linjc16/ctgov huggingface dataset:
Laparoscopic Retrovesical Colpopectinopexia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify whether a new operative technic would be acceptable in female with pelvic organ prolapse.

Detailed Description
-----------------
A new operative technic use to treat pelvic organ prolapse in women. Investigators plan to evaluate the results of procedure in the field of recurrence rate, effectiveness, mortality,morbidity and learning curves.

Official Title
-----------------
Laparoscopic Retrovesical Colpopectinopexia in Treatment Pelvic Organ Prolapse

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

Intervention / Treatment
-----------------
* Procedure: laparoscopic retrovesical colpopectinopexia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all female with cystocele 1-2-3 grade? hysterocele 1-2 (POP-Q) Exclusion Criteria: rectocele more then 1 grade (POP-Q) hysterocele more then 2
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Other: laparoscopic retrovesical colpopectinopexia<br>new operative technic | Procedure: laparoscopic retrovesical colpopectinopexia<br>* Laparoscopic correction of pelvic organ prolapse using a mesh in retrovesical space with pectineal ligament fixation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POP-Q assessment | assessment of vaginal wall accordion to POP-Q score | first post operation day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POP-Q assessment | assessment of vaginal wall accordion to POP-Q score | 6 month after operation | 
| POP-Q assessment | assessment of vaginal wall accordion to POP-Q score | 1 year after operation |
Knee Hinge Prosthesis Following TKA Infection

Study Overview
=================
Brief Summary
-----------------
Between 2009 and January 2016, the investigators included 49 patients from four hospitals in Lyon who had a Total Knee Arthroplasty (TKA) infection and who benefited of a knee arthroplasty revision with a rotating hinge prosthesis. This retrospective and descriptive cohort aims at studying the functional results after 2 years follow up.

Official Title
-----------------
Rotating Hinge Knee Arthroplasty for Septic Revision After Total Knee Arthroplasty: a Retrospective Cohort About 50 Patients With 2 Years Follow up

Conditions
-----------------
TKA Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All the patients who had a rotating hinge knee arthroplasty for septic revision after total knee arthroplasty, proved by bacteriological samples or purulent drainage at involved site or other obvious clinical signs or radiological signs of infection Exclusion Criteria: - Patients who benefited of a hinge prosthesis following a unicompartmental prosthesis, following a mechanical issue on a total prosthesis

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 91 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 |
| --- | --- | --- |
| functional results | Objective functional results : joint motions (Physician assessment) | at two years follow up | 
| functional results | Subjective functional results : satisfaction, patient expectations, functional activities. These items are based on the new IKS score | at two years follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infection control | presence or absence of clinical and/or biological signs of infection, recurrence of the infection or new secondary infection | after 2 years follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hinge Knee Prosthesis, TKA infection, rotating hinge prosthesis, hinge knee arthroplasty
Fear of Hypoglycemia and Glycemic Variability

Study Overview
=================
Brief Summary
-----------------
Subjects with type 1 diabetes are invited to provide usual blood glucose monitoring and a blood glucose profile (Pre/ post prandial Blood Glucose + Night Blood Glucose) on 3 occasions in a 2 week time period, in addition to the filling of 5 questionnaires including fear of hypoglycemia-2 questionnaire.

Detailed Description
-----------------
Subjects with type 1 diabetes are invited to provide usual blood glucose monitoring and a blood glucose profile (Pre/ post prandial Blood Glucose + Night Blood Glucose) on 3 occasions in a 2 week time period, in addition to the filling of questionnaires including fear of hypoglycemia-2 questionnaire. Biobanking of urine/blood Collection of key medical informations by investigators Questionnaires : socio-economic status Fear of hypoglycemia-2 Anxiety Depression scale (HAD) Health survey (SF36, SF12) Satisfaction to treatment (DHP-18) Dutch Eating Behavior Questionnaire (DEBQ) Pittsburgh quality of sleep (PSQI) Blood Glucose diary

Official Title
-----------------
Peur De l'Hypoglycémie et Variabilité Glycémique Chez Les Sujets Diabétiques de Type 1

Conditions
-----------------
Type 1 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : type 1 diabetes at least 2 Blood Glucose monitoring daily on insulin for more than 5 years Exclusion Criteria : not stable metabolic condition (infection, steroid therapy) below 3 months change in insulin treatment other clinical trial renal failure (eDFG below 30 ml/min/1.73 m²) Pregnancy and/or lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Fear of hypoglycemia score | hypoglycemia questionnaire and hypoglycemia reported by patients | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | SF12 questionnaire done once at home and sent at least 2 weeks after onsite visit | from 2 weeks up to 3 months | 
| Standard Deviation (SD) of recorded Home Monitoring of Blood Glucose (HMPG) | reports of 2 weeks 4 points profil of HMPG and 3 days of 7 points profil of HMPG | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes
Study to Evaluate the Immune Response to Pneumococcal Vaccine in Alefacept-treated Adults With Chronic Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
A vaccine causes the immune system to produce antibodies (immune response) to specific germs to protect the patient. This study evaluates the immune response to the pneumococcal vaccine in adults with Alefacept-treated chronic plaque psoriasis.

Detailed Description
-----------------
This is a 1 arm study designed to evaluate the immune response to pneumococcal vaccine in adults with Alefacept-treated chronic plaque psoriasis.

Official Title
-----------------
An Open-Label Phase 4 Study in Adult Patients With Chronic Plaque Psoriasis to Evaluate the Immune Response to Pneumococcal Vaccine in Subjects Treated With Alefacept

Conditions
-----------------
Chronic Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: alefacept
* Drug: polyvalent pneumococcal vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has chronic plaque psoriasis Subject has at least 5% body surface area affected with psoriasis Exclusion Criteria: Skin disorder other than plaque psoriasis in affected area Previously immunized with any pneumococcal vaccine Subject has pustular or erythrodermic psoriasis Subject is immunocompromised Six or more herpes simplex virus outbreaks per year History or malignancy, chronic serious infection or hepatic disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: alefacept<br>* Intramuscular<br>* Other names: ASP0485;Drug: polyvalent pneumococcal vaccine<br>* Injection<br>* Other names: PNEUMOVAX® 23;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number and percentage of subjects with at least a 2-fold increase in 2 or more of 5 pneumococcal antibody titers. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number and percentage of subjects with an antibody response to pneumococcal antigens |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psoriasis, alefacept, polyvalent pneumococcal vaccine, Immunization
Assessment of the V600E Mutation in the B-RAF Gene in Chronic Lymphoproliferative Disease

Study Overview
=================
Brief Summary
-----------------
The presence of a specific mutation in the gene known as B-RAF has been found in patients who have Hairy Cell Leukemia. In this study this specific mutation known as V600E will be ascertained in peripheral blood samples of patients who have this disease and in a group of patients who have a similar chronic lymphoproliferative conditions such as splenic marginal lymphoma. The finding of this specific mutation will help to verify or exclude the diagnosis of Hairy Cell Leukemia and determine whether patients are in remission.

Official Title
-----------------
Assessment of the V600E Mutation in the B-RAF Gene in Chronic Lymphoproliferative Disease.

Conditions
-----------------
Hairy Cell Leukemia, Splenic Marginal Zone Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over the age of 18 years - Exclusion Criteria: Patients less than 18 years in age or mentally defectives. -

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 |
| --- | --- | --- |
| detection of the B-RAF V600E mutation |  | 2 weeks |
Lateral Sagittal vs Costoclavicular Brachial Plexus Block in Children

Study Overview
=================
Brief Summary
-----------------
Costoclavicular approach has lots of advantages compared to the lateral sagittal approach for infraclavicular brachial plexus block. Although the efficacy of this block has been demonstrated in adults, there are no randomized controlled trials in the literature on the application of pediatric patients. Our aim was to compare the ultrasound-guided infraclavicular and costoclavicular approach in pediatric patients.

Official Title
-----------------
The Comparison of Lateral Sagittal vs Costoclavicular Brachial Plexus Block in Children

Conditions
-----------------
Hand Injuries and Disorders, Forearm Injuries

Intervention / Treatment
-----------------
* Drug: Lidocaine and Bupivacaine solution
* Device: Costoclavicular block
* Device: Lateral Sagittal block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-II patients Patients who will undergo hand or forearm surgery Exclusion Criteria: Infection in the area to be injected Coagulopathy, Previously known neurological damage

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 15 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Lateral Sagittal<br>Ultrasound-Guided lateral sagittal brachial plexus block with 1:1 ratio 2% lidocaine, and 0.5% bupivacaine | Drug: Lidocaine and Bupivacaine solution<br>* 1:1 ratio 2% lidocaine, and 0.5% bupivacaine<br>Device: Lateral Sagittal block<br>* Ultrasound-guided lateral sagittal brachial plexus block<br>|
| Active Comparator: Group Costoclavicular<br>Ultrasound-Guided costoclavicular brachial plexus block with 1:1 ratio 2% lidocaine, and 0.5% bupivacaine | Drug: Lidocaine and Bupivacaine solution<br>* 1:1 ratio 2% lidocaine, and 0.5% bupivacaine<br>Device: Costoclavicular block<br>* Ultrasound-guided costoclavicular brachial plexus block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Block performance time | The time interval between the contact of the ultrasound probe to skin and end of local anesthetics injection. | Twenty minutes before surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog pain score | Pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) | Postoperative 24 hours |
Compassionate Use (CU) of REGN5458 for Patients With Relapsed or Refractory Multiple Myeloma (MM)

Study Overview
=================
Brief Summary
-----------------
Provide Compassionate Use' of REGN5458 for Patients with Relapsed or Refractory Multiple Myeloma

Detailed Description
-----------------
Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications.

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: REGN5458


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: REGN5458|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapsed, Refractory
Allopurinol in Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Study Overview
=================
Brief Summary
-----------------
The investigators evaluated the role of allopurinol in prevention of post-ERCP pancreatitis. 100 Egyptian patients who were candidates for ERCP were included and divided into two groups. Group 1 (study group) included 50 patients who received two doses of allopurinol 300 mg each, 15 hours and 3 hours before ERCP and Group 2 (control group) included 50 patients who did not receive allopurinol prophylaxis.

Detailed Description
-----------------
A diagnosis of procedure-related pancreatitis was based on an increased serum amylase level greater than three times the upper normal limits, associated with abdominal pain requiring analgesics and persisting for at least 24 hours after the procedure.

Official Title
-----------------
Role of Allopurinol in Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Conditions
-----------------
Endoscopic Retrograde Cholangiopancreatography

Intervention / Treatment
-----------------
* Drug: Allopurinol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were going to be subjected to ERCP due to different causes Exclusion Criteria: Patients with clinically evident acute pancreatitis or hyperamylesemia (≥150 IU/L) before the procedure. Current or recent use of allopurinol (within the last 48 hours). Hypersensitivity to allopurinol or hydro-soluble contrast solutions. Current use of drugs with a known interaction with allopurinol, including cyclophosphamide, chlorpropamide, azathioprine, mercaptopurines, or probenecid. NSAIDS intake within a week prior to assessment. Previous endoscopic or surgical sphincterotomy. Those with severe co-morbid conditions. Female patients with a known or suspected pregnancy and/or lactation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study Group<br>Received 600 mg of allopurinol divided in two oral doses before the procedure (300 mg at 15 hours and 300 mg at 3 hours before ERCP) | Drug: Allopurinol<br>* 600 mg of allopurinol divided in two oral doses before the procedure (300 mg at 15 hours and 300 mg at 3 hours before ERCP)<br>|
| No Intervention: Control Group<br>Underwent ERCP without allopurinol prophylaxis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of procedure-related pancreatitis |  | At least 24 hours after the ERCP |
Severe Adverse Events Biomarkers Investigation on Extensive Stage Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the trial is to find some biomarkers to predict the the severe adverse events of Atezolizumab plus etoposide and platinum based chemotherapy as the first line treatment in extensive stage small cell lung cancer. Mainly observe the patient's abnormal symptoms after treatment.

Official Title
-----------------
Severe Adverse Events Biomarkers Investigation on Extensive Stage Small Cell Lung Cancer Who Treated With Atezolizumab Plus Etoposide and Platinum Based Chemotherapy

Conditions
-----------------
Extensive Stage Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: First line EC/EP+Atezolizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18， Extensive Stage Small Cell Lung Cancer Confirmed by Histopathology Treated with Atezolizumab plus Etoposide and Platinum Based Chemotherapy Exclusion Criteria: - Patients with contraindication of chemotherapy Pregnant or breast feeding women

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

| Intervention/Treatment |
| --- |
|Drug: First line EC/EP+Atezolizumab|Etoposide (100mg/㎡) Carboplatin (AUC=4) Atezolizumab(1200mg) ivgtt, every 21 days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | April 2019- July 2021 | 
| OS | Overall survival | April 2019- July 2021 |
Symbicort SMART Satisfaction From Patient Perspective 2009

Study Overview
=================
Brief Summary
-----------------
To characterize the level of asthma control and patient satisfaction amongst diagnosed asthma sufferers who are currently receiving Symbicort Maintenance and Reliever Therapy (SMART) in Malaysia.

Official Title
-----------------
Symbicort SMART Satisfaction From Patient Perspective 2009

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have been prescribed Symbicort SMART (1 or 2 inhalation twice daily) by their Dr's for the past 3 months Informed consent Exclusion Criteria: Symbicort SMART treatment < 3 months Patients requiring short courses of oral steroids more than twice in a month

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 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 |
| --- | --- | --- |
| Score level of Satisfaction in Asthma Treatment Questionnaire (SATQ) |  | After 3 months on SMART - once | 
| Score level of Asthma Control Test (ACT) |  | After 3 months on SMART - once | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Control, Satisfaction
Unilateral Cutaneous Ureterostomy - Long Term Follow up

Study Overview
=================
Brief Summary
-----------------
This observational study is aimed at exploring bladder function following temporary unilateral low loop cutaneous ureterostomy carried out in newborns suffering from severe congenital hydro-ureteronephrosis

Official Title
-----------------
Bladder Function Following Temporary Unilateral Cutaneous Ureterostomy - Long Term Follow up

Conditions
-----------------
Bladder Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Living patients Bilateral functioning kidneys Unilateral ureteral cutaneous diversion Exclusion Criteria: Dead patients Single kidney High percutaneous ureteral diversion (e.g: cutaneous pyelostomies, bilateral cutaneous urinary diversion)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>adolescents and young adults who underwent, as newborns, unilateral low loop cutaneous ureterostomy for severe bilateral hydro-ureteronephrosis, and that, afterwards, underwent stomal closure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bladder function, cutaneous ureterostomy, hydronephrosis