linjc16/ctgov huggingface dataset:
Management of Bleeding and Coagulopathy in Trauma and Compliance to European Trauma Guidelines

Study Overview
=================
Brief Summary
-----------------
This cohort study describes the epidemiology of trauma patients and their management in a French academic trauma center. It also aims to determine what recommendations from the European trauma guidelines is applied in routine.

Detailed Description
-----------------
Severe trauma is responsible for more than 5 millions of deaths annually worldwide. Haemorrhagic shock secondary to uncontrolled bleeding is the leading cause of preventable death in this population, making bleeding and coagulopathy treatment a key element of the early phase of trauma management. European trauma guidelines have been developed to help clinicians in severe trauma management and improve bleeding and coagulopathy treatment in this population. Investigating who these guidelines are followed in routine is crucial to identify opportunities to improve early management of bleeding severe trauma patients.

Official Title
-----------------
Management of Bleeding and Coagulopathy in Trauma and Compliance to European Trauma Guidelines

Conditions
-----------------
Wounds and Injury, Bleeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Trauma patients with injury severity score equal to or higher than 16 year old admitted to the Brest academic trauma centre within the 24 hours following the trauma 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 |
| --- | --- |
| severe trauma patients<br>Severe trauma patients admitted to the site in the first 24 hours | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients treated as per studied guidelines |  | first 24 hours of trauma management | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
trauma, bleeding, coagulopathy, guidelines compliance, recommendation, transfusion
Compassionate Use of Hyperbaric Oxygen Therapy

Study Overview
=================
Brief Summary
-----------------
This is an observational patient registry of COVID-19 patients treated with HBOT.

Detailed Description
-----------------
The retrospective analysis will focus on the reduction in need for mechanical ventilation in COVID-19 patients. The information will be gathered prospectively. Data will be collected from the patients' medical record, including medical notes and data recorded into the study database.

Official Title
-----------------
The Compassionate Use of Hyperbaric Oxygen Therapy in the Treatment of COVID-19

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with COVID-19. The clinical decision to use HBOT is independent of the decision to participate in registry. A signed and dated informed consent form for the off-label use of Hyperbaric Oxygen Therapy specific to the institution where treatment is rendered. Subject is willing and able to comply with instructions and scheduled visits. Exclusion Criteria: The Subject has other concurrent conditions that in the opinion of the Investigator may compromise patient safety. The patient has an untreated pneumothorax.

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 |
| --- | --- | --- |
| Gather information on patients treated with hyperbaric oxygen therapy | Collect information on the reduction in need for mechanical ventilation in COVID-19 patients. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gather information on adverse events | Follow adverse events associated with the treatment of COVID-19 related to HBOT | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Mechanical Ventilation, Hyperbaric Oxygen Therapy, Patient Registry
Pre-operative Therapy in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is a prospective and retrospective study to evaluate the effect of pre-operative therapy on response and survival, and compare the difference in response and survival by pre-operative regimen or by patient's clinicopathological characteristic in early or advanced breast cancer.

Official Title
-----------------
The Effect of Pre-operative Therapy on Response and Survival in Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: pre-operative therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, Aged ≥18 years Histologically confirmed primary breast cancer Plan to receive pre-operative therapy Adequate organ function Exclusion Criteria: History of neurological or psychological disease, including epilepsy or dementia Not suitable to participate in this study judged by investigators

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| early breast cancer<br>no requirements for therapy | Drug: pre-operative therapy<br>* pre-operative therapy includes pre-operative chemotherapy, radiation, endocrine therapy, target therapy and other anti-tumor therapy<br>|
| advanced breast cancer<br>no requirements for therapy | Drug: pre-operative therapy<br>* pre-operative therapy includes pre-operative chemotherapy, radiation, endocrine therapy, target therapy and other anti-tumor therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic Complete Response | ypT0 ypN0, ypT0/is ypN0 | at surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | the rate of complete response and partial response | from the start of pre-operative treatment until the completion of surgery up to 6 months | 
| Disease-free Survival | Disease-free survival time is defined as the time from date of randomization until the first occurrence of disease recurrence, distant metastasis and death from any cause. | From surgery until time of event up to 8 years |
A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis.

Study Overview
=================
Brief Summary
-----------------
This study will investigate the safety, efficacy and pharmacokinetics of R3421 in patients with moderate to severe chronic plaque psoriasis. Patients will be randomized to one of 3 treatment groups to receive once daily oral treatment with a)R3421 20mg, b)R3421 120mg, or c)placebo. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Official Title
-----------------
A Randomized, Placebo-controlled Dose-ranging Pilot Study to Assess the Effect on Clinical Response, and the Safety and Tolerability of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: RG3421 120mg
* Drug: RG3421 20mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-70 years of age; medically stable, moderate to severe chronic plaque psoriasis. Exclusion Criteria: any skin condition which may interfere with evaluation of the effect of study medication on plaque lesions; confounding or concomitant condition or treatment.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>po daily | Drug: Placebo<br>* po daily<br>|
| Experimental: RG3421 120mg<br>120mg po daily | Drug: RG3421 120mg<br>* 120mg po daily<br>|
| Experimental: RG3421 20mg<br>20mg po daily | Drug: RG3421 20mg<br>* 20mg po daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs), laboratory parameters, pharmacokinetics |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in static physician global assessment (PGA) score, Psoriasis Area and Severity Index (PASI) and exploratory biomarkers |  | Throughout study |
Cultural Competency, Risk Management, and Patient Safety Internet-Based Curriculum for OB/GYN Resident Physicians

Study Overview
=================
Brief Summary
-----------------
Additional educational training lectures were provided to healthcare workers. Outcome measure of cultural competency was completed to assess patient safety, risk management, and cultural competency of healthcare providers in an urban academic Labor and Delivery Unit.

Detailed Description
-----------------
Introduction: Patient safety, risk management, and cultural competency are essential topics for healthcare provider mastery in a high stakes, urban academic Labor and Delivery Unit. Methods: A prospective cross sectional pilot study was performed with IRB exempt status to examine the effect of an internet based educational curriculum on topics including patient safety, risk management and cultural competency over 6 months amongst OB/GYN and Family Medicine medical students, nurses, and physicians. 76 healthcare providers participated. Assessments took place before and after curriculum implementation. Primary outcome measures were cultural competency as measured by the Tucker-Culturally Sensitive Health Care Inventory (TCSHCI) Provider Form, Pascal Metrics of Patient Safety survey for healthcare providers, patient satisfaction measured by the Press Ganey patient survey scores, and poor Labor and Delivery Outcomes. The curriculum intervention included five online lectures lasting 30-60 minutes pertaining to cultural competency, risk management, patient safety, and Team STEPPS training.

Official Title
-----------------
Cultural Competency, Risk Management, and Patient Safety Internet-Based Curriculum for OB/GYN Resident Physicians and Adverse Patient Events

Conditions
-----------------
Risk Reduction

Intervention / Treatment
-----------------
* Other: Lectures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:. Inclusion criteria were OB/GYN medical students, Labor and Delivery nurses, and resident/ attending physicians in OB/GYN, Pediatrics, Anesthesia, and Family Medicine. - Exclusion Criteria: .Exclusion criteria were those providers that refused participation, or those that did not complete the course by June 2013.

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthcare Worker Education<br>Educational Lectures | Other: Lectures<br>* Lectures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tucker-Culturally Sensitive Health Care Inventory (TCSHCI) Provider Form | Questionniare | 6 months |
Self-management and Cognitive Function in Adults With Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the relationship between cognitive impairment, patient self-management, health, and health service use in adults with heart failure (NYHA Class 2 and 3). The research questions are: How is cognitive impairment (memory, attention, global and executive function) related to various aspects of impaired self-management (knowledge of adherence, adherence to sodium restriction and medications, symptom monitoring of weight changes, and decision and action to seek care)? How are these relationships altered when adjusting for medical, demographic, and psychosocial factors? What are the relationships among degree of cognitive impairment, quality self-management, health status, and health service use?

Official Title
-----------------
Cognitive Impairment and Self-management in Adults With Heart Failure

Conditions
-----------------
Cognitive Impairment, Cardiac Disease, Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: documented systolic heart failure NYHA class II, III of at least 6 months duration 50-85 years of age has a telephone (land line) or be willing to allow a telephone installed for duration of study Exclusion Criteria: history of neurological disorder or injury moderate or severe head injury past or current history of severe psychiatric illness; specifically, psychotic disorders and bipolar disorder 5 year past or current history of alcohol or drug abuse history of learning disorder or developmental disability renal failure requiring dialysis history of sleep apnea current home telemonitoring program to assist w/ HF self-management cardiac surgery < 3 months

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 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 |
| --- | --- |
| heart failure<br>left systolic heart failure (EF </= 40%) | |

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
-----------------
cognitive impairment, cognitive function, hospitalization, self-management, cardiac disease, heart failure
Factors Affecting Therapeutic Efficacy of Vaginal Laser Therapy for Female Stress Urinary Incontinence, and the Effect of Vaginal Laser Therapy on Overactive Bladder Syndrome and Sexual Function

Study Overview
=================
Brief Summary
-----------------
The main aim of this study is to elucidate factors affecting treatment efficacy of vaginal laser therapy.

Detailed Description
-----------------
Laser thermotherapy can increase the stiffness of vaginal wall. It has been reported that vaginal laser therapy can be used to treat stress urinary incontinence. However, factor affecting treatment efficacy of vaginal laser therapy remains unknown. Thus the main aim of this study is to elucidate factors affecting treatment efficacy of vaginal laser therapy. Besides, the durability of vaginal laser therapy will be assessed. The above knowledge should be helpful for clinical decision making.

Official Title
-----------------
Far Eastern Memorial Hospital

Conditions
-----------------
Laser Thermotherapy, Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Procedure: Vaginal laser thermotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >20 years old female had stress urinary incontinence symptoms Sexual behavior No urinary tract infection At their own expense for vaginal laser therapy Exclusion Criteria: Abnormal vaginal bleeding Vaginal fistula

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Vaginal laser thermotherapy|Laser thermotherapy can increase the stiffness of vaginal wall. It has been reported that vaginal laser therapy can be used to treat stress urinary incontinence.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global response assessment |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of sustained efficacy | Duration of global response assessment ≥ 2 at each visit | 2 years |
Molecular Mechanism of Trophinin in Cancer Invasion and Metastasis

Study Overview
=================
Brief Summary
-----------------
Our study established a model combine the in silico biology and empirical methods to identify clinically useful biomarker from information of microarray gene expression profiles in public domain. Through this method, we found trophinin as a novel prognostic marker for early stage lung cancer, which provide insight towards the process of cancer metastasis and the potential target for treatment.

Detailed Description
-----------------
This study was to combine the in silico biology and empirical methods to identify clinically useful biomarker of lung cancer from microarray gene expression profiles in public database. Using the expression profile of a known metastasis suppressor, CRMP-1, as a template to search for and compare transcriptome expressions in publicly accessible microarray datasets, trophinin (TRO) was identified as the best correlated gene. The expression pattern of trophinin in a lung cancer cell lines of invasion model was investigated using quantitative RT-PCR. The role of trophinin in cancer metastasis was investigated by measuring the change of invasion activity in trophinin gene-transfected cell lines. The relationship of trophinin and the clinicopathological characteristics of lung cancer were further examined by immunohistochemical staining.

Official Title
-----------------
Molecular Mechanism of Trophinin in Cancer Invasion and Metastasis

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent surgery for non-small-cell lung cancer at the National Taiwan University Hospital from 1991 to 2000 with available stored tissue blocks were included as potential subjects in this study. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 0 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
-----------------
metastasis, survival, malignancy, female, trophinin
Effects of Different Postures and Ventilator Flow Waveforms on the Cuff Leak Test

Study Overview
=================
Brief Summary
-----------------
the purpose of this study is to analyzes the factors influencing the results of cuff leak test, in order to improve the cuff leak test on the accuracy of the prediction on airway edema after extubation.

Official Title
-----------------
Effects of Different Postures and Ventilator Flow Waveforms on the Cuff Leak Test: A Prospective Cohort Study

Conditions
-----------------
Cuff Leak Volume

Intervention / Treatment
-----------------
* Behavioral: Position, waveform


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intubation less than 24 hours before amitting respiratory intensive care unit; Exclusion Criteria: unstable hemodynamics;PEEP≥10cmH2O or FiO2≥0.8

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 |
| --- | --- |
| observation<br>this study measure the cuff leak volume and cuff leak ratio according to the cuff leak test with different positions and waveform,, at the same time observe the patient general condition, vital signs, oxygen saturation, cuff leak test results under different conditions and the breathing machine parameters, the diameter of the airway, the use of sedatives and hormones, after extubation stridor and intubation is happening again, the use of NPPV after extubation, patient outcomes | Behavioral: Position, waveform<br>* different positions and waveform<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-extubation stridor | Inspiratory stridor within 48 hours of extubation and was usually associated with respiratory distress | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extubation failure due to PES | the need for reintubation in the 48 hours following extubation in a patient with post-extubation stridor. | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cuff leak test, relative factors