louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04199975: Customized Self-Controlled Power-Driven or Mechanical Orthoses for the Upper Limb - A Pilot Study
Official title: Customized Self-Controlled Power-Driven or Mechanical Orthoses for the Upper Limb - A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Upper Limb Deformities, Congenital
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Patients with congenital or acquired upper limb structural abnormalities and peripheral nerve or brachial plexus palsies have significant loss of function. The use of orthoses may improve function particularly in performing specific tasks for which the orthoses are designed, depending on the patients' deficiencies and needs. The performance of orthoses may be enhanced by being light-weight, motor-driven, and ergonomic.

This pilot, prospective study is designed to test the feasibility and effectiveness of the specially designed orthoses.


Eligibility criteria: Inclusion Criteria:

* Patients with any congenital or acquired upper limb structural abnormalities
* Patients' condition is not suitable for surgical intervention or patients are not keen for surgical treatment

Exclusion Criteria:

* Patients have no available muscle signal input
* Patients fitted with a pacemaker or an implantable cardioverter defibrillator (ICD) or other implantable electrical devices
* Patients with contact dermatitis

Primary outcomes:
measure: Visual Analogue Scale (VAS) Pain Score
timeFrame: Baseline
measure: Visual Analogue Scale (VAS) Pain Score
timeFrame: 1-week after
measure: Short-Form Survey (SF-36)
timeFrame: Baseline
measure: Short-Form Survey (SF-36)
timeFrame: 1-week after
measure: Active and passive range of motion (ROM)
timeFrame: Baseline
measure: Active and passive range of motion (ROM)
timeFrame: 1-week after
measure: Disability of Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: Baseline
measure: Disability of Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: 1-week after
measure: Patients' Satisfaction Score
timeFrame: Baseline
measure: Patients' Satisfaction Score
timeFrame: 1-week after
measure: Grip Strength
timeFrame: Baseline
measure: Grip Strength
timeFrame: 1-week after
Secondary outcomes:
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Chu Kay Michael Mak, FRCSEd(Orth)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00775775: Fatigue, Sleep Disorders and Endocrine Abnormalities in TBI Patients
Official title: The Relationship Between Fatigue, Sleep Disorders and Endocrine Abnormalities Following Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Brain Injury
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2008-10-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will consist of 50 participants taken from the outpatient brain injury program at Kessler.

Brief summary: This study will test if patients with moderate to severe traumatic brain injuries also have endocrine abnormalities, examine any existing relationships among fatigue, depression and endocrine abnormalities, and the relationship between endocrine abnormalities, quality of life, and community integration.


Eligibility criteria: Inclusion Criteria:

* Having moderate to severe TBI at least 3 months prior to enrollment. This can be demonstrated by a history of loss of consciousness, amnesia or another neurologic deficit after brain injury
* Be between the ages of 18 and 70 years

Exclusion Criteria:

* History of prior TBI, stroke, seizures, severe psychiatric disturbances (i.e., those known to influence memory performance, such as schizophrenia, bipolar disorder), or drug abuse will be excluded.
* Pregnant, nursing, or planning pregnancy during the study period.
* Dementia
* Other neurological conditions which are associated with aging and known to cause fatigue (e.g. Parkinson's Disease)

Primary outcomes:
measure: To further study the incidence of fatigue and endocrine abnormalities in an outpatient TBI population
timeFrame: 1 year
Secondary outcomes:
measure: To study the relationship between fatigue and endocrine abnormalities
timeFrame: 1 year
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation Research Center
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Anthony Lequerica, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01022775: Dynamic Humeral Centering in Impingement Syndrome
Official title: Assessment of Dynamic Humeral Centering in Impingement Syndrome: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Degenerative Rotator Cuff Disease With Impingement Syndrome
Keywords: Degenerative rotator cuff disease
Impingement syndrome
Dynamic humeral centering
Randomized clinical trial
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Societe Francaise de Rhumatologie
First posted: 2009-12-01
Enrollment: 70
Sex: ALL
Minimum age (years): 31
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine wether dynamic humeral centering is effective in patients with impingement syndrome of the shoulder

Detailed description: Clinical trial with randomization for treatment and physiotherapist

Eligibility criteria: Inclusion Criteria:

* age \> 30 years
* pain duration \> 1 month
* presence of at least 2 positive impingement test results from Neer, Yocum and Hawkins testing
* total Constant score \< 80.

Exclusion Criteria: concerning the shoulder

* stiffness
* anteroposterior instability
* tendinous calcification
* corticosteroid injection within the previous 30 days
* previous surgery
* humeral fracture
* inflammatory joint disease
* neoplastic disorders

Primary outcomes:
measure: Constant total score as a mean and by category
timeFrame: at 3 months
Secondary outcomes:
measure: Constant total score
timeFrame: at 12 months
measure: Constant subscores for pain, activity, mobility and strength, and self-assessed disability on a 0- to 100-point visual analog scale, and analgesic and nonsteroidal anti-inflammatory drug (NSAID) use
timeFrame: at 3 months
measure: Constant subscores for pain, activity, mobility and strength, and self-assessed disability on a 0- to 100-point visual analog scale, and analgesic and nonsteroidal anti-inflammatory drug (NSAID) use
timeFrame: at 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Department of Rheumatology, Lariboisière Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Johann BEAUDREUIL, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beaudreuil J, Ostertag A, Lasbleiz S, Vicaut E, Yelnik A, Bardin T, Orcel P. Efficacy of dynamic humeral centering according to Neer test results: a stratified analysis of a randomized-controlled trial. Int J Rehabil Res. 2015 Mar;38(1):81-3. doi: 10.1097/MRR.0000000000000079.
citation: Beaudreuil J, Lasbleiz S, Richette P, Seguin G, Rastel C, Aout M, Vicaut E, Cohen-Solal M, Liote F, de Vernejoul MC, Bardin T, Orcel P. Assessment of dynamic humeral centering in shoulder pain with impingement syndrome: a randomised clinical trial. Ann Rheum Dis. 2011 Sep;70(9):1613-8. doi: 10.1136/ard.2010.147694. Epub 2011 May 29.
Clinical trial NCT04606875: Correlation of Campbell Score With Suicidal Ideation
Official title: Assessment of Campbell Score as a Means of Predicting Suicidal Ideation High Risk Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Suicidal Ideation
Keywords: interleukin-6, suicidal ideation, immunology
Lead sponsor: Therapeutic Solutions International
Sponsor class: INDUSTRY
First posted: 2020-10-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will comprise of 10 healthy volunteers, as well as 20 patients with suicidal ideations. 10 of the patients will have low acquired capability for suicide, and 10 will have high acquired capability for suicide.

Brief summary: The Campbell Score is a blood based means of assessing molecules believed to be associated with suicidal ideation and in some cases successful suicide.

The current clinical trial will assess the Campbell Score in 3 groups:

Group 1: 10 patients with no personal or family psychiatric history and no suicide attempts.

Group 2: 10 patients with suicidal ideation (Hamilton Depression Rating Scale suicide item \>2) and reported low acquired capability for suicide (Acquired Capability for Suicide Scale \<20).

Group 3: 10 patients with suicidal ideation (Hamilton Depression Rating Scale suicide item \>2) and reported high acquired capability for suicide (Acquired Capability for Suicide Scale \>60).

The goal of the study is to confirm efficacy of Campbell Score in identifying patients with high suicidal ideation potential.


Eligibility criteria: Inclusion Criteria:

* Capability of giving informed consent
* Agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study.
* Be diagnosed with Suicide ideation/attempts/gestures

Exclusion Criteria:

- Not currently pregnant or lactating (due to potential confounding of brain activity as a result of differing hormone levels)

Primary outcomes:
measure: Assessment of Campbell Score
timeFrame: 1 week to compare the records with the Campbell Score
measure: Assessment of Correlation between Campbell Score and Beck Scale for Suicidal Ideation
timeFrame: 1 week to compare the records with the Campbell Score
Secondary outcomes:
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: Therapeutic Solutions International
state: California
Study officials:
References:
Clinical trial NCT06380075: COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Inherited Retinal Disease
Official title: COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Inherited Retinal Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Retinal Disease
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this research study is to compare two ultrawide field cameras to the gold standard imaging system to evaluate the back of the eye. The main question it aims to answer is the same results and information can be acquired from all of the cameras for evaluating and monitoring inherited retinal diseases (IRDs).

Participants will:

* undergo pupillary dilation
* have photographs taken of the inside of the eyes using three different cameras


Eligibility criteria: Inclusion Criteria:

* Participants 18 years and older with a clinical and/ or genetic diagnosis of IRD recruited either from the clinic and/or the Inherited Ocular Disease Registry to participate in this trial
* Participants that are willing to participate as evidenced by signing the written informed consent

Exclusion Criteria:

* Presence of ocular conditions other than an IRD which may affect the quality of ocular imaging including but not limited to advanced cataracts, corneal disorders, nystagmus, vitreous hemorrhage, or poor dilation
* Presence of ocular conditions other than an IRD which may affect interpretation of retinal imagining including but not limited to epiretinal membrane, choroidal neovascular membrane, or macular scarring
* Patients with advanced IRDs who are unable to fixate for imaging
* Patients unable to tolerate ocular imaging
* Patients who do not wish to participate

Primary outcomes:
measure: Compare FAF retinal patterns by Clarus and standard Spectralis FAF imaging
timeFrame: Up to 2 hours
measure: Compare FAF retinal patterns by Optos and standard Spectralis FAF imaging
timeFrame: Up to 2 hours
measure: Compare FAF retinal patterns by Clarus and Optos FAF imaging
timeFrame: Up to 2 hours
measure: Compare Spectralis FAF imaging to Spectralis OCT imaging
timeFrame: Up to 2 hours
Secondary outcomes:
measure: Prevalence of FAF retinal pattern changes beyond the standard 30 degress in Clarus and Optos ultrawide field images
timeFrame: Up to 2 hours
measure: Prevalence of other autofluorescence abnormalities unique to the IRD across all imaging
timeFrame: Up to 2 hours
Other outcomes:
Locations:
city: Madison
country: United States
facility: Department of Ophthalmology and Visual Sciences
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Kimberly Stepien, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01615575: Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy
Official title: Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy. A Randomized Trial With Long-term Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Haemorrhoids
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2012-06-08
Enrollment: 124
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: The aim of the present study was to compare the results of transanal haemorrhoidal dearterialisation and stapler haemorrhopidopexy in the treatment of grade III and IV haemorrhoids with a long-term follow-up.


Eligibility criteria: Inclusion Criteria:

* grade III and IV hemorrhoids requiring hemorrhoidectomy.

Exclusion Criteria:

* first and second degree hemorrhoids
* patients with firm and fibrotic external irreducible haemorrhoids
* thrombosed hemorrhoids; recurrent hemorrhoids after previous surgical treatment
* history of inflammatory bowel disease; history of colon, rectal or anal cancer
* inability to give informed consent
* age \< 18 years
* pregnant women.

Primary outcomes:
measure: Recurrence
timeFrame: 42 months
Secondary outcomes:
measure: Postoperative pain
timeFrame: 24 hr
measure: Complications
timeFrame: One month
Other outcomes:
Locations:
city: Dubai
country: United Arab Emirates
facility: The City Hospital
Study officials:
name: Pierino Lucarelli, MD, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06100575: Tool for Sibling and Children of Someone With Suicidal Thoughts
Official title: A Tool for Siblings and Children of Someone With Suicidal Thoughts and/or Behaviors: Evaluation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 29
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study aims to investigate to what extent a website developed for siblings and children (16-25 years old) of someone with suicidal thoughts and/or behaviors is effective in improving perceived pressure, knowledge, attitudes, self-confidence and hopelessness. Moreover, it aims to examine how participants evaluate the website.


Eligibility criteria: Inclusion Criteria:

* Siblings and children of someone who has suicidal thoughts and/or behavior
* 16-25 years old
* Have access to internet
* Speak Dutch

Exclusion Criteria:

* /

Primary outcomes:
measure: Changes in self-efficacy: Gatekeeper Self-Efficacy Scale (Takahashi et al., 2020)
timeFrame: Change from Baseline (before intervention) to post-test (after 3 days of access to website)
Secondary outcomes:
measure: Changes in perceived pressure: Perceived pressure informal care ('Ervaren druk informele zorg', Pot et al., 1995)
timeFrame: Change from Baseline (before intervention) to post-test (after 3 days of access to website)
measure: Changes in attitudes: 5 subscales of Attitudes Towards Suicide Scale (Rensberg & Jacobson, 2003; De Clerck et al., 2006)
timeFrame: Change from Baseline (before intervention) to post-test (after 3 days of access to website)
measure: Changes in hopelessness: Beck Hopelessness Scale (4-item version; Beck et al., 1974; Aish & Wasserman, 2001) and self-developed questionnaire
timeFrame: Change from Baseline (before intervention) to post-test (after 3 days of access to website)
measure: Changes in self-care and awareness
timeFrame: Change from Baseline (before intervention) to post-test (after 3 days of access to website)
measure: Evaluation of the website
timeFrame: post-test (after 3 days of access to website)
Other outcomes:
measure: Socio-demographic characteristics
timeFrame: Baseline
measure: Characteristics of the suicidal family member
timeFrame: Baseline
Locations:
city: Ghent
country: Belgium
facility: Flemish Centre of Expertise in Suicide Prevention, Ghent University
Study officials:
affiliation: University Ghent
name: Gwendolyn Portzky, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00116675: Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects
Official title: A Single-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel Applied 3 Times Per Week for 4 Weeks for the Treatment of Common Warts in Pediatric Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Warts
Keywords: Common Wart(s)
Pediatric
Wart(s)
Children
3M Pharmaceuticals
Resiquimod
Lead sponsor: Graceway Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2005-07-01
Enrollment: 84
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the effectiveness in pediatric subjects of three different strengths of resiquimod gel applied to common wart(s) three times a week for four weeks.

A second purpose is to evaluate the safety of the drug.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of common warts
* Ages between 3 to 11

Exclusion Criteria:

* Other types of wart(s), ie. plantar
* Currently participating in another clinical study
* Chronic viral hepatitis B or C

Primary outcomes:
measure: Clearance of treated wart(s)
Secondary outcomes:
measure: Partial clearance of treated wart(s)
measure: Wart recurrence
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Children's Clinic of Jonesboro, PA
state: Arkansas
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: Longmont
country: United States
facility: Longmont Clinic/Longmont Medical Research Network
state: Colorado
city: St. Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Providence
country: United States
facility: Rhode Island Hospital - Jane Brown Building
state: Rhode Island
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Pleasant Grove
country: United States
facility: Alpine Pediatrics
state: Utah
city: Walla Walla
country: United States
facility: Walla Walla Clinic
state: Washington
city: Milwaukee
country: United States
facility: Advanced Healthcare
state: Wisconsin
Study officials:
References:
Clinical trial NCT03119675: Evaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population
Official title: Prospective Evaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amblyopia
Keywords: Myopia
Hyperopia
Anisometropia
Amblyopia Risk Factors
Risk Factors
Smartphone Application (App)
Photoscreening
Vision Screening
Mobile Vision Screening
Lead sponsor: Gobiquity Mobile Health
Sponsor class: INDUSTRY
First posted: 2017-04-18
Enrollment: 358
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Objective: Prospective evaluation of GoCheckKids™, a smartphone application ('App') as a photo screening device in a pediatric population to detect amblyopia risk factors (ARFs)

Method: Photorefraction images are captured using up to 4 different devices with GoCheckKids™ App and patients are evaluated with cycloplegic refraction.


Eligibility criteria: Inclusion Criteria:

* Age 12 months to 6 years inclusive.
* Informed consent given by parent or legal guardian.

Exclusion Criteria:

* History of ocular surgery and any condition that would preclude the ability of the investigator to obtain a reliable image and measurement

Primary outcomes:
measure: Sensitivity and specificity of amblyopia risk factors detected by photo refraction
timeFrame: 1 Day
Secondary outcomes:
measure: Number of patients with gaze error identified by photo screening
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University
name: Sean Donahue, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: