louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01574430: Study of Photodynamic Therapy (PDT) in Patients With Central Serous Chorioretinopathy (CSC)
Official title: A Randomized, Double-masked, Multicenter, Controlled Study of Photodynamic Therapy in Patients With Central Serous Chorioretinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Central Serous Chorioretinopathy
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 131
Sex: ALL
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: The purpose of this study is to determine the safety and efficacy of PDT at 30% verteporfin dose in the treatment of CSC.


Eligibility criteria: Inclusion Criteria:

* patients with CSC
* patients signed the ICF
* patients with course of CSC less than 6 months
* patients did not undertake any treatment for CSC

Exclusion Criteria:

* patients with porphyria
* patients allergic to verteporfin
* pregnant or nursing women
* poor patients compliance
* sever liver dysfunction
* dioptric media opacities which make it difficult to exam fundus

Primary outcomes:
measure: Change from baseline in BCVA
timeFrame: 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year
Secondary outcomes:
measure: Leakage at RPE level in FA
timeFrame: 1 week
measure: Change from baseline in central retinal thickness
timeFrame: 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year
measure: The incidence rate of adverse event
timeFrame: 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: People's Hospital of Peking University
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Mingwei Zhao, M.D
role: STUDY_DIRECTOR
affiliation: Peking Union Medical College
name: Youxin Chen, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tongren Hospital of Capital Medical University
name: Feng Zhang, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Hospital
name: Hong Dai, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University People's Hospital
name: Xiaoxin Li, M.D
role: STUDY_CHAIR
References:
citation: Zhao M, Zhang F, Chen Y, Dai H, Qu J, Dong C, Kang X, Liu Y, Yang L, Li Y, Zhou P, Pan CT, Zhang L, Liu P, Zhou H, Jiao X, Xiong Y, Tian R, Lu Y, Yu X, Li X. A 50% vs 30% dose of verteporfin (photodynamic therapy) for acute central serous chorioretinopathy: one-year results of a randomized clinical trial. JAMA Ophthalmol. 2015 Mar;133(3):333-40. doi: 10.1001/jamaophthalmol.2014.5312.
Clinical trial NCT05661630: THE EFFECT OF SEX EDUCATION AND COUNSELING GIVEN TO WOMEN WITH STOMIA WITH THE EX-PLISSIT MODEL ON SEXUAL LIFE
Official title: THE EFFECT OF SEX EDUCATION AND COUNSELING GIVEN TO WOMEN WITH STOMIA WITH EX-PLISSIT MODEL ON SEXUAL QUALITY OF LIFE AND SEXUAL LIFE SATISFACTION
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stoma Colostomy
Stoma Ileostomy
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, it was aimed to determine the effect of sexual education and counseling given to women with stoma with the Ex-PLISSIT model on their sexual life quality and sexual life satisfaction.

H1: Female patients with permanent stoma who were given sexual education and counseling with the EX-PLISSIT model had a higher quality of life score measured by the Sexual Quality of Life scale.

H2: Female patients with permanent stoma who were given sexual education and counseling with the EX-PLISSIT model had higher mean scores of sexual life satisfaction.


Eligibility criteria: Inclusion Criteria for Research

* Permanent stoma for at least 6 months
* Not receiving active surgical treatment, chemotherapy and radiotherapy (at least 6 previous treatments have been completed)
* Married
* Agreeing to participate in the research and obtaining written permission,
* Over 18 years Research Exclusion Criteria
* Using antidepressants or using sedatives
* Having a diagnosed psychiatric problem,
* Women with diagnosed sexual dysfunction will not be included in the study. Exclusion Criteria from Research
* Do not complete the study,
* Surgical treatment, radiotherapy or chemotherapy started due to an urgent necessity during the working process, Patients who die during the study will be excluded.

Primary outcomes:
measure: Change in Sexual Life Quality
timeFrame: at the beginning of the study, 1 month later and 3 months later
measure: Change in satisfaction with sexual life
timeFrame: at the beginning of the study, 1 month later and 3 months later
measure: Change in satisfaction with marital relationship
timeFrame: at the beginning of the study, 1 month later and 3 months later
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00959530: Comparison of Lingualized and Full Bilaterally Balanced Articulation
Official title: A Randomized Clinical Trial Comparing Lingualized and Full Bilaterally Balanced Articulation for Complete Dentures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous
Keywords: complete dentures
patient satisfaction
treatment cost
Lead sponsor: Nihon University
Sponsor class: OTHER
First posted: 2009-08-14
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find the difference between patient satisfaction, masticatory performance and cost between two occlusal schemes for complete denture prosthodontics.

Detailed description: Two occlusal scheme applied to complete denture prosthodontics has been compared in RCT. This will have clinical benefit for deciding which occlusal scheme is better according to patient conditions. It will also have impact on dental educational curriculum.

Eligibility criteria: Inclusion Criteria:

* edentulous both maxilla and mandible, asking for new denture fabrication

Exclusion Criteria:

* psychiatric problem
* those who have difficulty answering the questionnaire
* oral cancer
* radiation experience

Primary outcomes:
measure: patient satisfaction on 100mm visual analogue scale
timeFrame: 6month
Secondary outcomes:
measure: treatment cost
timeFrame: 6month
Other outcomes:
Locations:
city: Matsudo
country: Japan
facility: Nihon University Hospital
state: Chiba
Study officials:
affiliation: Nihon University
name: Yasuhiko Kawai, DDS MMedSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Nihon University
name: Yuichi Matsumaru, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heydecke G, Vogeler M, Wolkewitz M, Turp JC, Strub JR. Simplified versus comprehensive fabrication of complete dentures: patient ratings of denture satisfaction from a randomized crossover trial. Quintessence Int. 2008 Feb;39(2):107-16.
citation: Sutton AF, Worthington HV, McCord JF. RCT comparing posterior occlusal forms for complete dentures. J Dent Res. 2007 Jul;86(7):651-5. doi: 10.1177/154405910708600713.
citation: Sutton AF, McCord JF. A randomized clinical trial comparing anatomic, lingualized, and zero-degree posterior occlusal forms for complete dentures. J Prosthet Dent. 2007 May;97(5):292-8. doi: 10.1016/j.prosdent.2007.03.003.
citation: Kimoto S, Gunji A, Yamakawa A, Ajiro H, Kanno K, Shinomiya M, Kawai Y, Kawara M, Kobayashi K. Prospective clinical trial comparing lingualized occlusion to bilateral balanced occlusion in complete dentures: a pilot study. Int J Prosthodont. 2006 Jan-Feb;19(1):103-9.
citation: Matsumaru Y. Influence of mandibular residual ridge resorption on objective masticatory measures of lingualized and fully bilateral balanced denture articulation. J Prosthodont Res. 2010 Jul;54(3):112-8. doi: 10.1016/j.jpor.2009.11.008. Epub 2010 Jan 19.
Clinical trial NCT05829330: Ambulatory Versus Inpatient Initiation of Home Mechanical Ventilation
Official title: Ambulatory Versus Inpatient Initiation of Home Non-invasive Mechanical Ventilation in Patient With Amyotrophic Lateral Sclerosis: a Prospective, Noninferiority Randomized Controlled Trial (The NIB-study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 46
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 investigation is to see if outpatient initiation of noninvasive home mechanical ventilation combined with closed telemonitoring and follow-up in patients with amyotrophic lateral sclerosis is non-inferior to initiation during admission to the hospital

The primary hypothesis is that outpatient intiation of noninvasive home mechanical ventilation combined with closed telemonitoring and follow-up is non-inferior to initiation during hospitalization in patients with amyotrophic lateral sclerosis.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Diagnosed with amyotrophic lateral sclerosis
* Indication for start of non-invasive mechanical ventilation

Exclusion Criteria:

* No informed consent
* Does not understand Danish or English
* Indication for invasive mechanical ventilation
* No morning baseline PCO2
* Hospitalization

Primary outcomes:
measure: Use of non-invasive mechanical ventilation
timeFrame: The 83th to the 90th day after initiation of non-invasive mechanical ventilation
Secondary outcomes:
measure: Patient satisfaction with the treatment
timeFrame: Measured at the 3 months follow-up visit
measure: Patient satisfaction with the proces in relation to the start of the treatment
timeFrame: Measured at the 3 months follow-up visit
Other outcomes:
Locations:
city: GLostrup
country: Denmark
facility: Department of Anaesthesia, Pain and REspiratory Support
Study officials:
References:
Clinical trial NCT00620230: Safety and Tolerability of Single and Multiple Doses of VAK694 in Healthy and Atopic Subjects
Official title: A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic Profile and Pharmacodynamic Effect of Single and Multiple Doses of VAK694 in Healthy and Atopic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergic Rhinitis
Keywords: Allergic rhinitis, anti-interleukin 4
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study will evaluate the safety and tolerability of single and multiple doses of VAK694 in healthy volunteers and otherwise healthy volunteers with a history of allergies.


Eligibility criteria: Inclusion Criteria:

* History of allergic rhinitis (Part 2 only)

Exclusion Criteria:

* Very low or high body weight
* Heavy or recent smoker
* Exposure to human monoclonal antibodies

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Routine safety observations and pharmacokinetic measurements
timeFrame: throughout the study
Secondary outcomes:
measure: Routine safety observations and pharmacokinetic measurements
timeFrame: throughout the study
Other outcomes:
Locations:
city: North Miami Beach
country: United States
facility: Novartis Investigator Site
state: Florida
Study officials:
affiliation: Novartis investigator site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02155530: COmparison and Modification in Neointimal Pattern Assessed by Optical Coherence Tomography With High Versus Moderate Efficacy Statin Treatment After Drug Eluting Stent Implantation: COMPASS Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective randomized trial to evaluate and compare the quantitative and qualitative characteristics of neointimal formation between high and low efficacy statin treatment after drug eluting stent (DES) implantation, in patients with homogeneous or heterogeneous neointimal pattern accessed by Optical Coherence Tomography (OCT). The investigators postulate that high efficacy statin could have superior effect on modification of neointimal pattern, compared with lower efficacy statin. Our main hypothesis is that Atorvastatin 40mg, high efficacy statin might have superior effect on modification of neointimal pattern evaluated by serially followed OCT, compared with pravastatin 20mg in patients with DES implantation.


Eligibility criteria: Inclusion Criteria:

* Patient is ≥ 20 years old
* Patients who received OCT related to clinical needs or the end point of other study
* Patients who received DES within 1 year before OCT evaluation
* Patients with homogenous or hetero neointimal pattern by OCT
* Non-statin user and moderate or low efficacy statin user

Exclusion Criteria:

* Refuse to participate
* Contraindication to statin treatment
* Women with current or potential childbearing
* Life expectancy \<1 year
* High efficacy statin user (Atorvastatin 80mg or Rosuvastatin 20mg)

Primary outcomes:
measure: Change of neointimal patterns assessed by 1-year followed OCT
timeFrame: at 1 year
Secondary outcomes:
measure: stent coverage and neointimal thickness
timeFrame: at 1 year
measure: Major adverse cardiac events
timeFrame: at 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT02882230: Evaluation of Neurologic and Psychiatric Adverse Events of Several Antiretroviral Drugs in Real Life Setting
Official title: Prospective Evaluation of Neurologic and Psychiatric Adverse Events of Rilpivirine, Elvitegravir, or Dolutegravir in a Real Life Setting
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: HIV
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-08-29
Enrollment: 1
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: HIV patients with a prescription of rilpivirine, elvitegravir, or dolutegravir (modification or initiation of an antiretroviral treatment) and non exposed HIV patients, who don't take these drugs.

Brief summary: The frequency of neurological and psychiatric complaints for participants taking rilpivirine, elvitegravir, or dolutegravir reaches on average 20-30% during clinical trials. The inclusion and exclusion criteria for enrolling people living with HIV are at times so selective and the subsequent descriptions of minor or severe adverse events (AE's) so often imprecise and ambiguous that one cannot extrapolate these particular research results to practicing medicine. These adverse events negatively affect the patient's quality of life and ultimately his or her good adherence to treatments.

This study aims at assessing the prevalence and at describing the neurological and psychiatric adverse events related to these drugs.


Eligibility criteria: Inclusion Criteria:

* HIV infection
* age \> 18
* treatment with rilpivirine, elvitegravir, or dolutegravir (for exposed patients)
* treatment with none of these drugs (for non exposed patients)
* capacity of reading French language

Exclusion Criteria:

* drugs addiction (except for amyl nitriles ("poppers") and cannabis)
* alcoholism
* co-infection with hepatitis C virus
* pregnant or breast feeding patient

Primary outcomes:
measure: number of patients with neurologic and/or psychiatric adverse events
timeFrame: 6 months after modification or initiation of a treatment with one of the following drugs: dolutegravir, elvitegravir ou la rilpivirine
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: France
Study officials:
affiliation: Fondation Ophtalmologique A. de Rothschild
name: Antoine MOULIGNIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02949830: A Study to Evaluate Long-term Safety and Clinical Activity of Givosiran (ALN-AS1) in Patient With Acute Intermittent Porphyria (AIP)
Official title: A Multicenter, Open-label Extension Study to Evaluate the Long-term Safety and Clinical Activity of Subcutaneously Administered ALN-AS1 in Patients With Acute Intermittent Porphyria Who Have Completed a Previous Clinical Study With ALN-AS1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Intermittent Porphyria
Keywords: RNAi therapeutic
Porphyria
AIP
Heme/Haem Arginate
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-10-31
Enrollment: 16
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: The purpose of this study is to determine the long-term safety, tolerability and pharmacokinetics of givosiran (ALN-AS1) in AIP patients who completed study ALN-AS1-001 (NCT02452372).


Eligibility criteria: Inclusion Criteria:

* Completed participation in Part C of study ALN-AS1-001 (NCT02452372)
* Not on a scheduled regimen of hemin
* Women of child bearing potential must have a negative serum pregnancy test, not be nursing, and use acceptable contraception
* Willing and able to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Clinically significant abnormal laboratory results
* Received an investigational agent (other than ALN-AS1) within 90 days before the first dose of study drug or are in follow-up of another clinical study
* History of multiple drug allergies or intolerance to subcutaneous injection

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Through Month 49
Secondary outcomes:
measure: The Pharmacodynamic (PD) Effect of Givosiran on Urine Levels of Delta-aminolevulinic Acid (ALA) as Measured by Percent Decrease From Baseline
timeFrame: Baseline; Month 48
measure: The Pharmacodynamic (PD) Effect of Givosiran on Urine Levels of Porphobilinogen (PBG) as Measured by Percent Decrease From Baseline
timeFrame: Baseline; Month 48
measure: Annualized Rate of Composite Porphyria Attacks
timeFrame: Through Month 48
measure: Annualized Rate of Hemin Administration
timeFrame: Through Month 49
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Clinical Trial Site
state: California
city: New York
country: United States
facility: Clinical Trial Site
state: New York
city: Galveston
country: United States
facility: Clinical Trial Site
state: Texas
city: Stockholm
country: Sweden
facility: Clinical Trial Site
city: London
country: United Kingdom
facility: Clinical Trial Site
Study officials:
affiliation: Alnylam Pharmaceuticals
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02762630: Use of a Novel Weight Bearing Cone Beam Computed Tomography (CBCT) Scanner for Imaging of the Patellofemoral Joint
Official title: Use of a Novel Weight Bearing Cone Beam Computed Tomography (CBCT) Scanner for Imaging of the Patellofemoral Joint
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patellofemoral Joint
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: Healthy volunteers will have a weight bearing cone beam CT scan of their knee to assess normal alignment of the knee joint


Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written informed consent
* Be 16 or more years of age
* Subject is able to be positioned properly in the investigational device and be still during the exam to reduce the potential of motion during the images

Exclusion Criteria:

* Have a history of patella instability
* Have had any type of previous knee surgery
* Have had a significant fracture of the patellofemoral joint
* Have a knee ligament injury
* Are pregnant at the time of screening or become pregnant during the study
* Have a history of high radiation exposure (i.e., undergone radiation therapy)
* Non-English speakers

Primary outcomes:
measure: Tibial tubercle-trochlear groove (TT-TG) offset distance (mm)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01359930: Phase 1 Naltrexone-Bupropion-Methamphetamine Interaction Study
Official title: Phase 1 Study of Interactions Between Oral Naltrexone and Bupropion and Intravenous Methamphetamine in Methamphetamine Experienced Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Methamphetamine Dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2011-05-25
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study is to primarily measure safety and interactions between oral doses of Naltrexone/Bupropion and i.v. Methamphetamine.


Eligibility criteria: Inclusion Criteria:

* Are MA experienced but not dependent, males or females aged 21-to-50 years.
* Reported use of MA during the past six months without experiencing an adverse consequence plus a life time MA or amphetamine use history of at least four occasions of use.
* Have a body mass index (BMI) between 18 and 30.
* Are willing and able to give written consent.
* Are not currently a subject (including still in the follow-up period) of another drug research study.
* Have no medical contraindications determined by the following: an adequate medical history, a physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis.
* Have a negative drug test for barbiturates, benzodiazepines, opiates, cocaine, amphetamines and ethanol at the time of hospital admission (Day 0).
* Are females who have a negative pregnancy test at hospital admission.
* Are of either non-childbearing (tubal ligation or total hysterectomy) or of childbearing potential using one or more of the following barrier methods of contraception: male or female condoms (with/without spermicide), diaphragm (with spermicide) and/or copper containing intrauterine device (with/without spermicide). No other contraceptives are acceptable.

Exclusion Criteria:

* Please contact site for more information

Primary outcomes:
measure: Cardiovascular System Effects
timeFrame: daily during the 10 day treatment period
measure: Number of subjects with adverse events
timeFrame: Day 0 through Day 10
Secondary outcomes:
measure: Plasma concentrations obtained at specific timepoints
timeFrame: daily during the 10 day treatment period
measure: Assessment of Vital Signs and Clinical Chemistries
timeFrame: Daily during the 10 day treatment period
measure: Cognitive Assessments as reported by the subject
timeFrame: Dailly during the 10 day treatment period
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Langley Porter Psychiatric Institute
state: California
Study officials:
References: