louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04415684: Projected Peripheral Defocus Using a Wearable Device
Official title: Effects of Projected Peripheral Defocus on Ocular Biometrics Using a Wearable Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Kubota Vision Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Acucela Inc. intends to develop a medical device to significantly halt or reverse myopic progression, which is a significant public health concern across the world, especially in Asian demographics. Acucela is working towards a spectacle-like device (eSPECs), which will have a clear zone for unimpeded central visual tasks and a periphery that provides defocus in order to alter retinal physiology leading to myopia regulation. This study will establish the changes seen during a proof-of-concept that projected defocus in the periphery utilizing a wearable device will stimulate physiological changes similar to those in the literature.


Eligibility criteria: Inclusion Criteria:

* Spherical equivalent +2.00 to -4.00 diopters
* Refractive cylinder ≤ 0.75 diopters
* Visual acuity 20/20 -3 or better

Exclusion Criteria:

* Pregnant or lactating
* Active ocular infection
* History of dry eye, strabismus, or amblyopia
* Previous or planned ocular surgery
* Use of medication known to affect vision or accommodation

Primary outcomes:
measure: Axial length (AL)
timeFrame: 1 hour
measure: Choroidal thickness (CT)
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Vision Associates/institute of Vision Research
state: New York
Study officials:
affiliation: Manhattan Vision Associates/Institute of Vision Research
name: Arkady Selenow, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03466684: BIA Guided-fluid Management in Postinjury Open Abdomen
Official title: Bioelectrical Impedance Analysis Guided-Fluid Management Promotes Primary Fascial Closure of Postinjury Open Abdomen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Damage Control
Trauma Abdomen
Acute Compartment Syndrome
Keywords: Trauma
Open abdomen
Fluid resuscitation
Fascial closure
Bioelectrical impedance analysis
Lead sponsor: Nanjing PLA General Hospital
Sponsor class: OTHER
First posted: 2018-03-15
Enrollment: 140
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: Fluid overload (FO), resulting from high volume fluid therapy, is frequent and contributes to excessive visceral edema, delayed fascial closure, and adverse outcomes among postinjury open abdomen (OA) patients. Bioelectrical impedance analysis (BIA) is a promising tool in monitoring fluid status and FO. Thus, we sought to investigate the efficacy of BIA-directed resuscitation among postinjury OA patients.


Eligibility criteria: Inclusion Criteria:

* Adult trauma patients admitted to SICU with OA after emergent abbreviated laparotomy were considered eligible.

Exclusion Criteria:

* (a) age less than 18 years; (b) pregnancy; (c) lactation; (d) limb amputations; (e) mental disorders; (f) diabetes mellitus; (g) pre-existing blood disorders; (h) pre-existing abdominal fistulas; (i) pre-existing terminal illness; (j) liver dysfunction (Child-Pugh class C); (k) New York Heart Association (NYHA) class IV; (l) chronic renal failure requiring dialysis; (m) therapy with an extra-corporeal membrane oxygenator (ECMO); (n) enrolled in an ongoing, interventional RCT; (o) received prior fluids for resuscitation during their ICU stay; (p) expected to die within 1 hour of ICU admission for devastating injuries; (q) activated opt-out process for BGFM trial.

Primary outcomes:
measure: Rate of 30-day primary fascial closure
timeFrame: 30 days
Secondary outcomes:
measure: Time to fascial closure
timeFrame: 30 days
measure: Postoperative 7-day fluid volume
timeFrame: 7 days
measure: Postoperative 30-day mortality
timeFrame: 30 days
measure: Postoperative 30-day adverse effects
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06210984: Caffeine and Training Intensity Quantification
Official title: The Effects of Caffeine Supplementation on Training Intensity Quantification
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caffeine
Lead sponsor: St. Mary's University, Twickenham
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to learn about the effects of caffeine on exercise physiology and the subsequent quantification of athlete training zones in trained cyclists. The main questions that it aims to answer are:

* What are the effects of low and moderate doses of caffeine on exercise physiology.
* How do the effects of caffeine on exercise physiology affect the calculation of training zones.
* Do the effects of caffeine on exercise physiology differ between men and women.

Participants will complete four trials on a cycle ergometer as follows:

* Trial 1: participants will complete two incremental tests to determine the power outputs required to elicit 50-80% of maximal oxygen consumption for trials 2-4.
* Trials 2-4: participants will consume (in a randomized order) either a low (2 mg/kg) dose of caffeine, a moderate (5 mg/kg) dose of caffeine, or a placebo (maltodextrin), 45 minutes prior to to completing an incremental cycling test from 50-80% of maximal oxygen uptake.

Measures of heart rate, oxygen uptake, blood lactate, and perceived exertion will be recorded throughout all trials.

Researchers will compare the effects of exercise intensity, caffeine dose, and sex to see if they affect exercise physiology and training zone quantification.


Eligibility criteria: Inclusion Criteria:

* To be considered for inclusion in the study, participants must be regular cyclists, between 18 and 45 years of age, capable of completing a 20 km cycling time trial at a minimum speed of 30 km/h for men and 28 km/h for women (arbitrary inclusion criteria to ensure a sufficient standard of athlete). Female participants must have a regular menstrual cycle and not be taking oral contraceptives.

Exclusion Criteria:

-

Primary outcomes:
measure: Blood lactate concentration
timeFrame: From baseline to completion, up to 31 days
measure: Heart rate
timeFrame: From baseline to completion, up to 31 days
measure: Oxygen uptake
timeFrame: From baseline to completion, up to 31 days
measure: Perceived exertion
timeFrame: From baseline to completion, up to 31 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01185184: Pharmacokinetics And Safety Study Of Two CP-690,550 Controlled Release Formulation Following Single Dose In Healthy Volunteers
Official title: A Phase 1, Randomized, 3-Period, Open Label, Single Dose, Cross Over Study To Evaluate The Pharmacokinetics And Safety Of Two Controlled Release Formulations Of CP-690,550
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Relative bioavailability
controlled release
Phase 1
CP-690
550
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-08-19
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will explore the drug behavior and safety following single dose of two 20 milligram CP-690,550 osmotic capsules in 12 healthy volunteers. These will be compared to a 10 milligram immediate release tablet, using a 3 way crossover design.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Clinically significant infections within the past 3 months.

Primary outcomes:
measure: Pharmacokinetic parameters: AUCinf(dn), Frel and Cmax(dn) of CP-690,550
timeFrame: 36 hours
Secondary outcomes:
measure: Pharmacokinetic parameters: AUCinf, AUClast, AUClast(dn), Cmax, Tmax, t½, C12h, C24h of CP-690,550
timeFrame: 9 days
measure: Safety: laboratory tests, adverse events reporting, ECG and vital signs
timeFrame: 9 days
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 NCT02383784: Effects of Low- or High-glycemic Index Diets on Metabolic and Inflammatory Responses in Diabetics
Official title: Effects of Low- or High-glycemic Index Diets in Metabolic and Inflammatory Responses in Type 2 Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Federal University of Vicosa
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
First posted: 2015-03-09
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background/Aims: Verify the effects of glycemic index (GI) on body composition, and on inflammatory and metabolic markers concentrations. Methods: Eighteen type 2 diabetics, (aged 42.4 + 5.1 years, BMI 29.2 + 4.8 kg.m-2) were randomly allocated to low GI (LGI) or high GI (HGI) groups. High or low GI meals were provided in the laboratory twice a day during 30 consecutive days. The other meals were consumed under free living condition and subjects were instructed to select foods presenting GI values corresponding to the allocated group. Body composition (body mass index, body fat percentage, waist circumference and waist-hip ratio), and inflammatory markers concentrations (interleukin-6, tumor necrosis factor-alpha, high molecular weight adiponectin, ultra-sensitive C-reactive protein and fibrinogen) and metabolic markers (glucose, insulin, total cholesterol, HDL cholesterol, free fatty acids, triglycerides and fructosamine) were assessed at baseline and after intervention. Food intake was monitored during the study. The criterion for statistical significance was P\<0.05.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Level of physical activity light to moderate
* Use of sulfonylureas or biguanides oral hypoglycemic drugs
* Stable medications for the previous 3 months

Exclusion Criteria:

* Cardiovascular, renal, or liver disease
* Treatment for cancer
* Smokers
* Daily consumption of \> 50g/day of alcohol
* Pregnant, lactating, postmenopausal women,
* Hormone replacement therapy
* Recent change (last three months) in the level of physical activity or diet
* Weight instability (\> 3 kg in the previous three months),
* Therapeutic diet
* Allergies, test foods intolerance
* Use of drugs affecting body metabolism and/or food intake.

Primary outcomes:
measure: Body fat content determined by tetrapolar bioelectrical impedance .
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Vicosa
country: Brazil
facility: Metabolism and body composition laboratory, Federal University of Vicosa
state: Minas Gerais
Study officials:
References:
Clinical trial NCT02265484: To Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism
Official title: A Randomized Open Labelled Placebo Controlled Trial to Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis Related Parkinsonism
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2014-10-16
Enrollment: 50
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: After successful screening of liver cirrhosis patients attending ILBS OPD for signs of parkinsonism ( tremor, rigidity or bradykinesia, any 2 of 3). Diagnosis of hepatic/cirrhosis related parkinsonism will be made. Patients will be randomized into Bromocriptine and Placebo. Patients will be followed up every month in OPD (Out Patient Department), ILBS (Institute of liver \& Biliary Sciences) for 3 months. Detailed neurological examination will be done at each visit \& UPDRS (Unified Parkinson's Disease Rating Scale ) score will be calculated.


Eligibility criteria: Inclusion Criteria:

* Patients with cirrhosis of liver with signs of parkinsonisms
* Patients consented for the study protocol by signing the informed consent.

Exclusion Criteria:

* Age \< 18 years.
* Patient s with HCC (Hepatocellular Carcinoma).
* Patients diagnosed as Wilsons disease.
* Patient who withdrew or non complaint to the study protocol.
* ALF (Acute Liver failure)
* Classical Parkinsonism
* Atypical Parkinsonism
* Pregnancy
* Hypotension
* Uncontrolled hypertension
* CAD
* Psychiatric illness
* Acute episode of Hepatic encephlopathy

Primary outcomes:
measure: The primary outcome will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score by 30 %.
timeFrame: 3 months
Secondary outcomes:
measure: The secondary end point will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score of 10% to 30%.
timeFrame: 3 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver & Biliary Sciences
name: Amrish Sahney, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sahney A, Sharma BC, Jindal A, Anand L, Arora V, Vijayaraghavan R, Dhamija RM, Kumar G, Bhardwaj A, Sarin SK. A double-blind randomized controlled trial to assess efficacy of bromocriptine in cirrhotic patients with hepatic parkinsonism. Liver Int. 2019 Apr;39(4):684-693. doi: 10.1111/liv.14024. Epub 2019 Feb 4.
Clinical trial NCT03483584: Incidence of HANA Conditions in HIV-infected Individuals
Official title: A Prospective Longitudinal Cohort Study to Determine the Incidence of HIV-associated Non-AIDS Conditions in Newly Diagnosed HIV-infected Individuals Initiating Integrase Inhibitor-based and Other Anti-retroviral Regimens
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
Metabolic Syndrome
Osteopenia
Osteoporosis
Vitamin D Deficiency
Renal Impairment
Liver Fibroses
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All newly diagnosed HIV-infected patients meeting inclusion criteria, who attend the government HIV clinic, which is the largest HIV clinic in Hong Kong, over a 12-month period, will be invited to participate in this study. Subjects will also be referred by non-governmental organizations providing support to HIV-infected individuals at the time of diagnosis.

Brief summary: With the availability of effective anti-retroviral therapy, HIV-infected individuals are expected not to die of AIDS and have longer life expectancy. But at the same time, HIV-associated non-AIDS (HANA) conditions are becoming more important in their clinical management. It is currently uncertain whether patients started on different anti-retroviral regimens will have different incidence of HANA conditions.

This study aims to evaluate the incidence of various HANA conditions in a cohort of newly diagnosed HIV-infected individuals in Hong Kong initiating anti-retroviral treatment. The incidence of various HANA conditions will be evaluated for those receiving INSTI versus other non-INSTI-based regimens.

The HANA conditions evaluated will include 1. Hypertension 2. Diabetes and insulin resistance 3. Dyslipidemia 4. Lipodystrophy 5. Metabolic syndrome 6. Osteopenia and osteoporosis 7. Vitamin D deficiency 8. Renal impairment and kidney tubular dysfunction and 9. Liver fibrosis. Patients will be assessed prior to initiation of anti-retroviral therapy, and 48 weeks and 96 weeks after initiation of treatment. The incidence of development of each HANA condition will be determined and compared between those initiated different anti-retroviral regimens.


Eligibility criteria: Inclusion Criteria:

1. Confirmed HIV infection by HIV antibody or RNA test
2. Age ≥40 years old
3. Anti-retroviral treatment naïve
4. Agree to initiate anti-retroviral therapy (ART) as determined by in-charge HIV physician

Exclusion Criteria:

1. Pregnancy
2. Unable to give informed consent

Primary outcomes:
measure: HANA incidence
timeFrame: 96 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: CUHK
name: Grace Lui
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00761202: Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-09-29
Enrollment: 50
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: This study evaluates the performance and acceptance of Optive versus Hylocomod eyedrops, when administered for one month to patients with mild to moderate dry eye symptoms, with and without contact lenses.


Eligibility criteria: Inclusion Criteria:

* 18 years or over
* Contact lens wearer, spectacle wearer or non-spectacle wearer
* Mild to severe dry eye symptoms, defined as OSDI score 13 to 100
* Mild to moderate conjunctival staining in each eye and/or mild to moderate corneal staining in each eye
* Best corrected visual acuity of 6/9 in each eye

Exclusion Criteria:

* Previously used Hylocomod or Optive eyedrops
* Systemic allergy or eye allergy
* Systemic disease which might have an ocular component and/or interfere with contact lens wear
* Autoimmune disease which might have an ocular component and/or interfere with contact lens wear
* Systemic medication which might have eye side effects and or interfere with contact lens wear
* Eye infection or use of eye medication

Primary outcomes:
measure: Conjunctival Staining by Lissamine Green
timeFrame: week 1, month 1
Secondary outcomes:
measure: Corneal Staining by Fluorescein
timeFrame: week 1, month 1
measure: Conjunctival Hyperaemia
timeFrame: week 1, month 1
measure: Ocular Comfort and Ocular Symptoms on Visual Analogue Scale
timeFrame: week 1, month 1
measure: Daily Eyedrop Usage
timeFrame: Month 1
measure: Lipid Layer Pattern Assessment
timeFrame: Week 1, month 1
Other outcomes:
Locations:
city: London
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04559802: Submerged Versus Non-Submerged Healing of Implants Subjected To Contour Augmentation
Official title: Submerged Versus Non-Submerged Healing of Implants Subjected to Contour Augmentation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Loss
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is a randomized controlled trial to evaluate two surgical techniques for dental implant placement simultaneously with bone augmentation.

Detailed description: Implants receiving Contour Augmentations at the time of placement are randomized into two groups, submerged and non submerged. Healing is evaluated at 4 months post op compared to the day of surgery.

Eligibility criteria: Inclusion Criteria:

* Age more than 21 years - ASA I or II.
* Patient's willingness to participate in this study.
* Availability for 4-month follow-up.
* Absence of active periodontal disease.
* Single tooth replacement is needed with simultaneous contour augmentation.
* Available pre-operative CBCT study.
* Extraction of tooth at least 8 weeks prior to planned implant therapy.

Exclusion Criteria:

* Pregnancy at the screening visit.
* Smoking more than 10 cig/day.
* Active infection at the site of surgery (teeth involved).
* Multiple missing teeth adjacent to each other (long span edentulous area).
* Vertical bone defect less than 2mm (intra surgical assessment)

Primary outcomes:
measure: Hard tissue healing around dental implants
timeFrame: 4 months
Secondary outcomes:
measure: Soft tissue healing around dental implants
timeFrame: 4 months
Other outcomes:
Locations:
city: Davie
country: United States
facility: Nova South Eastern university
state: Florida
Study officials:
affiliation: Nova Southeastern University
name: Stavros Sofos, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03517202: Duration of Stay After Urologic Surgery : Neuraxial Versus General Anesthesia
Official title: Duration of Stay for Outpatient Surgery After Tension Free Vaginal Tape (TVT) Urologic Surgery : Neuraxial Versus General Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Retention
Keywords: Urologic surgery
Urinary incontinence
Tension Free Vaginal Tape
Post-operative urinary retention
Outpatient surgery
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-05-07
Enrollment: 260
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient undergoing outpatient urinary incontinence surgery using TVT between 2012 and 2016

Brief summary: Outpatient midurethral surgery is a frequent surgery. It is performed either under general anesthesia or neuraxial anesthesia. A frequent complication is postoperative urinary retention requiring urinary catheterization, which implies a higher infectious risk.

The investigators compared the complication rate after TVT surgery depending on the type of anesthesia.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Sex: Female
* Patient who has consented to the use of her medical data for research purposes.
* Patient undergoing outpatient urinary incontinence surgery using TVT between 2012 and 2016

Exclusion Criteria:

* Specific clinical forms of the disease,
* Interfering treatments and associated diseases, history,
* Refusal of the patient to participate in the study

Primary outcomes:
measure: The investigators compared the rate of complications after TVT surgery depending on the type of anesthesia and the need for urinary catheterization, requiring longer hospital stay after surgery.
timeFrame: The period from January 1st, 2012 to December 31st, 2016 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Anesthésiologie - Réanimation
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Valentina FAITOT, MD
role: PRINCIPAL_INVESTIGATOR
References: