linjc16/ctgov huggingface dataset:
Efficacy and Safety of Betamethasone Microsphere in Patients With Macular Edema Following Branch Retinal Vein Occlusion (HIKARI)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for macular edema following branch retinal vein occlusion

Official Title
-----------------
A Randomized, Sham Controlled, Multicenter, Double-Masked, Phase 2/3 Study Assessing Efficacy and Safety of Betamethasone Microsphere in Patients With Macular Edema Following Branch Retinal Vein Occlusion

Conditions
-----------------
Macular Edema Following Branch Retinal Vein Occlusion

Intervention / Treatment
-----------------
* Drug: Betamethasone Microsphere (DE-102） Low Dose
* Drug: Betamethasone Microsphere (DE-102） High Dose
* Drug: Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 years of age or older Diagnosis of macular edema following branch retinal vein occlusion Exclusion Criteria: BCVA ETDRS letter score in non-study eye < 35 Known steroid-responder

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Betamethasone Microsphere (DE-102） Low Dose<br> <br> |
| Experimental: 2<br> | Drug: Betamethasone Microsphere (DE-102） High Dose<br> <br> |
| Sham Comparator: 3<br> | Drug: Sham<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in retinal thickness from baseline |  |  |
Escorting Octogenarian for Gastric Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
An objective analysis of postoperative complications is vital to escort octogenarian for gastric cancer surgery. Investigator carefully collected clinical data prospectively to pave way for standard management in high risk patients.

Detailed Description
-----------------
An objective analysis of postoperative complications is vital to escort octogenarian for gastric cancer surgery. Investigator carefully collected clinical data prospectively to pave way for standard management in high risk patients. Detailed data on surgical indication, assessment for proposed surgery and perioperative management are analyzed for future guidelines in senile.

Official Title
-----------------
Escorting Octogenarian for Gastric Cancer Surgery

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: gastric cancer surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Pathologically confirmed gastric cancer patients Clinically fit for gastric cancer surgery Exclusion Criteria: - Non gastric cancer patients Clinically unfit for gastric cancer surgery

Ages Eligible for Study
-----------------
Minimum Age: 80 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: gastric cancer surgery|Gastric cancer surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Morbidity and mortality | Postoperative Morbidity and mortality according to standard definition | One month after hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival | upto two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric cancer, postoperative complication, octogenarian
Macular Pigment Optical Density in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein and zeaxanthin, which are contained in vegetables and fruits. The highest concentrations of lutein and zeaxanthin are found in the fovea. Since light entering the eye passes through the MP before reaching the photo receptors it absorbs a significant portion of short-wavelength light. There is evidence that these absorbing properties of the MP as well as the ability of inactivating highly reactive oxygen species are protective for the retina. Measurement of macular pigment is difficult and the investigators have recently proposed a way of measuring macular pigment optical density (MPOD) based on optical reflectometry. There is increased interest in these measurements in the recent years, because a number of studies has provided evidence that low fruit and vegetable consumption increases the risk of age related macular degeneration (AMD). The present study investigates MP optical density (OD) in healthy volunteers and is used to form a database. Furthermore the nutritional habits and the influence on MP density will be evaluated.

Official Title
-----------------
Macular Pigment Optical Density in Healthy Subjects

Conditions
-----------------
Age Related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects without any signs of AMD Age between 18 and 90 years, (20 subjects aged between 18 and 40, 20 subjects aged between 41 and 50, 20 subjects aged between 51 and 60, 20 subjects aged between 61 and 70, 20 subjects aged between 71 and 80, 20 subjects aged between 81 and 90) Clear non-lenticular ocular media Visual acuity > 0.6 Exclusion Criteria: Any sign of AMD, or another retinal or optic nerve head disease Ocular surgery within the last 6 months Treatment with photosensitizing drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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>20 healthy subjects between 18 and 40 years | |
| 2<br>20 healthy subjects between 41 and 50 years | |
| 3<br>20 healthy subjects between 51 and 60 years | |
| 4<br>20 healthy subjects between 61 and 70 years | |
| 5<br>20 healthy subjects between 71 and 80 years | |
| 6<br>20 healthy subjects between 81 and 90 years | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MPOD as measured with optical reflectometry |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
macular pigment, to measure macular pigment in the retina
Pancreatic Exocrine Insufficiency After Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
Main proposed benefit of sleeve gastrectomy is loss of ghrelin secreting tissue. Some studies express that ghrelin augment pancreatic regeneration. Therefore we hypothesized that with sleeve gastrectomy it may result with pancreatic insufficiency.

Detailed Description
-----------------
Mechanism of weight loss differs in bariatric surgery according to type of surgery. With sleeve gastrectomy which has restrictive mechanism, ghrelin excretion decreases, and this condition is attributed as an additional mechanism in weight loss. Ghrelin effects pancreatic regeneration, and loss of ghrelin may result with pancreatic insufficiency. Therefore we aimed to deteremine this association.

Official Title
-----------------
Effect of Sleeve Gastrectomy on Pancreatic Exocrine Insufficiency.

Conditions
-----------------
Obesity, Morbid, Pancreatic Insufficiency

Intervention / Treatment
-----------------
* Procedure: SleeveGastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients underwent bariatric surgery (Sleeve gastrectomy) after concordonce with NIH criteria Exclusion Criteria: Additional operations to sleeve gastrectomy like duodenal switch. Other bariatric operations.

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 |
| --- | --- |
| SleeveGastrectomy<br>Sleeve Gastrectomy will be performed. Preoperative and Postoperative pancreatic enzyme sufficiency (with steatocrit or fecal elastase) will be compared. | Procedure: SleeveGastrectomy<br>* Preoperative enzyme test before and after sleeve gastrectomy. Sleeve Gastrectomy will be performed. Preoperative (in one month) and Postoperative (after 3 months) pancreatic enzyme sufficiency (with steatocrit or fecal elastase) will be compared.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatic excorine enzyme difference | Effect of operation on pancreatic excorine enzyme | post operative 3 months |
Soluble Dietary Fibres in the Prevention of Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Controlling the glycemic impact of foodstuffs (by reducing the glycemic load of the diet by using soluble dietary fibres) may reduce the glycemic or insulinemic response. This may in turn result in a reduced inhibition of postprandial fat oxidation rate and a lower plasma triacylglycerol concentration A higher postprandial fat oxidation may result in less lipid accumulation in non-adipose tissue thereby improving insulin sensitivity and the metabolic profile in the longer term.

Official Title
-----------------
Soluble Dietary Fibres as Dietetic Aid to Reduce the Risks of Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Other: Polydextrose and soluble gluco fibre


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overweight men and women Exclusion Criteria: regular smokers, athletes, diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: polydextrose<br> | Other: Polydextrose and soluble gluco fibre<br>* Polydextrose and soluble gluco fibre<br>|
| Experimental: soluble glucofibre<br> | Other: Polydextrose and soluble gluco fibre<br>* Polydextrose and soluble gluco fibre<br>|
| Placebo Comparator: isocaloric dietary control<br> | Other: Polydextrose and soluble gluco fibre<br>* Polydextrose and soluble gluco fibre<br>|
| Placebo Comparator: full caloric control<br> | Other: Polydextrose and soluble gluco fibre<br>* Polydextrose and soluble gluco fibre<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fat oxidation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24h glucose pattern |  |  |
Study to Evaluate Smecta® vs Placebo on the Time to Recovery Following an Acute Diarrhoea Episode in Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether Smecta® is more effective than placebo with respect to time to recovery following an acute diarrhoea episode.

Official Title
-----------------
Efficacy of Diosmectite (Smecta®) in the Treatment of Acute Diarrhoea in Adults. A Multicentre, Randomised, Double Blind, Placebo Controlled, Parallel Groups Study.

Conditions
-----------------
Diarrhea

Intervention / Treatment
-----------------
* Drug: Diosmectite (Smecta®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute diarrhoea episode defined as at least 3 watery stools per day for 48 hours or less Patient with, usually, normal bowel habits, i.e. at least 3 stools per week and no more than 3 stools per day Exclusion Criteria: Gross blood, pus in the stools Fever >39ºC Other episode of acute watery diarrhoea within the last 30 days History of chronic diarrhoea or motor diarrhoea

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: Diosmectite (Smecta®)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery ie time (hours) from the first sachet intake to the first formed stool (this formed stool must have been followed by a non-watery stool) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (hours) from first sachet intake to the last watery stool |  |  | 
| Number of stools and number of watery stools per 12 hour period |  |  | 
| % of patients with recovery, per 12 hour period |  |  | 
| % of patients with associated symptoms such as nausea, abdominal pain, anal irritation, per 12 hour period |  |  | 
| Global evaluation of efficacy by the patient at Day 4 and Day 8 visits by a mean Visual Analogue Scale (VAS) |  |  |
Influence of Sperm With Large Nuclear Vacuole on ICSI Outcomes

Study Overview
=================
Brief Summary
-----------------
Current research on sperm morphology has been directed towards the dysmorphisms of the sperm head. A new technique based on the motile sperm organelle morphology examination (MSOME) allows the detection of sperm with large nuclear vacuoles (SLV). Large nuclear vacuoles are specific sperm alterations observed under high magnification, and their presence has been related to increased DNA fragmentation and denaturation.

Detailed Description
-----------------
A new method for the detailed morphological evaluation of motile spermatozoa in real time, under high magnification, named motile sperm organellar morphology examination (MSOME) was developed. This magnification provides an accurate description of spermatozoa abnormalities, particularly the presence of head vacuoles, which is indicative of abnormal chromatin packaging in spermatozoa. However, the influence of sperm with large nuclear vacuoles (SLV) on ART outcomes is still a matter of debate. The goals for this study were to identify whether there is a connection between SLV under high magnification and ICSI outcomes.

Official Title
-----------------
Influence of Sperm With Large Nuclear Vacuoles on the Cycles' Outcomes of Couples Couples Undergoing ICSI

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Other: MSOME


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Couples undergoing intracytoplasmic sperm injection (ICSI) as result of male factor or tubal factor or unexplained infertility Women with regular menstrual cycles of 25-35 days Women with normal basal follicle stimulating hormone (FSH) and luteinizing hormone (LH) levels Women with body mass index (BMI) less than 30 kg/m2 Women with both ovaries and intact uterus Exclusion Criteria: Women with polycystic ovaries syndrome Women with endometriosis Women with gynaecological/medical disorders Couples with any sexually transmitted disease Women who had received any hormone therapy for less than 60 days preceding the study
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSOME<br>Couples in which the sperm cells were analysed through MSOME | Other: MSOME<br>* A total of 200 spermatozoa of each sample will be analyzed under high magnification (x6600) and the incidence of SLV (sperm cells presenting at least one vacuole that occupied > 13% of nuclear area) in each sample will be assessed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy | Number of clinical pregnancy rate divided by the number of couples in which embryo transfer was performed | 1 month |
Requests for Euthanasia and Assisted Suicide in Establishment of Accommodation for Dependent Old Persons.

Study Overview
=================
Brief Summary
-----------------
The main aim of this project is to analyze and understand the meaning of explicit requests to hasten death (euthanasia and assisted suicide) from older people living in an Establishment of accommodation for dependent old persons. This involves conducting interviews with patients, carers to whom the request has been expressed and a relative chosen by the patient. This study aims to describe the request over time. This will be done through two series of interviews, one as soon as it is first expressed, then one week later.

Official Title
-----------------
Requests for Euthanasia and Assisted Suicide in Establishment of Accommodation for Dependent Old Persons.

Conditions
-----------------
Aging, Qualitative Research, Euthanasia, Assisted Suicide

Intervention / Treatment
-----------------
* Other: qualitative interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: They live in an establishment of accommodation for dependent old persons They have to be ill. They have request for euthanasie or assisted suicide They are in capacity to meet researchers for interview, They aggreed to make an individual interview They are covered by the French social security system Exclusion Criteria: They have neurocognitives disorders that can't allow an individual interview They did not express themselves a request for euthanasia ou assisted suicide They disagreed to participate

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| qualitative interview<br>This study has only one arm | Other: qualitative interview<br>* individual qualitative interview<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative analyse | Describe, analyze and understand the content, the meaning and factors of evolution of euthanasia or assisted suicide's requests, by crossing the speech of residents, caregivers and family. | One year |
Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis

Study Overview
=================
Brief Summary
-----------------
The protocol will measure a number of cytokines in addition to vascular endothelial growth factor in response to 0.3mg Lucentis.

Detailed Description
-----------------
Lucentis injections are the current standard of care for diabetic macular edema. The only deviation from the standard of care in the current protocol is an aqueous tap before the first Lucentis injection and the fourth Lucentis injection for diabetic macular edema.

Official Title
-----------------
Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Lucentis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of diabetes mellitus Best corrected visual acuity 20/32 - 20/320 Diabetic macular edema involving the center of the macula Optical coherence tomography central subfield thickness of at least 250 microns Exclusion Criteria: History of anti-vascular endothelial growth factor treatment in the past 12 months Any diabetic macular edema treatment in the past 4 months Heart attack, stroke, transient ischemic attack or acute congestive heart failure within 4 months

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.3 mg Lucentis<br>Aqueous Humor sample post injection of 0.3 mg Lucentis | Drug: Lucentis<br>* 0.3mg Lucentis<br>* Other names: Aqueous Tap;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular Endothelial Growth Factor Levels | An aqueous humor specimen was obtained at baseline and at 12 weeks to determine if the levels of VEGF had decreased with treatment. | 12 weeks |