louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06112080: Wearable Auscultation Device Validation in Children
Official title: Wearable Auscultation Device Validation in Children
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Asthma
Asthma in Children
Wheezing
Pediatric Asthma
Lead sponsor: Strados Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-01
Enrollment: 36
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric subjects who present to Lurie Children's Hospital with or without wheezing.

Brief summary: This observational clinical study is an evaluation of a diagnostic tool through comparison. Similar to a validation study, the output of the RESP device will be compared to physician auscultation, surrogated by having an attending pulmonologist listen to blinded recordings.


Eligibility criteria: Inclusion Criteria:

* Any child aged 4-17 years of age
* Admitted to Lurie Children's Hospital or the Emergency Department at Lurie
* Normal breath sounds cohort: (16 patients ages 4-10, 16 patients ages 11-17)

  * Admitted for a non-respiratory complaint
  * Normal breath sounds on screening examination
* Wheeze cohort: (53 patients ages 4-10, 53 patients ages 11-17)

  * Admitted for pathologic process that may lead to wheezing (e.g., asthma)
  * Presence of wheeze on screening examination

Exclusion Criteria:

* Children less than age 4, adults (age 18 and above)
* Patients in the ambulatory setting
* Unable to provide consent
* Intubated patients
* Unstable disease posing a threat to life
* Adhesive allergy

Primary outcomes:
measure: Compare the output of the RESP Biosensor System to breath sound interpretation of an attending physician via collected recordings from stethoscope and completion of a comparison questionnaire
timeFrame: 12 months
Secondary outcomes:
measure: Tolerability and usability assessed utilizing The System Usibility Scale to evaluate attitudes towards the use and tolerance of the device by patients and caregivers
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
References:
Clinical trial NCT04410380: Patient Portal Use by Parents of Spanish-Speaking Children
Official title: Patient Portal Use by Parents of Spanish-Speaking Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Engagement
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether patient portal access is feasible and useful for Spanish-speaking parents.

Participants will be given an electronic tablet and will be taught how to access their child's medical record and other electronic health resources using the tablet.


Eligibility criteria: Inclusion Criteria:

* Be parent/legal guardians of children receiving care in UNC's Children's Clinics
* Have Spanish as preferred language of individual identifying as primary caregiver
* Have never activated MyChart (patient portal)
* Have internet service at home OR ability to easily access internet service
* Have at least one child under age 13

Exclusion Criteria:

* Medically unstable at time of recruitment

Primary outcomes:
measure: Percent of Parents Activating Patient Portal
timeFrame: 6 months
Secondary outcomes:
measure: Change in Parent Attitudes Toward Health Information Technology
timeFrame: Baseline, 1 month
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Kori Flower, MD, MS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05590780: Analysis of Cell-free DNA (cfDNA) During Periodontitis
Official title: Analysis of the Impact of Cell-free DNA (cfDNA) During Periodontitis and Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Cardiovascular Diseases
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 122
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy controls (n=30) and subjects with CVD (n=31), periodontitis (n=31) and periodontitis+CVD (n=30) were enrolled.

Brief summary: The purpose of this study was to examine the association between circulating cfDNA concentration and CVD risk in patients with periodontitis, CVD, and periodontitis plus CVD. In addition, the secondary objective was to identify, among other confounders, the impact of periodontitis and cardiovascular disease as potential significant predictors of circulating cfDNA levels in the enrolled population.

Detailed description: Recent emerging evidence has shown that circulating cell-free (cf) DNA are involved in in several epigenetic processes linked with periodontitis, coronary stenosis and systemic inflammation. The present study was aimed at assessing the impact of periodontitis on circulating cfDNA levels and evaluating possible confounders that influenced this association. Healthy controls (n=30) and subjects with CVD (n=31), periodontitis (n=31) and periodontitis+CVD (n=30) were enrolled. All subjects underwent regular periodontal examination and blood sampling. The analysis of the plasma cfDNA concentrations was performed using a dsDNA Assay Kit.

Eligibility criteria: Inclusion Criteria:

* Presence of at least 15 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Primary outcomes:
measure: Clinical attachment level loss
timeFrame: baseline changes
measure: circulating cell-free DNA
timeFrame: baseline changes
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: University of Catania
state: CT
Study officials:
affiliation: Università degli Studi di Catania
name: Gaetano Isola
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01066780: ClearVoice Sound-processing Strategy for AB HiRes 120 Cochlear Implant Users
Official title: Evaluation of the ClearVoice™ Strategy in Adults Using HiResolution® Fidelity 120® Sound Processing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant
Keywords: cochlear implant
adults
HiResolution
Fidelity 120
listening benefits
noise
cochlear implant benefit
Lead sponsor: Advanced Bionics
Sponsor class: INDUSTRY
First posted: 2010-02-10
Enrollment: 48
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: The purpose of this study is to collect information about how the new sound-processing affects the ability to hear in everyday listening situations.


Eligibility criteria: Inclusion Criteria:

* Post-lingually deafened,
* experienced (6 months device use),
* adult users of the Harmony HiResolution Bionic Ear System and HiRes Fidelity 120 sound processing.
* English language proficiency

Primary outcomes:
measure: Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise
timeFrame: 4 Weeks
Secondary outcomes:
measure: The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble.
timeFrame: 2-4 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: House Ear Clinic
state: California
city: Urbana
country: United States
facility: Carle Clinic Association
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Midwest Ear Institute
state: Missouri
city: Saint Louis
country: United States
facility: Washington University Medical Center
state: Missouri
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Halifax
country: Canada
facility: Nova Scotia Hearing and Speech Centres
state: Nova Scotia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
Study officials:
References:
Clinical trial NCT05746780: Bilateral Elective Neck Dissection in Salvage Total Laryngectomy
Official title: Clinical Value and Prognostic Impact of Bilateral Elective Neck Dissection in Salvage Total Laryngectomy of cN0 Cases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Cancer
Larynx
Larynx Cancer
Neck
Keywords: neck dissection
SALVAGE TOTAL LARYNGECTOMY
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient affected by recurrent laryngeal cancer, after failure of primary radiotherapy or conservative surgery, with clinically negative neck (cN0) and treated with salvage total laryngectomy and concomitant elective selective bilateral neck dissection (levels II-IV + VI).

Brief summary: The aim of this study is to evaluate the role of elective bilateral neck dissection in patients with clinically negative lymph nodes (cN0) who underwent salvage total laryngectomy, by estimating the prevalence of histologically positive occult lymph nodes (pN+). Secondary objective will be the assessment of complication rate and the evaluation of 5-year Overall Survival (OS) and 5-year Disease-Specific Survival (DSS) in these patients.


Eligibility criteria: Inclusion criteria

-patients affected by recurrent laryngeal cancer after primary treatment failure (surgery or radiotherapy or chemoradiotherapy), with no clinical or radiological evidence of lymph node metastasis in the neck (cN0),who underwent salvage total laryngectomy and concomitant bilateral elective neck dissection (levels II, III, IV and VI).

Exclusion Criteria:

* patients who received other salvage laryngeal resection such as open partial horizontal laryngectomy, endoscopic partial laryngectomy, or who did not undergo bilateral selective neck dissection.

Primary outcomes:
measure: Occult lymph node metastasis
timeFrame: At the time of salvage surgery
Secondary outcomes:
measure: Complications of bilateral neck dissection during hospitalization
timeFrame: Up to 15 days from salvage surgery
measure: Overall survival
timeFrame: 5 year
measure: Disease specific survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Stefano Settimi
Study officials:
References:
Clinical trial NCT01108562: Treatment of Postoperative Pain After Total Hip Arthroplasty Using Intravenous Lidocaine Infusion
Official title: Treatment of Postoperative Pain After Total Hip Arthroplasty Using Intravenous Lidocaine Infusion in Combination With Patient Controlled Analgesia: a Prospective Randomized, Double-blinded, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Postoperative Pain Management After Total Hip Arthroplasty
Keywords: postoperative pain management
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: Charles Lee MD
name: Michelle Schlunt MD
First posted: 2010-04-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This study will focus on patients undergoing total hip arthroplasty and Loma Linda University Medical Center \& East Campus. These patients will be randomized to receive a low dose lidocaine infusion or placebo, in addition to the patient controlled analgesia pump. These groups will be compared to one another statistically to determine which group shows the safest and most satisfying pain control.


Eligibility criteria: Inclusion Criteria:

* Adult male or female undergoing a total hip arthroplasty Subject is American Society of Anesthesiologists physical status 1, 2, or 3 Subject has voluntarily signed and dated the informed consent document approved by the IRB Be English speaking

Exclusion Criteria:

* Age \> 80 years old or younger than 18 years old Congestive heart failure Hepatic insufficiency Neurological disorders Psychiatric disorders Steroid treatment No history of atrial fibrillation Chronic pain disorder with opioid treatment

Primary outcomes:
measure: We propose to test the hypothesis that adding a low dose lidocaine infusion to patient controlled analgesia will lower the amount of opioids that these patients will receive, thereby improving patient safety while still providing adequate analgesia.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Loma Linda University Medical Center
name: Michelle L Schlunt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04462562: Quantitative US for Evaluation of Hepatic Steatosis in NAFLD
Official title: The Diagnostic Performance Assessment of Quantitative Ultrasound Imaging Indices for Differentiating Hepatic Steatosis Grade in Patients With Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Liver
Fatty Liver, Nonalcoholic
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medison
First posted: 2020-07-08
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate diagnostic performance of quantitative ultrasonographic parameters for the assessment of hepatic steatosis with find optimal cut-off values in patients with non-alcoholic fatty liver disease using magnetic resonance imaging proton density fat fraction (MRI-PDFF) and MR spectroscopy as the reference standard.


Eligibility criteria: Inclusion Criteria:

* patients with known NAFLD or suspected of having NAFLD
* Patients who are scheduled hepatectomy for living donor liver donation
* aged ≥ 18 years who are willing and able to complete all procedures

Exclusion Criteria:

* excessive alcohol consumption within 2 years (40g/day for men, 20g/day for women)
* clinical, laboratory, or histologic evidence of a liver disease other than NAFLD, including viral hepatitis, autoimmune hepatitis, or genetic or acquired disorders
* use of steatogenic or hepatotoxic medication
* evidence of decompensated liver disease
* history of liver surgery
* contraindication to MRI
* any other condition believed by investigator to affect a patients' compliance, or completion of the study

Primary outcomes:
measure: Diagnostic performance (area under the ROC curve (AUC)) of quantitative US (QUS) parameters (TAI, TSI) for detection of fatty liver (MRI-PDFF 5 percent)
timeFrame: 1 month
Secondary outcomes:
measure: Diagnostic performance (area under the ROC curve (AUC)) of QUS parameters (TAI, TSI) for detection of moderate fatty liver (MRI-PDFF 10, 20 percent)
timeFrame: 1 month
measure: Correlation of QUS parameters and MR fat fraction
timeFrame: 1 month
measure: Intra-observer agreement of quantitative US parameters
timeFrame: 1 day
measure: Correlation between estimated fat fraction from deep learning model and MRI-proton density fat fraction
timeFrame: 1 month
measure: Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (10 percent, 15 percent, 15 percent, 20 percent)
timeFrame: 1 month
measure: Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (5 percent)
timeFrame: 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee
role: STUDY_DIRECTOR
References:
Clinical trial NCT05164562: Prevalence of Musculoskeletal Disorders of Upper Limb in Type 1 Diabetes Patients
Official title: Prevalence of Musculoskeletal Disorders of Upper Limb in Type 1 Diabetes Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes
Keywords: musculoskeletal disorders
prevalence
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with type 1 diabetes

Brief summary: Osteopenia and osteoporosis, particularly related to insulinopenia, are common in type 1 diabetes and increase the risk of fractures. Musculoskeletal disorders of the upper limb are a common complication of type 1 diabetes. However, there is no official recommendation for screening for musculoskeletal disorders in France.

Detailed description: The aim of the study is to describe prevalence of musculoskeletal disorders of upper limb in type 1 diabetes patients.

Eligibility criteria: Inclusion Criteria:

* male or female
* aged of 18 and more
* with type 1 diabetes
* agreeing to participate in the study

Exclusion Criteria:

* none

Primary outcomes:
measure: musculoskeletal disorders of upper limb
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Centre Hospitalier Universitaire de Reims
state: Grand-Est
Study officials:
References:
Clinical trial NCT01562262: Comparison of RT in Patients With Sleep Apnea With and Without Complaints of Daytime Sleepiness
Official title: Behavior of Psychomotor Vigilance Task Performance in Subjects With Obstructive Sleep Apnea With and Without Complaints of Daytime Sleepiness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea
Keywords: Apnea
PVT
Reaction Time
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-03-23
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Man, ages between 20 and 45 years with and without drowsiness and no sleep disturbances checked before the study

Brief summary: Not all patients with the Obstructive Sleep Apnea Syndrome (OSAS), mostly mild, have excessive daytime sleepiness. Sleep fragmentation provides the performance decrease with increasing reaction time to external stimuli and correlates with excessive sleepiness. So, the study aims at assessing the effect of sleep fragmentation on the Reaction Time and it's maintenance in patients with OSAS compared with healthy, to better clarify were patients with and without somnolence differ. For that, will be recruited 30 male volunteers aged between 20 and 50 year old to participate in the study. They will be distributed in three groups: "CONTROL" (without symptoms of sleepiness and apnea and hypopnea index (AHI) less than 5), "SS" (with AHI between 5 and 15 without symptoms of somnolence) and group "CS" (with AHI between 5 and 15 with symptoms of somnolence). The groups will undergo a polysomnography and subsequently, the Test and Maintenance of Wakefulness and PVT Battery Tests. The reaction time will be compared, as well as the ability to keep the reaction time over time between groups to see whether there is a difference between the motor performance throughout the day and the perception of sleepiness.


Eligibility criteria: Inclusion Criteria:

* Man
* Aged between 20 and 45 years old
* BMI between 20-30

Exclusion Criteria:

* Cigarette Smoke
* Drug intake
* Other sleep disturbances

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
state: SP
Study officials:
References:
Clinical trial NCT05073562: Nutrition Intervention to Address Anemia Among Adolescent Girls in Liberia
Official title: A Study on the Effectiveness of IFA Supplementation, Deworming, and Nutrition Education in Addressing Anemia Among Adolescent Girls in Two Counties in Liberia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Nutritional Anemia
Nutritional Deficiency
Iron Deficiency Anemia Treatment
Folic Acid Deficiency Anemia, Dietary
Adolescent Development
Knowledge, Attitudes, Practice
Food Habits
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: UNICEF
name: Ministry of Health, Liberia
name: Liberia Institute of Statistics and Geo-Information Services
First posted: 2021-10-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the feasibility and effectiveness of weekly iron and folic acid (IFA) supplementation and one-time deworming treatment at the community level in improving hemoglobin levels among adolescent girls in Liberia, West Africa, and to assess the feasibility and effectiveness of a targeted nutrition education program in improving nutrition knowledge, attitudes, and practices in the same population.


Eligibility criteria: Inclusion Criteria:

* Adolescent girl aged 10 - 19 years at the time of enrollment
* Lives within the selected study communities in Montserrado or Margibi counties
* Caregiver/adolescent consents to participate in the study

Exclusion Criteria:

* Currently pregnant
* Active malaria infection as defined by positive rapid diagnostic test (RDT)
* Severe acute malnutrition at the time of enrollment
* Known malignancy
* Known sickle cell disease

Primary outcomes:
measure: Change in participants' hemoglobin level from enrollment to completion of the study
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Changes in responses to questions in the Nutrition Knowledge, Attitudes, and Practice (KAP) survey from baseline to follow up evaluation
timeFrame: Baseline and Week 12
measure: Feasibility of targeted intervention for scale-up to country-wide enhanced nutrition services
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Boston Children's Hospital
name: Julia Rubin-Smith, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: