linjc16/ctgov huggingface dataset:
Echocardiographic Parameter and Sleep Apnea Changes After Mitral Valve Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators evaluate the changes of echocardiographic and sleep apnea parameters after mitral valve surgery. The patients undergo echocardiographic and sleep apnea control before surgery. After a period of 3-5 months, they undergo a second echocardiographic and sleep apnea control and the results are evaluated.

Official Title
-----------------
Echocardiographic Parameter and Sleep Apnea Changes After Mitral Valve Surgery

Conditions
-----------------
Sleep Apnea

Intervention / Treatment
-----------------
* Procedure: Echocardiographic and sleep apnea test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mitral valve defect NYHA II-IV no additional cardiac surgical procedure Exclusion Criteria: Pregnancy lung disease regular follow-up in the study Center in the first 6 months after surgery not guaranteed congenital heart 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Echocardiographic and sleep apnea test<br>Echocardiographic Evaluation of systolic and diastolic function of both ventricles and evaluation of apnea-hypopnea index and type of apnea | Procedure: Echocardiographic and sleep apnea test<br>* Echocardiographic evaluation (Vivid 7, GE) of systolic and diastolic function of both ventricles as well as evaluation of apnea-hypopnea index and type of apnea (ApneaLink®)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of left ventricular systolic function |  | 1-4 weeks before and 3 months after surgery | 
| Changes of apnea-hypopnea index |  | 1-4 weeks before and 3 months after surgery | 
| Changes of global longitudinal strain |  | 1-4 weeks before and 3 months after surgery | 
| Changes of right ventricular systolic function |  | 1-4 weeks before and 3 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mitral valve, valve surgery, echocardiography
Manual Therapy Treatment for Myofascial Pain

Study Overview
=================
Brief Summary
-----------------
This study is a pain intensity evaluation in patients with myofascial pain submitted kinesitherapy after trigger point injection.

Detailed Description
-----------------
Randomized prospective study conducted on 30 patients of both genders ranging in age from 18 to 60 years, with neck and shoulder girdle Myofascial Pain Syndrome (MFS), with a duration of ≥ 4 months and pain intensity ≥ 4. Trigger point injection of 1 mL 0.25% bupivacaine at each point, once a week for 8 weeks (T1 to T8). Group 1: kinesiotherapy once a week for 8 weeks Group 2: not submitted to kinesiotherapy Evaluation of pain intensity on the first assessment (T0) and after 1, 2, 3, 4, 5, 6, 7, 8, and 9 weeks

Official Title
-----------------
Effect of Manual Therapy After Trigger Point Injection for Myofascial Pain Syndrome

Conditions
-----------------
Myofascial Pain Syndromes

Intervention / Treatment
-----------------
* Procedure: Manual therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: myofascial pain of neck and shoulder girdle, lasting ≥ 4 months, pain intensity ≥ 4. Exclusion Criteria: arrhythmia heart block coagulopathy cognitive alterations and infection at the site patients using anticoagulants, and pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single-arm studies<br>Manual therapy for one group | Procedure: Manual therapy<br>* Manual therapy, once a week for 8 weeks<br>* Other names: mobilization;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | once a week for 8 weeks (T1 to T8) | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myofascial pain, trigger point injection, manual therapy
Biomarkers in Thoracic Aorta Surgery

Study Overview
=================
Brief Summary
-----------------
Biomarkers can play a vital role in prognosing the perioperative complications in thoracic aorta surgery. The goal of a study is to determine the correlation between intraoperative level of certain biomarkers and total amount of peroperative complications.

Official Title
-----------------
Role of Intraoperative Biomarkers in Prognosis of Perioperative Complications in Reconstructive Thoracic Aorta Surgery

Conditions
-----------------
Aortic Aneurysm, Thoracoabdominal Aneurysm, Aortic Dissection, Complication

Intervention / Treatment
-----------------
* Diagnostic Test: blood sample tests for determination of biomarkers levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective thoracic and thoracoabdominal surgery Exclusion Criteria: Hemolysis in blood sample

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thoracic aorta surgery patients<br>Blood samples on proadrenomedullin, presepsin, NT-proBNP, Troponin I, procalcitonin are acquired | Diagnostic Test: blood sample tests for determination of biomarkers levels<br>* Using of proadrenomedullin, presepsin, NT-proBNP, Troponin I to determine the correlation of perioperative complications.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Total amount of various postoperative complications | up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | mortality rate | up to 10 days | 
| Multiorgan failure | Number of more than 2 organs failure | up to 10 days | 
| Respiratory failure | Number of patients who require prolonged and/or repeated artificial lung ventilation | up to 10 days | 
| Renal failure | Number of patients who require extracorporeal detoxication | up to 10 days | 
| Heart failure | Need in medicamental cardiotonic support more than 1 day | up to 10 days | 
| Circulatory insufficiency | Need in medicamental vasopressor support more than 1 day | up to 10 days | 
| Infection rate | Number of patients who develop systemic infection and/or operation wound infection | up to 10 days | 
| Length of intensive care stay | Duration of summarized length in ICU, including readmission to ICU | up to 10 days |
Negative Pleural Suction for Tube Thoracostomy in Patients With Chest Trauma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the use of negative pleural suction in tube thoracostomy is more effective than water seal alone for the treatment of pneumothorax and/or hemothorax in patients with chest trauma.

Official Title
-----------------
Efficacy of Negative Pleural Suction in Tube Thoracostomy for Patients With Penetrating and/or Blunt Chest Trauma: a Randomized Clinical Trial

Conditions
-----------------
Hemothorax, Pneumothorax, Hemopneumothorax, Chest Injury Trauma Blunt, Chest Injury Trauma, Chest Injury Penetrating Wound

Intervention / Treatment
-----------------
* Other: Negative Pleural Suction at -20 cm H2O
* Other: Water seal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pneumothorax after penetrating o blunt chest trauma Hemothorax after penetrating o blunt chest trauma Hemopneumothorax after penetrating o blunt chest trauma Require tube thoracostomy Exclusion Criteria: Invasive mechanical ventilation Emergent Surgery (thoracoscopy, open thoracotomy) Chronic pulmonary diseases (COPD, CRPD) Severe traumatic brain injury Glasgow coma scale upon arrival <8/15

Ages Eligible for Study
-----------------
Minimum Age: 15 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: With negative pleural suction<br>Patients are put on negative pleural suction at - 20 cm H2O | Other: Negative Pleural Suction at -20 cm H2O<br> <br> Other: Water seal<br> <br> |
| Active Comparator: With water seal<br>Patients al left on water seal only | Other: Water seal<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lenght of Hospital stay |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of persistent bronchopleural fistulae |  | 30 days | 
| Incidence of coagulated Hemothorax |  | 30 days | 
| Incidence of empyema |  | 30 days | 
| Incidence of recurrent pneumothorax |  | 30 days | 
| Number of patients necessitating surgical interventions (includes new thoracostomy, thoracoscopy and open thoracotomy) |  | 30 days |
Hospital Discharge Oral Nutrition Support Trial

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of different strategies for managing malnutrition in the community

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Dietary Supplement: Oral Nutritional Supplement 1
* Dietary Supplement: Oral Nutritional Supplement 2
* Dietary Supplement: Dietary Advice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female Age 50 years and over Able to eat and drink without the need for altered texture fluids Identified at risk of disease related malnutrition Competent to provide written informed consent Willingness to take part in the study and to follow the study protocol Exclusion Criteria: Individuals unable to eat or drink Chronic renal disease requiring dialysis Galactosaemia Dysphagia Normally or going to be residing in an institution e.g. care home upon discharge from hospital Palliative care Cancer (active treatment) Liver failure Poorly controlled diabetes Diagnosed lactose intolerance Participation in other clinical trials currently or in the previous 4 weeks Due to be discharged to an area out of the hospital region Requiring tube or parenteral nutrition Due to be discharged from hospital on oral nutrition support recommended by a Dietitian

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ONS 1 and DA<br>Oral Nutritional Supplement 1 and Dietary Advice | Dietary Supplement: Oral Nutritional Supplement 1<br>* Containing macro and micronutrients<br>Dietary Supplement: Dietary Advice<br> <br> |
| Other: ONS 2 and DA<br>Oral Nutritional Supplement 2 and Dietary Advice | Dietary Supplement: Oral Nutritional Supplement 2<br>* Containing macro and micronutrients<br>Dietary Supplement: Dietary Advice<br> <br> |
| Other: DA Alone<br>Dietary Advice Alone | Dietary Supplement: Dietary Advice<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutrient Intake | Measured by 3 day diet diaries and 24 hour recall | 12 weeks (8 week intervention followed by 4 week follow up) |
Assessment of Atrophogenic Potential of Triple Combination Cream for Treatment of Melasma

Study Overview
=================
Brief Summary
-----------------
Evaluate atrophogenic potential of long-term use of Tri-Luma Cream on facial Melasma through biopsy examination.

Detailed Description
-----------------
Same as above.

Official Title
-----------------
An Assessment of the Atrophogenic Potential of Triple Combination Cream Using Histology Measures in the Treatment of Moderate to Severe Melasma

Conditions
-----------------
Melasma

Intervention / Treatment
-----------------
* Drug: Fluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have a clinical diagnosis of moderate to severe melasma Subjects willing to undergo biopsy four times throughout the study, two biopsies at baseline (one in a melasma involved area and one in a non-involved area). The third and fourth biopsies will be performed at 3 months and 6 months, respectively; in order to avoid variability in histopathological findings, Subjects must have substantial melasma involvement of the cheeks and be willing to have the same general site biopsied at the baseline, month 3 and month 6 visits. Exclusion Criteria: Subjects with diagnosis of dermal melasma Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.) Subjects who have used retinoids, steroids, and/or skin lightening products 4 weeks prior to study entry Subjects who show signs of Poikiloderma of Civatte (mandibular hyperpigmentation) Subjects with a history of hypertrophic scarring or a history of keloids Subjects who are unable to avoid the use of a class 1 steroid during their participation in the study

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05%|Apply topically daily for 12 weeks and continue until condition is clear or almost clear for up to 24 weeks; Maintenance phase: Apply topically twice weekly until the end of study (24 weeks) or condition relapses|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Skin biopsy evaluation - histological assessment of skin atrophy |  | Baseline, 12 weeks and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability assessments; Incidence of adverse events; Global Assessment of Lesion Severity; MASI; Physician Global Assessment |  | Baseline, 12 weeks and 24 weeks |
Intubation With Storz Videolaryngoscope® Versus Airtraq® - in an Infant Population

Study Overview
=================
Brief Summary
-----------------
The purpose of the pilot study is to compare new laryngoscopes for infants by assessing the equipment best suited to assist the intubation, with the best overview, shortest time to intubation and use these numbers to make a sample size calculation for the full protocol. The investigators hypothesis is that the Storz videolaryngoscope® has a better success rate than infants (<2 years). The patients will be optimally anaesthetized with neuromuscular blockade for the intubation. All patient will be evaluated with af Macintosh blade laryngoscope, with an Airtraq® or a Storz videolaryngoscope®, and finally intubated with the other one of the later, which the patient was randomized to.

Official Title
-----------------
Intubation With Storz Videolaryngoscope® Versus Airtraq® - in an Infant Population

Conditions
-----------------
Intubation, Videolaryngoscopy, Infant

Intervention / Treatment
-----------------
* Device: Storz videolaryngoscope
* Device: Airtraq


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective surgical patients ASA-class 1-2 below the age of 2 years, with indication for intubation. Informed consent from parent. The parents must have legal custody of the child. The parents must be able to read and understand Danish. Exclusion Criteria: Expected difficult airway.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 2 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Storz videolaryngoscope<br>Macintosh overview followed by Airtraq overview followed by Storz videolaryngoscope overview and intubation. | Device: Storz videolaryngoscope<br>* Storz videolaryngoscope being used for the actual intubation<br>|
| Active Comparator: Airtraq<br>Macintosh overview followed by Storz videolaryngoscope overview followed by Airtraq overview and intubation. | Device: Airtraq<br>* Airtraq being used for the actual intubation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate | Succes is defined by intubation being executed in the first try. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Cormack evaluation |  | 5 minutes | 
| Time to intubation |  | 5 minutes | 
| Number of intubation attempts |  | 5 Minutes | 
| Quality of laryngeal overview before intubation | Evaluated by Cormack score | 5 Minutes | 
| Prevalence of post intubation stridor |  | 12 hours | 
| Intubation conditions |  | 5 Minutes |
Breath Analysis to Diagnose Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Determination of volatile organic compounds to discriminate patients with lung cancer from healthy smokers and non-smokers healthy subjects.

Official Title
-----------------
Analysis of Volatile Organic Compounds in Exhaled Air as a Diagnostic Tool for Thoracic Cancers

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Device: Collection of volatile organic compounds during exhalation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with histologically proven lung cancer Controls: healthy smoker or non-smoker subjects without respiratory diseases excepted chronic obstructive pulmonary disease. Exclusion Criteria: history of cancer other than lung cancer within 5 years before inclusion oral or facial malformation incomprehension of maneuvers for the collection

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients<br>Patients with bronchopulmonary cancer who have not yet received therapeutic treatment. | Device: Collection of volatile organic compounds during exhalation<br>* The volatile organic compounds (VOCs) are collected in sorbents at rest and at the end of exhalation according to the concentration of carbon dioxide using ReCIVA breath sampler. The identification of the VOCs will be done by chromatography (Gas Chromatography Mass Spectrometry GC-MS)<br>|
| Active Comparator: controls<br>The controls consisted of 2 groups: smokers and non-smokers. | Device: Collection of volatile organic compounds during exhalation<br>* The volatile organic compounds (VOCs) are collected in sorbents at rest and at the end of exhalation according to the concentration of carbon dioxide using ReCIVA breath sampler. The identification of the VOCs will be done by chromatography (Gas Chromatography Mass Spectrometry GC-MS)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discriminating power of VOCs | Discriminating power of VOCs using discriminant analyzes using innovative data mining methods based on multi-objective combinatorial optimization. | 34 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung cancer, diagnosis, volatile organic compounds
Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis

Study Overview
=================
Brief Summary
-----------------
During the past years many investigators have focused on the immunological changes in sepsis disease, and great attention has been paid to the development of practicable means of immunomonitoring. Little is known about diagnostic and prognostic vascular biomarkers during the time course of patients with sepsis.

Detailed Description
-----------------
Primary Outcome Measures: New diagnostic and prognostic markers for septic patients Estimated Enrollment: 300 patients Study Start Date: January 2012 Estimated Study Completion Date: open Estimated Primary Completion Date: open Intervention Details: Procedure: vein puncture comparison of different inflammatory markers in the blood of septic patients

Official Title
-----------------
Evaluation of Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SIRS-Criteria Proven Infection One sepsis-induced organ-failure Adults < 18 years old Exclusion Criteria: Anemia Pregnancy Blood donor in the last 3 month

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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
-----------------
sepsis, inflammation, diagnosis, prognosis, survival, mortality