linjc16/ctgov huggingface dataset:
Clinical Efficacy of a Cephalic Mask for Noninvasive Ventilation During Acute Hypercapnic Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
Noninvasive ventilation (NIV) is now a major therapeutic option to manage patients with acute hypercapnic respiratory failure (AHRF). Otherwise, patient-ventilator interfaces are determinant to get an optimal NIV efficacy in parallel with ventilatory comfort. Facial masks during NIV are associated with deleterious consequences like gas leaks around the mask, skin breakdown (especially on the nasal bridge), claustrophobia and mask discomfort. In order to limit these side effects, a cephalic interface has been recently designed. Cephalic mask covers the whole anterior surface of the face and excessive mask fit pressure is therefore spread over a larger surface outside the nose area. However, this mask has a high volume that may interfere with NIV efficacy and may also induce claustrophobic sensations. The aim of this study is to compare the clinical efficacy and tolerance of a cephalic mask versus a conventional oronasal mask during AHRF.

Conditions
-----------------
Acute Hypercapnic Respiratory Failure

Intervention / Treatment
-----------------
* Device: Interface for noninvasive ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute hypercapnic respiratory failure Indication to noninvasive ventilation Exclusion Criteria: Requirement for endotracheal intubation Proven pulmonary embolism Present or previous history of ophthalmologic disease

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

| Intervention/Treatment |
| --- |
|Device: Interface for noninvasive ventilation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial blood gases |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory frequency |  |  | 
| Severity scores |  |  | 
| Ventilatory settings |  |  | 
| Patient-ventilator adaptation |  |  | 
| Tolerance |  |  | 
| Outcome |  |  | 
| Complications |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Noninvasive ventilation, Acute hypercapnic respiratory failure, Cephalic mask, Facial Mask
MR Radiomic Features in Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
A combination of correct interpretation of imaging and biopsy has given promising results in terms of detecting clinically significant cancer at radical prostatectomy.

Detailed Description
-----------------
Quantitative approaches to medical image analysis have been developed in recent years with the aim to overcome the limitation of qualitative image interpretation, and provide biomarkers for disease characterization. In particular, the new paradigm, radiomics, is emerging as the high-throughput extraction of quantitative features from imaging which can aid in characterizing phenotype as in vivo expression of tumoral genotype. The goal of radiomics is to extract accurate and reliable quantitative biomarkers which enhance diagnostic confidence in oncology. A combination of correct interpretation of imaging and biopsy has given promising results in terms of detecting clinically significant cancer at radical prostatectomy.

Official Title
-----------------
MR Radiomic Features in Prostate Cancer

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years of age In house MRI with contrast medium PCa (prostate cancer) biopsy proven diagnosis In house radical prostatectomy Exclusion Criteria: < 18 years of age MRI without contrast medium Radical prostatectomy executed not in Institution

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

Sexes Eligible for Study
-----------------
Male

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 surrogate bioimaging markers of histological characteristics in MR images | Segment tumor volumes on the ADC map and extract different imaging features | 0-2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiomic features from MRI | Evaluate if radiomic features on primitive prostate lesions can describe lymph node involvement. | 0-2 years | 
| Extract radiomic features | Evaluate if radiomic features fro MRIon primitive prostate lesions can describe disease extension. | 0-2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, prostate, radiomics, MRI, prognostic factors
Development of a Noninvasive Method of Evaluation of Pulmonary Inflammation in the Condensates of Exhaled Air

Study Overview
=================
Brief Summary
-----------------
The aim of the study is identify biological parameters reflecting proteolytic activity in the exhaled condenstaes which might be useful to follow up pulmonary inflammation in various conditions including cystic fibrosis, COPD, asthma, tobacco exposure. Three proteases will be analyzed, i.e. elastase, proteinase 3 and cathepsin G. Results in the condensates will be compared to those obtained in sputum.

Detailed Description
-----------------
5 groups of 20 individuals each: group 1 CF, group 2 COPD, group 3 asthma, group 4 tobacco exposure, group 5 control subjects. Collection of exhaled condensates in all subjects and of sputum in subjects belonging to groups 1 and 2. Clinical examination and PFTs in all patients.

Official Title
-----------------
Development of a Noninvasive Method of Evaluation of the Pulmonary Inflammation in the Condensates of Exhaled Air

Conditions
-----------------
Bronchopulmonary Ignition, Condensate of Exhaled Air, Mucoviscidosis, Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Subjects suffering from CF, COPD, asthma and tobacco exposure (groups 1 to 4) and controls (group 5) aged more or equal to 18 stable disease able to perform PFTs informed consent signed affiliated to french social insurance Exclusion Criteria: acute exacerbation of the disease during the last 2 weeks IV or oral steroids or antibiotics during the last 2 weeks hospitalization during the last 2 weeks colonization by S aureus methicillin resistant and/or Burkholderia cepacia

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?
-----------------
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
-----------------
Mucoviscidosis, bronchopulmonary ignition, condensate of exhaled air, Asthma
Effects of Montelukast on Airway Regulatory T Cells in Asthma

Study Overview
=================
Brief Summary
-----------------
Montelukast is one of anti-inflammatory agents and a good controller for the patients with asthma. The hypothesis of the study is that the Montelukast will have airway anti-inflammatory effects and up-regulated regulatory T cells functions in asthma.

Official Title
-----------------
Effects of Montelukast on Airway Foxp3+ and CTLA4+CD25highCD4+ T Cells in Asthmatics

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

Intervention / Treatment
-----------------
* Drug: Montelukast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: asthma mild status stable status nonsmoker Positive of airway hyperresponsiveness (Methacholine-PC20<16mg/mL) Exclusion Criteria: taken other asthmatic medications such as oral, injective, and inhaled steroids, leukotriene antagonists, oral, inhaled, and transdermal beta-agonists, theophylline, anti-histamine agents, anti-IgE antibodies and long acting muscarinic receptor antagonists. respiratory tract infections within 4wks moderate to severe other organ disorders active malignancies past histories of side effects of leukotriene antagonists psychological disorders pregnancy or nursing

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Montelukast<br> | Drug: Montelukast<br>* 10mg/day, once a daily after dinner, for 28dyas<br>|
| Sham Comparator: Vitamin B6<br> | Drug: Montelukast<br>* 10mg/day, once a daily after dinner, for 28dyas<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montelukast will up-regulate airway regulatory T cell in the patients with asthma |  | 4wks of treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montelukast will improve airway inflammation, lung function and hyperresponsiveness in the patients with asthma |  | 4wks of treatment periods | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, regulatory T cells, leukotriene antagonist
Incidence of Pulmonary Embolism During Temporary Pacing Via Femoral Versus Subclavian Vein

Study Overview
=================
Brief Summary
-----------------
Temporary pacing via femoral vein is used widely in mainland China, because of its feasibility and simplicity. However, pulmonary embolism often occurred after the procedure. It is not known that whether there was any difference in incidence of pulmonary embolism between via different approaches. This randomized and multi-center study was designed to verify whether temporary pacing via subclavian vein has lower incidence than via femoral vein.

Official Title
-----------------
Study of Incidence of Pulmonary Embolism During Peroperative Period of Temporary Pacing Via Femoral Vein Versus Subclavian Vein in China

Conditions
-----------------
Pulmonary Embolism

Intervention / Treatment
-----------------
* Procedure: temporary pacing femoral vein
* Procedure: temporary pacing subclavian vein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or older There is indication for temporary pacing Patients agreed to participate in the clinical trial and sign a written informed consent Exclusion Criteria: History of pulmonary embolism or deep vein thrombosis Devices existing in vein system Patients who could not receive randomization Severe coagulation disorder Severe liver, kidney dysfunction Mental diseases Pregnancy Patients investigators believed not suitable for enrollment

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: Femoral Vein<br>patients receiving temporary pacing via femoral vein | Procedure: temporary pacing femoral vein<br>* Temporary pacing via femoral or subclavian vein<br>|
| Experimental: Subclavian Vein<br>patients receiving temporary pacing via subclavian vein | Procedure: temporary pacing subclavian vein<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants suffering from pulmonary embolism |  | 12 hours to 7 days after extraction of temporary pacing leads | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants suffering from deep vein thrombosis |  | 12 hours to 7 days after extraction of temporary pacing leads | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Femoral Vein, Pulmonary Embolism, Temporary Pacing, Subclavian Vein
Russian Study of the Efficacy and Safety of Tarka in Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
This study will investigate antihypertensive activity and safety profile of Tarka in Russian hypertension patients by ambulatory blood pressure measurement (ABPM)

Official Title
-----------------
A Multicenter, Open, Phase IV, 24-Hour Ambulatory Blood Pressure Monitoring Study of the Efficacy and Safety of Tarka in Patients With Arterial Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: trandolapril/verapamil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertension Exclusion Criteria: SBP > 180 mm Hg, DBP > 114 mm Hg Subject has a hypersensitivity to trandolapril or verapamil

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: trandolapril/verapamil<br>* 180/2 mg QD<br>* Other names: Tarka;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure from baseline/blood pressure control |  | Baseline to 3 months of Tx | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute BP reduction from baseline, safety |  | Baseline to 3 months of Tx | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Tarka
Tumor Registry Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The registry aims to collect and analyse information on the antineoplastic treatment of patients with unresectable locally advanced or metastatic pancreatic cancer, treated in palliative intention (cohort 1) and patients with localized, resectable pancreatic cancer treated in neo-adjuvant or adjuvant intention (cohort 2) in daily routine practice in Germany. The registry will follow up patients for two years. It will identify common sequences of treatments used as well as changes in the treatment of the disease. Health-related quality of life will be analysed during the course of the treatment (PanLife). Based on the available data a prognostic score will be developed.

Official Title
-----------------
Clinical Registry on Treatment Reality and Sequential Treatments of Patients With Resectable or Locally Advanced/Metastatic Pancreatic Cancer in Real-life Practice in Germany

Conditions
-----------------
Pancreas Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: resectable or locally advanced/metastatic pancreatic cancer 18 years and older Antineoplastic treatment Date of consent no later than 2 weeks after start of first-line treatment Exclusion Criteria: No pancreatic cancer Below 18 years and older No antineoplastic treatment Date of consent later than 2 weeks after start of first-line treatment

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 |
| --- | --- |
| Cohort 1<br>2,200 patients with unresectable locally advanced or metastatic pancreatic cancer, treated in palliative intention | |
| Cohort 2<br>125 patients with localized, resectable pancreatic cancer treated in neo-adjuvant or adjuvant intention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment reality in Germany | description of treatments selected for patients per line of therapy over the course of the project | over 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic neoplasms, neoplasms, registry, advanced pancreatic cancer, health services research, epidemiology, Germany, palliative treatment, palliative care, localized, resectable pancreatic cancer, adjuvant treatment
Clinical Assessment of Insulin Fast Dissolving Film in Treatment of Post Infection Anosmia

Study Overview
=================
Brief Summary
-----------------
The study aimed to investigate the efficacy of insulin in a new dosage form ( fast dissolving film) in treatment of anosmia in patients post infested with Covid-19. The study implication based in two methods evaluations Threshold test identification test.

Detailed Description
-----------------
This study was designed to improve smell disorders after corona infection that is very anxious for all patients. Inclusion criteria were loss of smell, post covid-19 infection, age from 18 to 70 years and accept sharing and follow up. The application of dosage form by ENT specialist at otorhinolaryngology clinic at Minia University hospital. Dose was 100iu of insulin 3 times weekly for 4 weeks. The new dosage form with insulin was compared with a placebo to ensure statistical improvement. The tests were performed in each visit. Primary outcome was the improvement of smell sensors in those patients

Official Title
-----------------
Insulin Fast Dissolving Film for Intranasal Delivery Via Olfactory Region, a Promising Approach for the Treatment of Anosmia in COVID 19 Patients: Design, In-vitro Characterization and Clinical Evaluation.

Conditions
-----------------
Anosmia

Intervention / Treatment
-----------------
* Combination Product: Insulin film
* Device: Fast dissolving film


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anosmia post covid-19 infection Exclusion Criteria: nasal polyps or fractions or syrgery in nose from 6 months or less

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: Insulin fast dissolving film<br>Formulated bioadhesive fast dissolving film contains 100IU of insulin | Combination Product: Insulin film<br>* Insulin suspension vials<br>Device: Fast dissolving film<br>* Fast dissolving film<br>|
| Placebo Comparator: Plain fast dissolving film<br>Formulated bioadhesive fast dissolving film contains no drug | Combination Product: Insulin film<br>* Insulin suspension vials<br>Device: Fast dissolving film<br>* Fast dissolving film<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smell sensation improvement | By decrease the threshold sensation with butanol test | 4 weeks |
Ibuprofen Concentration in Cerebro Spinal Fluid (CSF) of Infants and Children

Study Overview
=================
Brief Summary
-----------------
Ibuprofen, the active ingredient in Nurofen and Advil, is a commonly used drug in children. There is very limited data about Ibuprofen concentrations in the cerebro spinal fluid (CSF). The objective of the current study is to describe concentrations of ibuprofen in the CSF of infants and children after administration of ibuprofen. We will study infants presenting to the Emergency Department (ED) with fever who received ibuprofen. A complete sepsis workup including sampling of blood and CSF is conducted in cases of suspected meningitis. We will measure ibuprofen in the blood and CSF obtained during the sepsis workup. A better understanding of the pharmacokinetics of ibuprofen and its penetration into the CSF will unable us to suggest more accurate dosing guidelines, and to better predict the effects of this commonly used drug.

Conditions
-----------------
Fever

Intervention / Treatment
-----------------
* Drug: Ibuprofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 3 month-18 years Rectal temperature > 38.0OC or oral temperature > 37.6 OC measured in the ED or at home. A sepsis work up is indicated At least one dose of Ibuprofen was given in the last 8 hours prior to lumbar puncture (LP) Exclusion Criteria: Hypersensitivity to Ibuprofen Known metabolic disorder Known liver or kidney disease Hydrocephalus Informed consent could not be obtained from a legal guardian

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum 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 |
| --- | --- |
| Children with fever<br> | Drug: Ibuprofen<br>* Ibuprofen (10mg/kg BW) will be given orally if the temperature on presentation is higher than 38.0OC according to the decision of the attending physician.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ibuprofen concentration in the CSF |  | 30 - 360 minutes after administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fever, Ibuprofen