louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01947517: The Retention Rate Between Brand A and Brand B Punctal Plugs
Official title: The Retention Rate Between Superflex Punctal Plugs, and Parasol Punctal Occluders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2013-09-20
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited from cornea and general ophthalmology specialist practices at Hotel Dieu Hospital, Queens University

Brief summary: The purpose of this study is to determine if Parasol punctal occluders (Brand A) have a higher rate of retention than Superflex punctal plugs (Brand B).

Detailed description: Eyes will be randomized to either Brand A or Brand B punctal plug. The primary outcome measure is length of time punctual plugs are retained, measured in months. This will be measured at monthly assessments for 6 months. Secondary outcome measures include patient satisfaction, and improvement in subjective and objective dry eye scores, as well as complications related to punctual plugs including spontaneous plug loss, and intolerance. We will evaluate these measures by repeating the Canadian Dry Eye Assessment, Schirmer 1, tear meniscus height, fluorescein corneal staining (NEI scale), and lissamine green conjunctival staining (NEI scale) at month 1, month 3, and month 6 visits.

Eligibility criteria: Inclusion Criteria:

* moderate dry eye, severe dry eye

Exclusion Criteria:

* silicone allergy, punctal stenosis, punctal occlusion, punctal cautery

Primary outcomes:
measure: Length of Retention
timeFrame: 6 months
Secondary outcomes:
measure: Canadian Dry Eye Assessment Score
timeFrame: 6 months
measure: National Eye Institute Corneal Fluorescein Staining Pattern
timeFrame: 6 months
measure: National Eye Institute Grading for Conjunctival Staining
timeFrame: 6 months
measure: Tear Meniscus Height
timeFrame: 6 months
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Department of Ophthalmology, Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Queens University
name: Ashley R Brissette, BSc, MD
role: STUDY_DIRECTOR
affiliation: Queens University
name: Stephanie Baxter, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04520217: Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects
Official title: Pilot Studies Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Photosensitivity
Microvesicle Particle
Lead sponsor: Wright State University
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is three-fold. First, researchers will assess whether subjects who have clinically abnormal reactions to sunlight (photosensitivity) have increased levels of microvesicle particles (MVP) following ultraviolet B (UVB) treatment to localized area of skin. Second, researchers will assess if topical application of the medicine imipramine will block UVB-induced MVP release. Third, researchers will assess if the topical cream will block UVB-induced increased erythema reactions (reddening of the skin).


Eligibility criteria: Inclusion Criteria:

* Female and Male adult subjects age 18 to 50
* Must be able to give informed consent
* Have access to stable transportation
* All skin types on Fitzpatrick Scale (Type I-VI)
* Self-Identified photosensitivity
* Able to provide medical history and list of medications-control subjects will not be allowed to be taking a medication that is known to be photosensitizer.

Exclusion Criteria:

* Underlying diseases that could affect wound healing (e.g., uncontrolled diabetes mellitus)
* Taking medications that are known photosensitizers (e.g., doxycycline) or anti-inflammatories (e.g., NSAIDS \[except for low-dose aspirin\] or steroids)
* Utilizing imipramine or any other tricyclic antidepressant (oral or cream)
* Utilizing topical anti-inflammatory or systemic agents (e.g., prednisone)
* Large tattoos in the designated testing areas
* Tanning bed use within last 3 months
* Photodynamic Therapy or UVB treatments in past 3 months
* Female Subjects: pregnant or nursing
* History of abnormal scarring (i.e., keloids)

Primary outcomes:
measure: Change in microvesicle particle levels from baseline in clinically photosensitive subjects
timeFrame: 4 Hours
measure: Change in microvesicle particle levels from baseline post topical imipramine application
timeFrame: 4 Hours
measure: Change in skin erythema from baseline on topical imipramine treated skin
timeFrame: 4 Hours
measure: Change in skin erythema from baseline on topical imipramine treated skin
timeFrame: 24 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
Study officials:
affiliation: Wright State University
name: Jeffrey B Travers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07026617: Low Level Laser Therapy and Rocabado's Approach for Myogenic TMJ Disorders
Official title: Effectiveness of Adding Low Level Laser Therapy to Rocabado's Approach for Myogenic Temporomandibular Joint Disorders: A Double-Blind Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myogenic Temporomandibular Joint Disorders
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 42
Sex: ALL
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: Rocabado's 6x6 exercises are designed to improve muscular co-ordination, relax tense muscles, increase temporomandibular joint (TMJ) ROM, alter the jaw closure pattern and muscle strength. These exercises have been found to be beneficial in reducing pain and increasing masticatory muscle function, as well as restoring restricted joint mobility, muscle length limitation, and postural and functional limitations. In addition, low level laser therapy (LLLT) has been reported to reduce inflammation and pain in patients with TMJ dysfunction. Although that to the best of the authors' knowledge the combined effect of Rocabado's approach with LLLT has not been studied. So, the current study is the first double-blind placebo-controlled clinical trial that investigating the effect of adding LLLT to Rocabado's approach for TMJ myogenic disorders.


Eligibility criteria: Inclusion Criteria:

(1) The patient's ages ranged from 18 to 40 years ; (2) having symptoms of TMD for at least twelve weeks duration established by expert physician or orthopaedician; (3) mouth opening \< 25mm

Exclusion Criteria:

(1) TMJ fracture undergone any surgical procedure for TMJ; (2) Fracture surrounding TMJ; (3) Dislocation or subluxation of TMJ; (4) Systemic generalized joint diseases, such as rheumatoid arthritis, and osteoporosis, congenital diseases or facial paralysis; (5) recently any dental treatment taken or surgery over TMJ; (6) Hematological cervical disorders which may affect the jaw; (7) Neurological deficits e.g. Bells palsy, Trigeminal neuralgia; (8) Recent infections (within the last six months) affecting the head and neck e.g. bone infections, meningitis, encephalitis, malaria, ear infection; (9) Participants who were using any functional appliances e.g. dentures, braces, bite appliances which had been adjusted or fitted in the last 12 weeks prior to the commencement of this study.

Primary outcomes:
measure: Assessment of Pain pressure threshold of masticatory muscles
timeFrame: change from base line at 6 weeks.
Secondary outcomes:
measure: Assessment of Temporomandibular joint ROM
timeFrame: change from base line at 6 weeks.
measure: Assessment of the function of Temporomandibular Joints
timeFrame: change from base line at 6 weeks.
measure: Assessment of pain intensity using Numerical Rating Scale
timeFrame: change from base line at 6 weeks.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05943717: Lung Ultrasound Versus Cardiometry in Detection of Extravascular Lung Water in Pediatric Patients on Hemodialysis.
Official title: Lung Ultrasound Versus Cardiometry in Detection of Extravascular Lung Water in Pediatric Patients on Hemodialysis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid Volume Excess
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 children and adolescents with end stage renal disease on regular hemodialysis for three times weekly at TUH during the period of the study.

Inclusion criteria: Pediatric patients with end stage renal disease aged from 5 to 18 years on regular hemodialysis.

Exclusion criteria:

* Patients with coexisting lung fibrosis, atelectasis, and interstitial lung disease.
* Patients with heart failure.
* Patients with implantable cardiac pacemaker or defibrillator.

Brief summary: Comparing the efficacy of both lung ultrasound and electrical cardiometry to detect the extravascular lung water and volume status in pediatric patients on regular hemodialysis and use them as non-invasive methods for early detection of hypervolemia or euvolemia even before appearance of clinical symptoms to decrease morbidity and mortality

Detailed description: This cross sectional study will be conducted to compare between the efficacy of both lung ultrasound and electrical cardiometry to detect the extravascular lung water and volume status in pediatric patients on regular hemodialysis and use them as a non-invasive method for early detection of hypervolemia or euvolemia even before appearance of clinical symptoms of both conditions.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients with end stage renal disease aged from 5 to 18 years on regular hemodialysis

Exclusion Criteria:

* Patients with coexisting lung fibrosis, atelectasis, and interstitial lung disease.
* Patients with heart failure.
* Patients with implantable cardiac pacemaker or defibrillator

Primary outcomes:
measure: volume status in pediatric patients on regular hemodialysis
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sara Mabrouk Mohamed Elghoul
Study officials:
affiliation: Tanta University
name: Sara Mabrouk Mohamed Elghoul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07015541: Quadriceps Strengthening ACL Reconstruction
Official title: Effects of Quadriceps Focused Interventions in Adolescent With ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ACL Tear
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of quadriceps focused interventions on knee function and biomechanics in adolescent patients with anterior cruciate ligament reconstruction (ACLR)


Eligibility criteria: Inclusion Criteria:

* no history of knee injury/surgery of the contralateral limb

Exclusion Criteria:

* (1) bilateral knee injuries
* (2) prior knee ligament injury and/or surgery
* (3) multiple ligament injuries and/or ruptures
* (4) conditions in which NMES and BFR are contraindicated

Primary outcomes:
measure: Peak force as measured by isometric knee extension force test
timeFrame: 16 weeks post surgery
measure: Force steadiness as measured by isometric knee extension force test
timeFrame: 16 weeks post surgery
Secondary outcomes:
measure: Sagittal plane peak angle at the hip during countermovement jump landing
timeFrame: 16 weeks post surgery
measure: Sagittal plane peak angle at the knee during countermovement jump landing
timeFrame: 16 weeks post surgery
measure: Sagittal plane peak angle at the ankle during countermovement jump landing
timeFrame: 16 weeks post surgery
Other outcomes:
Locations:
city: Sunnyvale
country: United States
facility: Stanford Medicine Children's Health
state: California
Study officials:
affiliation: Stanford School of Medicine
name: Alexandra M Abbott, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ohta H, Kurosawa H, Ikeda H, Iwase Y, Satou N, Nakamura S. Low-load resistance muscular training with moderate restriction of blood flow after anterior cruciate ligament reconstruction. Acta Orthop Scand. 2003 Feb;74(1):62-8. doi: 10.1080/00016470310013680.
citation: Kim KM, Croy T, Hertel J, Saliba S. Effects of neuromuscular electrical stimulation after anterior cruciate ligament reconstruction on quadriceps strength, function, and patient-oriented outcomes: a systematic review. J Orthop Sports Phys Ther. 2010 Jul;40(7):383-91. doi: 10.2519/jospt.2010.3184.
Clinical trial NCT03554434: An Expanded Access Program for AM0010 (Pegilodecakin)
Official title: An Expanded Access Program for AM0010 (Pegilodecakin) Subcutaneous Injection
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Melanoma
Prostate Cancer
Ovarian Cancer
Renal Cell Carcinoma
Colorectal Carcinoma
Pancreatic Carcinoma
Non-small Cell Lung Carcinoma
Solid Tumors
Breast Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: ARMO BioSciences
First posted: 2018-06-13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an Expanded Access Program (EAP) available to patients who have advanced cancers, who have failed or progressed on standard of care systemic therapy and do not qualify for ongoing clinical trials.


Eligibility criteria: * Patient is NOT eligible for other AM0010 clinical trials currently open in the region
* Patient is in urgent need of therapy who fail to meet eligibility criteria for other clinical trials related to AM0010 (PEG-IL-10) can be considered for enrollment into this Expanded Access Program.
* Patient has advanced cancer in indications where preliminary anti-tumor efficacy of AM0010 has been demonstrated or where AM0010 mediated immune activation is likely to benefit the patient.
* Patient has failed or progressed on standard of care (SOC) systemic therapy
* Patient is refusing SOC therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Eli Lilly and Company
name: Contact Lilly at 1-800-LillyRx (1-800-545-5979)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00496834: LAAS (Losartan Anti-Atherosclerosis Study)(0954-330)(COMPLETED)
Official title: A Randomized, Open-label, Comparative, Non-inferiority, Multicenter Study to Compare Efficacy of Losartan Potassium Group and Carvedilol Group on Arterial Stiffness in Essential Hypertension Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-07-04
Enrollment: 201
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 primary objective of this study is to evaluate efficacy, arterial stiffness measured by Pulse Wave Velocity (PWV) of Losartan potassium group compared to Carvedilol group after 24 weeks of treatment in patients with the essential hypertension.


Eligibility criteria: Inclusion Criteria:

* Male or Female adults, 18 years or over
* Essential Hypertension with mean SBP (systolic blood pressure) ≥ 140 mm Hg or mean DBP (diastolic blood pressure) ≥ 90 mm Hg\* when blood pressure is measured at Visit 1(week -2) and at Visit 2(week 0).

If diabetes patients, mean SBP ≥ 130 mm Hg or mean DBP ≥ 80 mm Hg (Mean of blood pressure values measured consecutively at least 2 minutes apart)

* Patient who is willing to, and is able to sign the informed consent form

Exclusion Criteria:

* Patient Is Pregnant Or Breastfeeding, Or Expecting To Conceive Within The Projected Duration Of The Study
* Patient Has Known Or Suspected Secondary Hypertension Of Any Etiology
* Patient has history of malignant hypertension
* Patient has history of cerebrovascular accident (cerebral infarction) or myocardiac infarction within the last 6 months
* Patient takes antihypertensive drugs

Primary outcomes:
measure: Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
timeFrame: Baseline and 24 Weeks
measure: PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
timeFrame: Baseline and 24 Weeks
Secondary outcomes:
measure: Systolic Blood Pressure (SBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
timeFrame: Baseline and 24 weeks
measure: Diastolic Blood Pressure (DBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05942534: Pediatric Mask Fit Study
Official title: Pediatric Mask Fit Study: Comparing the Performance of Cloth Masks, Procedure Masks With and Without Modifications and Respirators in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Tract Infections
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 102
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children ages 4 to 17 years able to wear a mask

Brief summary: This study will evaluate the performance of various face masks and respirators on children by examining their fitted filtration efficiency (FFE) and mask fit. It will also evaluate the impact of different types of mask modifications (for example, twisting the ear loops, tuck and tie) on FFE and mask fit, with the goal of determining how to optimize mask performance in children. It will also provide information on mask and respirator comfort and acceptability. This data will help inform public health messaging around mask choice for children and also modifications that can be made to improve fit for children who may not have access to various mask types.

Detailed description: This will be a prospective cross-sectional study of 200 children aged 4 to 17 years. Participants will be assigned to either the mask type assessment (Objective 1) or the mask modification assessment (Objective 2) and have a date and time scheduled for testing.

The mask type assessment will compare the FFE and fit factor of a cloth mask, child and adult medical mask, child and adult KN95 respirator, and N95 respirator. The mask modification assessment will compare the FFE and fit factor of a child medical mask, adult medical mask with and without modifications (tuck and tie, twisted ear loops), and child and adult N95 respirator. Quantitative fit testing will be conducted using a TSI Portacount Pro Respirator Fit Tester model 8038+. Testing will be performed in an identified designated area at the hospital or in the community (i.e., schools or community center), monitored for ventilation, temperature and humidity. We will also measure the ambient particles to ensure adequate particle count. The participants will be asked to evaluate the mask, respirator or modification based on a variety of criteria including comfort, breathability and acceptability. This will be completed immediately after the fit assessment.

Eligibility criteria: Inclusion Criteria:

* Aged 4-17
* able to tolerate wearing a mask

Exclusion Criteria:

* Children will be excluded if they have contraindications to wearing a mask.

Primary outcomes:
measure: Fitter filtration efficiency and fit factor
timeFrame: First visit (1 hour)
Secondary outcomes:
measure: Mask and respirator comfort and acceptability
timeFrame: First visit (1 hour)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References:
Clinical trial NCT02283034: Effectiveness of Pediatric Resuscitation
Official title: Quality of Chest Compressions During 8 Min of Single-rescuer Pediatric Cardiopulmonary Resuscitation With Five Different CPR Feedback Devices. Randomised Crossover Manikin Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrest
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare five CPR feedback devices to standard BLS in terms of the quality of single rescuer pediatric resuscitation. Therefore, the investigators hypothesis was that there would be no difference between CPR methods in terms of chest compression quality parameters.

Detailed description: Cardiac arrest is a leading cause of death worldwide. High-quality chest compressions are of paramount importance for survival and good neurological outcome. Unfortunately, even health professionals have difficulty performing effective CPR. Chest compression (CC) is often too shallow, compression ratio is inadequate, and hands-off time is too long. CPR feedback devices might be an option for rescuers to in order to increase CC efficiency.

Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* medical profession (paramedics, nurses, physicians) or medical students (nurses, paramedics, physicians)

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases

Primary outcomes:
measure: Effective compressions was defined as compression with correct depth (40-50mm), correct hand position and complete decompressions
timeFrame: 1 month
Secondary outcomes:
measure: Chest compression depth
timeFrame: 1 month
measure: Chest compression rate
timeFrame: 1 month
measure: effective compressions ratio was defined as effective compressions [%] multiplied by flow time [%]
timeFrame: 1 month
measure: Flow time was defined as the sum of all periods during which chest compressions were performed
timeFrame: 1 month
measure: absolute hands-off time was defined as the sum of all periods without chest compressions or ventilation
timeFrame: 1 month
measure: VAS (visual analogue scale)
timeFrame: 1 month
measure: Prefered CPR device
timeFrame: 1 month
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: Institute of Cardiology
name: Andrzej Kurowski
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Cardiology
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References: