linjc16/ctgov huggingface dataset:
Identification and Characterization of the Biomarker in Synovial Fluid for Hyaluronic Acid Therapy in Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to use the proteomic analysis of synovial fluid to perform the comprehensive investigation of the biomarker that will be useful to assign the tratment effectiveness of five weekly intra-articular HA injection.

Detailed Description
-----------------
The intra-articular injection with HA is an accepted therapy for OA. However, the exact regulation of HA treatment is unclear. Compared the expression SF proteome from OA patients who received HA/800 treatment or not (post and pre-HA treatment) may be possible to identify the protein that response to the HA treatment and apply this to prognosis of OA. We used two-dimensional difference gel electrophoresis (2D-DIGE) combined with matrix-assisted laser desorption ionization time of light mass spectrometry (MALDI-TOF) to determine the differentially displayed proteins in human SF. Finally, we used Western blotting and ELISA analysis to validate the potential biomarkers.

Official Title
-----------------
Identification and Characterization of the Biomarker in Synovial Fluid for Hyaluronic Acid Therapy in Osteoarthritis

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Other: proteomic analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of osteoarthritis Accept the intra-articular HA injection therapy Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Basic Science
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: proteomic analysis<br> | Other: proteomic analysis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the protein expression of synovial fluid for hyaluronic acid therapy in osteoarthritis | We used two-dimensional difference gel electrophoresis (2D-DIGE) combined with matrix-assisted laser desorption ionization time of light mass spectrometry (MALDI-TOF) to determine the differentially displayed proteins in human synovial fluid. | up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, synovial fluid, hyaluronic acid
Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse

Study Overview
=================
Brief Summary
-----------------
Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. However, there remains no prospectively obtained data on the maximal time of effectiveness of vardenafil. The goal of the current study was to determine if vardenafil will significantly increase the percentage of successful intercourse attempts from 12 to 24 hours following dosing. A total of three time points 12, 18, and 24 hours were assessed in this pilot study to better quantify the effect of vardenafil.

Official Title
-----------------
A Pilot, Randomized, Double-Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy and Safety of Vardenafil Versus Placebo Administered 12, 18 and 24 Hours Prior to Initiation of Sexual Intercourse in Subjects With ED

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Levitra (Vardenafil, BAY38-9456)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men >/= 18 years of age ED >/= 6 months Stable sexual relationship for > 6 months Exclusion Criteria: Primary hypoactive sexual desire History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month Nitrate therapy Other exclusion criteria apply according to the Summary of Product Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
Male

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* 10mg and 20mg to be taken 12, 18, 24 hours prior to sexual intercourse<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual encounter profile Question 3 |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile Dysfunction, Vardenafil
Diabetes Coaching Program for Medicare Advantage Members With Type 2 Diabetes - Impact on A1c

Study Overview
=================
Brief Summary
-----------------
The Diabetes Coaching Program for Medicare Advantage Members with Type 2 Diabetes - Impact on A1c trial is a 26-week long, prospective, intent-to-treat, 2-arm randomized controlled trial that aims to evaluate the impact of the Digital Health Partnership on A1c levels for individuals with uncontrolled Type 2 diabetes.

Official Title
-----------------
Diabetes Coaching Program for Medicare Advantage Members With Type 2 Diabetes - Impact on A1c

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: Digital health Partnership program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Humana Medicare Advantage member Type 2 diabetes diagnosis HbA1c levels ≥ 8.0% verified by lab test Exclusion Criteria: Has any of the following conditions: cancer, chronic heart failure, chronic obstructive pulmonary disease, respiratory failure, chronic kidney disease, end stage renal disease, peripheral vascular disease Not fluent in English Humana membership is part of a Full or Global risk arrangement Enrolled in Humana at Home Care Management

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: Digital health Partnership program<br>* The program pairs patients with their own certified diabetes educator coach who will guide the patient through a personalized program that leverages a proven educational curriculum combined with proven patient engagement methods.<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1c | Change in A1c from study baseline to study end for participants | Baseline and 6 months |
MR Characterisation/Localisation of Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Objective: To determine the accuracy of multi-functional magnetic resonance (MR) in detecting, localising and characterising satellite lesions in relation to an index breast tumour in order to improve definition of clinical target volume after local excision. Hypothesis: Pre-operative multi-functional MR has high sensitivity and specificity for localising unsuspected multifocal and multicentric lesions in women diagnosed with early breast cancer.

Official Title
-----------------
Using Magnetic Resonance Techniques to Improve the Characterisation and Localisation of Breast Cancer

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy proven invasive ductal carcinoma of the breast Unifocal disease Patient proceeding to mastectomy Exclusion Criteria: Multifocal disease Previous surgery to ipsilateral breast Neoadjuvant chemotherapy Ferromagnetic implants Claustrophobia Cup size DD or greater

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

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

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 |
| --- | --- | --- |
| Sensitivity of MR techniques in detecting histopathologically-identified multifocal and multicentric lesions | Sensitivity of the MR technique in detecting histopathologically-identified multifocal/centric pre-invasive/invasive disease will be calculated (with 95% confidence intervals)from positive or negative correlates. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closeness of agreement between MR techniques and histopathology in localising satellite lesions relative to the index tumour. | Distance & distribution of lesions from reference tumour will be plotted and correlated with distances and signal characteristics seen on multifunctional MR. Pre-op MRI volume will be plotted against histopathological dimensions and examined for agreement between the two methods. Paired Wilcoxon signed-rank tests will be used to test for systematic differences between MRI and pathology measurements. | 4 years |
Oxaliplatin in Esophagus Cancer (Advanced) 1st Line

Study Overview
=================
Brief Summary
-----------------
To determine the activity and efficacy of the schema specified as dose regimen To determine the safety and tolerability of the oxaliplatin-cisplatin and 5FU

Official Title
-----------------
Phase II Open-label Single Arm Study of Oxaliplatin Combined With Cisplatin and 5FU in Advanced Esophagus Cancer Patients

Conditions
-----------------
Esophageal Neoplasms

Intervention / Treatment
-----------------
* Drug: Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ECOG 0-1 Patients with histologically proven epidermoid carcinoma or adenocarcinoma of esophagus or stomach, with unresectable or metastatic disease; No previous treatment with chemotherapy or radiotherapy Measurable lesion (uni or bidimensional) Exclusion Criteria: Creatinin clearance <50 mL/min Total bilirubin >1.5*ULN (Upper Limit of Normal) AST/ALT > 2.5*ULN Total White Blood Cell <1.500.000/mL Platelet count <100.000.000/mL symptomatic sensitive peripheral neuropathy pregnant or breast-feeding women The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxaliplatin<br> | Drug: Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU)<br>* OXALIPLATIN 60 mg/m2/d, CISPLATIN 55 mg/m2/d, 5-FU 600 mg/m2/d with dose range and followed by radiotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy endpoints include tumor response, progression free and overall survival. |  | Throughout the whole study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoints include summary of adverse events assessed by history, physical exams and laboratory evaluations. |  | Throughout the whole study duration |
Effects of Acute SCI on Colonic Motility & Tone

Study Overview
=================
Brief Summary
-----------------
This study will compare individuals with acute SCI to control patients in order to: 1. Determine if there are changes in colonic tone and sensation after SCI by comparing the fasting responses to the postprandial responses; 2. Determine if there are changes in colonic phasic motility after SCI by comparing the fasting responses to the postprandial responses; 3. Determine if colonic motor and sensory function after SCI change over time by repeating these studies six month later in SCI and control patients.

Official Title
-----------------
Effects of Acute SCI on Colonic Motility & Tone

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Procedure: Determine colonic tone


Participation Criteria
=================
Eligibility Criteria
-----------------
Acute SCI with impaired colonic tone

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: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Determine colonic tone|nan|

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
-----------------
Spinal cord injury, gastrointestinal motility, gastrointestinal transit
Economic Aspects Associated With the Implementation of an Orthogeriatric Setting in a General Hospital

Study Overview
=================
Brief Summary
-----------------
The economic and social burden of hip fractures is expected to increase dramatically, but financial resources remain limited. This calls for the investigation of innovative new forms of organization and integration of medical, surgical and rehabilitation services for these patients. The study will investigate economical aspects associated with implementation of a comprehensive orthogeriatric ward for elderly hip fracture patients in a general hospital, compared with the classic model of orthopedic treatment followed by rehabilitation period.

Official Title
-----------------
Economic Aspects Associated With the Implementation of an Orthogeriatric Setting in a General Hospital

Conditions
-----------------
Hip Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hip fracture Exclusion Criteria: Patients admitted for elective hip surgery Patients with multi-trauma injuries

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| 2<br>a group of consecutive hip fracture patients admitted to a dedicated comprehensive orthogeriatric ward and a group of similar patients admitted to an orthopedic ward and later on transferred to geriatric rehab center | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost-effectiveness |  | 1999-2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip fracture elderly orthogeriatric, cost effectiveness of hip fracture patients
BOVARI: A Non-Interventional Study of Avastin (Bevacizumab) as Front-Line Treatment in Patients With Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
This non-interventional study will evaluate the routine use and the safety and efficacy of Avastin (bevacizumab) as first-line treatment in patients with advanced ovarian cancer (epithelial ovarian cancer, fallopian tube carcinoma, primary peritoneal carcinoma). Newly diagnosed patients who are initiated on carboplatin/paclitaxel chemotherapy in combination with Avastin will be followed for up to 15 months of treatment and 12 months of follow-up.

Official Title
-----------------
A Non-interventional Trial With Avastin as Front-line Treatment for Ovarian Cancer

Conditions
-----------------
Ovarian Cancer, Peritoneal Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Patients with newly diagnosed advanced epithelial ovarian cancer (EOC), fallopian tube carcinoma (FTC) or primary peritoneal carcinomas (PPC) with indication for first-line carboplatin/paclitaxel chemotherapy in combination with Avastin Exclusion Criteria: Contraindications for Avastin according to the Summary of Product Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical/demographic patient characteristics at initiation of treatment |  | approximately 4 years | 
| Duration of treatment |  | approximately 4 years | 
| Treatment discontinuations/modifications |  | approximately 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | approximately 4 years | 
| Progression-free survival |  | approximately 4 years |
Medtronic PSR TDD PMCF

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide continuing evaluation and reporting of safety and performance of the SynchroMed II Infusion System within its intended use. Data will support post-market surveillance obligations.

Detailed Description
-----------------
This study was originally posted under NCT01524276 and now posted alone to adapt to new ISO regulation.

Official Title
-----------------
Product Surveillance Registry (PSR) - Targeted Drug Delivery (TDD) - SynchroMed II European Post-Market Clinical Follow-up (PMCF)

Conditions
-----------------
Chronic Pain, Spasticity, Muscle

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements Patient has or is intended to receive or be treated with an eligible Medtronic product Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment The indication for implant meets approved indications The patient can reasonably be expected to remain fully on label for a 48-month time period after implant Exclusion Criteria: Patient who is, or will be, inaccessible for follow-up Patient with exclusion criteria required by local law Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results There is no indication at enrollment (e.g., medical conditions, anticipated relocation, etc.) that the patient will be unable to complete 48 months of follow-up after implant
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 |
| --- | --- | --- |
| Pump accuracy | Demonstrate that the proportion of subjects treated as intended (p) with flow rate accuracy outside the interval of 0.75 to 1.25 (±25 percent) is < 10 percent with 95 percent confidence at 4 years post implant. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pump survival | Demonstrate pump survival (freedom from product performance events) is > 90 percent at 4 years post-pump implant | 4 years |
A Trial To Assess Switching From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System In Idiopathic Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to assess whether it is possible for subjects with idiopathic Parkinson's Disease to switch from ropinirole, pramipexole and cabergoline to rotigotine transdermal system (SPM 962) overnight without worsening of Parkinson's Disease symptoms. Subjects who meet eligibility criteria will be switched overnight to treatment with rotigotine transdermal patches at a dose considered equivalent to the dose of dopamine agonist that the subject is currently taking. Subjects on ropinirole or pramipexole will take their last dose at bedtime and then apply rotigotine patch(es) upon awakening the next morning. Subjects on cabergoline will apply rotigotine patches 24 hours after the final dose of cabergoline. Subjects will continue rotigotine treatment for 28 days, during which dose can be increased or decreased as needed. At the end of treatment, subjects can select to enroll in an open-label extension trial. The first subject was enrolled on 28 December 2004. The last subject was enrolled in June 2005 and the last subject visit was conducted in July 2005. This study is now closed.

Official Title
-----------------
A Phase 3b, Open-Label, Multicenter, Multinational Trial To Assess The Tolerability Of Switching Subjects From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System And Its Effect On Symptoms In Subjects With Idiopathic Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Rotigotine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic Parkinson's disease Exclusion Criteria: Not taking a dopamine agonist

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

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

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

| Intervention/Treatment |
| --- |
|Drug: Rotigotine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of rotigotine as determined by the total number of subjects completing the trial. |  |  | 
| Effect on symptoms and other variables. |  |  | 
| Safety. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IDIOPATHIC PARKINSON'S DISEASE