louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02537366: Dexmedetomidine for Non-invasive Ventilation After Chest Trauma
Official title: Dexmedetomidine for Non-invasive Ventilation After Chest Trauma (VENDETTA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thoracic Injuries
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2015-09-01
Enrollment: 20
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: Crossover randomized controlled double blinded trial :

* The primary endpoint is the duration of Non Invasive Ventilation (NIV) session (minutes) with dexmedetomidine (DEX) or placebo.
* Secondary endpoints will be the sedation level as assessed by the Richmond Agitation Sedation Scale (RASS), the number of interventions to allow the completion of NIV session, the pain intensity level as assessed by visual analogue scale, the morphine and ketamine consumption during NIV sessions, the comparison of blood gas measurements before and after NIV sessions, the reproducibility of NIV cycles. The side effects of DEX will be notified.


Eligibility criteria: Inclusion Criteria:

* Blunt chest trauma with thoracic trauma score\> 6, ICU admission and spontaneous breathing

Exclusion Criteria:

* Contra indication for NIV or Dexmedetomidine as specified by the French marketing authorization

Primary outcomes:
measure: Duration of NIV session
timeFrame: During ICU stay (expected average of 2 weeks)
Secondary outcomes:
measure: Richmond Agitation-Sedation Scale
timeFrame: During ICU stay (expected average of 2 weeks)
measure: Number of interventions on NIV settings
timeFrame: During ICU stay (expected average of 2 weeks)
measure: Morphine consumption
timeFrame: During ICU stay (expected average of 2 weeks)
measure: Ketamine consumption
timeFrame: During ICU stay (expected average of 2 weeks)
measure: Pain visual analogue scale
timeFrame: During ICU stay (expected average of 2 weeks)
measure: Variation of arterial partial pressure of Carbon dioxide (CO2) before and after NIV session
timeFrame: During ICU stay (expected average of 2 weeks)
measure: Variation of arterial partial pressure of dioxygen (O2) before and after NIV session
timeFrame: During ICU stay (expected average of 2 weeks)
measure: Variation of potential hydrogen (pH) before and after NIV session
timeFrame: During ICU stay (expected average of 2 weeks)
measure: Reproductibility of NIV sessions
timeFrame: During ICU stay (expected average of 2 weeks)
measure: Bradycardia
timeFrame: During ICU stay (expected average of 2 weeks)
measure: Hypotension
timeFrame: During ICU stay (expected average of 2 weeks)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Thibaut TROUVE-BUISSON, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06400966: The Effect of Jigsaw Technique on Childhood Epileptic Seizure Management Knowledge and Attitudes of Nursing Students
Official title: The Effect of Jigsaw Technique on Childhood Epileptic Seizure Management Knowledge and Attitudes of Nursing Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jigsaw Technique
Epilepsy in Children
Nursing Student
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 89
Sex: ALL
Minimum age (years): 20
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The population of the research consisted of 173 3rd grade students who participated in the Child Health and Disease Nursing practice in the 2022-2023 academic year.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to examine the effect of the education given to nursing students with the Jigsaw technique and traditional method on their knowledge and attitudes about childhood epileptic seizure management.

Detailed description: It is important for nursing students, future health professionals, to gain sufficient professional knowledge and positive attitudes about epileptic seizure management in order to improve the quality of care they provide to children with epilepsy. Studies emphasize that the nursing education curriculum should focus more on education regarding epilepsy and epileptic seizures, and that different educational methods should be used to positively develop nursing students' knowledge and attitudes towards patients with epilepsy. One of the collaborative learning methods used in nursing education is the Jigsaw technique. Jigsaw technique is a student-centered and collaborative learning method that improves knowledge, skills and attitudes in nursing education.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study

Exclusion Criteria:

* Not attending trainings and not filling out data collection forms

Primary outcomes:
measure: Childhood epilepsies and epileptic seizure management knowledge test scores
timeFrame: Before and after training (Half an hour before training and within half an hour after training)
measure: Epilepsy knowledge and attitude scale scores
timeFrame: Before and after training (Half an hour before training and within half an hour after training)
Secondary outcomes:
measure: Students' self-confidence
timeFrame: Before and after training (Half an hour before training and within half an hour after training)
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Faculty of Nursing
Study officials:
References:
Clinical trial NCT06300866: Gingivitis Reduction After Use of 0.45% Stannous Fluoride Toothpaste
Official title: The Clinical Investigation of Stannous Fluoride Containing Toothpaste Compared to Colgate Cavity Protection Toothpaste in Reducing Plaque and Gingivitis - a Six-month Study in California
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingivitis
Plaque, Dental
Keywords: Loe and Silness Gingival Index
Quigley and Hein Plaque Index
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2024-03-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the stannous fluoride containing toothpaste (SNAP) compared to Colgate Cavity Protection Toothpaste after 3 and 6 months of product use.


Eligibility criteria: Inclusion Criteria:

* Potential subjects must meet all of the following criteria
* Subjects, ages 18-70, inclusive
* Availability for the six-month duration of the clinical research study
* Good general health
* Initial gingivitis index of at least 1.0 as determined by the use of the Loe-Silness Gingival Index
* Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index
* Signed Informed Consent Form

Exclusion Criteria:

* Presence of orthodontic appliances
* Presence of partial removable dentures
* Tumor(s) of the soft or hard tissues of the oral cavity
* Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study
* Five or more carious lesions requiring immediate restorative treatment
* Antibiotic use any time during the one-month period prior to entry into the study -Participation in any other clinical study or test panel within the one month prior to entry into the study
* Dental prophylaxis during the past two weeks prior to baseline examinations
* History of allergies to oral care/personal care consumer products or their ingredients -On any prescription medicines that might interfere with the study outcome
* An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours
* History of alcohol and/or drug abuse
* Self-reported pregnancy and/or lactating subjects.

Primary outcomes:
measure: Whole-Mouth Gingivitis Measurement
timeFrame: baseline, 3 months and 6 months
measure: Whole-Mouth Dental Plaque Measurement
timeFrame: baseline, 3 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University School of Dentistry
state: California
Study officials:
affiliation: Loma Linda University
name: Yiming Li, DDS MSD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05207566: Reliability And Validity Of Urdu Version Of Boston Carpal Tunnel Syndrome Questionnaire
Official title: Psychometric Properties of Urdu Version of Boston Carpal Tunnel Syndrome Questionnaire : A Reliability and Validity Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carpal Tunnel Syndrome
Keywords: Boston Carpal Tunnel Questionnaire
Carpal tunnel syndrome
Cultural adaptation
Validity
Urdu Version
Reliability
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 110
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: Pakistani population with CTS was included in the study.

Brief summary: Translate and culturally adapt Boston Carpal Tunnel Syndrome Questionnaire into Urdu language and find its reliability and validity in Pakistani Carpal Tunnel Syndrome patients To check its correlation with Disabilities of the Arm, Shoulder and Hand questionnaire and Visual Analog Scale.

Detailed description: The original version of Boston Carpal Tunnel Syndrome Questionnaire will be translated into Urdu. Among idiopathic Carpal Tunnel Syndrome, 110 patients will be included in the study by convenience sampling. The selection of the patients will be done according to the criteria. Boston Carpal Tunnel Syndrome Questionnaire will be correlated with Disabilities of the Arm, Shoulder and Hand questionnaire and Visual Analog Scale and these questionnaires will be provided three times to a single patient for their assessment. Firstly, they will be provided prior to treatment and secondly just after having treatment. Thirdly, they will be given after seven days of treatment. Internal consistency and reproducibility will be used to determine reliability. Boston Carpal Tunnel Syndrome Questionnaire will be correlated with Disabilities of the Arm, Shoulder and Hand questionnaire and Visual Analog Scale to assess validity. From each patient informed consent will be obtained. Statistical Package of Social Sciences software, version 24 will be used for the analysis of data.

Eligibility criteria: Inclusion Criteria:

* Age equal to or above 18 years.
* Absence of any cognitive impairment.
* Patients having positive Tinel and Phalen test.

Exclusion Criteria:

Presence of any of following conditions.

* Diabetes
* Polyneuropathy
* Hypothyroidsm
* Rheumatoid arthritis

Primary outcomes:
measure: Boston Carpal Tunnel Syndrome Questionnaire
timeFrame: 1st day
measure: Disabilities of the Arm, Shoulder and Hand questionnaire
timeFrame: 1st day
measure: Visual Analog Scale
timeFrame: 1st day
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT02876666: Spinal Cord Injury Virtual Coach RCT
Official title: Spinal Cord Injury Virtual Coach to Promote Self-Care in Pressure Ulcer Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Spinal Cord Injuries
Health Behavior
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
name: Northeastern University
First posted: 2016-08-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The SCI Virtual Coach study has developed an on-screen, human-like character that will provide support, education and coaching to adults with spinal cord injury (SCI) to aid in the prevention of serious secondary conditions like pressure ulcers. In a randomized controlled trial, participants assigned to "the Coach" intervention will have a touch-screen computer placed in their homes and be asked to interact with the Coach on a daily basis for 2 months. Participants will be asked to complete surveys at baseline and 2 months.

The SCI Virtual Coach study aims to measure how accessible and usable participants feel the Coach is, as well as participants' adherence to the Coach's instructions. It will also gauge how effective the Coach is in changing self-care knowledge, health care behaviors, self-efficacy for self-care, and perception of social support in participants.


Eligibility criteria: Inclusion Criteria:

* Self-report of physician-confirmed chronic spinal cord injury diagnosis
* Injured within the last 6 months -10 years
* Speaks and understands conversational English
* Lives within approximately 1 hour of Boston, MA

Exclusion Criteria:

* Moderate to severe cognitive impairment
* Expected to live less than 1 year

Primary outcomes:
measure: Standardized Usability Questionnaire
timeFrame: Report at 2 month exit survey
Secondary outcomes:
measure: Health Education Impact Questionnaire - Skill Technique Acquisition
timeFrame: Baseline and 2 months
measure: Skin Care Behavior Compliance
timeFrame: Baseline and two months
Other outcomes:
Locations:
city: Boston
country: United States
facility: New England Regional SCI Center, Boston University School of Public Health
state: Massachusetts
Study officials:
affiliation: Boston University
name: Nancy Latham, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00366366: To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines
Official title: Phase III, Open, Randomised Immunogenicity and Reactogenicity Study to Assess the Interchangeability Between GSK Bios' DTPa-HBV-IPV/Hib and DTPa-IPV/Hib + HBV at 3rd Dose of Primary Vac. Course in Children Who Received HBV Vac. at Birth and One Month of Age and DTPa-IPV/Hib Vac at 3-4 Mth of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-21
Enrollment: 150
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study assessed the immunogenicity and safety of two vaccination regimens that employed either GSK Biologicals' combined DTPa-HBV-IPV/Hib vaccine or DTPa-IPV/Hib vaccine. In the two groups, infants received the DTPa-IPV/Hib vaccine at 3 and 4 months of age, as the first 2 doses of the primary vaccination course. At 5 months of age, they received either the DTPa-IPV/Hib vaccine co-administered with the HBV vaccine or a dose of the DTPa-HBV-IPV/Hib vaccine as a 3rd dose. Infants in the two groups had previously received 2 doses of HBV vaccine at birth and at 1 month of age.


Eligibility criteria: Inclusion Criteria:

* A male or female infant at the age of 11 - 17 weeks.
* Written informed consent obtained from the parents or guardians of the subject.
* Free of obvious health problems as established by clinical examination before entering into the study.
* Hepatitis B vaccine at birth and one month of age.

Exclusion Criteria:

* Previous vaccination against measles, mumps, rubella and/or varicella.
* Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* A family history of congenital or hereditary immunodeficiency.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
* Major congenital defects.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

Primary outcomes:
measure: Anti-HBs conc >=10 mIU/ml, 1 month after the last vaccine dose
Secondary outcomes:
measure: Ab conc/titers against all vaccine antigens
measure: Safety: Solicited symptoms, unsolicited AEs and SAEs
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Lim FS, Han HH, Jacquet JM, Bock HL. Primary vaccination of infants against hepatitis B can be completed using a combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliomyelitis-Haemophilus influenzae type B vaccine. Ann Acad Med Singap. 2007 Oct;36(10):801-6.
Clinical trial NCT03169465: Open Versus Endoscopic Surgical Management Of Posterior Calcaneal Deformity.
Official title: Open Versus Endoscopic Surgical Management Of Posterior Calcaneal (HAGLUND) Deformity. A Pilot Non Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 30
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: Patients with posterior calcaneal deformity may presented by many clinical data associated with retrocalcaneal bursitis which occurs due to the deformity this clinical complaining include pain and swelling in the back of the heel.

Many treatment choices available of this deformity with low level of response to conservative treatment which includes medical treatment , physiotherapy and corticosteroids injection. surgical treatment in cases of HAGLUND deformity is the treatment of choice including either endoscopic or open surgical approach for this deformity .


Eligibility criteria: Inclusion Criteria:

* Symptomatic patients.
* Continued refractory pain despite use of extensive conservative management.

Exclusion Criteria:

* Asymptomatic patients
* Patients which are unfit for surgery.

Primary outcomes:
measure: the mean difference in pain scores postoperative
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02305966: Evaluation of Implant Fixation in Reverse Total Shoulder Arthroplasty
Official title: Evaluation of Implant Fixation in Reverse Total Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Arthritis
Keywords: advanced arthritis
shoulder
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Reverse total shoulder replacement surgery (RTSA) is performed for individuals with advanced arthritis of the shoulder who also have tears in their rotator cuff muscles. A metal hemisphere is placed in the shoulder blade, and a plastic cup on a stem is placed in the upper arm. This orientation is opposite to the normal anatomy, giving rise to the term "reverse" shoulder replacement. While RTSA has a good clinical track record, no studies have examined how well fixed the implanted components are within patients.


Eligibility criteria: Inclusion Criteria:

* will be any patient with cuff tear arthropathy requiring reverse shoulder arthroplasty.

Exclusion Criteria:

* will be any patient with a previous RTSA or TSA (i.e. no revision surgery) or anyone unable to return for RSA imaging (e.g. living \>100 km outside of London).

Primary outcomes:
measure: migration between cemented and press-fit RTSA humeral components detected by Radiostereometric analysis
timeFrame: 24 months
Secondary outcomes:
measure: difference in component migration between conventional and lateralized glenoid components detected by Radiostereometric analysis
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05695066: Gastric Content After 6 vs 4 Hours of Preoperative Fasting in Children
Official title: Gastric Content After 6 vs 4 Hours of Preoperative Fasting in Children on Enteral Nutrition. A Randomized Controlled Trial Using Gastric Ultrasound
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Aspiration of Gastric Contents
Keywords: Preoperation fasting
Anaesthesia
Children
Enteral feeding
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial.
Primary purpose: PREVENTION

Brief summary: The primary objective of the study is to compare the risk of increased stomach contents after tube feeding (Enteral feeding) 6 and 4 hours before anesthesia using antrum measured by ultrasound.

Detailed description: Children must fast for a certain period of time before anesthesia and surgery to reduce the risk of food residues being vomited up and ending up in the trachea (so-called aspiration). But there are disadvantages to fasting for a long time before an operation, for example the blood sugar level can drop and the body can become dehydrated. Small children risk such side effects to a greater degree than adults, and therefore international work is underway to revise the rules for fasting before surgery.

Enteral feeding children are a special risk group because they are usually completely dependent on tube feeding for nutrition and fluid intake.

Eligibility criteria: Inclusion Criteria:

Child on intermittent or continuous enteral nutrition, scheduled for elective procedure requiring general anesthesia

Exclusion Criteria:

Moderate to severe gastrointestinal motility disorder Emergency surgery Anatomical risk factor for pulmonary aspiration such as achalasia or bowel obstruction Parents cannot understand study information due to language barrier

Primary outcomes:
measure: CSA
timeFrame: Immediately before anesthesia induction
Secondary outcomes:
measure: Suctioned GCV
timeFrame: Immediately after intubation
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University Hospital
name: Peter Frykholm, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: