linjc16/ctgov huggingface dataset:
The Use of a New Core Needle in the Endoscopic Ultrasound Assisted Tissue Sampling for Pancreatic Solid Masses

Study Overview
=================
Brief Summary
-----------------
Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and effective technique for obtaining samples from pancreatic masses. A new core biopsy needle has been developed by Beacon bnx® (Medtronic, Newton, MA) that allows the possibility to achieve a core for histology evaluation and the interchangibility of needle size using the same needle shelter and different needle sizes.

Detailed Description
-----------------
At every pass, the material will be fixed in formalin. Three passes will be done. Details of the aspirated material will be described at macroscopic evaluation by the endoscopist and then by the pathologist at macroscopic and microscopic evaluation, in order to find an interobserved agreement on the definition of the core.

Official Title
-----------------
The Use of a New Core Needle in the Endoscopic Ultrasound Assisted Tissue Sampling for Pancreatic Solid Masses

Conditions
-----------------
Pancreatic Masses

Intervention / Treatment
-----------------
* Device: FNA with 25 G Beacon needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 and less than 90, both genders.. Presence of a pancreatic solid lesion. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total. Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma or coagulation factors. Informed consent is obtained. Exclusion Criteria: Previous biopsy of the lesion with diagnosis of malignancy Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma. Pregnancy or breast-feeding. Patients unable to understand and/or read the consent form.

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 |
| --- | --- |
| Solid pancreatic masses<br>Consecutive patients with solid pancreatic masses, submitted to FNA with 25 G Beacon needle (Medtronic, Newton, MA, USA) | Device: FNA with 25 G Beacon needle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Core acquisition | The presence of a core adequate for histological evaluation for final diagnosis | 24 h |
Inhaled Bronchodilator Association and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
A pharmaco-epidemiological, observational study that aimed at assessing in a prospective manner the evolution of Quality of Life (QOL) in chronic obstructive pulmonary disease (COPD) patients treated with inhaled bronchodilators

Official Title
-----------------
COPD, Inhaled Bronchodilators Association, and Quality of Life

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

Intervention / Treatment
-----------------
* Drug: inhaled bronchodilator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of COPD confirmed by Pulmonary Function Test (PFTs) Recent treatment with a free or fixed association of inhaled bronchodilators
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic obstructive pulmonary disease<br>Patients with COPD treated with inhaled bronchodilators | Drug: inhaled bronchodilator<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of health-related quality of life (Short-Form Health Survey) |  | 4 months |
Assisted Reproductive Technology Survey (ART Survey)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to collate local information to better understand the motivations, accessibility and frequency of assisted reproductive technology (ART) use in the community.

Detailed Description
-----------------
The ART survey study recruitment will last about 6 months with the study completed within 1 year. Study participation is an online survey which takes approximately 3 minutes to complete. The goal is to apply for future funding to study the metabolic consequences of being conceived with ART.

Official Title
-----------------
ART Survey: Assisted Reproductive Technology Survey

Conditions
-----------------
Female Reproductive Problem, Male Reproductive Problem

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any individual may complete this survey Exclusion Criteria: No exclusion criteria
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 |
| --- | --- |
| Anyone<br>Any individual may complete this survey | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Method of Conception | ART Survey | 1 year |
Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide an opportunity for patients who exhibit progressive disease while receiving placebo on the companion 93-04-11 study to receive ONTAK. It is also designed to determine the effectiveness of ONTAK in Cutaneous T-cell Lymphoma (CTCL) patients whose tumors do not express CD25.

Official Title
-----------------
A Multicenter Open-Label Study to Evaluate the Safety and Efficacy of DAB389IL-2 in Cutaneous T-Cell Lymphoma (CTCL) Patients Following Protocol 93-04-10, Protocol 93-04-11, or Protocol 92-04-01 or Who Meet the Requirements for Protocol 93-04-11 Except Have Biopsy-Documented CTCL That Does Not Express CD25

Conditions
-----------------
Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome

Intervention / Treatment
-----------------
* Drug: ONTAK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must have been previously enrolled in Protocol 93-04-11 and randomized to the placebo arm; or the patient met all eligibility criteria for protocol 93-04-11 other than the expression of CD25 on CTCL tumor cells. CTCL disease Stage Ia - III. History of less than or equal to 3 previous therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic chemotherapy regimen is permitted. Topical or systemic steroids are not considered a therapy. Patient must have evaluable or measurable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow. No significant pulmonary or cardiac disease. No active CNS, kidney, or liver disease. No systemic infections. ECOG performance status of 0 or 1. Exclusion Criteria: • The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or 92-04-01.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ONTAK|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Rate of Response (ORR), defined as CR + CCR + PR |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-Treatment Failure |  |  | 
| Time-to-Progression |  |  | 
| Duration of Response |  |  |
The Effects of PaCO2 Levels on Cerebral Metabolism and Perfusion During Induced Hypothermia.

Study Overview
=================
Brief Summary
-----------------
Incidence of hypo- and hypercarbia during induced hypothermia after cardiac arrest is high. The original report from HACA-group reported that hypothermia treated patients had improved survival and neurological outcome. Suprisingly, in that trial normocarbia was not achieved even though the aim was set for ventilatory support as normoventilation. This study aims to investigate the effects of mild hypo- and hypercarbia on cerebral perfusion (blood flow, intracranial pressure) and metabolism (microdialysate metabolites). We hypothesize that uncontrolled ventilatory suppport may render the patients in risk of exacerbation of neuronal damage, conversely, further improvement in outcome may be achieved with succesfull ventilatory management. We intend to enroll 10 out-of-hospital cardiac arrest patients succesfully resuscitated and subsequently treated with controlled hypothermia for 24 hours. The patients in need of anticoagulation are excluded. We plan to induce mild hypocarbia and hypercarbia during and after induced hypothermia. Metabolic and perfusion data are collected with clinically used methods such as transcranial doppler, intracranial pressure measurement, near infrared spectroscopy, jugular bulb, intracerebral microdialysis).

Official Title
-----------------
The Effects of PaCO2 Levels on Cerebral Metabolism and Perfusion During Induced Hypothermia.

Conditions
-----------------
Cerebral Metabolism and Perfusion

Intervention / Treatment
-----------------
* Other: mild hypo- and hyperventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: succesfull resuscitation of out of hospital cardiac arrest, primary rhytm shockable Exclusion Criteria: known coagulopathy, need of anticoagulation therapy, need of interventional cardiological procedures

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 |
| --- | --- |
| Other: crossover: hypo- and hypercarbia<br> | Other: mild hypo- and hyperventilation<br>* induction of mild hypo- and hypercarbia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surrogate physiological endpoints |  | 60minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral metabolism, perfusion, induced hypothermia
Influence of the COvid-19 Epidemic on STRESS

Study Overview
=================
Brief Summary
-----------------
The Coronavirus has a major influence on stress for the general population. However, data are currently non-existent concerning the perception and knowledge of the epidemic, the feeling of information from companies / establishments / governments, the means of protection used, the feelings of fear generated and their impact on feelings of stigmatization towards certain ethnic groups or categories of patients (those who cough ...), or relationships with socio-demographic factors or lifestyle.

Detailed Description
-----------------
This is an observational study using a REDCap® questionnaire via an internet link, which will be distributed by any means (Facebook, Twitter, institution mailing lists via a referent, flash codes distributed to patients and the public, etc.). The self-questionnaire will assess stress, perception and knowledge of the epidemic, the feeling of information on the part of businesses / establishments / governments, the means of protection used the feelings of fear generated and their impact on feelings of stigmatization towards certain ethnic groups or categories of patients (those who cough ...), or relationships with socio-demographic factors or lifestyle.

Official Title
-----------------
The COVISTRESS Study: Influence of the COvid-19 Epidemic on STRESS

Conditions
-----------------
Stress, Psychological

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anyone volunteer to participate Exclusion Criteria: Anyone non-voluntary to participate
Sexes Eligible for Study
-----------------
All

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 |
| --- | --- | --- |
| Stress | Stress level will be assessed by questionnaire | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception and knowledge of the epidemic | Perception and knowledge of the epidemic will be assessed by questionnaire | Day 1 | 
| Feeling of information on the part of companies / establishments / governments | The feeling of information will be assessed by questionnaire | Day 1 | 
| Means of protection | the means of protection used will be assessed by questionnaire | Day 1 | 
| Feelings of fear generated and its impact on feelings of stigmatization towards ethnic groups or categories of patients | The feeling of fear and the impact on stigmatization will be assessed by questionnaire | Day 1 | 
| Sociodemographic factors and lifestyle habits | Sociodemographic factors and lifestyle habits will be assessed by questionnaire | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress, Psychological, Coronavirus, Epidemics
Aetiology of Children With Bronchiectasis in China

Study Overview
=================
Brief Summary
-----------------
This multicenter retrospective observation study is designed to investigate the etiology of children with bronchiectasis by review the medical records.

Detailed Description
-----------------
This study is divided into two parts. Part I. Retrospective review the 10 years medical records of the children with bronchiectasis from every center, and investigate the etiology of the cases by the standard diagnostic process. Part II. All new cases of bronchiectasis which was confirmed diagnosed at every center from the beginning of the study are made the investigation of the etiology by the standard diagnostic process.

Official Title
-----------------
Aetiology of Children With Bronchiectasis in China--A Multicenter Retrospective Study

Conditions
-----------------
Bronchiectasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:A included patient must be coincident at least one point of the four items of HRCT manifestations. Internal bronchial diameter greater than the accompanying pulmonary artery. lack of bronchial tapering bronchi visible in the peripheral 1cm of lung bronchial diameter greater than adjacent segmental bronchi Exclusion Criteria:Subject will be excluded if she or he has one of the following It is unable to provide complete medical records or the current condition can not accept the diagnosis process It does not agree to participate in the test

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| Number of participants with differential causes of bronchiectasis by reviewing the medical records or undergoing the standard diagnostic process | The cause of each paticipant with bronchiectasis will be recorded, for example post infection, PCD, PID, et al. | 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
etiology, children
Fibrosis, Valvular and Ventricular Function in Patients With TGA

Study Overview
=================
Brief Summary
-----------------
The aim of this project is to better evaluate the systemic right ventricular (RV) function in patients with transposition of the great arteries (TGA).

Detailed Description
-----------------
Patients with TGA frequently develop supraventricular and ventricular arrhythmia, conduction problems, systemic atrioventricular valve (SAVV) regurgitation, and congestive heart failure (CHF), all at young age. However, there is variation in time of onset of these adverse events. We want to evaluate ventricular and valvular function at rest, markers of RV fibrosis and cardiac reserve.

Official Title
-----------------
Fibrosis, Valvular and Ventricular Function in Patients With Transposition of the Great Arteries

Conditions
-----------------
Transposition of Great Vessels

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a TGA Informed consent to participate. If the patient is under the age of 18, the assent of the patient and the permission of the parents to participate Exclusion Criteria: Previous double-switch intervention Any medical contra-indication for cardiovascular magnetic resonance (CMR) imaging (e.g. pacemaker) The presence of exercise-induced arrhythmia, symptomatic myocardial ischemia, a resting systolic blood pressure > 200 mm Hg and/or diastolic blood pressure > 110 mm Hg, New York Heart Association (NYHA) class III or IV, or non-cardiac co-morbidity that could aggravate by exercise Additional exclusion criterion for delayed gadolinium enhancement CMR: any medical contra-indication for intravenous gadolinium

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| transposition of the great arteries<br>Patients with a TGA | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival | Composite clinical end point | 10 years |
EPC Performance Investigation for StereoElectroEncephaloGraphy

Study Overview
=================
Brief Summary
-----------------
The objective of this multicentre study is to collect preoperative, intra operative, early, short, intermediate and mid-term(one years) on the related clinical complications and functional outcomes of market-approved Alcis products to demonstrate safety and performance of these devices in a real-world setting.

Detailed Description
-----------------
Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Alcis devices and support peer-reviewed publications on products performance and safety.

Official Title
-----------------
EPISEEG - EPC Performance Investigation for StereoElectroEncephaloGraphy

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

Intervention / Treatment
-----------------
* Device: Depth Coagulation Electrode


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be included, patients must be: 18 months to 65 years Patient with drug-resistant and disabling focal epilepsy Informed and willing to sign an informed consent form approved by EC / For minors: if one of the parents cannot consent within the timeframe provided by the protocol, then only one parent's signature is required Affiliation to the social security or foreign regime recognized in France For prospective inclusion: Patient considered for SEEG exploration as part of pre-surgical assessment of epilepsy For ambispective inclusion: Must have undergone an SEEG exploration with one ALCIS device before the date of the initiation visit Follow-up visits (at least 12-month) must be prospective Must have complete information available for each completed visit (demographics, preoperative information, implantation information, device details) *. Exclusion Criteria: • Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times) Any medical condition that could impact the study at investigator's discretion (e.g. allergy…) Pregnant women (contraindication to SEEG exploration) Adult subject to legal protection measure Skull thickness inferior at 2 mm

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 65 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Depth Coagulation Electrode|SEEG and thermocoagulation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signal quality | percentage of contacts that measured a signal | through study completion, an average of 10 days. | 
| Modification of Electroencephalography trace post-coagulation | Modification of Electroencephalography trace post-coagulation | through study completion, an average of 1 hours. |