly language deficits.
Sufficiently good health to be treated using the study protocol in usual care circumstances;
Patient or surrogate and caregiver provides informed consent for participation in the study;
A caregiver is available who spends at least 10 hours per week with the patient, supervises her care, and is willing to accompany the patient to study visits and to provide information about the patient.
Female participants must be at least 2 years post menopause or surgically sterilized. Exclusion Criteria
Presence of a brain disease that might otherwise fully explain the presence of dementia, such as stroke, Parkinson's disease, traumatic brain injury, multiple sclerosis, and similar neurologic diseases;
Clinically significant psychosis that requires antipsychotic treatment; -Treatment with venlafaxine is contraindicated in the opinion of the attending psychiatrist, for example if there is a prior history of dangerous or -unacceptable side effects when treated with venlafaxine;
Failure of treatment with venlafaxine in the past for depression after convincing evidence of a "good trial," for example 8 weeks at the highest tolerated dose;
Treatment for a condition or with a medication that would prohibit the safe concurrent use of venlafaxine (specifically including systolic blood pressure > 180 mm Hg or diastolic blood pressure > 100 mm Hg);
Diagnosis of congenital long Q-T syndrome
The patient requires psychiatric hospitalization for depression or is suicidal;
Initiation, discontinuation or dose changes in cholinesterase inhibitor or memantine use within the 4 weeks prior to screening.
Intervention: Tiotropium
Trial phase: Phase 3
ATC code: R03AL06 | R03AL10 | R03BB04 | R03BB54
SMILES: [H][C@]1(OC(=O)C(O)(c2cccs2)c2cccs2)C[C@@]2([H])[C@]3([H])O[C@]3([H])[C@@]([H])(C1)[N+]2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 405
Group description: 18 μg capsules for inhalation, o.d
Eligibility criteria:
Inclusion criteria:

Male and female adults aged ≥40 years.
Patients with stable COPD according to GOLD strategy (GOLD 2011).
Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and <80% of the predicted normal, and a post-bronchodilator.
FEV1/FVC < 0.70.
Current or ex-smokers who have a smoking history of at least 10 pack years.
Patients with an mMRC ≥ grade 2

Exclusion criteria:

History of long QT syndrome or prolonged QTc.
Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1.
Patients with Type I or uncontrolled Type II diabetes.
Patients with a history of asthma or have concomitant pulmonary disease.
Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible.
Patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of safety.
Intervention: Sitagliptin
Trial phase: Phase 4
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 84
Group description: Sitagliptin 100 mg QD
Eligibility criteria:
Inclusion Criteria:

Age: 25~60 years
Duration of disease < 3 years,no drug treatment for diabetes
Newly diagnosed type 2 diabetic patients (fasting plasma glucose > 7.0mmol/L or/and 2h postprandial blood glucose>11.1mmol/L WHO 1999)
Fasting plasma glucose < 10 mmol/L

Exclusion Criteria:

Type 1 diabetes
DKA, infection and other stress status
Autoimmune disease
Hepatic and renal diseases
Intervention: Deferasirox
Trial phase: Phase 4
ATC code: V03AC03
SMILES: O=C(O)c1ccc(-n2nc(-c3ccccc3O)nc2-c2ccccc2O)cc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Oral dose of ICL670 at 10 mg/kg daily
Eligibility criteria:
Inclusion Criteria

Patients who had hematopoietic stem cell transplantation (HSCT) for beta-thalassemia major
hematopoietic stem cell transplantation (HSCT) was performed minimum 6 months and maximum 2 years ago
The washout period after the immunosuppressive therapy should be at least 3 months.
Signifacant IOL should be present including:

A. Serum ferritin >1000 μg/L or B. cardiac MRI <20 ms or C. liver iron concentration ≥ 5 mg/g dry weight measured by R2* MRI

Exclusion Criteria

Patients who had any contraindication for treatment with deferasirox according to the prescribing information

•Patients who depended on transfusion

Patients with clinical symptoms of cardiac dysfunction (shortness of breath at rest or exertion, orthopnea, exercise intolerance, lower extremity edema, arrhythmias)
Patients who were experiencing severe complication of HSCT e.g. acute Graft-versus host disease (GVHD)
Significant proteinuria / Increase in serum creatinine
Intervention: Ezetimibe
Trial phase: Phase 4
ATC code: C10AX09 | C10BA02 | C10BA05 | C10BA06 | C10BA10 | C10BA11 | C10BA12
SMILES: [H][C@]1(CC[C@H](O)c2ccc(F)cc2)C(=O)N(c2ccc(F)cc2)[C@]1([H])c1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: 10 mg oral dose once daily for 24 weeks
Eligibility criteria:
Inclusion Criteria:

Have hypercholesterolemia (high cholesterol) and have been diagnosed with type 2 diabetes that is being treated with oral anti-diabetic drugs or insulin or both.
No change in the medication (drugs, dose and administration) for the treatment of diabetes within previous 12 weeks with exception of small changes in insulin dosing
No change in diet and exercise therapy within previous 4 weeks

Exclusion Criteria:

Coexisting disease (hemoglobinopathy, hemolytic anemia, etc.) that may affect HbA1c measurement
Homozygous or heterozygous familial hypercholesterolemia
Previously received ezetimibe
Hypercholesterolemia associated with: hypothyroidism, obstructive gall bladder or biliary disease, chronic renal failure or pancreatitis
Hyperlipidemia caused by medication
Intervention: Pituitrin
Trial phase: Phase 2
SMILES: NC(=O)CCC1NC(=O)C(Cc2ccccc2)NC(=O)C(Cc2ccc(O)cc2)NC(=O)C(N)CSSCC(C(=O)N2CCCC2C(=O)NC(CCCN=C(N)N)C(=O)NCC(N)=O)NC(=O)C(CC(N)=O)NC1=O.NCCCCC(NC(=O)C1CCCN1C(=O)C1CSSCC(N)C(=O)NC(Cc2ccc(O)cc2)C(=O)NC(Cc2ccccc2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(N)=O)C(=O)N1)C(=O)NCC(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: Vasopressin will be given as an initial bolus (4 Units) followed by an infusion titrated between 0 units/min to 0.04 units per min to maintain a mean arterial blood pressure greater than or equal to 65 mmHg

Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours.
Eligibility criteria:
Inclusion Criteria:

Trauma patients between the ages of 18 and 65 who require 6 or more units of blood product during their initial 12 hours of resuscitation will be considered for enrollment.

Exclusion Criteria:

Patients with a traumatic brain injury requiring neurosurgical operative intervention or who have neurologic trauma deemed non-survivable will also be excluded.
Patients with an active coronary syndrome, history of myocardial infarction or coronary artery disease will be excluded.
Patients with known renal dysfunction requiring dialysis will be excluded.
Patients who are pregnant will be excluded.
Patients less than 18 years old will be excluded.
Patients who have opted out by bracelet identification or by listing themselves on the "Non-Participant" roster.
Patients under the jurisdiction of the department of corrections and considered prisoners prior to the initiation of the research intervention will be excluded
Intervention: Pituitrin
Trial phase: Phase 2
SMILES: NC(=O)CCC1NC(=O)C(Cc2ccccc2)NC(=O)C(Cc2ccc(O)cc2)NC(=O)C(N)CSSCC(C(=O)N2CCCC2C(=O)NC(CCCN=C(N)N)C(=O)NCC(N)=O)NC(=O)C(CC(N)=O)NC1=O.NCCCCC(NC(=O)C1CCCN1C(=O)C1CSSCC(N)C(=O)NC(Cc2ccc(O)cc2)C(=O)NC(Cc2ccccc2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(N)=O)C(=O)N1)C(=O)NCC(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: An initial bolus of normal saline will be given (10 cc) and an infusion of 0.1 ml per minute will be started and titrated down in as the mean arterial blood pressure reaches 65 mmHg or more.

Vasopressin: After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours.
Eligibility criteria:
Inclusion Criteria:

Trauma patients between the ages of 18 and 65 who require 6 or more units of blood product during their initial 12 hours of resuscitation will be considered for enrollment.

Exclusion Criteria:

Patients with a traumatic brain injury requiring neurosurgical operative intervention or who have neurologic trauma deemed non-survivable will also be excluded.
Patients with an active coronary syndrome, history of myocardial infarction or coronary artery disease will be excluded.
Patients with known renal dysfunction requiring dialysis will be excluded.
Patients who are pregnant will be excluded.
Patients less than 18 years old will be excluded.
Patients who have opted out by bracelet identification or by listing themselves on the "Non-Participant" roster.
Patients under the jurisdiction of the department of corrections and considered prisoners prior to the initiation of the research intervention will be excluded