linjc16/ctgov huggingface dataset:
Measuring Cholesterol in the Fasting and Postmeal State in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Many patients with type 2 diabetes have difficulty attaining cholesterol goals, partly due to the recommendations for fasting measurements that may not be practical in the typical clinical setting. Focus toward therapy is shifting toward non-fasting assessments but little is known about the usefulness of this approach in diabetes, where postmeal cholesterol levels are more abnormal. This is an observational study examining fasting and postmeal lipids (cholesterol) in patients with type 2 diabetes using standard means and NMR.

Detailed Description
-----------------
Current treatment guidelines for dyslipidemia focus on fasting lipid panels, specifically LDL cholesterol (LDL) but compliance has been shown to be poor. Therefore, focus has shifted to non-fasting measurements. However, there has been limited data in patients with type 2 diabetes and further study is needed to illuminate the lipid changes that occur in the non-fasting state. This observational study examines fasting and postprandial lipids in patients with type 2 diabetes using standard chemical analysis and NMR. For comparison, lipid panels will be obtained at baseline and 3 hours following a standard meal in 30 patients with type 2 diabetes. These measurements will then be analyzed based on current ATP III guidelines. We will investigate the degree to which the postprandial assessments agree with the fasting assessments and the agreement between LDL and the two alternative measures --- non-HDL and NMR-LDL.

Official Title
-----------------
A Comparison of NMR and Chemical Lipid Analysis in the Fasting and Postprandial State in Patients With Type 2 Diabetes

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20-75 male or female Type 2 diabetes Hemoglobin A1C less than 9 at last measurement (within 3 months) Exclusion Criteria: Pregnancy Non-English speaking. Inability to fast for 12 hours Hypoglycemia requiring assistance in the previous 6 months Unwilling to consume the standardized meal

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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
-----------------
type 2 diabetes, hyperlipidemia, dyslipidemia, fasting lipids, postprandial lipids, Non-HDL cholesterol, NMR lipoanalysis, ATP III guidelines
Phase I/II Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients

Study Overview
=================
Brief Summary
-----------------
To determine the tolerance and side effects of a combination of lentinan and didanosine (ddI) compared with ddI alone. To determine whether the combination of lentinan and ddI produces a significant immunorestorative effect within the study observation period (6-12 months) as measured by an increase in one or more of the following: neutrophil count and activity, T-cell subsets, and a decrease in p24 antigen.

Detailed Description
-----------------
Patients are randomized to receive either lentinan (40 patients) or placebo (10 patients) in combination with ddI for at least 26 weeks; those tolerating their dose may be offered continuation of therapy for an additional 26 weeks.

Official Title
-----------------
Phase I/II Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Lentinan
* Drug: Didanosine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV seropositivity. Absolute CD4 count of 200 - 500 cells/mm3. No active opportunistic infection or Kaposi's sarcoma. Prior Medication: Allowed: Prior ddI for no longer than 3 months. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Lymphoid malignancy. Pancreatitis. Peripheral neuropathy. Critical illness. Concurrent Medication: Excluded: Antiretroviral agents other than ddI. Steroids. Cytotoxic agents. Immunosuppressive agents. Immunomodulators. 1-Thyroxine. Concurrent Treatment: Excluded: Radiotherapy. Prior Medication: Excluded within 1 month prior to study entry: Antiretroviral agents other than ddI (patients may have received prior ddI for no longer than 3 months total). Steroids. Cytotoxic agents. Immunosuppressive agents. Immunomodulators. Prior Treatment: Excluded: Radiotherapy within 1 month prior to study entry. Active drug abuse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lentinan|nan|
|Drug: Didanosine|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
-----------------
Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Lentinan
Registry to Evaluate the ROX COUPLER in Patients With Resistant or Uncontrolled Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant or uncontrolled hypertension.

Official Title
-----------------
ROX CONTROL HTN Registry: To Evaluate the ROX Coupler in Patients With Resistant or Uncontrolled Hypertension

Conditions
-----------------
Hypertension, Blood Pressure, High, Blood Pressure, Resistant, Blood Pressure, Uncontrolled

Intervention / Treatment
-----------------
* Device: ROX COUPLER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of resistant or uncontrolled hypertension must be made on the basis of current findings, medical history, and physical examination. Exclusion Criteria: Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the registry, comply with follow-up requirements, or impact the scientific integrity of the study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Group A<br>ROX Coupler + continuing standard antihypertensive medications | Device: ROX COUPLER<br>* The COUPLER will be used to create an anastomosis in the iliac region (between the iliac artery and vein).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ambulatory daytime mean systolic blood pressure | Change in mean ambulatory daytime systolic blood pressure at six months as compared to Baseline. | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ambulatory daytime mean diastolic blood pressure | Change in mean ambulatory daytime diastolic blood pressure at six months as compared to Baseline. | Baseline, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, High blood pressure, Resistant blood pressure, Uncontrolled blood pressure
Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To investigate the efficacy, safety, and pharmacokinetics when R435 and paclitaxel are administered concomitantly to patients with metastatic breast cancer.

Official Title
-----------------
Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: bevacizumab
* Drug: Paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
At least 20 years old and obtained a written informed consent Advanced breast cancer (StageⅣ) or Inoperable metastatic breast cancer HER2 negative At least one measurable lesion based on RECIST criteria No previous chemotherapy for metastatic breast cancer

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: step 1<br>6 enrollment for 1 cycle(4 weeks) | Drug: bevacizumab<br>* 10mg/kg，Day1, 15 of 1 cycle(4 weeks)<br>Drug: Paclitaxel<br>* 90mg/ m2，Day1, 8, 15 of 1 cycle(4 weeks)<br>|
| Experimental: step 2<br>114 enrollment through to meet the stopping criteria | Drug: bevacizumab<br>* 10mg/kg，Day1, 15 of 1 cycle(4 weeks)<br>Drug: Paclitaxel<br>* 90mg/ m2，Day1, 8, 15 of 1 cycle(4 weeks)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | throughout study | 
| Progression-free survival (PFS) |  | event driven | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival(OS) |  | event driven | 
| Time to Treatment Failure(TTF) |  | evnt driven | 
| Response Rate(RR) |  | event driven | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inoperable metastatic breast cancer
Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures

Study Overview
=================
Brief Summary
-----------------
Approximately 1000 patients presenting with tibial shaft fractures (AO type 42) will be enrolled prospectively in this registry. All patients are treated and followed at 6 weeks, 6 months and 1 year postoperative always following the local standard of care (routine) visit schedule up to 36 months if required. Data collection includes patient and fracture details, treatment details, functional, clinical and patient-reported outcomes and anticipated or procedure- and implant-related adverse events (i.e. complications) and their corresponding treatment

Official Title
-----------------
Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures (FROST)

Conditions
-----------------
Tibial Fracture, Fracture of the Tibia Type AO/OTA 42

Intervention / Treatment
-----------------
* Procedure: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older at the time of the injury Diagnosis of a primary tibial shaft fracture (fracture type 42 according to the AO/OTA Fracture and Dislocation Classification) that will be treated operatively as part of standard of care Exclusion Criteria: Pathological fracture caused by malignancy Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

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 |
| --- | --- |
| Tibial Shaft Fracture<br>Patients sustaining a tibial shaft fracture (AO/OTA type 42) that requires surgery | Procedure: Surgery<br>* Surgical fracture fixation, using osteosynthesis, including single or multiple staged procedures (e.g. primary External Fixation and later conversion to internal fixation).<br>* Other names: Surgical treatment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported outcome | Change in PROMIS Pain interference (v1.0 - Pain Interference 8a) over the the follow-up period Change in PROMIS: Physical function (mobility) (v2.0 - Physical Function 10b) over the the follow-up period | 6 weeks / 6 months / 12 months / 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fracture fixation, Surgical treatment, Fracture reduction
A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy.

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to evaluate the efficacy and tolerability of the phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of subjects with erectile dysfunction of different aetiologies and severity, who have not been previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.

Official Title
-----------------
A Randomized, Double Blind, Placebo Controlled, Flexible Dose, Multicentre Study of Levitra in a Broad Population of Men With Erectile Dysfunction and Previously Untreated With PDE5 Inhibitors.

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Levitra (Vardenafil, BAY38-9456)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males with erectile dysfunction according to the National Institute of Health (NIH) Consensus statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance Heterosexual relationship for more than 6 months Partner willing to complete the TSS Exclusion Criteria: Primary hypoactive sexual desire History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months Nitrate use Other exclusion criteria apply according to the Summary of Product Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Matching Placebo<br>|
| Experimental: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hierarchical significance testing was applied to the 3 primary efficacy parameters at the 5% significance level. Parameters were to be tested: GAQ first, Sexual Encounter Profile 3 second and SEP 2 third. SEP 3 will only be tested if GAQ is sign. |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Index of Erectile Function |  | 16 weeks | 
| Treatment Satisfaction Scale |  | 16 weeks | 
| Other patient diary based variables |  | 16 weeks | 
| Safety and tolerability |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile Dysfunction, PDE5 inhibitors
Practical Use of Advagraf de Novo After Kidney Transplantation According to Recipient Genetic Polymorphism

Study Overview
=================
Brief Summary
-----------------
To optimize the Advagraf (tacrolimus once a day) initial daily dose used in de novo after kidney transplantation in combination with MMF (or MPA) and corticosteroids (CS) regarding of the genetic Cyp 450 3A5 polymorphism of the recipient. The study of the tacrolimus through level (ng/ml) determines if the therapeutic level is reached.

Official Title
-----------------
Influence of Recipient Cytochrome P450 3A5 Polymorphism on the Metabolism of Prolonged Release Tacrolimus Administered de Novo After Renal Transplantation

Conditions
-----------------
Kidney Diseases

Intervention / Treatment
-----------------
* Drug: Advagraf


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First or second Kidney Transplantation from deceased or living donor Exclusion Criteria: Donor age < 5 years. Patients who require plasma exchange because of high immunological risk

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CYP 3 A 5 *3/*3 control group<br>CYP 3 A 5 *3/*3 control group will receive 0,20 mg/kg of Advagraf® | |
| Active Comparator: CYP 3 A 5 *3/*3<br>CYP 3 A 5 *3/*3 will receive 0,25 mg/kg of Advagraf® | Drug: Advagraf<br>* daily dose adapted according to Cyp 3A5 polymorphism<br>* Other names: Tacrolimus prolonged release formulation;|
| Active Comparator: CYP 3 A 5 *1/*3<br>CYP 3 A 5 *1/*3 will receive 0,30 mg/kg of Advagraf® | Drug: Advagraf<br>* daily dose adapted according to Cyp 3A5 polymorphism<br>* Other names: Tacrolimus prolonged release formulation;|
| Active Comparator: CYP 3 A 5 *1/*1<br>CYP 3 A 5 *1/*1 will receive 0,35 mg/kg of Advagraf® | Drug: Advagraf<br>* daily dose adapted according to Cyp 3A5 polymorphism<br>* Other names: Tacrolimus prolonged release formulation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of tacrolimus | tacrolimus level (ng/ml) at C0 every 3 days during 2 weeks and thereafter every month during 1 year | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney graft function | serum creatinine level (mg/dl) and GFR (ml/min) | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transplant, immunosuppressive drug
Sport Cord Test Following ACL Reconstruction

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to determine the interrater reliability and validity of the Sportcord Test as a measure of physical performance following anterior cruciate ligament (ACL) reconstruction. A secondary purpose is to systematically track subjective and objective outcomes on patients following ACL reconstruction to help identify differences between those who have subsequent knee problems and those who do not. The study hypotheses are the following: 1) The Sportcord Test will provide a valid and reliable measure of functional performance following ACL reconstruction. 2) Patients who have subsequent knee problems in the 12 month study period will exhibit different scores on clinical special tests compared to those who do not.

Official Title
-----------------
The Use of the Sport Cord Test as a Measure of Physical Performance Following Anterior Cruciate Ligament Reconstruction

Conditions
-----------------
Injury of Anterior Cruciate Ligament

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing surgical reconstruction for a torn ACL. Returning to participation in a sport(s). Will receive physical therapy/rehabilitation after surgical reconstruction for a torn ACL. Between ages of 10 and 50. Exclusion Criteria: Non-weight bearing. At least 12 weeks removed from surgery. Unable to walk, squat, or jump/land without pain in the surgically repaired knee.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 50 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 |
| --- | --- | --- |
| Sportcord Test | The Sportcord Test measures physical performance following an ACL reconstruction. The Sportcord test consists of the following: single-leg squats lateral (side-to-side) agility forward running backward running | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical Therapy, Return to sport