linjc16/ctgov huggingface dataset:
Intensive Insulin Therapy and Acute Kidney Injury. Analysis Using RIFLE Criteria.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if intensive insulin therapy really reduces the incidence of acute kidney injury in critically ill patients, using for analysis the RIFLE criteria for definition of AKI.

Official Title
-----------------
INTENSIVE INSULIN THERAPY REALLY REDUCES THE INCIDENCE OF ACUTE KIDNEY INJURY IN CRITICALLY ILL PATIENTS? An Analysis Using the RIFLE Criteria for Definition of Acute Kidney Injury.

Conditions
-----------------
Kidney, Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: We included 337 adult patients, non pregnant, admitted from July 1, 2004 to December 31, 2006, to a 20-bed multidisciplinary ICU of a general hospital and to an 11-bed trauma center ICU that had at least two blood glucose levels above 150 mg/dl from three measurements obtained in the first 12 hours after admission. Exclusion Criteria: pregnant patients

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 |
| --- | --- |
| 1<br> | |
| 2<br> | |
| Group 1<br>Group 1 (Carbohydrate Restrictive Strategy). Patients received intravenous hydration with a glucose free solution (Ringer III) and enteral nutritional formula containing 33.3% carbohydrates, 16,7% proteins and 50% lipids (Glucerna, Abbott Laboratories). These patients received regular insulin subcutaneously four times daily, aiming to maintain blood glucose levels at least below 180 mg/dl, and, in stable patients, ideally below 150 mg/dl. | |
| Group 2<br>Group 2 (Intensive Insulin Therapy). Continuous intravenous insulin infusion was adjusted to maintain glycemic levels at least below 150 mg/dl, and, in stable patients and ideally, between 80 to 120 mg/dl. Patients were submitted to capillary glycemic measurements every 2 hours. The insulin dose was adjusted according to an algorithm run by nurses and overseen by physicians. These patients received glucosaline (5% glucose + 0.9 NaCl) hydration and enteral nutrition with a formula containing 45% carbohydrates, 17% proteins and 38% lipids (Diason, Nutricia Clinical Care Ltd). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the renal function outcome, defined by the RIFLE criteria in patients submitted to two different regimens of glycemic control: a carbohydrate restrictive strategy and intensive insulin therapy. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intensive insulin therapy, Carbohydrate restrictive strategy, RIFLE Criteria, Acute Kidney Injury, Critically ill patients, Acute
Best Cardiac Output During Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the patients cardiac output measured before cardiopulmonary bypass (CPB), is more sufficient to secure the patients oxygen needs than the estimated cardiac output from Ficks principle, and thereby prevent organ failure.

Detailed Description
-----------------
For more than 50 years, CPB has been used to mechanically support the functions of the heart and lungs. In early studies, systemic oxygen uptake, calculated using Ficks global principle, was used to assess the efficiency of CPB. Using this measure of efficiency, a pump flow rate in liters per minute, based on the product of the body surface area (BSA) and a constant of 2.4 was found adequate to perfuse the body during normothermia. Ficks global principle is still used together with other methods to secure adequated perfusion under CPB. The purpose of this study is to determine whether the patients cardiac output measured before CPB, is more sufficient to secure the patients oxygen needs than the estimated cardiac output from Ficks principle, and thereby prevent organ failure. The hypothesis is that the patients cardiac output is a better marker for the optimal cardiac output than the estimated cardiac output.

Official Title
-----------------
Best Cardiac Output During Cardiopulmonary Bypass

Conditions
-----------------
Bypass Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients admitted for scheduled cardiac surgery during cardiopulmonary bypass Aged 18-90 years LVEF > 50 % written consent from the patients Exclusion Criteria: Former cerebral emboli Former head trauma known stenosis of the arteria carotis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| cardiac output<br>Adult patients undergoing cardiac surgery with normothermic cardiopulmonary bypass | |

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
-----------------
cardiopulmonary bypass, cardiac output, flow rate, lactate
Daclizumab Experience in Pediatric Heart Transplant

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the outcomes of those who have received Daclizumab as part of their immuno-suppression protocol following heart transplantation. Literature suggests that the time to first rejection episode can be avoided or delayed by using induction therapy.

Detailed Description
-----------------
In August 2005 the heart transplant team at Children's Healthcare of Atlanta began a protocol of Daclizumab 1mg/kg IV every two weeks for 5 doses; 1st dose to be received in the operating room following discontinuation of cardiopulmonary bypass. Since one year has passed following initiation of this practice, it is necessary to review this immuno-suppression strategy and determine if, in fact, there was clinical benefit of reducing rejection without increasing the vulnerabilities of the immuno-compromised host. We wish to review all heart transplant recipient records between August 1, 2004 and October 15, 2006. Historically, Children's has done approximately 10 transplants per year; therefore, we will review approximately 15 charts at Children's Healthcare of Atlanta and Sibley Heart Center Cardiology.

Official Title
-----------------
A Retrospective Review of Daclizumab Experience in Pediatric Heart Transplant

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Status post heart transplant Age 0-21 years Received Daclizumab as induction therapy Exclusion Criteria: Those who do not meet inclusion criteria

Ages Eligible for Study
-----------------
Maximum Age: 21 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
-----------------
Daclizumab, Immuno-suppression protocol, Heart Transplant, Rejection
A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia

Study Overview
=================
Brief Summary
-----------------
Subjects from the AG-CLI-0206 phase 3 study that received AMG0001 will be eligible for the AG-CLI-0206-LTFU study

Detailed Description
-----------------
The study is designed to assess the long term safety of subjects who have been treated in the phase 3 study with AMG0001. A health questionnaire will be used to collect specific information from the subject every 6 months. Only those subjects that were randomized in the AG-CLI-0206 study and who received AMG0001 are eligible to participate in this long term follow-up study. Subjects that received placebo will not be eligible for participation in this study.

Official Title
-----------------
A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia

Conditions
-----------------
Critical Limb Ischemia

Intervention / Treatment
-----------------
* Biological: Subjects from Study AG-CLI-0206 who received AMG0001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have been treated with AMG0001 in the AG-CLI-0206 study. Subjects who have provided consent for this long term follow-up study either directly or through a legally authorized representative. Subjects who have provided a release of information to the sponsor. Exclusion Criteria: Subjects who were not enrolled in the AGCLI-0206 study. Subjects who enrolled in AG-CLI-0206 and who were not treated with AMG0001. Subjects who have not provided consent to this long term follow-up study either directly or through a legally authorized representative. Subjects who have not provided a release of information for the Sponsor to contact them directly via phone, email and/or mail.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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 |
| --- | --- |
| Subjects who received AMG0001<br>Subjects from Study AG-CLI-0206 who received the study product AMG0001 | Biological: Subjects from Study AG-CLI-0206 who received AMG0001<br>* Subjects from Study AG-CLI-0206 who received the study product AMG0001<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the long term safety of subjects from the AG-CLI-0206 study who have been treated with AMG0001 | A health questionnaire will be used to collect specific information from the subject every 6 months | 3 years from the date last subject randomized into AG-CLI-0206 study |
Double-Blind Trial of Miglitol in Type 2 Diabetic Patients Treated With Biguanide

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the clinical efficacy and safety of Miglitol in patients with Type2 Diabetes Mellitus treated with Biguanide.

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

Intervention / Treatment
-----------------
* Drug: Miglitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic patients treated with Biguanide Criteria for postprandial plasma glucose and HbA1c are met Exclusion Criteria: Type 1 diabetes Patients treated with other antidiabetic drugs or Insulin

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 69 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: Miglitol|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
-----------------
alpa-glucosidase inhibitor,Biguanide
Comparison of Insulin Detemir Plus Insulin Aspart With Insulin NPH Plus Human Soluble Insulin in Subjects With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.

Official Title
-----------------
A Multi-centre, Multinational, Open-labelled, Randomised, Parallel-Group Comparison of Insulin Detemir Plus Insulin Aspart With NPH Insulin Plus Human Soluble Insulin in Subjects With Type 1 Diabetes on a Basal-Bolus Regimen

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: insulin aspart
* Drug: insulin NPH
* Drug: human soluble insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes for at least 12 months Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months BMI below or equal to 35 kg/m^2 HbA1c below or equal to 12% Exclusion Criteria: Proliferative retinopathy or maculopathy requiring acute treatment Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the Investigator) Subjects with known hypoglycaemic unawareness as judged by the Investigator

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: Basal/bolus regimen 1<br> | Drug: insulin detemir<br>* Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily<br>Drug: insulin aspart<br>* Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals<br>|
| Active Comparator: Basal/bolus regimen 2<br> | Drug: insulin NPH<br>* Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily<br>Drug: human soluble insulin<br>* Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycosylated haemoglobin) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-subject variation in home measured blood glucose (3-point blood glucose profiles) |  |  | 
| 8-point blood glucose profiles |  |  | 
| Incidence of self-recorded hypoglycaemic episodes |  |  | 
| Incidence of adverse events |  |  |
Clinical Performance of Self-cured Universal Adhesive for Restoring Cervical Lesions in Geriatric Patients

Study Overview
=================
Brief Summary
-----------------
the study is conducted to evaluate the clinical performance of PALFIQUE universal adhesive (Tokuyama self-cure universal adhesive), Versus 3m ESPE™ single bond Universal Adhesive, for restoring cervical lesions in geriatric patients over one year.

Official Title
-----------------
Clinical Performance of Newly Introduced Self-cured Universal Adhesive for Restoring Cervical Lesions in Geriatric Patients Over One Year (A Randomized Clinical Trial)

Conditions
-----------------
Universal Adhesive

Intervention / Treatment
-----------------
* Other: universal adhesive
* Other: universal adhesive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient had to be in good general health Geriatric patients Have an acceptable oral hygiene level Class V cavities in anterior and posterior teeth Males & females included Anticipated availability for recalls (6 months and 12 months) through the 1-year study period Exclusion Criteria: Lack of written informed consent to participate Poor oral hygiene, Severe bruxism Severe or chronic periodontitis Allergies to components of the materials used Underage patients Non vital pulp

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>PALFIQUE universal adhesive (Tokuyama self-cure universal adhesive) | Other: universal adhesive<br>* PALFIQUE universal adhesive<br>|
| Active Comparator: control<br>3M™ ESPE™ single bond Universal Adhesive | Other: universal adhesive<br>* 3M™ ESPE™ single bond Universal Adhesive<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the Marginal adaptation | modified USPHS criteria, ordinal | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of Retention | binary , modified USPHS criteria | 1 year | 
| Level of Marginal discoloration | ordinal, modified USPHS criteria | 1 year | 
| Rate of Secondary caries | binary , modified USPHS criteria | 1 year | 
| level of Postoperative sensitivity | binary , modified USPHS criteria | 1 year |
New Multiplex Real-time PCR for Genital Ulcer Disease

Study Overview
=================
Brief Summary
-----------------
(i) To compare a new diagnostic PCR with established diagnostic procedures for T. pallidum (serology, dark field microscopy), H. ducreyi (cultivation), HSV types 1 and 2 (cultivation, PCR). (ii) To assess the frequency of infections with T. pallidum, H. ducreyi and HSV types 1 and 2 in patients with genital, anal and oropharyngeal ulcers by a new PCR.

Official Title
-----------------
A Prospective, Open Labeled, Multicenter, Diagnostic Study on the Detection of T. Pallidum, H. Ducreyi and HSV Type 1 and 2 From Genital, Anal and Oropharyngeal Ulcers With a New Multiplex Real-time Polymerase Chain Reaction

Conditions
-----------------
Genital Ulcer Disease (GUD)

Intervention / Treatment
-----------------
* Procedure: Diagnostic swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient with genital, anal or oropharyngeal ulcers Age minimum of 18 years. Informed consent must be obtained from each patient/control patient in written form prior to any study procedure. Exclusion criteria: Antibiotic therapy within 2 weeks before the visit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Diagnostic swab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Observational Study on the Diagnostic Evaluation of the Intestinal Microbiota of Patients With COVID-19.

Study Overview
=================
Brief Summary
-----------------
In the context of the COVID-19 pandemic, the role of the gut microbiome is yet unknown. The aim of this trial is to evaluate the clinical contribution of the gut microbiome composition and diversity on the disease severity and to estimate the viral load in stool samples.

Official Title
-----------------
Observational Study on the Diagnostic Evaluation of the Intestinal Microbiota of French People Infected With the SARS-CoV-2.

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Diagnostic Test: 1test1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 positive patients: hospitalised patients diagnosed with COVID-19 in one of the investigating sites, and able to provide a stool sample. Control subjects: Medical and paramedical personnel working at one of the investigating sites, having been in direct contact with the patients. Aged between 18 and 95 years. Subjects able to read the French-language study information leaflet. Patients with social cover. Exclusion Criteria: COVID-19 negative patients. Patients in critical care, heart failure or respiratory failure. Unable to provide naturally a stool sample. Patients without social cover. Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 patients<br>Hospitalised COVID-19 patients | Diagnostic Test: 1test1<br>* Loss of bacterial diversity diagnosis<br>|
| Controls<br>Exposed medical staff | Diagnostic Test: 1test1<br>* Loss of bacterial diversity diagnosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alpha-diversity | Alpha-diversity of the gut microbiota measured by 16S sequencing | at the time of inclusion in the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 load | SARS-CoV-2 load in stool measured by RT-PCR | at the time of inclusion in the study | 
| Microbiome composition | Genus level of the gut microbiota measured by 16S sequencing | at the time of inclusion in the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microbiome ; SARS-CoV-2 ; metagenomic ; stool