linjc16/ctgov huggingface dataset:
Lyon PJI Retrospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
Bone and joint infections (BJI), although infrequent (prevalence of 70 per 100,000 in France), have a significant economic and clinical impact. Between 2008 and 2013, the prevalence of BJI increased and infections involving joint prosthesis (PJI) represent a third of BJI in France. They are most often post-operative and more expensive than native IOAs. This study aims to describe PJI and understand the failure mechanisms of PJI in order to improve their management.

Official Title
-----------------
Lyon Prosthetic Joint Infection Retrospective Cohort Study

Conditions
-----------------
Bone and Joint Infection

Intervention / Treatment
-----------------
* Other: PJI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients having had a PJI between 2018 and 2020 Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PJI<br>Patients having had a PJI | Other: PJI<br>* patients having had a PJI managed at the CRIOAc Lyon, with or without relapse<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of PJI | proportion of PJI among all BJI | between 2018 and 2020 | 
| Description of PJI | acute/chronic | between 2018 and 2020 | 
| Description of type of prosthesis PJI | number of prosthesis | between 2018 and 2020 | 
| Description of patients having had a PJI | type of patients: age | between 2018 and 2020 | 
| Description of comorbidities of patients having had a PJI | type of comorbidities.. | between 2018 and 2020 | 
| rate of bacteria | epidemiologic description of PJI | between 2018 and 2020 | 
| description of antibiotic used | type of antibiotic : name | between 2018 and 2020 | 
| description of antibiotic treatment | duration of antibiotic treatment | between 2018 and 2020 | 
| description of surgical treatment | type of surgery: 1-step exchange, 2- step exchange, DAIR | between 2018 and 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of failure | proportion of patients having a failure | between 2018 and 2020 | 
| description of the failure | type of failure : persistence or surinfection and management of failure | between 2018 and 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prosthesis joint infection, relapse
Subconjunctival Bevacizumab and Recurrent Pterygium

Study Overview
=================
Brief Summary
-----------------
A study to research whether subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, retarding and decreasing the size of recurrent pterygium.

Detailed Description
-----------------
Pacients with recurrent pterygium Anti-VEGF therapy -Bevacizumab

Official Title
-----------------
Interventional Trial of Subconjunctival Bevacizumab in Recurrent Pterygium

Conditions
-----------------
Recurrent Pterygium

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recurrent pterygium Exclusion Criteria: Pregnant or lactating women History of myocardial infarction History of stroke

Ages Eligible for Study
-----------------
Minimum Age: 40 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subconjunctival Bevacizumab<br>One aplication of subconjunctival Bevacizumab 0,5 ml | Drug: Bevacizumab<br>* One subconjunctival aplication of Bevacizumabe 0,5ml<br>* Other names: Avastin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pterygium size after subconjunctival bevacizumab | -Size of recurrent pterygium (measured in mm) after injection | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | -Number of patients with hyposphagma and irritative symptoms after subconjunctival injection | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subconjunctival Bevacizumab, Recurrent pterygium
Prediction of Fluid Responsiveness Using Dynamic Preload Indices During Arthroscopic Shoulder Surgery in the Beach Chair Position

Study Overview
=================
Brief Summary
-----------------
The beach chair position (BCP) has been commonly used for shoulder arthroscopic surgery. Hemodynamic instability is frequently encountered problem associated with BCP. In addition, high rates of cerebral desaturation events have been reported during surgery in BCP. Although fluid loading could alleviate hypotension associated with BCP, it may lead to volume overload. As an alternative to static indices, dynamic preload indices such as pulse pressure variation (PPV) and stroke volume variation (SVV) were reported to be sensitive predictors of fluid responsivness in several surgical condition. The investigators will examine the abilities of PPV and SVV to predict fluid responsivness during shoulder arthroscopic surgery in BCP. Using transesophageal echocardiography (TEE), the investigators will directly estimate the change of cardiac output during BCP.

Conditions
-----------------
Shoulder Arthroscopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above 20 years of age. American Society of Anesthesiologists (ASA) Physical Status I, II, III. shoulder arthroscopy under Beach-chair position Exclusion Criteria: severe functional liver or kidney disease diagnosed HF ( NYHA class >3) cerebrovascular disease 4. Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| The changes between dynamic preload indices (SVV and PPV) and stroke volume index during beach chair position. We will measure them to evaluate the effect of beach chair position on PPV and SVV. | To investigate the ability of SVV adn PPV to predict fluid responsiveness during beach chair position, using ROC curve. | The participants will be followed up to 5 minutes after fluid challenge. |
Comparison of Conventional With Sonography Assisted Breast Surgery

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to test whether surgical removal of a tumor under sonographic control as compared to conventional method reduces the rate of resections and local relapse

Official Title
-----------------
Comparison of Sonographically Assisted With Conventionally Breast Surgery - Prospective, Randomised, Multicenter, Parallel Group Study With Two Study Arms

Conditions
-----------------
Breast Cancer Surgery

Intervention / Treatment
-----------------
* Device: Sonography assisted breast surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 70 years Female Presurgical validated breast cancer Exclusion Criteria: Sonographically not defined report Lobular breast cancer Extensive ductal carcinoma in situ

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Sonographically assisted breast surgery | Device: Sonography assisted breast surgery<br> <br> |
| Active Comparator: Arm 2<br>Conventional breast surgery | Device: Sonography assisted breast surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of second tumor resections |  | 2 years |
Effects of Plasmalogen on Obese Subjects

Study Overview
=================
Brief Summary
-----------------
This is a 12-week, randomized, double-blind, placebo-controlled study to evaluate the effects of scallop-derived plasmalogen on brain fatigue, body weight and changes in blood plasmalogen in obese subjects aged 20-75 years old.

Official Title
-----------------
A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Effects of Scallop-derived Plasmalogen on Obese Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Plasmalogen
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willingness to provide informed consent to participate in the study BMI ≥ 25 ㎏/㎡ HbA1C ≺ 8% without antidiabetic medication in the previous 3 months Stable medication for 3 months prior to the enrollment, and expectedly throughout the course of study Exclusion Criteria: Scallop allergy Symptomatic obesity, i.e., endocrinal, hypothalamic or drug-induced obesity Hypertension under medication with 4 or more drugs Hepatic disorder with AST ≥ 5 times upper limit of the normal range Mental disorder including schizophrenia and neurosis Alcohol dependence History of malignancy for which treatment completed in the past 5 years Inflammatory disease Use of plasmalogen supplement in the past 3 months Ineligible condition as determined by study physician

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Two 0.5 mg plasmalogen capsules per day | Dietary Supplement: Plasmalogen<br>* Treatment group takes two 0.5 mg plasmalogen capsules per day for 12 weeks.<br>|
| Placebo Comparator: Placebo Group<br>Two placebo capsules containing no plasmalogen per day | Dietary Supplement: Placebo<br>* Placebo Group takes two placebo capsules per day for 12 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Profile of Mood States 2nd Edition (POMS 2) | Psychological rating scale to assess transient feelings and mood | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  | 12 weeks | 
| Change in waist diameter |  | 12 weeks | 
| Change in blood levels of plasmalogen |  | 12 weeks | 
| Change in Athens Insomnia Scale (AIS) | Self-assessment psychometric tool to quantify sleep difficulty | 12 weeks | 
| Changes in adiponectin, leptin, IRI, GA, and high sensitive quantitation of C-reactive protein |  | 12 weeks |
Home Inotropic Therapy in Children

Study Overview
=================
Brief Summary
-----------------
Inotropic therapy is a well-established practice for children with advanced congestive heart failure (CHF). Inotropes are intravenous medications to help the heart pump stronger and prolong life while awaiting heart transplantation. Traditionally children have been maintained on inotropic therapy in the hospital under close, monitored supervision. The United Network for Organ Sharing (UNOS), which governs organ distribution, has now changed listing criteria allowing patients awaiting heart transplantation to be discharged to home, yet maintaining a higher status on the waiting list. In adults, home inotropic therapy has been shown to be a safe and cost-effective bridge to transplantation. To date, there are no data on the use of home inotropic therapy in children. Hypothesis: We request to do a retrospective chart review of patients receiving this therapy to determine safety and efficacy of continuous ambulatory home inotropic therapy in children.

Detailed Description
-----------------
Hypothesis: We request to do a retrospective chart review of patients receiving this therapy to determine safety and efficacy of continuous ambulatory home inotropic therapy in children. Methods: Data will be obtained from CHOA and Coram Home Healthcare, Inc over a two year period, January 1, 2004 through December 31, 2005. Data will be collected on approximately 35 children aged 0-18 years receiving therapy. The length of therapy, type of therapy, therapy-related complications, number of readmissions, deaths at home and catheter-related infections data will be collected. Inclusion Criteria: Receiving inotropic support at home Choa patients with Coram Healthcare only

Official Title
-----------------
Home Inotropic Therapy in Children

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving inotropic support at home Choa patients with Coram Healthcare only medical charts between 2.2.2004 and 12.31.2005 Exclusion Criteria: those who do not meet inclusion criteria

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric, congestive heart failure, inotropes
Johns Hopkins Weight Management Center Patient Data

Study Overview
=================
Brief Summary
-----------------
Patient records from Johns Hopkins Weight Management Center historical files

Detailed Description
-----------------
Examination of historical patient files from the Johns Hopkins Weight Management Center, to be conducted by a study team led by the attending physician and director of the Center. Analyses will examine weight-related outcomes based on participation in the Weight Management Center program.

Official Title
-----------------
Johns Hopkins Weight Management Center Patient Data

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Behavioral counseling and optional meal replacement program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: enrolled as a patient at the Johns Hopkins Weight Management Center Exclusion Criteria: none

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 |
| --- |
|Other: Behavioral counseling and optional meal replacement program|Medical assessment and medical supervision of weight loss Measurements of metabolism and body composition Individualized exercise programs Personal training Support group meetings Individual psychotherapy A variety of nutritional plans including meal replacement options Nutrition education Long-term weight maintenance and relapse prevention programs|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Weight-related measures for patients of the Johns Hopkins Weight Management Center. | 1990-2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity
Detection of Chemotherapy Induced Cardiotoxicity

Study Overview
=================
Brief Summary
-----------------
To identify patients that are at risk of heart damage after receiving chemotherapy (adriamycin).

Detailed Description
-----------------
To identify patients at risk of development of heart damage after receiving chemotherapy by obtaining the genetic profile of those who show: elevation of troponin, left ventricular systolic and diastolic dysfunction, and pro-oxidant stress markers.

Official Title
-----------------
Detection of Chemotherapy Induced Cardiotoxicity

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing anthracycline and/or trastuzumab therapy for the first time Exclusion Criteria: abnormal ventricular ejection fraction past history of, or active cardiac disease including: MI, CHF, angina, arrhythmia requiring medication, valvular disease, uncontrolled systemic hypertension

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 |
| --- | --- |
| Group A<br>Patients receiving chemotherapy (anthracycline and/or adjuvant trastuzumab) for the first time | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The genetic profile of patients with anthracycline-induced elevation of troponin-I |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the genetic profile of patient with anthracycline-induced left ventricular systolic and diastolic dysfunction |  | one year | 
| Assess the relationship of quantitative increases of pro-oxidant stress and a specific genetic profile |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chemotherapy, cardiotoxicity
Laparoscopic Incisional Hernia Repair in Liver Transplant Patients

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis of patients undergoing laparoscopic incisional hernia repair. Study group: Patients with incisional hernia post liver transplantation Control group: Patients with incisional hernia post any other laparotomy in the upper quadrant. Primary study outcome parameter: Risk of hernia recurrence. Secondary study outcome parameters: - Hernia repair-related infection rate - Postoperative morbidity Statistical analysis: Comparison of study versus control group, univariate and multivariate analysis, Chi² and Mann-Whitney-U tests. P-values <0.05 were considered significant.

Official Title
-----------------
Outcomes Analysis of Laparoscopic Incisional Hernia Repair and Risk Factors for Hernia Recurrence in Liver Transplant Patients

Conditions
-----------------
Hernia Recurrence Post Laparoscopic Incisional Hernia Repair in Liver Transplant Versus Non-transplant Patients.

Intervention / Treatment
-----------------
* Other: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Incisional hernia Laparoscopic repair possible Exclusion Criteria: Other types of ventral hernias Laparoscopy not possible

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 |
| --- | --- |
| Patients post liver transplantation<br>Patients after liver transplantation | Other: Surgery<br> <br> |
| Control group<br>Patients with an abdominal incisional hernia without a history of immunosuppresion | Other: Surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia recurrence post laparoscopic incisional hernia repair |  | 1 - 74 months post surgery |
Study About the Effect of Doxycycline and Acetylcystein in the Treatment of CD-associated Fistulae

Study Overview
=================
Brief Summary
-----------------
The investigators will study whether local instillation of Doxycycline and Acetylcystein results in fistula closure in CD patients.

Official Title
-----------------
FIST-MC-09 Study About the Effect of Doxycycline and Acetylcystein in the Treatment of CD-associated Fistulae

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Procedure: Colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: fistulizing CD CD < 6 months at least one insufficient fistula closure try Exclusion criteria: CDAI > 200 Abscesses CRP > 100

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Colonoscopy|During the colonoscopy, we instill Acetylcystein and Doxycyline into the fistula.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fistula closure |  | 01.08.2009 - 31.07.2012 |
Comparing the Effect of Vaginal Misoprostol With Dinoprostone in Term Pregnancies

Study Overview
=================
Brief Summary
-----------------
Hypothesis (H0): Labor duration and obstetric complications are not significantly different in the three groups (misoprostol-dinoprostone-oxytocin).

Conditions
-----------------
Preeclampsia, Fetal Death, Fetal Membranes, Premature Rupture

Intervention / Treatment
-----------------
* Drug: misoprostol
* Drug: dinoprostone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term pregnancy Singleton Vertex Bishop score below 6 Exclusion Criteria: History of drug reaction Medical disease IUGR Oligohydramnios Vaginal bleeding Fetal anomaly Uterine scar
Sexes Eligible for Study
-----------------
Female

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

| Intervention/Treatment |
| --- |
|Drug: misoprostol|nan|
|Drug: dinoprostone|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
-----------------
IUFD, POSTTERM, ROM