linjc16/ctgov huggingface dataset:
Short-term Effects Kinesiotaping (KT) on Balance and Gait in Parkinson's Disease (DP)

Study Overview
=================
Brief Summary
-----------------
To analyze the short-term effect of kinesiotaping in balance and gait on Parkinson's disease

Official Title
-----------------
Short-term Effects Kinesiotaping (KT) on Balance and Gait in Parkinson's Disease (DP)

Conditions
-----------------
Parkinson Disease, Kinesiotaping

Intervention / Treatment
-----------------
* Other: Kinesiotaping
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of stage III PD, according to the Hoehn and Yahr scale. Subjects who are in the age range of 50 to 80 years. Acceptance of informed consent. Not present a musculoskeletal disorder or other neurological disease that interferes with balance and / or walking. Not having a diagnosed vestibular disorder. Exclusion Criteria: Diagnosis of parkinsonism o Parkison-Like. Taking medications that may interfere with the different variables evaluated. Allergy to any component of the bandage. Being a pacemaker.
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 |
| --- | --- |
| Experimental: Kinesiotaping Group<br>We used kinesiotaping (gastrocnemius and lumbar back) plus exercise | Other: Kinesiotaping<br>* We used kinesiotaping in gastrocnemius and lumbar back<br>|
| Active Comparator: Exercise Group<br>We used only exercise | Other: Exercise<br>* Exercises about balance and gait<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Test - T0 | Berg Test pre-intervention | up to week | 
| Berg Test - T1 | Berg Test post-intervention two days | up to week | 
| Berg Test - T2 | Berg Test post-intervention seven days | up to week | 
| Tinetti Gait Test - T0 | Tinetti Gait Test pre-intervention | up to week | 
| Tinetti Gait Test - T1 | Tinetti Gait Test post-intervention two days | up to week | 
| Tinetti Gait Test - T2 | Tinetti Gait Test post-intervention seven days | up to week | 
| Up & Go Test - T0 | Up & Go Test pre-intervention | up to week | 
| Up & Go Test - T1 | Up & Go Test post-intervention two days | up to week | 
| Up & Go Test - T2 | Up & Go Test post-intervention seven days | up to week | 
| Parkinson's Disease Questionnaire - T0 | Parkinson's Disease Questionnaire pre-intervention | up to month | 
| Parkinson's Disease Questionnaire - T1 | Parkinson's Disease Questionnaire post-intervention | up to month | 
| surface electromyography -T0 | surface electromyography pre-intervention | up to week | 
| surface electromyography -T1 | surface electromyography post-intervention two days | up to week | 
| surface electromyography -T2 | surface electromyography post-intervention seven days | up to week |
Effect of VascuActive Device on Foot Perfusion, Hemodynamics and Exercise Capacity in Patients With PVD & Limb Ischemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and the immediate effect of the VascuActive device on patients with peripheral vascular disease and limb ischemia.

Official Title
-----------------
Assessment of the Safety of the VascuActive™ Device and Its Preliminary Efficacy on Foot Perfusion, Hemodynamics and Exercise Capacity in Patients With Peripheral Vascular Disease and Limb Ischemia

Conditions
-----------------
Peripheral Vascular Diseases

Intervention / Treatment
-----------------
* Device: VascuActive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Leg Ischemia, Fontaine grade IIa and IIb, i.e.: pain free walking distance in the range of 50 - 100 meters. Absent pulses in the two foot arteries (Anterior Tibial a., Posterior Tibial a.) ABI < 0.7 by Doppler, in at least one of the two foot arteries Exclusion Criteria: Absent femoral pulses Venous insufficiency by Duplex Pregnancy Infectious disease Malignant disease Severe cardiac disease, e.g., CHF grade 3 or higher Acute MI within last 3 months CABG within last 3 months Other severe systemic disease

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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

| Intervention/Treatment |
| --- |
|Device: VascuActive|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain-free and Maximal walking distance |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin temperature |  | 1 hour | 
| Skin blood flow |  | 1 hour | 
| Transcutaneous partial pressure of O2 and CO2 |  | 1 hour |
Post Market Surveillance of SeQuent Please Neo With Scoring Balloon

Study Overview
=================
Brief Summary
-----------------
The main objective of the SeQuent® Please Neo post market surveillance is to assess the clinical suitability of the combination of pre-dilatation using the NSE Alpha scoring balloon before the use of the paclitaxel-coated SeQuent® Please Neo in an 'all comer'/ 'real world' setting for the treatment of in-stent restenosis and de-novo lesions.

Detailed Description
-----------------
The aim of this post market surveillance is to document the safety and efficacy of the drug-coated balloon Sequent® Please Neo in combination with the NSE Alpha scoring balloon in the treatment of both in-stent restenosis and de-novo lesions in native coronary arteries with reference diameters of 2.5 mm up to 4.0 mm with lesion lengths of 30 mm for procedural success and preservation of vessel patency

Official Title
-----------------
Post MArket Surveillance of SeQuent Please Neo With ScORing Balloon Lesion Preparation in Real WorlD Patients

Conditions
-----------------
Coronary Artery Disease (CAD)

Intervention / Treatment
-----------------
* Device: Drug Coated Balloon Angioplasty, Scoring Balloon Dilatation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with in-stent restenosis and de-novo lesions in coronary arteries Exclusion Criteria: Intolerance to paclitaxel and/or the balloon coating Allergy to components of the balloon coating Pregnancy and lactation Complete occlusion of the treatment vessel Severely calcified stenosis Cardiogenic shock Risk of an intraluminal thrombus Haemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy

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: Drug Coated Balloon Angioplasty, Scoring Balloon Dilatation|Percutaneous Coronary Intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Vessel Failure | Target Vessel Failure = TLR + Myocardial Infarction (MI) + cardiac death | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedural success rate | lesion crossing success in in-stent restenotic lesions | intraprocedural | 
| Target Lesion Revascularization rate = Re-PCI + CABG(TLR) |  | 9 months | 
| cardiac death | death of cardiac or unknown causes | 9 months | 
| Rate of coronary arterial bypass grafting (CABG) |  | 9 months | 
| rate of myocardial infarction |  | 9 months |
Improving Hypertension Control

Study Overview
=================
Brief Summary
-----------------
The overall hypothesis for the project is that racial health disparities will be reduced by improving hypertension control in African Americans. This will be accomplished through the development, implementation, and evaluation of a cost-effective hypertension control strategy based on the involvement of a community health worker.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: Lifestyle counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African Americans with uncontrolled hypertension, followed at Progressive Community Health Centers

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br>Lifestyle counseling. 6 group meetings,facilitated by community health worker, focusing on lifestyle change, eg, weight loss, physical activity, low salt, stress reduction | Behavioral: Lifestyle counseling<br>* weight reduction, low salt, physical activity, stress reduction<br>|
| No Intervention: Control<br>Standard care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure (mmHg) |  | 6 months |
Contemporary Clinical Management Of Acute Pulmonary Embolism

Study Overview
=================
Brief Summary
-----------------
Acute pulmonary embolism is a potentially life-threatening disease with short-term mortality ranges from less than 1% to more than 30% during the hospital stay. Recent guidelines recommend to tailor diagnosis hospitalization and acute treatment based on the estimated risk for short-term Death. The assessment of the contemporary clinical management of patients with acute pulmonary embolism across different specialties would be of crucial value.

Detailed Description
-----------------
This is a prospective, non-interventional, multicenter study in patients with acute pulmonary embolism admitted to Cardiology, Emergency and Internal Medicine Departments in Italy. The aim of the study is to assess contemporary management strategies in patients with acute pulmonary embolism in terms of diagnosis, risk stratification, hospitalization and treatment in Italy and assess their association with in-hospital and 30-day mortality and their adherence to current guidelines of the European Society of Cardiology (ESC).

Official Title
-----------------
Contemporary Clinical Management Of Acute Pulmonary Embolism. The COPE Study

Conditions
-----------------
Acute Pulmonary Embolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute, symptomatic acute pulmonary embolism Age ≥ 18 years Informed consent Exclusion Criteria: refusal of informed consent participation in controlled trials on the management of patients with acute pulmonary embolism

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 |
| --- | --- | --- |
| In-hospital death | In-hospital Death and Death at 30 days | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause Mortality and clinical worsening | Death or clinical deterioration at 30 days from the diagnosis of pulmonary embolism | 30 days | 
| Pulmonary embolism related mortality for and clinical worsening | Pulmonary embolism-related death or clinical deterioration at 30 days from the diagnosis of pulmonary embolismembolism | 30 days | 
| Adherence to guidelines | Adherence to current guidelines on the management of acute pulmonary embolism released by the ESC regarding diagnosis, risk stratification and treatment | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute pulmonary embolism, International guidelines
Impact of C-arm CT in Decreased Renal Function Undergoing TACE for Tx of Hepato-Cellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Impact on contrast dose or total volume of contrast required to effectively treat the targeted tumor.

Official Title
-----------------
Impact of C-arm CT in Patients With Decreased Renal Function Undergoing Transhepatic Arterial Chemoembolization (TACE) for the Treatment of Hepato-Cellular Carcinoma

Conditions
-----------------
Kidney (Renal Cell) Cancer

Intervention / Treatment
-----------------
* Device: dTA/dBA C-arm fluoroscopy system with Dyna CT
* Procedure: DSA arteriogram- hepatic arteries
* Procedure: CO2 aortogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be affected by HCC Patients must have diminished renal function (GFR<60 ml/min/1.73m^2) Patients must be 18 years old or older Patients must have received an abdominal CT, PET/CT scan or MRI, completed prior to the TACE procedure. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Subjects under the age of 18 Patients currently on dialysis Pregnant women

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: dTA/dBA C-arm fluoroscopy system with Dyna CT|C-arm CT of the liver; state-of-the-art flat panel detector on a ceiling or floor mounted C-arm gantry|
|Procedure: DSA arteriogram- hepatic arteries|Standard of care|
|Procedure: CO2 aortogram|Standard of care|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients that develop renal failure (defined as a decline of renal function, as measured by glomerular filtration rate, of 25% or more from pre-procedural) |  | 3 weeks |
A Human Phase I Absolute Bioavailability Study of PRT054021 in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a open label, single center, single oral dose, study of PRT054021, in healthy subjects.

Official Title
-----------------
A Human Phase I Absolute Bioavailability Study of PRT054021 in Healthy Male Volunteers.

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Betrixaban


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult men ages of 19 and 65 years old, inclusive BMI of 18-35 kg/m2 Exclusion Criteria: Clinically significant comorbid disease History of substance abuse

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

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

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

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: Single Arm Oral and IV Betrixaban<br> | Drug: Betrixaban<br>* Single Oral dose 80 mg betrixaban and Single IV (15 ml) carbon 14 80 micrograms Betrixaban administered over 15 minutes, 2 hours after the oral dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of orally absorbed dose |  | over 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Betrixaban, Healthy, Bioavailability
Molecular Characterization of Acute Erythroid Leukemia (M6-AML) Using Targeted Next-generation Sequencing

Study Overview
=================
Brief Summary
-----------------
Acute erythroid leukemia (AEL) is a morphologically distinct, infrequent (o5%) acute myeloid leukemia (AML) designed as M6 in the French- American-British (FAB) classification. The World Health Organization classification recognizes two subclasses, M6a, a leukemia with myeloid blast cells, and M6b, a very rare, purely erythroid AML. It may be difficult to distinguish between a myelodysplastic syndrome and AEL because of the erythroblastic proliferation, which is increased when dysplasia is present. No recurrent cytogenetic abnormality is specific of AEL and the prognosis is poor with a median survival of 17 months. A study of 14 genes in a series of 92 cases has shown that mutations are frequent in AEL and somewhat differ from the other AMLs by the lower and higher proportion of FLT3-ITD and TP53 mutations, respectively. Only three cases of AEL are reported in the TCGA database. To further characterize AEL, determine whether it constitutes a distinct class of AML and document the reasons for its poor prognosis, the investigators will search for molecular alterations in 40 M6a-AMLs using array comparative genomic hybridization (aCGH) and next-generation sequencing (NGS) of 106 genes known or suspected to have a role in myeloid malignancies or in erythrocyte differentiation.

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Other: DNA sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 year Diagnosis of AML6 Written consent obtained Exclusion Criteria: No written consent No frozen samples

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 |
| --- |
|Other: DNA sequencing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular characterization of AML-6 by NGS and CGH array | Molecular characterization using array comparative genomic hybridization (aCGH) and next-generation sequencing (NGS) of 106 genes known or suspected to have a role in myeloid malignancies or in erythrocyte differentiation. | 1 year |
PRKAA2 Genetic Polymorphisms and Its Susceptibility to Chinese Type 2 Diabetes Mellitus and Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
Metformin is a classical oral antidiabetic drug, often recommended to be the first-choice treatment of type 2 diabetes mellitus (T2DM). Based on the previous research on PRKAA2, STK11 and diabetes, this study aimed to investigate the distributive characteristic of PRKAA2 and STK11 polymorphisms and the potential influence of STK11polymorphisms on metformin efficacy among Chinese T2DM patients, discuss the association of PRKAA2 polymorphisms between T2DM patients and healthy subjects.

Official Title
-----------------
The Influence of AMPK Subunit Alpha (PRKAA2) Genetic Polymorphisms With Susceptibility to Chinese Type 2 Diabetes Mellitus and Diabetic Nephropathy

Conditions
-----------------
T2DM (Type 2 Diabetes Mellitus)

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with T2DM in keeping with the WHO criteria in 1999 [14], with fasting blood glucose (FBG) ≥ 7.0mmol ⁄ L and ⁄ or postprandial blood glucose (PBG) ≥ 11.1mmol ⁄ L; not using other antidiabetic drugs within the experimental period. Exclusion Criteria: other significant illness such as cancer, myocardial infarction, stroke, severe liver, and kidney disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| T2DM patients<br>Metformin dosages ranged from 500 to 2000 mg per day | Drug: Metformin<br> <br> |
| healthy subjects<br>the healthy subjects was not intervened | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of T2DM | people whose fasting plasma glucose ≥7.0 mmol/L and/or postprandial plasma glucose ≥11.1 mmol/L is diagnosed with T2DM. | Jan 2014-Dec 2015 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metformin efficacy----the decrease level of HbA1c | patients whose HbA1c levels is decreased by more than 0.5 % from the baseline is deemed as the response group, while the decrease in HbA1c levels less than 0.5 % from the baseline is deemed as the non-response group. | Jan 2014-Dec 2015 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
T2DM, genetic polymorphism, diabetic nephropathy
An Evaluation of Near-Infrared Spectroscopy for Intracranial Hematoma Detection of Head Trauma Patients in the Emergency Department.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate Near-Infrared Spectroscopy for intracranial hematoma detection of head trauma patients

Official Title
-----------------
An Evaluation of Near-Infrared Spectroscopy for Intracranial Hematoma Detection of Head Trauma Patients in the Emergency Department.

Conditions
-----------------
Within 12 Hrs of Head Injury

Intervention / Treatment
-----------------
* Device: infrascanner


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients within 12 hours after head injury, visiting the Emergency Department of the National Taiwan University Hospital, and receiving computed tomography of head were enrolled. Exclusion Criteria: The patients over 12 hours after head injury, visiting the Emergency Department of the NTUH, and receiving computed tomography of head were excluded. Patients with massive scalp laceration or hematoma were excluded. -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| positive infrascanner finding<br> | Device: infrascanner<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detect the predictive value of the infrascanner for intracranial hemorrhage |  | within 12 hours after head injury | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
head injury, infrascanner, intracranial hemorrhage