linjc16/ctgov huggingface dataset:
CardioMEMS HF System OUS Post Market Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this Post Market Study (PMS) is to evaluate the use of the CardioMEMS HF System in patients with Class III Heart Failure in a commercial setting.

Official Title
-----------------
CardioMEMS HF System OUS Post Market Study

Conditions
-----------------
Heart Failure, Left-Sided Heart Failure, Congestive Heart Failure

Intervention / Treatment
-----------------
* Device: CardioMEMS HF System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent obtained from subject ≥ 18 years of age Diagnosis of NYHA Class III Heart Failure At least 1 HF hospitalization within 12 months of Baseline visit Subjects with reduced LVEF heart failure should be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the subject is intolerant to beta blockers, ACE-I or ARB. Subjects with a BMI ≤ 35. Subjects with BMI >35 will require their chest circumference to be measured at the axillary level, if > 65 inches the patient will not be eligible for the study. Subjects with pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the RHC) Subjects willing and able to comply with the follow-up requirements of the study Exclusion Criteria: Subjects with an active infection Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis Subjects who, in the Investigator's opinion, are unable to tolerate a right heart catheterization Subjects who have had a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within 2 months of Baseline Visit Subjects with Cardiac Resynchronization Device (CRT) implanted < 3 months prior to enrollment Subjects with a Glomerular Filtration Rate (GFR) < 25 ml/min (obtained within 2 weeks of the baseline visit) who are non-responsive to diuretic therapy or who are on chronic renal dialysis Subjects with congenital heart disease or mechanical right heart valve(s) Subjects likely to undergo heart transplantation or VAD within 6 months of baseline visit Subjects with known coagulation disorders Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel (not applicable for subjects taking anti-coagulation therapy or other approved anti-platelets therapy).

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 |
| --- |
|Device: CardioMEMS HF System|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from device/system related complications |  | Two year | 
| Freedom from pressure sensor failure. |  | Two year | 
| Annualized HF hospitalization rate at 1 year compared to the HF hospitalization rate in the year prior to enrollment. |  | One year |
Myoelectric Computer Interface to Reduce Muscle Co-activation After Stroke

Study Overview
=================
Brief Summary
-----------------
This study examines whether in-lab training with a myoelectric-computer interface (MyCI) can reduce abnormal muscle co-activation after stroke.

Official Title
-----------------
Myoelectric Computer Interface to Reduce Muscle Co-activation After Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Behavioral: 60-min isometric MyCI training
* Behavioral: 90-min isometric MyCI training
* Behavioral: 90-min movement MyCI training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stroke survivors at least 6 months after stroke onset Persistent moderate to severe arm impairment Increased arm tone Exclusion Criteria: Substantial impairment of vision, memory, language or concentration Botulinum toxin use in the affected arm Concomitant participation in another research study on the arm

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 60-minute Isometric<br>60-min Isometric MyCI training: EMG-controlled game training for 60-minutes per session | Behavioral: 60-min isometric MyCI training<br>* EMG-controlled in-lab training with arm restrained for 60 minutes per session<br>|
| Experimental: 90-minute Isometric<br>90-min Isometric MyCI training: EMG-controlled game training for 90-minutes per session | Behavioral: 90-min isometric MyCI training<br>* EMG-controlled in-lab training with arm restrained for 90 minutes per session<br>|
| Experimental: 90-minute Movement<br>90-min movement MyCI training: EMG-controlled game training for 90-minutes per session | Behavioral: 90-min movement MyCI training<br>* EMG-controlled in-lab training without restraint for 90 minutes per session<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment - Upper Extremity | Scale 0-66, total score | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment - Upper Extremity | Scale 0-66, total score | 10 weeks | 
| Wolf Motor Function Test | Timed test | 6 and 10 weeks | 
| Motor Activity Log | 30-question test, total score | 6 and 10 weeks |
Reference Population for Speckle Tracking Imaging

Study Overview
=================
Brief Summary
-----------------
The SCAR study uses a software program entitled QLAB, a proprietory program, developed by Philips Healthcare (Philips Healthcare, Andover, MA). Literature on two-dimensional speckle tracking imaging (2DSTE) is growing, but data relevant to the population in the SCAR study is minimal. Accumulation of data relevant for a population of subjects will provide a set of normal values for interpretation of 2DSTE and minimize any influences from differences in data produced from different companies. This data may also assist other researchers investigate other cardiac diseases and abnormalities.

Official Title
-----------------
Establishing a Reference Population for Normal Left Ventricular Function Parameters to Validate the Use of Two Dimensional Speckle Tracking Imaging Software in the Scar Study

Conditions
-----------------
Left Ventricular Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be between the ages of 20 - 80 years at study entry Provide written informed consent and be able to comply with study procedures, including permission to access medical records Have a BMI index equal to or less than 35 Less than 5% risk of developing coronary artery disease as determined using the Combined Diamond/Forrester and CASS data (ACC Stable CAD Guidelines) Exclusion Criteria: Have taken cardioactive drugs within 6 months prior to examination These include but are not limited to beta-blockers, calcium channel blockers, and angiotensin converting enzyme inhibitors Currently clinically significant chronic or acute illness Documented cardiovascular disease Possess abnormal cardiac structure and function after examination with routine ECHO This may include valvular defects, left ventricular hypertrophy, cardiomyopathies or pericardial disease Documented congenital heart conditions or defects History of diabetes Be unwilling to provide voluntary consent

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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 |
| --- | --- | --- |
| Establishment of normal values data in males and females aged 20 - 80 |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
speckle tracking echocardiography, database
Banded Versus Non-banded Roux-en-Y Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
This is a prospective randomized Study comparing Weight loss, Esophageal Motility and Reflux in lap. Gastric Bypass vs. lap. Banded-Gastric Bypass using the A.M.I. Soft Gastric Bypass Band (B-Band.

Official Title
-----------------
A Prospective Randomized Comparison on Weight Loss After Gastric Bypass and Banded Gastric Bypass Using the A.M.I B-Band (Soft Gastric Bypass Band)

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Procedure: gastric bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 40 or BMI > 35 + hypertension/diabetes mellitus pH metry and manometry preoperatively Exclusion Criteria: formerly operations of the stomach formerly open abdominal surgery malignancy within the last 5 years formerly gastric banding

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Active Comparator: banded gastric bypass<br>Banded gastric bypass (circular anastomosis 21mm) using the A.M.I. B-Band (Soft Gastric Bypass Band) | Procedure: gastric bypass<br>* laparoscopic gastric bypass with circular stapled 21mm gastrojejunostomy<br>* Other names: laparoscopic banded gastric bypass;|
| Active Comparator: non-banded gastric bypass<br>non-banded gastric bypass (circular anastomosis 21mm) | Procedure: gastric bypass<br>* laparoscopic gastric bypass with circular stapled 21mm gastrojejunostomy<br>* Other names: laparoscopic banded gastric bypass;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excessive Weight Loss |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pouch dilatation, band migration, reflux, esophageal motility | Pouch dilatation verified by double contrast upper GI series Band migrations verified by gastroscopy Reflux verifies by pH-metry and gastroscopy Esophageal motility measured by manomerty | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric bypass, banded gastric bypass, weight loss, weight regain, bariatric surgery
PET/MR in Locally Advanced Nasopharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
PET/MR in Locally Advanced Nasopharyngeal Carcinoma

Official Title
-----------------
PET/MR in Locally Advanced Nasopharyngeal Carcinoma

Conditions
-----------------
Nasopharyngeal Carcinoma, PET/MR

Intervention / Treatment
-----------------
* Diagnostic Test: PET/MR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with newly histologically confirmed non-keratinizing carcinoma. Tumor staged T1-4N0-3M0 （according to the 8th AJCC staging system） Performance status: KPS>70 With normal liver function test (ALT, AST <1.5ULN) Renal: creatinine clearance >60ml/min Without hematopathy,marrow: WBC >4*109/L, HGB>80G/L, and PLT>100*109/L. Written informed consent Exclusion Criteria: Adenocarcinoma Age >70 Prior malignancy (except adequately treated carcinoma in-situ of the cervix or · basal/squamous cell carcinoma of the skin) Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume) Patient is pregnant or lactating Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), or emotional disturbance.

Ages Eligible for Study
-----------------
Maximum Age: 70 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 |
| --- | --- |
| Other: PET/MR<br>Patients are examined with PET/MR. | Diagnostic Test: PET/MR<br>* Performed on a hybrid PET/MR scanner before treatment start (N = 150). Among those patients, 10 patients are examined with PET/MR in the completion of neoadjuvant chemotherapy and a follow-up scan three months after the completion of radiotherapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiparametric PET/MRI-based radiomics nomograms for locally advanced nasopharyngeal carcinoma | Radiomics-based prognostic model by PET/MRI | From day 1 of chemotherapy to the date of the event, a minimum follow-up of 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction model of the efficiency of treatment in locally advanced nasopharyngeal carcinoma | Radiomics-based prediction model of the efficiency of treatment by PET/MRI | about 4 years (all of patients complete treatment) |
Systolic Pressure Index in Assessing the Risk of Cardiovascular Events

Study Overview
=================
Brief Summary
-----------------
To investigate whether the presence of a Systolic pressure index (<0.9 or> 1.4) is a marker of risk of cardiovascular events after peri-operative high-risk surgery outside the cardiac and vascular surgery.

Official Title
-----------------
Interest of Measuring the Systolic Pressure Index in Assessing the Risk of Cardiovascular Events Peri-operatively in the Surgery, Settled Out of Cardiovascular Surgery

Conditions
-----------------
Cardio-vascular Events

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age> 40 years surgery set : Visceral surgery: gastrectomy or colectomy, abdomino-perineal amputation, pancreatic surgery, liver surgery, esophageal surgery In urological surgery: nephrectomy, total prostatectomy, cystectomy In thoracic surgery: pneumonectomy, lobectomy In orthopedic surgery: total hip replacement and total knee prosthesis Exclusion Criteria: pathology making it impossible to measure Systolic Pressure Index life expectancy less than 6 months emergency surgery

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Patients exposed<br>Patients with Systolic Pressure Index <0,9 ou >1,4. | |
| Patients not exposed<br>Patients with Systolic Pressure Index >0,9 ou <1,4. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| It is a composite involving the following events: death, cardiovascular death, acute coronary syndrome, left cardiac decompensation, stroke, transient ischemic attack |  | day1, day 2, day 3, 1 month, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - for the short term increase in the length of hospitalization - for the long term: death, cardiovascular death, hospitalization for acute coronary syndrome, cardiac decompensation left, TIA, stroke, acute ischemia and ischemia critical member. |  | day1, day 2, day 3, 1 month, 1 year |
Influence of Epidural Analgesia in Elective Laparoscopic Colorectal Resections

Study Overview
=================
Brief Summary
-----------------
Epidural anaesthesia in open surgery is a effective method for analgesia and has a positive effect on postoperative resolution of ileus. In laparoscopic surgery, the role of epidural surgery is not established. This prospective observational trial evaluates the effect of epidural analgesia in patients undergoing elective, laparoscopic colorectal surgery.

Detailed Description
-----------------
All patients with elective, laparoscopic colorectal resection between November 2004 and January 2007 were included in the trial. The decision for epidural analgesia was made by the anaesthetist and the patient. Contraindications were previous back surgery, coagulopathy, severe spondylarthrosis and refusal by the patient as contraindications. Primary outcome was subjective feeling postoperatively, assessed with a VAS for pain and cramps and amount of analgesics used. Secondary outcomes were duration of postoperative bowel dismotility (first flatus, first defecation, first solid food intake) and general and specific morbidity.

Official Title
-----------------
Influence of Epidural Analgesia in Elective Laparoscopic Colorectal Resections

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: epidural analgesia (Duracain/Fentanyl/Naropin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective laparoscopic colorectal resection Exclusion Criteria: emergency surgery preoperatively planned stoma formation

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>epidural analgesia | Drug: epidural analgesia (Duracain/Fentanyl/Naropin)<br>* naropin 0.3% or duracain 0.125% + Fentanyl via epidural catheter 4-12 ml/h<br>|
| No Intervention: 2<br>traditional analgesia with opioids | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain (VAS), cramps (VAS) and quantity of analgesics |  | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of postoperative ileus morbidity |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic colorectal surgery, epidural analgesia, pain score, postoperative ileus
Effects of Antibiotic Therapy on the Short and Long-term Results of Periodontitis Treatments

Study Overview
=================
Brief Summary
-----------------
Antibiotics are currently used in periodontology to specifically target the most pathogenic bacteria in subgingival biofilms and to improve treatments. The multiplicity of protocols / dosages tested and the variability of the results did not make it possible to reach an international consensus on antibiotic therapy and its cost / benefit ratio, in particular with regard to the significant side effects of taking antibiotics (resistance bacterial). The care environment as well as the clinical, biological and microbiological parameters can strongly influence the results in usual treatment.

Official Title
-----------------
Effects of Antibiotic Therapy on the Short and Long-term Results of Periodontitis Treatments: Impact of Risk Factors and Treatment Characteristics

Conditions
-----------------
Periodontitis, Adult

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient over 18 years old Patient treated for periodontitis between 01/01/2012 and 07/31/2021 Patient whose medical and periodontal file contains all the elements necessary for data analysis Subject not having expressed, after information, his opposition to the reuse of his medical data for the purposes of this research. Exclusion criteria: Patient who expressed his opposition to participating in the study Patient without periodontitis Patient smoking more than 10 cigarettes / day Patient presenting a dilapidated oral state (untreated caries, unrestored teeth), oral infectious foci whose management requires antibiotic treatment during the initial treatment Impossibility of giving the subject informed information Subject under safeguard of justice Subject under guardianship or guardianship

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A retrospective study of the use of antibiotic therapy on the short and long-term results of periodontitis treatments |  | Files analysed retrospectively from January 01, 2012 to July 07, 2021 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Periodontitis, Inflammatory diseases, Periodontal, Teeth, Aesthetic morbidity, Cardiovascular risk, Supragingival, Subgingival, Biofilms, Prosthetic restorations
Neuromuscular Ultrasound for Focal Neuropathies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a new diagnostic technique, called neuromuscular ultrasound, can improve our ability to diagnose focal nerve disease.

Official Title
-----------------
Neuromuscular Ultrasound for Focal Neuropathies

Conditions
-----------------
Focal Neuropathies, Carpal Tunnel Syndrome, Cubital Tunnel Syndrome, Median Neuropathy, Ulnar Neuropathy, Peroneal Neuropathy, Radial Neuropathy, Sciatic Neuropathy, Tibial Neuropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Electrodiagnostic finding of focal nerve disease Age 18 and older Exclusion Criteria: Skin lesions preventing ultrasound Known ultrasound gel allergy Unable to complete 6 months of follow-up

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ultrasound results reported<br> | |
| Ultrasound results NOT reported<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Neuropathy Sum Score | Neuropathy specific scale | 6 months |