louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02973867: Myokines Role During Obesity
Official title: Myokines Role in Bone Mineral Density Increase During Obesity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity, Adolescent
Keywords: Bone mineral density
Myokines
Adipokines
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-11-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: obese patients

Brief summary: We showed, for the first time, that Z-score increase during obesity was dependent on sex, severity of obesity and age but also on the bone site. Although the increase in BMD at bearing areas seems to be logically explained by the assumption that mechanical stresses have an osteogenic effect on bone tissue, BMD can in no way respond to the concomitant increase in BMD at non-load bearing areas such as the radius. These results suggest that changes in certain systemic compounds, induced by obesity, may interfere with bone metabolism. Moreover, the fact that the BMD or Z score is positively and only correlated with muscle mass and not with fat mass confirm that mechanical stresses are not the only factors acting on bone tissue.

Our objectives are to determine the relationship between plasma concentration of myokines, adipokines, bone markers and BMD in obese subjects.

Detailed description: We showed, for the first time, that Z-score increase during obesity was dependent on sex, severity of obesity and age but also on the bone site. Although the increase in BMD at bearing areas seems to be logically explained by the assumption that mechanical stresses have an osteogenic effect on bone tissue, BMD can in no way respond to the concomitant increase in BMD at non-load bearing areas such as the radius. (Maïmoun L and Col Bone 2015 Dec 1. S8756-3282 (15) 00421-4). These results suggest that changes in certain systemic compounds, induced by obesity, may interfere with bone metabolism. Moreover, the fact that the BMD or Z score is positively and only correlated with muscle mass and not with fat mass confirm that mechanical stresses are not the only factors acting on bone tissue.

Our objectives are to determine the relationship between plasma concentration of myokines, adipokines, bone markers and BMD in obese subjects.

Our objectives are to determine the relationship between plasma concentration of myokines (myostatin, follistatin), adipokines (leptin, adiponectin) and bone markers (CTX, Trap5, P1NP, ostéocalcin) in a cohort of obese patients, with differents obesity severity, differents ages.

Eligibility criteria: Inclusion Criteria:

* obese patients age above 18 years old

Exclusion Criteria:

* non agreement of inclusion

Primary outcomes:
measure: myosin concentration
timeFrame: 1 day
Secondary outcomes:
measure: adipokines concentration
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Montpellier
name: SULTAN ARIANE
role: STUDY_DIRECTOR
References:
Clinical trial NCT00102167: Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia (0928-006)(COMPLETED)
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study of MK0928 in Healthy Adult Volunteers Participating in a 4-Hour Phase Advance Model of Transient Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2005-01-24
Enrollment: 663
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the safety and effectiveness of Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia for insomnia (a sleep disorder).


Eligibility criteria: Inclusion Criteria:

* Healthy adults who are between the ages of 18 and 64

Exclusion Criteria:

* Adults who are diagnosed with insomnia

Primary outcomes:
measure: Amount of time spent awake and time to fall asleep during one night
timeFrame: one night
Secondary outcomes:
measure: Amount of deep sleep during one night.
timeFrame: one night
measure: Patient-reported sleep quality and awakenings during 1 night.
timeFrame: one night
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Walsh JK, Mayleben D, Guico-Pabia C, Vandormael K, Martinez R, Deacon S. Efficacy of the selective extrasynaptic GABA A agonist, gaboxadol, in a model of transient insomnia: a randomized, controlled clinical trial. Sleep Med. 2008 May;9(4):393-402. doi: 10.1016/j.sleep.2007.06.006. Epub 2007 Aug 30.
citation: Ma J, Dijk DJ, Svetnik V, Tymofyeyev Y, Ray S, Walsh JK, Deacon S. EEG power spectra response to a 4-h phase advance and gaboxadol treatment in 822 men and women. J Clin Sleep Med. 2011 Oct 15;7(5):493-501A. doi: 10.5664/JCSM.1316.
Clinical trial NCT01309867: A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses
Official title: A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2011-03-07
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of the study is to evaluate the product performance of the Bausch + Lomb toric investigational contact lenses compared to the currently marketed PureVision toric contact lenses.


Eligibility criteria: Inclusion Criteria:

* Subjects must have clear central corneas and be free of any anterior segment disorders.
* Subjects must be adapted lens wearers, wear a lens in each eye and each lens must be of the same manufacture and brand.
* Subjects must be myopic and require lens correction
* Subjects must be habitual wearers of toric soft contact lenses.

Exclusion Criteria:

* Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with an active ocular disease or who are using any ocular medication.
* Subjects with any grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Subjects who are allergic to any component in the study care products.

Primary outcomes:
measure: Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees.
timeFrame: 2 weeks
measure: Visual Acuity
timeFrame: 2 weeks
Secondary outcomes:
measure: Symptoms and Complaints
timeFrame: 2 weeks
measure: Percentage of Eyes With > Grade 2 Slit Lamp Findings
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Beverly Barna
role: STUDY_DIRECTOR
References:
Clinical trial NCT02891967: One-year Clinical Evaluation of Bulk-fill Versus Conventional Incremental Posterior Restoration by FDI Criteria
Official title: One-year Clinical Evaluation of Bulk-fill Resin Composite Using FDI Criteria in Comparison to Conventional Incremental Posterior Restoration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Dental Restoration
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: restoring posterior teeth by bulk fll and nanofill composite and clinical evaluation of performance and durability of both restorations during one year follow up

Detailed description: The treated cavities will be divided into 2 groups, cavities will be incrementally layered with resin composite and each increment will be cured as directed by the manufacturer with the light curing unit (XL 3000; 3M/eSPe), with an energy higher than 450 mW/cm² (±50 mw/cm²) and other group of cavities will be restored by bulk fill composite (3M ESPE) as one increment then will be cured as directed by the manufacturer with the light curing unit.

Articulation will be checked carefully with an articulating paper and occlusal adjustments will be performed using flame shaped carbide and diamond finishing burs (DENTSPLY) using water spray, restorations will be finished occlusally with finishing burs and finally polished with aluminium oxide polishing paste and a rubber cup (DENTSPLY).

Eligibility criteria: Inclusion Criteria:

* Good oral hygiene.Patients must show no signs of orofacial pain. The presence of molar teeth requiring composite restorations for the treatment of primary carious lesions

Exclusion Criteria:

* Teeth with abnormal periapical anatomy or caries that will be likely to result in very deep restorations. Teeth with old restorations or severely destructed dental crowns.Tempro-mandibular joint problems involving symptomatic pain.Pregnancy or breast feeding, acute and chronic systemic diseases, immune-compromised patients

Primary outcomes:
measure: clinical performance and durability of restoration
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mary
Study officials:
affiliation: Cairo University
name: Mary ST Tadros, Phd
role: STUDY_CHAIR
References:
Clinical trial NCT03044067: Effects of Pain Neuroscience Education in Fibromyalgia
Official title: The Effects of Pain Neuroscience Education Plus Exercise in the Management of Fibromyalgia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: Chronic pain
Fibromyalgia
Pain neuroscience education
Exercise
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2017-02-06
Enrollment: 24
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: Fibromyalgia is one of the main causes of chronic musculoskeletal widespread pain. This condition presents a global prevalence of 2.7%, and it is more prevalent in women (with a female to male ratio of 3:1) over 50 years of age with low education level and low socioeconomic status, living in rural areas. High direct medical costs and significant indirect costs of this condition can't be ignored.

Detailed description: Study design and setting: The design of the present study will be a randomized controlled trial with 2 follow-ups (one week and one month after intervention) that will be performed between May 2017 and June 2017 in one private clinic in Malaga, Spain. The outcomes will be assessed at baseline (t1), one week after intervention (t2), and one moth after intervention (t3). Written informed consent will be acquired for all participants prior to their participation. The study will be implemented and reported in line with the CONSORT statement.

Eligibility criteria: Inclusion Criteria:

* Age between 18-70 years.
* Willing and able to participate
* Diagnosis of Fibromyalgia

Exclusion Criteria:

* Systemic diseases
* Pain and function due to other rheumatic disorders such as: osteoarthritis, rheumatoid arthritis, ankylosing spondylitis.

Primary outcomes:
measure: Change from Baseline function at 1 month
timeFrame: 1 month
measure: Change from Baseline pain at 1 month
timeFrame: 1 month
Secondary outcomes:
measure: Change from Baseline self-efficacy at 1 moths
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: University of Malaga
name: Alejandro Luque Suarez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03907267: Taurine in Peripartum Cardiomyopathy
Official title: Taurine for Early Left Ventricular Recovery in Peripartum Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Peripartum Cardiomyopathy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Taurine as an adjunct for early left ventricular recovery in peripartum cardiomyopathy


Eligibility criteria: Inclusion Criteria:

* Peripartum Cardiomyopathy

Exclusion Criteria:

* Other identifiable cause for heart failure
* low LVEF ≤ 25%
* sepsis
* autoimmune disease
* severe chronic disease
* malignancy

Primary outcomes:
measure: improvement of the left ventricular ejection fraction >10 %
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
References:
Clinical trial NCT06008067: The Prognostic Role of Tricuspid Annular Plane Systolic Excursion in Critically Ill Patients With Septic Shock
Official title: The Prognostic Role of Tricuspid Annular Plane Systolic Excursion in Critically Ill Patients With Septic Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Keywords: Critical Care
Septic Shock
Echocardiography
RV dysfunction
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients (18 - 64 years old) with septic shock after admission according to 2016 consensus definition (Sepsis-3).

Brief summary: The aim of this study is to evaluate the possible prognostic performance of RV dysfunction, as assessed by TAPSE, in non-cardiac patients with septic shock.

Detailed description: The objective is to investigate the prognostic performance of right ventricular dysfunction, as assessed by tricuspid annular plane systolic excursion (TAPSE), in non-cardiac patients with septic shock.

Eligibility criteria: Inclusion Criteria:

* Adult patients (18 - 64 years old) with septic shock after admission according to 2016 consensus definition (Sepsis-3).

Exclusion Criteria:

* Pregnant females
* Trauma
* Documented coronary heart disease
* History of myocardial infarction
* Myocarditis
* Thrombo-embolic pulmonary disease
* Valvular heart disease
* Corpulmonale
* Arrhythmia
* Known left ventricular ejection fraction \< 40%
* Poor echocardiographic window

Primary outcomes:
measure: 28-day mortality
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Alexandria University Hospitals
Study officials:
affiliation: University of Alexandria
name: Tamer Habib, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02608567: Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis
Official title: Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Stenosis
Asymptomatic Conditions
Left Ventricular Function
Lead sponsor: European Association of Cardiovascular Imaging
Sponsor class: OTHER
First posted: 2015-11-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asymptomatic patients with at least moderate aortic stenosis (mean pressure gradient \>25mmHg or aortic valve area \<1.5cm²) and left ventricular ejection fraction \>50%.

Brief summary: In patients with asymptomatic aortic stenosis (AS), the prognostic value of reduced left ventricular (LV) ejection fraction is well known. Consequently, there is class I indication for surgery in these patients when LV ejection fraction \<50%. However, there is growing evidences suggesting that subclinical LV dysfunction, and more particularly longitudinal myocardial dysfunction, may be a powerful early predictor of outcome, even when LV ejection is still preserved. In asymptomatic AS patients with LV ejection fraction \>50%, a reduced LV global longitudinal strain, as assessed using speckle tracking imaging with transthoracic echocardiography, may be an accurate marker to identify early subclinical LV dysfunction and thus, to improve the risk stratification, the management and the timing of surgery. Several mono-centric observational small studies recently reported results emphasizing the role of LV global longitudinal strain in AS patients. Therefore, a meta-analysis may be conducted and may provide meaningful data. The investigators hypothesized that LV global longitudinal strain is a determinant of outcome in asymptomatic patients with AS and preserved LV ejection fraction.


Eligibility criteria: Inclusion Criteria:

* studies selected in PubMed, Embase, Ovid, and Google Scholar, published between 2005 and 2015 without language restriction according to the following criteria: "aortic stenosis" AND "longitudinal strain"

Exclusion Criteria:

* Studies reporting global longitudinal strain derived from VVI and not speckle tracking analysis.
* Studies with cohort of patients with aortic valve replacement indication

Primary outcomes:
measure: Combined outcome of death and cardiovascular-related hospitalization (including aortic valve replacement)
timeFrame: up to 10 years
Secondary outcomes:
measure: Combined outcome of death and cardiovascular-related hospitalization (without aortic valve replacement)
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU LImoges
Study officials:
affiliation: European Association of Cardiovascular Imaging
name: Erwan Donal, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01296867: Corneal Asphericity Adjustment (Q Adjustment) in Myopic and Hyperopic Patients Undergoing Refractive Correction With Excimer Laser
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Hyperopia
Keywords: Laser ablation algorithms
Excimer laser
Refractive correction
Corneal Asphericity Adjustment
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2011-02-16
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Forty eight myopic (24 patients) and 24 hyperopic eyes (12 patients)

Brief summary: To study the postoperative results in myopic and hyperopic eyes treated with two different laser ablation algorithms (STD and F-CAT), both FDA approved.


Eligibility criteria: Inclusion Criteria:

* Myopic and hyperopic eyes eligible for LASIK or PRK refractive correction
* Central corneal thickness more than 500 micrometers

Exclusion Criteria:

* Topographies of less than 55% of successful total sampled area and eyes exhibiting asphericity variations, in either the horizontal or the vertical axis, greater than 0.2
* Corneal scarring
* Cataract surgery
* Corneal ulceration
* Topographical abnormalities

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04173767: High-flow Nasal Cannula Oxygen Therapy for Ischemic Stroke Patients With Dysphagia and Obstructive Sleep Apnea
Official title: High-flow Nasal Cannula Oxygen Therapy for Ischemic Stroke Patients With Dysphagia and Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Infarction
Sleep Apnea, Obstructive
Deglutition Disorders
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: High flow nasal cannula (HFNC) ventilation therapy was found to improve the severity of obstructive sleep apnea in non-stroke subjects. The investigators hypothesized that HFNC might be effective in stroke patients with dysphagia who needed nasogastric tube feeding and can not receive continuous positive airway pressure ventilation for obstructive sleep apnea.


Eligibility criteria: Inclusion Criteria:

* ischemic stroke patients with dysphagia and obstructive sleep apnea who need nasogastric tube feedings

Exclusion Criteria:

* congestive heart failure, unconsciousness, chronic obstructive pulmonary disease, intracranial hemorrhage or malignancy, and unstable medical and neurological conditions
* central sleep apnea

Primary outcomes:
measure: apnea-hypopnea index
timeFrame: once at polysomnography study night when receive high flow nasal cannula titration study
measure: oxyhemoglobin desaturation index
timeFrame: once at polysomnography study night when receive high flow nasal cannula titration study
Secondary outcomes:
measure: pulse wave velocity
timeFrame: baseline and 1 week after high flow nasal cannula therapy
measure: heart rate variability
timeFrame: baseline and 1 week after high flow nasal cannula therapy
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital, Keelung
Study officials:
References:
Clinical trial NCT04638140: Retrospective Assessment of the Morphology of Acetabular Defects: A 3D Reconstruction Approach
Official title: Retrospective Assessment of the Morphology of Acetabular Defects: A 3D Reconstruction Approach
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hip Arthrosis
Hip Injuries
Keywords: Hip revision surgery
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Trainings dataset for statistical shape model:

* Bones with irregularities, such as fractures or osteophytes
* Patients who received radiation therapy in the past.
* Patients with bone related diseases

Dataset of defect acetabula used for reconstruction:

• Patients who received radiation therapy in the past.

Brief summary: In this study, we aim to develop a statistical shape model and use it to reconstruct the shape of acetabula with severe defects (Paprosky 3a-3b). This will allow us to visualise and assess the morphology of the missing bone. In future studies we will use the obtained results to improve the design of acetabular implants for revision surgery.


Eligibility criteria: Trainings dataset for statistical shape model:

* Patients where a bilateral CT of the hip was performed with unilateral pathologies.
* We aim to include an equal amount of scans from each gender and varying ages.

Dataset of defect acetabula used for reconstruction:

* Patients who received a CT scan of the hip after removal of a primary/revision implant (e.g. patients where debridement was performed due to infection.)
* Patients where the defect can be classified as a Paprosky 3a or 3b defect.

Primary outcomes:
measure: 3D morphology
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pellenberg
country: Belgium
facility: University Hospitals of Leuven
state: Vlaams-Brabant
Study officials:
References: