linjc16/ctgov huggingface dataset:
Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to describe the natural history of patients with alpha-1 antitrypsin associated emphysema and to figure out associated prognostic factors.

Detailed Description
-----------------
All patients who suffer from this disease are followed every 6 months during a 5 years period. FEV1 decline is the primary endpoint. Quality of life assessed using the Saint George's Respiratory Questionary is recorded too.

Official Title
-----------------
Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema. A National Registry.

Conditions
-----------------
Alpha 1-Antitrypsin Deficiency, Emphysema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serum alpha one antitrypsin < 0.8 g/l Emphysema diagnosed by CT scan Adult Obstructive disorder Exclusion Criteria: Liver or lung transplantation

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FEV1, mortality, Quality of life
Estimation of Standard Liver Volume in the Indian Population

Study Overview
=================
Brief Summary
-----------------
Estimation of liver volume is important for live donor liver transplant as well as extended liver resections. Computed tomography (CT) volumetry which is currently a gold standard for liver volumetry , is a time consuming process. A quicker method to estimate liver volume is essential. The aim of the present study is to try and formulate an equation based on patients height, weight etc to estimate liver volume.

Official Title
-----------------
Estimation of Standard Liver Volume in the Indian Population

Conditions
-----------------
Liver

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing CT scans Autopsy cases Exclusion Criteria: Patients with hepatobiliary disorders Autopsy cases with liver disease or trauma

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 90 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 |
| --- | --- |
| Live patients<br>All patients undergoing CT scans of the abdomen for non hepatobiliary conditions | |
| Autopsy cases<br>All autopsy cases with no liver disease or trauma. | |

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 volume estimation, Indian population
Determination of Genetic Susceptibility in Severe Recurrences of Ocular Toxoplasmosis

Study Overview
=================
Brief Summary
-----------------
Ocular toxoplasmosis (OT) is a major cause of visual impairment worldwide. OT is responsible for 30 to 50% of posterior uveitis. It is characterized by dormant infections that may reactivate without known reasons, causing severe irreversible visual loss. The overall recurrence rate of OT in Europe is greater than 80% for patients and may range from one episode to 11 episodes (1% of OT) in the most extreme cases. Current treatments do not reduce the risk of recurrences and the risk of toxoplasmosis recurrence cannot be predicted in these immunocompetent patients. These clinical and biological expression changes might be related to an individual genetic susceptibility of each patient. The advanced analysis of the entire genome now possible to consider the project.

Official Title
-----------------
Determination of Genetic Susceptibility in Severe Recurrences of Ocular Toxoplasmosis

Conditions
-----------------
Toxoplasmosis Infection, Genotype II, Ocular Toxoplasmosis With Recurrences

Intervention / Treatment
-----------------
* Biological: seropositive for Toxoplasma gondii


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: seropositive for Toxoplasma gondii (for patient and parents) Infection with genotype II (for patient and parents) ocular toxoplasmosis recurrences >5 (patients only) Exclusion Criteria: Parents seronegative for T. gondii infection Infection with others genotypes than type II

Ages Eligible for Study
-----------------
Minimum Age: 12 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: seropositive for Toxoplasma gondii<br> | Biological: seropositive for Toxoplasma gondii<br>* blood sample<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Highlighting of genetic mutations associated with the susceptibility to Toxoplasma gondii.severe eye recurrences. Mutation analysis will be done by exome sequencing of the subjects included in this study |  | This analysis will be performed on a blood sample taken in patients included in the inclusion visit |
Effect of Local Infiltration Anesthesia in a Hip Arthroplasty Fast Track Program.

Study Overview
=================
Brief Summary
-----------------
Fast-track programs in Orthopaedic Surgery require early motion that can only be achieved by optimal pain management protocols. Multimodal analgesia protocols including local infiltration anesthesia (LIA) have obtained excellent results in fast-track programs involving Total Knee Arthroplasty but further research and data is needed in Total Hip Arthoplasty programs.

Official Title
-----------------
Effect of Local Infiltration Anesthesia in a Hip Arthroplasty Fast Track Program.

Conditions
-----------------
Hip Osteoarthritis

Intervention / Treatment
-----------------
* Drug: 100cc of 2% ropivacaine
* Drug: Saline Solution
* Drug: Adrenaline 10mcg/ml


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hip osteoarthritis requiring Total Hip Replacement Exclusion Criteria: Mental Disorders contraindications for epidural anesthesia Neurologic disorders that could interfere with pain evaluation allergy to drugs in multimodal analgesic protocol

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 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 |
| --- | --- |
| Experimental: Multimodal analgesia + Local Infiltration Anesthesia<br>100cc of 2% ropivacaine + Adrenaline 10mcg/ml + 20cc saline solution | Drug: 100cc of 2% ropivacaine<br>* Multimodal analgesia + Local infiltration anesthesia<br>Drug: Adrenaline 10mcg/ml<br> <br> |
| Active Comparator: Multimodal analgesia + saline solution<br>120cc of saline solution | Drug: Saline Solution<br>* Multimodal analgesia + Saline solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measured in Visual Analog Scale | Pain assesed using Visual Analog Scale ( Scoring from 0 to 10) | Up to 48h postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Length of hospital stay measured in days | Up to 1 week | 
| Analgesic requirements | Analgesia requirements needed besides protocol medication Measured in miligrams of drug required(Sevredol) Analgesia required by patient | Up to 1 week | 
| Complications | Wound dehiscence, Infection, reoperation, dislocation. | Up to 1 week |
Phase I and II Study of Auranofin in Chronic Lymphocytic Leukemia (CLL)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of auranofin to treat patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or prolymphocytic lymphoma (PLL).

Official Title
-----------------
A Phase I Phase II Two-Step Study of the Oral Gold Compound Auranofin in Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL)/ Prolymphocytic Lymphoma (PLL)

Conditions
-----------------
Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma, Leukemia, Prolymphocytic

Intervention / Treatment
-----------------
* Drug: auranofin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed B-cell chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), prolymphocytic leukemia arising from CLL/SLL or Richter's transformation according to WHO criteria who require therapy based on the 2008 revised IWCLL criteria. Relapsed or refractory disease after receiving at least 1 prior therapy for CLL At least 18 years old; ECOG status of 1 or less; life expectancy 2 months or greater Adequate organ and marrow function (total bilirubin less than 1.5x IULN; ALT less than 2x IULN; serum creatinine less than 1.5x ULN) Exclusion Criteria: have had chemotherapy, radiotherapy or immunotherapy within 4 weeks prior to entering study have not recovered from AEs due to agents administered more than 4 weeks prior receiving any other investigational agent known second malignancy that limits survival to less than 2 years known HIV positive uncontrolled intercurrent illness pregnant or breastfeeding

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: Phase 2 Dose<br>Auranofin 6 mg orally in the morning / 6 mg orally in the evening | Drug: auranofin<br>* 6 mg twice a day for a total of 12 mg total daily dose<br>* Other names: Ridaura;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  | 24 months | 
| type, incidence, severity, seriousness and relationship to auranofin of adverse events and any laboratory abnormalities |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
auranofin, chronic lymphocytic leukemia, relapsed, refractory, CLL, SLL, PLL
Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of a system combining continuous glucose measurement with a computer-based algorithm for insulin delivery in patients undergoing elective cardiac surgery.

Official Title
-----------------
Feasibility Study of the Use of Continuous Glucose Monitoring Combined With Computer-based eMPC Algorithm for Tight Glucose Control in Cardiosurgical ICU

Conditions
-----------------
Hyperglycemia, Cardiac Surgery

Intervention / Treatment
-----------------
* Device: Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatment
* Other: Intensive insulin therapy using standard protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective cardiac surgery Exclusion Criteria: insulin allergy mental incapacity language barrier

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CGM-eMPC<br> | Device: Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatment<br>* Glucose measured with a real-time continuous glucose monitoring system served as an input for the enhanced model predictive control algorithm adjusting insulin infusion every 15 minutes for the first 24 hours after elective cardiac surgery<br>|
| Other: Control<br> | Other: Intensive insulin therapy using standard protocol<br>* Insulin dosage according to the standard protocol for intensive insulin delivery used at Department of Cardiothoracic Surgery, General University Hospital, Prague.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of glycemic values in the A and B zone of Clarke Error Grid Analysis (a tool for assessing the accuracy of glucose meters) |  | first 24 hours after cardiac surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Entire study average glycemia level; time within, above and below the target range throughout the whole study period and after reaching the target range |  | first 24 hours after cardiac surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
continuous glucose monitoring, intensive insulin therapy, critically ill, cardiac surgery, hyperglycemia of critically ill
Comparison of the HyperQ Versus Conventional Electrocardiogram (ECG) to Detect Ischemia

Study Overview
=================
Brief Summary
-----------------
The purpose of the investigation is to verify the efficiency of the HyperQ™ system in detecting exercise induced ischemia, with higher specificity and sensitivity than conventional ECG Stress testing. The study will be carried out by applying the HyperQ™ system during cycle ergometer stress testing in patients who are referred for angiography at the Department of Cardiology, Essen University Hospital, Essen, Germany. The HyperQ™ results will then be compared to the standard ECG stress test results using the angiography results as the gold standard. The study will be considered successful if analysis of the HyperQ provides a statistically significant improvement over the diagnostic accuracy of conventional ECG stress testing analysis.

Official Title
-----------------
Diagnostic Benefits of HyperQ™ vs. Conventional ECG During Stress Test. A Comparison Study in Patients Referred for Angiography

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A patient who was referred to angiography. A patient who is able (i.e., no contraindications) to perform an exercise stress test A patient who signed an informed consent form. Exclusion Criteria: Contraindications for an exercise test. Wolff-Parkinson-White (pre-excitation) syndrome. Left Bundle branch block, Complete Right bundle branch block or QRS duration > 120 ms, change in QRS morphology during exercise. Atrial Fibrillation or significant ventricular arrhythmia Treatment with Digoxin. Pacemaker. Having taken beta blockers within 24 hours before the exercise test. Pregnancy or suspected pregnancy.

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 |
| --- | --- |
| suspected coronary artery disease<br>patients referred to angiography because of suspected coronary artery disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to determine the incremental diagnostic value of HyperQ data over exercise stress testing parameters to detect significant coronary artery disease (CAD) in patients referred for coronary angiography. |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
angiography, exercise testing, high frequency ECG, coronary artery disease
Popliteal Artery of Treatment With Balloon Angioplasty vs. SUPERA VERITAS Peripheral Stent System

Study Overview
=================
Brief Summary
-----------------
Unblinded, randomized, balanced trial comparing 12 month target lesion patency rates of the IDEV SUPERA VERITAS peripheral stent system to PTA in the treatment of obstructive atherosclerotic popliteal artery disease.

Official Title
-----------------
Popliteal Artery Trial of Patients Undergoing Treatment With Balloon Angioplasty vs. the Adaptive SUPERA VERITAS Peripheral Stent System

Conditions
-----------------
Peripheral Vascular Disease

Intervention / Treatment
-----------------
* Device: IDEV SUPERA Stent
* Device: Percutaneous Transluminal Angioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has lifestyle limiting claudication or rest pain or at least a single de novo or restenotic popliteal artery lesion. Exclusion Criteria: Intervention distal to the target lesion is required at the time of the index procedure or within 30 days after the index procedure.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDEV SUPERA Stent<br>Following PTA of the target lesion, the SUPERA stent will be delivered to the treated segment. | Device: IDEV SUPERA Stent<br> <br> |
| Active Comparator: Percutaneous Transluminal Angioplasty<br>The target lesion will be treated by PTA alone. | Device: Percutaneous Transluminal Angioplasty<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency | Primary efficacy will be target lesion primary patency at 12 months. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAE-free survival rate. | Major Adverse Event-free survival rate that is non-inferior to that of PTA at 12 months. | 12 months |
MiRNAs Evaluate the Prognosis of Sepsis

Study Overview
=================
Brief Summary
-----------------
Sepsis is a common cause of death in intensive care unit, timely and accurate diagnosis and treatment directly affect the survival rate. MiRNA is a post-transcriptional small RNA which regulate mRNA expression. The present study was designed to screen several miRNA by microarray which evaluate the sepsis prognosis in order to be a new target for the treatment of sepsis.

Detailed Description
-----------------
The study is a non-intervention, prospective observational study. Purpose of this sudy is to screening several miRNAs by microarray which can evaluate the prognosis of sepsis . We will collect serum samples from patients with sepsis in SICU, RICU and EICU of 301 Hospital since September 2009 , and then use the chip and qRT-PCR to Screen miRNAs which can evaluate the prognosis of sepsis, and statistical analysis the miRNAS expression correlation with SOFA score.

Official Title
-----------------
miRNA in the Evaluation of the Value of Sepsis Prognosis Prospective Observational Study

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of sepsis Patients who agree with the study Exclusion Criteria: Aged <18 years; Into the group who died within 24 hours; Agranulocytosis (<0.5 × 109 / L); Combined HIV infection.

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 |
| --- | --- |
| Survival Group<br> | |
| Death group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | 28days after admited in ICU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, miRNA