louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02955186: Saracatinib and Alcohol Drinking
Official title: Fyn Kinase Inhibitors and Alcohol Drinking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Drinking
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2016-11-04
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the effects of the study medication, saracatinib/AZD0530 (placebo or 125 mg/day) on alcohol drinking behavior in a laboratory setting in which participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. The investigators hypothesize that saracatinib will reduce craving and number of drinks consumed prior to and after exposure to the initial drink of alcohol and during the three hour drinking period.


Eligibility criteria: Inclusion Criteria:

* Ages 21-50
* Able to read English at 6th grade level or higher and to complete study evaluations
* Regular alcohol drinker

Exclusion Criteria:

* Individuals who are seeking alcohol treatment
* Medical conditions that would contraindicate the use of saracatinib
* Regular use of other substances

Primary outcomes:
measure: Change in the Number of Drinks Consumed From Baseline to Day 8 (Minus Baseline)
timeFrame: Baseline and Day 8
measure: Craving-Baseline Adjusted Total Area Under the Curve (AUC) During the Drinking Session Using the YCS
timeFrame: Baseline and Day 7
Secondary outcomes:
measure: Area Under the Curve (AUC) During the Drinking Session Using the Stimulation Responses to Alcohol (BAES)
timeFrame: Day 8 Adlib
measure: Area Under the Curve (AUC) During the Drinking Session Using the Sedation Responses to Alcohol (BAES)
timeFrame: Day 8 Adlib
Other outcomes:
Locations:
city: New Haven
country: United States
facility: CMHC, Substance Abuse Center
state: Connecticut
Study officials:
References:
Clinical trial NCT01118286: Treatment of Hypertension With Adalat® in Combination With Other Drugs
Official title: AdADOSE - Antihypertensive Treatment With Adalat® in Different Doses and Combination Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension
Drug therapy, combination
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-05-06
Enrollment: 4497
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: Previously untreated hypertensive adult patients starting with combination therapy containing nifedipine or insufficiently controlled hypertensive patients receiving nifedipine as an add-on to existing non-CCB containing antihypertensive therapy

Brief summary: To investigate the therapeutic effectiveness of long acting nifedipine containing combination therapy in the treatment of hypertensive patients.


Eligibility criteria: Inclusion Criteria:

* Previously untreated hypertensive patients starting with combination therapy containing nifedipine or
* Insufficiently controlled hypertensive pts. receiving nifedipine as an add-on to existing non-CCB (calcium-channel-blocker) containing antihypertensive therapy

Exclusion Criteria:

* None. Exclusion criteria are defined by contraindications and precautions as stated in the local product information.

Primary outcomes:
measure: Evaluation of treatment success (lowering of blood pressure in mmHg) in adult hypertensive patients
timeFrame: After three months
Secondary outcomes:
Other outcomes:
Locations:
city: Many Locations
country: Bahrain
city: Many Locations
country: Egypt
city: Many Locations
country: Jordan
city: Many Locations
country: Lebanon
city: Many Locations
country: Morocco
city: Many Locations
country: Oman
city: Many Locations
country: Pakistan
city: Many Locations
country: Qatar
city: Many Locations
country: Russian Federation
city: Many Locations
country: Saudi Arabia
city: Many Locations
country: United Arab Emirates
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Motaweih AK, Usova E, Hussain W, Dello Z, Schmidt B, Petri T. Effectiveness of combination therapy with nifedipine GITS: a prospective, 12-week observational study (AdADOSE). BMC Cardiovasc Disord. 2015 May 9;15:35. doi: 10.1186/s12872-015-0037-x.
Clinical trial NCT00452686: Study to Assess Safety & Immunogenicity of GSK Biologicals' Boostrix (dTpa) Vaccine vs. Chinese DT Vaccine
Official title: Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix (dTpa) Vaccine and the Chinese DT Vaccine, When Administered as Booster Vaccination in Healthy Children Aged 6-8 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Acellular Pertussis
Tetanus
Keywords: Chinese DT vaccin
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-03-27
Enrollment: 660
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the safety and immunogenicity of a booster dose of GSK Biologicals' reduced antigen content diphtheria, tetanus, acellular pertussis (dTpa) vaccine - Boostrix in comparison with Chinese DT vaccine, in children 6-8 years of age.


Eligibility criteria: Inclusion Criteria:

* A male or female between, and including, 6-8 years of age at the time of vaccination,
* Written informed consent obtained from the parent or guardian of the subject,

Exclusion Criteria:

* Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life, subjects who have received previous DTP booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate.
* Subjects with history of diphtheria, pertussis or tetanus diseases can not participate.

Primary outcomes:
measure: Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN & anti-FHA antibody concentration.
Secondary outcomes:
measure: Solicited symptoms (Day 0-3), unsolicited AEs (Day 0-30) & SAEs
Other outcomes:
Locations:
city: Suining
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Zhu F, Zhang S, Hou Q, Zhang Y, Xu Y, Ma X, Lu X, Pan H, Chen D, Ramakrishnan G, Zhao R, Tang H, Van Der Meeren O, Bock HL. Booster vaccination against pertussis in Chinese children at six years of age using reduced antigen content diphtheria-tetanus-acellular pertussis vaccine (Boostrix()). Hum Vaccin. 2010 Mar 3;6(3):10503. doi: 10.4161/hv.6.3.10503. Epub 2010 Mar 3.
Clinical trial NCT03624686: Production of Clinical-grade Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory B-cell Malignancies
Official title: Production of Clinical-grade Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory B-cell Malignancies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leukemia
Keywords: Acute Lymphoblastic Leukemia,Immunotherapy,chimeric antigen receptor,non-Hodgkin's lymphoma
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 130
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Leukemia patients and healthy volunteer aged 14 and over

Brief summary: Immunotherapy is a promising therapeutic approach for patients with cancers. Patients with acute lymphoblastic leukemia (ALL) experiencing early relapse less than 18 months from diagnosis had very poor prognosis with 5-year survival rate of 21% (1). Recent clinical trials demonstrated that infusions of autologous T cell modified with chimeric antigen receptors (CARs) induced durable complete remissions in patients with relapse or refractory B-cell ALL (2-4). The editors of Science Journal announced cancer immunotherapy as the breakthrough of the year for 2013 (5). On Jan 30, 2015, Dr. Steven M. Altschuler, chief executive officer of the Children's Hospital of Philadelphia and 9-year-old ALL patient Emily Whitehead with 3-year leukemia free after CAR-T cell infusion were invited to White House for President Barack Obama's announcement of the Precision Medicine Initiative. The MIT Technology Review announced that the top one breakthrough technology in 2016 is genetically engineered immune cells saving the lives of cancer patients. This project will focus on the manufacturing of clinical-grade anti-CD19 CARs for B-cell malignancies in the future clinical trials.


Eligibility criteria: 1. At least 14 years of age (underage patients under the age of 20 only collect peripheral venous blood, do not perform double-lumen venous catheter and white blood cell separation).
2. There are no known serious systems or diseases with systemic immunodeficiency, but blood-related cancers are not.
3. Systemic chemotherapy and target treatment were not received within 14 days.
4. The subject consent form has been signed prior to the program-related procedures.

Primary outcomes:
measure: Clinical process of CAR-T cells
timeFrame: JAN/2018-DEC/2020
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: natinal taiwan university hospital
name: Yu-Hsiang Chang, MDPHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04249986: Backpack Weight Impacts
Official title: Backpack Weight Impacts on Perceived Exertion and Heart Rate Variability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exertion; Excess
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Backpacking is an increasingly popular outdoor recreational activity. The base pack weight (BPW) includes gear that is not consumed or worn on the body: shelter, sleep system, weather-proofing layers and personal gear to ensure a degree of comfort and safety. As such, reducing BPW is one of the most important tasks a backpacker manages when preparing for a trip. Available recommendations for ideal BPW are currently inconsistent, lack clear parameters, and rely on anecdotal evidence. The study aims to collect field data on perceived exertion and heart rate (HR) in relation to BPW during a day-long interval of hiking. Such findings can have implications on the cost and safety profiles extending from recreational backpacking to military and wilderness rescue operations.


Eligibility criteria: Inclusion Criteria:

* Only adult (age 18-65)
* Have gone on at least two overnight backpacking trips in the past 5 years
* Have hiked at least 8 miles in a day on one of those trips

Exclusion Criteria:

* Lower extremity injuries or surgeries in the past 6-months
* Daily Smokers
* Chronic medical problems:
* Hypertension
* High cholesterol
* Diabetes
* Heart attack
* Heart surgery, cardiac catheterization, or coronary angioplasty
* Pacemaker/implantable cardiac defibrillator/rhythm disturbance
* Heart valve disease
* Heart failure
* Heart transplantation
* Congenital heart disease
* Kidney disease
* Back pain

Primary outcomes:
measure: The Borg Rating of Perceived Exertion During the Total Hike
timeFrame: 2 weeks
Secondary outcomes:
measure: Heart Rate
timeFrame: 2 weeks
measure: The Borg Rating of Perceived Exertion During Incline and Decline Sections of the participant
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Fresno
country: United States
facility: UCSF Fresno
state: California
Study officials:
affiliation: University of California, San Francisco
name: Susanne Spano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02710786: Comorbidity After Gastric Bypass
Official title: Long-term Resolution of Comorbidites After Gastric Bypass
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Obesity
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: The Scandinavian Obesity Surgery Registry
First posted: 2016-03-17
Enrollment: 25000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals undergoing gastric bypass

Brief summary: To evaluate effect on comorbid disease and weight loss in the long-term (\>five years) after Roux-en-Y gastric bypass (RYGB) surgery for severe obesity.

Detailed description: Individuals with severe obesity frequently have comorbid diseases, e.g. diabetes, hypertension, hyperlipidemia, and sleep apnea. We will study the remission rate and weight loss in the long-term (10 years) after Roux-en-Y gastric bypass (RYGB) surgery in a nationwide large group of patients.

Eligibility criteria: Inclusion Criteria:

* Registered individuals in Scandinavian Obesity Surgery Registry (SOReg) having had gastric bypass

Exclusion Criteria:

* All other operations

Primary outcomes:
measure: Change in comorbid conditions, as defined by use of pharmacological treatment
timeFrame: 10 years
Secondary outcomes:
measure: Number of patients with pathological laboratory data (corresponding to the studied comorbid conditions)
timeFrame: 10 years
measure: Weight loss
timeFrame: 10 years
measure: BMI loss
timeFrame: 10 years
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Scandinavian Obesity Surgery Registry
name: Ingemar Näslund
role: STUDY_CHAIR
References:
Clinical trial NCT02436486: Study Investigating the Effect of Idalopirdine on Cardiac Repolarisation in Healthy Men
Official title: Interventional, Randomised, Double-blind, Placebo- and Positive Controlled, Single-dose, Cross-over Study Investigating the Effect of Idalopirdine on Cardiac Repolarisation in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2015-05-06
Enrollment: 76
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of idalopirdine (120 and 360 mg) on cardiac repolarisation in healthy men.


Eligibility criteria: Inclusion Criteria:

* Body weight at least 50 kg and Body Mass index \>18.5 and \< 30 kg/m2
* Good general health ascertained by a detailed medical history, laboratory tests and physical examination
* Use of contraception.

Exclusion Criteria:

* The subject has evidence of cardiac conduction abnormalities as calculated by the ECG equipment and evaluated by the investigator, at the Screening Visit or at the Baseline visit
* The subject has a history of long QT syndrome, history of cardiac arrhythmia, or history of cardiac disease (eg, coronary artery disease, valvular disease, etc.).

Other protocol defined inclusion and exclusion criteria do apply

Primary outcomes:
measure: Change from pre-dose baseline in the QT interval (ΔQTcF) at each post-dose time point within the ECG collection period
timeFrame: For 24 hours in each dosing period
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: FR801
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT00669786: Human Menopausal Gonadotropin (HMG) vs Recombinant Follicle Stimulating Hormone (rFSH) in Gonadotropin Releasing Hormone (GnRH) Antagonist Cycles
Official title: Highly Purified Human Menopausal Gonadotropin Versus Recombinant Follicle Stimulating Hormone in Ovarian Hyperstimulation With Gonadotropin Releasing Hormone Antagonists. A Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Stimulation
Keywords: Ongoing Pregnancy Rate
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2008-05-01
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: A randomized controlled trial comparing the ongoing pregnancy rate (primary end-point) in 280 patients undergoing IVF/ICSI after stimulation with hp-hMG or rFSH controlled with a GnRH antagonist. Non significant differences were observed between hp-hMG and rFSH in terms of the ongoing pregnancy rate per started cycle (35.0% vs. 32.1%; p=0.61); R.R: 1.09 (95% CI: 0.78-1.51; Risk Difference: 2.9%). No differences were observed for implantation, clinical pregnancy and pregnancy loss rates. Patients receiving rFSH obtained more oocytes (14.4 ± 8.1 vs. 11.3 ± 6.0; p=0.001). Estradiol was higher at the end of stimulation in the hp-hMG group, while Progesterone was higher in patients stimulated with rFSH.


Eligibility criteria: Inclusion Criteria:

* women with good physical and mental health
* aged 18-37 years
* regular menstrual cycles ranging from 25 to 35 days; body mass index (BMI) \< 30 kg/m2
* normal basal serum FSH (≤ 10 IU/L) and E2 (≤ 75 pg/mL) levels determined on the day 3 of the cycle previous to COH
* no uterine (fibroids, adenomyosis, mullerian malformations), ovarian (endometrioma, polycystic ovaries) or adnexa (hydrosalpinx) abnormalities assessed by vaginal ultrasound.

Exclusion Criteria:

* patients with a history of recurrent pregnancy loss
* any significant systemic disease, endocrine or metabolic disorder
* having concomitant medication interfering with the purposes of the study
* patients who have received any ovulation induction drug within one month before their inclusion in the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Instituto Valenciano de Infertilidad
Study officials:
References:
citation: Bosch E, Vidal C, Labarta E, Simon C, Remohi J, Pellicer A. Highly purified hMG versus recombinant FSH in ovarian hyperstimulation with GnRH antagonists--a randomized study. Hum Reprod. 2008 Oct;23(10):2346-51. doi: 10.1093/humrep/den220. Epub 2008 Jun 25.
Clinical trial NCT03449186: Th17 Inducing Cytokines Pregnancy and After Postpartum
Official title: Interleukin-17 and Th17 Inducing Cytokines Exacerbate Periodontal Disease During Pregnancy and Postpartum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: periodontitis
postpartum
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 114
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All participants had 20 teeth present at least.

Brief summary: The aim of this study was to investigate salivary and gingival crevicular fluid (GCF) levels of IL-17A, IL-17E, IL-6 AND IL-23 during 2/3 trimester of pregnancy and after delivery.

Detailed description: IL-17 have a synergytic effect with IL-6 and IL-23. IL-17A levels elevated with periodontal diseases. Many systemical chronic conditions such as atherosclerosis and cardiovascular disease, pregnancy may contribute increasing of IL-17 family cytokine.

Eligibility criteria: Inclusion Criteria:

* women 2 and 3 trimester of their pregnancy

Exclusion Criteria:

* any known systemic disease,
* periodontal treatment within the last six months,
* patients having less than 10 teeth,
* smokers,
* individuals with a BMI \> 30 kg/m2,
* gestational diabetes and preeclampsia during pregnancy.

Primary outcomes:
measure: Changing Il-17A levels
timeFrame: 6 month
Secondary outcomes:
measure: Changing IL-6 levels
timeFrame: 6 month
measure: Changing IL-23 levels
timeFrame: 6 month
measure: Changing IL-17E levels
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00977886: Safety and Pharmacokinetics of ELB353 in Healthy Men
Official title: A Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of Oral ELB353 in Healthy Male Volunteers - A Double-Blind, Randomized, Placebo-controlled, Sequential Group Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Biotie Therapies Corp.
Sponsor class: INDUSTRY
First posted: 2009-09-16
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to study the safety and tolerability of repeated oral doses of ELB353, to evaluate the plasma levels of ELB353 and to study their effect on substances mediating inflammation.


Eligibility criteria: Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Concomitant medication
* Concomitant disease

Primary outcomes:
measure: Adverse event frequency and intensity
timeFrame: 1 month
Secondary outcomes:
measure: Plasma levels of ELB353
timeFrame: 1 month
measure: Inflammatory transmitter response ex vivo
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Biotie investigational site
Study officials:
affiliation: Biotie Therapies Corp.
name: Antero Kallio, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01777386: Perforator Artery Changes During Suprafascial Pre-expansion of the Perforator Flaps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scar
Contracture
Flap Disorder
Keywords: scar
contracture
perforator flap
preexpanded perforator flap
perforator vessel
artery diameter
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tissue expansion methods have been recommended as a means of improving the clinical results with perforator flaps but in plastic surgery literature there are few clinical trials supporting this opinion. The purposes of this clinical study are to address the ''preexpanded perforator flap concept'' by demonstrating a case series of relevant reconstructive procedures and to evaluate the perforator vessel changes that happen during the expansion periods of various perforator flap donor sites.


Eligibility criteria: Inclusion Criteria:

* patients with broad scars and contracture bands
* patients with esophagocutaneous fistula
* patients with ambiguous genitalia

Exclusion Criteria:

* none

Primary outcomes:
measure: Transferred tissue dimensions
timeFrame: At least five months after the operation
Secondary outcomes:
measure: Diameter of the perforator artery in a particular tissue level
timeFrame: Measured the day before the expander implantation surgery and the day before the flap transfer surgery (second session following tissue expansion)
Other outcomes:
Locations:
Study officials:
References: