louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05997524: Clinical Efficacy of Trastuzumab in Combination With Capecitabine and Oxaliplatin for the Treatment of HER2-positive Advanced Gastric Cancer.
Official title: Clinical Efficacy of Trastuzumab in Combination With Capecitabine and Oxaliplatin for the Treatment of HER2-positive Advanced Gastric Cancer: A Multicenter, Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Gastric Carcinoma
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 60
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: Trastuzumab plus chemotherapy prolonged the median overall survival in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (AGC). Among chemotherapy regimens, oxaliplatin is generally more convenient and tolerable than cisplatin, and becoming an increasingly popular option for the treatment of AGC. The aim of the study was to evaluate the efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin (CAPOX) in HER2-positive AGC.


Eligibility criteria: Inclusion Criteria:

* HER2-positive AGC defined as either HER2 immunohistochemistry (IHC) 3+ or IHC 2+ and fluorescence in situ hybridization (FISH)+ with no history of previous treatment.

Exclusion Criteria:

-

Primary outcomes:
measure: Loco-regional and Distant Tumor Control After Completion of Treatment
timeFrame: 12 months
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 28 months
measure: Overall survival (OS)
timeFrame: 28 months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Bangabandhu Sheikh Mujib Medical University
Study officials:
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Sarwar Alam, MBBS, Mphil
role: STUDY_CHAIR
References:
Clinical trial NCT00117624: A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With a Non-Myeloid Malignancy
Official title: A Randomized, Double-Blind, Study of Front-Loading Darbepoetin Alfa Compared With Standard Weekly Administration for the Treatment of Anemia in Subjects With a Non-Myeloid Malignancy and Receiving Multicycle Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: Non-myeloid malignancy
Darbepoetin alfa
Clinical Trial
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-07-08
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: The purpose of this study is to compare the efficacy of darbepoetin alfa administered using a front-loading approach with subjects receiving standard weekly dosing in the treatment of anemia in subjects with a non-myeloid malignancy and receiving multicycle chemotherapy.


Eligibility criteria: Inclusion Criteria: - Non-myeloid malignancy - At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule - ECOG 0-2 - Cancer and/or chemotherapy-associated anemia Exclusion Criteria: - Known history of seizure disorder - Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy - Unstable or uncontrolled disease/condition, related to or affecting cardiac function - Clinically significant inflammatory disease - Inadequate renal and/or liver function

Primary outcomes:
measure: RBC transfusion during the treatment phase
Secondary outcomes:
measure: The time to hemoglobin response during the treatment phase
measure: The FACT-Fatigue score profile over time
measure: The change in hemoglobin
measure: Incidence and severity of adverse events
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Kotasek D, Canon JL, Mateos MV, Hedenus M, Rossi G, Taylor K. A randomized, controlled trial comparing darbepoetin alfa correction/maintenance dosing with weekly dosing for treating chemotherapy-induced anemia. Curr Med Res Opin. 2007 Jun;23(6):1387-401. doi: 10.1185/030079907X188053. Epub 2007 May 8.
Clinical trial NCT03613324: BOO and DU and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele
Official title: Prevalence Rates of Bladder Outlet Obstruction and Detrusor Underactivity and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Outlet Obstruction and Detrusor Underactivity in Women With Severe Cystocele
Keywords: Cystocele
Bladder outlet obstruction
Detrusor underactivity
Urodynamic study
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 455
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with more than stage II cystocele

Brief summary: Prevalence rates of bladder outlet obstruction (BOO) and detrusor underactivity (DU) and their related clinical and urodynamic findings in women with ≥ pelvic organ prolapse quantification stage II cystocele are important for clinical consultation. Thus, the aim of this study was to elucidate the above findings and between-group associations.

Detailed description: Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20 min pad testing and urodynamic studies in a medical center were reviewed. Only those with complete data of maximum flow rate (Qmax) and detrusor pressure at maximum flow rate (PdetQmax) were enrolled. ANOVA test and post-hoc testing with bonferroni's correction were used for statistical analysis. Woman were defined as having DU when Qmax was \<12 mL/s and PdetQmax was \<10 cmH2O, and were defined as having BOO when Qmax was \<12 mL/s and PdetQmax was ≥25 cmH2O with sustained detrusor contraction during voiding cystometry.

Eligibility criteria: Inclusion Criteria:

1. Age \> 20y/o
2. Cystocele \> stage II
3. Complete pad test and urodynamic study

Exclusion Criteria:

1. Pregnancy
2. Urinary tract infection
3. Had received pelvic reconstruction surgery

Primary outcomes:
measure: BOO
timeFrame: November 2011 to January 2017
measure: DU
timeFrame: November 2011 to January 2017
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01223924: Single-dose Escalation Trial of M2ES in Healthy Volunteer
Official title: Randomized ，Placebo-controlled,Single-dose Escalation Trial of M2ES in Healthy Volunteer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: cancer
Lead sponsor: Protgen Ltd
Sponsor class: INDUSTRY
First posted: 2010-10-19
Enrollment: 33
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized double-blinded placebo-controlled，single-dose escalation trial in healthy volunteer.

Detailed description: Randomized double-blinded placebo-controlled，single-dose escalation trial in health volunteer,to determine the safety and the max tolerate dose in health volunteer.

Eligibility criteria: Inclusion Criteria:

1. Physical and mental healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, electrocardiogram (ECG), vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening.
2. 19 to 45 years of age.
3. Body mass index (19-25 kg/m2) ,the body weight ≥55kg for male subject,≥45kg for female.
4. Negative pregnant test, no menstrual period for female.
5. willing to comply with the protocol.

Exclusion Criteria:

1. Be allergic to endostatin
2. Have taken any drug during the last 2 weeks
3. Have Participated any clinical trail during the last 2 week
4. Cardiovasculre, respiratory, Liver, renal, gastro-intestinal hematologic endocrine and mental disease
5. HIV-1 infected
6. HBV, HBV infected ,Hepatitis B surface antigen positive

Primary outcomes:
measure: To determine safety, toxicity and maxinum tolerable Dosage of M2ES injection in Safety and tolerability
timeFrame: 3 weeks
Secondary outcomes:
measure: Pharmacokinetic (PK) behavior
timeFrame: 3 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Perking Union Medical College Hospital
name: Ji JIANG, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06715124: QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations
Official title: A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Quanta Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-12-04
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544 as a single agent or in combination with cetuximab.


Eligibility criteria: Inclusion Criteria:

* Pathologically documented, locally advanced or metastatic malignancy with KRAS G12V mutations identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic.
* Part 1: Advanced solid tumors with at least one prior systemic therapy.
* Evaluable and measurable disease per RECIST v1.1.
* Part 2 and 3: Measurable disease per RECIST v1.1.

Exclusion Criteria:

* Active brain metastasis or carcinomatous meningitis
* Significant cardiovascular disease
* Active infection requiring intravenous (IV) antibiotics
* Prior treatment with a KRAS inhibitor

Other protocol-defined Inclusion/Exclusion Criteria may apply

Primary outcomes:
measure: Number of participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: up to 2 years
measure: Number of participants with Dose Limiting Toxicities (DLTs)
timeFrame: up to 21 days
Secondary outcomes:
measure: Area under the plasma concentration-time curve (AUC) of QTX3544
timeFrame: up to 2 years
measure: Peak plasma concentration of QTX3544 (Cmax)
timeFrame: up to 2 years
measure: Objective response rate (ORR)
timeFrame: up to 2 years
measure: Duration of response (DoR)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Sarasota
country: United States
facility: Florida Cancer Specialists & Research Institute
state: Florida
city: Grand Rapids
country: United States
facility: South Texas Accelerated Research Therapeutics, LLC Midwest
state: Michigan
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics, LLC San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute, University of Utah
state: Utah
city: West Valley City
country: United States
facility: South Texas Accelerated Research Therapeutics Mountain Region, LLC
state: Utah
Study officials:
References:
Clinical trial NCT03493724: Interest of Photographs by Smartphone in Dermatology
Official title: Interest of the Photographs by Smartphone During the Requests of Opinion Specialized in the Department of Dermatology of the CHRU of Nancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dermatitis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Major patients presenting with dermatitis, requiring specialized advice in dermatology at the University Hospital of Nancy

Brief summary: To study the diagnostic performance of the images on the smartphone compare the result of the clinical examination, all the dermatoses combined and by family of pathology (inflammatory, wound, oncology, infectious, allergology), during urgent request requests in dermatology

Detailed description: The study is conducted in the dermatology department, for a maximum duration of 6 months. We include patients who require dermatological advice and for whom their doctor sends us photographs.

Doctors contact us by telephone, describe the symptoms and send photographs according to the secure procedure.

Patients are admitted for consultation and the diagnosis by photography is compared with the clinical diagnosis

Eligibility criteria: Inclusion Criteria:

* For which our fellow doctors ask a dermatological opinion for diagnostic purposes, after clinical examination of the patient, in an emergency
* After obtaining the oral consent by the requesting doctor then informing and signing a non-opposition form during the consultation at the University Hospital of Nancy
* Affiliation to a social protection
* Doctors must have signed and sent back an ethical charter, where they undertake to send the image via MSsante, then to erase the image of the smartphone

Exclusion Criteria:

* Patients under the protection of justice, tutorship or curatorship
* Doctors : lack of smartphone powerful enough to offer a quality image

Primary outcomes:
measure: sensitivity, specificity, positive and negative predictive values globally
timeFrame: through study completion, an average 6 months
measure: sensitivity, specificity, positive and negative predictive values stratified
timeFrame: through study completion, an average 6 months
Secondary outcomes:
measure: Calculation of Cohen's kappa concordance between dermatologists
timeFrame: through study completion, an average 6 months
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy, hopitaux de Brabois
state: Vandoeuvre Les Nancy
Study officials:
References:
Clinical trial NCT00419224: Influenza Vaccination in Bone Marrow Transplantation
Official title: Immunogenicity of Influenza Vaccination (Flu Vac) in Patients Receiving Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation (NM Allo PBSCT) Compared to Healthy Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Peripheral blood stem cell transplantation
Non-myeloabalative
Influenza vaccination
Humoral immune response
Immunogenicity
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2007-01-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether influenza vaccination protects patients who receive a certain type of bone marrow transplantation.

Detailed description: Patients who receive bone marrow transplantation are at high risk for complications from influenza infection. It is not whether influenza vaccination protects patients who undergo a type of bone marrow transplantation called "nonmyeloablative", or "reduced intensity" bone marrow transplantation. This study compares the response to influenza vaccination in a group of these patients to that in healthy people.

Eligibility criteria: Inclusion Criteria:

* Patients were included if they had received RIC allo HSCT 3 months or more prior to enrollment, and were between the age of 18 and 65 years.
* Controls were health care providers at our institution, between the ages of 18 and 65 years, who were in good health, and who are routinely offered influenza vaccination.

Exclusion Criteria:

* Patients were excluded if they failed to engraft, or had relapse of the underlying disease requiring chemotherapy or immunotherapy.
* Patients and controls were also excluded if they had history of egg allergy, acute febrile illness at the time of vaccination, or influenza-like illness within 4 weeks prior to vaccination.

Primary outcomes:
measure: Is the influenza vaccine immunogenic in patients receiving nonmyeloabalative allogeneic PBSCT compared to healthy controls as judged by their humoral antibody response?
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Sherif B Mossad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02555696: Abraxane in Treatment of Metastatic Breast Cancer
Official title: Assessment of Abraxane in Metastatic Breast Cancer in a Real-life Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer
nab-paclitaxel
Abraxane
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2015-09-21
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic breast cancer

Brief summary: This observational project is collecting tolerability, safety and efficacy data with the routine use of Abraxane in the treatment of metastatic breast cancer. Additionally data on the dosage of Abraxane and general data on the disease and the health status of the patient will be collected.

Detailed description: This observational program is aimed at gaining tolerability, safety and efficacy data with the routine use of Abraxane in its labelled indication in metastatic breast cancer. Additionally data on real life dosing in daily clinical routine will be analyzed.

A detailed record of the medical history including co-morbidities and pre-treatment regimens will allow analysis of the impact thereof on tolerability, dosage and efficacy.

This data might also be supportive for further treatment optimization of Abraxane in Metastatic Breast Cancer (MBC).

Eligibility criteria: Inclusion Criteria:

1. Patients with metastatic breast cancer (according to European Summary of Product characteristics (SmPC)
2. Signed Informed Consent
3. Participants \> 18 Years of Age

Exclusion Criteria:

1. Pregnant or lactating females
2. Neutrophils \<1.5 X 10\^9/L
3. Hypersensivity to nab-paclitaxel

Primary outcomes:
measure: Adverse Events
timeFrame: Up to 3 years
Secondary outcomes:
measure: Overall Response
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: LKH Feldkirch
city: Graz
country: Austria
facility: Medical University Graz
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: Leoben
country: Austria
facility: LKH Leoben
city: Linz
country: Austria
facility: KH Barmherzige Schwestern Linz
city: Salzburg
country: Austria
facility: LKH Salzburg
city: St. Pölten
country: Austria
facility: LKH St. Pölten
city: Steyr
country: Austria
facility: LKH Steyr
city: Vienna
country: Austria
facility: Medical University Vienna
city: Vienna
country: Austria
facility: KH SMZ Ost
city: Vöcklabruck
country: Austria
facility: LKH Vöcklabruck
city: Wels
country: Austria
facility: Klinikum Wels
city: Wr. Neustadt
country: Austria
facility: LKH Wr. Neustadt
Study officials:
affiliation: Celgene
name: Guenter Voraberger
role: STUDY_CHAIR
References:
Clinical trial NCT03352596: Low Fructose Diet in Diabetes Type 2
Official title: Effects of Low Fructose Diet on Glycemic Control in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fructose Metabolism Disorder
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Diabetes is one of the most common and chronic diseases in the world, with the prevalence and incidence of this disease rising in most societies, especially in Iran. Suitable treatments for type 2 diabetes include changing lifestyle with exercise, nutrition, and drug use. New research suggests that added sugar, especially fructose, is the main trigger for diabetes and pre-diabetes even more potent than other carbohydrates. Fructose has a low glycemic index (23μg =) and slowly increases blood glucose levels. Therefore, it is thought that replacing fructose instead of glucose can have a positive effect on glycemic control of diabetic patients..


Eligibility criteria: Inclusion Criteria:

1. Age of 70-40 years
2. body mass index(BMI) between 18.5 and 27
3. Type 2 diabetes People who only control their diabetes by using glucose lowering tablets Type 2 diabetes (1 to 10 years)

Exclusion Criteria:

1. Pregnancy and lactation
2. Thyroid gland disorders
3. Kidney disease and inflammation
4. Follow the weight loss regimen 6 months before starting the study
5. Usage of fatty and fatty foods, fiber powder Vitamin A Mineral Supplements, Omega 3
6. Taking glucocorticoid drugs and non-steroidal anti-inflammatory drugs

Primary outcomes:
measure: fasting blood suger(FBS)
timeFrame: 8 weeks
measure: Homeostatic model assessment and insulin resistance(HOMA-IR)
timeFrame: 8weeks
measure: insulin
timeFrame: 8 weeks
Secondary outcomes:
measure: Triglyceride
timeFrame: 8 weeks
measure: Total cholestrole
timeFrame: 8 weeks
measure: LDL-C
timeFrame: 8 weeks
measure: HDL-C
timeFrame: 8 weeks
measure: Blood pressure
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06719596: Probiotics Combined with Enteral Nutrition Reduces Postoperative Infectious Complications in PD
Official title: Probiotics Combined with Enteral Nutrition on Infectious Complications After Pancreaticoduodenectomy:a Single-centre, Prospective Randomised, Open, Parallel-controlled, Superiority Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Infectious Complications
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: Probiotics combined with enteral nutrition reduces postoperative infectious complications in PD


Eligibility criteria: Inclusion Criteria:

* Adult patients greater than 18 years of age;
* Indication for elective pancreaticoduodenal surgery;
* Patients who understand the nature of the trial and are willing and able to provide written consent

Exclusion Criteria:

. Current or recent (within the previous 1 month) use of probiotic-based products or antibiotic therapy medications.

Inability to tolerate PD due to cardiopulmonary function and other parameters

* Received radiotherapy before surgery
* Emergency PD surgery
* Pregnant and breastfeeding women

Primary outcomes:
measure: infectious complication
timeFrame: 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: 321 Zhongshan Road, Nanjing Gulou Hospital, Gulou District, Nanjing, Jiangsu Province, China
state: Jiangsu
Study officials:
References: