louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06844474: A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC
Official title: A Phase II, Multicenter, Open-Label Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-1826 for Injection in Patients With NSCLC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: NSCLC
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an open-label, multicenter Phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in patients with NSCLC.


Eligibility criteria: Inclusion Criteria:

1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
2. ECOG performance score of 0-1.
3. Life expectancy ≥ 3 months.
4. Have at least one measurable tumor lesion per RECIST v1.1.
5. Subjects with histologically confirmed locally advanced or metastatic NSCLC.
6. Good level of organ function.
7. Provide archived or fresh tumor tissue for vendor test.

Exclusion Criteria:

1. Subjects with active central nervous system metastases or meningeal metastases;
2. History of serious cardiovascular and cerebrovascular diseases;
3. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;
4. Severe infection within 4 weeks prior to the first dose;
5. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
6. Subjects with uncontrolled tumor-related pain;
7. Received \>30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
8. Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
9. Unresolved toxicities from previous anti-tumor therapy to ≤ Grade 1 (based on NCI CTCAE v5.0);
10. History of immunodeficiency, including a positive HIV test;
11. Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.

Primary outcomes:
measure: Incidence and severity of adverse events (AEs) /serious adverse events(SAEs)
timeFrame: approximately 2 years
measure: Overall response rate (ORR)
timeFrame: approximately to 2 years
Secondary outcomes:
measure: Duration of response (DoR)
timeFrame: approximately to 2 years
measure: Disease control rate (DCR)
timeFrame: approximately to 2 years
measure: Progression-free survival (PFS)
timeFrame: approximately to 2 years
measure: Overall survival (OS)
timeFrame: approximately to 5 years after last subject enrolled
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese People's Liberation Army (PLA) General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04963374: the Effectiveness of Different Risk Scales In Predicting VTE in Respiratory Inpatients
Official title: Comparative Analysis of the Effectiveness of Different Risk Scales in Predicting Combined Venous Thrombophilia in Respiratory Inpatients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: VTE
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From January 2015 to December 2020, inpatients in respiratory department, Third Hospital of Peking University

Brief summary: To compare the predictive effectiveness of the Caprini risk assessment model, the Padua risk assessment model and the VTE risk assessment in medical patients mentioned in the 2018 edition of the Guidelines for the diagnosis, treatment and prevention of pulmonary thromboembolism on the risk of concomitant VTE in respiratory inpatients to provide a basis for clinical VTE assessment and treatment.

Detailed description: A case-control study was used to collect patients who developed VTE during hospitalization in the Department of Respiratory Medicine at Peking University Third Hospital Hospital from January 2015 to December 2020 as the case group, and 2-fold patients who did not develop VTE matched to the case group (age, sex, ADL score, diagnosis, and length of hospitalization) as the control group. The general status of the patients was also assessed using the Padua risk model, the Caprini risk model, and the VTE risk assessment scale for medical patients mentioned in the 2018 edition of the Guidelines for the diagnosis, treatment, and prevention of pulmonary thromboembolism, and the relevant items involved in the assessment form were obtained by reviewing the cases.

Eligibility criteria: Inclusion Criteria:

* age more than 18y respiratory inpatient

Exclusion Criteria:

* Patients with deep vein thrombosis or pulmonary thromboembolism, sequelae of deep vein thrombosis, and thrombosis in other parts of lower limbs were diagnosed; Patients with severe coagulation dysfunction or other hematological diseases

Primary outcomes:
measure: VTE incidence
timeFrame: during hospitalization， an average of 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking UTH
state: Beijing
Study officials:
affiliation: Peking UTH
name: Jing Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luo XY, Zhang FX. [Validation of the Caprini risk assessment model for venous thromboembolism in Chinese hospitalized patients in a general hospital]. Zhonghua Yi Xue Za Zhi. 2017 Jun 27;97(24):1875-1877. doi: 10.3760/cma.j.issn.0376-2491.2017.24.007. Chinese.
Clinical trial NCT03346174: Influence of Airway Clearance Techniques on GOR in Infants
Official title: Influence of Assisted Autogenic Drainage (AAD) and Bouncing Combined With Assisted Autogenic Drainage (BAAD) on Acid and Non-acid Gastro-oesophageal Reflux (GOR) in Infants < 1 Year
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-oesophageal Reflux
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 105
Sex: ALL
Minimum age (years): 1
Maximum age (years): 365
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Assisted Autogenic Drainage (AAD) or bouncing combined with Assisted Autogenic Drainage (BAAD), induces or aggravates acid and non-acid gastro-oesophageal reflux in infants under the age of one year. Infants, referred to the hospital for impedance-pH monitoring are included in this study.


Eligibility criteria: Inclusion Criteria:

* Each child under the age of 1 year, referred for 24 h impedance monitoring to confirm a clinically suspected diagnosis of pathological GOR will be included

Exclusion Criteria:

* prematurity (gestational age less than 37 weeks),
* the use of anti-reflux medication and reflux surgery (Nissen fundoplication)

Primary outcomes:
measure: number of refluxes
timeFrame: 20 minutes
Secondary outcomes:
measure: number of acid refluxes
timeFrame: 20 minutes
Other outcomes:
measure: number of non-acid refluxes
timeFrame: 20 minutes
Locations:
city: Jette
country: Belgium
facility: UZBrussel
state: Brussels
Study officials:
affiliation: Vrije Universiteit Brussel
name: Filip Van Ginderdeuren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04218474: Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury
Official title: Evaluation Of Cross Mental Nerve Transfer In Restoration Of Lower Chin &Lip Sensation Post Inferior Alveolar Nerve Injury and Ablative Mandibular Resectons
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Injury of Mental Nerve of One Side
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin \&Lip Sensation Post Inferior Alveolar Nerve Injury


Eligibility criteria: Inclusion Criteria:

* Patients with hemimandiblectomy
* Patients with Injured Inferior Alveolar Nerve which not showing any healing after 9 months
* Age group : from 15 to 60 years old
* No sex predilection
* Patients with no contraindications to surgical intervention

Exclusion Criteria:

* • Patients with systemic condition counteracting with the surgical procedure.

Primary outcomes:
measure: Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine Cairo University
Study officials:
References:
citation: Kaban LB, Upton J. Cross mental nerve graft for restoration of lip sensation after inferior alveolar nerve damage: report of case. J Oral Maxillofac Surg. 1986 Aug;44(8):649-51. doi: 10.1016/s0278-2391(86)80078-7. No abstract available.
Clinical trial NCT02333474: Safety and Efficacy of Mix Vaccine in Lung Carcinoma Patient
Official title: Safety Issue and Efficacy of Combining Mix Vaccine and Standard Therapy in the Treatment of Lung Carcinoma Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lung Neoplasms
Keywords: mix vaccine, lung neoplasms, immunotherapy
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 20
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: The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV). Enrolled patients will receive standard treatment according to National Comprehensive Cancer Network (NCCN) guide line with or without combining MV injection. The efficacy and side effect will be compared between the two groups.

Detailed description: In the study, after evaluation of the general and physical status, eligible patients will be enrolled and randomly assigned into two arms at an 1:1 ratio. In the control arm patients will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN) guide line (control group) and in experimental arm, patients will be receiving simultaneous standard therapy and injection of mix vaccine (MV). MV will be injected weekly till disease progression.

Blood sample will be obtained at baseline and every week before MV injection for the assessment of clinical hematology, biochemistry measurements and immunology index (including immunoglobin, interleukin and interferon). Patients will be evaluated for toxicity throughout the study. Side effect, progression free survival, immunology index and general status will be recorded.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with lung carcinoma based on histology
2. Evaluable lesions on imaging study
3. Without known immunodeficiency
4. Age \>18 and \<80 years ago

Exclusion Criteria:

1. Patients is unable or unwilling to sign informed consent
2. Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication
3. Positive HIV and/or RPR (rapid plasma reagin )
4. Female patient who is pregnant or breast feeding
5. Patients, based on the opinion pf the investigator, should not be enrolled into this study
6. Prior anti-cancer vaccine or biological immunotherapy
7. Allergic to any known ingredient of the MV compound

Primary outcomes:
measure: efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
timeFrame: 2 years
Secondary outcomes:
measure: Safety as measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria
timeFrame: 1 month
measure: immunology index
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biological treatment center in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Kecheng Xu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04657874: Bromelain and Escin in the Reduction of Postoperative Sequelae in Periodontal and Implant Surgery
Official title: Association Between Bromelain and Escin in the Reduction of Postoperative Sequelae in Periodontal and Implant Surgery: Randomized Clinical Trial, Placebo-controlled, Double-blind
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Edema
Swelling Lips & Face
Lead sponsor: University of L'Aquila
Sponsor class: OTHER
Collaborators: name: Dr. Leonardo Mancini
name: Tommaso Pizzolante
First posted: 2020-12-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized clinical trial will be performed in parallel, placebo controlled, triple-blind to evaluate the effectiveness of the association Bromelina and Horse-chestnut (titrated in escin) (Noflogo®, Mavenpharma s.r.l., Rome, Italy) in the management of post trauma-surgery following surgery periodontal and implant surgery.

Detailed description: At least 50 volunteers between the ages of 18 and 50, will be enlisted, with the need to perform one of the interventions described above and that fall within the criteria of inclusion.

The study will be carried out in accordance with the Helsinki Declaration on In Vivo Studies and will be initiated with the approval of the Internal Review Board of the University of L'Aquila.

The protocol follows the guidelines of the CONSORT Statement for parallel studies and will be recorded on the data base clinicaltrials.gov.

Eligibility criteria: Inclusion Criteria:

* No signs of gingival inflammation;
* FMBS and FMPS ≤ 20% after non-surgical causal therapy (Only for patients undergoing periodontal surgery)
* Smokers have to indicate how many cigarettes they smoke and how long have they been smoking

Exclusion Criteria:

* Gingival inflammation
* Positive anamensis for relevant systemic pathologies (renal, cardiovascular, hepatic, infectious, neoplastic and diabetological)
* Treatment with anti-inflammatory and/or antibiotics in the two weeks preceding the start of the trial
* History of allergy to one or more components of the medication to be tested
* Pregnant women

Primary outcomes:
measure: Edema - Cheek Volume
timeFrame: Baseline
measure: Edema - Cheek Volume
timeFrame: Post-surgical - 30 min
measure: Edema - Cheek Volume
timeFrame: 2 days
measure: Edema - Cheek Volume
timeFrame: 7 days
measure: Trismus - Vertical Opening
timeFrame: Baseline
measure: Trismus - Vertical Opening
timeFrame: Post-surgical - 30 min
measure: Trismus - Vertical Opening
timeFrame: 2 days
measure: Trismus - Vertical Opening
timeFrame: 7 days
measure: Pain - (VAS)
timeFrame: Baseline
measure: Pain - (VAS)
timeFrame: Post-surgical - 30 min
measure: Pain - (VAS)
timeFrame: 2 days
measure: Pain - (VAS)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: L'aquila
country: Italy
facility: University of L'Aquila, Division of Periodontology
state: AQ
Study officials:
References:
Clinical trial NCT02360774: Mechanisms of Weight Loss With SGLT2 Inhibition
Official title: Mechanisms of Weight Loss With SGLT2 Inhibition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Overweight
Obesity
Keywords: Canagliflozin
Obesity
Weight Loss
Body Weight
Body Weight Changes
Overweight
Sodium-glucose transporter subtype 2 inhibitor
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2015-02-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of canagliflozin, a medication approved by the FDA for the treatment of type 2 diabetes, on body weight and metabolism in people with type 2 diabetes who are overweight or obese.

Canagliflozin lowers glucose levels in the blood by making the kidneys excrete, rather than absorb, glucose. Canagliflozin is also often associated with weight loss.

The study population will generally be type 2 diabetics, ages 18-75 years old, who are overweight or obese.


Eligibility criteria: Inclusion Criteria:

1. Type 2 diabetes
2. BMI 25-45 kg/m2
3. Hemoglobin A1C \> 6.5% but \< 9%
4. Normal renal function (GFR \> 60)
5. Age 18-75

Exclusion Criteria:

1. Type 1 diabetes
2. History of recurrent UTI or mycotic genital infections
3. Treatment with insulin or a GLP1 agent
4. Pregnant or breastfeeding

Primary outcomes:
measure: Change in Body Weight
timeFrame: 18 weeks (duration of study)
Secondary outcomes:
measure: Change in Resting Energy Expenditure, Measured Using Indirect Calorimetery
timeFrame: 18 weeks (duration of study)
measure: Change in Body Composition, Measured Using DXA Scanning.
timeFrame: 18 weeks (duration of study)
measure: Change in Glycemic Control
timeFrame: 18 weeks (duration of study)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT00885274: A Randomized Controlled Trial Comparing Two Timing Regimens of Pico-salax for Colon Cleansing Prior to Colonoscopy
Official title: A Randomized Controlled Trial Comparing Two Timing Regimens of Pico-salax for Colon Cleansing Prior to Colonoscopy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonoscopy
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2009-04-21
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Pico-Salax is an osmotic and stimulant bowel cleansing agent used prior to colonoscopy. It is unknown whether splitting the doses (i.e. taking the second dose the morning of the colonoscopy) results in a better bowel cleansing, as research with other agents suggests this may be the case. This study aims to assess whether splitting the dose of Pico-Salax results in a better bowel cleansing than traditional dosing.


Eligibility criteria: Inclusion Criteria:

* colonoscopy indicated

Exclusion Criteria:

* congestive heart failure
* ascites
* renal failure
* hyponatremia
* previous intestinal surgery

Primary outcomes:
measure: bowel cleansing assessed by the Ottawa Bowel Preparation Scale
timeFrame: day of colonoscopy
Secondary outcomes:
measure: patient tolerance of preparation
timeFrame: day of colonoscopy
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Lawrence Hookey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flemming JA, Vanner SJ, Hookey LC. Split-dose picosulfate, magnesium oxide, and citric acid solution markedly enhances colon cleansing before colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2012 Mar;75(3):537-44. doi: 10.1016/j.gie.2011.09.018. Epub 2011 Dec 21.
Clinical trial NCT00213174: Study of Sand Versus Wood Chip Surfaces on School Playgrounds to Minimize Injury in School Children
Official title: School Playground Surfacing - A Randomized Prospective Comparison of Injury Rates on Sand Versus Wood Chip Surfaces
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Wounds and Injuries
Closed Head Injury
Keywords: pediatrics
injury
arm fractures
trauma
playground surfaces
fractures
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-09-21
Enrollment: 34
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study will compare children's injury rates (arm fracture, head injury and other injuries) when playing on playground equipment on granite sand versus wood fibre playing surfaces.

The hypothesis is that injury rates (arm fracture, head injury and other injuries) among school children are equal on granite sand and wood fibre playground surfaces.


Eligibility criteria: Inclusion Criteria:

* School children
* Ages 5-11
* Injured on falls from play equipment during supervised school hours

Exclusion Criteria:

* Children injured outside of supervised school hours

Primary outcomes:
measure: Upper extremity fracture rates
Secondary outcomes:
measure: Fracture rates, upper extremity
measure: Head injury rates
measure: All injury rates
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Andrew W Howard, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00287274: Impact of Computerized Physician Order Entry on Medication Prescription Errors in the Intensive Care Unit: a Controlled Cross-Sectional Trial.
Official title: Impact of Computerized Physician Order Entry on Medication Prescription Errors in the Intensive Care Unit: a Controlled Cross-Sectional Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Errors
Patient Safety
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-02-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Device: computerized physician order entry.

We wanted to investigate if the introduction of a computerized intensive care unit system reduced the incidence and severity of medication prescription errors (MPEs). A prospective trial was conducted during 5 weeks in a paper-based unit versus a computerized unit. The registration of different classes of MPEs was done by a clinical pharmacist. An independent panel evaluated the severity of MPEs.


Eligibility criteria: Inclusion Criteria:

* Adult patients admitted to the Surgical Intensive Care Unit

Exclusion Criteria:

* Adult Patients admitted to other units
* Pediatric patients

Primary outcomes:
measure: To compare the the incidence and severity of medication prescription errors between a CPOE unit and a paper-based unit at completion of the study.
Secondary outcomes:
measure: Description of MPEs in both units at completion of the study.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Kirsten Colpaert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colpaert K, Claus B, Somers A, Vandewoude K, Robays H, Decruyenaere J. Impact of computerized physician order entry on medication prescription errors in the intensive care unit: a controlled cross-sectional trial. Crit Care. 2006 Feb;10(1):R21. doi: 10.1186/cc3983.