louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05392062: Pathophysiology of Gas Exchange and Time Course Changes in Spontaneously Breathing Patients With Acute Respiratory Failure Due to COVID-19. A Multicenter Prospective Study.
Official title: Pathophysiology of Gas Exchange and Time Course Changes in Spontaneously Breathing Patients With Acute Respiratory Failure Due to COVID-19. A Multicenter Prospective Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Keywords: Gas exchange
COVID-19
acute respiratory distress syndrome
spontaneous breathing
Respiratory failure
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The pathophysiology of SARS-COV-2 related respiratory disease is still poorly understood, especially in its most severe form called acute respiratory distress syndrome (ARDS). In this case, very few studies have investigated changes in gas exchange during COVID-19 progression in spontaneously breathing patients. The investigators purpose in this study to explore the pathophysiology of gas exchange and time course changes in spontaneously breathing patients with acute respiratory failure due to COVID-19. Moreover, our aim is to identify early markers associated with worsening respiratory failure and requiring endotracheal intubation.


Eligibility criteria: inclusion criteria :

* Patients with a COVID-19 confirmed infection.
* Admission in intensive care unit for an acute respiratory failure requiring oxygen flow above 6l/min by facial mask.
* Presence of an arterial catheter for blood sampling.

exclusion criteria :

* Patients on mechanical ventilation on admission to the ICU.
* Patients requiring immediate intubation on admission.
* Patients admitted to the ICU for more than 48 hours at the time of inclusion.
* Pulmonary embolism diagnosed before admission to the ICU.
* Minor patients
* Pregnant women
* Patients under curatorship or guardianship
* Persons deprived of liberty by a judicial or administrative decision

Primary outcomes:
measure: Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and need to intubation.
timeFrame: Lenght of hospital stay in intensive care unit
Secondary outcomes:
measure: Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and mortality at D90.
timeFrame: Day 90
measure: Association between measurement of intrapulmonary right-to-left shunt, ventilatory ratio and mortality at D28.
timeFrame: Day 28
measure: Association between intrapulmonary right-to-left shunt, ventilatory ratio with percentage of lung damage on chest CT-scan.
timeFrame: At admission
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
Clinical trial NCT06170762: Sodiumhexametaphosphate Versus MTA as Pulp Capping Material for Immature Permanent Teeth
Official title: Sodiumhexametaphosphate Versus MTA as Pulp Capping Material for Immature Permanent Teeth ( Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulp Disease, Dental
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sodiumhexametaphosphate will be used as capping material for dental pulp of immature permanent teeth


Eligibility criteria: Inclusion Criteria:

* healthy children
* cooperative children
* deep carious lesion
* traumatic pulp exposure
* immature permanent teeth

Exclusion Criteria:

* uncooperative children
* children with systemic disorders
* non vital immature permanent teeth

Primary outcomes:
measure: Clinical success
timeFrame: One year
measure: Radiographic success
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03481062: Anatomy and Ultrasound Evaluation for Central Venous Access
Official title: Optimisation of Subclavian Venous Catheterization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Catheterization, Central Venous; Ultrasonography
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: adult Asian without past medical history of the infraclavicular region

Brief summary: The anatomy and ultrasound image of subclavian vein was investigated on cadavers, volunteers and patients, respectively. Structures，approach，position and complications were discussed to improve the success rate and safety of central venous catheterization.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* gender unlimited
* 18.5 \< body mass index (BMI) \< 30
* written consent signed.

Exclusion Criteria:

* abnormality of the infraclavicular region, including infection, deformity,
* history of bone, joint, muscle or neurovascular disease
* history of injury, radiation or invasive procedure
* subjects refused.

Primary outcomes:
measure: area
timeFrame: 12 months
measure: length
timeFrame: 12 months
Secondary outcomes:
measure: width
timeFrame: 12 months
measure: skin distance
timeFrame: 12 months
measure: comfort
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01765062: One Year Skeletal and Dental Arch Changes Following Rapid Maxillary Expansion Treatment in Children
Official title: One Year Skeletal and Dental Arch Changes Following Rapid Maxillary Expansion Treatment in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cross-bite
Keywords: Rapid maxillary expansion
Cross bite
Haas appliance
Lateral cephalograms
Lead sponsor: State University of Maringá
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 14
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample

Brief summary: Many author have exposed the rapid and slow expansion, the diversity of activation and containment protocols and the follow-up time, justify the need for more studies to evaluate the effects to the ERM for the long-term.


Eligibility criteria: Inclusion Criteria:

* cross-bite with maxillary atresia

Exclusion Criteria:

* patients had undergone orthodontic treatment or had a syndrome

Primary outcomes:
measure: changes in cephalometric variables
timeFrame: prior to rapid maxillary expansion (T0), after three months (T1) and after one year
Secondary outcomes:
measure: Dental casts
timeFrame: prior to rapid maxillary expansion (T0), after three months (T1) and after one year (T2).
Other outcomes:
Locations:
city: Maringa
country: Brazil
facility: Universidade Estadual de Maringa
state: Parana
Study officials:
affiliation: Universidade de São Paulo-USP-Faculdade de Odontologia de Bauru
name: Daniela G Garib, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03514862: Mindfulness Training for Medical Personnel
Official title: Mindfulness Resiliency Training Pilot for University of Miami Medical Personnel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Stress
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this project, the investigators propose to evaluate the impact of a Mindfulness-Based Intervention (MBI) Program on the well-being of University of Miami (UM) clinicians and faculty/staff. If successfully implemented and proven to be effective, this training program may be disseminated to other interested medical personnel.


Eligibility criteria: Inclusion Criteria:

* Medical faculty, fellows, residents, and other allied healthcare providers at UM Miller School of Medicine and Jackson will be eligible for participation in the study.

Exclusion Criteria:

* Those not falling into inclusion criteria.

Primary outcomes:
measure: Change in measure of stress
timeFrame: Baseline, 4-weeks, 3-months, 6-months
Secondary outcomes:
measure: Change in measure of burnout
timeFrame: Baseline, 4-weeks, 3-months, 6-months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: David J Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05033262: Our Care Wishes - Dementia
Official title: Adaptation of the OurCareWishes.Org ACP Platform for Persons With Dementia in NHs and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer Disease
Memory Impairment
Keywords: Advance Care Planning
Shared Decision-Making
Web-Based Platform
Memory Care
Nursing Homes
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-09-02
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This Our Care Wishes- Dementia pilot study is adapting an existing successful online advance care planning platform to the specific needs of persons living with dementia and shared decision-makers (SDMs) and testing the usability and acceptability among nursing home residents and SDMs.


Eligibility criteria: Inclusion Criteria:

* Eligible PLWD will be receiving short-or long-term care at a participating NH, have documented moderate to severe cognitive impairment as measured by the Cognitive Function Scale included in the Minimum Data Set 3.0, 65 and have an identified SDM.

Exclusion Criteria:

* Participants are not eligible discharged from participating NHs, or do not have access to a telephone or video chat.

Primary outcomes:
measure: Adapted Decision Making Confidence Scale
timeFrame: Baseline
measure: Post Adapted Decision Making Confidence Scale
timeFrame: 1 week
measure: Website Ease of Use
timeFrame: 1 week
measure: Rate of ACP Website Completion - Time
timeFrame: 1 week
measure: Rate of ACP Website Completion - Questions Completed
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
measure: COVID-19 Impact Questionnaire
timeFrame: 1 week
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03044262: Evaluation of the Influence of New Adhesives of Output on Skin
Official title: Evaluation of the Influence of Output on Skin Covered by Newly Developed Adhesives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma Ileostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2017-02-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard adhesive


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had an ileostomy for more than one year
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Participating in other interventional clinical investigations or have previously participated in this evaluation

Primary outcomes:
measure: Trans epidermal water loss
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebaek
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: R&D scientist
name: Lene Feldskov, M. Sci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04147962: Intense Pulsed Light in Meibomian Gland Dysfunctions
Official title: Intense Pulsed Light in Meibomian Gland Dysfunctions: Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndromes
Meibomian Gland Dysfunction
Keywords: intense pulsed light
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Quantel Medical
First posted: 2019-11-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Dry eye disease with meibomian gland dysfunction, preferentially mild to moderate, and having benefited from intense pulsed light treatment

Brief summary: Dry eye disease (DED) is an extremely common disease whose meibomian gland dysfunction is the main etiology.

Polychromatic intense pulsed light (IPL) is a promising new therapeutic alternative but few clinical data have been published.

A new IPL device has recently been marketed: LACRYSTIM (QUANTEL, France). The investigators have been using it in our clinical practice since June 2019.

The investigators present a retrospective study on our first clinical results.


Eligibility criteria: Inclusion Criteria:

* Patients with Dry eye disease with meibomian gland dysfunction, preferentially mild to moderate, and having benefited from intense pulsed light treatment.
* patient affiliated with a social security organization

Exclusion Criteria:

* patient with incomplete follow-up

Primary outcomes:
measure: Lacrydiag in current clinical practice
timeFrame: 6 months
Secondary outcomes:
measure: collection of adverse events
timeFrame: 6 months
measure: Ocular Surface Disease Index questionnaire
timeFrame: 6 months
measure: Slit lamp Photography x16 and x25
timeFrame: 6 months
measure: Oxford Score
timeFrame: 6 months
measure: Break-up time Test
timeFrame: 6 months
measure: Schirmer Test
timeFrame: 6 months
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: CHU de Saint Etienne
Study officials:
affiliation: CHU de Saint Etienne
name: Marie Caroline TRONE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trone MC, Garcin T, Ollier E, Thuret G, Gain P. A retrospective study of the efficacy of intense pulsed light delivered by the Lacrystim(R) for meibomian gland dysfunction therapy. BMC Ophthalmol. 2022 Aug 6;22(1):335. doi: 10.1186/s12886-022-02531-7.
Clinical trial NCT05689762: Promotion of Healthy Lifestyle Habits in a Primary Care Setting
Official title: Promotion of Healthy Lifestyle Habits in a Primary Care Setting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Lifestyle
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Intervention aiming to promote healthy dietary and physical activity behaviors in adults with low socio-economic position in a primary health care setting


Eligibility criteria: Inclusion Criteria:

* age, high metabolic risk- poor lifestyle habits (diet and physical activity)

Exclusion Criteria:

* overt disease

Primary outcomes:
measure: Change in blood glucose level
timeFrame: Before ; at 16 weeks; at 24 months
measure: Change in plasma triglycerides level
timeFrame: Before ; at 16 weeks; at 24 months
Secondary outcomes:
measure: Change in waist circumference
timeFrame: Before ; at 16 weeks; at 24 months
measure: Change in systolic and diastolic blood pressure
timeFrame: Before ; at 16 weeks; at 24 months
measure: Change in HDL-cholesterol level
timeFrame: Before ; at 16 weeks; at 24 months
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University
Study officials:
References:
Clinical trial NCT00166062: Safety and Effectiveness of Computer Screening for Intimate Partner Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Domestic Violence
Perpetration
Keywords: intimate partner violence
perpetration
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: National Institutes of Health (NIH)
First posted: 2005-09-14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to see if using a computer kiosk to screen men and women for intimate partner violence victimization and perpetration is safe and effective. We hypothesize that screening will not result in any adverse events.

Detailed description: All eligible ER patients will be screened during study times for IPV victimization and perpetration. All victims will be followed at 1 week and 3 months to determine any adverse outcomes. Perpetrators will only be followed in the ED for adverse outcomes after screening. All patients who disclose IPV victimization or perpetration will get a list of community resources. Victims will be asked at follow up what resources they used.

Eligibility criteria: Inclusion Criteria: Men and women age 18-55 who present to the emergency department waiting room during study hours

-

Exclusion Criteria:

* Acutely intoxicated, psychotic, unable to read, not English speaking

Primary outcomes:
measure: Adverse events in the ED
measure: Increased violence at follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Debra Houry
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05718362: Ayres Sensory Integration Therapy on Occupational Performance in Children With Autism Spectrum Disorder
Official title: Investigation of the Effect of Ayres Sensory Integration Therapy on Occupational Performance in Children With Autism Spectrum Disorder: A Randomized Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Ayres Sensory Integration
Occupational Performance
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 35
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups will be formed as study and control. A simple random distribution will be made when creating groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Ayres Sensory Integration (ASI) Therapy is an individualized intervention designed to address specific underlying sensorimotor issues that may affect children's performance during daily routines and occupations. The intervention takes place in the context of play, emphasizes the active participation of the child, involves a collaborative relationship between the occupational therapist and the child, and focuses on participation-oriented outcomes that are collected at regular intervals throughout the intervention program. In general, its content is to improve the child's occupational performance.

The program, which will be carried out in accordance with the Ayres Sensory Integration Fidelity Measure®, it is aimed to reduce the autism-specific symptoms of the child with autism and the dependence of the child on the caregiver in self-care activities. It is predicted that this whole process will increase the participation and his performance of the child with autism in his occupations related to his daily life.

H0: Ayres Sensory Integration Therapy has no effect on the occupational performance of the child with autism spectrum disorder.


Eligibility criteria: Inclusion Criteria:

* Children diagnosed with Autism Spectrum Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
* Level 1 (requiring support) and Level 2 (requiring substantial support) are severity levels for Autism Spectrum Disorder
* Age at first and second test between 3 years and 10 years

Exclusion Criteria:

* Accompanying neurodevelopmental, psychiatric, neurological or physical diagnosis

Primary outcomes:
measure: Occupational Performance
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University
state: İ̇stanbul
Study officials:
affiliation: Bezmialem Vakif University
name: Zeynep Çorakcı
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02884362: Prospective Melanoma Database
Official title: Creation of a Prospective Melanoma Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma
Keywords: melanoma clinical biological database
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with any histological type of melanoma and of any stage

Brief summary: In research on melanoma, translational research is the essential link between basic research and clinical research by facilitating the passage between discovery and improvement in the quality of patients care.That is the reason why it is very important to collect, and centralize clinical and biological data of patients with melanoma.

The aim of the project is to provide to scientific community a structured, mixed clinical and biological database, unique in France, in order to insure accessibility to clinical data.

Detailed description: collection of clinical and biological data from patients with melanomas of any stage in a structured and centralized database

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Histologically confirmed melanoma of any stage
* Affiliated to a social security system in france
* Who signed the informed consent

Exclusion Criteria:

* Any psychiatric or medical condition that would make the patient unable to give a signed informed consent

Primary outcomes:
measure: Database of patients with melanoma
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut claudius regaud IUCT ONCOPOLE
Study officials:
affiliation: Institut claudius regaud Toulouse ONCOPOLE
name: Nicolas MEYER, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: