linjc16/ctgov huggingface dataset:
A Study Comparing Mircera and Epoetin Beta for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta (3 times weekly, according to approved labelling). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
A Randomized, Open Label Study Comparing the Effect of Mircera and Epoetin Beta on Hemoglobin Response in Patients With Chronic Kidney Disease Who Are on Dialysis

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Epoetin beta
* Drug: methoxy polyethylene glycol-epoetin beta [Mircera]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; chronic renal anemia requiring dialysis; maintenance hemodialysis or peritoneal dialysis for >=2 weeks before and during screening; adequate iron status. Exclusion Criteria: previous epoetin treatment within 8 weeks prior to screening; failing renal graft in place; bleeding episode necessitating transfusion within 8 weeks prior to screening; poorly controlled hypertension; previous treatment with Mircera.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]<br>* 0.4 micrograms/kg iv every 2 weeks<br>|
| Active Comparator: 2<br> | Drug: Epoetin beta<br>* As prescribed, 3 times weekly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb response rate |  | Weeks 0-24 | 
| Change in Hb concentration between baseline and evaluation period |  | Months 4-6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb over time |  | Throughout study | 
| Time to Hb response |  | Throughout study | 
| RBC transfusions |  | Weeks 0-24 | 
| AEs, laboratory parameters, vital signs |  | Throughout study | 
| Serum concentration of Mircera |  | Throughout study |
Use of a Phosphodiesterase Type 5 Inhibitor to Improve Anabolic Resistance in Older Adults

Study Overview
=================
Brief Summary
-----------------
This study will be the first demonstration of the utility and feasibility of Phosphodiesterase Type 5 inhibitor as an effective pharmacological therapy for improving anabolic resistant states.

Official Title
-----------------
Use of a Phosphodiesterase Type 5 Inhibitor to Improve Anabolic Resistance in Older Adults

Conditions
-----------------
Sarcopenia

Intervention / Treatment
-----------------
* Drug: Tadalafil 5mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 60-75 yrs Recently prescribed 5mg of tadalafil daily for clinical purposes Exclusion Criteria: History of diabetes history of hypotension including orthostatic hypotension History of malignancy or chemo/radiation therapy in the 6 months prior to enrollment History of short gut syndrome, gastrointestinal bypass/reduction surgery (Lap band, gastric sleeve, etc.) Subjects who cannot refrain from using protein or amino acid supplements for 7 days prior to Visit 2 and 3. Alcohol consumption of ≥ 5 units/servings per day Concomitant use of oral or injectable corticosteroids testosterone, insulin like growth factor-1, or similar anabolic agent riociguat (Adempas) nitroglycerin isosorbide dinitrate (Isordil) isosorbide mononitrate (Imdur, Monoket) doxazosin (Cardura) prazosin (Minipress) terazosin (Hytrin) Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 5mg tadalafil once daily for 14 days<br> | Drug: Tadalafil 5mg<br>* Subjects will ingest one 5mg tablet of tadalafil each evening for 14 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maximal voluntary contraction of lower leg. | Lower leg strength using a dynamometer; performed both before and after 14 days of tadalafil. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle Fatigue | A test of lower leg muscular endurance using a dynamometer; performed both before and after 14 consecutive days of tadalafil. | 14 days |
OBSERVational Registry on Long-term Outcome of ICD Patients

Study Overview
=================
Brief Summary
-----------------
Multicentric, observational, retrospective registry including patients underwent ICD implantation for any indication. The primary aim of the registry is to evaluate the long-term outcome of patients receiving an ICD.

Detailed Description
-----------------
Multicentric, observational, retrospective registry including patients underwent ICD implantation for any indication in the period from 2010 to 2012. The aims of the registry are to evaluate the occurrence of complications related to ICD implantation (including ICD shocks and electrical storm), and the mortality during a long-term follow-up.

Official Title
-----------------
The Italian Multicentric OBSERVational Registry on Long-term Outcome of ICD Patients (OBSERVO-ICD Registry)

Conditions
-----------------
Cardiomyopathies

Intervention / Treatment
-----------------
* Device: Assesment of long-term outcome of ICD patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICD implantation fo any indication; age >18 years Exclusion Criteria: life expectancy of less than one year

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: Assesment of long-term outcome of ICD patients|Evaluation during follow-up of the occurrence of complications related to ICD implantation and of death|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death for any cause |  | an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications related to ICD implantation |  | an average of 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Implantable defibrillator, Cardiomyopathies
Acute Pancreatitis: Study of Possible Etiologies and Risk Factors Affecting Outcome

Study Overview
=================
Brief Summary
-----------------
This study is to assess the frequency of different etiologies of acute pancreatitis in our locality & assess the effect of different risk factors on outcome of the patients.

Official Title
-----------------
Acute Pancreatitis: Study of Possible Etiologies and Risk Factors Affecting Outcome (Hospital Based Study)

Conditions
-----------------
Pancreatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Diagnosis of acute pancreatitis according to the following: the presence of two of the three following criteria: abdominal pain consistent with the disease serum amylase and or lipase greater than three times the upper limit of normal characteristic findings from abdominal imaging Contrast-enhanced computed tomographic (CECT) and or magnetic resonance imaging (MRI) of the pancreas Exclusion Criteria: No exclusion criteria .

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 |
| --- | --- | --- |
| The frequency of different etiologies of AP in our locality | At the end of study, total number of patients of each etiology of acute pancreatitis will be calculated as (Gallstones, Alcohol, triglyceridemia, Idiopathic, ERCP,..) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome of the patients according to the Atlanta Classification 2012 revision | Effect of each risk factor on outcome as progression to mild, moderate severe and severe pancreatitis according to the Atlanta Classification 2012 revision, | 1 year | 
| Hospital duration of stay | Effect of each risk factor on hospital duration of stay | 1 year | 
| Rate of transfer to ICU | Effect of each risk factor on rate of transfer to ICU | 1 year | 
| Mortality | Effect of each risk factor on mortality | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatitis
Importance of Meal Fat Content and Gall Bladder Emptying for Postprandial GLP-1 Secretion in Type 2 Diabetes Patients

Study Overview
=================
Brief Summary
-----------------
PURPOSE The goal of the present project is to unravel the importance of bile acid-induced GLP-1 secretion (via the G protein-coupled receptor TGR5) in human physiology. In the present study the investigators examine the GLP-1 secretion in healthy subjects and in Type 2 Diabetes Mellitus (T2DM) patients. The investigators hypothesize that patients with T2DM of relatively long duration will be characterized by reduced gall bladder emptying, and, consequently, reduced intestinal TGR5 activation; resulting in attenuated postprandial GLP-1 responses (primary endpoint).

Conditions
-----------------
Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (Healthy) HbA1 < 6 % Normal haemoglobin levels Informed content Inclusion Criteria: (T2DM) T2DM > 5 years Normal haemoglobin levels Informed content Exclusion Criteria: (T2DM) Treatment with insulin, DPP-IV inhibitor or GLP-1 analogues Obesity (BMI > 30) Age > 70 years Gastrointestinal disease Nephropathy Liver disease Medication which cannot be on hold for 12h Gastrointestinal surgery Exclusion Criteria: (Healthy) 1st degree relatives with diabetes Obesity (BMI > 30) Age > 70 years Gastrointestinal disease Nephropathy Liver disease Medication which cannot be on hold for 12h Gastrointestinal surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy adults<br> | |
| Type 2 diabetes<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GLP-1 secretion |  | Postprandial |
Correction of Enophthalmos and Orbital Volume Using Pre-bent Mesh Versus 3d Printed Onlay in Orbital Fracture Cases

Study Overview
=================
Brief Summary
-----------------
this study evaluates the post-surgical correction of enophthalmos and orbital volume using 3D printed only versus pre-bent titanium mesh in blow-out fracture cases

Detailed Description
-----------------
Many materials had been used in reconstruction of blow out fractures, the aim of this study is to evaluate the enophthalmos correction and orbital volume restoration using 3D printed onlay versus pre-bent titanium mesh

Official Title
-----------------
Evaluation of Orbital Reconstruction Using Patient Specific 3-D Printed Onlay Versus Pre-Bent Titanium Mesh

Conditions
-----------------
Orbital Fractures, Enophthalmos, Periorbital Fracture

Intervention / Treatment
-----------------
* Combination Product: 3D printed PEEK onlay
* Combination Product: Pre-bent orbital mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (≤17 years old). Blow-out Orbital Fracture. Unilateral Orbital Trauma. Enophthalmos (≤ 2 mm). Patients with contralateral healthy, non-surgically operated orbit. Exclusion Criteria: Young Patients (> 17 years old). Patients with Systemic diseases. Bilateral Orbital Trauma. Enophthalmos (>2 mm). Patients whom cannot tolerate follow up intervals.

Ages Eligible for Study
-----------------
Minimum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Orbital fractues<br>Orbital fractures | Combination Product: 3D printed PEEK onlay<br>* 3d computer-designed Orbital onlay<br>Combination Product: Pre-bent orbital mesh<br>* Pre-bent orbital mesh on 3d printed template<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enophthalmos | CT based exphthalmometery - corneal projection from lateral orbital rim measured in millimeters | 1 week post-operative | 
| Enophthalmos | CT based - corneal projection from lateral orbital rim measured in millimeters | 1 year post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orbital volume | Change in orbital volume ratio on CT in centimeter cubic | one week post-operative | 
| Implant position accuracy | Superimposition of pre- and post-operative 3d bony structures on CT in 2d views of the x-ray | One week post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
3d printed onlay, PEEK, orbital mesh, computer-guided surgery
CT Data Collection Study

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to gather chest CT images as part of routine clinical procedure from subjects with and without prior sternotomy to characterize the substernal space. Specifically, the study will provide references for physicians to better understand substernal anatomy.

Official Title
-----------------
Computed Tomography Data Collection for Anatomical Analysis of Substernal Space in Patients With Cardiovascular Diseases

Conditions
-----------------
Cardiac Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be≥18 years old Subject must be indicated for high quality chest CT imaging as part of routine clinical procedure Subject must be willing to provide Informed Consent Exclusion Criteria: Subject has medical conditions that would limit study participation Subject is pregnant or have a pregnancy plan during the study Subject is enrolled in a concurrent study that may confound the results of this study

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-Sternotomy Group<br>Subjects who have no prior sternotomy | |
| Sternotomy Group<br>Subjects who previously underwent a sternotomy procedure. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT imaging data | High quality CT images | At enrollment |
Evaluation of the Influence of Output on Skin Wearing a New Adhesive

Study Overview
=================
Brief Summary
-----------------
The purpose is to investigate the impact real output has on the peristomal skin covered by a newly developed adhesive.

Official Title
-----------------
Evaluation of the Influence of Output in Skin Covered by Newly Developed Adhesives

Conditions
-----------------
Ileostomy - Stoma

Intervention / Treatment
-----------------
* Other: New adhesive strip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given written informed consent Be at least 18 years of age and have full legal capacity Have had a stoma for more than one year Have intact skin on the area used in the evalua-tion Has a stoma with a diameter up to (≤) 35 mm Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist) Exclusion Criteria: Currently receiving or have within the past 2 month received radio- and/or chemotherapy Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. Are pregnant or breastfeeding Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist) Actively participating in other interventional clinical investigations or have previously participated in this investigation.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test of a new adhesive strip<br>This is a sub-study testing the effect of real output applied under two adhesive strips on the skin after 24 hours. The adhesive strip is not yet part of a marketed ostomy device. | Other: New adhesive strip<br>* This is a newly developed strip.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trans epidermal water loss | The trans epidermal water loss is measured on the peristomal skin using a probe. The Tran epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin. | 24 hours |
Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery

Study Overview
=================
Brief Summary
-----------------
A randomized, double-blind, active-controlled, parallel, multicenter Phase 3 study of Tramadol hydrochloride/Acetaminophen SR Tab. & Tramadol hydrochloride/Acetaminophen Tab. in Acute Toothache Patients above Moderate Pain after Teeth Extraction Surgery.

Official Title
-----------------
A Randomized, Double-blind, Active-controlled, Parallel, Multicenter Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery

Conditions
-----------------
Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery

Intervention / Treatment
-----------------
* Drug: Tramadol hydrochloride/Acetaminophen Tab.
* Drug: Tramadol hydrochloride/Acetaminophen SR Tab.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males/Females aged over 20 years Patients with over 2 impacted wisdom teeth in the upper and lower jaws Pain VAS Value over 50 mm evaluated as 100mm VAS Subjects who voluntarily or legal guardian agreed with written consent Exclusion Criteria: Patients with severe heart disease, uncontrol hypertension, diabetes Patients who had taken a long period NSAID (eg. celecoxib, rofecoxib naproxen etc) within 3 days from the screening point Patients who had taken short-time anesthetic drugs and analgesics within 12 hours from the screening point (except short-time anesthetics before or during surgery) Patients with aspirin asthma(asthma seizure caused by NSAIDs) or medical history Patients with severe respiratory depression

Ages Eligible for Study
-----------------
Minimum Age: 20 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tramadol hydrochloride/Acetaminophen Tab.<br>1tab PO within 5hours from teeth extraction | Drug: Tramadol hydrochloride/Acetaminophen Tab.<br> <br> |
| Experimental: Tramadol hydrochloride/Acetaminophen SR Tab.<br>1tab PO within 5hours from teeth extraction and then 1tab more after 6hours | Drug: Tramadol hydrochloride/Acetaminophen SR Tab.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPID ; Sum of the pain intensity differences |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Toothache, Wontran, Wontran SR Tab., Tramadol Hydrochloride/Acetaminophen