linjc16/ctgov huggingface dataset:
Study of Minirin Melt® in Adult Patients With Nocturia

Study Overview
=================
Brief Summary
-----------------
Observation of safety and efficacy of Minirin Melt® in adult patients with nocturia

Official Title
-----------------
Non-interventional Study on Safety and Efficacy of Minirin Melt® in Adult Patients With Nocturia

Conditions
-----------------
Nocturia

Intervention / Treatment
-----------------
* Drug: Desmopressin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult aged between 19 and 65 years Patients having nocturia Decision made to prescribe Minirin Melt according to prescription information Willingness and ability to provide written informed consent Exclusion Criteria: When patients have habitual or psychogenic polydipsia (resulting in a urine production exceeding 40ml/kg/24hours) When patients have a history of known or suspected cardiac insufficiency and other conditions requiring treatment with diuresis When patients have moderate and severe renal insufficiency (creatinine clearance below 50ml/min) When patients have known hyponatremia When patients have secretion Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) When patients have hypersensitivity to the active substances or to any of the excipients

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Desmopressin|60μg or 120μg once daily at bedtime|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean number of nocturnal voids | Calculated by 72 hour frequency volume chart (FVC) | Baseline and treatment-related visits up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction from baseline in the mean number of nocturnal voids | Assessed as a (50% decrease) or reduction of nocturnal diuresis (>20%) | Baseline and treatment-related visits up to 3 months |
Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation

Study Overview
=================
Brief Summary
-----------------
A Prospective Randomized, Multi-center study to assess the Safety and Efficacy of Mucosta (Rebamipide), in combination with Omeprazole as adjuvant therapy in Gastric Ulcer Patients.

Official Title
-----------------
A Prospective Randomized, Multi-center Study to Assess the Safety and Efficacy of Mucosta (Rebamipide), in Combination With Omeprazole as Adjuvant Therapy in Gastric Ulcer Patients

Conditions
-----------------
Gastric Ulcer

Intervention / Treatment
-----------------
* Drug: Rebamipide and Omeprazole
* Drug: Omeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with dyspepsia or epigastric pain and endoscopically proven gastric and duodenal ulcers Required laboratory parameters and time limits (screening blood tests will be taken including hemoglobin, white blood cell count, random glucose, potassium, sodium, chlorine, creatinine, AST, ALT, bilirubin, and alkaline phosphatase) Age > 18 years A statement that all patients must have signed an informed consent form prior to registration in study Exclusion Criteria: Patients who had undergone surgery for ulcers History of hypersensitivity to drugs to be used in the study Women who are pregnant or lactating or intended to get pregnant during the study period

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 |
| --- | --- |
| Experimental: Mucosta and Omeprazole<br> | Drug: Rebamipide and Omeprazole<br>* open label, oral route, Rebamipide, 100mg tablet t.i.d and Omeprazole 20 mg tablet B.I.D. for 8 weeks<br>* Other names: Omeprazole;|
| Active Comparator: Omeperazole<br> | Drug: Omeprazole<br>* open label,oral route, Omeprazole 20mg tablet, B. I.D.; alone, for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing rates for gastric ulcer patients via endoscopic examination |  | 8 weeks treatment plus 4 weeks follow-up | 
| Improvement or absence of gastric ulcer associated symptoms | Improvement or absence of gastric ulcer associated symptoms, i.e. pain, burning, etc. | 8 weeks treatment plus 4 weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine and compare the Safety profile in both the treatment arms. |  | 8 weeks treatment plus 4 weeks follow-up |
SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to show that the noninvasive blood pressure software algorithm meets engineering requirements.

Official Title
-----------------
SNIPE:SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement

Conditions
-----------------
Blood Pressure (Low, Normal, High)

Intervention / Treatment
-----------------
* Device: Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide written informed consent or have a legally authorized representative including a parent or guardian provide written informed consent Ability of a minor subject ages 7 to 18 to provide written assent Ability to have multiple noninvasive blood pressures taken at one sitting Ability to apply three lead ECG, if needed for investigation Ability to detect the natural presence of an irregular pulse, for irregular pulse studies Exclusion Criteria: Any subject who cannot tolerate multiple blood pressure measurements Any subject who cannot undergo 3-lead ECG, if needed Any subject deemed unstable by the principal investigator Any subject for whom precautions are necessary because of communicable disease Any subject that has a known disease or condition compromises musculoskeletal integrity Any subject that has a known disease or condition that contraindicates use of an NIBP cuff and ECG patches on the skin.
Sexes Eligible for Study
-----------------
All

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

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: Subjects requiring blood pressure monitoring<br>Any subject (neonate-adult) requiring hospital or clinic blood pressure monitoring | Device: Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor<br>* 10-20 Non-Invasive Blood Pressure readings on investigational software in the DASH2500 Patient Monitor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data Collection for Engineering Development | This was a data collection for engineering development to demonstrate SuperSTAT 2.0 NIBP software algorithm meets the engineering specifications. Engineers reviewed data produced by each blood pressure determination to work on new software algorithm in development. This was not conducted as program was terminated prematurely. Software iterations are not pre-defined. | After each iteration of software development |
Adipokines and the Risk of Reflux Esophagitis

Study Overview
=================
Brief Summary
-----------------
We aimed to risk faoctors for GERD and association between visceral obesity, plasma adipoline(leptin, adiponectin, IL-6, TNF-α)and development of reflux esophagitis in healthy Koreans.

Official Title
-----------------
Adipokines and the Risk of Reflux Esophagitis : Prospective Case-control Study

Conditions
-----------------
Visceral Obesity, Reflux Esophagitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: endoscopically proven reflux esophagitis Exclusion Criteria: those with esophageal hiatal hernia, current PPI medication, upper GI operation history

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Reflux esophagitis<br>those with endoscopically proven reflux esophagitis | |
| Normal<br>those with normal GFS finding (without definite mucosal break at Z-line) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in serum adipokine levels between case and control groups |  | 2 month lager (after sampling) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, reflux esophagitis, adipokine, especially, endoscopically proven
Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
To demonstrate that import Mesalazine (Asacol®) is non-inferior to the reference drug, marketed Mesalazine, regarding the primary endpoint (reduction of UC-DAI score)in patients with active ulcerative colitis (UC) treated for 8 weeks.

Official Title
-----------------
Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis

Conditions
-----------------
Active Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Asacol®
* Drug: Mesalazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Ulcerative Colitis (UC) at active phase who are defined to show Ulcerative Colitis-Disease Activitiy Index (UC-DAI) score of 3 or higher but 8 or less, and bloody stool score of 1 or higher Exclusion Criteria: Patients with serious or higher according to diagnostic critera of seriousness and patients with chronic persistent type and with acute serious type in the classification by clinical course

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Asacol®<br>Import Mesalazine | Drug: Asacol®<br>* 400mg tablets<br>* Other names: Import Mesalazine;|
| Active Comparator: Mesalazine<br>Marketed Mesalazine | Drug: Mesalazine<br>* 400mg tablets<br>* Other names: Marketed Mesalazine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction degree of UC-DAI |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) Reduction degree of score of each UC-DAI item 2) Remission rate 3) Effective rate |  | Week 8 |
Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the evaluation of cardiac and pulmonary response to cardiopulmonary exercise in severe mitral regurgitation and its variation under treatment (surgical mitral valve repair, percutaneous mitral valve repair, optimal medical treatment). The study is conducted as a prospective, observational, single-center study. Patients suffering from symptomatic severe mitral regurgitation will be eligible, if they are referred to the University Hospital of Regensburg, Germany, for further diagnostic procedures and heart team discussion. Cardiopulmonary exercise testing is performed comprising standardized stress echocardiography as well as ergospirometry. Additional detailed assessment will be conducted including standardized questionary, clinical examination, transesophageal echocardiography and measurement of biomarkers.

Official Title
-----------------
Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation - a Single Center, Observational Echocardiographic Study

Conditions
-----------------
Mitral Valve Regurgitation, Pulmonary Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptomatic, severe mitral regurgitation referral for diagnostic work-up and heart team discussion declaration of informed consent Exclusion Criteria: contra-indication for cardiopulmonary stress examination (unstable angina pectoris, left main disease, abnormal electrolyte concentrations, acute decompensation) pregnancy exercise test on treadmill not possible (amputation of lower extremity, severe arthritis of lower extremities) no acceptable acoustic window at rest

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 |
| --- | --- |
| Severe mitral regurgitation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise-induced systolic pulmonary arterial pressure | exercise-induced systolic pulmonary arterial pressure measured by stress- echocardiography | Change from Baseline Exercise-Induced Systolic Pulmonary Arterial Pressure at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak oxygen uptake (peakVO2) | peak oxygen uptake measured by ergospirometry | Change from Baseline peakVO2 at 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress echocardiography, Cardiopulmonary exercise testing, ergospirometry
Inflammation and Steatosis: the Role of Alpha-defensin

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the correlation between the severity of non-alcoholic steatohepatitis/non alcoholic fatty liver disease (NASH/NAFLD) in naïve and hepatitis C (HCV) positive patients and the amplitude of alpha-defensin immunohistochemical staining in liver biopsy.

Official Title
-----------------
Inflammation and Steatosis: the Role of Alpha-defensin

Conditions
-----------------
Inflammation, Fatty Liver

Intervention / Treatment
-----------------
* Diagnostic Test: Immunohistochemical staining


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fatty liver disease patients with liver biopsy Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Immunohistochemical staining|Pathological liver slides to be immunohistochemically stained for alpha-defensin|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude of immunohistochemical stain | The amplitude of each slide will be graded from 1-4 | Six months |
Procalcitonin Reveals Early Dehiscence in Gastric Surgery: the PREDIGS Study

Study Overview
=================
Brief Summary
-----------------
Background. Gastric cancer surgery is associated with high risk for postoperative morbidity and mortality. Anastomotic leak (AL) is one of the worst complications associated with relevant short and long-term sequelae. Procalcitonin (PCT) is a biomarker used to monitor bacterial infections and guide antibiotic therapy and has been shown to have better predictive value of AL after colorectal surgery than C-reactive protein (CRP) and white blood cell count (WBC). Purpose. Investigators designed a monocentric pilot study to test if PCT might be a sensitive and reliable marker of AL after gastric surgery

Official Title
-----------------
Procalcitonin Reveals Early Dehiscence In Gastric Surgery: the PREDIGS Study

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Other: gastric cancer pts undergoing surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing all different kinds of gastric surgery (from partial to total gastrectomy) for cancer, WITH an anastomosis performed elective setting Exclusion Criteria: age < 18 years pregnant women patients undergoing gastric surgery for benign disease or other kinds of gastric surgery without an anastomosis being performed

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
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 |
| --- | --- |
| gastric cancer pts undergoing surgery<br>all pts receiving gastric resection for cancer, with anastomosis | Other: gastric cancer pts undergoing surgery<br>* Measure PCT (procalcitonin), CRP (C-reactive protein) and WBC (white blood cell count) in 3rd and 5th postoperative day and registration of all intra and postoperative complications<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients with leaks after gastric surgery correctly identified by the biomarkers (PCT and CRP) | PCT: procalcitonin, CRP: C-reactive protein | 2 years | 
| % of patients without leaks after gastric surgery correctly identified by PCT and CRP | PCT: procalcitonin, CRP: C-reactive protein | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCT cut-off that gives good negative predictive (NPV) value for leak after gastric surgery in 3rd POD | procalcitonin (PCT) cuts-off in 3rd post-operative day (POD) with a good NPV | 2 years | 
| PCT cut-off that gives good negative predictive value for leak after gastric surgery in 5th POD | PCT cuts-off in 5th POD with a good NPV | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric cancer, procalcitonin
Multiparametric Imaging for Analysis of MVNT (Multinodular and Vacuolating Neuronal Tumor)

Study Overview
=================
Brief Summary
-----------------
Differential diagnoses of MVNT include DNT (dysembryoplastic neuroepithelial tumor), low-grade gliomas, cortical dysplasias or even hamartomas.

Detailed Description
-----------------
Differential diagnoses of MVNT include DNT (dysembryoplastic neuroepithelial tumor), low-grade gliomas, cortical dysplasias or even hamartomas. However, in order to avoid an invasive surgical procedure to remove the lesion, a certain diagnosis of its benignity is essential. The contribution of advanced techniques in MRI, such as spectroscopy in the characterization of these lesions, has not yet been studied today

Official Title
-----------------
Multiparametric Imaging for Analysis of MVNT (Multinodular and Vacuolating Neuronal Tumor)

Conditions
-----------------
Benign Neuronal Desease

Intervention / Treatment
-----------------
* Device: cerebral MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years old Suspicion of MVNT on an MRI: it is considered that it will be necessary at least the 2 major criteria associated with at least 1 minor criterion to enter the definition of suspicion of MVNT: Major criteria: Multinodular aspect in cluster High FLAIR hypersignal / T2 Minor criteria: Absence of mass effect Hyposignal T1 Center of the lesion in hypsignal FLAIR or T1 hypersignal Affiliate or beneficiary of a Social Security scheme Having received informed information about the study and consenting to participate in the study Exclusion Criteria: Patient benefiting from a legal protection measure Pregnant or lactating woman Contraindication to MRI

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

| Intervention/Treatment |
| --- |
|Device: cerebral MRI|Patients who agree to participate in the study will perform a 3T multi-parametric MRI with advanced spectroscopic imaging techniques and standard protocol. A neurological consultation will take place during the inclusion visit as well as a questionnaire and a control MRI at 1 year and 2 years +/- 1 month.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of a new radiological entity on Spectroscopy : the MVNT (Multinodular and Vacuolating Neuronal Tumor) | ratio of N-Acetylaspartate / Choline on Spectroscopy | 1 day | 
| Description of a new radiological entity on Spectroscopy : the MVNT (Multinodular and Vacuolating Neuronal Tumor) | area under curve of the N-Acetylaspartate Spectroscopie | 1 day | 
| Description of a new radiological entity on Spectroscopy : : the MVNT (Multinodular and Vacuolating Neuronal Tumor) | area under curve of choline Spectroscopie | 1 day |