louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03733275: Efficacy of L/A Spray andL/A-soaked Nasal Packings on Postoperative Pain After Nasal Closed Reduction
Official title: Efficacy of Preoperative Lidocaine Spray and Local Aensthetics-soaked Nasal Packings on Postoperative Pain After Nasal Closed Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Fracture
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is perfored to investigate the efficacy of preoperative lidocaine spray and lidocaine-bupivacaine mixture-soaked nasal packing for acute postoperative pain after nasal closed reduction surgery.

Detailed description: To investigate the treatment of postoperative pain after nasal closed reduction surgery, we plan to investigate the effect of preoperative lidocaine spray and lidocaine-bupivacaine mixture-soaked nasal packing for the patinets undergoing nasal closed reduction under general aensthesia, compaing to the control group (normal saline spray and normal saline-soaked nasal packing).

Eligibility criteria: Inclusion Criteria:

* patients scheduled to receive nasal reduction surgery under general aensthesia

Exclusion Criteria:

* concomitant disorders (eg. facial bone fractures) concomitant surgery (eg. septoplasty)

Primary outcomes:
measure: postoperative pain in recovery room
timeFrame: immediately after surgery
Secondary outcomes:
measure: rescue analgesics in recovery room
timeFrame: 1 hr after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
state: Seocho-gu
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
state: Seocho-gu
Study officials:
affiliation: Associate Professor
name: Young Eun Moon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04753775: RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS.
Official title: RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL FOR ACHIVING REMISSION IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aloe Vera Gel, Proctosigmoiditis, Remission, Trial, Ulcerative Colitis (UC)
Lead sponsor: Ospedale Sandro Pertini, Roma
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Aloe vera is used for the treatment of inflammatory bowel disease (IBD), but no data are present in regard the gel formulation as topical therapy in active ulcerative colitis.

Detailed description: 44 ulcerative colitis (UC) patients were enrolled and randomly allocated to treatment for 4 weeks with oral mesalazine (800 mg three times daily) and enema (60 ml aloe vera gel) 1/day (n = 22, Group A) or enema (60 ml placebo) (n = 22, Group B).

Eligibility criteria: Inclusion Criteria:

* age over 18 years, mild to moderate active ulcerative proctosigmoiditis, diagnosed for the first time and no therapy started before. The maximum extension of the disease was accepted of 40-60 cm from the anal verge or distal disease.

Exclusion Criteria:

* an extension of disease above the sigma, renal impairment, pregnancy, lactation or established low compliance

Primary outcomes:
measure: endoscopic remission
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02885675: An Observational Study of the Correlation Between miRNA in Peripheral Blood and Prognosis in Patients With ARDS
Official title: An Observational Study of the Correlation Between miRNA in Peripheral Blood and Prognosis in Patients With ARDS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20 healthy controls and 60 patients diagnose as ARDS in ICU were included in this study.

Brief summary: To evaluate the correlation between the value of miRNA related to ARDS and vascular endothelial cell and ARDS severity, vascular endothelial cell damaging degree，mortality in patients with ARDS.

Detailed description: After consulting literature, we obtain 14 miRNAs related to ARDS and vascular endothelial cell(ARDS-VEC-miRNAs) and 2 biomarkers of scathing vascular endothelial.The ARDS-VEC-miRNAs include miR-15a-5p,miR-16-5p,miR-21-5p,miR-24-3p,miR-26a-5p,miR-27a-3p,miR-27b-3p,miR-126-3p,miR-150-5p,miR-146a-5p,miR-155-5p,miR-221-3p,miR-223-3p,miR-320a.The biomarkers of scathing vascular endothelial include vascular cell adhesion molecule-1(VCAM-1),von Willebrand factor(vWF).20 healthy controls and 60 patients diagnose as ARDS in ICU were included in this study.we blood every participants within 24 hours after enrollment and obtain the plasma.Then, we detecte ARDS-VEC-miRNAs,VCAM-1,vWF levels in plasma by real-time quantitative PCR,record the severity of the illness and survival status within 28 days of every patients.Finally,we evaluate the correlation between the value of miRNA related to ARDS and vascular endothelial cell and ARDS severity, vascular endothelial cell damaging degree，mortality in patients with ARDS.

Eligibility criteria: Inclusion Criteria:(1)Admitted to ICU, ARDS patients(Berlin criteria), (2)Patients diagnosed ARDS within 24 hours, (3)Patients age between 18 years old and 85 years.

Exclusion Criteria:1)Pregnant women, 2)Patients with malignant tumor, 3)Immunosuppression or immunocompromised patients.

Primary outcomes:
measure: mortality
timeFrame: 28-day
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhong-Da hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT03936075: Guided Imagery & Music in Cancer
Official title: Guided Imagery & Music in Active Treatment for Gynecologic or Breast Cancer: An RCT Pilot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer, Breast
Cancer, Metastatic
Cancer Ovaries
Cancer Uterus Cervix
Keywords: receptive music therapy
Guided Imagery & Music (GIM)
chemotherapy
radiotherapy
breast cancer
gynecologic cancer
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Aretaieion University Hospital
name: SONORA Organisation for Music Therapy and Research
First posted: 2019-05-03
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two randomised groups, one intervention group and one placebo group
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is an RCT pilot study to explore the potential effects of the Guided Imagery \& Music method for women with breast or gynecologic cancer, during active treatment. The study explores the potential impact in quality of life parameters such as mood, fatigue, and hope.

Detailed description: Guided Imagery and Music is a music-assisted psychotherapy method which has been used as a complementary, supportive psychosocial therapy in cancer care. However, its effects have never been explored during the period of active chemotherapy or radiotherapy treatment in various cancer populations, and especially gynecologic and breast cancer. This pilot study is an effort to explore the feasibility of the method to increase quality of life in this population by possibly reducing side-effects of treatment such as fatigue, improving mood, and building resilience as expressed through levels of hope.

Eligibility criteria: Inclusion Criteria:

* Speaking Greek
* receiving chemotherapy or radiotherapy treatment for breast or gynecologic cancer
* first occurrence or metastatic
* have an interest in engaging in creative psychotherapies through music

Exclusion Criteria:

* women with active psychosis or PTSD symptomatology
* women receiving other psychological support
* women too ill to participate according to doctors' instructions

Primary outcomes:
measure: Profiles of Mood States (POMS) Brief version (adapted)
timeFrame: Baseline and up to 12 weeks (post-intervention)
Secondary outcomes:
measure: Herth Hope Index
timeFrame: Baseline and up to 12 weeks (post-intervention)
measure: Cancer-related Fatigue Scale (CFS)
timeFrame: Baseline and up to 12 weeks (post-intervention)
measure: Visual Analogue Scale for Hope (VAS-H)
timeFrame: obtained 6 times throughout the completion of intervention (up to 12 weeks)
measure: Visual Analogue Scale for Fatigue (VAS-F)
timeFrame: Obtained 6 times throughout the completion of intervention (up to 12 weeks)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieion University Hospital
state: Attiki
Study officials:
affiliation: Aalborg University
name: Niels Hannibal, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04968470: SEBBIN Silicone Gel-filled Testicular Implants
Official title: Prospective Observational Study About SEBBIN Silicone Gel-filled Testicular Implants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Complication
Prosthesis Durability
Lead sponsor: Groupe SEBBIN
Sponsor class: INDUSTRY
First posted: 2021-07-20
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The intended target population for the silicone gel-filled testicular implants of Groupe SEBBIN is any patient (children or adults) with agenesis or testicular atrophy, undescended testicle, testicular tumour, epididymitis / orchitis, or a trauma, for whom an orchidectomy with placement of a testicular prosthesis is indicated. Testicular implants are also indicated for sex reassignment surgeries.

Brief summary: This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.


Eligibility criteria: Inclusion Criteria:

* The patient is an adult or a child at the time of implant placement with SEBBIN implant.
* The patient is candidate to a unilateral or bilateral testicular implant placement with SEBBIN implant.
* The patient has been informed of the study, has read the patient information letter and -provided oral consent.

Exclusion Criteria:

* The patient has silicone implants somewhere else than in the scrotal sac.
* The patient was diagnosed with one of the following pathologies:

  * Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.
  * Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.
  * Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.
* The patient has a pathology that could delay healing.
* Custom-designed implants are used for surgery.

Primary outcomes:
measure: Complication rate
timeFrame: At 10 years of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ Gent
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
References:
Clinical trial NCT01737775: Comparative Ultrasonic Study of Post Operative Diaphragmatic Dysfunction in Abdominal and Head and Neck Surgery
Official title: Comparative Ultrasonic Study of Post Operative Diaphragmatic Dysfunction in Abdominal and Head and Neck Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diaphragmatic Dysfunction
Keywords: diaphragmatic dysfunction
ultrasonography
respiratory distress
abdominal surgery
Age
gender
biometric
body mass index
ASA score
smoking status
history of respiratory disease
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Diaphragmatic dysfunction (DD) is one of the main risk factors for post operative respiratory distress syndrome. Ultrasonography is a diagnosis tool for DD but few studies have been published. The aim of this prospective study is to compare the achievement of diaphragmatic function depending on the type of surgery (abdominal and head and neck surgery).


Eligibility criteria: Inclusion Criteria:

* Age\>18 years
* Upper abdominal or head and neck surgery
* written consent

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* History of neuropathy or myopathy,
* History of diaphragm paralysis, thoracic surgery, pneumothorax, pneumomediastinum

Primary outcomes:
measure: Comparison of diaphragmatic amplitude measured by M-Mode ultrasonography performed the day before and the day after surgery in 3 groups: laparoscopic abdominal surgery, abdominal surgery by laparotomy and head and neck surgery.
timeFrame: two months
Secondary outcomes:
measure: All cause morbidity
timeFrame: within the first 28 days after surgery
Other outcomes:
Locations:
city: Lyon
country: France
facility: Département d'Anesthésie Hôpital de la Croix Rousse
Study officials:
References:
Clinical trial NCT06664775: A Phase III Study to Compare the Efficacy and Safety of TachoSil and Surgicel Original as an Adjunct to Control Mild to Moderate Soft Tissue Bleeding During Surgery
Official title: An Open Label, Prospective, Randomized, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of TachoSil® Versus Surgicel™ Original (Oxidized Regenerated Cellulose) as an Adjunct to Control Mild to Moderate Soft Tissue Bleeding During Surgery.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Hemorrhage
Lead sponsor: Corza Medical GmbH
Sponsor class: INDUSTRY
First posted: 2024-10-30
Enrollment: 116
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to assess the efficacy and safety of TachoSil compared to the widely known and used for \> 60 years local hemostatic product Surgicel Original as an adjunct to control mild to moderate soft tissue bleeding during surgery.


Eligibility criteria: Inclusion Criteria:

1. Elective open abdominal, retroperitoneal, pelvic, or thoracic surgery. Elective transplant surgery except for liver or heart transplants is included.
2. The participant has a need for secondary hemostatic study intervention at the TBS with mild to moderate bleeding Grade 1 and Grade 2 according to the VIBe Scale.
3. Presence of an appropriate mild to moderate bleeding soft tissue TBS identified intra-operatively by the surgeon.
4. The TBS size \< 21 cm2/3.3 in2.
5. Ability to firmly press study intervention at TBS until 3 minutes after randomization.

Exclusion Criteria:

1. Participants undergoing cardiovascular, hepatic, and laparoscopic and robotic surgeries.
2. Congenital or acquired disorders of coagulation.
3. Diseases requiring constant use of any anticoagulant drugs that cannot be safely washed out prior to randomization.
4. Screening Hemoglobin \< 9 mg/dL, platelets \< 75 × 103/µL, and/or international normalized ratio (INR) \> 1.5.
5. Acute major bleeding during surgery.
6. Participant with TBS in an actively infected field.
7. Target bleeding site is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency.
8. Target bleeding site with major arterial bleeding requiring suture or mechanical ligation.
9. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.
10. Participants with Grade '0', '3', and '4' bleeding at TBS according to VIBe Scale.

Primary outcomes:
measure: Hemostatic success within 3 minutes
timeFrame: within 3 minutes of study intervention
Secondary outcomes:
measure: Hemostatic success within 6 minutes
timeFrame: within 6 minutes of study intervention
measure: Study intervention failures
timeFrame: within 6 minutes of study intervention
measure: hemostatic success from moderate bleeding within 3 minutes
timeFrame: within 3 minutes of study intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02348775: Glutathione and Function in HIV Patients
Official title: Glutathione and Function in HIV Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infection
Erythrocyte Glutathione Deficiency
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 16
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: We have recently reported that older patients with HIV are deficient in glutathione (GSH) due to decreased availability of cysteine and glycine, and that oral supplementation with cysteine (as n-acetylcysteine) and glycine for 2-weeks corrects their own levels, and improves (but does not fully normalize) concentrations of red-cell GSH. We also found that when GSH deficient, subjects had impaired mitochondrial fuel oxidation and this improved with an increase in intracellular GSH concentrations. These older HIV patients also had significant increases in muscle strength with improvement of GSH levels.The current proposal in older HIV patients will investigate study if cysteine and glycine supplementation for a duration of 12 weeks will result in changes in : (a) GSH levels; (b) body composition/anthropometry; (c) strength and function; (d) quality of life; (e) mitochondrial energetics; (f) biochemistry (including dyslipidemia and oxidative stress); (g) protein and glucose metabolism; (h) cognition and memory. After completing supplementation for 3 months, GSH concentrations, strength, function, mitochondrial energetics and neurocognitive tests will be measured for a further 2 months to determine the effects of washout.

Detailed description: Detailed data are not as yet available

Eligibility criteria: Inclusion Criteria:

HIV patients:

* age 45-65 years

Non-HIV subjects:

* age 45-65 years

Exclusion Criteria:

1. Hospitalization in the past 3 months
2. Untreated hypothyroidism or hyperthyroidism
3. Known diabetes mellitus, hypercortisolemia, coronary artery disease.
4. Known liver impairment (ALT and AST \>2ULN)
5. Renal impairment (Creatinine\>1.4)
6. Inability to walk
7. Patients on anticoagulation or antiplatelet therapy.
8. Patient with triglyceride concentrations \>500 mg/dl.

Primary outcomes:
measure: Muscle Glutathione Concentration
timeFrame: 20-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor Metabolic Research Unit (MRU)
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: R V Sekhar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00704275: Comparison of Efficacy, Safety and Anti-Inflammatory Effect Between Topical 0.05%Cyclosporine A Emulsion and REFRESH® in Patients With Moderate to Severe Dry Eyes
Official title: Comparison of Efficacy, Safety and Anti-Inflammatory Effect Between Topical 0.05%Cyclosporine A Emulsion and REFRESH® in Patients With Moderate to Severe Dry Eyes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dry Eye
Keywords: dry eye
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2008-06-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy, safety and tolerability of 0.05% topical cyclosporin eye drop to Refresh in moderate to severe dry eye patients. Null hypothesis is: there is no difference between these two groups.

Detailed description: Inclusion criteria:

1. Participants are moderate to severe dry eye patients aged more than 18 years of age
2. Oxford staining scores of more than five.
3. OSDI scores of more than 0.1

Outcome measurements:

Main parameter is staining score (corneal + conjunctival) Other parameter is OSDI score, symptom of ocular surface discomfort score, number of daily artificial tear needed, TBUT, Schirmer I score, cytokines level \& markers Safety parameters: VA, IOP, cyclosporin level

Eligibility criteria: Inclusion Criteria:

* moderate to severe dry eye

Exclusion Criteria:

* lid anomaly, previous CsA use

Primary outcomes:
measure: Corneal and conjunctival staining score
timeFrame: 1 year
Secondary outcomes:
measure: Schirmer 1 score
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: OPD Chulalongkorn University Hospital
city: Bangkok
country: Thailand
facility: OPD Chulalongkorn University Hospital
Study officials:
References:
Clinical trial NCT00541775: Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801)
Official title: A Multicenter, Double-Blind, Placebo and Active Controlled, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg Once Daily in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-10
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the safety and effectiveness of sitagliptin in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Patient has Type 2 diabetes
* Currently taking metformin \>1500 mg/day for at least 10 weeks
* Male or female

Exclusion Criteria:

* Patient has peripheral edema
* History of type 1 diabetes
* Patient required insulin within prior 8 weeks
* Have participated or are currently participating in another study with an investigational compound or device within 12 weeks of starting this study
* Participating in a weight loss program

Primary outcomes:
measure: Hemoglobin A1C (A1C) at Week 18
timeFrame: Baseline and 18 Weeks
Secondary outcomes:
measure: Fasting Plasma Glucose (FPG) at Week 18
timeFrame: Baseline and 18 Weeks
measure: 2-hour Post-meal Glucose (PMG) at Week 18
timeFrame: Baseline and 18 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Scott R, Loeys T, Davies MJ, Engel SS; Sitagliptin Study 801 Group. Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2008 Sep;10(10):959-69. doi: 10.1111/j.1463-1326.2007.00839.x. Epub 2008 Jan 14.