anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: OXYTOCIN
Trial phase: Not Applicable
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 201
Group description: This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.

Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
Eligibility criteria:
Inclusion Criteria:

Spontaneous rupture of membranes (ROM) ≥1 hour prior to starting induction; ROM defined as clinical history with the presence of 2 of the following 4: pooling, ferning, nitrazine, oligohydramnios. In the absence of clinical history, oligohydramnios AND pooling must be present for ROM to be diagnosed. Oligohydramnios is defined as a total amniotic fluid index of <5cm or a maximum vertical pocket <2cm.
Unfavorable cervix, defined as sterile digital exam ≤ 2cm dilated / 80% effaced
Gestational age ≥ 34 weeks by best obstetric estimate
Clinical management decision is vaginal delivery
Singleton gestation
Cephalic presentation
Willing to participate and able to understand and sign the informed consent document before randomization
Women of reproductive age

Exclusion Criteria:

Multiple gestations
Lethal fetal anomalies, e.g., anencephaly, trisomy 13, trisomy 18
Latex allergy
Greater than 1 prior cesarean delivery
Active labor - defined as contractions more frequent than every 5 minutes (or ≥ 12 contractions in 1 hour) associated with ≥ 1 cm cervical change. In the absence of ≥ 1 cm cervical change after 2 hours, patients with contractions can be included in the study.
Suspicion of chorioamnionitis
Any contraindications to vaginal delivery, including malpresentation, active herpes, complete placenta previa, greater than two prior cesarean deliveries, etc.
HIV positive status or AIDS
Intrauterine fetal demise
Suspected placental abruption, significant hemorrhage
Nonreassuring fetal heart rate (FHR) pattern
Participation in a competing trial
Intervention: Safapryn
Trial phase: Phase 3
SMILES: CC(=O)Nc1ccc(O)cc1.CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 408
Group description: 2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg

Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg
Eligibility criteria:
Inclusion criteria:

Male or female aged 18 years and over.
International Headache Society (IHS) diagnosis of migraine without aura or typical aura with migraine headache.
History of experiencing at least 1, but not more than 8, acute migraine attacks monthly during the previous year.
History of at least moderate migraine pain intensity, if left untreated.
History of frequently or always experiencing nausea with the migraine attack.

Exclusion criteria:

Subjects eligible for inclusion in this study must not fulfill any of the following criteria:

Headache symptoms which may be due to or aggravated by:

Recent (within 6 months) head or neck trauma (e.g., whiplash)
Head or neck pain secondary to an orthopedic abnormality
Cluster headache
Specific migraine variants (e.g., basilar-type artery migraine, opthalmoplegic migraine, hemiplegic migraine, migraine aura without headache)
Other serious, non-migraine causes of headache (e.g., increased intracranial pressure, intracranial bleeding, meningitis, malignancy)
Non-serious, non-migraine causes of headache (e.g., cold, flu, hangover)
History of vomiting during more than 20% of migraine attacks.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Citalopram
Trial phase: Phase 4
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Participants are treated with a flexible-dose antidepressant medication for a period of 8 weeks.

Antidepressant Medication: If patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant.
Eligibility criteria:
Inclusion Criteria:

Anyone with 1 or more characteristics of frailty
HRSD>16 and a DSM-IV depressive disorder (e.g. MDD, Dysthymia)
Capable of providing informed consent
Currently followed by a PCP (had an eval in last 6-months)

Exclusion Criteria:

Acute cancer treatment
Acute, severe or unstable medical illness
End stage medical illness (e.g. liver, kidney, pulmonary)
Mini Mental Exam < 24 or a diagnosis of dementia
Individuals who do not have capacity to consent
Diagnosis of substance abuse or dependence (last 12 months), excluding Nicotine dependence
History of psychosis or psychotic disorder or bipolar disorder
Patient is considered a significant risk of suicide
Subject is considered based on history to be unlikely to respond to the single agent antidepressant (i.e., subjects with treatment resistant depression, including subjects with previous treatment with ECT)
History of allergic or adverse reaction to escitalopram or duloxetine, or non-response to adequate trial of escitalopram (at least 4 weeks at dose of 20 mg) or duloxetine (at least 4 weeks at dose of 90mg).
Intervention: Acetazolamide
Trial phase: Phase 4
ATC code: G01AE10 | S01EC01
SMILES: CC(=O)Nc1nnc(S(N)(=O)=O)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Patients receive 500 mg of intravenous acetazolamide immediately after randomization, with 250 mg intravenous acetazolamide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.
Patients receive 2 mg of intravenous bumetanide immediately after randomization, with 1 mg intravenous bumetanide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.
Spironolactone use is prohibited during the first 72 h, but encouraged at discharge.
Eligibility criteria:
Inclusion Criteria:

Older than 18 years and able to give informed consent
Clinical diagnosis of acute decompensated heart failure within the previous 8 h
At least two clinical signs of congestion (edema, ascites, jugular venous distension, or pulmonary vascular congestion on chest radiography)
Maintenance therapy with oral loop diuretics at a dose of at least 1 mg bumetanide (1 mg bumetanide = 40 mg furosemide = 20 mg torsemide) for at least 1 month before hospital admission
NT-proBNP >1000 ng/L
Left ventricular ejection fraction <50%

At least one out of three of the following criteria:

Serum sodium <136 mmol/L
Serum urea/creatinine ratio >50 (comparable to a BUN/creatinine ratio >25)
Admission serum creatinine increased with >0.3 mg/dL compared to previous value within 3 months before admission

Exclusion Criteria:

History of cardiac transplantation and/or ventricular assist device
Concurrent diagnosis of an acute coronary syndrome defined as typical chest pain and/or electrocardiographic changes in addition to a troponin rise >99th percentile
Mean arterial blood pressure <65 mmHg, or systolic blood pressure <90 mmHg at the moment of admission
Use of intravenous inotropes, vasopressors or nitroprusside at any time point during the study
A baseline estimated glomerular filtration rate <15 mL/min/1.73m² according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at the moment of inclusion
Use of renal replacement therapy or ultrafiltration before study inclusion
Treatment with acetazolamide within the previous month
Treatment with ≥2 mg bumetanide or an equivalent dose during the index hospitalization before randomization
Use of diuretics, vasopressin antagonists or mineralocorticoid receptor antagonist not specified by the protocol
Exposure to nephrotoxic agents (i.e. contrast dye) anticipated within 3 days
Intervention: Roflumilast
Trial phase: Phase 3
ATC code: R03DX07
SMILES: O=C(Nc1c(Cl)cncc1Cl)c1ccc(OC(F)F)c(OCC2CC2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: 500 ug tablet daily for 180 days

Roflumilast: PDE4 inhibitor
Eligibility criteria:
Inclusion Criteria:

Primary diagnosis of AECOPD defined as acute increase in dyspnea, sputum volume, and/or sputum purulence without other identified cause; admission to the hospital <12 hours; patient age >40, < 80 years old; cigarette smoking > 10 pack-years; informed written consent.

Exclusion Criteria:

Prior diagnosis or high suspicion for asthma based on investigator judgment; pulmonary edema, pneumonia, interstitial lung disease or significant bronchiectasis based on admission chest x-ray; intubated and mechanically ventilated at the time of evaluation; active liver disease, or transaminase elevations (> 3xULN); history of alcoholism or heavy ethanol use; history of suicidal behavior ≤ 2 years or suicidal ideation ≤ 6 months prior to enrollment; pregnant or lactating females. Those on the following excluded medications: P450 inducers (e.g., rifampicin, phenobarbital, carbamazepine, and phenytoin) and CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine.
Intervention: Dapsone
Trial phase: Phase 3
ATC code: D10AX05 | J04BA02 | J04BA50 | J04BA51
SMILES: Nc1ccc(S(=O)(=O)c2ccc(N)cc2)cc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1044
Group description: Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of acne vulgaris
Willing to avoid excessive or prolonged exposure to ultraviolet light (eg, sunlight, tanning beds) throughout the study

Exclusion Criteria:

Severe cystic acne, acne conglobata, acne fulminans, or secondary acne
Use of phototherapy devices (eg, ClearLight™), energy-based devices, adhesive cleansing strips (eg, Pond's®, Biore®), or cosmetic procedures (eg, facials, peeling, comedo extraction) in the past week
Use of anti-inflammatory medications, salicylic acid; corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products [eg, benzamycin]), retinoids; other topical acne treatments (eg, photodynamic therapy, medicated soaps such as those containing benzoyl peroxide, salicylic acid, sulfur, or sodium sulfacetamide) in the past 2 weeks
Use of birth control pills strictly for acne control
Intervention: Cholecalciferol
Trial phase: Phase 2
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: Cholecalciferol: 100,000 IU/week for 12 weeks
Eligibility criteria:
Inclusion Criteria:

25 (OH) < 20 ng/ml
Peritoneal dialysis or hemodialysis > 3 months

Exclusion Criteria:

Use of vitamin D or its analogues, corticosteroids and immunosuppressive
Peritonitis in the previous month at baseline
Liver, neoplastic, infectious or autoimmune diseases and positive HIV
Hypercalcemia
Intervention: Ethanol
Trial phase: Not Applicable
ATC code: D08AX08 | V03AB16 | V03AZ01
SMILES: CCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: The experimental group of the study is comprised of patients that will undergo percutaneous ethanol ablation for the management of papillary thyroid microcarcinoma.

percutaneous ethanol ablation: The volume of 99% ethanol to be injected is calculated using a standardized formula. Ethanol is instilled with a needle under ultrasound guidance after administration of local anesthesia.
Eligibility criteria:
Inclusion Criteria:

Age 18 years and older
Diagnosis: single, cytology-proven papillary thyroid carcinoma measuring 1 cm or less in diameter (microcarcinoma, T1a), without visible extrathyroidal extension, and with negative central and lateral neck lymph nodes by ultrasound

Exclusion Criteria:

Patient refusal to participate
History of prior thyroid or parathyroid surgery
Previous recurrent laryngeal nerve injury
Inability to make decisions or comply with follow up
Co-existing indication for thyroidectomy
Aggressive cytological or molecular features
Multifocal papillary thyroid carcinoma
Pregnant or breast-feeding
Anatomically unfavorable location of the tumor (proximity to recurrent laryngeal nerve or trachea)
Documented or suspected distant metastasis
History of radiation to neck or face
Family history of thyroid cancer
Intervention: Dapsone
Trial phase: Phase 3
ATC code: D10AX05 | J04BA02 | J04BA50 | J04BA51
SMILES: Nc1ccc(S(=O)(=O)c2ccc(N)cc2)cc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1117
Group description: Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of acne vulgaris
Willing to avoid excessive or prolonged exposure to ultraviolet light (eg, sunlight, tanning beds) throughout the study

Exclusion Criteria:

Severe cystic acne, acne conglobata, acne fulminans, or secondary acne
Use of phototherapy devices (eg, ClearLight™), energy-based devices, adhesive cleansing strips (eg, Pond's®, Biore®), or cosmetic procedures (eg, facials, peeling, comedo extraction) in the past week
Use of anti-inflammatory medications, salicylic acid; corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products [eg, benzamycin]), retinoids; other topical acne treatments (eg, photodynamic therapy, medicated soaps such as those containing benzoyl peroxide, salicylic acid, sulfur, or sodium sulfacetamide) in the past 2 weeks
Use of birth control pills strictly for acne control
Intervention: Betamethasone
Trial phase: Phase 4
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: 0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc

Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc
Eligibility criteria:
Inclusion Criteria:

60 patients (30 per group) undergoing foot and ankle procedures
Willingness and ability to sign an informed consent document
No allergies to anesthetic or analgesic medications
American Society of Anesthesiologists (ASA)physical status Class I - III
Aged 18-90 years,either sex

Exclusion Criteria:

Refusal to participate in the study
Age<18 or> 90 years -
Contraindications to regional blockage including but not limited to:
Patient refusal to regional blockade
Infection at the site of needle insertion
Systemic infection
Bleeding diathesis or coagulopathy
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc

Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Eligibility criteria:
Inclusion Criteria:

60 patients (30 per group) undergoing foot and ankle procedures
Willingness and ability to sign an informed consent document
No allergies to anesthetic or analgesic medications
American Society of Anesthesiologists (ASA)physical status Class I - III
Aged 18-90 years,either sex

Exclusion Criteria:

Refusal to participate in the study
Age<18 or> 90 years -
Contraindications to regional blockage including but not limited to:
Patient refusal to regional blockade
Infection at the site of needle insertion
Systemic infection
Bleeding diathesis or coagulopathy
Intervention: Amlexanox
Trial phase: Phase 2
ATC code: A01AD07 | R03DX01
SMILES: CC(C)c1ccc2oc3nc(N)c(C(=O)O)cc3c(=O)c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks

Amlexanox
Eligibility criteria:
Inclusion Criteria:

≥ 18 years old at baseline.

Is male, female not of childbearing potential, or meets all the following criteria if female of childbearing potential (including perimenopausal women who have had a menstrual period within one year):

Not breastfeeding.
Negative pregnancy test result (human chorionic gonadotropin, beta subunit [βhCG]) at baseline (not applicable to hysterectomized females).
Must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate when use consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire duration of study period.
Has physician-confirmed diabetes mellitus with a clear diagnosis or per ADA criteria with fasting glucose>126 mg/dL or HbA1c >6.4% or 2 hour GTT >200 mg/dL.
BMI ≥27 and <45 kg/m2.
On no medications or only on first line oral medications (such as Metformin and/or DPP IV inhibitors) for treatment of Type 2 diabetes mellitus with a stable regimen for >12 weeks.
Alcohol consumption of less than 40 grams/week.
A liver US confirming presence of fatty infiltration of the liver.
Is able to read, understand and sign the U of M IRBMED approved informed consent form (ICF), communicate with study physician and study team, understand and comply with protocol requirements.

Exclusion Criteria:

On insulin, or other injectables for treatment of Type 2 diabetes.
Unable to conduct home based glucose monitoring.
HbA1c <6.5% and >10.0% (set to achieve uniformity in the study population).
Presence of advanced liver disease (as evidenced by abnormal synthetic function, abnormal PT or albumin).
Evidence of other etiologies of viral hepatitis.
Presence of hematologic, bone marrow and/or other abnormalities.
Presence of hemoglobinopathy or other hematological abnormalities that will interfere with accurate measurement of HbA1c.
Presence of HIV infection.
Inability to give informed consent.
Presence of ESRD, any type of active cancer, or >class 2 congestive heart failure ((New York Heart Association Functional Classification System), based on medical history and physical examination.
Active chronic infection such as known chronic osteomyelitis or tb, etc. (may be transient).
Creatinine >1.5 mg/dL.
Proliferative diabetic retinopathy, nonproliferative retinopathy is allowed.
Unable to ambulate.
Clinically relevant CAD: history of stent, CABG or cardiologist confirmed angina.
Any other condition in the opinion of the investigators that may impede successful data collection.
Intervention: Hydroxyurea
Trial phase: Phase 3
ATC code: L01XX05
SMILES: NC(=O)NO
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 104
Group description: Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months

Hydroxyurea
Eligibility criteria:
Inclusion Criteria:

Pediatric subjects with documented sickle cell anemia (HbSS supported by hemoglobin electrophoresis or by peripheral blood smear showing sickled red blood cells)
Age range of 1.00-3.99 years, inclusive, at the time of enrollment
Weight at least 5.0 kg at the time of enrollment
Willingness to comply with all study-related treatments, evaluations, and follow up

Exclusion Criteria:

Known chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis)
Severe malnutrition determined by impaired growth parameters as defined by WHO (weight for length/height or weight-for-length/height > 3 z-scores below the median WHO growth standards)

Pre-existing severe hematological toxicity:

Hb <4.0 g/dL
Hb <6.0 g/dL AND ARC <100 x 10E9/L
Hb <7.0 g/dL AND ARC <80 x 10E9/L
Platelets <80 x 10E9/L
ANC <1.0 x 10E9/L
Alanine transaminase (ALT) or creatinine >2 times the upper limit of normal for age
Blood transfusion within 30 days prior to enrollment
Intervention: Dabigatran
Trial phase: Phase 4
SMILES: Cn1c(CNc2ccc(C(=N)N)cc2)nc2cc(C(=O)N(CCC(=O)O)c3ccccn3)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.

dabigatran etexilate mesylate: Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.
Eligibility criteria:
Inclusion Criteria:

Male or female sex, age 18-85 years.
Negative pregnancy test for women of childbearing potential
Planned pulmonary vein isolation by antral radiofrequency or cryoablation for paroxysmal or persistent atrial fibrillation, non-valvular atrial fibrillation (NVAF), or left atrial flutter following prior left atrial ablation procedures
CHADS2 score of 0-6 or CHADS2-VASc score 0-9
Vascular hemostasis within 4-6 hours of sheath pull
Able to give informed consent

Exclusion Criteria:

Unable to give informed consent
Currently participating in another clinical treatment trial
History of hereditary hemophilias
Presence of active bleeding
End stage renal disease, CrCl<15 mL/min
Prior treatment failure of dabigatran (stroke or systemic thromboembolism while on therapeutic dabigatran)
Known allergic reaction to dabigatran etexilate
Intolerance to dabigatran, if medication naïve, or other contra-indications as per the USPI.
Pregnancy
History of non-compliance
Inability to follow-up
Intervention: Propofol
Trial phase: Phase 4
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 139
Group description: Propofol 20 mg IV (2 ml)

Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication
Eligibility criteria:
Inclusion Criteria:

Willingness and ability to sign an informed consent document
No allergies to midazolam or propofol
18 - 70 years of age
American Society of Anesthesiologists (ASA) Class I-III adults of either sex

Exclusion Criteria:

Patients with known allergy, hypersensitivity or contraindications to midazolam, propofol, anesthetic or analgesic medications
Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases
Pregnant or lactating women
Subjects with a history of alcohol or drug abuse within the past 3 months
Patients chronically using sedative, anxiolytic drugs prior to the surgery
Morbid obesity (BMI >40 kg/m2)
Patients who are agitated or confused prior to receiving the drug ( verbal rating scale [VRS] greater then 6)