linjc16/ctgov huggingface dataset:
Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear

Study Overview
=================
Brief Summary
-----------------
Adequate upper limb function is critically important to maintenance of independence and prevention of disability in older adults. The goal of this work is to identify factors that contribute to rotator cuff rupture and improved outcomes for repair. Ultimately, the investigators seek to identify patients most at risk for rupture and to guide clinicians on optimal surgical and rehabilitation strategies. This pilot study will quantitatively characterize the morphological (muscle volume and fatty infiltration) and functional (shoulder isometric joint strength, movement when performing typical task) changes in the muscles of the rotator cuff following supraspinatus tear and surgical repair. The investigators hypothesize that patients with supraspinatus tear will have reduced muscle volume and increased fatty infiltration of rotator cuff muscles compared to their contralateral arm and age-matched controls, which will increase following surgery. The investigators further hypothesize that isometric joint strength in these individuals will be associated with muscle volume and the degree of fatty infiltration, and that older adults with a rotator cuff tear will use a restricted range of motion to accomplish functional tasks. This study emphasizes muscle function and composition with application to rehabilitation of upper limb function, which complements the theme of the Pepper Center.

Official Title
-----------------
Rotator Cuff Function and Muscle Morphology in Older Adults With Rotator Cuff Tear

Conditions
-----------------
Rotator Cuff Tear

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults ≥ 60 years of age free of any medical condition that might be exacerbated by physical testing patients: major thickness supraspinatus tear control subjects: no history of significant injury or pathology in either upper limb Exclusion Criteria: contraindication to undergoing MRI history of neuromuscular disorder, or any injury that may affect the upper limb (e.g. any history of stroke, Parkinson's, or spinal cord injury, or being confined to a wheelchair)

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rotator Cuff Tear-surgical<br> | |
| Health Older Adult Control<br> | |
| Rotator cuff tear - non surgical<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder strength |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aging
Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the mean average error (MAE) of measuring pulse rate using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).

Detailed Description
-----------------
The study design is to validate the pulse and heart rate accuracy as required per ISO 80601-2-61, Clause 201.12.1.104. The study is a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's pulse rate measurement compared to a reference heart rate manually measured by observing R-peaks in a standard concurrently recorded ECG from an FDA 510(k)-cleared reference clinical ECG (RCECG). The sponsor will ensure that the study staff enrolls a range of types of arrhythmias including tachycardia, bradycardia, atrial fibrillation, bigeminy, trigeminy, and others.

Official Title
-----------------
Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate

Conditions
-----------------
Healthy, Arrhythmia

Intervention / Treatment
-----------------
* Device: Norbert Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects aged 18 or over Ability to provide signed informed consent Exclusion Criteria: Pregnant Otherwise deemed unsuitable to participate in the study based on judgment of the study investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Norbert Device|The Norbert Device (ND) is a contactless, noninvasive device that provides measurements of body temperature, oxygen saturation (SpO2), and pulse rate.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Average Error (MAE) | MAE will be evaluated by Mean absolute error (MAE) of the pulse rate of the device compared to the heart rate measured from the RCECG. | Up to 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medical device, validation, arrhythmia, ECG, pulse rate, Norbert Device, Norbert Health
IPM Procedures With or Without Fluoroscopy: Outcome Comparison

Study Overview
=================
Brief Summary
-----------------
To determine clinically significant improvement in the patients undergoing procedures under fluoroscopy. To evaluate and compare the adverse event profile in both groups

Detailed Description
-----------------
For the target delivery of injectate, it is believed that fluoroscopy is mandatory. However, there is a view among some professionals that a procedure may be performed without fluoroscopy as effectively as under fluoroscopy. The outcomes among the two groups of patients have not been studied

Official Title
-----------------
Comparison of Outcomes of Interventional Pain Management Procedures Performed With or Without Fluoroscopy: A Retrospective Analysis

Conditions
-----------------
Low Back Pain, Neck Pain

Intervention / Treatment
-----------------
* Procedure: Fluoroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have undergone the following procedures: Cervical facet joint nerve blocks, thoracic facet joint nerve blocks, lumbar facet joint nerve blocks, lumbar interlaminar epidural steroid injections, cervical Interlaminar epidural steroid injections During 1998 to 2001 and 2004 to 2005 - Exclusion Criteria: Non-availability of appropriate data

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Fluoroscopy|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate clinically significant improvement in the patients undergoing procedures under fluoroscopy. |  |  | 
| To evaluate and compare the adverse event profile in both groups |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluoroscopy, Interventional Pain Management Procedures
Adipocyte Function and Somtropin Deficiency

Study Overview
=================
Brief Summary
-----------------
To assess the influence of exogenous GH (growth hormone) administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion in children with delayed growth due to GH deficiency. Study hypothesis: hormones produced by the adipocyte (leptin, adiponectin, and resistin) and ghrelin may exert a certain control on production of GH and IGF-I, and GH may in turn have a regulatory effect on such hormones.

Official Title
-----------------
The Fayds Project: Adipocyte Function and Somtropin Deficiency

Conditions
-----------------
Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: Growth Hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children of both sexes aged from 5 to 12 years, Tanner stage 1, with no signs of imminent pubertal development. Amenable to treatment with recombinant somatropin in the approved indication of low growth due to GH deficiency Selection of recombinant somatropin by the physician in the treatment authorization request, and subsequent approval of such treatment by the relevant growth hormone committee Body Mass Index (BMI) within ±1 SD Exclusion Criteria: Children with any of the reported contraindications for treatment with recombinant somatropin, existence of active neoplasms, progression or recurrence of intracranial lesion, etc. will not be studied Diabetes mellitus Intestinal inflammatory disease Celiac disease Uncontrolled hyperthyroidism AIDS Other diseases causing chronic malabsorption, hypercatabolism or malnutrition conditions Chronic liver disease Eating disorders: anorexia, bulimia, etc Long-term treatment with anti-obesity drugs or drugs causing malabsorption

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Growth hormone<br>Patients with a condition | Drug: Growth Hormone<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the potential influence of exogenous GH administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height assessment (using Harpenden stadiometer) |  | 1 year | 
| Weight assessment |  | 1 year | 
| BMI assessment |  | 1 year |
A Retrospective Review of Enseal Laparoscopic Vaginal Assisted Hysterectomy (LAVH) Versus Traditional LAVH

Study Overview
=================
Brief Summary
-----------------
Retrospective charts review from one surgeon to compare Group A- cases where the laparoscopic portion of the case used an EN SEAL device to Group B - the laparoscopic BSO was done using a 3mm EN-SEAL device through 2 lateral 5mm ports.

Detailed Description
-----------------
79 women with benign uterine disease underwent laparoscopic assisted vaginal hysterectomy with or without bilateral salpingo-oophorectomy. Subjects charts were divided into two groups based on surgical technique and the following parameters were reviewed retrospectively: surgical time, blood loss, uterine weight, patient weight, patient age, post operative fever >100.4 F, readmission to hospital within one week, return to operating room within 24 hours, length of hospital stay, and blood transfusion. Group A, N=35 used traditional suture technique vaginally. Group B, N=44 used Enseal coagulation cutting device vaginally.

Official Title
-----------------
A Retrospective Analysis of a Complete Enseal Laparoscopic Vaginal Assisted Hysterectomy Versus a Traditional Suture Laparoscopic Vaginal Hysterectomy

Conditions
-----------------
Benign Uterine Disease

Intervention / Treatment
-----------------
* Procedure: Laparoscopic assisted vaginal hysterectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: none, observational study Exclusion Criteria: none, observational study

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LAVH, techniques<br>Women aged 35-75 who underwent laparoscopic assisted vaginal hysterectomy via either suture technique vaginally or Enseal coagulation cutting device vaginally | Procedure: Laparoscopic assisted vaginal hysterectomy<br>* Surgical removal of uterus vaginally<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical time | The total time the subject spent in surgery was compared between the two groups | Operating room time in minutes | 
| Estimated blood loss | The total blood loss in cc per minutes operating was compared between the two groups | Blood loss during surgery in cc per minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic, vaginal, hysterectomy
Health in Smart Rurality: Impact on Coordination of Care of Telemonitoring and Data Centralization of Frailty Patients

Study Overview
=================
Brief Summary
-----------------
Chronic diseases are frequent (around 10% of the total population and 30% after 60 years) and accelerate age-related functional decline. Concerning cross-border patients, use of health services can be delayed given the distances, the lack of rapid road access and the limited availability of public transport and the complex organization of coordinated care. One of the ways to reduce acute exacerbations and preserve the quality of life of patients is to detect warning signs early. One of the ways to do this is to use new communication technologies.

Detailed Description
-----------------
The aim of the study is to assess feasibility of using a connected tablet to assess clinical parameters with an alert system in frailty patients aged over 60, living at home, with heart failure and / or chronic obstructive pulmonary disease, potentially requiring care cross-border (France and Belgium).

Official Title
-----------------
Health in Smart Rurality: Impact on Coordination of Care of Telemonitoring and Data Centralization of Frailty Patients

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Heart Failure

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged over 60 Patients living at home Patients with heart failure and / or chronic obstructive pulmonary disease, Patients potentially requiring care cross-border (France and Belgium). Patients agreeing to participate to the study Exclusion Criteria: Patients who do not speak French Patients with severe cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Connected tablet<br>Patients aged over 60, living at home, with heart failure and / or chronic obstructive pulmonary disease, potentially requiring care cross-border (France and Belgium). | Other: Data collection<br>* Daily record of temperature, weight, heart rate, systolic blood pressure and oxygen saturation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alert according to the connected tablet | significant change in temperature (egal or more 38°), weight (variation of more than 5%), heart rate (less than 50 beats per minute or greater than 100), systolic blood pressure (less than 85 mmHg or greater than 160 mmHg) and / or oxygen saturation (variation of more than 4%) | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic diseases, Aging people, Cross-border care, New communication technology
A Study of the Immunogenicity of M. Bovis BCG, Delivered Intradermally in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To assess the immunogenicity of M. bovis BCG, given intrademally in the standard dose used in clinical practice and to measure the development of the immune response in the first six months after administration. M. bovis BCG is a fully licensed vaccine that has been in routine clinical use for the last 50 years. It is the most widely administered vaccine in the world today and has an excellent safety record.

Detailed Description
-----------------
Volunteers for the study will be recruited through advertisements. Each volunteer will have received an information sheet concerning the study and will have agreed to participate in writing. Volunteers will be given at least 48 hours between reading the information leaflet and agreeing to participate. Female volunteers will have a pregnancy test prior to enrollment. Volunteers will give signed consent for their GP's to be notified about their participation in the trial. The GP will be faxed a letter on the day of screening and asked to reply if they know of a reason why the volunteer should not take part. The signed consent form will also be faxed with the letter.

Official Title
-----------------
A Study of the Immunogenicity of M. Bovis BCG, Delivered Intradermally in Healthy Volunteers

Conditions
-----------------
TB

Intervention / Treatment
-----------------
* Biological: BCG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult aged 18-65 years. Normal medical history and physical examination. Normal urine dipstick, blood count, liver enzymes, and creatinine. Exclusion Criteria: Exposure to TB/BCG vaccination at any point. Previous residence in a TB endemic area. Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy,immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder,liver disease, renal disease, gastrointestinal disease, neurological illness, psychiatric disorder, drug or alcohol abuse. Oral or systemic steroid medication or the use of immunosuppressive agents. Positive HIV or core HBV antibody test. Positive Heaf test Positive ANA or serum anti-DNA antibody. Confirmed pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: BCG|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction of T cell responses |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TB, BCG
Diagnostic Study of Temporal Arteritis

Study Overview
=================
Brief Summary
-----------------
Despite a large and growing body of knowledge concerning the diagnosis of temporal arteritis, this potentially crippling disease still requires pathological diagnosis in practically every case. It seems likely that a correctly estimated clinical probability could help in evaluating imaging results in a way that might safely obviate temporal biopsy in a large segment of suspect cases. With this aim in view, we intend to identify useful clinical items and integrate them in an appropriate diagnostic pathway.

Official Title
-----------------
Diagnostic Tools in Temporal Arteritis - Towards the Development of a Diagnostic Algorithm

Conditions
-----------------
Temporal Arteritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suspected of temporal arteritis and referred by their physicians to biopsy of a temporal artery. Exclusion Criteria: Pregnancy; age > 80 or < 18; unable to answer study questions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent decrease in future biopsy use. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No secondary outcome. |  | 2 years |
Splinting Versus Casting for Type I Supracondylar Fractures

Study Overview
=================
Brief Summary
-----------------
Elbow fractures are very common in young children. Type I supracondylar fractures are stable fractures to the elbow that are treated conservatively across the world and typically heal very well without complications. There are several treatment options, including an above elbow cast or long arm splint. This study aims to determine if one treatment is no worse than the other in order to standardize the treatment of these fractures at our institution. The investigators hope to save families from extra hospital visits and reduce the amount of x-rays required for treatment of these fractures.

Official Title
-----------------
Splinting Versus Above Elbow Casting for Type I Supracondylar Fractures of the Humerus in Children: A Randomized Controlled Trial

Conditions
-----------------
Bone Fractures

Intervention / Treatment
-----------------
* Procedure: Above Elbow Cast
* Procedure: Long Arm Splint


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 3-12 Type 1 supracondylar fracture Exclusion Criteria: A type 2 or 3 supracondylar fracture Neurovascular compromise associated with the fracture Previous diagnosis with a metabolic or structural bone disease Other fractures to ipsilateral upper extremity History of injury to affected elbow

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Above Elbow Cast + Collar/cuff<br>Participants randomized to this group will be treated with an Above Elbow Cast & collar/cuff for 3 weeks | Procedure: Above Elbow Cast<br> <br> |
| Long Arms Splint + Collar/Cuff<br>Participants randomized to this group will be treated with a long arm splint & collar/cuff for 3 weeks | Procedure: Long Arm Splint<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baumann's Angle | Baumann's angle of the injured elbow will be measured 6 months following the injury | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humero-Capitellar Angle | Humero-Capitellar Angle will be measured 6 Months following the injury | 6 Months | 
| Functional Outcome Questionnaire | All participants will complete the Activity Scale for Kids-P 6 months following the injury | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fracture, Supracondylar, Pediatric, Orthopedic