linjc16/ctgov huggingface dataset:
Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
Visualize surgical needles inserted in the prostate, under the ultrasound modality.

Detailed Description
-----------------
In order to help the surgeon to remove the prostate during a laparoscopic intervention, our goal is to provide an innovative medical device that merges intra-operative ultrasound and endoscopic images. We have already achieved the proof of concept of a device that merges ultrasound and endoscopic images. The objectives of this clinical trial are to accompany the maturation of the fusion device and to make the initial assessments of its Medical Service. The main difficulty is to visualize markers (surgical needles) under both modalities , in order to merge them.

Official Title
-----------------
Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Device: Software for acquiring ultrasound and endoscopic images


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: of-age patient patient for whom a radical prostatectomy is planned patient with a prostate volume between 30g and 100g patient affiliated to the social security or equivalent Written informed consent Exclusion Criteria: contraindication patient who has undergone a significant prostate resection patient who has undergone a prostate irradiation patient concerned by the L1121-6 à 8 of the health public code

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: medical device<br>medical device to acquire ultrasound and endoscopic images during surgery | Device: Software for acquiring ultrasound and endoscopic images<br>* Use of a medical device to acquire ultrasound and endoscopic images<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of surgical needles visible under the ultrasound modality (once inserted in the prostate) |  | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of data(ultrasound and endoscopic) on which the merging works |  | 1year | 
| Percent of accurate merging | the merging is accurate if its error is under 5mm | 1year | 
| Percent of mistaken segmentation of the vesical neck in the endoscopic image | The segmentation in the endoscopic image is mistaken if it differs of more than 5mm² from the segmentation in the ultrasound volume | 1year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, prostate
Effects of Bracing on Knee Osteoarthritis (OA)

Study Overview
=================
Brief Summary
-----------------
Knee osteoarthritis (OA) is characterized by complaints of knee pain, aching and stiffness that commonly alter the way one will climb stairs and walk reducing an individual's function and the activities they may perform on a day-to-day basis. Providing a person with a knee brace designed for OA can help unload the arthritic part of the knee, thereby reducing pain and lead to improved function. The purpose of this study is to determine if use of the Rebel Reliever knee brace manufactured by Townsend Design can reduce pain and stiffness, improve strength and balance, and enhance functional activities such as stair and level gait, and ultimately lead to increased participation in the community.

Official Title
-----------------
Effectiveness of Decompressive and Stabilizing Knee Bracing in Individuals With Unicompartment Knee Osteoarthritis

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

Intervention / Treatment
-----------------
* Device: Knee OA Brace


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Aged between 35 and 70 Present with diagnosed unicompartment osteoarthritis of the knee Exclusion Criteria: Severe cardiac or pulmonary disease that limits ability to walk. Presence of hip, ankle or foot OA or other lower limb pathology that limits ability to walk. Bilateral knee OA Previous use of an OA knee brace Surgical procedure in either leg within the past 6-months Anthropometrics that are incongruent with manufacturer's specifications for the Rebel Reliever

Ages Eligible for Study
-----------------
Minimum Age: 35 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 |
| --- | --- |
| Knee OA<br>People with knee OA of one knee | Device: Knee OA Brace<br> <br> * Other names: Rebel Reliever by Townsend Design;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knee Injury and Osteoarthritis Score (KOOS) |  | Baseline, 1 week, 2 week, 2 months, 3 months, 6 months | 
| Change in Adductory knee force during stair climbing |  | Baseline, 2 weeks, 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6 Minute Walk Test |  | Baseline, 2 weeks, 2 months | 
| Change in Balance |  | Baseline, 2 weeks, 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OA, arthritis, knee OA
Long-term Data Collection for Subjects in MDX-010 Studies

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to collect disease status and overall survival information for all Subjects in MDX-010 studies.

Detailed Description
-----------------
This is a multicenter, follow-up study in up to 191 subjects with metastatic melanoma who were previously enrolled and treated in ipilimumab studies MDX010-02, MDX010-08, and MDX010-15. The purpose of this study is to 1) collect the date and cause of death, if known, for all deceased subjects who participated in any of the specified studies; 2) collect the date of progression for subjects who completed the studies with stable disease or better; and 3) prospectively follow all surviving subjects to determine progression-free and overall survival.

Official Title
-----------------
Collection of Long-Term Outcome Data for Subjects Who Have Previously Participated in Selected Ipilimumab (MDX-010) Studies in Metastatic Melanoma

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who were previously enrolled in MDX-010 studies MDX010-02, MDX010-08, or MDX010-15. Subjects (or if applicable, next of kin), who are alive at the time of contact must have read, understood, and provided written informed consent and health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained. For subjects who have died or have been lost to follow-up(the subject status at end of original ipilimumab study), approval from the appropriate site IRB, specifying or limiting appropriate means for obtaining information, must be granted prior to collection of any information.

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 |
| --- | --- | --- |
Pegvisomant And Sandostatin LAR Combination Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and tolerability of combination therapy with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone.

Official Title
-----------------
A Randomized, Parallel Group, Three-Arm Study To Evaluate Treatment With A Combination Of Pegvisomant Plus Sandostatin Lar, Pegvisomant (Alone), And Sandostatin Lar (Alone) In Patients With Acromegaly

Conditions
-----------------
Acromegaly

Intervention / Treatment
-----------------
* Drug: Pegvisomant/ Sandostatin LAR
* Drug: Sandostatin LAR
* Drug: Pegvisomant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of acromegaly Received previous radiation and/or surgical treatment for their GH (Growth Hormone) producing pituitary adenoma and have required medical therapy due to failure to normalize GH (Growth Hormone) and/or IGF-I as a result of their primary treatment Patients that been receiving Sandostatin LAR for a minimum of 6 months prior to enrollment Exclusion Criteria: Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations Patients on current medical therapy other than Sandostatin LAR AST/ALT >= 3xULN (upper limits of normal) Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI Visual field defects (except post-surgical stable residual defects) Unable to self administer drug Radiotherapy within 12 months of entering the study

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pegvisomant/ Sandostatin LAR|nan|
|Drug: Sandostatin LAR|nan|
|Drug: Pegvisomant|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects experiencing treatment-emergent adverse events across the duration fo the study |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with normalization of IGF-I, at Week 40, in the two randomized groups (Sandostatin LAR plus pegvisomant and pegvisomant alone). Normal IGF-I is defined as a value within the normal reference range for age for the study specific |  |  |
Blood Concentration in Lorazepam and Treatment in Adult Catatonia

Study Overview
=================
Brief Summary
-----------------
Catatonia is a severe form of psychomotor disturbance with a heterogenous presentation. It affects approximately 10% of acute psychiatric inpatients. According to the fifth edition of DSM-5 the diagnosis of catatonia can be made when three or more symptoms from the twelve following are present : catalepsy, waxy flexibility, stupor, agitation, mutism, negativism, posturing, mannerisms, stereotypies, grimacing, echolalia, echopraxia. It can occur in various psychiatric diseases, including mood disorders or schizophrenia, but also in various non-psychiatric disorders [metabolic disturbances, viral infections (including HIV), typhoid fever, heat stroke, and autoimmune disease]. Benzodiazepines, especially LORAZEPAM, are the most common initial treatment, with a remission rate of approximately 70-80 %, regardless of the cause or the clinical manifestations. This first line treatment is titrated gradually according to the therapeutic response over a few days up to 20-25 mg per day. Electroconvulsive therapy (ECT) is initiated on patients with catatonia who do not respond to benzodiazepines. Interestingly, pharmacogenetic variants can alter the metabolism of lorazepam (e.g., the UGT2B15 * 2 allele slows it down). The main objective of this study is to assess the link between clinical response to lorazepam, residual plasma concentrations of lorazepam after 72 hours of fixed dosage, and the existence of genetic polymorphisms modifying the metabolism of lorazepam. Our hypothesis is that non-responding patients have lowered blood concentrations of lorazepam associated to a genetic profile of rapid metabolism. Evaluating the predictive factors of the response to treatment would allow early and precise identification of non-responder patients in order to adapt their first-line treatment.

Official Title
-----------------
Blood Concentration in Lorazepam and Treatment in Adult Catatonia

Conditions
-----------------
Catatonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: catatonia according DSM-5 Exclusion Criteria: Subject is less than 18 years of age Subject is pregnant at the time of the study Subject/legal guardian unwilling to participate in the study

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 |
| --- | --- | --- |
| Plasma concentrations of lorazepam measured after 72 hours of treatment with lorazepam at fixed dose | Compare the residual plasma concentration of lorazepam after 72 hours of taking fixed-dose lorazepam between responder and non-responder patients defined by the persistence of this diagnosis despite a daily dosage of 24 mg of lorazepam for 72 hours | at 72 hours of treatment with lorazepam |
How Can Rehospitalisations of Patients With Schizophrenia be Avoided? A Comparison Between Different Compliance Programs

Study Overview
=================
Brief Summary
-----------------
Participation in one of the three interventions psychoeducation by professionals, psychoeducation by peer-moderators, or video-education can reduce the rehospitalisation rate of patients with schizophrenia compared to a control group.

Official Title
-----------------
How Can Rehospitalisations of Patients With Schizophrenia be Avoided? A Comparison Between Different Compliance Programs

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Other: Psychoeducation by professonals
* Other: Psychoeducation by peer-moderators
* Other: Video-education
* Other: Noneducational video group (control group)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizophrenia or schizoaffective disorder (ICD-10) Age 18 to 67 years Hospitalised or treated in day care clinic Exclusion Criteria: More than 12 months of hospitalisation within the last two years Substance-dependency (principal diagnosis) Mental retardation ICD-10 Chapter F70-79 Fluency of German language not given

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 Years

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>Psychoeducation by peer-moderators | Other: Psychoeducation by peer-moderators<br> <br> |
| Experimental: 1<br>Psychoeducation by professionals | Other: Psychoeducation by professonals<br> <br> |
| Experimental: 3<br>Video-education | Other: Video-education<br> <br> |
| Placebo Comparator: 4<br>Control group | Other: Noneducational video group (control group)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehospitalisation rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehospitalisation days |  |  | 
| Resulting costs per patient |  |  | 
| Compliance |  |  | 
| Knowledge of illness |  |  | 
| Attitude towards illness |  |  | 
| Quality of life |  |  | 
| Satisfaction with treatment |  |  | 
| Duration of consultation time |  |  | 
| Dealing with mental illness |  |  |
Study to Explore the Mechanism of Acquired Immune Escape In Participants With Metastatic Cancer Progressing on CPI Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify mechanisms associated with acquired immune escape by comparing baseline and at-progression tissue samples from participants who derive clinical benefit from CPI treatment of metastatic cancer or hematologic malignancies.

Official Title
-----------------
A Multicenter Study to Explore the Mechanism of Acquired Immune Escape In Patients With Metastatic Cancer Progressing on Checkpoint Inhibitor Therapy

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Procedure: Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Response assessment of complete response (CR), partial response (PR), or long-term stable disease (SD) for >6 months with a cancer immunotherapy treatment for metastatic cancer or hematologic malignancies either through a marketed CPI or through participation in a Roche/Genentech CPI clinical trial. Availability of tissue sample. Exclusion Criteria: Pregnant, lactating, or intending to become pregnant during the study. Participants receiving CPI treatment as part of a non-Roche/Genentech clinical trial.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Checkpoint Inhibitor Therapy<br>Pre-treatment (archival) and at progression biopsy for participants with a demonstrated clinical benefit on CPI therapy will be asked to participate in the study. In addition, retrospective enrollment of patients who progressed on CPI therapy after documented response and for whom an at-progression biopsy is available, is also possible. | Procedure: Biopsy<br>* Participants who received or are receiving CPI therapy for metastatic cancer or hematologic malignancies.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Gene Alterations in at-Progression Biopsy of Patricipants with Acquired Immune Escape | Number of Gene Alterations Will Be Evaluated Using NGS Approaches by Comparing At-Progression Biopsy with Pre-Treatment Biopsy | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic Cancer
Inverted Internal Limiting Membrane Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes

Study Overview
=================
Brief Summary
-----------------
To evaluate efficacy of vitrectomy with inverted internal limiting membrane (ILM) flap technique for macular hole retinal detachment (MHRD) in highly myopic eyes, and to demonstrate postoperative clinical course of MHRD after inverted ILM flap technique using swept-source optical coherence tomography (OCT)

Detailed Description
-----------------
Macular hole retinal detachment (MHRD) threatens a certain number of highly myopic patients for irreversible visual dysfunction, and mostly requires immediate surgical intervention. The aim of they study is to evaluate efficacy of vitrectomy with inverted internal limiting membrane (ILM) flap technique for MHRD in highly myopic eyes, and to demonstrate postoperative clinical course of MHRD after inverted ILM flap technique using swept-source optical coherence tomography.

Official Title
-----------------
Efficacy of Inverted Internal Limiting Membrane Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes

Conditions
-----------------
Macular Hole Retinal Detachment

Intervention / Treatment
-----------------
* Procedure: Vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria were patients who underwent vitrectomy and internal limiting membrane removal or inverted for macular hole retinal detachment and had followed for more than 6 months. Exclusion Criteria: The patients with follow-up less than 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inverted ILM flap group<br>Eyes underwent vitrectomy with inverted internal limiting membrane technique | Procedure: Vitrectomy<br>* Vitrectomy with inverted ILM technique or ILM peeling<br>|
| Active Comparator: ILM peeling group<br>Eyes underwent vitrectomy with internal limiting membrane peeling | Procedure: Vitrectomy<br>* Vitrectomy with inverted ILM technique or ILM peeling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity before and after surgery |  | Changes from baseline to 1, 3, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical coherence tomography |  | Changes from baseline up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitrectomy, macular hole retinal detachment, high myopia