linjc16/ctgov huggingface dataset:
The Effect of DASH Diet on the Cardiometabolic Risks and Hepatic Function Among Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The investigators are not aware of any study regarding the effect of DASH eating pattern on different cardiovascular risks among type 2 diabetic patients. The investigators assumed that DASH eating pattern could reduce the cardio-metabolic risks and improve the hepatic function among type 2 diabetes.

Conditions
-----------------
Type 2 Diabetic Patients

Intervention / Treatment
-----------------
* Dietary Supplement: DASH diet
* Dietary Supplement: a usual diabetic diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having type 2 diabetes Exclusion Criteria: Having other chronic disease, hepatic or kidney disorders, cancer, hormone therapy

Ages Eligible for Study
-----------------
Minimum Age: 44 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DASH diet<br>DASH: Dietary approaches to stop hypertension eating plan | Dietary Supplement: DASH diet<br> <br> * Other names: Dietary aproaches to stop hypertension;|
| Placebo Comparator: Diabetic diet<br>Diabetic diet: a usual diabetic diet | Dietary Supplement: a usual diabetic diet<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardio-metabolic risks |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic function |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dietary Approach to Stop Hypertension, weight, coagulation, DASH eating pattern.
The Impact of Riboflavin on Sports-related Concussion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effectiveness of riboflavin to decrease the duration of time for a student-athlete to return to participation in sports after a sports related concussion.

Official Title
-----------------
The Impact of Riboflavin on Sports-related Concussion: A Randomized Control Trial

Conditions
-----------------
Sports-related Concussion

Intervention / Treatment
-----------------
* Biological: Riboflavin
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All UVa and JMU student-athletes over the age of 18 years old who are diagnosed with a sports related concussion Exclusion Criteria: Less than 18 years old Greater than 24 hours have elapsed since the concussion occurred. The student-athlete has already participated in the study during which he/she took Riboflavin Non-sports related concussion not incurred while participating in the sport or training for the sport. As an example, a student-athlete who sustains a concussion as a result of a motor vehicle accident will be excluded from the study for that concussion. A previous concussion within the last 12 months. Any concussion that is complicated by a cranial bleed, skull fracture, additional severe injury (e.g. torn knee ligament) that might affect the return to normal activities above and beyond the sport-related concussion. If the student athlete is cognitively impaired to a level that prevents verbal communication, the consent will be deemed 'opted out' and the student-athlete will not be enrolled in the study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group<br>Riboflavin 400mg daily | Biological: Riboflavin<br>* Riboflavin 400mg daily<br>* Other names: Vitamin B2;|
| Placebo Comparator: Placebo group<br>Placebo | Biological: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to return to participation in sports after a sports-related concussion |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
concussion, sports-related concussion, mTBI, Riboflavin, Vitamin B2
Nurses Helping Sudden Cardiac Arrest Survivors Recover After Getting An Implantable Cardioverter Defibrillator (ICD)

Study Overview
=================
Brief Summary
-----------------
To determine if an education and support nursing intervention program helped sudden cardiac arrest survivors adjust to the event and to getting an ICD

Detailed Description
-----------------
This study is one of the first large randomized clinical trials of nursing interventions aimed at improving health outcomes after receiving an ICD. Written informed consent was used in the study.

Official Title
-----------------
Nursing Interventions Following Sudden Cardiac Arrest

Conditions
-----------------
Sudden Cardiac Arrest

Intervention / Treatment
-----------------
* Behavioral: Nursing Telephone Support Protocol
* Behavioral: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First time sudden cardiac arrest with ICD implantation during hospitalization, over age 21 years, working telephone in the home, deliverable address for 1 year Exclusion Criteria: Receiving an ICD for primary prevention of sudden cardiac arrest, inability to read, speak, or understand English, no telephone at home or no current address, cognitive or physical impairments that prohibited ability to give informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Behavioral: Nursing Telephone Support Protocol<br> <br> |
| Active Comparator: 2<br> | Behavioral: Usual Care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if an education and support nursing intervention program helped sudden cardiac arrest survivors adjust to the event and to getting an ICD |  | Baseline, 1- and 3-months from implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved physical functioning |  | Baseline, 1- and 3-months from implantation | 
| Improved psychological adjustment |  | Baseline, 1- and 3-months from implantation | 
| Improved self-efficacy |  | Baseline, 1- and 3-months from implantation | 
| Lower health care use |  | Baseline, 1- and 3-months from implantation |
A Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 in Healthy Japanese Males

Study Overview
=================
Brief Summary
-----------------
To assess the safety and tolerability of ascending, multiple oral doses of AGG-523 in healthy Japanese subjects.

Official Title
-----------------
An Ascending, Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 Administered Orally to Healthy Male Japanese Subjects.

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

Intervention / Treatment
-----------------
* Drug: AGG-523


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men aged 20 to 40 years, inclusive, at screening; sexually active men must agree to use a medically acceptable form of contraception during the study and continue for 12 weeks after test article administration. Body mass index (BMI) in the range of 17.6 to 26.4 Kgm2, and body weight >45 kg. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12 lead ECG.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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: AGG-523|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and PK profile |  |  |
A New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology

Study Overview
=================
Brief Summary
-----------------
Laser treatment (LT) is the first-line treatment for Vascular Pathology. However even when LT is based on the selective photothermolysis it causes the first-degree burns. While being typically benign by affecting only the epidermis, or outer layer of skin, the burn site is remaining red, dry, and very painful. As Haemoblock contains nanoparticles of silver and is known for both bactericidal and bacteriostatic effects, it likely decreases the potential for infection postoperatively. Furthermore, after fibrin replaces the superficial structure Hemoblock-albumin, the polyacrylate matrix is plasmolyzed which initiates the cascade of signals required for the tissue regeneration processes. Objective of the study was to examine the effect of the Regenerative Solution Hemoblock in lowering postoperative complications in children diagnosed with Vascular Pathology undergoing a laser surgery if delivered with transdermal patches.

Official Title
-----------------
DOUBLE-SKIN: a New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology: a Randomised, Double-blind, Placebo-controlled Trial

Conditions
-----------------
Vascular Malformation, Capillary Malformation-Arteriovenous Malformation, Port-Wine Stain, Sturge-Weber Syndrome, Vascular Tumor, Vascular Diseases

Intervention / Treatment
-----------------
* Drug: Haemoblock
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically diagnosed Vascular Pathology Exclusion Criteria: age severe allergic reaction

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group with Haemoblock (A)<br> | Drug: Haemoblock<br>* Delivering with transdermal patches<br>|
| Placebo Comparator: Group without Haemoblock (B)<br> | Other: Placebo<br>* Delivering with transdermal patches<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preventing negative outcomes of postoperative infection | Validated scales | Early postoperative period and at 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preventing prolonged functional recovery | Validated scales | Early postoperative period and at 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vascular Diseases, Laser treatment, Capillary Malformation, Port-Wine Stain, Vascular Tumor
PRIMADOS Study:A Study of Avastin (Bevacizumab) Plus Docetaxel for First Line Treatment of Patients With Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This single arm study will assess the efficacy and safety of first line combination treatment with Avastin + docetaxel in patients with HER2 negative metastatic breast cancer.Patients will receive Avastin (15mg/kg iv every 3 weeks) plus docetaxel (75mg/m2 every 3 weeks for 6 cycles). The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.

Official Title
-----------------
An Open Label Study of the Effect of First Line Combination Treatment With Avastin and Docetaxel on Disease Response in Patients With Metastatic Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: bevacizumab [Avastin]
* Drug: docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female patients, >=18 years of age; stage IV, HER2 negative metastatic breast cancer; candidate for taxane-based therapy; ECOG performance status 0-2. Exclusion Criteria: prior chemotherapy for metastatic breast cancer; concomitant primary malignant disease, except for adequately treated cervical cancer in situ, or basal or squamous cell skin cancer within last 5 years; suspicion of CNS metastasis; clinically significant cardiovascular 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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: bevacizumab [Avastin]<br>* 15mg/kg iv every 3 weeks<br>Drug: docetaxel<br>* 75mg/m2 every 3 weeks for 18 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate, median progression free survival, overall survival |  | Event driven | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | Throughout study |
Prophylactic Fenestration of the Peritoneum in Kidney Transplantation

Study Overview
=================
Brief Summary
-----------------
A single centre open randomised parallel-group study to evaluate whether prophylactic fenestration of the peritoneum at the time of renal transplantation prevents lymphocele formation. Adult (>18 years old) recipients of renal transplants from deceased donors were eligible for inclusion. From March 2007 to May 2009 130 patients were included. The patients were randomized either to peroperative peritoneal fenestration, or to serve as controls. Block-randomization was conducted in groups of 10, drawn from envelopes containing five notes from each group. Patients who previously had undergone extensive abdominal surgery, or were included in other studies were excluded.

Official Title
-----------------
Prospective Open Randomized Study to Evaluate the Efficiency of Prophylactic Fenestration of the Peritoneum in Kidney Transplantation in Preventing the Occurrence of Postoperative Lymphoceles

Conditions
-----------------
Incidence of Symptomatic Lymphocele After Kidney Transplantation, Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks

Intervention / Treatment
-----------------
* Procedure: Fenestration
* Procedure: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult recipients of kidney transplants from deceased donors Exclusion Criteria: Former extensive abdominal surgery Participation in other studies

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 |
| --- | --- |
| Active Comparator: Fenestration<br>Fenestration of the peritoneum according to the length of the transplanted kidney | Procedure: Fenestration<br>* Fenestration of the peritoneum according to the length of the transplanted kidney<br>|
| Sham Comparator: Control<br>Standard kidney transplantation | Procedure: Control<br>* Standard kidney transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic lymphoceles | Symptomatic lymphoceles treated by surgical intervetion or ultrasound guided drainage | 1 - 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of fluid perirenal collections evaluated by ultrasound at 1, 5 and 10 weeks |  | 1 -10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kidney, transplantation, surgery, complications, lymphocele, fluid collections.
Pharmacokinetic and Pharmacodynamic of Rocuronium

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is characterize the dose-effect relationship of rocuronium bromide at the adductor pollicis and masseter muscles using an pharmacokinetic-pharmacodynamic (PKPD) model. The hypothesis is that masseter muscle has a greater sensitivity to the neuromuscular blockers (rocuronium), faster onset and slower recovery profile than the adductor pollicis muscle.

Official Title
-----------------
Pharmacokinetic and Pharmacodynamic of Rocuronium Bromide Measured in Adductor Pollicis and Masseter Muscles.

Conditions
-----------------
Neuromuscular Blockade

Intervention / Treatment
-----------------
* Drug: Rocuronium Bromide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for elective surgery under general anesthesia. Exclusion Criteria: Pregnancy. Body mass index (BMI) >25 kg/m2. Anticipated difficult airway. Surgery associated with great volume loss. Presence of any neuromuscular, hepatic, renal, cardiac or respiratory disease. Previous history of neuromuscular blockade allergy, and/or administration of drugs known to interfere with neuromuscular blockade

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Rocuronium Bromide<br>Rocuronium 0,3 mg/kg administered in less than five seconds, followed by a saline bolus. | Drug: Rocuronium Bromide<br>* Rocuronium 0,3 mg/kg in less than five seconds, followed by a saline bolus.<br>* Other names: Rocuronium Bromide Fresenius Kabi;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| strength measuring 2 acceleromyograph. One Placed at the masseter muscle and the other one at the adductor pollicis muscle. |  | 60 minutes | 
| Measure blood concentrations after administration rocuronium |  | 120 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rocuronium, Pharmacokinetics, Pharmacodynamics
A Study To Investigate The Effects Of GW856553 On Patients With COPD (Chronic Obstructive Pulmonary Disease)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety of GW856553 in COPD patients and to assess its affects on their COPD disease after 14 days.

Official Title
-----------------
A Randomised, Double-blind, Placebo-controlled Parallel Study to Assess the Safety, Tolerability,Pharmacodynamics and Steady State Pharmacokinetics of Repeated Doses of GW856553 in Patients With COPD

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive, Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Drug: GW856553


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Women of childbearing potential Established history of COPD Cigarette smoking history greater than 10 pack years FEV1 between 40 and 80% of predicted normal for height, age and sex. Exclusion criteria: Morbidly obese patients (body mass index >40) Hospitalisation or treatment for worsening of COPD in past 6 weeks History of increased liver function tests hypersensitivity to salbutamol or ipratropium bromide Blood pressure > 155/95

Ages Eligible for Study
-----------------
Minimum Age: 40 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW856553|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurements of adverse events, changes in heart rate, blood pressure, blood tests, heart function and lung function throughout the 14 day study. Exacerbations of COPD over the 14 day study. |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhibition of inflammatory agents in the blood after 7 and 14 days of dosing. |  | after 7 and 14 days of dosing | 
| Concentration of the drug in the blood after 1, 3, 7, 10 and 14 days of dosing. |  | after 1, 3, 7, 10 and 14 days of dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Pharmacodynamics, Pharmacokinetics, Tolerability, Safety