linjc16/ctgov huggingface dataset:
Assessment of the Prevalence of Extended-Spectrum Betalactamase Producing Enterobacteriaceae Among ICU Staff

Study Overview
=================
Brief Summary
-----------------
Evaluation of the prevalence of ESBL-Enterobacteriaceae colonization among ICU staff

Detailed Description
-----------------
Prospective epidemiological study with voluntary non-medical staff member (i.e. nurses and nursing assistants) and medical staff in two French ICUs. Assessment of self-reported risk factors for MDR-bacteria colonization. Self-performed rectal swab with isolation of ESBL-producting Enterobacteriaceae, identification of bacterial species and antibiotic suspectibilities. Characterization of Escherichia coli ESBL.

Official Title
-----------------
Assessment of the Prevalence of Extended-Spectrum Betalactamase Producing Enterobacteriaceae Among ICU Staff

Conditions
-----------------
Antibiotic Resistance, Extended-spectrum Betalactamase, Enterobacteriaceae, Escherichia Coli

Intervention / Treatment
-----------------
* Other: ESBL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: volunteers 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: ESBL|Evaluation of the prevalence of ESBL-Enterobacteriaceae colonization among ICU staff|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digestive tract colonization by ESBL | Digestive tract colonization by ESBL-producing Enterobacteriaceae on 1 faeces sample | at day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critical Care, Nursing staff, Medical staff, Extended-spectrum betalactamase, Digestive tract colonization, Cross-contamination
Cultivation of Hyalocytes From ILM and ERM Samples: a Pilot Study

Study Overview
=================
Brief Summary
-----------------
ILM and ERM are routinely excised during surgery, as part of the surgical technique, and cultivation of hyalocytes will be performed ex vivo after surgery.

Detailed Description
-----------------
Hyalocytes, typically located 20 to 50μm anterior the internal limiting membrane (ILM), have the potential to contribute to development of epiretinal membranes (ERM) in presence of vitreoschisis. For macular holes, hyalocytes located on the ILM are hypothesized to contribute to the closure of the macular hole after application of the inverted ILM flap technique. ILM is routinely excised during surgical repair of macular holes. During peeling of ERM it is excised in case of persisting wrinkling of the retinal surface or partial en bloc excision with the ERM. Furthermore, excision of ILM during ERM peeling is associated with significantly lower recurrence rates of ERM and better Long term visual acuity, according to the results reported by Chang et al. Removal of ERM and ILM is part of the surgical routine during surgical repair of macular holes and peeling of epiretinal membranes. Therefore, cultivation of excised ERM and ILM samples does not increase risks for patients in any way. During study it is planned to cultivate hyalocytes for investigation of their role in macular hole closure.

Official Title
-----------------
Cultivation of Hyalocytes From ILM and ERM Samples: a Pilot Study

Conditions
-----------------
Epiretinal Membrane

Intervention / Treatment
-----------------
* Procedure: membrane peeling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Macular hole or epiretinal Membrane Exclusion Criteria: Pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: studyarm<br>Hyalocytes from ERM and ILM are cultured in alphaMEM to examine their proliferation habits | Procedure: membrane peeling<br>* ERM and ILM are peeled routinely during surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proliferation of Hyalocytes | hyalocytes from ERM and ILM will be cultured and counted | 9 days |
Stroke in North of Norway and Denmark. A Prospective Cohort Study.

Study Overview
=================
Brief Summary
-----------------
The study is a comparative effectiveness study with comparision of two cohorts of patients with stroke in North of Norway and in Denmark. At baseline information is collected from the stroke registries in both countries. Time points for follow up are at 3 and 12 months post-stroke. Data are collected from medical charts and with use of telephone interview in addition to self-report questionnaires. The study will provide information about functional status, health related quality of life and rehabilitation needs. Information about rehabilitation services in both countries are collected and compared, and analysed in relation to patients outcome.

Official Title
-----------------
Stroke in North of Norway and Denmark. A Prospective Cohort Study.

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Verified stroke. Admitted to stroke unit. Exclusion Criteria: Patients outside the regions excluded.

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 |
| --- | --- |
| Norway<br>500 consecutive patients with stroke from the stroke units at the University Hospital of North Norway located in the cities Narvik, Harstad and Tromsø. At baseline 155 patients with first ever stroke were registered. At 3 and 12 months follow-up 135-155 patients were enrolled. | Other: Observational study<br>* Function, health related quality of life and rehabilitation needs will be analysed in the two country region groups<br>|
| Denmark<br>500 consecutive patients from the stroke unit at Århus Hospital in Denmark. At baseline 402 patients with first ever stroke were included. At 3 and 12 months follow-up 318/ 170 patients were enrolled. | Other: Observational study<br>* Function, health related quality of life and rehabilitation needs will be analysed in the two country region groups<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehabilitation Needs | Not enough help or training | 3 months post-stroke | 
| Health related Quality of life questionnaire | Qolibri_OS | 3 and 12 months post-stroke | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation; Functional outcome
E-cigarette vs. Nicotine Inhaler Comparisons

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to get information from current smokers about how they feel towards both the electronic cigarette (e-cigarette) and the nicotine oral inhaler. This will include beliefs, harms, appeal, ease of use, enjoyment, and their use for helping people stop smoking.

Detailed Description
-----------------
Subjects will be seen at Baseline, then 3-days post-baseline, then 9 days post-baseline for post product use questionnaires and carbon monoxide monitoring. The time frame for follow up is 6 months post Baseline visit.

Official Title
-----------------
Comparative Evaluation of the Perceptions and Utilization of Nicotine Inhalation Devices

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Other: Electronic Cigarette
* Other: Nicotrol Inhaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will be smokers 18 years or older, who have had no previous experience with either the e-cigarette or the nicotine oral inhaler, and will be recruited from the local community. They can currently smoke any amount or frequency and with any level of motivation to stop smoking. Exclusion Criteria: Exclusion criteria include recent (within 2 weeks) myocardial infarction or angina, poorly controlled asthma/chronic obstructive pulmonary disease , active substance abuse, pregnancy, or current use of any other cessation medications

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nicotrol Inhaler<br>Subjects will use the Nicotine Inhaler for 3 days. | Other: Nicotrol Inhaler<br>* Subjects will use the Nicotrol Inhaler for 3 days.<br>|
| Active Comparator: Electronic Cigarette<br>Subject will use the electronic cigarette for 3 days. | Other: Electronic Cigarette<br>* Subject will use electronic cigarette for 3 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceptions about devices | The goal of this study is to gather data from current smokers regarding their perceptions and experiences with both the e-cigarette and the nicotine oral inhaler over a 6 month time period. | 6 months (August 2012-December 2013) |
Serum FGF-23 and Vitamin D Deficiency

Study Overview
=================
Brief Summary
-----------------
We aimed to determine the effect of vitamin D replacement therapy on serum FGF-23 concentrations in vitamin D deficient women and to compare the FGF-23 concentrations of vitamin D deficient patients with healthy subjects and patients with genetically-determined hypophosphatemic rickets.

Detailed Description
-----------------
Study group was composed of vitamin D deficient females (n =18, mean age 29.1±9.9 yrs), vitamin D sufficient healthy females (control group; n = 19, mean age 28.5±5.2 yrs) and patients with genetically-determined hypophosphatemic rickets (n=13, mean age 26.5±15.1 yrs). Groups were compared for serum FGF-23, 1,25 dihydroxy vitamin D3, calcium, phosphate, bone turnover markers, intact parathyroid hormone and urinary excretion of calcium and phosphate. Vitamin D deficient group was re-evaluated after a standard treatment regimen.

Official Title
-----------------
Effects Of Vitamin D Replacement Therapy on Serum FGF-23 Concentrations in Vitamin D Deficient Women In Short Term

Conditions
-----------------
Osteomalacia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serum 25OHD Vitamin <30 ng/mL for group 1 Serum 25OHD Vitamin >30 ng/mL for control group Exclusion Criteria: Receiving medication(s) affecting bone metabolism History of gastrointestinal disease and malabsorption History of renal and liver disease

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 44 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vitamin D deficient females<br>(n =18, mean age 29.1±9.9 yrs) | |
| vitamin D sufficient healthy females<br>(control group; n = 19, mean age 28.5±5.2 yrs) | |
| genetically-determined hypophosphatemic rahitis<br>(n=13, mean age 26.5±15.1 yrs) | |

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
-----------------
fibroblast growth factor 23, Osteomalacia, vitamin D
Exercise in Autoimmune Myasthenia Gravis and Myasthenic Syndromes

Study Overview
=================
Brief Summary
-----------------
A few recent observational studies show that despite the lack of clear recommendations, many individuals with myasthenia participate in exercise. However, no link has been found between exercise and the severity of myasthenia symptoms, measured by the Muscle Myasthenia Score or the Myasthenia Gravis Composite Score. This suggests that there are other factors that may limit or prevent some individuals from being active, or factors which may facilitate participation in exercise. Studies in other diseases have shown that there are internal (beliefs, motivation, etc.) and external (cost, accessibility, etc.) factors unrelated to the disease which may play a role in exercise participation. The aim of this study is to identify factors that facilitate or limit exercise in individuals with autoimmune myasthenia gravis, congenital myasthenia syndrome and Lambert-Eaton syndrome.

Official Title
-----------------
Barriers and Facilitators to Exercise for Individuals With Autoimmune Myasthenia Gravis, Congenital Myasthenic Syndrome or Lambert-Eaton Myasthenic Syndrome in France: a Descriptive, Cross-sectional Study

Conditions
-----------------
Autoimmune Myasthenia Gravis, Lambert-Eaton Myasthenic Syndrome, Congenital Myasthenic Syndrome, Myasthenia Gravis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years old confirmed diagnosis of MG or SMC or LEMS Live in France or its territories Provide consent Exclusion Criteria: -

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 |
| --- | --- |
| Autoimmune Myasthenia Gravis<br> | |
| Congenital Myasthenic Syndrome<br> | |
| Lambert Eaton Syndrome<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barriers and facilitators to exercise |  | Six months |
Study Comparing Isolated Pelvic Perfusion With TNF-α 0.3 mg and Melphalan 1.5 mg/kg Versus Standard Treatment in Patients With Non Resectable, Recurrent Gynaecologic or Digestive Pelvic Cancer

Study Overview
=================
Brief Summary
-----------------
Randomised phase 3 trial comparing 2 arms: an experimental treatment (Isolated pelvis perfusion) and a standard treatment (systemic chemotherapy +/- radiotherapy +/- surgery). Patients included have a non resectable, recurrent gynaecologic or digestive pelvic cancer. The aim of the study is to show a 25% increase in 1 year overall survival rate with isolated pelvic perfusion.

Conditions
-----------------
Gynaecologic or Digestive Pelvic Cancer

Intervention / Treatment
-----------------
* Drug: Isolated pelvis perfusion
* Radiation: radiotherapy
* Procedure: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proved locally advanced gynaecologic or digestive tumours (epidermoid carcinomas, adenocarcinomas, neuroendocrine tumours, sarcomas or melanomas), (cervix, vagina, rectal, anal). Locally recurrent tumours for which surgical treatment will be mutilating or marginal (R1 or R2) and/or for cervix cancer, primary tumours non accessible for standard treatment (radiotherapy- chemotherapy - brachytherapy and surgery). Surgically resectable tumour (R0 type) but for which patient does not agree with surgery. Patients aged over 18 and under 76 ans Performance OMS Index ≤ 2 Normal biologic parameters Good general and cardiac state (ASA I or II and NYHA I or II) Exclusion Criteria: Surgically resectable tumour (RO) or peritoneal tumour extension or distant metastasis. Cardiac or vascular pathology Pulmonary disease Uncontrolled Sepsis disease Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 76 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemotherapy<br>Isolated pelvis perfusion | Drug: Isolated pelvis perfusion<br>* injection of TNF-α 0.3 mg followed 5 minutes later by melphalan 1,5mg/kg<br>|
| Active Comparator: Control<br>Standard treatment | Radiation: radiotherapy<br>* chemotherapy and/or radiotherapy and/or surgery<br>Procedure: Surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate |  | From randomization to death |
Monitoring the Changes of Tumor-related Biomarkers Before and After Pulmonary Nodule Biopsy.

Study Overview
=================
Brief Summary
-----------------
In the past few years, circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), microRNAs, autoantibodies, and T-cell receptor repertoire are new biomarkers of liquid biopsy in cancer, which has been demonstrated to have a great value in diagnostics, treatment evaluation, and prognosis prediction. However, most of previous data were based on late stage tumor patients. This study plans to utilize the minimally invasive method to detect the changes of numbers of CTCs, ctDNA hot spot mutations and methylation signals, microRNAs, autoantibodies, and T-cell receptor repertoire in early stage lung cancer patients before and after pulmonary nodule biopsy, during therapeutic and follow-up periods, in order to evaluate the clinical values of above tumor-related biomarkers.

Official Title
-----------------
Changes of Tumor-related Biomarkers Before and After Pulmonary Nodule Biopsy and Their Clinical Implications.

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed as suspected lung cancer patients with pulmonary nodules (single or multiple) by CT scans, and the maximum diameter of nodule is between 8mm and 3cm; Male or female, with age of 18 80 years; Agree to take the pulmonary nodule biopsy, and sign the Informed Consent. Exclusion Criteria: With severe comorbidities and unable to participate in this study; Diagnosed with acute respiratory tract infection, for instance fungus, mycobacterium tuberculosis or other bacteria, virus, etc., one month prior to the study recruitment; Pregnant or maternal women; Diagnosed with other carcinoma, and the pulmonary nodules suspected of stemming from other sites; Unable for regular follow-ups according to the research protocol; Blood sample is not qualified for biomarker testing.

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 |
| --- | --- | --- |
| Death or survival | Death or survival | Baseline and every three- or six-month follow-up within two years for each patient. | 
| Disease progress | Complete Response(CR), Partial Response(PR), Stable Disease(SD), Progressive Disease(PD) | Baseline and every three- or six-month follow-up within two years for each patient. | 
| Reasons of study termination | Complete the study, Lost to follow-up, Withdrawal of informed consent, Terminated by the investigator, Severe adverse event(SAE). | Baseline and every three- or six-month follow-up within two years for each patient. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Nodule; Lung Cancer; Biopsy; Biomarker.
Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in Children.

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy of prophylaxis with 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit.

Detailed Description
-----------------
Randomised controlled trial to determine the efficacy of 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit.

Official Title
-----------------
Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in a Pediatric Intensive Care Unit.

Conditions
-----------------
Mechanical Ventilation for More Than 48 Hours.

Intervention / Treatment
-----------------
* Drug: 0.12% chlorhexidine solution
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 1 month to 18 years admitted to the intensive care unit. Intubated for more than 48 hours. Exclusion Criteria: Clinical or radiological diagnosis of pneumonia previous to the endotracheal intubation. Allergy to chlorhexidine. Known immune deficiency. Elimination Criteria: Transfer to another hospital.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.12% Chlorhexidine<br>Bexident® (0.12% chlorhexidine) solution, applied topically, every 8 hrs. | Drug: 0.12% chlorhexidine solution<br>* Bexident® (0.12% chlorhexidine solution)<br>* Other names: Peridex, Betasept, PerioGard.;|
| Placebo Comparator: Placebo<br>7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs. | Drug: Placebo<br>* 7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ventilator associated pneumonia |  | Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks | 
| Days of mechanical ventilation |  | From date of randomization until the date of death or date of extubation, whichever comes first, an expected average of 2 weeks | 
| Length of stay |  | From date of randomization until the date of death or date of discharge from the intensive care unit, an expected average of 2 weeks |