linjc16/ctgov huggingface dataset:
Impact of Therapeutic Education, Being Set up Under the Authorized Program for Diabetics Patients in Hospital

Study Overview
=================
Brief Summary
-----------------
To Assess the impact of therapeutic education on: the occurrence of long term diabetes complications . balance of his diabetes

Detailed Description
-----------------
evaluation of the benefits of therapeutic education by: glycated hemoglobin assay telephone monitoring quiz monitoring of adverse event related to diabete

Official Title
-----------------
Impact Des Actions d'éducation thérapeutique Mises en Place Dans le Cadre d'un Programme autorisé auprès de Patients diabétiques hospitalisés

Conditions
-----------------
Diabetes Complications

Intervention / Treatment
-----------------
* Other: Therapeutic Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diabetic hospitalized in Léon Berard with telephone line written consent given belong to a social security system Exclusion Criteria: no diabetics patient having alredy completing a therapeutic education program minor patient (<18 years) pregnant woman without telephone line no belong to a social security system patient alredy inclued on clinical study. patient tutelage or under curatorship

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 |
| --- | --- |
| Therapeutic Education + Documentation<br>diabetic patient hospitalized patient particpating in therapeutic education program | Other: Therapeutic Education<br>* participation in a therapeutic education program on diabetes<br>|
| No Therapeutic Education No Documents<br>diabetic patient hospitalized patient without therapeutic education program no documentation submitted | |
| Documentation, No Therapeutic Education<br>diabetic patient hospitalized patient without therapeutic education program documentation submitted | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycated hemoglobin measure | blood sample | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hopitalization | hospitlization related to diabetes | 3 months |
Effect of High-dose Pitavastatin on Glucose Control in Patients With Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
This purpose of this study is to evaluate effect of high-dose Pitavastatin on glucose control in patients with metabolic syndrome.

Official Title
-----------------
the Long-term Effects of High-doSe pitavaStatin on Diabetogenicity in Comparison With Atorvastatin in Patients With Metabolic Syndrome (LESS-DM) Randomized Clinical Trial

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Drug: Pitavastatin 4 mg orally daily
* Drug: Atorvastatin 20 mg orally daily


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed as metabolic syndrome according to National cholesterol Education Program criteria Patients with hypercholesterolemia who required to start statin therapy Exclusion Criteria: overt diabetes acute coronary syndrome within 2 months acute cerebrovascular event within 2 months recent treatment of statin within 1month recent diagnosed neoplasm recent diagnosed liver disease chronic kidney disease patients with myopathy pregnant women, nursing mothers, women with possibility of pregnant patients being adminstered cyclosporine patients with genetic disease such as galactose intolerance, lactose intolerance, glucose-galactose malabsorption patients with treatment cyclosporin

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Pitavastatin 4 mg orally daily<br> | Drug: Pitavastatin 4 mg orally daily<br>* Pitavastatin 4 mg orally daily for 24months<br>|
| Placebo Comparator: Atorvastatin 20 mg orally daily<br> | Drug: Atorvastatin 20 mg orally daily<br>* Atorvastatin 20 mg orally daily for 24months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in HbA1c level |  | baselina and after 24months treatment |
Clinical Evaluation of a Wheelchair Mounted Robotic Arm

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this project, is to evaluate the effect of a wheelchair mounted robotic arm (WMRA) to improve the functional independence of veterans with SCI. The study will determine if the ability to perform marker tasks within the following four categories is improved after the 4 week training period using the robotic arm: 1. activities of daily living, 2. vocational tasks, 3. advanced tasks, and subject-specific tasks.

Detailed Description
-----------------
The primary purpose of this project, is to evaluate the effect of a wheelchair mounted robotic arm (WMRA) to improve the functional independence of veterans with SCI. The study will determine if the ability to perform marker tasks within the following four categories is improved after the 4 week training period using the robotic arm: 1. activities of daily living, 2. vocational tasks, 3. advanced tasks, and subject-specific tasks. The secondary purposes of this project are the following: 1.Does quality of life (life satisfaction and health status) improve after a 4 week period of using the WMRA? 2. What are the perceived advantages of the WMRA to the veteran with SCI? Additionally, the study will evaluate the following: 1) ease of installation and usefulness of instructional manuals; 2) training requirements (time, tasks); 3) safety features; 4) reliability of the device; 5) home, community, and vocational applications; 6) user acceptability; 7) maintenance/ service; 8) portability; and possible modifications.

Official Title
-----------------
Clinical Evaluation of a Wheelchair Mounted Robotic Arm

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Device: Robotic Arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with spinal cord injuries

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Robotic Arm|nan|

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
-----------------
Robotics; Activities of Daily Living; Spinal Cord Injuries
Luminopia One Pilot Study

Study Overview
=================
Brief Summary
-----------------
A single-arm, multi-center, open-label pilot study to evaluate the feasibility, safety, and efficacy of the Luminopia One digital therapeutic in improving visual acuity in a pediatric amblyopia population.

Official Title
-----------------
Luminopia One Pilot Study

Conditions
-----------------
Amblyopia

Intervention / Treatment
-----------------
* Device: Luminopia One


Participation Criteria
=================
Eligibility Criteria
-----------------
Major Eligibility Criteria: Age 4 to <8 years (phase 1) or age 4 to <13 years (phase 2) Monocular amblyopia associated with anisometropia, strabismus or both combined Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive (0.3-1.0 logMAR) Fellow eye BCVA 20/25 or better (phase 1) or 20/32 or better (phase 2) Interocular BCVA difference ≥3 lines (≥0.3 logMAR) Visual acuity stability in current refractive correction (phase 2) Corrected distance heterotropia ≤5 prism diopters on simultaneous prism and cover test (SPCT)

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 12 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
Interventional Model Description: A single-arm, multi-center, open-label pilot study conducted in two phases. Phase 1 enrolled 10 participants at 1 site and phase 2 enrolled 74 participants at 9 sites.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Regimen A<br>Treatment Regimen A will use the Luminopia device for an hour per day for 12 weeks. | Device: Luminopia One<br>* Luminopia One is a digital therapeutic that allows patients to watch videos with therapeutic modifications applied.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amblyopic eye best-corrected visual acuity | Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amblyopic eye best-corrected visual acuity | Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age | 8 weeks | 
| Amblyopic eye best-corrected visual acuity | Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age | 4 weeks | 
| Adherence | Duration spent using the device divided by duration of treatment prescribed (objectively monitored) | 12 weeks |
Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the feasibility of performing a randomized clinical trial evaluating the effect of salpingectomy (removal of the fallopian tubes) during laparoscopic hysterectomy on ovarian function. The hypothesis is that removal of the tubes can prevent diseases of the fallopian tubes such as infection, hydrosalpinx (fluid-filled tubes)and additional invasive procedures such as further imaging work-ups and further surgery related to the tubes.

Official Title
-----------------
Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function

Conditions
-----------------
Laparoscopic Hysterectomy

Intervention / Treatment
-----------------
* Procedure: Salpingectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women ages 18-45 scheduled for laparoscopic hysterectomy with planned preservation of both ovaries. Exclusion Criteria: Carrier for the gene that codes for breast cancer type 1 susceptibility protein (BRCA1) or the gene that codes for breast cancer type 2 susceptibility protein (BRCA 2). Personal history of gynecologic cancer Pregnancy Non-English speaking Unable to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salpingectomy group<br>Participants in this group will have their fallopian tubes removed. | Procedure: Salpingectomy<br>* Removal of the fallopian tubes<br>|
| No Intervention: No Salpingectomy Group<br>Participants in this group will not have their fallopian tubes removed. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in ovarian function as measured by Anti-Mullerian Hormone (AMH) |  | AMH blood samples collected prior to surgery at day 1 (the day of the surgery) and at 1 and 3 months after day 1. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient demographics | The following routinely collected information will be included in the data analysis: age, body mass index, and surgery indication. | Prior to surgery | 
| Patient surgical outcomes | The following surgical outcomes will be collected postoperatively: total operating time, estimated blood loss, surgical complications, and surgical pathology. | Postoperatively on day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian function tests
Evaluation of Comfort With Xibrom (Bromfenac Ophthalmic Solution)0.09% and Nevanac (Nepafenac Ophthalmic Suspension) 0.1% Following Selective Laser Trabeculoplasty (SLT)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate and compare the comfort of bromfenac or nepafenac following SLT.

Detailed Description
-----------------
Open label, single armed, cross over controlled study to evaluate comfort and IOP (Intraocular Pressure) changes of specific NSAIDs post SLT. Patients (n= 25, total 50 eyes) scheduled to undergo bilateral Selective Laser Trabeculoplasty (SLT) will instill bromfenac in the first eye to undergo SLT, and the contra lateral eye will receive nepafenac.

Official Title
-----------------
Evaluation of Comfort With the Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Xibrom (Bromfenac Ophthalmic Solution) 0.09% and Nevanac (Nepafenac Ophthalmic Suspension) 0.1% Following Selective Laser Trabeculoplasty (SLT)

Conditions
-----------------
Intraocular Pressure

Intervention / Treatment
-----------------
* Drug: Xibrom
* Drug: Nevanac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years old, either gender or any race. Diagnosis of open-angle glaucoma or ocular hypertension requiring laser trabeculoplasty. Completion of written and informed consent/authorization prior to any study related procedures. Able to follow study protocol and likely to complete study schedule. Exclusion Criteria: Known sensitivity to NSAIDs. History of neovascular or ocular inflammatory disease. Current use of topical or systemic anti-inflammatory medications. Females of childbearing potential.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Xibrom (bromfenac) | Drug: Xibrom<br>* Xibrom: two times a day for seven days in the first eye.<br>* Other names: bromfenac;|
| Active Comparator: 2<br>Nevanac (nepafenac) | Drug: Nevanac<br>* Nevanac: three times a day for seven days in the second eye.<br>* Other names: nepafenac;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of study medication |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure changes |  | 28 days | 
| Visual Acuity |  | 28 days |
Acquired Von Willebrand Syndrome in Severe Aortic Stenosis

Study Overview
=================
Brief Summary
-----------------
Patients with severe aortic stenosis often suffer from an acquired Von Willebrand syndrome by degeneration of the polymers during passage through the narrow valve leading to turbulences. We hypothesized that the diagnosis of acquired von Willebrand syndrome influence perioperative blood loss in patients undergoing open cardiac valve replacement.

Detailed Description
-----------------
Patients with severe aortic stenosis often suffer from an acquired Von Willebrand syndrome by degeneration of the polymers during passage through the narrow valve leading to turbulences. After written consent and an extended anamnesis of existing coagulopathy, we take three blood samples in these patients: before surgery, on the day after surgery and 4 weeks after surgery. We determine von Willebrand factor in lab and by a point-of-care platelet function analyzer (Multiplate TM). We measure amount of mediastinal drainage after 24 hours and blood product consumption in these patients.

Official Title
-----------------
Does an Acquired Von Willebrand Syndrome Influence Perioperative Blood Loss in Patients With Severe Aortic Stenosis Undergoing Aortic Valve Replacement?

Conditions
-----------------
Bleeding, Von Willebrand Disease, Aortic Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe aortic stenosis (Orifice area < 1 cm2) Exclusion Criteria: missing consent severe hepatic or renal disfunction

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 |
| --- | --- |
| Severe aortic stenosis<br>Patients undergoing aortic valve replacement because of severe aortic stenosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of mediastinal drainage in the first 24 hours |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of given blood products in the first 24 hours |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aortic stenosis, aortic valve replacement, von Willebrand disease, blood loss
Efficacy and Safety Study of Soluble Beta-1,3/1,6-glucan (SBG) Versus Placebo in Chronic Diabetic Foot Ulcers

Study Overview
=================
Brief Summary
-----------------
Evaluation of efficacy and safety of SBG vs placebo in the treatment of chronic diabetic foot ulcers.

Detailed Description
-----------------
The objective of this study is to evaluate efficacy and safety of soluble beta-1,3/1,6-glucan (SBG) on chronic diabetic foot ulcers.

Official Title
-----------------
A Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Soluble Beta-1,3/1,6-glucan (SBG) in Chronic Foot Ulcers in Patients With Diabetes

Conditions
-----------------
Diabetes, Diabetic Ulcer

Intervention / Treatment
-----------------
* Drug: SBG
* Drug: Placebo Comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic diabetic foot ulcer Exclusion Criteria: Insufficient nutritional status, renal function or diabetes control

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: SBG<br>* Solution for topical use<br>|
| Placebo Comparator: 2<br> | Drug: Placebo Comparator<br>* Solutin for topical use<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the proportion of patients in the two arms who have complete healing of target ulcer |  | Maximum 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SBG, Diabetes, Diabetic ulcer, Chronic ulcer
Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury (TBI)

Study Overview
=================
Brief Summary
-----------------
The study will explore the neurocognitive effect of four weeks of treatment with amantadine versus placebo in patients with traumatic brain injury using the Interval Bisection Timing Task. Approximately 16 individuals with traumatic brain injury are expected to participate in this study. Subject participation is expected to last up to 8 weeks with 16 study visits.

Official Title
-----------------
Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Drug: amantadine
* Drug: amantadine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 55 inclusive. History of post-MVA close head TBI. Female subjects must use an acceptable method of contraception during entire study. Acceptable methods of contraception are: history of surgical sterility, postmenopausal status, hormonal contraceptives, or accepted barrier devices (i.e., male/female condom, diaphragm, cervical cap, intrauterine device). Exclusion Criteria: Current or past history of major psychiatric disorder (schizophrenia, bipolar disorder, major depressive disorder) Substance use disorder Current or past history of serious chronic medical condition (pulmonary (lung), cardiovascular (heart), hepato-renal (liver-kidney) disease, diabetes) Seizures Smoking one or more packs of cigarettes per day If you are pregnant or breastfeeding, or plan to become pregnant during the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active<br> | Drug: amantadine<br>* amantadine twice daily<br>Drug: amantadine<br>* amantadine 100 mg twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is the Interval Bisection Timing Task. |  | 12 -16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary efficacy measure is the Barrett Impulsiveness Scale (BIS-11). |  | 12-16 moths | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perception of time, traumatic brain injury, amantadine