linjc16/ctgov huggingface dataset:
Effects of Late Dinner Against Early Dinner on Weight Loss Healthy Obese Women

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to test whether late eating dinner could affect the amount of weight loss in healthy obese women in a weight-loss program.

Official Title
-----------------
Effects of Late Dinner Against Early Dinner on Weight Loss Healthy Obese Women in a Weight-loss Program: a Randomized Clinical Trial

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Behavioral: Early dinner+Diet
* Behavioral: Late dinner+Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have Body mass index (BMI) between 27-35 kg/ m². Must be able to have moderate exercise. Must be interested to have weight loss. Exclusion Criteria: Participating in a research project involving weight loss or physical activity in the previous six months. Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months. Taking medication that could affect metabolism or change body weight. Report heart problems, chest pain, and cancer within the last five years. Smoking Menopause Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

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

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: early dinner+Diet<br> | Behavioral: Early dinner+Diet<br>* Subjects are asked to eat dinner meals between 7:00- 7:30 PM in the ED group, while they are on a multidisciplinary weight loss plan for 12 weeks.<br>* Other names: ED;|
| Experimental: late dinner+Diet<br> | Behavioral: Late dinner+Diet<br>* Subjects are asked to eat their dinner meal between 10:30-11:00PM, while they are on a multidisciplinary weight loss plan for 12 weeks.<br>* Other names: LD;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss | kg | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| waist circumference | cm | 12 Weeks | 
| fasting plasma glucose | mmol/L | 12 Weeks | 
| insulin level | mU/l | 12 Weeks | 
| insulin resistance (HOMA-IR) | Score | 12 Weeks | 
| glycosylated hemoglobin (HbA1c) | percentage (%) | 12 Weeks | 
| lipid profiles | mmol/l | 12 Weeks | 
| Liver Enzyme (SGOT, SGPT) | U/l | 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weight loss, dietary pattern, late dinner, early dinner
Assessment of Color Vision in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema

Official Title
-----------------
Assessment of Color Vision in Diabetic Patients Before and After the Use of Anti-vegf in the Treatment of Diabetic Macular Edema

Conditions
-----------------
Retinopathy, Diabetic

Intervention / Treatment
-----------------
* Drug: lucentis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having diabetic retinopathy with macular edema Exclusion Criteria: Not having diabetic retinopathy with macular edema

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 100 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 |
| --- | --- |
| Anti-Vegf<br>Use intravitreous anti-vegf | Drug: lucentis<br>* Use of lucentis and other anti-vegf in patients with diabetic retinopathy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema | Using the Ishihara's test to analise the possible loss of vision | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frame between the injections | Ant-Vegf | 1 months |
Does Myocardial Bridge Appear More Frequently and Diffusely on Radial Access Coronary Angiography

Study Overview
=================
Brief Summary
-----------------
Although the incidence of myocardial bridge (MB) has been defined in different conventional coronary angiography (CCA) studies,the frequency of MB in radial access coronary angiography (RACA) is unknown.The aim of this study was to determine the incidence of MB in patients undergoing RACA.

Official Title
-----------------
Cigli Training and Research Hospital Organization

Conditions
-----------------
Myocardial Bridge of Coronary Artery

Intervention / Treatment
-----------------
* Procedure: radial access coronary angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing radial access coronary angiography Have myocardial bridge Exclusion Criteria: A history of coronary artery bypass grafting (CABG)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| those with myocardial bridges<br> | Procedure: radial access coronary angiography<br>* The right radial artery was cannulated with a 6-f radial sheath after local infiltration with 2% lidocaine.All patients received 5000 units of unfractionated heparin, 100 - 200 μg (depending on blood pressure) of nitroglycerin and 5 mg of diltiazem unless there was an absolute contraindication to diltiazem and anticoagulants.Coronary angiography was performed using the standard Judkins' technique via right radial access with a 5-f diagnostic catheter<br>|
| those without myocardial bridges<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does Myocardial Bridge Appear More Frequently and Diffusely on Radial Access Coronary Angiography? | the incidence of MB able to be detected on RACA was much higher than reported in previous CCA studies. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myocardial bridge, radial access coronary angiography
Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control

Study Overview
=================
Brief Summary
-----------------
This is a randomized, triple-blind, placebo-controlled, multicenter study to investigate the safety of pramlintide treatment using pramlintide dose-titration coupled with insulin adjustments in subjects with type 1 diabetes who are actively trying to improve their glycemic control.

Official Title
-----------------
A Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Investigate the Safety of Pramlintide Treatment Employing Pramlintide Dose-Titration Followed by Insulin Dose Optimization in Subjects With Type 1 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Intensive Insulin Therapy

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

Intervention / Treatment
-----------------
* Drug: Pramlintide acetate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HbA1c value between 7.5-9% Using multiple daily insulin injections

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.Ingredients: D-Mannitol 43.0 mg/mL Metacresol 2.25 mg/mL Glacial acetic acid 1.53 mg/mL Sodium acetate trihydrate 0.61 mg/mL pH 4.0 Water for injection qs to 5.0 mL | Drug: Placebo<br>* The placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.<br>|
| Active Comparator: Pramlintide Acetate (AC137)<br>Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide injection is 0.6 mg/mL | Drug: Pramlintide acetate<br>* Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - To investigate the safety of pramlintide treatment employing dose titration upon initiation of pramlintide followed by insulin dose optimization in subjects with type 1 diabetes. |  | 29 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - To examine the change in HbA1c, postprandial glucose concentration, and body weight over the course of the study. |  | 29 Weeks | 
| - To examine the pattern of daily insulin use over the course of the study. |  | 29 Weeks |
Profile of Newborn Undergoing Early Stimulation in a Neonatal Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
To describe the profile of newborns undergoing early stimulation in a neonatal intensive care unit, characterizing the study population, according to its variables and neonatal risk factors, indications for treatment of early stimulation.

Detailed Description
-----------------
Objective: To describe the profile of newborns undergoing early stimulation in a neonatal intensive care unit, characterizing the study population, according to its variables and neonatal risk factors, indications for treatment of early stimulation. Methods: It was conducted a descriptive, cross-sectional and analytical study carried out in the General Hospital Dr. Cesar calls, from July to December 2010. The sample consisted of 116 medical records of newborns indicated for the treatment of early stimulation, representing (9.2%). The study excluded seven infants who had some type of congenital malformation. It was used the following variables: weight, sex, gestational age, Apgar score, diagnosis of Respiratory Distress Syndrome and Intracranial Hemorrhage and the use of mechanical ventilation and CPAP.

Official Title
-----------------
Profile of Newborn Undergoing Early Stimulation in a Neonatal Intensive Care Unit.

Conditions
-----------------
Motor Skills Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All cases of newborns who were admitted to the NICU and were referred for treatment of early stimulation Exclusion Criteria: all records relating to incomplete study variables and newborns who had a congenital malformation.
Sexes Eligible for Study
-----------------
All

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

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
-----------------
newborns, intensive care unit, early stimulation
Improved Preoperative Selection of Cold Thyroid Nodules

Study Overview
=================
Brief Summary
-----------------
Molecular gene profiling of fine-needle aspiration samples in addition to fine-needle aspiration cytology can improve the selection of patients with benign versus malignant thyroid nodules with improved sensitivity.

Official Title
-----------------
Preoperative Selection of Solitary Solid Cold Thyroid Nodules - A Prospective Study on the Value of Sonography, Cytology, Immunostaining and Molecular Profiling

Conditions
-----------------
Thyroid Nodules

Intervention / Treatment
-----------------
* Other: No intervention. Applying gene profiling on needle aspirates


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Solitary thyroid nodules that appear solid on ultrasound and cold on a scintiscan Exclusion Criteria: Pregnancy and lactation Age below 20 years

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention. Applying gene profiling on needle aspirates|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
-----------------
Solitary solid and scintigraphically cold thyroid nodules
TopQ Cutoff Threshold Validation Study for DRI OCT Triton Plus

Study Overview
=================
Brief Summary
-----------------
To determine optimal cut-off value for the TopQ cut-off on the DRI OCT Triton plus

Detailed Description
-----------------
Scans with a TopQ score below the optimum cut-off should be considered to be poor or unacceptable quality, and scans with a TopQ score above the cut-off should be considered good or acceptable quality. The study will evaluate the predetermined cut-off values by investigating measurement variability of scans.

Official Title
-----------------
TopQ Cutoff Threshold Validation Study for DRI OCT Triton Plus

Conditions
-----------------
Healthy Eyes

Intervention / Treatment
-----------------
* Device: DRI OCT Triton plus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Participants must be at least 18 years of age Participants must be able to complete all testing (all OCT scans) Participants must volunteer to be in the study and sign the consent form Exclusion Criteria Subject with history of ocular disease or ocular pathology

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects Presenting With Normal Eyes<br>Subjects with no known ocular diseases will be scanned on the DRI OCT Triton Plus device | Device: DRI OCT Triton plus<br>* OCT Machine used for diagnostic purposes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement Variability of Signal to Noise Ratio |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
no known ocular pathology
Physical and Mental Load in the Surgeon Performing Laparoscopic Tasks

Study Overview
=================
Brief Summary
-----------------
The surgeons load during laparoscopic surgery is still unclear. Laparoscopic surgery is more demanding because of the challenge of operating through small scars in the abdominal wall without any tactile feedback depending only on the visual feedback on a monitor. The purpose is to establish a model of how to measure mental and physical load in laparoscopy.

Detailed Description
-----------------
The surgeons load during laparoscopic surgery is still unclear. Laparoscopic surgery is more demanding because of the challenge of operating through small scars in the abdominal wall without any tactile feedback depending only on the visual feedback on a monitor. Most studies have been conducted in laboratory set-ups: Black Box. This study will establish a model of how to measure the biomechanical loads at muscular, joint and postural level, as well as measuring stress-hormone and cardiac rhythm. The study is a precursor of ergonomic studies performed inside the operating room. Advanced operating rooms designed specially for laparoscopy have been introduced in many departments. We do not know if they are more ergonomically correct. We will simulate laparoscopic tasks in an operating room. The hypothesis is that a traditional laparoscopic set-up is more demanding than a set-up mimicking an advanced operating room.

Official Title
-----------------
Physical and Mental Load During Laparoscopic Tasks. A Prospective Randomized Trial of the Ergonomics in a Black Box Model

Conditions
-----------------
Stress

Intervention / Treatment
-----------------
* Device: Electrogram (EMG), heart rate variability (HRV), salivary cortisol, goniometry, inclinometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy doctors Exclusion Criteria: Pregnancy Left handed Endocrine disease Cardiac rhythm disturbances History of recent injury in shoulder/arms

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Electrogram (EMG), heart rate variability (HRV), salivary cortisol, goniometry, inclinometry|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EMG |  |  | 
| Goniometry |  |  | 
| Inclinometry |  |  | 
| HRV |  |  | 
| Salivary Cortisol |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electromyography, Glucocorticoids, Heart Rate, Physical workload, Mental workload, Ergonomics, Laparoscopy, Workload, Biomechanics
Posterior Wall Osteotomy for Old Acetabular Fracture

Study Overview
=================
Brief Summary
-----------------
Posterior wall osteotomy would be conducted to manage the old acetabular fracture. The outcome was reviewed to assess the feasibility of the surgical procedure.

Detailed Description
-----------------
More and more patients with old acetabular fracture were admitted in our institution during the past years. There is little literature especially depicts the therapeutic principle of the kind of damage. Posterior wall osteotomy would be conducted to eliminate the fragments or callus from the hip joint. Then, the deformed healing acetabulum could become mobile and the reduction may be achieved. However, the surgical procedure is technique demanding and some intraoperative risk may be accompanied. Surgical time, blood loss, complication and fracture healing would be reviewed to assess the feasibility of the surgical procedure. The function outcome is evaluated with HHS score at the follow up.

Official Title
-----------------
Surgical Treatment of Old Acetabular Fracture With Posterior Wall Osteotomy

Conditions
-----------------
Surgical Procedure, Unspecified

Intervention / Treatment
-----------------
* Procedure: posterior wall osteotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acetabular fracture no surgical procedure has been obtained over 3 weeks deformed healing receive posterior wall osteotomy completed more than one year follow-up Exclusion Criteria: accompanied with other fracture pathological fracture reject the posterior wall osteotomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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: old acetabular fracture<br>posterior wall osteotomy would be conducted for thr patient with displaced acetabular fracture without surgical treatment over three weeks. | Procedure: posterior wall osteotomy<br>* posterior wall osteotomy is conducted through Kocher-Langenbeck approach.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frecture union time | the fracture line in the radiography | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication | iatrogenic neurovascular injury | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
old acetabular fracture; posterior wall osteotomy