louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01659372: Low Level Laser Therapy Versus Pharmacotherapy in in Improving Masticatory Muscle Pain
Official title: Phase 1 Study of Low Level Laser Therapy Versus Naproxen
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: TMD
Keywords: temporomandibular disorder
myofascial pain syndrome
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: tempromandibuar disorders are a group of heterogenous pathologies affecting temporomandibular joint,muscles or both.in more than 90%of cases muscles are the origin of pain.TMDs cause pain,movement disability and deficit in quality of life.in more than 90%of cases pain is the major complaint.we run this investigation to find the analgesic effct of low level laser therapy versus pharmacotherapy with naproxen in improving pain.


Eligibility criteria: Inclusion Criteria:

* patients with TMD affecting masticatory muscles

Exclusion Criteria:

* systemic disease
* GI problem
* pregnancy
* epidermal cancer

Primary outcomes:
measure: reduction of paim measured by VAS
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shahid Beheshti University
city: Tehran
country: Iran, Islamic Republic of
facility: Shahid Beheshti University
Study officials:
References:
Clinical trial NCT01243372: Biomarkers in Predicting Response to Cetuximab in Patients With Advanced Colorectal Cancer
Official title: Evaluating BRAF Mutations as Predictors of Efficacy in Cetuximab-Treated Colorectal Cancer Patients: A Retrospective Study of Tissues From CALGB / SWOG
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: recurrent colon cancer
stage IIIA colon cancer
stage IIIB colon cancer
stage IIIC colon cancer
stage IVA colon cancer
stage IVB colon cancer
recurrent rectal cancer
stage III rectal cancer
stage IV rectal cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-11-18
Enrollment: 1142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients previously enrolled on CALGB-C80405 who have KRAS WT or KRAS mut tumor and have been randomized to treatment with either bevacizumab or cetuximab alone in a primary care clinic setting.

Brief summary: RATIONALE: Studying samples of tissue in the laboratory from patients who received cetuximab may help doctors understand and predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in predicting response to cetuximab in patients with advanced colorectal cancer.

Detailed description: OBJECTIVES:

Primary

* To determine, among patients with advanced CRC, whether the effect of treatment (cetuximab vs bevacizumab) on progression-free survival (PFS) depends on tumor BRAF V600E mutational status.

Secondary

* To study the relationships between tumor BRAF V600E mutational status, OS, and tumor response.

OUTLINE: This is a multicenter study.

Previously collected formalin-fixed and paraffin-embedded baseline tumor samples are analyzed for BRAF V600E mutation. Mutation status is correlated with clinical response and outcome data from patients enrolled on CALGB-C80405.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Participation in CALGB-C80405

  * Have KRAS WT or KRAS mut tumor
  * Randomized to treatment with either bevacizumab or cetuximab alone

    * Patients randomized to the combination therapy are not eligible
* Available specimens at the PCO for BRAF mutation detection
* Patient consent for use of samples

Primary outcomes:
measure: Progression-free survival as measured by RECIST
timeFrame: Up to 36 months
Secondary outcomes:
measure: overall survival
timeFrame: Up to 36 months
measure: tumor response as measured by RECIST
timeFrame: Up to 36 months
Other outcomes:
Locations:
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Najjia N. Mahmoud, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00475072: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Ribavirin in Hemophiliac Patients With Chronic Hepatitis C.
Official title: An Open Label Study to Evaluate the Safety and Effect on Sustained Virological Response of PEGASYS Plus Ribavirin in Patients With Hemophilia A and Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-05-17
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of PEGASYS plus ribavirin in male patients with hemophilia A and chronic hepatitis C. All patients will receive PEGASYS 180 micrograms s.c. weekly plus ribavirin 1000-1200mg p.o. daily (depending on body weight) for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* male patients, \>=18 years of age;
* hemophilia A;
* chronic hepatitis C;
* compensated liver disease.

Exclusion Criteria:

* therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment \<=6 months before start of study drug;
* hepatitis A, hepatitis B or HIV infection;
* chronic liver disease other than chronic hepatitis C.

Primary outcomes:
measure: SVR
timeFrame: Week 72
Secondary outcomes:
measure: AEs, laboratory parameters.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Mexico City
country: Mexico
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01330472: An Bioequivalence Study Of Xanax Extended Release Tablets From Two Different Manufacturing Sites
Official title: An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study Of Xanax XR Tablet 3 mg (Sourced From Caguas) Versus Xanax XR Tablet 3 mg (Sourced From Barceloneta) In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Alprazolam
Xanax
Bioequivalence
Panic disorder with or without agoraphobia.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-04-07
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Study to evaluate if Xanax sustained release tablets manufactured at two different sites provide similar drug levels in the blood.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 20 and 55 years, inclusive.
* An informed consent document signed and dated by the subject.

Exclusion Criteria:

* Evidence or history of clinically significant abnormality.
* A positive urine drug screen.
* Subjects who are hypersensitive to alprazolam or related compounds.

Primary outcomes:
measure: Area under the curve from time zero to infinity (AUCinf) of alprazolam
timeFrame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
measure: Peak plasma conc (Cmax) of alprazolam
timeFrame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
Secondary outcomes:
measure: Area under the curve from zero to the last time point (AUClast) of alprazolam
timeFrame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
measure: Area under the curve extrapolated (AUC%extrap) of alprazolam
timeFrame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
measure: Terminal half life of alprazolam
timeFrame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
measure: Time to peak concentration (Tmax) of alprazolam
timeFrame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02700672: Influence of Cognition and Gait on Falls
Official title: Predicting Falls Among Institutionalized and Non-institutionalized Older Adults: The Role of Cognition and Gait Speed
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Accidental Falls
Keywords: Ageing
Cognition
Executive Function
Gait
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty-five individuals living in a long term care facility and twenty-five older adults from community

Brief summary: The study analyses if cognition and gait speed can predict falls in a community-dwelling people and ambulant long term care residents

Detailed description: Falls are some of the most common events among elderly people. The odds of recurrent falls increase every year, which can cause impairment in basic activities of daily living, social isolation, fear of falling again and death. The aim of the present study is to analyze the role of cognition and gait speed as predictors to falls in institutionalized and non-institutionalized elderly people.

Methods:Twenty-five individuals living in a long-term care facility and 25 non-institutionalized individuals participated in the study. A questionnaire about their history of falls, tests to evaluate cognition (global and executive function) and a pedometer with an accelerometer to measure kinematic variables were applied.

Eligibility criteria: Inclusion Criteria:

* People who could walk with or without ambulation devices
* Mini-Mental State Examination score according to schooling

Exclusion Criteria:

* Terminal illnesses
* Bedridden
* Unable to see or hear
* Use of benzodiazepines

Primary outcomes:
measure: Cognitive predictor of falls assessed with the Mini-Mental State Examination
timeFrame: falls on past 12 months
Secondary outcomes:
measure: Executive function predictor of falls assessed with the Wisconsin Card Sort Test
timeFrame: falls on past 12 months
measure: Gait speed predictor of falls assessed with an accelerometer
timeFrame: falls on past 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: José Carlos Galduróz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02003872: The Long Term Effect of Adjustable Spaatz 3 Intragastric Balloon on Weight Loss
Official title: The Long Term Effect of Adjustable Spaatz 3 Intragastric Balloon on Weight Loss
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Diabetes
Hypertension
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-12-06
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label trial investigating the effect of Spatz 3 intragastric balloon on weight loss on obesity and associated co- morbidities.

The study aim is to evaluate the effect of the intra gastric balloon on weight reduction and on related co- morbidities during 1 year of balloon implantation and a year following explantation.


Eligibility criteria: Inclusion Criteria:

- 1. Subjects willing to comply with study requirements and have signed an informed consent form.

2. Age 18-70 3. BMI ≥ 35 kg/m² or BMI ≥ 30 kg/m² and hypertension or diabetes mellitus 4. Documented negative pregnancy test in women of childbearing potential. 5. Women of childbearing potential agree to remain on contraceptives for the duration of their trial participation.

Exclusion Criteria:

* 1. Subjects receiving any prescription or over the counter weight loss medication within 30 days prior to randomization (including GLP-1 analogs).

  2. Previous GI surgery that could preclude the ability to place the device. 3. Subjects with a history of abnormal GI anatomical findings documented on imaging study, which in the opinion of the investigator, may impair implantation of the IGB device 4. Subjects with severe GERD that are not responding to Proton Pump Inhibitor (PPI) 5. Known abnormal pathologies or conditions of the upper gastrointestinal tract.

  6. Subjects with symptomatic gallstones within 6 months prior to randomization 7. Coagulopathy defined as hgb \<10g/dl and platelet \< 100,000/ml or diagnosis of hemophilia, factor X deficiencies or fibrinogen abnormalities 8. Subjects requiring prescription antithrombotic therapy (i.e. anticoagulant or antiplatelet agent) 9. Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) or any other drugs with bleeding as a potential side effect during the study duration.

  10. Subject is or has been enrolled in another investigational study within 3 months of participation into the current study 11. Subjects not residing within a 3 hour driving distance of the study center.

Primary outcomes:
measure: Excess weight loss
timeFrame: 2 years
Secondary outcomes:
measure: liver fat infiltration
timeFrame: 2 years
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Alon Lang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04840472: Study Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer
Official title: Pilot Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Head and Neck Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2021-04-12
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: The primary purpose of the study is to assess the safety of 111In-panitumumab as a molecular imaging agent in patients with Head and Neck Squamous Cell Carcinoma.

The secondary objective is to compare sensitivity and specificity of identifying sentinel lymph nodes by systemic injection of 111In-panitumumab prior to Day of Surgery versus conventional local injection with an optical dye at the time of surgery.


Eligibility criteria: Inclusion Criteria:

* Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck.
* Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Subjects with recurrent disease or a new primary will be allowed.
* Planned standard of care elective neck dissection for a cN0 or cN1 disease. Clinical N1 disease will be defined as metastasis in a single, ipsilateral lymph node, 3 cm or less in greatest dimension by clinical exam, cross sectional imaging or metabolic imaging.
* Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results:
* Hemoglobin ≥ 9 gm/dL
* White blood cell count \> 3000/mm3
* Platelet count ≥ 100,000/mm3
* Serum creatinine ≤ 1.5 times upper reference range

Exclusion Criteria:

* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
* History of infusion reactions to monoclonal antibody therapies.
* Pregnant or breastfeeding.
* Magnesium or potassium lower than the normal institutional values.
* Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
* Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
* Severe renal disease or anuria.

Primary outcomes:
measure: Assess the safety of 111In panitumumab as a molecular imaging agent in patients with HNSCC.
timeFrame: 15 days
Secondary outcomes:
measure: Compare sensitivity of systemic 111In panitumumab versus conventional local optical dye
timeFrame: 10 days after surgery
measure: Compare specificity of systemic 111In panitumumab versus conventional local optical dye
timeFrame: 10 days after surgery
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford Universiy
name: Fred Baik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03805672: Below Knee DVT Study
Official title: Is Therapeutic Anticoagulation Necessary for the Treatment of Distal Deep Venous Thrombosis of the Lower Extremity? A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Deep Vein Thrombosis (DVT)
Blood Clots
Keywords: Lovenox
enoxaparin
DVT
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hospitalized patients are at risk of developing blood clots in the legs (Deep Vein Thrombosis or DVT), which can lead to death if those clots break off and migrate to the lungs. We know that if there is a blood clot in the large leg veins near the hips and in the thighs, treating these patients with high-doses of blood thinners reduces the risk of these deaths.

It is unclear if treating blood clots in the calf with high doses of blood thinners is better than using low doses. In this study, after being diagnosed with a blood clot in the calf, patients will be treated with either low dose or high dose enoxaparin (Lovenox), a blood thinner. We will then see if low dose blood thinner has similar results as high dose blood thinner.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 admitted to a trauma or general surgery service will be eligible
* Patients diagnosed with an isolated distal DVT
* Able to obtain informed consent

Exclusion Criteria:

* Patients with a previous diagnosis of hypercoagulability
* Patients on chronic anticoagulation
* Patients with a history of heparin induced thrombocytopenia
* Patients have preexisting contraindications to anticoagulation
* Patients in renal failure requiring adjusted enoxaparin dosing
* Pregnant patients

Primary outcomes:
measure: Deep Vein Thrombosis Resolution
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Martin Schreiber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05892172: Heart Failure and Sleep Disordered Breathing
Official title: Characteristics of Arrhythmia and Heart Rate Variability in Patients With Heart Failure and Sleep Disordered Breathing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: sleep disordered breathing
arrhythmia
heart rate variability
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Heart failure patients hospitalized in the Department of Cardiology of the First Affiliated Hospital of Harbin Medical University

Brief summary: The purpose of this study is to analyze and summarize the characteristics of arrhythmia and heart rate variability of Chinese patients with three different types of heart failure combined with sleep disordered breathing based on the clinical data, to provide new diagnosis and treatment ideas for domestic patients, and then to improve the prognosis of patients betterly.


Eligibility criteria: Inclusion Criteria:

1. Age \>18 years.
2. The diagnosis of heart failure conforms to the criteria of the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure .
3. Echocardiography, dynamic electrocardiogram and polysomnography monitoring should be improved during the period of hospitalization.
4. Patients with sleep apnea have not received standard treatment.

Exclusion Criteria:

1. Patients undergoing cardiac surgery in the past 6 weeks.
2. Patients with acute decompensated heart failure or heart failure requiring oxygen therapy.
3. All patients with sleep apnea who receive standard treatment.
4. Patients who use pacemakers or implantable cardioverter defibrillators.
5. The patient did not complete the echocardiography, dynamic electrocardiogram, and polysomnography monitoring during hospitalization.

Primary outcomes:
measure: heart failure and sleep apnea
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: Yihui Kong
state: Heilongjiang
Study officials:
References:
Clinical trial NCT01762072: Effect of Vitamin B12 and n-3 Polyunsaturated Fatty Acids on Plasma Homocysteine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: homocysteine-vitamin B12-fish oil-ferritin
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Vitamin B12and n-3 polyunsaturated fatty acids (PUFA) decrease blood homocysteine (Hcy) concentration. However, the combined effect of these nutrients on Hcy and ferritin, and C-reactive protein is limited and inconclusive. The objective was to examine the synergistic effect of vitamin B12 in combination of n-3 PUFA on plasma Hcy, ferritin, and other biochemical markers. In a randomized controlled trial, thirty eligible subjects were randomly divided into three groups, and assigned to receive 1000 μg of vitamin B12, 2g fish oil, or 1000 μg vitamin B12 and 2g fish oil respectively for 8 weeks. Plasma phospholipid (PL) fatty acids and biochemical markers were determined. we hypothesize that combination of vitamin B12 and fish oil have synergistic effect on lowering plasma concentrations of Hcy and ferritin.


Eligibility criteria: Inclusion Criteria:

* reliability, regular eating habits, normal weight, nondrinking, and nonsmoking status

Exclusion Criteria:

* None of the selected subjects used any vitamins or dietary supplements and was taking no medication for at least 8 weeks before the start of and during the entire experimental period

Primary outcomes:
measure: homocysteine,umol/L
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang university
state: Zhejiang
Study officials:
References:
citation: Huang T, Li K, Asimi S, Chen Q, Li D. Effect of vitamin B-12 and n-3 polyunsaturated fatty acids on plasma homocysteine, ferritin, C-reaction protein, and other cardiovascular risk factors: a randomized controlled trial. Asia Pac J Clin Nutr. 2015;24(3):403-11. doi: 10.6133/apjcn.2015.24.3.19.