linjc16/ctgov huggingface dataset:
Effect of Dietary Fiber on Glucose & Lipids in Non Insulin Dependent Diabetes Mellitus (NIDDM)

Study Overview
=================
Brief Summary
-----------------
Effect of Dietary Fiber on glucose, lipid, and mineral metabolism in patients with non insulin dependent diabetes mellitus.

Detailed Description
-----------------
Two diets will be compared,a low fiber diet and a high fiber diet. These two diets will differ only in the content of total dietray fiber derived from natural food products. The diets will be identical in terms of total energy, percentage of total energy as proteins, fat and carbohydrates.

Official Title
-----------------
Effect of Dietary Fiber on Glucose, Lipid, and Mineral Metabolism in Patients With Non Insulin Dependent Diabetes Mellitus

Conditions
-----------------
Non-Insulin-Dependent Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: High Fiber and Moderate Fiber Diets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NIDDM age 35 to 80 years stable oral hypoglycemic treatment for at least one month fasting triglycerides < 500 mg/dl Exclusion Criteria: insulin dependent NIDDM insulin dependent diabetes hepatic disease significant hepatic dysfunction signifiacnt renal dysfunction presence of significant hematological, neurological, cardiovascular or gastrointestinal disorder, unless stable for past 6 months, serious intercurrent illness or anticipated major surgery female pregnant or likely to become pregnant chronic drug abuse, alcoholism or psychaitric disorder within the past 2 years treated with beta adrenergic blockers on lipid lowering drugs

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>High Fiber Diet | Other: High Fiber and Moderate Fiber Diets<br>* Dietary<br>* Other names: Dietary Fiber Study;|
| Active Comparator: 2<br>Moderate Fiber Diet | Other: High Fiber and Moderate Fiber Diets<br>* Dietary<br>* Other names: Dietary Fiber Study;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose and lipid metabolism |  | Baseline and during the last 5 days of each 6 week dietary phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| calcium isotope absorption in the gastrointestinal tract, stool mineral content, 24 h urinary mineral concentration, and serum chemistry including mineral concentration. |  | Baseline and during the last 5 days of each 6 week dietary phase | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, lipids, fiber
Efficacy of Quetiapine in Generalised Social Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
This trial will explore the efficacy of quetiapine in Social Anxiety Disorder, generalized type. The following elements of response will be tested: number of responders to treatment, time to response, effect size as measured with the LSAS

Official Title
-----------------
Efficacy of Quetiapine in Generalised Social Anxiety Disorder, a Double-blind, Placebo-controlled Study

Conditions
-----------------
Social Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: quetiapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written Confirmed Consent, All patients meet the DSM IV criteria for generalized social anxiety disorder, A score ≥ 60 on the LSAS, male and female aged between 18 and 65 years Exclusion Criteria: Presence of any primary axis I diagnosis other than social anxiety disorder according to DSM-IV, alcohol and/or substance abuse according to DSM-IV criteria within the last 12 months, any personality disorder as the primary diagnosis, with the exception of avoidant personality disorder, patients at risk of suicide

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: quetiapine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on Lebowitz Social Anxiety Scale (LSAS) from baseline to endpoint |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of responders, time to onset of response of sustained response to treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with SAD
Sexual Health Impact of Using Pre-exposure HIV Prophylaxis

Study Overview
=================
Brief Summary
-----------------
Epidemiological and psychosociological survey of people on pre-exposure HIV prophylaxis (PrEP).

Detailed Description
-----------------
This study is perform to study the sexual health satisfaction of men who have sex with men (MSM), since the use pre-exposure HIV prophylaxis (PrEP), compared to the time before PrEP.

Official Title
-----------------
Sexual Health Impact of Using Pre-exposure HIV Prophylaxis

Conditions
-----------------
Pre-exposure HIV Prophylaxis (PrEP)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient, male having sex with men, not infected with HIV, and using HIV prophylaxis by pre-exposure treatment (PrEP) for at least 1 year, received in consultation for renewal of this prescription. Able to give his non-opposition to participate in the research. Affiliation to a social security scheme. Exclusion Criteria: Patient under curatorship/guardianship or safeguard of justice Refusal to participate

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

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

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 |
| --- | --- | --- |
| Sexual health satisfaction | To study the sexual health satisfaction of men who have sex with men (MSM), since the use of HIV prophylaxis by pre-exposure treatment (PrEP), compared to the time before PrEP. | 1 day during the scheduled consultation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sentimental satisfaction | To study the sentimental satisfaction since the use of HIV prophylaxis by treatment before exposure (PrEP), compared to the time before PrEP. | 1 day during the scheduled consultation | 
| Risky behaviours | To study risky behaviours without, then on PrEP since the use of HIV prophylaxis by treatment before exposure (PrEP), compared to the time before PrEP. | 1 day during the scheduled consultation | 
| Specific care | Describe the use of specific care during PrEP. | 1 day during the scheduled consultation | 
| Predictors of satisfaction | Define possible predictors of satisfaction with PrEP. | 1 day during the scheduled consultation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PrEP, MSM
Predictive Value of β2-microspheres for Postoperative Delirium

Study Overview
=================
Brief Summary
-----------------
This study evaluated the predictive value of β2-microspheres for postoperative delirium (POD) in the elderly after orthopedic surgery. For this purpose, the levels of β2-microspheres in plasma and cerebrospinal fluid were compared between the POD and non-POD groups.

Detailed Description
-----------------
In this study, plasma and cerebrospinal fluid of the patients were collected to detect the levels of β2-microspheres before operation. Also, the patients were interviewed one day before the surgery and on postoperative days 1-3 by the Confusion Assessment Method and then divided them into POD and non-POD groups. The aim of the present study was to assess whether higher levels of β2-microspheres could predict the occurrence of POD.

Official Title
-----------------
The Predictive Value of β2-microspheres for Postoperative Delirium in the Elderly After Orthopedic Surgery

Conditions
-----------------
Postoperative Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥65 years old, American Standards AssociationⅠ-Ⅲ, undergoing orthopedic operations under spinal anesthesia Exclusion Criteria: decline to participate

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| POD group<br>POD group refers to the patients who were diagnosed to be delirious by the Confusion Assessment Method. | |
| Non-POD group<br>Non-POD refered to the patients who did not become delirious by the Confusion Assessment Method. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of POD | The patients were interviewed one day before the surgery and on postoperative days 1-3 by the Confusion Assessment Method and then divided them into POD and non-POD groups. | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The levels of β2-microspheres in plasma and cerebrospinal fluid | Before surgery, plasma and cerebrospinal fluid of the patients were collected to detect the levels of β2-microspheres. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delirium β2-microspheres
Post-treatment Novmalized Urodynamiz Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug

Study Overview
=================
Brief Summary
-----------------
Post-treatment Novmalized Urodynamiz Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug and Its Conelations With Voiding Diary, King's Health Quentionaire, Overactive Bladder Sympton Scores and Patient Perception of Bladder Condition.

Official Title
-----------------
Post-treatment Normallized Urodynamic Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug and Its Correlations With Voiding Diary, King's Health Questionnaire, and Overactive Bladder Sympto

Conditions
-----------------
Overactive Bladder Syndrome

Intervention / Treatment
-----------------
* Drug: Solifenacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female patients within 18 years old to 99 years old with overactive bladder syndrome Exclusion Criteria: unwilling or unable to perform testing procedure

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

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

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: antimuscariniz drug<br> | Drug: Solifenacin<br>* Solifenacin 5 mg qd,<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of normalized urodynamic pattern after treatment |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of recurrence rates after treatment during follow-up and further to analyze the risk factors of recurrence |  | 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overactive bladder syndrome, derusor overactivity, urodynamic studies, bladder oversensitivity
Intraperitoneal Pressure Measurements in Children

Study Overview
=================
Brief Summary
-----------------
Pediatric peritoneal dialysis is prescribed according to the type of dialysis, the volume infused and the dialysis time. The measurement of intraperitoneal pressure (IPP) is an important and easy indicator to perform. A IPP greater than 18 cmH20 has been correlated with pain and dyspnea, a IPP greater than 14 has been correlated with a higher risk of peritonitis and a IPP greater than 13 was correlated with higher mortality and a switch on hemodialysis. These data suggest the importance of routine IPP measurement. Few data are available in the pediatric population.

Official Title
-----------------
Intraperitoneal Pressure Measurements in Children: a Retrospective Study

Conditions
-----------------
Peritoneal Dialysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Minor subject (<18 years old) In stable peritoneal dialysis for more than 3 months Subject having had at least 3 IPP measurements At least 3 months after surgery to insert a peritoneal dialysis catheter Subject (and / or his parental authority) not having expressed, after being informed, his opposition to the reuse of his data for the purposes of this research. Exclusion criteria: - -Subject (or his parents) having expressed his (their) opposition to participating in the stud

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of good prescribing practices in children followed by peritoneal dialysis at Strasbourg University Hospital, by intraperitoneal pressure measurements |  | Files analysed retrospectively from January 01, 2001 to August 31, 2019 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peritoneal Dialysis
Study to Compare the Blood Levels of Sildenafil Following Administration of an Experimental Tablet vs. the Conventional Oral Tablet in Healthy Subjects.

Study Overview
=================
Brief Summary
-----------------
This study to will compare the blood levels of sildenafil following administration of an experimental tablet vs. the conventional oral tablet.

Official Title
-----------------
An Open-Label, Crossover Study In Healthy Volunteers To Evaluate The Pharmacokinetics Of Sildenafil Following Administration Of An Experimental Tablet Of Sildenafil With Or Without Water Relative To Viagra® Conventional Oral Tablet With Water.

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

Intervention / Treatment
-----------------
* Drug: Sildenafil
* Drug: Sildenafil
* Drug: Sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males between the ages of 18 and 55 years. Body Mass Index of 18 to 30 kg/m2, and a total body weight >50 kg (110 lbs). Exclusion Criteria: Smoking in excess of the equivalent of 5 cigarettes per day. Treatment with an experimental drug within 30 days or sildenafil, vardenafil, tadalfil within 4 days before first study dose. Develop blood pressure lowering or experience dizziness, lightheadedness when going from the laying down position to standing position.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Oral Tablet With Water<br> | Drug: Sildenafil<br>* Single Dose of 50 mg Sildenafil Oral Tablet With Water<br>|
| Experimental: Experimental Tablet With Water<br> | Drug: Sildenafil<br>* Single Dose of 50 mg Sildenafil Experimental Tablet With Water<br>|
| Experimental: Experimental Tablet Without Water<br> | Drug: Sildenafil<br>* Single Dose of 50 mg Sildenafil Experimental Tablet Without Water<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of sildenafil |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of a metabolite of sildenafil |  | 1 day | 
| Safety |  | 1 day |
Artificial Intelligence System for Assessing Image Quality of Fundus Images and Its Effects on Diagnosis

Study Overview
=================
Brief Summary
-----------------
Fundus images are widely used in ophthalmology for the detection of diabetic retinopathy, glaucoma and other diseases. In real-world practice, the quality of fundus images can be unacceptable, which can undermine diagnostic accuracy and efficiency. Here, the researchers established and validated an artificial intelligence system to achieve automatic quality assessment of fundus images upon capture. This system can also provide guidance to photographers according to the reasons for low quality.

Official Title
-----------------
Artificial Intelligence System for Assessing Image Quality of Fundus Images and Its Effects on Diagnosis: A Clinical Trial

Conditions
-----------------
Retinal Diseases, Artificial Intelligence

Intervention / Treatment
-----------------
* Device: Taking a fundus image


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients should be aware of the contents and signed for the informed consent. Exclusion Criteria: 1. Patients who cannot cooperate with a photographer such as some paralytics, the patients with dementia and severe psychopaths. 2. Patients who do not agree to sign informed consent.
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 |
| --- | --- |
| Fundus image quality assessment<br>Device: an artificial intelligence system for quality assessment of fundus images. These patients are enrolled in primary healthcare units or the AI clinic at Zhongshan Ophthalmic Center. | Device: Taking a fundus image<br>* The participant only needs to take a fundus image as usual.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of artificial intelligence system for distinguish between good image quality and poor image quality | Area under the receiver operating characteristic curves, sensitivity, specificity, positive and negative predictive values, accuracy | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The comparison of the performance for previous artificial intelligence diagnostic system with fundus images of different image quality | Cohen's kappa coefficient, P value and other related statistic results | 3 months |
Clinical Study to Investigate the Pharmacokinetics and Pharmacodynamics of Metformin in the Elderly

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the pharmacokinetics/pharmacodynamics metformin IR after oral administration in healthy elderly male volunteers.

Official Title
-----------------
A Phase I Clinical Study to Investigate the Pharmacokinetics and Pharmacodynamics of Metformin in Elderly Healthy Male Volunteers

Conditions
-----------------
Healthy Elderly

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males aged 65-85 years with a body mass index (BMI) of 18-28 kg/m2 Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations including hematology (blood cell count, hemoglobin, and platelet count), liver function test (aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin), serum creatinine, blood glucose and urinalysis Exclusion Criteria: If they had clinically relevant disorders Past history of diabetes or clinical findings to suspect diabetes Abnormal clinical laboratory values (i.e., platelets ≤ 75,000/mm3, hemoglobin ≤ 9 g/dL, neutrophils absolute ≤ 1000/mm3, fasting glucose > 126mg/dL, creatinine ≥ 1.5 mg/dL, or AST, ALT > 3 × upper limit of normal)

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 85 Years

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

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: Metformin<br>Metformin 750mg(D1), Metformin 500mg(D2) | Drug: Metformin<br> <br> * Other names: Diabex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(area under the plasma concentration-time curve) | AUC(area under the plasma concentration-time curve), Cmax(maximum plasma concentration), t1/2 | Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUGC(total area under the serum concentration-time curve for glucose concentration) | AUG (total area under the serum concentration-time curve for glucose) Gmax(maximum serum glucose concentration) | predose and 15, 30, 45, 60, 90, 120 min oral glucose tolerance test | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metformin, Pharmacokinetics/ Pharmacodynamics