anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Naltrexone
Trial phase: Phase 1 | Phase 2
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 66
Group description: Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg
Eligibility criteria:
Inclusion Criteria:

Meets DSM-IV criteria for opioid dependence
Age > 18 years
Confirmed HIV infection, either through positive HIV antibody or detectable HIV-1 RNA level.
Within the Connecticut Department of Corrections (CTDOC) or Hampden County Correctional Center (HCCC) and within 30 days of being released to the greater New Haven, Hartford or Springfield areas or within 30 days after release from CTDOC or HCCC.
No participation in pharmacotherapy trial in the previous 30 days
Not pregnant

Exclusion Criteria:

Unable to provide informed consent
Verbally or physically threatening to research staff
Unable to communicate in either English or Spanish
Pending trials for a felony
Liver failure (Childs-Pugh Class B or C Cirrhosis)
Grade IV Hepatitis (liver function tests > 10X normal)
Receiving opioid prescription narcotics or has pain syndrome necessitating future use of opioid prescription narcotics.
Receiving active methadone or buprenorphine/naloxone for the treatment of opioid dependency
Active opioid withdrawal (within 3-5 days since last opioid ingestion)
Pregnancy or unwilling to take contraceptives measures
Breast-feeding
Intervention: Naltrexone
Trial phase: Phase 1 | Phase 2
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 27
Group description: Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg
Eligibility criteria:
Inclusion Criteria:

Meets DSM-IV criteria for opioid dependence
Age > 18 years
Confirmed HIV infection, either through positive HIV antibody or detectable HIV-1 RNA level.
Within the Connecticut Department of Corrections (CTDOC) or Hampden County Correctional Center (HCCC) and within 30 days of being released to the greater New Haven, Hartford or Springfield areas or within 30 days after release from CTDOC or HCCC.
No participation in pharmacotherapy trial in the previous 30 days
Not pregnant

Exclusion Criteria:

Unable to provide informed consent
Verbally or physically threatening to research staff
Unable to communicate in either English or Spanish
Pending trials for a felony
Liver failure (Childs-Pugh Class B or C Cirrhosis)
Grade IV Hepatitis (liver function tests > 10X normal)
Receiving opioid prescription narcotics or has pain syndrome necessitating future use of opioid prescription narcotics.
Receiving active methadone or buprenorphine/naloxone for the treatment of opioid dependency
Active opioid withdrawal (within 3-5 days since last opioid ingestion)
Pregnancy or unwilling to take contraceptives measures
Breast-feeding
Intervention: Curcumin
Trial phase: Phase 2 | Phase 3
SMILES: COc1cc(/C=C/C(=O)CC(=O)/C=C/c2ccc(O)c(OC)c2)ccc1O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 686
Group description: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week

Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week
Eligibility criteria:
Inclusion Criteria:

a diagnosis of non-inflammatory breast adenocarcinoma (including in situ and bilateral)
scheduled to begin radiotherapy without concurrent chemotherapy; concurrent hormone or Herceptin® (trastuzumab)treatment is okay
can have been treated by lumpectomy or mastectomy with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment
can have had breast reconstruction
scheduled to receive 25-35 radiation treatment sessions (1 session per day) using standard irradiation fractionation (1.8-2.0 Gy per sessions) OR 16-20 radiation treatment sessions (1 session per day) using Canadian irradiation fractionation (2.2-3.0 Gy per session)(100, 101).
able to swallow medication.
three weeks must have elapsed after chemotherapy and surgery before the patient can begin the study
able to understand English

Exclusion Criteria:

inflammatory breast cancer
previous radiation therapy to the breast or chest
concurrent chemotherapy treatment
concurrent treatment with anti-coagulants (e.g., coumadin®, warfarin®), or anti-EGFR (human epidermal growth factor receptor) drugs (e.g. Iressa® (gefitinib), Erbitux® (cetuximab, C225); aspirin is allowed
known radiosensitivity syndromes (e.g., Ataxia-telangiectasia)
collagen vascular disease, unhealed surgical sites, or breast infections
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 62
Group description: Nebulized 3% saline: 4 mL of nebulized 3% saline once
Eligibility criteria:
Inclusion Criteria:

Age 8 weeks through 23 months
First episode of wheezing associated with respiratory distress and upper respiratory tract infection.
Respiratory Distress Assessment Instrument (RDAI) rating of ≥4 and ≤15 after initial albuterol nebulization per standard care
Pediatric Emergency Medicine (PEM) physician does not plan additional bronchodilator therapy within the hour after initial assessment.
Parental/guardian permission (informed consent)

Exclusion Criteria:

Subjects with prior history of wheezing or asthma or who have received bronchodilator therapy prior to the current illness
Chronic lung or heart disease
Critically ill infants requiring immediate airway stabilization
Non-English speaking parent/guardian
Inability to take nebulized medications
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 62
Group description: Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
Eligibility criteria:
Inclusion Criteria:

Age 8 weeks through 23 months
First episode of wheezing associated with respiratory distress and upper respiratory tract infection.
Respiratory Distress Assessment Instrument (RDAI) rating of ≥4 and ≤15 after initial albuterol nebulization per standard care
Pediatric Emergency Medicine (PEM) physician does not plan additional bronchodilator therapy within the hour after initial assessment.
Parental/guardian permission (informed consent)

Exclusion Criteria:

Subjects with prior history of wheezing or asthma or who have received bronchodilator therapy prior to the current illness
Chronic lung or heart disease
Critically ill infants requiring immediate airway stabilization
Non-English speaking parent/guardian
Inability to take nebulized medications
Intervention: Tranexamic acid
Trial phase: Not Applicable
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Tranexamic Acid: Infusion during cardiac surgery
Eligibility criteria:
Inclusion Criteria:

Is the subject 18 years of age or older?
Is the subject scheduled for primary cardiac surgery utilizing cardiopulmonary bypass(CPB)?
Is the subject more than 30 kg ( 66 lbs)?
Does subject understand English?

Exclusion Criteria:

Does the subject have existing coagulation defects (INR > 1.5, platelets < 100 ?
Does the subject have renal failure (defined as BUN/Cr ratio 20:1 ?
Does the subject have severe liver disease (AST & ALT> 3x normal) ?
Is the subject having emergency cardiac surgery, complex aortic surgery, combination valve/CABG surgeries, or redo cardiac surgery?
Is the subject having any procedure where CPB is not anticipated?
Is the patient weight greater than 150 kg?
Intervention: Aminocaproic acid
Trial phase: Not Applicable
ATC code: B02AA01
SMILES: NCCCCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Aminocaproic Acid: Infusion during cardiac surgery
Eligibility criteria:
Inclusion Criteria:

Is the subject 18 years of age or older?
Is the subject scheduled for primary cardiac surgery utilizing cardiopulmonary bypass(CPB)?
Is the subject more than 30 kg ( 66 lbs)?
Does subject understand English?

Exclusion Criteria:

Does the subject have existing coagulation defects (INR > 1.5, platelets < 100 ?
Does the subject have renal failure (defined as BUN/Cr ratio 20:1 ?
Does the subject have severe liver disease (AST & ALT> 3x normal) ?
Is the subject having emergency cardiac surgery, complex aortic surgery, combination valve/CABG surgeries, or redo cardiac surgery?
Is the subject having any procedure where CPB is not anticipated?
Is the patient weight greater than 150 kg?
Intervention: Growth hormone
Trial phase: Phase 3
SMILES: CC(C)CC1NC(=O)C(CCC(=O)O)NC(=O)C2CSSCC3NC(=O)C(C)NC(=O)C4CCCN4C(=O)C(CC(N)=O)NC(=O)C(CSSCC(NC(=O)C(Cc4ccc(O)cc4)NC(=O)C(CC(N)=O)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(N)CC(N)=O)C(=O)N2)NC(=O)C(CSSC(C(=O)NC(Cc2ccc(O)cc2)C(=O)O)NC(=O)CNC(=O)C(C(C)O)NC3=O)NC1=O
Sex: Male
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years

Growth Hormone
Eligibility criteria:
Inclusion Criteria:

Males: Ages: 12 - less than 18 years.
Bone age less than 14 ½ years at study initiation.
Presence of puberty.
Idiopathic short stature will be defined as a short child equal or less than -2SD for height, with normal GH responses to stimuli (> or = 5ng/ml to at least 2 secretagogues) or a normal IGF-I and BP-3, normal body proportions and no other identifiable growth pathology.
Accurate growth data for at least 6 months at baseline is available.

Exclusion Criteria:

Chronic illnesses.
Chronic use of glucocorticosteroids.
Previous use of hormonal treatment with AIs, sex steroids or GH in the preceding 6 months.
Birth weight small for gestational age (SGA).
Intervention: Sumatriptan
Trial phase: Phase 4
ATC code: G01AE10 | N02CC01
SMILES: CNS(=O)(=O)Cc1ccc2[nH]cc(CCN(C)C)c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 271
Group description: 1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
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.

Exclusion 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, ophthalmoplegic 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)
Routine use (≥ 10 days per month, on average) of any medication having the potential to interfere with the pharmacologic effects or evaluation of the study medications (e.g., narcotic and non-narcotic analgesic products (prescription or over-the-counter), ergotamine-containing and ergot-type medication, anxiolytics, hypnotics, sedatives, 5HT-1 agonists, anti-emetics, or prokinetic drugs).
History of vomiting during more than 20% of migraine episodes or confined to bedrest for more than 50% of migraine episodes.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Oseltamivir
Trial phase: Phase 4
ATC code: J05AH02
SMILES: CCOC(=O)C1=C[C@@H](OC(CC)CC)[C@H](NC(C)=O)[C@@H](N)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: These patients will receive early oseltamivir plus current, standard empiric antibacterial therapy.

oseltamivir: These patients will receive early (within 8-12 hours of admission, no later than 24 hours after admission) oseltamivir plus current, standard empiric antibacterial therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP (2). Anti-influenza therapy will be given using oseltamivir at a dose of 75 mg twice daily. The oseltamivir dose will be adjusted in patients with renal insufficiency according to the package insert. Duration of antiviral therapy will be for a minimum of 5 days for patients with evidence of early clinical improvement and prolonged depending on clinical stability
Eligibility criteria:
Inclusion Criteria:

For oseltamivir and standard of care groups:

18 years of age or older
No oseltamivir or zanamivir ordered in hospital admission orders
Meets criteria for acute LRTI
Signed informed consent.

Exclusion Criteria:

For oseltamivir and standard of care groups:

Oseltamivir or zanamivir ordered in hospital admission orders
Patients hospitalized for the LRTI for more than 24 hours before enrollment into the trial.
Patients with mental conditions who are unlikely to comply with the study protocol and who cannot give informed consent and have no guardian or proxy.
Patients who have had severe allergic reactions such as anaphylaxis or serious skin reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, or erythema multiforme to any component of oseltamivir (TAMIFLU).
Prisoners
Intervention: Carboplatin
Trial phase: Phase 2
ATC code: L01XA02
SMILES: [H]N([H])([H])->[Pt]1(<-N([H])([H])[H])OC(=O)C2(CCC2)C(=O)O1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatin containing chemotherapy regimen.

carboplatin: Carboplatin Standard 30-minute infusion. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg (or famotidine 20mg IV)IV and diphenhydramine 50mg IV before carboplatin infusion.
Eligibility criteria:
Inclusion Criteria:

MSKCC Histologically confirmed ovarian, fallopian tube or primary peritoneal carcinoma.
Patient has received at least one prior platinum-containing (cisplatin or carboplatin) regimen
Age ≥ 21 years old
Karnofsky Performance Status (KPS) > or = to 70%
Adequate hematologic, hepatic and renal function as defined below:
Hemoglobin ≥ 7.0 g/dl
Absolute neutrophil count ≥ 1,000/mm3
Platelet count ≥ 100,000/mm3
Serum creatinine ≤ 1.5 x the upper limit of normal or calculated creatinine clearance ≥ 60 mL/min

Exclusion Criteria:

Prior carboplatin or cisplatin hypersensitivity reaction
Uncontrolled intercurrent illness including infection, congestive heart failure, myocardial infarction, transient ischemic attack or stroke within 6 months. Any such conditions that have occurred in the last 6 months but are no longer active at the time of registration are not considered exclusionary.
Patients receiving other investigational agents
Patients with HIV disease will be permitted, only if they are on effective antiretroviral therapy, have a CD4 count greater than 400, and have had no opportunistic infections within the past 6 months
Pregnant or lactating women
Life expectancy of less than 12 weeks
Intervention: Carboplatin
Trial phase: Phase 2
ATC code: L01XA02
SMILES: [H]N([H])([H])->[Pt]1(<-N([H])([H])[H])OC(=O)C2(CCC2)C(=O)O1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatincontaining chemotherapy regimen.

carboplatin: Extended 3-hour infusion carboplatin. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg IV (or famotidine 20mg IV) and diphenhydramine 50mg IV before carboplatin infusion.
Eligibility criteria:
Inclusion Criteria:

MSKCC Histologically confirmed ovarian, fallopian tube or primary peritoneal carcinoma.
Patient has received at least one prior platinum-containing (cisplatin or carboplatin) regimen
Age ≥ 21 years old
Karnofsky Performance Status (KPS) > or = to 70%
Adequate hematologic, hepatic and renal function as defined below:
Hemoglobin ≥ 7.0 g/dl
Absolute neutrophil count ≥ 1,000/mm3
Platelet count ≥ 100,000/mm3
Serum creatinine ≤ 1.5 x the upper limit of normal or calculated creatinine clearance ≥ 60 mL/min

Exclusion Criteria:

Prior carboplatin or cisplatin hypersensitivity reaction
Uncontrolled intercurrent illness including infection, congestive heart failure, myocardial infarction, transient ischemic attack or stroke within 6 months. Any such conditions that have occurred in the last 6 months but are no longer active at the time of registration are not considered exclusionary.
Patients receiving other investigational agents
Patients with HIV disease will be permitted, only if they are on effective antiretroviral therapy, have a CD4 count greater than 400, and have had no opportunistic infections within the past 6 months
Pregnant or lactating women
Life expectancy of less than 12 weeks
Intervention: Pentoxifylline
Trial phase: Phase 2
ATC code: C04AD03 | R03DA20
SMILES: CC(=O)CCCCn1c(=O)c2c(ncn2C)n(C)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: All patients received same intervention.
Eligibility criteria:
Inclusion Criteria:

Male and female patients ages 18 to 76 years.

Established diagnosis of PBC based on at least three of the following criteria:

Detectable anti-mitochondrial antibodies (AMA)
Cholestatic biochemical pattern
Liver biopsy compatible with PBC
Appropriate exclusion of other liver diseases.
Therapy with UDCA at adequate dose (13-15mg/kg/d) for at least six months and evidence of suboptimal response defined by alkaline phosphatase levels that did not normalize and remain elevated by at least 1.5 times the upper limit of normal.
No history or present hepatic decompensation (e.g. variceal hemorrhage, encephalopathy, or poorly controlled ascites).

Exclusion Criteria:

Findings highly suggestive of liver disease of other etiology.
A score >=10 points on the Revised Scoring System for autoimmune hepatitis (AIH), supporting a diagnosis of PBC/AIH overlap.
Patients on steroids (systemic), immunosuppressants, or immunomodulatory agents within the previous 6 months.
Patients with clinical or laboratory evidence suggestive of decompensated cirrhosis.
Hypersensitivity to PTX or the methylxanthines (caffeine, theophylline, theobromine).
History of cerebral or retinal hemorrhage.
Other medical comorbidities (such as cardiac, renal, cancer) that would interfere with completion of the study.
Patients taking Theophylline or Coumadin because of potential drug-drug interactions with PTX. In addition, patients taking low molecular weight heparin preparations.
Pregnant or nursing women.
Intervention: RISEDRONIC ACID
Trial phase: Phase 3
ATC code: M05BA07 | M05BB02 | M05BB04 | M05BB07
SMILES: O=P(O)(O)C(O)(Cc1cccnc1)P(=O)(O)O
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Risedronate 5mg years 1-7, no drug year 8
Eligibility criteria:
Inclusion Criteria:

Post-menopausal women who sequentially completed studies RVE009093, RVE1996077, RVE1998080

Exclusion Criteria:

Less than 60% compliant between drug start and month 21
Using bisphosphonates, glucocorticoids, anabolic steroids, vitamin D supplements, calcitrol, estrogen or estrogen-related drugs, progestogen, depot injection >10,000 IU vitamin D, investigational drug
Intervention: Omeprazole
Trial phase: Phase 4
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: esomeprazole 40 mg once daily, 8 weeks
Eligibility criteria:
Inclusion Criteria:

Male or female aged 20 years or more
Documented history of reflux esophagitis verified by endoscopy in the past, including the grade of Los Angeles (LA) classification (Lundell LR et al 1999) before treatment
Ongoing (until date of Visit 1) treatment with rabeprazole 20 mg, given once daily, for a period of 4 to 8 weeks. The subject must take Rabeprazole at least 4 days a week in the past 7 days prior to Visit 1.
Persisting symptoms of heartburn during the past 7 days prior to Visit 1, judged by the investigator(s) as follows: At least 2 days with moderate (i.e. discomfort sufficient to cause interference with normal activities) to severe symptoms (i.e. incapacitating, with inability to perform normal activities) OR At least 4 days with symptoms including mild ones (i.e. awareness of sign or symptom, but easily tolerated).
The subject needs to be able to understand and read the official languages of the country.

Exclusion Criteria:

Use of other PPIs and/or H2RA during rabeprazole treatment
Previous use of esomeprazole 40 mg during the 12 weeks before enrolment
Current or historical evidence of gastrointestinal pathology
History, signs or symptoms of clinically significant or uncontrolled cardiovascular, pulmonary, renal, endocrine, hematologic, neurologic, psychiatric pancreatic or hepatic disease as judged by the investigator to interfere with the conduct of the study, the interpretation of study results, subject compliance, or the health of the subject during the study.
Documented upper gastrointestinal surgery such as gastric resection, vagotomy and/or pyloroplasty, hiatus hernia surgery or fundoplication. Note: endoscopic polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection or simple suturing of an ulcer are not exclusion criteria.
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: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Group A (study group) Lidocaine administration
Eligibility criteria:
Inclusion Criteria:

Female patients undergoing outpatient laparoscopic gynecologic surgery
American society of anesthesiologists class (ASA) Physical status (PS) I and II
Age between 18 and 64 years
Fluent in English
Body mass index (BMI) less than 35

Exclusion Criteria:

History of allergy to local anesthetics
History of chronic opioid use
Pregnant patients
Body Mass Index (BMI) greater than 35
History of electrocardiogram (EKG) abnormalities
Hepatic Impairment
History of congestive heart failure
Electrocardiogram (EKG) abnormalities
History of heart block (subject with history of heart block)
Current use of anti-arrhythmic medications

Drop -Outs:

Patient or surgeon request
Conversion of the surgery from laparoscopic to open