louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02383914: Clinical Study on Diagnostics and Outcome of Ruptures of the Subscapularis After Arthroscopic Refixation
Official title: Prospective Multicenter Trial on Diagnostics and Outcome of Ruptures of the Subscapularis After Arthroscopic Refixation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subscapularis Tendon Rupture
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2015-03-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of the patients, who got the operative therapy (refixaton of the subscapularis tendon) inclusive the post- treatment and satisfy the criteria .

Brief summary: The purpose of the trial is to optimize the diagnostics of subscapularis tendon tears and as the circumstances require to found a new classification.

The prime objective is a comparison of the conclusive of the clinic check-up, the sonographic and magnetic resonance tomography findings.

The secondary objective is to detect the correlation of the outcome with the age , the gender, the pathogenesis and attendant injuries.


Eligibility criteria: Inclusion Criteria:

* patients, who have turned 18
* suspected subscapularis tendon rupture

Exclusion Criteria:

* disability to understand the trial
* intraoperative intact supbscapularis tendon
* pre-surgical operation of the affected shoulder
* tumor
* infection

Primary outcomes:
measure: Shoulder function (Constant Score)
timeFrame: 52 weeks post- operative
Secondary outcomes:
measure: Strength
timeFrame: 12 and 52 weeks post-operative
measure: Rerupture Rate
timeFrame: 12 and 52 weeks post-operative
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: Orthopaedic Clinic of the University of Rostock
state: Mecklenburg-Vorpommern
Study officials:
References:
Clinical trial NCT02946814: Immediate Effect and Substantivity of the Essential Oils Without Alcohol on the Oral Biofilm in Situ
Official title: Immediate Effect and Substantivity of the Essential Oils Without Alcohol on the Oral Biofilm in Situ. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Biofilms
Substantivity
Oils, Essential
Keywords: essential oils
microscope, colfocal
dental plaque
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
First posted: 2016-10-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the in situ antibacterial activity of a mouthwash containing essential oils with and without alcohol on undisturbed de novo plaque-like biofilm (PL-biofilm) up to 7 h after its application.

An appliance was designed to hold six glass disks on the buccal sides of the lower teeth, allowing PL-biofilm growth. Twenty healthy volunteers will the appliance for 48 h and then performed a mouthwash with essential oils. Disks will be removed after 30 s and at 1, 3, 5, and 7 h later. After a washout period, the same procedure will be repeated with a sterile water mouthwash and a mouthwash with essential oils without alcohol. After PL-biofilm vital staining, samples will be analyzed using a confocal laser scanning microscope analysing their bacterial viability and thickness.


Eligibility criteria: Inclusion Criteria:

Systemically healthy adults.

* Minimum of 24 permanent teeth.
* No gingivitis (Community Periodontal Index score = 0).
* No periodontitis (Community Periodontal Index score = 0).
* Absence of untreated caries.

Exclusion Criteria:

* Smoker or former smoker.
* Presence of dental prostheses.
* Presence of orthodontic devices.
* Antibiotic treatment or routine use of oral antiseptics in the previous 3 months.
* Presence of any systemic disease that could alter the production or composition of saliva.

Primary outcomes:
measure: Percentage of bacterial viability
timeFrame: 48 hours after the volunteer has started to wear the splints
Secondary outcomes:
measure: thickness in microns
timeFrame: 48 hours after the volunteer has started to wear the splints
Other outcomes:
Locations:
Study officials:
References:
citation: Quintas V, Prada-Lopez I, Prados-Frutos JC, Tomas I. In situ antimicrobial activity on oral biofilm: essential oils vs. 0.2 % chlorhexidine. Clin Oral Investig. 2015 Jan;19(1):97-107. doi: 10.1007/s00784-014-1224-3. Epub 2014 Apr 1.
Clinical trial NCT04499014: Ultrasound and Phonophoresis in Carpal Tunnel Syndrome
Official title: Evaluation of the Effects of Steroid Phonophoresis and Therapeutic Ultrasound in Carpal Tunnel Syndrome: A Randomized Placebo - Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: carpal tunnel syndrome
steroid phonophoresis
ultrasound
Lead sponsor: Eskisehir City Hospital
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: In this placebo-controlled, randomized, prospective study, the efficacy of ultrasonography (US) and steroid phonophoresis (PH) treatments was evaluated in patients with idiopathic carpal tunnel syndrome.

Detailed description: Twenty-seven patients (46 hands) were admitted in this study. Patients were randomly divided three groups. The first group was ultrasound group, the second group was PH group and the third group was placebo US group. Continuous ultrasound with a frequency of 1 MHz, an intensity of 1.0 W/cm2 was used in the US and the PH groups. PH group received 0,1% dexamethasone. Placebo group received a frequency of 0 MHz, an intensity of 0 W/cm² ultrasound. Treatments were administered for 5 days a week, a total of 10 sessions. All patients also wore night splints during treatment. Visual Analogue Scale (VAS), Boston Symptom Severity Scale, Functional Capacity Scale, grip strength and electroneurophysiological evaluations were compared before the treatment, after the treatment and three months later.

Eligibility criteria: Inclusion Criteria:

* Mild or moderate idiopathic carpal tunnel syndrome (without thenar atrophy or spontaneous activity on electrophysiological examination of the abductor pollicis brevis (APB) muscle)

Exclusion Criteria:

* The patients with medical problems (diabetes mellitus, hypothyroidism, rheumatic diseases, acute trauma, pregnancy etc.)
* cervical radiculopathy
* etiologic factors which predispose to or polyneuropathy
* reinnervation or fibrillation potentials in their abductor pollicis brevis muscles
* physical or medical therapy within 3 months for CTS and steroid injection applied
* experience CTS median nerve trauma and CTS surgery
* serious thenar atrophy and anesthesia
* contraindication in steroid treatment (steroid allergies, hypertension etc.)
* contraindication in ultrasonic therapy (bleeding disorders, acute inflammation of the joints, acute infections, cancer and precancerous lesions, arteriovenous circulatory disorders etc.)

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: three month
measure: Boston Symptom Severity Scale
timeFrame: three month
measure: Boston Functional Capacity Scale
timeFrame: three month
measure: grip strength
timeFrame: three month
measure: electroneurophysiological evaluations
timeFrame: three month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Eskişehir City Hospital
name: Burcu Ortanca
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03344614: A Study of Apatinib in Combination With Raltitrexed Treatment in Patients With Advanced Colorectal Cancer
Official title: An Open Single Arm Exploratory Study of Apatinib Mesylate Tablets in Combination With Raltitrexed Treatment in Patients With Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: third-line treatment
apatinib
raltitrexed
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 30 patients with advanced colorectal cancer will be enrolled to observe the efficacy and safety of raltitrexed combined with apatinib as a third-line treatment.

Detailed description: In this study, we plan to enroll 30 patients with advanced colorectal cancer after failure of second-line standard chemotherapy. The therapeutic regimen is raltitrexed, 3 mg/㎡, ivgtt, d1, apatinib 500 mg, qd,po, d1-21, Every 3 weeks for 1 cycles, the primary end point was PFS, the secondary end point was OS, DCR, ORR etc. Aim to observe the efficacy and safety of raltitrexed combined with apatinib as a third-line treatment of in patients with advanced colorectal cancer.

Eligibility criteria: Inclusion Criteria:

* 1.Male or female, ≥ 18 of age;
* 2.Histological confirmed advanced colorectal adenocarcinoma，and at least one measurable lesion;
* 3.Have failed for ≥ 2 lines of standard chemotherapy(included Fluorouracil, irinotecan and oxaliplatin);
* 4.ECOG performance status 0-2;
* 5.Life expectancy of more than 3 months;
* 6.The main organs function is well, and randomized within 14 days before the relevant inspection indicators to meet the following requirements:

  1. blood routine test Hgb ﹥90g/L, ANC﹥1.5×109/L, Platelets ﹥ 100×109/L,
  2. biochemical tests Serum Total bilirubin ≤ 1.5 X UNL(upper normal limit), ALT or AST ≤ 2 xUNL, and ﹤ 5 x UNL（Hematogenous metastases）, Creatinine clearance rate≥ 60 ml/min(Cockcroft-Gault formula),
  3. Doppler echocardiography assessment：LVEF ≥ 50%;
* 7.No serious heart, lung, liver, kidney dysfunction; no jaundice and gastrointestinal obstruction; no acute infection;
* 8.Signed informed consent;
* 9.Good compliance, and family members agree to receive survival follow-up.

Exclusion Criteria:

* 1.Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);

Primary outcomes:
measure: PFS
timeFrame: 6 months
Secondary outcomes:
measure: OS
timeFrame: 12 months
measure: ORR
timeFrame: 12 months
measure: DCR
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital (301 Military Hospital)
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital (301 Military Hospital)
name: Haiyan Si, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00790114: Determine the Effect of Multiple Doses of AZD7325, CYP Study
Official title: A Phase I Open-Labeled, Fixed Sequence Study to Determine the Effect of Multiple Doses of AZD7325 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Phase I
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-11-13
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To determine the effects of repeated doses of AZD7325 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine \[3-desmethyl\] metabolite).


Eligibility criteria: Exclusion Criteria:

* Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor.
* Enrollment in another concurrent investigational study or intake of an investigational drug within 3 months or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit

Primary outcomes:
measure: To determine the effects of repeated doses of AZD7325 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine [3-desmethyl] metabolite).
timeFrame: Blood samples will be taken during the study.
Secondary outcomes:
measure: To evaluate the safety and tolerability of repeated doses of AZD7325 in combination with midazolam and caffeine.
timeFrame: Blood samples will be taken during the study.
measure: Evaluation of the pharmacodynamic effects of AZD7325
timeFrame: Test batteries will be performed at specified times both before and following study drug administration.
measure: To evaluate the pharmacokinetics of AZD7325
timeFrame: Blood samples will be taken on Days 1, 11 and 12.
Other outcomes:
Locations:
Study officials:
affiliation: Guy's Drug Research Unit Quintiles
name: Darren Wilbraham, MBBS, DCPSA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06586814: Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery
Official title: A Randomized Study of Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Extremity Fracture
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 50
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: This pilot study is designed to assess the feasibility of comparing skin closure methods - sutures versus staples - and subsequent rates of surgical site infection following open reduction and internal fixation surgery for orthopaedic trauma injuries. The primary objectives are to determine if enrollment, randomization, and compliance are feasible and to refine data collection methods. Patients =18 years of age with closed fractures of the tibial plateau, tibial pilon, patella, and distal femur presenting within 3 weeks of injury undergoing definitive treatment of their fracture will be approached for participation. If enrolled, they will be randomized to having their surgical wound closed with either nylon sutures or metallic staples. Patient follow up will be standard of care besides answering PROMIS surveys.


Eligibility criteria: Inclusion Criteria:

* Adult Patients 18-80 years old
* Tibial Pilon, Tibial Plateau Fractures, Patella Fractures, and Distal Femur Fractures
* Incisions must be able to be approximated with subdermal sutures intraoperatively
* English and Spanish speaking patients only

Exclusion Criteria:

* Open fractures
* Incarcerated patients
* Pregnant patients
* Patients who do not speak English or Spanish
* History of infection at surgical incision site at the time of definitive fixation
* Pre-existing skin condition associated with risk of infection (psoriasis, eczema)
* Unable to obtain consent from patient prior to surgery or from legally authorized representative (LAR) prior to skin closure if the patient is unable to consent dur to their medical condition.
* The absence of a subcutaneous closure during the index procedure

Primary outcomes:
measure: Feasibility of participant enrollment
timeFrame: 12 Months
measure: Feasibility of randomization to each of the treatments
timeFrame: 6 Months
measure: Assess Protocol Compliance
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References:
Clinical trial NCT02052895: Utility of Presepsin in Distinguishing Between Sepsis and SIRS
Official title: Utility of Presepsin in Distinguishing Between Sepsis and SIRS (Systemic Inflammatory Response Syndrome): an Exploratory, Prospective Observational Study in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SIRS
Sepsis
Keywords: Presepsin
Sepsis
SIRS
Lead sponsor: Mochida Pharmaceutical Company, Ltd.
Sponsor class: INDUSTRY
First posted: 2014-02-03
Enrollment: 226
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with presentation to ICU with critical illness compatible with either sepsis or systemic inflammatory response syndrome (SIRS).

Brief summary: This is an observational study to evaluate the diagnostic accuracy of presepsin levels to discriminate between sepsis and SIRS upon presentation with critical illness compatible with either sepsis or systemic inflammatory response syndrome (SIRS).


Eligibility criteria: Sepsis/SIRS Patients

Inclusion Criteria:

* Male or female aged ≥ 21 years
* Appropriate clinical data to enable classification into sepsis or SIRS
* Written informed consent by the patient or legally authorized representative
* Critical illness consistent with SIRS or sepsis, to be enrolled within 18 hours of presentation

Exclusion Criteria:

* No informed consent
* Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \< 20%

Control

Inclusion Criteria:

* Male or female aged ≥ 21 years
* Does not meet clinical criteria for sepsis or SIRS
* Written informed consent by the patient or legally authorized representative

Exclusion Criteria:

* No informed consent
* Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \< 20%

End Stage Renal Disease

Inclusion Criteria:

* Male or female aged ≥ 21 years
* Documented diagnosis of end stage renal disease currently undergoing dialysis
* Does not meet clinical criteria for sepsis or SIRS
* Written informed consent by the patient or legally authorized representative

Exclusion Criteria:

* No informed consent
* Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \< 20%

Primary outcomes:
measure: Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis
timeFrame: Up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Stanley Nasraway, MD, FCCM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05254795: Precision Medicine Randomized Clinical Trial Comparing Molecular Tumor Board Assisted Care to Usual Care
Official title: Precision Medicine Randomized Clinical Trial Comparing Molecular Tumor Board Assisted Care to Usual Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Keywords: Molecular tumor board
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2022-02-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This trial will compare Molecular Tumor Board (MTB) assisted care to usual care for patients who have newly diagnosed histologically or cytologically confirmed stage IIb-IV Non-Small Cell Lung Cancer (NSCLC) and are planning to undergo treatment for their cancer.


Eligibility criteria: Inclusion Criteria:

* Clinically suspected or histologically confirmed stage IIb-IV NSCLC who are planning to undergo treatment
* No prior systemic therapies for NSCLC, with the exception of adjuvant therapy for early stage NSCLC. Prior surgery and/or radiation is allowed.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with targeted therapy, in the opinion of the treating physician.
* Pregnancy

Primary outcomes:
measure: Overall survival
timeFrame: 1 year
measure: Change in quality of life (QOL)
timeFrame: At enrollment, 8 weeks, and 12 weeks.
Secondary outcomes:
measure: Overall survival
timeFrame: 1 year
measure: Change in guideline concordant care
timeFrame: 8 weeks, 12 weeks, and 1 year
measure: Change in satisfaction with treatment
timeFrame: At enrollment, 8 weeks, and 12 weeks.
Other outcomes:
measure: Association of ctDNA variant allele frequency
timeFrame: 1 year
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Timothy Mullett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00813995: A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus (MK0431-074)
Official title: A Phase III, Multicenter, Double-Blind, Placebo-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: 2008-12-23
Enrollment: 395
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.


Eligibility criteria: Inclusion Criteria:

* 18 - 78 years of age
* Currently on metformin monotherapy

Exclusion Criteria:

* History of Type 1 diabetes mellitus or ketoacidosis
* Currently on a weight loss program and not in the maintenance phase or has started on a weight loss medication within the last 8 weeks
* Has undergone surgery requiring general anesthesia within the past 4 weeks or has planned major surgery
* Currently participating in a study or has participated in a study with or without an investigational compound or device within the past 12 weeks
* History of active liver disease such as chronic active hepatitis B or C, cirrhosis or symptomatic gallbladder disease
* HIV positive
* Pregnant, breast-feeding or planning to become pregnant during the study
* User of recreational or illicit drugs or has a recent history (within the past year) of drug or alcohol abuse or dependence

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (A1C) at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1000 mg/Day
timeFrame: Baseline and Week 24
measure: Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1700 mg/Day
timeFrame: Baseline and Week 24
measure: Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Yang W, Guan Y, Shentu Y, Li Z, Johnson-Levonas AO, Engel SS, Kaufman KD, Goldstein BJ, Alba M. The addition of sitagliptin to ongoing metformin therapy significantly improves glycemic control in Chinese patients with type 2 diabetes. J Diabetes. 2012 Sep;4(3):227-37. doi: 10.1111/j.1753-0407.2012.00213.x.