linjc16/ctgov huggingface dataset:
Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency

Study Overview
=================
Brief Summary
-----------------
This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular filtration rate (GFR) < 30 mL/min) for a period of 24 weeks.

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Active-controlled Clinical Trial to Evaluate the Safety and Tolerability of 24 Weeks Treatment With Vildagliptin (50 mg qd) Versus Sitagliptin (25 mg qd) in Patients With Type 2 Diabetes and Severe Renal Insufficiency

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: vildagliptin
* Drug: Sitagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria History T2 DM Severe Renal Impairment Exclusion criteria Glucose ≥ 270 mg/dL (≥15 mmol/L) Patients undergoing any method of dialysis Treatment with therapy other than sulfonylureas, TZDs ,insulin, and metiglinides

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin<br> | Drug: vildagliptin<br> <br> |
| Active Comparator: Sitagliptin<br> | Drug: Sitagliptin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability in patients with T2DM and severe renal insufficiency over 24 weeks of treatment |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between renal function and concentration levels of vildagliptin and its metabolites after repeated doses of vildagliptin in patients with T2DM and severe renal insufficiency. |  | 24 weekd | 
| Efficacy of vildagliptin versus sitagliptin in patients with T2DM and severe renal insufficiency by assessing the hemoglobin A1c (HbA1c ) and fasting plasma glucose (FPG) reduction from baseline |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, vildagliptin
Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of the Low Profile Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of wide-necked intracranial aneurysms with coils.

Official Title
-----------------
Pivotal Study of the Microvention, Inc Neurovascular Self-Expanding Retrievable Stent System LVIS

Conditions
-----------------
Intracranial Aneurysms

Intervention / Treatment
-----------------
* Device: LVIS™ and LVIS™ Jr


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject age between 18 and 75 years Subject with an unruptured or ruptured(>30days since occurence), wide-necked (neck ≥4mm or dome to neck ratio <2)intracranial saccular aneurysm (<20mm maximum diameter in any plane) Exclusion Criteria: Subject with significant extra or intracranial stenosis of the parent artery (>50%) proximal to the target aneurysm. Subject with any condition which in the opinion of the treating physician would place the subject at high risk of embolic stroke Subject with contraindications to the use of antiplatelet agents Subject who is unable to complete the required follow-up

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

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Low Profile Visualized Intraluminal Support device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Device: LVIS<br>The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms. Device: LVIS™ and LVIS™ Jr. MicroVention Low-profile Visualized Intraluminal Support Device | Device: LVIS™ and LVIS™ Jr<br>* The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.<br>* Other names: Low Profile Visualized Intraluminal Support device;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Composite Success Number of Participants With Primary Effectiveness Composite Success (100% Aneurysm Occlusion Without Clinically Significant In-stent Stenosis or Target Aneurysm Retreatment |  | 12 months | 
| Primary Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intracranial, saccular, aneurysms, stenting, coiling
Population Pharmacokinetics of Imatinib in CML Patients in Iran

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine population Pharmacokinetics and differences and variation of pharmacokinetics parameters of Imatinib as a tyrosine kinase inhibitor in treatment of chronic myeloid leukemia patients in Iranian population.

Detailed Description
-----------------
patients with chronic myeloid leukemia who receive Imatinib as treatment in Iran entered in this study then population pharmacokinetics parameters is determined.

Official Title
-----------------
Population Pharmacokinetics of Imatinib in CML Patients in Iran

Conditions
-----------------
Chronic Myelogenous Leukemia

Intervention / Treatment
-----------------
* Drug: Imatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient in chronic phase of myeloid leukemia no liver and renal failure Exclusion Criteria: multiple dug treatment previous treatment of interferon patients in blast or accelerated phase

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Imatinib, CML<br>Patients with chronic myeloid leukemia who receive Imatinib as treatment in Iran entered in this study | Drug: Imatinib<br>* Patients with chronic myeloid leukemia who receive Imatinib as treatment<br>* Other names: Glivec;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of changes of AUC, trough Concentration from predicted values | The influence of patients' characteristic on the pharmacokinetics of Imatinib will be assessd. | Blood sampling are collected on atleast the 30th day of treatment at the following time: 1 hour before the dose and 1 hour after the dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cml
Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with pancreaticoduodenectomy.

Detailed Description
-----------------
The investigators reported that preoperative immunonutrition improve the incidence of postoperative infectious complication in patients after pancreaticoduodenectomy, and modulation of Th1/Th2 differentiation may play important roles in this effect. Object of this study is to investigate the effects preoperative immunonutrition on incidence of postoperative infectious complication, and Th1/Th2 balance after pancreaticoduodenectomy.

Official Title
-----------------
Effects of Preoperative Immunonutrition on Infectious Complication and Th1/Th2 Differentiation in Patients Undergoing Pancreaticoduodenectomy

Conditions
-----------------
Pancreatic Cancer, Bile Duct Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: Oral IMPACT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients underwent pancreaticoduodenectomy Exclusion Criteria: age younger than 18 years ongoing infection gastrointestinal obstruction respiratory dysfunction cardiac dysfunction hepatic dysfunction renal failure history of recent immunosuppressive or immunological diseases preoperative evidence of widespread metastatic disease

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>preoperative immunonutrition | Dietary Supplement: Oral IMPACT<br>* oral supplementation for 5 days (1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA<br>* Other names: Oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan;|
| No Intervention: Group B<br>ordinary diet | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Infectious Complication |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma IL-6, CRP, Th1/Th2 Balance |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immunonutrition, pancreaticoduodenectomy, Th1, Th2
Database Maintenance for Bariatric Procedures

Study Overview
=================
Brief Summary
-----------------
Bariatric surgery registry for quality control and investigational purposes.

Official Title
-----------------
Institutional Bariatric Database Registry

Conditions
-----------------
Obesity, Morbid, Bariatric Surgery Candidate

Intervention / Treatment
-----------------
* Procedure: bariatric surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: morbid obesity Exclusion Criteria: unfit for surgery
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: bariatric surgery|All bariatric procedures|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery type | Sleeve gastrectomy or Roux-Y gastric bypass (RYGBP) or Single anastomosis gastric bypass (SAGB) or biliopancreatic diversion (BPD/DS) or single anastomosis duodeno-ilial bypass (SADI) | 10 years | 
| Percent total weight loss (%TWL) | [(Weight at time of surgery - Weight at time point)/Weight at time of surgery]X100 | 1 year from surgery | 
| Percent total weight loss (%TWL) | [(Weight at time of surgery - Weight at time point)/Weight at time of surgery]X100 | 5 years from surgery | 
| Percent total weight loss (%TWL) | [(Weight at time of surgery - Weight at time point)/Weight at time of surgery]X100 | 10 years from surgery | 
| Percent BMI loss (%BMIL) | [BMI at time of surgery - BMI at time point)/BMI at time of surgery] X 100 | 1 year from surgery | 
| Percent BMI loss (%BMIL) | [BMI at time of surgery - BMI at time point)/BMI at time of surgery] X 100 | 5 years from surgery | 
| Percent BMI loss (%BMIL) | [BMI at time of surgery - BMI at time point)/BMI at time of surgery] X 100 | 10 years from surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Co-morbidity resolution | Cessation of medication/s used to treat weight-related co-morbidities (i.e. diabetes mellitus type 2, hypertension, dyslipidemia, degenerative joint disease etc.) | 1 year from surgery | 
| Co-morbidity resolution | Cessation of medication/s used to treat weight-related co-morbidities (i.e. diabetes mellitus type 2, hypertension, dyslipidemia, degenerative joint disease etc.) | 5 years from surgery | 
| Co-morbidity resolution | Cessation of medication/s used to treat weight-related co-morbidities (i.e. diabetes mellitus type 2, hypertension, dyslipidemia, degenerative joint disease etc.) | 10 years from surgery | 
| 30 day morbidity/mortality | 30 day morbidity/mortality according to Clavien Dindo criteria | up to 30 days from intervention | 
| long-term morbidity/mortality | morbidity/mortality according to Clavien Dindo criteria after 30 days | 31 days to 10 years from surgery |
Sucralose, Stevia, Gut Microbiome and Glucose Metabolism

Study Overview
=================
Brief Summary
-----------------
This study will determine the influence of two non-caloric sweeteners on glucose metabolism via the gut microbiome in adult men and women.

Detailed Description
-----------------
This study will determine the influence of two non-caloric sweeteners on glucose metabolism via the gut microbiome in adult men and women aged 35-55 years.

Official Title
-----------------
Sucralose, Stevia, Gut Microbiome and Glucose Metabolism

Conditions
-----------------
Impaired Glucose Tolerance

Intervention / Treatment
-----------------
* Other: Sucralose
* Other: Stevia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally health adult men and women aged 35-55 years old - Exclusion Criteria:Adults will not be eligible who have chronic disease (cancer, CHD, diabetes, chronic kidney disease); pregnant or breast feeding; menopausal; has a history of bariatric surgery; taking prednisone/steroids, taking medication for PCOS, or take medications that influence blood glucose. -

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sucralose<br>Participants will be asked to consume 180 mg/day of sucralose (in the form of capsules which is equivalent to three 12-oz cans of diet soda) for 14 days. According to the FDA, a 150 lb. person may consume up to 340 mg/day of sucralose (or 5.5 12-oz cans of sucralose-sweetened diet soda). | Other: Sucralose<br>* Sweetner<br>|
| Active Comparator: Stevia<br>Participants will be asked to consume 180 mg/day of stevia (in the form of capsules which is equivalent to three 12-oz cans of diet soda) for 14 days. According to the FDA, a 150 lb. person may consume up to 800 mg/day of stevia (or about 12 cans of stevia-sweetened diet soda). | Other: Stevia<br>* Sweetner<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-hour glucose | An oral glucose tolerance test will be administered before and after consuming assigned sweetener to determine change in 2-hour glucose | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiome | Gut microbiota will be measured before and after consuming assigned sweetener to determine change in gut microbiota. | 14 days |
Non-invasive Assessment of Intraocular Pressure in MPS by Use of the Ocular Response Analyzer.

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to compare intraocular pressure (IOP) values assessed with Ocular Response Analyzer to the classical gold standard of IOP measurement, to Goldmann applanation tonometry by mucopolysacchyridosis-, Fabry-patients and healthy controls. We want to investigate biomechanical characteristics of the cornea and their influence on the IOP-measurements.

Official Title
-----------------
Corneal-Compensated Intraocular Pressure, Corneal Hysteresis and Corneal Resistance Factor Measurements Performed With the Ocular Response Analyzer and Their Correlation to Conventional Goldmann Applanation Tonometry.

Conditions
-----------------
Mucopolysaccharidosis, Fabry Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MPS I, II, IV, VI patients with at least grade 3 of corneal clouding (Couprie et al.) Fabry patients with cornea verticillata > grade 1 Age ≥ 12 years Patient is able to comply with the study procedure Patient has consented to be in the trial Ability to fixate a target Exclusion Criteria: History of corneal transplantation or refractive surgery Corneal pathologies other than MPS-associated corneal opacity Corneal, conjunctival or intraocular inflammation

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| mucopolysaccharidosis<br>mucopolysaccharidosis | |
| Fabry disease<br>Fabry disease | |
| healthy controls<br>healthy controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| agreement between ccIOP and GAT in MPS, Fabry and healthy controls | Evaluation of agreement between ccIOP and GAT in MPS, Fabry and healthy controls | Sep 2013 (anticipated) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mucopolysaccharidosis, Fabry disease
Multi Point Pacing vs. Conventional STUDY PROTOCOL

Study Overview
=================
Brief Summary
-----------------
The Purpose of this study is to compare two programming modalities for CRT devices in Heart Failure patients with an indication for Cardiac Resynchronization Therapy

Official Title
-----------------
Observational, Multicentre, Investigator and Patient Blinded, Prospective, Randomized Comparator Study of Cardiac Resynchronization Therapy (CRT) Multi Point Pacing (MPP) Compared to Conventional CRT Pacing Response in Heart Failure Patients.

Conditions
-----------------
Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization Therapy

Intervention / Treatment
-----------------
* Device: conventional CRT
* Device: MPP CRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with indication for CRT (-P or -D) as per ESC guidelines. Ability to provide written informed consent. Optimal Medical Therapy for at least 3 months Exclusion Criteria: < 18 years and younger Pregnant or breastfeeding patients Non-LBBB patients (RBBB, intra-ventricular delay) Non-ambulatory NYHA class IV effort tolerance Myocardial infarction within 40 days before enrolment Cardiac surgery or revascularization procedure within 3 months before enrolment, or scheduled in the following 6 months Atrial Fibrillation (AF) patients unless AV node ablation is performed, or complete AV block is present (to ensure optimal CRT delivery) Patients with life expectancy of less than 12 months due to other medical conditions Patients who are involved in another investigational study (device or medical)

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: conventional CRT<br> | Device: conventional CRT<br>* Conventional CRT or biventricular pacing resynchronizes left ventricular contraction by pacing the right and left ventricles (LV) simultaneously<br>|
| Experimental: MPP CRT<br> | Device: MPP CRT<br>* CRT with Multipoint pacing (MPP) where pacing can occur from more than one LV site simultaneously<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome 1 | To evaluate the clinical improvement of CRT MPP as compared to conventional CRT in Heart Failure patients with indication for CRT using automated intra-cardiac EGMs analysis (QuickOpt™) for device optimization, in a large multicentre international study. | 12 months |