linjc16/ctgov huggingface dataset:
Validation of HealthCare Standards in Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
VESALIO is a pilot study aimed at evaluating the feasibility and reliability (time stability and interobserver reliability) of healthcare quality standards in chronic obstructive pulmonary disease (COPD) recently outlined by SEPAR (Spanish Pneumology and Thoracic Surgery Society), and at establishing the foundation for a future validation (construct and criterion validation) of the aforementioned standards.

Official Title
-----------------
Validation of HealthCare Standards in COPD

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 40 years of age or older Diagnosis of COPD at hospital discharge Hospitalization for a COPD exacerbation Exclusion Criteria: Patients hospitalized for the first time at the participating site without a documented history of COPD Patients currently participating of having ever participated in a COPD-related clinical trial Patients with a serious disease that might affect the measured outcomes (terminal oncologic disease, neoplastic disease for which the patient is receiving chemo/radiotherapy, terminal renal insufficiency, AIDS)

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| COPD Exacerbation Cohort<br>Patients hospitalized for a COPD exacerbation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD exacerbation |  | Within 12 months after hospitalization | 
| Mortality |  | within 90 and 180 days after hospitalization | 
| Healthcare-associated cost | Hospital-stay lenght ER visits | within 12 months after hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD
Effect of Dexmedetomidine on Heart-rate Corrected QT(QTc) Interval Prolongation During Robotic-assisted Laparoscopic Radical Prostatectomy -Randomized Blind Clinical Trial-

Study Overview
=================
Brief Summary
-----------------
Sympathetic activity could be increased during robot-assisted laparoscopic radical prostatectomy, which is performed in a steep trendelenburg position under CO2 pneumoperitoneum. Stimulation of the sympathetic nervous system prolongs the QT interval and can increases the susceptibility to life threatening cardiac arrhythmias. Dexmedetomidine has sympatholytic effects and potential antiarrhythmic properties. Perioperative administration of dexmedetomidine is a potential preventive and treatment strategy for tachyarrhythmia. Thus the investigators decided to evaluate the effect of dexmedetomidine on heart-rate corrected QT interval during robot-assisted laparoscopic radical prostatectomy. Furthermore, the investigators evaluated the Tp-e, Tp-e/QT ratio and Tp-e/QTc ratio as well.

Conditions
-----------------
Prostate Cancer, Robotic Surgery

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA class I-II Otaining written informed consent from the patients who were undergoing robot- assisted laparoscopic radical prostatectomy Exclusion Criteria: Emergency operation Cardiac disease (unstable angina, congestive heart failure, valvular heart disease) Ventricular conduction abnormality Prior pacemaker insertion Abnormal electrolyte values Patients who take antiarrythmic agent Hepatic or renal failure Drug hyperactivity Neurological or psychiatric illnesses
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br> | Drug: Dexmedetomidine<br>* Dexmedetomidine infusion (0.3㎍/kg/hr) from anesthetic induction to the end of pneumoperitoneum<br>|
| Active Comparator: Saline<br> | Drug: Saline<br>* Saline infusion during the same time period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dexmedetomidine on heart-rate corrected QT(QTc) interval | QTc intervals (msec) are recorded from pre-induction until 60 min after the end of pneumoperitoneum | From pre-induciton until 60 min after the end of pneumoperitoneum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexmedetomidine, pneumoperitoneum, trendelenburg position, QTc interval, Tp-e interval, robotic prostatectomy
Investigation of Heart Rate Variability During the Menstrual Cycle

Study Overview
=================
Brief Summary
-----------------
In this study, women will be required to wear a heart rate monitor continuously and collect daily early morning urine samples for the duration of one complete menstrual cycle. This will enable comparisons between data collected from the heart rate monitor and hormone analysis in urine samples to be made.

Detailed Description
-----------------
This pilot study is a prospective observational study of women's heart rate and heart rate variability throughout one complete menstrual cycle. A minimum of 10 volunteers aged 18 years of age or over will be recruited via a variety of methods according to the criteria detailed in section 9. They will be required to wear a heart rate monitor continuously and collect daily early morning urine samples throughout one menstrual cycle. Urine samples will be returned to SPD on a regular basis for measurement of urinary hormones related to pregnancy and fertility. Data collected via the monitor including heart rate and heart rate variability will be downloaded for comparison.

Official Title
-----------------
Investigation of Heart Rate Variability During the Menstrual Cycle

Conditions
-----------------
Ovulation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years and over Regular menstrual cycles Exclusion Criteria: Taking any hormonal medications Taking any medications that may affect heart rate Known heart condition or use of a pacemaker Skin condition where there is sensitivity to wearing a skin monitor Currently suffering with anxiety or panic attacks Pregnant or breastfeeding

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | Heart rate at time points throughout the menstrual cycle | 1 month | 
| Heart Rate Variability | Heart rate variability at time points throughout the menstrual cycle | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Day of ovulation | Day of ovulation determined by urinary LH surge +1 day | 1 month | 
| Fertile window | Fertile window onset determined by E3G surge | 1 month | 
| Fertile window closure | Fertile window closure determined by P3G rise | 1 month |
Epidemiology, Management, Prognosis and Medical Cost Analysis of IHCA and OHCA

Study Overview
=================
Brief Summary
-----------------
The study is a retrospective analysis of Taiwan national health insurance in cardiac arrest patients. The factors related to the outcomes of cardiac arrest patients were analyzed.

Official Title
-----------------
Epidemiology, Management, Prognosis and Medical Cost Analysis of In-hospital and Out-of-hospital Cardiac Arrest Patients

Conditions
-----------------
Out-Of-Hospital Cardiac Arrest

Intervention / Treatment
-----------------
* Drug: Statin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: out-of-hospital cardiac arrest, Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Statin treatment prior to cardiac arrest<br> | Drug: Statin<br>* continuous statin treatment for 3 months prior to cardiac arrest<br>|
| No Statin treatment prior to cardiac arrest<br> | Drug: Statin<br>* continuous statin treatment for 3 months prior to cardiac arrest<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| one year survival |  | up to one year |
Lacosamide in Neonatal Status Epilepticus

Study Overview
=================
Brief Summary
-----------------
Lacosamide in neonatal status epilepticus

Detailed Description
-----------------
The study will assess the efficacy of Lacosamide in neonatal status epilepticus

Official Title
-----------------
Efficacy of Lacosamide in Neonatal Status Epilepticus: A Randomized Controlled Study

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Lacosamide
* Drug: Phenobarbital


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neonates with status epilepticus Exclusion Criteria: congenital anomalies or organ dysfunction

Ages Eligible for Study
-----------------
Maximum Age: 28 Days

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: Lacosamide<br>Lacosamide will be given. | Drug: Lacosamide<br>* lacosamide will be given<br>* Other names: lacosa;|
| Active Comparator: Phenobarbitone<br>Phenobarbital will be given | Drug: Phenobarbital<br>* phenobarbital will be given<br>* Other names: phenobarbitone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of children with cessation or improved duration of status epilepticus | the number of children with cessation or improved duration of status epilepticus | 1 year |
Analysis of Extraperitoneal Rectal Neoplasms Between 3D Endorectal Ultrasonography and Magnification Chromoendoscopy

Study Overview
=================
Brief Summary
-----------------
ERUS-3D and CMI demonstrated good diagnostic accuracy in parietal staging of rectal extraperitoneal neoplasms, however with greater efficiency of the endoscopic method. The association of studies can improve diagnostic efficacy and influence the most appropriate approach.

Detailed Description
-----------------
Larger lesions present less chance of deep parietal invasion. The methods show moderate agreement with each other for lesion size and distance from the anal verge and good agreement for the rectal wall percentage of involvement. Circumferential or almost circumferential lesions have a greater chance of postoperative stenosis. Patients with more advanced lesions on AP who underwent radical resections had lower overall survival.

Official Title
-----------------
Results of the Comparative Analysis of Invasion Depth of Extraperitoneal Rectal Neoplasms Between Three-dimensional Endorectal Ultrasonography and Magnification Chromoendoscopy

Conditions
-----------------
Rectal Cancer, Rectal Cancer Stage I

Intervention / Treatment
-----------------
* Procedure: three-dimensional endorectal ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with diagnosis of mid or distal rectum neoplasms stage 1 - Exclusion Criteria: advanced rectal cancer (stage II, III or IV) -

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Extraperitoneal rectal cancer stage 1
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: three-dimensional endorectal ultrasonography<br>three-dimensional endorectal ultrasonography | Procedure: three-dimensional endorectal ultrasonography<br>* three-dimensional endorectal ultrasonography<br>|
| Sham Comparator: magnification chromoendoscopy.<br>magnification chromoendoscopy. | Procedure: three-dimensional endorectal ultrasonography<br>* three-dimensional endorectal ultrasonography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of parietal invasion (T), | Patients with Stage T after procedure | immediately after the procedure |
Community Acquired Pneumonia in Telemark and Ostfold

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the bacterial causes in community acquired pneumonia in adults admitted to hospital in two counties in Norway and to look at possible factors that makes the patients susceptible to pneumonia.

Detailed Description
-----------------
In Norway there is little knowledge of which bacterias that causes pneumonia in patients admitted to hospital. There are also few registered cases of Legionnaires disease every year, compared to our neighbour countries. Therefore 500 patients with community acquired pneumonia admitted to Telemark hospital and Ostfold hospital in Norway will be tested by urin antigen test for the detection of Legionella pneumophila serogroup 1 and Streptococcus pneumoniae. We will also perform routine bacterial culture of sputum and culture on medium for isolation of Legionella species. A throat swab from the patients will be tested for Mycoplasma pneumoniae, Chlamydophila pneumoniae and Bordetella pertussis using PCR-techniques. Legionella-serology will also be performed. In addition all the included patients are invited to fill in a questionnaire in order to look for risk factors for developing community acquired pneumonia.

Official Title
-----------------
Prevalence of Legionella Infections, Bacterial Etiology in Pneumonia Among Patients Admitted to Hospital,- and Risk Factors/Characteristics for These Patients.(Translated From Norwegian)

Conditions
-----------------
Community Acquired Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms of lower airway infection and radiologic sings of pneumonia. Exclusion Criteria: Age<18 Serious psychiatric illness Mentally retarded Hospitalized last 14 days

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pneumonia, Legionnaires disease, risk factors
Non Invasive Ventilation (NIV) Related Practices, Monitoring of the NIV Treatment Effect and of the Patient's Comfort

Study Overview
=================
Brief Summary
-----------------
The practices and processes related to the administration of noninvasive ventilation (NIV) in the adult intensive care unit (ICU) of the University hospital of Lausanne will be recorded by an investigator at the bedside. The effect of the NIV treatment on various respiratory parameters ( respiratory rate, expired tidal volume, minute ventilation) will also be recorded using a pneumotachograph. Finally patient's comfort during NIV treatment will be evaluated.

Official Title
-----------------
Observation of Non Invasive Ventilation (NIV) Related Practices, Monitoring of the NIV Treatment Effect and of the Patient's Comfort During NIV

Conditions
-----------------
Respiratory Failure Requiring Non Invasive Ventilation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Respiratory failure Therapeutic treatment by NIV required Exclusion Criteria: Age < 18 years old Prophylactic NIV treatment Continuous Positive Airway Pressure (CPAP)treatment Denied consent

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 |
| --- | --- |
| Patients requiring NIV<br>Patients requiring NIV because of acute respiratory failure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of practices and processes related to NIV treatment | Documentation of practices and processes related to NIV administration in the adult intensive care unit(type of ventilator used, type of interface chosen, initial settings, organization of the care team and interactions between caregivers). |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Respiratory comfort | Patient's respiratory comfort during NIV will be assessed both by the patients themselves with a visual analogic scale and by the investigator. |  | 
| Ventilatory parameters | Tidal volume, respiratory rate, inspiratory time, expiratory time and maximal and mean airway pressure will be measured from the continuous recording of airway pressure and flow obtained with a pneumotachograph. |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non invasive ventilation, Respiratory failure, Respiratory comfort
PD-L1 Targeting Molecular Imaging of Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to constrcut a noninvasive approach WL12 PET/CT to detect the PD-L1 expression of tumor lesions in patients with gastrointestinal tumors and to identify patients benefiting from anti-PD-1/L1 treatment.

Official Title
-----------------
PD-L1 Targeting Molecular Imaging of Solid Tumors

Conditions
-----------------
Gastrointestinal Tumors

Intervention / Treatment
-----------------
* Other: 68Ga-WL12 PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Aged >18 years old; ECOG 0 or 1; 2. Patients with Gastrointestinal tumors; 3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1); 4. life expectancy >=12 weeks. Exclusion Criteria: 1. Significant hepatic or renal dysfunction; 2. Is pregnant or ready to pregnant; 3. Cannot keep their states for half an hour; 4. Refusal to join the clinical study; 5. Suffering from claustrophobia or other mental diseases; 6. Any other situation that researchers think it is not suitable to participate in the experiment.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imaging cohort<br>All study participants will be allocated to this arm (single-arm study).Study participants will undergo 68Ga-WL12 PET/CT scans | Other: 68Ga-WL12 PET/CT<br>* WL12, labeled with PET radio-nuclide ( Ga-68 )will be used as a molecular imaging tracer for PET/CT scanning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized uptake value（SUV） | The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value（SUV）on PET/CT | 2 years |
Endothelial Glycocalyx Damage in Brain Death Organ Donors

Study Overview
=================
Brief Summary
-----------------
The study aims the assessment of endothelial glycocalyx (EG) degradation in deceased organ donors. There is a lack of organs for the transplantation program. By the description of the EG status, we can open room for organ optimization before transplantation and improve the organ function after transplantation in marginal donors.

Official Title
-----------------
Endothelial Glycocalyx Status and Damage in Brain Death Organ Donors

Conditions
-----------------
Brain Damage Due to Hypoxia, Organ Donors, Organ Transplant Failure or Rejection

Intervention / Treatment
-----------------
* Diagnostic Test: Endothelial glycocalyx damage assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients in critical condition declared as brain dead by clinical examination Exclusion Criteria: N/A

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 |
| --- | --- |
| Brain dead organ donors<br>Patients with clinically proven bain death were assigned to the paraclinical confirmatory investigation of the brain death and subsequently accepted into the transplantation program. | Diagnostic Test: Endothelial glycocalyx damage assessment<br>* Degradation products of endothelial glycocalyx will be assessed in the blood and urine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Markers of endothelial glycocalyx damage | Levels of syndecan-1 in serum and urine | baseline at the time of inclusion |