linjc16/ctgov huggingface dataset:
Mortality of Patients Undergoing Fracture of the Upper Extremity u Femur at the University Hospital of Amiens

Study Overview
=================
Brief Summary
-----------------
Fractures of the upper femur (EFSF) represent a major public health problem in the elderly. Approximately 1.6 million patients are victims each year of an EFSF and this number is increasing as a result of the aging of the population. In a recent Amiens retrospective study the mortality was estimated to be 22.5% at 1 year of the fracture. In surviving patients, the impact on loss of autonomy and degradation of quality of life is considerable. The reduction of the incidence of post-operative complications includes the identification of risk factors. No prospective study in Amiens has investigated the mortality and the study of the variables involved in the prognosis and long-term mortality of these patients.

Official Title
-----------------
Mortality of Patients Undergoing Fracture of the Upper Extremity u Femur at the University Hospital of Amiens

Conditions
-----------------
Femur Fracture, Morality

Intervention / Treatment
-----------------
* Other: Study of mortality at 6 months


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the patients operated from a fracture of traumatic origin of the ESF to the emergency block at the CHU of Amiens Patients transferred to the CHU after being cared for in another structure will be included. If a patient successively presents a fracture of each upper extremity of the femur outside of a surgical resumption, two inclusions will be realized Exclusion Criteria: Do not include non-traumatic fractures of the upper end of the femur (pathological fractures: cancer, for example) Fractures of the upper end of the femur associated with polytrauma will not be included.

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: Study of mortality at 6 months|The objective is to provide strong arguments for establishing a dynamic of collective care for patients suffering from an EFSF|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at 6 months of EFSF patients |  | 6 months |
ASP 8825 - Study in Patients With Painful Diabetic Polyneuropathy

Study Overview
=================
Brief Summary
-----------------
To demonstrate the superiority of ASP8825 over placebo and dose response in patients with painful diabetic polyneuropathy.

Detailed Description
-----------------
Three doses of ASP8825 are compared to placebo in efficacy and safety point of view in patients with painful diabetic polyneuropathy.

Official Title
-----------------
ASP 8825 Phase II Study-A Double- Blind, Placebo- Controlled Study in Patients With Painful Diabetic Polyneuropathy

Conditions
-----------------
Diabetic Neuropathies

Intervention / Treatment
-----------------
* Drug: ASP8825
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects aged 20 - 79 years Diabetes mellitus patients with diabetic polyneuropathy who have pain symptom for 26 weeks prior to the study Subjects who are compliant with diary completion Exclusion Criteria: Subjects who have pain from other diseases at the evaluating site Subjects who have nerve diseases at the evaluating site Subjects with foot ulcer or gangrene

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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: 1<br>Low dose group | Drug: ASP8825<br>* oral<br>|
| Experimental: 2<br>Middle dose group | Drug: ASP8825<br>* oral<br>|
| Experimental: 3<br>High dose group | Drug: ASP8825<br>* oral<br>|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain severity rating |  | 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of numbness, maximum pain, night pain and sleep disturbance. |  | 8 week | 
| Responder rate |  | 8 week | 
| Patient's global impression of change |  | 8 week | 
| Clinical's global impression of change |  | 8 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASP8825, Diabetic Neuropathies, Pain
Subglottic Secretion Culture in Predicting Tracheal Microbial Flora

Study Overview
=================
Brief Summary
-----------------
Ventilator-associated pneumonia (VAP) continues to be a major cause of morbidity and mortality in the intensive care unit (ICU). Microaspiration of subglottic secretions accumulated above the endotracheal tube cuff is the primary route of bacterial entry into the lower respiratory tract.Therefore, removal of secretions from the subglottic spacehas been recommended as a preventive strategy to avoid microaspiration and VAP. In this context, whereas considerable literature exists on the use subglottic secretion drainage (SSD) in patients at risk for developing VAP, there is a lack of data on the bacterial growth in the subglottic fluid above the cuff. The primary objective of the study will be to assess the value of subglottic secretion culture in predicting microbial flora of endotracheal aspirate samplein patients admitted to our ICU and under invasive mechanical ventilation for at least 48 hours. Secondary end-point will be to estimate the predictive value of subglottic secretion culture in identifying bacterial pathogens in the sub-population of patients who will develop VAP.

Official Title
-----------------
Value of Subglottic Secretion Culture in Predicting Microbial Flora of Tracheal Secretions in Intubated Patients. A Prospective Observational Study

Conditions
-----------------
Pneumonia

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years of age Invasive mechanical ventilation for at least 48 hours Exclusion Criteria: age <18 years absence of informed consent pregnancy documented treatment-limitation orders in the patient's chart

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: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with the same pathogens in both subglottic secretions and endotracheal aspirates |  | 6 months |
A Safety and Tolerability Evaluation of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 in Alzheimer's Patients

Study Overview
=================
Brief Summary
-----------------
A 10-week safety and tolerability study of a potential treatment for mild to moderate Alzheimer's disease.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled, Phase IIa, Multiple Dose, Multicenter Study in Subjects With Mild to Moderate Dementia of the Alzheimer's Type to Evaluate the Safety and Tolerability of Two 10-Week Dose Regimens of Orally-Administered PF-04494700

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: PF-04494700 - Low Dose Arm
* Drug: PF-04494700 - High Dose Arm
* Drug: Placebo Comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of probably Alzheimer's disease for at least 1 year. Mini Mental State Exam (MMSE) score between 12-26 at screening. Participants must be receiving a cholinesterase inhibitor and/or memantine for at least 4 months, and on a stable dose for at least 2 months. Exclusion Criteria: Current evidence of a neurological or psychiatric illness that could contribute to dementia. Living alone. Poorly controlled high blood pressure.

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Low Dose Arm<br> | Drug: PF-04494700 - Low Dose Arm<br>* 30 mg loading dose for 6 days, followed by 10 mg daily<br>|
| Experimental: High Dose Arm<br> | Drug: PF-04494700 - High Dose Arm<br>* 60 mg loading dose for 6 days, followed by 20 mg daily<br>|
| Placebo Comparator: Placebo Control<br> | Drug: Placebo Comparator<br>* Matching placebo.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Measures include Adverse Events |  | Every Visit | 
| Laboratory Tests |  | Every Office Visit | 
| 12-Lead Electrocardiogram |  | Every Office Visit | 
| 24-Hour 12-Lead Serial ECGs |  | Baseline, Study End | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surrogate Efficacy Markers in Plasma: A-Beta, C-Reactive Protein, IL-1, IL-6, Isoprostanes, TNF-alpha, TNF-beta |  | Baseline, Visit 5, Study End | 
| Cognitive Function Tests: ADAS-Cog, CDR-Sum of Boxes, MMSE, ADCS-ADL |  | Screening Visit, Baseline, Study End | 
| Pharmacokinetic Profile |  | Baseline and Every Office Visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interventional, Alzheimer, Safety and Tolerability
Investigation on the Effect of Smoking on the Expression of Pro- and Anti-thrombotic, Anti-oxidative, and Inflammatory Markers in Humans

Study Overview
=================
Brief Summary
-----------------
Investigation on the effect of smoking on thrombus formation in humans. The expression of pro- and anti-thrombotic, anti-oxidative, and inflammatory markers will be assessed in 25-50 year old healthy smokers and non-smokers. The investigators are interested in possible differences between the two groups.

Conditions
-----------------
Smoking, Inflammation, Thrombosis

Intervention / Treatment
-----------------
* Other: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Smoker Non-smokers Exclusion Criteria: Disease Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 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 |
| --- | --- |
| Smokers<br>Healthy smokers | Other: Blood sample<br> <br> |
| Non-Smokers<br>Healthy non-smokers | Other: Blood sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of pro- and anti-thrombotic, anti-oxidative, and inflammatory markers in blood |  | Single time point, no follow-up (cross sectional) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smokers, non-smokers
Nervous System Infections Among Patients With Febrile Seizure

Study Overview
=================
Brief Summary
-----------------
Few studies dealing with the risk of infectious of nervous system and the utility of lumbar puncture and of emergent neuroimaging among patients with simple febrile seizure between 3 and 11 months age and with complex seizure has been reported. None of these studies was multicentric. Recommendations about management of these children are heterogeneous. The investigators aim to study by an observational retrospective multicentric study the rate of infectious of central nervous system among patients with a complex febrile seizure and among patients between 3 and 11 months age with simple febrile seizure.

Official Title
-----------------
Nervous System Infections Among Patients With Febrile Seizure : Retrospective Cohort Review of Consecutive Patients Admitted in 7 Pediatric Emergency Departments in Ile-de-France Between 2007 and 2011

Conditions
-----------------
Seizure, Febrile Seizure, Meningitis, Encephalitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: febrile (>38°) Seizure Exclusion Criteria: previous non febrile seizure known trauma immunodeficiancy status Underlying illness

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 5 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 |
| --- | --- | --- |
| Bacterial meningitis | Results of lumbar puncture or meningitis history in charts | 7 days after emergency visit | 
| Herpes simplex virus meningitis/encephalitis | Results of lumbar puncture or meningitis history in charts | 7 days after emergency visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emergent intracranial processus |  | 7 days after emergency visit |
Development and Clinical Application of Two New Genetic Deafness Gene Diagnostic Kit

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop and applicate two new genetic deafness gene diagnostic kit for Waardenburg syndrome and large vestibular aquduct syndrome.

Detailed Description
-----------------
For the pathogenic gene of Waardenburg syndrome and large vestibular aqueduct syndrome, based on the second-generation sequencing technology, the investigators develop multiplex PCR system for these two hereditary deafness gene diagnostic kit. Using CNVplex high-throughput gene copy number detection technology to analyse Warrdenburg syndrome pathologic gene. CNVs analysis for Warrdenburg deafness syndrome develop special testing system / kit achieve SNP / CNVs detected simultaneously, as a supplementary means of genetic testing in clinical deafness.

Official Title
-----------------
Development and Clinical Application of Two New Genetic Deafness Gene

Conditions
-----------------
Waardenburg Syndrome, Large Vestibular Aqueduct Syndrome

Intervention / Treatment
-----------------
* Device: gene diagnostic kit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Waardenburg syndrome Clinical diagnosis of large vestibular aqueduct syndrome Exclusion Criteria: Could not be able to exsanguinate
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| WS<br>WS diagositic kit | Device: gene diagnostic kit<br> <br> |
| LVAS<br>LVAS diagositic kit | Device: gene diagnostic kit<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the positive rate of WS diagnosis |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the positive rate of LVAS diagnosis |  | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Waardenburg syndrome, Large vestibular aqueduct syndrome, Diagnosis, copy number variation, Multiplex polymerase chain reaction
Delivery Timing in Morbidly Adherent Placentas: a Randomized, Controlled Trial

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial to investigate the optimal timing of delivery in clinically stable women with a suspected morbidly adherent placenta.

Detailed Description
-----------------
This is a randomized controlled trial to investigate the optimal timing of delivery in clinically stable women with a suspected morbidly adherent placenta dispositioned for a scheduled delivery. The primary outcome will be assessed by comparing the composite neonatal morbidity and composite maternal morbidity between the two groups (delivery at 34 versus 36 weeks gestational age).

Conditions
-----------------
Morbidly Adherent Placenta, Placenta Accreta

Intervention / Treatment
-----------------
* Other: Scheduled timing of delivery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with monographically morbidly adherent placenta with or without a placenta previa. Scheduled delivery via cesarean hysterectomy Exclusion Criteria: Delivery planned prior to 36 weeks (e.g. non-reassuring fetal status, preterm labor, severe preeclampsia, other medical/fetal indication for delivery as determined by the managing physician).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Scheduled delivery at 34 weeks<br>Scheduled delivery at 34 weeks (range 33 weeks 5 days to 34 weeks 3 days) | Other: Scheduled timing of delivery<br> <br> |
| Active Comparator: Scheduled delivery at 36 weeks<br>Scheduled delivery at 36 weeks (range 35 weeks 5 days to 36 weeks 3 days) | Other: Scheduled timing of delivery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite neonatal morbidity |  | Within 72 hours of newborn discharge | 
| Maternal neonatal morbidity |  | Within 72 hours of patient discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Placenta, Accreta, Morbidly, Adherent Placenta
Evaluation of End of Life Quality of Care

Study Overview
=================
Brief Summary
-----------------
The study uses a mixed method study to evaluate wether the use of the indicators of the Quality of end-of-life cancer care, developed by Earle et al [Earle JCO 2003; DOI: 10.1200/JCO.2003.03.059] would be relevant and measurable in France. The qualitative part of study was designed to investigate the representations of quality by face-to face interviews with family carer of recently deceased cancer patients, and with their oncologists, and nurses. The quantitative part of the study, consisted in a decedents case series analysis, diagnosed with advanced cancer and followed up in 5 centers. Data on trajectory of care were collected from different complementary sources associating national mortality data, hospital activity data, and health records. The study was approved by the French data protection authority (CNIL) number 611273.

Official Title
-----------------
Evaluation of the Relevance Indicators of Quality of Care for Dying Patients Based on Analysis of Care and Follow-up Course of the Leonetti Law. EFIQUAVIE Study

Conditions
-----------------
Neoplasm Malignant, Quality of Life, End of Life Care

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Patients aged ≥ 18, diagnosed with advanced cancer (recruited from hospital activity data, by a stay with a ICD code of metastatic cancer between Oct 1st, 2009 and Dec 31, 2010) deceased between, Jan 1st, 2010 and Dec 31, 2010 (vital status identified either from hospital activity data, or from national mortality statistics) Exclusion Criteria: diagnosis with non solid tumor (haematology) age < 18

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of emergency services within last 30 days before death |  | Through study completion, up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients received chemotherapy in the last 14 days of life |  | Through study completion, up to 1 year | 
| Location of death |  | Through study completion, up to 1 year | 
| Among patients who died in palliative care unit, those who died within 3 days after admission |  | Through study completion, up to 1 year | 
| Admission in intensive care unit within last 30 days before death |  | Through study completion, up to 1 year | 
| Among patients with pain relief opioid treatment, those with combined short term and long acting opioid orders |  | Through study completion, up to 1 year |