linjc16/ctgov huggingface dataset:
Safety and Efficacy Study of Rituximab in Renal Transplantation

Study Overview
=================
Brief Summary
-----------------
Current strategies for the medical management of transplant patients are largely focused on the prevention and treatment of T-lymphocyte mediated processes. However there is an increasing evidence to suggest that B-lymphocytes have a role in the otherwise classic T-cell mediated rejection of transplants by there ability to act as antigen presenting cells and T-cell activators. Thus there is a significant medical need for effective therapies targeting B cells of transplant patients.One such potential therapy would be to use rituximab, a monoclonal antibody against B-cells in all renal transplant patients. In the present study the efficacy and safety of prophylactic rituximab is studied.

Official Title
-----------------
A Prospective, Randomised, Placebo Controlled, Multicenter Study of the Efficacy and Safety of Rituximab as Induction Therapy Together With Tacrolimus, Mycophenolate Mofetil and Steroids for Patients Undergoing Renal Transplantation

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 years or above Recipients of first or second renal transplants Recipients of kidneys from living or cadaveric donors Single organ recipients (kidney only) Patients providing written informed consent Patients cooperative and able to complete all the assessment procedures Exclusion Criteria: Patients receiving other immunosuppressive therapy within the preceding 28 days Recipients of HLA-identical sibling kidneys Patients with flow-PRA >50% within 6 months prior to enrolment Recent history of malignancy Active infection Pregnant or lactating females Women of childbearing potential not willing to use reliable form of contraception

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of biopsyproven rejection, graft loss or death during the first 6 months following transplanation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function at 6 months |  |  | 
| Incidence of infections |  |  | 
| Incidence of rituximab-related adverse events |  |  | 
| Incidence of malignancies |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney, Transplantation, Immunosuppression, Rituximab
Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

Study Overview
=================
Brief Summary
-----------------
Primary: To assess the efficacy and safety of DVS-233 SR compared with placebo for treatment of vasomotor symptoms (VMS) associated with menopause and to compare the bleeding incidence of DVS-233 SR and tibolone. Secondary: To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

Conditions
-----------------
Menopause

Intervention / Treatment
-----------------
* Drug: DVS-233


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women of age 40 to 65 seeking treatment for hot flashes with last natural menstrual period (LNMP) completed at least 12 months prior to screening. Minimum of 7 moderate to severe hot flashes per day or 50 per week recorded for 7 consecutive days Body Mass Index less than or equal to 34 kg/m2 using the nomograph for BMI. Exclusion Criteria: History, presence, or suspicion of estrogen-dependent neoplasia; Malignancy, or treatment for malignancy, within the previous 2 years. Active or recent arterial thromboembolic disease; History of venous thromboembolism History of cerebrovascular accident, stroke, or transient ischemic attack - Presence of major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy Persistent elevated blood pressure

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DVS-233|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy and safety of DVS-233 SR compared with placebo for treatment of vasomotor symptoms (VMS) associated with menopause and to compare the bleeding incidence of DVS-233 SR and tibolone. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menopause
Effect of Deep Brain Stimulation on Depression and Quality of Life in Parkinson's Patients

Study Overview
=================
Brief Summary
-----------------
We will evaluate the effect of deep brain stimulation on the depression and quality of life in Parkinson's disease. We aim to compare depression pre-operatively and post-operatively in Parkinson's patients with deep brain stimulation to Parkinson's patients evaluated and approved for deep brain stimulation but who did not complete surgery. We will also compare quality of life measures between patients with and without deep brain stimulation.

Detailed Description
-----------------
Deep brain stimulation is an approved therapy for Parkinson's patients, and this procedure is actively performed at Vanderbilt University Hospital. Questions have been raised concerning the effect of deep brain stimulation on the depression commonly seen in Parkinson's patients. Through this study, we plan to evaluate and compare the incidence and severity of depression in Parkinson's patients with deep brain stimulation to those who did not complete the surgery. Primary literature has indicated a general increase in quality of life of those patients receiving DBS, but no studies have compared these two specific patient populations.

Official Title
-----------------
Effect of Deep Brain Stimulation on Depression and Quality of Life in Parkinson's Patients

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Procedure: Deep Brain Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with idiopathic Parkinson's disease. Patients who have received neuropsychological testing in preparation for possible deep brain stimulation. Patients are within the age of 50 and 85. Exclusion Criteria: Parkinson's patients not approved for deep brain stimulation on the basis of neuropsychological testing. Patients who received deep brain stimulation less than a year ago. Patients who do not consent to the study procedures.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Deep Brain Stimulation|nan|

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
-----------------
Parkinson's Disease, Depression, Quality of Life, Deep Brain Stimulation
Clinical Significance of Occult Central Nervous System Disease In Adult Acute Lymphoblastic Leukemia

Study Overview
=================
Brief Summary
-----------------
Central nervous system involvement at diagnosis remains an obstacle to a long-term cure of patients affected by acute lymphoblastic leukemia. The investigators have previously reported that flow cytometry (FCM) is better than conventional cytology (CC) in demonstrating the presence of leukemic cells in the patients'(pts) cerebrospinal fluid (CSF), especially in samples with low cell counts. In the framework of the national Campus ALL program aimed at improving the management of adult ALL patients in the context of the GIMEMA protocols, in the present study the investigators retrospectively evaluated the incidence of occult CNS positivity and its impact on outcome in 241 adult pts with newly diagnosed ALL from 13 centers.

Detailed Description
-----------------
Demographic and of laboratory data of 241 adult patients with ALL were retrospectively recorded. All patients underwent diagnostic lumbar puncture and each cerebrospinal fluid sample was examined by CC and FCM. The investigators identified patients with the only FCM positivity and the investigators correlated this condition with clinical and of laboratory data and with clinical outcome.

Official Title
-----------------
Clinical Significance of Occult Central Nervous System Disease In Adult Acute Lymphoblastic Leukemia: A Multicenter, Retrospective Study From The Campus All/Gimema Network

Conditions
-----------------
Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Diagnostic Test: evaluation of cerebrospinal fluid of ALL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ALL at onset Age >18 years Exclusion Criteria: ALL relapsed or refractory 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 |
| --- | --- |
| acute lymphoblastic leukemia patients<br>We observed within adult patients with ALL three groups of patients: patients without central nervous system (CNS) involvement, patients with manifest CNS involvement and patients with occult CNS involvement. | Diagnostic Test: evaluation of cerebrospinal fluid of ALL<br>* We evaluated cerebrospinal fluids of patients with ALL by conventional cytology and by flow cytometry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact of occult CNS disease | relapse rate | 10 years | 
| impact of occult CNS disease on outcome | overall survival | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute lymphoblastic leukemia, flow cytometry
French Observatory of ElectroConvulsive Therapy (ECT)

Study Overview
=================
Brief Summary
-----------------
Since the 30s, ECT has been a psychiatric treatment mainly used for drug-resistant depressive illnesses. Clinical studies have shown its therapeutic efficiency compared to standard treatments also in other psychiatric illnesses. Although efficient, ECTs also induce side effects. In France, there is currently no consensus on providing the suitest medical care. It is therefore important to review our nowadays health care models in order to maintain and improve the recommendations of the French National Agency for Accreditation and Evaluation in Health, the last of which date from 1997! Within this context, this project has the dual objective of (1) identifying ECT medical procedure in France and (2) developing research to evaluate and to improve the effectiveness of this treatment.

Official Title
-----------------
Observatoire National d'ElectroConvulsivoThérapie (ECT)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients consecutively referred for ECT. Exclusion Criteria: Not specified
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 |
| --- | --- | --- |
| ECT efficiency on patients |  | 2018-2022 |
Biomechanical Analysis of Scapula and Humerus With Different Shoulder Slings

Study Overview
=================
Brief Summary
-----------------
Participants will be measured with motion monitor system while using 6 different slings. Measurement order will be randomized, and 5 minutes resting period will be given prior measurement. Scapula, humerus and thorax positions will be recorded in resting position and then with slings.

Official Title
-----------------
Biomechanical Analysis of Scapula and Humerus With Different Shoulder Slings

Conditions
-----------------
Shoulder Injuries, Surgery

Intervention / Treatment
-----------------
* Other: Sling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: Having a shoulder surgery Having scapular dyskinesis, Having shoulder pain, Having any disease that could affect posture and/or shoulder (such as scoliosis)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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
Interventional Model Description: Participants wore different sling in a randomized order.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Participants received intervention. | Other: Sling<br>* Participants wore six different shoulder slings in a randomized order.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motion Monitor | Motion monitor device was used to analyze 3D positions of the arm, shoulder, scapula and thorax. | During rest position without and with different slings for 5 seconds. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation, Shoulder Surgery, Postoperative
Assessment of the Effects of Maela Connected Follow-up on Well-being and Pain After Lumbar Spine Surgery

Study Overview
=================
Brief Summary
-----------------
Digital technologies could reduce the length of hospital stay and improve post-operative recuperation after discharge by offering a remote follow-up. No study has investigated the effects of connected follow-up on lumbar spine inpatients. The purpose of this project is to assess the effects of connected follow-up on pain and quality of life after lumbar spine surgery.

Official Title
-----------------
Assessment of the Effects of Maela Connected Follow-up on Well-being and Pain After Lumbar Spine Surgery

Conditions
-----------------
Lumbar Spine Surgery, Quality of Life, Pain

Intervention / Treatment
-----------------
* Other: Maela connected follow-up
* Other: traditional follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First ever lumbar spine surgery in the context of a degenerative spinal pathology Age between 18 and 60 yo Providing free and informed consent to participate Having a smartphone able to process MAELA application

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maela connected follow-up<br>patient will benefit of the Maela connected follow-up | Other: Maela connected follow-up<br>* Measures of pain, quality of life and health related variables (coping, self-efficacy, beliefs about pain) will be done at four times before and after surgery.<br>|
| Active Comparator: control group<br>control group with a traditional follow-up | Other: traditional follow-up<br>* medical recommendations and prescriptions at hospital discharge. Measures of pain, quality of life and health related variables (coping, self-efficacy, beliefs about pain) will be done at four times before and after surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of number of well-being patients in both groups | Variation of number of well-being patients in both groups | two months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mobile app follow-up, lumbar spine surgery, Quality of Life, Pain
Copeptin During a Standardized Psychological Stress Test

Study Overview
=================
Brief Summary
-----------------
The aim of the PsyCo Study is to determine whether psychological Stress has an influence on copeptin levels.

Detailed Description
-----------------
healthy volunteers undergo the TSST and stress hormones as cortisol and copeptin are measured

Official Title
-----------------
Copeptin During a Standardized Psychological Stress Test

Conditions
-----------------
Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: •Aged over 18 years Exclusion Criteria: Intake of any kind of medication (except birth control pill) BMI >30 kg/m2 Evidence of any acute illness History of chronic illness Baseline glucose level >7 mmol/l Baseline sodium level <135 mmol/l or >145 mmol/l

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| no treatment<br>no treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in copeptin levels after a psychological stress test in healthy volunteers |  | 30min before, at time point 0, +10, +20, +40, +60 after the psychological stress test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in copeptin levels after a psychological stress test in patients with central diabetes insipidus |  | Timpepoint 0, +10, +20, +40, +60 after the psychological stress test | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Copeptin, psychological stress, The Trier Social Stress Test (TSST)
Depression and Immune Function in Multiple Sclerosis (MS)

Study Overview
=================
Brief Summary
-----------------
Depression is one of the most common symptoms of multiple sclerosis (MS) with a life-time prevalence of major depressive disorder (MDD) of up to 50%. Depression occurs more frequently in MS than in other chronic diseases including other neurological and inflammatory disorders and may contribute to lower quality of life, cognitive problems, difficulties at work, and poorer long term health outcomes. Despite its clinical relevance, the biological mechanisms which may be responsible for the high risk for MS patients to develop depression are unknown. In this observational study, investigators explore the molecular mechanisms responsible for the impaired regulation of immune cells in relapsing-remitting (RR) MS patients with depression. Investigators will compare the molecular and phenotypical profile of immune cells obtained from RRMS patients with clinical depression (n=50), matched MS patients who do not suffer from depression (n=50) as well as matched healthy controls (n=50) and matched patients with depression but without a comorbid neurological disorder (n=50).

Official Title
-----------------
Depression and Immune Function in Multiple Sclerosis (MS)

Conditions
-----------------
Multiple Sclerosis, Depressive Disorder, Major

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsing remitting MS by McDonald Criteria (for RRMS and RRMS+MDD groups). Currently meeting diagnostic criteria for Major Depressive Disorder (for MDD and RRMS+MDD groups) Age 18-55. On stable treatment regime, either untreated or on disease modifying therapy (DMT) for > 6 months Exclusion Criteria: Secondary-progressive or primary progressive MS. Substance abuse for more than 6 months. Pregnancy Use of steroids or vaccination or infections in the previous 3 months. Signs of serious psychiatric pathology other than depression including schizophrenia, bipolar disorder or developmental and learning disorders including disorders on the autism spectrum Antidepressant medication.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Healthy controls<br>Healthy controls | Other: No intervention<br> <br> |
| RRMS<br>Relapsing-Remitting Multiple Sclerosis | Other: No intervention<br> <br> |
| RRMS+MDD<br>Relapsing-Remitting Multiple Sclerosis and Major Depressive Disorder | Other: No intervention<br> <br> |
| MDD<br>Major Depressive Disorder | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory - II |  | 14 days |