linjc16/ctgov huggingface dataset:
Evaluation of Glycocalyx in Major Abdominal and Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
Background: The glycocalyx is a fundamental component of the endothelial barrier and alterations at this level have been shown to exacerbate the inflammatory response in the microcirculation. Its degradation in the surgical patient, has been tested in interventions that involve regional or general ischemia, for example in cardiac surgery, major vascular surgery or transplantation. On interventions that do not involve ischemic events the literature is limited, such is the case of those patients undergoing major abdominal and thoracic surgery. Objective: Assess whether there is a glycocalyx degradation in major elective abdominal and thoracic surgery, measured as an increase in plasma syndecane-1 levels during the first 24 hours of postoperative care. Methodology: Prospective observational study in patients undergoing major elective thoracic and abdominal surgery at the University Hospital Vall d´Hebrón. Measurement of the syndecane-1 plasma levels are going to be done during the first 24 hours after the intervention. It is intended to evaluate whether its elevation is related to anesthetic perioperative factors, and if it has an impact con morbildity and mortality in the following 6 months after the procedure.

Official Title
-----------------
Prospective Observational Study to Evaluate Glycocalyx Alteration in Major Abdominal and Thoracic Surgery

Conditions
-----------------
Major Elective Abdominal and Thoracic Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years old Patients that are scheduled to major abdominal and thoracic elective surgery in Universtity Hospital Vall d´ Hebrón. Patients ASA I, II and III. Patients that after the intervention have their recovering in the Surgical ICU Exclusion Criteria: Patients ASA IV and V. Patients that are hospitilized previous to the surgery. Patients that undergo emergent surgery. Patients with Chronic or Acute Renal Failure previous to the surgery. Patients with past medical history of autoinmune disseases. Patients with an active infection previous to the surgery. Patients in treatment with steroids previous to the surgery

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 |
| --- | --- | --- |
| plasmatic syndecan -1 levels | Degradation of glucocalix measured by plasmatic syndecan -1 levels | In the first 24 hours after the procedure |
A Study of the Effect of Fluvoxamine on the Pharmacokinetics of RO4917523 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This single-center, open-label, cross-over study will evaluate the effect of fluvoxamine on the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a single dose of RO4917523 alone and in combination with multiple doses of fluvoxamine in a cross-over design. The anticipated time on study treatment is 40 days.

Official Title
-----------------
A Single-Center, Open-Label, One-Sequence, Crossover Study to Investigate the Effects of Multiple Doses of Fluvoxamine on the Pharmacokinetics of a Single Dose RO4917523 in Healthy Subjects

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: Fluvoxamine
* Drug: RO4917523


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers, 18-65 years of age inclusive Non-smokers Body mass index (BMI) between 18 and 30 mg/m2 inclusive Women who are not menopausal or surgically sterile agree to use two adequate methods of contraception Exclusion Criteria: Evidence of any active or chronic disease History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer History or presence of clinically significant psychiatric condition Any condition or disease that would render the volunteer unsuitable for the study, place the volunteer at undue risk or interfere with the ability of the volunteer to complete the study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dosing Period 1<br> | Drug: RO4917523<br>* Single dose of RO4917523<br>|
| Experimental: Dosing Period 2<br> | Drug: Fluvoxamine<br>* Multiple doses of fluvoxamine<br>Drug: RO4917523<br>* Single dose of RO4917523<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area under the concentration time curve |  | Period 1: Pre-dose and up to Day 14, Period 2: pre-dose and up to Day 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: incidence of adverse events |  | 9 weeks |
Descriptive Epidemiology of a Specialized Consultation on ADHD in Adults at the Strasbourg University Hospital

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to carry out a descriptive study of the clinical and demographic characteristics of patients having consulted for a specialized opinion about ADHD in adults of the psychiatric service of the Strasbourg University Hospital. The characteristics of patients were collected during the first consultation, by the psychiatrist, and analyzed retrospectively. The secondary objective is to evaluate the evolution at one year in terms of follow-up, maintenance under medical treatment and perceived effects of it. The patients who had a prescription for pharmacological treatment of ADHD were contacted between 9 and 15 months after the first consultation and responded to a questionnaire assessing the evolution.

Official Title
-----------------
Descriptive Epidemiology of a Specialized Consultation on Attention Deficit Hyperactivity Disorder in Adults at the Strasbourg University Hospital, and Evolution Analysis at One Year

Conditions
-----------------
Attention Deficit and Hyperactivity Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Having a specialized consultation about ADHD in adults in the psychiatric service of the Strasbourg University Hospital Agree with the use of medical files from the consultation for medical research Exclusion Criteria: Disgree with the use of medical files from the consultation for medical research

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperactivity Disorder | Measuring from the medical files of patients and questionnaire | Between 9 and 15 months after the first consultation, contact of patients and collection of data for the evolution at one year analyze | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Attention deficit, hyperactivity disorder, Adult, Epidemiology, Evolution, treatment
Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to compare the effectiveness and safety of INS365 Ophthalmic Solution with Placebo when applied topically in subjects with dry eye disease.

Official Title
-----------------
A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Subjects With Dry Eye Disease

Conditions
-----------------
Dry Eye Disease

Intervention / Treatment
-----------------
* Drug: diquafosol tetrasodium (INS365) Ophthalmic Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: best corrected visual acuity in both eyes of at least +0.7 six-month documented history of dry eye disease at least mild severity in 2 of the 4 dry eye symptoms unanesthetized Schirmer score of less than or equal to 7mm corneal fluorescein staining of greater than or equal to 4 (out of 15) Exclusion Criteria: nasally stimulated Schirmer score of less than 3mm in subjects with an initial Schirmer score of 0mm ongoing contact lens wear current topical ophthalmic medication use

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: diquafosol tetrasodium (INS365) Ophthalmic Solution|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in dry eye testing measures and symptoms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in dry eye testing measures and symptoms |  |  |
CT Perfusion Changes in GI Cancer During Adenosine Vasodilation Test

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate changes in abdominal tissue perfusion during adenosine vasodilation. Our hypotheses were that CT perfusion measurements are altered by changes in the circulatory system mediated by adenosine, and a more differentiated assessment of the circulatory capacity of abdominal tumours could be achieved by sequential rest and adenosine vasodilation CT perfusion measurements.

Official Title
-----------------
Abdominal Tissue Perfusion Changes in Esophageal and Gastric Cancer During Adenosine Vasodilation Measured With Computed Tomography (CT) Perfusion

Conditions
-----------------
Esophageal Cancer, Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tumour larger than 1.5 cm on diagnostic CT Normal serum creatinine Age above 18 Informed written and oral consent. Exclusion Criteria: Contrast allergy or contrast induced nephropathy BMI > 40 Asthma or Chronic Obstructive Lung Disease Heart failure (NYHA III+) Heart conduction disorder Atrial fibrillation 2nd/3rd Heart block Long QT syndrome Wolf Parkinson White Syndrome Moderate / severe aortic stenosis Haemodynamic contraindications for adenosine, systolic pressure below 90

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Adenosine Vasodilation test<br>Group scanned with CT perfusion during adenosine vasodilation test. | |
| Reference group<br>Group scanned twice without adenosine vasodilation test for a reference. No randomization. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in arterial flow during adenosine vasodilation test (CT perfusion parameter) |  | 0 min and 15 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood pressure during adenosine vasodilation test |  | 0 min and 15 min | 
| Change in Heart rate during adenosine vasodilation test |  | 0 min and 15 min | 
| Change in Area under arterial input curve during adenosine vasodilation test | Area Under Curve (AUC) is correlated to cardiac output | 0 min and 15 min | 
| Change in Blood volume (CT perfusion parameter) during adenosine vasodilation test |  | 0 min and 15 min | 
| Change in Permeability (CT perfusion parameter) during adenosine vasodilation test. |  | 0 min and 15 min |
Trial Comparing Two Techniques of Celiac Plexus Neurolysis for Treatment of Pain in Carcinoma Pancreas

Study Overview
=================
Brief Summary
-----------------
Coeliac plexus neurolysis (CPN) is a management option for pain control in carcinoma pancreas.CPN is conventionally performed by percutaneous technique with fluoroscopic guidance. Endoscopic ultrasound (EUS) is increasingly used for CPN as it offers a better visualization of the plexus. There are limited data comparing the two modalities.The patients are on follow-up for 6 months post neurolysis.

Detailed Description
-----------------
Carcinoma pancreas patients with abdominal pain requiring daily analgesics for more than 4 weeks were included.we are randomising about 100 patients into two groups to undergo either of the two procedures, i.e. celiac plexus neurolysis by percutaneous technique or by endoscopic ultrasound guided technique.The pain scores have been recorded by visual analogue scale for an average follow-up of 6 months.

Official Title
-----------------
A Randomized Trial Comparing Fluoroscopy Guided Percutaneous Technique Versus Endoscopic Ultrasound Guided Technique of Celiac Plexus Neurolysis for Treatment of Pain in Carcinoma Pancreas

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Procedure: percutaneous fluoro guided celiac plexus neurolysis
* Procedure: EUS guided neurolysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with carcinoma pancreas Exclusion Criteria: patients below 18 years of age and who have not given consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: percutaneous fluoro guided celiac plexus neurolysis<br> | Procedure: percutaneous fluoro guided celiac plexus neurolysis<br>* It is percutaneous injection of neurolytic agent in and around the celiac ganglion<br>|
| Active Comparator: EUS guided neurolysis<br> | Procedure: EUS guided neurolysis<br>* It is injection of neurolytic agent in and around the celiac ganglion using an echo endoscope.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immediate pain relief |  | day of block to six months of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carcinoma pancreas, percutaneous celiac plexus neurolysis, endosonography guided celiac plexus neurolysis
Prevalence and Impact in Work Productivity of Gastroesophageal Reflux Disease (GERD) in Primary Care Patients With Upper Gastrointestinal (GI) Symptoms Using GerdQ

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to provide data on the GERD prevalence as percentage of patients with upper GI symptoms that are identified with GERD using the GerdQ Questionnaire. Furthermore the study aims to estimate GERD prevalence in patients based on their symptoms as they respond to a physician's questionnaire, to observe possible variations between the two methods (physicians' symptom rating and GerdQ), to objectively measure treatment response and to identify the percentage of patients that may require alterations of their treatment. Finally, to describe the impact of GERD symptoms on work productivity.

Official Title
-----------------
A Cross-sectional Study on the Prevalence and Impact in Work Productivity of GERD in Primary Care Patients With Upper GI Symptoms Using the Novel Questionnaire GERD-Q. The Greek GERD-Q Study

Conditions
-----------------
Gastroesophageal Reflux Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with upper-GI symptoms the last week prior visiting the investigator Exclusion Criteria: History of oesophageal, gastric or duodenal surgery Treatment with NSAIDs/Acetylsalicylic acid within the last week prior to the study visit PPI use for healing of NSAIDs induced ulcer or for HP eradication

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 |
| --- | --- |
| Upper-GI symptoms in primary-care patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GERD prevalence as percentage of patients with upper GI symptoms that are identified with GERD using the GerdQ Questionnaire (GerdQ score >=8). |  | Single Visit - once | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of GERD prevalence in patients based on their symptoms as they respond to a physician's questionnaire and to observe possible variations between the two methods (physicians' symptom rating and QerdQ) |  | Single Visit - Once | 
| Describe the impact of GERD symptoms on work productivity. |  | Single Visit - Once | 
| To objectively measure treatment response and to identify the percentage of patients that may require alterations of their treatment. |  | Single Visit - Once | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gerd, GerdQ questionnaire, work productivity, Greece
Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effects of a complex pulmonary rehabilitation program on mobility measured by 6 minute walking distance (6MWD) and physical activity, measured via Dynaport and Actibelt Aktivitätsmonitor, dyspnoea (VAS), quality of life (HRQL (SF36, EuroQul)), anxiety and depression (HADS)and PaCO2-behavior under physical activity.

Official Title
-----------------
Effects of a Complex Pulmonary Rehabilitation Program on Patients With End Stage Lung Diseases Undergoing Evaluation for Lung Transplantation (Pre-LTx)

Conditions
-----------------
COPD, Pre-Lung-Transplantation, Hypercapnia, Respiratory Insufficiency

Intervention / Treatment
-----------------
* Other: continuous endurance training
* Other: interval training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pre-LTx (listed for lung-transplantation or currently undergoing evaluation) COPD Stadium IV GOLD α-1-Antitrypsin-deficiency-Emphysema respiratory Insufficiency oxygen therapy (LTOT) Exclusion Criteria: serious Exacerbation (Symptoms longer than three days, change of therapy, e.i. antibiotics, steroids) during the last four weeks before rehabilitation clinical signs of manifest heart insufficiency acute coronar syndrome left heart insufficiency(EF < 40%) missing Compliance

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: interval training<br>interval training in lung transplant candidates | Other: interval training<br>* at 100 percent of peak Watt<br>|
| Other: Continuous Training<br>continuous training in lung transplant candidates | Other: continuous endurance training<br>* at 60 percent of peak Watt<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD) |  | value at day 21 minus value at day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnoea During Exercise Measured on the Borg Scale | The Borg scale is a numeric scale that ranges from 0 to 10 points to rate dyspnea. The scale is like follows: 0 Nothing at all Very slight Slight Moderate Somewhat severe Severe 7 Very severe 8 9 Very, very severe (almost maximal) 10 Maximal | mean values from day 1 to day 21 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Pre-Lung-Transplantation, Intervall versus continuous training, 6 MWD
Blown Nasal Secretion Measurements in Rhinosinusitis: Repeatability and Validity Compared to Nasal Lavage

Study Overview
=================
Brief Summary
-----------------
To process blown nasal secretions from subjects with rhinosinusitis and to obtain a specimen by nasal lavage. To investigate the reliability and validity of the measurements we will determine their repeatability and compare them with those of nasal lavage in the same subjects.

Official Title
-----------------
Repeatability and Validity of Measurements in Blown Nasal Secretion in Patients With Rhinosinusitis

Conditions
-----------------
Rhinosinusitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients suffering from rhinitis with our without sinusitis Exclusion Criteria: unable to provide blown nasal sample
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 |
| --- | --- | --- |