linjc16/ctgov huggingface dataset:
The Israeli MGuard Registry

Study Overview
=================
Brief Summary
-----------------
the objective of the Israeli MGurad Registry is to evaluate the 'Real World' Clinical Performance of the InspireMD MGuard Coronary Stent System

Detailed Description
-----------------
A Prospective, Observational, Multicenter Registry The primary objective of this registry is to document the safety and overall clinical performance of the MGuard Coronary Stent System in a real world patient population requiring stent implantation. The secondary objective is to assess the event rate in patient subgroups with specific clinical indications and/or vessel and/or lesion characteristics.

Official Title
-----------------
A Prospective, Observational, Multicenter Registry To Evaluate the 'Real World' Clinical Performance of the MGuard Coronary Stent System

Conditions
-----------------
Ischemic Heart Disease, Acute Coronary Syndrome, Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Device: MGuard Coronary Stent system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is > 18 years of age The patient has consented to participate by signing the Patient Informed Consent Form Patient is suitable for implantation of one or more MGuard Stent System in one or more target lesions Target lesion(s) are according to the Indications for Use and Israeli regulatory approval of the MGuard Stent System The patient is willing and able to cooperate with registry procedures and required follow up Exclusion Criteria: Heavily calcified target lesions Target lesions with side branch bigger then 2.5mm Target lesions which are distal to newly stented lesion (less than 1 month). Women with known pregnancy Current medical condition with a life expectancy of less than 12 months Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits study participation

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 |
| --- | --- |
| MGuard<br>eligible patients implanted with minimum one MGuard stent | Device: MGuard Coronary Stent system<br>* MGuard Coronary Stent system implanted within a PCI<br>* Other names: MGuard;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Cardiac Adverse Events rate (MACE) |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Cardiac Adverse Events rate (MACE) |  | 6 months | 
| Lesion success rate |  | 1 day | 
| Bleeding complications |  | 6 months | 
| Stent thrombosis rate |  | 6 months | 
| Any death |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
distal embolization, thrombotic lesions, AMI, ACS, SVG
Managed Access Programs for LEE011, Ribociclib

Study Overview
=================
Brief Summary
-----------------
The purpose of this registration is to list Managed Access Programs (MAPs) related to LEE011, Ribociclib

Detailed Description
-----------------
CLEE011A2408 - No longer available - Managed Access Program (MAP) Cohort to provide access to ribociclib (LEE011, Kisqali®), for locally advanced or metastatic cancer resistant or refractory to available treatment options and candidate for therapy with a CDK inhibitor (including tumors with D-cyclin-CDK4/6-INK4a-Rb pathway abnormalities) CLEE011A2006M - Available - Managed Access Program (MAP) Cohort to provide access to Ribociclib for patients diagnosed with early-stage HR+HER2 (stages II and III) - breast cancer requiring adjuvant treatment with an ET based regimen

Official Title
-----------------
Managed Access Programs for LEE011, Ribociclib

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

Intervention / Treatment
-----------------
* Drug: Ribociclib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An independent request was received from a licensed physician. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment. The patient is not eligible or able to enroll in a clinical trial or continue participation in such trial. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable). Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program. Managed Access provision is allowed per local laws/regulations.

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

| Intervention/Treatment |
| --- |
|Drug: Ribociclib|Patients receive ribociclib|

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
-----------------
MAP, Manage access program, Breast Cancer, CLEE011, Ribociclib
Proposal of a Method Using the PMSI and SNIIRAM National Databases to Estimate the Frequency of Physical Abuse and to Identify th Eassociated At-risk Situations and Consequences in Children Aged 0 to 5 Years in France

Study Overview
=================
Brief Summary
-----------------
The epidemiological data currently available on child abuse in France are very inadequate. They do not make it possible to know the number of child victims, nor the precise context and impact of this violence. Very often, the figures put forward are underestimated. Improving the knowledge of these situations would make it possible to develop targeted primary and secondary prevention programs. In this study, is proposed an innovative method of exploiting existing national databases, the PMSI and SNIIRAM, with the aim of 1) approaching an order of magnitude of the frequency of physical abuse in children and 2) evaluating its contexts and consequences. The PMSI is a high-quality database that has been used for many years for medical research purposes. It provides a large amount of epidemiological information and can be used to create cohorts large enough to detect rare events. The SNIIRAM/EGB data allows the recovery of all data on reimbursed consumption, such as drug treatments, biological examinations carried out or consultations (with general practitioners or specialists).

Official Title
-----------------
Proposal of a Method Using the PMSI and SNIIRAM National Databases to Estimate the Frequency of Physical Abuse and to Identify th Eassociated At-risk Situations and Consequences in Children Aged 0 to 5 Years in France

Conditions
-----------------
Child Abuse

Intervention / Treatment
-----------------
* Other: ICD-10


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children aged 0 to 5 years hospitalized in France between 2007 and 2014. Based on ICD-10 codes generated within the PMSI, 3 groups of children were defined: those with at least one code dedicated to physical abuse, those with at least one code or combination of codes suspected of physical abuse, and all other hospitalized children, control group. Exclusion Criteria: NA

Ages Eligible for Study
-----------------
Maximum Age: 5 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 |
| --- | --- |
| children from 0 to 5 years old, hospitalized<br> | Other: ICD-10<br>* A collection of ICD-10 codes used within the PMSI that relate to physical abuse.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of confirmed diagnoses for child abuse |  | Through study completion, an average of 2 years |
Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of two different drugs in the treatment of patients diagnosed with moderate to severe back pain.

Detailed Description
-----------------
double-blind, double-dummy, non-inferiority, prospective, parallel group, intent to treat trial. Experiment duration: 04 days. 03 visits (days 0, 2 and 4). Efficacy will be evaluated for back pain relief based on visual analog scale. Adverse events evaluation.

Official Title
-----------------
Randomized, Double Blind, Double Dummy To Non-Inferiority Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment

Conditions
-----------------
Back Pain

Intervention / Treatment
-----------------
* Drug: Ketorolac Tromethamine
* Drug: Naproxen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consent of the patient or legal guardian. Men or women aged between 18 and 65. Diagnosis of acute low back pain with moderate to severe pain (Visual Analog Scale greater than 4 cm) Exclusion Criteria: fracture confirmed by X-ray Diagnosis of infection, fever, Pregnancy, lactation; Diagnosis of fibromyalgia; Hypersensitivity to ketorolac tromethamine, any of the ingredients of the formula or other Nonsteroidal anti-inflammatory

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Naproxen<br>Every 8 hours for 4 days. | Drug: Naproxen<br>* Every 8 hours for 4 days.<br>|
| Experimental: Ketorolac Tromethamine<br>Every 8 hours for 4 days | Drug: Ketorolac Tromethamine<br>* Every 8 hours for 4 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of treatment in back pain relief based on Visual Analog Scale (VAS). | The individual response rate to the relieve of pain is calculated by measuring VAS during the first and last visit. The response rate is calculated using the following formula: Response rate = (VASvi - VASvf) / VASvi Considering: VASvi: VAS in the first visit; VASvf: VAS at the last visit; | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be evaluated by the adverse events occurrences | Adverse events will be collected and followed in order to evaluate safety and tolerability | day 4 |
Cohort of Inflammatory Bowel Disease Patient in Yeouido St. Mary's Hospital

Study Overview
=================
Brief Summary
-----------------
Pathologically Inflammatory bowel disease (IBD) is in chronic complex inflammatory gut pathological condition. Although the etiology of IBD is unknown, gut microbiota alteration (dysbiosis) is considered a novel factor involved in the pathogenesis of IBD. The aim of this study is to analyze gut microbiota in IBD patients.

Detailed Description
-----------------
Inflammatory bowel disease (IBD) (Crohn's disease (CD) and ulcerative colitis (UC)) occurs worldwide with differences in epidemiology, etiology, and phenotype between regions. Pathologically Inflammatory bowel disease (IBD) is in chronic complex inflammatory gut pathological condition. Although the etiology of IBD is unknown, gut microbiota alteration (dysbiosis) is considered a novel factor involved in the pathogenesis of IBD. The DNA of microbiota will be investigated with samples of stool, colon tissue. The aim is to establish a cohort group for IBD (1), to make a database on cohort group characteristics such as endoscopic findings, disease severity, epidemiology, and prognosis (2), to analyze gut flora in IBD patients (3).

Official Title
-----------------
Development of the Cohort of the Patients With Inflammatory Bowel Disease in Yeouido St. Mary's Hospital

Conditions
-----------------
Inflammatory Bowel Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The below 3 conditions must be met simultaneously. Patient who can voluntarily consent to this study. Patient who has inflammatory bowel disease. Patient who is aged less than 75 years. Exclusion Criteria: a patient meets any of the below conditions. If a patient has an IBD other than UC and CD. If a patient is vulnerable due to his/her position as an employee of Yeouido St.Mary's hospital or a medical student of the Catholic University of Korea. If a patient is pregnant. Foreign personal who cannot speak Korean.

Ages Eligible for Study
-----------------
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 |
| --- | --- | --- |
| Number of participants with the remission of disease activity. | Disease activity is assessed in a clinical, endoscopic, and biochemical way. Each activity is determined by the Mayo score (in UC), Crohn's Disease Activity Index (in CD), Ulcerative Colitis Endoscopic Index of Severity (in UC), Simple Endoscopic Score for Crohn Disease (in CD), and biochemical findings (e.g. fecal calprotectin). | through study completion, an average of 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammatory Bowel Disease
Study of Prophylactic Vs Preemptive Valganciclovir

Study Overview
=================
Brief Summary
-----------------
This is a study of prophylactic Vs preemptive oral valganciclovir for management of cytomegalovirus infection in adult renal transplant recipients looking at clinical and pharmacoeconomic outcomes

Detailed Description
-----------------
This is a study of prophylactic Vs preemptive oral valganciclovir for management of cytomegalovirus infection in adult renal transplant recipients looking at clinical and pharmacoeconomic outcomes. Patients at risk for CMV (D+/R-, D+/R+, D-/R+) were randomized to prophylaxis (valganciclovir 900 mg qd for 100 days, n=49) or preemptive therapy (900 mg bid for 21 days, n=49) for CMV DNAemia (CMV DNA level >2000 copies/ml in ≥ 1 whole blood specimens by quantitative PCR done weekly for 16 weeks then at months 5, 6, 9, and 12. Clinical and virologic outcomes were measured and pharmacoeconomic outcomes will be analyzed

Official Title
-----------------
Prophylactic Vs Preemptive Oral Valganciclovir for Management of Cytomegalovirus Infection in Adult Renal Transplant Recipients: A Clinical and Pharmacoeconomic Study

Conditions
-----------------
Cytomegalovirus Infection

Intervention / Treatment
-----------------
* Drug: Valganciclovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who received a kidney transplant at Washington University Medical Center between March 2003 and June 2004. Exclusion Criteria: Age younger than 18 Refusal to consent for the study Allergy to ganciclovir and severe illness too serious to justify randomization

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcomes included occurrence of CMV infection and disease and response to therapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes were incidence of acute rejection, allograft survival, allograft dysfunction, death, and incidence of neutropenia |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cytomegalovirus, kidney, transplantation, valganciclovir, preemptive
Propofol Versus Midazolam for Lower Gastrointestinal Endoscopy

Study Overview
=================
Brief Summary
-----------------
propofol versus use of midazolam as sedative agent in patients with liver cirrhosis presented for lower gastrointestinal endoscopy

Detailed Description
-----------------
Effect of use of propofol versus use of midazolam as sedative agent in patients with liver cirrhosis presented for lower gastrointestinal endoscopy, Randomised controlled trial.

Official Title
-----------------
Effect of Use of Propofol Versus Use of Midazolam as Sedative Agent in Patients With Liver Cirrhosis Presented for Lower Gastrointestinal Endoscopy, Randomised Controlled Trial

Conditions
-----------------
Cirrhosis, Liver

Intervention / Treatment
-----------------
* Drug: Midazolam
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver cirrhosis presented to colonoscopy Exclusion Criteria: Encephalopathy Hypersensitivity Coagulopathy

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Midazolam<br>Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg till reaching satisfactory level of sedation | Drug: Midazolam<br>* Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg till reaching satisfactory level of sedation<br>|
| Active Comparator: Propofol<br>Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v till reaching satisfactory level of sedation | Drug: Propofol<br>* Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v till reaching satisfactory level of sedation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients adequately sedated | The number of patients adequately sedated | 6 months |
Plasma Levels of Danger-Associated Molecular Patterns in Young Children After Cardiac Surgery Under Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
The investigators have previously reported that cardiac surgery with CPB ( cardiopulmonary bypass) in young infants induced a drastic reduction in mHLA-DR ( Human Leucocyte Antigen) expression, which represents one of innate immune mediator. Danger-Associated Molecular Patterns (DAMPs) can elicit immune response and may subsequentely induce an immune-suppressed state. The investigators hypothesize that CPB causes excessive DAMP release, leading to the development of immune suppression. Thus, DAMPs release will be assessed in patients undergoing CBP, and consequences on immune suppression will be evaluated.

Detailed Description
-----------------
Plasma levels of heat shock protein (HSP 70), high mobility group box (HMGB1), S100A9 and IL-33 will be measured at four time points (prior to the onset of CPB, Hour 6 postoperative, day 1 and day 3 after surgery). HLA-DR gene expression will be determined before surgery and at day 3 postoperative. The direct effect of DAMPs release and immune suppression will be assessed by in vitro experiments.

Official Title
-----------------
Plasma Levels of Danger-Associated Molecular Patterns (DAMPs) in Young Children After Cardiac Surgery Under Cardiopulmonary Bypass (IMMUNOPED 2)

Conditions
-----------------
Cardiac Surgical Procedure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≤ 3 months undergoing cardiac surgery with cardiopulmonary bypass Exclusion Criteria: Lack of parental consent

Ages Eligible for Study
-----------------
Maximum Age: 3 Months

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 levels of heat shock protein (HSP 70), high mobility group box (HMGB1), S100A9 and IL-33 before and after CBP. | Change of plasma levels of DAMPs after cardiopulmonary bypass Plasma levels of heat shock protein (HSP 70), high mobility group box (HMGB1), S100A9 and IL-33 before and after CBP. | prior to the onset of CPB, 6 hours, day 1 and day 3 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of DAMPs on immune function:In vitro change of HLA-DR expression. | In vitro change of HLA-DR expression induced by plasma containing different concentrations of DAMPs. | 6 hours after surgery | 
| Effect of DAMPs on immune function:Secretion of IL-10 ( Interleukine 10). | Secretion of IL-10 by different immune cells induced by plasma containing different concentrations of DAMPs. | 6 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiopulmonary bypass; immunosuppression; infant, immunosuppression, infant