louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02324413: Pilot Study: Intraoperative Clonidine and Postoperative Behaviour
Official title: Randomised Controlled Pilot Study: Does Intraoperative Clonidine Reduce the Incidence of Post-hospitalisation Negative Behaviour Changes in Children Who Are Distressed During the Induction of General Anaesthesia?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Negative Behaviour Change
Lead sponsor: University Hospitals Bristol and Weston NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 45
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Children who are upset during induction of general anaesthesia are frequently distressed postoperatively and are more likely to demonstrate negative behaviour changes.

This pilot study is a randomised controlled study of clonidine vs placebo during anaesthesia to identify whether postoperative behavioural disturbance may be minimised.


Eligibility criteria: Inclusion Criteria:

* age 2 to 10 years inclusive
* healthy (ASA 1 or 2)

Exclusion Criteria:

* inability of parents to understand english

Primary outcomes:
measure: Number of negative changes on the post-hospitalization behavior questionnaire
timeFrame: 24 hours and 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Bristol Dental Hospital
Study officials:
References:
Clinical trial NCT06617013: GERD in Children With Cystic Fibrosis
Official title: Characteristics of Gastroesophageal Reflux in Children With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: GERD in Children
Cystic Fibrosis in Children
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2024-09-27
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to use a survey to measure reflux symptoms in patients with Cystic Fibrosis who are on reflux treatment, and to monitor their symptoms after stopping the reflux treatment.


Eligibility criteria: Inclusion Criteria:

* Children 6-17 years of age with a confirmed CF diagnosis by either a positive sweat test or 2 disease causing CFTR mutations.
* GERD medications documented at visit 1
* Stable GERD medication dose for 3 months
* Pediatric GERD Symptom Assessment Score \<80
* Signed consent

Exclusion Criteria:

* Declining to participate in the study or sign consent
* Unwillingness to stop GERD therapy
* History of severe GERD per gastroenterology diagnosis and documentation
* GSAS score \>80

Primary outcomes:
measure: Change from baseline in the mean GSAS score
timeFrame: baseline and 12 weeks
measure: Mean GSAS score in children with CF on GERD therapy
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University Hospital
name: Shatha Yousef
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04401813: Efficacy and Safety of IBI310 Combined with Sintilimab in Patients with Advanced Hepatocellular Carcinoma
Official title: An Open-label, Single-arm, Phase Ib Study of the Efficacy and Safety of IBI310 Combined with Sintilimab in Patients with Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Hepatocellular Carcinoma
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-26
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label, single-arm, Ib study of the efficacy and safety of IBI310 combined with sintilimab in patients with advanced hepatocellular carcinoma

Detailed description: In this study, approximately 18 to 47 patients who have previously received sorafenib, lenvatinib, or oxaliplatin-containing chemotherapy . After determining the dose of IBI310, the study will enter the expansion phase

Eligibility criteria: inclusion criteria：

1. Locally advanced or metastatic hepatocellular carcinoma, confirmed by histology/cytology.
2. Disease progression after surgery and / or local treatment.
3. Previous standard systemic treatments for advanced hepatocellular carcinoma have failed or developed intolerable toxicity.

exclusion criteria：

1. Histology contains fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components.
2. Have a history of hepatic encephalopathy, or have a history of liver transplantation.
3. Diffuse liver cancer.

Primary outcomes:
measure: adverse event
timeFrame: 21-42days
measure: Evaluation of the objective response rate of IBI310 combined with 308 in the second-line treatment of advanced hepatocellular carcinoma
timeFrame: 21-42days
Secondary outcomes:
measure: Evaluate the ORR of IBI310 combined with 308 in the second-line treatment of advanced hepatocellular carcinoma (researched by the investigator according to RECIST V1.1).
timeFrame: 1years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
Study officials:
References:
Clinical trial NCT03876613: Different Music Types in Reducing Dental Anxiety in Young People
Official title: Comparison of Different Music Types in Reducing Dental Anxiety in Young People Undergoing Third Molar Tooth Surgery - A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Anxiety
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Anxiety is an important issue in dental care for adults, children and adolescents. Dental anxiety affects 10-20% of adults and 43% of children and adolescents. Dental anxiety often leads to avoiding dental treatment; this can cause serious deterioration of oral and dental health. Such deterioration can significantly increase dental care costs. Therefore, reducing anxiety is important both in terms of patient, physician and cost. Music intervention is a psychological therapy that has many advantages when used in outpatient treatment, including cost-effectiveness, lack of negative physical effects, rapid effect, lack of safety in terms of non-use and lack of concern for recovery. Some types of studies suggested but not tested against each other include classical music, soft rock, calming music, pop, easy listening music, and music of choice.

With the contradictory results of various studies, the fact that the distraction of music and its distraction on the reduction of tooth anxiety is not common shows that a more structured study is needed. The lack of precise data on the effects of different music types on anxiety has led to this study.


Eligibility criteria: Inclusion Criteria:

* 3. Molar tooth extraction,
* 18-30 years old,
* Symptomatic

Exclusion Criteria:

* Who does not agree to participate in the study,
* Under 18 years, over 30 years,
* patients with impaired hearing (ie, not suitable for musical intervention),
* arrhythmia
* patients with physical condition III or higher (American Society of Anesthesiologists)

Primary outcomes:
measure: Number of the patients with anxiety
timeFrame: six month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Erzincan University
name: ilke kupeli
role: PRINCIPAL_INVESTIGATOR
References:
citation: Almoznino G, Zini A, Sharav Y, Shahar A, Zlutzky H, Haviv Y, Lvovsky A, Aframian DJ. Sleep quality in patients with dental anxiety. J Psychiatr Res. 2015 Feb;61:214-22. doi: 10.1016/j.jpsychires.2014.11.015. Epub 2014 Dec 9.
citation: Gordon D, Heimberg RG, Tellez M, Ismail AI. A critical review of approaches to the treatment of dental anxiety in adults. J Anxiety Disord. 2013 May;27(4):365-78. doi: 10.1016/j.janxdis.2013.04.002. Epub 2013 Apr 13.
citation: Shim YS, Kim AH, Jeon EY, An SY. Dental fear & anxiety and dental pain in children and adolescents; a systemic review. J Dent Anesth Pain Med. 2015 Jun;15(2):53-61. doi: 10.17245/jdapm.2015.15.2.53. Epub 2015 Jun 30.
Clinical trial NCT04395313: Gender Discrimination Against Female Surgeons A Study in a Lower-Middle-Income Country
Official title: Gender Discrimination Against Female Surgeons May Pass Unrecognized: A Study in a Lower-Middle-Income Country
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gender Issues
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 98
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all consultants

* fellows
* instructors
* medical officers
* residents working in the Department of Surgery

Brief summary: our study explores how GD is perceived and reported by surgeons in Pakistan.

Detailed description: Due to an increasing spotlight, gender discrimination (GD) is identified and reported in many aspects of surgical training and practice in the developed world 1, 2. In contrast, lower-middle-income countries like Pakistan lack awareness and strategies to counteract GD, which manifests as a lack of females in leadership and academic positions, and pay inequities. GD often occurs insidiously, as a result of complex interplay between societal norms, gender stereotypes and learned behaviors. Thus, our study identifies how GD is perceived and reported by surgeons in Pakistan.

Eligibility criteria: Inclusion Criteria:

* all consultants
* fellows
* instructors
* medical officers
* residents working in the Department of Surgery

Exclusion Criteria:

* all consultants
* fellows
* instructors
* medical officers
* residents not working in the Department of Surgery

Primary outcomes:
measure: gender bias
timeFrame: 2 months
Secondary outcomes:
measure: experience of gender discrimination
timeFrame: 2 months
Other outcomes:
measure: impact
timeFrame: 2 months
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Stadium Road
Study officials:
References:
Clinical trial NCT03039413: Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy
Official title: Targeting a Genomic Biomarker for PET Imaging and Staging of Urothelial Cancer: A Preliminary Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Bladder Urothelial Carcinoma
Urothelial Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot clinical trial studies how well copper Cu-64 TP3805 positron emission tomography (PET)/computed tomography (CT) works in imaging patients with urothelial cancer undergoing surgery or biopsy. Radioactive tracers, such as copper Cu-64 TP3805, may bind to tumor cells. PET/CT imaging performed with copper Cu-64 TP3805 may be a better way to detect urothelial cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To determine if copper Cu-64 TP3805 (Cu-64-TP3805) shall image urothelial carcinoma (UC) as confirmed by postsurgical or biopsy histology.

SECONDARY OBJECTIVES:

I. To determine blood clearance of Cu-64-TP3805. II. To determine in vivo stability of Cu-64-TP3805.

TERTIARY:

I. To determine if Cu-64-TP3805 is bound to malignant cells and if it is internalized.

Eligibility criteria: Inclusion Criteria:

* Provide signed and dated informed consent form
* Willing to comply with all study procedures and be available for the duration of the study
* Must have diagnosis of urothelial cancer
* Scheduled for extirpative surgery or biopsy of suspected metastatic lesion
* Women of reproductive potential must have a urine pregnancy test day of injection
* Men of reproductive potential must use condoms

Exclusion Criteria:

* Pregnancy or lactation
* Known allergic reactions to components of the study product(s)
* Treatment with another investigational drug or other intervention with 24 hours of injection
* Must not have had an injection of a radioisotope 24 hours prior to exam

Primary outcomes:
measure: Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology
timeFrame: Up to 4 weeks post-intervention
Secondary outcomes:
measure: Blood clearance defined as the point at which radioactivity decreases to 50% of the initial value
timeFrame: Up to 120 minutes post injection
measure: Radioactivity internalization of copper Cu 64 TP3805 as analyzed in centrifuged urine samples
timeFrame: Up to 120 minutes post injection
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Madhukar Thakur, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01797913: The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
Official title: The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: THE Efficacy and Safety of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-02-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: assess the efficacy and safety of gemcitabine in the maintenance treatment of advanced non-small cell lung cancer


Eligibility criteria: Inclusion Criteria:

18\~75 years Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer patients who have acceptted combination chemotherapy based on platinum 4 course,SD OR PR,the CR patients should accept 6 course of combination chemotherapy.

3\~8 weeks after patients complete first line chemotherapy(include radiotherapy) Ecog0-2 Expected life time longer than 3 monthes

Normal laboratory values:

* leucocyte ≥ 4×109/L
* neutrophil ≥ 1.5×109/L
* platelet ≥ 100×109/L
* Hemoglobin ≥ 10g/L
* ALT and
* AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis) Signed written informed consent

Exclusion Criteria:

* Patients have used drugs according to protocol
* Uncontrolled infection of Bacterial or virus or fungal
* Patients with other malignant tumor
* Uncontrolled brain metastases
* Female patients during their pregnant and lactation period, or patients without contracep

Primary outcomes:
measure: PFS
timeFrame: from the first cycle of treatment (day one) to two month after the last cycle
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer hospital Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT04867213: Breath Analysis of Patients Diagnosed With COVID-19 Using Infrared Spectroscopy
Official title: Breath Analysis of Patients Diagnosed With COVID-19 Using Infrared Spectroscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV-2 Infection
Covid19
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Breathe BioMedical Inc
First posted: 2021-04-30
Enrollment: 200
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: Hospitalized patients

Brief summary: To analyze Volatile Organic Compounds (VOCs) in the breath of patients with SARS-CoV-2 and controls in SARS-CoV-2 breath specimens.

Detailed description: The study is a prospective cohort study, which enrol patients presenting to hospital and are tested for SARS-CoV-2. There will be two cohorts, COVID-19 positive and COVID-19 negative, who will have exhaled breath collection and analysis by infrared spectroscopy to characterize the composition of VOCs and identify differences in VOC profiles between the two groups.

Eligibility criteria: Inclusion Criteria for Covid-19 positive patients:

* Clinically tested for SARS-CoV-2 (as completed by standard laboratory testing e.g. RT-PCR) with a positive result
* Clinical features in keeping with COVID-19 illness.

Inclusion criteria for Covid-19 negative patients:

* Negative RT-PCR COVID-19 test
* Without any clinical features to suggest COVID-19 illness.
* No known or current features of respiratory infection, COPD, asthma, interstitial lung disease, other respiratory inflammatory conditions or lung cancer.
* Able to provide a breath sample (as based on clinical judgement).

Exclusion Criteria for Covid-19 positive and negative patients:

- Unable to provide a breath sample

Primary outcomes:
measure: Breath VOCs in covid positive and negative patients.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Effect of time of symptom onset on VOCs in Covid-19 positive patients
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: McMaster University Hospital
name: Mylinh Duong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00293813: A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
Official title: A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postmenopausal Osteoporosis
Keywords: Post Menopausal
Osteoporosis
MicroCT
Amgen
denosumab
Extreme CT
XCT
Fosamax
Alendronate
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2006-02-20
Enrollment: 247
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.


Eligibility criteria: Key Inclusion Criteria:

* Postmenopausal, ambulatory women between 50 and 70 years old who are generally in good health.
* Must have low bone mineral density and meet specific eligibility criteria.

Key Exclusion Criteria:

-Subjects must not currently be receiving any medication that affects bone metabolism or have an underlying condition that affects their ability to take alendronate or receive denosumab.

Primary outcomes:
measure: Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12
timeFrame: 12 months
Secondary outcomes:
measure: Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Seeman E, Delmas PD, Hanley DA, Sellmeyer D, Cheung AM, Shane E, Kearns A, Thomas T, Boyd SK, Boutroy S, Bogado C, Majumdar S, Fan M, Libanati C, Zanchetta J. Microarchitectural deterioration of cortical and trabecular bone: differing effects of denosumab and alendronate. J Bone Miner Res. 2010 Aug;25(8):1886-94. doi: 10.1002/jbmr.81.
citation: Zebaze RM, Libanati C, Austin M, Ghasem-Zadeh A, Hanley DA, Zanchetta JR, Thomas T, Boutroy S, Bogado CE, Bilezikian JP, Seeman E. Differing effects of denosumab and alendronate on cortical and trabecular bone. Bone. 2014 Feb;59:173-9. doi: 10.1016/j.bone.2013.11.016. Epub 2013 Nov 22.
citation: Hu YJ, Chines A, Shi Y, Seeman E, Guo XE. The effect of denosumab and alendronate on trabecular plate and rod microstructure at the distal tibia and radius: A post-hoc HR-pQCT study. Bone. 2022 Jan;154:116187. doi: 10.1016/j.bone.2021.116187. Epub 2021 Sep 14.
Clinical trial NCT05172713: Outcomes of Patients Who Had an Incomplete Colonoscopy After a Positive Fecal Immunological Test
Official title: Outcomes of Patients Who Had an Incomplete Colonoscopy After a Positive Fecal Immunological Test: Study of Practices in the Grand-Est
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Immunological test
Colonoscopy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject aged between 50 and 75 years old at the time of the colonoscopy with incomplete colonoscopy performed in 2018 after a positive fecal immunological test as part of the DOCCR

Brief summary: In France, colorectal cancer (CRC) is the second leading cause of cancer death. Its organized screening (Organized ColoRectal Cancer Screening: DOCCR), now carried out by immunological test for occult blood in the stool, has proven its effectiveness. When the immunological test is positive, the Haute Autorité de Santé recommends a total colonoscopy. In 5 to 10% of cases, this colonoscopy is incomplete. The renewal of the endoscopic procedure or the performance of additional second-line examinations are then recommended. At present, however, the respective place of second-line examinations to be performed in this situation is not the subject of specific and validated recommendations.


Eligibility criteria: Inclusion criteria:

* Age between 50 and 75 years old at the time of the colonoscopy
* With incomplete colonoscopy performed in 2018 after a positive fecal immunological test as part of the DOCCR
* Patient whose follow-up has ended
* Patient living in the Grand-Est region and in the department of the site concerned
* Examination carried out by a gastroenterologist from the Grand-Est region
* Subject not having expressed, after information, his opposition to the reuse of his data for the purposes of this research

Exclusion criteria:

* Age ≥ 76 years at the time of colonoscopy
* Colonoscopy performed after a positive Hemoccult® test (screening technique older than the immunological test and different sensitivity / specificity)
* Colonoscopy performed before the fecal immunological test
* Gastroenterologist performing the examination practicing outside the Grand-Est region
* Subject not able to understand the objectives of this research
* Subject under judicial control
* Subject under tutorship or curatorship

Primary outcomes:
measure: Retrospective study of the patient outcomes who had an incomplete colonoscopy after a positive immunological fecal test
timeFrame: Files analysed retrospectively from January 01, 2018 to December 31, 2018 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Hépato-Gastroentérologie et Assistance Nutritive - Hôpitaux Universitaires de Strasbourg
Study officials:
References: