linjc16/ctgov huggingface dataset:
Severe Sepsis and Septic Shock Registry

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to construct multi-center sepsis registry that can be used for data warehousing and clinical research.

Detailed Description
-----------------
This registry prospectively enrolls adult patients with severe sepsis or septic shock in 21 tertiary hospital emergency departments. Registered data can be used for quality control and clinical research to reduce sepsis-related mortality.

Official Title
-----------------
Severe Sepsis and Septic Shock Registry

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: two of more systemic inflammatory reaction syndrome criteria fever > 38.3 'C or hypothermia < 36'C, tachycardia over 90 bpm tachypnea over 20 per minute, leukocytosis (WBC over 12k/microL) or leukopenia (WBC below 4k/microL) suspected or proven infection any organ dysfunction as follows: cardiovascular (hypotension, systolic blood pressure <90 mmHg, mean arterial pressure <70mmHg) tissue hypoperfusion (lactate above upper limits laboratory normal) acute lung injury (PaO2/inspired oxygen fraction < 250 in the absence of pneumonia, PaO2/inspired oxygen fraction < 200 in the presence of pneumonia) acute kidney injury (Urine output < 0.5mL/kg/hr for at least 2 hrs Serum creatinine > 2.0 mg/dL) acute liver injury (Total bilirubin > 2mg/dL) acute coagulopathy (Platelet count < 100,000/μL or prothrombin time, international normalized ratio > 1.5) Exclusion Criteria: age less than 18 years old patients with cardiac arrest at presentation patients with advanced directives not to deliver aggressive organ supportive management

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 |
| --- | --- | --- |
| 28-day mortality | According to hospital discharge record review and telephone follow-up. | 28-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day mortality | According to hospital discharge record review and telephone follow-up. | 90-day | 
| Organ support treatment (mechanical ventilation) | According to hospital record review | hospital discharge (non-survivors) or 90 days (survivors) | 
| Organ support treatment (renal replacement therapy) | According to hospital record review | hospital discharge (non-survivors) or 90 days (survivors) | 
| ICU length of stay | According to hospital record review | hospital discharge (non-survivors) or 90 days (survivors) | 
| Hospital length of stay | According to hospital record review | hospital discharge (non-survivors) or 90 days (survivors) |
Evaluation of Preoperative Endobronchial Ultrasound (EBUS) in Non Small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
This study aims to assess both the role and cost-effectiveness of EBUS in preoperative Non small cell lung cancer staging. This controlled multicentric study will be conducted in 22 centers in France. The study design includes two prospective phases. In phase 1, one investigator in each center will prospectively be evaluated for its ability to perform EBUS, with a required goal of 9 informative samplings out of 10 consecutive patients. The phase 2 will include the medico-economic assessment of the technique in the preoperative setting. A maximum of 420 patients for each phase is forecasted.

Official Title
-----------------
Medico-economic Evaluation of a Preoperative Algorithm Including EBUS for NSCLC Initial Staging

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Procedure: EBUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients over 18 non small cell lung cancer histologically or cytologically proved Clinical Stage IIIA anatomically and functionally resectable Exclusion Criteria: uncorrected bleeding disorders absence of lymphadenopathy superior to 1cm in small axis at CT scan contraindication to bronchoscopy extrathoracic or intrathoracic metastasis respiratory function tests not compatible with curative resection of lung cancer

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 |
| --- | --- |
| NON SMALL CELL LUNG CANCER<br>Non small cell lung cancer, with clinical N2 disease, otherwise operable. | Procedure: EBUS<br>* a minimally invasive technique of mediastinal lymph node staging using an integrated videoendoscopic device equipped with ultrasound for the localization and transbronchial sampling of lymph nodes in real time<br>* Other names: NSCLC;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of mediastinoscopy avoided |  | 24h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-small cell lung cancer, mediastinal lymph node, resectable, EBUS, stage IIIA, significant mediastinal lymph node at thoracic CT Scan
Improving Asthma Care for Very Low Birth Weight Infants

Study Overview
=================
Brief Summary
-----------------
Children born less than 1500 grams are being enrolled into a study to test the effectiveness of a parental educational intervention in reducing the risk of future breathing problems. The intervention teaches parents of these children how to reduce the risk of / and recognize breathing problems.

Official Title
-----------------
Improving Asthma Care for Very Low Birth Weight Infants

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Behavioral: Asthma education for parents of very low birth weight infants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature babies weighing less than 1500 grams at birth receiving care at Strong Memorial Hospital Neonatal Intensive Care Unit Exclusion Criteria: Non-English speaking parents

Ages Eligible for Study
-----------------
Minimum Age: 30 Days
Maximum Age: 1 Year

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Parents of children in the experimental group receive asthma education prior to NICU discharge. | Behavioral: Asthma education for parents of very low birth weight infants<br>* Asthma education is provided to parents of children in the experimental group prior to nicu discharge.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate whether education about asthma improves parent knowledge about the disease and its management and to evaluate whether education about asthma influences healthy behaviors to reduce breathing problems |  | 7-9 months post discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the feasibility of implementing the intervention in terms of cost and personnel time and to obtain parental feedback about the intervention. |  | 1-3 years post baseline |
Pilot Study of a Nerve Block Simulator for the Training in Axillary Blocks

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether an ultrasound-guided nerve block simulator is effective for the training of the axillary block technique.

Detailed Description
-----------------
Ultrasound-guided nerve blocks are becoming the standard of care in patients requiring regional anesthesia. Cost-effective training is needed for the implementation of these techniques in the global anesthesia practice. Existing simulators are expensive and not available in low income countries. The investigators aimed to test an inexpensive simulator for the training in this technique.

Official Title
-----------------
Simulator Versus Cadaver Training to Perform Ultrasound-guided Axillary Nerve Bocks

Conditions
-----------------
Arm Injuries

Intervention / Treatment
-----------------
* Procedure: Simulator
* Procedure: Cadaver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anesthesia residents Exclusion Criteria: Previous training in regional anesthesia techniques
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simulator<br>One training session with the simulator. | Procedure: Simulator<br>* Axillary nerve anatomy lecture plus training with the simulator.<br>|
| Active Comparator: Cadaver<br>One training session with a cadaver. | Procedure: Cadaver<br>* Axillary nerve anatomy lecture plus training with the cadaver model.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to locate axillary nerve in a cadaver |  | At the end of the procedure, expected average of 30 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to identify axillary nerve in a cadaver |  | During the procedure, expected average of 15 seconds |
Zinc Status and Growth in Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to improve the understanding of the relationship of zinc status and growth in infants and young children who were diagnosed with cystic fibrosis via newborn screening.

Detailed Description
-----------------
The objective of this study is to improve the understanding of the relationship of zinc (Zn) status and growth in infant and young people with cystic fibrosis (PWCF). The investigators hypothesize that Zn deficiency in infant and young PWCF is associated with poor growth. Aim #2: To study the association between Zn levels in red blood cells and nutritional status in PWCF at 3 months to 3 years of age and compare it to the association between serum Zn and nutritional status in the same population. Hypothesis: Lower Zn levels in red blood cells is associated with poorer nutritional status in infant and young PWCF and is a better measure of Zn status compared to serum Zn.

Official Title
-----------------
Zinc Status and Growth in Cystic Fibrosis

Conditions
-----------------
Cystic, Fibrosis

Intervention / Treatment
-----------------
* Biological: Serum Zn
* Biological: Red Blood Cell Zn


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients ages 3 months to 3 years with CF identified via new born screening Exclusion Criteria: History of meconium ileus History of prematurity (born prior to completing 36 weeks 6 days gestation)

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 3 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 |
| --- | --- |
| Pediatric CF Patients<br>Pediatric patients ages 3 months to 3 years with CF identified via newborn screening. | Biological: Serum Zn<br>* The investigators will obtain an additional 2 mL of blood in an extra tube. This will be collected at the same time blood is collected for the participant's yearly CF screening labs so as to minimize additional needle sticks.<br>Biological: Red Blood Cell Zn<br>* If the participant is greater or equal than 5 kg, an additional 2 mL of blood will be obtained in an extra tube. This will be collected at the same time blood is collected for the participant's yearly CF screening labs so as to minimize additional needle sticks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Zinc Status | Zn status in infant and young PWCF as measured by serum Zn and red blood cell Zn | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Zinc, Growth, Nutrition, Cystic, Fibrosis
Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effective dose(s) of RPC4046 in the treatment of Eosinophilic Esophagitis (EoE). This trial consists of two phases: 16 weeks of double-blind treatment and 52 weeks of open-label extension.

Official Title
-----------------
A Phase2, Multi-Center, Multi-national, Randomized, Double-blind, Placebo-controlled Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of RPC4046 in Adult Subjects With Eosinophilic Esophagitis

Conditions
-----------------
Eosinophilic Esophagitis

Intervention / Treatment
-----------------
* Drug: RPC4046
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic evidence of EoE Clinical symptoms of EoE including dysphagia Exclusion Criteria: Primary causes of esophageal eosinophilia other than EoE

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: RPC4046 Low Dose<br>intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, low dose | Drug: RPC4046<br> <br> |
| Experimental: RPC4046 High Dose<br>intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, high dose | Drug: RPC4046<br> <br> |
| Placebo Comparator: Placebo<br>intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Eosinophil Count |  | Week 16 |
Renal Denervation in Patients With Resistant Hypertension and Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of resistant hypertension coexisting with obstructive sleep apnea.

Official Title
-----------------
Effects of Renal Denervation on Blood Pressure and Clinical Course of Obstructive Sleep Apnea in Patients With Resistant Hypertension

Conditions
-----------------
Hypertension, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Renal denervation with a catheter-based procedure (Symplicity® Catheter System)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >= 18 and =< 70 years of age. systolic blood pressure >=140mmHg (office); on 3 or more antihypertensive medications (including diuretic) mean daytime systolic ABPM >= 135 mmHg obstructive sleep apnea (AHI >=15 event/hour, indications for CPAP treatment) Exclusion Criteria: renal artery abnormalities eGFR < 60mL/min previous TIA, stroke, heart failure Type 1 diabetes ICD or pacemaker others

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Denervation<br>Renal Denervation and maintenance of anti-hypertensive medications and continuous positive airway pressure therapy | Device: Renal denervation with a catheter-based procedure (Symplicity® Catheter System)<br>* Disruption of the renal nerves with a catheter-based procedure.<br>* Other names: Renal Denervation (Symplicity® Catheter System);|
| No Intervention: Maintenance of Medications<br>Maintenance of anti-hypertensive medications and continuous positive airway pressure therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Reduction |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responses to renal denervation (e.g., blood pressure reduction, sleep apnea course, metabolic assessment, cardiac changes) |  | Through 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, resistant, obstructive sleep apnea, renal denervation, continuous positive airway pressure therapy
Vitrectomy Without Internal Limiting Membrane Removal in the Treatment of Diffuse Diabetic Macular Edema: a Comparative Kenalog Vs Bevacizumab Intravitreal Injection Vs Control Study

Study Overview
=================
Brief Summary
-----------------
Diabetic macular edema is the most common cause of visual loss among patients with diabetic retinopathy. Pars plana vitrectomy has been reported to be effective for the treatment of diabetic macular edema. Previous report showed a limited improvement in visual acuity and macular thickness posterior intraoperative triamcinolone acetonide. Bevacizumab intravitreal injection has been proven be effective in the treatment of diabetic macular edema, in recent publications. The purpose of this study is to evaluate whether vitrectomy with and without intravitreal triamcinolone acetonide and bevacizumab injection affects vision outcome and macular thickness in patients with diabetic macular edema.

Conditions
-----------------
Diffuse Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Triamcinolone Acetonide and Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diffuse diabetic macular edema Non proliferative diabetic retinopathy No VPP previa No previous treament with laser, Triamcinolone acetonide, and Bevacizumab Exclusion Criteria: Proliferative diabetic retinopathy Previous pars plana vitrectomy Previous treatment with diabetic macular edema Focal macular edema Macular Ischemia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Triamcinolone Acetonide and Bevacizumab|nan|

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
-----------------
Macula, Edema
Testing Ascensia Contour Glucometer for the Measurement of Blood Glucose

Study Overview
=================
Brief Summary
-----------------
Present practice: Measurement of fasting glucose values in 2nd trimester of pregnancy, if above 4.8 mmol/l, a Glucose Tolerance Test is performed. (Two-step procedure: 1. Appointment for the fasting glucose measurement, 2. Appointment for the Glucose Tolerance Test)

Detailed Description
-----------------
Present practice: Measurement of fasting glucose values in 2nd trimester of pregnancy, if above 4.8 mmol/l, a Glucose Tolerance Test is performed. (Two-step procedure: 1. Appointment for the fasting glucose measurement, 2. Appointment for the Glucose Tolerance Test) Study: Testing of reliability and applicability of the Ascensia Contour Glucometer, Bayer. Comparison of 100 fasting glucose values measured in venous plasma by the hexokinase method in the Laboratory with 100 fasting glucose values measured in capillary whole blood on the Ascensia Contour Glucometer Outcome: If Ascensia Contour Glucometer shows applicable accuracy (narrow scatter of values), the two-step procedure should be replaced by one-step procedure: 1 only one appointment for the measurement of the fasting glucose value in capillary whole blood on Ascensia Contour Glucometer and if above 4.8 mmol/l Glucose Tolerance Test on the same day

Official Title
-----------------
Testing Ascensia Contour Glucometer for the Measurement of Blood Glucose Values in Pregnancy

Conditions
-----------------
Gestational Diabetes

Intervention / Treatment
-----------------
* Device: capillary blood glucose measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy pregnant women in 2nd Trimester of pregnancy scheduled for the measurement of fasting glucose value Exclusion criteria: Pregnant women with pre-existent (Type 1 or 2) diabetes or already diagnosed diabetes of pregnancy
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: capillary blood glucose measurement|nan|

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
-----------------
Gestational diabetes, screening, glucose monitoring