louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05697432: Orodental Hygiene in Children With Special Needs
Official title: Evaluation of Oral and Dental Hygiene in Individuals With Special Needs Between 6 to 12 Years of Age
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Hygiene
Keywords: Disabled Children
Oral Hygiene
Streptococcus mutans
Lead sponsor: Altinbas University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This clinical trial aims to learn about the general oral hygiene status of children with special needs and test the effect of hygiene education on their oral and dental hygiene. The main questions it aims to answer are:

* What is the general oral hygiene status of children with special needs?
* Does brushing education and dietary guidance to parents improve oral and dental hygiene in children with special needs? Participants will receive a complete oral and dental examination. Following this examination parents/legal guardians will be educated about the maintenance of oral and dental hygiene and dietary guidance will be provided. Patients will be evaluated one year after the education

Detailed description: One hundred and thirty children with special needs who are being rehabilitated at three rehabilitation centers (Maviel, Sirinler and Ugurlu Kalpler Rehabilitation Centers) in Kilis will undergo a complete oral and dental examination at which their oral bacteria (str. mutans) levels, PUFA and plaque indexes (indices that measure oral health) will be recorded. The parents/legal guardians of the children will be educated about dental hygiene toothbrushing and dietary habits leading to caries. After a year, the examination and assessments will be repeated. The change in oral hygiene indices will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Children with special needs
* Aged between 6-12 years

Exclusion Criteria:

* Refusal
* Being unable to complete oral examination due to lack of cooperation

Primary outcomes:
measure: Change from baseline in Saliva Check mutans test at 52 weeks
timeFrame: Baseline and 1 year after the education
measure: Change from baseline in the number of teeth with each element of PUFA index at 52 weeks
timeFrame: Baseline and 1 year after the education
measure: Change from baseline on the 5 point plaque index at 52 weeks
timeFrame: Baseline and 1 year after the education
Secondary outcomes:
Other outcomes:
Locations:
city: Kilis
country: Turkey
facility: Maviel Rehabilitation Center
city: Kilis
country: Turkey
facility: Sirinler Rehabilitation Center
city: Kilis
country: Turkey
facility: Ugurlu Kalpler Rehabilitation Center
Study officials:
affiliation: Altinbas University
name: Mine Tirnaksiz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05100732: Corrections of Anterior Imbalances by Posterior Instrumentation and Osteotomies
Official title: Analysis of Corrections of Anterior Imbalances by Posterior Instrumentation and Osteotomies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthrodesis
Keywords: Arthrodesis
degenerative lumbar scoliosis
Scoliosis
spinal dysmorphism
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subjects with a surgical indication for arthrodesis and surgical correction of anterior imbalance by transpedicular osteotomy

Brief summary: Several deformities of the spine exist such as the anterior imbalance. These deformities can generate functional discomfort and limit the patient's quality of life.

In the event of severe trunk imbalance and progression of the deformity, operative correction of the spinal deformity by instrumentation and posterior arthrodesis may be indicated.

Surgical techniques and instrumentation have evolved over the past 5 years. These changes in surgical strategies have a potential impact on the patient's quality of life and the correction results in the medium and long term.

the aim of the study is to analyze the surgical corrections obtained by transpedicular osteotomy and radiological changes over time with classic 2-rod techniques versus modern 4-rod instrumentation techniques


Eligibility criteria: Inclusion criteria:

* Major subjects\> 18 years old
* Subject operated at HUS between 01/01/2010 to 31/12/2020
* Subject with a surgical indication for arthrodesis and surgical correction of anterior imbalance by transpedicular osteotomy
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship or guardianship
* Subject under safeguard of justice

Primary outcomes:
measure: Retrospective analysis of corrections of anterior imbalances by posterior instrumentation and osteotomies
timeFrame: Files analysed retrospectively from January 01, 2010 to December 31, 2010 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT04483232: Achromobacter Spp: Description of Epidemiology and Resistance in Chronic Ear Infections and in Healthy Individuals.
Official title: Achromobacter Spp: Description of Epidemiology and Resistance in Chronic Ear Infections and in Healthy Individuals.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Achromobacter
Epidemiology
Chronic Ear Infection
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 1800
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Protected adult (curatorship, guardianship)
* Person deprived of their liberty by judicial or administrative decision
* Pregnant, parturient or breastfeeding woman
* Adult unable to give consent
* For healthy subjects:

  * current ear infection or within the last 6 months
  * Antibiotics (local or systemic) taken within the previous month
* For sick subjects who have already been included once, new episode \< 3 months after the previous one

Brief summary: Hearing loss can be the result of chronic ear infections. The role of bacteria of the genus Achromobacter is not known in these conditions. An epidemiological study including a large number of patients is needed to compare the prevalence of these bacteria in sick and healthy subjects, and to highlight the characteristics of the strains and the factors favouring their emergence.


Eligibility criteria: Inclusion Criteria:

* Person or parent who has given his or her non-opposition
* Person over 10 years of age
* Sick Subjects Group :

diagnosis of chronic infection by an ENT specialist doctor if patient already included: new episode \> 3 months after the complete clinical recovery from the previous episode observed by the ENT doctor - Healthy group: no ear infection in the last 6 months and no antibiotics in the previous month.

Exclusion Criteria:

-

Primary outcomes:
measure: Achromobacter positive sample number
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT05083832: Effect of Two Different Plane Blocks on Post-thoracotomy Pain
Official title: Effects of Ultrasound-guided Continuous Erector Spina Plane Block and Continuous Serratus Anterior Plane Block on Post-thoracotomy Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Thoracotomy
Erector Spinae Plane Block
Serratus Anterior Plane Block
Keywords: Pain, Postoperative
Thoracotomy
Erector spinae plane block
Serratus anterior plane block
Lead sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 60
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: Thoracotomy is recognized as one of the most painful surgical procedures. This increases the frequency of postoperative pulmonary complications. Erector Spinae Plane Block (ESPB) and Serratus Anterior Plane Block (SAPB) are more superficial, easier to perform, and less likely to have complications. In addition, ESPB and SAPB applications are increasing in patients who underwent thoracotomy and thoracoscopic surgery.

In this study, the investigators aimed to evaluate the effect of continuous ESPB and continuous SAPB via US-guidance on post-thoracotomy pain.


Eligibility criteria: Inclusion Criteria:

* 18 to 65 years old
* ASA physical status I-II-III
* BMI 18 to 30 kg/m2
* Elective thoracotomy surgery

Exclusion Criteria:

* Patient refusing the procedure
* Emergency surgery
* History of chronic opioid or analgesic used

Primary outcomes:
measure: Pain scores
timeFrame: 72 hours after surgery
Secondary outcomes:
measure: Morphine consumption
timeFrame: 24 hours after surgery
measure: Side effects
timeFrame: 72 hours after surgery
Other outcomes:
Locations:
city: Kecioren
country: Turkey
facility: Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
state: Ankara
Study officials:
References:
Clinical trial NCT05700032: Impact of High Mechanical Index Ultrasound Impulses on Left Ventricular Stroke Volume With Intravenous Microbubbles
Official title: The Impact of High Mechanical Index Ultrasound Impulses on Left Ventricular Stroke Volume in Patients Receiving Intravenous Microbubbles
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiac Disease
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will investigate whether applying high mechanical index (MI) impulses from a diagnostic ultrasound transducer when using ultrasound enhancing agent (UEA) microbubble infusion will result in subclinical improvement in left ventricle systolic function.

Detailed description: The purpose of this study is to investigate whether applying high MI impulses from a diagnostic ultrasound transducer when using ultrasound enhancing agent(UEA) microbubble infusion will result in subclinical improvement in LV systolic function detected by left ventricular outflow tract velocity time integral (LVOT VTI).

Eligibility criteria: Inclusion Criteria:

age 19 years or older

Exclusion Criteria:

1. severe aortic valve stenosis
2. pregnant or lactating women
3. atrial fibrillation
4. very poor image quality despite contrast use.
5. unstable cardiac condition such as cardiogenic shock.
6. allergy to UEA
7. presence of right to left or bidirectional shunts.
8. Patients on mechanical circulatory support.

Primary outcomes:
measure: Left Ventricle Outflow Tract (LVOT) First Ventilatory Threshold VTI
timeFrame: 10 minutes
Secondary outcomes:
measure: stroke volume
timeFrame: 10 minutes
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska
name: Swethika Harini Sundaravel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005732: Develop and Implement Asthma Controlling Strategies (1)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lung Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY

Brief summary: To develop and implement asthma controlling strategies for inner city and high risk populations.

Detailed description: BACKGROUND:

Asthma is a serious chronic disease affecting about 12 million Americans; about 3 million are children. The study was part of an initiative, "Developing and Implementing at the State and Local Level Educational Strategies and Interventions for Controlling Asthma in Inner City and High Risk Populations", released in February 1993 by the National Asthma Education Program of the Office of Prevention, Education and Control.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03798132: Peritoneal Carcinomatosis Extent Evaluation: Radiologic, Laparoscopic and Pathologic.
Official title: Imaging Evaluation of Peritoneal Carcinomatosis Extent
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peritoneal Carcinomatosis
Keywords: Ovarian Neoplasms, Laparoscopy, Cytoreduction Surgical Procedures.
Lead sponsor: South Egypt Cancer Institute
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pathologically proved ovarian cancer patients recived cytoreductive surgery and underwent preoperative CT and diagnostic laparoscopy

Brief summary: pathologically proved ovarian cancer patients that underwent contrast enhanced abdomino-pelvic CT and diagnostic laparoscopy before cytoreductive surgery (CRS) will be included in the study. Calculation of PCI (peritoneal cancer index) using Sugarbaker's method, peritoneal carcinomatosis extent will be categorized into low, moderate and large. Agreement in general and in each category between CT, laparoscopy, surgery and pathology will be assessed using kappa agreement.

Detailed description: we will search medical records of primary ovarian cancer patients underwent CT abdomen, laparoscopy followed by cytoreductive surgery to calculate peritoneal carcinomatosis extent by each modality.

Regional PCI was calculated in each of the 13 anatomical abdominopelvic regions, then total PCI by summation of the lesion size score, it ranged from 0 to 39. Categorization of peritoneal carcinomatosis was classified into 3 categories low if PCI \< 10, moderate if 10-20, and large if \>20.

Eligibility criteria: Inclusion Criteria:pathologically proved ovarian cancer patients underwent contrast enhanced abdominopelvic CT and diagnostic laparoscopy before cytoreductive surgery -

Exclusion Criteria:recurrent ovarian cancer

-

Primary outcomes:
measure: peritoneal carcinomatosis
timeFrame: one year
Secondary outcomes:
measure: surgical decision making.
timeFrame: one year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: South Egypt Cancer Institute
Study officials:
References:
citation: Fagotti A, Ferrandina G, Fanfani F, Garganese G, Vizzielli G, Carone V, Salerno MG, Scambia G. Prospective validation of a laparoscopic predictive model for optimal cytoreduction in advanced ovarian carcinoma. Am J Obstet Gynecol. 2008 Dec;199(6):642.e1-6. doi: 10.1016/j.ajog.2008.06.052. Epub 2008 Sep 17.
Clinical trial NCT04656132: PAVS in Cardiology
Official title: Physical Activity Assessment, Promotion and Monitoring in a Preventive Cardiology Clinic: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Diseases
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-12-07
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: PREVENTION

Brief summary: Brief Summary This is a pilot study implemented physical activity assessment, promotion and monitoring in patients. Patients will be assessed by the physical activity vital sign (PAVS) during check-in for their appointment. During their visit with the cardiologist, a clinical decision support tool will alert the cardiologist to patients achieving low (\<50% of recommended) physical activity. The cardiologist may refer the patient to cardiac rehabilitation if appropriate and/or counsel them to increase their physical activity levels. The patients may opt to enroll in the monitoring phase of the study. They will be given a Fitbit pedometer and their Fitbit account can sync to their MyChart account. After that sync, the patients step counts will be available for their cardiologists to review as needed.


Eligibility criteria: Inclusion Criteria:

Adult patients in the Center who are age 18 and above will be assessed with the PAVS as part of routine care. To enroll in the home monitoring of PA:

1. Patients must achieve \< 50% of PA recommendations according to PAVS screening questions
2. Have a cellular phone with data plan or a computer to sync Fitbit data
3. Speak English or Spanish
4. Be willing to wear a Fitbit Zip for 3 months

Exclusion Criteria:

1. Adults with a physical disability or medical diagnosis limiting their ability to exercise (e.g. wheelchair bound, aortic stenosis, unstable angina)
2. Planned surgery within three months
3. Those with decisional incapacity therefore unable to comply with study requirements (i.e. related to cognitive deficits or psychiatric diagnosis)
4. Pregnant or breastfeeding women.

Primary outcomes:
measure: Step Counts
timeFrame: Month 3
measure: BMI
timeFrame: Month 3
measure: Waist Circumference
timeFrame: Month 3
measure: Blood Pressure
timeFrame: Month 3
measure: Blood Lipid Levels
timeFrame: Month 3
measure: Framingham Heart Study Risk Score
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone
state: New York
Study officials:
References:
Clinical trial NCT03036332: Exercise Training and Metabolic Syndrome
Official title: Effects of Aerobic Interval Training on Clinical Biomarkers and Quality of Life in Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: aerobic interval training
biomarkers
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 53
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aimed to determine the effects of 16 weeks of aerobic interval training on quality of life and a set of clinical biomarkers.

Detailed description: Besides the traditional metabolic syndrome risk factors (dyslipidemia, raised blood pressure, central obesity and dysglycemia) subclinical disorders related to chronic inflammation and cell damage have been reported on metabolic syndrome. Therefore, regarding the systemic feature of metabolic syndrome, we investigated an new approach of aerobic interval training on several clinical biomarkers widely used. Such training used differs from current aerobic protocols in order to attenuate metabolic and musculoskeletal overload on untrained and unhealthy subjects.

Eligibility criteria: Inclusion Criteria:

* Having metabolic syndrome according to international diabetes foundations definition (IDF).
* Age between 35 - 60 years and untrained subjects.

Exclusion Criteria:

* Musculotendinous or osteoarticular injuries in the lower limbs and/or spine
* Chronic pulmonary diseases
* Neurological disorders
* Kidney failure
* High-risk cardiovascular diseases (Unstable angina pectoris, Uncompensated heart failure, complex ventricular arrhythmias or myocardial infarction during the last month).

Primary outcomes:
measure: Pro-inflammatory marker
timeFrame: 16 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 16 weeks
measure: A set of clinical biomarkers
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Estadual Paulista Júlio de Mesquita
name: Rodolfo AT Miranda, Me
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01016132: Clinical Evaluation of a Silicone Hydrogel Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-11-18
Enrollment: 152
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the performance of an investigational contact lens among contact lens wearers.


Eligibility criteria: Inclusion Criteria:

* Currently wearing lotrafilcon A lenses in both eyes for a minimum of 5 days per week, 8 hours per day, for 3 months.
* Removes contact lenses daily or sleeps overnight in contact lenses (up to 30 consecutive nights) as prescribed by regular eye care practitioner.
* Able to achieve distance visual acuity of at least 20/40 in each eye with study lenses.
* Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within 12 months prior to enrollment.
* Currently enrolled in any clinical trial.
* History of corneal refractive surgery.
* Other protocol inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Overall Preference
timeFrame: 4 weeks of wear
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: