louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06373432: Frequency of Glucose Monitoring in Labor
Official title: Intrapartum Glucose Monitoring of GDM: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neonatal Hypoglycemia
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to assess rates of neonatal hypoglycemia with differing intrapartum glucose protocols. Currently at this time there is no guidance from professional medical organizations about when and how frequent to assess maternal glucose levels intrapartum. Several institutions have no protocols in place. The study will be a randomized controlled trial placing patients with Gestational Diabetes Mellitus (GDM) in "frequent" vs "infrequent" glucose monitoring intrapartum and assessing neonatal glucose levels at birth.


Eligibility criteria: Inclusion Criteria:

* All female patients of reproductive age who have the diagnosis GDM
* Patient with singleton gestation presenting in labor or for induction

Exclusion Criteria:

* Patients below the age of 18
* Multiple gestation pregnancy
* Patients undergoing scheduled c-section

Primary outcomes:
measure: Neonatal Hypoglycemia
timeFrame: end of study at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New york
country: United States
facility: Mount Sinai West Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Thomas Owens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02085837: Healthy Transitions in Late Stage Kidney Disease
Official title: An Open Label Randomized Controlled Study to Compare the Impact of Patient Centered Nursing Services in Addition to a Nephrologist's Usual Patient Care With Usual Nephrologist's Care in Late Stage Chronic Kidney Disease Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Improve health and outcome for people with late stage chronic kidney disease by providing patient centered nursing services in addition to a Nephrologist's routine patient care.


Eligibility criteria: Inclusion Criteria:

* Stage 4-5 Chronic Kidney Disease (CKD), defined as estimated glomerular filtration rate (eGFR) between 0-30 ml/minute
* 18 years of age or older

Exclusion Criteria:

* Cognitive impairment that is clinically apparent

Primary outcomes:
measure: Hospitalization rate
timeFrame: 18 months
Secondary outcomes:
measure: Improve hemodialysis access rates
timeFrame: 18 months
measure: Home dialysis
timeFrame: 18 months
Other outcomes:
Locations:
city: Great Neck
country: United States
facility: Division of Kidney diseases and Hypertension
state: New York
Study officials:
affiliation: Northwell Health
name: Steven Fishbane, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03665337: The Reducing Risk Study
Official title: Reducing Risk: A Comprehensive mHealth Sleep Health Intervention for Adolescents at Risk for Depression and Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Delayed Sleep Phase
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study will test an innovative mobile health adaptation of a behavioral intervention that improves sleep and mental health concerns among adolescents.


Eligibility criteria: Inclusion Criteria:

Exclusion Criteria:

* any current psychiatric illness
* currently use of medications or herbs with known effects on sleep
* hospitalization for substance use or suicide within the past 12 months
* known sleep apnea
* unstable major medical conditions
* current psychotherapy for depression, anxiety or sleep health deficits

Primary outcomes:
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline to end of treatment (anticipated average exposure 2 months), months 3 and 8
Secondary outcomes:
measure: Change in the PHQ-9 (The 9 Item Patient Health Questionnaire For Depression)
timeFrame: baseline to end of treatment (anticipated average exposure 2 months), months 3 and 8
measure: Change in the SCARED (Screen for Child Anxiety Related Disorders) total score
timeFrame: baseline, and at months 1, 2, 3 and 8
measure: Change in cortisol reactivity and recovery in response to a stress exposure
timeFrame: baseline and at month 3
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Lauren Asarnow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05222737: Quantitation of Bacteria Associated With Severe Periodontitis by Real -Time PCR Following Application of Diode Laser
Official title: Quantitave Assessment of Aggregatibacter Actinomycetemcomitans and Porphyromonas Gingivalis by Real -Time PCR Following Application of Diode Laser in Severe Periodontitis (A RANDIOMIZED CONTROLLED CLINICAL TRIAL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Periodontal Pocket
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Primary objective To measure the gingival crevicular levels of A.actinomycetemcomitans and P.gingivalis after intra-pocket application of diode laser in severe periodontitis (stage 3 grade C) patients.
2. Secondary objective To compare the levels of the same microorganisms as in cases of diode laser therapy to those after conventional treatment with systemic antibiotic administration in severe periodontitis (stage 3 grade C) patients.
3. to measure clinical parameters probing depth,attachment loss and mobility grade


Eligibility criteria: Inclusion Criteria:

1. Patients of both sexes having severe periodontitis (stage 3 grade C) with interdental clinical attachment loss (CAL) ≥ 5.
2. Patients' age between 15 and 35 years old with rapid bone loss showed by radiograph.
3. Systemically healthy patients.
4. Radiographic bone loss extending to middle or apical third of root.
5. Probing depth (PD) ≥ 6 mm.

Exclusion Criteria:

1. Use of antibiotics during the last 3 months.
2. Pregnancy.
3. Any systemic condition that might affect the study.
4. Use of mouthwash containing antimicrobials during the previous 3 weeks.
5. Smoking.

Primary outcomes:
measure: Quantitation of Aggrecatibacter .actinomycetemcomitans and porphyromonas gingivalis bacteria
timeFrame: baseline
Secondary outcomes:
measure: comparing levels of bacteria between test and control groups
timeFrame: baseline
Other outcomes:
measure: Probing depth(PPD)
timeFrame: Baseline ,one month and 3 months
measure: Clinical Attachment loss(CAL)
timeFrame: Baseline ,one month and 3 months
measure: Mobility grade
timeFrame: Baseline ,one month and 3 months
Locations:
city: Alexandria
country: Egypt
facility: Amira Hafez
Study officials:
References:
Clinical trial NCT04401137: The Evaluation of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of QDX in Healthy Korean Male Subjects
Official title: A Single Center, Randomized, Double Blind, Placebo Controlled, Dose Escalation Clinical Trial to Evaluate Pharmacokinetic/Pharmacodynamic Characteristics and Safety of QDX After Single Oral Administration in Healthy Korean Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-26
Enrollment: 42
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate pharmacokinetic/pharmacodynamic characteristics and safety of QDX after single oral administration in healthy Korean male subjects


Eligibility criteria: Inclusion Criteria:

* Participants who have fully understood this clinical trial via detailed explanation, are willing to voluntarily participate in this study, and agree to give written informed consent which is confirmed from IRB.
* Healthy male participants aged between 19 and 45 years at screening
* Those whose body weight is over 50kg, and BMI is between 18.0 and 27.0
* Participants who have demonstrated at least a 100 percent (%) increase in dermal blood flow in 30 minutes after capsaicin challenge as part of the screening procedures.

Exclusion Criteria:

* Those who have a clinically significant disease of liver, kidney, digestive, respiratory, endocrine, neurologic, blood/tumor, cardiovascular system, or history of those diseases
* Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs (containing Topiramate etc.)
* Those who have a hereditary galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption syndrome
* Those who have irritating skin, wounds, eczema, and wounds on the area where capsaicin is applied

Primary outcomes:
measure: The Capsaicin-Induced Dermal Blood Flow (DBF)
timeFrame: Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 24 hour post-dosing on Day1
measure: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T])
timeFrame: Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1
measure: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration (AUClast)
timeFrame: Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1
measure: Time to Reach Maximum Plasma Concentration (Tmax)
timeFrame: Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Dept. of Clinical Pharmacology
Study officials:
References:
Clinical trial NCT06468137: Follow Up of an Online Hearing Support for First-time Hearing Aid Users
Official title: Follow Up of an Online Hearing Support for First-time Hearing Aid Users Using the Swedish I-ACE, Clinical Visit or Nothing
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hearing Loss
Hearing Impairment
Hearing Disorders
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Horselvarden Region Ostergotland
First posted: 2024-06-21
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main questions the research aims to answer are short- and long-term effects on consequences of hearing loss depending on which type of follow-up the participant chooses.

Detailed description: Investigation of the emotional and social consequences of hearing loss that the participants experience, use of communications strategies, experienced listening in complex sound environments and perceived effectiveness and satisfaction with hearing aids. The goal is also to assess changes in use of communication strategies and the emotional consequences, knowledge and acceptance of hearing loss.

Eligibility criteria: Inclusion Criteria:

* People who have participated in NCT06051968 are automatically enrolled to participate in the follow-up according to the study protocol.

Primary outcomes:
measure: The Hearing Handicap Inventory for the Elderly (HHIE)
timeFrame: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
Secondary outcomes:
measure: The 12-item Speech, Spatial and Qualities of Hearing Scale (SSQ12)
timeFrame: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
measure: Communication Strategies Scale (CSS)
timeFrame: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
measure: The International Outcome Inventory for Hearing Aids (IOI-HA)
timeFrame: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
measure: Communication and Acceptance Scale (CAS)
timeFrame: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
measure: The International Outcome Inventory for Alternative Interventions (IOI-AI)
timeFrame: Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
Other outcomes:
measure: Subjective impact of the intervention, reported by the users: Memory of the intervention
timeFrame: Time Frame: 6 months post intervention
measure: Subjective impact of the intervention, reported by the users: Seeking more or other information
timeFrame: Time Frame: 6 months post intervention
measure: Subjective impact of the intervention, reported by the users: Adverse effects
timeFrame: Time Frame: 6 months post intervention
Locations:
city: Lund
country: Sweden
facility: Audiologimottagningen Lund
Study officials:
affiliation: Horselvarden Region Ostergotland
name: Marie Öberg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01508637: Diesel Exhaust and Vascular Function
Official title: Effect of Diesel Exhaust Exposures on Vascular Function in Humans: The Role of Sympathetic Activation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Effects
Keywords: air pollution
vasoconstriction
blood pressure
diesel exhaust
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
name: Environmental Protection Agency (EPA)
First posted: 2012-01-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Double-blind, sham- and placebo-controlled randomized study of effects of freshly-generated diluted diesel exhaust inhalation on vascular function. To examine role of adrenergic system a trial of alpha-blocker terazosin is also used. Each participant completes four study sessions, separated by at least three weeks: 1) Diesel exhaust inhalation (DE, controlled at 300 micrograms/cubic meter for two hours) and terazosin (2 mg prior to inhalation exposure); 2) DE plus placebo (matched for terazosin); 3) filtered air plus terazosin; and 4) filter air plus placebo. The investigators assess outcomes of blood pressure, forearm brachial artery ultrasound, and plasma measures of endothelial activation. The investigators hypothesize that DE exposure will be associated with increased blood pressure, decreased brachial artery diameter, and increased circulating endothelins, and that these effects will be attenuated by terazosin administration.


Eligibility criteria: Inclusion Criteria:

* healthy without chronic illness
* Body Mass Index 18.5 - 26.0
* tolerates 2 mg terazosin dose without unacceptable symptoms
* able to return for four exposure sessions

Exclusion Criteria:

* any chronic disease
* tobacco user
* asthma
* elevated cholesterol
* obesity
* hypertension
* diabetes
* any chronic cardiovascular or pulmonary disease
* pregnancy or unwillingness to use effective contraception, if female

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 30-90 minutes after exposure initiation
Secondary outcomes:
measure: Brachial artery diameter
timeFrame: Assessed 30 minutes prior to exposure and 30 minutes post-exposure
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Joel D Kaufman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05547737: Multicenter, Prospective, Real World Study of Camrelizumab in Cross-line Treatment of Non-small Cell Lung Cancer
Official title: Multicenter, Prospective, Real World Study of Camrelizumab in Cross-line Treatment of Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: NSCLC
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2022-09-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage IIIb, IV, or relapsed non-small cell lung cancer diagnosed cytologically or histopathologically as EGFR/ALK-

Brief summary: To explore the effectiveness and safety of Camrelizumab based cross-line therapy for patients with advanced NSCLC in the real world


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent and volunteered to join the study
2. Aged \>=18 years
3. Patients with stage IIIb, IV, or relapsed non-small cell lung cancer diagnosed cytologically or histopathologically as EGFR/ALK-
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
5. At least one measurable lesion (according to RECIST 1.1)
6. No prior systemic therapy for advanced/metastatic NSCLC
7. contraception

Exclusion Criteria:

1. Those who are allergic to drug treatment；
2. Patients who were also treated with other immunodrugs or therapies；
3. Patients who are participating in other intervention studies；
4. Patients with other malignant tumors at the same time；
5. Pregnant or lactating women；
6. The investigator did not consider the patients eligible to participate in the study under any other circumstances.

Primary outcomes:
measure: Objective Response Rate (ORR) in second-line treatment of patients with non-small cell lung cancer based on Camrelizumab regimen
timeFrame: Up to 12 months
Secondary outcomes:
measure: Evaluation of Progression Free survival (PFS) in patients with non-small cell lung cancer based on first-line/second-line treatment with Camrelizumab
timeFrame: Up to 36 months
measure: Evaluation of second progression-free survival (PFS2) in patients with non-small cell lung cancer based on Camrelizumab regimen
timeFrame: Up to 12 months
measure: OS
timeFrame: Up to 12 months
measure: To evaluate the safety of Camrelizumab based first/second line therapy in patients with non-small cell lung cancer
timeFrame: Up to 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02718937: Safety, Efficacy and Pharmacokinetics of BTA-C585 in a RSV Viral Challenge Study
Official title: A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity Against Respiratory Syncytial Virus Infection, and the Pharmacokinetics of Multiple Oral Doses of BTA-C585 in the Virus Challenge Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus (RSV) Infection
Keywords: Viral diseases
Antiviral
Paramyxoviridae infections
RSV
Aviragen Therapeutics, Inc.
Aviragen Therapeutics
Aviragen
Lead sponsor: Vaxart
Sponsor class: INDUSTRY
First posted: 2016-03-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the antiviral activity of oral BTA-C585 compared to placebo in healthy volunteers after intranasal challenge with RSV-A Memphis 37b virus.


Eligibility criteria: Inclusion Criteria:

1. Healthy male or female
2. Between 18 to 50 years old
3. Body mass index of 18 to 30 kg/m2

Exclusion Criteria:

1. Acute or chronic medical illness
2. Abnormal lung function Positive for HIV, Hepatitis B or C
3. Any significant abnormality of the nose or nasopharynx

Primary outcomes:
measure: Area under the curve (AUC) viral load of RSV-A Memphis 37b
timeFrame: Days 2-13
Secondary outcomes:
measure: Area under the curve (AUC) of total RSV symptom scores
timeFrame: Days 1-13
measure: Number of adverse events
timeFrame: Screening to Day 28
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Biota Investigational Site
Study officials:
affiliation: Aviragen Therapeutics, Inc.
name: Anna Novotney-Barry
role: STUDY_DIRECTOR
References:
Clinical trial NCT01295437: Comparison of Three Meshes in Lichtenstein Hernia Repair
Official title: A Single-surgeon Randomized Study Comparing Three Composite Meshes on Chronic Pain After Lichtenstein Hernia Repair in Local Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Recurrences
Keywords: inguinal hernia, Lichtenstein hernioplasty, chronic pain
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Mikkeli Central Hospital
First posted: 2011-02-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic pain may be a long-term problem after inguinal Lichtenstein hernioplasty. The aim of this study was to compare long-term results of hernioplasty using three different meshes (partly absorbable, lightweight polypropylene and thick polypropylene mesh).

Detailed description: Inguinal hernioplasty was performed under local anesthesia in 300 patients in day-case surgery by the same surgeon and exactly by the same surgical technique. The patients were randomized to receive either a partly polypropylene-polyglactin mesh (Vypro II, 100 hernias), a lightweight polypropylene mesh (Premilene LP, 100 hernias) or a conventional densely woven polypropylene mesh (Premilene, 100 hernias). Pain, patients discomfort and recurrences of hernias were carefully followed 5 years after surgery.

Eligibility criteria: Inclusion Criteria:

* uni-or bilateral primary or recurrent inguinal hernia
* patients age \>18yrs

Exclusion Criteria:

* previous mesh hernioplasty
* femoral hernia
* emergency operation
* allergy to polypropylene

Primary outcomes:
measure: Presence of chronic pain
timeFrame: 5 years
Secondary outcomes:
measure: Presence of recurrences
timeFrame: 5 years
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Hannu Paajanen
Study officials:
affiliation: University Hospital of Kuopio, Finland
name: Hannu EK Paajanen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paajanen H. A single-surgeon randomized trial comparing three composite meshes on chronic pain after Lichtenstein hernia repair in local anesthesia. Hernia. 2007 Aug;11(4):335-9. doi: 10.1007/s10029-007-0236-1. Epub 2007 May 10.
citation: Paajanen H, Ronka K, Laurema A. A single-surgeon randomized trial comparing three meshes in lichtenstein hernia repair: 2- and 5-year outcome of recurrences and chronic pain. Int J Surg. 2013;11(1):81-4. doi: 10.1016/j.ijsu.2012.11.020. Epub 2012 Dec 13.