louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05397561: Turkish Translation of Physical Activity Barriers and Facilitators Scale; Validity, Reliability, and Cultural Adaptation
Official title: Turkish Translation of Physical Activity Barriers and Facilitators Scale; Validity, Reliability, and Cultural Adaptation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Youth
Physical Activity
Physical Activity Barriers
Physical Activity Facilitators
Keywords: reliability
validity
facilitator
barrier
physical activity
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy university students aged 18-24.

Brief summary: Background:The aim of our study is to examine the validity and reliability of the Turkish version of the "Barriers \& Facilitators to Youth Physical Activity Questionnaire" in young individuals after cultural adaptation. The results of this study may shed light on youth PA participation studies, enable a clear explanation of the barriers and facilitators of physical activity in community-based research, and develop goal-oriented strategies for PA participation.

Material\&Method: The research will be carried out at İstinye University and young individuals between the ages of 18-24, who accepted to participate in the study as a result of the invitation and whose family consent was obtained, will participate in the research. The socio-demographic characteristics, age, gender, body weight, height and Body Mass Index (BMI) of the participants will be evaluated and recorded with a specially prepared evaluation form. All participants in the study will complete the Turkish version of the BFYPA,The Exercise Benefits/Barriers Scale (EBBS), Motivation for Participation in Physical Activity Scale (MPPAS), and the International Physical Activity Questionnaire (IPAQ) at their first visit. Translation and cultural adaptation process of the original BFYPA Beaton et al. (2000) with reference to the guideline .


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18and 24
* Being Turkish literacy

Exclusion Criteria:

* Having neurological and musculoskeletal problems that can change physical activity habits, -Having heart and respiratory system problems,
* Having diabetes mellitus,
* Using chronic medication,
* Having a body mass index of 35 kg/m2 and being above,
* Any other condition that prevents physical activities.

Primary outcomes:
measure: Physical Activity Barriers and Facilitators Scale (BFYPA)
timeFrame: 01.07.2022-01.07.2023
Secondary outcomes:
measure: The Exercise Benefits/Barriers Scale (EBBS)
timeFrame: 01.07.2022-01.07.2023
measure: Motivation Scale for Participation in Physical Activity (MSPPA)
timeFrame: 01.07.2022-01.07.2023
measure: Physical Activity Questionnaire (IPAQ) Short Form
timeFrame: 01.07.2022-01.07.2023
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yunus Emre TÜTÜNEKEN
state: Zeytinburnu
Study officials:
References:
Clinical trial NCT04464161: The Effects of Perioperative Nutritional Optimization on Blood Markers
Official title: The Effects of Perioperative Nutritional Optimization on Blood Markers of Nutritional Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervertebral Disc Disorders With Radiculopathy, Lumbar Region
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 120
Sex: ALL
Minimum age (years): 55
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to see if taking an oral nutrition supplement (Ensure Nutrition Shake) before and after lumbar spine surgery affects blood tests related the nutritional status of patients. Patients with poor nutritional statuses who undergo elective lumbar spine surgery are at increased risk for complications and longer hospitalizations.

Detailed description: The study will examine whether a simple and cost-effective perioperative nutritional program will affect blood markers of nutritional status (albumin, pre-albumin, transferrin, electrolytes). All patients 55 years and older who are undergoing lumbar spine surgery at our institution by a single surgeon and meet all inclusion criteria will be added to this study. Patients will be randomized into one of two arms; the interventional group will be provide with daily Ensure protein drinks for two weeks pre-operatively and four weeks post-operatively, while the control group will be instructed to continue their current diet plans. Four weeks post-operatively, blood markers (serum albumin, pre-albumin, transferrin, electrolyes) will be obtained to assess objective differences in nutritional status.

N/A

Eligibility criteria: Inclusion Criteria:

* Patients aged 55 years and older undergoing primary lumbar spine surgery for the treatment of radiculopathy and other lumbar pathologies
* Patients have the willingness and ability to participate in a study procedure

Exclusion Criteria:

* Patients who are younger than 55 years old
* Patients undergoing revision surgery
* Patients undergoing surgery due to trauma/fractures
* Patients with lactose intolerance

Primary outcomes:
measure: Difference in blood markers in patients
timeFrame: Baseline, 4 weeks post-operative visit
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Hleath
name: Peter Passias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05119361: Early Dry Cohort : Impact on the Fluid Balance of a Perfusion Based Protocol to Adjust UFnet During Deresuscitation in Intensive Care Unit.
Official title: Impact on the Fluid Balance of a Perfusion Based Protocol to Adjust UFnet During Deresuscitation in Intensive Care Unit. A Before-after Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: ultrafiltration
deresuscitation
fluid overload
fluid balance.
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Patients in intensive care unit with acute kidney injury with continuous renal replacement therapy and fluid overload, with hemodynamic instability

Brief summary: Fluid overload is frequent and associated with mortality in critically ill patients, especially those with acute kidney injury. If fluid loading is a cornerstone of a resuscitation strategy, some authors promote an evacuation phase to limit the fluid overload exposure (deresuscitation strategy). In patients with continuous renal therapy, often presenting an inadequate diuresis, it includes the net ultrafiltration setting. A potential side effect of deresuscitation strategy is to induce iatrogenic hypovolemia.

We have implemented a perfusion-based protocol to induce systematic early fluid removal on patients after haemodynamic stabilization. We would like to observe the impact on the fluid balance of such a protocol and to explore the recruitment capacity of our centre and exploratory outcomes to lead a future randomized control study.


Eligibility criteria: Inclusion Criteria:

* - Age ≥ 18 ans
* Acute kidney injury with continuous renal replacement therapy
* Fluid overload \> 5%
* Equivalent Norepinephrine dose \< 0,5 µg/kg/min

Exclusion Criteria:

* - Chronic intermittent haemodialysis
* Active bleeding
* Stroke with coma
* Pregnancy
* advanced directives to withhold or withdraw life-sustaining treatment
* patient's opposition to the use of his/her personal health data."

Primary outcomes:
measure: Computed cumulative fluid balance (mL) at day 5 after protocol onset.
timeFrame: Day 5 after protocol onset.
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital cardiologique Louis Pradel - HCL
Study officials:
References:
Clinical trial NCT02967861: Effect of Pranayama on Periodontal Health
Official title: Effect of Pranayama on Peroxisome Proliferator-activated Receptor Gamma, Nuclear Factor Kappa B and Red Complex Microorganisms in Patients With Chronic Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Chronic Periodontitis
Keywords: chronic periodontitis
Nuclear factor-kappa B
Pranayama
Peroxisome proliferator - activated receptor gamma
Red complex microorganisms
Lead sponsor: Meenakshi Ammal Dental College and Hospital
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study was to evaluate the levels of Peroxisome proliferator-activated receptor gamma (PPAR-γ), Nuclear factor-kappa B (NF-kB) and the presence of red complex microorganisms (RCM) such as Treponema denticola (T.d), Porphyromonas gingivalis (P.g) and Tannerella forsythia (T.f) in the subgingival tissues of chronic periodontitis subjects before and after intervention with pranayama as an adjunct to scaling and root planing.

Detailed description: Sixty chronic periodontitis subjects were selected out of which 30 subjects (control group) were treated with scaling and root planing (SRP) and 30 subjects (pranayama group) also underwent SRP and pranayama for 3 months. Clinical parameters were recorded and the presence of PPAR-γ, NF-kB and RCM were assessed at baseline and after 3 months

Eligibility criteria: Inclusion Criteria:

* presence of at least 20 teeth
* Probing pocket depth ≥ 5 mm

Exclusion Criteria:

* aggressive periodontitis
* systemic disorders
* pregnant \& lactating females
* smokers \& alcoholics
* immunocompromised individuals

Primary outcomes:
measure: Clinical efficacy of pranayama in chronic periodontitis patients from baseline to 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Microbiological efficacy of pranayama in chronic periodontitis patients from baseline to 3 months
timeFrame: 3 months
measure: Efficacy of pranayama on nuclear factor-kappa B (NF-kB) in chronic periodontitis patients
timeFrame: 3 months
measure: Efficacy of pranayama on perosxisome proliferator-activated receptor (PPAR)-γ in chronic periodontitis patients
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Meenakshi Ammal Dental College & Hospital
name: Jaideep Mahendra, MDS, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baldwin AS Jr. The NF-kappa B and I kappa B proteins: new discoveries and insights. Annu Rev Immunol. 1996;14:649-83. doi: 10.1146/annurev.immunol.14.1.649.
citation: Pilkington K, Kirkwood G, Rampes H, Richardson J. Yoga for depression: the research evidence. J Affect Disord. 2005 Dec;89(1-3):13-24. doi: 10.1016/j.jad.2005.08.013. Epub 2005 Sep 26.
Clinical trial NCT04210661: Spelling Mistake Tolerant Word Prediction for Working, Writing and Communicating
Official title: Spelling Mistake Tolerant Word Prediction for Working, Writing and Communicating - Predict4All
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysorthographia
Neurologic Disorder
Keywords: word prediction
dysorthographia
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 13
Sex: ALL
Minimum age (years): 6
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: interventionnal, prsopective, randomized, multicentric
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main objective of the PREDICT4ALL project is to provide written communication in a computer, reducing the number of spelling errors for each user.

The effectiveness of written communication is defined in this study by the number of spelling errors for each user. Word prediction (and therefore correction) must be able to be configured by a therapist (speech therapist, occupational therapist).

Adapting the prediction to user errors should also allow it to be more relevant throughout the text input. This software efficiency must increase text input speed, Reduce the cognitive load, establish a classification of spelling errors adapted to the context of text input speed and develop the word prediction module tolerant of these spelling errors.


Eligibility criteria: Inclusion Criteria:

* Aged between 6 and 25 years old For center 1
* patient with dysorthographia
* educational level greater than or equal to CE2
* A developmental level in reading on the Evalouette test (Evaleo battery) greater than or equal to CE1 For center 2
* Neurologic disorder impacting communication

Exclusion Criteria:

* Patient's refusal to participate in the study
* Persons under guardianship
* Pregnant women
* No affiliation to a social security scheme (beneficiary or beneficiary)
* Having visual disturbances preventing the use of the computer tool

Primary outcomes:
measure: number of spelling errors
timeFrame: 20 min
Secondary outcomes:
measure: Text input speed
timeFrame: 20 min
measure: Prediction usage rate
timeFrame: 20 min
measure: Keystrokes Saving Rate
timeFrame: 5 min
measure: Attentional load
timeFrame: 1 min
measure: Fatigue
timeFrame: 1 min
measure: software Satisfaction
timeFrame: 1 min
Other outcomes:
Locations:
city: Garches
country: France
facility: Raymond Poincaré hospital
city: Ploemeur
country: France
facility: CMRRF Kerpape
Study officials:
References:
Clinical trial NCT01814761: A Study of Bimatoprost 0.01% in the Clinical Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Primary Open Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-03-20
Enrollment: 312
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with primary open-angle glaucoma or ocular hypertension

Brief summary: This is a study of bimatoprost 0.01% (LUMIGAN® 0.01%) in subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OH) who require further treatment for elevated intraocular pressure (IOP).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary open-angle glaucoma or ocular hypertension
* Determined by the treating physician to require treatment with bimatoprost 0.01%.

Exclusion Criteria:

* Previous use of Lumigan® 0.01%

Primary outcomes:
measure: Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
timeFrame: Baseline, Week 12
measure: Percentage of Patients Who Discontinue Due to an Adverse Event
timeFrame: 12 Weeks
measure: Overall Percent Change From Baseline in IOP
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Chen YY, Wang TH, Liu C, Wu KY, Chiu SL, Simonyi S, Lu DW. Tolerability and efficacy of bimatoprost 0.01 % in patients with open-angle glaucoma or ocular hypertension evaluated in the Taiwanese clinical setting: the Asia Pacific Patterns from Early Access of Lumigan 0.01 % (APPEAL Taiwan) study. BMC Ophthalmol. 2016 Sep 15;16(1):162. doi: 10.1186/s12886-016-0338-6.
Clinical trial NCT06254261: A Study of RAY1225 in Participants With Obesity
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants With Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Guangdong Raynovent Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-02-12
Enrollment: 270
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: The main purpose of this study is to learn more about the Tolerability of RAY1225 in participants with Obesity. The study will also explore the efficacy of RAY1225. The study will last about six months for each participant.


Eligibility criteria: Inclusion Criteria:

1. Have a body mass index (BMI) of ≥28 kilogram per square meter (kg/m²) or ≥24 kg/m² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, fatty liver disease,or HbA1c ≥5.7% and \< 6.5%;
2. Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.

Exclusion Criteria:

1. Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
2. with a history of diabetes or hypoglycemia;
3. Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2 or with thyroid nodules of unknown etiology found at screening and considered clinically significant by the investigator.
4. Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed \>1 year prior to screening)
5. allergic constitution;
6. not suitable for subcutaneous injection.

Primary outcomes:
measure: Change From Baseline in Body Weight
timeFrame: Baseline,Week26
Secondary outcomes:
measure: Percentage of Participants Who Achieve ≥10% Body Weight Reduction
timeFrame: Baseline,Week26
measure: Percentage of Participants Who Achieve ≥15% Body Weight Reduction
timeFrame: Baseline,Week26
measure: Percentage of Participants Who Achieve ≥5% Body Weight Reduction
timeFrame: Baseline,Week26
measure: Change from Baseline in Waist Circumference in Centimeter
timeFrame: Baseline,Week26
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Hebei
Study officials:
References:
Clinical trial NCT00863161: Renal Impairment Study
Official title: A Phase I, Open Label, Non-randomized, Parallel Group, Pharmacokinetic Study in Subjects With Normal Renal Function, Moderate or Severe Renal Impairment Receiving a Single Dose of Oral 130 mg AZD3355
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Reflux
Renal Excretion
Keywords: Safety
tolerability
exposure
healthy
renally impaired subjects
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-17
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to see how quickly AZD3355 is taken up in to the blood and leaves the blood in people with normal kidney function or with different degrees of reduced kidney function.


Eligibility criteria: Inclusion Criteria:

* Provision of signed informed consent
* Subjects should have either normal renal function or have a moderate renal impairment or severe renal impairment

Exclusion Criteria:

* History of heart disease
* Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder

Primary outcomes:
measure: Pharmacokinetic blood samples
timeFrame: 15 samples during 0-72 hours
Secondary outcomes:
measure: Pharmacokinetic urine samples
timeFrame: 8 samples during 72 hours
Other outcomes:
Locations:
city: Linkoping
country: Sweden
facility: Research Site
city: Lulea
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research
Study officials:
affiliation: Quintiles AB, Phase I Services, Strandbodgatan 1, 753 23 Uppsala, Sweden
name: Wolfgang Kuhn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02455661: Femoral Closure Versus Radial Compression Devices Related to Percutaneous Coronary Interventions Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Closure Device
Percutaneous Coronary Intervention (PCI)
Access Site Bleeding
Adverse Cardiac Events
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2015-05-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Radial closure by TR-Band.
Primary purpose: TREATMENT

Brief summary: FERARI is a single centre observational study comparing patients undergoing PCI either using radial compression devices or femoral closure devices at the corresponding access site.

First primary outcomes consist of the occurrence of vascular complications at the arterial access site including major bleedings as defined by common classification systems

Second primary outcomes consist of the occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR) during 30 days and 12 months of follow-up.


Eligibility criteria: Inclusion Criteria:

* Informed consent about the study
* Elective PCI with following indications:

Stable coronary artery disease, proven myocardial ischemia; cardiac arrhythmia; syncope; Unstable AP defined as NSTEMI but without cardiac troponin elevation; NSTEMI; STEMI

* patient eligible for coronary angiography and both radial and femoral PCI
* requirement of using a vascular closure device (without contraindications)

Exclusion Criteria:

* inability to understand and sign the informed consent term
* pregnancy
* less 18 years of age
* single diagnostic coronary angiography
* active or high bleeding risk (thrombocytopenia \<50,000/µl)
* femoral approach and PCI without using a vascular closure device
* other conditions hampering involvement in the study

Primary outcomes:
measure: Vascular complications at the arterial access site
timeFrame: 30 days
measure: Adverse cardiac events
timeFrame: 30 days
measure: Adverse cardiac events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: First Department of Medicine, University Medical Centre Mannheim
Study officials:
References:
citation: Sartorius B, Behnes M, Unsal M, Hoffmann U, Lang S, Mashayekhi K, Borggrefe M, Akin I. Arterial access-site complications after use of a vascular closure device related to puncture height. BMC Cardiovasc Disord. 2017 Feb 16;17(1):64. doi: 10.1186/s12872-017-0484-7.
citation: Fastner C, Behnes M, Unsal M, El-Battrawy I, Ansari U, Mashayekhi K, Hoffmann U, Lang S, Kuschyk J, Borggrefe M, Akin I. Clinical outcomes of femoral closure compared to radial compression devices following percutaneous coronary intervention: the FERARI study. Heart Vessels. 2017 May;32(5):520-530. doi: 10.1007/s00380-016-0901-3. Epub 2016 Nov 1.