linjc16/ctgov huggingface dataset:
Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients

Study Overview
=================
Brief Summary
-----------------
Evaluate the efficacy, Safety and Pharmacokinetics of Intravenous single injection LC28-0126 immediately before Percutaneous Coronary Intervention (PCI) in Patients with ST-segment Elevation Myocardial Infarction (STEMI).

Conditions
-----------------
ST-segment Elevation Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: LC28-0126 Dose A
* Drug: LC28-0126 Dose B
* Drug: LC28-0126 Dose C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 20 and 75 Within 12 hours after the onset of chest pain ST-segment elevation of more than 0.1 mV in two contiguous leads or new left bundle-branch block (LBBB) patients Signed for written informed consent Exclusion Criteria: Left Main disease Multi-vessel disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LC28-0126 Dose A<br> | Drug: LC28-0126 Dose A<br>* LC28-0126 Dose A<br>|
| Experimental: LC28-0126 Dose B<br> | Drug: LC28-0126 Dose B<br>* LC28-0126 Dose B<br>|
| Experimental: LC28-0126 Dose C<br> | Drug: LC28-0126 Dose C<br>* LC28-0126 Dose C<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of Troponin I for 72 hours post PCI |  | pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of CK-MB for 72 hours post PCI |  | pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h | 
| AUC of CK for 72 hours post PCI |  | pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h | 
| Infarct size assessed by Cardiac MRI |  | Day 4, 30 | 
| Myocardial function assessed by Cardiac MRI |  | Day 4, 30 | 
| Myocardial function assessed by Echocardiogram |  | Day 4, 30 |
Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise

Study Overview
=================
Brief Summary
-----------------
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise

Official Title
-----------------
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise

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

Intervention / Treatment
-----------------
* Drug: HD-6277
* Drug: HD-6277
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of T2DM with HbA1c between 7.0% and 10.0% (inclusive) while on diet and exercise alone for at least 6 weeks prior to screening. Exclusion Criteria: Type 1 diabetes or another immune-mediated diabetes syndrome

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HD-6277 100mg tab<br> | Drug: HD-6277<br>* HD-6277 Oral tablet 100mg<br>|
| Experimental: HD-6277 50mg tab<br> | Drug: HD-6277<br>* HD-6277 Oral tablet 50mg<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c(%) |  | 12 weeks |
Quantitative Ultrasound of Trapezius Muscle in Cervical Myofascial Syndrome

Study Overview
=================
Brief Summary
-----------------
The myofascial points within the trapezius muscle are hypoechogenic regions that can be depicted via ultrasound imaging. In this study we aimed to demonstrate the hypoechogenic regions within the trapezius muscle and to determine if physical therapy modalities change the appearance and size of these areas. We also wanted to explore if the presence of these areas correlate with pain.

Official Title
-----------------
Quantitative Ultrasound of Trapezius Muscle in Cervical Myofascial Syndrome

Conditions
-----------------
Myofascial Pain Syndrome

Intervention / Treatment
-----------------
* Other: Physical Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with myofascial pain syndrome in the cervical region Exclusion Criteria: Presence of cervical radiculopathies Previous history of cervical injusy Presence of rheumatologic diseases

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

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

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

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: Treatment<br>Patients who will receive physical therapy | Other: Physical Therapy<br>* Physical therapy consisting of the application of hotpack, TENS and treatment ultrasound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | Pain | 3 weeks |
Ultrasonography SWE for Hepatic Fibrosis Evaluation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure diagnostic performance of ultrasound shear wave elastography to detect advanced hepatic fibrosis.

Detailed Description
-----------------
Hepatic fibrosis causes liver dysfunction and HCC. Since hepatic fibrosis is reversible dynamic condition, its monitoring is important to predict long term outcome and to determine treatment plan. The reference of standard to diagnose hepatic fibrosis is biopsy, but recently non-invasive method such as stiffness imaging has been drawing a lot of attention. In this study, ultrasound shear wave elastography will be performed and its diagnostic performance to detect advanced hepatic fibrosis (= > F2) will be measured using histologic grade as a reference.

Official Title
-----------------
Diagnostic Performance of Shear Wave Elastography for Fibrosis Evaluation: Preliminary Study

Conditions
-----------------
Cirrhosis

Intervention / Treatment
-----------------
* Device: ultrasound shear wave elastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: volunteers who agree to undergo US shear elastography OR patients with chronic liver disease who are scheduled to undergo liver resection or liver parenchymal biopsy. AND = or > 18 years sign informed consent Exclusion Criteria: none

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ultrasound shear wave elastography|ultrasound shear wave elastography is performed in GE ultrasound scanner according to guidelines of ultrasound elastography.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic performance to detect advanced hepatic fibrosis | from ultrasound SWE to perform hepatic resection or percutaneous liver biopsy in patients (with histologic diagnosis) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interobserver agreement of ultrasound SWE | two observers perform ultrasound SWE on the same day in volunteers. | 1 day | 
| agreement with MR elastography | interval between US and MR elastography in patients with available MR elastography | 1 month | 
| Technical success rate | technical success or failure of US elastography using GE LOGIQ E9 scanner in ALL study population | 6 months | 
| Reliable measurement rate | reliable measurement rate (interquartile range of serial measurement/median LS value <30%) in patients with technically successful US elastography | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elastography, ultrasonography
Male Fertility Program

Study Overview
=================
Brief Summary
-----------------
Following spinal cord injury, most men are infertile and require medical assistance to father children. The conditions that contribute to their infertility are erectile dysfunction, ejaculatory dysfunction, and semen abnormalities. The Miami Project Male Fertility Program is a research study designed to understand and improve impairments to male fertility resulting from spinal cord injury.

Official Title
-----------------
The Miami Project Male Fertility Program

Conditions
-----------------
Spinal Cord Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any man with spinal cord injury over the age of 18. Control Subjects will be any healthy man over the age of 18 with no recent history of infertility Exclusion Criteria: Women will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spinal cord injury (SCI) subjects will learn the best method to obtain their semen and of their possible options for assisted conception. | Studies in the male fertility program will investigate the fertility potential of spinal cord injured men by retrieving semen which will be analyzed for sperm count, motility, morphology, etc., and correlated with patient variables such as age, time of injury, level of injury, bladder management, history of UTI's, hormonal status, etc. the outcome of the research will improve fertility in men with spinal cord injury. | 2 visits; subjects will provide samples each month up to an average of 2-3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abnormal semen, assisted conception
Cognitive Impairment and Imaging Correlates in End Stage Renal Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand cognitive impairment in end stage renal disease before and after a kidney transplant.

Detailed Description
-----------------
Cognitive impairment is very common in patients with End Stage Renal Disease (ESRD). It exact mechanisms are not clear, but patients with ESRD have more cerebral white matter changes. Several studies have shown that cognitive function improves post-transplant, indicating that there may be some reversibility in the process. This study will examine the correlation between cognitive impairment and structural brain changes before and after renal transplantation. We will also study the correlation of cognitive function with serum inflammatory markers before and after transplant. These results will be compared to aged matched healthy controls without kidney disease.

Official Title
-----------------
Cognitive Impairment and Imaging Correlates in End Stage Renal Disease

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Procedure: Kidney Transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-transplant ESRD patients between the ages of 30 and 70 years who are listed for renal transplantation Able to sign pre-transplant consent on their own will Have english as their native language Exclusion Criteria: Current use of antipsychotics or anti-epileptics Inability to read or write which will limit their ability to perform the cognitive tests Claustrophobia or inability to get MRI for other reasons Unable to sign consent

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| ESRD patients<br>ESRD patients awaiting renal transplantation | Procedure: Kidney Transplant<br>* Kidney Transplant Surgery<br>|
| Control Arm<br>Subjects without kidney disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cognitive Function | Cognitive testing will be performed for assessment | Change from Baseline to 3 Months after Renal Transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in brain MRI | Brain MRI will be performed before and after transplant | Change from Baseline to 3 Months after Renal Transplant | 
| Change in inflammatory markers |  | Change from Baseline to 3 months post transplant |
Benefits of the HiResolutionTM Bionic Ear System in Adults With Low-Frequency Hearing

Study Overview
=================
Brief Summary
-----------------
The goal of this investigation is to generate the needed PMCF data for the HiFocus Mid-Scala electrode. As a point of interest the investigators would like to evaluate the benefit to patients with low-frequency residual hearing implanted with the HiFocus Mid-Scala Electrode. The HiFocus Mid-Scala electrode array is designed to allow surgeons the flexibility to use a variety of contemporary surgical techniques that have been shown to enable easy insertion and to minimize cochlear trauma (see, e.g., Adunka and Buchman, 2007; Friedland and Runge-Samuelson, 2009; Roland et al., 2007). Temporal bone experiments have shown the HiFocus Mid-Scala electrode array to be straightforward to insert while causing minimal trauma to cochlear structures during and after surgery (Lenarz et al., 2010). In addition , the HiFocus Mid-Scala has already shown to be a safe electrode and promising post op clinical results in the premarketing study that is now in the final stage.

Official Title
-----------------
Benefits of the HiResolutionTM Bionic Ear System in Adults With Low-Frequency Hearing.

Conditions
-----------------
Severe-to-profound Hearing Loss

Intervention / Treatment
-----------------
* Other: Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Definite Postlingual onset of severe-to-profound hearing loss as documented by completing main stream primary education. Local language proficiency Bilateral, sensorineural hearing loss Exclusion Criteria: Previous inner ear surgery or active middle ear pathology. Cochlear malformation or obstruction Presence of additional disabilities that would prevent or interfere with participation in the required study procedures Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study-related procedures Evidence of central auditory lesion or compromised auditory nerve Concurrent participation in other study

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study population<br>Subjects will need to be standard CI patients acording to national implant criteria and the study criteria. | Other: Observational study<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CI aided word recognition scores in quiet and noise. | CI aided word recognition scores in quiet and noise. | 12 months post activation |
Surgical Outcomes in Pediatric Patients With Coarctation and VSD

Study Overview
=================
Brief Summary
-----------------
Recently, a paper was published that compared outcomes of patients requiring repair of aortic coarctation and ventricular septal defect. Some surgeons opt to repair both defects in one surgery while other surgeons do the repair in two separate operations. Recently at Children's Healthcare of Atlanta, we have adopted the practice of correcting both defects during the same operation but through two separate incisions (one on the chest and the other through the ribs on the side. This reduces the amount of time the patient is on the heart-lung bypass machine during surgery. This study is a review of patient charts to compare outcomes of patients who have had surgery to repair their coarctation and VSD during 2002 through 2005.

Detailed Description
-----------------
This study is a retrospective chart review of patients who carry the diagnosis of aortic coarctation and VSD and have had their surgical repair at Children's Healthcare of Atlanta between the dates of January 1, 2002 and December 31, 2005. The data collected will be surgical data such as type of repair, and the time the patient required cross clamp, circulatory arrest and cardiopulmonary bypass while in the operating room for the repair(s). We would also like to gather post-operative information such as time the patient required ventilation, whether they required a re-operation during the same admission, along with intensive care hours and hospital length of stay.

Official Title
-----------------
Staged Approach to Coarctation and VSD Can Offer Optimal Outcomes

Conditions
-----------------
Diagnosis of Coarctation of the Aorta and VSD, Surgical Repair at CHOA, Between January 1, 2002 and December 31, 2005

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of coarctation and VSD surgical repair at Children's Healthcare of Atlanta between January 1, 2002 and December 31, 2005. Exclusion Criteria: does not have coarctation and VSD did not have surgery at Children's Healthcare of Atlanta between January 1, 2002 and December 31, 2005.
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
-----------------
congenital heart disease, pediatric, surgical outcomes
Study of Rubella Immunity. Response to Vaccination of Subjects With Very Low, Equivocal or Undetectable Titers of Rubella Virus Antibodies

Study Overview
=================
Brief Summary
-----------------
The aim of the research is to study humoral and cellular immunity in pregnant women for who the level of rubella virus antibodies is weakly positive, equivocal or negative with the usual laboratory technique.

Official Title
-----------------
Study of Rubella Immunity. Response to Vaccination of Subjects With Very Low, Equivocal or Undetectable Titers of Rubella Virus Antibodies

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Biological: Determination of Anti-Rubella Antibody, E1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women over 18 Rubella serology negative, ambiguous or weakly positive during a first prenatal consultation and for which the second determination of the immunity anti rubella is necessary after 18 weeks of pregnancy Accepting the rubella vaccination after the childbirth; Accepting a blood test, during a postnatal consultation, 6 in 8 weeks after vaccination, to verify their immunity towards the virus of the rubella. Affiliated to a social security scheme Having given a written consent Exclusion Criteria: Rubella contracted since the first serology realized during the first prenatal consultation Autoimmune pathologies Intolerance / allergy known about a previous vaccination whatever it is Immunosuppression (HIV, transplants) Injection of multivalent immunoglobulins (except anti-D)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregnant women<br> | Biological: Determination of Anti-Rubella Antibody, E1<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Anti-Rubella Antibody, E1 |  | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rubeola