linjc16/ctgov huggingface dataset:
VR as a Facilitator for Participation in Society Among Persons With MHD/SUD

Study Overview
=================
Brief Summary
-----------------
This study is the first part of a larger project called Virtual Reality (VR) as a facilitator for participation in society among persons with mental health/substance use disorders in which aims to explore,develop and evaluate a VR-based paradigm that facilitates social participation and promotes social recovery of individuals with mental health and/or substance use disorders (MHD/SUD). The overall project comprises three work packages: an exploration study, a development study, and an evaluation study. This study will make up work package 1. The primary aim of this study (WP1) is to explore facilitators and barriers for participation in society among person with MHD/SUD, and to provide an understanding of mechanisms of social participation and social cohesion among persons with MHD/ SUD that may be affected by VR-based interventions. The investigators will derive a socio-emotional learning domain to facilitate key interpersonal and social processes among persons with MHD/SUD in VR-based interventions. To achieve the purpose of this study, the invistigators conduct 10 indepth interviews with service-user with MHD/SUD, 2 focus group interviews with 14 service-providers and an interview-survey with 100 service users. This gives the investigators the possibility to explore facilitators and barriers for social participation as experienced as by individuals with MHD/SUD and identify key interpersonal and social processes suitable to be addressed by tailored VR based interventions.

Official Title
-----------------
Complex Socio-emotional Learning in VR-based Simulation Training Among Persons With Mental Health and/or Substance Use Disorders

Conditions
-----------------
Substance Use Disorders, Mental Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above 18 years of age receiving services in the municipality due to mental health and or addiction problems. Exclusion Criteria: -visual and hearing impairment, neurological disorders, and mental retardation [score ≤70 on the Test of Intelligence].

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Practical and social functioning | measured by the Practical and Social Functioning Scale (PSF) | 2 hours | 
| Social inclusion | Measured by the Social and Community Opportunities Profile (SCOPE) | 2 hours | 
| Barriers for participation in society | This will be assessed within in-depth interviews | duration of the in-depth interview | 
| Facilitators for participation in society | This will be assessed within in-depth interviews | duration of the in-depth interview |
Preoperative Subclinical DVT Screening in Locally Advanced Bladder Cancer Patients Candidate for Radical Cystectomy.

Study Overview
=================
Brief Summary
-----------------
Preoperative subclinical DVT screening in locally advanced bladder cancer patients candidate for radical cystectomy.

Detailed Description
-----------------
60 patient with local advanced bladder cancer are subjected to preoperative lower limb duplex within 1 week preoperative to radical cystectomy

Official Title
-----------------
Preoperative Detection of Subclinical Lower Limb Deep Venous Thrombosis in Locally Advanced Bladder Cancer Patients Candidate for Radical Cystectomy

Conditions
-----------------
Bladder Cancer Patients Candidate for Radical Cystectomy

Intervention / Treatment
-----------------
* Diagnostic Test: Lower limb duplex & doppler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any age Any sex Muscle invasive bladder cancer local advanced patients candidate for radical cystectomy Exclusion Criteria: Unfit patients any contraindication for surgery obese coagulopathy bedridden
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 60 patients with local advanced bladder cancer<br>Local advanced bladder cancer patients candidate for radical cystectomy | Diagnostic Test: Lower limb duplex & doppler<br>* Lower limb duplex and doppler one week before radical cystectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative subclinical DVT | Asymptomatic patients candidate for radical cystectomy | 6 months |
Effect of rhIL-11 in Patients With Thrombocytopenia for Childhood ALL

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical research study is to find out if rhIL-11（Interleukin 11） may increase the platelet count in Childhood patients with acute lymphocytic leukemia (ALL) who develop low platelet counts while receiving standard CAT（cyclophosphamide+Cytosine arabinoside+mercaptopurine，7d） therapy.

Detailed Description
-----------------
Group A：patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80,000/mL Group B：control group

Official Title
-----------------
Effect of Treatment Using rhIL-11 in Patients With Thrombocytopenia After Chemotherapy for Childhood Acute Lymphoblastic Leukemia

Conditions
-----------------
Pancytopenia Due to Chemotherapy

Intervention / Treatment
-----------------
* Drug: rhIL-11


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: new diagnosis of ALL TBIL≤34umol/L，Cr≤120umol/L，a normal EF age <18 years Exclusion Criteria: patients with uncontrolled infection patients with Acute congestive heart failure or chronicity cardiorespiratory functional defect or serious cardiac arrhythmias

Ages Eligible for Study
-----------------
Maximum 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rhIL-11 group<br>patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80,000/mL | Drug: rhIL-11<br>* patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80000/mL<br>* Other names: Recombinant Human Interleukin-11;|
| No Intervention: control group<br>control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| platelet infusion | frequency of platelet infusion | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemorrhagic tendency | conditions of bleeding | 14 days | 
| infection | incident of infection during 14d after chemotherapy | 14 days | 
| remission rate | remission rate during 14d after chemotherapy | 14 days | 
| platelet Count | recovery of peripheral platelet count | 14 days |
Characterization of White Blood Cells Sub-populations From Multiple Sclerosis Patients.

Study Overview
=================
Brief Summary
-----------------
Multiple sclerosis (MS) is a chronic progressive neurological autoimmune disease, that gradually affects patient's quality of life. There are about 2.5 millions patients world wide, with an increasing cost Burdon. Up to date, it remains unclear who are the exact cells to initiate the disease. During the disease, the repertoire of cells expands and undergoes changes. The purpose of this study is to characterize those changes.

Official Title
-----------------
Characterization and Quantitative Analysis of White Blood Cells in the Blood and Cerebrospinal Fluid of MS Patients

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: Blood Sampling
* Other: CSF Sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of MS according to the revised criteria of McDonald or healthy volunteers Ability to provide written informed consent. Exclusion Criteria: - Active malignant disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Diagnosed with Multiple Sclerosis<br>Patients previously diagnosed with Multiple Sclerosis | Other: Blood Sampling<br>* Blood samples will be taken from all patients and healthy volunteers.<br>|
| Newly Diagnosed with Multiple Sclerosis<br>Patients diagnosed for the first time with Multiple Sclerosis and hospitalized | Other: Blood Sampling<br>* Blood samples will be taken from all patients and healthy volunteers.<br>Other: CSF Sampling<br>* CSF sample will be taken from hospitalized newly diagnosed patients only.<br>|
| Healthy Volunteers<br>Health volunteers who do not have an autoimmune diseases, including Multiple Sclerosis | Other: Blood Sampling<br>* Blood samples will be taken from all patients and healthy volunteers.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of disease related white blood cells from blood and/ or CSF |  | through study completion, an average of 6 months |
Levosimendan Pretreatment for Weaning Patients From Cardio-Pulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
The study evaluates the efficacy of intravenous levosimendan treatment started during a coronary artery bypass operation to wean patients from a heart lung machine.

Detailed Description
-----------------
Levosimendan or placebo infusion is started at the time of induction of anesthesia.

Official Title
-----------------
Impact of Levosimendan Pretreatment on Weaning From Cardiopulmonary Bypass (CPB) in Patients With Diminished Left Ventricular Function Before Coronary Artery Bypass Grafting (CABG)

Conditions
-----------------
Coronary Heart Disease

Intervention / Treatment
-----------------
* Drug: levosimendan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Three vessel coronary artery disease. Indication for on-pump coronary artery bypass surgery. Ejection fraction below 50% Exclusion Criteria: Indication for any cardiac valve surgery Previous coronary artery bypass surgery

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: levosimendan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of successful primary weanings |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
levosimendan, weaning, cardio-pulmonary bypass
Impact of Multi-tasking Situations on the Dismounted Soldier's Cognitive Load

Study Overview
=================
Brief Summary
-----------------
The increased complexity of the dismounted combatant's equipment can result in a strain on the various senses (e.g., visual, auditory) that can exceed an individual's limited information processing abilities. The combatant may thus be cognitively overloaded in multi-tasking operational situations. There has been a great deal of research conducted on cognitive load. A battery of multitasking tests has been developed in the field of aeronautics, but, to our knowledge, no measurement of cognitive load specifically dedicated to combatants has been conducted yet.

Official Title
-----------------
Impact of Multi-tasking Situations on the Dismounted Soldier's Cognitive Load

Conditions
-----------------
Cognitive Load

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be a group leader in an infantry regiment, be over 18 years old. Exclusion Criteria: be a woman, have a heart condition, have a visual disease not corrected by glasses or contact lenses, have a hearing score ≥ 2 on the SIGYCOP, have a psychiatric disorder, a progressive neurological or organic disease requiring drug treatment, take psychotropic drugs, take more than 28 units of alcohol per week.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive load level | Cognitive load level will be measured using NASA-TLX questionnaire. NASA-TLX questionnaire comprises 6 dimensions (mental demands, physical demands, time demands, performance, effort and frustration). Each dimension has a score ranging from 0 (low cognitive load) to 100 (high cognitive load), except for the performance dimension, whose score ranges from 0 (good performance) to 100 (low performance). | At enrollment (Day 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognitive load
Study Evaluating Safety, Tolerability, and PK of DVS SR in Healthy Japanese Women

Study Overview
=================
Brief Summary
-----------------
Safety, tolerability, and pharmacokinetics (PK) of desvenlafaxine succinate sustained release (DVS SR) in healthy Japanese female subjects.

Official Title
-----------------
Ascending, Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of DVS SR Administered Orally to Healthy Japanese Female Subjects

Conditions
-----------------
Vasomotor Symptoms

Intervention / Treatment
-----------------
* Drug: desvenlafaxine succinate sustained release (DVS SR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, first-generation (born in Japan, living in the US for less than 5 years) Japanese female subjects

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: desvenlafaxine succinate sustained release (DVS SR)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, Tolerability, PK |  |  |
Relationship Between Oral Lichen Planus and Autoimmune Thyroid Diseases

Study Overview
=================
Brief Summary
-----------------
On the basis of previous studies, a validation cohort will be established to explore the relationship between oral lichen planus and autoimmune thyroid diseases, and a disease efficacy prediction strategy can be formed.

Detailed Description
-----------------
For oral lichen planus patients, the prevalence of Hashimoto's thyroiditis will be investigated and the relationship between levels of anti-TG, anti-TPO antibodies and severity of oral lichen planus will be determined. Besides, for patients with Hashimoto's thyroiditis, the prevalence of oral lichen planus will be investigated and the relationship between levels of anti-TG, anti-TPO antibodies and severity of oral lichen planus will be determined.

Official Title
-----------------
Clinical Value of the Relationship Between Oral Lichen Planus and Autoimmune Thyroid Diseases

Conditions
-----------------
Oral Lichen Planus

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OLP patients without systemic disease Exclusion Criteria: OLP patients with severe periodontal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| OLP(-)<br>Oral lichen planus (OLP) with negative thyroid antibody group | |
| OLP(+)<br>OLP with positive thyroid antibody group | Other: no intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral lichen planus (OLP) lesions record | Record changes of lesions based on the symptoms and signs of the oral lichen planus patient. | 1 year | 
| Level of thyroid function and antibody | The levels of thyroid hormone and thyroid autoantibodies in serum of OLP patients were detected. | 1 year |
Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2

Detailed Description
-----------------
pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2

Official Title
-----------------
Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2 in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: NVP-1805-R1
* Drug: NVP-1805-R2
* Drug: NVP-1805-R1 and NVP-1805-R2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female adults aged 19-45 years. BMI of >18.5 kg/㎡ and <27.0 kg/㎡ subject, weight more than 50kg. Voluntarily provided a witten consent to participate in this clinical study. Exclusion Criteria: Treatment with an investigational product (Phase I study or Biological study) within 3month preceeding the first dose of study medication. History of (or presence) study medication absortion, distribution, metabolism(e.g., liver/ductal, kidney, cardio-vascular, endocrine, respiratory, GI, hematology, oncology, CNS, musculo-skeletal) or related past medical/surgery history Pregnant or lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NVP-1805-R1<br>Drug: NVP-1805-R1 1 tablet, oral dosing | Drug: NVP-1805-R1<br>* 1 tablet, multiple oral dosing<br>* Other names: NVP-1805-R1(M);|
| Experimental: NVP-1805-R2<br>Drug: NVP-1805-R2 1 tablet, oral dosing | Drug: NVP-1805-R2<br>* 1 tablet, multiple oral dosing<br>* Other names: NVP-1805-R2(C);|
| Experimental: NVP-1805-R1 and NVP-1805-R2<br>Drug: NVP-1801-R1 1 tablet and NVP-1801-R2 1 tablet co-administration(oral dosing) | Drug: NVP-1805-R1 and NVP-1805-R2<br>* NVP-1805-R1,1 tablet and NVP-1805-R2, 1 tablet, co-administration, multiple oral dosing<br>* Other names: NVP-1805-R1(M) and NVP-1805-R2(C);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic interaction | Area under the curve (AUC) | 0hours - 48hours |
Evaluation of Oesogastroduodenoscopy With Vision to 245 ° (Full Spectrum Endoscopy) to View the Main Disc and Accessory

Study Overview
=================
Brief Summary
-----------------
The monitoring and prognosis of patients with familial polyposis adenomatous rests on analysis of the transitional mucosa at the anal margin and especially on the tracking, characterization and resection of lesions of dysplasia type of high grade at the duodenal level, after total proctocolectomy. Currently, endoscopes with axial or lateral vision are used. The FUSE technology allows the simplification or even the improvement of patient surveillance with a 245° vision (versus150° in case of classical gastroscope). The use of a second screen to enlarge the field of view may allow both analysis of duodenum and the main and accessory papilla with one single endoscope and to decrease the number of omitted lesions .

Conditions
-----------------
Adenoma of the Accessory Papilla, Ampulloma of the Accessory Papilla

Intervention / Treatment
-----------------
* Device: gastroscope FUSE™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient eligible to any upper gastrointestinal endoscopy diagnostic Exclusion Criteria: History of duodenal or gastric surgery

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

| Intervention/Treatment |
| --- |
|Device: gastroscope FUSE™|All patients undergoing a diagnostic gastroscopy are eligible. Using the FUSE endoscope with side screen, the duodenal and accessory papilla are monitored. Data are collected by each operator. Clinical examination of patients is performed before they leave the centre.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Visualization of minor and major papilla Absence of necessity to change endoscope for viewing and / or for biopsies | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient with treatment-related serious adverse events | Evaluated serious advers events are mainly perforation, severe bleeding, acute pancreatitis | 5 day |