Cirugía

A continuación, se enumeran los ensayos clínicos actuales.

Filtra esta lista de estudios por sede, estatus, etc.

1. Analysis of the Cardiac, Aorta and Carotid Artery Walls for Hemodynamic Monitoring in the Intensive Care Unit

   Jacksonville, Fla.

   The primary aim of this study is to determine if biomechanical properties of cardiac and large arterial walls measured by ultrasound-based novel imaging technology correlate with hemodynamic parameters measured by other tools in the ICU.

2. A Study to Evaluate Outcomes of Rotator Cuff Repair

   Rochester, Minn.

   The purpose of this study is evaluate the outcomes and complications in patients who underwent a rotator cuff repair.

3. A Quality of Life Assessment of Patients with Biliary Obstruction Undergoing Endoscopic or Percutaneous Drainage

   Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

   The aim of this study is to compare the quality of life of patients with biliary obstruction who have undergone an endoscopic or percutaneous drainage. The quality of life of patients witll be assessed using the validated "European Quality of Life-5 Dimensions Questionnaire" and the "Intervention-Dependent Questionnaire" which was developed according to current literature as well as the expert opinion of gastroeneterologists.

    

4. A Study to Evaluate Maternal-fetal Immune Responses to Fetal Surgery

   Rochester, Minn.

   The purposes of this study are to determine whether maternal T cells are activated and expand after in utero intervention, and to determine whether placental macrophages and histology in the maternal-fetal interface exhibit increased activation and inflammation in surgical cases born preterm (<37 weeks) compared to term.

5. Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)

   Rochester, Minn., Minneapolis, Minn.

   The purpose of this study is to evaluate the continued safety and probable benefit of the MID-C system for 5 years post-implantation in Adolescent Idiopathic Scoliosis (AIS).

6. A Study to Examine Financial Distress in Patients Undergoing Treatment of Locally-advanced Rectal Cancer

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to examine the needs and gap in our understanding of financial burden experienced by rectal cancer patients from a patient perspective to help provide patient centered care and improve psychosocial outcomes of this group.

7. Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity- AIM 1

   Scottsdale/Phoenix, Ariz.

   This study is being done to better understand the relationship between inflammation in your AT, abnormal deposition of fat around your liver and how this affects its appearance and function and ultimately insulin resistance.

8. Umbilical Cord Blood Collection and Processing for Severe Congenital Heart Disease

   Rochester, Minn.

   Congenital heart disease (CHD) is an abnormal formation that occurs during the development of a baby’s heart, heart valves and/or large vessels such as the aorta artery. CHD is the most common cause of major congenital defects accounting for almost 30% of all defects (Van der Linde D, JACC 2011). While the statistics vary among studies, the best birth prevalence estimate is 8 per 1000 live births (Bernier PL 2010). In the USA, CHD affects 1% of all births per year (Krasuki & Bashore 2016), with an estimated 40,000 babies born with any type of heart defect every year (Benjamin Emelia 2018).  Twenty-five percentof these are affected by a severe congenital heart defect (https://www.cdc.gov/ncbddd/heartdefects/data.html#References). Children with CHD who survive after the surgical procedures can develop heart failure and require a heart transplant at any time in their lives. Infants born with CHD need immediate medical attention and multiple follow-ups throughout their lives. Besides the social and economic impact of CHD on the individual and family lives, CHD treatment places a significant financial burden on the healthcare system. Simeone et al, (2014) reported that the cost of CHD hospitalization in the US was approximately $5.6 billion in 2019, accounting for 15.1% of the total cost for all pediatric hospitalizations in that year.

   The important improvements in CHD diagnosis and surgical treatment in the last decades has led to an increased survival of newborns affected with heart defects. A large number of CHD can be diagnosed during pregnancy, and the patients can present a broad range of symptoms. Forms of CHD are usually classified based on their severity, from mild to severe. One of the mildest forms of CHD is atrial septal defect, which can be undetectable until adulthood (Hoffman & Kaplan, 2002) and VSD (Penny DJ, 2011). On the other hand, severe CHD that requires multiple palliative surgeries includes single ventricle defects, such as hypoplastic left heart syndrome (HLHS) and tricuspid atresia.

   The survival of infants with CHD will depend on the severity of the defect and the time of diagnosis and treatment received. The one-year survival of newborns with severe or critical CHD (generally any type of surgery/procedures in their first year of life) is estimated to be 75%.

   Stem cell therapy has emerged as a new paradigm of treatment in the field of CHD with promising results. Cardiac regeneration has been the focus of acquired, adult heart disease for many years. However, congenital heart disease with structural abnormalities may also be a good target for other research studies. In fact, the pediatric heart is naturally growing and may be amendable to regenerative strategies. Furthermore, the initial pre-clinical and clinical studies have demonstrated that the delivery of stem cells into the heart of patients with CHD is feasible and safe. Moreover, the cell therapy approach, along with the standard surgical palliation, seems to offer benefits over surgical treatment alone. Even though the number of cell therapy clinical trials for CHD has increased in the last decade, more long-term follow-up studies are needed in this population setting in order to define the role of stem cell therapy in the clinical practice. Therefore, confirming our ability to produce autologous cells (cells from the patient's own body) from patients with severe CHD is an important step towards the long-term goal of being able to discover innovative cell-based protocols.

9. A Study to Collect Clinical Outcomes of Anatomic and Reverse Total Shoulder Arthroplasty

   Scottsdale/Phoenix, Ariz.

   The purpose of the study is a multi-center prospective registry to collect clinical outcomes of anatomic and reverse total shoulder arthroplasty.

10. Allogeneic Mesenchymal Stromal Cell Donor Bank

    Rochester, Minn.

    The purpose of this study is to collect adipose tissue from patients undergoing elective surgery, or from healthy volunteers, test the donors to assure that they comply with all regulatory aspects required of healthy donors, expand and test mesenchymal stromal cells (MSC), and bank them for future use.

A continuación, se enumeran los ensayos clínicos actuales.

Filtra esta lista de estudios por sede, estatus, etc.

1. Analysis of the Cardiac, Aorta and Carotid Artery Walls for Hemodynamic Monitoring in the Intensive Care Unit

   Jacksonville, Fla.

   The primary aim of this study is to determine if biomechanical properties of cardiac and large arterial walls measured by ultrasound-based novel imaging technology correlate with hemodynamic parameters measured by other tools in the ICU.

2. A Study to Evaluate Outcomes of Rotator Cuff Repair

   Rochester, Minn.

   The purpose of this study is evaluate the outcomes and complications in patients who underwent a rotator cuff repair.

3. A Quality of Life Assessment of Patients with Biliary Obstruction Undergoing Endoscopic or Percutaneous Drainage

   Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

   The aim of this study is to compare the quality of life of patients with biliary obstruction who have undergone an endoscopic or percutaneous drainage. The quality of life of patients witll be assessed using the validated "European Quality of Life-5 Dimensions Questionnaire" and the "Intervention-Dependent Questionnaire" which was developed according to current literature as well as the expert opinion of gastroeneterologists.

    

4. A Study to Evaluate Maternal-fetal Immune Responses to Fetal Surgery

   Rochester, Minn.

   The purposes of this study are to determine whether maternal T cells are activated and expand after in utero intervention, and to determine whether placental macrophages and histology in the maternal-fetal interface exhibit increased activation and inflammation in surgical cases born preterm (<37 weeks) compared to term.

5. Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)

   Rochester, Minn., Minneapolis, Minn.

   The purpose of this study is to evaluate the continued safety and probable benefit of the MID-C system for 5 years post-implantation in Adolescent Idiopathic Scoliosis (AIS).

6. A Study to Examine Financial Distress in Patients Undergoing Treatment of Locally-advanced Rectal Cancer

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to examine the needs and gap in our understanding of financial burden experienced by rectal cancer patients from a patient perspective to help provide patient centered care and improve psychosocial outcomes of this group.

7. Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity- AIM 1

   Scottsdale/Phoenix, Ariz.

   This study is being done to better understand the relationship between inflammation in your AT, abnormal deposition of fat around your liver and how this affects its appearance and function and ultimately insulin resistance.

8. Umbilical Cord Blood Collection and Processing for Severe Congenital Heart Disease

   Rochester, Minn.

   Congenital heart disease (CHD) is an abnormal formation that occurs during the development of a baby’s heart, heart valves and/or large vessels such as the aorta artery. CHD is the most common cause of major congenital defects accounting for almost 30% of all defects (Van der Linde D, JACC 2011). While the statistics vary among studies, the best birth prevalence estimate is 8 per 1000 live births (Bernier PL 2010). In the USA, CHD affects 1% of all births per year (Krasuki & Bashore 2016), with an estimated 40,000 babies born with any type of heart defect every year (Benjamin Emelia 2018).  Twenty-five percentof these are affected by a severe congenital heart defect (https://www.cdc.gov/ncbddd/heartdefects/data.html#References). Children with CHD who survive after the surgical procedures can develop heart failure and require a heart transplant at any time in their lives. Infants born with CHD need immediate medical attention and multiple follow-ups throughout their lives. Besides the social and economic impact of CHD on the individual and family lives, CHD treatment places a significant financial burden on the healthcare system. Simeone et al, (2014) reported that the cost of CHD hospitalization in the US was approximately $5.6 billion in 2019, accounting for 15.1% of the total cost for all pediatric hospitalizations in that year.

   The important improvements in CHD diagnosis and surgical treatment in the last decades has led to an increased survival of newborns affected with heart defects. A large number of CHD can be diagnosed during pregnancy, and the patients can present a broad range of symptoms. Forms of CHD are usually classified based on their severity, from mild to severe. One of the mildest forms of CHD is atrial septal defect, which can be undetectable until adulthood (Hoffman & Kaplan, 2002) and VSD (Penny DJ, 2011). On the other hand, severe CHD that requires multiple palliative surgeries includes single ventricle defects, such as hypoplastic left heart syndrome (HLHS) and tricuspid atresia.

   The survival of infants with CHD will depend on the severity of the defect and the time of diagnosis and treatment received. The one-year survival of newborns with severe or critical CHD (generally any type of surgery/procedures in their first year of life) is estimated to be 75%.

   Stem cell therapy has emerged as a new paradigm of treatment in the field of CHD with promising results. Cardiac regeneration has been the focus of acquired, adult heart disease for many years. However, congenital heart disease with structural abnormalities may also be a good target for other research studies. In fact, the pediatric heart is naturally growing and may be amendable to regenerative strategies. Furthermore, the initial pre-clinical and clinical studies have demonstrated that the delivery of stem cells into the heart of patients with CHD is feasible and safe. Moreover, the cell therapy approach, along with the standard surgical palliation, seems to offer benefits over surgical treatment alone. Even though the number of cell therapy clinical trials for CHD has increased in the last decade, more long-term follow-up studies are needed in this population setting in order to define the role of stem cell therapy in the clinical practice. Therefore, confirming our ability to produce autologous cells (cells from the patient's own body) from patients with severe CHD is an important step towards the long-term goal of being able to discover innovative cell-based protocols.

9. A Study to Collect Clinical Outcomes of Anatomic and Reverse Total Shoulder Arthroplasty

   Scottsdale/Phoenix, Ariz.

   The purpose of the study is a multi-center prospective registry to collect clinical outcomes of anatomic and reverse total shoulder arthroplasty.

10. Allogeneic Mesenchymal Stromal Cell Donor Bank

    Rochester, Minn.

    The purpose of this study is to collect adipose tissue from patients undergoing elective surgery, or from healthy volunteers, test the donors to assure that they comply with all regulatory aspects required of healthy donors, expand and test mesenchymal stromal cells (MSC), and bank them for future use.