linjc16/ctgov huggingface dataset:
Study of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess xaliproden's potential capacity of slowing the deterioration of cognitive and global functions in patients with mild to moderate Alzheimer's disease. The patients participating in this study will take orally once daily xaliproden or placebo (inactive substance pill).

Official Title
-----------------
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 18-Month Study of the Efficacy of Xaliproden in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: xaliproden (SR57746A)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of probable Alzheimer's disease using NINCDS-ADRDA criteria Mild to moderate degree of severity of dementia as assessed by the Mini-Mental Status Examination score of 16 to 26 (inclusive) Potential participant may be treated with conventional Alzheimer's disease therapy and must be on a stable dose for at least 6 months prior to the randomization and during the entire study period Potential participant must have a reliable caregiver and must be living in a community or in an assisted living facility Mother tongue is English, Spanish or French (oral and written fluency) Signed informed consent from potential participant or legal representative and identified caregiver Exclusion Criteria: Potential participant with any other cause of dementia. Potential participant with serious health problems other than Alzheimer's disease Use of an investigational drug within two months prior to randomization or during this study

Ages Eligible for Study
-----------------
Minimum Age: 50 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: xaliproden (SR57746A)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life. |  |  |
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD

Study Overview
=================
Brief Summary
-----------------
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) - a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.

Official Title
-----------------
A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD Taken Daily at Bedtime (Protocol No. TNX-CY-P302)

Conditions
-----------------
PTSD

Intervention / Treatment
-----------------
* Drug: TNX-102 SL
* Drug: Placebo SL Tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female subjects between the years of 18-75 with a diagnosis of PTSD (diagnosis can be made at screening) Index trauma must have occurred within 9 years of Screening Visit Must have occurred when the patient was ≥18 years of age Exclusion Criteria: Use of antidepressant medication within 2 months of Baseline

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TNX-102 SL Tablet 2.8 mg<br>2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks. | Drug: TNX-102 SL<br>* Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks<br>* Other names: Tonmya(R);|
| Placebo Comparator: Placebo SL Tablet<br>2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks. | Drug: Placebo SL Tablets<br>* Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks<br>* Other names: TNX-102 SL Placebo Tablets;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change from baseline (Visit 2) in the Total CAPS-5 score evaluated at the landmark visit. |  | Week 0, Week 4, Week 8 and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in CGI-S score. |  | Week 0, Week 4, Week 8 and Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD
Comparison of the Effects of Bevacizumab Before vs After Pattern Panretinal Photocoagulation

Study Overview
=================
Brief Summary
-----------------
Compare the effect of an intravitreal injection of bevacizumab previous or posterior of panretinal laser photocoagulation (PRLP) with a pattern laser; to prevent and reduce diabetic macular edema (DME) in patients with proliferative diabetic retinopathy (PDR) with DME.

Official Title
-----------------
Phase 4 Comparison of the Effects of Bevacizumab Before vs After Pattern Panretinal Photocoagulation

Conditions
-----------------
Macular Edema

Intervention / Treatment
-----------------
* Drug: bevacizumab
* Drug: bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with proliferative diabetic retinopathy patients with macular edema Exclusion Criteria: patients with previous treatments patients with ocular surgeries

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Bevacizumab before panretinal photocoagulation. | Drug: bevacizumab<br>* Intravitreal bevacizumab before panretinal photocoagulation<br>|
| Experimental: Group B<br>Bevacizumab after panretinal photocoagulation | Drug: bevacizumab<br>* Intravitreal Bevacizumab after panretinal photocoagulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central macular thickness |  | baseline, 10 days, 52 days, 85 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity |  | baseline, 10 days, 52 days, 85 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intravitreal injection of Bevacizumab, Visual acuity, central retinal thickness, color studies, Farnsworth-Munsell, electroretinogram studies
Oculometry as an Attentional Mechanism Evaluation Tool and Attention Deficit Hyperactivity Inhibition

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to analyse thanks to eye tracking experiments ocular movement classical parameters in children with attention deficit hyperactivity (ADH) and to compare them to results obtained in healthy children and to results obtained with neuropsychological tests commonly used in standard health care. We should then be able to compare eye tracking with neuropsychological parameters. The final objective is to give to health professional a tool for ADH investigation with which they should be able to do a simple and effective follow up of children with ADH.

Official Title
-----------------
Oculometry as an Attentional Mechanism Evaluation Tool and Attention Deficit Hyperactivity Inhibition

Conditions
-----------------
Attention Deficit-Hyperactivity

Intervention / Treatment
-----------------
* Behavioral: Neuropsychological tests
* Behavioral: Oculometric tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children between 8 and 12 years old Boys and girls DSM-IV-TR diagnostic criteria for ADH Children with methylprednisone treatment Social security affiliation signed informed consent Exclusion Criteria: specialised scholarship refusal from children or parents too law results in WISC test (pre-inclusion test)

Ages Eligible for Study
-----------------
Minimum Age: 8 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oculometric and neuropsychological tests<br>Oculometric tests and neuropsychological tests | Behavioral: Neuropsychological tests<br>* WISC test, BRIEF test, NEPSY-2 test, TAP2.3 test, Teach test<br>Behavioral: Oculometric tests<br>* When the subject see a peripheric target, he should take a look not at the target but in the controlateral half-field, at a mirror position. This is called an anti-saccade task.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between oculometric and neuropsychological tests in ADH evaluation | Differentiation between simple oculomotor disorder and attentional-visual disorder | Day 1 |
Budesonide for Maintenance Treatment of Collagenous Colitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.

Detailed Description
-----------------
The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.

Official Title
-----------------
Efficacy and Safety of Budesonide in Maintenance Treatment of Collagenous Colitis

Conditions
-----------------
Collagenous Colitis

Intervention / Treatment
-----------------
* Drug: Budesonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: collagenous colitis diarrhea written informed consent Exclusion Criteria: infectious causes for diarrhea other inflammatory bowel diseases history of colonic surgery celiac disease malignancies severe concomitant diseases use of budesonide, steroids, mesalazine within the previous 2 weeks known intolerance to budesonide history of lack of response to budesonide pregnancy,lactation drug and/or alcohol abuse lack of compliance

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Budesonide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients in clinical remission after 6 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to relapse |  |  | 
| safety |  |  | 
| quality of life |  |  | 
| histological improvement |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
collagenous colitis, microscopic colitis, budesonide
Electromagnetic Field Effects of Mobile Communication (LTE) on Sleep in the Context of Genetic Variation

Study Overview
=================
Brief Summary
-----------------
The effect of electromagnetic fields of the latest standard in mobile communication (long term evolution, LTE) on sleep is studied in healthy, young individuals.

Official Title
-----------------
Electromagnetic Field Effects of Mobile Communication (LTE) on Sleep in the Context of Genetic Variation

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Other: LTE field
* Other: sham field


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-30 years German knowledge (reading and writing) Right-handedness Body mass index (BMI) 18.5-25.0 kg/m2 Mobile communication (phone calls) less than 2 hours per week Moderate alcohol consumption (less than 5 alcoholic beverages per week) Moderate caffeine consumption (less than 5 caffeinated foods per day, e.g. coke, coffee, energy drinks, green or black tea, chocolate) Informed consent Exclusion Criteria: Travels across more than 2 time zones in the last 30 days or during the study Nocturnal shift work Extreme chronotype or extreme sleep duration (less than 5 hours or more than 10 hours on average) Sleep disorders or problems Severe acute or chronic neurological, mental or general health disorders, which might impair the participant's safety or affect the study's outcome Use of medication (regular or during the study), which might affect the study's outcome Recreational drug use Smoking (or other tobacco products) Severe skin allergies Relevant findings in physical examination or during the screening night (e.g. sleep disorders) Participation in an other clinical trial in the last 30 days or during the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Male

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LTE field<br> | Other: LTE field<br>* electromagnetic field of the latest standard in mobile communication (long term evolution, LTE)<br>|
| Sham Comparator: sham field<br> | Other: sham field<br>* no electromagnetic field<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| electroencephalographic power during sleep after LTE exposure | electroencephalogram (EEG) | up to 9 hours (approximately 11 p.m. to 8 a.m.) |
A Multi-Center Protocol for Obtaining and Storing Human Samples for Immediate or Future Microbial, Immune, or Host-Microbe Scientific Study

Study Overview
=================
Brief Summary
-----------------
The intent of this protocol is to salvage human-related material that is normally destined for destruction, so it can be used in infection-related scientific studies. This clinical material can be studied in order to better understand the molecular, cellular, or ecological components of the infected or potentially infected tissue or device.

Detailed Description
-----------------
The samples can include material such as wound debridement, removed orthopedic implants, removed catheters or shunts, excised tonsils, amputated tissue, sputum, stool, or other excretions. The samples can be cultured for microbes, examined using microscopy, or analyzed using molecular techniques. The studies can examine microbes or the host's response to microbes by examining the nucleic acids (e.g. 16S DNA, mRNA), proteins, or other metabolites.

Official Title
-----------------
A Multi-Center Protocol for Obtaining and Storing Human Samples for Immediate or Future Microbial, Immune,or Host-Microbe Scientific Study

Conditions
-----------------
Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The Subject must be 18 years of age or older The Subject must be mentally competent as determined by the Investigator, or have a Legally Authorized Representative. Exclusion Criteria: The Subject may not be currently incarcerated. The Subject may not be knowingly pregnant. The Subject may not be institutionalized. The Subject may not be an employee or student of the investigator or sponsor.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No treatment<br> | |
| human samples<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The samples can be cultured for microbes, examined using microscopy, or analyzed using molecular techniques. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wound debridement, removed orthopedic implants, removed catheters or shunts, excised tonsils, amputated tissue, sputum, stool, other excretions.
Late Phase II Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye

Study Overview
=================
Brief Summary
-----------------
Dose response related to efficacy and safety of DE-089 ophthalmic solution are examined in patients with dry eye, using a multicenter, randomized, double-blind, parallel group comparison study, and the optimal concentration is determined.

Official Title
-----------------
Dose-Response Study of DE-089 Ophthalmic Solution in Patients With Dry Eye -Late Phase II Confirmatory Study-

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: DE-089 ophthalmic solution
* Drug: DE-089 ophthalmic solution
* Drug: Placebo ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those who show: Keratoconjunctival disorder confirmed with vital dye staining Abnormal Schirmer score results Exclusion Criteria: Eye disease that needs therapy other than that for dry eye Those who need to wear contact lenses during the clinical study

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High concentration<br> | Drug: DE-089 ophthalmic solution<br> <br> |
| Experimental: Low concentration<br> | Drug: DE-089 ophthalmic solution<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo ophthalmic solution<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Fluorescein Staining Score From Baseline | Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better. The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area. | Baseline and 4-week (discontinued(LOCF)) |
Application of Psychiatric Knowledge in the Rehabilitation Process in Return to Work.

Study Overview
=================
Brief Summary
-----------------
The hypothesis was that education of rehabilitation officers who were responsible for rehabilitation back to work for sick-listed individuals in screening for mental disorders and psychiatric topics would increase the rate of return to work and reduce the number of sicklisted days

Official Title
-----------------
Application of Psychiatric Knowledge in the Rehabilitation Process in Return to Work.

Conditions
-----------------
Mental Disorders

Intervention / Treatment
-----------------
* Behavioral: control Rehabilitation as usual
* Behavioral: education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sick-listed and belonging to the case-load of rehabilitation officers who participated in the intervention Exclusion Criteria: no
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>Rehabilitation as usual | Behavioral: control Rehabilitation as usual<br>* Rehabilitation as usual<br>|
| Experimental: education<br>education of rehabilitation officers in psychiatric topics plus rehabilitation as usual | Behavioral: education<br>* Education as add on to to rehabilitation as usual<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of return to work | The rate of return to work was estimated by Poisson regression and Cox regression based on the duration from the date being sicklisted until the date of return to normal work. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of sickness absence days | After eight weeks of continuous sickness absence the number of sickness absence days within ½ year was counted | ½ year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
screening, sickness absence, rehabilitation, mental disorders