louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01102842: Unattended In-home Sleep Recording: A Pilot Study
Official title: Unattended In-home Sleep Recording: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2010-04-13
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult volunteers (18 years of age and older) who have had a polysomnography recording in the laboratory at the University of Chicago.

Brief summary: Laboratory studies have found that insufficient sleep duration and impaired sleep quality are associated with disease risk, including obesity, diabetes and heart disease. The limitation to the laboratory studies is that they are conducted in artificial environments that do not reflect real-world behavior. Although the epidemiologic studies do reflect habitual behavior, the vast majority of them rely on self-reported measures of sleep, which are only moderately correlated with objective measures of sleep.. The next logical step in the examination of sleep's role in cardiometabolic health is to conduct objective, detailed measures of sleep in people's homes. This project is a pilot study that will develop ideal methodologies for recording sleep in the home environment. Because there is currently is a gap between laboratory models of sleep loss and real world conditions, the ultimate goal of this research is to expand our work on sleep and cardiometabolic health outside of the laboratory. Given the strong evidence for a link between impaired and insufficient sleep and increased disease risk, it is critical that we understand how people sleep in their daily lives and what factors can impact sleep. This project will record sleep in people's homes using ambulatory polysomnography recordings and wrist actigraphy.


Eligibility criteria: Inclusion Criteria:

* Must have had a polysomnography recording at the University of Chicago.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Sleep Architecture
timeFrame: once
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Kristen Knutson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03822806: Augmenting Patching Treatment for Amblyopia With Physical Exercise
Official title: Augmenting Patching Treatment for Amblyopia With Physical Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amblyopia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 4
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Researches are trying to establish whether moderate exercise enhances the treatment benefit of patching 2 hours a day for residual amblyopia in children.


Eligibility criteria: Inclusion Criteria:

* Aged 5 to \< 17 years old
* Cycloplegic refraction within past year
* Diagnosis of residual amblyopia, with no evidence of regression of amblyopic eye visual acuity by 1 or more LogMAR from best previous
* Completed at least 6 months prior patching treatment (minimum 2 hours/day) or atropine treatment.
* Stable visual acuity as defined by \<1 LogMAR change over 2 visits
* Xbox 360 Kinect, Wii or WiiU gaming system in the home, or a different gaming system with a version of Just Dance® already in the home.

Exclusion Criteria:

* Known problems with exercise tolerance
* No gaming system in the home that supports Just Dance® Kids 2014, and no existing version of Just Dance® in the home
* Current atropine treatment for amblyopia

Primary outcomes:
measure: Visual Acuity
timeFrame: 1 month (3 weeks to 8 weeks) after initiating game play
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Erick Bothun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05323006: Scapular Stabilization Exercises on the Clavicular Movement
Official title: The Effect of the Scapular Stabilization Exercises on the Clavicular Movement on the Girl Adolescents,
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clavicle
Keywords: adolescent,
clavicula,
scapula,
exercise
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 40
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study was planned to indicate efficiacy of the scapular stabilization exercises on the clavicula movements.

Detailed description: All subjects in the study were evaluated for range of motion (Goniometer), muscle strength (Manuel Muscle Strength Test), angular displacements of clavicula during abduction and skapular plan elevation of arm (Video Analysis Method), disability of the arm (Quıck Dash Turkish). The study was applied in two groups for three times per week during 8 weeeks.

Eligibility criteria: Inclusion Criteria:

* Having no ınjury for lower anda upper extremites

Exclusion Criteria:

* Having ınjury for lower anda upper extremites

Primary outcomes:
measure: the effect of the scapular stabilization exercises
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Şehi̇tkami̇l
country: Turkey
facility: Hasan Kalyoncu Üniversitesi
state: Gazi̇antep
Study officials:
affiliation: HKU
name: GÖNÜL ELPEZE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01352806: Identification of the Lumbar Interspinous Spaces; Palpation Versus Ultrasound Versus Fluoroscopy
Official title: Identification of the Lumbar Interspinous Spaces; Palpation Versus Ultrasound Versus Fluoroscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Accuracy of Identifying the Intralaminar Space
Keywords: accuracy of identifying intralaminar space
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-05-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The of epidurals and spinals, relies primarily on palpation of anatomic landmarks that are not always easy to find, More so, even after correct identification of palpable landmarks, Variability exists leading to performing neuraxial injection in undetermined intralaminar level. The most accurate method for identifying the interspace is the using of the fluoroscopy or CT technique, but exposure to radiation and availability make it unpractical in majority of cases. As ultrasound technology becomes more accessible to the clinician, it holds great potential to facilitate performing neuraxial anesthesia by the anesthesiologist in routine cases.

The aim of this study to compare the accuracy of identifying the intervertebral space, between manual palpation, versus ultrasound versus fluoroscopy.

Detailed description: Neuraxial anesthesia relies upon a sound knowledge of anatomy to accurately direct needle placement both to achieve consistent success, and to avoid damage to other nearby structures. This prospective randomized study, will be performed in the pain management unit. We will assess patients who are scheduled to receive an epidural steroid injection. The investigator will request permission fro the ethics committee of Hadassah Medical Hospital.

Three anesthesiologist will perform this study, every one of the anesthesiologist will be asked to identify intralaminar space by one technique and we will compare the accuracy of the identifying of the intralaminar space.

Eligibility criteria: Inclusion Criteria:

* Patient scheduled for epidural steroid injection under fluoroscopy technique.
* Age above 18 years

Exclusion Criteria:

* Inability to understand consent form.
* refusing to sign the consent form.
* contraindication for neuraxial injection.
* local or systemic infection.
* pregnant women.
* previous spine surgery.

Primary outcomes:
measure: accuracy of identifying the intralaminar space
timeFrame: one year
Secondary outcomes:
measure: Patient satisfaction
timeFrame: one year
Other outcomes:
Locations:
city: Jerusalem 91120
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Fayez Saifi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01686906: Isolated Bowman Layer Graft for Reducing and Stabilizing Advanced Keratoconus
Official title: Mid-stromal Isolated Bowman Layer Graft Implantation to Reduce and Stabilize Advanced Keratoconus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Keratoconus
Keywords: Keratoconus
Bowman layer
Lead sponsor: Netherlands Institute for Innovative Ocular Surgery
Sponsor class: OTHER
Collaborators: name: Amnitrans Eyebank Rotterdam
First posted: 2012-09-18
Enrollment: 35
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of mid-stromal implantation of an isolated Bowman layer graft, to reduce and stabilize ectasia in eyes with advanced keratoconus


Eligibility criteria: Inclusion Criteria:

•Advanced keratoconus

Exclusion Criteria:

* Further ophthalmic diseases
* History of ocular surgery
* Pregnancy, brest feeding

Primary outcomes:
measure: Corneal power
timeFrame: 2011-2020
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: 2011-2020
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Netherlands Institute for Innovative Ocular Surgery
Study officials:
affiliation: Netherlands Institute for Innovative Ocular Surgery
name: Gerrit RJ Melles, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Dijk K, Liarakos VS, Parker J, Ham L, Lie JT, Groeneveld-van Beek EA, Melles GR. Bowman layer transplantation to reduce and stabilize progressive, advanced keratoconus. Ophthalmology. 2015 May;122(5):909-17. doi: 10.1016/j.ophtha.2014.12.005. Epub 2015 Jan 14.
citation: van Dijk K, Parker J, Tong CM, Ham L, Lie JT, Groeneveld-van Beek EA, Melles GR. Midstromal isolated Bowman layer graft for reduction of advanced keratoconus: a technique to postpone penetrating or deep anterior lamellar keratoplasty. JAMA Ophthalmol. 2014 Apr 1;132(4):495-501. doi: 10.1001/jamaophthalmol.2013.5841.
citation: Groeneveld-van Beek EA, Parker J, Lie JT, Bourgonje V, Ham L, van Dijk K, van der Wees J, Melles GR. Donor Tissue Preparation for Bowman Layer Transplantation. Cornea. 2016 Dec;35(12):1499-1502. doi: 10.1097/ICO.0000000000000905.
citation: Parker JS, van Dijk K, Melles GR. Treatment options for advanced keratoconus: A review. Surv Ophthalmol. 2015 Sep-Oct;60(5):459-80. doi: 10.1016/j.survophthal.2015.02.004. Epub 2015 Mar 5.
citation: van der Star L, van Dijk K, Vasiliauskaite I, Dapena I, Oellerich S, Melles GRJ. Long-Term Outcomes of Bowman Layer Inlay Transplantation for the Treatment of Progressive Keratoconus. Cornea. 2022 Sep 1;41(9):1150-1157. doi: 10.1097/ICO.0000000000002871. Epub 2021 Oct 5.
Clinical trial NCT02043106: Can Vibration Stimulation of the Foot Sole Activate Leg Muscles?
Official title: Plantar Cutaneous Stimulation Used to Elicit Muscle Activity in Individuals With Incomplete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: Wilfrid Laurier University
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Participants will be asked to complete three different tests (standing, stepping and assisted walking) and will experience three different experimental conditions during each test. The three conditions are types of vibratory plantar cutaneous stimulation, which include no vibratory stimulation, submaximal vibratory stimulation and supramaximal vibratory stimulation. In the first condition, participants will experience no stimulation applied to any part of the body. In the second condition, a submaximal vibratory stimulus will be delivered at 90% of the participant's threshold to the surface of the foot. In the third condition, a supramaximal vibratory stimulus will be delivered at three times the participant's threshold. The hypothesis is that this plantar stimulation (90% threshold and supramaximal) will elicit increased muscle activity during these tests. If the hypothesis is positive then this protocol will also be presented in incomplete spinal cord injuried participants.


Eligibility criteria: Inclusion Criteria:

* no spinal cord injury

Exclusion Criteria:

* any musculoskeletal or neurological disease that affects movement or balance

Primary outcomes:
measure: Muscle activity
timeFrame: up to 2 months after experiment
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Biomechanics Lab, Wilfrid Laurier University
state: Ontario
Study officials:
affiliation: Wilfrid Laurier University
name: Stephen D Perry, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01888406: Binge Eating Self-help Treatment for University Students
Official title: Targeting Binge Eating to Prevent Weight Gain in College Students
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Binge Eating Disorder
Keywords: Obesity
Weight gain prevention
Eating disorder
Binge eating
Lead sponsor: Wesleyan University
Sponsor class: OTHER
Collaborators: name: Wesleyan University
First posted: 2013-06-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: BEST4US compares the effectiveness of two forms of self-help interventions that target college students, ages 18 years to 22 years, who report binge eating. The overall question is whether one or the other format will prevent excess weight gain and lead to differences in eating behaviors. The two formats are (1) "pure self-help" (receipt of a self-help program via book form or online texts) and (2) a combination of the self-help program and guidance provided by a trained peer coach over the course of 8 weekly sessions.


Eligibility criteria: Inclusion Criteria:

* binge eating episodes at least once per week in the past 28 days
* 18 to 22 years old
* full-time student at Wesleyan University (Middletown, CT, USA) or Manchester Community College (Manchester, CT, USA)

Exclusion Criteria:

* purging more than once per week in the past three months
* BMI less than 18 or greater than/equal to 40
* currently pregnant
* severe depressive symptoms or suicidality

Primary outcomes:
measure: BMI
timeFrame: Baseline, post-intervention (8-week), and 6-month follow-up
Secondary outcomes:
measure: Cessation of Binge Eating
timeFrame: Baseline, post-intervention (8-week), and 6-month follow-up
Other outcomes:
Locations:
city: Manchester
country: United States
facility: Manchester Community College Department of Psychology
state: Connecticut
city: Middletown
country: United States
facility: Wesleyan University Department of Psychology
state: Connecticut
Study officials:
affiliation: Wesleyan University
name: Ruth Striegel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Manchester Community College
name: Francine Rosselli, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04687306: Reliability of Sacral Slope, Pelvic Femoral Motion and Cup Ante-inclination on AP Pelvic Radiographs in Healthy Pts
Official title: Inter-observer Reliability of Sacral Slope, Pelvic Femoral Motion and Cup Ante-inclination on Anteroposterior Pelvic Radiographs in Healthy Individuals.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 33
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy individuals, both male and females aged 25-50 without major co-morbidities and without spine/hip/pelvis issues including previous injuries or surgeries

Brief summary: Currently, there are no validated anatomical landmarks that can be used to predict risk of and diagnose abnormal patterns of pelvic motion.This proposed study will measure sacral slope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions, using healthy individuals without a history of spinal and/or lower extremity pathology. All radiographs will be evaluated for the three measurements by four individuals with the intent of evaluating inter-observer reliability. Determining the reproducibility of these angles between observers will give insight into the potential clinical utility of these measurements in evaluating and treating patients with hip-spine syndrome.

Detailed description: The purpose of this study is to evaluate the mechanics and influence of spinopelvic motion and balance from normal healthy subjects for the purpose of establishing radiographic measurements which are reliable and reproducible and which could give insight into the potential clinical utility of these measurements as future predictors of who may/may not have spinal pelvic issues and in evaluation and treatment of patients with hip-spine syndrome.

This specific objective of this study will be to measure sacral slope, pelvic femoral angle and cup ante-inclination via radiographs in both sitting and standing positions. The radiographs will be evaluated for the three measurements by four individuals with the intent of evaluating inter-observer reliability.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals without major co-morbidities and without spine/hip/pelvis issues including previous injuries or surgeries

Exclusion Criteria:

* no history of spine/hip/pelvis issues
* females who are trying to get pregnant

Primary outcomes:
measure: Intraclass correlation coefficient (ICC) for Consistency in Spinopelvic Radiographic Measurements.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Kevin L Garvin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00802906: Bevacizumab Versus Micropulse in Central Serous Chorioretinopathy (CSC)
Official title: Prospective Study on the Efficacy of 1.5mg Bevacizumab Versus Selective Subthreshold Micropulslaser in Central Serous Chorioretinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Serous Chorioretinopathy
Keywords: micropulselaserphotocoagulation
bevacizumab
CSC
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2008-12-05
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical efficacy of an initial subthreshold retinal micropulselasercoagulation versus a single intravitreal 1.5mg bevacizumab injection in central serous choriretinopathy, as the micropulse will selectively treat the damaged RPE to induce reproliferation of healthy RPE cells, whereas the intravitreal injection should non-selectively stop the RPE leakage.

Detailed description: To evaluate the clinical efficacy of an initial subthreshold retinal micropulselasercoagulation in twelve eyey per group versus a single intravitreal 1.5mg bevacizumab injection in central serous choriretinopathy, as the micropulse will selectively treat the damaged RPE to induce reproliferation of healthy RPE cells. BCVA in EDTRS score, OCT, and leakage in FLA, static perimetry of both groups will be correlated to a control group without treatment over 10 months.

Eligibility criteria: Inclusion criteria:

* CSC of \>4 months duration

Exclusion Criteria:

* History of macular or chorioretinal inflammation
* Lens / corneal opacities

Primary outcomes:
measure: BCVA in EDTRS values
timeFrame: 24 months
Secondary outcomes:
measure: OCT, leakage in FA, defects in satic perimetry
timeFrame: 24 months
Other outcomes:
Locations:
city: Frankfurt / Main
country: Germany
facility: ZAU Department of VR surgery
state: Hessen
Study officials:
affiliation: ZAU Department of Vitreoretinal surgery
name: Michael Koss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koss MJ, Beger I, Koch FH. Subthreshold diode laser micropulse photocoagulation versus intravitreal injections of bevacizumab in the treatment of central serous chorioretinopathy. Eye (Lond). 2012 Feb;26(2):307-14. doi: 10.1038/eye.2011.282. Epub 2011 Nov 11.