louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05107414: Journey 2 Multi Center Kinematic Study
Official title: Multi-center In Vivo Kinematics for Subjects Implanted With Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Total Knee Arthroplasty
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants will be selected by their respective surgeons. Participants will be screened by eligible surgeon staff and will have the required implant for each site.

Brief summary: The objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs.


Eligibility criteria: Inclusion Criteria:

1. Patients in the age range of 18 years to 85 years (both inclusive)
2. Patients who have a BMI less than 35
3. Patients who do not have previous surgery on the implanted knee that might restrict their movement
4. Patient who are at least 6 months post-operative
5. Patients who do not experience any pain or other post-operative complications
6. Patients who have a stable TKA and can perform a deep knee bend activity
7. Patients who are willing to participate in this study and are willing to sign appropriate HIPAA and informed consent forms
8. Subjects will have a Journey II knee system

Exclusion Criteria:

1. Pregnant, potentially pregnant, or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
2. Patients who have currently enrolled in a fluoroscopic study within the past year.
3. Patients currently involved in any personal injury litigation, medical/legal or workman's compensation claims.
4. Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study.
5. Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability
6. Subjects who are unable to perform a deep knee bend.
7. Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
8. Subjects without the required type of knee implant.

Primary outcomes:
measure: Femorotibial Medial Condylar Rollback
timeFrame: Baseline, at time of observation
measure: Femorotibial Lateral Condylar Rollback
timeFrame: Baseline, at time of observation
measure: Femorotibial Axial Rotation
timeFrame: Baseline, at time of observation
measure: Femorotibial Weight Bearing Flexion
timeFrame: Baseline, at time of observation
Secondary outcomes:
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee
state: Tennessee
Study officials:
References:
Clinical trial NCT03592914: Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation Patients
Official title: Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Insufficiency
Lead sponsor: Nonin Medical, Inc
Sponsor class: INDUSTRY
Collaborators: name: Valley Inspired Products
First posted: 2018-07-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who might be seen in a respiratory rehabilitation center.

Brief summary: Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour.

Detailed description: Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour.

Objective(s):

The primary objective of this study is to evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3 by attempting to demonstrate a mean error for FTRR \< 1.0 BPM during spontaneous breathing.

Eligibility criteria: Inclusion Criteria:

* The subject is at least 18 years old;
* The subject has given written informed consent to participate in the study;
* The subject is both willing and able to comply with study procedures.

Exclusion Criteria:

* The subject has a history of or current atrial fibrillation;
* The subject has a documented history of frequent premature ventricular contractions (PVCs), defined as \>3 per 30 seconds;
* The subject has an implanted pacemaker;
* The subject has had any relevant injury at the sensor location site (self-reported);
* The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination);
* The subject is currently or trying to get pregnant (self-reported); and/or
* The subject has another health condition which in the opinion of the principal investigator makes subject unsuitable for testing.

Primary outcomes:
measure: Evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3
timeFrame: 40 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Plymouth
country: United States
facility: Nonin Medical, Inc.
state: Minnesota
Study officials:
References:
Clinical trial NCT03628014: The Hospital Elder Life Program at the Jewish General Hospital
Official title: A Measure of the Effects of the Hospital Elder Life Program at the Jewish General Hospital: a Pre-post Intervention Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Delirium
Fall Injury
Mortality
Keywords: older, hospital, program
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 51
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Older patients (i.e.; ≥ 65 years) with a hip fracture, and who are admitted to orthopedics for surgery are particularly at risk of adverse health events such as delirium, recurrent falls and prolonged hospital stay caused by their frailty status. The Hospital Elder Life Program (HELP) is a comprehensive inpatient-care program that ensures optimal care for older adults in the hospital and, thus, might reduce the incidence of postoperative adverse health events. The overall objective of this study is to examine in a quantitative fashion the effects of the HELP program on adverse health events in geriatric inpatients admitted to the orthopedic ward at JGH for surgery after a hip fracture.

Detailed description: Delirium and mobility impairment with high risk of falls are important medical complications after a hip surgery. More than 95% of hip fractures are caused by falling and the risk of a new fall after a hip surgery may be up to 50%. Both postoperative delirium and fall are associated with increased length of stay and high perioperative mortality.

The Hospital Elder Life Program (HELP) is a comprehensive inpatient-care program that ensures optimal care for older adults in the hospital. The primary goals of the HELP program are:

Maintaining cognitive and physical functioning of high risk older adults throughout hospitalization, maximizing independence at discharge, assisting with the transition from hospital to home, and preventing unplanned hospital readmissions. These goals have been accomplished using a multicomponent intervention strategy. In addition to targeted interdisciplinary geriatric assessment, the program uses an innovative volunteer model to provide personal, supportive attention to vulnerable older inpatients.

Eligibility criteria: Inclusion Criteria:

* age 65 and over
* admitted to orthopedic ward for hip surgery after a fracture

Exclusion Criteria:

* younger than 65 years of age
* palliative care

Primary outcomes:
measure: Presence of delirium after a hip surgery
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Number of falls before having a hip fracture
timeFrame: Up to one month
measure: In-hospital mortality
timeFrame: Up to one month
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Olivier Beauchet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03123614: Loteprednol vs. Prednisolone and Fluorometholone
Official title: Efficacy and Safety of Loteprednol 0.5% Gel for Routine Prophylaxis After Photorefractive Keratectomy Compared to Prednisolone Acetate 1% Suspension and Fluorometholone 0.1% Suspension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intraocular Pressure
Corneal Opacity
Keywords: Photorefractive keratectomy
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 131
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Corneal haze, in which the cornea becomes cloudy, is a well-known and a potentially vision-threatening postoperative complication of photorefractive keratectomy (PRK). Topical ophthalmic corticosteroids are routinely prescribed by most surgeons postoperatively to help prevent this complication.

Goals of topical steroids use after PRK include effective modulation of the healing response to prevent corneal haze while at the same time minimizing side effects, such as intraocular pressure elevation or cataract formation. Loteprednol etabonate is a corticosteroid that exerts its therapeutic effects and is then quickly changed into inactive metabolites. This relatively fast metabolism of loteprednol gives it a lower side effect profile than other steroids, including a smaller effect on intraocular pressure. In the ophthalmic literature, there is currently no consensus on a standard regimen or which type of corticosteroid should be used after PRK.

Investigators are conducting a prospective, randomized trial to compare the incidence of intraocular pressure rise and visually significant postoperative corneal haze after PRK with the use of loteprednol 0.5% gel compared to the use of earlier generation steroids, prednisolone acetate 1% suspension and fluorometholone 0.1% suspension.


Eligibility criteria: Inclusion Criteria:

* All subjects who are deemed suitable candidates for PRK after routine refractive surgery screening will be considered eligible for participation in this study.
* Subjects must be at least 21 years of age and not pregnant or nursing (due to fluctuations in visual parameters during pregnancy).

Exclusion Criteria:

* Selection will be consistent with the current standard of care for PRK. Any patient that is not a suitable candidate for PRK will not be included.

Primary outcomes:
measure: Change in Intraocular Pressure (IOP) From Baseline Through Month 3
timeFrame: Baseline, 1 week post-op, 1 month post-op, 2 months post-op, 3 months post-op
Secondary outcomes:
measure: Number of Eyes With Corneal Haze
timeFrame: 12 months
measure: Uncorrected Visual Acuity
timeFrame: 3 months
measure: Best Corrected Visual Acuity at 3 Months
timeFrame: 3 months
Other outcomes:
Locations:
city: Murray
country: United States
facility: Moran Eye Center - Midvalley Location
state: Utah
Study officials:
affiliation: University of Utah Moran Eye Center
name: Mark Mifflin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02123914: The Effect of Exercises on Physiological Changes and Clinical Symptoms in Allergic Rhinitis Patients
Official title: Effects of Chronic Exercise Training and Vitamin C Supplementation on Physiological Changes and Symptoms in Allergic Rhinitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis
Keywords: Exercise training
Allergic rhinitis
Vitamin C
Cytokine
Rhinitis symptoms
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 1. Moderate exercise training decrease cytokine response and rhinitis symptoms in patients with allergic rhinitis
2. Moderate exercise training combined with vitamin C supplementation decrease cytokine response and rhinitis symptoms in patients with allergic rhinitis
3. Moderate exercise training combined with vitamin C supplementation has more beneficial effects than moderate exercise training alone for decreasing cytokine response and rhinitis symptoms in patients with allergic rhinitis


Eligibility criteria: Inclusion Criteria:

The inclusion criteria included patients with allergic rhinitis who had a clinical history of persistent rhinitis, and had positive skin prick test (wheal diameter ≥ 3 mm) to house dust mite (D. pteronyssinus).

Exclusion Criteria:

Subjects with known asthma, chronic rhinosinusitis, hypertension or cardiovascular diseases were excluded.

Primary outcomes:
measure: Changes from baseline in rhinitis symptoms
timeFrame: Baseline, week 8
measure: Changes from baseline in cytokine
timeFrame: baseline, week 8
Secondary outcomes:
measure: Changes from baseline in pulmonary function
timeFrame: Baseline, Week 8
measure: Changes from baseline in cardiorespiratory fitness (VO2max)
timeFrame: Baseline, Week 8
measure: Changes from baseline in nasal blood flow
timeFrame: Baseline, week 8
measure: Changes from baseline in peak nasal inspiratory flow
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Patumwan
country: Thailand
facility: Faculty of Sports Science, Chulalongkorn University
state: Bangkok
Study officials:
affiliation: Faculty of Sports Science, Chulalongkorn University
name: Daroonwan Suksom, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klaewsongkram J, Ruxrungtham K, Wannakrairot P, Ruangvejvorachai P, Phanupak P. Eosinophil count in nasal mucosa is more suitable than the number of ICAM-1-positive nasal epithelial cells to evaluate the severity of house dust mite-sensitive allergic rhinitis: a clinical correlation study. Int Arch Allergy Immunol. 2003 Sep;132(1):68-75. doi: 10.1159/000073266.
Clinical trial NCT04784195: Functional and Morphological Characteristics of Neck Muscles in Acrobatic Skydivers
Official title: Functional and Morphological Characteristics of Neck Muscles in Acrobatic Skydivers: an Observational Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neck Muscle Issue
Sternocleidomastoid; Contracture
Deltoid Muscle Strain
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 40
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a high level of physical activity and actualy involved in skydiving practices.

Brief summary: An observational cohort study, following the Strengthening the Reporting of Observational Studies in Epidemiology(STROBE) guidelines.

Two groups will be examined, a group composed by spanish acrobatic skydivers and a control group composed by general physically active population(GPAP).

Detailed description: Two groups will be examined for veryfing the morfology and the function of neck muscles.

The profesional group composed by spanish acrobatic skydivers and a general group composed by general physically active population(GPAP). Both groups are matched at known confounder outcomes such as: physical activity level, age, sex, body weight and history of neck pain. Frequency matching will be carried out, subjects will be matched on known confounders.

Eligibility criteria: Inclusion Criteria:

* pain-free in the neck area in the last three months
* didn't actually take any drugs that can interfere with muscle strength

Exclusion Criteria:

* participants that not mached with the skydivers caracteristics

Primary outcomes:
measure: Anticipatory postural adjustment
timeFrame: 10 minutes
measure: Isometric cervical strength
timeFrame: 10 minutes
measure: Neck flexor and extensor endurance
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03770195: Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty
Official title: Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Abdominoplasty
Keywords: Hemostatics
Coagulants
Lead sponsor: Biom'Up France SAS
Sponsor class: INDUSTRY
First posted: 2018-12-10
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing elective full abdominoplasty procedures without concomitant liposuction that meet all eligibility criteria.

Brief summary: The purpose of this post-market observational registry is to collect additional data on the safety and efficacy of the HEMOBLAST™ Bellows device in abdominoplasty procedures.

Detailed description: A maximum of 100 subjects will be enrolled at up to 5 centers in the United States.

Enrollment occurs intraoperatively after confirmation of eligibility criteria. Data collection will occur during the surgical procedure as well as during patient follow up and will follow site standard of care. Subjects will be discontinued from the study after completion of the final follow up visit. The estimated duration of the study is approximately 6 months from the time of first subject enrollment to completion of the last subject follow up.

Eligibility criteria: Preoperative Inclusion Criteria:

* Patient is undergoing a primary full abdominoplasty procedure without concomitant liposuction; and
* Patient is willing and able to give written informed consent for registry participation

Preoperative Exclusion Criteria:

* Patient has a known sensitivity or allergy to bovine and/or porcine substance(s); and
* Patient has religious or other objections to porcine, bovine, or human components

Intraoperative Inclusion Criteria

* Patient has at least one Target Bleeding Site (TBS) with minimal, mild, or moderate bleeding for which conventional means for hemostasis are ineffective or impractical; and
* The surgeon elects to utilize HEMOBLAST™ Bellows per its approved Indications for Use

Primary outcomes:
measure: Achievement of Hemostasis at the Target Bleeding Site
timeFrame: Intraoperatively, expected within 3-10 minutes of application
Secondary outcomes:
measure: Incidence of Serious Adverse Device Effects (SADEs)
timeFrame: Through study completion, on average 14 days post-surgery
measure: Incidence of Unanticipated Serious Adverse Device Effects (UADEs)
timeFrame: Through study completion, on average 14 days post-surgery
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Hunstad Kortesis Bharti Cosmetic Surgery
state: North Carolina
Study officials:
References:
Clinical trial NCT03351595: Ewha Birth and Growth Study (Birth Cohort)
Official title: Evaluation of Influencing Factors Affecting Childhood Metabolic Indicators in Korea (Repeated Measures Analysis; Longitudinal Birth Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric Health
Keywords: Growth pattern
Environmental and prenatal exposure
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2017-11-24
Enrollment: 734
Sex: ALL
Minimum age (years): 24
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy infants and Participants' mothers

Brief summary: Ongoing longitudinal birth cohort established at Mok-dong Hospital, Ewha Woman's University, Seoul, South Korea, between 2001 and 2006.

Detailed description: Cohort composed of mothers, who visited to prenatal care between 24 and 28 weeks of gestation, between 2001 and 2006. After the child was born then, we collected information at birth outcome and conducted mail surveys at 6, 12, 18, and 24 months. Regular check-up was conducted at 3, 5, and every year after 7 years of age(last check up point: 15 years old). In check-up survey, after an 8-hour overnight fast, blood and urine samples (3 ml EDTA-blood and 5 ml serum) were obtained from subjects by venepuncture. following parameters were checked: physical growth, blood pressure. metabolic biomarker(Total cholesterol, HDl-cholesterol, TG(triglyceride), glucose, uric acid, etc.), K-CBCL(Korea-child behavior checklist), 24 hour recall method for nutrition, FFQ(Food Frequency Questionnaire), Questionnaires including Socio-economic status and physical activity.

Eligibility criteria: Inclusion Criteria:

* Participants' mothers, who visited to prenatal care between 24 and 28 weeks of gestation.
* An individual who can be followed up during the study period and is capable of complying with the study requirements

Exclusion Criteria:

* An individual thought to have difficulty participating in the study due to other reasons, based on the judgment of the investigator

Primary outcomes:
measure: Profile of participants received regular medical check-up and result feed back for growth development
timeFrame: 365days
Secondary outcomes:
measure: Profile of participants received blood pressure measurement for pediatric hypertension
timeFrame: 365days
Other outcomes:
Locations:
Study officials:
References: