louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05677854: The Effect of Health Literacy Based Practices
Official title: The Effect of Health Literacy Based Motivational Interviewing and Health Education on Nutrition and Physical Activity Behaviors of Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Literacy Level
Keywords: health literacy
motivational interview
health education
nutrition
physical activity
adolescent
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2023-01-10
Enrollment: 63
Sex: ALL
Minimum age (years): 14
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: It is important to adopt healthy lifestyle behaviors such as nutrition and physical activity in adolescence. Health literacy, which is the competence of adolescents to participate in their own health decisions and takes responsibility for health, needs to be developed. Developing healthy nutrition and physical activity behaviors with a focus on health literacy is important in terms of maintaining the desired behavior in adulthood. This study aims to examine the effects of health literacy-based motivational interviewing and health education on nutrition and exercise behaviors of adolescents. The research will be conducted with a single-blind randomized controlled experimental design. The population of the research consists of ninth-grade students. It is planned to include 72 people in the research sample according to the power analysis calculation. The research will be carried out with two intervention groups as motivational interview and health education and a control group.


Eligibility criteria: Inclusion Criteria:

* Continuing education in 9th grade
* Volunteering to participate in the research
* Permission by their families to participate in the research
* Being at a low or moderate level of health literacy according to the Health Literacy Scale for School-Age Children

Exclusion Criteria:

* Have a chronic illness
* Dieting within a program
* Doing regular physical activity
* Having a high level of health literacy according to the Health Literacy Scale for School-Age Children

Primary outcomes:
measure: Health literacy level (Health Literacy Scale for School-Age Children)
timeFrame: before the implementation
measure: Health literacy level (Health Literacy Scale for School-Age Children)
timeFrame: after the implementation
measure: Health literacy level (Health Literacy Scale for School-Age Children)
timeFrame: three months after completion of the intervention
measure: Health literacy level (Health Literacy Scale for School-Age Children)
timeFrame: six months after completion of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University
state: Çubuk/Türkiye
Study officials:
References:
Clinical trial NCT03625154: Operative Versus Non Operative Management Outcomes of Isolated Lateral Malleolar Weber B Ankle Fractures
Official title: Operative Versus Non Operative Management Outcomes of Isolated Lateral Malleolar Weber B Ankle Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankle Fractures
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine the failure rate and difference in clinical outcomes between operative and non operative treatment of patients with Weber B lateral malleolus ankle fractures with medial clear space widening on gravity stress views. All patients presenting will be treated non operatively, and compared to an observational group comprised of patients with Weber B lateral malleolus ankle fractures without medial clear space widening, for which the standard of care is non operative management.

Patients who decline non operative management and elect to undergo operative open reduction internal fixation with plates and screws will comprise an operative observational cohort.

All patients will be followed for a total of 12 months from the time of injury. Clinical outcomes will be based on radiographic monitoring for ankle mortise congruency, as well as standardized SF-36 and AOFAS questionnaire scores.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* able to provide informed consent

Exclusion Criteria:

* pregnancy
* prisoners
* psychiatric conditions that prevent ability to provide informed consent or present barriers to follow up
* insulin dependent diabetics
* patients with prior musculoskeletal issues affecting the same extremity
* Patients cannot simultaneously be enrolled in any other studies.

Primary outcomes:
measure: radiographic outcome of ankle congruency
timeFrame: 1 year
Secondary outcomes:
measure: functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) scoring system
timeFrame: 1 year
measure: additional functional outcome by Short Form Survey (SF-36) Score scoring system
timeFrame: 1 year
measure: functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - Pain score
timeFrame: 1 year
measure: functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - function - activity limitations, support requirements
timeFrame: 1 year
measure: functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - alignment
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00174954: Magnetic Resonance Imaging in Subjects With Gouty Tophi
Official title: A Study to Validate Magnetic Resonance Imaging (MRI) in the Quantitative Assessment of Gouty Tophi.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperuricemia
Gout
Keywords: Gout
Tophus
MRI
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with palpable gouty tophi.

Brief summary: The purpose of this study is to determine the reproducibility of Magnetic Resonance Imaging (MRI) in the quantitative assessment of tophus volume.

Detailed description: This is a multi-center, validation study of MRI in the quantitative assessment of gouty tophi. Subjects with palpable gouty tophi (confirmed by aspiration of the tophus) in select anatomical sites (foot, hand or elbow) will undergo pre- and post contrast MRI on two occasions separated by 5 to 10 days. This study will consist of up to 4 study visits.

Eligibility criteria: Inclusion Criteria:

* Subjects with gout and at least one tophi.

Exclusion Criteria:

* Unable to undergo MRI.

Primary outcomes:
measure: Measurement of Tophi by MRI - Difference in Volument Between Visits
timeFrame: Visit 1 (Day 1) and Visit 2 (Days 6-11)
measure: Measurement of Tophi by MRI - Difference in Volume Between Readers
timeFrame: Visit 1 (Day 1) and Visit 2 (Days 6-11)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_CHAIR
References:
citation: Schumacher HR Jr, Becker MA, Edwards NL, Palmer WE, MacDonald PA, Palo W, Joseph-Ridge N. Magnetic resonance imaging in the quantitative assessment of gouty tophi. Int J Clin Pract. 2006 Apr;60(4):408-14. doi: 10.1111/j.1368-5031.2006.00853.x.
Clinical trial NCT01107054: A Study to Investigate the Effects of PF00610335 on the QT/QTC Interval in Healthy Volunteers
Official title: A Double Blind, Randomized, Multiple Dose, Placebo And Active Controlled 4-Way Crossover Study To Investigate The Effects Of Inhaled PF-00610355 On QT/QTC Interval In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Disease
Lung Disease
Moxifloxacin
Keywords: QTC
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-04-20
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study to determine the cardiovascular effects of PF00610335 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects aged 18 to 55 years
* Informed consent document signed by the subject or a legally acceptable representative
* Subjects who are willing and able to comply with the scheduled visits, treatment tests, laboratory tests, and other study procedures

Exclusion Criteria:

* Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic psychiatric, neurologic or allergic disease or clinical findings at screening
* Conditions possibly affecting drug absorption
* 12-lead ECg demonstrating QTc \> 450ms or any other clinically significant abnormalities at screen
* Positive urine drug screen
* Hypersensitivity to moxifloxacin or PF00610335
* Unwilling or unable to comply with the lifestyle guidelines in the protocol Treatment with an investigational drug within 3 months or 5 half lives (whichever is longer) preceding the first dose of study medication

Primary outcomes:
measure: To assess whether multiple dose administration of PF00610335 has the potential to affect QTc in healthy volunteers
timeFrame: 24 hours
Secondary outcomes:
measure: To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers
timeFrame: 24 hours
measure: To asses the the relationship between plasma concentrations of PF00610335 and its effects, if any on the QTc interval
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06170554: Study of Hydration Levels in Sports and Non-sports Schoolchildren (EHC)
Official title: Study of Hydration Levels in Sports and Non-sports Schoolchildren
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hydration
Keywords: Water
Beverage
Sports
Children
Middle school students
Adolescents
dehydration
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 259
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The studied population includes middle school students from two classes of 6th, 5th, 4th, and 3rd grades at Sainte Anne College in Brest, as well as middle school students from two classes of 6th, 5th, 4th, and 3rd grades at Pays des Abers College in Lannilis.

Brief summary: New knowledge regarding the negative impact of poor hydration on health highlights the need to provide recent epidemiological data on the water intake of the French population, especially among middle school students, a group that has been minimally studied until now. Given the crucial role of adequate hydration in sports performance, it is essential to assess fluid intake and hydration habits among middle school students, who often engage in intense physical activities. The primary outcome of this study is to evaluate whether the proportion of middle school students hydrating adequately according to current recommendations is higher among those engaging in moderate to intense sports compared to those who do little or no sports. The goal is to determine if daily fluid intake is significantly influenced by physical activity among this population. To achieve this, investigators have developed a questionnaire to gather information on the physical activity levels of middle school students, their daily hydration habits, and their liquid intake in relation to their sports activities, using appropriate visuals. This study involves distributing the questionnaire in two middle schools in Brittany between November 2023 and January 2024.


Eligibility criteria: Inclusion Criteria:

* Middle school students with little or no sports involvement and middle school students with a moderate to intense level of physical activity

Exclusion Criteria:

* Refusal of the middle school student to participate and parental opposition to their child's participation in this research

Primary outcomes:
measure: Proportion of middle school students adhering to current hydration recommendations among both athletic and non-athletic middle school students
timeFrame: baseline
Secondary outcomes:
measure: Proportion of middle school students adhering to current hydration recommendations
timeFrame: baseline
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: Universitary Hospital of Brest
name: Marie-Agnes Giroux-Metges, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00992654: A Treatment Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India
Official title: A Local, Multicentre, Open Label Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Human Immunodeficiency Virus (HIV)
Keywords: Open Label Access Program
Treatment experienced
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2009-10-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The new protocol will allow the patients enrolled on A4001050 to have continuous access of Maraviroc and the treatment will not be interrupted until the drug is commercially available in India.


Eligibility criteria: Inclusion Criteria:

* Subjects who complete the A4001050 study and are continuing to derive benefit from Maraviroc.
* Subjects who are willing and able to comply with scheduled visits, treatment plan and other study procedures.

Exclusion Criteria:

* Subjects who discontinued in A4001050 study.
* Unable to provide consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00225654: The ELUTES Clinical Trial
Official title: The ELUTES Clinical Trial (European Evaluation of Paclitaxel Eluting Stent)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary artery
stent
drug eluting
patency
restenosis
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2005-09-26
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ELUTES is a European multicenter, randomized, controlled, triple-blinded study designed to evaluate the ability of the Paclitaxel Eluting V-Flex Plus coronary stent to reduce restenosis in the coronary artery.


Eligibility criteria: Inclusion Criteria:

* Patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.
* Patient must be an acceptable candidate for coronary artery bypass surgery.
* Patient or legal guardian must have signed informed consent.
* Patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status and for a diagnostic angiogram.

Exclusion Criteria:

* Patient must be less than 18 years old.
* Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
* Patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
* Patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye.
* Women of child bearing potential.
* Patient has other medical condition that may cause non-compliance with the protocol, confound the results, or is associated with limited life expectancy.
* Patient has been diagnosed with a myocardial infarction within 72 hours prior to procedure.

Primary outcomes:
measure: Angiographic in-stent % diameter stenosis and late loss at follow up.
Secondary outcomes:
measure: Major adverse events
measure: Total lesion revascularization
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Contact Sponsor
state: Indiana
Study officials:
affiliation: Glenfield Hospital
name: Anthony Gershlick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03470454: Contrast Nephropathy in Type 2 Diabetes
Official title: Prevalence of Contrast Nephropathy in Type 2 Diabetes Patients With Microalbuminuria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Function Affection Upon Exposure to Radiocontrast
Diabetes
Microalbuminuria
Lead sponsor: Fayoum University
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2018-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetics undergoing any intervention using radiocontrast material for any medical indication in Fayoum university hospital will be selected.

Brief summary: To study the effect of radiocontrast material on kidney functions in diabetics with microalbuminuria

Detailed description: Study design:

This study will be an observational prospective cohort study.

Study population:

Diabetics undergoing any intervention using radiocontrast material for any medical indication in Fayoum universiy hospital will be selected. There will be two arms of the study,each arm will contain 20 patients first arm diabetics on linagelptin, second arm diabetics on other DPP4 inhibitors.

Data collection:

Patients will be subjected to; full clinical examination,waist hip ratio assessment,BMI assessment fasting blood glucose,Serum uric acid, urine ACR, eGFR will be done before and after the investigation.

Eligibility criteria: Inclusion Criteria:

* Diabetics on DPP 4 inhibitor treatment

Exclusion Criteria:

* Diabetics on insulin

Primary outcomes:
measure: affection of estimated glomerular filtration rate
timeFrame: Two months
Secondary outcomes:
measure: change in serum uric acid
timeFrame: Two months
Other outcomes:
measure: Affection of albumin creatinine ratio
timeFrame: Two months
Locations:
city: Fayoum
country: Egypt
facility: Faculty of medicine Fayoum univesity
city: Fayoum
country: Egypt
facility: Fayoum University
Study officials:
affiliation: Cairo University
name: Usama A Sharafeldin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04253054: Chinese Multi-provincial Cohort Study-Beijing Project
Official title: Chinese Multi-provincial Cohort Study-Beijing Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Cardiovascular Risk Factor
Aging Problems
Smell Disorder
Sleep
Lead sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 3000
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants were recruited from the Chinese Multi-provincial Cohort Study-Beijing Project

Brief summary: The Chinese Multi-provincial Cohort Study (CMCS)-Beijing project is a sub-study in CMCS participants from Beijing, which intended to investigate the progression and determinants of atherosclerosis and aging related health problems through repeat examinations. Exam 0 to Exam 3 have been conducted during 1992 to 2012. Exam 4 is scheduled in 2020.


Eligibility criteria: Inclusion Criteria:

* Participants from CMCS-Beijing
* sign the informed consent

Exclusion Criteria:

* participanting in clinical trials

Primary outcomes:
measure: All fatal and nonfatal acute coronary and stroke events
timeFrame: From date of enrollment until the date of first documented event or date of cardiovascular death, whichever came first, assessed at least 5 years
Secondary outcomes:
measure: New-onset of coronary events
timeFrame: From date of enrollment until the date of first documented event or date of CHD death, whichever came first, assessed at least 5 years
measure: New-onset of stroke
timeFrame: From date of enrollment until the date of first documented event or date of stroke death, whichever came first, assessed at least 5 years
measure: Total death
timeFrame: From date of enrollment until date of death from all cause, assessed at least 5 years
measure: Cognitive dysfunction
timeFrame: From date of enrollment until date of first documented event, assessed at least 5 years
measure: Olfactory Disorders
timeFrame: From date of enrollment until date of first documented event, assessed at least 5 years
measure: Valvular disease
timeFrame: From date of enrollment until the date of first documented event or date of valvular disease death, whichever came first, assessed at least 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Sijiqing Hospital, Beijing
city: Beijing
country: China
facility: Peking University Hospital, Beijing
city: Beijing
country: China
facility: Peking University Shougang Hospital
Study officials:
affiliation: Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases
name: Jing Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: