louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00998244: Study to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease
Official title: A Randomized, Double-Blind Crossover Study to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Overweight
Acid Reflux Disease
Keywords: low carbohydrate
low fat
diet
overweight
GERD
gastroesophageal reflux disease
acid reflux
heartburn
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Takeda Pharmaceuticals North America, Inc.
First posted: 2009-10-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to learn if a very low carbohydrate (sugar) diet or traditional low fat diet is able to reduce symptoms related to gastroesophageal reflux disease (GERD) in people who are overweight. Patients with GERD may experience all or some of the following symptoms: stomach acid or partially digested food re-entering the esophagus (which is sometimes referred to as heartburn or regurgitation) and belching. In this study, the investigators also hope to find out if acid in the esophagus is reduced more by a low carbohydrate diet than a low fat diet.


Eligibility criteria: Inclusion Criteria:

* 18 to 70 years old
* BMI between 30 kg/m2 and 45 kg/m2

Exclusion Criteria:

* Known history of Barrett's esophagus or esophageal adenocarcinoma
* Previous surgical anti-reflux procedure
* Previous weight loss surgery, including gastric bypass
* Diabetes
* Pregnancy
* Heart Disease
* Unwillingness to discontinue use of proton pump inhibitors (PPI's) or H2-receptor antagonists per study protocol

Primary outcomes:
measure: Change in distal esophageal acid exposure after initiating a very low carbohydrate diet compared to the decrease seen after initiating a low fat diet
timeFrame: Baseline, 10 days after baseline, and at 25 days after baseline.
Secondary outcomes:
measure: The change in serum levels of pro-inflammatory cytokines after initiating a very low carbohydrate diet compared to a traditional low fat diet as measured with blood samples.
timeFrame: Baseline, 10 days after baseline, and at 25 days after baseline
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Nicholas J Shaheen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05688644: Sacral Neuromodulation in Neurogenic Patients
Official title: Efficacy and Safety of Sacral Neuromodulation With InterStim II in Neurogenic Bladder and/or Bowel Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurogenic Bladder
Neurogenic Bowel
Urge Incontinence
Overactive Bladder
Retention, Urinary
Fecal Incontinence
Keywords: Sacral Neuromodulation
Neurogenic Bladder
Neurogenic Bowel
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with approved indication for sacral neuromodulation

Brief summary: The goal of this observational study is to evaluate efficacy and safety of sacral neuromodulation in neurogenic patients compared to non-neurogenic (idiopathic) patients. \[. The main question\[s\] it aims to answer are:

* determine efficacy and safety of the therapy in neurogenic patients.
* compare outcomes of the therapy to idiopathic patients.

If there is a comparison group: Researchers will compare the outcomes of the therapy between the neurogenic and non-neurogenic subset of patients.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent InterStim II advanced evaluation for approved indication

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Decrease of at least 50% in number of catheterizations per day
timeFrame: 1 year
measure: Decrease of at least 50% in number of fecal incontinence episodes
timeFrame: 1 year
measure: Decrease of at least 50% in number of urge urinary incontinence episodes
timeFrame: 1 year
Secondary outcomes:
measure: Number of revision surgeries
timeFrame: 1 year
measure: number of follow-up visits for programming and/or troubleshooting
timeFrame: 1 year
Other outcomes:
Locations:
city: Kfar-Sava
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT01568944: Role of Infected Blood Dendritic Cells in Heart Disease Risk
Official title: Peripheral Blood Dendritic Cells and Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Keywords: periodontal
disease
dendritic
cells
antibiotics
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2012-04-02
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators hypothesize that blood dendritic cells harbor pathogens from the oral cavity in chronic periodontitis and disseminate these pathogens to atherosclerotic plaques.

Detailed description: To address this hypothesis, a clinical study in humans with moderate to severe chronic periodontitis has been designed. This is an interventional study involving scaling and root planing and two arms: 1. treatment with PO amoxocillin/metronidazole plus chlorhexidine oral rinse; 2. no antibiotics or oral rinse. It is expected that the antibiotics plus chlorhexidine will prevent the dendritic cell response to infection (bacteremia) elicited by scaling and root planing.

Eligibility criteria: Inclusion Criteria:

* generalized moderate to severe chronic periodontitis

Exclusion Criteria:

* diabetes
* antibiotics treatment within 3 months
* treatment with steroids, phenytoin, cyclosporin, coumadin
* presence of conditions requiring prophylactic antibiotics per AHA
* cancer, HIV, hepB, lupus, prediagnosed heart disease, renal disease
* smoker

Primary outcomes:
measure: Frequency of Blood Dendritic Cells From Baseline
timeFrame: 30 days
Secondary outcomes:
measure: Probing Attachment Levels
timeFrame: 30 days
measure: Serum Cytokine Response
timeFrame: 30 days
measure: Probing Depths
timeFrame: 30 days
measure: Plaque Index
timeFrame: 30 days
measure: Gingival Index
timeFrame: 30 days
Other outcomes:
Locations:
city: Augusta
country: United States
facility: GHSU-CDM Clinical Research Center
state: Georgia
Study officials:
affiliation: GHSU-College of Dental Medicine
name: Christopher Cutler, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeituni AE, McCaig W, Scisci E, Thanassi DG, Cutler CW. The native 67-kilodalton minor fimbria of Porphyromonas gingivalis is a novel glycoprotein with DC-SIGN-targeting motifs. J Bacteriol. 2010 Aug;192(16):4103-10. doi: 10.1128/JB.00275-10. Epub 2010 Jun 18.
citation: Zeituni AE, Carrion J, Cutler CW. Porphyromonas gingivalis-dendritic cell interactions: consequences for coronary artery disease. J Oral Microbiol. 2010 Dec 21;2. doi: 10.3402/jom.v2i0.5782.
Clinical trial NCT04865744: The Effect of Semaglutide on Pituitary Function
Official title: The Effect of Semaglutide on Pituitary Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: University of Tartu
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Blinded Randomised Single-group Crossover
Primary purpose: DIAGNOSTIC

Brief summary: The primary aim of the study is to describe the effect of a single oral dose of semaglutide 7 mg on growth hormone secretion.

Detailed description: The randomized blinded placebo-controlled clinical trial is conducted on 10 healthy volunteers.

5 study subjects receive once 7 mg of oral semaglutide and once placebo. 5 study subjects receive once 14 mg of oral semaglutide and once placebo. The study group and order of administration of study medication are decided on randomization. The placebo and oral semaglutide are administered at least 4 weeks apart.

Blood samples are taken before and during 4 hours after the study medication administration (at 60, 90, 120, 150, 180, and 240 minutes after study medication administration).

The primary endpoint is the peak value of growth hormone measured during the 4 hours after study medication administration.

Eligibility criteria: Inclusion Criteria:

* Age 18-50 years
* The body weight \>65 kg

Exclusion Criteria:

* presence of chronic illness
* the daily use of medications
* pregnancy
* lactation.

Primary outcomes:
measure: Growth hormone peak
timeFrame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
Secondary outcomes:
measure: Cortisol peak
timeFrame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
measure: Adrenocorticotropin (ACTH) peak
timeFrame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
measure: Aldosterone peak
timeFrame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
measure: Glucose nadir
timeFrame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
measure: C-peptide peak
timeFrame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
measure: Copeptin peak
timeFrame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
Other outcomes:
measure: Nausea
timeFrame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
measure: Heart rate
timeFrame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
measure: Blood pressure
timeFrame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
Study officials:
affiliation: University of Tartu
name: Vallo Volke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01154244: Insulin Resistance as Primary Pathogenesis in Newly Diagnosed, Drug naïve Type 2 Diabetes Patients in Korea
Official title: Insulin Resistance as Primary Pathogenesis in Newly Diagnosed, Drug naïve Type 2 Diabetes Patients in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: Insulin resistance
Insulin deficiency
HOMA-IR
Drug naive
Diabetes mellitus, type II
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-06-30
Enrollment: 1439
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly diagnosed Type II DM, Drug naive

Brief summary: The purpose of this study is investigating the clinical characteristics of newly diagnosed, drug naïve type 2 diabetic patients according to insulin secretion and insulin resistance.

Detailed description: Primary Objective:To investigate whether insulin resistance or insulin deficiency is primary in the pathogenesis of type 2 diabetes mellitus in Korea Secondary Objectives:To investigate proportion of patients with severe insulin deficiency at diagnosis,To investigate proportion of metabolic syndrome in patients with newly diagnosed, drug-naïve type 2 diabetes mellitus,To investigate proportion of obesity in patients with newly diagnosed, drug-naïve type 2 diabetes mellitus

Eligibility criteria: Inclusion Criteria:Newly diagnosed, drug naïve type 2 DM patients who gave informed consent, Diagnosis of type 2 DM will be made according to ADA guideline 2009 Exclusion Criteria:Patients age under 18 years

Primary outcomes:
measure: insulin resistance assessed using HOMA-IR
timeFrame: within 3months after DM diagnosis
Secondary outcomes:
measure: proportion of patients with severe insulin deficiency assessed using C-peptide
timeFrame: within 3months after DM diagnosis
measure: proportion of metabolic syndrome in patients
timeFrame: within 3months after DM diagnosis
measure: proportion of obesity in patients
timeFrame: within 3months after DM diagnosis
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02638844: Assessment of Right Ventricular 2d-strain in Acute Respiratory Distress Syndrome
Official title: ARDStrain : Assessment of Right Ventricular 2d-strain in Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS
Keywords: echocardiography
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2015-12-23
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients with moderate or severe ARDS receiving invasive mechanical ventilation

Brief summary: Assessment of right ventricular (RV) function in patients with acute respiratory syndrome (ARDS) is warranted because RV failure is frequent and associated with worse outcome. Transthoracic echocardiography is the cornerstone of RV assessment but it remains challenging. Quantification of RV deformation by speckle-tracking imaging echocardiography (STE) is a widely available and reproducible technique that readily provides an integrated analysis of all segments of the RV. This study aims to investigate the accuracy of STE-derived strain parameters in assessing RV function during ARDS.


Eligibility criteria: Inclusion Criteria:

* patients with moderate or severe ARDS (Berlin definition)
* receiving mechanical ventilation (\>48h estimated length)
* Transthoracic echocardiography performed during the first 36h after ICU admission

Exclusion Criteria:

* pregnancy
* protected or deprived of Liberty major
* chronic respiratory disease
* history of clinical right heart failure
* chronic heart failure with LVEF \< 35%
* severe valvular heart disease
* under 18 or protected-adults

Primary outcomes:
measure: Measure of longitudinal peak systolic strain
timeFrame: up to 36 hours after Intensive Care Unit admission
Secondary outcomes:
measure: Measure of PaO2/FiO2 ratio
timeFrame: up to 36 hours after Intensive Care Unit admission
measure: Ventilator-free days
timeFrame: 28 days
measure: Mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Nancy
country: France
facility: Lemarie Jeremie
Study officials:
References:
citation: Lemarie J, Maigrat CH, Kimmoun A, Dumont N, Bollaert PE, Selton-Suty C, Gibot S, Huttin O. Feasibility, reproducibility and diagnostic usefulness of right ventricular strain by 2-dimensional speckle-tracking echocardiography in ARDS patients: the ARD strain study. Ann Intensive Care. 2020 Feb 13;10(1):24. doi: 10.1186/s13613-020-0636-2.
Clinical trial NCT00922844: The Effect of Sevoflurane Versus Isoflurane on Vasopressor Need
Official title: The Effect of Sevoflurane Versus Isoflurane on Vasopressor Need
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypotension
Keywords: hypotension
low blood pressure
vasopressor need
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2009-06-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Aim of this study is to determine the effect of isoflurane versus sevoflurane on blood pressure and systemic vascular resistance.

Detailed description: In modern anesthesia a variety of volatile anesthetics is available. In cardiac anesthesiology both isoflurane and sevoflurane are frequently used. At present the number of studies comparing the influence of isoflurane and sevoflurane on blood pressure and systemic vascular resistance is limited. Moreover, the results presented in the available literature are inconsistent. The decision as to which of both volatiles should be used during cardiac surgery is not evidence-based, but is based on personal preference of the anesthesist. The most reliable way to compare the effects of isoflurane and sevoflurane on blood pressure and systemic vascular resistance is a randomized controlled trial in patients during Cardiopulmonary bypass (CPB).

Eligibility criteria: Inclusion Criteria:

* competent adult patients (18 years or older)undergoing elective coronary artery bypass grafting with the use of the cardiopulmonary bypass.

Exclusion Criteria:

* Patients undergoing valve surgery or combined surgical procedures (e.g. coronary artery bypass grafting in combination with valve reconstruction.
* uncontrolled hypertension
* a poor left ventricular function
* renal failure
* a body mass index of \> 25
* history of cerebrovascular accident, transient ischemic accident or carotid artery stenosis.

Primary outcomes:
measure: Total amount of the vasopressor phenylephrine that is needed to maintain blood pressure above 60 mmHg during 10 minutes of Cardiopulmonary bypass.
timeFrame: 10 minutes
Secondary outcomes:
measure: Mean blood pressure throughout the 10 minute periods, the need for a stronger vasopressor (norepinephrine) and the inability to keep mean blood pressure below 75 mmHg at MAC 0.6.
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center
Study officials:
affiliation: UMC Utrecht
name: C.J. Kalkman, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03200444: Evaluation of the Peel Force of New Adhesives From the Skin
Official title: Evaluation of the Peel Force of New Adhesives From the Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma Ileostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2017-06-27
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the impact and adhesion of new adhesives to the skin.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have intact skin on the area used in the investigation

Exclusion Criteria:

1. Currently receiving or have within the past 2 months received radio- and/or chemotherapy
2. Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Have dermatological problems in the abdominal area (assessed by investigator)

Primary outcomes:
measure: Peel Force
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
References:
Clinical trial NCT00603044: Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome
Official title: Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Childhood Obstructive Sleep Apnea Syndrome (OSAS)
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2008-01-28
Enrollment: 24
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research is to find out how a nasal spray (fluticasone furoate), sometimes given to children with obstructive sleep apnea syndrome (OSAS), works on certain cells within a child's adenoids. We hypothesize that intranasal steroids lead to an upregulation of T regulatory cells in the adenoid tissues of children with OSAS. This will result in a local reduction in inflammation and edema explaining the improvement in OSAS.

Detailed description: The objective was to determine the effect of intranasal corticosteroid therapy on T-regulatory cells and other inflammatory cytokines in adenoid tissues in children with obstructive sleep apnea syndrome.Children were randomized to either no treatment or treatment with fluticasone furoate nasal spray, 55 μg/nostril daily, for 2 weeks before adenotonsillectomy. Adenoid tissue was obtained at the time of the procedure.

Eligibility criteria: Inclusion Criteria:

* Age: between 2 and 12 years
* Polysomnogram results showing AHI \>5/hr irrespective of saturations
* No other significant medical problems except well controlled asthma
* No chronic medication intake except bronchodilators and leukotriene receptor antagonists
* No systemic steroids within the past month
* No intranasal steroids within the past 2 weeks

Exclusion Criteria:

* Patients with OSAS who are overweight (BMI\>95th percentile for age) or who have neurological or craniofacial abnormalities as these tend to have OSAS related to these factors per se.
* Females of the specified age group who have already had their first period.

Primary outcomes:
measure: Number of CD25 Pos/FoxP3 Positive Cells
timeFrame: following adenoidectomy (2 weeks)
measure: Number of CD4 Pos/FOXP3 Positive Cells
timeFrame: following adenoidectomy (2 weeks)
measure: IL-10 Staining Intensity
timeFrame: following adenoidectomy (2 weeks)
measure: Amount of IL-10 Secreted by Adenoid Cells After PHA Stimulation
timeFrame: following adenoidectomy (2 weeks)
measure: Amount of TGF Secreted by Adenoid Cells After PHA Stimulation
timeFrame: following adenoidectomy (2 weeks)
Secondary outcomes:
measure: Adjusted Volume of the Removed Adenoids
timeFrame: following adenoidectomy (2 weeks)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Fuad M Baroody, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04605744: Peri-procedural Smoking Cessation Program in Patients With Chronic Pain
Official title: Implementation of a Peri-procedural Smoking Cessation Program in Patients With Chronic Pain Undergoing Interventional Pain Management Procedures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pain
Smoking
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This single arm study will assess whether smoking cessation counseling offered to chronic pain patients is effective in reducing pain and cigarette use.


Eligibility criteria: Inclusion Criteria:

* Chronic Pain of 3 months or greater
* Scheduled for interventional pain procedure

Exclusion Criteria:

* Cancer related pain
* Current participation in smoking abstinence program
* History of schizophrenia or other pyschotic disorder
* History of dementing illness
* Pregnant patients
* Diagnosis of depression or anxiety

Primary outcomes:
measure: Pain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
Study officials:
References: