linjc16/ctgov huggingface dataset:
PPAR-COMBO With Sulfonylurea

Study Overview
=================
Brief Summary
-----------------
A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Glyburide Therapy in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone.

Official Title
-----------------
A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Glyburide Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone

Conditions
-----------------
Metabolics Diabetes Nos

Intervention / Treatment
-----------------
* Drug: Muraglitazar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes, HbA1c > 7.0% and < 10.0%, mean serum triglyceride < 600 mg/dL, body mass index < 41 kg/m2, fasting c-peptide . 1.5 ng/mL. Exclusion Criteria: History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months, congestive heart failure (NYHA Class III and IV, uncontrolled hypertension, history or renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Muraglitazar|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + glyburide vs placebo + glyburide |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in hs-CRP from baseline to W24 |  |  |
ALERT-HF: Adherence to Guidelines in the Treatment of Patients With Chronic Heart Failure

Study Overview
=================
Brief Summary
-----------------
ALERT-HF is an observational study aimed to evaluate the diagnostic criteria adopted and the adherence to the current therapeutic guidelines in a large series of patients affected with chronic heart failure. Secondary objective is to evaluate the prevalence of chronic heart failure among all the patients referring to the ambulatory cardiologists of the healthcare district.

Official Title
-----------------
ALERT-HF:Adherence to Guidelines in the Treatment of Patients With Chronic Heart Failure

Conditions
-----------------
Chronic Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Heart Failure Signature of informed consent Age older than 65 years Exclusion Criteria: indication for cardiac surgery or cardiac surgery by less than 3 months age less than 65 years inability to perform periodic checks presence of malignant neoplasms and other severe diseases.

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Chronic Heart Failure Patients<br>Chronic Heart Failure patients older than 65 years, which accept to participate to the study and give their informed written consent and consecutively refer to the A.R.C.A Campania Cardiologists in the pertaining healthcare districts. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients treated with each of the following indicators of adherence to the current therapeutic guidelines:-ACEI -ARB -beta blockers -loop diuretics -aldosterone antagonists -digoxin -anticoagulant therapy - implantation of cardiac devices |  | first physical examination and clinical evaluation performed during a 3 months period, from November 2012 to January 2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the prevalence of chronic heart failure among all the patients referring to the ambulatory cardiologists of the healthcare district |  | first evaluation |
Analgesia for Positioning Hip Fracture Patients for Spinal Anesthesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two analgesic methods performed preoperatively to assist positioning patients for performance of spinal anesthesia, namely fascia iliaca blockade and intravenous fentanyl.

Official Title
-----------------
Fascia Iliaca Compartment Block Versus Fentanyl for Positioning Patients With Hip Fractures for Central Nervous Blockade: a Randomized Trial.

Conditions
-----------------
Hip Fracture

Intervention / Treatment
-----------------
* Drug: Fentanyl
* Procedure: Fascia iliaca compartment block
* Drug: ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hip fracture Exclusion Criteria: contraindications for central nervous blockade impaired cognition or dementia multiple fractures any previous analgesic administration during the last 12 hours
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: Fascia iliaca compartment block<br> | Procedure: Fascia iliaca compartment block<br>* Fascia iliaca compartment block using ropivacaine<br>Drug: ropivacaine<br> <br> |
| Active Comparator: Fentanyl<br> | Drug: Fentanyl<br>* Fentanyl IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores on the Numeric Rating Scale |  | Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of spinal anesthesia performance | It will be measured in minutes, from the start of positioning maneuvers to the spinal needle removal | Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block) | 
| Quality of patient's position | The position will be characterized as unsatisfactory, satisfactory, good or very good | Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block) |
Study to Explore Drug-drug Interactions Between DWC20155 and DWC20156 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
A randomized, open-label, oral dose, crossover study to explore drug-drug interactions between DWC20155 and DWC20156 in healthy subjects.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: DWC20155
* Drug: DWC20156


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Accepts healthy volunteers. Exclusion Criteria: Who has allergy to investigational product

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study effect of DWC20156 on DWC20155 PK<br>To study effect of DWC20156 on DWC20155 PK | Drug: DWC20156<br> <br> |
| Experimental: Study effect of DWC20155 on DWC20156 PK<br>To study effect of DWC20155 on DWC20156 PK | Drug: DWC20155<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) |  | 0 24hr | 
| Area under the plasma concentration versus time curve (AUC) |  | 0 24h |
Clinical Trial of YuWell YE660D Blood Pressure Monitor in General Population According to the ISO 81060-2:2018

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the accuracy of the YuWell YE660D oscillometric upper-arm blood pressure monitor for clinic and home in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018).

Official Title
-----------------
Validation of the YuWell YE660D Oscillometric Upper-arm Blood Pressure Monitor for Clinic and Home in General Population According to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Diagnostic Test: YuWell YE660D Electronic Sphygmomanometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12 Years and older; Subjects voluntarily participate in the clinical trial and sign the informed consent. Exclusion Criteria: Disturbance of consciousness; Patients requiring hemodialysis; Taking anticoagulant drugs due to cardiovascular and cerebrovascular diseases; Pregnant and lactating women; Patients with cardiac arrhythmias; Other conditions that the investigator considers ineligible for clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YuWell YE660D and mercury sphygmomanometer<br>Blood Pressure Measurement with the YuWell YE660D Electronic Sphygmomanometer (YuWell YE660D) and with Desk Mercury Sphygmomanometer. | Diagnostic Test: YuWell YE660D Electronic Sphygmomanometer<br>* Measurement blood pressure by YuWell YE660D Electronic Sphygmomanometer and Desk Mercury Sphygmomanometer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure measurement data | Systolic Pressure and Diastolic Pressure | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood pressure monitor, blood pressure measurement, validation study, AAMI/ESH/ISO Universal Standard, ISO 81060-2:2018, YuWell YE660D
Mastering Hospital Antimicrobial Resistance and Its Spread Into the Community

Study Overview
=================
Brief Summary
-----------------
Data on occurrence of antimicrobial resistant bacteria acquisition in rehabilitation centers will be collected. After removal of patient identifiers, information regarding the patients population will be entered into electronic sheet. The phase will last twelve months in each center.

Detailed Description
-----------------
All patients admitted to the department will be examined on admission, two weeks latter and monthly by obtaining nares and perirectal cultures. These cultures will be processed for detection the target organisms. This activity is part of the good medical practice and is performed on routine basis in various hospital units Epidemiological data will be collected from patient records. This data will be stored after removal of all patients' identifiers. These data will be transferred for analysis to Tel Aviv Medical Center

Official Title
-----------------
Mastering Hospital Antimicrobial Resistance and Its Spread Into the Community

Conditions
-----------------
ESBL Infection, Methicillin-Resistant Staphylococcus Aureus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients are older then 18 years old Exclusion Criteria: Age 18 years or less

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rehabilitation center's hospitalized patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A rehabilitation center's department in which the hospitalized patients are older then 18 years old. |  | 1 YEAR | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
To define activities and patient characteristics likely to lead to dissemination of resistant bacteria in rehabilitation centers and, To define specific risk factors for acquisition of resistant bacteria (ESBL producers and MRSA) in rehabilitation centers., ESBL producers, MRSA
Pathogenesis of Hematologic Malignancies

Study Overview
=================
Brief Summary
-----------------
The cause of blood and bone marrow cancers is poorly understood; however, most research focuses on how cancer cells grow and develop. Because the causes of these cancers are unknown, current treatments may be unnecessarily harsh and often do not provide a cure. Identifying the causes of blood cancers would allow for the development of treatments that are more likely to provide a cure. To find the causes of blood and bone marrow cancers, we will look for specific cancer cell abnormalities that are responsible for cancer cell growth. We will then look to see if drugs that can reverse these abnormalities can kill cancer cells.

Official Title
-----------------
Pathogenesis of Acute Leukemia, Lymphoproliferative Disorders, and Myeloproliferative Disorders

Conditions
-----------------
Acute Leukemia, Lymphoproliferative Disorders, Myeloproliferative Disorders, Myelodysplastic Syndromes

Intervention / Treatment
-----------------
* Procedure: blood draw, bone marrow procedure, or tissue biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected or confirmed diagnosis of AL, LPD, MDS, or MPD Male or female of all ages Willing and able to sign informed consent Willing guardian consent for participants under 18 years of age Exclusion Criteria: No suspected or confirmed diagnosis of acute leukemias (AL), lymphoproliferative disorders (LPD), myelodysplastic syndromes (MDS), or myeloproliferative diseases (MPD)

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Blood Draw<br> | Procedure: blood draw, bone marrow procedure, or tissue biopsy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify and determine the frequency of mutations causing aberrant signaling pathway function in patients with acute leukemias (AL), lymphoproliferative disorders (LPD), myelodysplastic syndromes (MDS), and myeloproliferative neoplasms (MPN) | Integrated functional genomics studies (whole genome sequencing, RNAi, proteomics, drug sensitivity, expression profiling) will be used to identify aberrant signaling pathways that contribute to the formation of hematologic malignancies. | After laboratory analyses are complete. Lab samples are collected at the time of a scheduled blood draw, bone marrow procedure, tissue biopsy, or other visit for usual medical care |
Diagnosis of Fabry Disease: Impact of an Educational Brochure Intended for Cardiologist

Study Overview
=================
Brief Summary
-----------------
The cardiac Fabry disease are early, frequent and severe, dominated by the frequency of left ventricular hypertrophy. They are responsible for a high morbidity and mortality, reducing life expectancy of 15 to 20 years for men. Fabry disease and heart attacks are still diagnosed late. This delay in diagnosis is due to the non-specificity of clinical, electrocardiographic and echocardiographic disease, but also by a certain ignorance of this pathology in the medical community. The importance of early diagnosis of Fabry disease and heart disease is well established: enzyme replacement therapy is most effective when instituted early, before the onset of irreversible damage such as fibrosis. With the blotter, we now have a simple and robust screening tool for Fabry disease, achievable consultation. Targeted educational interventions to physicians have shown their effectiveness in improving the screening and diagnosis of rare diseases. We offer a prospective observational type before / after study, which aims to assess the value of an educational brochure for cardiologists to improve the screening and diagnosis of Fabry disease in Normandy.

Official Title
-----------------
Diagnosis of Fabry Disease: Impact of an Educational Brochure Intended for Cardiologist

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with left ventricular hypertrophy of unknown etiology or of sarcomeric MHC pace, followed in Normandy, has given its consent to the search of Fabry disease Criteria Exclusion: Patients under 18 years patient refusal to participate in the study. Lack of consent to the search of Fabry disease

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 |
| --- | --- | --- |
| Number of new cases of Fabry disease diagnosed a year after distribution of educational brochure cardiologists |  | 1 year |
Diagnostic Evaluation of Patients With Neuromuscular Disease

Study Overview
=================
Brief Summary
-----------------
The objectives of this protocol are to: 1) screen patients with various neuromuscular disorders and facilitate their entry into appropriate research protocols; 2) help resolve puzzling diagnostic neuromuscular problems and train fellows in the evaluation and treatment of Neuromuscular Diseases; and 3) provide follow up to patients who finished their participation in a previous study but they are not currently entered in another research protocol. No investigational treatments will be performed on this protocol but the tissues collected can be used for future research studies.

Detailed Description
-----------------
The objectives of this protocol are to: 1) screen patients with various neuromuscular disorders and facilitate their entry into appropriate research protocols; 2) help resolve puzzling diagnostic neuromuscular problems and train fellows in the evaluation and treatment of Neuromuscular Diseases; and 3) provide follow up to patients who finished their participation in a previous study but they are not currently entered in another research protocol. No investigational treatments will be performed on this protocol but the tissues collected can be used for future research studies.

Official Title
-----------------
Diagnostic Evaluation of Patients With Neuromuscular Diseases

Conditions
-----------------
Neuromuscular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Research patients will be studied under this protocol if they fulfill the following criteria: Have an identifiable neuromuscular disorder that may be suitable for a specific current or future protocol; Present a diagnostic puzzle in spite of the previously performed diagnostic work-up; Have unusual manifestation of a more usual neuromuscular disease; Have a disorder useful for teaching purposes. Patients should be referred by a physician who will continue their care after our evaluation. A report of the patients' visit and tests, along with suggestions or recommendations will be sent to each referring physician. There is a wide spectrum of neuromuscular diseases to be studied, among them are: peripheral neuropathies, myopathies, dystrophies, myasthenia, stiff person syndrome, muscle cramps, myotonias, motor neuron diseases, post-polio syndrome, and certain demyelinating disorders affecting both the central and the peripheral nervous system.
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
-----------------
Myopathy, Dystrophy, Neuropathy, Muscle Weakness, Muscle Cramps and Pains, Neuromuscular Disorders