louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00202761: Project:Intensive Habilitation (PIH)
Official title: Project:Intensive Habilitation (PIH) -a New Norwegian Multidisciplinary Program for Intensive Training for Children With Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
Functional training
preschool children
Gross Motor Functional Classification Level
Gross motor functional Measure test
Pediatric Evaluation of Disability Inventory
Parental Stress Index
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2005-09-20
Enrollment: 20
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to document that taking part in this program is beneficial for the child, its parents and local professionals.

The study hypothesis are:

Intensive training will speed up the childs motor, cognitive and social development.

Intensive habilitation will increase the childs family's empowerment Children having participated in this intensive habilitation will speed up their process of development further than children in the control group The cooperation between first and second line health service is strengthened by participation in the intensive habilitation program The professionals in the first line(community)in Norway that participates in this program increases their empowerment and motivation


Eligibility criteria: Inclusion Criteria:

About three years of age Cerebral Palsy Multidisciplinary diagnosed -

Exclusion Criteria:

Not have Pervasive Developmental Disorder (PDD) No Specific Speech and Language Disorders No Serious Sensory Defects -

Primary outcomes:
measure: PEDI
timeFrame: dec 2006
Secondary outcomes:
measure: PSI
timeFrame: Dec 2006
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sorlandet Hospital HF
Study officials:
affiliation: Sorlandet Hospital HF
name: Jon Skranes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02898961: Impact of 30 mg/kg Amikacin and 8 mg/kg Gentamicin on Serum Concentrations in Critically Ill Patients With Severe Sepsis
Official title: Impact of 30 mg/kg Amikacin and 8 mg/kg Gentamicin on Serum Concentrations in Critically Ill Patients With Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sepsis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Low first-dose peak serum concentrations of amikacin and gentamicin are commonly reported in ICU patients. The present study aimed to assess whether 30 mg/kg amikacin or 8 mg/kg gentamicin achieved target concentrations in ICU patients with severe sepsis.


Eligibility criteria: Inclusion Criteria:

* ICU patient with severe sepsis
* Treated with aminoglycosides

Exclusion Criteria:

* Renal replacement therapy
* Allergy to aminoglycosides
* Confirmed and/or suspected to have myasthenia
* ICU-acquired neuromuscular disorder
* Under guardianship
* Prisoners
* The patient has already participated in the present protocol

Primary outcomes:
measure: Presence/absence of target peak serum concentration of aminosides
timeFrame: 30 minutes after the end of the infusion.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Roger C, Nucci B, Louart B, Friggeri A, Knani H, Evrard A, Lavigne JP, Allaouchiche B, Lefrant JY, Roberts JA, Muller L. Impact of 30 mg/kg amikacin and 8 mg/kg gentamicin on serum concentrations in critically ill patients with severe sepsis. J Antimicrob Chemother. 2016 Jan;71(1):208-12. doi: 10.1093/jac/dkv291. Epub 2015 Oct 1.
Clinical trial NCT02419261: Assessment of Adductor Canal Blockade in Anterior Cruciate Ligament Surgery
Official title: Assessment of Sensory and Motor Blockade of the Adductor Canal Blockade Performed for Surgery of Arthroscopic Anterior Cruciate Ligament Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgery of Arthroscopic Anterior Cruciate Ligament Repair
Keywords: knee surgery
anterior cruciate ligament surgery
nerve block
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 40
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: Assessment of sensory and motor blockade of adductor canal blockade performed for anterior cruciate ligament repair in comparison with femoral nerve blockade.

Detailed description: The adductor canal blockade is a reliable technique for analgesia after knee surgery. It is a safe technique, avoiding muscle weakness, and by this way limiting the risk of fall. Injection of local anaesthetics in the adductor canal does not block the sole saphenous nerve. Demonstration of a proximal spreading, around the branches of the femoral nerve have been made. The aim of this study is to assess a possible spreading from the adductor to the the popliteal fossa, where sciatic nerve and its branches are located. Pinprick test all around the knee and the leg, combined with motor assessment of the muscle of the leg and the ankle will be realised. This assessment was compared with femoral nerve blockade, classically used for analgesia after this kind of surgery (anterior cruciate ligament repair)

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for anterior cruciate ligament repair

Exclusion Criteria:

* Refusal to study,
* coagulation disorder,
* infection at the puncture site,
* preexisting neuropathy,
* allergy to local anesthetics,
* renal or hepatocellular insufficiency,
* context of chronic pain,
* drugs abuse,
* pregnant patient

Primary outcomes:
measure: Cold sensitivity assessment (cold, very cold, no sensation)
timeFrame: From 30 to 60 minutes after nerve blockade
measure: Motor blockade assessment (dynamometer)
timeFrame: From 30 to 60 minutes after nerve blockade
Secondary outcomes:
measure: Postoperative pain assessment (visual analgesic scale)
timeFrame: At 2, 4, 6 postoperative hours
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: University of Liege, University Hospital
Study officials:
affiliation: University of Liege, University Hospital
name: Jean-Pierre H Lecoq, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00815061: Epidemiology of Ulcerative Colitis and Crohn's Disease in Non Jewish Israel Population
Official title: Epidemiology of Ulcerative Colitis and Crohn's Disease in Non Jewish Israel Population
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ulcerative Colitis
Crohn's Disease
Keywords: prevalence
Incidence
crohn's disease
ulcerative colitis
Epidemiology
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2008-12-29
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Crohn's and ulcerative colitis patients

Brief summary: The aim of the present study was to describe the incidence and prevalence of IBD in non Jewish Israel population

Detailed description: We are interest to collect the detail of gender, age, duration of the disease and therapy

To obtain the information we wont to contact each physician by e-mail, phone , and fax .

Eligibility criteria: Inclusion Criteria:

* ulcertive colitis and crohn's disease patients

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Prevalence and incidence of IBD
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: RMC
Study officials:
affiliation: RMC
name: Yaron Niv, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03886961: The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients
Official title: The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Transplant
GERD
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Somna Therapeutics, L.L.C.
First posted: 2019-03-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A prospective, open label, study designed to assess the affect of the Reflux Band® UES Assist Device (Reflux Band) on reflux in patients that have undergone lung transplantation.


Eligibility criteria: Inclusion Criteria:

* Clinically stable lung transplant patients(single lung, double lung, or re-transplant) as defined by stable FEV1 over the prior two visits
* 13 Abnormal pH impedence or esophagram or documented gastric reflux at pre-transplant evaluation
* Patient must be willing and able to provide informed consent
* Understands the clinical study requirements and is able to comply with follow-up schedule

Exclusion Criteria:

* Currently being treated with another investigational medical device and/or drug
* Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP)
* Previous head or neck surgery / radiation
* Carotid artery disease, thyroid disease, or history of cerebral vascular disease
* Nasopharyngeal cancer
* Suspected esophageal cancer

Primary outcomes:
measure: Change in pepsin levels
timeFrame: Baseline; Week 4; Week 8
measure: Change in amylase levels
timeFrame: Baseline; Week 4; Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health at the University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Manuel Amaris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05912361: Impact of Training Dental Students for an AI-Based Platform
Official title: The Impact of Training Dental Students for Using a Novel Artificial Intelligence-based Platform for Pulp Exposure Prediction Before Deep Caries Excavation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Artificial Intelligence
Education
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The emergence of artificial intelligence (AI) and specifically deep learning (DL) have shown great potentials in finding radiographic features and treatment planning in the field of cariology and endodontics . A growing body of literature suggests that DL models might assist dental practitioners in detecting radiographical features such as carious lesions, periapical lesions, as well as predicting the risk of pulp exposure when doing caries excavation therapy. Although, current literature lacks sufficient research on the effect of sufficient training of dental practitioners for using AI-based platforms. This prospective randomized controlled trial aims to assess the performance of students when using an AI-based platform for pulp exposure prediction with and without sufficient preprocedural training. The hypothesis is that participants performance at group with sufficient training is similar to the group without sufficient training.


Eligibility criteria: Inclusion Criteria:

* perhaps 4th year and 5th year dental students at the university of Copenhagen who are willing to participate voluntarily and have signed the consent letter.
* Limited or no previous knowledge and experience about AI

Exclusion Criteria:

* None

Primary outcomes:
measure: Performance of students at pulp exposure prediction in the AI-based platform with and without training session based on their accuracy
timeFrame: 30 days
measure: Performance of students at pulp exposure prediction in the AI-based platform with and without training session based on their sensitivity
timeFrame: 30 days
measure: Performance of students at pulp exposure prediction in the AI-based platform with and without training session based on their specificity
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen Department of Odontology Cariology and Endodontics Section for Clinical Oral Microbiology
Study officials:
References:
Clinical trial NCT05582161: Efficacy Biomarkers of DAOIB for Dementia
Official title: Efficacy Biomarkers of DAOIB for Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Dementia
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 123
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label clinical trial will enroll patients with aMCI or mild AD, and they will be treated with DAOIB for 24 weeks. We will assess the patients before entering the study, 8 weeks, 16 weeks, and end point (24 weeks) of the study, and measure blood NMDA and oxidative stress - related biomarkers every 8 weeks. We hypothesize that NMDA and oxidative stress - related biomarkers can predict the efficacy of DAOIB for patients with aMCI or mild AD.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Alzheimer's disease or mild cognitive impairment
* MMSE between 10-26
* CDR 1 or 0.5

Exclusion Criteria:

* Hachinski Ischemic Score \> 4
* Substance abuse/dependence
* Parkinson disease, epilepsy, dementia with psychotic features
* Major depressive disorder
* Major physical illnesses
* Severe visual or hearing impairment

Primary outcomes:
measure: Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
Secondary outcomes:
measure: Change from baseline in the composite score of a battery of additional cognitive tests at week 24
timeFrame: week 0, 24
measure: Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24
timeFrame: week 8, 16, 24
measure: Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
measure: Change from baseline of Geriatric Depression Scale
timeFrame: week 0, 8, 16, 24
measure: Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References:
Clinical trial NCT05578261: Explore the Impacts of One Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder
Official title: Explore the Impacts of One Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigator would like to investigate the impact of theta-burst stimulation over cerebellum in adults with autism spectrum disorder


Eligibility criteria: Inclusion Criteria:

* Adults with autism spectrum disorder (≥18 years old), confirmed by Autism Diagnostic Observation Schedule.

Exclusion Criteria:

* Previous or current severe neurological disorder such as epilepsy, visual or hearing impairment.
* Previous or current severe systemic disease such as cardiovascular disease, diabetes or infection.
* Previous or current severe brain injury
* Implementation of metal materials such as pacemaker or medication pump
* Previous or current severe psychiatric disorders such as schizophrenia, bipolar disorder or substance abuse
* Pregnancy
* Individuals with a significant brain abnormality such as intracranial space occupied lesions
* History of brain surgery or nervous system infection, such as meningitis and encephalitis
* Concurrent use of medications which increased the risk of seizure attack
* Participate another clinical trial within one month
* Skin trauma on application site
* Individuals suffering from multiple sclerosis
* Individuals with a large ischemic scar
* Individuals suffering from sleep deprivation during rTMS procedures
* Individuals with a heavy consumption of alcohol
* Current taking antiepileptic drugs
* Individuals with a migraine headache from increased intracranial pressure
* Unable to complete MRI scan

Withdrawal criteria:

* Seizure attack during study period
* Autistic symptoms worsened obviously during study period
* Extreme agitation or irritability during study period
* Participants request
* Take antiepileptic drug during study period

Primary outcomes:
measure: Adverse effects report form (Headache)
timeFrame: 1 week after iTBS (post iTBS)
measure: Adverse effects report form (Dizziness)
timeFrame: 1 week after iTBS (post iTBS)
measure: Adverse effects report form (Tinnitus)
timeFrame: 1 week after iTBS (post iTBS)
measure: Adverse effects report form (Seizure)
timeFrame: 1 week after iTBS (post iTBS)
measure: Adverse effects report form (Other)
timeFrame: 1 week after iTBS (post iTBS)
Secondary outcomes:
measure: MRI T1
timeFrame: Within one month
measure: functional MRI (resting-state/biological motion task) - BOLD signal
timeFrame: Within one month
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT03853161: High Flow Nasal Cannula Versus Nasal Intermittent Positive Pressure (NIPPV) in Preterm Infants
Official title: A Multicenter Randomized Controlled Trial Comparing High Flow Nasal Cannula and NIPPV in Preterm Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Infant
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effectiveness of Heated Humidified High Flow Nasal Cannula (HHHFNC) versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) in preventing intubation when used as primary respiratory support for Respiratory Distress Syndrome (RDS) or post extubation in preterm infants

Detailed description: Patient population will include preterm infants born at 24 - 36+6 weeks of gestation who are candidates for non-invasive respiratory support post extubation or as primary respiratory support after birth. They will be will be randomized to 2 groups: Heated Humidified High Flow Nasal Cannula (HHHFNC) and Nasal Intermittent Positive Pressure Ventilation (NIPPV).

This will be a prospective unblinded randomized controlled study, designed as a non-inferiority trial.

Primary outcome: The primary outcome will be rate of treatment failure (need for intubation) within 7 days of starting the study treatment

Eligibility criteria: Inclusion Criteria:

* Infants born at 24-27+6 weeks of gestation and up to 28 days of life who are extubated for the first time after birth or immediately after surfactant administration via (intubation-surfactant-extubation) INSURE or (minimally invasive surfactant therapy) MIST procedures.
* Infants born at 28-36+6 weeks of gestation and up to 28 days of life who are candidates for non-invasive support either as a primary modality after birth or post extubation.
* Signed parental informed consent by one of the parents

Exclusion Criteria:

* Infants who are unlikely to survive the immediate postnatal period or who have significant congenital abnormalities
* Presence of a pneumothorax prior to enrollment
* Hemodynamic instability due to sepsis or hemorrhage
* Inability to obtain parental consent
* Shortage of suitable equipment
* Infants who were intubated solely for surgery

Primary outcomes:
measure: Rate of intubation within 7 days of starting the study treatment
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Carmel Medical Center
name: Ayala Gover, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05994911: Mindfulness Education in Adolescents
Official title: The Effect of Mindfulness Education on Interpersonal Style and Perceived Social Competence in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Keywords: Mindfulness Training
Adolescent
Interpersonal Style
Perceived Social Competence
Psychiatric nursing
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: It was planned to evaluate the impact of mindfulness training on interpersonal style and perceived social competence in adolescents.

Detailed description: In the research, high school students will form the universe according to the education in the relevant institution. Based on a study with a similar design, it was decided to include 60 people, 30 in the intervention group and 30 in the control group, according to the effect size.

Eligibility criteria: Inclusion Criteria:

be a high school student

Exclusion Criteria:

Having any psychiatric illness that prevents adequate communication will not be included in the study.

Primary outcomes:
measure: Mindfulness training affects interpersonal style in adolescents.
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Mindfulness training affects perceived social competence in adolescents
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Osmaniye
country: Turkey
facility: Türkiye
state: Korkut Ata University
Study officials:
affiliation: Korkut Ata University Osmaniye, Center, Türkiye, 80000
name: Ejdane Coşkun, Lect.
role: PRINCIPAL_INVESTIGATOR
affiliation: Korkut Ata University Osmaniye, Center, Türkiye, 80000
name: Ayşe İNEL MANAV, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University Ankara, Center, Türkiye, 06500
name: Hüsne Demirel, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Korkut Ata University Osmaniye, Center, Türkiye, 80000
name: Yunus Ömer Arık, Grad. stud.
role: PRINCIPAL_INVESTIGATOR
References: