linjc16/ctgov huggingface dataset:
Effect of the Consumption of a Fermented Dairy Drink on the Immune Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the regular consumption of the active product enhances the immune function, in comparison to the control product.

Conditions
-----------------
Healthy Free-living Elderly

Intervention / Treatment
-----------------
* Other: 1-Fermented Dairy Product (test)
* Other: 2-Milk-based non-fermented dairy product (control)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy free-living both gender elderly aged from 65 to 80 years old on the day of inclusion Able to comply with all the trial procedures Having given written consent to take part in the study prior to participation. Body mass index (BMI): 18,5 < BMI < 30 kg/m². Exclusion Criteria: Contra-indication to any of the products and procedures used for the study purpose Participation in another clinical trial People currently institutionalised Immunocompromised conditions or other conditions that may impact the immune response or the product effect Subjects suffering from a not stabilized chronic disease Subjects suffering from a sever acute or chronic disease Subjects suffering from a condition which is at a stage where it might prevent him/her from being able or willing to comply with the study procedures or completion Subject known to be deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. Subject identified as employees of the Investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the centre's employees or the Investigator.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 80 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 = Tested product<br> | Other: 1-Fermented Dairy Product (test)<br>* 1 = Intervention 1 (test product)<br>|
| Placebo Comparator: 2 = Control product<br> | Other: 2-Milk-based non-fermented dairy product (control)<br>* 2 = Intervention 2 (control product)<br>|

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
-----------------
Probiotic - dairy product - influenza vaccination - healthy elderly
Ocular Graft Versus Host Disease After Hematopoietic Stem Cell Transplantation in Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the presence and manifestations of ocular graft versus host disease in adults that had hematopoietic stem cell transplantation in the past 3 years at the sheba medical center, Israel. As well as correlate the degree of the presentation to the therapeutic protocol (chemotherapy and irradiation).

Official Title
-----------------
Ocular Graft Versus Host Disease After Hematopoietic Stem Cell Transplantation in Adults

Conditions
-----------------
Graft Versus Host Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: after hematopoietic stem cell transplantation done at sheba medical center Israel 3 month have past from transplantation but no more then 3 years Exclusion Criteria: transplantation done in the last 3 month or more than 3 years have past since

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 |
| --- | --- |
| hematopoietic stem cell transplantation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Blood Draw Study for Liver Transplant Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see what a lab test will show and if there is a way to predict which patients will be more likely to have rejection after receiving a liver transplant.

Detailed Description
-----------------
The purpose of this study is simply to see what the new oligonucleotide microarrays will show when comparing the the different patient groups. The results of this study will be one of the first steps In exploring the potential use of this new test.

Official Title
-----------------
Immunomonitoring of Transplant Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received a liver Transplant Exclusion Criteria: Received Multiple Organ Transplant

Ages Eligible for Study
-----------------
Minimum Age: 17 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 |
| --- | --- |
| Control<br> | |
| Rejection<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify signatures predictive of graft rejection or tolerance. | Analyze the pattern of gene expression in patients undergoing solid organ transplantation | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver Transplant
Behavioral Activation for Perinatal Depression

Study Overview
=================
Brief Summary
-----------------
This pilot study will examine the feasibility, acceptability, and effectiveness of a brief behavioral activation psychotherapy for women with perinatal depression.

Official Title
-----------------
Pilot Trial of Behavioral Activation Psychotherapy for Perinatal Depression

Conditions
-----------------
Depression During Pregnancy

Intervention / Treatment
-----------------
* Behavioral: Behavioral activation psychotherapy
* Other: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Pregnant PHQ9 Depression Score of 15 or greater Receiving prenatal care at one of the participating sites Exclusion Criteria: - Known diagnosis of bipolar or psychotic disorder Active substance dependence Immediate risk of self harm Immediate need for inpatient mental health treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Activation<br>Behavioral activation psychotherapy | Behavioral: Behavioral activation psychotherapy<br>* Up to 10 sessions of behavioral activation psychotherapy delivered in person or by telephone.<br>|
| Placebo Comparator: Usual Care<br>Continued care as usual | Other: Usual care<br>* Continued usual care (could include referral for medication or psychotherapy)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PHQ9 Depression Score | Mean PHQ9 depression score 3 months postpartum | 3 months post-partm | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, pregnancy
Photodynamic and Pharmacologic Treatment of CNV

Study Overview
=================
Brief Summary
-----------------
The goal of this pilot study is to validate the use of the combination of Lucentis (ranibizumab) and Visudyne (verteporfin) in the treatment of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) and to explore the use of a volumetric analysis of the CNV lesion to determine disease activity, response to therapy, and as a tool for determining the need for retreatment.

Official Title
-----------------
Photodynamic and Pharmacologic Treatment of Choroidal Neovascularization (Photodynamic Booster Study)

Conditions
-----------------
Choroidal Neovascularization, Macular Degeneration

Intervention / Treatment
-----------------
* Drug: verteporfin (Visudyne)
* Drug: ranibizumab (Lucentis)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All previously untreated CNV secondary to MD
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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>Combined treatment with verteporfin (Visudyne) and ranibizumab (Lucentis) | Drug: verteporfin (Visudyne)<br>* Verteporfin (Visudyne) 6 mg/m2 at 300mW/cm2 given on week O and then at week 5, given as indicated per protocol; ranibizumab (Lucentis) 0.3 mg given at week 1<br>* Other names: Lucentis = ranibizumab;|
| Experimental: II<br>Treatment with ranibizumab (Lucentis) | Drug: ranibizumab (Lucentis)<br>* ranibizumab (Lucentis) 0.3 mg on weeks 1,5,9,13,17,21,25,29,33&37 per study protocol<br>* Other names: Lucentis = ranibizumab;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual change |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of treatment |  | 18 months |
Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the detection rate and false negative rate of sentinel lymph node biopsy following previous surgical biopsy for early breast cancer diagnosis.

Official Title
-----------------
Prospective Multicentric Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: sentinel node
* Procedure: GAS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Previous conservative surgical biopsy Secondary pathological diagnosis of infiltrative cancer No clinically involved axillary node (N0) No previous neoadjuvant treatment Performance status European Cancer Conference (ECCO) Grade ≤ 1 Patient's written informed consent to participate in the study according to French law Surgeon must have performed its learning curve Exclusion Criteria: Lack of infiltrative breast carcinoma (in situ) pT4d > N0 Breast cancer relapse Pregnancy Known patent blue allergy Indication for radical or partial mastectomy Patient unable to understand the trial

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: sentinel node|detection of the sentinel node in breast cancer|
|Procedure: GAS|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| false negatives |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast infiltrative cancer
Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers

Study Overview
=================
Brief Summary
-----------------
To evaluate tolerance and efficiency of cryopreserved amniotic membranes in local treatment of resistant vascular ulcers. To evaluate complete cicatrisation, efficiency on pain, prevention of infection, improvement of quality of life. To evaluate rate of amputations and recurrence at one year after complete cicatrisation

Detailed Description
-----------------
Treatment of patients suffering from vascular ulcers or amputation's wound from at least 6 months after or without possibility for surgical treatment. A cryopreserved amniotic membrane, obtained after caesarean from consenting women without any disease, is applied on the ulcer after serological checking and changed once a week. Main criterias: Tolerance will be evaluated on clinical criterias. Efficiency will be evaluated by measuring reduction of ulcer's area (reduction of at least 50 % at 6 months). Secondary criterias: Reduction of pain will be evaluated by analogic visual scale and evaluation of analgesic consumption. Evaluation of infections, amputations, complete healing, improvement of quality of life by SF36 questionnaire and recurrence at one year for patients with complete healing.

Official Title
-----------------
Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers

Conditions
-----------------
Resistant Vascular Ulcers

Intervention / Treatment
-----------------
* Procedure: amniotic membranes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obtained informed consent Leg or foot arterial or mixed ulcer older than at least 3 months Exclusion Criteria: No obtained informed consent Possibility for surgical treatment (revascularisation) Age less than 18 Pregnancy Indication for major amputation (below /above the knee) Venous ulcer Ulcer with infection and / or necrosis Mycotic ulcer

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: amniotic membranes<br> | Procedure: amniotic membranes<br>* The amniotic membrane is taken with a sterile crowbar then applied side foetal face against the ulcer and displayed in a homogeneous way<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of the diameter of the ulcer |  | Every week |
LAAO With DAPT Versus Antithrombotic Therapy

Study Overview
=================
Brief Summary
-----------------
This study will retrospectively review and compare clinical outcomes between left atrial appendage occlusion with dual antiplatelet therapy versus conventional antithrombotic therapy in patients with atrial fibrillation undergoing drug-eluting stent implantation.

Detailed Description
-----------------
Composite of stroke and major bleeding will be compared after adjusting those groups using inverse probability weighted model.

Official Title
-----------------
Comparison of Clinical Outcomes Between Left Atrial Appendage Occlusion With Dual Antiplatelet Therapy Versus Conventional Antithrombotic Therapy in Patients With Atrial Fibrillation Undergoing Drug-eluting Stent Implantation

Conditions
-----------------
Coronary Artery Disease, Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: ACP or Watchman


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with AF who underwent PCI and treated with LAAO and DAPT or conventional antithrombotic therapy Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LAAO with DAPT<br>patients with AF who underwent PCI and treated with LAAO(either ACP or Watchman) and DAPT | Procedure: ACP or Watchman<br>* Left atrial appnedage occlusion using ACP or Watchman<br>|
| Conventional antithrombotic therapy<br>patients with AF who underwent PCI and treated with conventional antithrombotic therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of stroke and major bleeding | Primary endpoint is a composite of stroke and major bleeding. Stroke is defined as ischemic cerebrovascular event included both transient ischemic attack and ischemic cerebral infarction. Major bleeding event was defined as moderate or severe bleeding according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries criteria. | From date of index procedure until the date of primary endpoint occur or date of last follow up, whichever came first, assessed up to 50 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
left atrial appendage occlusion, antithrombotic therapy, atrial fibrillation, percutaneous coronary intervention, drug eluting stent
Obalon Navigation/Touch System Post-Approval Study

Study Overview
=================
Brief Summary
-----------------
Post-approval study for the Obalon Navigation/Touch System (NTS)

Detailed Description
-----------------
The Obalon NTS PAS is a prospective, observational, open-label and multi-center study with an objective to collect continued safety and performance of the Obalon NTS in a commercial setting and confirm results observed in the supplemental PMA IDE study.

Official Title
-----------------
Obalon Navigation/Touch System Post-Approval Study

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Device: Obalon Navigation/Touch System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 22 years and older Starting or current therapy BMI of 30.0-40.0 kg/m2 Commercially purchased the Obalon Balloon Device Exclusion Criteria: Known history of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic removal procedure, including, Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation or any other disorder of the esophagus. Known history of structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms. Known history of structural or functional disorders of the stomach including, gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (> 2 cm), cancer or any other disorder of the stomach. Active implantable devices, such as a pacemaker of defibrillator, or with metal implants in the thoracic region.

Ages Eligible for Study
-----------------
Minimum Age: 22 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 |
| --- | --- |
| Obalon NTS<br>Patients who commercially purchased the NTS Compatible Obalon Balloon System | Device: Obalon Navigation/Touch System<br>* The NTS Compatible Obalon Balloon System does NOT require the use of radiographic verification prior to the inflation of the intragastric balloon<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal Inflation | Percentage of esophageal Inflation during the balloon administrations using the Obalon NTS. | Up to 20 Weeks | 
| System Success | Percentage of appropriate inflation in the stomach with the use of NTS only (without radiography) or correctly determining failed balloon transit (device in the esophagus) as confirmed by endoscopic removal | Up to 20 Weeks |