linjc16/ctgov huggingface dataset:
Glucose-insulin-potassium Therapy Improves Lactic Acidosis in Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Lactic acidosis is a common phenomenon occurring during orthotopic liver transplantation (OLT), especially during the anhepatic and early postreperfusion phases. However, little drugs effectively decrease the degree of lactic acidosis when it happens. The aim of this study is to explore whether glucose-Insulin-Potassium(GIK) infusion can relieve metabolic acidosis and improve perioperative outcome in patients undergoing OLT.

Detailed Description
-----------------
Intraoperative metabolic acidosis begins soon after graft reperfusion and persists for several days. The current standard treatment for severe acidosis during OLT is NaHCO3, although it may compromise myocardial performance, exacerbate lactic acid accumulation and cause central nervous system demyelination. Surgical procedure is a primary source of endogenous lactic acid production, especially visceral ischemia originating from anhepatic stage. The present study thus hypothesized that GIK solution may improve metabolic acidosis in OLT patients through its unique effects of metabolic alleviation. Patients for orthotopic liver transplantation was enrolled and received either GIK or placebo. GIK or placebo infusion started after anesthesia induction. Intraoperative measures were mean arterial pressure, HR, arterial blood gases, lactate, glucose, Na, liver and renal function indexes. Outcome measures were time to tracheal extubation, intensive care unit, length of stay, complications, hospital length of stay, requirement for postoperative plasma transfusion, retransplantation, and perioperative mortality.

Official Title
-----------------
Glucose-insulin-potassium Therapy Improves Lactic Acidosis in Liver Transplantation

Conditions
-----------------
Liver Transplantation

Intervention / Treatment
-----------------
* Other: saline
* Other: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who were to undergo OLT Exclusion Criteria: diabetes mellitus, hyperkalemia on arrival (K+ > 5.5 mEq/L) and the inability to give informed consent
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 |
| --- | --- |
| Placebo Comparator: control group<br>saline | Other: saline<br>* saline<br>|
| Experimental: GIK group<br>glucose-Insulin-Potassium(GIK) infusion | Other: Insulin<br> <br> * Other names: glucose-Insulin-Potassium(GIK) infusion;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of lactic acidosis | Blood samples for arterial blood pH, PCO2 , PO2 , base excess, hematocrit, and plasma concentrations of lactic acid and Na were analyzed | up to 1 weeks |
Short or Long Schemes of Antibiotic Prophylaxis for Prostate Biopsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether long antibiotic prophylactic is more effective than a short traitement in infective complications for prostate biopsy

Detailed Description
-----------------
Prophylactic antibiotic is used to minimize the infective complications risk following transrectal biopsy of the prostate. The majority of works points to the need of antibiotic prophylaxis previously to transrectal prostate biopsy. However, there is a lot of controversy and diversity of therapeutic schemes in the literature concerning the ideal drug to be used and the time employed for infectious prophylaxis. The objective of this randomised study was to assess 2 different schemes of antimicrobial prophylaxis, aiming to determine the difference in infective complications with a single dose of ciprofloxacin 2 hours before the procedure vs. ciprofloxacin for 3 days

Official Title
-----------------
Comparison Between Short and Long Schemes of Antibiotic Prophylaxis for Transrectal Prostate Biopsy. A Multicentre Prospective Randomised Study

Conditions
-----------------
Men Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion.

Intervention / Treatment
-----------------
* Drug: Ciprofloxacine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: abnormal digital rectal examination abnormal PSA values To be excluded those patients with: ciprofloxacine contraindication indwelling urethral catheter, positive urine culture, presence of cardiac valve prosthesis, uncontrolled diabetes mellitus, use of antimicrobials in the 7 days prior to biopsy. Urinary endoscopic procedure in the 7 days prior to biopsy coagulation defect Renal insufficiency Hepatic insufficiency

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

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

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: Ciprofloxacine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteriuria five days after prostate biopsy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Clinically diagnosed infectious complications |  |  | 
| - Other complications related to the procedure |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate,, Infection,, Biopsy,, Antibiotic,, Prophylaxis
Expanded Access to Everolimus, for an Individual Patient With Uterine Sarcoma (CTMS#18-0020)

Study Overview
=================
Brief Summary
-----------------
Single patient treatment with everolimus.

Official Title
-----------------
Expanded Access to Everolimus, for an Individual Patient With Uterine Sarcoma (CTMS#18-0020)

Conditions
-----------------
Uterine Sarcoma

Intervention / Treatment
-----------------
* Drug: Everolimus


Participation Criteria
=================

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Everolimus|mTOR inhibitor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Propofol Versus Midazolam and Fentanyl for Diagnostic and Screening Colonoscopy in Patients With Advanced Liver Disease

Study Overview
=================
Brief Summary
-----------------
Prospective, randomized-controlled trial (RCT) comparing the use of Propofol and traditional sedation (Midazolam and Fentanyl) for diagnostic and screening endoscopies in patients with liver diseases. The investigators' working hypothesis is that the use of propofol will be translated in a shorter recovery and discharge times with a higher patient satisfaction and a decrease in general complications in the context of patients with advanced liver disease.

Official Title
-----------------
Propofol Versus Midazolam and Fentanyl for Diagnostic and Screening Colonoscopy in Patients With Advanced Liver Disease

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

Intervention / Treatment
-----------------
* Drug: Propofol VS. midazolam and fentanyl, endoscopies, liver diseases


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients older than 18 and younger than 75 years with advanced liver disease, defined by the presence of liver fibrosis at least F3 and higher in the METAVIR score or with established cirrhosis (Child Pugh A, B and C) Exclusion Criteria: Patients with significant cardiorespiratory disease i.e. advanced respiratory, renal and heart failure (ASA class III or higher except for patients with decompensate liver cirrhosis), obstructive sleep apnea or those with mild degree of liver fibrosis (less than F3)

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol, endoscopies, liver diseases<br>Propofol, endoscopies, liver diseases | Drug: Propofol VS. midazolam and fentanyl, endoscopies, liver diseases<br>* Intervention group (Propofol): It will be administered as a monotherapy under direct gastroenterologists' Control group (Midazolam with or without Fentanyl): Both drugs will be administered by the gastroenterologists<br>|
| Active Comparator: midazolam and fentanyl, endoscopies, liver diseases<br>Control: midazolam and fentanyl, endoscopies, liver diseases | Drug: Propofol VS. midazolam and fentanyl, endoscopies, liver diseases<br>* Intervention group (Propofol): It will be administered as a monotherapy under direct gastroenterologists' Control group (Midazolam with or without Fentanyl): Both drugs will be administered by the gastroenterologists<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy of propofol in liver diseases |  | At the end of each endoscopy |
Structural and Functional Left Ventricular Remodelling in Patients With Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in left ventricular function and structure after 06 months of continuous positive airway pressure treatment.

Detailed Description
-----------------
Several studies have been suggesting that Obstructive Sleep Apnea contributes to deterioration of left ventricular diastolic function. It may be associated to increased risk of cardiovascular events. We hypothesized that morphological and functional left ventricular changes might be reverted after treatment with Continuous positive airway pressure.

Official Title
-----------------
Structural and Functional Left Ventricular Remodelling in Patients With Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: CPAP (continuous positive airway pressure)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Apnea-hypopnea index higher than 5 events per hour Exclusion Criteria: Body mass index higher than 40 kg/m2

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham CPAP<br>Patients submitted to SHAM CPAP use for 06 months | Device: CPAP (continuous positive airway pressure)<br>* Patients treated by CPAP for 06 months<br>|
| Active Comparator: CPAP<br>OSA patients submitted to 06 months of CPAP treatment | Device: CPAP (continuous positive airway pressure)<br>* Patients treated by CPAP for 06 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of left ventricular diastolic echo variable |  | 06 months |
Metabolic Capacity of Israeli Populations

Study Overview
=================
Brief Summary
-----------------
The ability to metabolize drugs varies greatly among individuals. Major fraction of this variability lies in genetic polymorphisms of genes encoding for enzymes responsible for both phase I and phase II reactions. The purpose of this study ws to evaluate the phenotypic activity and the frequency of genetic polymorphisms in different phase II and phase I enzymes among various populations residing in Israel.

Official Title
-----------------
Phenotypic and Genotypic Evaluation of Cytochrome P450 Isoforms in Populations of Different Ethnic Composition

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Debrisoquine
* Drug: Mephenytoin
* Drug: Dapsone
* Drug: Caffeine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range 20-50 Absence of significant disease state Exclusion Criteria: The presence of significant disease states The regular use of drugs (including birth control pills)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cocktail<br> | Drug: Debrisoquine<br> <br> Drug: Mephenytoin<br> <br> Drug: Dapsone<br> <br> Drug: Caffeine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phenotypic measurements of various P450 and non-P450 enzymes involved in drug metabolism. |  | 24 hours | 
| Frequency of genetic polymorphisms in these enzymes among different Israeli populations. |  | 24 hours |
Zink and Bone Strength

Study Overview
=================
Brief Summary
-----------------
Zink and bone strength

Detailed Description
-----------------
blood- and urine samples collected from 20 OA patients and 20 osteoporosis patients who all had a hip-replacement. All patients were evaluated by DEXA-scanning.

Official Title
-----------------
Zink and Bone Strength

Conditions
-----------------
Coxarthrosis, Fracture of Femoral Neck

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women with osteoarthrosis or femoral neck-fracture i one hip Exclusion Criteria: pathology or prosthesis in contralateral hip

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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 |
| --- | --- | --- |
Five Year Follow-up of Internet-based Cognitive Behaviour Therapy (CBT) for Social Anxiety Disorder (SAD)

Study Overview
=================
Brief Summary
-----------------
Social anxiety disorder (SAD) is one of the most prevalent anxiety disorders in the western world. Cognitive behavioural therapy (CBT) is the psychological treatment that has the largest empirical support. However, the availability to CBT is very limited in Sweden due to lack of therapists with proper training. Therefore it is important to evaluate alternative forms of treatment that are more time efficient. One of these methods is Internet based self-help therapy, which has proven to be an effective treatment for social anxiety disorder. In this study, the investigators aim to conduct a follow-up assessment five years after completed Internet-based CBT. Participants received treatment within the context of a randomised controlled trial conducted in 2005. Thus, in the present study there will be no treatment interventions, only assessment.

Official Title
-----------------
Five Year Follow-up of Internet-based Cognitive Behaviour Therapy for Social Anxiety Disorder

Conditions
-----------------
Social Anxiety Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have a primary diagnosis of social phobia Exclusion Criteria: Substance abuse during the last 6 months Other dominating diagnosis (not phobic personality disorder) A history of bipolar disorder or psychosis Major depression according to DSM-IV and >20 on madrs-s Risk of suicide Start of medication or change of dosis during the last 2 months Other parallel psychological treatment Previous CBT (last 3 years) for social phobia

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 |
| --- | --- |
| Internet-based CBT<br>All participants in this cohort received Internet-based CBT for social anxiety disorder in 2005. All participants were Swedish adults with a DSM-IV diagnosis of social anxiety disorder. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of social anxiety and avoidance - Liebowitz Social Anxiety Scale (LSAS) |  | 5-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of social anxiety in interaction and performance situations - SIAS & SPS |  | 5-year follow-up | 
| Measure of depressive symptoms - MADRS-S |  | 5-year follow-up | 
| Measure of general anxiety - BAI |  | 5-year follow-up | 
| Measure of quality of life - QOLI |  | 5-year follow-up | 
| Measure of social anxiety disorder diagnosis - SPSQ |  | 5-year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognitive behaviour therapy
Acute and Cronic Evaluation of AV/PV and VV Delay IEGM Based Optimisation Algorithm-QuickSept Study

Study Overview
=================
Brief Summary
-----------------
AtrioVentricular (AV) and InterVentricular (VV) delay optimization can improve ventricular function in Cardiac Resynchronization Therapy (CRT) and is usually performed by means of echocardiography. St Jude Medical has developed an automated algorhythm which calculates the optimal AV and VV delays (QuickOptTM) based on Intracardiac ElectroGrams, (IEGM), within 2 minutes. So far, the efficacy of the algorhythm has been tested acutely with standard lead position at right ventricular (RV) apex. Aim of this project is to evaluate the algorhythm performance in the mid- and long-term with RV lead located in mid-septum.

Detailed Description
-----------------
Primary end-point was to evaluate the relationship between the series of aortic flow Velocity Time Integral (aVTI) values calculated by the two methods at the PV, AV, and VV interval settings recommended by both the QuickOptTM and the standard ECHO optimization in CRT-D patients, at three index times: pre-discharge, at 6-month and at 12-month follow-ups. Secondary end-point was to define the correlation between the optimal AV, PV and VV intervals defined by ECHO, using aVTI measurements and by the QuickOptTM algorithm, IEGM-based.

Official Title
-----------------
Acute and Cronic Evaluation of AV/PV and VV Delay IEGM Based Optimisation Algorithm (QuickOpt™) Compared With Echocardiographic Method for Cardiac Resincronization Therapy in CRT Implants With Right Interventricular Basal-Mid Septum Placement of Leads (QuickSept Study)

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Optimization CRT-D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with CRT-D stable and safe placement of an active-fixation RV lead on mid-interventricular septum; achievement of an efficacious LV intravenous pacing from a Coronary Sinus (CS) branch. Exclusion Criteria: AF Patients without spontaneous rhythm

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 |
| --- |
|Device: Optimization CRT-D|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between QuickOptTM and standard ECHO optimization | The primary endpoint was assessed by means the linear correlation analysis by the Pearson product-moment correlation coefficient to assess the agreement between the ECHO-based and the IEGM-based aVTIs for each of the AV/PV, and VV delay determinations | 12-month |
Cardiovascular Responses in Congestive Heart Failure With Cheyne- Stokes Respiration

Study Overview
=================
Brief Summary
-----------------
The purpose of the trial is to investigate the cardiovascular response to peripheral chemoreceptor stimulation in Congestive Heart Failure with Cheyne- Stokes Respiration

Official Title
-----------------
Cardiovascular Response to Peripheral Chemoreceptor Stimulation in Congestive Heart Failure With Cheyne- Stokes Respiration

Conditions
-----------------
Heart Failure, Congestive, Cheyne-Stokes Respiration

Intervention / Treatment
-----------------
* Procedure: Experimental lung function test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe heart failure (NYHA Class II or above) on optimal medical therapy LVEF less than or equal to 45% Stable condition as defined as no hospital admission or changes to medical therapy within two weeks prior to enrolment Exclusion Criteria: Patients taking known respiratory stimulants or depressants Clinically significant asthma requiring therapy Significant parenchymal lung disease Primary pulmonary hypertension Myocardial infarction within three months prior to enrolment Patients with cardiac resynchronisation devices and permanent pacemakers Anaemic (haemoglobin < 12g/dL)

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Procedure: Experimental lung function test<br>* Administration of several CO2 gas mixtures<br>|
| Active Comparator: 2<br> | Procedure: Experimental lung function test<br>* Administration of several CO2 gas mixtures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular parameters such as continuous blood pressure and heart rate. |  | During administration of the intervention |