louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05034900: Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Health Benefits in Children With Bronchiectasis?
Official title: Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Health Benefits in Children With Bronchiectasis?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis
Keywords: bronchiectasis
children
oscillatory positive expiratory pressure device
chest physiotherapy
pulmonary function
exercise capacity
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
Collaborators: name: Ege University
First posted: 2021-09-05
Enrollment: 42
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oscillatory positive expiratory pressure (OPEP) devices such as Flutter®, Aerobika® or Shaker ® are commonly prescribed in the clinical practice for airway clearance in children with chronic lung diseases including bronchiectasis, cystic fibrosis, and primary ciliary dyskinesia. Health insurance companies may cover these devices in some countries; but this is not a common practice around the world. Therefore, many families have to purchase these devices themselves. Unfortunately, these devices are rather expensive especially in the developing countries and consequently, families become financially burdened. Aim of this study is to investigate whether the addition of OPEP devices to a comprehensive chest physiotherapy program provide additional benefits on pulmonary function and exercise capacity in children with bronchiectasis. Results of this study may help better interpreting the cost-effectiveness of these devices.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of bronchiectasis

Exclusion Criteria:

* Hospitalization history during past month
* Diagnosis of any other chronic childhood diseases such as cerebral palsy or neuromuscular diseases which may impede exercise tolerance

Primary outcomes:
measure: Change from baseline Forced Vital Capacity (FVC) at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline maximum minute ventilation at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline breathing reserve at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline six-minute walk distance at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline M. Quadriceps strength at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline Leicester Cough Questionnaire score at 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Faculty of Medicine, Department of Pediatrics, Division of Pediatric Pulmonology
Study officials:
References:
Clinical trial NCT03023800: Effects of Macular Buckle Versus Vitrectomy on Macular Schisis and Macular Detachment in Highly Myopic Eyes
Official title: A Randomized, Open Label, Single Center Study Comparing the Efficacy of Macular Buckle Versus Vitrectomy + Internal Limiting Membrane Peeling + Gas Tamponade on Macular Schisis and Concurrent Macular Detachment in Eyes With Highly Myopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinoschisis
Macular Detachment
High Myopia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 80
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: Macular schisis associated with macular detachment is a one of the complications of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling + gas injection versus vitrectomy + internal limiting membrane peeling + gas tamponade in a cohort of highly myopic eyes with macular retinal detachment associated with macular schisis.

Detailed description: A randomized, open label, single center study comparing the efficacy of macular muckle + gas injection versus internal limiting membrane peeling + gas tamponade on macular schisis associated with macular detachment in eyes with high myopia.

Eligibility criteria: Inclusion Criteria:

* axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter
* macular schisis
* macular retinal detachment
* evidence of posterior staphyloma on clinical examination

Exclusion Criteria:

* severe macular scar
* macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant)
* prominent vitreomacular traction
* a history of vitrectomy or macular buckle
* intraocular active hemorrhage or inflammation
* any media opacity which precluded imaging or clinical evaluation of the macula

Primary outcomes:
measure: Retinal re-attachment rate
timeFrame: 3 month
Secondary outcomes:
measure: Post-operative best corrected visual acuity
timeFrame: 12 month
measure: Post-operative macular structure on optical coherance tomography
timeFrame: 12 month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Lin Lu, MD，PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06189300: The Effect of Education and Counseling Given to People With Stoma by Telephone on Stoma Compliance and Complications
Official title: The Effect of Telephone Education and Counseling to Individuals With Stoma on Stoma Compliance and Complications: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stoma Colostomy
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study will be conducted on individuals with stoma followed in the stoma therapy outpatient clinic of a university hospital. Based on the f values of the methods to be studied in the literature review, the total sample size found using the GPOWER program with an effect size of 0.4 (Cohen), 90% power and 0.05% margin of error was found to be n = 44. The sample of the research was determined as 52 in this direction. "Informed Consent Form, State-Trait Anxiety Scale, Adaptation Scale for Individuals with Ostomies" will be filled out. Scales will be collected for both groups on postoperative day 1, day 15, and 1 month after surgery. The patients were called by phone on the 7th, 14th and 21st postoperative days and education and counseling services were provided. SPSS package program will be used to analyze the data.


Eligibility criteria: Inclusion Criteria:

* Having undergone stoma surgery in a university hospital,
* No vision or hearing problems,
* Verbal communication is possible,
* Without diagnosed psychiatric problems.

Exclusion Criteria:

* Want to leave the research

Primary outcomes:
measure: The effect of education and counseling given to individuals with stoma on complications.
timeFrame: 1 mounth
measure: The effect of education and counseling given to individuals with stoma on stoma compliance.
timeFrame: 1 mounth
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
References:
Clinical trial NCT04300400: Treatment of the Overactive Bladder Syndrome: A Delphi Study
Official title: Development of a Flowchart Reflecting the Current Attitude and Approach Towards the Idiopathic Overactive Bladder Treatment in Belgium: A Delphi Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder Syndrome
Keywords: Overactive bladder Syndrome
Delphi study
Treatment algorithm
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
name: Medtronic
First posted: 2020-03-09
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Belgian Urologists: members of the working group of Functional Urology.

Brief summary: Idiopathic overactive bladder syndrome (iOAB) is a prevalent condition in urological practice. The variability in management between specialists and between centers remains high. Even guidelines are not always clear on the treatment management of drug therapy resistant OAB. Standardization in OAB treatment is needed.

Detailed description: Guidelines on the overactive bladder syndrome (European Association of Urology, American Urology Association and International Consultation on Incontinence) are comparable but remain vague mainly on the level between conservative and major surgery. They do not specify combinations of medications and do not distinguish between intradetrusor botulinum toxin injections (BTX) and sacral neuromodulation (SNM) because of lack of evidence.

To reduce the variability in the treatment management of OAB, standardization is needed.

By use of a Delphi technique, the current perception of Belgian urologists towards the most appropriate treatment approach for idiopathic OAB (iOAB) was explored.

Based on these results a practical treatment algorithm for its use in daily clinical practice could be developed.

Eligibility criteria: Inclusion Criteria:

* Profession: MD, Urologist
* Member of the working group of Functional Urology

Exclusion Criteria:

* Retirement
* Non-operative as an urologist.

Primary outcomes:
measure: Degree of consensus on the level of appropriateness
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
state: East-Flanders
Study officials:
affiliation: University Hospital, Ghent
name: Lynn Ghijselings, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05952700: inContAlert: Machine Learning Algorithms for Individual Bladder Filling Level Prediction
Official title: Evaluation and Optimization of Machine Learning Algorithms for Individual Bladder Filling Level Prediction by a Sensor System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Monitoring of the Bladder Filling
Keywords: bladder monitoring
digital Health
bladder filling level
incontinence
neurourology
neurogenic bladder
spinal cord injury
Lead sponsor: inContAlert GmbH
Sponsor class: INDUSTRY
Collaborators: name: University of Bayreuth
First posted: 2023-07-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The selection of the study participants is based on a voluntary basis by inContAlert GmbH.

Brief summary: The aim of this study is to evaluate the bladder filling level of the study participants using the inContAlert sensor. The generated data will be used for the evaluation and optimization of the machine learning algorithms to be able to make precise predictions about the individual bladder fill level.

In particular, the hypothesis that the bladder filling level can be estimated by the algorithm will be tested. When testing the hypothesis, it should be determined which deviation (measured by the mean absolute percentage error) of the estimation/prediction differs from the actual value (obtained by measuring the urine output using a measuring cup in combination with kitchen scales).


Eligibility criteria: Inclusion Criteria:

* informed consent

Exclusion Criteria:

* Missing informed consent

Primary outcomes:
measure: Difference between the predicted bladder filling level and the actual value
timeFrame: December 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Bayreuth
country: Germany
facility: inContAlert GmbH
Study officials:
affiliation: inContAlert GmbH
name: Jannik Lockl, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03066700: Prognostic Factors in Malignant GI Bleeding Treated With Hemostatic Powder
Official title: Prognostic Factors of Outcome in Patient With Malignant Gastrointestinal Bleeding Treated With a Novel Hemostatic Power
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Death
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
Collaborators: name: McGill University
First posted: 2017-02-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases will have been treated at the McGill University Health Centre in Montreal, Canada (MUHC; Royal Victoria Hospital - RVH and Montreal General Hospital - MGH sites) and King Chulalongkorn Memorial Hospital (KCMH), Chulalongkorn University, Bangkok, Thailand.

Brief summary: This is a retrospective study to identify the prognostic factors of the good outcomes in patients who presented with upper GI bleeding from tumor and received Hemospray via endoscopy for hemostatic control. The good outcomes were assessed by immediate hemostasis, rebleeding at 72 hours as well as 7, 14 and 30 days following presentation at initial bleeding episode and also 6-month survival rate.

Detailed description: Tumor-related gastrointestinal (GI) bleeding is increasing due to the advancement of treatment in oncology. However, conventional endoscopic hemostatic methods are not reliable to control bleeding. Surgery, embolization, and radiotherapy can served as the salvage hemostasis; though, a bridging endoscopic therapy is required during resuscitation and stabilization of the patients. Hemospray is a recent novel endoscopic hemostatis powder which has a trend to be an effective instrument for controlling the active upper GI tumor bleeding from a match-pair, case-control study by the author's recent publication. Consequently, the authors hypothesized that there are some prognostic factors related to the outcome of Hemospray treatment in tumor bleeding.

Eligibility criteria: Inclusion Criteria:

* All patients seen in the emergency room and/or hospitalized for malignant gastrointestinal haemorrhage from 2011 to 2017

Exclusion Criteria:

* Age \< 18 years

Primary outcomes:
measure: Mortality rate
timeFrame: 6 months
Secondary outcomes:
measure: Rebleeding rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King chulalongkorn memorial hospita
state: Pathum Wan
Study officials:
References:
citation: Pittayanon R, Rerknimitr R, Barkun A. Prognostic factors affecting outcomes in patients with malignant GI bleeding treated with a novel endoscopically delivered hemostatic powder. Gastrointest Endosc. 2018 Apr;87(4):994-1002. doi: 10.1016/j.gie.2017.11.013. Epub 2017 Nov 20.
Clinical trial NCT04877600: Dual Task Performance in Community Dwelling Older Adults
Official title: The Relationship Between Cognitive and Motor Functions, and Dual Task Performance in Community Dwelling Older Adults: Gender Differences
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dual Task
Community Dwelling Older Adult
Keywords: dual task
community dwelling older adult
motor performance
cognitive status
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 82
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dual task performances may be impaired with the impairment in motor performance and cognitive functions due to aging. Because of this, we aimed to investigate the gender differences in dual task performance.

Brief summary: Dual task performances may be impaired with the impairment in motor performance and cognitive functions due to aging. The aim of the present study is to investigate the gender differences in dual task performance. A total of 82 community dwelling older adults (41 males and 41 females) aged between 65 and 75 years were included in the study. Motor performance was evaluated with sit-to-stand test, the timed up and go test, 10 m walking test and cognitive functions were evaluated with Montreal Cognitive Assessment Test. Dual task performances were evaluated as motor-motor and cognitive-motor performance.


Eligibility criteria: Inclusion Criteria:

* The individuals aged between 65 and 75 years, who agreed for participation, who received 8 or higher points from Hodkinson Mental test, who had no neurologic/orthopedic problems that could affect balance and walking, or communication problem were included in the study.

Exclusion Criteria:

* The individuals who were using 3 or more medications that could affect motor and cognitive functions, and the ones who could not complete the tests were excluded.

Primary outcomes:
measure: Dual Task Performance
timeFrame: 5 minutes
Secondary outcomes:
measure: Montreal Cognitive Assessment Scale
timeFrame: 5 minutes
measure: Timed Up and Go
timeFrame: 5 minutes
measure: 30 Seconds Sit-to-Stand Test
timeFrame: 5 minutes
measure: 10 Meter Walking Test
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References:
Clinical trial NCT04928300: Low Dose Dexmedetomidine Versus Ketamine in Multiple Fracture Ribs
Official title: Diaphragmatic Function, Pain Quality & Anti-inflammatory Properties: A Low Dose Dexmedetomidine Versus Ketamine in Patients With Multiple Fracture Ribs Needing Conservative Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Rib Fractures
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In our study, we assess the diaphragmatic function, pain quality and anti-inflammatory properties between low dose infusion of dexmedetomidine and ketamine in patients with multiple fracture ribs on conservative treatment.

Detailed description: A written informed consent from patients or thier legal guardians, Patients will be assigned randomly to three groups (30 subjects each) with traumatic multiple fracture ribs 3 ribs or more. After thoracic epidural is inserted, the drug study intervention will be started and run for 5 days during ICU admission. In (Group D) low dose dexmedetomidine infusion 0.2 µ/kg/hour IV for 5 days. In (Group K) low dose ketamine infusion 2.5 µ/kg/min for 5 days. In (Group C) the same dose and duration of normal saline will be given.

Eligibility criteria: Inclusion Criteria:

* Adults (age 18-65 years) of American Society of Anaesthesiologists (ASA) physical status I-II
* Traumatic multiple fracture ribs 3 ribs or more, who will be subjected to thorough assessments including chest 3D-CT
* Undergoing conservative treatment (chest strappings)
* Intractable pain with visual analogue scale (VAS) over 6 after traditional therapies
* Glasgow Coma Scale (GCS) ≥ 13.

Exclusion Criteria:

* Multiple traumas to body parts other than chest with an abbreviated injury scale over 3
* Serious head trauma with a Glasgow coma scale lower than 13
* Mechanically ventilated patients
* Massive hemothorax
* Injury to the trachea or bronchus with requirement for immediate surgery
* Dementia
* Use of corticosteroids during ICU stay
* Sepsis
* Continued use of neuromuscular blocking agents and aminoglycosides antibiotic use as they are known risk factors for ICU-acquired weakness and any known hypersensitivity
* Contraindication to the study drugs.

Primary outcomes:
measure: Ultrasonographic diaphragm function
timeFrame: 5 days
Secondary outcomes:
measure: Visual analogue scale for pain
timeFrame: 48 hours
Other outcomes:
measure: Neutrophil/lymphocyte ratio (NLR)
timeFrame: 3 days
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
state: Assuit
Study officials:
affiliation: Assiut University
name: Omar Soliman, MD
role: STUDY_DIRECTOR
References:
citation: Bossolasco M, Bernardi E, Fenoglio LM. Continuous serratus plane block in a patient with multiple rib fractures. J Clin Anesth. 2017 May;38:85-86. doi: 10.1016/j.jclinane.2016.12.015. Epub 2017 Jan 30. No abstract available.
Clinical trial NCT02605200: Identification and Treatment of Diabetes In Solid Organ Transplant Recipients
Official title: Identification and Treatment of Diabetes In Solid Organ Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications of Transplanted Organs and Tissue
Keywords: Diabetes
Endocrinology
Pediatrics
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-11-16
Enrollment: 65
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the influence of post-transplant diabetes on medical and psychosocial outcomes in individuals who receive solid-organ transplant prior to 18 years of age and their families.

Detailed description: This study seeks to understand how organ transplant patients are affected by the development of diabetes, and to test whether early diagnosis of diabetes and comprehensive professional support will:

1. facilitate the adjustment of children and their families to the rigors of diabetes care
2. improve adherence to medication regimens
3. reduce acute complications of diabetes and organ rejection.

Eligibility criteria: Inclusion Criteria:

* Patients of Children's Healthcare of Atlanta who have received a kidney, liver, or heart transplant

Exclusion Criteria:

* Received a transplant after 18 years of age
* Cognitively unable to participant as determined by the study team psychologist
* Not receiving a solid organ transplant for kidney, liver, or heart
* Declines participation invitation

Primary outcomes:
measure: Change in the Pediatric Quality of Life Inventory Transplant Module (PedsQL)
timeFrame: Baseline, interval, and end of participation (Up to 18 years of age)
Secondary outcomes:
measure: Transplant Rejection Rate Post Diabetes Diagnosis
timeFrame: Up to three years
measure: Rate of Vascular Disease Post Diabetes Diagnosis
timeFrame: Up to three years
measure: Mortality Rate Post Diabetes Diagnosis
timeFrame: Up to three years
measure: Change in the Wechsler Abbreviated Scale of Intelligence II (WASI-II) Score
timeFrame: Baseline, interval, and end of participation (Up to 18 years)
measure: Change in the Children Depression Inventory (CDI 2) Score
timeFrame: Baseline, interval, and end of participation (Up to 18 years)
measure: Change in the Behavior Assessment System for Children (BASC) Score
timeFrame: Baseline, interval, and end of participation (Up to 18 years)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta-Egleston
state: Georgia
city: Atlanta
country: United States
facility: Emory Children's Center
state: Georgia
Study officials:
affiliation: Emory University
name: Nina Ham, MD
role: PRINCIPAL_INVESTIGATOR
References: