linjc16/ctgov huggingface dataset:
Post Market Surveillance of OZURDEX® for Branch Retinal Vein Occlusion (BRVO) and Central Retinal Vein Occlusion (CRVO)

Study Overview
=================
Brief Summary
-----------------
This multicenter observational study will assess the efficacy and tolerability of OZURDEX® in clinical practice, and will assess the time at which patients are considered for retreatment.

Conditions
-----------------
Retinal Vein Occlusion, Macular Edema

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Macular Edema Prescribed OZURDEX® Exclusion Criteria: None

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 |
| --- | --- |
| OZURDEX®<br>Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study. | Other: No Intervention<br>* No intervention was administered in this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Re-treatment | Time to first re-treatment was defined as the time in days between the first administration of Ozurdex® and the following administration of Ozurdex® (re-treatment) in the study eye. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) Score | BCVA was measured in the study eye using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision improved. | Baseline, Weeks 12, 24 and 48 | 
| Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) | Central Retinal Thickness was measured in the study eye using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicated an improvement. | Baseline, Weeks 12, 24 and 48 |
Horizontal Mattress vs. Interrupted Suture in Surgical Techniques of Pancreaticojejunostomy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to verify that the frequency of pancreatic fistula (ISGPF grade B and C) in horizontal mattress suture are lower than in interrupted suture during pancreaticojejunostomy in pancreatoduodenectomy by randomized clinical trial.

Conditions
-----------------
Patients Who Undergo Pancreatoduodenectomy

Intervention / Treatment
-----------------
* Procedure: pancreaticojejunostomy with horizontal mattress suture
* Procedure: pancreaticojejunostomy with interrupted suture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients from whom we obtained written informed consent of this study Exclusion Criteria: Patients with severe ischemic cardiac disease Patients with severe liver damage Patients requiring oxygen administration due to interstitial pneumonia or pulmonary fibrosis Patients requiring dialysis treatment due to chronic renal failure Patients who are considered as inappropriate by attending physician

Ages Eligible for Study
-----------------
Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: horizontal mattress<br>pancreaticojejunostomy with horizontal mattress suture | Procedure: pancreaticojejunostomy with horizontal mattress suture<br> <br> |
| Experimental: interrupted suture<br>pancreaticojejunostomy with interrupted suture | Procedure: pancreaticojejunostomy with interrupted suture<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of pancreatic fistula including ISGPF grade B and C |  | Ninety days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rates of postoperative complications |  | Ninety days after operation |
Rebreathing of Carbon Dioxide With a Device Used for Giving Inhalational Anaesthesia

Study Overview
=================
Brief Summary
-----------------
The anesthesia gas reflector (AnaConDa) is built on the adsorptive capacity of active carbon which also adsorbs carbon dioxide in exhaled air. Rebreathing of carbon dioxide thus occurs and must be compensated for by increased ventilation. This study aims at determining how much compensation must be given, based on the hypothesis that rebreathing depends on carbon dioxide level in blood and exhaled air.

Official Title
-----------------
Dead Space Effect of an Anaesthesia Gas Reflector (AnaConDa)

Conditions
-----------------
Anesthetic Ventilatory Requirements

Intervention / Treatment
-----------------
* Device: Anesthetic Conserving Device (AnaConDa )


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective coronary artery by-pass graft surgery elective valve replacement surgery normal left ventricular ejection fraction on preoperative echocardiography Exclusion Criteria: obstructive lung disease restrictive lung 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AnaConDa<br> | Device: Anesthetic Conserving Device (AnaConDa )<br>* Standard HME was replaced by AnaConDa. AnaConDa has charcoal filter, HME does not.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway Dead Space With Devices for Heat and Moisture Exchange of Respiratory Gas. | A conventional heat and moisture exchanger used in a respiratory circuit during anasthesia was exchanged by an AnaConDa. The AnaConDa causes re-breathing of carbon dioxide which clinically is equivalent to an increased airway dead space. The total airway dead space effect of the AnaConDa, i.e. volume of the device plus rebreathing from the charcoal filter was measured using the Single Breath Test for carbon dioxide, as was airway deadspace of the conventional Heat and Moisture Exchanger. Airway dead space differences between devices was calculated by subtraction of volumes thus achieved. Difference= Airway dead space AnaConDa - Airway dead space conventional Heat and Moisture Exchanger. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quantification, ventilatory requirements, charcoal filter
Withdrawal of Artificial Nutrition at the End of Life (PERCEPAL)

Study Overview
=================
Brief Summary
-----------------
Withdrawing artificial nutrition in palliative care is an issue that often leads to ethical dilemmas among health care providers, despite clinical guidelines.

Detailed Description
-----------------
The benefit of artificial nutrition in terminally ill patients has been a highly debated issue for the past 30 years, and abundant data are available regarding its effects on patients. Several clinical guidelines have specified the criteria to be considered before initiating artificial nutrition or hydration. If these guidelines appear consensual in theory, the situation is much less straightforward in practice. The attitude of physicians appeared very variable when it came to prescribing or withholding artificial nutrition or hydration, and the lack of training, among other parameters, seemingly encouraged health care professionals to prescribe artificial nutrition or hydration. Furthermore, the decision of the care provider is unconsciously complicated due to figurative representations associated with food regarding, among other aspects, the mother-child relationship, social cohesion, or religious beliefs. These differences are more important since the opinion of physicians and nurses is the one that carries the most influence on the patients' decision when deciding to initiate artificial nutrition and because artificial nutrition and hydration are a common source of ethical dilemmas in health care teams. Furthermore, stopping artificial nutrition or hydration could be misconstrued as euthanasia.

Official Title
-----------------
Caregivers Confronted With the Withdrawal of Artificial Nutrition at the End of Life: Perception and Experienced Difficulties

Conditions
-----------------
Palliative Care Nursing

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nurses, and nurses' aides working in medicine, surgery, and palliative care departments of the regional hospital of Metz-Thionville Exclusion Criteria: Care providers working in pediatrics, gynecology and obstetrics, psychiatry, and emergency departments

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 |
| --- | --- | --- |
| Experience of health care providers confronted with the withdrawing of artificial nutrition at the end of life | Cross-sectional survey questionnaire | month 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experienced difficulties | Cross-sectional survey questionnaire | month 4 |
Gait and Alzheimer Interaction Tracking (GAIT) Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine and to compare gait characteristics under single- and dual-task conditions among healthy subjects together with AD patients at different stages of disease (i.e., pre-dementia, mild and moderate dementia stages).

Detailed Description
-----------------
Although gait disorders are frequently associated with Alzheimer's disease (AD), few studies have focused on their characterization and mechanism. Exploring the associations of the gait characteristics - more particularly the gait variability - with the cognitive performance of AD patients on one hand, and with the morphological brain abnormalities on the other hand, could be useful to understanding the mechanisms of gait disorders in AD. The main objective of this study is to examine and to compare gait characteristics under single- and dual-task conditions among healthy subjects together with AD patients at different stages of disease (i.e., pre-dementia, mild and moderate dementia stages).

Official Title
-----------------
Maladie d'Alzheimer et Troubles Locomoteurs : Caracterisation Des Anomalies Temporelles de la Marche et Etude Des Correlats Anatomo-cognitifs

Conditions
-----------------
Gait Apraxia, Alzheimer Disease, Impaired Cognition, Cerebral Atrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 60 years Able to walk without walking aid on 15 metres Score of Mini-Mental Examination (MMSE) > 10 Written informed consent to participate in the study (or trustworthy person) Being affiliated to a social security regime Near visual acuity ≥ 2/10 Absence of severe depression (score in the 15-item Geriatric Depression Scale ≤ 10) Exclusion Criteria: Score of Mini-Mental Examination (MMSE) ≤ 10 Subject suffering from pre-existing impellent disturbances History of cerebrovascular accident or other cerebro-spinal pathology Poor workmanship of the written or oral French language Refusal of subject to be informed on possible hanging bare anomaly during study Use of walking aid Acute medical or surgical disease in the past 3 months Refusal to participate (or trustworthy person) Contra-indication to the achievement of a Magnetic Resonance Imaging Near visual acuity < 2/10 Presence of severe depression (score in the 15-item Geriatric Depression Scale > 10)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Healthy subjects | |
| Group 2<br>Patients with Mild Cognitive Impairment | |
| Group 3<br>Patients with Mild AD | |
| Group 4<br>Patients with Moderate AD | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stride-to-stride variability of stride time |  | baseline |
The Impact of Two-field or Three-field Lymphadenectomy on Overall Survival in Middle and Lower Thoracic Esophageal Squamous Cell Carcinoma: An Observational Study

Study Overview
=================
Brief Summary
-----------------
To clarify the effect of Two-field or Three-field Lymphadenectomy on the survival of esophageal squamous cell carcinoma.

Official Title
-----------------
The Impact of Two-field or Three-field Lymphadenectomy on Overall Survival in Middle and Lower Thoracic Esophageal Squamous Cell Carcinoma: A Single Center Retrospective Analysis

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Since the data were collected retrospectively, there were no interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Men and women aged 18-85 years 2. Histologically confirmed primary thoracic esophageal squamous cell carcinoma, 3. Staging PT1b-4A, N0-3, M0 AJCC eighth edition 4. Excluding lymph node dissection < 15, (meeting the guideline criteria) 5. The tumor located in the lower middle thoracic. Exclusion Criteria: 1. Patients with a history of previous thoracic and abdominal surgery that may affect lymphatic reflux 2. Patients with distant metastasis confirmed by imaging 3. Patients with obvious surgical contraindications.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| 2F Group<br>Patients with Two-field Lymphadenectomy | Diagnostic Test: Since the data were collected retrospectively, there were no interventions<br>* Since the data were collected retrospectively, there were no interventions<br>|
| 3F Group<br>Patients with Three-field Lymphadenectomy | Diagnostic Test: Since the data were collected retrospectively, there were no interventions<br>* Since the data were collected retrospectively, there were no interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of lymph nodes | Surgical data were retrospectively collected | 2010.1.1-2017.12.30 |
The Effectiveness of Continuous Glucose Monitoring in Diabetes Treatment for Infants and Young Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if the use of a real-time glucose sensor improves diabetes control in young children (less than 4 years old) with Type I diabetes when they are initiated on insulin pump therapy.

Detailed Description
-----------------
A randomized controlled clinical trial involving patients 0-3 yrs old with type 1 diabetes. After successful screening the subjects will be randomized into one of two groups: a CSII group alone and a CSII group + Real Time Sensor Augmentation group (RTSA) group. The CSII group will serve as the control for the CSII+RTSA group. The trial will last for one year.

Official Title
-----------------
Gerber Pump Trial: Effectiveness of Continuous Subcutaneous Insulin Infusion (CSII) and Real-Time Sensor Augmentation (RTSA) in 0-3 Years Old Diabetes Patients; A One Year Randomized Controlled Clinical Trial.

Conditions
-----------------
Diabetes Mellitus, Type I

Intervention / Treatment
-----------------
* Device: Real-time glucose sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children less than 4 years of age with Type I diabetes for at least 3 months Exclusion Criteria: Children greater than 4 years of age Monogenic diabetes

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 3 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Observational arm | |
| Experimental: Real-time glucose sensor<br>Subjects wear real-time glucose sensor | Device: Real-time glucose sensor<br>* Children assigned to this intervention will use a real-time sensor continuously<br>* Other names: Minimed Paradigm Real-time sensor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduce blood glucose variability among 0-3 year old children with type I diabetes. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Type I, Children, Insulin pump therapy, Continuous glucose monitor
A Phase 2 Study Exploring The Safety And Efficacy Of Novel Drug Treatment In Subjects With Diabetic Macular Edema (DME)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of AG-014699 in diabetic patients

Official Title
-----------------
A Phase 2, Multi-Stage, Multi-Center Trial Exploring The Safety And Efficacy Of AG-014699 In Subjects With Diffuse Diabetic Macular Edema (DME) Involving The Center Of The Retina

Conditions
-----------------
Diabetes Mellitus, Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: AG-014699


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic patients, either man or woman, with diabetic retinopathy, at least 18 years of age Exclusion Criteria: patients treated with laser therapy within the last 90 days patients with likelyhood to require cataract surgery within 3 months Uncontrolled diabetes

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AG-014699|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of retinal thickness at Day 15 or Day 25 depending on dosing regimen |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with reduction in retinal thickness from baseline in 2 months |  |  | 
| Change in retinal thickness for 2 months |  |  | 
| Change in visual acuity for 2 months |  |  | 
| ; Proportion of eyes experiencing an improvement in the degree of retinopathy at Day 28 |  |  |