louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05068986: Asthma Education and Emergency Department Visits by Asthmatic Children
Official title: Asthma Education and Its Impact on Emergency Department Visits by Asthmatic Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: The Frequency of ER Visits in Asthmatic Children
Keywords: asthma, pediatric, education
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will be conducted to evaluate the effects of an educational asthma program on the frequency of emergency department visits and identifying factors associated with frequent emergency department visits by asthmatic children and determine its effect on asthma severity and quality of life among asthmatic children and their caregivers.

Detailed description: This one-arm interventional clinical trial study will be conducted at pediatric chest clinics and the emergency department of the children's hospital of Ain Shams University located in Cairo during the period from September 2021 to the end of December 2021.

The study will be conducted on 30 asthmatic pediatric patients aged from 1-15 years old with documented asthma diagnoses (intermittent wheezes, breathlessness, dry cough, etc)

Inclusion criteria:

: Objective asthma diagnostic testing consists of 2 components: (1) demonstration of airway obstruction and (2) documentation of variability in the degree of obstruction.

Exclusion criteria:

1. Underlying chronic lung diseases like: (Cystic fibrosis, tuberculosis, childhood interstitial lung diseases).
2. Asthmatic patients with major systemic illness (diabetes, chronic renal failure, chronic liver disease).

All the study participants will be subjected to an educational asthma program for 3 months to provide parents and children with information and skills to manage their asthma, through avoiding triggers, training in the correct use of medicines, including inhaler technique, information, and support to maximize adherence. All patients will be followed up by a phone call every 2 weeks and a follow-up visit monthly to confirm compliance with the educational program.

Eligibility criteria: Inclusion Criteria:

* Children with a documented asthma diagnosis Children aged from 1 to 15 years

Exclusion Criteria:

* Children with underlying chronic lung diseases

Primary outcomes:
measure: The emergency room visits frequency
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Children hospital
state: Abbasia
Study officials:
References:
Clinical trial NCT00939796: Clinical Study of the Tympanostomy Tube Delivery System
Official title: A Clinical Study of the Acclarent Tympanostomy Tube Delivery System For the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media (inVENT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis Media With Effusion
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Acclarent
First posted: 2009-07-15
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube \[TT(s)\] in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).


Eligibility criteria: Inclusion Criteria:

1. Patients scheduled to undergo bilateral or unilateral tympanostomy tube insertion.
2. Either male or female

Exclusion Criteria:

1. History of sensitivity or reaction to anesthesia chosen for the procedure
2. Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane
3. Otitis externa
4. Active acute otitis media
5. Otitis media pathology
6. Stenosed ear canal

Primary outcomes:
measure: Device Success
timeFrame: At procedure visit
Secondary outcomes:
measure: Cross-Over to Manual Myringotomy and Tube Placement
timeFrame: at procedure visit
measure: Tube Retention
timeFrame: two weeks post-procedure
Other outcomes:
Locations:
city: Biloxi
country: United States
facility: Bay Area ENT
state: Mississippi
city: San Antonio
country: United States
facility: Ear Medical Group
state: Texas
Study officials:
affiliation: Ear Medical Group
name: Charles Syms, III, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bay Area ENT
name: Charles Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02793596: Reliability of Waveform Analysis as an Adjunct to Loss of Resistance for Obstetrical Epidural Blocks
Official title: Reliability of Waveform Analysis as an Adjunct to Loss of Resistance for Obstetrical Epidural Blocks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study, we will set out to confirm the reliability of epidural waveform analysis (EWA) as an adjunct to loss of resistance for obstetrical epidural blocks.

Detailed description: After loss of resistance, 5 mL of normal saline will be injected through the epidural needle; the latter will then be connected to a pressure transducer (leveled with the heart) using a rigid tubing. A pressure recording of the epidural waveform will be saved for future assessment by a blinded observer.

After the recording of the waveform, the rigid tubing will be disconnected from the epidural needle. A 4 mL bolus of lidocaine 2% with epinephrine 5 µg/mL will be injected through the latter. An epidural catheter will be advanced 3-4 cm past the tip of the needle inside the epidural space. The needle will then be removed and the catheter secured to the skin in the usual fashion.

Fifteen minutes after the injection of the local anesthetic bolus, a blinded observer will apply ice to the T1-L5 dermatomes and assess the epidural block.

Eligibility criteria: Inclusion Criteria:

-American Society of Anesthesiologists classification 1-3

Exclusion Criteria:

* adults who are unable to give their own consent
* coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
* renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie creatinine ≥ 100)
* hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie transaminases ≥ 100)
* allergy to local anesthetic
* prior surgery in the lumbar spine

Primary outcomes:
measure: Success rate
timeFrame: 15 minutes
Secondary outcomes:
measure: Epidural waveform analysis
timeFrame: Immediately after epidural catheter insertion
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Albert Moore, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00588796: Study of Fibrinogen Metabolism During Severe Trauma and Burns
Official title: Alteration in Fibrinogen Metabolism in Patients With Severe Burns and Traumatic Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burn Injury
Major Trauma
Keywords: fibrinogen
burns
trauma
metabolism
Lead sponsor: United States Army Institute of Surgical Research
Sponsor class: FED
First posted: 2008-01-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Burn patients Trauma patients Healthy Volunteers

Brief summary: To study the fibrinogen metabolic changes in relation to coagulation disorder in patients with severe burns and trauma injuries. As a result of the burn or trauma injury breakdown of fibrinogen is accelerated.

Detailed description: In this protocol, we will investigate fibrinogen metabolism in burn and trauma patients, using an 8h infusion of stable isotopes labeled amino acids (1-13C-phenylalanine, 2H5-phenylalanine, and 2H3-ketoisocaporate). The increase of the labeled amino acids incorporating into fibrinogen during the infusion and the decay of labeled fibrinogen after stopping the isotopes infusion (as measured by GC-MS) will be used to calculate fibrinogen synthesis and degradation. Stable isotopes are non-radioactive.

Eligibility criteria: Inclusion Criteria:

* 20% total body surface area burn or more
* severe trauma with injury severity score greater than 10
* between ages of 18 and 65 years

Exclusion Criteria:

* history of blood clotting disorder
* history of liver disease such as cirrhosis or hepatitis
* pregnant or nursing
* allergic to iodine, shellfish or dye used in X-Rays
* taking long term medications for blood clotting usch as Coumadin or Plavix
* prisoners
* receiving total parenteral nutrition

Primary outcomes:
measure: During the flow phase following burn or trauma injury, fibrinogen degradation is accelerated
timeFrame: 7
Secondary outcomes:
measure: Fibrinogen degradation stimulates fibrinogen synthesis at the expense of whole body protein catabolism
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: United States Army Institute of Surgical Research
name: Wenjun Z Martini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zuckerman L, Caprini JA, Lipp V, Vagher JP. Disseminated intravascular multiple systems activation (DIMSA) following thermal injury. J Trauma. 1978 Jun;18(6):432-9. doi: 10.1097/00005373-197806000-00008.
Clinical trial NCT04224896: Narrow-Band Imaging (NBI) Versus Lugol Chromoendoscopy in the Detection of Oesophagus Squamous Cell Carcinoma in High Risk Population
Official title: Narrow-Band Imaging (NBI) Versus Lugol Chromoendoscopy in the Detection of Oesophagus Squamous Cell Carcinoma in High Risk Population: a Randomised Controlled Multicentre Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: FRENCH STUDY
Lead sponsor: Hôpital Edouard Herriot
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIGH RISK OF OESOPHAGEAL SQUAMOUS CELL CARCINOMA

Brief summary: Narrow-Band Imaging (NBI) is as sensitive as Lugol chromoendoscopy to detect oesophageal squamous cell carcinoma (SCC) and appears more specific than Lugol chromoendoscopy in expert centres but its specificity in current practice is not known. This study aimed to prove the superiority of NBI specificity over Lugol chromoendoscopy to detect oesophageal SCC and high-grade dysplasia (HGD) in current practice (including tertiary care centres, local hospitals and private clinics).


Eligibility criteria: Inclusion Criteria:

* Patients had a history or current SCC

Exclusion Criteria:

* NONE

Primary outcomes:
measure: SPECIFICITY OF THE TWO DIAGNOSTIC STRATEGIES
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gruner M, Denis A, Masliah C, Amil M, Metivier-Cesbron E, Luet D, Kaasis M, Coron E, Le Rhun M, Lecleire S, Antonietti M, Legoux JL, Lefrou L, Renkes P, Tarreirias AL, Balian P, Rey P, Prost B, Cellier C, Rahmi G, Samaha E, Fratte S, Guerrier B, Landel V, Touzet S, Ponchon T, Pioche M. Narrow-band imaging versus Lugol chromoendoscopy for esophageal squamous cell cancer screening in normal endoscopic practice: randomized controlled trial. Endoscopy. 2021 Jul;53(7):674-682. doi: 10.1055/a-1224-6822. Epub 2020 Oct 1.
Clinical trial NCT04579796: The Accuracy of Ultrasound in the Detection of Placenta Site in the First Trimester.
Official title: The Accuracy of Ultrasound in the Detection of Placenta Site in the First Trimester When Compared to Hysteroscopy in Early Abortions
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Placenta; Implantation
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-10-08
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators speculate that ultrasound examination in the first trimester can accurately detect placental location. By performing both transabdominal ultrasound and later hysteroscopy on women with a first trimester missed abortions and comparing the ultrasound findings to those of the hysteroscopy the investigators will evaluate the performance of the ultrasound in detecting the placenta location.

Detailed description: All women with a first trimester missed abortion who will sign an informed consent form will undergo an ultrasound examination. During the examination, the operator will assess the location of the placenta/sac insertion. After the performance of the ultrasound, the women will undergo hysteroscopy with a different operator who will be blinded to the results of the previous exam result. During the hysteroscopy the second operator will assess again the location of the sac insertion .The investigatorswill then compare the results of the two tests using the histeroscopy as the gold standard and evaluate the performance of abdominal ultrasound exam in the evaluation of placenta/ sac inserion.

Eligibility criteria: Inclusion Criteria:

* Healthy women .
* Clinical diagnosis of first trimester spontaneous abortion.

Exclusion Criteria:

* viable pregnancy
* women below 18 years
* women with chronic disease

Primary outcomes:
measure: The accuracy of placental site/ gestational sac implantation with ultrasound in the first trimester
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Asaf ha Rofeh, MC
Study officials:
References:
Clinical trial NCT03427996: Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice
Official title: Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atherosclerosis, Coronary
Coronary Stenosis
Keywords: rotational atherectomy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2018-02-09
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive percutaneous coronary intervention patients receiving rotational atherectomy

Brief summary: This study evaluates the effectiveness and safety rotational atherectomy in routine clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 19 years old
* Patients who received rotational atherectomy
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

* Life expectancy \<1y

Primary outcomes:
measure: Target vessel failure (TVF)
timeFrame: 1 year
Secondary outcomes:
measure: All death
timeFrame: 1-,6-, and 12-months, and 3-,5-years
measure: Cardiac death
timeFrame: 1-,6-, and 12-months, and 3-,5-years
measure: Myocardial infarction
timeFrame: 1-,6-, and 12-months, and 3-,5-years
measure: Composite of death or myocardial infarction
timeFrame: 1-,6-, and 12-months, and 3-,5-years
measure: Composite of cardiac death or myocardial infarction
timeFrame: 1-,6-, and 12-months, and 3-,5-years
measure: Target-lesion revascularization (TLR)
timeFrame: 1-,6-, and 12-months, and 3-,5-years
measure: Target-vessel revascularization (TVR)
timeFrame: 1-,6-, and 12-months, and 3-,5-years
measure: Stent thrombosis
timeFrame: 1-,6-, and 12-months, and 3-,5-years
measure: Stroke
timeFrame: 1-,6-, and 12-months, and 3-,5-years
measure: Procedural success
timeFrame: 7 days
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon ST. Mary's Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Seongnam
country: Korea, Republic of
facility: Bundang CHA Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT05381896: The Effect of Inspiratory Muscle Training on Postural Stability, Posture Perception and Trunk Rotation in Children With Adolescent Idiopathic Scoliosis.
Official title: The Effect of Inspiratory Muscle Training on Postural Stability, Posture Perception and Trunk Rotation in Children With Adolescent Idiopathic Scoliosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Scoliosis
Keywords: postural stability
posture perception
inspiratory muscle training
adolescent idiopathic scoliosis
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
Collaborators: name: Bezmialem Vakif University
name: Istanbul Kent University
First posted: 2022-05-19
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trunk rotation and distortion of the rib cage, which are common in patients with adolescent idiopathic scoliosis, result in abnormal configuration of the diaphragm and intercostal muscles. This reduces the capacity of the respiratory muscles to produce force, and results in respiratory muscle weakness. The diaphragm, which is the major respiratory muscle, is also a component of the core muscles responsible for postural stability. Therefore, diaphragm muscle weakness results in deterioration of postural stability. Our aim in this study is to investigate the effect of inspiratory muscle training added to the routine scoliosis exercise program on postural stability and posture perception.


Eligibility criteria: Inclusion Criteria:

* Having adolescent idiopathic scoliosis with a Cobb angle of 20-50° diagnosed by an orthopedic surgeon

Exclusion Criteria:

* Having a documented diagnosis of neurological disorders
* Having a documented diagnosis of mental disorders which may affect cooperation
* Having a documented diagnosis of chronic airway diseases
* Having a documented diagnosis of orthopedic disorders which may affect mobility

Primary outcomes:
measure: Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline "Walter Reed Visual Assessment Scale" at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline maximum inspiratory pressure (MIP) at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline maximum expiratory pressure (MEP) at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline angle of trunk rotation at 8 weeks.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
References:
Clinical trial NCT01402596: Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam
Official title: Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Traumatic Brain Injury
Computed Tomography
Procedural Sedation
Keywords: Deep Sedation
Pediatrics
Emergency Hospital Services
Midazolam
Chloral hydrate
Randomized controlled trial
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Thousands of children receive sedation for diagnostic and therapeutic interventions annually, and this number is expected to increase. Children are at higher risk for sedation-related complications than adults. In different scenarios, multiple drugs are used to achieve sedation, each one with particular adverse events that must be monitored and reported.

Children that need CT scans for traumatic brain injuries often need sedation, without needing and IV line for that. Chloral hydrate is an hypnotic agent used since 1832 with low incidence of adverse events; however, despite its worldwide use, it's being abandoned due to bitter taste, long time of sedation onset, vomiting and mild sedation. Intranasal midazolam, on the other hand, produces high and fast concentrations on CSF with greater rates of success but probably with higher adverse events. There are no prospective studies with large series of patients using intranasal midazolam.

The aim of this study is to determine if nasal midazolam is a safer approach and more effective sedative regimen when compared to rectal chloral hydrate to children undergoing CT scans.


Eligibility criteria: Inclusion Criteria:

* children undergoing CT scanning for TBI

Exclusion Criteria:

* epistaxis
* suspected or confirmed skull or nasal fracture
* Moderate to severe traumatic brain injury
* hemodynamically unstable

Primary outcomes:
measure: Adverse Events
timeFrame: Participants will be followed for the duration of hospital (emergency department) stay, an expected average of 2-3 hours
Secondary outcomes:
measure: Efficacy of both drugs
timeFrame: Participants will be followed for the duration of hospital (emergency department) stay, an expected average of 2-3 hours
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Eduardo Mekitarian Filho, MSc
role: STUDY_DIRECTOR
References: