louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01695486: Sedation Monitoring During Open Muscle Biopsy in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sedation Monitoring in Children
Keywords: BIS
Comfort
open muscle biopsy
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2012-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children aged 1-18 years undergoing open muscle biopsy as diagnostic procedure

Brief summary: The purpose of this study is to compare sedation monitoring by bispectral index and comfort score during open muscle biopsies in children.


Eligibility criteria: Inclusion Criteria:

* infants, children, adolescents undergoing open muscle biopsy as diagnostic procedure

Exclusion Criteria:

* missing caregiver or patient consent
* intolerance of sedative agents in patients´medical history
* structural brain abnormalities

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital
state: NRW
Study officials:
affiliation: University Hospital, Essen
name: Eva Tschiedel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tschiedel E, Muller O, Schara U, Felderhoff-Muser U, Dohna-Schwake C. Sedation monitoring during open muscle biopsy in children by Comfort Score and Bispectral Index - a prospective analysis. Paediatr Anaesth. 2015 Mar;25(3):265-71. doi: 10.1111/pan.12547. Epub 2014 Oct 3.
Clinical trial NCT04546386: Long-term Follow up for Retinal Vascular Changes After Endoscopic Endonasal Pituitary Surgery.
Official title: Retinal Vascular Changes After Endoscopic Endonasal Pituitary Surgery During One Year's Follow up, by Optical Coherence Tomography Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pituitary Adenoma
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 14
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The partecipants were older than 45 years and they underwent long term follow up after endoscopic endonasal pituitary surgery to remove pituitary adenoma.

They did not present other neurological and ophthalmological diseases

Brief summary: This study investigates the retinal vascular features, using optical coherence tomography angiography, in patients during one year's follow up after the endoscopic endonasal surgery to remove an intra-suprasellar pituitary adenoma compressing the optic nerve.

Detailed description: The role of the optical coherence tomography angiography to detect the changes in retinal vascular networks in patients after 48 hours and 1 year from the endoscopic endonasal surgery to remove an intra-suprasellar pituitary adenoma compressing the optic nerve.

The optical coherence tomography angiography allows a detailed and quantitative analysis of the retinal vascular networks and to follow their changes over time.

Eligibility criteria: Inclusion Criteria:

* age older than 45 years
* diagnosis of pituitary adenoma
* treatment-naive with endoscopic endonasal pituitary surgery
* absence of other neurological disease
* absence of vitreoretinal and vascular retinal diseases

Exclusion Criteria:

* age younger than 45 years
* No diagnosis of pituitary adenoma
* previous treatment with endoscopic endonasal pituitary surgery
* presence of neurological disease
* presence of vitreretinal and vascular retinal diseases

Primary outcomes:
measure: Study of vessel density of the retinal vascular network in patients underwent endoscopic endonasal pituitary surgery, by optical coherence tomography angiography, during long-term follow up.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples "Federico II"
Study officials:
affiliation: Federico II University
name: Gilda Cennamo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06556186: Surgical and Pharmacological Efficacy of Knosp Grade 0-2 Prolactinoma
Official title: Surgical and Pharmacological Efficacy of Knosp Grade 0-2 Prolactinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pituitary Tumor
Keywords: pituitary tumor
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: West China Hospital
name: First Affiliated Hospital of Wenzhou Medical University
name: Ningbo Medical Center Lihuili Hospital
First posted: 2024-08-15
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators carried out a multi-center comparative study, involving hospitals including the Second Affiliated Hospital of Zhejiang University School of Medicine, Peking Union Medical College Hospital, West China Hospital, Wenzhou First Hospital, and Li Huili Hospital. This study aimed to compare the efficacy of medication and surgery for specific subtypes of microadenomas and clearly defined macroadenomas (Knosp grades 0-2), in order to determine which is more effective and which has fewer benefits, thereby enhancing the evidence base.


Eligibility criteria: Inclusion Criteria:

* Prolactin level greater than three times the normal upper limit
* MRI indicates Knosp Grade 0-2 pituitary adenoma

Exclusion Criteria:

* MRI indicates Knosp grade 3-4 pituitary adenoma
* Taking antidepressants or other psychotropic drugs
* Patients allergic to bromocriptine or cannot tolerate surgery
* Women defined as surgical infertility (i.e. hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), or amenorrhea for more than 2 years
* Critical illness patients, such as those with progressive consciousness disorders, cerebral hernias, and other emergency situations

Primary outcomes:
measure: pituitary hormone levels
timeFrame: At 1, 3, 6, 9 and 12 months postoperatively
measure: pituitary MRI
timeFrame: At 1,6 and 12 months postoperatively
Secondary outcomes:
measure: sexual function evaluation
timeFrame: At 1,6 and 12 months postoperatively
measure: menstrual condition
timeFrame: At 6 and 12 months postoperatively
measure: lactation
timeFrame: At 1,6 and 12 months postoperatively
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01045486: the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy
Official title: A Double Blind, Randomized, Placebo-Controlled, Crossover Study to Compare the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy in Korean Infants
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
Food allergy
Probiotics
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2010-01-11
Enrollment: 36
Sex: ALL
Minimum age (years): 6
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: There is not enough evidence to support the use of probiotics for prevention or treatment of AD in children in clinical practice.

The purpose of this study is to determine whether probiotics is effective in the treatment of atopic dermatitis with cow milk allergy.


Eligibility criteria: Inclusion Criteria:

* Under the 2 years old, 36 children
* Mild to moderate atopic dermatitis with cow milk allergy
* Volunteers who agreed by their parents.
* The severity of their disease was assessed by modified SCORAD index

Exclusion Criteria:

* Severe atopic dermatitis
* Patients on systemic steroids, immune-suppression or Korean herbal medicine during the previous 6 weeks
* Anaphylaxis, Angioedema, or severe allergic reaction to the cow milk
* Chronic diarrhea

Primary outcomes:
measure: Check SCORAD index for severity of atopic dermatitis, symptom diary, blood cytokine and chemokine (IL-4,IL-6, IL-10, IL-13, total IgE, IFN-γ, TGF-β, TNF-α, and IgG4) after drug administration
timeFrame: 6 weeks after patient recruitment
Secondary outcomes:
measure: Check SCORAD index for severity of atopic dermatitis, symptom diary, blood cytokine and chemokine (IL-4,IL-6, IL-10, IL-13, total IgE, IFN-γ, TGF-β, TNF-α, and IgG4) after drug administration
timeFrame: 6 weeks after wash-out period
Other outcomes:
Locations:
Study officials:
affiliation: Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital
name: Bok Yang Pyun
role: STUDY_CHAIR
References:
Clinical trial NCT01973686: GO-ACTIWE Energy Metabolism
Official title: Active Commuting To Improve Well-being and Health in Everyday Life (ACTIWE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2013-10-31
Enrollment: 188
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of the present study is to investigate the changes in body composition and the degree of compensation to exercise induced energy expenditure after 1 year of physical activity with either moderate or vigorous intensity in overweight and class 1 obese men and women. The present study is a sub study to main study "Active Commuting To Improve Well-being and Health in Everyday Life" (NCT 01962259)


Eligibility criteria: Inclusion Criteria:

* Participation in main study (NCT 01962259)

Exclusion Criteria:

* No participation in main study

Primary outcomes:
measure: Total body fat
timeFrame: Change from baseline in body fat at 3 months
measure: Total body fat
timeFrame: Change from baseline in body fat at 6 months
Secondary outcomes:
measure: Net energy balance and degree of compensation
timeFrame: 3 and 6 months
measure: Compensatory mechanisms
timeFrame: Baseline, 3 and 6 months
measure: Appetite control
timeFrame: Baseline, 3 and 6 months
measure: Anthropometry
timeFrame: Baseline, 3 and 6 months
Other outcomes:
measure: Exercise compliance and energy expenditure
timeFrame: Baseline, 3 and 6 month
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen, Department of Biomedical Sciences
Study officials:
affiliation: Professor
name: Bente M Stallknecht, MD PhD DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quist JS, Rosenkilde M, Petersen MB, Gram AS, Sjodin A, Stallknecht B. Effects of active commuting and leisure-time exercise on fat loss in women and men with overweight and obesity: a randomized controlled trial. Int J Obes (Lond). 2018 Mar;42(3):469-478. doi: 10.1038/ijo.2017.253. Epub 2017 Oct 10.
Clinical trial NCT00582686: Open Reduction Internal Fixation of Calcaneus Fractures With and Without Bone Graft
Official title: Prospective Comparison of Open Reduction Internal Fixation of Calcaneus Fractures With and Without Tricortical Iliac Crest Bone Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calcaneus Fractures
Keywords: Calcaneus Fractures
Iliac Crest Bone Grafting
Open Reduction & Internal Fixation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2007-12-28
Enrollment: 49
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare patient functional outcomes for surgical fixation of calcaneus fractures with and without tricortical iliac crest bone grafting

Detailed description: This study was designed as a randomized, prospective evaluation of patients who have sustained an intra-articular calcaneus fracture that requires open reduction with internal fixation as the preferred method of treatment. Patients who desire to participate in this study will be randomized into one of two groups. Group A will be made up of patients that undergo open reduction with internal fixation and Tricortical iliac crest bone grafting. Group B will consist of patients that undergo open reduction with internal fixation without bone grafting. All other surgical techniques and management of the fracture and patient will remain unchanged.

Eligibility criteria: Inclusion Criteria:

* intra-articular calcaneus fractures requiring open reduction and internal fixation
* Adult patient (19 years or older)
* Mental capacity to comply with post-operative regimen, evaluation and data collection

Exclusion Criteria:

* non-operative fractures for primary or secondary reasons
* prior surgery to the hindfoot of the involved lower extremity
* inability to comply with post-operative regimen, evaluation and data collection
* inability or unwillingness to give informed consent

Primary outcomes:
measure: Union and healing of Calcaneus Fracture
timeFrame: 3 month to 12 month healing period
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham, Orthopaedic Trauma
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham
name: Rena L Stewart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04321486: Natural History and Patient Journey in Dementia: a Nationwide Linked Electronic Health Records Study of 5.6 Million Individuals.
Official title: Natural History and Patient Journey in Dementia: a Nationwide Linked Electronic Health Records Study of 5.6 Million Individuals.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dementia, Alzheimer, Electronic Health Records, Hospitalizations, Epidemiology, Comorbidity, United Kingdom, Incidence, Mortality, Cause of Death
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 4309481
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We implement two study designs, first a longitudinal cohort study to assess dementia incidence and second a matched case-control study for mortality, cause of death and hospitalization.

We identify individuals aged 30 years or older and registered in the current primary care practice for at least one year. Individuals are excluded if they had a prior history of dementia before study entry. For the nested case-control study, controls are matched to incident dementia patients according to sex and age (10-year age strata).

Brief summary: The trajectory of dementia patients within the national health system and their recent temporal trends remains to be fully elucidated. To study the dementia incidence, mortality and case-fatality, we implemented a longitudinal cohort study with the linked electronic health records of 5.6 million population in the UK from 1998 to 2016 (CALIBER). A matched case-control study design was used to investigate the causes of hospitalization and death comparing individuals with and without incident dementia.


Eligibility criteria: Inclusion Criteria:

* We identify individuals aged 30 years or older and registered in the current primary care practice for at least one year.

Exclusion Criteria:

* Individuals are excluded if they had a prior history of dementia before study entry.

Primary outcomes:
measure: Incidence and mortality of dementia
timeFrame: Jan 1st 1998 - May 31st 2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01249586: E-learning: Teaching of Blindness Prevention
Official title: E-learning as a Complement to Traditional Teaching of Blindness Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Teaching Technique
Lead sponsor: Clinica Oftamologica Zona Sul
Sponsor class: OTHER
First posted: 2010-11-30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT

Brief summary: E-learning material increases the student knowledge level before the traditional class of blindness prevention and help to fix this information a short period (one month) after the class.


Eligibility criteria: Inclusion Criteria:

* being a medical student matriculated in the course of ophthalmology. This course is taught to fourth-year students at State University of Campinas.

Exclusion Criteria:

-

Primary outcomes:
measure: Immediate pretest score
Secondary outcomes:
measure: One-month posttest score
measure: Immediate posttest score.
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Clinics Hospital of the State University of Campinas
state: São Paulo
Study officials:
References:
Clinical trial NCT06640686: The Effects of Inspiratory Muscle Training in Children With Cerebral Palsy
Official title: The Effects of Inspiratory Muscle Training on Respiratory Parameters, Trunk Control, Walking, and Functional Independence in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: respiratory function test
muscle strength
gait
trunk
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Okan University
First posted: 2024-10-15
Enrollment: 36
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled study
Primary purpose: PREVENTION

Brief summary: Cerebral palsy (CP) is characterized by permanent or variable sensory-motor function impairments resulting from developmental anomalies or damage to the brain. Spasticity, dystonia, postural disorders, and weakened movement patterns can hinder the development of the respiratory system in children with CP. As the severity of postural disorders increases in children with CP, inadequate or improper use of respiratory muscles and insufficient ventilation reduce the mobility of the thoracic cage. The aim of study is to investigate the effects of respiratory muscle training on respiratory parameters, trunk control, walking, and functional independence in children with CP.

Detailed description: In this prospective randomized controlled study, participants will be divided into two groups: the Inspiratory Muscle Training (IMT) group and the control group. The IMT group will receive IMT in addition to the traditional physical therapy program, while the control group will only receive the traditional physical therapy program. Respiratory muscle strength, respiratory functions, chest expansion, trunk control, walking speed and endurance, and functional independence will be assessed before and after the training.

Eligibility criteria: Inclusion Criteria:

* Aged between 4 and 12 years
* Classified as levels 1, 2, and 3 according to the Gross Motor Function Classification System (GMFCS)
* Diagnosed with spastic diplegia and/or hemiplegic cerebral palsy
* Ability to cooperate during the exercises

Exclusion Criteria:

* Presence of acute or chronic respiratory diseases
* Presence of acute medical conditions
* History of active epilepsy
* Scoliosis with a Cobb angle greater than 30 degrees
* Presence of chest deformities
* Severe visual and hearing impairments

Primary outcomes:
measure: PP Check device
timeFrame: 6 months
measure: spirometer
timeFrame: 6 months
measure: trunk control mesurement scale
timeFrame: 6 months
measure: 10 m walking test
timeFrame: 6 months
measure: 2 minutes walking test
timeFrame: 6 months
measure: WeeFIM scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Okan University
name: Gamze Aydın, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02140086: Buteyko Based Remedial Breathing Therapy With Children With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma
Buteyko
remedial breathing
children
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
First posted: 2014-05-16
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, controlled trial to investigate the effects of a buteyko based remedial breathing therapy on children with asthma regarding to their symptoms, use of medication and lung function tests.


Eligibility criteria: Inclusion Criteria:

* signed informed consent of the parents
* age 6- 15 years
* information and consent of the consulting doctor
* levels of asthma therapy 1-3

Exclusion Criteria:

* participation in another study

Primary outcomes:
measure: Reduction of Betamimetics (-30%) at 3- and/or 6-month follow up
timeFrame: asthmaspezific parameters are measured before and after intervention as well as 3- and 6- month follow up
Secondary outcomes:
measure: Asthma Control Questionnaire (ACQ)
timeFrame: parameters are measured before and after intervention as well as 3- and 6- month follow up
measure: Paediatric Asthma Quality of Life Questionnaire (PAQLQ)
timeFrame: parameters are measured before and after intervention as well as 3- and 6- month follow up
measure: ARCIM Questionnaire (AFB)
timeFrame: parameters are measured before and after intervention as well as 3- and 6- month follow up
measure: Peak Flow
timeFrame: parameters are measured before and after intervention as well as 3- and 6- month follow up
measure: NO-measurement nasal and oral
timeFrame: parameters are measured before and after intervention as well as 3- and 6- month follow up
measure: Buteyko-Questionnaire
timeFrame: parameters are measured before and after intervention as well as 3- and 6- month follow up
measure: parameters of spirometry
timeFrame: parameters are measured before and after intervention as well as 3- and 6- month follow up
measure: Paediatric asthma caregiver´s quality of life questionnaire (PACQLQ)
timeFrame: parameters are measured before and after intervention as well as 3- and 6- month follow up
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: Filderklinik
state: Baden-Württemberg
Study officials:
References: