linjc16/ctgov huggingface dataset:
Hearing and Vestibular Interactions in the Collection of Own Body and Sense of Self

Study Overview
=================
Brief Summary
-----------------
The investigators objective is twofold. Investigators propose to study how the vestibular and auditory information interact in the construction of coherence between the staff and extrapersonal space. Furthermore, investigators want to investigate whether, even in the absence of gravity, the auditory spatial information allocentric provide a framework for spatial reference.

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

Intervention / Treatment
-----------------
* Other: Hearing and Vestibular Interactions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers (men or women) Aged between 18-65 years Affiliates to a social security system or, for non-residents in France, holder of a European Health Insurance Card European (EHIC European Health Insurance Card) Who are willing to take part in the study, Who gave written informed consent, Declared fit after a similar visit to a medical aeronautical medical fitness for the non-professional cabin crew in civil aviation. There will be no other aptitude tests for the selection of subjects. Exclusion Criteria: People who took part in a biomedical research protocol for which the exclusion period is complete, People with psychotic disorders and / or depression, People receiving psychotropic medication, People with alcohol dependence or illicit substances, People with visual acuity less than 8 / 10ths corrected by lenses or glasses, People with a significant decrease in hearing, pregnant women.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HEARING AND VESTIBULAR INTERACTIONS<br>Hearing and Vestibular Interactions during two body positions (standing / supine) and three gravity conditions (weightlessness hyper gravity and normal gravity). | Other: Hearing and Vestibular Interactions<br>* in two body positions (standing / supine) and three gravity conditions (weightlessness hyper gravity and normal gravity).<br>* Other names: in two body positions and three gravity conditions;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responses to the questionnaire Botvinick Cohen on the sensations of the body out experiments |  | baseline | 
| Answers on the location of auditory stimuli |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volunteers
Circulating Melanoma Cells in Metastatic Patients Treated With Selective BRAF Inhibitors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study, is to evaluate Circulating Melanoma Cell (CMC) changes in Metastatic Melanoma (MM) patients, undergoing treatment with selective inhibitors of mutated BRAF.

Detailed Description
-----------------
This is an observational prospective pilot study aimed to investigate the association between changes of total and apoptotic CMC count and disease progression in MM patients undergoing treatment with selective inhibitors of mutated B-RAF.

Official Title
-----------------
Predictive Value of Circulating Melanoma Cells (CMCs) in Metastatic Melanoma (MM) Patients Treated With Selective Inhibitors of BRAF

Conditions
-----------------
Metastatic Melanoma

Intervention / Treatment
-----------------
* Drug: Anti-B-RAF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fourth stage Melanoma patients with both measurable and not measurable lesions undergoing treatment with selective B-RAF inhibitors will be included. To determine the prevalence of CMC-positive patients in IV stage Melanoma, patients without mutated B-RAF undergoing chemotherapy and/or vaccines will be also enrolled at baseline, as part of study protocols approved and activated in the participating centers. Informed written consent. Exclusion Criteria: Inadequate compliance to multiple blood draws (baseline, 15 days, 1th month, 4th month, and/or at progression) as scheduled in this adjunctive biologic study for patients carrying B-FAF mutation; inadequate compliance to adjunctive blood draws, as scheduled at baseline for BRAF wild-type Previously exposure to immunological treatment.

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 |
| --- | --- |
| Mutated Anti-B-RAF<br>Fourth stage Melanoma patients with both measurable and not measurable lesions undergoing treatment with selective B-RAF inhibitors. | Drug: Anti-B-RAF<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of CMC count during treatment and comparison with CT and PET |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Circulating Melanoma cells in metastatic melanoma
Posterior Fossa Mutism on Quality of Life

Study Overview
=================
Brief Summary
-----------------
Posterior fossa mutism (PFM) occurs in up to 30% of patients after resection of a posterior fossa tumor, most commonly a medulloblastoma. PFM is characterized by delayed onset of mutism 1-6 days after surgery that can spontaneously improve on average from 7-8 weeks later. Few patients recover normal speech. Most of their speech continues to be marked by dysarthria, dysfluency and slowed rate. Researchers have not identified the pathophysiologic mechanism for PFM nor have they found a cure. Despite the improvements in speech, patients with PFM have shown multiple areas of neurocognitive deficits 12 months after diagnosis. Few studies have looked at long term outcomes of patients affected by PFM. We propose to survey patients who developed PFM after resection of a medulloblastoma to determine long term effects of PFM on patient's quality of life.

Official Title
-----------------
Long-Term Impact of Posterior Fossa Mutism on Quality of Life

Conditions
-----------------
Posterior Fossa Mutism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be between 8 years and 25 years of age at the time of enrollment and have completed treatment for their initial diagnosis of medulloblastoma. Exclusion Criteria: Patient is less than 8 years old or greater than 25 years old at the time of the administration of the survey. Patients are too ill to complete the survey as identified by their treating physician. Patients who are unable to speak or understand English. Patients who are currently being treated for their original diagnosis of medulloblastoma.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 25 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 |
| --- | --- |
| Posterior Fossa Mutism<br>Patients with Posterior Fossa Mutism | |
| Non Posterior Fossa Mutism<br>Patients that did not develop Mutism | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | Thirty minutes, no follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life in terms of anger, anxiety, depression, fatigue, social functioning, pain and stigma |  | 30 minutes, no follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mutism
A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the lipid lowering effects of an investigational drug in patients with hypercholesterolemia (high cholesterol).

Detailed Description
-----------------
The duration of treatment is 4 months.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Factorial Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet in Patients With Primary Hypercholesterolemia

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: MK0653A, ezetimibe (+) simvastatin
* Drug: Comparators: simvastatin and ezetimibe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High cholesterol Exclusion Criteria: Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.

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: MK0653A, ezetimibe (+) simvastatin|nan|
|Drug: Comparators: simvastatin and ezetimibe|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma LDL-C |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma LDL-C, TG and HDL-C. The proportion of patients achieving LDL-C targets. Tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary hypercholesterolemia
Relationship of Staphylococcal Colonization to Infection

Study Overview
=================
Brief Summary
-----------------
Inpatients will be prospectively have nares screened and MRSA strains collected. All clinical MRSA strains of patients will also be prospectively collected. A sensitive strain discrimination test of spa typing will be used to determine if the strains are related. Hypotheses are Strain colonization durations vary and may be very short in days to weeks. Colonizing strains rarely infect 3) Both 1 and 2 may be affected by the patient's co-morbidity.

Detailed Description
-----------------
Patients of special interest: Skin and soft tissue infection Nursing home patients Vascular patients with leg lesions ICU patients Hemodialysis patients Outpatients without history of infections(controls) will have nares screened for MRSA and then monthly for 1 year. All strains will be saved and spa typed. Analysis of the data will be performed to answer the questions and hypotheses and to answer is the screening effort and the isolation of patients for MRSA as is in current practice worthwhile and is there any scientific data to support this practice

Official Title
-----------------
Relationship of Staphylococcal Colonization to Infection

Conditions
-----------------
MRSA Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted and one of the co-morbid groups Ambulatory care patient with no infections Exclusion Criteria: All others
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Hemodialysis | |
| 2<br>Intensive care | |
| 3<br>vascular patients with open wounds | |
| 4<br>nursing home | |
| 5<br>skin infections | |
| 6<br>control- ambulatory care clinic patients with no infections | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of infection strains which were also colonizer earlier |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of strain colonization among co-morbidity cohorts |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methicillin-resistant Staphylococcus, colonization
Identification of Potential Biomarkers of Response to Peptide Immunotherapy for Ragweed Allergy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to identify changes in potential biomarkers after peptide immunotherapy for that may subsequently be developed as biomarkers that correlate with clinical efficacy.

Official Title
-----------------
An Optional Research Study to Identify Potential Biomarkers of Response to Peptide Immunotherapy for Ragweed Allergy in Subjects Already Enrolled in Clinical Study TR002

Conditions
-----------------
Ragweed Allergy

Intervention / Treatment
-----------------
* Biological: ToleroMune Ragweed
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled in study TR002 but have not yet commenced dosing Exclusion Criteria: None; no criteria additional to TR002 exclusion criteria are applicable to this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ToleroMune Ragweed 4<br> | Biological: ToleroMune Ragweed<br>* Intradermal administration 1x8 administrations, 2 weeks apart<br>|
| Experimental: ToleroMune Ragweed Regimen 3<br> | Biological: ToleroMune Ragweed<br>* Intradermal administration 1x8 administrations, 2 weeks apart<br>|
| Experimental: ToleroMune Ragweed Regimen 2<br> | Biological: ToleroMune Ragweed<br>* Intradermal administration 1x8 administrations, 2 weeks apart<br>|
| Placebo Comparator: Placebo<br>Placebo | Biological: Placebo<br>* Intradermal injection 1x8 administrations, 2 weeks apart<br>|
| Experimental: ToleroMune Ragweed Regimen 1<br> | Biological: ToleroMune Ragweed<br>* Intradermal administration 1x8 administrations, 2 weeks apart<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of potential plasma biomarkers of response to peptide immunotherapy | Blood samples derived from the study will be submitted for proteomics analyses aimed at the identification of one or more plasma proteins whose concentration over the course of the study varies in relation to the treatment administered. The outcome will be determined on the basis of measurements from samples collected over a period commencing prior to treatment and ending 6 months following treatmen | 6 months after start of dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ragweed allergy, immunotherapy
Evaluation of Liver Disease With Elastography Measurements in Patients Undergoing Liver Transplant Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare ultrasound measurements of the liver obtained prior to surgery on the skin to measurements obtained during surgery directly on the diseased liver. The objective is to determine if ultrasounds of the liver on the skin can provide accurate measurements of disease of the liver to provide an alternative option to liver biopsies.

Detailed Description
-----------------
A non-invasive, ultrasound platform based, ShearWaveTM Elastography measurement will be obtained at two time points on each qualified patient. The first time point will be in the operating room before the initial incision is made. The second time point involves placement of a small, hand-held modified ultrasound probe directly on the patient's diseased liver during the liver transplant surgery. The probe used in this study is the SuperCurved™SC6-1, capable of a band width of 1-6MHz with 192 elements.

Official Title
-----------------
Quantitative Evaluation of Liver Disease With Liver Elastography Measurements Using the Supersonic Imagine Aixplorer ShearWaveTM Elastography Ultrasound Machine in Patients Undergoing Liver Transplant Surgery

Conditions
-----------------
Liver Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and Females over the age of 18 Patients undergoing a liver transplant surgery Exclusion Criteria: Any person unable to provide informed consent

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 |
| --- | --- | --- |
| To obtain quantitative evaluation of the progression of liver disease, using ShearWaveTM Elastography measurements obtained with the Supersonic Imagine Aixplorer ultrasound machine in patients undergoing a liver transplant surgery. |  | on day of surgery |
Interstitial Lung Diseases in Primary Sjogren's Syndrome

Study Overview
=================
Brief Summary
-----------------
Patients with pSS seen in the Division of Rheumatology, the second affiliated hospital of Zhejiang University, School of Medicine (SAHZU) during January 2016 to July 2018, were retrospectively reviewed. Characteristics were analyzed.

Detailed Description
-----------------
Patients with pSS were retrospectively reviewed, and pSS-ILD and pSS non-ILD were identified. Clinical data, laboratory parameters, pulmonary high-resolution CT (HRCT), and pulmonary function tests (PFTs) were collected. pSS-ILD patients were further categorized into subgroups according to HRCT patterns or PFTs.

Official Title
-----------------
Characteristics of Patients With Primary Sjögren's Syndrome Associated Interstitial Lung Disease and Relevant Features of Disease Progression

Conditions
-----------------
Sjogren's Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with pSS fulfilled the 2002 revised version of the European criteria proposed by the American-European Consensus Group Patient with pSS evaluated with pulmonary HRCT and/or PFTs were included in the pSS-ILD group Exclusion Criteria: patients with hepatitis C infection, past head and neck radiation treatment, sarcoidosis, acquired immunodeficiency syndrome, pre-existing lymphoma, graft-versushost disease, and use of anticholinergic drugs, IgG4-related disease Patients with other connective tissue diseases (CTD) or other pulmonary diseases were further excluded, including those with pulmonary arterial hypertension, pulmonary infections, tuberculosis, chronic bronchitis, emphysema, asthma, chronic obstructive pulmonary disease, malignancies, pulmonary lesions related with environmental, occupational or medication exposures, or history of smoking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| pSS-ILD<br>diagnosis of pSS-ILD was based on abnormal HRCT and PFTs | Other: No intervention<br>* No intervention<br>|
| pSS non-ILD<br>pSS patients after exclusion of pSS-ILD and concomitant pulmonary diseases were considered as pSS non-ILD | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| observational study, data analysis to identify the risk factors of pSS-ILD | ILD progressed in 6 months from baseline | 6 months from baseline |
Efficacy and Safety of Basiliximab in Hepatitis C Virus Positive Patients Undergoing Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The natural history of HCV infection in liver transplant recipients may be accelerated when compared to that in patients with normal immune systems. The objective of this trial is to assess the efficacy and safety of basiliximab, in combination with cyclosporin and MMF on the success rate of liver transplants for HCV related cirrhosis, in comparison with standard steroid treatment.

Official Title
-----------------
Efficacy and Safety of Basiliximab in HCV+ Patients Undergoing Liver Transplantation, as Compared With Steroids, Both Given in Combination With Cyclosporine and Mycophenolate Mofetil (MMF)

Conditions
-----------------
Liver Transplant

Intervention / Treatment
-----------------
* Drug: Basiliximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients undergoing first cadaver liver transplant Patients receiving an AB0 identical or compatible graft HCV+ patients (serology test within the last 12 months) Exclusion Criteria Antiretroviral prophylactic treatment post-transplant Serological markers positive for Hepatitis B surface Antigen and Human Immunodeficiency Virus Recipients of a split liver transplant Other protocol-defined inclusion/exclusion criteria applied

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-month cumulative incidence of post-surgical graft loss and death |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hepatitis C recurrence (see definition 3.5.2) at 6 and 12 months after transplant surgery. |  |  | 
| treated and biopsy proven acute rejection at 6 and 12 months after transplant surgery. |  |  | 
| graft survival and patient survival after treatment with either Simulect or steroids at 6 and 12 months. |  |  | 
| viral load (HCV-RNA) after treatment with Simulect or steroids at Baseline, Month 1 and 3 post transplantation. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver transplant, HCV+, steroid free