linjc16/ctgov huggingface dataset:
Serious Games Rehabilitation Programme to Treat Gait and Balance Disorders in PD Patients

Study Overview
=================
Brief Summary
-----------------
To test the effects of a serious game rehabilitation programme in 50 patients with Parkinson's disease with gait and balance disorders in a randomised controlled study

Official Title
-----------------
Serious Games Rehabilitation Programme to Treat Gant and Balance Disorders in Patients With Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Device: Serious game
* Device: Placebo serious game


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's disease Gait and balance disorders resistant to dopaminergic medication Exclusion Criteria: dementia contra-indication to magnetic resonance imaging

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rehabilitation with active serious game<br>25 patients will perform motor rehabilitation programme using the serious game | Device: Serious game<br>* Serious game with movements<br>|
| Placebo Comparator: No active serious game<br>25 patients will not perform motor rehabilitation programme using the serious game | Device: Placebo serious game<br>* Serious game without movement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the time-up-go test |  | change between baseline and at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the time-up-go test |  | change between baseline and at 18 weeks | 
| Step length |  | change between baseline and at 6 weeks | 
| step velocity |  | change between baseline and at 6 weeks | 
| Movement disorders Unified Parkinson's disease rating scale |  | change between baseline and at 6 weeks | 
| freezing of gait questionnaire |  | change between baseline and at 6 weeks | 
| Parkinson's disease quality of life scale |  | change between baseline and at 6 weeks | 
| gait and balance scale |  | change between baseline and at 6 weeks | 
| Montreal Cognitive Assessment |  | change between baseline and at 6 weeks | 
| Magnetic resonance imaging |  | change between baseline and at 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gait, Parkinson's disease, Rehabilitation, Serious game
Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial This explorative post-hoc analysis is a substudy of the DEX-2-TKA-trial (NCT03506789) investigating diffefferent subgroups of the patients included in the main trial.

Detailed Description
-----------------
Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial This explorative post-hoc analysis is a substudy of the DEX-2-TKA-trial (NCT03506789) investigating diffefferent subgroups of the patients included in the main trial.

Official Title
-----------------
Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Isotonic saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in the DEX-2-TKA-trial

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment A<br>24 mg dexamethasone i.v. perioperatively and 24 mg dexamethasone i.v. on the first postoperative day | Drug: Dexamethasone<br>* 24 mg intravenous Dexamethasone (6 ml)<br>|
| Active Comparator: Treatment B<br>24 mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day | Drug: Dexamethasone<br>* 24 mg intravenous Dexamethasone (6 ml)<br>Drug: Isotonic saline<br>* 6 ml of isotonic saline<br>|
| Placebo Comparator: Placebo<br>Placebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day | Drug: Isotonic saline<br>* 6 ml of isotonic saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative usage of morphine 0-48 hours postoperatively | Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine 0-24 hours and oral morphine on demand 24-48 hours, and any other supplemental morphine administered postoperatively. Consumption in mg | Time Frame: 0-48 hours postoperatively |
Coronary Artery Disease Progression in Patients With Acute Coronary Syndromes and Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
A total of 100 patients with non-ST-segment elevation acute coronary syndromes with or without diabetes mellitus will be included. All patients will undergo coronary angiography with identification of the infarct-related vessel and percutaneous revascularization with implantation of a stent/scaffold. After revascularization patients will undergo a combined positron emission tomography (PET)-coronary computed tomography (CT) protocol to quantify atherosclerotic burden (i.e. plaque volume) and activity (i.e. 18 fluorum-sodium-fluoride [18FNaF] uptake) in non-infarct related vessels, to assess calcium score (aim 1), and to quantify the acute results of PCI in the infarct-related vessel (aim 2). At 12-month follow-up, all patients will repeat longitudinal 18FNaF PET-coronary CT evaluation to characterize progression of atherosclerosis in the non-infarct related vessels (aim 1) and to quantify neointimal suppression at the site of the treated coronary segment in the infarct-related vessel (aim 2). Blood samples will be collected at baseline and 12 months for all patients. The aims of the study are: To evaluate coronary artery disease progression in acute coronary syndromes patients with and without diabetes mellitus, and to investigate the predictive value of metabolic profiles, patterns of circulating miRNAs and inflammatory mediators on coronary artery disease progression; To evaluate the progression of disease within the infarct-related vessel treated with the use of bioresorbable stent/bioresorbable polymer stents in diabetic and non-diabetic patients with acute coronary syndromes.

Official Title
-----------------
Coronary Artery Disease Progression in Patients With Acute Coronary Syndromes and Diabetes Mellitus

Conditions
-----------------
Coronary Artery Disease, Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 and <80 years, evidence of non-ST-segment elevation acute coronary syndromes, ability to provide informed consent Exclusion Criteria: ST-segment elevation myocardial infarction, cardiogenic shock, suspected stent thrombosis, known allergy to aspirin or ticagrelor, childbearing potential, life expectancy <1 year due to non-cardiac disease, severe chronic kidney disease.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentual atheroma volume | Assessed by CT | 12 months | 
| Minimal lumen area | Assessed by CT | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentual change in 18FNaF uptake |  | 12 months | 
| Change in minimal lumen area |  | 12 months |
Myopic Macular Haemorrhages

Study Overview
=================
Brief Summary
-----------------
To identify the underlying causes of macular haemorrhages in patients with high myopia In the eyes found to have macular haemorrhages secondary to choroidal neovascularisation, we hope to identify the risk factors for the development of choroidal neovascularisation in high myopia To study the functional outcome of these eyes as assessed by visual acuity To study the morphological outcome of these eyes by clinical assessment (and fundal photography) and fluorescein angiography

Detailed Description
-----------------
Primary Aims To identify the underlying aetiologies of macular haemorrhages in myopic eyes To study the functional and morphological outcome of these eyes with macular haemorrhages 6 months later Secondary Aims To study the subgroup of eyes with myopic choroidal neovascularisation (CNV), in particular the risk factors for CNV in myopes To study the subgroup of eyes with macular haemorrhages in the absence of CNV Plan of investigation: Patient with myopia (>-6.00DS) presents with loss of central vision Examination reveals a macular haemorrhage Investigations Refraction Axial length* Fundus fluorescein angiography Indocyanine green angiography* Determine if a myopic CNV is present or absent Management of patient: Treatment vs No treatment Treatment being Conventional laser PDT Review at 6 months BCVA Clinical appearance (fundal photo) FFA Review at 12 months BCVA Clinical appearance

Official Title
-----------------
Myopic Macular Haemorrhages

Conditions
-----------------
Myopic Macular Haemorrhages

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High myopia (greater than -6.00DS) Macular haemorrhage Exclusion Criteria: Macular haemorrhages from other causes eg. diabetic retinopathy, hypertensive retinopathy Allergy to fluorescein or indocyanine green dyes

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High myopia, Choroidal neovascularisation, Lacquer crack, Fundus fluorescein angiography, Indocyanine green angiography, Axial length
SBRT for Oligometastatic Lymph Node Recurrence in Prostate Cancer: a Single Institution Experience

Study Overview
=================
Brief Summary
-----------------
Single-institution retrospective analysis for predictive factors of prostate cancer patients presenting with isolated or limited lymph node (LN) recurrence (1-3 lesions) on F-Ccholine PET-CT (CholPET) treated with SBRT between January 2010 and July 2015.

Detailed Description
-----------------
Single-institution retrospective analysis of consecutive prostate cancer patients after definitive primary treatment, without local recurrence, presenting with isolated or limited lymph node (LN) recurrence (1-3 lesions) on F-Ccholine PET-CT (CholPET) treated with SBRT between January 2010 and July 2015. Endpoints of interest are biochemical response rate (defined as a reduction by at least 10% of the initial PSA value), time to biochemical recurrence (TBR) (defined as the time interval from SBRT until second PSA rise), and time interval between SBRT and ADT start. Univariate analysis is used to identify prognostic factors.

Official Title
-----------------
Predictive Factors for the Benefit of Stereotactic Body Radiotherapy for Oligometastatic Lymph Node Recurrence in Prostate Cancer: a Single Institution Experience

Conditions
-----------------
Prostate Cancer Recurrent, Prostate Cancer, Lymph Node Metastases

Intervention / Treatment
-----------------
* Radiation: Cyberknife Radiation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically proven diagnosis of prostate cancer Radical prostatectomy (± salvage radiotherapy) PSA relapse (defined by two consecutive rising PSA values >0.2 ug/l) one to three lymphnodes positive on Choline-PET no recurrence in prostatic bed on Choline-PET WHO performance status of 0-1 no previous chemotherapy or ADT for prostate cancer. Exclusion Criteria: primary treatment for prostate cancer by RT or brachytherapy bone (M1b) metastases visceral (M1c) metastases any symptomatic nodal lesion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Cyberknife Radiation Therapy|Stereotactic Radiotherapy of lymphnode recurrence after prostatectomy +/- salvage radiotherapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to biochemical recurrence | time interval from SBRT until second PSA rise | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biochemical response rate | reduction by at least 10% of the initial PSA value | 18 months | 
| time interval between SBRT and ADT start | time interval between SBRT and ADT start | 18 months |
Epidemiology of Resistant Microbial Strains Among Different Groups of People (Healthy, Infected and Exposed to Animals)

Study Overview
=================
Brief Summary
-----------------
This study investigates carriage rate and risk factors for acquiring multiresistant bacteria (ESBL producing E.coli and K.pneumoniae, carbapenem-resistant and multidrug resistant P.aeruginosa, MRSA and VRE) in hospitalised patients and healthy volunteers.

Official Title
-----------------
Transfer Routes of Antibiotic Resistance

Conditions
-----------------
ESBL Producing E.Coli, ESBL Producing K.Pneumoniae, Multidrug Resistant P.Aeruginosa, Carbapenem Resistant P.Aeruginosa, Vancomycin (Glycopeptide) Resistant Enterococcus (VRE), Methicillin Resistant Staphylococcus Aureus (MRSA)

Participation Criteria
=================
Eligibility Criteria
-----------------
I group Hospitalised patients Inclusion Criteria MDR bacteria (listed above) isolated from clinical specimen hospitalisation to the Tartu University Hospital or North Estonia Medical Centre or West Tallinn Central Hospital or East-Tallinn Central Hospital or The Hospital of Reconstructive Surgery II group Healthy volunteers Inclusion Criteria age >6 months have not received any antibacterial treatment in previous 3 months have not been hospitalised in previous 3 months III group Dog owners Inclusion Criteria age >6 months have not received any antibacterial treatment in previous 3 months have not been hospitalised in previous 3 months owning a dog IV group veterinarians Inclusion Criteria have not received any antibacterial treatment in previous 3 months have not been hospitaliZed in previous 3 months working as a veterinarian V group pig farmers Inclusion Criteria have not received any antibacterial treatment in previous 3 months have not been hospitalized in previous 3 months occupation as a pig farmer
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 |
| --- | --- |
| Hospitalised patients<br>No intervention | |
| Healthy volunteers<br>No intervention | |
| Dog owners (healthy volunteers)<br>No intervention | |
| Veterinarians (healthy volunteers)<br>No intervention | |
| Pig farmers (healthy volunteers)<br>No intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colonization rate with multiresistant (MDR) bacteria in hospitalized patients | To evaluate the impact of hospitalization for carriage and infection rate with MDR bacteria | March 2012 - March 2014 | 
| Colonization rate with multiresistant (MDR) bacteria in healthy humans | To evaluate the impact of animal exposure for carriage rate with MDR bacteria | March 2012 - March 2014 |
Evaluation of Fontan-Associated Liver Disease

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.

Detailed Description
-----------------
This is open-label, long-term prospective study in a cohort of Fontan subjects taking drug daily for one year. The study will determine the scope of hepatic stiffness in the cohort by ultrasound and magnetic resonance imaging elastography and evaluate MZ101 pharmacotherapy as a potentially efficacious treatment to reduce liver stiffness.

Official Title
-----------------
Imaging and Biomarker Evaluation of Hepatic Stiffness in Children Enrolled in the Fontan Udenafil Exercise Longitudinal Study

Conditions
-----------------
Single Ventricle Heart Disease

Intervention / Treatment
-----------------
* Drug: MZ101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrollment in on-going Phase 3 Open-Label Safety Study Informed assent from subject, informed consent from parent/legal guardian as appropriate Exclusion Criteria: Non-enrollment in the on-going Phase 3 Open-Label Study Subjects with contra-indications for MRI (these subjects will be excluded from the MRI component of this study) Other exclusionary criteria will match those used for the Open-Label Safety Study

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| MZ101<br>Dosing per treatment regimen | Drug: MZ101<br>* Drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Liver Stiffness in Adolescents with Single Ventricle Heart Disease | Liver Stiffness as measured by Shear Wave Ultrasound Elastography (meters/second) or Magnetic Resonance Ultrasound (kilopascals). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Drug Therapy on Liver Stiffness | Liver Stiffness as measured by Shear Wave Ultrasound Elastography (meters/second) or Magnetic Resonance Ultrasound (kilopascals). | 12 months | 
| Effect of Drug Therapy on Brain Type Natriuretic Peptide (BNP) Levels | Measurement of plasma levels of BNP | 12 months | 
| Effect of Drug Therapy on n-Terminal BNP (NT-proBNP) | Measurement of plasma levels of NT-proBNP | 12 months | 
| Effect of Drug Therapy on MicroRNA Measures. | Measurement of MicroRNA by miRNA qRT-PCR analysis of total RNA from plasma | 12 months | 
| Effect of Drug Therapy on Enhanced Liver Fibrosis (ELF) Score | Measurement of ELF Score | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fontan, Ultrasound, Magnetic Resonance Imaging Elastography
The GRADE Capillary Blood Collection Pilot Study

Study Overview
=================
Brief Summary
-----------------
This pilot study is planned to validate the comparability of HbA1c results obtained from whole blood collection via venous phlebotomy versus a capillary collection of whole blood. The participant will self-collect capillary blood into HbA1c prep vials containing a buffer; these prep vials will be sent to the CBL at ambient temperature via US Postal System (USPS) mail. The feasibility of self-collection of these capillary samples by GRADE participants will also be evaluated.

Official Title
-----------------
The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE Study) Capillary Blood Collection: A Pilot Study

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

Intervention / Treatment
-----------------
* Procedure: Capillary HbA1c collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current GRADE participant with a scheduled follow-up visit Exclusion Criteria: GRADE participants attending first quarterly (Month 3) visit or an annual visit

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Capillary HbA1c collection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c obtained from venous versus capillary measurements at one point in time for each participant. |  | Cross sectional |