linjc16/ctgov huggingface dataset:
Effect of Procrit (Epoetin Alfa) on Preventing Delayed Graft Function After Deceased Donor Renal Transplantation

Study Overview
=================
Brief Summary
-----------------
Delayed graft function (DGF) is a major complication following deceased donor renal transplantation. The surgical procedure of harvesting a kidney from a cadaveric donor and implanting the kidney into the recipient inevitably causes some amount of injury. While not always clinically significant, anywhere from 10-50% of transplant patients may develop DGF. Ongoing research in animal models has demonstrated benefit with administration of erythropoietin. The investigators propose to study the effect of Procrit(Epoetin Alfa) on delayed graft function in subjects undergoing kidney transplantation.

Official Title
-----------------
Effect of Procrit(Epoetin Alfa) on Preventing Delayed Graft Function After Deceased Donor Renal Transplantation

Conditions
-----------------
Delayed Graft Function

Intervention / Treatment
-----------------
* Drug: Epoetin Alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting for kidney transplantation Age > 18 Deceased donor kidney transplant Exclusion Criteria: History of thrombosis or hypercoagulable state Receiving Coumadin or Heparin Hemoglobin >=14 g/dl Uncontrolled hypertension

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Epoetin Alfa|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Delayed Graft Function |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delayed Graft Function, Kidney Transplantation
Acute Pancreatitis and Acute Fluid Collections

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if percutaneous drainage of sterile fluid collections recurring after initial aspiration in acute pancreatitis yielded better results than their conservative management.

Official Title
-----------------
Randomized Controlled Trial on Sterile Fluid Collections Management in Acute Pancreatitis

Conditions
-----------------
Pancreatitis

Intervention / Treatment
-----------------
* Procedure: Catheter drainage
* Drug: Conservative treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms and signs of acute pancreatitis and if pancreatic or/and peripancreatic fluid collections were confirmed by ultrasound and computed tomography examination Exclusion Criteria: Collections resulting from pancreatic surgery, chronic pancreatitis and encapsulated collections and collections with uncertainty about the relationship between the collections and clinical symptoms and signs of acute pancreatitis were excluded.
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: drainage<br> | Procedure: Catheter drainage<br> <br> |
| Active Comparator: 2<br>Conservative treatment | Drug: Conservative treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion to more aggressive procedure |  | Sep 2007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients turning culture positive, length of hospital stay, catheter dwell time, catheter problems and changes per patient |  | Oct 2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Conversion to more aggressive treatment of recurrent fluid collection
Genetic Modifiers for 22q11.2 Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of the project is the determination of how the deletion of DNA from chromosome 22 at the q11.2 band causes the phenotypes observed in velo-cardio-facial syndrome (VCFS). In other words, the purpose remains genotype-to-phenotype matching. Current methods includes the use of whole genome chips and microarray analysis. Blood samples are collected for DNA from every patient who consents from the VCFS Center at Upstate Medical University. They are examined for phenotypic features consistent with our typical clinical evaluation. The information from these examinations will be entered anonymously into a database. Genomic information is then matched to clinical phenotype with appropriate statistical method applied.

Official Title
-----------------
Genetic Modifiers for 22q11.2 Syndrome

Conditions
-----------------
22q11.2 Deletion Syndrome

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FISH confirmed diagnosis of 22q11.2 deletion syndrome Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals with 22q11.2 deletions<br>Individuals confirmed with the diagnosis of velo-cardio-facial syndrome by positive FISH or CGH microarray confirming the diagnosis and deletion of 22q11.2 | Other: Observation<br>* Observe development of syndrome over time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gene signal strength |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical phenotype |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
22q11.2 deletion syndrome, velo-cardio-facial syndrome, congenital anomalies, mental illness, congenital heart disease
The Effects of Flaxseed Supplement on Weight and Biochemical Factors in Overweight and Obese Subject

Study Overview
=================
Brief Summary
-----------------
To study the effects of Flaxseed supplement on weight, lipid profile and inflammatory factors in subjects with over weight and obesity, 50 patients will be randomly allocated to receive placebo or 30 grams milled Flaxseed for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, weight, waist and hip circumference, lipid profile and some inflammatory markers will be assessed and compared between groups.

Official Title
-----------------
The Effects of Flaxseed Supplement on Weight, Lipid Profile and Inflammatory Factors in Overweight and Obese Subjects

Conditions
-----------------
Overweight and Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: flaxseed
* Dietary Supplement: Placebo
* Behavioral: Exercise recommendation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 18 to 70 years Body Mass Index (BMI) between 25-40 Exclusion Criteria: diabetes mellitus cardiovascular diseases and cancers major systemic diseases gastrointestinal problems liver and renal failure history of allergy or high consumption of nuts, flaxseed, or sesame seeds weight loss within the past 6 mo of >5% of body weight or current adherence to a weight-reduction diet pregnancy, lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flaxseed<br>30 grams Flaxseed powder combine with dietary and exercise recommendation | Dietary Supplement: flaxseed<br> <br> Behavioral: Exercise recommendation<br> <br> |
| Placebo Comparator: control<br>dietary and exercise recommendation | Dietary Supplement: Placebo<br> <br> Behavioral: Exercise recommendation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight |  | 12 weeks | 
| waist and hip circumference |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid profile |  | 12 weeks |
Simultaneous Multiple Cruciate Ligament Reconstructions Using a Single Achilles Allograft

Study Overview
=================
Brief Summary
-----------------
This study introduce cases of simultaneous multiple cruciate ligament reconstructions with a single free tendon Achilles allograft using new technique.

Official Title
-----------------
Simultaneous Multiple Cruciate Ligament Reconstructions Using a Single Achilles Allograft

Conditions
-----------------
Rupture of Posterior Cruciate Ligament, Rupture of Anterior Cruciate Ligament

Intervention / Treatment
-----------------
* Procedure: cruciate ligament reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects who had any concomitant meniscus or cartilage injuries Exclusion Criteria: subjects who required reconstruction of medial or lateral collateral ligament, or posterolateral ligament complex subject who wanted reconstruction with autograft subject who denied participation in this study subject who would meet the national reimbursement criteria
Sexes Eligible for Study
-----------------
Male

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: Achilles allograft<br> | Procedure: cruciate ligament reconstruction<br>* Multiple cruciate ligament reconstructions with a single Achilles allograft with was divided into two or three strips according to the thickness and length of the allograft.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| circumference and length of the Achilles allograft | After the fresh frozen Achilles allograft was thawed, circumference and length of the tendinous portion of the allograft were measured. According to the circumference and length of the allograft, it was divided into two or three grafts for cruciate ligament reconstruction. | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Achilles allograft, cruciate ligament, reconstruction
Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE) is effective in treating the symptoms of severe premenstrual syndrome (PMS).

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of a Combination of Levonorgestrel and Ethinyl Estradiol in a Continuous Daily Regimen in Subjects With Premenstrual Dysphoric Disorder

Conditions
-----------------
Menstruation Disturbances, Premenstrual Syndrome

Intervention / Treatment
-----------------
* Drug: levonorgestrel/ethinyl estradiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy, women aged 18 to 49 years. History of severe PMS symptoms over the last year, as determined by the investigator. Regular 21 to 35 day menstrual cycle for 2 months prior to first study visit. Exclusion Criteria: Major depressive disorder requiring antidepressant treatment or hospitalization within the last 3 years. Contraindication to combination oral contraceptives. Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study. Other exclusions apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: levonorgestrel/ethinyl estradiol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each estimated treatment cycle |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premenstrual Syndrome (PMS), Hormone Therapy
IV Cocaine Abuse: A Laboratory Model - 4

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of pergolide on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving in non-opiate dependent cocaine users.

Official Title
-----------------
IV Cocaine Abuse: A Laboratory Model

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Pergolide


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Direct cocaine effects (cardio, subjective) |  |  | 
| Interaction of cocaine/pergolide on cardio |  |  | 
| Interaction of coc/pergolide on coc's subjective |  |  | 
| Effects of pergolide on cocaine craving |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
C2 -CORVUS Cholesterol-Control (C2) Controlled Targets for High Vascular Risk Patients Using Effective Statins (CORVUS)

Study Overview
=================
Brief Summary
-----------------
To demonstrate a higher percent rate of achieved target lipid goals among patients at high cardiovascular risk using more potent lipid-lowering treatment options including high-potency statins and combination therapies.

Official Title
-----------------
C2 -CORVUS Cholesterol-Control (C2) Controlled Targets for High Vascular Risk Patients Using Effective Statins (CORVUS)

Conditions
-----------------
Cardiovascular Risk

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at high cardiovascular risk according to Framingham or SCORE rates Exclusion Criteria: Not eligible for lipid or statin therapy Intolerance to therapy Patients at low or intermediate CV risk

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 |
| --- | --- |
| Patients at high cardiovascular risk<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent rate of patients achieving target LDL cholesterol goals |  | On each of the 3 visits performed during the study | 
| Percent rate of patients achieving 50% or more reduction in LDL-cholesterol |  | On each of the 3 visits performed during the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent rate of patients achieving target secondary (total Ch, triglycerides, HDL Ch) goals |  | On each of the 3 visits performed during the study | 
| Percent rate of compliance among patients in the study |  | On each of the 3 visits performed during the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lipid therapy, high CV risk, lipid goal attainment, High cardiovascular risk patients
Accuracy of Noninvasive Pulse Oximeter Sensor (MightySat RX)

Study Overview
=================
Brief Summary
-----------------
In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: MightySat RX Pulse Oximeter Sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Competent non-smoking adults Inclusion Criteria: Subjects must understand and consent to be in the study. American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all). Exclusion Criteria: Subjects who have any systemic disease at all. Subjects who do not understand the study and the risks. Smokers. Subjects who are pregnant. Subjects having either signs or history of peripheral ischemia. Others deemed ineligible by the clinical staff.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Test Subject<br>All subjects are enrolled into the test group and all subjects receive the MightySat RX Pulse Oximeter Sensor. | Device: MightySat RX Pulse Oximeter Sensor<br>* Noninvasive pulse oximeter finger sensor.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Sensor | Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value. | 1-5 hours | 
| Accuracy of Sensor during motion | Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample during motion conditions and calculating the arithmetic root mean square error (Arms) value. | 1-5 hours |
Glucose Containing and Glucose Free Hemodialysate in Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate differences in glycemia during the whole hemodialysis day and the whole freeday during hemodialysis, during the evening and the night after hemodialysis and at the same time intervals during the freeday in an unselected type 2 diabetic patient group using both glucose-containing and glucose-free dialysate.

Official Title
-----------------
Glucose Control During Glucose Containing And Glucose Free Hemodialysate Evaluated By Continuous Glucose Monitoring In Type 2 Diabetic Patients

Conditions
-----------------
End-Stage Kidney Disease, Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Glucose-containing compared to glucose-free hemodialysate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetic patient undergoing stable intermittent thrice weekly hemodialysis for at least one month Exclusion Criteria: None

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

| Intervention/Treatment |
| --- |
|Other: Glucose-containing compared to glucose-free hemodialysate|Comparison of effects on glucose variation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose below 4.0 mmol/l | In the end of a two-week glucose-containing and glucose-free period percentage of hypoglycemic values of continuous glucose monitoring during the whole hemodialysis day is compared to the whole freeday. Similar comparison is made between the whole glucose-containing and the whole glucose-free hemodialysis day as well as between the whole glucose-containing and the whole glucose-free freeday. | In the end of a two week period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose below 4.0 mmol/l during specified time intervals | Percentage of hypoglycemia during the specified time intervals is compared within the glucose-containing and glucose-free hemodialysis day and freeday, and between the glucose-containing and glucose-free hemodialysis day and the freeday. Lastly comparisons are made between the glucose-containing and glucose-free hemodialysis day, and between the glucose-containing and glucose-free freeday. | In the end of a two-week period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis, Continuous glucose monitoring, Hypoglycemia, Hyperglycemia