linjc16/ctgov huggingface dataset:
Predictive Factors of Ranibizumab Treatment in Macular Edema With CRVO

Study Overview
=================
Brief Summary
-----------------
Recent studies have shown that intravitreal injection of anti-VEGF agent, Lucentis (Ranibizumab) is effective for macular edema associated with central retinal vein occlusion (CRVO). However, there is little information on whether there are any predictive factors of treatment outcome after this treatment. We plan to perform comprehensive functional and imaging tests to determine significant predictive factors.

Detailed Description
-----------------
The purpose of the present study is to investigate predictive factors of treatment outcome after intravitreal injection of Lucentis (Ranibizumab) in eyes with macular edema associated with central retinal vein occlusion (CRVO) using various comprehensive clinical tests including visual filed, spectral-domain optical coherence tomography (SD-OCT), ultra wide-field fluorescein angiography, new flicker electroretinogram (ERG) using skin electrodes. Corrected visual acuity, visual filed, spectral-domain optical coherence tomography (SD-OCT), ultra wide-field fluorescein angiography, and new flicker electroretinogram (ERG) using skin electrodes are performed before and 3, 6, 9, 12 months after the treatment. Predictive factors of treatment outcome are statistically analyzed.

Official Title
-----------------
Predictive Factors of Treatment Outcome After Intravitreal Injection of Lucentis (Ranibizumab) in Eyes With Macular Edema Associated With Central Retinal Vein Occlusion (CRVO)

Conditions
-----------------
Central Retinal Vein Occlusion

Intervention / Treatment
-----------------
* Drug: Ranibizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Macular edema associated with central retinal vein occlusion Best corrected visual acuity < 20/30 Central macular thickness > 300 Period from symptom onset to treatment < 12 months Exclusion Criteria: Any past history of treatment for macular edema (e.g. anti-VEGF injection, steroid, vitrectomy)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: Intravitreal injection of Ranibizumab<br> | Drug: Ranibizumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected visual acuity |  | 12 months |
Representations of Oral Nutritional Supplementation (ONS) in Hospitals : Gender differences_observational Study

Study Overview
=================
Brief Summary
-----------------
Over 30% of hospitalized patients are malnourished. These figures range from 20% to 60% in geriatric units. Undernutrition results either from a decrease in energy intake, an increase in needs, an increase in losses or a combination of these three causes. As a factor in mortality, morbidity and lengthening the time of hospital stays, undernutrition induces health costs 45 to 102% higher than a person who is not undernourished. The nutritional management of patients initially includes hygieno-dietary advice, then the implementation of an oral nutritional supplementation (ONS). A recent study conducted by our teams highlighted the low ONS consumption among women compared to men (39.48% vs 73.41%). Interviews with patients showed that 13 out of 17 had a negative opinion of ONS. The aim of this study is to show, on a larger scale, whether ONS consumption differs according to sex and if so, to highlight the obstacles to this consumption through the implementation of semi-directive interviews with patients. Ultimately, this research will lead to the implementation of alternative strategies to improve ONS consumption and to a better understanding of the obstacles to ONS consumption.

Official Title
-----------------
Representations of Oral Nutritional Supplementation (ONS) in Hospitals : Gender differences_observational Study

Conditions
-----------------
Malnutrition, Oral Nutritional Supplementation

Intervention / Treatment
-----------------
* Dietary Supplement: semi-structured interviews


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient who has given oral consent over 18 years orally fed with a prescription for ONS speaks and understands French hospital stay longer than 4 days Exclusion Criteria: adult under tutelage pregnant or breastfeeding women cognitive disorders patient does not speak or understand French

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 |
| --- | --- |
| patients hospitalized at the Dijon University Hospital<br>Patients hospitalized in the endocrinology, digestive surgery, pneumology and geriatric units of the Dijon University Hospital with a prescription for ONS | Dietary Supplement: semi-structured interviews<br>* About 30 minutes and touching on the following subjects: perception of hospital meals patient representation of ONS taking ONS and feelings about it<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semi-structured individual interviews |  | 1 day on inclusion |
Different Doses of ZED1227 vs. Placebo in NAFLD

Study Overview
=================
Brief Summary
-----------------
This is a double-blind, randomized, multicenter, placebo-controlled, comparative, exploratory phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 20, 50, or 100 mg ZED1227 vs. placebo for the treatment of patients with NAFLD with fibrosis.

Official Title
-----------------
Double-blind, Randomized, Placebo-controlled, Phase II Dose-finding Study Comparing Different Doses of ZED1227 Capsules With Placebo in the Treatment of Non-alcoholic Fatty Liver Disease (NAFLD) With Significant Fibrosis

Conditions
-----------------
NAFLD, Liver Fibrosis

Intervention / Treatment
-----------------
* Drug: ZED1227
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has provided signed informed consent Is a male or female ≥ 18 and < 75 years of age Has diagnosed NAFLD Has diagnosed significant fibrosis (stages 2 or 3) Exclusion Criteria: Has a history of significant alcohol consumption (an average of > 20 g/d in females and > 30 g/d in males) Has a history or presence of any other significant concomitant liver diseases Has diagnosed type 1 diabetes mellitus (T1DM) Has presence of cirrhosis

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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZED1227 (low dose) 10 mg<br> | Drug: ZED1227<br>* ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2).<br>|
| Experimental: ZED1227 (middle dose) 25 mg<br> | Drug: ZED1227<br>* ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2).<br>|
| Experimental: ZED1227 (high dose) 50 mg<br> | Drug: ZED1227<br>* ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2).<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change of PRO-C3 levels | Relative change (%) of serum levels of PRO-C3 between baseline and the EOT. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Incidence of treatment-emergent adverse events. | from baseline to 16 weeks |
Is There Hearing Loss After Acute Mastoiditis

Study Overview
=================
Brief Summary
-----------------
Following acute mastoiditis there is a possible risk to develop hearing loss. The cause could be either possible involvement of the inner ear, or in cases that underwent surgery, secondary to the effect of the drill's noise. Extended hearing test will be performed for 25 children that suffered acute mastoiditis that resolved with conservative treatment and compared with 25 children that needed surgical intervention.

Conditions
-----------------
Acute Mastoiditis, Acute Otitis Media

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of acute mastoiditis 4 years and older Exclusion Criteria: Younger than 4 years old Not cooperative for hearing test Active ear disease Major medical illness

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute mastoiditis, Hearing loss, Mastoidectomy, Audiogram
Macro and Micro Haemodynamic Responses to Shock in the Renal and Systemic - MICROSHOCK - RENAL

Study Overview
=================
Brief Summary
-----------------
An observational study of the state of the renal and systemic circulations in patients with early septic shock. Both macro and microvascular parameters will be assessed using echocardiography, sublingual incident dark field video-microscopy and renal contrast enhanced ultrasound. Patients will be categorised by KDIGO degree of kidney injury at Day 7 and stratified. Haemodynamic and perfusion based variables over time for these groups will be compared to assess the impact of changes in same on the development of AKI. Lab based work to quantify renal injury biomarkers will also be undertaken.

Official Title
-----------------
Macro and Micro Haemodynamic Responses to Shock in the Renal and Systemic Circulations; a Prospective Observational Study

Conditions
-----------------
Acute Kidney Injury, Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Within 48 hours of ICU admission Evidence of suspected or confirmed infection Serial Organ Failure Assessment (SOFA) score increase of 2 or more (assuming baseline 0 if no previous measures) Requiring vasopressor therapy to maintain a MAP > 65mmHg Lactate > 2 mmol/l despite initial fluid resuscitation Exclusion Criteria: Known intolerance to Sonovue or any other ultrasound contrast agent Acute Respiratory Distress Syndrome Pregnancy Breast Feeding mothers Patients not expected to survive 24 h in whom the intent of treatment is palliative

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 |
| --- | --- | --- |
| KDIGO AKI grade |  | Day 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Septic shock, acute kidney injury, haemodynamic monitoring, microcirculation
Dreaming and EEG Changes During Anaesthesia Maintained With Propofol or Desflurane

Study Overview
=================
Brief Summary
-----------------
We hypothesise that patients who receive propofol for maintenance of anaesthesia will report dreaming more often when they emerge from anaesthesia than patients who receive desflurane for maintenance of anaesthesia.

Detailed Description
-----------------
Patients commonly report that they have been dreaming when they emerge from anaesthesia. Data from observational studies and small randomised trials suggests that reports of dreaming are more commonly made after anaesthesia maintained with propofol than anaesthesia maintained with inhaled anaesthetic agents. We propose to randomise 300 healthy patients to receive a standardised general anaesthetic for surgery that includes either propofol or desflurane for maintenance. We will measure the raw and processed electroencephalogram during and after anaesthesia and interview patients about dreaming as soon as they emerge from anaesthesia.

Official Title
-----------------
Dreaming and EEG Changes During Anaesthesia Maintained With Propofol or Desflurane

Conditions
-----------------
Anaesthesia

Intervention / Treatment
-----------------
* Drug: Propofol
* Drug: desflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients Age between 18 and 50 years Presenting for elective surgery under general anaesthesia Exclusion Criteria: Inadequate English language comprehension Major drug abuse problem

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Propofol based anaesthetic maintenance with propofol effect-site steered target-controlled infusion, in addition to fentanyl and non-opioid analgesics | Drug: Propofol<br>* target controlled infusion of propofol<br>|
| Active Comparator: 2<br>Desflurane based anaesthetic maintenance with manually controlled administration in 100% oxygen in addition to fentanyl and non-opioid analgesics | Drug: desflurane<br>* Anaesthetic maintenance with desflurane<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dreaming reported by patients interviewed immediately on emergence from anaesthesia using a standardised questionnaire |  | recovery room stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anaesthesia, propofol, desflurane, dreaming, electroencephalography
Post Marketing Surveillance for PROSENSE™ a Cryotherapy Treatment of Renal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
This experiment is designed for post marketing data collection of a cryosurgical system [PROSENSE™ of IceCure Medical], for the treatment of renal cell carcinoma (RCC).

Detailed Description
-----------------
A post marketing data collection of a cryosurgical system [PROSENSE™] of IceCure Medical], for the treatment of renal cell carcinoma (RCC).

Official Title
-----------------
ICE-SECRET PROSENSE™ Cryotherapy For Renal Cell Carcinoma Trial

Conditions
-----------------
Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Device: PROSENSE™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is above 18 years old. The patient has enhanced solid mass of renal origin located in the kidney or elsewhere proved by imaging. Patient's mass size is up to 5 cm at its largest dimension. Patient is able to visit the clinic as needed during the 60-month follow-up period following the cryoablation procedure. The patient has been informed of the study and agrees to its provisions, and has signed an IRB approved written informed consent, including data privacy authorization. Exclusion Criteria: Patients with permanent coagulation disorders or severe medical instability or active infection. Patients with any terminal illness. Patient participating in other trials using drugs or devices.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single arm, open label, treatment<br>single arm, open label, treatment; ProSenseTM Cryoablation treatment, post marketing surveillance | Device: PROSENSE™<br>* single arm, open label, PROSENSE™ treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success in creating an ice ball that engulfs the whole tumor with 5 mm margins using the ProSense™ as seen under laparoscopic, US or CT imaging during the procedure. |  | During intervention | 
| Recurrence free survival |  | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success in verification of the ProSense™ safety as demonstrated by having no complications related to the cryoablation procedure other than the well-known ones. |  | a follow up visit at 6 weeks, 6 months, 12 months and every 1 year afterwards up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RCC, Renal Cell Carcinoma, Kidney tumors
Biological Standarization of Cupressus Arizonica Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP)

Study Overview
=================
Brief Summary
-----------------
Biological Standardization of Cupressus arizonica Allergen Extract.

Detailed Description
-----------------
This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.

Official Title
-----------------
Biological Standarization of Cupressus Arizonica Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP)

Conditions
-----------------
Allergy to Tree Pollen

Intervention / Treatment
-----------------
* Biological: Cupressus arizonica


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has provided written informed consent, appropriately signed and dated by subject. Subject can be male or female of any race and ethinic group. Age 18 years and 60 years ata the study inclusión day. Positive clinical history of inhalatory allergy to Cupressus arizonica. A positive prick test with a standarices commercially Cupressus arizonica allergen extract. A positive prick test with positive control of histamine 10 mg/ml. A positive test for specific IgE to Cupressus arizonica. Exclusion Criteria: Immunotherapy in the past 5 years with an allergen extract Cupressus arizonca or other allergen extract than may interfere with the allergene to be tested. Use of drugs that may interfere before and after with the skin reactions. Treatment with certain drugs.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cupressus arizonica allergen extract at 4 different concentrations. Positive control. Negative control | Biological: Cupressus arizonica<br>* Four different concentrations of Cupressus arizonica allergen extract, positive control and negative control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wheal size area (mm2) on the skin at the site of the puncture during the inmediate phase |  | Test sites should be inspected and recorded 15-20 min after application | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergy to Cupressus pollen