linjc16/ctgov huggingface dataset:
Assessment of Patient's Satisfaction Regarding the Handiness of Two Hyaluronic Acid Eye Drops Vials

Study Overview
=================
Brief Summary
-----------------
Assess the patient feeling about the handiness of two different vials used to deliver both, unpreserved hyaluronic eye drops.

Conditions
-----------------
Assess the Patient Feeling About the Handiness of Two Different Vials Used to Deliver Both, Unpreserved Hyaluronic Eye Drops

Intervention / Treatment
-----------------
* Device: HYABAK®
* Device: HYLO-COMOD®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or woman aged 18 and older Patient with dry eye for at least 3 months Having given his written informed consent Exclusion Criteria: Intolerance to studied products Patient's inability to understand the study procedures and give informed consent. Patient unwilling to follow the study procedures and visits defined by the protocol. Pregnant or lactating women. Patient under guardian ship

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HYABAK®<br>Hyaluronic Acid eye drops CE marked, packaged in multidose ABAK® container (preservative free) | Device: HYABAK®<br>* Hyaluronic Acid eye drops CE marked, packaged in multidose ABAK® container (preservative free)<br>|
| Active Comparator: HYLO-COMOD®:<br>Hyaluronic Acid eye drops CE marked, packaged in multidose COMOD® container (preservative free) | Device: HYLO-COMOD®<br>* Hyaluronic Acid eye drops CE marked, packaged in multidose COMOD® container (preservative free)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall preference of the patient | At Visit2: Week 6 +/- 1week: End of Study Visit. Overall preference of the patient: number of answers Hyabak, Hylo-comod. | 6 weeks |
A Drug-Drug Interaction Study of Omeprazole and PA21

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if Omeprazole is affected by PA21.

Official Title
-----------------
A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Omeprazole in Healthy Male and Female Adults

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: PA21 and Omeprazole with food
* Drug: No PA21; Omeprazole with food
* Drug: PA21 with food, Omeprazole 2hrs later


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers Written informed consent Exclusion Criteria: No significant medical conditions Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PA21 and Omeprazole with food<br> | Drug: PA21 and Omeprazole with food<br>* The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Omeprazole will be 40 mg/day<br>|
| Experimental: No PA21; Omeprazole with food<br> | Drug: No PA21; Omeprazole with food<br>* The maximum dosage of Omeprazole will be 40 mg/day<br>|
| Experimental: PA21 with food, Omeprazole 2 hrs later<br> | Drug: PA21 with food, Omeprazole 2hrs later<br>* The maximum dose of PA21 will be 15 g/day. The maximum dose of Omeprazole will be 40 mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve from time zero to 24 hours (AUC0-24) | Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours post omeprazole dose on Days 0, 11, 22 | 
| Area Under the Curve from time zero to infinite (AUC0-infinity) | Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours post omeprazole dose on days 0, 11, 22 | 
| Maximum observed plasma concentration (Cmax) |  | pre-dose, 0.25, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours post omeprazole dose on days 0, 11, 22 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PA21, Drug-drug interaction, Pharmacokinetics, Drug Interaction Potentiation
Screening for Vulnerability in the Elderly Supported at the Oscar Lambret Centre

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to uncover the prevalence of vulnerability among patients aged ≥ 70 coming to the medical oncology division of the Oscar Lambret Centre, according to the short screening test Vulnerable Elders Survey 13 (VES-13). The objective is to better understand the value of routine screening of patients before the consultation, it was proposed as a secondary objective of this study to assess the correlation between the identification of the vulnerability in the screening test VES-13 and the identification made by the clinician during the consultation. The correlation between VES-13 and opinion of the clinician for three categories of patients (self - intermediate - fragile) will also be studied.

Official Title
-----------------
Screening for Vulnerability in the Elderly Supported at the Oscar Lambret Centre

Conditions
-----------------
Solid Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient aged ≥ 70 coming for a first visit, whatever the purpose and the disease stage Exclusion Criteria: neglect or refusal to answer to the VES-13 test

Ages Eligible for Study
-----------------
Minimum Age: 70 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 |
| --- | --- | --- |
| To assess the Vulnerable Elders Survey score (VES-13) | A patient is identified vulnerable if the score is ≥ 3 | Within 3 months after recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the correlation between the VES-13 score and the vulnerability judged by a clinical expert | A patient will be identified as vulnerable if he/she belongs to the intermediate or frail category. The Kappa coefficient of agreement will be used to correlate the VES-13 score and clinical observations. | Within 3 months after recruitment | 
| To measure the muscle strength using the grip strength test | Hand Dynamometer Range values : 0-90 | Within 3 months after recruitment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, vulnerability, frail
Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System

Study Overview
=================
Brief Summary
-----------------
Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System

Detailed Description
-----------------
The objective of the study is to establish performance of the Dexcom CGM System (System) in comparison to a blood glucose comparator method.

Official Title
-----------------
Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM)

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Continuous Glucose Monitoring System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 2 or older Diagnosis of Type 1 diabetes or Type 2 diabetes Willing to wear the required number of Systems for the total duration of study wear Willing to participate in Clinic Session(s) during study wear Exclusion Criteria: Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin Known allergy to medical-grade adhesives Pregnancy Hematocrit outside specification ≥ 18 years of age: Male: 36.0%; Female: 33.0%; 13-17 years of age: 35.0%; 7 years - 12 years of age: 32.0%; End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period Required or scheduled to have a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the study wear period

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CGM Users<br>Glucose challenge during clinic sessions to assess performance of CGM compared to comparator measurement. | Device: Continuous Glucose Monitoring System<br>* Continuous Glucose Monitoring System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Performance | System Performance will be characterized with respect to comparator venous plasma measurements. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Related Adverse Device Effects | System will be characterized by Adverse Device Effects experienced by study participants | 10 days |
DEpth of EPinephrine Delivery With Auto-injectors Devices

Study Overview
=================
Brief Summary
-----------------
Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. Although there are several causes of fatal anaphylaxis, food allergy is one of the most common. Epinephrine is recommended as the initial treatment of choice for anaphylaxis. A delay in epinephrine administration may contribute to an increased risk of death. Therefore, the World Allergy Organization recommends that, for the treatment of anaphylaxis, epinephrine solution be administered intramuscularly in the mid-anterolateral thigh. In France 3 auto-injector pens are available: Anapen®, Epipen® and Jext®. For weight> 30 kg, the devices have a needle size respectively of 7.49 mm, 15.02 mm and 15.36 mm. For the weights between 15 and 30 kg needle size is 7.49 mm to 12.7 mm and Anapen® for Epipen® and Jext®. Several studies suggest that the needle length needle is sometim

Official Title
-----------------
Determinants of Muscle - Skin Distance at the Injection Site in Patients With an Indication for the Use of Epinephrine Auto- Injector Pens

Conditions
-----------------
Anaphylactic Shock

Intervention / Treatment
-----------------
* Other: skin ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a weight of over 30 kg at Baseline with food or an Hymenoptera venom allergy (diagnosed by skin tests or serum-specific IgE testing, requiring prescription epinephrine auto-injector pen according to European recommendations, Exclusion Criteria: having a skin lesion on the lateral aspect of the thigh, with a known or suspected allergy to the contact gel

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ultrasound images<br>ultrasound images of the anterolateral aspect of the mid-right thigh | Other: skin ultrasound<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin-to-muscle and muscle-to-bone distance assessment, with compression, for intramuscular injection depending on needle length of the auto-injector pen. |  | Day 1 |
Brief Intervention to Reduce Drinking and Intimate Partner Violence in Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether adding a brief alcohol treatment to standard violence intervention programs for women will result in reduced drinking, reduced partner violence perpetration, and reduced partner violence victimization. We hypothesize that, relative to standard care, women receiving the additional brief alcohol intervention will have better alcohol use and partner violence outcomes.

Official Title
-----------------
Brief Intervention to Reduce Drinking and Intimate Partner Violence in Women

Conditions
-----------------
Intimate Partner Violence, Substance Use

Intervention / Treatment
-----------------
* Behavioral: Standard Care
* Behavioral: Brief Alcohol Intervention combined with standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hazardous drinking Participation in a batterer intervention program
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Other: 1<br>Standard Care only (standard batterer intervention program) | Behavioral: Standard Care<br>* Standard 40 hour state mandated batterer intervention program<br>|
| Other: 2<br>Brief alcohol intervention combined with standard care | Behavioral: Brief Alcohol Intervention combined with standard care<br>* Brief alcohol intervention combined with standard 40 hour state mandated batterer intervention program<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance use and intimate partner violence |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intimate partner violence, alcohol use, substance use
Educational Technology to Enhance Diabetes Care - Retention Study

Study Overview
=================
Brief Summary
-----------------
This study mapped the time course of forgetting among resident physicians after they use an online learning exercise covering principles of diabetes care. Participants took a pre-test followed by an online tutorial covering aspects of diabetes care. They then completed a post-test on the same topics after a randomly-assigned time delay from 0 to 55 days. We hypothesized that post-test scores after these different time delays would decline following a curvilinear relationship with increasing time. This understanding of forgetting will inform our selection of a time for delivering reinforcement exercises in future educational studies among physicians.

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Participation in LOFTS online tutorial


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Family medicine residents (physicians in training) Internal medicine residents (physicians in training)
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Participation in LOFTS online tutorial|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge related to blood pressure and lipid management for diabetes patients |  | Up to 8 weeks |
Treatment With Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic FOLFIRI Chemotherapy and Bevacuzimab in Patients With Liver-only Colorectal Liver Metastases (CRLM): Conversion to Complete Resection in Patients With Initially Inoperable Liver-only CRLM.

Study Overview
=================
Brief Summary
-----------------
A few studies have documented that some patients can be down-staged from an initially inoperable state to a potentially resectable state. Five-year survival in initially inoperable patients that ultimately come to a complete resection appears to be similar to patients who are resected at first presentation. The investigators goal is to assess the rate of conversion to complete resection in patients with initially inoperable liver-only metastases due to colorectal cancer after treatment with HAI of oxaliplatin with FOLFIRI and bevacuzimab systemic treatment.

Official Title
-----------------
Treatment With Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic FOLFIRI Chemotherapy and Bevacuzimab in Patients With Liver-only Colorectal Liver Metastases (CRLM): Conversion to Complete Resection in Patients With Initially Inoperable Liver-only CRLM.

Conditions
-----------------
Liver Metastasis Colon Cancer

Intervention / Treatment
-----------------
* Drug: oxaliplatin
* Drug: FOLFIRI Protocol
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Subject Inclusion Criteria: Histologically confirmed colorectal adenocarcinoma metastatic to the liver. The patient must have inoperable liver metastases as agreed upon by any two hepatobiliary surgeons and the assigned radiologist. A patient may have had prior chemotherapy or be previously untreated. ECOG PS <2 Subject Exclusion Criteria: Prior radiation, hepatic thermo ablation or resection (other than biopsy) to the liver. Patient may not have received prior treatment with hepatic artery infusion (HAI). Extrahepatic metastases Female patients who are pregnant or lactating

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 |
| --- | --- |
| Experimental: single arm prospective trial<br> | Drug: oxaliplatin<br>* intra-arterial oxaliplatin administration<br>Drug: FOLFIRI Protocol<br>* systemic FOLFIRI chemotherapy<br>Drug: Bevacizumab<br>* systemic bevacuzimab therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| conversion rate to complete resection in patients with initially inoperable liver-only metastases due to colorectal cancer after treatment with HAI of oxaliplatin with FOLFIRI and bevacuzimab systemic treatment. |  | 2 years |
Multicenter Trial of Immunologic Markers to Predict Long Term Virologic Outcomes

Study Overview
=================
Brief Summary
-----------------
Purpose is to identify whether immune markerscan predict success of salvage anti-retroviral therapy.

Detailed Description
-----------------
Over the last several years two markers of disease have been utilized to determine if antiretroviral therapy has been successful, one is a CD4 cell count (reflects the immunocompetence of an infected individual) and a HIV viral load (a blood test used to determine the amount of HIV in the infected individual). However in patients who fail their first line of therapythe likelihood of extended resuppressing viral replication with subsequent therapies may be as low as 25-50%. This information may take several months to determine the new therapies possible continuing success. It would be preferable to have additional markers that respond to therapies in the first several weeks to such therapies, therfore possibly offering patients alternate treatment earlier without potentiatinglong term side effects and possible further drug resistance.

Official Title
-----------------
Multicenter Trial of Immunologic Markers to Predict Long Term Virologic Outcomes

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must be HIV infected must be &#8805;18 years old must have been taking the same combination ARV regimen (&#8805;3 drugs) for at least 3 months. Must be experiencing virologic failure (viral load &#8805;50 copies/mL on two occasions at least 2 weeks apart). must be changed to a salvage antiretroviral regimen Patient has to have signed and dated a full infomred consent. Exclusion Criteria: Patient with any of the following abnormal laboratory test results in the previous 3 months: Hemaglobin &lt;100 g/L Platelet count &lt;20,000 cells/L INR &#8805;3.5 IU PTT &#8805;60 IU Patient with other significant underlying disease (non-HIV) that might impact immune markers ( eg. advanced liver disease, malignancy).

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Immune Markers