louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05428904: Virtual Reality Simulation for Nursing Education
Official title: Developing a Virtual Reality-Based Simulation Program for Nursing Students and Using in Nursing Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Education
Virtual Reality
Simulation
Satisfaction
Critical Thinking
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Today, thanks to the developing hardware technology, various distance education projects are carried out with virtual reality, augmented reality and even mixed reality glasses. The visual writing fields of the content they provide can be extended as much as necessary.

With this research, it is aimed to develop a virtual reality-based simulation program and to ensure its use in nursing education and research.

Detailed description: The universe of the research will consist of 219 students who are studying at Hacettepe University Faculty of Nursing in the Spring Semester of the 2021-2022 Academic Year and who have successfully completed the Internal Medicine Nursing course. As a result of the power analysis, it is aimed to reach a total of 100 people, with 50 students in each group. Our research was planned in a randomized controlled design. The data of the research will be collected through Student Information Form, Knowledge Tests, Perceived Learning Scale, General Self-Efficacy Scale, Satisfaction with Educational Methods Questionnaire and California Critical Thinking Disposition Scale. With this research, it is predicted that there will be an increase in nursing students' knowledge score, perceived learning, general self-efficacy, satisfaction with the education method, and critical thinking dispositions.

Eligibility criteria: Inclusion Criteria:

* Successfully completing the Internal Medicine Nursing Course
* Having internet access
* Volunteering to participate in the research

Exclusion Criteria:

* Not being able to communicate in Turkish
* Being in the intervention groups and not participating in the virtual simulation application
* Not participating in any of the pre-test, post-test, or follow-up tests

Primary outcomes:
measure: Knowledge Tests
timeFrame: Changes from baseline to one day post-test and after one month follow-up
measure: Perceived Learning Scale
timeFrame: Changes from baseline to one day post-test and after one month follow-up
measure: Satisfaction Survey with Training Methods
timeFrame: Changes from baseline to one day post-test and after one month follow-up
measure: Critical Thinking Disposition Scale
timeFrame: Changes from baseline to one day post-test and after one month follow-up
measure: General Self-Efficacy Scale
timeFrame: Changes from baseline to one day post-test and after one month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT06065904: Randomized One-Center Controlled Trial on a Comprehensive Nutritional Intervention for Children With Cerebral Palsy and ASD
Official title: Exploring the Efficacy of a Comprehensive Nutritional Intervention for Children With Cerebral Palsy and ASD: A Randomized Controlled Trial at a Single Center
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nutrition Disorder, Child
Lead sponsor: Medical University of Varna
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2023-10-04
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief summary: The study is a prospective, single-center, randomized controlled trial that will be conducted at the Medical University of Varna. This setting offers access to a wealth of clinical expertise in managing CP and ASD and a rich tradition of conducting robust nutritional interventions.


Eligibility criteria: Inclusion Criteria:

* A formal diagnosis made by a qualified neurologist. The diagnosis can span across the different types of CP and ASD.
* Expressed willingness to participate in the study.
* Availability for the entire duration of the study.

Exclusion Criteria:

* Children with acute medical conditions or comorbidities that may significantly disrupt study assessments.
* Any severe infections within the last 10 days prior to the study.
* Presence of genetic syndromes that could influence nutritional status, e.g., Silver Russel syndrome or Down syndrome.
* Parents with cognitive impairments, which might pose challenges in their participation during assessments/intervention.
* Children who have been part of any major dietary or nutritional interventions in the last three months.

Primary outcomes:
measure: bedridden days monthsmean duration of bedridden days over six months
timeFrame: six months
Secondary outcomes:
measure: Weight-for-Age Z-Score
timeFrame: six months
measure: Height-for-Age Z-Score
timeFrame: six months
measure: BMI-for-Age Z-Score
timeFrame: six months
measure: Number of social interactions per week with non-family members
timeFrame: six months
measure: Total Number of New Spoken Words per Month
timeFrame: six months
measure: Total Days of School or Kindergarten Attendance per month
timeFrame: six month
measure: Number of Leisure Activities per Month
timeFrame: six months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00499304: Forced Oscillation Technique (FOT) and Expiratory Flow Limitation (EFL)
Official title: Diagnosing Expiratory Flow Limitation in COPD Patients With the Forced Oscillation Technique Using Linear Regression in the Time Frequency Domain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: Forced oscillation Technique (FOT)
Expiratory flow limitation (EFL)
Breathing artifacts
COPD
Lead sponsor: Medical Center Alkmaar
Sponsor class: OTHER
First posted: 2007-07-11
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stable GOLD 2-4 COPD patients

Brief summary: The aim of this study is to distinguish COPD patients with expiratory flow limitation in body plethysmography (open loop) from the patients without expiratory flow limitation in body plethysmography (closed loop) with the obtained FOT parameters.

Detailed description: In daily practice the expiratory flow limitation is measured by body plethysmography. An open loop in body plethysmography shows expiratory flow limitation in COPD patients. But body plethysmography requires that the patient quietly sits in a closed box and is not able to follow changes breath by breath. The goal of this study is to validate the Forced oscillation technique (FOT) for measuring expiratory flow limitation in COPD patients.30 COPD patients with an open loop in body plethysmography are compared to 30 COPD patients with a closed loop. The methods used in this study are the maximal overlap discrete short time Fourier transform (MODFT) combined with a total least squares analysis. It is hypothesized that the obtained FOT parameters are able to distinguish the patients with expiratory flow limitation in body plethysmography from the patients without expiratory flow limitation in body plethysmography.Secondary study questions are: 1) to what extend are the FOT parameters distorted by breathing artifacts and measurement noise. 2)What changes can be detected by FOT in expiratory flow limitation after administration of salbutamol.

Eligibility criteria: Inclusion Criteria:

* Presenting to the outpatient clinic
* Age 50-80 years
* Diagnosed with COPD according to the standard criteria
* Gold Stage II to IV COPD
* Current or ex-smokers (at least 10 PY)
* Stable disease (No current exacerbation or exacerbation during the 4 weeks previous to the inclusion)

Exclusion Criteria:

* History of exacerbation of COPD in the preceding month
* Upper airway obstruction
* Allergic Asthma
* OSAS (obstructive sleep apnea syndrome)
* Extreme obesity (BMI\>35)
* Clinically manifest cardiac disease (for example clinically relevant congestive heart failure, unstable angina pectoris)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Medical Center Alkmaar
Study officials:
affiliation: Medical Center Alkmaar
name: Dewi Tjiong, drs
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02152904: Risk Factors of Rebleeding After Peptic Ulcer Bleeding: a Nationwide Cohort Study
Official title: Risk Factors of Rebleeding After Peptic Ulcer Bleeding: a Nationwide Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peptic Ulcer Bleeding
Keywords: Peptic ulcer bleeding
rebleeding
mortality
nationwide
Lead sponsor: Incheon St.Mary's Hospital
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 892
Sex: ALL
Minimum age (years): 20
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 who visit the hospital with symptoms suggestive of peptic ulcer bleeding such as melena or hematemesis. These patients recieve endoscopy and when they are diagnosed with peptic ulcer bleeding are eligible for enrollment.

Brief summary: The purpose of the investigators study is to investigate the factors associated with rebleeding in patients with peptic ulcer bleeding.

Detailed description: The investigators are performing a nationwide population based cohort study to investigate the factors associated with rebleeding in patients with peptic ulcer bleeding. The results of the investigators study should give us information about patients who are at high risk of rebleeindg and enable us to manage these patients appropriately.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with peptic ulcer bleeding by endoscopy
* Patients who consent to be enrolled in the study

Exclusion Criteria:

* Patients who refuse to be enrolled in the study

Primary outcomes:
measure: Rebleeding rate of peptic ulcer bleeding
timeFrame: 1 year
Secondary outcomes:
measure: Mortality rates of peptic ulcer bleeding
timeFrame: 30 days
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon St. Mary's Hospital
Study officials:
affiliation: Incheon St. Mary's Hospital, The Catholic University of Korea
name: Byung-Wook Kim, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06123104: Assessment of Automatic Tourniquets for Soldiers During Wartime
Official title: Assessment of Automatic Tourniquets for Soldiers During Wartime as Part of Accelerated Research and Development
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trauma Injury
Hemorrhage Wound
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The goal of this clinical trial is to compare usability and performance of automatic tourniquets (AUT) and standard mechanical tourniquets (CAT) in healthy adults. The main questions it aims to answer are:

* Are AUTs effective in occlusion of blood flow
* Are AUTs easy to use

Participants will be asked to place AUT and CAT on their upper limbs and lower limbs (8 applications overall).

Following each application, the following parameters will be assessed:

1. Limb blood flow
2. Ease of use

Researchers will compare the results of the AUT and CAT to see if AUT is as effective as CAT in blood occlusion, and if AUT is easy to use as the CAT.

Detailed description: The goal of this clinical trial is to compare usability and performance of automatic tourniquets (AUT) and standard mechanical tourniquets (CAT) in healthy adults. The main questions it aims to answer are:

* Are AUTs effective in occlusion of blood flow
* Are AUTs easy to use

Participants will be asked to place AUT and CAT on their upper limbs and lower limbs (8 applications overall).

Eligibility criteria: Inclusion Criteria:

-Soldier in active service or active reserve service.

Exclusion Criteria:

* Muscle disorders
* Peripheral nerve disorders
* Skin diseases of the limbs
* Limb surgery in the past
* Rickets
* Hypertension

Primary outcomes:
measure: Time to distal limb arterial occlusion as assessed by Doppler
timeFrame: 60 seconds
Secondary outcomes:
measure: Safety of using automatic tourniquets
timeFrame: Will be assessed via questionnaire up to 5 minutes following the intervention.
measure: Usability of using automatic tourniquets
timeFrame: Ease of use will be assessed via questionnaire up to 5 minutes following the intervention.
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Tel hashomer
Study officials:
affiliation: Head of Medical innovation and R&D
name: Tomer Erlich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04820504: Augmented Infant Resuscitator to Enhance Newborn Ventilation
Official title: Augmented Infant Resuscitator (AIR): Transitioning a Novel Behavior Change Innovation to Drive Newborn Ventilation Skills Enhancement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asphyxia Neonatorum
Birth Asphyxia
Perinatal Asphyxia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Augmented Infant Resuscitator (AIR) is an inexpensive add-on, compatible with nearly every existing bag-valve mask and many types of ventilation equipment. AIR monitors ventilation quality and provides real-time objective feedback and actionable cues to clinicians to both shorten training times and improve resuscitation quality, adoption, retention, and confidence.

Detailed description: Longitudinal, randomized control trial that examined the effectiveness of AIR among 270 participants, with 1,080 recorded ventilation scenarios, and across 20 sites in Uganda and the U.S. Birth attendants - including a mix of midwives, nurses, respiratory therapists, pediatricians, and neonatologists - with recent HBB and/or NRP training were recruited to participate in this randomized control trial. Participants ventilated training mannequins for a fixed duration of time. Participants were randomized to receive visual feedback from AIR (intervention) or have the AIR feedback covered (control). They were then requested to administer effective ventilation and verbally assess the mannequin condition. All mannequins appeared to be identical, but each session's mannequin was randomly selected with an upper airway that was normal, partially leaking, or partially obstructed.

Eligibility criteria: Inclusion Criteria:

* Midwives, nurses, respiratory therapists, pediatricians, and neonatologists working as birth attendants in select hospitals in Uganda and the U.S. who are either previous trained in Helping Babies Breathe (HBB) and/or have a current Newborn Resuscitation Program (NRP) certification.

Exclusion Criteria:

* None

Primary outcomes:
measure: Effective bag-mask ventilation
timeFrame: 2 minutes
measure: Time to effective bag-mask ventilation
timeFrame: 2 minutes
measure: Clinician's correct assessment of mannequin airway issues
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bennett DJ, Itagaki T, Chenelle CT, Bittner EA, Kacmarek RM. Evaluation of the Augmented Infant Resuscitator: A Monitoring Device for Neonatal Bag-Valve-Mask Resuscitation. Anesth Analg. 2018 Mar;126(3):947-955. doi: 10.1213/ANE.0000000000002432.
Clinical trial NCT00682604: The Nutritional Status and Food Intake of Community Health Agents
Official title: Community Health Agents From East Zone of Sao Paulo City, Brazil: A Look at Their Nutritional Status and Food Intake
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutritional and Metabolic Diseases
Keywords: Family Health Program; Food consumption; Nutritional status
Lead sponsor: Unidade Itaquera
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community health agents from East Zone of Sao Paulo City, Brazil.

Brief summary: This research had as a goal to characterize the social demographic profile, nutritional status, the presence of chronic non-transmissible diseases and food intake of the community health agents who belong to five family health units in the east zone of Sao Paulo City.

Detailed description: It's a descriptive, exploratory and quantitative study developed among 88 individual.

Eligibility criteria: Inclusion Criteria:

* Be an agent comunnity health who belong in the family health unit choosed to participate of this study;
* Assign the autorization to participate of the study;
* Answer a questionary of health, social demographic profile and food intake.

Exclusion Criteria:

* Refuse to participate or assign the autorization;
* Don´t answer the questionary of health and food intake;
* Don´t participate of the nutricional status evaluation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculdade Santsa Marcelina - Unidade Itaquera
state: SP
Study officials:
affiliation: Faculdade Santa Marcelina - Unidade Itaquera
name: Alexandra C. Freitas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06498804: The Blood Patch in the Management of Intracranial Hypotension
Official title: The Blood Patch in the Management of Intracranial Hypotension: Description of a Population and Professional Practices
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Hypotension
Keywords: Intracranial Hypotension
post-dural puncture headache
cranial nerve symptoms
hearing disturbances
vertigo
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 50
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: Major subject (≥18 years old) having benefited from a bloodpatch between 01/01/2021 and 12/31/2022

Brief summary: Intracranial hypotension results from leakage and/or hypotension of cerebrospinal fluid. It can be spontaneous or secondary to a dural puncture complicating perimedullary anesthesia or a lumbar puncture. The incidence remains low with less than 1% post spinal puncture (25 gauge needle), but is observed more frequently following a lumbar puncture, up to 36% with a 20 or 22 gauge needle. Accidental puncture of the dura mater with a 17 gauge needle used for epidural anesthesia is associated with postpuncture headaches in 75-80% of cases. Classically, symptoms appear 24 to 48 hours after the puncture and consist of very intense, postural, fronto-occipital headaches which may be associated with cranial nerve symptoms such as visual or hearing disturbances or vertigo. Among the risk factors are the size and type of the needle, age under 60 and female gender. About 90% of PDPH are self-limiting within 7-10 days.


Eligibility criteria: Inclusion Criteria:

* Major subject (≥18 years old)
* Subject having benefited from a bloodpatch between 01/01/2021 and 12/31/2022

Exclusion Criteria:

- Subject (and/or their legal representative if applicable) having expressed their (their) opposition to the reuse of their data for scientific research purposes

Primary outcomes:
measure: Descriptions of professional practices in the management of intracranial hypotension by blood patch at the University Hospitals of Strasbourg
timeFrame: Through study completion, an average of 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Anesthésie Réanimation médecine Péri-Opératoire - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT00137904: Sleep Disorders in Patients With Multiple Sclerosis
Official title: Study of Sleep Disorders and Fatigue in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
fatigue
sleep disorders
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2005-08-30
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: Fatigue is a frequent and disabling symptom in patients with multiple sclerosis (MS). The pathophysiology of this sign is not fully understood. Some data suggest that the fatigue is associated with sleep disorders. The aim of this study is to determine the polysomnographic parameters in MS patients with fatigue in comparison to MS patients without fatigue.


Eligibility criteria: Inclusion Criteria:

* Patients with multiple sclerosis
* Expanded Disability Status Scale score \< or = 5
* Fatigue (Modified Fatigue Impact Scale \> 45), with a disease duration \> 3 months

Exclusion Criteria:

* Depression
* Cognitive disorders
* EDSS \> 5
* Epilepsia
* Obesity
* Drug inducing sleep disorders

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Investigation Clinique-Hopital Pitié-Salpêtrière
Study officials:
affiliation: CIC-Pitié-Salpêtrière
name: Bruno Stankoff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: