linjc16/ctgov huggingface dataset:
Cellular and Molecular Mechanisms Governing Bone Marrow Stem Cells in Gaucher Disease

Study Overview
=================
Brief Summary
-----------------
Gaucher disease is an inherited autosomal recessive lysosomal storage disorder caused by the defective activity of the glucocerebrosidase, leading to accumulation of glucocerebroside particularly in cells of the macrophage lineage. Clinical manifestations associate hematological, neurological and bone disorders.

Detailed Description
-----------------
Gaucher disease is an inherited autosomal recessive lysosomal storage disorder caused by the defective activity of the glucocerebrosidase, leading to accumulation of glucocerebroside particularly in cells of the macrophage lineage. Clinical manifestations associate hematological, neurological and bone disorders. In this project, the investigators aimed to study the cellular and molecular mechanisms governing the biology of various cell populations of the bone marrow and blood in these patients in order to define their potential role in the physiopathology of the disease. The main research topics the investigators plan will then be focused on characterization and functional analysis of hematopoietic stem cells, mesenchymal stem cells (with a special focus on osteogenic differentiation), macrophages and osteoclastic differentiation, B lymphocytes and plasma cells.

Official Title
-----------------
Cellular and Molecular Mechanisms Governing Bone Marrow Stem Cells, Macrophages and Plasma Cell Biology in Gaucher Disease.

Conditions
-----------------
Gaucher Disease

Intervention / Treatment
-----------------
* Other: Bone marrow and blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years Gaucher disease clinical examination written consent Exclusion Criteria: pregnancy HIV seropositive contraindication to bone marrow sampling

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 |
| --- | --- |
| Experimental: Bone marrow and blood sampling<br> | Other: Bone marrow and blood sampling<br>* Bone marrow and blood sampling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stem cells |  | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gaucher disease
Is There is a Role of Prophylactic Therapy With Tamsulosin Before Extracorporeal Shock Wave Lithotripsy to Avoid Development of Steinstrasse ?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if there is a role of prophylactic therapy with tamsulosin prior extracorporeal shock wave lithotripsy to avoid development of steinstrasse. 150 persons that will go to Extracorporeal shock wave lithotripsy will randomize to 2 groups. Group 1 -of 75 persons will recieve tamsulosin 0.4 mg x 1/d 2 days before the lithotripsy . Group 2 - of 75 persons will not recieve tamsulosin. 48 hour after the ESWL all 2 group will take abdominal radiograph to evaluate the presence of steinstrasse.

Conditions
-----------------
Kidney Stones

Intervention / Treatment
-----------------
* Drug: tamsulosin 0.4mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: size of stone 1-2 cm Exclusion Criteria: ureteral stricture Presence of internal stent prior use of alfa bloker prior ESWL

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tamsulosin 0.4mg|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
-----------------
size of stone 1-2 cm, Pt. with no use of alfa bloker prior ESWL, Pt. without internal stent
Cerebral Oxygen, Blood Flow and Ammonia Uptake in Patients With Cirrhosis and an Acute Episode of Hepatic Encephalopathy (HE)

Study Overview
=================
Brief Summary
-----------------
We wish to study patients with liver cirrhosis during and 2 weeks after an acute episode of liver coma (hepatic encephalopathy). By means of Positron Emission Tomography we investigate; brain blood flow, brain ammonia uptake and brain oxygen consumption. We hypothesize that blood flow an oxygen consumption is diminished and ammonia uptake increased during an acute episode of hepatic encephalopathy.

Official Title
-----------------
Cerebral Oxygen, Blood Flow and Ammonia Uptake in Patients With Cirrhosis and an Acute Episode of HE

Conditions
-----------------
Liver Cirrhosis, Hepatic Encephalopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with an acute episode of hepatic encephalopathy Exclusion Criteria: previous stroke

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver cirrhosis, hepatic encephalopathy, ammonia, cerebral blood flow
Italian Register for the Study of Complicated Intra-Abdominal Infections

Study Overview
=================
Brief Summary
-----------------
The study will identify the epidemiological and treatment profiles of acute peritonitis in Italy

Detailed Description
-----------------
The primary objectives of the study are: (1) the identification of specific risk factors for in-hospital mortality, in order to perfect the clinical management of patients with complicated intra-abdominal infections (cIAIs); (2) the identification of specific risk factors for multi-drug resistant organisms (MDROs) isolation in patients with cIAIs, in order to improve the adequacy of empirical antimicrobial therapy. The secondary objectives are: (1) the description of the clinical, diagnostic and treatment profiles of patients with cIAIs in Italian surgical departments; (2) the analysis of epidemiology and patterns of antimicrobial susceptibility of the microorganisms isolated in samples in intra-operative samples of peritoneal fluid or purulent exudate/discrete abscesses in patients with cIAIs; (3) the identification of specific risk factors for post-operative complications in patients with cIAIs.

Official Title
-----------------
Italian Register for the Study of Complicated Intra-Abdominal Infections (IRCA) Study

Conditions
-----------------
Complicated Intra-abdominal Infections

Intervention / Treatment
-----------------
* Other: Epidemiological/treatment profiles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutively hospitalized adult patients (older than 18 years of age) undergoing surgery, interventional drainage or conservative treatment, with diagnosis of cIAIs (defined as abdominal infections originating in an organ cavity, extending into the peritoneal space, and forming an abscess or peritonitis) Exclusion Criteria: Patients younger than 16 years-old, patients with pancreatitis or primary peritonitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 110 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Epidemiological/treatment profiles|All consecutively hospitalized adult patients (older than 18 years of age) undergoing surgery, interventional drainage or conservative treatment, with diagnosis of cIAIs (defined as abdominal infections originating in an organ cavity, extending into the peritoneal space, and forming an abscess or peritonitis, will be included in the study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rates linked to different sources of infection |  | 12 months | 
| Mortality rates linked to different bacteria causing infection |  | 12 months |
A Ten-Week Study Evaluating The Effectiveness And Safety Of Zoloft In Children And Adolescents With A Diagnosis Of PTSD

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of sertraline compared to placebo in children and adolescents (6 to 17 years of age) who are outpatients with Posttraumatic Stress Disorder.

Detailed Description
-----------------
This study was terminated on July 11, 2007. The results of the primary endpoint analysis at the interim showed that the Zoloft group was not significantly different than the placebo on the primary endpoint and therefore the decision was made to terminate the trial. The decision to terminate the trial was not based on any safety concerns.

Official Title
-----------------
A Multicenter, 10-Week, Randomized, Double-Blind Study Of Sertraline And Placebo In Children And Adolescents With Posttraumatic Stress Disorder (PTSD)

Conditions
-----------------
Stress Disorders, Post-Traumatic

Intervention / Treatment
-----------------
* Drug: Zoloft (Sertraline)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be from 6 to 17 years of age and will have a maximum age of 17 at the Baseline Visit of the study. Subjects must have a diagnosis of Posttraumatic Stress Disorder as defined by DSM-IV and determined by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL). Exclusion Criteria: Subjects whose trauma is ongoing, or who are living in the same home as their abuser, or who are expected to participate in litigation related to their trauma during the course of the study will be excluded from participation. Subjects who are likely to or are at high risk for experiencing re-exposure to their index trauma.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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: Zoloft (Sertraline)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy parameter is the University of California at Los Angeles Post-Traumatic Stress Disorder Index for DSM-IV (UCLA PTSD-I). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary efficacy measures include |  |  | 
| Child Stress Disorder Checklist (CSDC) |  |  | 
| Clinical Global Impression Severity (CGI-S) |  |  | 
| Clinical Global Impression Improvement (CGI-I) |  |  | 
| Children's Depression Rating Scale - Revised edition (CDRS-R) |  |  |
Epidemiology of Coronary Heart Disease in Blacks

Study Overview
=================
Brief Summary
-----------------
To conduct an analysis of the epidemiology of coronary heart disease (CHD) in Blacks using data collected from the 'Survival and Ventricular Enlargement (SAVE) Following Myocardial Infarction' study.

Detailed Description
-----------------
BACKGROUND: Ample data now exist to dispel the prevailing clinical impression that coronary heart disease (CHD) occurs infrequently in United States Blacks. It is well known that CHD is the leading cause of death among United States Blacks. Among patients with acute myocardial infarction who often present with typical ischemic chest pain, it has been shown that Blacks present more often without chest pain when compared to whites and Hispanics. In addition, more than 25 percent of the myocardial infarction patients have unrecognized infarctions. Morbidity and mortality associated with angina pectoris, cardiovascular disease, and myocardial infarction occurs in United States Blacks at rates which are at least comparable to their white counterparts. Yet, there are limited epidemiological studies designed to identify the determinants of CHD in the Black population. The patients were originally screened to participate in a multicenter clinical trial on 'Survival and Ventricular Enlargement (SAVE) Following Myocardial Infarction.' Only 28 patients out of 599 screened subjects were eligible for the SAVE study. The baseline data obtained from the 599 screened subjects comprised the database. DESIGN NARRATIVE: Data analysis was performed to: determine the prevalence of coronary heart disease in Blacks presenting with chest pain; identify the correlates of CHD in Blacks; determine the sensitivity and specificity of a Rose questionnaire angina in Blacks; determine the association between the Rose questionnaire angina and CHD manifestations in Blacks, and identify predictive and causal models of CHD. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Coronary Disease, Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Study Investigating the Best Method of Treatment of Bile Duct Stones in Higher Risk Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the trial is to compare two operations which are used to treat bile duct stones. The hypothesis of the study is that there is no difference between endoscopic sphincterotomy followed by laparoscopic cholecystectomy or laparoscopic bile duct exploration during laparoscopic cholecystectomy in the treatment of bile duct stones in higher risk patients.

Official Title
-----------------
A Randomised Clinical Trial to Compare Endoscopic Sphincterotomy and Subsequent Laparoscopic Cholecystectomy With Primary Laparoscopic Bile Duct Exploration During Cholecystectomy in Higher Risk Patients With Choledocholithiasis

Conditions
-----------------
Choledocholithiasis, Higher Risk Patients

Intervention / Treatment
-----------------
* Procedure: Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy
* Procedure: Laparoscopic bile duct exploration during cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gallbladder stones At least strong evidence of bile duct stones (abnormal LFTs and dilated bile duct) Higher risk (>70yrs, >60yrs with co-morbidity, >50 with BMI>40) Exclusion Criteria: Not fit for general anaesthesia Cholangitis requiring emergency ERCP Previous upper GI surgery making ERCP impossible

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Procedure: Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy<br>* Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy<br>|
| Experimental: B<br> | Procedure: Laparoscopic bile duct exploration during cholecystectomy<br>* Laparoscopic bile duct exploration during cholecystectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bile duct clearance |  | Peri-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity and mortality |  | 30 day or directly relating to intervention | 
| Post-operative stay |  | Post-operative stay | 
| Procedures per patient |  | Interventions required to acheive duct clearance | 
| Conversion to open surgery |  | Peri-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Common Bile Duct Calculi, Choledocholithiasis, Endoscopic sphincterotomy, Cholecystectomy, laparoscopic, Laparoscopic bile duct exploration
Cerebral Activation and Bilateral Stimulation by Cochlear Implantation in Bilateral Deaf Adults

Study Overview
=================
Brief Summary
-----------------
The primary objective to this study is to describe bilateral auditory information processing in profoundly deaf patients with bilateral cochlear implants compared with normal hearing patients. Assumption used is that due to the central consequences of bilateral deafness on binaural auditory information central processing, time between activation of the two cochlear implants is a decisive factor in bilateral implantation compared to unilateral implantation

Official Title
-----------------
Cerebral Activation and Bilateral Stimulation by Cochlear Implantation in Bilateral Deaf Adults

Conditions
-----------------
Deafness

Intervention / Treatment
-----------------
* Other: Positron Emission Tomography (PET)
* Other: Electroencephalogram (EEG)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria for patients: - profoundly deaf patients with bilateral cochlear implants Exclusion criteria for patients: post-operative complications incomplete surgical insertion of one of the cochlear implant age under 18 years non-compliant patient pregnant woman or woman with no efficient contraception method informed consent not signed no health insurance Inclusion criteria for control - normal hearing subjects Exclusion criteria control normal hearing subject subject under 18 years old unilateral or bilateral hearing loss non-compliant subject pregnant woman or woman with no efficient contraception method informed consent not signed no health insurance

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Profound deaf patients<br>Profound deaf patients with bilateral cochlear implants: Cortical brain activation pattern obtained by PET and EEG | Other: Positron Emission Tomography (PET)<br> <br> Other: Electroencephalogram (EEG)<br> <br> |
| Other: Healthy volunteers<br>Healthy volunteers: Cortical brain activation pattern obtained by PET and EEG | Other: Positron Emission Tomography (PET)<br> <br> Other: Electroencephalogram (EEG)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortical brain activation pattern | Cortical brain activation pattern obtained by PET or EEG cartography. Activation pattern will be compared between normal hearing subjects and deaf adults with bilateral cochlear implants | 6 months |
XIENCE Xpedition/Alpine/Sierra in Routine Clinical Practice

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate effectiveness and safety of XIENCE Xpedition/Alpine/Sierra in Routine Clinical Practice

Official Title
-----------------
Evaluation of Effectiveness and Safety of XIENCE Xpedition/Alpine/Sierra in Routine Clinical Practice; A MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY

Conditions
-----------------
Percutaneous Transluminal Coronary Angioplasty, Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: XIENCE Xpedition/Alpine/Sierra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 and more Intervention with XIENCE Xpedition or Alpine or Sierra everolimus eluting coronary stent Agreed with written informed consent form Exclusion Criteria: Intervention with XIENCE Xpedition or Alpine or Sierra everolimus eluting coronary stent and other drug eluting stent at the same time Life expectancy of 1year and under Cardiac shock

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| IRIS-Xpedition/Alpine/Sierra Cohort<br>XIENCE Xpedition/Alpine/Sierra | Device: XIENCE Xpedition/Alpine/Sierra<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite event rate | Death, non fatal myocardial infarction, Target Vessel Revascularization | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All death |  | 5year | 
| Cardiac death |  | 5year | 
| Myocardial infarction |  | 5year | 
| Composite event of death or myocardial infarction |  | 5year | 
| Composite event of cardiac death or myocardial infarction |  | 5year | 
| Target Vessel revascularization |  | 5year | 
| Target lesion revascularization |  | 5year | 
| Stent thrombosis by an Academic Research Consortium (ARC) criteria |  | 5year | 
| Stroke |  | 5year | 
| procedural success | defined as less than 30% residual stenosis at the completion of procedure without death or Q wave myocardial infarction or urgent revascularization participants will be followed for the duration of hospital stay, an expected average of 3days. | 3day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alpine, XIENCE Xpedition, Routine Clinical Practice, Sierra