linjc16/ctgov huggingface dataset:
Perfusion Assessment of Wound Closure Techniques in Primary Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This study will assess which of the three most common methods of wound closure in primary total knee arthroplasty (staples, interrupted vertical mattress, or running subcuticular suture) provide the best wound vascular perfusion. This can be achieve by using SPY intra-operative vascular angiography, which is commonly used in clinical practice to assess perfusion of wound closure at the clinic. By understanding the differences in perfusion afforded by different closure techniques, surgeons will then be able to select the technique that optimizes this parameter so as to avoid complications such as tissue necrosis, wound dehiscence, or infection.

Official Title
-----------------
Assessment of Wound Closure Techniques in Primary Total Knee Arthroplasty Using SPY Intra-operative Angiography

Conditions
-----------------
Total Knee Arthroplasty

Intervention / Treatment
-----------------
* Procedure: Staple Closure
* Procedure: Vertical Mattress Closure
* Procedure: Running Subcuticular Closure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years old Primary diagnosis of osteoarthritis Surgical indication for index total knee arthroplasty Exclusion Criteria: Previous surgery about the knee Systemic corticosteroid use Active infection of any kind or chronic infection with HIV, Hepatitis C, or Syphilis

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Staple Closure<br>Staple closure will be one technique employed to close the wound in primary total knee arthroplasty. | Procedure: Staple Closure<br> <br> |
| Experimental: Running Subcuticular Closure<br>Running subcuticular closure will be one technique employed to close the wound in primary total knee arthroplasty. | Procedure: Running Subcuticular Closure<br> <br> |
| Experimental: Vertical Mattress Closure<br>Vertical mattress closure will be one technique employed to close the wound in primary total knee arthroplasty. | Procedure: Vertical Mattress Closure<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perfusion of Wound Closure |  | Surgical Point of Care | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TKA, Wound Closure, Wound Perfusion
Frequency of Functional Gastrointestinal Disorders in Children

Study Overview
=================
Brief Summary
-----------------
cross sectional study to detect frequency of functional gastrointestinal disorders among schhol aged children complaining of recurrent abdominal pain

Detailed Description
-----------------
school aged children from age of 5 to age of 15 who are complaining of recurrent abdominal pain will be included in the study , detailed history , examination and investigations will be done

Official Title
-----------------
Frequency of Functional Gastrointestinal Disorders Among School Aged Children

Conditions
-----------------
Functional Abdominal Pain Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: abdominal ultra sound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of recurrent abdominal pain the child can express and locate site of the pain Exclusion Criteria: children less than 5 and adolescents more than 14 mentally retarded children

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 14 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| abdominal pain<br>one group of children complaining of recurrent abdominal pain | Diagnostic Test: abdominal ultra sound<br>* non invasive tests to exclude pathological causes<br>* Other names: C reactive protein;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| no structural or biochemical abnormality | percentage of functional gastrointestinal disorders | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abdominal pain, recurrent
Efficacy and Safety of Therapy With Tri-Luma® Cream in Sequence With Glycolic Acid Peels for Melasma

Study Overview
=================
Brief Summary
-----------------
To determine the effectiveness and safety of sequential therapy with of Tri-Luma® Cream and a series of Glycolic Acid peels in treatment of moderate to severe melasma.

Detailed Description
-----------------
To determine the efficacy and safety of sequential therapy with Fluocinolone acetonide 0.01%, Hydroquinone 4% and Tretinoin 0.05%, and a series of Glycolic Acid peels in the treatment of moderate to severe melasma.

Official Title
-----------------
Open Label Study to Evaluate the Efficacy and Safety of Sequential Therapy With Fluocinolone Acetonide 0.01%, Hydroquinone (HQ) 4% and Tretinoin 0.05% (TriLuma® Cream) and a Series of Glycolic Acid Peels for the Treatment of Melasma

Conditions
-----------------
Melasma

Intervention / Treatment
-----------------
* Drug: Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects diagnosed with moderate to severe melasma Exclusion Criteria: Subjects under treatment for a dermatologic condition, which may interfere with the safe evaluation of the study combination (e.g. eczema, psoriasis, severe sun-damage, dermatitis) Subjects with a diagnosis of skin cancer (BCE, SCC, Melanoma) in the areas to be treated

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels | Drug: Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels<br>* Apply cream once daily at night. Subjects will be asked to discontinue use of Fluocinolone acetonide/hydroquinone/tretinoin Cream 2 days prior to the peel and restart 2 days after the peel; Glycolic Acid Peels - In office treatment at weeks 2, 4, 6, 8 and 10<br>* Other names: NeoStrata® Glycolic Acid Skin Renewal Peel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - Improvement in Investigator's global assessment of melasma |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Tolerability assessments and adverse event reporting |  | 12 weeks |
Home With TablO outcoMEs (HOME) Registry

Study Overview
=================
Brief Summary
-----------------
Prospective, multicenter, single arm, post-market study to evaluate real world clinical outcomes in ESRD patients receiving in-home dialysis on the Tablo Hemodialysis System.

Official Title
-----------------
Home With TablO outcoMEs (HOME) Registry

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Device: Tablo Hemodialysis System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant (patient and/or care partner) is at least 15 years of age and has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement. Participant weighs ≥ 34kg. Participant has end stage renal disease (ESRD) adequately treated by maintenance dialysis. Participant plans to start or has started home treatment (≤ 6 months) with the Tablo Hemodialysis System. Participant is willing and able to comply with the Protocol requirements and perform all site required treatments and clinical evaluations. Exclusion Criteria: Participant and/or care partner is unable to read English or Spanish. Participant has a home environment that is deemed inappropriate for home dialysis. Participant and/or care partner is unable to successfully complete the Tablo training program Participant is pregnant or plans to become pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Tablo Hemodialysis System<br>Home dialysis treatment with the Tablo Hemodialysis System | Device: Tablo Hemodialysis System<br>* Home hemodialysis treatments  4 times a week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly Standardized Dialysis Adequacy | Weekly standardized dialysis adequacy (stdKt/V) measured using the second-generation formula of Daugirdas. This formula normalizes urea clearance among heterogeneous hemodialysis schedules, where K=dialyzer clearance or urea, t=treatment time, and V=subject's volume of urea distribution. stdKt/V values of ≥ 2.1 are regarded as being adequate. | 12-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tablo, Outset Medical, ESRD, Home Hemodialysis, HHD, ESKD
Post-Marketing Study of the Safety of Prevenar (Pneumococcal Conjugate Vaccine, 7-valent)

Study Overview
=================
Brief Summary
-----------------
To collect post-marketing information on the safety of Prevenar in Filipino patients

Official Title
-----------------
A Prospective, Observational Study to Monitor Safety in Patients Who Were Administered With Pneumococcal Conjugate Vaccine, 7-valent (Prevenar) 0.5 mL by Intramuscular Injection

Conditions
-----------------
Vaccines, Pneumococcal Conjugate Vaccine

Intervention / Treatment
-----------------
* Biological: Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients from the study center who received or will receive at least one dose of Prevenar according to the approved product indication. Exclusion Criteria: Previously discontinued Prevenar therapy due to safety concerns.
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 |
| --- | --- |
| 1<br> | Biological: Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Spontaneous Adverse Events |  | 30 days post injection up to 3 years |
14-3-3η Protein, Disease Activity and Bone Mineral Density, in Female Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Is to investigate the relation between 14-3-3η protein, disease activity, and bone mineral density in female patients with rheumatoid arthritis.

Detailed Description
-----------------
Methods: all patients in the study will subject to: Clinical assessment, WT, Height ,BMI, parity, medications, DAS 28. Serum 14-3-3η protein. DEXA scan. Grouping: Group I: RA Patients with low BMD. Group II: RA Patients with normal BMD. Group III: normal control.

Official Title
-----------------
14-3-3η Protein, Disease Activity and Bone Mineral Density, in Female Patients With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis, Osteoporosis

Intervention / Treatment
-----------------
* Diagnostic Test: 14-3-3η Protein assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rheumatoid arthritis according to ACR 2010 criteria with at least one year duration. Premenopausal females. On conventional DMARD with maximum 5 mg steroids. Exclusion Criteria: Biological treatment. Previous antiresorptive treatment, or bone anabolics. High dose corticosteroid. Chronic renal or kidney disease. Medications affecting bone metabolism. Thyroid or adrenal dysfunction,

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study group<br>RA Patients | Diagnostic Test: 14-3-3η Protein assay<br>* blood sampling for assessment of serum 14-3-3η Protein<br>|
| control group<br>normal control | Diagnostic Test: 14-3-3η Protein assay<br>* blood sampling for assessment of serum 14-3-3η Protein<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 14-3-3η Protein and RA disease activity | percent of active RA disease and study the correlation between 14-3-3η Protein and RA disease activity | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 14-3-3η Protein and osteoporosis in RA patients | percent of low BMD and study the correlation between 14-3-3η Protein and osteoporosis in RA patients | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
14-3-3η Protein
A Study of UK-369,003 on the Safety and Efficacy in Patients With COPD

Study Overview
=================
Brief Summary
-----------------
A randomised, controlled study investigating the effect of UK-369,003 on exercise tolerance in patients with COPD

Official Title
-----------------
A Multi-Centre, Multinational, Randomized, Double-Blind, Placebo Controlled, Proof Of Concept Trial To Assess The Effects Of A Subject-Optimized Dose Of UK-369,003 On Exercise Capacity In Subjects With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: UK-369,003


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GOLD criteria 2 to 4 10 pack year history of smoking Exclusion Criteria: Women of child bearing potential

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: UK-369,003|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on exercise tolerance |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on lung function and quality of life |  |  |
Interscanner Variation in Musculoskeletal Computed Tomography (CT) Measures

Study Overview
=================
Brief Summary
-----------------
Maintaining strong muscles is important for the independence and quality of life in our older population. Strong muscles provide mobility and reduce the chance of falls that lead to injury. Many researchers are carrying out studies to examine different types of exercise and drug treatments to prevent loss of muscle strength in older people. Often, these research studies use x-ray computed tomography (CT) scans to measure the size and the amount of fat in different muscles. These factors are known to reflect muscle health. Large studies can involve many research subjects recruited at many different clinics with different CT scanners. To ensure that these studies provide reliable results, the investigators must have procedures to make sure that different CT scanners measure the same results for the same amount of fat or muscle. The goal of our study is to develop these procedures. In this project, the investigators will study women because they have the highest risk of bone fractures resulting from falls. Thus, the subjects are being asked to volunteer for a study where the subjects will be scanned on different scanners.

Official Title
-----------------
Inter-scanner Comparison of Muscle Attenuation Measures

Conditions
-----------------
Accidental Falls, Loss of Muscle Strength

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 60-70 years old healthy Exclusion Criteria: no history of spine surgery no history of hip implantation or replacement no scoliosis or other spine deformity not using walking canes or wheelchair

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 70 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
on two models of CT scanner acquire CT images of the abdomen pelvis and midthigh in 20 Postmenopausal female volunteers
Carpal Tunnel Release in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to extend a previously reported 1 year follow-up on carpal tunnel release, in matched diabetic and non-diabetic patients,to compare outcomes 5 years after surgery.

Detailed Description
-----------------
The Follow-up investigation includes: Clinical examination of sensory and motor function Generic and disease specific self-administered questionnaires Nerve conduction study Vibration threshold testing

Official Title
-----------------
Five Years Follow-up After Carpal Tunnel Release in Diabetic and Non-diabetic Patients

Conditions
-----------------
Carpal Tunnel Syndrome, Diabetes, Nerve Entrapment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic and non-diabetic patients operated for carpal tunnel syndrome 5 years ago. Exclusion Criteria: previous carpal tunnel release in the hand under study clinical signs of nerve entrapment other than CTS cervical radiculopathy, inflammatory joint disease renal failure thyroid disorders previous wrist fracture on the affected side daily long-term exposure to vibrating tools pregnancy

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetics<br>Diabetic patients operated for carpal tunnel syndrome | |
| Non-diabetics<br>Non-diabetic patients operated for carpal tunnel syndrome | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient self-reported outcome questionnaire | Measured by 1). Boston Carpal Tunnel Questionnaire regarding carpal tunnel symptoms and disability. 2). Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) registering health-related quality of life. 3). Cold intolerance on a CISS score | 5 years after carpal tunnel release | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve conduction study and vibrotactile sense | Change in Median nerve function by measuring Distal motor latency and antidromic sensory conduction velocity over the carpal tunnel segment. Evaluate development of peripheral neuropathy by measure of sural nerve sensory conduction velocity, sural nerve amplitude and peroneal nerve motor conduction velocity. Vibrotactile sense of the hand measured at 7 difference frequences from 5 - 500 Hz. | 5 years after carpal tunnels release | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carpal tunnel syndrome, Entrapment neuropathies, Diabetes