louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00293826: A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: ACR criteria
methotrexate
DMARDs
patient reported outcomes
joint assessment
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2006-02-20
Enrollment: 813
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 determine if AMG 108 in combination with methotrexate is safe and effective in the treatment of rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Subjects with active rheumatoid arthritis as diagnosed by meeting ACR classification criteria for at least 6 months.
* Must be taking MTX consecutively for \>/= 12 weeks and at a stable dose of methotrexate at 15-25 mg weekly for at least 4 weeks prior to screening

Exclusion Criteria:

* Receipt of commercial or experimental biologic therapies for the treatment of inflammatory disease
* Presence of serious infection
* Class IV rheumatoid arthritis
* Prior or current history of tuberculosis infection or exposure
* Any other DMARDs other than methotrexate within 6 weeks of screening
* Pregnant or nursing
* Receipt of live vaccines within 3 months
* Felty's syndrome

Primary outcomes:
measure: ACR20 response
timeFrame: 24 Weeks
Secondary outcomes:
measure: Change in subject reported outcomes
timeFrame: 24 Weeks
measure: ACRn, AUC ACRn, ACR50, ACR70, and DAS28
timeFrame: 24 Weeks
measure: PK parameters
timeFrame: 24 Weeks
measure: Safety endpoints including AEs, SAEs, SIEs, and change in anti-AMG 108 antibody status
timeFrame: 24 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Cardiel MH, Tak PP, Bensen W, Burch FX, Forejtova S, Badurski JE, Kakkar T, Bevirt T, Ni L, McCroskery E, Jahreis A, Zack DJ. A phase 2 randomized, double-blind study of AMG 108, a fully human monoclonal antibody to IL-1R, in patients with rheumatoid arthritis. Arthritis Res Ther. 2010;12(5):R192. doi: 10.1186/ar3163. Epub 2010 Oct 15.
Clinical trial NCT03473626: Phase 1 Food Effect Study for Alicaforsen Tablets
Official title: A Two-Period, Randomised, Crossover Study Designed to Evaluate the In Vivo Performance of a Modified Release Formulation of Alicaforsen in Healthy Male Subjects in the Fed and Fasted State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: IBD
Lead sponsor: Atlantic Pharmaceuticals Ltd
Sponsor class: INDUSTRY
First posted: 2018-03-22
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Phase 1 study to compare the effect of food on alicaforsen tablet.

Detailed description: A study on healthy male vounteers in a phase 1 unit. Alicaforsen tablets are gievn in a fed and fasted state

Eligibility criteria: Inclusion Criteria:

* Healthy Volunteer

Exclusion Criteria:

* Drugs of abuse
* Alcohol abuse

Primary outcomes:
measure: Pharmacokinetics
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Phase 1 unit
Study officials:
affiliation: Atlantic Pharmaceuticals
name: Chris Dunk
role: STUDY_DIRECTOR
References:
Clinical trial NCT02311426: Stroke in North of Norway and Denmark. A Prospective Cohort Study.
Official title: Stroke in North of Norway and Denmark. A Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Rehabilitation; Functional outcome
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2014-12-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with stroke admitted to the stroke units at the University Hospital of North Norway and Århus Hospital in Denmark

Brief summary: The study is a comparative effectiveness study with comparision of two cohorts of patients with stroke in North of Norway and in Denmark. At baseline information is collected from the stroke registries in both countries. Time points for follow up are at 3 and 12 months post-stroke. Data are collected from medical charts and with use of telephone interview in addition to self-report questionnaires. The study will provide information about functional status, health related quality of life and rehabilitation needs. Information about rehabilitation services in both countries are collected and compared, and analysed in relation to patients outcome.


Eligibility criteria: Inclusion Criteria:

* Verified stroke. Admitted to stroke unit.

Exclusion Criteria:

* Patients outside the regions excluded.

Primary outcomes:
measure: Rehabilitation Needs
timeFrame: 3 months post-stroke
measure: Health related Quality of life questionnaire
timeFrame: 3 and 12 months post-stroke
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: University Hospital of North Norway
name: Audny Anke, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06373926: Evaluation of Cell Membrane Expression of Annexin A2 on Monocytes by Flow Cytometry in Primary Antiphospholipid Syndrome
Official title: Evaluation of Cell Membrane Expression of Annexin A2 on Monocytes by Flow Cytometry in Primary Antiphospholipid Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Antiphospholipid Syndrome
Keywords: annexin A2
antiphospholipid syndrome
monocytes
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Annexin A2 (ANXA2), an endothelial cell receptor for plasminogen and tissue plasminogen activator, plays a pivotal role in regulation of fibrinolysis in vitro and in vivo and has been identified as a new autoantigen in antiphospholipid syndrome (APS). ANXA2 can exist as a monomer or a heterotetrameric complex with S100A10 protein. The aim of this study was to evaluate the cell membrane expression of ANXA2 on circulating monocytes in APS by flow cytometry. Several pathogenic mechanisms are involved in APS such as activation of endothelial cells, platelets and monocytes, inhibition of the natural anticoagulant protein C/protein S pathway, activation of the complement system and also impairment of fibrinolysis. Annexin A2 which hits binding partner S100A10, ANXA2 forms a cell surface complex that regulates generation of plasmin. ANXA2 is involved in the pathogenesis of APS-associated through several possible mechanisms. Human peripheral blood monocytes represent the major circulating ANXA2-expressing cell and ANXA2-mediated assembly of plasminogen and tissue activator of plasminogen (tPA) on monocyte/macrophages contributes to plasmin generation. Thus the investigators could suppose that decrease of cell membrane expression of ANXA2 on circulating monocytes represent a new pathogenic mechanism in APS.


Eligibility criteria: Inclusion Criteria:

* APS patients who fulfilled the revised criteria for APS

Exclusion Criteria:

* Patients less than 18 years old
* Solid and hematological malignancies
* Other autoimmune diseases
* Cirrhosis

Primary outcomes:
measure: Cell membrane expression rate of ANXA2 on circulating monocytes in APS
timeFrame: 1 hour
Secondary outcomes:
measure: Cellular expression of ANXA2 and S100A10 in APS patients
timeFrame: 1 hour
measure: cell membrane expression of ANXA2 and S100A10 in APS patients
timeFrame: 1 hour
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT03489226: Capsimax Effect on Metabolic Rate, Satiety and Food Intake
Official title: A Pilot Study of the Effect of a Dietary Herbal Supplement Containing Capsaicin or Placebo on Satiety, Metabolic Rate and Food Intake in Healthy Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy Metabolism
Eating
Hunger
Keywords: capsaicin
energy expenditure
satiety
food intake
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: OmniActive Health Technologies
First posted: 2018-04-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 4 arm crossover trial
Primary purpose: TREATMENT

Brief summary: Comparison of Capsimax™ 2mg and 4mg of capsicum extract vs. placebo on metabolic rate and satiety.

Detailed description: Capsimax™ is a capsicum extract in a bead technology to avoid oral and gastric burning. Capsimax™ 2mg, Capsimax™ 4 mg and placebo was initially given as a single dose on an empty stomach with measures of metabolic rate, and satiety before and after and food intake at 1 hour after Capsimax™.

Eligibility criteria: Inclusion Criteria:

1. BMI between 25 and 40 kg/m2 inclusive
2. Healthy
3. If of child-bearing potential, use of effective contraception

Exclusion Criteria:

Subjects excluded will:

1. Have received an investigational product in another trial within 30 days of enrollment.
2. Have lost 10 or more pounds in the 3 months prior to randomization and maintained the weight loss.
3. Use tobacco products
4. Use a nicotine patch or gum.
5. Take regular medication other than oral contraceptives or estrogen replacement therapy.
6. Take products containing ephedra or medications known to increase metabolic rate like stimulants taken for attention deficit disorder.
7. Not eat at regular mealtimes.
8. Have a history of alcohol or drug abuse in the past year.
9. Nurse a baby or be a member of a vulnerable population including adults unable to consent, pregnant women, prisoners or minors.
10. Have a clinically significant history of diabetes, high blood pressure (\>140/90), thyroid disease, heart disease, kidney disease or liver disease.
11. Have a known allergy to capsaicin caffeine, piperine or niacin.
12. Have clinically significant laboratory findings in the opinion of the investigator.
13. Score greater than 13 on the restraint scale of the 3-factor eating questionnaire.

Primary outcomes:
measure: Resting Metabolic Rate
timeFrame: up to 5 hours
Secondary outcomes:
measure: Satiety by Visual Analog Scale (hunger, fullness, prospective food intake and satisfaction)
timeFrame: Baseline to 4 hours
measure: Food Intake
timeFrame: 1 hour after intervention
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Frank L Greenway, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02684526: Is Eovist Suitable for Arterial-Phase MR Imaging of Liver
Official title: Is Eovist Suitable for Arterial-Phase MR Imaging of Liver
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Disease
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 198
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To examine the quality of liver images produced when the contrast agent Eovist is used during MRI.

Detailed description: Researchers will review data from the Eovist MRI and compare the scan with previous MRI exams the patient had with the same or other contrast agents.

To determine the efficacy of Eovist contrast agent in producing MRI images of the liver. We will monitor patients for any unusual symptoms (adverse events) when the contrast is given.

Patients are asked to hold their breath during an MRI scan. Eovist may interfere with the "breath hold" which could result in more breathing artifacts (based on a qualitative scale) on arterial images when the patients are given Eovist vs. other contrast agents.

Eligibility criteria: Inclusion Criteria:

1. You have had a scheduled MRI(magnetic resonance imaging) scan using the contrast agent EOVIST.
2. Male and females 21 years of age or older.

Exclusion Criteria:

1. Does not have a contraindication for MRI (e.g. cardiac pacemaker, ferromagnetic or metallic implants).
2. Pregnancy

Primary outcomes:
measure: Scanning artifacts on MRI with Eovist
timeFrame: 5 years
Secondary outcomes:
measure: Adverse events (including dyspnea)
timeFrame: 30 min
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Hero Hussain, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05695326: Effects of a 3D Printing Technology Learning Program
Official title: Effects of a 3D Printing Technology Learning Program for Rehabilitation Professionals: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Educational Problems
Lead sponsor: Gunma PAZ College
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 3D printing technology helps rehabilitation professionals make an order-made assistive device (AD). However, most have not learned how to use the technology for clinical practice. The study is aimed to evaluate a 3D printing technology learning program for rehabilitation professionals. Eligible participants who have a licence for physical, occupational or speech-language therapy and have not experienced learning any 3D printing technology. The learning program was conducted in accordance with Kolb's Experiential Learning Theory (Morris TH, 2020). The program was conducted over eight weeks. The outcome measure included the Japanese version of the modified Technology Acceptance Model questionnaire (TAM-J). It consists of 13 items and four scales; Perception of usefulness (28 points total), Perception of ease of use (35 points total), Attitude toward use (14 points total) and Intention to use (14 points total). Within-group analyses were performed using the Wilcoxon signed-rank test for the TAM-J between different time points.


Eligibility criteria: Inclusion Criteria:

* Eligible participants who have a licence for physical, occupational or speech-language therapy

Exclusion Criteria:

* Participants who have experienced learning any 3D printing technology.

Primary outcomes:
measure: The Japanese version of modified Technology Acceptance Model questionnaire
timeFrame: Change from Baseline a score of the Japanese version of modified Technology Acceptance Model questionnaire at 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fujisawa
country: Japan
facility: shonan keiiku Hospital
state: Kanayama
Study officials:
References:
Clinical trial NCT01045057: Clinical Feasibility of New Tracheoesophageal Puncture Set
Official title: Clinical Feasibility of a New Surgical Tool for Primary or Secondary Tracheoesophageal Puncture and Voice Prosthesis Insertion for Prosthetic Voice Rehabilitation After Total Laryngectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Larynx Cancer
Keywords: voice prosthesis, larynx cancer, laryngectomy
Lead sponsor: Atos Medical AB
Sponsor class: INDUSTRY
First posted: 2010-01-08
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Provox Vega Puncture Set
Primary purpose: TREATMENT

Brief summary: During a total laryngectomy a puncture is created in the tracheoesophageal wall and a voice prosthesis is inserted. With this voice prosthesis the patient learns to speak again. During this study a new surgical tool will be investigated that creates the puncture and places the voice prosthesis.


Eligibility criteria: Inclusion Criteria:

* primary puncture during total laryngectomy
* secondary puncture some time after total laryngectomy

Exclusion Criteria:

* anatomical abnormalities that prevent appropriate pharynx protection during secondary puncture
* not eligible to use a voice prosthesis for other reasons

Primary outcomes:
measure: Success Rate of Procedure
timeFrame: immediate observation during surgery
Secondary outcomes:
measure: Satisfaction of Physician
timeFrame: 1 month
measure: Cost Effectiveness Calculation
timeFrame: 1 month
measure: Postoperative Results
timeFrame: 1 month
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Ulm
country: Germany
facility: Bundeswehr Krankenhaus
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
state: Noord Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau Universitat Autònoma de Barcelona
Study officials:
affiliation: The Netherlands Cancer Institute
name: Frans JM Hilgers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00931957: Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease
Official title: Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Behcet Syndrome
Uveal Disease
Keywords: Etanercept
Behcet's syndrome
Behcet's Disease
Ocular Lesions
Uveitis
Retinal Vasculitis
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2009-07-02
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find if Etanercept can improve the outcome of ocular lesions of Behcet's Disease treated with Methotrexate and Prednisolone

Detailed description: To test in a randomized single blind control trial the efficacy of Etanercept in patients with posterior uveitis and/or retinal vasculitis of Behcet's disease treated with Methotrexate and prednisolone

Eligibility criteria: Inclusion Criteria:

* Behcet's Disease according to the International Criteria for Behcet's disease (ICBD)
* Active posterior uveitis and/or retinal vasculitis

Exclusion Criteria:

* Visual acuity inferior to 1/10 on Snellen chart
* Being under cytotoxic drugs or having received them in the past 2 months
* Not being able to follow the one year treatment and the regular follow ups

Primary outcomes:
measure: Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis
timeFrame: One Year
Secondary outcomes:
measure: DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index
timeFrame: One Year
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)
Study officials:
affiliation: Rheumatology Research Center, Medical Sciences/University of Teheran
name: Fereydoun Davatchi, MD
role: STUDY_CHAIR
References:
citation: Melikoglu M, Ozvazgan y Fresko I et al. The response of treatment resistant uveitis in Behcet's syndrome (BS) to a TNF-α blocker, Etanercept: an open study. Arthritis Rheum 2002; 46: S181, (Abstract) 400
citation: Davatchi F, Shahram F, Chams H, Jamshidi AR, Nadji A, Chams C, Akbarian M, Gharibdoost F. High dose methotrexate for ocular lesions of Behcet's disease. Preliminary short-term results. Adv Exp Med Biol. 2003;528:579-84. doi: 10.1007/0-306-48382-3_118. No abstract available.
citation: Davatchi F. New and innovative therapies for Behcet's Disease. APLAR Journal of Rheumatology 2004; 7: 141-145
citation: Davatchi F, Shams H, Nadji A, Jamshidi AR, Akhlaghi M, Sadeghi Abdollahi B, Ziaie N, Akbarian M, Gharibdoost F. Management of ocular manifestations of Behcet's Disease: outcome with cytotoxic drugs. APLAR Journal of Rheumatology 2005; 8: 119-123
Clinical trial NCT01229657: Evaluation of Anatomic and Visual Outcomes of Initially Closed Macular Holes
Official title: Study of the Anatomic and Visual Outcomes in Patients With Initially Closed Macular Holes After Vitreoretinal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Holes
Keywords: Reopening of macular hole;
Visual acuity;
Phacoemulsification cataract surgery;
Vitrectomy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2010-10-28
Enrollment: 79
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with initially closed macular holes after vitreoretinal surgery and with one to seven years of follow-up

Brief summary: To evaluate the anatomic and visual outcomes in patients with initially closed macular holes after vitreoretinal surgery and with one to seven years of follow-up.

Detailed description: In recent years, peeling of the internal limiting membrane (ILM) has been used as a supplementary treatment to reducing the tangential tractional forces and inducing hole closure in macular hole surgery, and thus the anatomic success rate has increased to over 90%. However, despite these high rates of surgical success, the reopening of initially closed macular holes has also been observed from the first month to several years following surgery. Because about 45% to 95% of phakic patients frequently develop a progressive nuclear sclerosis cataract after macular hole surgery and require combined or subsequent cataract extraction to improve visual acuity, cataract extraction has become a potential factor in causing macular hole reopening, although this is still under debate. The purpose of this study is to describe the long-term anatomic and visual outcomes in patients who had initial anatomic success with macular hole surgery and who had postoperative follow-up of one or more years. All patient's charts were reviewed for age, macular hole stage (using the Gass classification), macular hole duration, epiretinal membrane of macula presence, ILM peeling, preoperative and postoperative visual acuity, rate of macular hole reopening, cataract extraction, and length of follow-up after vitrectomy.

Eligibility criteria: Inclusion Criteria:

* successful closure of a macular hole after initial vitreoretinal surgery
* a follow-up of at least one year

Exclusion Criteria:

* post-traumatic holes,
* myopic macular holes,
* macular holes associated with a rhegmatogenous retinal detachment,
* eyes with silicone oil tamponade.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Shaochong Zhang, MD
role: STUDY_CHAIR
References: