linjc16/ctgov huggingface dataset:
Risk Factors of Medistinal Metastasis in Endoscopic Staging of Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate risk factors for mediastinal lymph node metastasis in potentially operable non-small cell lung cancer in order to find indications for endoscopic mediastinal staging. Chest CT, integrated PET/CT, and endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) +/- endoscopic ultrasound with bronchoscope-guided fine needle aspiration (EUS-B-FNA) are performed for mediastinal staging. CT and PET/CT findings, histologic types and other risk factors will be analyzed. The investigators develop the prediction method for mediastinal metastasis.

Official Title
-----------------
Risk Factors of Medistinal Metastasis in Endoscopic Medistinal Staging of Non-small Cell Lung Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed or strongly suspected non-small cell lung cancer (NSCLC) Potentially operable Exclusion Criteria: M1 disease Inoperable T4 disease Mediastinal infiltration or extranodal invasion of the mediastinal lymph node visible on chest CT Confirmed supraclavicular lymph node metastasis Pancoast tumours T1 ground glass opacity nodule (with solid part 1<cm) Solid T1 (1<cm)N0 M0 by CT & PET/CT Inoperable patients (after evaluating medical and surgical operability) Patients who refused surgical treatment Contraindications for bronchoscopy Drug reaction to lidocaine, midazolam, fentanyl Pregnancy

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 |
| --- | --- | --- |
| Relative risk of risk factors for mediastinal metastasis | risk factors; CT staging (N0-3), PET staging (N0-3), tumor location(central or peripheral), tumor size and histologic types of lung cancer. | When confirmative diagnosis are available in all subjects ;3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic values of endoscopic staging | sensitivity, negative predictive value, accuracy | When confirmative diagnosis are available in all subjects ;3 years | 
| Survival | survival after lung cancer treatment | After the diagnosis ; 7 years | 
| Molecular test | EGFR, ALK etc | for each subject; up to 60 days, available in all subjects ; 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endobronchial ultrasound, EBUS-TBNA, lung cancer, staging
Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mild Alzheimer's disease.

Official Title
-----------------
A 52-week,Multi-center,Randomized,Double-blind,Placebo-controlled,Parallel Group Study in Patients With Mild Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106

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

Intervention / Treatment
-----------------
* Biological: Placebo
* Biological: CAD106


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Mild Alzheimer's Disease Mini-Mental State Examination (MMSE) 20 to 26 at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 6 weeks Exclusion Criteria: Previously participated in an AD vaccine study and received active treatment History or presence of an active autoimmune and/or with an acute or chronic inflammation, and/or clinically relevant atopic condition. History or presence of seizures and/or cerebrovascular disease. Presence of an other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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> | Biological: CAD106<br> <br> |
| Placebo Comparator: 2<br> | Biological: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/tolerability assessments at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52. |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune response, cognitive and functional assessments at multiple timepoints including but not limited to baseline and through the end of the study to Week 52. |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Active immunization, Alzheimer disease, Antibody, Central Nervous System Diseases, Neurodegenerative diseases, Vaccine
SH Dr. Chen Gastric Bypass Study

Study Overview
=================
Brief Summary
-----------------
Evaluation of serum gastrin levels and their effect on marginal ulcer formation.

Detailed Description
-----------------
Prospective, randomized, interventional trial. Participants will be randomized to one of two surgical techniques, either with transection of the vagal nerves, or without. Outcomes including compare marginal ulcer rates will be compared using serum gastrin levels before and after surgery and gastric pH during surgery.

Official Title
-----------------
Effect of Vagus Nerve Preservation During Gastric Bypass on Gastrin Level and Marginal Ulcer Formation

Conditions
-----------------
Gastric Bypass

Intervention / Treatment
-----------------
* Procedure: Gastric bypass with transection of vagal nerves
* Procedure: Gastric bypass without transection of vagal nerves


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years and older Diagnosis of obesity or disorder of metabolism undergoing routine gastric bypass surgical intervention Capable of giving signed informed consent. Exclusion Criteria: Under 18 years of age Ineligible for gastric bypass surgery Pregnant women or women actively seeking to become pregnant.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gastric Bypass with Transection of Vagal Nerves<br> | Procedure: Gastric bypass with transection of vagal nerves<br>* Vagal nerve interruption above the level of the stomach is a known treatment for complicated peptic ulcer disease. It is not commonly performed during routine gastric bypass. The vagi are, however, interrupted part-way down the stomach to create the gastric pouch. This is the pars flaccida technique.<br>|
| Placebo Comparator: Gastric Bypass Without Transection of Vagal Nerves<br> | Procedure: Gastric bypass without transection of vagal nerves<br>* Dissection between the neurovascular bundle and the stomach, spareing the vagus nerves. This is the perigastric technique.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Marginal Ulcer | Number of participants with a change in serum gastrin levels compared pre- and post-surgery. | From surgical intervention to five years after surgery |
The Use of Serratus Block for Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this randomized, un-blinded study is to determine if serratus blocks or Patient Controlled Analgesia (PCA)-alone (no block) offer patients adequate pain relief. This study will compare two standard of care pain management options and the patients narcotic requirements in the immediate postoperative period.

Official Title
-----------------
The Use of Serratus Block for Cardiac Surgery

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Procedure: Anesthetic regimen including SB
* Procedure: Anesthetic regimen including SB or no block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over the age of 18 years of age undergoing robotic cardiac surgery. Exclusion Criteria: Patients who are not candidates for serratus block

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Active Comparator: Serratus blocks<br>The serratus plane is interstitial tissue, below the serratus muscle. The injection of bupivacaine numbs the anterior branch of the thoracodorsal nerve. This technique allows for the medication to diffuse along the area of the serratus plane to provide numbing of that area. Upon completion of the block, the patient will be evaluated for extubation and emerged from general anesthesia if appropriate. | Procedure: Anesthetic regimen including SB<br>* Group receiving general anesthesia with the serratus block<br>|
| Active Comparator: PCA-alone (no block)<br>All subjects will receive fentanyl intravenous patient controlled anesthesia pumps as part of standard care. The amount of fentanyl self-administered by the patient or given by a clinician during 24 hours following surgery will be compared amongst the two groups. | Procedure: Anesthetic regimen including SB or no block<br>* Group receiving general anesthesia alone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of intravenous opiates used during the immediate postoperative period | The primary endpoint of the study will be comparison of the amount of intravenous opiates used during the immediate postoperative period between the 2 groups, the group receiving general anesthesia with the serratus block and the group receiving general anesthesia alone. | 24 Hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Robotic Cardiac Surgery
Effect of Preparation Design on the Functional and Esthetic Outcome of CAD/CAM Lithium Disilicate Laminate Veneers

Study Overview
=================
Brief Summary
-----------------
Conservatism is considered the main concern in any treatment plan, the feather edge preparation design of laminate veneers have been introduced yet clinical studies are lacking to evaluate their clinical performance.The aim of this study is to evaluate the effect of the two different preparation designs on the functional and esthetic outcome of laminate veneers in terms of marginal adaptation, retention, fracture, marginal discoloration and patient satisfaction

Official Title
-----------------
Effect of Preparation Design on the Functional and Esthetic Outcome of CAD/CAM Lithium Disilicate Laminate Veneers (Split Mouth Randomized Clinical Trial)

Conditions
-----------------
Dental Disorders Hard Tissues of Teeth, Tooth Discoloration

Intervention / Treatment
-----------------
* Procedure: Laminate veneers preparation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: From 18-60 years old, and able to read and sign the informed consent document. Patients with teeth problems indicated for laminate veneers. Physically and psychologically able to tolerate conventional restorative procedures. Have no active periodontal or pulpal diseases. Maintenance of good oral hygiene . Willing to return for follow-up examinations and evaluation. Exclusion Criteria: Patients in the growth stage with partially erupted teeth. Patients with para-functional habits. Cases that need modification in the incisal edge. Patients with poor oral hygiene and motivation . Psychiatric problems or unrealistic expectations.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Conventional preparation design (Chamfer finish line with Butt joint incisal preparation design)<br>conventional treatment | Procedure: Laminate veneers preparation<br>* facial laminate veneers teeth preparation<br>|
| Experimental: New preparation design (Feather edge finish line with feather edge incisal preparation design)<br>New preparation design | Procedure: Laminate veneers preparation<br>* facial laminate veneers teeth preparation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| marginal gap distance | the gap between the laminate and the prepared tooth is measured before cementation using silicon replica and digital microscope | at time of laminate cementation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laminates, Vertical preparation, veneers
Rhinosinusites Chroniques

Study Overview
=================
Brief Summary
-----------------
To analyse and describe sinus microbiota, during hard to treat (or refractory) rhinosinusitis, using culturomic and metagenomic methods (i.e. to culture on many different medium of culture to grow hard to cultivate bacteria + to sequence and analyse all DNA contained in samples). Samples are middle meatus swabs or pus aspiration, done during usually patient following.

Official Title
-----------------
ETUDE DU MICROBIOTE DES RHINOSINUSITES CHRONIQUES DIFFICILES A TRAITER PAR METAGENOMIQUE ET CULTUROMIQUE

Conditions
-----------------
Sinusitis, Chronic Disease, Refractory

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 year old chronic refractory rhinosinusitis to require middle meatus swab or other sinus sample absence of opposition Exclusion Criteria: <18 year old pregnant women breastfeeding under trusteeship under guardianship

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: biological sample<br>Genomic & culturomic analyses | Other: Biological sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sinusian microbiota description | species, number and type of isolated microbes | 6 months |
Fructose Extra-splanchnic Metabolism and Its Effects on Systemic Flux of Substrates (FruPP)

Study Overview
=================
Brief Summary
-----------------
In parallel to the dramatic rise in metabolic diseases and diabetes observed over the past fifty years, the generalization of added sugar in processed food led to a marked increase in fructose consumption in almost all countries, and epidemiological studies demonstrated that the consumption of sugar-sweetened beverage (containing at least 50% of fructose) is associated with the development of diabetes, hepatic steatosis, dyslipidemia and obesity. The objective of the study is to measure the amount of fructose that escape first-pass hepatic extraction after oral ingestion (fructose+glucose), and gain insights into its metabolic fates with the use of tracers.

Official Title
-----------------
Fructose Extra-splanchnic Metabolism and Its Effects on Systemic Flux of Substrates (FruPP)

Conditions
-----------------
Test Meal

Intervention / Treatment
-----------------
* Other: Test meal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged from 18 to 40 years Body Mass Index of 18.5 to 25 kg/m² Sex male of female Exclusion Criteria: Fructose intolerance Antidiabetic and hypolipemic drugs Alcohol consumption >10g/day Severe eating disorders Severe psychological problems Vegetarian diet or other specific diet Consumption of illicit substances Pregnancy Weight gain or weight loss > 3 kg in the last 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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: Test meal<br>The subjects will receive a liquid test meal containing glucose and fructose with 13C fructose. | Other: Test meal<br>* Liquid test meal (fructose+glucose)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the amount of fructose that escape first-pass hepatic extraction after oral ingestion. | Calculation with 13C fructose enrichment in blood samples at T0; 30; 60; 90; 120; 150; 180; 210 and 240 min. | The quantity of 13C fructose will be calculated, during the post prandial period, until 240 min. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolism, Post-prandial kinetics, Fructose, Obesity
Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home

Study Overview
=================
Brief Summary
-----------------
We hypothesize that when offered influenza vaccine at little or no cost, in a setting where the value of the vaccine is connected to one's high risk child, vaccination rates for parents will approach 90-95%, similar to rates obtained in the Neonatal Intensive Care Unit environment.

Official Title
-----------------
Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Drug: Influenzae vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents or caregiver adults who accompany at-risk children to a Pediatric Care outpatient clinic appointment. High risk children are defined as those 0 to 5 years of age, or who have any of the following diagnoses: Sickle cell disease Asthma Cystic fibrosis Chronic renal disease Congenital heart disease Cancer Any immunodeficiency Exclusion Criteria: Caregivers of children residing in group homes Persons whose children do not meet the Center for Disease Control (CDC) definition of high-risk Persons who have had allergic reactions to influenza vaccination or any other vaccination in the past Persons who are allergic to eggs or egg products Persons who are allergic to thimerosol Previous diagnosis of Guillain-Barré syndrome (GBS) Persons who are moderately to severely ill at the time the vaccination is to be given

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Influenzae vaccine|0.5 mL Deltoid Intramuscular Injection X 1|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Received Influenza Vaccine. | Caregivers identified for participation were offered influenza vaccine. This describes the number who accepted vaccination | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population? | Number of participants who received influenza vaccine the prior year. | 16 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza prevention