linjc16/ctgov huggingface dataset:
Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono-therapy in Chinese Type 2 Diabetes Mellitus (T2DM)

Study Overview
=================
Brief Summary
-----------------
To investigate the glycosylated hemoglobin (HbA1c) control of Glimepiride (AMARYL) as OAD initiation mono-therapy in type 2 diabetic patients in China.

Official Title
-----------------
Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono- Therapy in Chinese Type 2 Diabetes Mellitus (T2DM)

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

Intervention / Treatment
-----------------
* Drug: GLIMEPIRIDE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed T2DM and inadequately controlled with diet and exercise or T2DM diagnosed <6 months and who had not taken oral antidiabetic medication or insulin for >3months. HbA1C more than 7.5 and less than 11. Exclusion Criteria: Fasting plasma glucose of >13.5mmol/L Type 1 Diabetes Mellitus (T1DM) Patient with acute illness hospitalized in last 2 months Patient with active liver disease, impaired renal or hepatic functions Known hypersensitivity to glimepiride, other sulfonylureas, other sulfonamides or any other excipients of AMARYL Pregnant and lactating women The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>The treatment period is 16 weeks with 5 visits: at weeks 2, 4, 8, 12, 16. At every visit if Fasting Blood Glucose (FBG) >7.0mmol/L the Glimepiride dosage is increased from 1mg to 2mg or 2mg to 4mg. At every visit if FBG<3.9mmol/L the Glimepiride dosage is decreased from 4mg to 2mg or 2mg to 1mg. Patients who have been on 4mg for 4 weeks and FBG>11.0mmol/L at visit, another treatment can be added at the physician's discretion. | Drug: GLIMEPIRIDE<br>* Dosage of 1mg, 2mg and 4mg of AMARYL (Glimepiride)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycosylated hemoglobin (HbA1c) rate |  | week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Plasma Glucose (FPG) rate |  | week 16 | 
| Post Prandial Glucose (PPG) rate |  | week 16 | 
| Percentage of patients achieving HbA1c <7.0 |  | week 16 |
Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy

Study Overview
=================
Brief Summary
-----------------
Primary objectives a. To evaluate the Effects of intravitreal Bevacizumab on polypoidal choroidal vasculopathy(PCV) Secondary objectives To assess the changes in visual acuity To assess the change in lesion characteristics of PCV size of PCV fluorescein leakage foveal thickness To investigate the safety of intravitreal Bevacizumab in patients with PCV To assess the effect of intravitreal Bevacizumab on the recurrence rate and the the incidence of submacular hemorrhage in patients with PCV

Official Title
-----------------
Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy

Conditions
-----------------
Polypoidal Choroidal Vasculopathy

Intervention / Treatment
-----------------
* Drug: Intravitreal Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, CNV secondary to PCV BCVA of 20/40 to 20/320 (Snellen equivalent) Evidence of presumed recent disease progression (blood, growth by FA, or recent VA loss) Exclusion Criteria: Uncontrolled glaucoma or any other ocular condition that would prevent an improvement in visual acuity Media opacity in the study eye that precludes clinical and photographic evaluation Intraocular surgery < 1 month before day 0 Use of heparin/warfarin within 1 month prior to injection Known allergy or hypersensitivity to fluorescein, indocyanine green or povidone iodine Contraindication to pupil dilation in either eye Any condition which precludes patients' ability to comply with study requirements including completion of the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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

| Intervention/Treatment |
| --- |
|Drug: Intravitreal Bevacizumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the percentage of patients who gained an improvement in best corrected visual acuity (BCVA) by 15 letters of more. |  |  | 
| To assess the percentage of patients whose final visual acuity resulted in Snellen equivalent of 20/200 or worse |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the resolution time of macular edema, subretinal fluid, and/or pigment epithelial detachment (PED) using optical coherence tomography (OCT) |  |  | 
| To evaluate change in size and leakage of PCV, using fluorescein angiography (FA) and/or indocyanine angiography (ICGA) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polypoidal choroidal vasculopathy, Intravitreal Bevacizumab
Assessment of the Potential for Pressure Ulcer Formation

Study Overview
=================
Brief Summary
-----------------
Pressure ulcers are a significant problem in institutionalized, elderly, and critically ill patients. Pressure ulcers result in significant pain, changing quality of life, and often leading to significant morbidity and prolonged hospital stays, and ultimately increased the healthcare cost. According to the International Pressure Ulcer Prevalence Survey, the prevalence of hospital acquired pressure ulcers in the United States was 13.5% in 2008 and 12.8% in 2009. This survey also indicated that the highest rate of pressure ulcers is in the long term acute care population (22%).

Detailed Description
-----------------
Researchers developed a non-contact optical imaging technology call Spatial Frequency Domain Imaging which can identify the tissue regions that are at risk of developing pressure ulcers prior to development of irreversible tissue damage. The Spatial Frequency Domain Imaging can identify metabolic and biochemical differences in the tissues near bony prominences which are at risk for developing pressure ulcers.

Official Title
-----------------
Assessment of the Potential for Pressure Ulcer Formation Using a New Optical Imaging Technology: Spatial Frequency Domain Imaging

Conditions
-----------------
Pressure Ulcer Not Visible

Intervention / Treatment
-----------------
* Other: Spatial Frequency Domain Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 years of age and older Diagnose with potential of pressure ulcers Exclusion Criteria: No potential of pressure ulcers Has history of vascular disease in both lower extremities

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 |
| --- | --- |
| Pressure Ulcer Formation<br>Assessment of Pressure Ulcer Formation using Spatial Frequency Domain Imaging | Other: Spatial Frequency Domain Imaging<br>* Assessment of Pressure Ulcer Formation using Spatial Frequency Domain Imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Formation of Pressure Ulcer | Assessment of Pressure Ulcer Formation using Spatial Frequency Domain Imaging | up to 6 months |
Diet and Microbiome Longitudinal Monitoring With Food Intervention

Study Overview
=================
Brief Summary
-----------------
The main goal of this project is to identify the microbiome components change in abundance in response to food ingested including provided foods.

Official Title
-----------------
Diet and Microbiome Longitudinal Monitoring With Food Intervention

Conditions
-----------------
Microbiome, Human, Gastrointestinal Tract

Intervention / Treatment
-----------------
* Other: Food provided from a commercial meal service provider for a week


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: willing to sign consent and have samples collected, able to read and speak English, participants must be willing to use an electronic food diary and consume study provided foods, only individuals able to provide a US address will be included. Exclusion Criteria: Subjects not able to sign consent on their own accord (ie requiring a Legally Authorized Representative [LAR]), Current parenteral nutrition, Received cancer treatment within past 6 months prior to signing consent, Taken antibiotic treatment within the past 1 month prior to signing consent, Received oral x-ray contrast within the past 1 month prior to signing consent, Received any type of gastrointestinal bowel preparation in the past 1 month prior to signing consent, History of organ transplant, Shellfish allergy, Insect allergy, Cacti allergy, Carmine allergy, Dragon fruit (pitaya) allergy,

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Food provided<br>Food provided from a commercial meal service provider for a week | Other: Food provided from a commercial meal service provider for a week<br>* Meals from a commercial meal service provider provide for a week to participant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiota variation | Ecological statistics will be used to analyze the longitudinal microbiome composition modification | Up to 2 weeks |
A Prospective Active-Reference Study of Gaboxadol in Primary Insomnia

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy safety and tolerability of gaboxadol in primary insomnia

Detailed Description
-----------------
To compare the hypnotic efficacy and safety of different dose levels of gaboxadol with placebo in non-elderly patients with primary insomnia over two weeks of treatment

Official Title
-----------------
A Prospective Randomised Double-Blind Parallel-Group Placebo-Controlled Active-Reference Study of Gaboxadol in Primary Insomnia

Conditions
-----------------
Primary Insomnia

Intervention / Treatment
-----------------
* Drug: Gaboxadol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of Primary insomnia

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  |  | 
| Safety |  |  | 
| Tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary insomnia
Prospective Cohort Study of Patients Intolerant to High Pressure Under Continuous Positive Airway Pressure Treated With Bilevel Positive Airway Pressure as Second-line Therapy.

Study Overview
=================
Brief Summary
-----------------
Prospective observational study of obstructive Sleep Apnea patients treated with Bilevel Positive Airway Pressure: AirCurve 10 VAutoTM

Detailed Description
-----------------
To characterize, in routine practice, non compliant patient to continuous positive airway pressure who can get a benefit of a bilevel positive airway pressure therapy as a second line treatment (Aircurve 10 VAutoTM ) To evaluate the clinical management of obstructive sleep apnea patients treated by Aircurve 10 VAutoTM , especially impact on compliance and residual apnea hypopnea Index. To evaluate Aircurve 10 VAutoTM benefit on quality of Life and quality of sleep

Official Title
-----------------
Prospective Cohort Study of Patients Intolerant to High Pressure Under Continuous Positive Airway Pressure, Treated With Bilevel Positive Airway Pressure (AirCurve 10 VAutoTM) as Second-line Therapy: PoP IN VAuto

Conditions
-----------------
Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient Obstructive Sleep Apnea Patient previously treated by Continuous positive airway pressure non-compliant to therapy Patient naive of bilevel Positive Airway Pressure therapy Exclusion Criteria: Bilevel positive airway pressure Contraindication Severe respiratory disease diagnostic

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Compliance | hours of usage of the device per night | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleepiness | Epworth sleepiness score evolution | 3 months | 
| sleep quality | Pittsburgh sleep questionnaire index | 3 months |
Malnutrition in People With Complex Multiple Disabilities

Study Overview
=================
Brief Summary
-----------------
Underweight is more prevalent in people with a mental handicap than in people without a mental handicap, especially in people with a severe mental handicap. It is unknown if these people are malnourished. There is no validated screening instrument available to determine the nutrition status in people with complex multiple disabilities. Research regarding malnutrition based on body composition and nutrients in stead of anthropometric data is important. The aim of the study is to understand the nutritional status of people with complex multiple disabilitiest through measurement of body composition and nutritients. The primary objective of the study is: What percentage of people with complex multiple disabilities are malnourished, based on altered body composition and nutritients? Understanding the nutritional status of these patients is important in order for them to receive appropriate and effective treatment. This treatment is of interest for general health and the quality of daily life.

Official Title
-----------------
Understanding of Malnutrition in People With Complex Multiple Disabilities

Conditions
-----------------
Complex Multiple Disabilities, Malnutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person with complex multiple disabilities; Living in a care institution participating in the Governor Kremers Centre (GKC); Chronically confined to a wheelchair or bedridden; 18+ years Exclusion Criteria: Parenteral nutrition; Serious infection; Terminal illness

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 |
| --- | --- |
| Complex multiple disabilities<br>People with complex multiple disabilities, living in a care institution participating in the Governor Kremers Centre (GKC.) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| What percentage of people with complex multiple disabilities are malnourished, based on altered body composition and nutritients? | Concerning measurement of body composition, the Deuterium dilution method will be used. A blood sample will be collected for measurement of nutrients. Furthermore, clinical parameters (weight, height and abdominal girth) will be measured. | One hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Complex multiple disabilities, Malnutrition
Modified Allen's Test and Peripheral Perfusion Index

Study Overview
=================
Brief Summary
-----------------
to detect the relation between results of the peripheral perfusion index and modified Allen's test.

Detailed Description
-----------------
The modified Allen's test (MAT) is commonly used to assess hand perfusion. Other non-invasive methods including plethysmography, pulse oximetry and duplex ultrasonography are used nowadays. The perfusion index is calculated as the ratio of the pulsatile blood flow to non- pulsatile blood flow in peripheral tissue. In this study, we will try to detect the relation between results of the peripheral perfusion index and modified Allen's test.

Official Title
-----------------
Relation of the Peripheral Perfusion Index Derived From Pulse Oximetry to Modified Allen's Test in Evaluation of Hand Perfusion

Conditions
-----------------
Peripheral Perfusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients or healthy volunteers Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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 |
| --- | --- | --- |
| Perfusion of the hand using the perfusion index |  | Preoperative | 
| Perfusion of the hand using the modified Allen's test |  | Preoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perfusion index, modified Allen's test
Hand Grip Strength as a Marker of Frailty in Surgical Patients

Study Overview
=================
Brief Summary
-----------------
This study aims to assess if grip strength can be used as a single, objective surrogate of frailty assessment in the surgical population.

Detailed Description
-----------------
Frailty is associated with worse outcomes. Current screening surveys are cumbersome, most containing multiple components. For frail patients particularly, it can be difficult to ascertain all the information requested. There is a need for a simple, one step, objective screening measure of frailty. There is some evidence in the medicine patients that grip strength may be related to frailty, but no such information is available for surgical patients.

Official Title
-----------------
Hand Grip Strength as a Marker of Frailty in Surgical Patients

Conditions
-----------------
Frailty

Intervention / Treatment
-----------------
* Device: Obtain grip strength from a standardized gripometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General surgery patient admitted to the Section of General Surgery, Trauma, and Surgical Critical Care Age >60 Exclusion Criteria: Pregnancy Untreated or metastatic malignancy Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| General surgery patient<br>General surgery patient admitted to the Section of General Surgery, Trauma, and Surgical Critical Care who are over 60. | Device: Obtain grip strength from a standardized gripometer<br>* Obtain grip strength from a standardized gripometer, 3 times on each hand<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| linear regression of grip strength to frailty survey score | Their frailty survey and grip strength scores will also be recorded for analysis. We will analyze the data by linear regression of grip strength to frailty survey score. | 10 minutes at the time of admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgical outcomes
Evaluation of Retinal Structure With High Resolution Optical Coherence Tomography (OCT)

Study Overview
=================
Brief Summary
-----------------
Comparison of different OCT instruments to assess retinal thickness, correlation to fluorescein angiography, and visual outcome after therapy with anti-VEGF therapy

Detailed Description
-----------------
Comparison of different OCT instruments to assess retinal thickness, correlation to fluorescein angiography, and visual outcome after therapy with anti-VEGF therapy

Official Title
-----------------
Evaluation of Retinal Structure With High Resolution OCT

Conditions
-----------------
CNV, Macular Edema

Intervention / Treatment
-----------------
* Other: Examination with an OCT device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Macular disease Healthy subjects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| 1<br>Healthy volunteers | Other: Examination with an OCT device<br> <br> |
| 2<br>CSME secondary to diabetic retinopathy | |
| 3<br>ARMD with CNV before and after therapy | Other: Examination with an OCT device<br> <br> |
| 4<br>ARMD atrophic | Other: Examination with an OCT device<br> <br> |
| 5<br>Retinal vein occlusion | Other: Examination with an OCT device<br> <br> |
| 6<br>retinitis pigmentosa | Other: Examination with an OCT device<br> <br> |
| 7<br>vitreoretinal proliferation | Other: Examination with an OCT device<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Integrity of retinal layers |  | End of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OCT