linjc16/ctgov huggingface dataset:
Large-scale ex Vivo Expansion and Characterization of Two Kinds of MSC From Knee for Clinical Application

Study Overview
=================
Brief Summary
-----------------
According to many researches, mesenchymal stem cells (MSC) isolated from synovial membrane and infrapatellar fat pad have higher ex vivo proliferation capacity, multipotency and ability to undergo chondrogenesis. Based on this concept, the investigators plan to get two removed tissues (synovial membrane and infrapatellar fat pad) from patients who have an operation of TKR (Total Knee Replacement). The investigators are going to isolate and expand MSC from these two tissues respectively, and then compare their characterization and potential for clinical application. In the other hand, the investigators plan to build techniques and procedures which comply with Good Tissue Practices (GTP).

Official Title
-----------------
Large-scale ex Vivo Expansion and Characterization of Synovial Membrane MSC (SM-MSC) and Infrapatellar Fat Pad MSC (IF-MSC) for Clinical Application

Conditions
-----------------
Knee Injuries

Intervention / Treatment
-----------------
* Biological: MSC from synovial membrane and infrapatellar Fat Pad


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who have an total knee replacement surgery Exclusion Criteria: Patient who don't sign the agreement

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 |
| --- |
|Biological: MSC from synovial membrane and infrapatellar Fat Pad|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare MSCs from synovial membrane and infrapatellar fat pad | Comparison items include doubling time, phenotype, chondrogenesis and biological activity. | 2 months |
Evaluation of the Avaulta Procedure for the Correction of Pelvic Organ Prolapse - Results at 1 Year

Study Overview
=================
Brief Summary
-----------------
This study is a 1 year review of all patients who had surgery to correct pelvic organ prolapse (i.e. cystocele, rectocele, enterocele) using the Avaulta synthetic mesh kit.

Detailed Description
-----------------
This is a retrospective cohort analysis of all patients who experienced vaginal prolapse and were operated on with the Avaulta synthetic vaginal mesh kit from January 2006 to April 2007. The Avaulta synthetic mesh is composed of polypropylene which is a monofilament. The objective of this trial is to compare patients objectively and subjectively at least one year after placement of the Avaulta synthetic vaginal mesh in terms of prolapse symptoms. This data will be compared to pre-operative data already collected for these patients as a part of their routine surgical work-up. Mesh-related complications will be quantified, including erosions, new-onset pain, and infections. Success and anatomic recurrence rates will be recorded as well

Official Title
-----------------
Retrospective Cohort of the Avaulta Vaginal Mesh Procedure as a Treatment of Pelvic Organ Prolapse

Conditions
-----------------
Pelvic Organ Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patiAll patients who underwent surgery with the Avaulta synthetic mesh kit from 1/06 - 4/08. Exclusion Criteria: Unable to give informed consent to participate

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

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

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 |
| --- | --- | --- |
| Anatomical success rates 1 year after surgery to correct pelvic organ prolapse with the Avaulta synthetic mesh kit |  | 1 year post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mesh complications 1 year after surgery with the Avaulta synthetic mesh kit |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic Organ Prolapse, Cystocele, Rectocele, Enterocele, Synthetic Mesh, Vaginal Mesh, Transobturator
Cognitive-Behavioural and Hypnotic Treatment of Chronic Primary Insomnia Among the Elderly

Study Overview
=================
Brief Summary
-----------------
The present study examines the short- and long-term clinical efficacy of cognitive-behavior therapy and pharmacological treatment in patients suffering from late-life primary insomnia. 46 subjects suffering from chronic primary insomnia were randomized into either cognitive-behavior therapy (CBT, n=18), hypnotics (7.5 mg Zopiclone, n=16), or placebo treatment (n=12). All active treatments lasted 6 weeks with follow-ups conducted at 6 months. Ambulant clinical polysomnography (PSG) and sleep diaries were used on all three assessment points.

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Behavioral: Cognitive behavior therapy (CBT)
* Drug: Zopiclone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 55 years or older fulfilment of the DMS-IV criteria for insomnia, including difficulties initiating sleep, maintaining sleep, and/or early morning awakenings with no ability of return to sleep duration of at least 3 months complaints of impaired daytime functioning. Exclusion Criteria: use of hypnotic medication the last 4 weeks before project start use of antidepressive or antipsychotic medications signs of dementia or other serious cognitive impairment defined by a score under 25 on the Mini-Mental State Examination presence of a major depressive disorder or other severe mental disorder as identified by a clinical assessment based on The Structured Clinical Interview for DSM-IV (SCID-I) presence of sleep apnea defined as (A/H index > 15) or periodic limb movements during sleep (PLM index with arousal > 15), working nightshifts and unable or unwilling to discontinue this work pattern, willingness or inability to stop taking sleep medication before start having a serious somatic conditions preventing further participation

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Cognitive behavior therapy (CBT)|nan|
|Drug: Zopiclone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Renal Function During Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
Aim of this study was to investigate the cardiac and renal responses to the administration of different amount of crystalloids, with and without dopamine, during gynaecological laparoscopic surgery.

Official Title
-----------------
Dopamine Infusion and Crystalloids Administration Improve Renal Function During Laparoscopic Surgery

Conditions
-----------------
Intra Operative Fluid Management

Intervention / Treatment
-----------------
* Drug: Dopamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I age 24-42 patients undergoing gynaecological laparoscopy Exclusion Criteria: cardiovascular diseases renal and endocrine disorders obesity (BMI > 30 Kg/m2) the assumption of drugs that could interfere with renal parameters considered in the study

Ages Eligible for Study
-----------------
Minimum Age: 24 Years
Maximum Age: 42 Years

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

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

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 |
| --- | --- |
| No Intervention: control<br>Patients received intravenously saline solution at 5 ml/Kg/h | |
| Experimental: dopamine<br>Patients received intravenously saline solution at 5 ml/Kg/h and dopamine at 3 mcg/Kg/min | Drug: Dopamine<br> <br> * Other names: Revivan;|
| No Intervention: crystalloids<br>Patients received intravenously saline solution at 10 ml/Kg/h | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimated glomerular filtration rate, tissue Doppler imaging, E/Ea | EGFr, tissue Doppler imaging and E/Ea are registered after the induction of pneumoperitoneum and Trendelemburg position, and compared to those registered before the induction of anesthesia. | patients will be followed for the duration of surgery, an expected average of 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total intra operative diuresis (TID) | TID will be measured at the end of surgery | patients will be followed for the duration of surgery, an expected average of 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dopamine, laparoscopy, fluid management
Delayed Visual Maturation: Outcome and Predictive Factors

Study Overview
=================
Brief Summary
-----------------
The objectives of the study are to describe the developmental outcome in a population of children with delayed visual maturation.

Detailed Description
-----------------
description of the developmental outcome of children with delayed visual maturation.

Official Title
-----------------
Delayed Visual Maturation: Outcome and Predictive Factors

Conditions
-----------------
Delayed Visual Maturation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants (male or female) with suboptimal/absent visual contact at the age of ≥3 months, without other known general developmental delay at the time diagnosis of delayed visual contact and without anatomic ocular abnormalities at the initial ophthalmological examination. Exclusion Criteria: Children with known underlying psychomotor developmental delay or epilepsy at first ophthalmic consultation. Children with ophthalmic (anatomical) abnormalities that explain delayed visual maturation.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum 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 |
| --- | --- |
| delayed visual maturation<br>children with delayed visual maturation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delayed visual maturation. | the prevalence of developmental problems in children with delayed visual maturation. | 1998-2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of development | by questionnaire:type of education/school , problems with writing, mathematics: yes or no | 1998-2016 | 
| Fine and gross motor skills | by questionnaire: physiotherapy needed yes or no | 1998-2016 | 
| ophthalmological problems | by questionnaire : visual problems, wearing glasses? taped eyes? | 1998-2016 | 
| Visual acuity | assested at the last consultation indicated in Snellen | 1998-2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
delayed visual maturation
Prediction of Intra-abdominal Adhesion Before CS

Study Overview
=================
Brief Summary
-----------------
Recognition of intraabdominal adhesion before doing repeated cesarean section is helpful for the surgeon and patients.

Detailed Description
-----------------
the repeated cesarean section is associated with recorded maternal morbidity including placenta preavia and accreta , liability to injuries to the bladder, intestine or vascular injuries. The anticipation of the problem is important for decreasing its adverse effect . preoperative diagnosis of pelvic adhesion between the uterus and anterior abdominal wall, bladder, intestine or omentum could b of help to give time for a surgeon to prepare senior staff obstetrician or others and theatre requirements to overcome any problem happened.

Official Title
-----------------
Prediction of Intra-abdominal Adhesion Before CS: A Diagnostic Test Study

Conditions
-----------------
Intra-Abdominal; Adhesion

Intervention / Treatment
-----------------
* Diagnostic Test: sliding test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant in their 9th-month singleton, planned for elective CS and had a history of previous CS Exclusion Criteria: included multiple pregnancies, preterm labour, emergency CS, skin burn at the site of CS

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 39 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| repeated caesarean section<br>full term pregnant women with singleton baby with a history of at least previous one caesarean section | Diagnostic Test: sliding test<br>* ultrasound detected sliding test before doing repeated caesarean section<br>* Other names: ultrasound detected sliding test;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra-abdominal adhesion | presence of adhesion between uterus and abdominal wall or intestine on bladder | intra-operative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin to uterine incision time | time consumed by surgeon from skin incision to uterine incision in minutes | intra-operative period | 
| need to insert intra-peritoneal drain | if there in marked adhesion and vascular injury a drain could be inserted | intraoperative period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sliding test , ceaserean section
To Evaluate the Safety of Duloxetine in Patients With Stress Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
The patients are being followed in this study to determine the safety of taking the medication Duloxetine for a long period of time. The patients participating in this study suffer from Stress Urinary Incontinence.

Official Title
-----------------
Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Drug: Duloxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Successfully completed the protocol for Study F1J-MC-SBAV. - Exclusion Criteria: Treatment with a drug, not including study medication, that has not received regulatory approval at the time of study entry. Use of excluded medications within 14 days prior to study entry or at any time during the study. -

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

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

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: Duloxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence(SUI). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect data to demonstrate the maintenance of effect of duloxetine as measured by Patient Global Impression of Improvement (PGI-I) questionnaire. |  |  |
Clinical Values of Mature Fistulas in Hemodialysis

Study Overview
=================
Brief Summary
-----------------
The arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis(HD), and fistula-first is the general recommendation for all HD patients. But in clinical practice in China, quite a few patients start HD before AVF maturation due to various situations. Whether HD initiation with mature AVF will influence the patency and complications is controversial. This study is aim to compare the AVF patency in incident HD patients with mature or immature AVF on HD initiation, and to compare other clinical outcomes, including abandonment without use, infection, and other AVF complications occurrence.

Official Title
-----------------
Clinical Values of Mature Fistulas in Hemodialysis

Conditions
-----------------
Hemodialysis Access Failure, Hemodialysis Complication

Intervention / Treatment
-----------------
* Procedure: AVF puncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: underwent initial upper-extremity AVF creation for incident HD at Zhongshan Hospital, Fudan University Exclusion Criteria: with malignancies not followed-up at Zhongshan Hospital, Fudan University

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| mature AVF<br>Patients initiate HD with mature AVF. | Procedure: AVF puncture<br>* For patients with mature/immature AVF on HD initiation, AVF puncture will be conducted.<br>|
| immature AVF<br>Patients initiate HD with immature AVF. | Procedure: AVF puncture<br>* For patients with mature/immature AVF on HD initiation, AVF puncture will be conducted.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AVF patency | A functional AVF was defined as allowing at least six adequate HD sessions without any AVF-related complications. Primary AVF patency was defined as the interval from HD initiation via a functional AVF to any intervention designed for maintenance or reestablishment of AVF function, AVF failure, or study end, whichever occurred first, and secondary AVF patency was defined as the interval from HD initiation via an AVF until the termination of HD via AVF due to any cause, regardless of the number of subsequent interventions. | June 2020 to June 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abandonment without use, infection, and other complications of AVF creation. | Abandonment without use, infection, and other complications of AVF creation. | June 2020 to June 2021 |
Randomized Parallel Group Trial Of The Efficacy And Safety Of Ezetimibe With A Statin Versus Statin Dose Doubling In Patients With Persistent Primary Hypercholesterolemia (0653-152)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
To compare the percent (%) change in plasma LDL-C concentration, after a six week course of treatment with ezetimibe 10 mg/day co-administered with an existing statin versus doubling of the existing statin dose

Official Title
-----------------
Randomized Parallel Group Trial Of The Efficacy And Safety Of Ezetimibe With A Statin Versus Statin Dose Doubling In Patients With Persistent Primary Hypercholesterolemia

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: ezetimibe
* Drug: statins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients With A Diagnosis Of Primary Hypercholesterolemia And Who Are Defined As Being High Risk (10-Year Risk Of Coronary Artery Disease > 20 % Based On The Framingham Model Or History Of Diabetes Mellitus Or Any Atherosclerosis Disease) And Have Not Reached Their Recommended Ldl-C Target Levels Of 2.5 Mmol/L While On A Statin Alone Exclusion Criteria: -

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br>group 1: ezetimibe 10 mg per day is added to actual statin regimen for 6 weeks followed by an observational phase of 6 months. | Drug: ezetimibe<br>* ezetimibe 10 mg/day for a six week course of treatment.<br>* Other names: MK0653;Drug: statins<br>* patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase<br>|
| Active Comparator: Group 2<br>Group 2: patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase. | Drug: statins<br>* patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary measure of efficacy will be the percent change in plasma LDL-cholesterol between baseline and the final study assessment after six weeks of treatment. |  | 6 weeks |