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  • Open Access
    Authors: 
    Ram, Ron;
    Publisher: nct

    Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing allogeneic hematopoietic cell transplantation (HCT). Despite prophylactic measures, the incidence of acute GVHD is estimated at 40-60% among patients receiving allograft from HLA-identical sibling donors, and may even reach 75% in patients receiving HLA-matched unrelated grafts. Approximately 20% of the patients will develop the severe variant of the disease and there is a tight association between the severity of GVHD and transplantation-related-mortality. The treatment of GVHD is largely based on high dose steroids regimen which is associated with long term morbidity and mortality. In the subgroup of patients with steroid-refractory or slowly resolving GVHD, there are currently no recommendations on the best timing of tapering down the steroids dose in the case of resolution of the disease, or adding a second line medication, in case of non-resolving or progression of the symptoms. 18F-FDG PET/CT (2-[fluorine-18] fluoro-2-deoxy-D-glucose, Positron emission tomography- CT) is a noninvasive technique that allows quantifying and precisely localizing 18F-FDG uptake in the entire body. 18F-FDG uptake is caused by increased local metabolic activity. Such increased uptake has been described not only in neoplastic lesions but also in inflammatory lesions (2). In this condition, uptake has been correlated with local stimulation of tumor necrosis factor, and with monocyte priming and activation. A physiologic variable uptake may be observed in the bowel, especially the cecum, and has limited the use of PET in inflammatory bowel diseases. The advantage of combined PET and CT devices leads to significant improvements in the interpretation of the bowel areas, and greatly reduces the number of false-positive findings in the gastrointestinal tract. CT-PET has been recently evaluated in our center as a diagnostic tool for Crohn disease. In this study, CT-PET had a good correlation between FDG uptake and the severity of Crohn disease. In the acute GVHD setting, a study reported on a small cohort suggested a correlation between CT-PET findings, FDG uptake, and the diagnosis of lower gut acute GVHD. In this study, we aim to evaluate and characterize the correlation between CT-PET findings in patients suspected to have acute GVHD, and the disease course. Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing allogeneic hematopoietic cell transplantation. 18F-FDG PET/CT (2-[fluorine-18] fluoro-2-deoxy-D-glucose, Positron emission tomography- CT) is a noninvasive technique that allows quantifying and precisely localizing 18F-FDG uptake in the entire body. 18F-FDG uptake is caused by increased local metabolic activity. In this study, we aim to evaluate and characterize the correlation between CT-PET findings in patients suspected to have acute GVHD, and the disease course.

  • Open Access
    Authors: 
    Gittelman, Marc;
    Publisher: nct

    Fedovapagon is a selective vasopressin V2 receptor (V2R) agonist that has an antidiuretic effect through stimulation of V2 receptors in the kidney and is being developed for the treatment of nocturia. Nocturia, defined as the complaint that the individual has to wake at night one or more times to void, is a common condition and shows an age-dependent increase in both prevalence and severity (number of nocturnal voids). It has a significant detrimental impact on the quality of life in patients with benign prostatic hyperplasia (BPH). The purpose of this study is to determine the efficacy and safety of fedovapagon in the treatment of nocturia with BPH. This study will investigate the efficacy and safety of fedovapagon in the treatment of nocturia in men with BPH.

  • Open Access
    Authors: 
    Emberton, Mark;
    Publisher: nct

    The aims of this study are: - to assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and - to determine the difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active surveillance (co-primary objective B). This is a Phase 3, multicentre, open label, randomised controlled study in subjects diagnosed with low risk prostate cancer on TransRectal Ultrasound (TRUS) guided biopsy. Subjects will be randomised to either Active Surveillance or TOOKAD® Soluble VTP. Subjects will remain in the study for approximately 24 months following randomisation. A total of 400 subjects will be entered into the study; 200 will receive Active Surveillance and 200 will receive TOOKAD® Soluble-VTP.

  • Open Access
    Authors: 
    Brown, Patrick;
    Publisher: nct

    PRIMARY OBJECTIVES: I. Determine the potential of lestaurtinib with or without chemotherapy agents in treating samples from infants with leukemia. II. Determine whether FLT3 protein expression level and/or activation and sensitivity to lestaurtinib differ between subgroups of infants with leukemia. III. Determine whether lestaurtinib activates STAT5, AKT, and RAS-MAPK and other pathways. IV. Determine whether lestaurtinib can synergize with other chemotherapy agents kill infant leukemia cells. OUTLINE: This is a multicenter study. Cryopreserved specimens are studied in vitro with lestaurtinib with or without chemotherapy agents. Samples are analyzed for FLT3 protein expression and/or activation; sensitivity to lestaurtinib with or without chemotherapy agents; and activation of STAT, AKT, and RAS-MAPK and other pathways by western blot. The most effective treatment from this study is then validated in vivo in a NOD/SCID xenograft model. This research study is studying lestaurtinib with or with chemotherapy in samples from young patients with leukemia. Studying the effects of lestaurtinib with or without chemotherapy in cell samples from patients with cancer in the laboratory may help doctors learn more about the effects of this treatment on cancer cells. It may also help doctors identify biomarkers related to cancer.

  • Open Access
    Authors: 
    Feng, Yifan;
    Publisher: nct

    Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber layer (RNFL) and measure its thickness. A reduction of the RNFL thickness has been detected in several neurodegenerative diseases, such as multiple sclerosis, CADASIL and Alzheimer's disease. Different studies have reported RNFL changes also in Parkinson's disease (PD),a common neurodegenerative disease characterized by motor dysfunctions, originally described by James Parkinson in 1817. PD is characterized by selective dopaminergic neuronal cells loss, which may correlate with RNFL thinning. Previous studies on this subject, however, reported contradicting results. Some investigations reported reductions of the RNFL thickness while others did not. In the present study, in order to determine whether RNFL thickness is reduced in PD patients, we performed a meta-analysis and systematically evaluated RNFL thickness measurements with OCT in a series of PD patients and in the healthy control groups.

  • Open Access
    Authors: 
    Niemann, Claus U;
    Publisher: nct

    Every year in the US, there is a shortage of many thousands of kidneys needed for transplant. Furthermore, kidneys that are available and are transplanted often exhibit delayed or slow graft function (DGF and SGF, respectively), which lowers quality of life for patients and their families and requires significant additional medical care. These needs result in significant but preventable human suffering and health care spending. To address these needs, the investigators' project will test the use of intensive insulin therapy (IIT) in donors after neurological determination of death (DNDDs) as an intervention that will decrease acute kidney injury and improve renal function at the time of organ recovery. This should translate into a decreased incidence of DGF and SFG in recipients receiving organs from the IIT group. The investigators also expect to find a trend toward an increase in the number of organs available for transplant due to better organ protection in the DNDD. Taken together, these data can provide the requisite justification for a larger study that can be powered to evaluate the effect of IIT on increasing the number of kidneys available for transplantation. There is evidence that brain death often leads to hyperglycemia that may negatively impacts the organs of DNDDs. These observations led us to conduct a retrospective study, in which the investigators found that hyperglycemia in DNDDs is indeed associated with decreased terminal renal function. Because it has been reported that intensive insulin therapy (ITT) is renoprotective in the ICU more than conventional insulin therapy (CIT), the investigators propose to evaluate the use of IIT on DNDDs to: (1) improve organ function, (2) reduce DGF in recipients, and (3) possibly increase the number of kidney available for transplant. Methods: This is a prospective observational study to document the impact of IIT on acute kidney injury in DNDDS and on allograft function in recipients. DNDDs will be divided into two groups: CIT and IIT. In the first study, the investigators will evaluate the effect of ITT on biochemical parameters in blood samples that predict kidney health and function in DNDDs. All methods used in this proposal are well documented in the literature and established in the applicant's laboratory. In the investigators' second study, they will compare the effects of ITT in DNDDs on graft function in allograft recipients in terms of number of patients showing either DGF or SGF. Additionally, there is currently no established set of advanced biochemical criteria in DNDDs for predicting kidney function in recipients. The investigators will correlate the evaluated biochemical markers of kidney function and health in order to possibly develop more refined methods of predicting transplant success. Such a set of criteria would be useful for designing studies to systematically test additional interventions in DNDDs to further improve organ function before recovery and further increase the number of available organs. Taken together, the results of this study may lead to new therapies that significantly improve patient outcomes while significantly reducing disease associated costs. These results can also set the stage for a follow on study for increasing the number of kidneys available for transplant.

  • Open Access
    Authors: 
    Narkus, Annemie;
    Publisher: nct

    Safety and efficacy of recombinant birch pollen allergen in the treatment of allergic rhinoconjunctivitis

  • Open Access
    Authors: 
    Hoffman, Amy J;
    Publisher: nct

    Study Procedures: Participants will be randomly assigned (like flipping a coin) to one of the following groups upon completion of collection of initial information about the participant's: current and prior health history, symptoms, and health-related quality of life, and take a 6-minute self-paced walking test to measure walking ability. This test will occur at Spectrum Health facility before surgery. Groups: 1) The Symptom Experience Group and the 2) Light Physical Activity Group Description of the Symptom Experience Group: In addition to receiving conventional treatment for your cancer, as prescribed by your health care providers, you will receive planned, structured, weekly telephone visits to report the experience of your symptoms and health-related quality of life questions. In the Symptom Experience Group you will: - Provide information about your current and prior health history. - Take a 6-minute self-paced walking test to measure your walking ability at Spectrum Health facility before surgery and at approximately 6-weeks after returning home from the hospital (prior to possible chemotherapy and/or radiation therapy). - Wear a pedometer each day of the study and record the number of steps you take each day. - Contact the nurse researcher if you have any study related questions. - Record information and comments in a daily diary (takes approximately 2 minutes to complete each day) and answer research questions via a weekly telephone visit throughout the study. If you wish to take part in this study you will need to: - Keep your study appointments. - Tell your telephone research assistant about any medications you are taking. - Tell your telephone research assistant about any side effects, doctor visits, or hospitalizations that you may have whether or not you think they are related to the study. In the Symptom Experience Group you will receive: - Program education prior to surgery. - A telephone visit within 3 days (24 hours is optimum) after being discharged from the hospital to ask questions about your health with the interview taking approximately 30 minutes. - The health interview can be rescheduled for completion within 3 days of hospital discharge should you not feel well enough to complete the interview. - At the end of weeks 1-6, we will make a telephone visit to complete health questionnaires with most interviews taking 15 minutes except on weeks 3 and 6 taking approximately 30 minutes. - Upon completion of your participation in the Symptom Experience Group, you will receive information regarding the light physical activity program. - Upon completion of the study, you will be provided an overview of the results of the study. Description of the Light Physical Activity Group: In addition to receiving conventional treatment for cancer, as prescribed by your health care providers, you will receive a home-based light physical activity program to help you manage a specific symptom related to cancer and cancer treatment. In the Light Physical Activity Group you will: - Provide information about your current and prior health history. - Take a 6-minute self-paced walking test to measure your walking ability at a Spectrum Health facility before surgery and at approximately 6-weeks after returning home from the hospital (prior to possible chemotherapy and/or radiation therapy). - Participate in a self-scheduled, home-based physical activity program to help you learn how to manage a specific symptom related to cancer and cancer treatment for a total of six weeks following your return home from the hospital. - Participate in a time commitment starting at 5 minutes a day 5 days a week gradually increasing to 30 minutes a day 5 days a week as able by week 6. - Wear a pedometer each day of the study and record the number of steps you take each day. - Record information and comments in a daily diary (takes approximately 2 minutes to complete each day) and answer research questions via a weekly telephone visit throughout the study. - Contact the nurse researcher if you have any study related questions. If you wish to take part in this study you will need to: - Keep your study appointments. - Tell your nurse about any medications you are taking. - Tell your nurse about any side effects, doctor visits, or hospitalizations that you may have whether or not you think they are related to the study. In the Light Physical Activity Group you will receive: - Program education prior to surgery. - A telephone visit from a nurse within 3 days (24 hours is optimum) after being discharged from the hospital to: - Ask questions about your symptoms to see if you are ready to start light physical activity program taking approximately 5 minutes. - If you are ready, we will arrange a home visit within 4 days of discharge. - If not ready, we will contact your surgeon to help you and call you each day to assess if you are ready to start. - A telephone visit from a research assistant within 3 days (24 hours is optimum) after being discharged from the hospital to: - Ask questions about your health with the interview taking approximately 30 minutes. - The health interview can be rescheduled for completion within 3 days of hospital discharge should you not feel well enough to complete the interview. - The first home visit from the nurse after surgery will take approximately 2 hours and the nurse will: - Assemble and teach you how to operate the physical activity equipment. - Assist you in completing your first physical activity on this day. - Follow-up your first home visit with a telephone visit within 24 hours to answer any questions and concerns about the program. - At the beginning of week two, the nurse will make one more home visit, and at the beginning of weeks 3-6 the nurse will make a telephone visit to collect and review your recorded information. - The nurse will be available to make additional home and telephone visits should you need assistance. - At the end of weeks 1-6, research staff will make a telephone visit to complete the health questionnaires with most interviews taking 15 minutes except on weeks 3 and 6 taking approximately 30 minutes. We expect 86 persons, 21 years of age or older who are scheduled for surgery to treat lung cancer from the west Michigan area to participate in the study. The potential risks for the Symptom Experience and Light Physical Activity Groups Include: Risks associated with the six-minute walk test are considered low. The study may involve risks to you which are currently unknown or unforeseeable. Risks may include and are not limited to: - You may stumble or fall, get short of breath, experience muscle cramps, nausea, chest pain, and abnormal blood pressure. - The walk test is self-paced by the participant for six-minutes and will be stopped if you want it to be stopped. The potential risks of this study for the Light Physical activity Group Include: - The light physical activity program as prescribed in this study corresponds to normal every day activities that are mildly exerting and pose no greater challenge than normal activities of daily living such as: - Strolling slowly in your home or at work. Grocery shopping. - Performing light work in the house such as making a bed, washing dishes, preparing food, dusting, and carrying out the trash. - Riding a lawn mower to mow the lawn or walking applying seed or fertilizer to the lawn. - Walking in the mall; Bird watching. - The development or increase of activity-dependent symptoms such as fatigue or muscle or joint soreness. - The reaction to the body to physical activity cannot always be predicted with accuracy and there is a risk of falling while walking and/or standing in place. - As part of the program involves the use of your television, some people (1 in 4,000) may have seizures or blackouts triggered by light flashes or patterns while they are watching television or playing such things as video games even if they haven't had a seizure before. - The reaction of the body to physical activity cannot always be predicted with accuracy so safety procedures are being provided to each participant prior to participation. Safety procedures include but are not limited to: - Following your physical activity prescription and safety procedures. - Using tools to monitor your heart rate such as through a heart rate wristwatch monitor. - Telephone access available during light physical activity. - Accessing your nurse researchers if you have a concern. Potential Benefits of the Study: We cannot promise any benefits to you or others from your taking part in this research. It is hoped that what is learned in this study may benefit other lung cancer patients in the future. If you agree to take part in this study you will receive results of this study in the future following study completion. We will notify you if any significant new findings develop during the course of the study which might affect your willingness to participate. The potential benefits of being in the Light Physical Activity Group may include: - Increased ability to manage a symptom related to cancer and its treatment. - Increased ability in performing day-to-day activities. - Increased heart and lung (cardiorespiratory) fitness. - Receiving symptom management help from professional registered nurses. - Feeling more in control of your symptoms. Are there any costs and compensations for being in the study? Neither you nor your insurance company will be billed for your participation in the study. You will receive a potential $100.00 in gift cards in appreciation for your time and willingness to share your experiences and to compensate you for your travel. You will be given a $50.00 gift card following completion of the initial six-minute walk test, and a $50.00 gift card upon the completion of the study including the second six-minute walk test, and return of the physical activity equipment. In addition, all participants will keep their pedometers upon completion of the study. Little is known about the symptom experience of persons having undergone surgery for lung cancer. What we do know is that symptoms are common and can become severe and lasting. The main purpose of this study is two-fold: 1. To better understand the symptom experience of persons with lung cancer prior to surgery and for up to six weeks after returning home from the hospital. 2. To examine the role of a light physical activity program in persons who are undergoing surgery for lung cancer for the treatment of a specific symptom. The goals of this study include: - Collecting information about the participant's current and prior health history, symptoms, and health-related quality of life. - Assessing our ability to recruit participants to the study. - Assessing participant's level of participation. - Evaluating the participant's satisfaction with the program. We expect that patients after undergoing surgery for lung cancer during the recovery process will experience multiple symptoms. We also expect to find that a light intensity physical activity program will be feasible, acceptable, and show a positive impact on symptoms such as cancer-related fatigue and confidence for cancer-related fatigue self-management. Information gained from this randomized controlled trial study will be used to refine the design of future larger-scale studies targeting symptoms such as cancer-related fatigue for the lung cancer population.

  • Open Access
    Authors: 
    Koo, Kyung-Hoi;
    Publisher: nct

    Version of the femoral stem is an important factor influencing the risk of dislocation after total hip replacement (THR) as well as the position of the acetabular component. However, there is no radiological method of measuring stem anteversion described in the literature. Investigators propose a radiological method to measure stem version and have assessed its reliability and validity. In 40 patients who underwent THR, a hip radiograph and CT scan were taken to measure stem anteversion. The purpose of this study was to develop a radiological method to measure stem anteversion and to determine its validity and reliability.

  • Open Access
    Authors: 
    Robinson, Cliff;
    Publisher: nct

    The investigators propose to treat patients with metastatic esophageal cancers and dysphagia with two fractions of brachytherapy followed by pembrolizumab. The brachytherapy is hypofractionated and will provide a radiation dose of sufficient intensity to induce the release of tumor-derived antigens and trigger an antitumor immune response. The simplicity of the design should maximize the chance to examine the hypothesis that radiotherapy can induce an immune response, which can then be augmented by pembrolizumab treatment. Success in this study would provide the impetus to conduct further trials aimed at developing this unique strategy as a more broadly applicable therapeutic option in the treatment of patients suffering from these deadly cancers, and will provide important mechanistic insights into the relationship between radiation treatment and immune therapy augmentation. Taken together, these data indicate that targeting the PD-1/PD-L1 axis in esophageal cancers in combination with radiation therapy may be a rational treatment strategy for these cancers.

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139,695 Research products, page 1 of 13,970
  • Open Access
    Authors: 
    Ram, Ron;
    Publisher: nct

    Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing allogeneic hematopoietic cell transplantation (HCT). Despite prophylactic measures, the incidence of acute GVHD is estimated at 40-60% among patients receiving allograft from HLA-identical sibling donors, and may even reach 75% in patients receiving HLA-matched unrelated grafts. Approximately 20% of the patients will develop the severe variant of the disease and there is a tight association between the severity of GVHD and transplantation-related-mortality. The treatment of GVHD is largely based on high dose steroids regimen which is associated with long term morbidity and mortality. In the subgroup of patients with steroid-refractory or slowly resolving GVHD, there are currently no recommendations on the best timing of tapering down the steroids dose in the case of resolution of the disease, or adding a second line medication, in case of non-resolving or progression of the symptoms. 18F-FDG PET/CT (2-[fluorine-18] fluoro-2-deoxy-D-glucose, Positron emission tomography- CT) is a noninvasive technique that allows quantifying and precisely localizing 18F-FDG uptake in the entire body. 18F-FDG uptake is caused by increased local metabolic activity. Such increased uptake has been described not only in neoplastic lesions but also in inflammatory lesions (2). In this condition, uptake has been correlated with local stimulation of tumor necrosis factor, and with monocyte priming and activation. A physiologic variable uptake may be observed in the bowel, especially the cecum, and has limited the use of PET in inflammatory bowel diseases. The advantage of combined PET and CT devices leads to significant improvements in the interpretation of the bowel areas, and greatly reduces the number of false-positive findings in the gastrointestinal tract. CT-PET has been recently evaluated in our center as a diagnostic tool for Crohn disease. In this study, CT-PET had a good correlation between FDG uptake and the severity of Crohn disease. In the acute GVHD setting, a study reported on a small cohort suggested a correlation between CT-PET findings, FDG uptake, and the diagnosis of lower gut acute GVHD. In this study, we aim to evaluate and characterize the correlation between CT-PET findings in patients suspected to have acute GVHD, and the disease course. Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing allogeneic hematopoietic cell transplantation. 18F-FDG PET/CT (2-[fluorine-18] fluoro-2-deoxy-D-glucose, Positron emission tomography- CT) is a noninvasive technique that allows quantifying and precisely localizing 18F-FDG uptake in the entire body. 18F-FDG uptake is caused by increased local metabolic activity. In this study, we aim to evaluate and characterize the correlation between CT-PET findings in patients suspected to have acute GVHD, and the disease course.

  • Open Access
    Authors: 
    Gittelman, Marc;
    Publisher: nct

    Fedovapagon is a selective vasopressin V2 receptor (V2R) agonist that has an antidiuretic effect through stimulation of V2 receptors in the kidney and is being developed for the treatment of nocturia. Nocturia, defined as the complaint that the individual has to wake at night one or more times to void, is a common condition and shows an age-dependent increase in both prevalence and severity (number of nocturnal voids). It has a significant detrimental impact on the quality of life in patients with benign prostatic hyperplasia (BPH). The purpose of this study is to determine the efficacy and safety of fedovapagon in the treatment of nocturia with BPH. This study will investigate the efficacy and safety of fedovapagon in the treatment of nocturia in men with BPH.

  • Open Access
    Authors: 
    Emberton, Mark;
    Publisher: nct

    The aims of this study are: - to assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and - to determine the difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active surveillance (co-primary objective B). This is a Phase 3, multicentre, open label, randomised controlled study in subjects diagnosed with low risk prostate cancer on TransRectal Ultrasound (TRUS) guided biopsy. Subjects will be randomised to either Active Surveillance or TOOKAD® Soluble VTP. Subjects will remain in the study for approximately 24 months following randomisation. A total of 400 subjects will be entered into the study; 200 will receive Active Surveillance and 200 will receive TOOKAD® Soluble-VTP.

  • Open Access
    Authors: 
    Brown, Patrick;
    Publisher: nct

    PRIMARY OBJECTIVES: I. Determine the potential of lestaurtinib with or without chemotherapy agents in treating samples from infants with leukemia. II. Determine whether FLT3 protein expression level and/or activation and sensitivity to lestaurtinib differ between subgroups of infants with leukemia. III. Determine whether lestaurtinib activates STAT5, AKT, and RAS-MAPK and other pathways. IV. Determine whether lestaurtinib can synergize with other chemotherapy agents kill infant leukemia cells. OUTLINE: This is a multicenter study. Cryopreserved specimens are studied in vitro with lestaurtinib with or without chemotherapy agents. Samples are analyzed for FLT3 protein expression and/or activation; sensitivity to lestaurtinib with or without chemotherapy agents; and activation of STAT, AKT, and RAS-MAPK and other pathways by western blot. The most effective treatment from this study is then validated in vivo in a NOD/SCID xenograft model. This research study is studying lestaurtinib with or with chemotherapy in samples from young patients with leukemia. Studying the effects of lestaurtinib with or without chemotherapy in cell samples from patients with cancer in the laboratory may help doctors learn more about the effects of this treatment on cancer cells. It may also help doctors identify biomarkers related to cancer.

  • Open Access
    Authors: 
    Feng, Yifan;
    Publisher: nct

    Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber layer (RNFL) and measure its thickness. A reduction of the RNFL thickness has been detected in several neurodegenerative diseases, such as multiple sclerosis, CADASIL and Alzheimer's disease. Different studies have reported RNFL changes also in Parkinson's disease (PD),a common neurodegenerative disease characterized by motor dysfunctions, originally described by James Parkinson in 1817. PD is characterized by selective dopaminergic neuronal cells loss, which may correlate with RNFL thinning. Previous studies on this subject, however, reported contradicting results. Some investigations reported reductions of the RNFL thickness while others did not. In the present study, in order to determine whether RNFL thickness is reduced in PD patients, we performed a meta-analysis and systematically evaluated RNFL thickness measurements with OCT in a series of PD patients and in the healthy control groups.

  • Open Access
    Authors: 
    Niemann, Claus U;
    Publisher: nct

    Every year in the US, there is a shortage of many thousands of kidneys needed for transplant. Furthermore, kidneys that are available and are transplanted often exhibit delayed or slow graft function (DGF and SGF, respectively), which lowers quality of life for patients and their families and requires significant additional medical care. These needs result in significant but preventable human suffering and health care spending. To address these needs, the investigators' project will test the use of intensive insulin therapy (IIT) in donors after neurological determination of death (DNDDs) as an intervention that will decrease acute kidney injury and improve renal function at the time of organ recovery. This should translate into a decreased incidence of DGF and SFG in recipients receiving organs from the IIT group. The investigators also expect to find a trend toward an increase in the number of organs available for transplant due to better organ protection in the DNDD. Taken together, these data can provide the requisite justification for a larger study that can be powered to evaluate the effect of IIT on increasing the number of kidneys available for transplantation. There is evidence that brain death often leads to hyperglycemia that may negatively impacts the organs of DNDDs. These observations led us to conduct a retrospective study, in which the investigators found that hyperglycemia in DNDDs is indeed associated with decreased terminal renal function. Because it has been reported that intensive insulin therapy (ITT) is renoprotective in the ICU more than conventional insulin therapy (CIT), the investigators propose to evaluate the use of IIT on DNDDs to: (1) improve organ function, (2) reduce DGF in recipients, and (3) possibly increase the number of kidney available for transplant. Methods: This is a prospective observational study to document the impact of IIT on acute kidney injury in DNDDS and on allograft function in recipients. DNDDs will be divided into two groups: CIT and IIT. In the first study, the investigators will evaluate the effect of ITT on biochemical parameters in blood samples that predict kidney health and function in DNDDs. All methods used in this proposal are well documented in the literature and established in the applicant's laboratory. In the investigators' second study, they will compare the effects of ITT in DNDDs on graft function in allograft recipients in terms of number of patients showing either DGF or SGF. Additionally, there is currently no established set of advanced biochemical criteria in DNDDs for predicting kidney function in recipients. The investigators will correlate the evaluated biochemical markers of kidney function and health in order to possibly develop more refined methods of predicting transplant success. Such a set of criteria would be useful for designing studies to systematically test additional interventions in DNDDs to further improve organ function before recovery and further increase the number of available organs. Taken together, the results of this study may lead to new therapies that significantly improve patient outcomes while significantly reducing disease associated costs. These results can also set the stage for a follow on study for increasing the number of kidneys available for transplant.

  • Open Access
    Authors: 
    Narkus, Annemie;
    Publisher: nct

    Safety and efficacy of recombinant birch pollen allergen in the treatment of allergic rhinoconjunctivitis

  • Open Access
    Authors: 
    Hoffman, Amy J;
    Publisher: nct

    Study Procedures: Participants will be randomly assigned (like flipping a coin) to one of the following groups upon completion of collection of initial information about the participant's: current and prior health history, symptoms, and health-related quality of life, and take a 6-minute self-paced walking test to measure walking ability. This test will occur at Spectrum Health facility before surgery. Groups: 1) The Symptom Experience Group and the 2) Light Physical Activity Group Description of the Symptom Experience Group: In addition to receiving conventional treatment for your cancer, as prescribed by your health care providers, you will receive planned, structured, weekly telephone visits to report the experience of your symptoms and health-related quality of life questions. In the Symptom Experience Group you will: - Provide information about your current and prior health history. - Take a 6-minute self-paced walking test to measure your walking ability at Spectrum Health facility before surgery and at approximately 6-weeks after returning home from the hospital (prior to possible chemotherapy and/or radiation therapy). - Wear a pedometer each day of the study and record the number of steps you take each day. - Contact the nurse researcher if you have any study related questions. - Record information and comments in a daily diary (takes approximately 2 minutes to complete each day) and answer research questions via a weekly telephone visit throughout the study. If you wish to take part in this study you will need to: - Keep your study appointments. - Tell your telephone research assistant about any medications you are taking. - Tell your telephone research assistant about any side effects, doctor visits, or hospitalizations that you may have whether or not you think they are related to the study. In the Symptom Experience Group you will receive: - Program education prior to surgery. - A telephone visit within 3 days (24 hours is optimum) after being discharged from the hospital to ask questions about your health with the interview taking approximately 30 minutes. - The health interview can be rescheduled for completion within 3 days of hospital discharge should you not feel well enough to complete the interview. - At the end of weeks 1-6, we will make a telephone visit to complete health questionnaires with most interviews taking 15 minutes except on weeks 3 and 6 taking approximately 30 minutes. - Upon completion of your participation in the Symptom Experience Group, you will receive information regarding the light physical activity program. - Upon completion of the study, you will be provided an overview of the results of the study. Description of the Light Physical Activity Group: In addition to receiving conventional treatment for cancer, as prescribed by your health care providers, you will receive a home-based light physical activity program to help you manage a specific symptom related to cancer and cancer treatment. In the Light Physical Activity Group you will: - Provide information about your current and prior health history. - Take a 6-minute self-paced walking test to measure your walking ability at a Spectrum Health facility before surgery and at approximately 6-weeks after returning home from the hospital (prior to possible chemotherapy and/or radiation therapy). - Participate in a self-scheduled, home-based physical activity program to help you learn how to manage a specific symptom related to cancer and cancer treatment for a total of six weeks following your return home from the hospital. - Participate in a time commitment starting at 5 minutes a day 5 days a week gradually increasing to 30 minutes a day 5 days a week as able by week 6. - Wear a pedometer each day of the study and record the number of steps you take each day. - Record information and comments in a daily diary (takes approximately 2 minutes to complete each day) and answer research questions via a weekly telephone visit throughout the study. - Contact the nurse researcher if you have any study related questions. If you wish to take part in this study you will need to: - Keep your study appointments. - Tell your nurse about any medications you are taking. - Tell your nurse about any side effects, doctor visits, or hospitalizations that you may have whether or not you think they are related to the study. In the Light Physical Activity Group you will receive: - Program education prior to surgery. - A telephone visit from a nurse within 3 days (24 hours is optimum) after being discharged from the hospital to: - Ask questions about your symptoms to see if you are ready to start light physical activity program taking approximately 5 minutes. - If you are ready, we will arrange a home visit within 4 days of discharge. - If not ready, we will contact your surgeon to help you and call you each day to assess if you are ready to start. - A telephone visit from a research assistant within 3 days (24 hours is optimum) after being discharged from the hospital to: - Ask questions about your health with the interview taking approximately 30 minutes. - The health interview can be rescheduled for completion within 3 days of hospital discharge should you not feel well enough to complete the interview. - The first home visit from the nurse after surgery will take approximately 2 hours and the nurse will: - Assemble and teach you how to operate the physical activity equipment. - Assist you in completing your first physical activity on this day. - Follow-up your first home visit with a telephone visit within 24 hours to answer any questions and concerns about the program. - At the beginning of week two, the nurse will make one more home visit, and at the beginning of weeks 3-6 the nurse will make a telephone visit to collect and review your recorded information. - The nurse will be available to make additional home and telephone visits should you need assistance. - At the end of weeks 1-6, research staff will make a telephone visit to complete the health questionnaires with most interviews taking 15 minutes except on weeks 3 and 6 taking approximately 30 minutes. We expect 86 persons, 21 years of age or older who are scheduled for surgery to treat lung cancer from the west Michigan area to participate in the study. The potential risks for the Symptom Experience and Light Physical Activity Groups Include: Risks associated with the six-minute walk test are considered low. The study may involve risks to you which are currently unknown or unforeseeable. Risks may include and are not limited to: - You may stumble or fall, get short of breath, experience muscle cramps, nausea, chest pain, and abnormal blood pressure. - The walk test is self-paced by the participant for six-minutes and will be stopped if you want it to be stopped. The potential risks of this study for the Light Physical activity Group Include: - The light physical activity program as prescribed in this study corresponds to normal every day activities that are mildly exerting and pose no greater challenge than normal activities of daily living such as: - Strolling slowly in your home or at work. Grocery shopping. - Performing light work in the house such as making a bed, washing dishes, preparing food, dusting, and carrying out the trash. - Riding a lawn mower to mow the lawn or walking applying seed or fertilizer to the lawn. - Walking in the mall; Bird watching. - The development or increase of activity-dependent symptoms such as fatigue or muscle or joint soreness. - The reaction to the body to physical activity cannot always be predicted with accuracy and there is a risk of falling while walking and/or standing in place. - As part of the program involves the use of your television, some people (1 in 4,000) may have seizures or blackouts triggered by light flashes or patterns while they are watching television or playing such things as video games even if they haven't had a seizure before. - The reaction of the body to physical activity cannot always be predicted with accuracy so safety procedures are being provided to each participant prior to participation. Safety procedures include but are not limited to: - Following your physical activity prescription and safety procedures. - Using tools to monitor your heart rate such as through a heart rate wristwatch monitor. - Telephone access available during light physical activity. - Accessing your nurse researchers if you have a concern. Potential Benefits of the Study: We cannot promise any benefits to you or others from your taking part in this research. It is hoped that what is learned in this study may benefit other lung cancer patients in the future. If you agree to take part in this study you will receive results of this study in the future following study completion. We will notify you if any significant new findings develop during the course of the study which might affect your willingness to participate. The potential benefits of being in the Light Physical Activity Group may include: - Increased ability to manage a symptom related to cancer and its treatment. - Increased ability in performing day-to-day activities. - Increased heart and lung (cardiorespiratory) fitness. - Receiving symptom management help from professional registered nurses. - Feeling more in control of your symptoms. Are there any costs and compensations for being in the study? Neither you nor your insurance company will be billed for your participation in the study. You will receive a potential $100.00 in gift cards in appreciation for your time and willingness to share your experiences and to compensate you for your travel. You will be given a $50.00 gift card following completion of the initial six-minute walk test, and a $50.00 gift card upon the completion of the study including the second six-minute walk test, and return of the physical activity equipment. In addition, all participants will keep their pedometers upon completion of the study. Little is known about the symptom experience of persons having undergone surgery for lung cancer. What we do know is that symptoms are common and can become severe and lasting. The main purpose of this study is two-fold: 1. To better understand the symptom experience of persons with lung cancer prior to surgery and for up to six weeks after returning home from the hospital. 2. To examine the role of a light physical activity program in persons who are undergoing surgery for lung cancer for the treatment of a specific symptom. The goals of this study include: - Collecting information about the participant's current and prior health history, symptoms, and health-related quality of life. - Assessing our ability to recruit participants to the study. - Assessing participant's level of participation. - Evaluating the participant's satisfaction with the program. We expect that patients after undergoing surgery for lung cancer during the recovery process will experience multiple symptoms. We also expect to find that a light intensity physical activity program will be feasible, acceptable, and show a positive impact on symptoms such as cancer-related fatigue and confidence for cancer-related fatigue self-management. Information gained from this randomized controlled trial study will be used to refine the design of future larger-scale studies targeting symptoms such as cancer-related fatigue for the lung cancer population.

  • Open Access
    Authors: 
    Koo, Kyung-Hoi;
    Publisher: nct

    Version of the femoral stem is an important factor influencing the risk of dislocation after total hip replacement (THR) as well as the position of the acetabular component. However, there is no radiological method of measuring stem anteversion described in the literature. Investigators propose a radiological method to measure stem version and have assessed its reliability and validity. In 40 patients who underwent THR, a hip radiograph and CT scan were taken to measure stem anteversion. The purpose of this study was to develop a radiological method to measure stem anteversion and to determine its validity and reliability.

  • Open Access
    Authors: 
    Robinson, Cliff;
    Publisher: nct

    The investigators propose to treat patients with metastatic esophageal cancers and dysphagia with two fractions of brachytherapy followed by pembrolizumab. The brachytherapy is hypofractionated and will provide a radiation dose of sufficient intensity to induce the release of tumor-derived antigens and trigger an antitumor immune response. The simplicity of the design should maximize the chance to examine the hypothesis that radiotherapy can induce an immune response, which can then be augmented by pembrolizumab treatment. Success in this study would provide the impetus to conduct further trials aimed at developing this unique strategy as a more broadly applicable therapeutic option in the treatment of patients suffering from these deadly cancers, and will provide important mechanistic insights into the relationship between radiation treatment and immune therapy augmentation. Taken together, these data indicate that targeting the PD-1/PD-L1 axis in esophageal cancers in combination with radiation therapy may be a rational treatment strategy for these cancers.

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