linjc16/ctgov huggingface dataset:
Efficacy of Information System Regarding the Consumption of Antibiotics and Bacterial Resistance in Primary Care

Study Overview
=================
Brief Summary
-----------------
France is a country strong consumer of antibiotics in Europe, specially in primary care. Outpatient antibiotic use represents around 90% of total antibiotic use and prescriptions come mainly from general practitioners. A literature review of antibiotic stewardship in primary care show that there is no evaluation of interest of giving information about consumption of antibiotics and bacterial resistance to general practitioners. The objective of this study is to demonstrate that practitioners implicated in the followed of consumption of antibiotics and bacterial resistance around their geographical area of practice could change and improve their practices in good use of antibiotics.

Official Title
-----------------
Efficacy of Information System Regarding the Consumption of Antibiotics and Bacterial Resistance on the Use of Antibiotics in Primary Care

Conditions
-----------------
Chronic Disease

Intervention / Treatment
-----------------
* Behavioral: Training program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General practitioners in a Meurthe-et-Moselle french department Exclusion Criteria: General practitioners out of Meurthe-et-Moselle french department
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Training program<br>Physicians will be given informations regarding antibiotic consumptions and bacterial resistance in their activity area every 3 months during 12 months. | Behavioral: Training program<br>* Physicians will be given informations regarding antibiotic consumptions and bacterial resistance in their activity area every 3 months during 12 months.<br>|
| Nothing<br>Not Trained Physicians | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of antibiotics | Antibiotics consumptions are provided by CNAMTS and calculated in defined daily dose DDD/1000 patient-days around the geographical area concerned by this study. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial resistance of Escherichia coli and Staphylococcus aureus | The number of intermediate and resistant strains of E.coli and S.aureus are provided by MedQual around the geographical area concerned by this study. | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotics, Primary care, Stewardship, General practitioners
Piperacillin/Tazobactam for Bacteremia With Organisms Producing Chromosomally-Encoded AmpC Beta-Lactamase

Study Overview
=================
Brief Summary
-----------------
Nosocomial bloodstream infections are important causes of morbidity and mortality caused by AmpC beta-lactamase-producing Enterobacteriaceae. The information collected will optimize the management of patients with nosocomial bloodstream infections.

Detailed Description
-----------------
The following information will be collected: age, sex, occupation, hospital location at the time of positive culture (ER, medical ward, ICU etc), prior hospitalization, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures, time and location of positive cultures, underlying diseases and severity of illness, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 30 days of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome,gender, height, weight, ethnicity, and past medical history. We will collect information retrospectively.

Official Title
-----------------
Piperacillin/Tazobactam for Bacteremia With Organisms Producing Chromosomally-Encoded AmpC Beta-Lactamase

Conditions
-----------------
Bacteremia, AmpC Beta-lactamase

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical information is collected by chart review of case and control patients. A case patient is defined as follows: One or more blood cultures are positive for E. cloacae, E. aerogenes, C. freundii, S. marcescens or M. morganii. The patient received piperacillin/tazobactam as the initial empiric therapy. The organism was susceptible to piperacillin/tazobactam. A control patient is defined as follows: One or more blood cultures are positive for E. cloacae, E. aerogenes, C. freundii, S. marcescens or M. morganii. The patient received a carbapenem or fluoroquinolone antimicrobial as the initial empiric therapy. The organism was susceptible to the empiric regimen.

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 |
| --- | --- | --- |
| dead or alive | health status | end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AmpC beta-lactamase, Bacteremia, Piperacillin, Tazobactam
Anxiety Before Non-cardiac Surgery in Adults

Study Overview
=================
Brief Summary
-----------------
Adult patients undergoing elective non-cardiac surgery were enrolled. Anxiety before the operation was evaluated by The State Anxiety Inventory (S-AI). Logistics regression would be used for identifying the independent factors of preoperative anxiety and prediction model would be established.

Official Title
-----------------
Status and Independent Risk Factors of Preoperative Anxiety in Adults Undergoing Non-cardiac Surgery: a Cross-sectional Study

Conditions
-----------------
Myoma of Uterus, Colon Cancer, Gastric Carcinoma, Prostate Cancer, Femoral Head Necrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing elective with general anesthesia surgery (gynecologic oncology, general surgery, orthopedics and urinary); The estimated operation time is more than 2 hours. 3)18≤ age ≤ 80; 4)be able to communicate normally in daily life, without serious hearing and visual impairment; 5)ASA:I-II; 6)sign informed consent and volunteer to participate in this study. Exclusion Criteria: Having a history of brain diseases, such as stroke, epilepsy, psychosis other history of neuropsychiatry. Patients with serious diseases of heart, liver, lung, kidney or other organs. Having a definite diagnosis of cognitive impairment, such as Alzheimer's disease; Those who use sedatives before evaluation in this study; Drug addicts; Alcoholics; pregnant women; participated in other clinical trials as a subject in the past 3 months.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Independent risk factors of preoperative anxiety and establishment of prediction model | To identify the independent factors related to preoperative anxiety, which would be analyzed by Logistic regression according to anxiety or not before surgery evaluated by the State anxiety inventory（20-80，lower is better) . Meanwhile, the prediction model of preoperative anxiety would be established based on independent factors. | From the 1 day before surgery to 7 days after surgery or discharge, whichever came first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of preoperative anxiety | The State anxiety inventory (20-80，lower is better) was used to investigate the incidence of Preoperative anxiety | The 1 day before surgery |
Virtual Exercise Rehabilitation Treatment Program for Post Exacerbation of Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
Respiratory rehabilitation is an intervention proven to improve quality of life in those with chronic lung disease but access remains poor. The investigators will assess the feasibility and acceptability of a virtual platform for respiratory rehabilitation as an alternative to in person rehabilitation. The aim is to use the technology in those post admission with COPD where access has been even more of a challenge as during this period patients find it difficult to access an out patient program due to their frailty.

Detailed Description
-----------------
People living with lung disease struggle with activities. An exercise program can help but these programs are limited and are hard to get to and generally have a long wait list. The investigators will offer exercise and education through a tablet with internet provided 2 times per week for 10 weeks for patients admitted to hospital with a worsening of their COPD. Patients will work with a trained therapist for the exercise sessions and with the team for the education sessions. The investigators will assess outcomes on functional and quality of life improvements as well as feasibility and scalability of the technology.

Official Title
-----------------
Virtual Exercise Rehabilitation Treatment Program for Post Exacerbation of Chronic Obstructive Pulmonary Disease

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Other: Virtual rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: minimum age of 18 years maximum age of 90 years diagnosis of COPD Exclusion Criteria: inability to perform exercise severe debilitating conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Virtual rehabilitation<br>Virtual pulmonary rehabilitation will be provided by a tablet with connection to a physiotherapist for monitored exercise sessions with educational videos provided on the tablet. | Other: Virtual rehabilitation<br>* Patient who are assigned to this group will receive virtual rehabilitation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk test distance | The distance walked during the 6 minute | 1 year | 
| 1-MSTST | One-minute sit to stand test | 1 year |
Gyni™ Study With Leumit Health Services

Study Overview
=================
Brief Summary
-----------------
About one third of the women referring to gynecological clinics present with vulvovaginal inflammation symptoms (vaginitis) possibly caused by seven different conditions or mixed infections. The Gyni™ system is intended to provide physicians with the means to obtain an accurate, fast and inexpensive diagnosis which is unavailable today. Gyni™ is comprised of a compact tabletop scanner, a disposable sample collector and a cloud based algorithm that provides a suggested diagnosis within 5 minutes. The trial is a prospective evaluation of the cost-effectiveness of using Gyni™ by comparing its usage outcomes in a practice setting to the outcomes obtained using the current standard of care.

Official Title
-----------------
Gyni™ System Pilot Study With Leumit Health Services - Prospective Study

Conditions
-----------------
Vaginitis

Intervention / Treatment
-----------------
* Diagnostic Test: Gyni


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female ≥18 years old Able to read, understand and sign an informed consent form At least one of the following: abnormal vaginal discharge, odor, vulvovaginal itch, burning, irritation, dyspareunia, vaginal dryness or pain. Exclusion Criteria: Patients under the age of 18 years Patient is unfit to provide an informed consent Patient with vaginal bleeding, including menstruation within past 24 hours21 Patient who used intra vaginal preparations within 72 hours prior to study enrollment (antimicrobials, spermicides, lubricants, diaphragm)22 Uninterpretable sample (e.g. patients who used vaginal creams or lubricants before the visit or insufficient sampling material)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Group-A Blinded Group-B Unblinded
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Symptomatic vaginitis patients<br>All participants will be enrolled according to their complaints, All will be tested by the Gyni system, Only in the second group the physician will be unblinded to the Gyni results. | Diagnostic Test: Gyni<br>* Vaginal discharge collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison parameter | Number of visits (from initial visit until the cause of vaginitis is detected) | 12 months | 
| Comparison parameter | Total cost of medication | 12 months | 
| Comparison parameter | Total Cost of lab tests | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gynecology, IVD
Short-term Clinical Feasibility of the Provox XtraHMEs for Pulmonary Rehabilitation After Total Laryngectomy

Study Overview
=================
Brief Summary
-----------------
This study is a short term feasibility study that aims to investigate patient satisfaction with and performance of new Provox Xtra HME in 20 laryngectomized patients. Aspects that are considered are for example performance for stoma occlusion, speaking, breathing, appearance, compliance, and short-term impact on pulmonary symptoms.

Official Title
-----------------
Phase 1 Study. Short-term Feasibility of the Next Generation Provox HMEs for Pulmonary Rehabilitation After Total Laryngectomy

Conditions
-----------------
Total Laryngectomy

Intervention / Treatment
-----------------
* Device: Provox Xtra HME


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: total laryngectomy compliant Provox HME user (24/7 use) Exclusion Criteria: current medical problems that might influence HME use

Ages Eligible for Study
-----------------
Minimum Age: 21 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compliant HME users<br>Laryngectomized patients who are currently compliant (24/7) users of a Provox HME | Device: Provox Xtra HME<br>* Heat and Moisture Exchanger for pulmonary Rehabilitation after total laryngectomy<br>* Other names: Provox HME;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Preference for Provox HME or Provox XtraHME | the patient preference is based on a structured questionnaire on several aspects regarding the use of the new Provox XtraHME in comparison with the Provox HME. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Noise at Stoma Occlusion | the number of patients presenting any hissing, whistling, or plopping noises before, during, or after stoma occlusion while using the new XtraHME | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laryngectomy, HME, Provox, voice prosthesis
A Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces

Study Overview
=================
Brief Summary
-----------------
This is a Phase II open-label trial evaluating the efficacy, and safety of Erbitux in patients with mucinous gastrointestinal adenocarcinoma involving the peritoneal surface.

Official Title
-----------------
A Phase II Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces

Conditions
-----------------
Mucinous Gastrointestinal Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: cetuximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to take care of self. Out of bed less than 50% of the day Absolute neutrophil count >=1,500 Platelet count >=100,000 Total bilirubin count <=1.5 times the upper limit of normal Exclusion Criteria: Prior epidermal growth factor receptor antibody Prior treatment with Erbitux Other cancers

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: cetuximab<br>* mg, IV, 225 mg/m2, weekly, 4-52 weeks depending on response.<br>* Other names: Erbitux;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy of Erbitux in the treatment of mucinous gastrointestinal adenocarcinoma involving the peritoneal surfaces based on clinical response rate. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaulate surgically resected tumor specimens of the EGF receptor, mucins 1-6, and anglogenic indices such as vessel counts, VEGF expression, and Ki-67 expression. To evaluate the safety of Erbitux monotherapy in this patient population. |  |  |
The Interrelation of the Vasculature, Endothelium, Bone Metabolism and Uremic Toxins in Peritoneal Dialysis

Study Overview
=================
Brief Summary
-----------------
Despite major advances in the treatment of chronic kidney disease, the age and sex matched mortality far exceeds that of the normal population. As in the normal population, the majority of deaths are related to cardiovascular disease. Mounting data point to the lethal synergy between chronic kidney disease and cardiovascular disease. This relation is present from early stages of chronic kidney disease on. Several uremic toxins have been demonstrated to play an important role in kidney disease related endothelial dysfunction. In peritoneal dialysis patients, data on the relation between uremic toxins, endothelial dysfunction and microparticles are lacking. The investigators hypothesize that endothelial dysfunction and uremic toxins are interrelated in peritoneal dialysis patients

Official Title
-----------------
The Interrelation of the Vasculature, Endothelium, Bone Metabolism and Uremic Toxins in Peritoneal Dialysis

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Procedure: peritoneal dialysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 Maintenance peritoneal dialysis Exclusion Criteria: No informed consent Peritonitis

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 |
| --- |
|Procedure: peritoneal dialysis|individualised|

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
-----------------
peritoneal dialysis, endothelium, endothelial dysfunction