linjc16/ctgov huggingface dataset:
Mannitol Bronchoprovocation Challenge Ancillary Study/ACRN

Study Overview
=================
Brief Summary
-----------------
This is an ancillary study conducted as part of the BASALT trial [NCT00495157]. The overall hypotheses are: 1) an indirect airway challenge procedure using mannitol can safely characterize asthma phenotypes, predict asthma control and exacerbations, predict responses to interventions, and perform more specifically than a direct methacholine challenge and; 2) PX27 pore function in whole blood correlates with measures of airway hyperresponsiveness induced by methacholine and/or mannitol challenges

Official Title
-----------------
Mannitol Bronchoprovocation Challenge Ancillary Study Protocol to Best Adjustment Strategy for Asthma Over Long Term

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

Intervention / Treatment
-----------------
* Drug: mannitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all subjects randomized to the BASALT protocol Exclusion Criteria: positive urine pregnancy test requirement for more than two albuterol treatments for reversal of the methacholine bronchoprovocation challenge procedure at visit 4 in the BASALT parent trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exploratory Mannitol<br>This is an exploratory / ancillary study open to all participants in the BASALT trial [NCT00495157] who consented to undergo mannitol bronchoprovocation procedures during the 36 week treatment period | Drug: mannitol<br>* indirect mannitol challenge<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | Mannitol bronchoprovocation challenge testing is safe, effective and well tolerated as compared to methacholine (conducted as part of the main BASALT trial). | At 6 weeks, 20 weeks, and 32 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, bronchoprovocation challenge test, mannitol, methacholine
Eisenmenger Syndrome in the Nordic Countries

Study Overview
=================
Brief Summary
-----------------
This is a historical cohort study with retrospective collection of data comprising all Nordic patient's diagnosed with Eisenmengers syndrome in the period 1977 through 2011. The goal is to determine prognostic factors for mortality and morbidity.

Detailed Description
-----------------
The following variables are obtained from national registries for each individual fulfilling the inclusion criteria: Personal data: Gender, day of birth, vital status (dead/alive), date of death, cause of death, all cause hospitalization days Specific cardiac malformation diagnosis Heart-lung transplantation. Social data: Highest educational level, marital status, employment status (Denmark only) Primary endpoints Incidence and prevalence of Eisenmenger Syndrome All-cause mortality All-cause morbidity (hospitalization for any cause) Heart-lung transplantation Advanced treatment Mortality with AT Highest educational level Personal income Marital status Job status

Official Title
-----------------
Eisenmenger Syndrome in the Nordic Countries: Advanced Treatment and Mortality 1977-2012

Conditions
-----------------
Eisenmenger Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eisenmenger syndrome Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- |
| Advanced therapy, Heart-lung transplantation, dead<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 10 years |
Impact of Anaesthesia Mode on Evaluation of LEEP Specimen Dimensions

Study Overview
=================
Brief Summary
-----------------
To study the influence of anaesthesia (local by cervical block vs. general or spinal anaesthesia) on height and volume of resection specimens in case of conization treatment for cervical intraepithelial neoplasia (CIN). Prospective observational study of all patients who underwent a first treatment by loop electrosurgical excision procedure (LEEP) for CIN. Height of fresh resection specimens was first measured by the operator and then by the pathologist after formaldehyde fixation. Volume of fresh specimens was measured in a measuring cylinder by fluid displacement.

Detailed Description
-----------------
Measure of conization specimens can be done in the operating theatre on fresh specimen or by pathologist after fixation. Methods and conditions of specimen measurement are rarely, if ever, described in published studies. To study the influence of anaesthesia (local by cervical block vs. general or spinal anaesthesia) on height and volume of resection specimens in case of conization treatment for cervical intraepithelial neoplasia (CIN). Prospective observational study of all patients who underwent a first treatment by loop electrosurgical excision procedure (LEEP) for CIN. Height of fresh resection specimens was first measured by the operator and then by the pathologist after formaldehyde fixation. Volume of fresh specimens was measured in a measuring cylinder by fluid displacement.

Official Title
-----------------
Impact of Anaesthesia Mode on Evaluation of LEEP Specimen Dimensions

Conditions
-----------------
Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: every patient who underwent a first conization procedure regardless of indication Exclusion Criteria: patient's refusal to participate.

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| Impact of anaesthesia on height of resection specimens. | evaluate the impact of the excision procedure technique by the mode of anesthesia using the loop electrosurgical on height of resection specimens in case of conization treatment for cervical intraepithelial neoplasia. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
loop electrosurgical excision procedure
The Influence of NPPA/NPPB Haplotype on Natriuretic Peptide Plasma Levels

Study Overview
=================
Brief Summary
-----------------
Crosssectional study to analyse the genetic influence on levels of cardiac biomarkers (BNP, NT-proBNP).

Detailed Description
-----------------
Background Natriuretic peptides play an important role in risk stratification and management of patients undergoing non-cardiac surgery. However, due to genetic variability, the levels of these biomarkers may differ in individual patients with cardiac derangement. In the preoperative setting, genetic contribution to natriuretic peptide plasma level variability has not yet been determined. Objective The aim of this study is to assess genetic contribution to NP plasma level variability in a Swiss cohort. Methods Cross-sectional association study in a cohort of non-cardiac surgery patients. This study is a Subproject of a prospective cohort study registered under the ID 041/09.

Official Title
-----------------
The Influence of NPPA/NPPB Haplotype on Natriuretic Peptide Plasma Levels

Conditions
-----------------
Anesthesia, Surgical Procedure, Operative

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older Written informed consent Scheduled surgery Exclusion Criteria No informed consent Cognitive impairment

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 |
| --- | --- |
| All patients<br>Patients undergoing elective surgery with anesthesia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of NPPA/NPPB haplotype on natriuretic peptide plasma levels | Estimation of genetic effects on natriuretic peptide (BNP, NT-proBNP) plasma levels | Blood samples collected at start of anesthetic procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
genetic association study
Phase I Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are: To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers

Official Title
-----------------
A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet After a Single Oral Administration in Healthy Male Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: CJ Amlodipine/Valsartan 10/160mg
* Drug: Novartis Exforge 10/160mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male volunteers in the age between 20 and 45 years old Body Mass Index (BMI) in the range of 19 to 27 kg/m2 Exclusion Criteria: History of allergy or sensitivity to any drug, including amlodipine or valsartan History of clinically significant hepatic, renal, gastrointestinal, neurology, pulmonary, endocrine, musculoskeletal, hematologic, oncologic, psychiatric, especially cardiovascular disease History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines Hypotension (Systolic Blood Pressure(SBP) ≤ 100 mmHg or Diastolic Blood Pressure(DBP) ≤ 65 mmHg) Hypertension (SBP ≥ 150 mmHg or DBP ≥ 95 mmHg) Clinical laboratory test values are outside the accepted normal range Aspartate Transaminase(AST) or Alanine Transaminase(ALT) > 1.25 times to normal range Total bilirubin > 1.25 times to normal range Positive for Hepatitis B Virus surface Antigen(HBsAg), Hepatitis C Virus Antibody(HCVAb) or Human Immunodeficiency Virus Antibody(HIVAb)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CJ Amlodipine/Valsartan 10/160mg<br> | Drug: CJ Amlodipine/Valsartan 10/160mg<br>* single dose<br>|
| Active Comparator: Novartis Exforge 10/160mg<br> | Drug: Novartis Exforge 10/160mg<br>* single dose<br>|

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
-----------------
Safety, Pharmacokinetics
Establishing Effective Screening Methods for Diagnosing Hereditary Nonpolypoisis Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
Correct identification of Lynch syndrome at the time of colorectal cancer presentation is important. We aim to find best ways to screen patients with colorectal cancer in Korea.

Detailed Description
-----------------
Patients with newly diagnoised colorectal cancer will be eligible. They will undergo detailed history taking including family history, and molecular stuidies including microsatellite instability test and immunohistochemistry for DNA mismatch repair protein with pre-selection. Any abnormal finding in molecular stuides will be offered genetic testing (after testing methylation status for patients with abnormalities in MLH1).

Official Title
-----------------
Establishing Effective Screening Methods for Diagnosing Hereditary Nonpolypoisis Colorectal Cancer

Conditions
-----------------
Colonic Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colorectal cancer Exclusion Criteria: Histology showing other than adenocarcinoma
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonic Neoplasms, Lynch syndrome
Quantification of Arm Non-Use After a Stroke

Study Overview
=================
Brief Summary
-----------------
Reproducibility assessment of a quantitative measure of the amount of trunk compensation by kinematic analysis in a grasping task in stroke patients.This maladaptive trunk compensation is suspected to be underlined by arm non-use in some patients, since this abnormal movement impairs the ability of patients to correctly flex their shoulder and extend their elbow during grasping.

Official Title
-----------------
Reliability of Kinematic Analysis in Assessment and Rehabilitation of the Upper Arm of Stroke Patients Following a Cerebral Vascular Accident, Hemiparetic Subjects

Conditions
-----------------
Hemiplegia

Intervention / Treatment
-----------------
* Other: Kinematic analysis of trunk compensation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: · Patient hemiparetic Hemiplegic Patient Patient can perform a global task with the gripping limb Exclusion Criteria: Patient can not actively tender elbow of the affected limb, Patient who can not actively flex the shoulder of the affected limb, Patient with a passive extension deficit elbow> 30 °, Patient with a shoulder flexion passive deficit> 60 °, Patient with severe neglect Patient bearer severe cognitive impairment A patient with aphasia understanding disorders

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

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: stroke patients<br>Kinematic measurement of the amount of trunk displacement during a grasping task Two separated measurements are recorded with a 6-hours interval A third measurement provided by a second examinator is conducted | Other: Kinematic analysis of trunk compensation<br> <br> |
| Experimental: control patients<br>Kinematic measurement of the amount of trunk displacement during a grasping task Two separated measurements are recorded with a 6-hours interval A third measurement provided by a second examinator is conducted | Other: Kinematic analysis of trunk compensation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinematic measurement of trunk displacement by the maladaptive index trunk compensation | The Maladaptive Index Trunk Compensation (MTC) is the difference between the compensation index (CI) in the free trunk condition and to the fixed core condition. The compensation index is the core of the movement of the report on the movement of the hand. | 1 day |
Interest of Thromboelastography (ROTEM) as a Biomarker of Revascularisation in Stroke

Study Overview
=================
Brief Summary
-----------------
Revascularisation using recombinant tPA is the reference treatment of stroke. However, the efficacy of fibrinolysis is about 50%. Several factors, including the size of thrombus, have been associated with revascularisation efficacy. The aim of this prospective study is to evaluate ex vivo the effect of tPA in patients with stroke with thromboelastography and to correlate results with the clinical outcome of patients. Results may predict revascularisation in patients with stroke.

Official Title
-----------------
Interest of Thromboelastography (ROTEM) as a Biomarker of Revascularisation in Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Biological: Thromboelastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient (> 18 years) with a neurological deficit compatible with a neurovascular pathology eligible for fibrinolysis rtPA and having a proximal occlusion of the middle cerebral artery (segment M1 / M2) or basilar trunk objectified brain imaging (MRI angiography or angio CT). Exclusion Criteria: Any patient with major comorbidity, a pathology of hemostasis or anticoagulant treatment (vitamin K antagonist (VKA), direct oral anticoagulant).

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 |
| --- | --- |
| Success of revascularisation<br> | Biological: Thromboelastography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of revascularisation 24 hours after tPA injection using CT scan or MRI |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation using NIHSS scale |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tPA, Fibrinolysis
The EBC Recovery Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study to find out if clinically unconscious acute traumatic brain injury patients that show brain activation on electroencephalogram (EEG) (bedside test) have better results and wake up in the future.

Official Title
-----------------
Electrophysiologic Biomarkers of Consciousness (EBC) Recovery After Traumatic Brain Injury

Conditions
-----------------
Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For TBI Participants TBI adult (18 years and older) patients who are admitted to the intensive care unit Unconscious with Glasgow Coma Scale (GCS) <8 on presentation and unable to follow bedside commands. A negative COVID-19 test on arrival For Healthy Volunteers: 18 years and older Exclusion Criteria: For All Participants: <18 years of age Pregnant woman Patients with cardiac arrest on presentation

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 |
| --- | --- |
| Traumatic Brain Injury Patients<br>Traumatic brain injury (TBI) patients will be recruited and studied using electroencephalogram (EEG) to monitor their brain response to auditory and visual stimuli. | |
| Healthy Volunteers<br>Healthy volunteers will serve as the control group and will undergo electroencephalogram (EEG) to monitor their brain response to auditory and visual stimuli. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Outcome Scale-Extended (GOSE) Scale | The GOSE is an outcome scale, range 1-8 evaluating the patients' functional outcomes - higher score indicates better recovery | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coma Recovery Scale - Revised (CRS-R) | The CRS-R will evaluate the patients' conscious state, range 0-23 -higher score indicates a better conscious state | Up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Consciousness, Coma, Recovery, Electroencephalogram
Study Evaluating the Association of Antibiotic Measures and Control of Bacterial Resistance

Study Overview
=================
Brief Summary
-----------------
Assess efficacy of piperacillin/tazobactam in reducing the cases of colonization and infection of bacteria.

Detailed Description
-----------------
Primarily, this study is designed to assess the efficacy of piperacillin/tazobactam in reducing the cases of colonization and infection of extended-spectrum betalactamases (ESBLs) producing E.coli or K pneumoniae, S aureus methicillin resistant (MRSA) and Enterococcus vancomycin resistant (VRE). Secondly, this study plans to determine the acquisition rate of ESBL producing E Coli or K pneumoniae, methicillin resistant S Aureus (MRSA) and vancomycin resistant Enterococcus spp (VRE), both pre- and post-intervention.

Official Title
-----------------
Association of Antibiotic Measures and Control of Bacterial Resistance

Conditions
-----------------
Bacterial Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
All patients admitted in ICU will be enrolled (who qualify for treatment).
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 |
| --- | --- | --- |
| Endpoints will be efficacy of piperacillin/tazobactam in reducing colonization rates and infection of E coli or K pneumoniae, vancomycin resistant enterococcus and methicillin resistant S aureus |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endpoints will be acquisition and infection rate of ESBL producing E coli or K pneumoniae, vancomycin resistant enterococcus and methicillin resistant S aureus |  | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotic Bacterial Resistance