linjc16/ctgov huggingface dataset:
Fluid Status of Outpatients With Dyspnea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the distribution of lung fluid status as reported by the IMED-4 system in patients presenting to the emergency department or urgent care facility with shortness of breath.

Official Title
-----------------
Fluid Status of Outpatients With Dyspnea

Conditions
-----------------
Dyspnea,, Acute Heart Failure Syndrome, Pulmonary Congestion

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA Shortness of breath as the most prominent presenting symptom Age greater ≥ 45 Willingness, ability, and commitment to participate in the study EXCLUSION CRITERIA Patients with any active implantable medical device Patients who are pregnant or lactating Patients who have tattoos and or non-intact skin directly under the electrode position Patients who have had past allergic reactions to medical grade adhesives Patients that are dialysis dependent Patients who have had a lung lobectomy Patients in whom the shortness of breath presentation is due to obvious non HF cause such as acute chest trauma Patients who have received nitrates (sub-lingual, topical or IV), diuretics or vasopressors ≥ 1 hour prior to IMED-4 Recording Patients who decline to have their backs photographed with the IMED-4 device in position Patients who are receiving invasive or non-invasive positive airway pressure (PAP) ventilation prior to or following presentation to the ED (Self presentation or admission via EMS). Severe co-morbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, incarceration, shortened life expectancy, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- | --- |
| Lung Fluid Status | The IMED 4 is a new device designed to measure the lung fluid status by assessing how wet or dry the lungs are | Up to 1 year |
Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single-arm study to demonstrate the proof-of-concept of semi-elective lung transplantation. We plan to evaluate 15 patients that receive lung(s) delayed for transplantation under our study criteria.

Official Title
-----------------
Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation: A Proof-of-Concept Study

Conditions
-----------------
Pulmonary Disease

Intervention / Treatment
-----------------
* Procedure: Delayed Lung Transplantation
* Procedure: Conventional Lung Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recipient is ≥ 18 years old Recipient, or their Legally Authorized Representative is able and willing to sign informed consent Recipient meets standard listing criteria for lung transplantation Exclusion Criteria: Donor lungs meet criteria for transplantation with ex vivo lung perfusion (EVLP) Recipient is < 18 years old Recipient, or their Legally Authorized Representative is unable to sign informed consent for re-transplantation Recipient has any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delayed Lung Transplantation<br>Patients that received lung(s) delayed for transplantation | Procedure: Delayed Lung Transplantation<br>* Transplants with a planned recipient anesthesia start time between 10:00 pm and 6:00 am will be allowed to move to a start time between 6:00 am and 8:00 am at the earliest. Donor lung(s) cross clamp time must occur between 5:00 pm and 4:00 am. Lungs that meet criteria will be transported in the usual fashion in a cooler of ice at 4oC. Upon arrival to NYULH, the lungs will be transferred to cold static preservation at 10oC within a specific incubator located in a NYULH OR (MYTEMP™65HC, Benchmark Scientific).<br>|
| Active Comparator: Conventional Lung Transplantation<br>Reference Therapy | Procedure: Conventional Lung Transplantation<br>* Reference Therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ISHLT primary graft dysfunction grade 3 at 72 hours post-transplant | As defined by International Society of Heart and Lung Transplantation (ISHLT) | 72 hours |
GOUTMETALSAIN: Comparison of the Perception of Metallic Taste According to Lingual Locations in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a mono center , observational study carried out within otorhinolaryngology department in CH Valence. This is a descriptive and exploratory study in healthy volunteers. Based on the hypothesis that Metallic taste is imperfectly assessed, this study will provide a better understanding of the Metallic Taste.

Detailed Description
-----------------
The study consists of the application of a swab soaked in iron sulfate at a concentration of 10g/l. each patient will rate the intensity he/she perceives (on a numerical scale from 1 to 5) at each of the 4 predefined lingual locations

Official Title
-----------------
Comparison of the Perception of Metallic Taste According to Lingual Locations in Healthy Volunteers

Conditions
-----------------
Taste Disorders, Sensation Disorders, Taste, Metallic, Taste Disorder, Glossopharyngeal Nerve

Intervention / Treatment
-----------------
* Other: swab with iron sulfate solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old Healthy volunteers Read, write and understand the French language Patient affiliated to a social security system Written and signed informed consent Exclusion Criteria: head and Neck cancer history olfactory and gustatory disorder Refusal to participate in research Patient under guardianship, deprived of liberty, safeguard of justice

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1: intensity of perception of metallic taste<br>For this study, there is only one arm: swab with iron sulfate solution at a concentration of 10g/l. Each subject complete visual scale | Other: swab with iron sulfate solution<br>* measurement of the intensity of perception of metallic taste by affixing a swab iron sulfate solution 10g/l at 4 places on the tongue depending on the glossopharyngeal nerve: tip of the tongue (right and left); base of the tongue (right and left). Visual analogic Scale (0 to 5)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of the intensity of metallic taste | visual analogue scale (0 to 5); A score of 5 means the highest intensity of metallic taste | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Taste, Metallic
Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to compare the outcomes of the biodegradable implants for the fixation of ankle fracture and those of metallic implants, and to assess the problems of the biodegradable implants. Null hypothesis is that the clinical outcomes of biodegradable plate and screws for ankle fracture are not different from those of metallic implants.

Official Title
-----------------
Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants

Conditions
-----------------
Ankle Fracture

Intervention / Treatment
-----------------
* Device: fixation of the ankle fracture (Solco )
* Device: fixation of the ankle fracture (Freedom)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: skeletally mature subjects (≥16 years old) with unilateral ankle fractures Exclusion Criteria: subjects less than 16 years old, subjects not followed up at this hospital, multiple injuries, bilateral ankle fractures, open fractures, pathologic fractures, concomitant tibial shaft fractures, previous history of immobilization due to significant injury or a fracture of either ankle, significant peripheral neuropathy, soft tissue infection in the region on either injured ankle, or inability to complete the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 16 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: metallic implant<br>fixation of the ankle fracture with metallic implants | Device: fixation of the ankle fracture (Solco )<br>* fixation with metallic implant<br>* Other names: metallic implant: Solco;|
| Active Comparator: biodegradable implant<br>fixation of the ankle fracture with Freedom plate and screws | Device: fixation of the ankle fracture (Freedom)<br>* fixation with biodegradable implant<br>* Other names: biodegradable implant: Freedom;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Orthopaedic Foot and Ankle Society(AOFAS) score | change from baseline(3 months after surgery) | 3 months, 6 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Musculoskeletal Functional Assessment(SMFA) scale | change from baseline (3 months after surgery) | 3 months, 6 months, 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ankle, metallic, biodegradable, Freedom
Helmet Ventilation in Acute Hypercapnic Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
Lack of tolerance to the treatment, makes the interface choice for non-invasive ventilation (NIV) one of the key factor. To date the helmet is rarely used in Acute Hypercapnic Respiratory Failure (AHRF), because of its large dead space, despite in hypoxic respiratory failure, it is largely employed as a rotating strategy when the facial mask is poorly tolerated. In a multicenter randomized controlled trial, the investigators will compare the clinical efficacy of a new helmet designed to specifically improve the performance in chronic obstructive pulmonary disease (COPD) versus a full face mask during an episode of AHRF.

Official Title
-----------------
Hypercapnic Acute Respiratory Failure: Is the Helmet an Effective Interface?

Conditions
-----------------
Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Device: Helmet (Starmed)
* Device: Total Face mask (Respironics)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pH < 7,35 and PaCO2 > 45 mmHg respiratory rate > 20 b/min Exclusion Criteria: hypoxic respiratory failure coma inability to stand NIV lack of informed 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Helmet to deliver NIV<br> | Device: Helmet (Starmed)<br>* The helmet is a kind of interface similar to a hood to deliver NIV<br>* Other names: Starmed Helmet;|
| Active Comparator: Total Face to deliver NIV<br> | Device: Total Face mask (Respironics)<br>* The total face mask is the classical interface for NIV delivery<br>* Other names: Respironics Performax or similar;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Blood gases |  | at 1 hour after the start of NIV | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Blood Gases |  | Once a day at 8 am until discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, NIV, Acute Hypercapnic Respiratory Failure, COPD patients with hypercapnic respiratory failure
The Effect of N-acetylcysteine on Oxidative Stress Status and Iron Overload in Thalassemia Major

Study Overview
=================
Brief Summary
-----------------
The effect of N-acetylcysteine as antioxidant and its effect on pretransfusion hemoglobin and iron overload in patients with thalassemia were compared to patients who didn't receive n-acetylcysteine after 3 months of study duration

Detailed Description
-----------------
N-acetylcysteine( NAC) is a widely used mucolytic drug and several studies had reported its efficacy as anti oxidant. Patients with thalassemia major are at great risk for oxidative stress due to excess of b-globin chains and iron overload. In this study the investigators compared the effect of NAC on oxidative status , pretransfusion hemoglobin levels and iron overload in thalassemia patients before and after treatment with NAC for 3 months and with that of patients who served as controls.

Official Title
-----------------
The Effect of N-acetylcysteine on Oxidative Stress Status and Iron Overload in Thalassemia Major

Conditions
-----------------
Thalassemia Major

Intervention / Treatment
-----------------
* Drug: N-acetyl cysteine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thalassemia major children on regular blood transfusion and iron chelation therapy Exclusion Criteria: Renal or hepatic impairments Complicated thalassemia major Non adherence to therapy or follow up visits Change in the iron chelation dose within 3 months before enrollment or during study period

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 14 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
Interventional Model Description: Two groups are followed up for study parameters for 3 months one group is the intervention group and the other is the control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: N-acetylcysteine group<br>Patients received oral n-acetylcysteine syrup on dose of 10 mg/kg/day as single dose for 3 months | Drug: N-acetyl cysteine<br>* Mucolytic and antioxidant drug<br>|
| No Intervention: Non n-acetylcysteine group<br>Thalassemia major patients on regular chelation therapy who didn't receive n-acetylcysteine and served as controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative stress index (pg/mmol) | Oxidative stress index is calculated as the ratio of total oxidative status (pg/dl) to total anti oxidative capacity (mmol/dl) | 3 months | 
| Serum ferritin level ( mg/dl) |  | 3 months |
Observational Study to Assess the Safety of Omnipure® Inj.(Iohexol) Contrast Media in CT Scanning Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess safety of Omnipure inj. (lohexol) contrast media in CT scanning patients

Official Title
-----------------
Multi-center, Prospective, Non-interventional, Observational Study to Assess the Safety of Omnipure® Inj.(Iohexol) Contrast Media in CT Scanning Patients

Conditions
-----------------
CT Scanning Patients

Intervention / Treatment
-----------------
* Drug: Other: Not applicable-observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects in need of CT scanning subjects who signed up informed consent Exclusion Criteria: Known allergy or hypersensitivity to the study medication, ingredient of the medication, and Iodine type medication severe renal insufficiency patients severe hypothyroidism severe local infection or bacteremia
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Not applicable-observational study<br>Not applicable-observational study | Drug: Other: Not applicable-observational study<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events, adverse drug reaction, serious adverse events, serious drug reaction, laboratory data, vital signs |  | 14 days |
Multicenter Myocardial Viability Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the hypothesis of whether contrast enhanced Magnetic Resonance Imaging can be used to predict improvement of the wall motion in regions of the heart with abnormal movement following bypass surgery or percutaneous angioplasty in various institutions across three continents.

Official Title
-----------------
An International, Multicenter Trial Assessing Myocardial Viability With Contrast - Enhanced Magnetic Resonance Imaging

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: > 21 years and < 85 years Sinus rhythm Weight < 120 kg LVEF > 30% Wall motion abnormality on Echo. or LV-gram Scheduled for revascularization - Angioplasty/Stent or CABG - within 30 days Exclusion Criteria: Resting heart rate > 100 bpm Frequent atrial or ventricular ectopy Severe aortic stenosis or HOCM Unstable angina Myocardial infarction within 14 days Active congestive heart failure Pregnancy Known allergy to gadolinium Contraindication to MRI

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| To examine whether the extent of irreversible myocardial injury as assessed by Delayed Enhancement Magnetic Resonance Imaging can predict the extent of functional recovery after revascularization in patients with chronic coronary artery disease (CAD). |  | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial Viability, Delayed Enhancement Magnetic Resonance Imaging, Functional Recovery
A Pilot Study to Explore the Role of Gut Flora in Metastatic Mesothelioma

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Metastatic Mesothelioma

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Metastatic Mesothelioma

Conditions
-----------------
Mesothelioma, Mesothelioma Malignant, Mesothelioma; Lung, Mesotheliomas Pleural, Mesothelioma Peritoneum, Mesothelioma; Liver, Mesothelioma; Omentum

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent Male or female of all ages. (interest is given to children who present with autism or Crohn's and whose parents wish to analyze their children's gut flora. Also of interest analysis of development of the child's microbiome. In the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome) Diagnosis of metastatic mesothelioma through biopsy and/or advanced imaging Exclusion Criteria: Refusal to sign informed consent form History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition
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 with metastatic mesothelioma<br>Patients who have been diagnosed with metastatic mesothelioma | Other: No intervention<br>* There is no intervention for this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized with metastatic mesothelioma | Three years |