linjc16/ctgov huggingface dataset:
CHARITE™ vs. ALIF 5-Year Follow-up

Study Overview
=================
Brief Summary
-----------------
To assess the clinical and radiographic outcomes through 5-years following treatment with CHARITÉ™ Artificial Disc vs. the BAK Cage for treatment of degenerative disc disease at one level (L4-S1).

Detailed Description
-----------------
This study is an extension out to 5 year follow-up of a randomized comparative IDE trial of the CHARITÉ™ Artificial Disc vs. ALIF with the BAK cage for treatment of degenerative disc disease. The original 2-year trial demonstrated non-inferiority of the CHARITÉ™ compared to ALIF. This extension will continue to follow-up the original outcome measures and will also examine adjacent segment progression.

Official Title
-----------------
Five-year Follow-up of the CHARITÉ™ Artificial Disc Compared to Anterior Lumbar Interbody Fusion With the BAK Cage.

Conditions
-----------------
Degenerative Disc Disease

Intervention / Treatment
-----------------
* Device: CHARITE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participated in either the training or randomized arm of the CHARITÉ Artificial Disc IDE study, Still have the original implant they received in their index surgery. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Training- CHARITE<br>Non-Randomized Training (TDR with CHARITE) | Device: CHARITE<br>* Lumbar Total Disc Replacement<br>|
| CHARITE<br>Randomized Subjects treated by Lumbar Total Disc Replacment with CHARITE | Device: CHARITE<br>* Lumbar Total Disc Replacement<br>|
| Control<br>Randomized Subjects treated by ALIF with BAK cage | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Success | ODI Improvement greater than or equal to 15 points from baseline No device failures (i.e., revision, re-operation, supplemental fixation, or removal) No major complications Maintenance or improvement in neurological status compared to baseline. | 5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoints | Components of the Overall Success definition (neurological and ODI scores) Visual Analog Scale (VAS) Disc height Range of Motion Migration of the device Radiolucency | 5 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arthroplasty, lumbar, disc
Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Currently the most use solution to volemic reposition in hip replacement arthroplasty is the crystalloid solution. This trial intends to compare two different volemic replacements: HES and Ringer's lactate. This research has been analyzing hemodynamic parameters and the coagulation status before and after the pre-expansion with the solutions above mentioned.

Detailed Description
-----------------
This trial is randomized an blind to the physician who is analyzing the results.It has been select adults; both sex; ASA I and II. These patients must be submitted to hip arthroplasty replacement. The anesthesia technique is single shot spinal anesthesia. Primary endpoint: assessment alternative; technique replacement volemic with HES 130/04. Secondary endpoint: haemostatic abnormalities; blood loss; transfusion blood.

Official Title
-----------------
Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty: Hydroxyethyl Starch Versus Ringer's Lactate

Conditions
-----------------
Hip Replacement Arthroplasty

Intervention / Treatment
-----------------
* Drug: Hydroxyethyl Starch
* Drug: Ringer's lactate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients involved: adults, ASA I and II; Surgery: hip replacement arthroplasty. Exclusion Criteria: Allergy starch; Anemia; Dysfunction renal; Heart insufficiency; Morbid obesity.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: HES 130/04<br>Pre-expansion with HES | Drug: Hydroxyethyl Starch<br>* Dosage: 30ml/kg; frequency: one time; duration: 60min<br>* Other names: Voluven;|
| Active Comparator: Ringer's lactate<br>Pre-expansion with Ringer's lactate | Drug: Hydroxyethyl Starch<br>* Dosage: 30ml/kg; frequency: one time; duration: 60min<br>* Other names: Voluven;Drug: Ringer's lactate<br>* Dosage: 30ml/kg; frequency: one time; duration: 60min.After 10ml-kg-h both groups<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HES expansion plasmatic efficacy |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood transfusion |  | 24 hours | 
| Haemostatic alterations |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip Replacement Arthroplasty, Hydroxyethyl Starch, Hemodilution, Hetastarch, Colloids
Errector Spinae Plane Block for Postoperative Pain Management in Cardiac Surgery: A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess efficacy of erector spinae plane block (ESP) for postoperative pain management in cardiac surgery patients.

Detailed Description
-----------------
After being informed about the study and potential risks, all patients giving written informed consent will be randomised (single blind) as block group(patients is performed esp block) and control group. All patients will be evaluate during 48 hours for postoperative pain.

Official Title
-----------------
Errector Spinae Plane Block for Postoperative Pain Management in Cardiac Surgery: A Randomized Controlled Trial

Conditions
-----------------
Erector Spinae Plane Block, Cardiac Surgery

Intervention / Treatment
-----------------
* Procedure: erector spinae plane block
* Drug: iv analgesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be ASA score I-III Must be 18-75 years old must undergo cardiac surgery Exclusion Criteria: emergency surgery, bleeding diathesis, presence of contraindications to LA agents used in this study, use of chronic opioids, psychiatric disorders. prolonged extubation presence of infection at the injection site. cardiovascular conditions (EF<40, LMCA obstruction)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: esp block group<br> | Procedure: erector spinae plane block<br>* ESP Block: Bilateral ESP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.<br>Drug: iv analgesia<br>* iv contromal<br>|
| Active Comparator: control group<br> | Drug: iv analgesia<br>* iv contromal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in pain the 10 point Visual Analog Scale (VAS) at hours 3,6,9,12,24,36,48. | The VAS is validated instrument assessing average pain. Possible scores range from 0 (no pain) to 10 (worst possible pain) Change= (hours 3,6,9,12,24,48 score- baseline) | baseline and hours 3-6-12-24-36-48 | 
| time to mobilize the patient | time to mobilize the patient is reported as when the patient is mobilized | Any time for 7 days |
Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases

Study Overview
=================
Brief Summary
-----------------
The aim of this study is the identification of familial congenital arrhythmogenic disorders and their clinical follow-up.

Detailed Description
-----------------
Molecular genetic screening in patients with: supraventricular ventricular arrhythmia syncopes of unknown origin and/or suspicion of an arrhythmogenic origin family members of patients with sudden cardiac death and aborted sudden cardiac death Examination of patients includes routine testing like electrocardiogram (ECG), sequential ECGs, exercise testing, invasive electrophysiological stimulation, cardiac magnetic resonance imaging, intravenous drug challenge for identification/exclusion of eg Brugada syndrome. Examples are patients with Long QT Syndrome, Short QT Syndrome, Brugada Syndrome, familial atrial fibrillation, WPW-syndrome, arrhythmias due to familial hypertrophic cardiomyopathy or arrhythmogenic right ventricular dysplasia. Blood samples are taken for further molecular genetic screening.

Official Title
-----------------
Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases

Conditions
-----------------
Long QT Syndrome, Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a history of syncope, abnormal ECG and suspicion of an arrhythmogenic disease Patients with long QT syndrome Patients with short QT syndrome, shortened QT intervals, borderline shortened QT intervals Patients with Brugada syndrome Patients with hypertrophic cardiomyopathy Patients with arrhythmogenic right ventricular dysplasia Exclusion Criteria: Inability to understand study protocol
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Long QT Syndrome, Hypertrophic cardiomyopathy, arrhythmogenic right ventricular dysplasia, Short QT Syndrome, Brugada Syndrome
Aortic Valve Neocuspidization With Glutaraldehyde-Treated Autologous Pericardium (Ozaki Procedure)

Study Overview
=================
Brief Summary
-----------------
The Ozaki aortic valve reconstruction procedure uses autologous or bovine pericardium as an aortic cusp replacement without the use of struts and with use of the patient's own native aortic root. In this technique one can replace individual aortic cusps, 1, 2, or all 3 cusps. Ideally the patient's autologous pericardium will be harvested and fixed in gluteraldehyde at the time and prepared for the patient's specific annular dimensions with the neoaortic root sizers. Based on the measured size, one then uses a leaflet template to independently replace the cusps resulting in more effective preservation of the natural motion of the aortic valve annulus in coordination of the left ventricle, aortic annulus, sinus of Valsalva, and aorta compared to stented bioprosthetic and/or mechanical aortic valve replacements. Professor Ozaki has now performed 1000 Ozaki neoaortic valve reconstructive operations and has better than 95% freedom from re-operation at late follow-up. The objective of this study is to collect a large collection of prospective data from patients undergoing aortic neocuspidalization surgery for aortic valve insufficiency or stenosis isolated or combined with other procedures

Official Title
-----------------
Aortic Valve Neocuspidization With Glutaraldehyde-Treated Autologous Pericardium

Conditions
-----------------
Aortic Valve Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe aortic valve stenosis or insufficiency Written informed consent Willingness to carry out the follow-up visits Exclusion Criteria: Other types of aortic valve surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| postoperative complications |  | 5 years |
Induction of Mixed Hemopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post Transplant in Immunosuppression w/CSA & Mycophenolate Mofetil

Study Overview
=================
Brief Summary
-----------------
Induction of mixed hemopoietic chimerism in patients using Fludarabine, Low Dose TBI, PBSC Infusion and post transplant in immunosuppression w/CSA & Mycophenolate Mofetil

Official Title
-----------------
Induction of Mixed Hemopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post Transplant in Immunosuppression w/CSA & Mycophenolate Mofetil

Conditions
-----------------
Post Transplant in Immunosuppression w/CSA & Mycophenolate Mofetil

Intervention / Treatment
-----------------
* Drug: Mycophenolate Mofetil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving Fludarabine, Low Dose TBI, PBSC Infusion and post transplant in immunosuppression w/CSA & Mycophenolate Mofetil. Exclusion Criteria: Uncontrolled major medical illnesses
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mycophenolate Mofetil|Induction of Mixed Hemopoietic Chimerism in Patients Using Mycophenolate Mofetil|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | 2001-2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mixed hemopoietic chimerism, Fludarabine, TBI, PBSC, immunosuppression, Mycophenolate Mofetil
Forced Oscillation Versus Spirometry in Diagnosing Post Pulmonary Transplant Bronchiolitis Obliterans Syndrome

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the role of forced oscillation in precocious diagnosis of bronchiolitis obliterans syndrome in patients with pulmonary transplant (time difference in detecting distal airways functional impairment by forced oscillation and the standard technique using spirometry).

Conditions
-----------------
Bronchiolitis Obliterans Syndrome

Intervention / Treatment
-----------------
* Other: Forced oscillation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of more than 18 year-old. Patients with cardiopulmonary transplant or bilateral lung transplant. Clinically stable patients Exclusion Criteria: Patients already diagnosed with bronchiolitis obliterans. Respiratory infection. Acute graft rejection. Mechanical complications (bronchial dehiscence, pneumothorax, pleural effusion). Iatrogenic pneumopathy. Inability to perform Respiratory function test.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: post allogreffe patients<br>Functional evaluation of distal airway by forced oscillation technique : relevance earlier diagnostic of pulmonary syndrom of oblitérant bronchiolit in post allogreffe patients | Other: Forced oscillation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time difference in diagnosing distal airways functional disturbance by forced oscillation and by spirometry (standard methode). |  | 2 years |
Outcomes of Stem Cells for Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in patients with cerebral palsy.

Detailed Description
-----------------
The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in 30 patients with cerebral palsy at Vinmec International Hospital, Hanoi, Vietnam.

Official Title
-----------------
Outcomes of Autologous Bone Marrow Mononuclear Cells for Cerebral Palsy: A Self-Controlled Clinical Trial

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Biological: Autologous Bone Marrow Mononuclear Cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cerebral palsy of any types caused by oxygen deprivation. Exclusion Criteria: Epilepsy Hydrocephalus with ventricular drain Coagulation disorders Allergy to anesthetic agents Severe health conditions such as cancer, failure of heart, lung, liver or kidney Active infections

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem cell transplantation<br>2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 3 months afterward | Biological: Autologous Bone Marrow Mononuclear Cells<br>* Transplantation of Autologous Bone Marrow Mononuclear Cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Score of Gross Motor Function Measure (GMFM)-88 | GMFM-88 | 3 months and 6 months after transplantation | 
| Change in Gross Motor Function Measure (GMFM)-66 Percentile | GMFM-66 percentile | 3 months and 6 months after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Muscle tone | Muscle tone are assessed by Modified Ashworth Scale | 3 months and 6 months after transplantation | 
| Number of adverse events | Examples of adverse events to look for: anaphylaxis, allergy, respiratory distress, fever, infections, vomit, epilepsy | Through study completion, an average of 6 months | 
| Change in Denver Developmental Score | Denver II | 3 months and 6 months after transplantation | 
| Change in Quality of Life | Quality of life questionnaire for cerebral palsy (CPQOL) | 3 months and 6 months after transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral Palsy, Stem Cells
Enzastaurin as Second and Third-Line Treatment for Non-Small Cell Lung Cancer.

Study Overview
=================
Brief Summary
-----------------
Enzastaurin given daily to patients with non-small cell lung cancer who have failed at least one prior therapy.

Official Title
-----------------
A Phase II Evaluation of Oral Enzastaurin HCl in Second-and Third- Line Treatment of Patients With Non-Small Cell Lung Cancer

Conditions
-----------------
Non-Small-Cell Lung Carcinoma

Intervention / Treatment
-----------------
* Drug: Enzastaurin HCL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be at least 18 years old Must have been diagnosed with advanced or metastatic non-small cell lung cancer Must be able to visit the doctor's office every 28 days for 6 months or longer. Exclusion Criteria: Pregnant or breastfeeding women Have other significant medical problems as determined by your physician Are unable to swallow tablets Have a history of significant heart disease

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

| Intervention/Treatment |
| --- |
|Drug: Enzastaurin HCL|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the rate of progression-free survival at 6 months for patients receiving oral enzastaurin with NSCLC who are eligible for second-or third-line therapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetics of enzastaurin using sparse sampling methodology in this population |  |  | 
| To assess the QTc interval at anticipated steady state levels of enzastaurin (centrally collected 12-lead ECG on Day 1 of Cycle 2) |  |  | 
| To estimate the objective response rate (complete response [CR] and partial response [PR]) |  |  | 
| To estimate time-to-event variables, such as overall survival time, duration of overall response (up to 1 year), and duration of stable disease (up to 1 year) |  |  | 
| To evaluate the safety of enzastaurin in this patient population |  |  | 
| To assess PKCb expression by immunohistochemistry in readily available tumors from patients |  |  | 
| To evaluate enzastaurin's effect on patients' symptoms, functioning, and health-related quality of life using validated patient questionnaires |  |  | 
| To explore biomarkers relevant to tumor progression and PKCb signaling |  |  |