louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06931444: The Beijing Childhood Eye Study
Official title: School Based Cohort Study for Myopia-The Beijing Childhood Eye Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Myopia
Keywords: myopia
child
axial length
refractive error
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 3760
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Grades 1-3 primary school students.

Brief summary: Axial myopia has emerged as the leading cause of irreversible vision loss in East Asia, driven by its progression to sight-threatening complications including myopic macular degeneration, retinal detachment, open-angle glaucoma, and other complications. In the current study, we aim to observe the natural course of the development , progression, and its associated factors in children

Detailed description: This is a prospective epidemiological cohort study, recruiting students in grades 1-3 in primary school for myopia. Through stratified cluster random sampling, among aii the primary schools in Dongcheng District, Beijing, schools were stratified into key and ordinary schools, with 2 schools randomly selected from each stratum.

A prospective study cohort comprising 3,667 subjects was established. All study subjects completed a standard questionnaire and underwent routine ophthalmic examinations. Follow-up assessments will be conducted regularly to monitor changes in refractive errors and fundus indicators. Informed consent, approved by the Ethics Committee of Beijing Tongren Hospital, was obtained from all participants.

Eligibility criteria: Inclusion Criteria: 1) Currently enrolled students in grades 1-3 of the selected primary schools, in good health, with normal ocular appearance. 2) No ocular diseases, no strabismus, ocular trauma, or history of intraocular surgery, with unaided visual acuity of 20/20 or better. 3) Parental and student consent to participate in the survey and signed informed consent form.

Exclusion Criteria: 1) Not currently enrolled in grades 1-3 of a primary school. 2) Students with pre-existing strabismus, other ocular diseases, or a history of ocular surgery at baseline, or those allergic to cycloplegic eyedrops. 3) Students unable to continue studying at their current school for more than three years from the baseline, including those who transfer to another school or withdraw from the study; 4) parental or student disagreement with participation in the survey.

Primary outcomes:
measure: Myopia development
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03814044: PMCF Study on PEEK Suture Anchors for Hip Indications
Official title: PMCF Study on PEEK Suture Anchors for Hip Indications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Soft Tissue to Bone Fixation
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-23
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have undergone hip joint repair using PEEK Suture Anchors:

* BIORAPTOR Knotless Suture Anchors
* SpeedLock Hip

Brief summary: Post-market clinical follow-up (PMCF) on the PEEK Suture Anchors in the hip.


Eligibility criteria: Inclusion Criteria:

1. Subjects who have undergone hip joint repair using the study devices.
2. Subjects aged 18 years and older at the time of surgery.
3. Subjects who had a visit to their provider between 3 and 15 months postoperative.

Exclusion Criteria:

1. Subjects who are \< 12 months post-operative.
2. Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 30 days prior to surgery
3. Subject had off-label use of the PEEK suture anchor during surgery.

Primary outcomes:
measure: Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 12 Months After Intervention
timeFrame: 12 months
measure: Visual Analog Scale (VAS) - Pain
timeFrame: 6 and 12 months
measure: Count of Participants With Range of Motion (ROM) Full Functional Arc
timeFrame: 6 months and 12 months
measure: Range of Motion (ROM)
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: West Des Moines
country: United States
facility: DMOS Orthopedic Centers
state: Iowa
city: Auburn Hills
country: United States
facility: Center for Advanced Orthopedic and Sports Medicine
state: Michigan
city: Oklahoma City
country: United States
facility: Community Hospital - Oklahoma City
state: Oklahoma
city: Oklahoma City
country: United States
facility: Southwest Orthopaedic Reconstructive Specialists
state: Oklahoma
Study officials:
affiliation: Smith & Nephew, Inc.
name: Judith Horner
role: STUDY_CHAIR
References:
Clinical trial NCT05600244: PENG vs. QLB vs. Lumbar ESPB in Total Hip Surgery
Official title: Comparison of Pericapsular Nerve Group Block, Quadratus Lumborum Block and Lumbar Erector Spinae Plane Block for Acute Pain Management in Total Hip Surgery: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Hip Surgery
Pericapsular Nerve
Quadratus Lumborum
ESPB
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare between Pericapsular Nerve Group Block, Erector Spinae Plane Block and Quadratus Lumborum Block for managing acute postoperative pain in patients undergoing total hip surgeries under spinal anesthesia.

Detailed description: Total hip surgeries are one of the most common major orthopedic procedures to improve patient's functional status and quality of life. However, despite these advantages, the immediate postoperative period can be associated with severe pain that delays mobilization and increases hospital stay and the risk of thromboembolic events.

Various methods are used for postoperative pain management. Intravenous opioid agents are among them, but they may cause undesirable side effects, such as respiratory depression, sedation, constipation, allergic reaction, nausea, and vomiting. Thus, alternative techniques are preferred.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Both genders
* Body mass index \< 40 kg/m\^2
* American Society of Anesthesiologists (ASA) physical status I-III
* Posted for total hip surgeries under spinal anesthesia

Exclusion Criteria:

* The presence of contraindications or allergy to local anesthetic agents
* Chronic use of opioids or corticosteroids
* Infection at the puncture site
* Coagulopathy
* Psychiatric disorders (dementia or cognitive impairment.

Primary outcomes:
measure: Total amount of rescue analgesia
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: First analgesic request
timeFrame: 24 hours Postoperatively
measure: Pain level
timeFrame: 48 hours Postoperatively
measure: Adverse events
timeFrame: 48 hours Postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Mohammad Fouad Algyar
state: ElGharbiaa
Study officials:
References:
Clinical trial NCT02251444: Regulation of Emotions and Coping Behaviour in Patients With Chronic Recurrent Low Back Pain
Official title: Emotionsregulation Und Bewältigungsverhalten in Zusammenhang Mit Ambulanter Rehabilitation Oder Physikalischer Therapie Bei Chronischem Rückenschmerz
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Karl Landsteiner Institute of Remobilization and Functional Health
Sponsor class: OTHER
First posted: 2014-09-29
Enrollment: 42
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates effects of a multidisciplinary rehabilitation program or physical therapy in patients with chronic low back pain on emotion regulation and coping behaviour.

Hypothesis: Significant differences of negative emotions pre and post treatment and between groups after intervention.

Standardised questionnaires are used for investigation

Detailed description: Emotionsregulations-Inventar ERI Emotion Regulation Questionnaire ERQ Positive and Negative Affect Schedule PANAS Brief Symptom Inventory BSI-18

Eligibility criteria: Inclusion Criteria:

* chronic low back pain \> 3 months
* VAS \>= 2
* understanding of german language

Exclusion Criteria:

* retired
* psychiatric disorders
* dementia
* sick headache
* chronic pain disease other than chronic low back pain
* patients with general contraindications of the therapy

Primary outcomes:
measure: Emotion regulation before and after treatment
timeFrame: 6-8 months
Secondary outcomes:
measure: Isometric muscle strenght before and after treatment
timeFrame: 6-8 months
measure: Pain in the spine before and after treatment
timeFrame: 6-8 months
measure: Emotion regulation before and after treatment
timeFrame: 6-8 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Karl Landsteiern Institute of Remobilisation and Functional Health
Study officials:
References:
Clinical trial NCT05470244: TENS in Post-operative Total Knee Arthroplasty Recovery and Intra-venous Analgesics Requirement
Official title: Effects of Transcutaneous Electrical Nerve Stimulation in Post-operative Total Knee Arthroplasty Recovery and Intra-venous Analgesics Requirement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthoplasty
Knee Pain
Keywords: Total Knee Arthoplasty
Knee Pain
Post-operative
Transcutaneous electrical nerve stimulation
Intra-venous
Analgesics requirement
Recovery
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 60
Sex: ALL
Minimum age (years): 31
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Total knee arthroplasty (TKA) is among the major advancements for the treatment of knee pain and improvement of physical function when conservative management fails to comply with. The success of this arthoplasty results in more functional mobility and better quality of life. However, management of pain after TKA in post-operative period is a big challenge to deal.

Detailed description: Transcutaneous electrical nerve stimulation is a cost effective, non-invasive electrotherapeutic modality used in alleviating pain in both acute and chronic conditions affecting neuromusculoskeletal system of the body.

Eligibility criteria: Inclusion Criteria:

1. Both male and female
2. Aged between 31-70 years
3. Total Knee Arthoplasty, who had been diagnosed with knee osteoarthritis, inflammatory arthritis, trauma, fracture result in total knee arthoplasty.

Exclusion Criteria:

1. Any allergic condition of skin
2. Chronic consumption of opioids
3. History of dysplasia or malignancy to knee joint
4. Any major bone operation of lower limb
5. BMI higher than 35 kg m-2
6. History of mental disorder
7. Neurological illness e.g. Alzheimer which might interfere with assessment process.

Primary outcomes:
measure: Pain Intensity
timeFrame: Pain intensity will be measured at baseline,and change in pain intensity will be measured from baseline to 24 hour, 48 hour and 72 hours.
measure: Rang of Motion
timeFrame: Knee Range of Motion will be measured at baseline, and Change in Knee Range of Motion will be measured from baseline to 24 hour, 48 hour and 72 hours
measure: Intra-venous analgesic requirement
timeFrame: Analgesics requirement will be observed at first post-operative day, at second post-operative day, at third post-operative day
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: It will be measured from the time of randomization till the time of discharge from hospital upto ten days
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The University of Lahore
state: Punjab
Study officials:
affiliation: The University of Lahore
name: Prof. Dr. Ashfaq Ahmed, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01563744: EGD-assisted Bowel Preparation for Colonoscopy
Official title: EGD-assisted Bowel Preparation for Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophagoscopy Techniques
Colonoscopy
Keywords: colonoscopy
bowel preparation
tolerability
EGD-assisted
Lead sponsor: Rockford Gastroenterology Associates
Sponsor class: OTHER
First posted: 2012-03-27
Enrollment: 82
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adequate bowel preparation is of critical importance for colonoscopy. Particularly among hospitalized patients, inadequate bowel preparation for colonoscopy may arise due to patient intolerance to prescribed laxative regimen, elderly population, and co-existing conditions that impair the ability to ingest a large-volume laxative regimen. Improvements in bowel preparation for colonoscopy in hospitalized patients would likely improve patient care and reduce hospital costs. The purpose of this study is to determine if administering a portion of the bowel purgative via EGD could improve colonoscopy preparation in hospitalized patients.

Detailed description: In this randomized controlled trial in hospitalized patients, patients in whom colonoscopy was anticipated the day following EGD were consented and randomized to either standard prep by mouth (split-dose PEG) or intervention group (instillation of the first 2 liters of Nulytely solution through the channel of the endoscope into the duodenal bulb, then continue standard prep). Data is collected on quality of prep and patient satisfaction in both groups.

Eligibility criteria: Inclusion Criteria:

* hospitalized patients
* having EGD and expected to have colonoscopy the following day
* written informed consent

Exclusion Criteria:

* unable to tolerate EGD-assisted prep administration

Primary outcomes:
measure: Quality of bowel preparation
timeFrame: Twenty four to 48 hours - from time of consent prior to EGD until end of colonoscopy performed the following day
Secondary outcomes:
measure: Patient tolerance of bowel preparation
timeFrame: administered just prior to sedation for colonoscopy
Other outcomes:
Locations:
city: Rockford
country: United States
facility: SwedishAmerican Hospital
state: Illinois
city: Rockford
country: United States
facility: St. Anthony Medical Center
state: Illinois
Study officials:
affiliation: Rockford Gastroenterology Associates, University of Illinois College of Medicine, Rockford
name: Robert L. Barclay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03132844: Epidemiological Study on the Vaccination Coverage of the Population Aged 75 Years and Over in Picardy. According to the Study of 200 Patients Followed by General Practitioners of the Somme in 2016.
Official title: Epidemiological Study on the Vaccination Coverage of the Population Aged 75 Years and Over in Picardy. According to the Study of 200 Patients Followed by General Practitioners of the Somme in 2016.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaccination
Elderly
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 200
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 75 years of general practice in the Somme

Brief summary: In France, the vaccination coverage of seniors is clearly deficient. It seems to be a cultural specificity, dating back more than 100 years, and which does not exist in Scandinavia, nor in much of the Anglo-Saxon world. Only influenza vaccination is a success for seniors. The high public health council sets the objective of immunization coverage in patients over 65 years of age to 80% whether or not the patient is benefiting from an exonerative ALD. The data collections carried out with the various pension funds objective have a lower immunization coverage with a rate ranging from 48.8 to 64%. Thus any medical consultation should be an opportunity to update the vaccination schedule of adults and the elderly.


Eligibility criteria: Inclusion Criteria:

* Man or woman,\> 75 years old.
* Seen in consultation at the doctor's office
* In 2016.

Exclusion Criteria:

* Patient seen during a home visit.
* Patient resident in EHPAD.

Primary outcomes:
measure: Analysis of the rate of patients over 75 years old followed in general medicine in the Somme, with an up-to-date immunization schedule
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT03239444: Foresight Intracardiac Echocardiography System (ICE)
Official title: Visualization of Human Cardiovascular Anatomy With Foresight Intracardiac Echocardiography (ICE) System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atrial Fibrillation
Keywords: ICE
Ablation
Trans-septal
Septum
Echocardiography
Lead sponsor: Conavi
Sponsor class: INDUSTRY
First posted: 2017-08-04
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study will evaluate the efficacy of the Foresight Intracardiac Echocardiography system ,with improved image quality, in guiding trans-septal punctures during atrial fibrillation ablation procedures.

Detailed description: The study will recruit 10 patients at a single center.

Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years old.
* Patient is undergoing an atrial fibrillation ablation procedure.
* Patient has a transesophageal echocardiogram (TEE) within the 48 hours prior to ablation procedure to rule out left atrial thrombus.
* Patient provides informed, written consent for participation in the study.

Exclusion Criteria:

* Patients in whom placement of an ICE catheter in the right atrium for adequate atrial visualization is not technically feasible (as evaluated and determined by the physician/study investigator performing the procedure).
* Patients in whom transseptal puncture is relatively contraindicated.
* Patients in whom left atrial clot or dense spontaneous contrast is identified on TEE, which would increase thromboembolic risk.
* Women of child bearing potential, in whom pregnancy cannot be excluded.
* Patients unable to grant informed, written consent for participation in the study.

Primary outcomes:
measure: Evaluation of the study device for guiding transseptal puncture in order to gain access to the left atrium of the heart during an ablation procedure in patients suffering with atrial fibrillation.
timeFrame: For each patient, the individual physician satisfaction survey will be completed on the day of the procedure.
Secondary outcomes:
measure: Collection of first human images with Conavi's Foresight System.
timeFrame: An individual physician satisfaction survey will be completed for each case on the day of the procedure.
Other outcomes:
Locations:
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
Study officials:
affiliation: Southlake Regional Health Center, Newmarket, Ontario, Canada, L3Y2P6
name: Atul Verma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02127944: Assessment of Ovarian Reserve Tests in Unexplained Infertile Women
Official title: Assessment of Ovarian Reserve Tests in Unexplained Infertile Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Infertility, Female
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2014-05-01
Enrollment: 80
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALL STUDY PARTICIPANTS SHOULD BE LESS THAN 35 YEARS OLD, MARRIED , SHOULD HAVE REGULAR MENSES AND SHOULD HAVE AT LEAST A YEAR OF UNPROTECTED SEX.

Brief summary: IN UNEXPLAINED INFERTILITY IN WOMEN ,OVARY RESERVE IS BORDERLINE IF ASSESSED USING HIGH-SENSITIVE TESTS.

Detailed description: IN UNEXPLAINED INFERTILITY OVARIAN RESERVE TESTS WERE ASSESSED.

IN THIS STUDY, A COMPARISON IS DONE BETWEEN 35 WOMEN WITH UNEXPLAINED FERTILITY(THE PATIENT) AND 35 WOMEN WHO DON'T HAVE ANY FERTILITY PROBLEMS AND HAVE AT LEAST A CHILD (THE CONTROL GROUP).

THE STUDY PARTICIPANTS SHOULD HAVE THE FOLLOWING CRITERIA

Inclusion Criteria:

LESS THAN 35 YEARS OLD, MARRIED WOMEN SHOULD HAVE REGULAR MENSES SHOULD HAVE AT LEAST A YEAR OF UNPROTECTED SEX. THE HUSBAND'S SPERMOGRAM SHOULD HAVE NO ABNORMALITIES THE SUBJECT SHOULD HAVE A NORMAL HYSTEROSALPHINGOGRAPHY

Exclusion Criteria:

HAVING ANY SYSTEMIC DISEASE. LONG HISTORY OF ANY DRUG USAGE.

FOR THE CONTROL GROUP

Inclusion Criteria:

LESS THAN 35 YEARS OLD, MARRIED WOMEN SHOULD HAVE REGULAR MENSES AT LEAST HAVE A CHILD THE HUSBAND'S SPERMOGRAM SHOULD HAVE NO ABNORMALITIES THE SUBJECT SHOULD HAVE A NORMAL HYSTEROSALPHINGOGRAPHY

Exclusion Criteria:

HAVING ANY SYSTEMIC DISEASE. LONG HISTORY OF ANY DRUG USAGE.

THE STUDY INCLUDES THE FOLLOWING TESTS BEING DONE ON THE PATIENTS:

THE FOLLOWING HORMONES' LEVELS WERE STUDIED:AMH (ANTI-MULLERIAN HORMONE),FSH (FOLLICULAR STIMULATING HORMONE) , E2 (ESTRADIOL) AND INHIBIN B.THE FORMER THREE HORMONE LEVELS SHOULD BE ASSESSED ON THE THIRD DAY OF MENSES IN THE STUDY,TRANSVAGINAL ULTRASONOGRAPHIC OVARIAN VOLUME ,OVARIAN ANTRAL FOLLICULE NUMBER,OVARIAN STROMAL BLOODFLOW AND OVARIAN ARTERIAL RESISTANCE WAS MEASURED USING DOPPLER ULTRASONOGRAM.

Eligibility criteria: Inclusion Criteria:

* LESS THAN 35 YEARS OLD,
* MARRIED WOMEN
* SHOULD HAVE REGULAR MENSES
* SHOULD HAVE AT LEAST A YEAR OF UNPROTECTED SEX.

Exclusion Criteria:

* HAVING ANY SYSTEMIC DISEASE.
* LONG HISTORY OF ANY DRUG USAGE.

Primary outcomes:
measure: LEVELS OF OVARIAN RESERVE MARKERS IN THE SERUM
timeFrame: ONE DAY
Secondary outcomes:
measure: ULTRASONOGRAPHIC ASSESSMENT OF OVARIAN RESERVE MARKERS
timeFrame: ONE DAY
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Ktu Farabi Hospital
Study officials:
affiliation: KARADENIZ TECHNICAL UNIVERSITY -MEDICAL FACULTY
name: SULEYMAN GUVEN
role: PRINCIPAL_INVESTIGATOR
References: