louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01798511: Oral Refeeding IntOlerance After Nasogastric Tube Feeding (ORION)
Official title: A Randomized Controlled Trial of Oral Refeeding Intolerance After Nasogastric Tube Feeding
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Pancreatitis
Keywords: enteral nutrition
acute pancreatitis
oral food intolerance
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Acute pancreatitis (AP) is one of the most common diseases in routine clinical practice of surgeons and gastroenterologists throughout the world. The high rate of pain relapse after oral refeeding contributes to high consumption of healthcare resources and prolonged hospital stay in AP patients. The data from the pilot MIMOSA trial suggest that early administration of nasogastric tube feeding may prevent pain relapse after oral refeeding in AP. The potential beneficial effects of enteral tube feeding include induction of postprandial gastrointestinal motility and improving the tolerance of oral refeeding. This may reduce the risk of pain relapse, thereby shortening length of hospital stay and reducing cost of treatment. The primary endpoint of the ORION trial will be the incidence of oral food intolerance. All eligible AP patients will be randomly allocated to either the Early Nasogastric Tube (ENT) group or Conventional Nutritional Management group (CNM) at 24h of hospital admission.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of AP
* Age 18 years or older
* Written informed consent
* Ongoing need for opiates

Exclusion Criteria:

* 96 hours after onset of symptoms
* Chronic pancreatitis
* Post-ERCP pancreatitis
* Intraoperative diagnosis
* Pregnancy
* Malignancy
* Received nutrition before randomisation

Primary outcomes:
measure: Incidence of oral food intolerance
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcomes:
measure: Progression of severity
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
measure: Pain relapse
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
measure: Use of opioids
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
measure: Duration of hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: University of Auckland
Study officials:
affiliation: University of Auckland, New Zealand
name: Max Petrov, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05714228: Validation of the EuroSCORE II in Open and Trans-catheter Mitral Valve Repair.
Official title: Validation of the EuroSCORE II in Open and Trans-catheter Mitral Valve Repair.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Valve Regurgitation
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 2645
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent surgical or transcatheter mitral valve repair

Brief summary: The EuroSCORE II is widely used to predict 30-day mortality in patients undergoing open and trans-catheter cardiac surgery

* However, it has not been validated in patients undergoing surgical or trans- catheter mitral valve repair.
* The aim of this study is to evaluate the predictive value of the EuroSCORE II in estimating 30-day mortality in a large cohort of patients undergoing surgical and trans-catheter repair by means of Mitraclip implantation.

Methods

* Institutional database retrospective review for surgical mitral repair and MitraClip implantation.
* Time frame: January 2012-December 2019
* 2793 patients identified; Euroscore II 1.3% \[0.6%-2%\]
* Survival after hospital discharge was assessed by outpatients visit, usually done 2 months after the index procedure.

Statistical analysis

* Receiver operating characteristic (ROC) curves were used to determine the cut-offs of Euroscore II. ROC Area Under the Curve (AUC) values varies between 0 and 1, where 0.5 denotes a bad diagnostic test and 1 denotes an excellent diagnostic test.
* The maximum Youden's Index (J=sensitivity + specificity - 1) was employed to define the optimal cut-point.
* ROC curves were repeated for surgical and MitraClip patients separately, and for primary and secondary etiology as well.


Eligibility criteria: Inclusion Criteria:

* Patients undewent mitral valve repair with an open surgical approach, also in association with concomitant procedures (for example, but not limited to, aortic valve replacement, tricuspid repair, etc.)
* Patients undergoing transcatheter mitral valve repair with MitraClip implantation
* Patients operated on at the U.O. of Cardiac Surgery at the San Raffaele Hospital from January 2012 to December 2019

Exclusion Criteria:

* Patients underwent mitral valve replacement with prosthesis
* Cardiac surgery patients not eligible for mitral valve surgery
* Patients undergoing mitral implantation, both open and transcatheter, of devices in experimental clinical study (e.g., but not limited to, adjustable rings and neocords, etc.)

Primary outcomes:
measure: Euroscore II overall predictive power
timeFrame: 30 days postop
measure: Euroscore II predictive power for surgery
timeFrame: 30 days postop
measure: Euroscore II predictive power for transcatheter
timeFrame: 30 days postop
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References:
Clinical trial NCT01695928: Effect of Shock Waves on Tooth Movement and Miniscrew Stability
Official title: Effect of Low-energy Extracorporeal Shock Waves on Orthodontic Tooth Movement and Miniscrew Stability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Mesial Movement of Teeth
Miniscrew Stability
Keywords: Velocity
Location
Periodontal status
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The low-energy extracorporal shockwave is a scientifically approved method to activate respectively increase bone-turnover processes especially in orthopedic medicine. The aim of this clinical study is to apply this effect in orthodontic dentistry and evaluate the orthodontic tooth movement respectively miniscrew stability clinically.

This randomized clinical study is carried out in orthodontic patients undergoing space closure therapy at the university clinic of dentistry. During this period the tooth movement rate as well as the miniscrew stability are evaluated consecutively chairside.


Eligibility criteria: Inclusion Criteria:

* healthy patients which don´t fulfill the exclusion criteria

Exclusion Criteria:

* disease (syndroms,infections,...) which influence the bone turnover and the oral health
* medication, which influences the bone turnover and the oral health
* pregnancy

Primary outcomes:
measure: Orthodontic tooth movement
timeFrame: 4 months
Secondary outcomes:
measure: Miniscrew stability
timeFrame: 4 months
Other outcomes:
measure: Periodontal status
timeFrame: 4 months
Locations:
city: Vienna
country: Austria
facility: Bernhard Gottlieb University clinic of Dentistry
Study officials:
affiliation: Bernhard Gottlieb University Clinic of Dentistry, Department of Orthodontics
name: Hans P Bantleon, Prof, M.D.
role: STUDY_CHAIR
References:
citation: Sathishkumar S, Meka A, Dawson D, House N, Schaden W, Novak MJ, Ebersole JL, Kesavalu L. Extracorporeal shock wave therapy induces alveolar bone regeneration. J Dent Res. 2008 Jul;87(7):687-91. doi: 10.1177/154405910808700703.
citation: Martini L, Giavaresi G, Fini M, Torricelli P, de Pretto M, Schaden W, Giardino R. Effect of extracorporeal shock wave therapy on osteoblastlike cells. Clin Orthop Relat Res. 2003 Aug;(413):269-80. doi: 10.1097/01.blo.0000073344.50837.cd.
citation: Hazan-Molina H, Kaufman H, Reznick ZA, Aizenbud D. [Orthodontic tooth movement under extracorporeal shock wave therapy: the characteristics of the inflammatory reaction--a preliminary study]. Refuat Hapeh Vehashinayim (1993). 2011 Jul;28(3):55-60, 71. Hebrew.
citation: Falkensammer F, Rausch-Fan X, Arnhart C, Krall C, Schaden W, Freudenthaler J. Impact of extracorporeal shock-wave therapy on the stability of temporary anchorage devices in adults: a single-center, randomized, placebo-controlled clinical trial. Am J Orthod Dentofacial Orthop. 2014 Oct;146(4):413-22. doi: 10.1016/j.ajodo.2014.06.008.
Clinical trial NCT01480128: Multicenter Single-port Colectomy RCT
Official title: A Multicenter Prospective Randomized Clinical Trail on the Efficacy of the Single Port Laparoscopic Surgery Compared With Multiport Laparoscopic Surgery
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Colon Neoplasms
Keywords: Single-port
Laparoscopy
colectomy
Single port
colon cancer
minimally invasive surgery
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: Kyunghee University
name: Chonnam National University
First posted: 2011-11-28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This clinical trial is going to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment, in terms of safety, efficacy, and cost.

The investigators hypothesize that the single-port laparoscopic colectomy is not inferior to multiport laparoscopic colectomy.

Detailed description: This clinical trial is a multicenter prospective randomized trial to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment.

Eligibility criteria: Inclusion Criteria:

* colon adenocarcinoma
* curative resection
* age : 20 \~ 85

Exclusion Criteria:

* distal transverse colon cancer
* splenic flexure colon cancer
* descending colon cancer
* emergency operation
* obstruction
* perforation
* ASA 3 or 4
* pregnant woman
* tumor associated with FAP, HNPCC, or IBD
* distant metastasis
* adjacent organ invasion
* synchronous colorectal cancer
* other malignancy within last five years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: St. Vincent's hospital
Study officials:
affiliation: The Catholic University of Korea
name: Jun-Gi Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang BM, Lee YS, Kim JH, Kim HJ, Lee SC, Kim CW, Lim SW, Kim JG, Lee SH. Quality of life and patient satisfaction after single- and multiport laparoscopic surgery in colon cancer: a multicentre randomised controlled trial (SIMPLE Trial). Surg Endosc. 2021 Nov;35(11):6278-6290. doi: 10.1007/s00464-020-08128-9. Epub 2020 Nov 3.
citation: Lee YS, Kim JH, Kim HJ, Lee SC, Kang BM, Kim CW, Lim SW, Lee SH, Kim JG. Short-term Outcomes of Single-port Versus Multiport Laparoscopic Surgery for Colon Cancer: The SIMPLE Multicenter Randomized Clinical Trial. Ann Surg. 2021 Feb 1;273(2):217-223. doi: 10.1097/SLA.0000000000003882.
citation: Kang BM, Kim HJ, Kye BH, Lee SC, Lee KY, Park SJ, Lee SH, Lim SW, Lee YS, Kim JH, Lee J, Kim MK, Kim JG. Multicenter, randomized single-port versus multiport laparoscopic surgery (SIMPLE) trial in colon cancer: an interim analysis. Surg Endosc. 2018 Mar;32(3):1540-1549. doi: 10.1007/s00464-017-5842-0. Epub 2017 Sep 15.
Clinical trial NCT01278628: SUMCO Metabolic Syndrome Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metabolic Syndrome
Lead sponsor: Fukuoka University
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 114
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Physical activity is considered important in prevention and treatment of obesity and metabolic syndrome. Genotype of genes involved in metabolism is also known to be associated with the development of metabolic syndrome. However, scarce evidence exists regarding the influence of physical activity intensity and genotype on metabolic syndrome in people with obesity. The investigators examine physical activity using an uniaxial accelerometer, as well as aerobic fitness using an electric bicycle ergometer, several genotypes of genes related to glucose and lipid metabolisms in middle-aged men with obesity and/or abdominal obesity who were employees in silicon wafer manufacture and participated in a health checkup.


Eligibility criteria: Inclusion Criteria:

* healthy people and individuals with obesity and metabolic syndrome

Exclusion Criteria:

-

Primary outcomes:
measure: Components of metabolic syndrome
timeFrame: every year
Secondary outcomes:
Other outcomes:
Locations:
city: Imari
country: Japan
facility: SUMCO corporation
state: Saga
Study officials:
References:
Clinical trial NCT03947528: Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fed Conditions
Official title: A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2019-05-13
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fed Conditions

Detailed description: To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg after a single oral dose administration in healthy volunteers under fed conditions

Eligibility criteria: Inclusion Criteria:

* Healthy, non-smoking, male and female subjects, 19 years of age or older
* BMI ≥ 18.0 and ≤ 30.0 kg/m2.
* Females who participate in this study will be of childbearing or non- childbearing potential

Exclusion Criteria:

* Know history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results

Primary outcomes:
measure: Maximum Plasma Concentration
timeFrame: 0~24hours
measure: Area under the plasma concentration versus time curve
timeFrame: 0~24hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Daewoong pharmatceutical
Study officials:
References:
Clinical trial NCT01897428: PK Comparisons of Bepotastine Besilate 10 mg and Bepotastine Salicylate 9.64 mg
Official title: Clinical Trial to Evaluate Pharmacokinetic Characteristics of Belion in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergic Rhinitis
Urticaria
Pruritus
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: Hanlim Pharm. Co., Ltd.
First posted: 2013-07-12
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To compare the relative bioavailability and pharmacokinetic characteristics of a newly developed bepotastine formulation, bepotastine salicylate, with a conventional formulation, bepotastine besilate, in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.


Eligibility criteria: Inclusion Criteria:

* subjects aged between 20 and 45 years
* Body weight \> 50 kg (in case of female \> 45 kg) with BMI between 18 and 29 kg/m2
* Signed and dated informed consent form which meets all criteria of current FDA and KFDA regulations

Exclusion Criteria:

* subjects with acute conditions.
* presence of history affecting ADME
* Clinically significant history or current evidence of a hepatic, renal, gastrointestinal, or hematologic abnormality
* Hepatitis B, hepatitis C, or HIV infection revealed on the laboratory findings
* Any other acute or chronic disease
* A history of hypersensitivity to bepotastine
* A history of alcohol or drug abuse
* Participation in another clinical trial within 2 months
* smoked \>10 cigarettes daily
* consumption over 5 glasses daily of beverages containing xanthine derivatives
* use of any medication having the potential to affect the study results within 10 days before the start of the study.
* medication of the inhibitors or inducers of DME including barbiturates within 1 month
* one of abnormal lab findings as like

  * c. AST/ALT \> UNL (upper normal limit) x 1.5
  * Total bilirubin \> UNL x 1.5

Primary outcomes:
measure: bepotastine pharmacokinetics: peak plasma concentrations (Cmax)
timeFrame: 24 hr
measure: Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to 24 hr(AUCall)
timeFrame: 24 hr
measure: Bepotastine Pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to infinity(AUCinf)
timeFrame: 24 hr
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Dept. of Clinical Pharmacology & Toxicology, Anam Hospital
Study officials:
References:
citation: Kim KA, Park JY. Pharmacokinetic comparisons of bepotastine besilate and bepotastine salicylate in healthy subjects. Clin Drug Investig. 2013 Dec;33(12):913-9. doi: 10.1007/s40261-013-0140-7.
Clinical trial NCT03309228: Subjective Factors of Polymedication in the Elderly: a Qualitative Study of the Perceptions of Patients, Relatives and Referent Physicians.(DOSAGE)
Official title: Subjective Factors of Polymedication in the Elderly: a Qualitative Study of the Perceptions of Patients, Relatives and Referent Physicians.(DOSAGE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Frail Elderly Syndrome
Keywords: elderly people
polymedication,
ethics
qualitative research
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2017-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women aged 75 and over, fulfilling the conditions of major polymedication: (10 different simultaneous drugs)

Brief summary: The DOSAGE Study is a qualitative transversal study aiming to describe and understand the subjective factors of polymedication in the elderly population (75 years old and more), defined as 10 simultaneous drugs. Semi-structured interviews will be conducted with patients, relatives and general practitioners in one French region. 20 situations will be included. After analysing the data of the individual interviews, focus groups will be conducted with health professionals.


Eligibility criteria: Inclusion Criteria:

* For patients:

  * Men and women aged 75 and over
  * Beneficiary of a prescription of medicinal products fulfilling the conditions of major polymedication: to include 10 different drugs whatever the way of use (per os, subcutaneous, intravenous, intra muscular, cutaneous, instillation)
  * Informed consent stating that the subject understood the purpose and methodology of the study and agrees to participate in the study.
* For the relatives:

  * Men and women 18 years of age or older
  * Informed consent
  * Regularly participating in helping the patient's daily life
* For Physicians :

  * Identified as the patient's physician or family physician.
  * Informed consent

Exclusion Criteria:

* Persons with proven and significant cognitive impairment preventing the completion of semi-strutured interviews
* Person who does not speak French easily
* Generally, any person unlikely to cooperate in the study
* Adults under guardianship
* Refusal of relatives and/or general practitioner to participate to the study

Primary outcomes:
measure: 60 semi-structured interviews
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References:
Clinical trial NCT00709228: Study of Patients With Chronic Hepatitis C Infected With HCV LVL G1 and Effect of Peg-Intron Plus Rebetol Treatment (Study P04793)
Official title: PREDICT - Prospective Observational Study Of A Cohort Of Naïve Patients With Chronic Hepatitis C Infected With Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) And Treated With Peg-Intron 1.5 ug/Kg/Week Plus Rebetol 800-1200 mg/Day Who Achieved A Negative HCV-RNA At Week 4 and at Week 24
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-03
Enrollment: 496
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: To determine the relapse rate at 24 weeks follow up in Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) patients treated for 24 weeks with Peg Intron and Rebetol who are Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) negative at treatment week 4 and week 24. To determine the proportion of patients (%) with sustained virological response at 24 weeks post follow up treatment.

Detailed description: Approximately 500 patients from about 100 sites to be identified as HCV LVL G1 patients

Eligibility criteria: Inclusion Criteria:

* Willingness to participate
* 18 years or older, either gender, any race
* Must have Hepatitic C Virus Low Viral Load \[LCV LVL\] (positive, but \<600,000 IU/mL on the assay used by the individual study site. Only Hepatitis C Virus-Ribonucleic acid/quantitative polymerase chain reaction \[HCV-RNA/qPCR\] assays with results in IU/ml are acceptable) AND been diagnosed with Genotype 1
* Subject considered suitable for treatment per local label
* Investigator considers suitable and subject consents to be treated

Exclusion Criteria:

* Does not show negative polymerase chain reaction \[PCR\] at week 4
* Pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant
* Subject does not qualify based on contra-indication, special warning, special population, and/or pregnancy \& lactation section of the Summary of Product Characteristics \[SmPC\]

Primary outcomes:
measure: Number of HCV LVL G1 Participants Who Relapsed
timeFrame: Week 24 of follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Craxi A, Koutsounas S, Ogurtsov P, Chemello L, Maticic M, Torras J, Diago M, Tartaglione MT, Witthoeft T, Yu X, Faruqi R, Chaudhri E, Pedicone LD, Zuckerman E. Peginterferon alfa-2b plus weight-based ribavirin for 24 weeks in patients with chronic hepatitis C virus genotype 1 with low viral load who achieve rapid viral response. J Viral Hepat. 2012 Feb;19(2):e120-5. doi: 10.1111/j.1365-2893.2011.01515.x. Epub 2011 Sep 19.