louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01684930: Nitrites, Exercise, and Peripheral Arterial Disease
Official title: Increased Plasma Nitrite, Tissue Oxygenation and Functional Changes in PAD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral Arterial Disease
Keywords: Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Exercise
Functional Capacity
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-09-13
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis of this proposal is that in subjects with PAD, regular consumption of a high nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of supervised exercise training at the limb ischemic threshold (SET) will produce a greater clinical benefit (increases in COT and PWT) than placebo plus supervised exercise at the limb ischemic threshold (PET).


Eligibility criteria: Inclusion Criteria:

* Peripheral Arterial Disease (ABI of less than 0.9)
* Intermittent Claudication for 3 or more months

Exclusion Criteria:

* Individuals with known alcohol or drug abuse problems
* Individuals who have suffered a heart attack or stroke, or have changes on a resting ECG, in the last 3 months
* Those classified as American Heart Association Class D
* Gangrene, impending limb loss or osteomyelitis
* Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment
* Severe peripheral neuropathy
* Any condition other than PAD that limits walking
* Chest pain during treadmill exercise which appears before the onset of claudication, or \>3mm ST depression during exercise
* Subjects taking nitrates or nitroglycerin products
* Must not be taking protein pump inhibitor medications

Primary outcomes:
measure: Change in Exercise Capacity: VO2peak (Maximal Oxygen Consumption)
timeFrame: Baseline and 16 Weeks
measure: Change In Time To Exhaustion
timeFrame: Baseline and 16 weeks
Secondary outcomes:
measure: Change in Functional Ability
timeFrame: Baseline and 16 Weeks
measure: Change In Claudication Onset Time
timeFrame: Baseline and 16 weeks
measure: Change In Vascular Function (BAFMD)
timeFrame: Baseline and 16 weeks
measure: Change in Angiogenesis
timeFrame: Baseline and 16 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Diet & Fitness Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Jason Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woessner M, VanBruggen MD, Pieper CF, Sloane R, Kraus WE, Gow AJ, Allen JD. Beet the Best? Circ Res. 2018 Aug 31;123(6):654-659. doi: 10.1161/CIRCRESAHA.118.313131.
citation: Woessner MN, VanBruggen MD, Pieper CF, O'Reilly EK, Kraus WE, Allen JD. Combined Dietary Nitrate and Exercise Intervention in Peripheral Artery Disease: Protocol Rationale and Design. JMIR Res Protoc. 2017 Oct 3;6(10):e139. doi: 10.2196/resprot.7596.
Clinical trial NCT01493830: Biomarkers in Tumor Samples From Younger Patients With Neuroblastoma
Official title: Proposed Studies on the Role of Growth Factor Receptor Trafficking in Neuroblastoma Pathogenesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroblastoma
Keywords: neuroblastoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-12-16
Enrollment: 5
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients With Neuroblastoma

Brief summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in tumor samples from younger patients with neuroblastoma.

Detailed description: OBJECTIVES:

* To determine the expression of UBE4B, hrs, and members of the ubiquitination protein complex in previously banked primary neuroblastoma tumor samples from the Children's Oncology Group.
* To determine the correlation of expression levels and cellular localization of the UBE4B and hrs proteins with growth factor-receptor tumor cell-surface expression.
* To determine the 1p36 deletion status by fluorescence in situ hybridization (FISH) analysis and their association with expression levels of UBE4B and hrs in previously banked primary neuroblastoma tumor samples from the Children's Oncology Group.

OUTLINE: Banked tumor tissue samples are analyzed for expression of UBE4B, hrs, members of the ubiquitination protein complex, growth factor receptors, and 1p36 deletion status by immunohistochemistry (IHC), fluorescent microscopy, and fluorescence in situ hybridization (FISH).

Eligibility criteria: DISEASE CHARACTERISTICS:

* Tumor tissue microarrays from the Children's Oncology Group neuroblastoma tumor bank

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Expression of UBE4B, hrs, and members of the ubiquitination protein complex
measure: Expression levels and cellular localization of the UBE4B, hrs, and growth factor receptors
measure: 1p36 deletion status and its association with UBE4B
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Texas Children's Cancer Center
name: Peter Zage, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00178230: Circulating Cytokines as Predictors of Radiation Induced Pulmonary Toxicity
Official title: Circulating Cytokines as Predictors of Radiation Induced Pulmonary Toxicity in Thoracic Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Neoplasms
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 82
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: Patients receiving radiation therapy for lung cancer combined with surgery either pre or post RT to the chest for lung cancer not associated with atelectasis, pleural effusion.

Brief summary: This study is being conducted by the University of Rochester Cancer Center to determine the levels of cytokines in the blood, and to determine if blood levels of these cytokines are related to the side effects of radiation therapy combined with other treatments.


Eligibility criteria: Inclusion Criteria:

Patients receiving radiation therapy for lung cancer combined with surgery either pre or post RT to the chest for lung cancer not associated with atelectasis, pleural effusion.

Patients receiving HDR Brachytherapy for lung cancer.

Patients receiving concomitant radiation and interferon therapy for lung cancer.

Patients receiving concomitant chemotherapy and radiation for lung cancer. Prior drug therapy does not make patients ineligible.

Karnofsky ≥ 70 %.

There are no age restrictions.

Acceptable bone marrow function - WBC 2 3000/mm3, platelet count \> 100,000, hematocrit ≥ 33%, hemoglobin ≥ 11 gms/dl.

Life expectancy \> 6 months.

Patients must sign informed consent meeting all federal and institutional guidelines.

Exclusion Criteria:

Patients not meeting eligibility criteria stated above

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester, Dept. Radiation Oncology
state: New York
Study officials:
affiliation: Universtiy of Rochester, Dept of Radiation Oncology
name: Yuhchyau Chen, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06974630: Cervical Erector Spinae Plane Block vs Cervical Plexus Block in Controlling Acute Postoperative Pain After Thyroidectomy
Official title: Cervical Erector Spinae Plane Block vs Cervical Plexus Block in Controlling Acute Postoperative Pain After Thyroidectomy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical
Erector Spinae Plane Block
Cervical Plexus Block
Postoperative Pain
Thyroidectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the efficacy and safety of cervical erector spinae plane block vs. cervical plexus block in controlling acute postoperative pain after thyroidectomy.

Detailed description: Thyroidectomy is one of the most commonly performed surgeries in females worldwide, as thyroid disease predominantly affects females with a ratio of 4:1. Thyroid operations can cause mild to moderate incisional pain. It has also been reported that the morphine consumption on the first postoperative day is 90%.

Cervical plexus block, either superficial or deep or combinations given bilaterally, could easily lead to an adequate block appropriate for thyroid surgery without any significant side effects.

Erector spinae plane block (ESPB) is the new favorite among various fascial plane blocks. Local anesthetic drug is injected in the fascial plane superficial to the transverse process and deeper to the erector spinae muscle (ESM).

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years.
* Both genders.
* American Society of Anesthesiologists (ASA) physical status I-II.
* Scheduled for either hemi- or total thyroidectomy.

Exclusion Criteria:

* Known allergy to local anesthetics.
* Allergy to all opioid medications.
* Pregnant patient.
* Previous neck surgery.
* Recent use of non-steroidal anti-inflammatory drugs (NSAIDs), opioids or steroid injection within 2 weeks.
* Those who cannot utilize the numeric rating scale (NRS) .
* Chronic opioid use.
* Coagulopathy.

Primary outcomes:
measure: Total morphine consumption
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Time to the 1st rescue analgesia
timeFrame: 48 hours postoperatively
measure: Intraoperative fentanyl consumption
timeFrame: Intraoperatively
measure: Degree of pain
timeFrame: 48 hours postoperatively
measure: Incidence of adverse events
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT05302830: Effectiveness of the Snackability Smartphone Application to Improve Quality of the Snack Intake, General Diet Quality, and Weight Among College Students
Official title: Snackability Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diet, Healthy
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Snackability was a two-arm, 12-week randomized control trial among 272 overweight college students. Participants were equally randomized to the intervention group (access to the app) or control group (no access to the app). Diet and weight were assessed at baseline, at 4 weeks, at 8 weeks, and at 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Overweight or obese college students-
* Aged 18-24 years
* Owner of a smartphone with Android or iOS platforms with access to an internet connection to use the app
* Willingness to participate in a clinical trial of 3 months and complete assessments at baseline and every 4 weeks at home

Exclusion Criteria:

* Nutrition students
* Enrolled in a weight loss and/or nutrition program
* Taking medications known to influence weight
* Pregnant or breastfeeding

Primary outcomes:
measure: Change in general diet quality
timeFrame: 12 weeks
measure: Change in snack quality
timeFrame: 12 weeks
measure: Change in snack patterns
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in weight
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
References:
Clinical trial NCT05986630: Safety and Effectiveness Evaluation of TEOSYAL® TPVM Versus COMPARATOR for the Remodeling of the Lower Face
Official title: A Prospective, Randomized, Blinded Evaluator, Multicenter, Clinical Study to Evaluate Safety and Effectiveness of TEOSYAL® TPVM Versus COMPARATOR for the Remodeling of the Lower Face
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Chin Retrusion
Keywords: Dermal filler
Hyaluronic acid (HA)
Chin
Lead sponsor: Teoxane SA
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical study is designed to prospectively evaluate the safety and effectiveness of TEOSYAL® TPVM when compared to COMPARATOR for the remodeling of the lower face

Detailed description: This is a prospective, randomized, blinded evaluator, multicenter, clinical study to evaluate safety and effectiveness of TEOSYAL® TPVM versus COMPARATOR for the remodeling of the lower face.

Subject will be enrolled in the study based on evaluation of their chin retrusion severity.

For the purpose of this study, all injections will be done by principal investigators (PIs) with several years of experience in aesthetic treatment.

An external aesthetic and cosmetic surgeon will act as a BE to assess the performance of the treatment and the product based on photographs.

Eligibility criteria: Inclusion Criteria:

* Healthy adult subjects over 18 years old seeking correction of their lower face
* Subject scored grade 2 or 3 on the TCRS
* Female subjects of childbearing potential must have a negative UPT and practice a reliable method of contraception throughout the study.
* Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
* Able to follow study instructions and complete all required visits.
* Having given its signed informed consent

Exclusion Criteria:

* Known hypersensitivity or previous allergic reaction to any component of the study devices
* Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
* History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
* Subject exhibits any physical attribute that may prevent assessment or treatment of the lower face as judged by the PI
* Clinically significant alcohol or drug abuse.
* Subject has received any investigational product within 90 days prior to Visit 1 or planning to participate in another investigation during the course of the study.

Primary outcomes:
measure: Change in TCRS score between Baseline and 8 weeks after last treatment as assessed by the Blinded Evaluator
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Care- Geneva
Study officials:
References:
Clinical trial NCT01740830: The Effect of Anodal tDCS on Motor Learning in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anodal tDCS
Recruitment Curves
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 31
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 current study investigates the effects of tDCS in patients with multiple sclerosis (MS). The investigators hypothesize that anodal tDCS will increase motor performance in patients with MS.


Eligibility criteria: Inclusion Criteria:

* at least 18 years old
* male and female

Exclusion Criteria:

* relapse in the last 3 months
* when not suitable for tDCS (screening)
* if TMS measures can not be completed

Primary outcomes:
measure: Motor performance on a unimanual sequence learning task
timeFrame: Baseline, during training and POST (30 min after baseline) intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04628130: Efficacy of Yoga Based Self-Management Program for Chronic Pain
Official title: Efficacy of Yoga Based Self-Management Program for Chronic Pain: Community Based Clinical Efficacy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Aarogyam UK
Sponsor class: OTHER
Collaborators: name: Patanjali Yog Peeth (UK) Trust
First posted: 2020-11-13
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community based project in partnership with community organisation, health care providers and academic included chronic pain patients for yoga self management therapy.

Brief summary: Chronic pain is a major health issue with substantial economic burden.To support chronic pain patients during the COVID-19 pandemic, yoga based self-managed intervention was delivered through tele-health platform. Project was designed as community-based program, creating new social networks for patients, health care providers and academics. Platform to deliver intervention and data collection was AiM COVID mobile app.

Our objective was to determine the efficacy of Yoga based self-management intervention for people living with chronic pain pain intensity, disability and health related quality of life.


Eligibility criteria: Inclusion Criteria:

* Chronic pain for at least 3 months
* Having access to internet and video calls

Exclusion Criteria:

* Pregnant or breast-feeding women,
* Patients not willing to give written consent
* Patients with severe psychiatric or personality disorder
* Malignancy

Primary outcomes:
measure: Pain intensity and disability
timeFrame: From baseline to 6 week post intervention
measure: Health Related Quality of Life
timeFrame: From baseline to 6 week post intervention
measure: Self-efficacy of pain
timeFrame: From baseline to 6 week post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Aarogyam UK
state: Leicestershire
city: Glasgow
country: United Kingdom
facility: Patanjali Yog Peeth (UK) Trust
state: Scotland
Study officials:
affiliation: Aarogyam UK
name: Neha Sharma
role: PRINCIPAL_INVESTIGATOR
affiliation: East Park Medical Centre, NHS trust, Leicester
name: Deepa Modi
role: STUDY_CHAIR
affiliation: University of Warwick
name: Vishwesh Kulkarni
role: STUDY_DIRECTOR
affiliation: Patanjali Yog Peeth (UK) Trust
name: Sunita Poddar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01947530: Study Using Combined Virtual 4-D Electromagnetic (EM) Tip-Tracked Devices & EBUS in Diagnosis of Lung Nodules
Official title: Pilot Study Using Combined Virtual 4-D EM Tip-Tracked Devices and Endobronchial Ultrasound (EBUS)in the Diagnosis of Peripheral Pulmonary Nodules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2013-09-20
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the safety and biopsy yield of EM Tip Tracked devices compared to standard bronchoscopy.


Eligibility criteria: Inclusion Criteria:

* Any adult patient aged 18 and older, able to sign an informed consent and is scheduled for flexible bronchoscopy with biopsies of peripheral nodules. Patient needs to have a recent chest CAT scan within last 4 weeks or will obtain a chest CAT scan prior to bronchoscopy.

Exclusion Criteria:

* Pulmonary nodules less than 1.0 cm
* patients must be able to tolerate general anesthesia
* patients with significant coagulopathy having International Ratio (INR)\>2.0 or Prothrombin Time (PTT) \>2x normal
* patients unable to tolerate bronchoscopy
* pregnant patients or patients who believe they are pregnant
* patients with implantable devices susceptible to Radio Frequency (RF) fields
* severely obese patients

Primary outcomes:
measure: Observe yield of EM Tip-tracked Devices compared to standard bronchoscopy
timeFrame: up to 1 year
Secondary outcomes:
measure: Observe safety of EM Tip-tracked devices in the collection of samples for diagnosis of peripheral nodules
timeFrame: up to 1 year
measure: Total virtual bronchoscopy time
timeFrame: Day 1
measure: Total procedure time
timeFrame: Day 1
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: UHN
name: Kazuhiro Yasufuku, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03403530: Efficacy of IgM Rich Immunoglobulin With Antibiotics for Bacterial Sepsis in Very Low Birth Weight Preterm Neonates
Official title: A Prospective Study to Analyze the Efficacy of IgM Rich Immunoglobulin as an Adjunct to Antibiotics in the Treatment of Bacterial Sepsis in Very Low Birth Weight Preterm Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neonatal SEPSIS
Very Low Birth Weight Baby
Keywords: IgM
Immunoglobulin
Neonatal sepsis
very low birth weight preterm
Lead sponsor: Sir Takhtasinhji General Hospital
Sponsor class: OTHER_GOV
First posted: 2018-01-18
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study comprises of giving IVIG to half of the septic VLBW preterm neonates along with ongoing antibiotics and placebo to the other half. The immunoglobulin will be given for 3 days and neonates will be monitored for the results. The data will be analysed on the basis of blood culture results and outcome of the patients.


Eligibility criteria: Inclusion Criteria:

* Preterm
* Very low birth weight baby: birth weight 1-1.5 kg
* Both inside and outside delivered babies
* Gender: males and females
* Probable severe sepsis (septic score)

Exclusion Criteria:

* Extremely low birth weight babies: \< 1 kg
* Babies \>1.5 kg birth weight
* Babies born with congenital malformations
* Full term babies
* IUGR babies
* Child with no signs of sepsis
* HBsAg Positive
* HIV Positive

Primary outcomes:
measure: Discharge rates
timeFrame: 6 months
Secondary outcomes:
measure: Duration of hospital stay
timeFrame: 6 months
Other outcomes:
Locations:
city: Bhavnagar
country: India
facility: NICU, Sir T Hospital, Bhavnagar
state: Gujarat
Study officials:
affiliation: SirTakhtasinhjiGH, Prof Pediatrics, Govt MC, Bhavnagar
name: Jayendra R Gohil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Capasso L, Borrelli A, Cerullo J, Pisanti R, Figliuolo C, Izzo F, Paccone M, Ferrara T, Lama S, Raimondi F. Role of immunoglobulins in neonatal sepsis. Transl Med UniSa. 2014 Dec 19;11:28-33. eCollection 2015 Jan-Apr.
citation: Haque KN, Zaidi MH, Bahakim H. IgM-enriched intravenous immunoglobulin therapy in neonatal sepsis. Am J Dis Child. 1988 Dec;142(12):1293-6. doi: 10.1001/archpedi.1988.02150120047038.