肺科

以下为当前的临床试验。

按院区、状态和其他条件筛选该研究列表。

1. A Study to Evaluate Wellness Coaching for Caregivers of Thoracic Transplant Candidates

   Rochester, Minn.

   The purpose of this study is to examine the effects of a health coaching intervention on the stress and burden of caregivers of patients awaiting heart or lung transplant.

   Hypotheses:  Caregivers will have traits and behaviors pre-transplant that will predict caregiver readiness, quality of life, and transplant recipient outcomes. Specifically, thoracic pre-transplant caregivers report stress, symptoms of anxiety or depression, and perceive high caregiver burden. These factors may be amenable to pre-transplant intervention to improve overall patient and caregiver outcomes.

   Aims, purpose, or objectives:  We will conduct a pilot trial to test whether caregivers of heart and lung transplant candidates who receive wellness coaching will experience improvement in caregiver-related distress. We will also explore the relationship between caregiving and factors such as uncertainty, resilience, stress level, and affect.

2. A Study to Evaluate the Effectiveness and Safety of an Amikacin Liposome Inhalation Suspension-based Regimen in Adults with Nontuberculous Mycobacterial Lung Infection

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to evaluate the effectiveness of ALIS + azithromycin (AZI) + ethambutol (ETH) compared to the empty liposome control (ELC) + AZI + ETH on patient reported respiratory symptoms at Month 13.

3. Registry for the EVolution Of LUng Cancer Therapy Implementation and Outcomes Now

   Rochester, Minn.

   REVOLUTION will be a US multicenter observational registry in scope and governed by a steering committee of approximately 8 experts in NSCLC and outcomes research. The primary goal of the registry is characterizing patterns of use for NSCLC therapy. REVOLUTION will be a multicenter registry enrolling approximately 2,500 patients. Additional patients limited to those with EGFR mutations may be enrolled following the initial study period as needed to ensure adequate sample sizes needed to examine primary questions of interest in the EGFR mutant population. Patients will be enrolled over a three year period across approximately 25 geographically diverse academic as well as community based sites within the US. The five year follow-up period will ensure robust survival data for correlations with clinical, tumor, and treatment variables.

   The target of 2,500 patients is meant to ensure adequate numbers of NSCLC patients with particular characteristics of interest including patients with adenocarcinoma, and EGFR mutations and effectively evaluate these patients with respect to key outcomes of interest including overall survival, time to progression, stage at progression, secondary metastases including brain metastases (at diagnosis and progression), comorbidity burden, and performance status at index date.

   The study design allows a cross-sectional perspective with collection of detailed patient and clinical characteristics at enrollment followed by longitudinal assessment of clinician and patient-reported endpoints every three months. Centralized follow-up will be conducted by having sites upload patient data following each visit via the web-based data system, with patients who do not show up for site visits being contacted via telephone by the Duke Clinical Research Institute (DCRI) call center. Site recruitment and patient enrollment will be weighted based upon provider specialty and ability to enroll patients with NSCLC with the specified inclusion criteria.

4. Safety and Durability of Sirolimus for Treatment of LAM

   Rochester, Minn., Jacksonville, Fla.

   The MIDAS study aims to follow women with LAM who are currently taking, have previously failed or been intolerant of, or are considering treatment with mTOR inhibitors sirolimus or everolimus as part of their clinical care.

5. Donor-Specific Cell Free DNA Monitoring of Thoracic Allografts

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to determine if DNA originating from the transplanted heart or lung can be detected in the blood and used to monitor for rejection.

6. The Relationship Between Critical Care Physicians' Characteristics and Their Clinical Practice Patterns

   Rochester, Minn.

   The purpose of this study is to  identify the magnitude of variation among intensivists in use of diagnostic testing and to determine whether variation in diagnostic test ordering patterns among intensivists attributables to their personal characteristics, or to factors in the clinical environment.

    

7. A Study of Performing Surgery for Resectable Malignant Pleural Mesothelioma After Radiation Therapy

   Rochester, Minn.

   The purpose of this study is to assess the possibility, safety, and therapeutic effect of administering a short, quick course of high-dose radiation treatment focused on half of the chest, followed by surgery to remove that portion of the lungs, in patients with malignant pleural mesothelioma.  

8. A Study to Evaluate Lamprene (Clofazimine) to Treat Non-Tuberculous Mycobacterial (NTM) Infections

   Jacksonville, Fla.

   The purpose of this study is to  evaluate Lamprene (Clofazimine) to treat non-tuberculous mycobacterial (NTM) infections.

9. A Study to Collect Thoracic Specimens to Develop a Thoracic Specimen Registry

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The primary objective of this proposal is to develop a Thoracic Specimen Registry at Mayo Clinic. The purpose of the registry will be to support ongoing research in the etiology, early diagnosis, clinical management, and prognosis of lung cancer and other cancers and diseases of the thorax by developing a complete repository of specimens from patients with thoracic disease including but not limited to suspected lung cancer, mediastinal and pleural tumors and from patients at a very high risk of developing other thoracic cancers or other thoracic diseases. 

10. An Expansion Study to Evaluate Dose Escalation, Safety and Tolerability of SAR444881 in Patients with Advanced Solid Tumors

    Rochester, Minn., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of SAR444881 alone and in combination with pembrolizumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy and will be comprised of two parts - an initial "3 + 3" dose escalation phase (Part 1) with Sub-Parts 1A (monotherapy SAR444881), 1B (SAR444881 in combination with pembrolizumab) and 1C (SAR444881 in combination with cetuximab) followed by a dose optimization/expansion phase (Part 2), including Sub-Part 2A (Dose Optimization) with Cohorts A1 (SAR444881 in combination with pembrolizumab, carboplatin, and pemetrexed), A2 (SAR444881 in combination with pembrolizumab), B1 (SAR444881 in combination with pembrolizumab and later therapy), and C1 (SAR444881 in combination with cetuximab and later therapy), as well as Sub-Part 2B (Dose Expansion) with Cohort D1 (monotherapy SAR444881).

以下为当前的临床试验。

按院区、状态和其他条件筛选该研究列表。

1. A Study to Evaluate Wellness Coaching for Caregivers of Thoracic Transplant Candidates

   Rochester, Minn.

   The purpose of this study is to examine the effects of a health coaching intervention on the stress and burden of caregivers of patients awaiting heart or lung transplant.

   Hypotheses:  Caregivers will have traits and behaviors pre-transplant that will predict caregiver readiness, quality of life, and transplant recipient outcomes. Specifically, thoracic pre-transplant caregivers report stress, symptoms of anxiety or depression, and perceive high caregiver burden. These factors may be amenable to pre-transplant intervention to improve overall patient and caregiver outcomes.

   Aims, purpose, or objectives:  We will conduct a pilot trial to test whether caregivers of heart and lung transplant candidates who receive wellness coaching will experience improvement in caregiver-related distress. We will also explore the relationship between caregiving and factors such as uncertainty, resilience, stress level, and affect.

2. A Study to Evaluate the Effectiveness and Safety of an Amikacin Liposome Inhalation Suspension-based Regimen in Adults with Nontuberculous Mycobacterial Lung Infection

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to evaluate the effectiveness of ALIS + azithromycin (AZI) + ethambutol (ETH) compared to the empty liposome control (ELC) + AZI + ETH on patient reported respiratory symptoms at Month 13.

3. Registry for the EVolution Of LUng Cancer Therapy Implementation and Outcomes Now

   Rochester, Minn.

   REVOLUTION will be a US multicenter observational registry in scope and governed by a steering committee of approximately 8 experts in NSCLC and outcomes research. The primary goal of the registry is characterizing patterns of use for NSCLC therapy. REVOLUTION will be a multicenter registry enrolling approximately 2,500 patients. Additional patients limited to those with EGFR mutations may be enrolled following the initial study period as needed to ensure adequate sample sizes needed to examine primary questions of interest in the EGFR mutant population. Patients will be enrolled over a three year period across approximately 25 geographically diverse academic as well as community based sites within the US. The five year follow-up period will ensure robust survival data for correlations with clinical, tumor, and treatment variables.

   The target of 2,500 patients is meant to ensure adequate numbers of NSCLC patients with particular characteristics of interest including patients with adenocarcinoma, and EGFR mutations and effectively evaluate these patients with respect to key outcomes of interest including overall survival, time to progression, stage at progression, secondary metastases including brain metastases (at diagnosis and progression), comorbidity burden, and performance status at index date.

   The study design allows a cross-sectional perspective with collection of detailed patient and clinical characteristics at enrollment followed by longitudinal assessment of clinician and patient-reported endpoints every three months. Centralized follow-up will be conducted by having sites upload patient data following each visit via the web-based data system, with patients who do not show up for site visits being contacted via telephone by the Duke Clinical Research Institute (DCRI) call center. Site recruitment and patient enrollment will be weighted based upon provider specialty and ability to enroll patients with NSCLC with the specified inclusion criteria.

4. Safety and Durability of Sirolimus for Treatment of LAM

   Rochester, Minn., Jacksonville, Fla.

   The MIDAS study aims to follow women with LAM who are currently taking, have previously failed or been intolerant of, or are considering treatment with mTOR inhibitors sirolimus or everolimus as part of their clinical care.

5. Donor-Specific Cell Free DNA Monitoring of Thoracic Allografts

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to determine if DNA originating from the transplanted heart or lung can be detected in the blood and used to monitor for rejection.

6. The Relationship Between Critical Care Physicians' Characteristics and Their Clinical Practice Patterns

   Rochester, Minn.

   The purpose of this study is to  identify the magnitude of variation among intensivists in use of diagnostic testing and to determine whether variation in diagnostic test ordering patterns among intensivists attributables to their personal characteristics, or to factors in the clinical environment.

    

7. A Study of Performing Surgery for Resectable Malignant Pleural Mesothelioma After Radiation Therapy

   Rochester, Minn.

   The purpose of this study is to assess the possibility, safety, and therapeutic effect of administering a short, quick course of high-dose radiation treatment focused on half of the chest, followed by surgery to remove that portion of the lungs, in patients with malignant pleural mesothelioma.  

8. A Study to Evaluate Lamprene (Clofazimine) to Treat Non-Tuberculous Mycobacterial (NTM) Infections

   Jacksonville, Fla.

   The purpose of this study is to  evaluate Lamprene (Clofazimine) to treat non-tuberculous mycobacterial (NTM) infections.

9. A Study to Collect Thoracic Specimens to Develop a Thoracic Specimen Registry

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The primary objective of this proposal is to develop a Thoracic Specimen Registry at Mayo Clinic. The purpose of the registry will be to support ongoing research in the etiology, early diagnosis, clinical management, and prognosis of lung cancer and other cancers and diseases of the thorax by developing a complete repository of specimens from patients with thoracic disease including but not limited to suspected lung cancer, mediastinal and pleural tumors and from patients at a very high risk of developing other thoracic cancers or other thoracic diseases. 

10. An Expansion Study to Evaluate Dose Escalation, Safety and Tolerability of SAR444881 in Patients with Advanced Solid Tumors

    Rochester, Minn., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of SAR444881 alone and in combination with pembrolizumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy and will be comprised of two parts - an initial "3 + 3" dose escalation phase (Part 1) with Sub-Parts 1A (monotherapy SAR444881), 1B (SAR444881 in combination with pembrolizumab) and 1C (SAR444881 in combination with cetuximab) followed by a dose optimization/expansion phase (Part 2), including Sub-Part 2A (Dose Optimization) with Cohorts A1 (SAR444881 in combination with pembrolizumab, carboplatin, and pemetrexed), A2 (SAR444881 in combination with pembrolizumab), B1 (SAR444881 in combination with pembrolizumab and later therapy), and C1 (SAR444881 in combination with cetuximab and later therapy), as well as Sub-Part 2B (Dose Expansion) with Cohort D1 (monotherapy SAR444881).