louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03479073: Risk Factors of Stroke or Systemic Embolism After Atrial Fibrillation Ablation
Official title: The Characteristics of Patients Experiencing Stroke or Systemic Embolism During Follow up Period After Atrial Fibrillation Ablation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
Collaborators: name: Hanmi Pharmaceutical Company Limited
First posted: 2018-03-27
Enrollment: 3198
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population was extracted from a consortium of registry of AF ablation by three University Hospitals (Korea univ Guro, Korea univ Anam and Seoul National University) from 1998 to 2016.

Brief summary: To investigate the rate and risk factors of stroke or systemic embolism (SE) following atrial fibrillation (AF) ablation.

Detailed description: Since catheter ablation for AF reduces the burden of AF effectively, several studies have demonstrated that catheter ablation not only improves the quality of life but also reduces the risk of stroke and all cause mortality. However, until now the guideline has recommended the continuation of oral anticoagulation (OAC) therapy in patients who are at risk of stroke or systemic embolism (SE) based on the CHA2DS2-VASc score, even though they have sinus rhythm following catheter ablation. The aims of this retrospective study is to assess the rate of stroke/SE during follow-up period after AF ablation and identify the independent risk factors for stroke/SE in patients who underwent catheter ablation for AF.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent catheter ablation for AF

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of stroke or systemic embolism after AF ablation
timeFrame: From the time of catheter ablation until the date of the last visit or the date of event.(Retrospective period of up to 20 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Ahn J, Shin SY, Shim J, Kim YH, Han SJ, Choi EK, Oh S, Shin JY, Choe JC, Park JS, Lee HW, Oh JH, Choi JH, Lee HC, Cha KS, Hong TJ, Lip GYH, Lim HE. Association between epicardial adipose tissue and embolic stroke after catheter ablation of atrial fibrillation. J Cardiovasc Electrophysiol. 2019 Nov;30(11):2209-2216. doi: 10.1111/jce.14154. Epub 2019 Sep 19.
Clinical trial NCT02271373: Effect of Increasing Time Spent Outdoors on Myopia Prevention in School-Aged Children in Northeast China
Official title: Development and Application of Appropriate Technology for Myopia Prevention and Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Vision, Ocular
Physical activity
Schoolchildren
Intervention Studies
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 3521
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to develop a school-based intervention aimed at prevent the onset and development of myopia among school aged children by increasing time spent outdoors in northeast China.

Detailed description: The purpose of this study is to develop a school-based intervention aimed at prevent the onset and development of myopia among school aged children by increasing time spent outdoors among elementary and secondary school students in northeast China. It is expected that the results will provide evidences for policy-makers and school healthcare providers for their school children myopia prevention.

Eligibility criteria: Inclusion Criteria:

* Grade of 1 to 5 in elementary schools and grade of 7 to 8 in secondary schools.

Exclusion Criteria:

* Visual defect or other eye diseases; wearing orthokeratology; refractive surgery history.

Primary outcomes:
measure: Changes in uncorrected visual acuity
timeFrame: Baseline, Month 6, Month 12
Secondary outcomes:
measure: Questionnaire survey
timeFrame: Baseline
measure: Changes in ocular biometric parameters
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
Study officials:
affiliation: Department of Maternal, Child and Maternal Health, School of Public Health, Anhui Medical University
name: Fangbiao Tao, PhD
role: STUDY_DIRECTOR
References:
citation: Jin JX, Hua WJ, Jiang X, Wu XY, Yang JW, Gao GP, Fang Y, Pei CL, Wang S, Zhang JZ, Tao LM, Tao FB. Effect of outdoor activity on myopia onset and progression in school-aged children in northeast China: the Sujiatun Eye Care Study. BMC Ophthalmol. 2015 Jul 9;15:73. doi: 10.1186/s12886-015-0052-9.
Clinical trial NCT03205631: Comparison of the Natural Frequencies Technology Sleep Patches to Sham Patches During Sleep in the Home Environment
Official title: Comparison of the Natural Frequencies Technology Sleep Patches to Sham Patches During Sleep in the Home Environment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disturbance
Lead sponsor: IC-IT Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-02
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Prospective, randomized crossover study to compare the NFT sleep patches to sham device to assess sleep via home sleep testing device in the home environment


Eligibility criteria: Inclusion Criteria:

* capacity to provide informed consent
* BMI \<30
* between 30 and 65 years old
* in overall good health as determined by history and physical assessment subjects pre-screened to ensure they are drug free
* work a typical day job/work week.
* not traveled \> 3 time zones in the last month
* typical bedtime between 9-12 PM
* estimated on average 6 hours per night
* negative urine drug screen
* have self-reported unrefreshing sleep for the past month
* agree to limit alcohol use to no more than two drinks a night during the testing period and four hours prior to bedtime
* agree to limit caffeine consumption to four hours prior to bedtime
* ≤ 2 on the depression scale
* ≤ 3 on the anxiety scale

Exclusion Criteria:

* pregnant or nursing a child
* self-induced short sleep habits (\<6 hours per night)
* unstable medical conditions as determined by the clinician
* current sleep disorder (sleep apnea AHI/REI\<5, restless legs, periodic limb movements, narcolepsy)
* self-reported sleep latency of \>30 minutes or early (3-4 AM) awakenings on a regular basis
* contact dermatitis to adhesives
* excluded Medications: over the counter sleep aids, prescribed sleep aids, central nervous system stimulants, antidepressants, sedating antihistamines, over the counter decongestants and opioids

Primary outcomes:
measure: Sleep Quality
timeFrame: three nights
Secondary outcomes:
Other outcomes:
Locations:
city: Alameda
country: United States
facility: California Center for Sleep Disorders
state: California
Study officials:
References:
Clinical trial NCT03310931: Predictive Significance of TEG on END in Patients With Acute Ischemic Stroke
Official title: Predictive Significance of Thrombelastography on Early Neurological Deterioration in Patients With Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Lead sponsor: Dongguan People's Hospital
Sponsor class: OTHER_GOV
First posted: 2017-10-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes consecutively admitted patients with acute ischemic stroke in Dongguan people's Hospital. Patients would take TEG study within 6 hours after admission, as well as other routine lab tests. Serial MRI studies would be taken on admission and followed up on 7th day afterward, except when patients experience END, in which case followup MRI should be preformed immediately.

Brief summary: The purpose of this study is to evaluate whether Thromboelastography (TEG) parameters on admission might be predictive for early neurological deterioration in acute ischemic stroke patients, specifically for the DWI lesion evolution within the first week after stroke onset.

Detailed description: Early neurological deterioration (END ) is a major concern in stroke care, consistently associated with adverse clinical outcomes.END is a heterogeneous complex of pathophysiological and clinical entities. Despite some straight forward causes, DWI lesion growth is reportedly a primary underlying mechanism. Early recognition of END risk would allow for timely identification and proper intervention, improving stroke health care.

Thromboelastography (TEG) measures the coagulation process from initial clotting cascade to clot strength, providing an integrated picture of two separate but simultaneously occuring components of coagulation, thrombosis and lysis. It has been reported to be associated with short and long-term outcome in patients with trauma, coronary artery diseases , pulmonary embolism and, most recently, stroke prevention.The purposes of this study is to evaluate how effective TEG is on predicting END, by producing a range of TEG values correlated with clinical and radiological assessment.

Eligibility criteria: Inclusion Criteria:

* acute ischemic stroke within 24 hours after symptom onset
* first ever stroke
* give informed consent

Exclusion Criteria:

* receiving thrombolysis
* cardiogenic embolism
* contradiction to serial MRI studies
* taking hemostatic agents (warfarin, oral anticoagulants and etc. )

Primary outcomes:
measure: END
timeFrame: fist week after admission
Secondary outcomes:
measure: DWI lesion growth
timeFrame: 7 days
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Dongguan peoples' hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT03281473: Comparison of Positive End Expiratory Pressure Titration Methods in ARDS Patients
Official title: Comparison of Positive End Expiratory Pressure Titration Methods in Patients With Acute Respiratory Distress Syndrome: a Physiological Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: ARDS
Esophageal pressure
Mechanical ventilation
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2017-09-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study aims at assessing the short-term physiological effects of 2 positive end expiratory pressure titration strategies in patients with ARDS.


Eligibility criteria: Inclusion Criteria:

* Age\> 18 years
* Moderate or severe ARDS
* Consent to participation obtained from a relative

Exclusion Criteria:

* Protect adult
* Pregnant or breastfeeding woman
* No-affiliation to the social security scheme
* Contra-indication to the placement of an esophageal pressure measuring catheter
* Pneumothorax
* Hemodynamic and / or respiratory instability
* Extra-corporeal membrane oxygenation

Primary outcomes:
measure: Short-term effects of 2 PEEP titration strategies on gas exchange
timeFrame: 2 hours 15 minutes
Secondary outcomes:
measure: Short-term effects of 2 PEEP titration strategies on respiratory mechanics
timeFrame: 2 hours 15 min
measure: Short-term effects of 2 PEEP titration strategies on hemodynamics
timeFrame: 2 hours 15 min
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
affiliation: Angers teatching hospital
name: Study Official is required by the WHO and BELONCLE, Ass.Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05291273: Influence of Anthropometric Data, Shoulder Complex Muscle Strength, and Abdominal-lumbar Endurance in Closed Kinetic Chain Upper Extremity Stability Test
Official title: Influence of Anthropometric Data, Shoulder Complex Muscle Strength, and Abdominal-lumbar Endurance in Closed Kinetic Chain Upper Extremity Stability Test
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Pain
Keywords: CKCUEST
Physical activity
Rehabilitation
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a monocentric interventional prospective study
Primary purpose: PREVENTION

Brief summary: A previous study of the Closed Kinetic Chain Upper Extremity Stability Test (EPOLTEST) in a population aged 18 to 25 years isolated 3 main factors influencing the CKCUEST score: upper extremity span, weight, and sex of the individual. A predictive equation for the CKCUEST score was thus established and to date has a capacity to determine the real score of approximately 51%.

The results of this first study show that a certain number of variables have not been studied.

The purpose of this study, EPOLTEST 2, is to take into account the variables already studied on a larger population (18-50 years old) and to add an assessment of shoulder muscle strength and abdominolumbar endurance.


Eligibility criteria: Inclusion Criteria:

* Aged to 18 to 50 years
* Capacity to consent
* Who has signed the consent

Exclusion Criteria:

* Fracture history or upper limb luxation \< 1 year
* Pain or discomfort that prevents the test from being performed
* History of abdominal surgery or hernia \< 1 year
* Pregnant or nursing
* Refuse to participate
* Guardianship or protection of vulnerable adult

Primary outcomes:
measure: Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST) score
timeFrame: Day 1
measure: Anthropometric data
timeFrame: Day 1
measure: Anthropometric data
timeFrame: Day 1
measure: Anthropometric data
timeFrame: Day 1
measure: Anthropometric data
timeFrame: Day 1
measure: Anthropometric data
timeFrame: Day 1
measure: Anthropometric data
timeFrame: Day 1
measure: Anthropometric data
timeFrame: Day 1
measure: Muscular strength of the shoulder complex
timeFrame: Day 1
measure: Abdominal-lumbar stability
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
Study officials:
References:
Clinical trial NCT05873673: Coenzyme Q10 and Dentoalveolar Cyst
Official title: The Effect of Coenzyme Q10 on Bone Regeneration in Jaw Defect After Cyst Enculation: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cyst, Jaw
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 20
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: 10 patients in each group will undergo cyst removal under local anesthesia. After cyst removal, the cystic cavity will be filled with placebo gel in the control group or coenzyme gel in the coenzyme group.

Bone density and volume will be assessed by cone beam CT immediately postoperative and 6months later for all patients


Eligibility criteria: Inclusion Criteria:

* Adult patients with critical-size jaw cysts
* Medically stable
* No cystic lesion recurrence

Exclusion Criteria:

* Cystic lesion recurrence
* Medical problem

Primary outcomes:
measure: bone density
timeFrame: 6 months
Secondary outcomes:
measure: bone volume
timeFrame: 6months
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University
Study officials:
References:
Clinical trial NCT05410873: Examining the Effects of Mitochondrial Oxidative Stress in DCM
Official title: Examining the Effects of Mitochondrial Oxidative Stress in DCM
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Dilated Cardiomyopathy
Keywords: Energetics
Mitochondria
Oxidative stress
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2022-06-08
Enrollment: 106
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Double blind, randomised, placebo-controlled trial of MitoQ (mitoquinol mesylate) in 106 patients with dilated cardiomyopathy, examining the effect of reducing mitochondrial oxidative stress on myocardial energetics and myocardial function using 31-phosphorus magnetic resonance spectroscopy and cardiovascular magnetic resonance.


Eligibility criteria: Inclusion criteria

1. idiopathic or familial DCM
2. LVEF ≤45% on 2 imaging studies of any modality ≥3 months apart (may include CMR scan at baseline visit)
3. on guideline therapy for ≥3 months as determined by usual clinicians
4. sinus rhythm on 12-lead electrocardiogram
5. plasma NT-pro-BNP \>250ng/L for those \>65 years and \>100ng/L for those aged ≤65 years within the last 6 months (may include sample at baseline visit)

Exclusion criteria

1. current persistent atrial fibrillation
2. contraindication to CMR
3. estimated glomerular filtration rate (eGFR) \<30mls/min
4. current or planned pregnancy or current breast-feeding
5. clear environmental trigger such as excess alcohol intake, cardiotoxic chemotherapy or peripartum presentation
6. fibrosis burden \>25% on CMR
7. current cancer (other than non-melanoma skin cancers)
8. current use of CoQ10
9. current participation in another randomised controlled trial

Primary outcomes:
measure: Vanguard phase - change in myocardial PCr:ATP
timeFrame: 3 months
measure: Vanguard phase - change in circulating markers of oxidative stress
timeFrame: 3 months
measure: Primary outcome - change in LVESVi
timeFrame: 12 months
Secondary outcomes:
measure: Vanguard phase - change in skeletal muscle PCr recovery
timeFrame: 3 months
measure: Follow-on phase - change in LVEF
timeFrame: 12 months
measure: Follow-on phase - change in LVEDVi
timeFrame: 12 months
measure: Follow-on phase - change in GLS
timeFrame: 12 months
measure: Follow-on phase - change in NT-pro-BNP
timeFrame: 12 months
measure: Follow-on phase - change in renal function
timeFrame: 12 months
measure: Follow-on phase - change in symptom burden
timeFrame: 12 months
measure: Follow-on phase - change in exercise capacity
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Imperial College London and Royal Brompton Hospital
name: Brian Halliday, MBChB PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02799173: Determination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular Calcification
Official title: Determination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular Calcification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Lupus Erythematosus, Systemic
Keywords: cardiovascular calcification
RANK: Receptor Activator of Nuclear Factor kappa B
RANKL: Receptor Activator of Nuclear Factor kappa B Ligand
OPG: Osteoprotegerin
SLE: Systemic lupus erythematosus
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Patients with Systemic lupus erythematosus (SLE) are known to present an increased risk of osteoporosis and cardiovascular calcification. It has also been suggested that bone remodelling and cardiovascular calcification are regulated by the same mechanisms, but inversely in terms of calcium deposition, as osteoporosis is often associated with cardiovascular calcification. Inflammatory and immune factors have been implicated in these two processes.

The role of the RANKL/OPG system in osteoclast differentiation has been elucidated over the last ten years. RANKL induces differentiation of monocytes-macrophages into osteoclasts, while, inversely, OPG exerts an inhibitory role by inactivating RANKL. Differentiation of smooth muscle cells into osteoblasts in the vessel wall induces calcification, and this phenomenon is counterbalanced by differentiation of monocytes into osteoclasts. Although the role of the RANKL/OPG ratio in the pathogenesis of osteoporosis has now been clearly established, its role in vascular calcification is only hypothetical at the present time.

This study will focus on patients with SLE diagnosed and followed in the Amiens University Hospital Internal Medicine and Nephrology departments


Eligibility criteria: Inclusion Criteria:

* Women over 18 years old
* suffering from systemic lupus erythematosus.

Exclusion Criteria:

underlying diseases that can lead to bone and cardiovascular metabolic disturbances :

* Malignancies such as cancer metastasized
* Autoimmune disease other than LED or of overlap syndrome ( rhupus , MCTD )
* Infection by HIV, hepatitis B and C
* Hepatic Cirrhosis
* Chronic renal failure
* Parathyroid disorders

Primary outcomes:
measure: RANKL/OPG ratio
timeFrame: Day 0
measure: presence of osteoporosis
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Rouen
country: France
facility: CHU Rouen
Study officials:
affiliation: CHU Amiens
name: Cécile MAZIERE, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References: