louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03461562: Effectiveness of Exercise Applications on Hepatic Steatosis and Physical Fitness in Patients With NAFLD
Official title: Effectiveness of Exercise Applications on Hepatic Steatosis and Physical Fitness in Patients With Nonalcholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonalcoholic Fatty Liver Disease
Keywords: Aerobic Exercise
Whole Body Vibration Therapy
Lead sponsor: Okan University
Sponsor class: OTHER
Collaborators: name: Marmara University
name: Medipol University
First posted: 2018-03-12
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose of the study will investigate the effects of two different training programs on hepatic steatosis and physical fitness parameters. This trial is designed in a randomized controlled study plan and aerobic training (40 minutes) wil be combined with Whole Body Vibration Training (WBVT for 15 minutes) which is made up of a shorter time application. WBVT to be applied instead of the resistance exercises.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of NAFLD
* Age range of 18-65 years
* Participants who are not in an active exercise program
* Participants who are not on an active diet program

Exclusion Criteria:

* Pregnancy
* Chronic inflammatory process
* Rheumatic disease
* Cognitive disorders
* Obstacles to achieve physical performance tests
* Presence of other conditions that may cause liver steatosis
* Inability to do WBVT or Aerobic Exercises

Primary outcomes:
measure: FibroScan
timeFrame: 8 weeks
Secondary outcomes:
measure: Profile of liver enzymes
timeFrame: 8 weeks
Other outcomes:
measure: Body composition
timeFrame: 8 weeks
measure: Cardiopulmonary exercise testing
timeFrame: 8 weeks
measure: Body Fat Percentage
timeFrame: 8 weeks
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Medipol University
name: Fatma Mutluay, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05165862: Evaluation and Monitoring of the Protocol Post Operative Atrial Fibrillation
Official title: Evaluation and Monitoring of the Protocol for the Management of Post Operative Atrial Fibrillation Based on Intravenous Beta-blockers in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Operative Atrial Fibrillation
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 54
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: POAF after cardiac surgery, hospitalized in ICU

Brief summary: Objectives The aims of this study is to evaluate the efficacy and tolerance of our post-operative AF management protocol after cardiac surgery, including beta-blockers, digoxin, amiodarone.

Methods This study concerns patients From brest university Hospital who underwent cardiac surgery between November 2019 and November 2021. Patients with a previous history of atrial arrhythmias were excluded. The primary endpoint is assess effectiveness of service protocol to maintain cardiac frequency below. 110 bpm. The secondary endpoints included hemodynamic tolerance and outcomes.

Detailed description: Background Atrial fibrillation (AF) is the most common complication after open heart surgery. Its reported incidence is about 30%, and it is associated with a significant increase rate of thromboembolic events, respiratory failure, a longer lenght of stay in hospital and mortality. (1 ;2) Gillinov's study has shown equivalent effectiveness of a rhythm control and rate control strategy, in AF patients after cardiac surgery, with increased side effects in patients treated with rhythm control agents. (3) The introduction of beta-blockers can be poorly tolerated hemodynamically in patients hospitalized in intensive care unit, unless untroducing a cardio-selective beta-blocker..

Methods Patients who underwent a cardiac surgery from Novembre 2019 to Novembre 2021 were included. Patients with a previous history of atrial arrhythmias were excluded. The primary endpoint is assess effectiveness of service protocol to maintain cardiac frequency below. 110 bpm. The secondary endpoints included hemodynamic tolerance and outcomes.

Eligibility criteria: Inclusion Criteria:

* POAF after cardiac surgery non-opposition formulated

Exclusion Criteria:

* pregnant woman opposition hemodynamic unstability with inotropic drugs or CI\<2 L/min/m2

Primary outcomes:
measure: Heart Rate
timeFrame: 72 hours (3 days)
Secondary outcomes:
measure: sinusal Rythm
timeFrame: 72hours ( 3 days)
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest - Service d'anesthésie-Réanimation
Study officials:
References:
Clinical trial NCT03581162: Atherosclerosis in Juvenile Mixed Connective Tissue Disease (ACTID)
Official title: Atherosclerosis in Juvenile Mixed Connective Tissue Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Carotid Atherosclerosis
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with diagnosis of Juvenile Mixed Connective TIssue Disease in Norway

Brief summary: This Study investigates presence of preclinical atherosclerosis in patients with Juvenile Mixed Connective Tissue Disease in Norway.

Detailed description: Patients and controls are examined with carotid ultrasound, venous blood is drawn, and they undergo a clinical examination.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of MIxed Connective Tissue Disease

Exclusion Criteria:

-

Primary outcomes:
measure: Presence of carotid atherosclerosis
timeFrame: 20 minutes
Secondary outcomes:
measure: blood markers of endothelial dysfunction
timeFrame: 20 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03278262: The Impact of Baseline Visual Acuity on the Treatment Outcomes in Patients Treated With AflIbercept in Real-life Clinical Setting
Official title: INSIGHT - The Impact of baseliNe viSual Acuity on the Treatment Outcomes in Patients Treated With AflIbercept in Real-life Clinical settinG. Analysis of Data From the SwedisH Macula RegisTer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wet Macular Degeneration
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2017-09-11
Enrollment: 2312
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients registered in the Swedish Macula Register during the study period.

Brief summary: The study will assess the mean change in Visual Acuity (VA) (overall and stratified by baseline VA) at year 1 and 2 of treatment with Aflibercept in real-life setting.

In addition, the study will ascertain the baseline VA in treatment -naïve Wet Age-Related Macular Degeneration or neo-vascular AMD (wAMD) patients who start treatment with Aflibercept in a real-life setting and it will assess the impact of baseline VA on the outcomes of Aflibercept treatment.


Eligibility criteria: Inclusion Criteria:

* Treatment-naïve eyes with neovascularization AMD, with the indication to be treated with Aflibercept. One and/or two eyes per patient.

Exclusion Criteria:

* Eyes treated previously with another anti-VEGF drug.

Primary outcomes:
measure: Change in Visual Acuity (VA) (Snellen)
timeFrame: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up
measure: Change in Early Treatment Diabetic Retinopathy Study (ETDRS)
timeFrame: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up
measure: Change in Lasbarhetsindex (LIX, Readability Index)
timeFrame: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up
Secondary outcomes:
measure: Proportion of patients with Gain of vision 5 to 15 letters; > 15 letters; Loss of vision >5 to <15 letters; >15 letters or Stable -5 to +5 letters at the annual time points
timeFrame: At year 1 and year 2
measure: Proportion of patients that recuperate 20/20 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3)
timeFrame: Up to 2 years
measure: Proportion of patients that recuperate 20/40 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3)
timeFrame: Up to 2 years
measure: Proportion of patients with no need of Vision Aid support
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Many locations
Study officials:
References:
Clinical trial NCT04398862: Pulmonary Health in Children With Down Syndrome
Official title: Measures of Pulmonary Health in Children With Down Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Down Syndrome
Dysphagia, Oropharyngeal
Keywords: oscillometry
spirometry
outcomes
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-05-21
Enrollment: 75
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 3-18 years (inclusive) with a diagnosis of Down syndrome who have had a swallow study in the previous 5 years

Brief summary: The goal of the study is to learn more about tests that can assess lung health in children with Down syndrome.


Eligibility criteria: Inclusion Criteria:

* Children aged 3 to 18 years, inclusive, at time of consent
* Diagnosis of Down syndrome/trisomy 21 or mosaicism
* Able to walk
* Had a swallow study (video fluoroscopic swallow study or fiberoptic endoscopic evaluation of swallowing) performed within 5 years of consent date

Exclusion Criteria:

* Pregnant or lactating
* Nonambulatory
* Have a tracheostomy or other known severe glottic or subglottic obstruction that would significantly affect the results of testing
* Have a significant acute respiratory illness, defined as treatment with steroids, antibiotics, or an increase in supplemental oxygen
* have a medical illness that would a)increase the risk the participate would incur by participating in the study, b) interfere with the outcomes of the study, or c) interfere with the performance of study participants
* Have a severe behavioral problem that would interfere with the performance of study procedures

Primary outcomes:
measure: Total airway resistance
timeFrame: Baseline
measure: Airway reactance
timeFrame: Baseline
Secondary outcomes:
measure: Change in total airway resistance after albuterol
timeFrame: Baseline
measure: Change in airway reactance after albuterol
timeFrame: Baseline
measure: Health-related quality of life, as measured by the Pediatric Quality of Life Inventory
timeFrame: Baseline
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Emily DeBoer, MD, MSCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00345280: Ocular Surface Changes in Patients With Cystic Fibrosis
Official title: Chosen Parameters of the Immune Response in the Origin of Ocular Changes in Patients With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eye Manifestations
Keywords: Cystic fibrosis
eye
inflammation
apoptosis
C11+
Lead sponsor: University of Bialystok
Sponsor class: OTHER_GOV
First posted: 2006-06-28
Enrollment: 26
Sex: ALL
Minimum age (years): 3
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 26 male and female patients aged 3-25 with clinically definite diagnosis of cystic fibrosis

Brief summary: Cystic fibrosis(CF) is an inherited disease affecting children, adolescents and young adults with dysfunction of secretory glands.It is caused by mutations in the protein-coding gene which function as the cystic fibrosis transmembrane regulator (CFTR), responsible for the secretion of chloride ions in epithelial cells, adenocytes, sweat gland cells, pancreatic ducts,alimentary and respiratory tracts and eye. Assessment of the relationship between the inflammatory processes and apoptosis in the eye in the course of cystic fibrosis will allow determination of immunological exponents which may facilitate diagnosis.

Detailed description: The aim: To assess the role of chosen parameters of immunological response in the induction of ocular changes in cystic fibrosis patients, particularly chosen chemokine concentrations in the tear fluid and analysis of chosen apoptotic markers expression on conjunctival epithelial cells.

Eligibility criteria: Inclusion Criteria:

* male and female patients aged 3-25 with clinically definite diagnosis of cystic fibrosis
* all patients must give written consent for participation in the study at screening

Exclusion Criteria:

* patients with a history of chronic disease of the immune system
* patients with the history of systemic diseases
* patients with the history chronic ocular diseases
* patients who have been treated with corticosteroids in the past 3 months prior to the screening visit

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bialystok
country: Poland
facility: Medical University
Study officials:
affiliation: Department of Pediatric Ophthalmology Medical University of Bialystok, Poland
name: Malgorzata Mrugacz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01083680: Effectiveness and Safety in Patients With Crohn´s Disease in Clinical Routine
Official title: Post-marketing Observational Study to Evaluate the Safety and Efficacy of HUMIRA® (Adalimumab SC) for the Treatment of Moderate to Severe Crohn's Disease in Daily Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Keywords: Routine clinical setting
Long-term efficacy and safety
Crohn's Disease
Humira®
Adalimumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-03-10
Enrollment: 4107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population consisted of participants with Crohn's Disease (CD) who were treated with adalimumab.

Brief summary: The purpose of this study was intended to evaluate the long-term safety and effectiveness of adalimumab in participants with Crohn's disease (CD) who are treated as recommended in the product label.

Detailed description: This study was a 60-month prospective, multicenter, observational study of adalimumab in adult participants with CD who resided in Germany. Visits were scheduled every 3 months for the first year and every 6 months thereafter. Participants continued in the study for a maximum of 60 months or until discontinuation from adalimumab therapy.

Eligibility criteria: Inclusion Criteria:

- Severe, active Crohn's Disease in patients with insufficient response to a complete and adequate therapy of glucocorticoid and/or immunosuppressive drug and/or hypersensitivity against such a therapy or in patients where such a therapy is contraindicated.

Exclusion Criteria:

- Hypersensitivity against the drug or one of the other ingredients.

Primary outcomes:
measure: Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit
timeFrame: Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
measure: Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time
timeFrame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
measure: Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants
timeFrame: Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
measure: Percentage of Participants With Adverse Events (Excluding Serious Adverse Events)
timeFrame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Secondary outcomes:
measure: 4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time
timeFrame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
measure: Compliance With the Self-injection Via the Humira®-PEN
timeFrame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie Deutschland GmbH & Co. KG, Medical Department
name: Sandra Bloch, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03504280: Changes in Serum Vitamin D Level After Different Loading Doses of Cholecalciferol
Official title: Changes in Serum Vitamin D Level and Clinical Parameters After Different Loading Doses of Cholecalciferol (D3) in Young Adults With Vitamin D Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypovitaminosis D
Keywords: hypovitaminosis D
cholecalciferol
mehadose
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 105
Sex: ALL
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single center, interventional, open labelled study
Primary purpose: TREATMENT

Brief summary: it is a clinical trial to observe increase in serum vitamin D level and clinical symptoms after 3 different doses of cholecalciferol given either intramuscularly or oral.

Detailed description: A prospective, interventional study was conducted in Department of Rheumatology, BSMMU, Dhaka, Bangladesh from October 2015 to January 2017. One hundred and five clinically healthy adults of age 21-39 with serum vitamin D concentration were enrolled in the study. Serum vitamin D level was estimated by chemiluminescent micro particle immunoassay method at baseline and 3 months after the intervention. The participants were divided into three groups using random number table. Group A was given 6 lakh IU of cholecalciferol IM stat dose, group B was given 6 lakh IU of cholecalciferol orally with a glass of milk stat dose and group c was given 2 lakh IU of cholecalciferol orally once a month for 2 months followed by tablet cholecalciferol 1000 IU daily.

Eligibility criteria: Inclusion Criteria:

* hypovitaminosis D (serum 25 OH D \< 20 ng/ml)

Exclusion Criteria:

* Chronic disease causing Vitamin D deficiency like CKD, nephrotic syndrome, liver disease, hyperparathyroidism, history of skin graft, malabsorption, hyperthyroidism, drugs like anticonvulsants, glucocorticoids, HAART Current pregnancy Lactose intolerance Previously treated with bolus Vitamin D supplementation within previous three months

Primary outcomes:
measure: serum 25(OH)D
timeFrame: 3 months
Secondary outcomes:
measure: fatigue
timeFrame: 3 months
measure: generalized weakness
timeFrame: 3 months
measure: bone pain
timeFrame: 3 months
measure: muscle cramps
timeFrame: 3 months
measure: pain in weight bearing joints
timeFrame: 3 months
measure: difficulty in climbing stairs
timeFrame: 3 months
measure: difficulty in standing from squatting position
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Shweta Nakarmi, resident
role: PRINCIPAL_INVESTIGATOR
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Md Nazrul Islam, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02117180: Nutritional Adequacy of a FODMAP Diet in Children
Official title: Evaluation of the Nutritional Adequacy of a Diet Low in Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols (FODMAP's) in Children With Functional Gastrointestinal Disorders.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Functional Gastrointestinal Disorders in Children
Keywords: functional gastrointestinal disorders
FGID
children
FODMAP
Lead sponsor: University of Plymouth
Sponsor class: OTHER
Collaborators: name: University of London
First posted: 2014-04-17
Enrollment: 15
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot study aims to establish whether a low FODMAP diet is safe in children with functional gastrointestinal disorders. The practicality of implementing this diet will be evaluated as well as symptom improvement and quality of life. A larger intervention trial, if deemed appropriate, will then follow to assess symptom efficacy in children.


Eligibility criteria: Inclusion Criteria:

* Patients aged 10-16 years
* Informed consent and assent obtained
* Patients with diagnosed FGID according to Rome III criteria: i.e. category H2b (irritable bowel syndrome) and H2d (childhood functional abdominal pain)

Exclusion Criteria:

* Patients with other gastrointestinal conditions (e.g. coeliac disease, inflammatory bowel disease)
* Patients with food allergies
* Patients with a weight for age below -2 Standard Deviations (SD) (below 0.4th centile) on the UK WHO growth charts.
* Patients with known micronutrient deficiencies determined by blood levels prior to study
* Patients without informed consent and assent obtained

Primary outcomes:
measure: Energy and nutrient intake
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Practicality of the FODMAP diet; impact of diet on Functional Gastro-Intestinal .Disorders (FGID) symptoms and stools
timeFrame: Baseline, 6 weeks
measure: Anthropometry: weight and mid-arm circumference
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster NHS Foundation Trust
Study officials:
affiliation: University of Plymouth
name: Anne Payne, PhD
role: STUDY_DIRECTOR
affiliation: Chelsea and Westminster NHS Foundation Trust, UK
name: Claire de Koker, BSc (Hons)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02898480: Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning
Official title: Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Artery Occlusion
Retinal Vein Occlusion
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Remote ischemic conditioning (RIC) is a therapeutic strategy for protecting organs or tissue against the detrimental effects of acute ischemia-reperfusion injury. It remains unknown whether this can be used in retinal vascular occlusive diseases. The purpose of the present study is to examine whether the autoregulation of retinal vessel diameters in normal persons change after remote ischemic conditioning.


Eligibility criteria: Inclusion Criteria:

* Normal persons

Exclusion Criteria:

* Present or previous eye disease
* Use of medications except anti-conceptive
* Epilepsy
* Pregnancy or lactation

Primary outcomes:
measure: Diameter change of retinal vessel
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: