linjc16/ctgov huggingface dataset:
Epidemiology and Management of Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, national, retrospective chart-review study that will be based on the collection of data from electronical or paper-based medical records with available data on female patients diagnosed with metastatic brest cancer . The main purpose of this study is to provide accurate, evidence based description on the incidence of progression of metastatic breast cancer and its clinical management.

Detailed Description
-----------------
Epidemiology and Therapeutic Management of Metastatic Breast Cancer in Romania: A retrospective cohort study

Official Title
-----------------
Epidemiology and Therapeutic Management of Metastatic Breast Cancer in Romania: A Retrospective Cohort Study

Conditions
-----------------
Breast Cancer Nos Metastatic Recurrent

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female aged 18 years and over Diagnosis of breast cancer according to ICD-10 diagnostic criteria with confirmed metastasis Confirmed diagnosis between 1st July 2010 - 30th June 2011 Female patient managed for her disease at the same setting where final diagnosis of MBC was performed Exclusion Criteria: History of concurrent or other primary malignancies (except curatively resected non-melanoma skin cancer or in situ cervical cancer)

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

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female patients diagosed with metastatic breast cancer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence rate of progression of disease in a cohort of patients newly diagnosed with MBC, either De Novo or having progressed from a non-metastatic stage |  | At 12 and 18 months after diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The progression free survival (PFS) rates |  | At 12 and 18 months after diagnosis | 
| The progression free survival (PFS) time |  | At 18 months after diagnosis | 
| Time to progression (TTP) |  | At 18 months after diagnosis | 
| The clinical and pathological characteristics of newly diagnosed MBC patients |  | At 18 months after diagnosis | 
| The socio-demographic and anthropometric characteristics of newly diagnosed MBC patients |  | At 18 months after diagnosis | 
| Health care utilization associated with the disease in Romania |  | At 18 months after diagnosis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metastatic breast cancer,, epidemiology,, retrospective cohort
Temporary Biventricular Pacing

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that temporary biventricular pacing will improve hemodynamic performance in patients with right ventricular dysfunction after open cardiac chamber cardiac surgery.

Official Title
-----------------
Hemodynamic Effect of Temporary Biventricular Pacing After Mitral and/or Tricuspid Valve Surgery in Patients With Preoperative Biventricular Dysfunction

Conditions
-----------------
Right Ventricular (RV) Dysfunction

Intervention / Treatment
-----------------
* Other: left ventricular epicardial pacing lead


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mitral or tricuspid valve surgery patients identified as having preoperative Right Ventricular dysfunction and Left Ventricular Ejection Fraction less than 45 percent Exclusion Criteria: Patients with in-situ biventricular pacemakers Pregnant or lactating females

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 84 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 |
| --- | --- |
| Experimental: left ventricular epicardial pacing lead<br>Enrolled patients will have a temporary left ventricular epicardial pacing lead placed in addition to the standard right ventricular and right atrial temporary epicardial pacing leads after open cardiac chamber cardiac surgery. | Other: left ventricular epicardial pacing lead<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right ventricular function of the heart | Right Ventricular function is evaluated through combined echocardiographic interventricular synchrony variables which include pulmonary artery catheter derived cardiac index, pulmonary artery (PA) pressure, central venous pressure (CVP), CVP versus PA diastolic pressure, and systolic blood pressure. | 24 hours after cardiac surgery completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
after open cardiac chamber cardiac surgery
Observational, Real-life, Retrospective, Data Collection, Use Sibutramine/Topiramate in Overweight Comorbidities/Obesity

Study Overview
=================
Brief Summary
-----------------
An observational, multicenter, national study with retrospective real-life data collection on the combined treatment of sibutramine and topiramate (off-label use) for the treatment of overweight with comorbidity(ies) or obesity. Data from all adult patients, of both sexes, for whom combination treatment with sibutramine and topiramate, both at any dose/dosage, were prescribed between the year 2011 and the beginning of the study will be included in the study.

Official Title
-----------------
An Observational, Multicenter, National Study With Real-life Retrospective Data Collection on the Combined Use of Sibutramine and Topiramate as Anti-obesity Treatment in Overweight Patients With Comorbidity(Ies) or Obesity.

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Other: Source document data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients Both sexes Diagnose of overweight with comorbidity(ies) or obesity Treatment use of sibutramine combined with topiramate Treatment prescription between 2011 and the beginning of the study Exclusion Criteria: Use of topiramate for other condition besides overweight with comorbidity(ies) or obesity Individual use of one of the medications (sibutramine or topiramate)

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

| Intervention/Treatment |
| --- |
|Other: Source document data collection|Data from all adult patients, of both sexes, for whom combination treatment with sibutramine and topiramate, both at any dose/dosage, were prescribed between the year 2011 and the beginning of the study will be colected in the study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients who achieved a weight loss greater than 5% | Identification of the percentage of patients who achieved a weight loss greater than 5% in relation to the initial body weight. | 20 years |
Search for Serum/Plasma Biomarkers in Pompe's Disease

Study Overview
=================
Brief Summary
-----------------
This study aims to analyze serum and plasma samples from patients with late onset Pompe disease treated and not treated with enzyme replacement therapy (ERT) to identify microRNA that could be specific of the disease. The investigators will correlate the concentration of these microRNA with several muscle function tests and quantitative muscle MRI to know whether they are good biomarkers of progression.

Official Title
-----------------
Search for Serum/Plasma Biomarkers in Pompe's Disease

Conditions
-----------------
Late Onset Pompe Disease, Pompe Disease

Intervention / Treatment
-----------------
* Drug: Enzyme Replacement Agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Genetic confirmation of Pompe disease Exclusion Criteria: Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- |
| Treated patients<br>Patients with late onset Pompe disease treated with the enzyme replacement therapy | Drug: Enzyme Replacement Agent<br>* Patients will be treated following the decision of their doctors. The investigators are going to analyze serum samples of these patients<br>* Other names: Myozyme;|
| Non treated patients<br>Patients with late onset Pompe disease non treated with the enzyme replacement therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MicroRNA in serum samples | Investigators are going to study microRNA following a microarray analysis of serum samples from patients treated and non treated | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle function test | 6 minutes walking test (6MWT), time to climb 4 steps, time to descend 4 steps, Activlim, time to walk 10 meter, Medical Research Council scale (MRC), myometry | Baseline and one year | 
| Whole body muscle MRI | 2 point dixon studies of thigh muscles | Baseline a and one year | 
| Changes in microRNA concentration | Investigators will analyze concentration of microRNA after one year follow up in every single patients | One year period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glycogenosis, Pompe, microRNA, biomarker, muscle MRI
Effect of Incretin-related Drugs on Dietary Intake in Japanese Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
It is well known that incretin, particular GLP-１enhances satiety and reduces energy intake in controlling appetite and dietary in humans (Flint A, et al. Gutzwiller JP et al.). Recently, incretin-based therapy has been attracted a lot of interest (Hare KJ, Knop FK). However, it is not clear how the incretin-based therapy affects energy and content of dietary intake in patients with type 2 diabetes mellitus (T2DM). Previously, the investigators reported the amount of energy and content of dietary intake in type 2 diabetic Japanese patients with more than 10 years of long time duration after discovery using questionnaire (Inoue K et al.) and the patients were impaired a secretion of active GLP-1 (Kamoi et al). The investigators examine whether the incretin-based therapy effects on the energy and content of dietary intake in the same patients before and one year after administration of incretin-related drugs using the same method previously (Inoue K et al.).

Official Title
-----------------
Effect of Incretin-related Drugs on Energy and Contents of Dietary Intake in Japanese Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Incretin-related drugs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese patients with T2DM without incretin-based therapy, who participated to examine the energy and content of intake using questionnaire reported previously. Exclusion Criteria: Patients with a serious complication in the heart, liver or kidney Pregnant or possibly pregnant patients or lactating patients Patients complicated with a malignant tumor at present. Patients participating in other clinical study. Other than the above, patients judged inappropriate as the subjects of this study by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 95 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 |
| --- | --- |
| Incretin-related drugs<br> | Drug: Incretin-related drugs<br>* DPP-IV inhibitors are administered via per os. GLP-L receptor agonists are administered via subcutaneous injections.<br>* Other names: If necessary, other hypoglycemic and insulin drugs;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI |  | One year | 
| Calory of dietary intake |  | One year | 
| Content of dietary intake |  | One year |
Validity and Reliability the Turkish Version of the Oxford Participation and Activities Questionnaire in Older People

Study Overview
=================
Brief Summary
-----------------
To evaluate the validity and reliability of Turkish version of the Oxford Participation and Activities Questionnaire (Ox-PAQ) for Turkish older population. Following the translation protocol of the Ox-PAQ, Short Form-12, Katz Index of Independence in Activities of Daily Living Scale, The Five Times Sit to Stand Test were administered to 230 older people. End of this study, occupational therapists, physiotherapists can use the it to assess activity and participation level of older people living in community

Official Title
-----------------
Validity and Reliability the Turkish Version of the Oxford Participation and Activities Questionnaire (Ox-PAQ) in Older People

Conditions
-----------------
Healthy Aging

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 65 years or older Mini Mental State Examination score greater than 24, Able to mobilize independently. Exclusion Criteria: Severe vision and hearing loss Having an orthopaedic, vestibular, neurological or mental problem Failure to cooperation Presence of an acute disease during recovery.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire|Patients evaluated with different questionnaire.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ox-PAQ | It contains 23 items, each measured on a five-point Likert scale. Each of the 23 items is scored in the same direction (0=Never, 1=Rarely, 2=Sometimes, 3=Often, 4=Always). Also, Ox-PAQ consist of three domains, Routine Activities (14 items: nos. 1,2,3,4,5,6,7,8,9,10, 13,14,16,17), Social Engagement (4 items: nos. 11,12,15,18) and Emotional Well-Being (5 items: nos. 19,20,21,22,23). Raw scores of Ox-PAQ are transformed to a range from 0 to 100. The formula for scoring each dimension is as follows: sum of scores of each question in dimension/ ((4 x number of questions in dimension) x 100) (10). Higher scores reflect greater problems with activity and participation. | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aged, Community Participation, Health, Physical Activity, Questionnaire
Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and tolerability of MS-R001 at escalating doses in patients with diabetic macular edema secondary to diabetic retinopathy

Official Title
-----------------
A Phase 1, Open-Label, Dose-Escalation Clinical Study to Assess the Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

Conditions
-----------------
Diabetic Macular Edema, Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: MS-R001 (rapamycin)
* Drug: MS-R001 (rapamycin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria include but are not limited to: Diagnosed with diabetes mellitus Visual acuity of 20/40 to 20/200 in study eye Exclusion Criteria include but are not limited to: Any other ocular disease that could compromise vision in the study eye Intraocular surgery of the study eye within 90 days prior to study start Capsulotomy of the study eye within 30 days prior to study start

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Subconjunctival injection | Drug: MS-R001 (rapamycin)<br>* Subconjunctival injection in various dosages<br>* Other names: sirolimus;|
| Experimental: 2<br>Intraocular injection | Drug: MS-R001 (rapamycin)<br>* Intraocular injection in various dosages<br>* Other names: sirolimus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as assessed by visual acuity, intraocular pressure, slit lamp and indirect ophthalmoscope |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity |  | 90 days |
Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function

Study Overview
=================
Brief Summary
-----------------
Some nutraceuticals are often advised for their lipid lowering effects. Although many clinical trials have been conducted to assess their efficacy many doubts remain whether they could be considered an effective alternative to statins therapy. The aim of this study was to evaluate the lipid lowering effects and the improvement of endothelial dysfunction in patients with hyperlipidemia, treated with a nutraceutical product (Armolipid Plus)

Official Title
-----------------
Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function

Conditions
-----------------
Hyperlipidemia, Endothelial Dysfunction

Intervention / Treatment
-----------------
* Dietary Supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females aged between 18 and 70 Total cholesterol levels > 220 mg/dl and LDL-Cholesterol > 130 mg/dl; Patients with concomitant pathology such as diabetes, chronic heart failure, coronary artery disease, arterial hypertension, dysthyroidism, were admitted as long as stable in the previous three months Exclusion Criteria: Proven intolerance to an Armolipid Plus compound Pregnant women, and women planning to conceive Patients in therapy with lipid lowering drugs within the previous 6 weeks Triglycerides concentration > 500mg/dl were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| A<br> | Dietary Supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo<br>* A tablet one a day for 6 weeks<br>* Other names: Armolipid Plus;|
| B<br> | Dietary Supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo<br>* A tablet one a day for 6 weeks<br>* Other names: Armolipid Plus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure of this study was the percentage change from baseline of total cholesterol (C), LDL- cholesterol (LDL-C), HDL-cholesterol (HDL-C),and Triglycerides (Tg) plasma concentrations. |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary end point included improvement of endothelial dysfunction assessed by an echo flow mediated distribution test. |  | 6 weeks |
Recovery After Fast Track THA / TKA

Study Overview
=================
Brief Summary
-----------------
The development and implementation of fast-track principles in total knee and hip arthroplasty have resulted in early recovery and rehabilitation alongside a reduced length of hospital stay. This without a concomitant increase in morbidity or readmissions for medical or surgical complications and with reduced mortality. However, only little is known about function in the subacute period after arthroplasty, and there is a need for further data on physical and psychological functioning following discharge from hospital.This to ensure, that the positive results from the perioperative setting are carried forward in the subacute phase.

Detailed Description
-----------------
Data will be published in three papers: Physical function and related factors following discharge from THA and TKA Luna IE, Kehlet H, Aasvang EK. Postoperative hypoxemia following fast-track hip and knee arthroplasty Luna IE, Kehlet H, Aasvang EK. Cognitive dysfunction after fast-track hip- and knee arthroplasty - prevalence and related factors. Luna IE, Kehlet H, Aasvang EK.

Official Title
-----------------
Prospective Descripive Study of Subacute Function After Total Hip or Knee Arthroplasty

Conditions
-----------------
Hip and Knee Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary total hip or knee arthroplasty Age 55 to 80 years Exclusion Criteria: Deficient written or spoken danish Alcohol abuse (>21 U per week) Immunocompromised Anticoagulant therapy ASA class 4-5 Functional impairment from psychological or neurological disease Sleepapnea

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Pain | VAS when walking | 48 hours postoperatively |