linjc16/ctgov huggingface dataset:
Vitiligo Treated With TL01 Combined With Tacrolimus Ointment Versus Placebo

Study Overview
=================
Brief Summary
-----------------
BACKGROUND Vitiligo is a common, often distressing condition. Many of the patients do not achieve sufficient effect from what is regarded as the treatment of choice at present, narrow band(NB)UVB(Tl01). There are reports on some patients partly successfully treated with Tacrolimus ointment. AIM OF THE STUDY We want to study whether Tacrolimus ointment may give an additive effect on symmetric vitiligo in combination with NB-UVB. METHODS This is a double blind left/right comparative study with 6 months treatment time. Patients are treated with whole body NB-UVB x 2 or x 3 weekly, in addition to Tacrolimus ointment versus placebo every night on affected half body sites. To measure effects we use photodocumentation in addition to morphometric registration of symmetric target lesions every 6 weeks.

Official Title
-----------------
Treatment of Vitiligo With Narrowband UVB (TL01) Combined With Tacrolimus (0.1%) Versus Placebo Ointment, a Randomized Right/Left Double Blind Comparative Study

Conditions
-----------------
Vitiligo

Intervention / Treatment
-----------------
* Drug: Tacrolimus ointment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged at least 18 years with a stable, symmetric vitiligo Exclusion Criteria: Patients with segmental vitiligo, aged < 18 years, known hypersensitivity to Tacrolimus, pregnant or breastfeeding women

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tacrolimus ointment|Tacrolimus ointment 0.1%every night for at least 3 months, half body side|

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
-----------------
vitiligo, tacrolimus ointment 0.1%, narrowband UVB (TL01)
Lymphocyte Sub-populations and Auto Immune Diseases

Study Overview
=================
Brief Summary
-----------------
To determine if artificial intelligence allow to detect lymphocyte subpopulations specific of diseases (such as primary Sjogren' syndrome and systemic lupus erythematosus) among patients with suspicion of autoimmune diseases.

Detailed Description
-----------------
The goal of this study is to determine if artificial intelligence allow to detect lymphocyte subpopulations specific of diseases (such as primary Sjogren' syndrome and systemic lupus erythematosus) among patients with suspicion of autoimmune diseases. All patients who had an evaluation of their lymphocyte subpopulations between january 2010 and december 2016 will be included in a retrospective analysis.

Official Title
-----------------
Lymphocyte Sub-populations and Auto Immune Diseases : What Type of Profile ? (SPLIT)

Conditions
-----------------
Autoimmune Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: autoimmune or infectious disease Exclusion Criteria: No
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 |
| --- | --- | --- |
| Diagnosis of autoimmune disease | Diagnosis (systemic lupus erythematosus, primary Sjopgren's ....) according to current ACR/EULAR criteria | an average of 1 year |
Efficacy and Safety of Aripiprazole in First Episode Psychosis

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the efficacy and safety of aripiprazole in patients with first episode psychosis.

Official Title
-----------------
Efficacy and Safety of Aripiprazole in Patients With First Episode Psychosis: an Open-label, Prospective Multi-center Study

Conditions
-----------------
First Episode Psychosis

Intervention / Treatment
-----------------
* Drug: Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-59 years and meet DSM-IV diagnostic criteria for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version. Exclusion Criteria: Meeting DSM-IV criteria for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness. Pregnant or lactating women or women without adequate contraception will be also excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: drug<br> | Drug: Aripiprazole<br>* 6 week prospective study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms assessment by objective rating scales | PANSS total score, SANS, CGI | week 1 | 
| Symptoms assessment by objective rating scales | PANSS total score, SANS, CGI | week 2 | 
| Symptoms assessment by objective rating scales | PANSS total score, SANS, CGI | week 3 | 
| Symptoms assessment by objective rating scales | PANSS total score, SANS, CGI | week 4 | 
| Symptoms assessment by objective rating scales | PANSS total score, SANS, CGI | week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of adverse events by objective rating scales and self report scales | NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS | week 1 | 
| Assessment of adverse events by objective rating scales and self report scales | NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS | week 2 | 
| Assessment of adverse events by objective rating scales and self report scales | NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS | week 4 | 
| Assessment of adverse events by objective rating scales and self report scales | NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS, Lipid profile | week 6 |
Combination Of PAXIL Tablet And Benzodiazepines

Study Overview
=================
Brief Summary
-----------------
This study was designed to assess the efficacy and safety of combination therapy of PAXIL and benzodiazepine anxiolytics. PAXIL Tablet will be administered to patients with depression or depressive episodes who have received Benzodiazepines for at least 4 weeks, and changes in the symptoms of depression will be evaluated by use of the rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D).

Official Title
-----------------
Post-marketing Clinical Study on PAXIL Tablet in Patients With Depression or Depressive Mood - A Study on Combination of PAXIL Tablet and Benzodiazepines

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

Intervention / Treatment
-----------------
* Drug: paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with depression or depressive episodes who are diagnosed to have major depressive disorders according to the DSM-IV criteria. Patients with 14 or higher points in total scores for Items No.1 - 17 on HAM-D. Patients who have continuously received Benzodiazepine anxiolytics. Exclusion criteria: Patients with a strong suicide tendency.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: paroxetine<br>paroxetine 20 to 40mg/day | Drug: paroxetine<br>* 1 or 2 tablets once a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate and extent of decrease in each item of HAM-D. The rate and extent of decrease of SRQ-D. Percentage of subjects who started tapering Benzodiazepine dose. Success rate in Benzodiazepine tapering Extent increase of SF-8. CGI responder rate. |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depressive episodes, paroxetine, PAXIL, depression, benzodiazepine, combination
Augmenting Patching Treatment for Amblyopia With Physical Exercise

Study Overview
=================
Brief Summary
-----------------
Researches are trying to establish whether moderate exercise enhances the treatment benefit of patching 2 hours a day for residual amblyopia in children.

Official Title
-----------------
Augmenting Patching Treatment for Amblyopia With Physical Exercise

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

Intervention / Treatment
-----------------
* Other: Physical Exercise in addition to Patching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 5 to < 17 years old Cycloplegic refraction within past year Diagnosis of residual amblyopia, with no evidence of regression of amblyopic eye visual acuity by 1 or more LogMAR from best previous Completed at least 6 months prior patching treatment (minimum 2 hours/day) or atropine treatment. Stable visual acuity as defined by <1 LogMAR change over 2 visits Xbox 360 Kinect, Wii or WiiU gaming system in the home, or a different gaming system with a version of Just Dance® already in the home. Exclusion Criteria: Known problems with exercise tolerance No gaming system in the home that supports Just Dance® Kids 2014, and no existing version of Just Dance® in the home Current atropine treatment for amblyopia

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 16 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: Physical Exercise in addition to Patching<br>Patch for 2 hours a day, and exercise (using the videogame JustDance) for the first 30 minutes of those 2 hours using the video game (continuing to wear the patch for 90 minutes after exercise). | Other: Physical Exercise in addition to Patching<br>* Patch for 2 hours a day, and exercise for the first 30 minutes of those 2 hours using the video game<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | The primary outcome measure will be LogMAR visual acuity measured 1 month (primary analysis window 3 weeks to 8 weeks) after initiating game play. | 1 month (3 weeks to 8 weeks) after initiating game play |
Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex Versus AGC

Study Overview
=================
Brief Summary
-----------------
A randomized blinded study is conducted comparing 2 different knee prostheses. Range of motion (ROM), pain, feel of prosthesis, satisfaction and ability to do daily activities are registered at intervals up to one year postop, where patients are informed on which prosthesis they received. We want to: determine whether an increased ROM is achieved with a high-flex knee compared to a standard knee and if so, does it matter

Detailed Description
-----------------
100 patients operated on with unilateral TKR are included and randomized to either prostheses. Patients operated on with bilateral simultaneous TKR receive one of each prostheses but are blinded to which prosthesis is on which side. They have gait analyses performed preop and at intervals up to one year.

Official Title
-----------------
Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex and AGC

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Device: Nexgen LPS-flex and AGC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age below 75 years and active preop ROM at least 120 degress flexion BMI below 30 intact ligaments Exclusion Criteria: below 18 years unable to understand language or purpose

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Nexgen LPS-flex and AGC|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROM |  |  | 
| Pain |  |  | 
| Satisfaction |  |  | 
| Feel of prosthesis |  |  | 
| Gait analysis |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoarthritis, knee, total knee arthroplasty, range of motion, satisfaction
Validation of a Novel Thoracic Neoplasm Radiotherapy Image Guidance Technique: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
The overall, broad objective of this study is to pilot the BSD technique. The specific purpose of this particular study is to generate pilot data to validate several crucial steps of the BSD technique, in particular steps 1, 2, and 4. Radiation treatments will proceed per standard of care, and will not be modified in any way during this protocol. This study is a non-treatment protocol.

Official Title
-----------------
Validation of a Novel Thoracic Neoplasm Radiotherapy Image Guidance Technique: A Pilot Study

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Procedure: reproduce breathing cycle utilizing spirometry
* Procedure: Freebreathing in Body fix mold


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any thoracic neoplasm scheduled to undergo radiation therapy 18 years or older Must be treated with radiation as part of standard of care Able to tolerate the mouthpiece for spirometry and video glasses Ability to provide written informed consent Exclusion Criteria: None

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2. Free breathing<br>Freebreathing in Body fix mold | Procedure: Freebreathing in Body fix mold<br>* Freebreathing in Body fix mold<br>|
| Experimental: 1. breathing cycle<br>reproducing breathing cycles | Procedure: reproduce breathing cycle utilizing spirometry<br>* reproduce breathing cycle utilizing spirometry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducibility of the guided breathing cycle |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability of motion envelope derived from initial 4D imaging compared to CT's obtained throughout the course of therapy |  | 6 weeks |
The Influence of MitraClip on Apnoea Asleep

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to influence the central and obstructive sleep apnoea in patients with severe mitral insufficiency by an interventional MitraClip examination to evaluate.

Official Title
-----------------
the Influence of MitraClip on Apnoea Asleep

Conditions
-----------------
Sleep Apnoea

Intervention / Treatment
-----------------
* Other: MitraClip Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient suffer on severe symptomatical mitral insufficience male and female patients is planned an interventional MitraClip examination Dyspnea with a NYHA (New York Heart Association) II - III an high logistic Euro-Score (> 20) no execution of surgical intervention because of relevant comorbidities Exclusion Criteria: younger than 18 years pregnancy and breast-feeding persons without mental ability of capacity to understand and follow the instructions of the investigator persons in dependence from the sponsor or working with the sponsor participation in other studies

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 |
| --- | --- |
| MitraClip Intervention<br>the influence of MitraClip on Apnoea Asleep | Other: MitraClip Intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnoea-Hypopnoea-Index |  | 12 months |
Anxiety Assessment Before Regional Anesthesia.

Study Overview
=================
Brief Summary
-----------------
We want to assess the level of anxiety of patients who arrive in the operating room before performing regional anesthesia.

Detailed Description
-----------------
When patients arrive in the operating room, we want to submit them a validated questionnaire (APAIS score and STAI-6 score) to assess their anxiety. After that, the care (anesthesia and surgeries) will take place in a very usual way and similar to our standards of care.

Official Title
-----------------
Assessment of Anxiety Incidence Before Regional Anesthesia Achieving.

Conditions
-----------------
Anxiety Regional Anesthesia Pre-operative

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient> 18 years surgery performed under general anesthesia or not but preceded by a regional anesthesia. Exclusion Criteria: refusal of the patient psychiatric disorders (pathological anxiety, psychosis, depression) language barrier major drug impregnation.

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 |
| --- | --- | --- |
| APAIS score | anxiety measurement score | Achievement of the score on arrival at the operating area (between 15-30 minutes before to realise the regional anesthesia block). Only one determination of the score is made | 
| STAI-6 score | anxiety measurement score | Achievement of the score on arrival at the operating area (between 15-30 minutes before to realise the regional anesthesia block). Only one determination of the score is made |
Functional Testing and Performance in Tennis

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to correlate functional tests, clinical tests and rotator cuff strength with the speed of serve. For that purpose, tennis players (ITN 2-4) will be recruted among tennis players in the Province of Liege. They will be assessed 2 times. During the first assessment, lateral medicine ball throw, 2 ball throws, upper extremity y balance test and shoulder rotation range of motion will be assessed. During the second assessment, lateral medicine ball throw, the 2 ball throws and rotator cuff strength will be assessed.

Detailed Description
-----------------
Forty healthy tennis players (ITN 2-4) will be recruted among players in the club of the Province of Liege. First session : Clinical testing Upper extremity Y Balance Test Range of motion (internal/external rotation) Functional tests a. Lateral Medecine Ball throw (5 repetitions) b. Single arm ball throw (1,5kg) d. Core endurance test Assessment of serve speed (radar) during 15 serves Second session : Clinical testing a. Assessment of rotator cuff muscles strength Functional tests Lateral Medecine Ball throw (5 repetitions) Single arm ball throw (1,5kg)

Official Title
-----------------
Functional Testing and Performance in Tennis

Conditions
-----------------
Tennis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: playing tennis at a level of ITN2-4 being healthy

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 30 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder range of motion | Internal/external rotation range of motion assessment | through study completion, an average of 3 months | 
| Shoulder strength | Internal/external rotators strength measurement | through study completion, an average of 3 months | 
| Serve speed | Measurement of serve speed with a radar | through study completion, an average of 3 months | 
| Upper extremity Y balance test | Maximal score in the 3 directions will be retained | through study completion, an average of 3 months | 
| Lateral Medicine Ball Throw | Measurement of the time to do 5 repetitions | through study completion, an average of 3 months | 
| Single Arm ball throw | Measurement of the maximal distance reached | through study completion, an average of 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tennis serve, performance, functional testing