louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01936194: The Effects of Polyunsaturated Fatty Acids (PUFA) on Allergic/Atopic Dermatitis
Official title: The Effects of Polyunsaturated Fatty Acids on Allergic/Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Atopic Dermatitis
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
Collaborators: name: International Peace Maternity and Child Health Hospital
name: Chinese Academy of Sciences
First posted: 2013-09-05
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This clinical trial will study the effects of PUFA supplementation during pregnancy and lactation period on fatty acid composition in human milk and plasma of the mothers and the clinical outcome of atopic dermatitis in infants at increased risk.


Eligibility criteria: Inclusion Criteria:

* Woman is pregnant between 16 and 20 weeks
* Mother delivers after 36 weeks
* Mother is willing to breast-feed for four months
* Mother has potential to deliver a child with increased risk of atopic dermatitis
* Signed Informed Consent

Exclusion Criteria:

* Mother is smoking
* Disease with influence on breast feeding
* Complicated pregnancy
* Allergic to seafood
* Allergic to soy
* Allergic to marine fish
* Mother has more than two salmon or tuna meals per week
* Mother is undergoing treatment with anticoagulants

Primary outcomes:
measure: Lipid Analysis
timeFrame: Baseline, Delivery, Within one week after delivery, 6 weeks postpartum, 4 months postpartum
measure: Metabolomics Study of PUFA
timeFrame: Baseline, Delivery, Within one week after delivery, 6 weeks postpartum, 4 months postpartum, 12 months postpartum
measure: Skin Prick Test to Common Allergens
timeFrame: 4 months postpartum, 12 months postpartum
measure: Clinical Assessment of IgE-mediated Allergic Eczema
timeFrame: 4 months postpartum, 12 months postpartum
Secondary outcomes:
measure: Fatty Acid Desaturase (FADS) Genotypes
timeFrame: Baseline
measure: immunoglobulin E immunoglobulin E Immunoglobulin E (IgE) Antibodies
timeFrame: Baseline
measure: Immunological Biomarkers
timeFrame: 4 months postpartum, 12 months postpartum
measure: Medically-confirmed adverse events collected throughout the study period
timeFrame: 12 months postpartum
Other outcomes:
Locations:
city: Shanghai
country: China
facility: International Peace Maternity and Child Health Hospital of China welfare Institute
state: Shanghai
Study officials:
affiliation: International Peace Maternity and Child Health Hospital of China Welfare Institution
name: Zhiwei Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese Academy of Sciences
name: Huiyong Yin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mead Johnson & Company
name: Bryan Liu, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00546494: Study Evaluating Effexor® (Venlafaxine) in Achieving Response and Maintaining Remission
Official title: A Study Of The Utility Of Effexor® (Venlafaxine) In Achieving Response And Maintaining Remission Among Taiwanese Patients With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-19
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to determine the utility of Effexor® (venlafaxine) in achieving response, including time to response, maintaining remission, and time to remission as measured by the 17-item Hamilton Rating Scale for Depression (HAM-D) and to determine the utility of Effexor® (venlafxine) on the various cluster of symptom scales in the 17-item HAM-D.


Eligibility criteria: INCLUSION CRITERIA:

* Patients meeting criteria for a diagnosis of major depression, single or recurrent episode as described by the DSM-IV manual (appendix 1).
* A HAM-D 17 total score of at least 16 at baseline (DSM-IV manual, appendix 2).
* Patients above 18 years of age who meet the eligibility requirements.

EXCLUSION CRITERIA:

* Patients taking MAOI's within 2 weeks prior to the survey.
* Patients known to be suffering from bipolar disorder or schizophrenia.
* Patients who are treatment-resistant, i.e., in the past 3 years have failed (a) three previous adequate trials of greater than or equal to 2 classes of antidepressant medication, or (b) electroconvulsive therapy.
* Drug or alcohol dependence or abuse in the past 6 months per DSM IV criteria.

Primary outcomes:
measure: Primary efficacy variable will be the proportion of patients with remission defined as a HAM-D score of less than or equal to 7 at 8 weeks of treatment.
Secondary outcomes:
measure: Safety and tolerability will be assessed based on adverse events that occurred during the survey for all patients who received at least one dose of Effexor®.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01069094: A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
Official title: A Single Dose lead-in PK Followed by a Randomized, Double-blinded, Controlled, Multiple Dose Study of the Selective Progesterone Receptor Modulator Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Uterine Leiomyomata
Keywords: Uterine fibroids
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata.

Detailed description: Three doses of Progenta (CDB4124 - 12.5, 25, 50 mg) versus placebo versus Lucron Depot (leuprolide acetate for depot suspension) was initiated in females with symptomatic leiomyomata. A single dose PK visit was conducted only for subjects randomized to the Progenta arm, between screening and visit 1. A second PK assessment was conducted at Visit 3 (one month on drug) to collect steady state data. Treatment period lasted for 3 months.

Eligibility criteria: Inclusion Criteria:

* Had at least one leiomyomata lesion that was identifiable and measurable by transvaginal ultrasound.
* Had a regular or steady menstrual cycle lasting from 24 to 36 days.

Exclusion Criteria:

* Post-menopausal
* Subject with documented endometriosis

Primary outcomes:
measure: Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata.
timeFrame: 90 days
Secondary outcomes:
measure: Determine the tolerability of three doses of Progenta (12.5 mg, 25 mg, and 50 mg) as compared to placebo and Lucron Depot (leuprolide acetate for depot suspension) in pre-menopausal women with symptomatic leiomyomata.
timeFrame: 90 days
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University /MTZ Clinical Research Sp.zo.o.
Study officials:
affiliation: Repros Therapeutics Inc.
name: Ronald Wiehle, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00820794: A Phase 1 Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects
Official title: A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Generalized Anxiety Disease
Keywords: Drug-drug interaction, lithium, PD 0332334, pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-12
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to investigate if PD 0332334 affects the pharmacokinetics of lithium by co-administering both drugs to healthy adults.

Detailed description: Additional Study Purpose Details: To investigate potential drug-drug interaction between PD 0332334 and lithium

Eligibility criteria: Inclusion Criteria:

* Healthy males and/or females
* Age from 21 to 55 (inclusive)
* BMI ranges from 18 to 30 kg/m2

Exclusion Criteria:

* Previous participation in a PD 332334 study
* Pregnant or nursing females
* Hypersensitivity (allergic) to lithium, Neurontin (gabapentin), or Lyrica (pregabalin)

Primary outcomes:
measure: Lithium pharmacokinetic endpoints: area under curve from 0 to infinity (AUCinf), area under curve from 0 to last quantifiable concentration (AUClast), half-life (T1/2), and maximum serum concentration (Cmax).
timeFrame: 10 days
measure: The nature, incidence, duration, and severity of adverse events; discontinuation due to adverse events; clinical safety lab; 12-lead ECG; and vital signs will be monitored in this study.
timeFrame: 10 days
Secondary outcomes:
measure: No Secondary Outcomes
timeFrame: No Secondary Outcomes
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01156194: Homeopathic Remedy for the Third Stage of Delivery
Official title: Effect of a Homeopathic Remedy on the Third Stage of Delivery: a Prospective, Randomized, Double-Blind Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Third Stage of Labor
Keywords: third stage, labor, postpartum hemorrhage, homeopathy, arnica, bellis perennis
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2010-07-02
Enrollment: 210
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The homeopathic remedy consisting of Arnica and Bellis perennis have been shown in a previous pilot study (n=33) to reduce blood loss during the third stage of delivery, when compared with placebo treatment. The purpose of this study is to repeat the previous methodology, this time on a larger population.

210 parturients will be randomized to one of three groups: Arnica montana C6 and Bellis perennis C6 (n=70), Arnica montana C30 and Bellis perennis C30 (n=70), or double placebo (n=70).


Eligibility criteria: Inclusion Criteria:

* healthy women in 3rd stage of labor
* age 20-35
* second to fifth gestation
* spontaneous PV delivery
* term delivery (37-42nd weeks)

Exclusion Criteria:

* scarred uterus
* multifetal pregnancy
* history of bleeding problems
* caesarian section delivery
* chorioamnionitis
* pregnancy-induced hypertension
* gestational diabetes mellitus
* polyhydramnios, premature rupture of membrane
* suspected macrosomy/SGA

Primary outcomes:
measure: Hemoglobin levels at 2d postpartum
timeFrame: 48h
Secondary outcomes:
measure: incidence of endometritis
timeFrame: 7d
measure: time to extrusion of placenta following birth
timeFrame: 24h
measure: duration of lochiae secretion
timeFrame: 7days
measure: duration of third stage of labor
timeFrame: 24h
measure: assessment of quality-of-life parameters
timeFrame: 7 days
measure: assess toxic effects of the homeopathic remedies
timeFrame: 7 days
measure: serum cortisol levels
timeFrame: within 12h postpartum
measure: state of perineum postpartum
timeFrame: 48h
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Maternity Ward, Shaare Zedek Medical Center
Study officials:
References:
Clinical trial NCT01210794: The Influence of Different Food Componente on Zinc Absorption in Young Adults Consuming Zinc Fortified Porridges Prepared From Maize, Beans and Sorghum: a Series of Six Similar Randomized, Single-blind Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Study Not Related to a Disease. Nutrition Study Without Drug Administration.
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: ETH Zurich, Human Nutrition Laboratory
First posted: 2010-09-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: Study not related to a disease. Nutrition study without drug drug administration. Investigation on the influence of different food components on zinc absorption in young adults consuming zinc fortified porridges prepared from maize, beans and sorghum.

Brief summary: The influence of different food componente on zinc absorption in young adults consuming zinc fortified porridge's prepared from maize, beans and sorghum: a series of six similar randomized, single-blind studies.


Eligibility criteria: Inclusion criteria:

1. Male or female of 18 to 45 years old
2. Body Mass Index in the range of 19 to 25
3. No mineral and vitamin supplements two weeks prior to the study and during the whole duration of the study

Exclusion criteria:

1. Any metabolic, gastrointestinal or chronic disease (according to the subjects own statement)
2. Long-term medication during the whole study (except for contraceptives)
3. Smoking
4. Pregnancy
5. Lactating
6. Earlier participation in any other clinical study within the last 30 days

   * Subject Withdrawal:

     * Incomplete consumption of test meal
     * Missing of test meal Missing of iv dose
     * Incomplete urine collection (studies 2-6); exceptions to be discussed for study 1
     * No blood sample at start of study
     * Consumption of food within 3 hours after iv dose - to be evaluated
     * Vomiting within 3 hours after test meal administration - to be evaluated
     * Sick subjects and subjects taking any medication during study - to be evaluated (postponement of test meal possible)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: ETh Zurich
Study officials:
affiliation: ETH Zurich, Human Nutrition Laboratory
name: Rita Wegmueller, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brnic M, Wegmuller R, Zeder C, Senti G, Hurrell RF. Influence of phytase, EDTA, and polyphenols on zinc absorption in adults from porridges fortified with zinc sulfate or zinc oxide. J Nutr. 2014 Sep;144(9):1467-73. doi: 10.3945/jn.113.185322. Epub 2014 Jun 25.
Clinical trial NCT05762094: A Retrospective Study on Personalized Dosing Strategy of Patients Treated by Carbapenems: 2018-2021
Official title: A Retrospective Study on Personalized Dosing Strategy of Patients With Bacterial Infections Treated by Carbapenems From a Tertiary Medical Center During 2018-2021
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bacterial Infections
Keywords: Carbapenem
Bacterial Infections
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 1000
Sex: ALL
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: Chinese adult patients with bacterial infections treated by carbapenem

Brief summary: Patients may benefit from the personalized carbapenem dosing strategy based on pharmacokinetics. The objective of this study is to retrospectively review and analyze the clinical outcomes of patients with different dosing strategy.

Detailed description: Rational use of carbapenem is closely associated with the clinical outcome of patients with infections. Serum concentration of carbapenem varies from different populations. The objective of this study is to describe the clinical outcome of patients with infection treated by carbapenem in China, regarding diagnosis, treatment and follow-up. It is a single-center, retrospective, descriptive study. Inclusion criteria are an age ≥ 18, diagnosed as bacteria infection and serum concentration must be determined during therapy. Data concerning clinical presentation, biological samples, treatment and follow-up will be assessed. A descriptive analysis will be performed.

Eligibility criteria: Inclusion Criteria:

Age over 18 years Chinese patient: male or female Diagnosed as bacterial infection Treated by carbapenem Serum concentration determined during therapy

Exclusion Criteria:

Duration of carbapenem treatment less than 48 hours Patients renal or liver function not tested before treatment started Using more than two kinds of carbapenem

Primary outcomes:
measure: Mortality
timeFrame: January 2018-December 2021
measure: Attainment of Target Trough Concentration
timeFrame: January 2018-December 2021
Secondary outcomes:
measure: Proportion of patients reach clinical response at end of treatment
timeFrame: January 2018-December 2021
measure: Proportion of patients reach clinical response at day 4 of treatment
timeFrame: January 2018-December 2021
measure: Daily Sequential Organ Failure Assessment score change
timeFrame: January 2018-December 2021
measure: Incidence of Septic Shock
timeFrame: January 2018-December 2021
measure: Safety outcome measures
timeFrame: January 2018-December 2021
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
References:
Clinical trial NCT00926094: Prevalence of Impaired Glucose Tolerance (IGT) in Patients With Frozen Shoulder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frozen Shoulder
Impairment Glucose Tolerance
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-06-23
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people that were diagnosed with frozen shoulder at the last three years and are not diabetic.

Brief summary: Idiopathic Adhesive Capsulitis, Frozen Shoulder is a condition in which there is a limitation and significant pain at the shoulder and it is increases with shoulder movements. The causes are not clear. The prevalence of this condition is four times higher in diabetic patient compare to the general population.

The relation between frozen shoulder and impaired glucose tolerance remain unclear.

Our hypothesis is that patients with no diabetes and that suffer from frozen shoulder have a higher prevalence of impaired glucose tolerance than the general population age matched.


Eligibility criteria: Inclusion Criteria:

1. age 30-60.
2. previous Xray that eliminates other disease of the shoulder.
3. previous US that eliminates tendon shoulder rupture
4. shoulder movement in all directions, with limitation in the external rotation (at least 50%)

Exclusion Criteria:

1. Diagnosed Diabetes (pregnancy diabetes includes)
2. Taking Hyperglycemic medications (like Steroids)
3. Fracture or operation in the shoulder before the diagnosis of frozen shoulder.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT02449694: Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation
Official title: Single-arm Prospective Trial to Evaluate The Safety and Performance of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Preservation
Lead sponsor: TransMedics
Sponsor class: INDUSTRY
First posted: 2015-05-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, single-center controlled trial to evaluate the safety and performance of the portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for transplantation.


Eligibility criteria: Inclusion Criteria:

* Registered male or female primary Liver transplant candidate
* Age ≥18 years old
* Signed: written informed consent

Exclusion Criteria:

* Acute, fulminant liver failure;
* Prior solid organ or bone marrow transplant;
* Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of \>3 mg/dl (\>265 mmol/L) for \>2 weeks and/or requiring hemodialysis;
* Multi-organ transplant;
* Ventilator dependent;
* Dependent on \> 1 IV inotrope to maintain hemodynamics;
* Malignancy excluding HCC;
* Infection.

Primary outcomes:
measure: Number of donor livers preserved by OCS in a near physiologic state.
timeFrame: Within 1 day of organ retrieval
measure: Number of events directly related to the use of the OCS Liver that led to the donor liver being deemed not clinically acceptable and, as a result, not transplanted
timeFrame: Within 1 day of organ retrieval
Secondary outcomes:
measure: Number of donor livers maintained in a metabolically active and functioning state during preservation.
timeFrame: Within 1 day of organ retrieval
measure: Number of donor livers monitored for perfusate temperatures, SvO2, hematocrit, Hepatic Artery flow rates, Portal Vein flow rate, Hepatic Artery pressure, Portal vein pressure, and bile production during preservation.
timeFrame: Within 1 day of organ retrieval
measure: Frequency of liver graft-related serious adverse events
timeFrame: 30 days after transplantation
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: St. James's University Hospital
state: West Yorkshire
Study officials:
References:
Clinical trial NCT04654494: Colorectal Cancer in Crohn's Disease
Official title: Colorectal Cancer in Crohn's Disease: Long Term Outcomes of Different Surgical Procedures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Colorectal Cancer
Inflammatory Bowel Diseases
Keywords: colorectal surgery
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 70
Sex: ALL
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: Patients with Crohn's disease complicated by occurrence of colorectal cancer, treated surgically between 01/2010 and 01/2020

Brief summary: Retrospective multicentre study. All patients with a diagnosis of Crohn's disease (CD) and operated for colorectal cancer (CRC) between 01/01/2010 and 01/01/2020 will be included in the dataset.

Data will include preoperative, intraoperative and postoperative variables, with long term follow up when feasible.

The study will focus on a comparison between patients treated with total proctocolectomy (TPC) and patients treated with subtotal colectomy (STC) or segmental resection (SR).

Primary endpoints will be oncologic outcomes, postoperative morbidity and mortality. Secondary endpoints include quality of life (QoL).


Eligibility criteria: Inclusion Criteria:

* All patients with a diagnosis of Crohn's disease and concomitant primary colorectal cancer who underwent surgery in an expert centre between 01/01/2010 and 01/01/2020

Exclusion Criteria:

* Patients who underwent non-oncologic segmental resection will be excluded from outcome analysis.
* Patients with known genetic colorectal cancer syndromes (eg. Familial Adenomatous Polyposis, Hereditary Non-Polyposis ColoRectal Cancer Syndrome)

Primary outcomes:
measure: Overall Survival
timeFrame: 5 years
measure: disease free survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Tor Vergata
state: RM
Study officials:
References: