louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06852989: Shared Interactive Book Reading in Preschool Children With Neurodevelopmental Disorders: Effects on Language Development and Reading Habits
Official title: Shared Interactive Book Reading in Preschool Children With Neurodevelopmental Disorders: Effects on Language Development and Reading Habits
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Neurodevelopmental Disorders
Autism Spectrum Disorder
Intellectual Disabilities
Language Disorders in Children
Keywords: shared reading
early literacy
neurodevelopmental disorder
autism
intellectual disability
vocabulary
shared reading habits
language disorders
shared interactive book reading
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 53
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preschool children with neurodevelopmental disorders attending Fondazione Don Carlo Gnocchi's rehabilitation center

Brief summary: The goal of this observational retrospective study is to explore the effects of a parent-based book reading intervention on children with neurodevelopmental disorders. The project consisted of interactive lessons for parents and shared reading experiences. It took place between May 2021 and June 2022 in Rome and at the time children were receiving neuropsychomotor and speech therapy sessions based on the developmental profile.

The investigators'primary goal is to investigate lexical quotients of children who participated in the project to explore whether it had an impact on their language development. The secondary goal is to assess shared reading habits.

For both outcome measures, researchers will compare the group who partecipated in the study with a cohort of children with the same characteristics who also attended Fondazione Don Carlo Gnocchi for rehabilitation purposes.

Patients and their family will not be asked for any further engagement because all data will be taken from medical records.


Eligibility criteria: Inclusion criteria for the study group:

* age between 1 and 6 years old
* having attended at least 2 out of 5 parent training meetings and 2 out of 9 reading aloud sessions
* at least one caregiver with a good command of the Italian language,
* having given written consent to participate

Exclusion Criteria for both groups:

* cerebral palsy or severe sensory disorder (deafness, blindness)
* limited command of the italian language
* lack of informed consent

Primary outcomes:
measure: Lexical quotients (receptive and expressive)
timeFrame: February 2025 - August 2025
Secondary outcomes:
measure: Non-standardized shared-reading habits questionnaire
timeFrame: February 2025 - August 2025
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Don Carlo Gnocchi Onlus
Study officials:
affiliation: Fondazione Don Carlo Gnocchi Onlus
name: Laura Iuvone, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02906189: Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices
Official title: Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arrhythmias, Cardiac
Lead sponsor: Banner Health
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-MRI conditional pacemakers and ICDs referred for clinically indicated MRI scans.

Brief summary: The primary objective of the study is to determine the safety of MRI in patients with non-MRI conditional pacemakers. The secondary objective is to determine if there are clinically relevant parameter changes in the devices.


Eligibility criteria: Inclusion Criteria. All patients with non-MRI conditional pacemakers and ICDs between the ages of 18-85 will be eligible to participate. Medical records will be reviewed to confirm the date and make/model of device implanted. Ordering physician discusses the MRI request with radiologist, documenting that there is no appropriate alternate imaging test. Patient must have an appointment with a cardiologist/electrophysiologist prior to MRI. Banner Health policy for standard of care guidelines involving patients receiving MRI's will be followed.

Exclusion Criteria. Patients will be excluded from MRI based on the Department of Radiology protocol. Additional exclusion criteria include: ICD and pacemaker dependent, Pacemaker inserted before 2002, Epicardial leads, fractured leads, abandoned leads, or temporary pacemakers (post-coronary artery bypass graft temporary epicardial pacing wires are acceptable), Patient not awake or unable communicate, Battery voltage at elective replacement interval, implanted non-MRI conditional device (other than pacemaker/ICD).

Primary outcomes:
measure: Death during the MRI scan
timeFrame: Immediate
Secondary outcomes:
measure: Decrease in battery voltage >0.04v
timeFrame: 6 months
measure: Change in pacing lead impedance ≥ 50 Ω
timeFrame: 6 months
measure: Change in high-voltage lead impedance ≥ 3 Ω
timeFrame: 6 months
measure: Increase in pacing threshold ≥ 0.50 V @ 0.4 ms
timeFrame: 6 months
measure: Decrease in P wave measurement ≥ 50%
timeFrame: 6 months
measure: Decrease in R wave measurement ≥ 25%
timeFrame: 6 months
measure: Generator failure requiring immediate replacement
timeFrame: Immediate
measure: Lead failure requiring immediate replacement
timeFrame: Immediate
measure: New onset atrial or ventricular arrhythmia during MRI
timeFrame: Immediate
measure: Loss of pacemaker capture during MRI
timeFrame: Immediate
measure: Electrical reset of the device
timeFrame: Immediate
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenix
state: Arizona
Study officials:
affiliation: Banner University Medical Center
name: Michael Morris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02743689: Perioperative Risk Factors for Intensive Care Delirium After Cardiac Surgery
Official title: Incidence and Perioperative Risk Factors for Early Intensive Care Delirium Following Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: Postoperative
Cardiac surgery
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients scheduled for elective cardiac surgery

Brief summary: The aim of the study is to identify the incidence of early postoperative delirium in intensive care patients after cardiac surgery and detect possible risk factors associated with increased risk for developing delirium after cardiac surgery.

Detailed description: A consecutive series of patients scheduled for elective cardiac surgery is included in the study. Delirium screening is performed using Intensive Care Delirium Screening Checklist. Preoperative cognitive state is evaluated with Mini-Mental State Examination. Information of possible risk factors is collected from patient's history and chart. The Snoring, Tiredness, Observed apnea, high blood Pressure-Body mass index (BMI), Age, Neck circumference and Gender questionnaire (STOP-BANG questionnaire) is used for obstructive sleep apnea screening.

Eligibility criteria: Inclusion Criteria:

* elective cardiac surgery
* patient spends more than 1 day in the intensive care unit after the surgery

Exclusion Criteria:

* refusal to participating in the study
* documented severe central nervous system, cognitive or psychiatric disorder
* unable to be screened with Intensive Care Delirium Screening Checklist up to 6th postoperative day (e.g. deeply sedated, intubated patients)

Primary outcomes:
measure: Incidence of early postoperative delirium in intensive care patients after cardiac surgery
timeFrame: Within 5 days after the surgery
Secondary outcomes:
measure: Perioperative risk factors for delirium after cardiac surgery
timeFrame: Up to 5 postoperative days or occurence of delirium if it develops earlier
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinics
Study officials:
affiliation: Vilnius University Hospital Santariskiu Clinics
name: Vilma Kuzminskaite, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01875289: Efficacy of a Modified Obturator Nerve Block Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Surgery
Knee Surgery
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 36
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: Efficacy of a modified obturator nerve block technique by using only a single morphological landmark, a double-blinded randomised pilot study.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists 1-3, older than 18 y, cooperative patient

Exclusion Criteria:

* infection, neuromuscular deficits of the lower extremities,pregnancy, neurologic disease

Primary outcomes:
measure: Adductor strengths
timeFrame: pre operative, 30 minutes before start surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
Study officials:
References:
citation: Feigl GC, Ulz H, Pixner T, Dolcet C, Likar R, Sandner-Kiesling A. Anatomical investigation of a new vertical obturator nerve block technique. Ann Anat. 2013 Jan;195(1):82-7. doi: 10.1016/j.aanat.2012.05.008. Epub 2012 Aug 10.
Clinical trial NCT06266689: Project humAn dieTary daTa rEtuRN
Official title: Effects of Diet Data Return on Human Dietary Patterns
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diet Habit
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 600
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is designed to test the effects of diet data return on human dietary patterns. The investigators' working hypothesis is that returning diet data, collected via an empirical biomarker-based assessment method, will promote participant eating behavior changes towards a more healthful diet, and that these dietary patterns may also be reflected in the structure and function of the gut microbiome and in participant health outcomes. Here, the investigators will explore this hypothesis with participants supplying stool (poop) samples that will be used to assess their diet using the investigators' DNA-biomarker based method. Participants will have their diet data returned to them, and will then supply post-intervention stool samples for dietary assessment to investigate the efficacy of diet data return in impacting subject dietary patterns and health. It is anticipated that the investigators will enroll infants, children, and adults across the age span, including infants that are currently participating in Project HOPE 1000, a longitudinal observational study of mothers and infants from pregnancy through early childhood (Pro00100000). This study represents a minimal risk to subjects; namely, the potential loss of privacy involved with study participation.


Eligibility criteria: Inclusion Criteria:

* Participant's parent/legal guardian is over age 18 and able to understand English
* Plans to remain in the area for the next two years
* Primary caregiver for infant less than 12 months old
* Able to collect and ship the requested infant stool samples

Exclusion Criteria:

There will be no specific exclusions for this study. However, the following biospecimens will not be collected for research purposes from individuals who have a condition that, in the opinion of the site investigators and/or providers, would place the subject at unacceptable risk of injury or confound data interpretation; including but not limited to:

* Health conditions that impact the infant feeding in a way that may confound interpretation of study results.

Primary outcomes:
measure: Number of participants with diet improvement
timeFrame: 12 months
measure: Number of participants with increased dietary diversity
timeFrame: 12 months
Secondary outcomes:
measure: Number of participants with changes in the composition and function of the gut microbiome
timeFrame: 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
References:
Clinical trial NCT01027689: Bioequivalence of a New Sublingual and a Reference Alprazolam Immediate Release Tablet Formulation
Official title: Open-Label, Randomized, Single-Dose, 2-Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Immediate Release Tablet
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Keywords: alprazolam
bioequivalence
sublingual
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing commercial immediate release tablet formulation.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects
* BMI 17.5 - 30.5
* Must provide informed consent

Exclusion Criteria:

* Clinically significant disease
* Narrow angle glaucoma
* Positive drug screen

Primary outcomes:
measure: Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax)
timeFrame: 11 days
Secondary outcomes:
measure: Alprazolam time of maximum concentration (Tmax) and half life
timeFrame: 11 days
measure: Adverse events, clinical laboratory tests, vital signs
timeFrame: 11 days
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04375189: High Risk Outpatient Intern-led Care (HeROIC) Clinic Initiative
Official title: Impact of a Novel Complex Outpatient Clinic Setup on Patient Outcomes and Intern Education
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Comorbidities and Coexisting Conditions
Risk Reduction
Emergencies
Keywords: High utilizer
High needs
Multimorbidity
Intensive outpatient care
Resident education
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 0
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: Background: A small subset of the patient population is responsible for a significant proportion of healthcare expenditures. These patients are cared for in academic medical centers by internal medicine residents however there has been no research to date about the education or the management of patients with complex multimorbidity in the outpatient setting.

Objective: To evaluate the impact of the High Risk Outpatient Intern-led Care (HeROIC) Clinic on internal medicine interns' perceived ability to manage complex outpatients as well as pre and post intervention total patient healthcare cost.

Methods: The investigators created the HeROIC outpatient clinic environment to comprise longer visit time slots, "bedside" presentations, and team-based care (one intern primary care provider, one secondary intern, and one longitudinal attending). All non-preliminary interns based at one primary care site participated in the intervention while interns at a second site continued to practice in the usual outpatient clinic environment. The interns in the HeROIC clinic arm assumed the roles of primary care providers for 34 complex patients in total. The primary outcome was the perceived confidence in the management of complex outpatients as assessed by a survey. Secondary outcomes included perceptions about the ability to provide high-quality outpatient and evidence-based outpatient care, as well as statewide pre-post patient healthcare cost data.


Eligibility criteria: Inclusion Criteria:

* ≥ 6 medical comorbidities
* ≥ 2 admissions past 6 months or ≥ 4 past 1 year
* New or returning patient in resident primary care clinic

Exclusion Criteria:

* Primary mental health disease driving hospitalizations

Primary outcomes:
measure: Number of Inpatient or ER visits
timeFrame: Up to 2 years post enrollment
Secondary outcomes:
measure: Total medical cost
timeFrame: Up to 2 years post enrollment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Outpatient Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jeremy Epstein
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02287389: Study of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture
Official title: Prospective, Randomized, Open, Controlled, Multicenter Stucy of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Airway Disease
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: The First Affiliated Hospital of Guangzhou Medical University
name: Xinqiao Hospital of Chongqing
name: China Meitan General Hospital
name: Micro-Tech (Nanjing) Co., Ltd.
First posted: 2014-11-10
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of four interventional pulmonology techniques for the treatment of fibrotic central airway stricture.

The four techniques are：

* balloon dilation
* balloon dilation plus cryotherapy
* balloon dilation plus spiculiform electrosurgery
* balloon dilation plus mitomycin C injection


Eligibility criteria: Inclusion Criteria:

* tracheal incision,intubation or bronchial tuberculosis caused central airway fibrotic stenosis
* the degree of stenosis is above 50%
* estimated survival duration is longer than 3 months
* recieved no treatment one month before
* can understand the statement informed consent
* agree to enroll in the study

Exclusion Criteria:

* older than 70 years or younger than 18 years
* not fibrotic stenosis
* not central airway stenosis
* existence of lumina collapse or twisting
* severe arrhythmia, myocardial ischemia or hypertensive crisis
* coagulation disorders
* existence of severe organ disfunction
* allergic to anesthesia drugs
* refuse to participate the study

Primary outcomes:
measure: percentage of the cases that got Ⅰand Ⅱlevel remission
timeFrame: 3 months
Secondary outcomes:
measure: the values of dispnea index
timeFrame: 3 months
measure: Karnofsky Physical scales
timeFrame: 3 months
Other outcomes:
measure: adverse event during the treatment
timeFrame: 3 months
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
Study officials:
affiliation: Tang-Du Hospital
name: Faguang Jin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05747989: A Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques Following Carpal Tunnel Decompression
Official title: A Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants will be randomly assigned to suture-based wound closure (n=50) or tissue adhesive-based wound closure (n=50) with two-component skin adhesive Glubran Tiss 2®. The outcomes will be assessed during the follow-up period at intervals of 2, 6, and 12 weeks postoperatively. A scar assessment will be using the POSAS (Patient and Observer Scar Assessment Scale) and cosmetic VAS (Visual Analog Scale). The VNRS (Verbal Number Rating Scale) will used to assess pain.


Eligibility criteria: Inclusion Criteria: (all of the above)

* age \>18 years
* carpal tunnel syndrome
* weakness of thumb abduction
* with atrophy of the thenar
* median nerve conduction impairment estimated by electromyography

Exclusion Criteria: (one or more)

* threatening haemorrhagic complications (patients with peroral anticoagulation and/or antithrombotic therapy)
* previous wrist trauma or surgery on the wrist region
* another aetiology of neuropathy
* previous allergic reactions (with lidocaine, cyanoacrylate, formaldehyde, tapes, or adhesives)
* personal or family history of keloids or hypertrophic scars
* severe general illness with cachexia

Primary outcomes:
measure: scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Verbal Number Rating Scale (VNRS) - to assess the degree of pain
timeFrame: 12 weeks
measure: VAS - Visual Analog Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University Hospital of Split, 21000 Croatia
Study officials:
affiliation: University of Split, School of Medicine
name: Vedran Kovacic, Prof
role: PRINCIPAL_INVESTIGATOR
References: