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The aim is to determine the prevalence of intestinal inflammation by measurement of fecal calprotectin and/or histological evaluation of intestinal tissue biopsies in both pediatric and adult CF populations.~Pediatric CF population (Age 10-18 years):~Determine the prevalence of intestinal inflammation in a cohort of pediatric CF patients based on fecal calprotectin levels in stool samples.~Assess the correlation between fecal calprotectin and abdominal symptoms/QOL.~Adult CF population (Age ≥ 18 years):~Determine the prevalence of intestinal inflammation in a cohort of adult CF patients based on histological evaluation of intestinal tissues biopsies and fecal calprotectin levels in stool samples~in adult CF patients who have not undergone lung or liver transplantation.~in adult CF patients who have undergone lung or liver transplantation.~Assess the correlation between fecal calprotectin and histological-proven intestinal inflammation in adult CF patients.~Assess the correlation between histological-proven intestinal inflammation and abdominal symptoms/QOL as well as the correlation between fecal calprotectin and abdominal symptoms/QOL. | Cystic Fibrosis (CF) is a disease that affects salt and water transport in multiple organs. Many CF patients suffer from abdominal pain and this could be due to intestinal inflammation. However, so far we do not know how many of the CF patients actually do have intestinal inflammation when looking at intestinal specimens. There is a proven connection between chronic inflammation and developing colorectal cancer and over the years more CF patients are developing colorectal cancer. Thus, it becomes increasingly important to look for the presence of intestinal inflammation in CF patients since early treatment may improve their symptoms and reduce the risk for colorectal cancer. |
Till recently, it was assumed that patients with type 2 diabetes have to eat frequently, especially to avoid hypoglycemia, which is still true if they are using sulphonylurea or insulin. Especially because patients with diabetes often have one or more diabetic complications, they were advised against Ramadan fasting, as it is not allowed to eat or drink anything for long hours. There are increasing data supporting intermittent fasting, where individuals won't eat anything for 12-18 hours but are permitted to drink sugar-free beverages. The new antihypoglycemic agents have the advantage of causing very low or no hypoglycemia, which allows these patients to eat less frequently. There are studies about the metabolic effect of intermittent fasting in patients with type 2 diabetes, but we don't have enough data for the safety of religious fasting where no kind of fluid intake is allowed. In this study, we aimed to investigate the effect of fasting on the fluid status of diabetic patients. To this effect, we used serum osmolarity to determine fluid status. The patients who preferred to fast were our study group, and the patients who were healthy otherwise but preferred not to fast were our control group. In Ramadan, contrary to the customary practice of intermittent fasting, fasting starts with the sunrise and continues till sunset. We planned to take the first blood sample at 10 am and the second blood sample at 06 pm in both groups and compare the serum osmolarity accordingly. | In Ramadan, Muslims perform a special kind of fasting. Their fasting start with the first lights of the sunrise and end with the sunset. Especially in summer, it is a real challenge, as the time for fasting might be as long as 18 hours, and hot weather might cause severe dehydration. This might be dangerous, especially in patients with diabetes. Serum osmolarity is a good surrogate marker to evaluate the body's fluid content. We aimed to investigate if summertime Ramadan fasting causes further fluid loss in patients with type 2 diabetes. |
Accordingly, previously-published studies have demonstrated large discrepancies in the reported incidence of osteoporosis, based on measurement of bone mineral density (BMD), in patients with AS ranging from 18.7% to 62%. Measurement of trabecular bone score (TBS) is a novel tool used to evaluate bone microarchitecture. Aim of the work: to compare bone quality using TBS between AS patients and healthy controls and to evaluate factors associated with TBS in patients with AS. Patients and methods: A total of 40 male AS patients recruited from Outpatient Clinic of Rheumatology, Mansoura University Hospital. 40 age-matched healthy males as matched control. TBS was analyzed using DXA images over exactly the same region as the lumbar BMD assessment (L1-L4). Lumbar spine DXA images were reanalyzed using TBS iNight software version 2.1 (Med-I maps, Merignac, France). Patients were divided in 3 TBS groups according to guidelines for fracture risk: any TBS >1.31 was considered as normal; TBS values between 1.23 and 1.31 were consistent as partially degraded structure; and any TBS <1.23 was considered as degraded structure | Osteoporosis is a common complication of AS even in the early stages of disease. Yet, AS is also characterized by new bone growth that leads to syndesmophytes formation and subsequent vertebral ankyloses. |
This study was designed as a retrospective case-control study. All 116 patients with locally advanced rectal cancer who started neoadjuvant chemoradiotherapy and underwent radical surgery in West of China Hospital and completed the required MR examination before and after neoadjuvant treatment were included from March 2016 to December 2019. MRI imaging indicators of patients before and after neoadjuvant therapy, including tumor location, longitudinal diameter, circumferential Angle, DWI signal, mrTRG and texture feature data, were retrospectively collected to analyze the changes before and after treatment, and compared with patients receiving NCT in PART1. At the same time, indicators with statistical differences will be included in the construction of models predicting different pathological outcomes after NCT and NCRT, and the efficacy of the models was evaluated through c-index values and ROC analysis of bootstrap resampling 500 times. | This trial was designed to to study whether there is a difference in MRI image evaluation between NCRT and NCT, and try to build a model to predict the efficacy of neoadjuvant therapy by combining multiple imaging indexes. |
Primary Objective:To determine the maximum tolerated dose (MTD) of d limonene when combined with radiation and platinum based chemotherapy in subjects with loco regionally advanced head and neck squamous cell carcinoma (HNSCC) based upon dose limiting toxicity (DLT)~Secondary Objective:~To evaluate the feasibility and subject compliance with adjuvant administration of d limonene daily up to a maximum of 4 months after completion of chemoradiation~To correlate the level of d-limonene measured in the plasma to the dose levels(s) administered to the subject~To correlate the level of d limonene measured in the plasma to saliva flow rate and xerostomia questionnaire scores in subjects enrolled in this trial | This study explores the safety of d-limonene, a commercially-available dietary supplement (food) as a potential therapeutic for the severe dry mouth (xerostomia) experienced by patients with head and neck cancer as a side effect of their anti-cancer treatment. |
The drug that is being tested in this study is called TAK-573. The study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TAK-573 when used in combination with dexamethasone and either bortezomib, pomalidomide or cyclophosphamide in participants with RRMM.~The study will be conducted in 2 phases: Dose Escalation Phase and Dose Expansion Phase. The study will enroll approximately 135 participants (approximately 60 participants in Dose Escalation Phase and approximately 75 participants in Dose Expansion Phase). The dose escalation phase will determine the recommended dose of TAK-573 along with the combination agents for the dose expansion phase.~This multi-center trial will be conducted in the United States, Germany, France, Spain, and Canada. The overall time to participate in this study is approximately 3 years. Participants will be followed up for 30 days after the last dose of study drug for a follow-up assessment. | The purpose of this study is to determine the safety, tolerability, and recommended phase 2 dose (RP2D) of TAK-573 when used with dexamethasone and in combination with bortezomib, pomalidomide, or cyclophosphamide, in participants with RRMM. |
Antiviral potency significantly differs among various antiviral agents，Entecavir and tenofovir disoproxil fumarate are equally recommendedas first-line treatments for patients with chronic hepatitis B (CHB). However, it is unclear whether treatment with these drugs is associated with equivalent clinical outcomes,especially impacts the risk of HCC recurrence. Entecavir and tenofovir disoproxil fumarate have comparable efficacy in achieving surrogate end points, including virologic response,but they do by different mechanisms .~Entecavir, a guanosine nucleoside analogue with activity against HBV reverse transcriptase (rt),is efficiently phosphorylated to the active triphosphate form, which has an intracellular half-life of 15 hours. By competing with the natural substrate deoxyguanosine triphosphate, entecavir triphosphate functionally inhibits all three activities of the HBV reverse transcriptase: (1) basepriming, (2) reverse transcription of the negative strand from the pregenomic messenger RNA,and (3) synthesis of the positive strand of HBV DNA.~Tenofovir fumarate is a cyclic nucleoside phosphine diester structural analog of adenosine monophosphate. Tenofovir disoproxil fumarate first needs to be converted to tenofovir by hydrolysis of the diester, followed by phosphorylation of cellular enzymes to form tenofovir diphosphate. Tenofovir diphosphate competes with the natural substrate 5'-deoxyadenosine triphosphate for its involvement in the synthesis of viral DNA, which, after entering the viral DNA strand, can cause DNA elongation to be blocked due to its lack of 3'-OH groups,thereby blocking the replication of the virus. Tenofovir diphosphate is a weak inhibitor of mammalian DNA polymerase alpha, beta and mitochondrial DNA polymerase gamma. | This study evaluates the addition of Tenofovir and Entecavir in the treatment of Hepatitis B-related hepatocellular carcinoma after curative resection in adults. Half of participants will receive Tenofovir disoproxil fumarate, while the other half will receive Entecavir. |
The primary objective of this study is to determine the pharmacokinetic (PK) profile of 600 mg oral TPOXX (3 × 200-mg capsules) administered twice daily (BID) for 7 days in adult subjects weighing more than 120 kg to determine if a change in dosing regimen would be needed in these patients.~Secondary:~The secondary objective of this study is to evaluate the safety and tolerability of 600 mg oral TPOXX administered BID for 7 days in healthy adult subjects weighing more than 120 kg. | Safety and PK study in adults weighing more than 120 kg |
Introduction:~The COVID-19 corona virus epidemic has spread from Wuhan, China to the whole world, and has been declared a pandemic by WHO worldwide. In severe patients, ARDS and multiple organ failure can be seen. This condition is associated with cytokine storm in the body. When the virus invades the body, dentric cells can activate macrophages, lymphocytes and natural killer cells. Mesenchymal stem cells (MKH) not only inhibit the abnormal activation of T lymphocytes and macrophages, but also encourage them to differentiate into regulatory T cell subsets (Treg) clusters and anti-inflammatory macrophages. MSCs application proved therapeutic efficiency during influenza infection resulting in reduced impairment of alveolar fluid clearance and lung injury. This was attributed towards attenuation of pro-inflammatory cytokine secretion, inflammatory cell recruitment and increased alveolar macrophages content.~Aim of study:~To provide immune modulation to patients with COVID-19 who are taken to intensive care and resistant to treatment by performing MSCs transplantation and to reduce the damage caused by cytokin storm to tissues and organs,~Correcting immunosuppression in patients and increasing the fight against COVID-19 virus by CD4+T, CD+8T cellular cell arrangement,~It is to accelerate the recovery in organ damage by increasing growth factors by means of MSCs.~Materials and method:~Patients diagnosed with COVID-19 infection as clinically, radiologically and laboratory-wise will be divided into three groups:~Group 1: patients that are not on a ventilator (n=10) Group 2: patients that are on a ventilator and will receive saline injections (n=10) Group 3: patients that are on a ventilator and will receive MSC transplantation injections (n=10)~Mesenchymal stem cells originating from allogenic umbilical cord produced under GMP conditions will be administered in 3 times, with doses indicated below, intravenously within 1 week.~Dose:~Application: 3 million cells / kg IV ---------------------------------------- --------- 1 day~Application: 3 million cells / kg IV ---------------------------------------- --------- 3. Day~Application: 3 million cells / kg IV ---------------------------------------- --------- 6. Day~The blood will be analyzed for the expression levels of growth factors, including vascular endothelial growth factor, fibroblast growth factor, platelet derived-growth factor, epidermal growth factor, transforming growth factor beta, hepatocyte growth factor, nerve growth factor, VEGF receptor (VEGFR), angiopoietin1 (Angpt-1), and Angpt-2, using sandwich enzyme-linked immune sorbent assays (ELISAs). Investigators also analyzed the caspase-3 system in the blood. immunoassay kits will be used for analyses in accordance with the manufacturer's instructions.~Biochemical parameters of the liver, such as alanine transaminase (ALT), aspartate transaminase (AST), total protein, albumin, total bilirubin, direct bilirubin, and alkaline phosphatase (ALP) levels, will be measured in the venous blood samples.~Proinflammatory (IL1-β, IL-6, TNFα, INF-γ) and anti-inflammatory (IL-2, IL-4, IL-10, IL-13) cytokines will be examined in venous blood in order to determine the immune modulatory effect of stem cells. CD4 + T, CD4 + T killer cells Granulocyte macrophage colony factor BLC-2 VEGF-R angiopoetin-1, angiopoetin-2 Total antioxidant capacity (TAC) Total oxidant capacity (TOC). | This study aims to use the regenerative and repair abilities of stem cells to fight against the harmful effects of the novel coronavirus Covid-19 and therefore develop a treatment strategy. It is known that fatalities from this virus is largely caused by its damage to lungs and other organs. As the disease progresses, these organs fail and lead to mortality. Our hope is that the stem cell transplantation from healthy donors will repair the damage caused by the virus and result in a healthy recovery. |
After including the patients into the study, patient needs to sign a written consent. After that, the next appointment will be scheduled. On the next appointment, each patient included in this study will undergo ultrasound cleaning and receive guidance for adequate everyday oral hygiene. The next appointment, after 10 days will be scaling and root planing for selected periodontal pockets. Because it is painful treatment, anesthesia is needed to be administrated. Patients will be split into three groups by picking cards, for receiving different doses of 4% articaine with 1:100,000 epinephrine ORABLOC® (40 mg/ml Articaine + 0.01 mg/ml Epinephrine, PIERREL S.P.A, Capua, Italy) in each group. Doses will be 0.1 ml, 0.2 ml, and 0.3 ml of 4% articaine with epinephrine for one appointment scaling and root planing. Anesthesia will be obtained by CCLADS device Anaject® (Septodont, Sallanches, Franc). The Intraseptal anesthesia (ISA) will be the method of administrating the anesthesia. Parameters of the device will be a mode with constant pressure, injection speed - mode LOW 0.005 ml/s. Time for application will depend on the dose, and it will be 20 s for 0.1 ml, 40 s for 0.2 ml, and 60 s for 0.3 ml.~Parameters of local anesthesia will be recorded by the pin-prick test. The pain will be rated by the visual-analogue scale (VAS). The pain will be rated immediately upon termination of the local anesthetic delivery and during the scaling and root planing.~Patients will be followed up the next day for local side effects and their need for analgesic medication. | The aims of our study were to evaluate the clinical anesthetic parameters of the intraseptal anesthesia (ISA), achieved by computer-controlled local anesthetic delivery system CCLADS, for scaling and root planing, as a primary outcome of the study. In addition, as secondary outcome of the study the impact of destruction of the periodontal supporting tissues on clinical anesthetic parameters of the ISA achieved by 4% articaine with 1:100,000 epinephrine, using CCLAD system. |
The study was carried on 40 patients having articulation errors in cases of velopharyngeal valve dysfunction attending the unit of phoniatrics, otorhinolaryngology department, Alexandria University.~The patients met the specified inclusion and exclusion criteria. The patient underwent pre intervention evaluation and 3 parameters were chosen to compare efficacy of the program before and after therapy.~these include auditory perceptual assessment of speech, nasometer test and articulation test.~The patient underwent the remediation software program as individual sessions. then after finishing the therapy, the patients underwent post therapeutic evaluation with the 3 specified criteria~Statistical analysis Was carried out using SPSS statistics software version 23. Quantitative data were tested for normality using the Kolmogorov-Smirnov test. The variables which were normally distributed were described by Mean± SD. The variables which were not normally distributed, were described by median (Min-Max). Qualitative data were expressed by numbers and percentages. The results were calculated at a level of significance of 5% or less. | To develop a remediation software program that is specific for correcting speech errors in patients with velopharyngeal dysfunction in the Arabic language and test its efficacy, on one group comparing pre and post results |
Because patients with type 1 diabetes (T1D) are required to estimate and administer their own insulin requirements, they frequently overestimate their needs. This often leads to debilitating insulin-induced hypoglycemia, which is the number one barrier to the safe, effective management of glycemia in this population. In addition to the difficulty estimating one's own insulin requirements after a meal, counterregulatory hormone responses to hypoglycemia are impaired in patients with T1D, thereby reducing hepatic glucose production (HGP) and increasing the depth and duration of the hypoglycemic episode.~The discovery of ways by which counterregulatory responses to hypoglycemia can be improved is a priority. In previous experiments in the dog, we observed that experimentally decreasing liver glycogen content (using a 4-hour infusion of glucagon into the hepatic portal vein) reduces counterregulatory hormone secretion during insulin-induced hypoglycemia, thereby reducing hepatic glucose production (HGP). Interestingly, people with T1D have low fasting hepatic glycogen concentrations and the accretion of the sugar in the liver throughout the day is also diminished. Therefore, it is of great interest to understand the relationship between fasting, which would lower liver glycogen levels compared to normal caloric intake, and the counterregulatory responses to insulin-induced hypoglycemia. Furthermore, the translational significance of the investigator's previous findings is also of great importance. To these ends, the studies proposed herein will determine the effect of fasting on hypoglycemic counterregulation in healthy, non-T1D subjects. We hypothesize that fasting will diminish the hormonal and hepatic responses to insulin-induced hypoglycemia.~Each subject will undergo two trials; one where they eat an isocaloric breakfast and lunch prior to an insulin-induced hypoglycemic challenge and a second one during which they remain fasted prior to the hypoglycemic challenge. This study design will allow us to assess the relationship between fasting and the counterregulatory responses to insulin-induced hypoglycemia. For these preliminary studies, only healthy subjects will be studied, thereby reducing their complexity (e.g., no overnight inpatient visits or the need to adjust insulin doses during the feeding periods). Upon completion, we intend to study the more metabolically vulnerable T1D patients. | Iatrogenic hypoglycemia is still considered to be the number one barrier to effective glycemic control in patients with type 1 diabetes (T1D). In a previous study, we observed in dogs that liver glycogen content can be a determinant of hormonal and hepatic responses to insulin-induced hypoglycemia. In the experiments described herein, we will determine if nutritionally-manipulated changes in liver glycogen concentrations have an impact on hypoglycemic counterregulation in non-T1D control subjects. |
The European Strategy for the Homeless People states that homelessness is the most extreme form of poverty and exclusion, which violates human dignity and poses a risk to health and life. Women constitute a particularly vulnerable subgroup among homeless people. Women living homeless show significant deterioration in their psychological welfare and mental health, which, among other aspects, is an obstacle in the access to care resources and inclusion processes.~There is a growing interest in the effectiveness and efficiency of intervention techniques to address mental health problems. The high comorbidity between mental health disorders, and especially emotional disorders, has promoted the development and consolidation of a transdiagnostic perspective. This perspective raises the existence of common mechanisms involved in the maintenance of different disorders, so that there would be a preamble to cognitive and/or behavioral processes shared by various psychological disorders. The design of a transdiagnostic treatment strategy allows a more inclusive approach to mental health and facilitates the design of similar treatment programs applicable to a wide range of mental disorders. Therefore, the transdiagnostic treatment could be a feasible and effective alternative to address some of the most common problems in mental health among women in a homeless situation. This approach could be useful to improve a diversity of symptoms in the own context of homeless living women and facilitate a systematic evaluation of its effectiveness.~The overall objective of this project is the development of a feasible and effective intervention adapted to the needs of women in a homeless situation and the service resources where they are attended. Moreover, the project aims to compare the group versus individual delivery of the UP among women in a homeless situation. This research is based on the hypothesis that the UP adaptation, both in group and individual delivery, will be effective in reducing anxiety and depression symptoms, decreasing negative affect and increasing psychological well-being, health state, positive affect, social support and quality of life. Strengths but also barriers and difficulties encountered in each format of intervention will be examined. This knowledge will be key to develop specific and adapted materials that enable effective interventions practices in the services resources for homeless people.~The UP intervention will consist of 12 weekly sessions lasting an hour and a half, applied in different centers for homeless people in Madrid. There will be several assessment moments: before the intervention, twelve intersession assessments (i.e., one per session), after the intervention, and 3 months, 6 months and 9 months follow-ups. The psychological intervention will be carried out by therapists with a background in psychology.~With this research it is expected to achieve results with impact at the technical level (in the design of effective interventions for psychological treatment of women in a homeless situation), on a scientific level (expanding knowledge about the effectiveness of intervention programs for women in social exclusion situations), and, especially, at the social level (affecting the quality of life and the processes of social inclusion of women in a homeless situation). | The aim of this study is to assess the effectiveness and feasibility of an adaptation of the Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders to women living homeless in Madrid, Spain. To address this goal, both clinical and psychosocial outcomes will be measured. The application of the UP is postulated as an effective tool for improving mental health and well-being of women in a homeless situation, which in turn will enhance their social inclusion process. |
Lots of scientific evidences have shown that autobiographical episodes' narrative has a beneficial effect on the elaboration of memories. Indeed, narrating is a way to order thoughts and moods, which are connected to particular episodes of one's life, in order to rework and relive them. Since the diagnosis, a relationship and an open and sincere dialogue between the various parts of the pediatric triangle can promote a process of adaptation to the experience of illness and an integrated biopsychosocial healing. The first aim of this study is to explore and analyze autobiographical memories of pediatric patients, parents and healthcare staff. Also, it aims to investigate possible common and discordant element between deposition.~Phases of the present study:~Sample recruitment and informed consent collection.~Diagnosis communication audio recording.~Communication of the autobiographical memory of the diagnosis audio recording of patients, parents, oncologist, nurse and psychologists involved, the day after the communication.~Questionnaire APAM administration for adult participants.~Audio Transcription and data coded. Data will be registered and operated by means of statistical software as SPSS (IBM) and T-Lab (Lancia, 2004).~Statistical processing: ANOVA and t of Student tests will be implemented in order to compare collected questionnaires. Narrative analysis will be implemented by means of textual analysis software. | Present project aims to investigate memories related to a cancer communication diagnosis in pediatric oncology. It evaluates possible common elements and specificity between family and healthcare staff. |
The aim of this study is to investigate the short term effects of physiotherapy in SIS patients on pain, range of motion, muscle strength, joint position sense and functionality and its relation to the acromion shape. Fifty patients (26 female, 24 male) with SIS were evaluated in this study. Patiens were divided into 3 groups according to the their acromion morphology. A conservative physiotherapy method was applied to the patients. All patients were evaluated before and 4 weeks after the treatment. | In this study, we aimed to evaluate the short-term effects of conservative physiotherapy in the subacromial impingement syndrome (SIS) and its relation to the acromion morphology. |
In this trial, the investigators want to evaluate the efficacy of the combination of Favipiravir and Hydroxychloroquine as potential therapy for moderate and severe cases with COVID -19. Favipiravir which is a new type of RNA-dependent RNA polymerase (RdRp) inhibitor has activity against influenza virus, and Hydroxychloroquine, an analogue of chloroquine, has a clinical safety profile better than that of chloroquine and allows higher daily dose, Chloroquine is a widely used antimalarial that was found to be a potential broad-spectrum antiviral.~There is an urgent need to explore therapeutic options for SARS-CoV-2 in order to face the pandemic. The selected combination was based on limited evidence clinically and in vitro on the efficacy of the Favipiravir and Hydroxychloroquine in SARS-CoV-2. The two medications were listed in many guidelines as treatment options and ongoing trials assessing their efficacy and safety. Thus, the investigators want to prove the effectiveness of the combination as therapy. | This study is a randomized, open-label, parallel groups multi-centered trial were participants are assigned to either an intervention arm ( a combination of Favipiravir and Hydroxychloroquin) or standard of care. |
Fifty patients were enrolled with 25 underwent Intracranial Stenting 25 received optimal medicall treatment without stenting and comparative study of primary outcome was conducted | Cerebral Endovascular Stenting of medically refractory Intracranial Stenotic Blood Vessels with Recurrent Ischemic Strokes patients |
This phase 2/3 study will evaluate the efficacy and safety of ABX464 50mg QD (oral capsule), on treating inflammation and preventing acute respiratory failure in patients infected with SARS-CoV-2.~Eligible patients will be randomized according to a 2:1 ratio into 2 treatment cohorts as follows:~Standard of Care + Placebo cohort: 344 patients~Standard of Care + ABX464 50mg QD: 690 patients~Study design:~The study will consist of 2 periods:~Treatment phase: randomized patients will be treated for 28 days~Safety follow-up phase of 14 days after which the End of Study visit (EOS) will be performed. | A phase 2/3, randomized, double blind, placebo-controlled study to evaluate the efficacy and the safety of ABX464 in treating inflammation and preventing acute respiratory failure in patients aged ≥65 and patients aged ≥18 with at least one additional risk factor who are infected with SARS-CoV-2 (the MiR-AGE study). |
Organophosphates (OPs) are cholinesterase inhibitors that are widely used as pesticides and organophosphate (OP) poisoning is an important public health concern in Egypt especially in the rural farming population. Organophosphate toxicity lead to a characteristic toxidrome that includes muscarinic, nicotinic and central nervous system signs and symptoms and, without proper and early antidotal treatment, death. A new antidote is the need of the hour. Lipid emulsion being inexpensive, easily available and effective in management of other lipid soluble toxins may be a novel option. The exact mechanisms by which ILE exert their beneficial effects are not fully understood, and several have suggested synergistic effects of several mechanisms. The mechanisms of action can be divided into intravascular, membrane, and intracellular effects. The original theory explaining the mechanism of lipid rescue was that of lipid sink, suggesting sequestration of lipophilic compounds to an expanded intravascular lipid phase, extracting the offending agent from the target tissue, and reversing the toxicity. Other hypotheses relate to the mechanism by which ILEs facilitate cardiac rescue from drug poisoning. These include:~increasing myocardial energy substrate delivery and a direct cardiotonic effect of ILE on the poisoned heart.~an effect of ILE on calcium ion channels through high levels of long-chain fatty acids, leading to increased cardiomyocyte calcium and positive inotropic effect. | Aim of the study:~To assess the role of intralipid emulsion in the acute man-agement of organophosphorus toxicity and its benefits in de-creasing mortality rates among victims. |
This is an observational, cross-sectional study. For the purposes of the study a sample group was selected from a clinic specialised in ACL reconstruction and rehabilitation based in Athens, Greece. Patients of the specific clinic had received the same surgical technique and rehabilitation protocol. Ability to return to sport was examined 9 months after surgery and approval was given according to the rehabilitation progress. A list of eligible study subjects was formed and, after inclusion and exclusion criteria were screened for, they were invited to participate in the study. Study participants, after having declared consent and passed the criteria were asked to answer the study questionnaires. Communication with participants was done through telephone and email, and all questionnaires were completed online. | The main research objective of this study is whether athletes who have sustained an anterior cruciate ligament injury, experience chronic nociplastic pain and psychosocial factors, including kinesiophobia and pain catastrophizing, after having been through ACL reconstruction surgery and rehabilitation and have returned to sport. |
Transverse, observational and descriptive study involving household contacts of documented patients with COVID-19 infection: contacts will be invited to participate and a blood sample will be drowned: IgM and IgG qualitative and quantitative measurements will be performed. Demographic data regarding age, comorbidities, calculated time spent before and after the patients diagnosis, isolation practices etc. | SARS-CoV-2 has now crossed the 1 million number of cases and tens of thousands of deaths. It´s R0 has been calculated between 2 and 5.7 solely based on clinical symptoms but it is estimated to likely be higher. Serologic evidence of infection has not been analyzed. |
The study is a multi-center, randomized trial of women with symptomatic utero-vaginal or post-hysterectomy vaginal vault prolapse desiring non-surgical treatment with a pessary. This study will compare outcomes in women randomized to vaginal estrogen cream or vaginal placebo cream.~Women who meet the inclusion/exclusion criteria will be evaluated. A pessary (ring with support) will be fit by an experienced physician. After successful pessary fitting, they will be randomly divided into experimental active medication and control groups. The experimental group will start intravaginal estrogen cream, and the control group will start intravaginal estrogen-free cream. Then patients will be followed every 3months until 1year.~The purpose of this trial is to evaluate the effect of intravaginal estrogen use on pessary treatment for pelvic organ prolapse, including short-term and long-term use rate, patient impression of improvement, improvement in symptom-specific quality of life and complication incidence. | The primary purpose of this two-arm randomized clinical trial is to determine if in women desiring use of a pessary for pelvic organ prolapse (POP) and are successfully fit, if 1-year use and patient impression of improvement is superior in women using vaginal estrogen cream versus those using a vaginal placebo cream. |
Activation of anti-tumor immune response using programmed death receptor-1 (PD-1)blockade showed benefit only in a fraction of hepatocellular carcinoma (HCC) patients. Specific blockade of vascular endothelial receptor 2 (VEGFR-2) using a murine antibody significantly delayed primary tumor growth but failed to prolong survival. Combining PD-1 blockade with antiangiogenesis has shown promise in substantially increasing the fraction of HCC patients who respond to treatment in vitro. Based on these clinical data, we are aimed to investigation the safety and efficacy of combination therapy for HCC patients. | The aie of this clinical study is the safety and efficacy of combination therapy for HCC patients. |
Three dimensional sensor technology (3DS) is available for fall detection and fall prevention (e.g. unwanted getting up in persons with risks for frequent falls) in several institutions in Europe and Switzerland. 3DS are capable to analyze completely anonymized data and alert nurses towards a dangerous (fall) or potentially dangerous (getting out of bed) event during day- and nighttime. Multi-sensor technology has been applied to assess activities of daily living in persons cognitive problems living at home. To our knowledge, 3DS technology has not been examined as part of a structured clinical protocol. In addition, the combination of two digital technologies (3DS and a server based software) as an integrative platform could help to develop algorithms to analyze complex human activities such as using a toilet. Automated analyses of such complex activities have the potential to support nursing staff in the future. | This is an observational study that intends to compare falls or fall-risk related alarms derived from a three-dimensional sensor system with the clinical reality definded by attending nurses. |
Background~The worldwide SARS-CoV-2 pandemic has put healthcare systems under the extreme pressure, with intensive care units being faced with a previously unseen number of patients with severe respiratory failure requiring admission for endotracheal intubation and mechanical ventilation.~Methods~The study describes how the critical care resources adapted to the sudden surge of severe Covid-19 in the province of Madrid, which developed at the beginning of March 2020. The response consisted of a swift increase in ICU capacity and the relocation of patients. ICU beds were mounted outside the usual intensive care areas. Transfer of critically ill intubated patients with COVID-19 was managed in an instant messenger service group composed of representatives of 53 intensive care units and performed by the Madrid Emergency Medical Systems (EMS). The investigators will compare transferred with non-transferred patients matched for risk factors for cardiovascular and respiratory complications. | Description of the adaptation of ICUs in the region of Madrid to que surge in demand of critical care due to COVID-19 |
Haematological malignancies can be treated with chemotherapy if the patient tolerates the treatment. However, many patients develop complications during treatment including chemotherapy-induced peripheral neuropathy (CIPN) and/or impaired memory. Even though it is a well-known complication, no gold standard for CIPN assessment is known. Besides chemotherapy reduction or cessation, there is so far no sufficient prevention or treatment, therefore early detection and intervention is crucial.~The main purpose of this study is to find a reliable test for chemotherapy-induced peripheral neuropathy (CIPN) in order to predict early signs of CIPN. All included patients has to be scheduled for treatment with vincristine, bortezomib or lenalidomide regardless of haematological malignancy. Neuropathy and cognitive impairment will be tested at baseline (prior to treatment with chemotherapy), before each treatment course, 1 month after treatment and finally 1 year after onset of chemotherapy. CIPN will be examined by different methods: Clinician-based assessment, objective neurophysiological parameters and patient-reported outcome. A novel test using Perception Threshold Tracking (PTT), developed at Aalborg University, is included in the study. The test investigates the nerve excitability in both large and small fiber nerve fibers using two different electrodes. Blood samples will be collected, stored, and analyzed for deficiencies correlated to neuropathy. | Chemotherapy-induced peripheral neuropathy (CIPN) is a common, but not well understood complication to treatment with chemotherapy. In this study the investigators will investigate a novel method for early detection of CIPN and compare it to other methods in patients treated for haematological cancers. |
To prospectively collect and assess safety and efficacy data on the AcoArt drug-coated PTA balloon catheters carrying the CE Mark per current Instructions for Use in a real-world cohort of patients with symptomatic arterial disease undergoing endovascular lower limb revascularization per the institution's standard practice. | All-comers, prospective, multi-center, single-arm, non-interventional post market clinical follow-up (PMCF) Cohort 1 - Claudicants: Rutherford Clinical Category (RCC) 2-3 Cohort 2 - Critical Limb Ischemia: Rutherford Clinical Category (RCC) 4-6 |
Despite recent therapeutic strategies, including immunotherapy, treatment alternatives for patients with metastatic mismatch-repair deficient (dMMR) solid tumors remain scarce. Pre-clinical data suggests that dMMR tumors are susceptible to rapamycin (sirolimus), a mTOR inhibitor. In these tumors, characterized by higher levels of oxidative stress, sirolimus can exert a cytotoxic effect, led by the failure to repair DNA damage by inhibition of antioxidant enzymes such as FOXO3a triggered by Akt hyperactivation.~This proposal presents a phase 2 clinical trial designed to evaluate the efficacy of sirolimus in patients with dMMR solid tumors after immunotherapy. The investigators hypothesize that sirolimus will increase the overall response rate (ORR) by 20%. | To evaluate the efficacy of sirolimus by estimating the overall response rate (ORR) as assessed by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1) in patients with metastatic dMMR solid cancer after immunotherapy (either due to disease progression or to inability to tolerate treatment). |
The aim of this single-blind randomized prospective study is to find out whether including robotic therapy in addition to conventional rehabilitation program has an effect on quality of life, motor function and activities of daily living of the hemiplegic patients. Hemiplegic patients diagnosed by anamnesis, physical examination and radiological analysis, which have been referred to the outpatient clinic of Ege University Faculty of Medicine Department of Physical Therapy and Rehabilitation between April 2016 and April 2019 have been taken to the study. The demographic and clinical data of the patients were recorded and they were randomized into 2 groups. 17 patients assigned to the robotic rehabilitation group (Study group) receiving robot-assisted rehabilitation in addition to conventional treatment and 20 assigned to the conventional rehabilitation group (control group) receiving only conventional therapy completed the study. Robotic-based rehabilitation given additionally was arranged to be 30-45 minutes, 5 days per week for 4 weeks. All patients were assessed at the beginning of therapy and at the end of 4th week with Brunnstrom stages of motor recovery, Fugl Meyer Assessment (FMA), hand grip strength, Purdue peg test, Minnesota manual dexterity test, Modified Ashworth Scale (MAS) , Functional Independance Measure (FIM), Stroke Specific Quality of Life Scale (SS-QOL), Nottingham Extended Activities of Daily Living (NEADL) Scale, Montreal Cognitive Assessment (MoCA), Center for Epidemiological Studies Depression Scale (CES- D). In the study, improvements in motor function scores, spasticity, general functioning, activities of daily living, cognitive assessment scale are better in robotic group when compared with control group but this difference was not statistically significant (p>0,05). The investigators have found statistically significant improvement in CES- Depression scale in robotic group compared with control group (p=0,018). Significantly improved motor function gains are observed before and after the treatment in both groups being better in the robotic group however no significant differences were observed between the groups after the treatment. Robotic rehabilitation provides a favorable alternative bringing slight benefits, and also advantageous in terms of work power and psychological recovery so robotic rehabilitation addition to conventional neurological rehabilitation is effective and useful in patient management after stroke or cerebrovascular events. | Comparison of Upper Extremity Robotic Rehabilitation Efficiency with Conventional Rehabilitation in Patients with Hemiplegia after Cerebrovascular Event |
In a patient with type 1 cardiorenal syndrome, we tried to compare two Furosemide strategies: both with a morning bolus, and randomized in two groups:~Group A: Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:~Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution~Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution~Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution~Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution~Group B: Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:~Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.~Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.~Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.~Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.~ution + Chlortalidone 50mg VO every 24 hours + Spironolactone 25mg VO every 24 hrs.~With the primary objective of improving renal function measured by serum creatinine, as secondary objectives the efficacy in vascular decongestion and electrolyte alterations. | In double-blind clinical trial, determine renal recovery with two different furosemide strategies in patients with type 1 cardiorenal syndrome. |
NEPTUN consists of liver cirrhosis receiving transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Internal Medicine I, University of Bonn, Germany and receiving a structured routine evaluation and follow up program. The diagnosis of cirrhosis was based on clinical, hemodynamic and biochemical parameters, and ultrasound and/or biopsy criteria. | Evaluation of non-invasive prognostic parameters in patients receiving transjugular intrahepatic portosystemic shunt (TIPS) for complications of portal hypertension. Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value. |
Aim 1:~Each enrolled participant will be asked to wear the sensor on a daily basis. Duration of the participation varies based on the symptom severity. With the currently available information, recovery times are ranging from 7 days to 56 days. The duration of the study participation can begin at the early detection to all the way until complete recovery or discharge. Participants may be asked to use the sensors anywhere from 7 days to 60 days. Duration of study will be based on the participant's self-reported symptoms or as appropriate determined by the PI. This will allow the research team to collect a comprehensive data set that can characterize both COVID-like and non-COVID-like signs and symptoms.~Aim 2:~Data collected from Aim#1 will aid in generating machine learning algorithms to characterize the signs and symptoms. Further algorithm development will be carried out to develop signs and symptoms progression and regression models for early warning or warning to prevent return to work of health-care staff or civilians~Wearable sensors are compact battery powered miniature electronic devices that are attached to a user's body to record physiological, biochemical and physical activity information. Different types of sensors can be used to monitor these digital biomarkers. Inertial measurement units (IMUs), including accelerometers, gyroscopes, magnetometers are typically used to measure physical activity, movement signatures. Miniature temperature, galvanic skin response (GSR), photoplethysmogram (PPG), oxygen saturation (SPO2) sensors are increasingly embedded in wearable devices for vital sign monitoring. Non-invasive monitoring is very ideal in the current pandemic situation. These sensors can be potentially deployed in large scale to monitor cases of suspected infection and patients recovering from COVID-19.~This project is planning to develop a sensor system that is capable of gathering data on COVID-19 like symptoms such as cough, body temperature, respiratory parameters. Machine algorithms will be developed to handle data analysis and derive useful clinical and monitor signs and symptoms in cases of suspected infection and individuals actively recovering from COVID-19 like symptoms | Develop a wearable sensor package to gather data on COVID-19-like signs and symptoms such as elevated body temperature, respiratory parameters, heart rate ,cough and gait.~Create algorithms to monitor and track changes to COVID19-like signs and symptoms for developing a better care and isolation strategies for COVID-19 pandemic. |
The percentage of patients with lost follow up is significantly high. Previously all other studies mainly focused on the radiographic outcome after acetabular fractures and rarely on patient reported functional outcomes and quality of life. The use of patient-reported outcome measures (PROMs) is increasing and may lead to modifications of treatment. Recent technologic advances, namely smartphones, capable of measuring outcomes after acetabular fractures are now very important in quantifying value-based care. This was previously accomplished through office assessments and surveys with variable follow-up but this strategy lacks continuous and complete data. Studies show that these remote modes of follow-up are safe and that patients are as equally satisfied with them as they are with in-person follow- up care | Acetabular fractures are articular fractures involving the hip joint that needs anatomical reduction and a strict long follow up after fixation. |
Aims for the current study are two-fold: 1. conduct a randomized trial testing the effects of an emotion regulation skill (cognitive reappraisal) on stress-induced drinking among women with alcohol misuse and varying levels of co-occurring PTSD; 2. examine whether progesterone levels and/or severity of co-occurring PTSD - factors which impact women's stress reactivity and emotion regulation - moderate the effectiveness of the cognitive reappraisal in reducing stress-induced drinking.~The proposed study will combine experimental, in-person sessions with daily self-report data from the Veterans to assess the effect of cognitive reappraisal on alcohol craving, cognitive (inhibitory) control, physiological arousal (HRV), and alcohol use. Participation will take place across a period of at least 35 days, to encompass an entire menstrual cycle. All participants complete all sections of the study - the experimental sessions and the longitudinal (35-day) data collection. | The purpose of the study Stress, Emotion Regulation, and Alcohol in Women Veterans is to learn about the effects of negative emotion and stress on behavior (including alcohol use) among women Veterans, including women with and without posttraumatic stress disorder. Additionally, the study looks at whether a woman's use of emotion regulation techniques changes the association between stress or negative emotion and behavior. Lastly, the study examines how women's reactions to stress, and the effects of stress, vary across the menstrual cycle - depending on the level of circulating hormones. |
The most important functions of the biceps brachii muscle are flexion and supination of the elbow. Patients with a partial or complete rotator cuff tear often suffer a lesion of the long head of the biceps tendon (LHBT). The two most common surgical treatments options are tenotomy or tenodesis. This study is to assess the Supination Strength Index SSI (the operated side in relation to the healthy side) after proximal biceps tenotomy versus tenodesis. | The most important functions of the biceps brachii muscle are flexion and supination of the elbow. Patients with a partial or complete rotator cuff tear often suffer a lesion of the long head of the biceps tendon (LHBT). The two most common surgical treatments options are tenotomy or tenodesis. This study is to assess the Supination Strength Index (SSI) (the operated side in relation to the healthy side) after proximal biceps tenotomy versus tenodesis. |
In Part A, patient participation is expected to last up to 63 days, including a 28-day screening period(consisting of a 7-day diary run-in to build baseline itch NRS) and a 36-day on study period (consisting of 56 total doses from Day 1 to Day 29, and a 7 day follow-up/EOS visit at Day 36).~In Part B, patient participation is expected to last up to 85 days, including a 28-day screening period (consisting of a 7-day diary run-in to build baseline itch NRS) and a 57-day on study treatment period. | A Randomized, Double Blind, Placebo-Controlled study to assess the Safety, Local Tolerance, and Pharmacokinetics of LT5001 drug product in Hemodialysis Patients with Uremic Pruritus |
Astigmatism is a common vision condition that causes blurred vision. Astigmatism is an error of refraction in which incident parallel rays can't be focused to a single point .It could be corneal or lenticular astigmatism or both . Regarding Corneal astigmatism it is due to difference in the corneal curvature in the different meridian of both the anterior and posterior surface .~The are 2 methods of studing corneal curvature :~Corneal topography which depend on placcido disc to study anterior corneal surface .~Corneal tomography is more precise in detecting anterior and posterior corneal curvature depending on Scheimpflug principle which uses a rotating Scheimpflug camera .~Pentacam is a device which depend on Scheimpflug technique .~The importance of studing the posterior corneal curvature includes :~• The posterior corneal curvature is a more sensitive indicator of early keratoconus detection especially posterior corneal elevation.~Previously, The change in the posterior corneal surface plays a more subtle role than the anterior corneal surface in optical performance because of the smaller difference in refractive indices between the cornea and aqueous, and it has been thought that the magnitude of PCA in the normal population is clinically negligible.~Posterior corneal astigmatism (PCA) is important for better predictability of toric intraocular lens calculation to avoid under- or overestimation of toricity in intraocular lens (IOL) power calculations.~But recently it has been demonstrated how neglecting PCA will lead to overcorrection of astigmatism in eyes with with-the-rule astigmatism (WTR) and undercorrection in eyes with against-the-rule astigmatism (ATR).(3) In our study we aim to Determine the contribution of posterior corneal astigmatism to total corneal astigmatism and the error in estimating total corneal astigmatism from anterior corneal measurements only using Scheimpflug analyzer (Pentacam ).~Our patients will undergo Scheimpflug imaging using pentacam .~From the corneal parameters displayed in pentacam we can calculate :~Anterior corneal astigmatism by substracting Ksteep -Kflat on the front surface~Posterior corneal astigmatism by substracting Ksteep-Kflat on the back surface.~Total corneal astigmatism is calculated by addition of anterior and posterior corneal astigmatism using vector analysis by using ASSORT vector calculator.*~The percentage of contribution of posterior corneal astigmatism to magnitude of Total corneal astigmatism is then calculated .~ASSORT vector calculator:~Is a total planning and outcomes analysis software for astigmatism using Alpins method ,cheltman ,Victoria ,Australia . | The magnitude of posterior corneal astigmatism was considered negligible due to the smaller difference in the refractive index between the cornea and the aqueous .~though ,neglecting the posterior corneal astigmatism lead to errors during calculation of the toric iols (over or under estimation ) .~so we aim to determine the percentage of contribution of posterior corneal astigmatism to total corneal astigmatism in a sample of Egyptian population using scheimpflug imaging (Pentacam ). |
This is a single arm, prospective, multicenter, post-market, observational registry that will evaluate subjects for up to 5 years post treatment. | To collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse. |
The HETHICO study aims to collect retrospectively documented clinical information on patients hospitalized in Veneto Region (Italy) for SARS-COVID-2 infection in 2 types of settings, medical environment (COORTE MED), and intensive / sub-intensive (COORTE ICU), to assess the safety and possible efficacy of the anticoagulant treatments used for thromboprophylaxis, or in preventing thrombotic complications related to hospitalization from COVID-19.~Furthermore, the possible association between the observed clinical evolution and the type of antithrombotic prophylaxis performed (class of drug and dose intensity) will be assessed in a large cohort of patients hospitalized in the various participating hospitals in the Veneto region and observed with follow-up. in the short term, gathering information on:~Clinical outcomes, Survival, Concomitant pathologies, Adverse events of anticoagulant drugs, Interactions with other concomitant drugs, and Risk factors.~The collected data, suitably anonymized, will be used to produce scientific works, the standardization of care paths, and the planning of targeted training events. | The HETHICO study aims to collect retrospectively documented clinical information on patients hospitalized in Veneto Region (Italy) for SARS-COVID-2 infection in 2 types of settings, medical environment (COORTE MED), and intensive / sub-intensive (COORTE ICU), to assess the safety and possible efficacy of the anticoagulant treatments used for thromboprophylaxis, or in preventing thrombotic complications related to hospitalization from COVID-19. |
Healthcare workers (HCWs) commonly present high levels of anxiety, depression, posttraumatic stress, acute disorder and burnout, both during and after viral outbreaks. Although educational and multifaceted interventions might mitigate the development of mental health problems, the certainty on the evidence is very low. The aim of this double-blinded randomized clinical trial is to examine the impact of a mobile phone based intervention to prevent and manage mental health problems in healthcare workers at the frontline against COVID-19 in Spain.~The trial will include HCWs having provided healthcare to patients with COVID19 in a healthcare centre (any setting) in Spain during the viral outbreak in Spain. Professionals from any medical speciality and role (doctors, nurses, nurse assistance, etc.) with access to a smartphone will be included. The investigators will collect expressions of interest via dissemination of the study through social media and key stakeholders (hospital managers, scientific societies and professional colleges). A team of psychologists will contact (via telephone) potential participants to confirm they meet the eligibility criteria (described above), obtain signed consent (audio-recorded), and carry out a psychological (pre-intervention) evaluation. The participants will then be randomly allocated to receive a fully functional App (full intervention) or an App with brief generic recommendations about mental health (control intervention). A post-intervention psychological assessment will be undertaken after two weeks. The primary outcome will be symptomatology of depression, anxiety or stress. Secondary outcomes will include posttraumatic stress, burnout, insomnia, and self-efficacy. After the two weeks follow-up, all participants allocated to the control intervention will be offered the full intervention. | This study aims at evaluating the effectiveness of a mobile phone based intervention to prevent and manage mental health problems in healthcare workers at the frontline against COVID-19 in Spain. The intervention will consist in psychoeducation, delivered via a mobile App. Participants will be followed up during two weeks. The primary outcome will be symptomatology of depression, anxiety or stress. |
Subjects will be randomized in a 1:1 ratio to Retzius nerve sparing versus non-Retzius nerve sparing to compare cancer outcomes and urinary/sexual outcomes following radical prostatectomy. Using the Retzius technique, the surgeon will remove the prostate in a way that preserves a portion of the nerves and tissue structures that are typically removed during the conventional technique.~The investigators will assess recovery of urinary and sexual function of patients through questionnaires at 1 week, 1 month, 6 months, 12 months, and 24 months after surgery. | The investigators propose a prospective study to assess recovery of urinary and sexual function by nerve sparing techniques after radical prostatectomy. |
The investigators will conduct a type 2 hybrid effectiveness-implementation study to test both the effect of and the implementation process of a WeChat-based integrative family intervention (WIFI) program. The program will include three core components: 1) psycho-education through WeChat Official Account (WOA), 2) peer support through WeChat chat group, and 3) professional support through WeChat video chat. A rigorous stepped wedge cluster randomized trial will be used to evaluate the implementation, effectiveness, and cost of the WIFI program. The WIFI program will be implemented in 12 communities affiliated with the Changsha psychiatric hospital through the free medicine delivery process in the 686 Program. 20 families of schizophrenia will be selected from each community. The 12 communities will be randomized to one of four fixed sequences every two months during an 8-month intervention period in four clusters of 3 communities each. All clusters will receive the usual financial benefit of the Reward Policy as the control condition, and then successively and in random order, will cross over to the WIFI program at 2-month intervals until the study ends. Outcomes will be assessed for both family caregivers and the family member with schizophrenia. Family caregivers will be assessed for their knowledge and skills about caregiving, social support and coping, perceived stigma, caregiver burden, family functioning, positive feelings, and psychological distress. Schizophrenia individuals will be assessed for their symptoms and functioning, quality of life, recovery and re-hospitalization. Cost data such as costs of the intervention, health care utilization, and costs associated with lost productivity will also be collected. In addition, the investigators will collect process data including fidelity and quality of program implementation as well as users' attitudes will also be collected. Treatment effects will be estimated using generalized linear maximum likelihood mixed modeling (GLMM) with clusters as a random effect and time as a fixed effect. Cost-effectiveness analysis will be performed from the societal perspective using incremental cost effectiveness ratios (ICERs). Qualitative analysis will use the grounded theory approach and immersion-crystallization process. All statistical analyses will be conducted according to the intention-to-treat principle. | The study aims to test both the effectiveness and implementation strategy of a WeChat-based integrative family intervention (WIFI) to support family caregiving of schizophrenia in China. |
After spinal cord injury (SCI), damage to descending motor pathways has been associated with the development of spasticity (Frigon and Rossignol, 2006; Trompetto et al., 2014). Self-reported questionnaires and clinical exams indicate that individuals with incomplete SCI, who showed residual descending connectivity, have a high prevalence of spasticity compared to individuals with complete SCI (Little et al., 1989; Holtz et al., 2017). In agreement, our recent electrophysiological and spinal cord imaging data in humans with a diagnosis of a clinically motor complete SCI showed the presence of descending motor pathway connectivity in individuals with spasticity compared to those without spasticity (Sangari et al., 2019). However, which descending motor pathways influence spasticity following SCI, and to what extent, remains poorly understood. This proposal has two main goals: 1) to examine the contribution of cortico- and reticulo-spinal pathways to spasticity in upper and lower limb muscles, and 2) to develop strategies to promote functional recovery of upper and lower limb spastic muscles in humans with chronic incomplete SCI. The aims below will test two main hypotheses.~In Aim 1, we will use transcranial magnetic stimulation and startle acoustic stimuli to examine the contribution of the cortico- and reticulo-spinal pathway to upper and/or lower limb muscles electromyographic activity. Spinal cord atrophy and morphological characterization of cortico- and reticulo-spinal pathways will be assessed with high-resolution magnetic resonance imaging. Physiological and neuroimaging outcomes will be associated with clinical assessment of spasticity.~In Aim 2, we propose to enhance cortico- and reticulo-spinal contribution to upper and/or lower limb function in spastic muscles by using a novel intervention combining startle acoustic stimuli with motor training.~This research will provide new knowledge about the contribution of descending motor pathways to the control of spasticity in upper and lower limb muscles following incomplete cervical SCI (Aim1) and might lead to the development of a novel rehabilitation intervention to improve upper and lower limb motor function recovery by enhancing residual descending control over spinal networks (Aim 2). | Very often, people who have a SCI have difficulty doing things with their arms or hands as a result of muscle stiffness , or spasticity. Spastacity can cause problems performing even the simplest of everyday tasks. This research will help us understand how the body recovers and changes neurologically after SCI. |
BMSM bear the highest burden of HIV in the US. PrEP is the single most effective HIV prevention strategy yet under-utilized among BMSM. When taken every day PrEP can prevent up to 92% of HIV infections. Studies estimate that 48-70% of BMSM are willing to use PrEP, yet, uptake among blacks remains low (~10%). Lower insurance rates among blacks compared to whites may be a barrier to PrEP, but, evidence of insurance rates, as well as prescription payment programs that cover most or all of the costs of PrEP do not completely explain significant disparities in PrEP uptake. Indeed, limited access to PrEP, distrust of physicians and stigma are noted as critical barriers to PrEP that must be improved to reduce HIV.~Neighborhood residence shapes BMSM HIV exposure and access to HIV prevention resources. Census tracts with high HIV had 20% higher poverty and 200% larger MSM populations. High poverty neighborhoods also have the fewest HIV physicians. While most census tracts are within 15 minutes of an HIV physician by car, residents in HIV prevalent areas have low rates of car ownership and commute time more than doubles when traveling by public transportation, which is unavailable in some areas.~There is a strong scientific premise for increasing PrEP delivery in pharmacies for BMSM. About 95% of Americans live within 5 miles of a pharmacy; pharmacies have flexible hours and pharmacists have high credibility with community members. Studies have shown pharmacies can engage with high risk populations including people who inject drugs (PWID) to reduce HIV risk behaviors and provide primary prevention services including immunizations, blood pressure screenings and HIV testing. PrEP has also been sustainably offered in a Seattle pharmacy, but mostly to white MSM (85%). Nevertheless, almost 100% initiated PrEP and 75% followed up for continued PrEP. Following this, Walgreens across the US have offered PrEP through their existing clinics.~Existing pharmacy PrEP models have limited potential for reaching BMSM. In Seattle, state regulations give pharmacists authority to administer biological screenings (HIV, sexually transmitted infections (STIs) and creatinine) and prescribe PrEP. Many states do not have legislation that expand pharmacists' purview in service delivery. Walgreens has overcome this regulatory limitation by using nurse practitioners to screen and prescribe PrEP in their existing clinics. While Collaborative Practice Agreements between pharmacists and physicians are another route to deliver services through pharmacies, they are time-consuming and thus infeasible for community pharmacists in high morbidity neighborhoods who already have a hectic workflow; and for chain pharmacies these partnerships are determined on a corporate rather than individual pharmacy level.~Accomplishing the study aims will be done through three steps: conducting interviews and workflow assessments with stakeholders, developing an intervention to deliver a culturally relevant pharmacy PrEP model, and perform a pilot test to study the delivery model in pharmacies in high poverty, racial minority neighborhoods.~In the pilot test phase, two pharmacies will be chosen to test the pharmacy PrEP delivery model by informing men of the study and performing their study activities. Pharmacists and technicians will complete a pharmacy-based HIV prevention training to equip them with the tools needed for optimal PrEP delivery. During the training, pharmacists and technicians will learn how to engage customers/ patients for recruitment into the study. Black race is not included in the eligibility criteria to avoid profiling and potentially stigmatizing one racial group. However, since the pharmacies selected to be a part of the study are located in racial minority neighborhoods, the researchers anticipate that most customers will be racial minorities. The researchers will be collecting both qualitative and quantitative data to assess the impact of the pharmacy PrEP intervention on the pharmacy environment, personnel, and business flow. Among the customers/patients, this study will assess feasibility, acceptability and safety of the intervention activities, satisfaction with the activities and participation in activities without stigmatization, discomfort or harm.~The study pharmacies will deliver the PrEP intervention for 6 months. Study participants will receive a 3-month follow-up phone call to see if they are continuing to use PrEP. | The proposed research will develop a culturally appropriate pharmacy PrEP delivery model for black men who have sex with men (BMSM) who live in high poverty, racial minority neighborhoods. Increasing access to PrEP through pharmacies has the potential to increase PrEP uptake among BMSM thereby reducing HIV incidence and racial inequities in HIV. |
The aim is to determine the effect of treatment compliance training given to patients with bipolar disorder on treatment compliance, social functioning, and quality of life.~The study was conducted with 38 bipolar disorder (n=17 intervention group; n=21 control group) using a quasi-experimental research design. Patients were evaluated using a pre-test, post-test, monitoring test, Medication~Adherence Rating Scale (MARS), Social Functioning Scale (SFS), and World Health Organization Quality of Life Instrument Short Form (WHOQOLBREF-TR). The measurements were taken 3 times:~pre test, post-test and 3-months post-test. | In bipolar disorder, treatment noncompliance is associated with high rates of recurrence and hospitalization. Furthermore, it is reported that that treatment noncompliance disturbs the social functioning of patients and reduces the quality of life. Improvement of the quality of life, social functioning and treatment compliance is as important as the long-term treatment of symptoms.This study aimed to determine the effect of treatment compliance training given to patients with bipolar disorder on treatment compliance, social functioning, and quality of life. |
Background Patients admitted to the Intensive Care Unit (ICU) are known to be at risk for thrombo-embolic events. Virchow's triad describes the major risk factors in three categories: venous stasis, vessel injury and activation of blood coagulation. A prolonged mechanical ventilation together with the hemodynamic effects of this ventilation with a high positive and expiratory pressure (PEEP), the presence of central venous catheters, the immobilization of these patients and the presence of obesity or other comorbidities can attribute to the occurrence of a deep venous thrombosis (DVT) in patients admitted at ICU. The incidence of DVT during ICU stay has been reported between 5 and 15%.~On the 13th of March, the first COVID-19 patient was admitted at the ICU at the Jessa Hospital. Within a few days, the admissions at our COVID-19 unit grew exponential. In these difficult time, research concerning COVID-19 has been performed indicating the COVID-19 virus induces a hyper-inflammatory state. It has been suggested that systemic inflammation induces endothelial injury. This will activate the coagulation cascade and impair fibrinolysis with disruption of endothelial barrier, and loss of physiologic antithrombotic factors which may elevated the risk for DVTs significantly. Up to now, there is still no causal treatment for COVID-19. The current management of COVID-19 is mainly supportive i.e. a prolonged inflammatory status and a prolonged risk for VTE.~We have shown in a previous cross sectional study that the prevalence of deep venous thrombosis (DVT) in critically ill ICU patients with COVID-19 treated with a prophylactic dose of low molecular weight heparin (LMWH) is more than 60% (submitted manuscript). Consequently, the risk of VTE complications in this patient group is very high. In the light of these findings, an intensified thromboprofylaxis protocol was applied in critically ill ICU patients with COVID-19 at our ICU units since 31st of March 2020.~Aim The aim of this study is to investigate and compare the mortality, the incidence of DVT and the incidence of kidney and liver failure in patients admitted to the ICU before and after the implementation of an intensified thromboprofylaxis protocol on 31st of March 2020. Patients in the before group are admitted at the ICU from 13/3/2020-30/3/2020 and patients in the after group are admitted to the ICU from 31/3 until 20/4/2020.~Design This is a retrospective, longitudinal, before-after controlled study investigating the mortality, the incidence of DVT and the incidence of kidney and liver failure in COVID-19 patients admitted to the ICU before and after the implementation of an intensified thromboprofylaxis protocol.~Outcome measures The primary endpoint of this retrospective study is to investigate the mortality in critically ill ICU patients before and after the implementation of the intensified thromboprofylaxis protocol in our hospital.~Secondary endpoints are the incidence of DVTs with the number and locations of these thromboses, the incidence of kidney failure and the incidence of liver failure in COVID-19 patients admitted to the ICU before and after the implementation of the thromboprofylaxis protocol.~Additional data collection~Additional collected parameters are listed below and are collected as a standard-of-care in our hospital:~Demographics: i.e age, gender, BMI, Apache II score (to predict mortality)~Comorbidities: smoking, obesity, hypertension, diabetes, cardiovascular disease, respiratory disease, malignancies, renal failure (AKI), liver failure, gastrointestinal disease, neurological conditions, mental state, other~Symptoms at the time of admission to ICU: i.e fever, body temperature, dyspnoea, headache, diarrhea etc…~Laboratory results of all standard parameters measured~Treatment: antiviral agents, antibiotics, etc…~Complications: shock, heart failure, sepsis, stroke, etc…~Ventilation: method, PEEP, FiO2, P/F ratio ..~SOFA score (Sequential Organ Failure Assessment)~Radiological findings: pneumonia, ground-glass opacity.. | The aim of this study is to investigate and compare the mortality, the incidence of DVT and the incidence of kidney and liver failure in patients admitted to the ICU before and after the implementation of an intensified thromboprofylaxis protocol on 31st of March 2020. Patients in the before group are admitted at the ICU from 13/3/2020-30/3/2020 and patients in the after group are admitted to the ICU from 31/3 until 20/4/2020. |
In March 2020, the third highest number of positive cases in the world was recorded in Italy, mainly due to 2 outbreaks of 2 different clusters in Lombardy and Veneto.~Fever is the most common symptom, followed by fatigue and dry cough; worsening of dyspnea and acute respiratory distress syndrome are found in severe cases. Previous reports have highlighted the key role of chest computed tomography (CT) and chest X-ray (CXR) in the diagnosis and follow-up of CoViD-19.~The most frequent clinical manifestation seems to be viral pneumonia, characterised by fever, cough, dyspnea. The severity of the disease varies widely: with evidence of mild disease in the majority of confirmed cases, severe pneumonia on a part of these, defined as dyspnea, hypoxia or lung involvement > 40% at imaging within 24-48 hours, and critical disease defined as respiratory failure, shock or multi-organ failure in particular patient cohorts.The mortality rate between cases ranges from approximately 4% in early reports to 14%, depending on the intensity of transmission and time of infection, and most fatal cases occurred in older patients or in patients with pre-existing medical co-morbidities.~Imaging plays an essential role in the diagnosis and follow-up of this infection.Several studies have been published describing the results of imaging, mainly using chest CT (computed tomography) with a limited number of articles describing disease in European patients or the possible different clinical/radiological presentation of the disease in European patients.~Pulmonary pathological findings appear to be similar to those previously described in SARS and MERS, with a prevalence of frosted glass densities and occasional consolidation.According to the literature, the 3 main features for the diagnosis of CoVid-19 pneumonia are: alveolar disease, represented by ground glass densities, bilateral distribution and prevalent peripheral involvement. This triad is more common in intermediate stages of the disease. In the early stages of the disease, a significant proportion of patients may present with negative or dubious X-rays and CT scans.There is an important overlap with imaging findings of other viral pneumonia, in particular with other members of the coronaviridae family: consolidation, however, seems to be less common in the early stages of CoViD-19 and bilateral distribution is less frequent in SARS and MERS pneumonia. Very little data have been published on the radiological evolution and modification of radiological aspects during infection: as the disease progresses, parenchymal consolidations begin to resorb and assume a frosted glass appearance. Another possible evolution is the progression towards the radiological aspect of the white lung. This study aims to describe imaging aspects of CoViD-19 infection in Italian patients and the data on the radiological evolution. | The novel coronavirus SARS-CoV2 clinically presents with pneumonia, characterised by fever, cough, dyspnea. The severity of the disease varies widely with evidence of mild disease in the majority of confirmed cases, severe pneumonia-dyspnea, hypoxia or lung involvement at imaging within 24-48 hours- and critical disease with respiratory failure, shock or multi-organ failure in particular patient cohorts. Imaging plays a key role is diagnosis and progression of this disease. |
Comparison of values relating to the texture parameters of tumors evaluated by MRI and ultra-high resolution CT between benign and malignant lesions using histological analysis as the standard of reference.~Comparison of the diagnostic performance of texture parameters derived from different MRI sequences and ultra-high resolution CT for musculoskeletal tumor characterization.~Evaluate the impact of ultra-high resolution with respect to standard resolution on CT images Comparison of the diagnostic performance of the texture parameters for the tumor on the diagnostic performance of texture analysis derived parameters for the characterization of musculoskeletal tumors.~Evaluate the effectiveness and accuracy of automatic artificial intelligence (AI) based tumor segmentation tools.~Evaluate the use of trabecular analysis on ultra-high resolution CT images for the evaluation of tumor-bone interfaces. | This study aims at evaluating the value of various artificial intelligence based techniques to improve the characterization and image post-processing for patients with musculoskeletal tumors. |
A 194-cm-long total-body positron emission tomography/computed tomography (PET/CT) scanner (uEXPLORER), has been constructed to offer a transformative platform for human radiotracer imaging in clinical research and healthcare. The objective of this study is to determine its specific effect in newly diagnosed nasopharyngeal carcinoma compared with conventional PET/CT and the quantitative kinetic parameters including glucose metabolic rate (Ki), glucose transport rate of flow-in (k1) and flow-out (k2) between tissue and blood, and glucosamine-6-phosphatization rate in tissue (k3). All the neck lymph nodes suspected for metastatic in PET/CT were biopsied under the guidance of ultrasound for a pathological diagnosis. | uEXPLORER total-body PET/CT in Nasopharyngeal Carcinoma |
Study hypothesis that people are tend to be depressed and the quality of life is affected negatively by Covid-19 pandemic. Although Turkey has affected moderately, the immediate change on depression and quality of life observable and measurable. It is aimed to investigate the depression and quality of life of Turkish society caused by Covid-19 pandemic and reveal the relationship between them. According to existing data and perspective of psychology and physiotherapy, potential solutions will be aligned. | It is aimed to investigate the depression and quality of life of Turkish society caused by Covid-19 pandemic and reveal the relationship between them |
Newly-diagnosed patients with stage III or IV non-metastatic Nasopharyngeal Carcinoma (AJCC 8th) will be recruited. All subjects receiving chemoradiotherapy will undergo a baseline integrated [18F]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) scan or traditional follow-up examination before the start of chemoradiotherapy.~NPC Patients receiving IMRT treatment will receive a dedicated FDG PET/CT and high-sensitivity PET/CT protocol simultaneously 12 weeks after the end of chemoradiotherapy (primary endpoint).~The results of FDG PET/CT and high-sensitivity PET/CT analyzed and compared. | NPC Patients receiving IMRT treatment will receive a dedicated FDG PET/CT and high-sensitivity PET/CT protocol simultaneously in the follow-up of Locally Advanced Nasopharyngeal Carcinoma. Hence we establish this prospective cohort study. |
The hypothesis of this study is that in contemporary practice, comprising the administration of multimodal analgesia, the continuous infusion of local anesthetic via a catheter remains superior in terms of analgesia at 24 h compared to a single-shot injection at the level of the interscalene brachial plexus after major shoulder surgery.~This prospective randomized monocentric superiority study will include two parallel groups: a SS (single-shot injection) group and a CI (continuous infusion) group.~All patients will have a preoperative ultrasound-guided interscalene brachial plexus block with 20 ml of lidocaïne 1% and epinephrine 1:100,000, followed by the insertion of a catheter. In the post-operative period, after clinical assessment of motor recovery in the operated limb (flexion of the forearm possible) in order to exclude any neurological damage of surgical origin, ropivacaine 0.5% 20 ml will be injected through the catheter. In the SS group, the catheter will be removed. In the CI group, a continuous infusion of ropivacaine 0.2% at a flow rate of 6 ml.h-1 will be running for 48h after the bolus administration of ropivacaine 0.5%.~In both groups, patients will receive during surgery multimodal analgesia inclusive of iv dexamethasone 8 mg, iv magnesium sulfate 40 mg.kg-1, iv ketorolac 30 mg, and iv acetaminophen 1000 mg, according to the current practice in our institution.~Assignment to one of these two groups will be done according to a computer-generated list of random numbers, and the sealed envelopes method will be used.~In the postoperative period, patients will be prescribed an iv pca of morphine. | The aim of this study is to study the analgesic efficacy of a continuous infusion of local anaesthetics for interscalene brachial plexus block after major shoulder surgery in the setting of multimodal analgesia, in order to determine whether the use of a catheter is still necessary in a contemporary practice. |
Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures. (Limit : 32 000 characters)~The soluble fms-like tyrosine kinase 1 (SFlt1) is the soluble form of VEGF-A receptor 1 (VEGFR1). By linking VEGF-A with a high affinity, sFlt1 blocks the VEGF-A / VEFR1 axis and impairs endothelial homeostasis. Its production increases during inflammation. We hypothesize that sFlt1 is upregulated and correlates with endothelial dysfunction and outcomes in critically-ill patients with COVID-19. | Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) The management of critically-ill patients with organ failure due to COVID-19 represents a major healthcare burden. While endothelial inflammation has been reported in these patients, the pathophysiological mechanisms remain incompletely elucidated. |
Oral disease and conditions can undermine self-image and self-esteem , dis-courage normal social interaction, and cause other health problems and lead to chronic stress and depression , They may also interfere with vital-functions such as breathing , food selection eating, swallowing and speaking, and with activities of daily living such as work, school, and family interactions .~Oral Health Related Quality of Life captures the aim of new prospective and defined as a multidimensional construct that reflects people's comfort when eating, sleeping and engaging in social inter-action, their self-esteem and their satisfaction with respect to their oral health .~Down syndrome (DS) is the most common neuro-developmental disorder of known genetic origin, arising from an extra copy of chromosome 21.~Children and adolescents with down syndrome present particular characteristics that may have a negative impact on their oral health and function. Protruding large tongue and facial muscle hypotonicity impairing speaking and chewing abilities. Bruxism, respiratory problems and mouth breathing are common among them.~Periodontal disease is the most significant oral health problem in people with Down syndrome due immunological deficiency, poor masticatory function and poor oral hygiene .~Another common oral manifestation associated with the syndrome is malocclusion. In this regard, mandibular protrusion, anterior open bite, and posterior crossbite have been reported as prevalent outcomes among DS individuals .~It has been shown that the impact of oral disease on Oral Health Related Quality Of Life of children with disabilities can be used in health service planning and priority setting.~Studies have recommended that people with a negative oral condition should receive treatment first , Hence this vulnerable group of children needs to be prioritized in the planning of health services and oral health care programs | The aim of the study is to evaluate Oral Health related quality of life of children and adolescents with down syndrome and Parental Perception, knowledge and Attitude on oral health conditions of children and adolescents with down syndrome |
Over 15 million family caregivers provide more than $200 billion in unpaid care to a person living with dementia (PLWD). This dynamic has been shown to influence the PLWD, as well as the physiological and psychological health of the caregiver. Depression and stress have been linked to caregiving, and both are independent risk factors for dementia. In addition to subjective indices of stress and depression, stress biomarkers have been shown to be higher in dementia caregivers vs. non-caregivers.~The complex caregiving experience depends on many factors, including the disease state of the PLWD, the nature of the relationship (spouse vs. child vs. friend), as well as the race, ethnicity, gender identity, and sexual orientation of the individuals involved. Informal caregiving for PLWD by lesbian, gay, bisexual, and transgender (LGBT) individuals continues to receive limited attention, and current research rarely examines how caregiving for PLWD affects the LGBT community. Estimates of the number of LGBT adult caregivers range from 27% to more than 45%.~Although the National Institutes of Health and the Institute of Medicine have recently emphasized the disparity in LGBT aging issues, little is known about stress experienced by LGBT caregivers compared with non-LGBT caregivers. Research with LGBT caregivers of PLWD has shown that they experience higher rates of physical, emotional, and financial strain, and are more likely to help with medical/nursing tasks. Higher levels of LGBT caregiver stress may be due to the fact that LGBT caregivers are less likely to seek out supportive services or disclose their LGBT identities. Higher rates of caregiving stress for LGBT caregivers may stem from years of stigma and failure of current interventions and resources to assess the unique stressors of LGBT persons adequately. Fear of discrimination, denial of services, and receiving poor-quality services may also contribute to reluctance to seek assistance. Moreover, LGBT persons are more likely to suffer from behavioral, psychological and physiological health issues than non-LGBT persons, all of which are independent predictors of Alzheimer's disease and related dementias (ADRD).~The Savvy Caregiver Program (SCP) was developed by Kenneth Hepburn PhD to train informal caregivers of community dwelling PLWD. The SCP consists of educational instruction and in-class exercises that engage participants on a functional level. Course material was designed to provide informal caregivers with the knowledge, skills, and attitude needed to carry out their role as a caregiver for a PLWD. The existing SCP is comprised of weekly, two-hour interactive classes, over six consecutive weeks. Dr. Hepburn and his team also created four, one hour and 45 minute long, videos to be used as a method of remote learning that cover the same material as the in-person program. These videos will be used in this study.~The primary goal of this study is to adapt the SCP to address the context-specific challenges faced by LGBT informal caregivers of PLWD, in preparation for a larger efficacy trial. The researchers will conduct focus groups to engage LGBT caregivers and a LGBT Community Advisory Board in the process of adapting the existing SCP to their needs. | The goal of this study is to adapt existing Savvy Caregiving Program (SCP) for lesbian, gay, bisexual, transgender (LGBT) caregivers of person living with dementia (PLWD). After watching the SCP Remote Learning videos, participants will attend a focus group to discuss how the program could be changed to meet the specific needs of LGBT caregivers of PLWD. |
This study will consists of 3 dose cohorts with 2-7 participants in each of the three ascending dose cohorts. Initially 2 participants will be dosed in Cohort 1, followed by dosing of up to 5 additional participants if the cohort is expanded. Participants in cohort 2 and 3 will receive 2-fold or 3-fold dose escalation to their respective preceding cohort doses if required. | The purpose of this study is to evaluate the safety and dose escalation of SHP648 an adeno-associated viral vector for gene transfer in hemophilia B participants. |
Chronic obstructive pulmonary disease (COPD) is considered a progressive but potentially treatable and preventable disease. The clinical view of COPD is moved from a lung-centered model to a novel one that considers COPD as an umbrella term encompassing different pulmonary and extra-pulmonary manifestations.~Prior researches suggest the presence of impaired lung function may be linked to cognitive impairment (CI). Among these studies, one prospective found that a diagnosis of COPD is associated with an increased risk of mild cognitive impairment (MCI), mainly nonamnestic MCI (NA-MCI), in a dose-response relationship between COPD duration and risk of MCI. Moreover, CI associated with severe COPD stage increases mortality. Among these studies only one shows that CI decreases adherence to pharmacological and non-pharmacological therapies. However, while it is well known that an MMSE score of 23-24 points or less is predictive of poor inhaler technique no studies report the impact of CI on PR outcomes. It has been reported that patients with MMSE < 24 walk lesser, at the basal level, than patients with a MMSE score > 24 (146 ±134 versus 242 ± 152 m) in the six minutes walking tests (6MWT) but no data are reported after rehabilitation. On the other hand, some papers report an association between participation in exercise rehabilitation programs and enhanced performance on cognitive tests.~The aim of this study is to compare cognitive functioning in patients with COPD referred for pulmonary rehabilitation to the response of the programme itself. More specific objectives of the present study are to:~Study whether and to what extent CI in patients with COPD impacts outcomes of pulmonary rehabilitation such as 6MW distance (6MWD), Barthel and Borg scales for assessing dyspnea, Maugeri Foundation Respiratory Failure Questionnaire and the disease-specific respiratory quality of life (QoL) [St. George's Respiratory Questionnaire (SGRQ) and the Medical Research Council (MRC)].~Investigate clinical and demographic characteristics of patients with COPD with cognitive impairment.~The hypothesize is that COPD patients with CI have worse response to PR compared with patients with no CI.~These results are important on the light of a personalized approach according to the so called P4 medicine, for predictive, preventive, personalized and participatory Recently, the so-called Rehabilomics research framework, initially introduced r in traumatic brain injury rehabilitation, was applied on COPD rehabilitation. The Rehabilomics represents an exclusive and distinctive model in the path of the personalized-medicine approaches to rehabilitation. Thus, in previousstudy the Rehabilomics-like approach was used to afford the complexity of COPD rehabilitation, incorporating social/demographic data (i.e. gender, education, presence of a caregiver) clinical, psychological/emotional traits, genetics (i.e. DNA variants) and biological factors (i.e. DNA damage, levels of interleukins, et cet.) in a real life setting. | Prior researches suggest the presence of impaired lung function may be linked to cognitive impairment (CI). A recent study shows that lung disease, and specifically Chronic obstructive pulmonary disease (COPD) are associated to a greater risk of CI in a population of 14,184 individuals followed for over 23 years. Moreover, the study shows that low forced expiratory volume in 1 second (FEV1) is associated to an increased risk of dementia and MCI, indipendently of smoking habit. |
The study is a prospective and longitudinal Randomised Control Trial (RCT) study with an Action Research (AR) participatory design approach, including mixed-method data collection, i.e., standardised instruments, interviews (face-to-face and telephone), diaries, observation, and time measurements. The timeline for the study is scheduled between autumn 2020 to spring 2022. The study will consist of two arms: A) an intervention group (n=80), who will receive standard care and information and the digital information tool; and B) a control group (n=80) who will receive standard care and information (verbal and written). Recruitment and randomisation will be completed at two hospitals in the South western part of Sweden.~As a pre-phase, a pilot study was performed for the development and testing of the digital information tool (Digi-Do), approved by the Regional Ethics Committee (Dnr 917-17) with 30 patients in total (15 women with breast cancer and 15 men with prostate cancer). According to the study's co-design, iterative methodology [26-27 in manuscript], changes have since been made to the digital information tool and a second version has now been developed for the full RCT. The present study has been approved by the Swedish Ethical Review Authority (Dnr 2020-00170). An ongoing systematic literature review will also guide the present study, and the project is registered in PROSPERO (PROSPERO;168073).~The digital information tool applied in this project is divided into two separate but coherent applications (apps) for mobile devices: one (VR-app) with a guided tour of the RT-department with a voice-over to describe 360 images to create a sense of actually having visited the department prior to start of RT, and one (information app) containing information obtained through the pre-treatment phase. If a VR-effect is not desirable, the patient can complete the simulated study-visit on their mobile phone or tablet as well as present the images in the browser of an integrated media player. Three areas of information are available in the information app: 1) Q&As from the existing written information, presented both in writing and a recorded voice; 2) practical information, such as maps, public transportation options with relevant links to public transport, telephone numbers, and information about possibilities for staying at the patient hotel; and 3) three short animated films about cancer and physical activity during RT. | This project uses participatory design combined with qualitative and quantitative methods to develop, explore and evaluate the usefulness of a digital information tool to prepare and support patients before, during and after RT as treatment for breast cancer. |
Patients admitted to hospital with confirmed COVID-19, and who meet the eligibility criteria will be invited to participate in the proposed study. Following the application of the informed consent form, they will collect the D-dimer (if they have not yet collected it routinely from the hospital) and confirm the value over the normal limit in patients with confirmed COVID-19, will be randomized to 2 groups in the 1:1 ratio. Group 1 will follow the strategy of routine use of full anticoagulation therapy (oral or parenteral when indicated); and group 2 will follow the usual standard care with in-hospital prophylactic anticoagulation (without routine full anticoagulation). | Pragmatic randomized clinical trial of patients admitted to the hospital with confirmed COVID-19 infection and elevated D-Dimer.~Randomization 1:1 - Group 1 will undergo a routine full anticoagulation (oral or parenteral when needed) strategy; and group 2 will receive usual standard of care with prophylactic anticoagulation |
The current study examines an adapted guided self-help stress reduction program, focusing on reducing stress in the time of COVID-19. Two studies are proposed: 1) an international study in English in which individuals proficient in English throughout the world will participate and 2) a study in Hebrew. The first study will publicize via social media and participants will be randomized to either immediate participation or a 6 week waitlist period. Assessments will be conducted pre, (again after waitlist for the control group), posttx (after completion/cessation of the program), 6 month and 1 year followup. Two forms of assessment will be conducted: pre-post-follow-up (with the CRISIS measure) and weekly during the program (via the DASS-21). For the full program see: https://www.iterapi.se/sites/coronastress/ | The current study examines an adapted guided self-help stress reduction program, focusing on reducing stress in the time of COVID-19. Two studies are planned: 1) an international study in English in which individuals proficient in English throughout the world will participate and 2) a follow-up study in Hebrew. |
Coronavirus disease 2019 (COVID-19) is an ongoing global pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and at present with no approved or proven antiviral treatment.~Imatinib is a tyrosine kinase inhibitor that has been approved for treatment of many hematologic and solid neoplasm. Imatinib is a weak base that compared to the extracellular compartment is enriched over 1000-fold in the lysosome within several hours as a result of its lysosomotropic property. Imatinib as a weak base accumulates in lysosomes resulting in some antiviral activities by lysosomal alkalization required for virus/cell fusion.~Imatinib demonstrates in vitro activity against SARS-CoV viruses. Imatinib inhibit SARS-CoV and MERS-CoV with micromolar EC50s (range, 9.8 to 17.6 μM) with low toxicity. The mechanism of action studies suggested that ABL-1 tyrosine kinase regulates budding or release of poxviruses and Ebola virus, demonstrating that the c-ABL-1 kinase signaling pathways play an important role in the egress of these viruses. It is also reported that kinase signaling may also be important for replication of two members of the Coronaviridae family, SARS-CoV and MERS-CoV. In vivo studies performed in the mouse model of vaccinia virus infection showed that imatinib was effective in blocking dissemination of the virus.~Imatinib has anti-inflammatory activity including its effectiveness in a two-hit murine model of acute lung injury (ALI) caused by combined lipopolysaccharide (LPS) and ventilator-induced lung injury (VILI). Imatinib significantly decreased bronchoalveolar lavage protein, total cells, neutrophils, and TNFα levels in mice exposed to LPS plus VILI, indicating that it attenuates ALI in this clinically relevant model. In another experiment, imatinib attenuated ALI when given 4 hours after LPS, suggesting potential efficacy when given after the onset of injury. Overall, these results strongly suggest the therapeutic potential of imatinib against inflammatory vascular leak and a potential role of imatinib combination therapy for patients with acute respiratory distress syndrome (ARDS) on mechanical ventilation.~The investigators hypothesize that addition of imatinib to the best conventional care (BCC) improves the outcome of hospitalized adult patients with COVID-19. This hypothesis is on the bases of 1) intralysosomal entrapment of imatinib will increase endosomal pH and effectively decrease SARS-CoV-2/cell fusion, 2) kinase inhibitory activity of imatinib will interfere with budding/release or replication of SARS-CoV-2, and 3) because of the critical role of mechanical ventilation in the care of patients with ARDS, imatinib will have a significant clinical impact for patients with severe COVID-19 infection in Intensive Care Unit (ICU). | This study is a randomized Double-Blind Placebo-Controlled Trial on the Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19 |
The psychotherapeutic interventions are going to be delivered from June to August at each participating center. Subjects will be allocated randomly in each of the two interventional arms independently by stratification in each participating center. The population for intervention will be medical staff from three different national hospitals in the frontline during the pandemic. After valid informed consent, a screening process will take place to identify symptoms as baseline evaluation using validated self-assessment tools delivered through electronic invitation. Post-intervention measurements will take place at 3 and 6 months from baseline. Intention to treat analysis and per-protocol analysis will take place. CONSORT guidelines were followed. | The purpose of this randomized controlled trial is to determine the effect of two behavioral interventions: brief cognitive-behavioral therapy and crisis intervention therapy through telepsychiatry, over the level of perceived stress, anxiety, depression and post-traumatic stress symptoms during the COVID-19 pandemic in medical residents and medical staff at three hospitals in two cities of Honduras. |
This is an interventional, comparative, randomized, controlled study versus reference treatment, in 2 parallel groups, double blind (patient and evaluator), multicenter, aiming to demonstrate the superiority of This is an interventional, comparative, randomized, controlled study versus reference treatment, in 2 parallel groups, double blind (patient and evaluator), multicenter, aiming to demonstrate the superiority of Dexmedetomidine over the absence of Dexmedetomidine, in adjuvantation of a loco regional anesthesia (interscalenic bloc of the brachial plexus + intravenous injection of Dexamethasone), on the prolongation of the analgesia, following a surgery of the rotator cuff of the shoulder under arthroscopy.~Patients will be randomized into 2 groups according to the treatment received:~Dexmedetomidine;~Nothing (control arm). The investigator (anesthesiologist) who will perform the randomization will not be blinded to the treatment. | The main objective of the study is to demonstrate the efficacy of Dexmedetomidine on the prolongation of analgesia obtained by interscalenic bloc of the brachial plexus and intravenous injection of Dexamethasone (efficacy objective). |
Using random digit dialing (RDD) sampling technique, RDD participants will be randomized to one of five introduction and consent combinations and then have them complete noncommunicable disease risk factor survey with an additional module regarding their understanding of the survey and of its voluntariness. This mobile phone survey will be sent as an interactive voice response (IVR). In IVR surveys, participants use their touch tone key pad to answer pre-recorded questions. (i.e. If you are male, press 1; If you are female, press 2). This study will be conducted in both Colombia and Uganda. | This study evaluates the effect of one new form of introduction language and three new modes of providing consent on interactive voice response (IVR) survey cooperation, response, refusal and contact rates, as compared to control group, in Colombia and Uganda. |
This study is a prospective, randomized, multi-center global investigation. Subjects will be randomized to either the WATCHMAN FLX Left Atrial Appendage Closure Device (Device Group) or a commercially available non-vitamin K oral anticoagulant (Control Group). | The primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation. |
The investigators aim to investigate the role of intramyocardial fat on ventricular arrhythmogenesis. Intramyocardial fat deposition has been frequently observed in patients with ischemic heart disease and is readily detectable by multi-detector computed tomography (MDCT) with high sensitivity and specificity, unlike other modalities. Like intramyocardial fat, reentrant ventricular tachycardia (VT) tends to occur late after the onset of myocardial infarction and the investigators hypothesize that lipomatous metaplasia within the infarct may precipitate later onset ventricular arrhythmias (VA). Prior studies have shown that intramyocardial fat correlates with slow myocardial conduction velocity and with critical circuits for VA but the investigators do not know the causal relationship between intramyocardial fat and future risk of VA.~Intramyocardial fat deposition or lipomatous metaplasia has been frequently observed in patients with ischemic heart disease and is readily detectable by multi-detector computed tomography (MDCT) with high sensitivity and specificity. Like intramyocardial fat, reentrant ventricular tachycardia (VT) tends to occur late after the onset of myocardial infarction and the investigators hypothesize that there may be a causal relationship. Prior studies have shown that intramyocardial fat correlates with slow myocardial conduction velocity and with critical circuits for VT in patients referred for VT ablation who already manifest VA.~However, the correlation of intramyocardial fat on CT with late gadolinium enhancement (LGE) on cardiac magnetic resonance (CMR) in a general population of patients with ischemic cardiomyopathy with no prior history of VA has not been reported. Specifically, it is unknown whether the presence, distribution and/or volume of fat is an independent predictor of VA. Further CMR is less widely available in medical centers, and is more expensive with longer scanning times compared to CT. CT provides higher spatial resolution, is widely available and is not as susceptible to magnetic interference from internal cardiac defibrillator (ICD) generators and thus makes it an attractive imaging modality for risk stratification, particularly longitudinally over time.~Hypothesis: The investigators' objective is to define the prevalence and distribution of intramyocardial fat in patients with ischemic heart disease scheduled for or with in-situ implantable defibrillators. Further, the investigators aim to assess the independent association of intramyocardial fat with VA and determine whether it adds any utility above LGE measured by CMR. Finally, the investigators will assess how well delayed enhanced CT correlates with LGE on MRI and test its association with ventricular arrhythmias.~Importance: The significance of the investigators' research is that the investigators will: 1) test whether intramyocardial fat on CT can be used as a non-invasive tool for sudden cardiac death risk stratification in patients who have or are scheduled to undergo ICDs, and 2) define whether delayed enhancement CT is comparable to the current non-invasive gold standard of CMR for identifying myocardial scar. | This research is being done to determine how well cardiac computed tomography (CT) scanning measures of fat within the heart can predict abnormal heart rhythms and how well cardiac CT can measure scar within the heart versus cardiac magnetic resonance imaging (MRI).~People who have been enrolled in PROSe-ICD (NA_00045142) and Reynolds (NA_00037404) studies may join~The procedures, tests, drugs or devices that are part of this research and will be paid for by the study |
Laparoscopic and robotic surgery has revolutionized post-operative outcomes across surgical specialties. However, the use of pneumoperitoneum comes with known risks given the change in physiological parameters that accompany its utilization. The effects of increased intra-abdominal pressure on cardiopulmonary function has been well documented. Increased pressure on the large vessels may lead to decreased cardiac output and thereby decreased blood flow to various organ systems and cause irreversible damage. Some studies have advocated lower pressures to further optimize cardiopulmonary parameters. McDougall, et. al, for instance, demonstrated a significant reduction in oliguria when pressures of 10mm Hg were used. The purpose of this study is to evaluate the effect of using lower pressure pneumoperitoneum in the abdominal cavity during RARP. The investigators hypothesize that low pressure pneumoperitoneum has a multitude of clinical benefits due to improved physiologic parameters including a reduction in the occurrence of post-operative ileus, reduced need for narcotics post operatively, and a decrease in cardiopulmonary complications. A previously completed study concluded a reduction in post-operative ileus at a pneumoperitoneum pressure of 8 mm Hg vs 12 mm Hg. This new study will evaluate the standard pneumoperitoneum pressure of 15 mm Hg vs 12 mm Hg in order to validate the previous study vs the standard pneumoperitoneum pressure.~The study is a prospective randomized blinded cohort study. Patients who meet eligibility criteria will be randomly assigned to undergo RARP at a pneumoperitoneum pressure of 15mm Hg or 12mm Hg. This will be done by computer generated randomization protocol. Surgeon and patients will be blinded to the pneumoperitoneum pressure used. A cover will be placed over the insufflation system so that the surgeon(s) are not able to visualize the pneumoperitoneum used during the procedure. The remainder of the procedure will be carried out based on current standard of care. All patients will be admitted post operatively and the same standardized orderset in EPIC EHR will be used for all patients in order to control for other factors, such as opioid use, to control for confounders. | The purpose of this study is to evaluate clinical significance of low pressure pneumoperitoneum during robotically assisted radical prostatectomy (RARP). |
Cardiovascular disease (CVD) remains the leading cause of death in most developed countries, including the United States. A key risk factor for CVD is an elevation in low-density lipoprotein cholesterol, or LDL-C. Based on favorable results from large clinical trials, guidelines support the use of high intensity statin therapy for the reduction of LDL-C in very high risk patients and addition of non-statin therapies including ezetimibe and PCSK9 inhibitors if the LDL-C remains above 70 mg/dL. However, implementation of these guidelines is poor and there remains substantial underuse of evidence-based lipid lowering therapies across healthcare systems.~Real-time alerting to important clinical conditions, when fired in an appropriate and timely manner, can have positive impacts on patient outcomes through increased physician awareness and adherence to best practices. To this end, this study has been designed to evaluate whether automated electronic alerts built into the Epic electronic health record can improve the management of hyperlipidemia among patients of outpatient internal medicine and cardiology practices within the Yale New Haven Health System who are at very high risk for future atherosclerotic CVD (ASCVD) events.~One hundred physicians will undergo cluster randomization to either the alert group or the control (usual care) group. Upon opening the order entry screen of an eligible patient with hyperlipidemia, the alert group will receive an informational alert that informs the provider that the patient has hyperlipidemia and is at very high risk for future ASCVD events and provides ACC/AHA-guideline-directed actionable items, including a link to a hyperlipidemia order set to include both diagnostic and therapeutic options.~The primary outcome will be the proportion of patients who have intensification of their lipid lowering therapy (increase in statin dose or addition of ezetimibe or addition of a PCSK9 inhibitor) at 90-days. The secondary outcomes will be achieved LDL-C at 6-months and proportion of patients with LDL-C levels less than 70 mg/dL and less than 55 mg/dL. In an optional extension phase, long-term exploratory outcomes looking at the rate of major cardiovascular cardiac events (MACE), defined as hospitalization for myocardial infarction, stroke, unstable angina, or coronary or peripheral artery revascularization will be evaluated at 2 years. | This study is designed to evaluate the efficacy of automated electronic alerts in the electronic health record to improve rates of best practices in the treatment of patients with hyperlipidemia who present in the setting of outpatient primary care and family medicine practices within the Yale New Haven Health System. |
This investigation enrolled patients with unresectable and/or metastatic soft tissue sarcoma not responsive to the first-line treatment based on anthracycline/ifosfamide. Patients underwent trabectedin monotherapy that was administered intravenously at the dose of 1.3 mg/m2 every 21 days.~Single overnight fasting urine and blood samples were collected on day-1 of the first trabectedin administration.~Plasma pharmacokinetics was performed during cycle 1. Blood samples, drawn from a site separate from the drug infusion site, were obtained prior to the infusion (basal) at 2, 8, 24 (end of infusion) and 0.5, 1.0, 4.0, 8.0, 24.0 after the end of the infusion. Plasma concentrations of trabectedin were measured by liquid chromatography, tandem mass spectrometry assay (LC-MS/MS) and the pharmacokinetic parameters (Cmax, Clearance, AUC and T1/2) were calculated from the concentration-time curve using a non-compartmental model.~Metabolomics profiles were explored by LC-MS/MS in predose urine and serum and encompassed a total of 192: a) 45 amino acid derivatives, virtually involved in a wide set of biochemical pathways; b) 40 different acylcarnitines, principally involved in the cellular energy metabolism; c) 15 lysophosphatidylcholine metabolites, 77 phosphatidylcholine derivatives, and 15 sphingomyelins, involved in fatty acid metabolism and cellular signaling. The identification of predictive metabolomics biomarkers is performed using univariate and multivariate statistical analyses. | This perspective, mono institutional study is addressed to find potential serum and urine biomarkers predictive of the pharmacokinetic and pharmacodynamic profile of soft tissue sarcomas patients treated with trabectedin. |
Heart failure is the most common cause of mortality and morbidity in the United States and in Western Europe. However, patient etiology and prognosis varies considerably, and guidance about how to best treat patients has relied on large clinical trials that only include snapshots of the syndrome (at the time the patient interaction with the healthcare system). It remains to be seen whether behavioral interventions can improve patient engagement, increase self-management of the conditions, and thus improve overall clinical outcomes.~Digital health technologies have a great potential to streamline and optimize the clinical management of heart failure. Such technologies can take the form of mobile applications or wearable devices that may provide both patients and providers with valuable real-time information about patient status and cardiovascular health, provide automated patient-tailored coaching and motivational tools, or a mix of both. Integration of these technologies into healthcare systems may allow for genuine engagement of the patient in their own care and management of their disease and/or enhance clinical decision making. To date, no prior study has comprehensively examined the ability of digital heath technologies to improve self-management of heart failure or subsequent clinical outcomes.~This study is an unblinded, 4-arm, parallel group randomized controlled trial to measure the efficacy of four digital health technologies in improving the management of care and quality of life of patients with congestive heart failure (CHF). Patients actively managed by one of Yale New Haven Hospital's heart failure-based clinics will be eligible for this study and approached for consent. Enrolled subjects will be randomized to one of four groups: a control (usual care) arm, or to one of three intervention arms, each of which assesses one of three digital health technologies. These technologies are:~BodyPort: A data-driven smart scale that provides enhanced cardiac monitoring and risk assessment data.~Noom: A live, data-driven coaching application providing personalized diet and weight management.~Conversa: An automated conversational platform providing patient motivation and educational tools for CHF management.~Patients will be enrolled in the study for 6 months. The first three months will typically involve active clinic management and will be the point of our primary outcome assessment, while the final three months will assess stability of effect on patient care and outcomes.~The primary outcome is the rate of improvement in quality of life after 90 days post-enrollment, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). A variety of prespecified secondary outcomes will be measured to determine effects on patient outcomes, quality of care, clinical efficiency, and provider and patient satisfaction with the product. | The purpose of this study is to determine the efficacy of three novel digital health technologies versus usual care in the management of congestive heart failure, as assessed by a primary outcome of improvement in quality of life, and a variety of secondary outcomes that include metrics measuring patient and provider satisfaction, clinical efficiency, and patient outcomes. |
Upper limb spasticity greatly affects the hand functions of patients with cerebral palsy (CP) and impairs quality of life. The most important goal in rehabilitation; despite the existing deficiencies, the highest level of functional independence of the patient is to increase the quality of life. EMG-triggered biofeedback electrical stimulation (EMG-triggered-BF-ES) increases the patient's active participation and motivation in rehabilitation, creates visual or auditory BF, provides muscle reeducation, decreases spasticity, prevents atrophies and increases joint mobility and increases muscle functionality by increasing the patient's functionality. There are areas of use the EMG-triggered-BF-ES such as cerebrovascular disease (CVO), spinal cord injury, and CP. When the literature is examined; studies were found to be few, and no study evaluating the upper extremity was found in children with CP. The purpose of our study is the investigation of the effects of EMG-triggered-BF-ES treatment applied on hand functions, muscle strength, and quality of life in patients with CP. | The purpose of our study; to investigate the effects of EMG-induced ES treatment on hand functions, muscle strength, and quality of life in patients with hemiplegic CP. |
Primary objective: to validate the usefulness of the esophageal print in avoiding temperature rises caused by radiofrequency (RF) application at the left atrial (LA) posterior wall during atrial fibrillation ablation~Secondary objectives:~to establish if there is a linear relationship between intraesophageal temperature rise and atrio-esophageal distance as calculated by the MDCT-derived esophageal print.~to analyze the need for ablation line modification.~to analyze the need for energy (power settings, ablation index, ablation time, etc.) modification.~to develop a new multimodal approach to esophageal monitoring during AF/AT ablation.~Interventions~Pre-procedural scan and Esophageal Isodistance Print~The methods for the acquisition of the cardiac MDCT and the image processing have been described in Part 1. During the segmentation process, the epicardial layer of the posterior atrial wall and the esophageal wall have been defined. The distance between these two structures is computed at each epicardial point, allowing to create an esophageal print on top of the epicardial layer. The isodistance color map uses a color scale to depict a range of distance; red being the closest (< 1 mm) and purple being the most distant (> 4 mm). Yellow, green and blue will be considered the intermediate values.~Luminal esophageal temperature (LET) monitoring~A multi-thermocouple temperature probe (SensiTherm, St. Jude Medical, Inc., St. Paul, MN, USA) will be advanced via transnasal or transoral access into the esophagus once the patient is under general anesthesia. When the esophageal print is close to the ablation line, the temperature probe position will be adjusted under fluoroscopic guidance before application at each pair of pulmonary veins to ensure that it overlaps the ablation line. All esophageal temperature rises above 39 °C will be documented and RF application will be stopped.~Pulmonary vein ablation lines regarding Esophageal Isodistance Print~Before randomization, an investigator blinded to the esophageal position will draw the PVI ablation line around both pairs of veins based on the type of AF (closer to the ostium for paroxysmal AF and wider for persistent AF). | A multimodal strategy integrating esophageal visualization with the multidetector computed tomography (MDCT) and simultaneous temperature monitoring has never been put into practice. We have developed an isodistance map (esophageal print) to depict the atrio-esophageal relationship and to analyze the esophageal position peri procedurally. The present randomized study intends to analyze the usefulness of the esophageal print in predicting local thermal heating of the esophagus. |
With this study, the study team hopes to address two important unanswered questions: (1) Does combination treatment consisting of duloxetine and web-based Cognitive Behavioral Therapy (CBT) optimize treatment outcomes? (2) Would adherence-focused guidance delivered by nurse clinician using motivational interviewing (MI) techniques enhance treatment effectiveness? This study is significant because the study team aims to optimize pain-related treatment outcomes at the primary care level where most patients with pain are managed. Importantly, the use of nurse clinician providing adherence-focused guidance (as opposed to content-focused guidance) on the continued practice (or use) of pain coping skills increases the likelihood that the study's intervention is scalable in the future. Effective, accessible and scalable psychoeducational treatments are needed to manage CMP in real world clinic settings. | The purpose of this research is is to determine if the combination of non-opioid medication (duloxetine) and web-based pain-coping skills training (PCST) is beneficial for individuals with chronic musculoskeletal pain (CMP). |
This study is an open label, prospective, multicenter, non-randomized single-arm study to evaluate the safety and efficacy of the closing iatrogenic atrial septal defects in patients undergoing transcatheter mitral valve procedures using large sheaths.~A maximum of 5 Clinical Sites (referred to as Sites in the remainder of this document) in the U.S. Two hundred and ten patients will be enrolled in this study. The patients will randomized 1:2 device: control. The anticipated accrual rate is approximately 20 Subjects per month for a total accrual period of approximately 12-18 months.~Patients may be enrolled into the study provided all inclusion and no exclusion criteria are met as specified in Section 4. Subjects will be evaluated through hospital discharge and return for follow-up visits at 30 days, 6 months, and 12 months. | This is an open-label, randomized, controlled trial of iatrogenic atrial septal defect closure with the an atrial septal occluder versus usual care observation in patients post-mitral valve intervention requiring large bore transspetal access. |
The study population will be patients (≥18 years) hospitalized by COVID-19 but still with an early form of the disease (in states 1-3 of the ordinal scale) who do not require mechanical ventilation (invasive or non-invasive) and who can give their consent informed.~All the participants will receive non-specific supportive treatment for COVID-19 such as oxygen, IV liquid or corticosteroids. Additionally, they will be randomized to one of the following arms:~Experimental arm 1: Plasma with inactivation/reduction of pathogens from convalescent patients with COVID-19 and who at the same time receive support therapy, in the 200 - 250 mL scheme, on days 1 and 3 of the intervention.~Experimental arm: Anti-COVID-19 human immunoglobulin produced by Lifefactors Zona Franca S.A.S, intravenous at a dose of immunoglobulin 10% IgG solution (10% mL vial) for:~Patient of 50 Kg or more, a dose of 50 mL will be applied on days 1 and 3 of treatment.~Patients of less than 50 Kg, the dose will be 1 mL / Kg, will be applied on days 1 and 3 of treatment.~This arm will be included once available. The supply of anti-COVID-19 human immunoglobulin produced by LifeFactors will be carried out once the national regulatory agency (Invima) grants authorization and/or the regulatory requirements for the production of medications are met.~Control arm: Standard (specific) therapy for COVID-19 according to the suggested pharmacological recommendations of the Colombian Association of Infectious Diseases - ACIN. This therapy is subject to changes that are determined by the Colombian Health Regulatory Authorities. | A randomized, open-label, multicenter, three-arm clinical trial to study the efficacy and safety of passive immunotherapy (convalescent plasma and anti-COVID-19 human immunoglobulin) compared to the standard treatment in Colombia. |
This study is a prospective phase II non-inferiority study investigating tocilizumab as a potential alternative to anti-thymocyte globulin (ATG) in haplo-cord transplantation. It is a single-center study based at Weill Cornell Medicine/NewYork Presbyterian Hospital.~The hypothesis is that tocilizumab is a safe and effective alternative to ATG in haplo-cord transplantation, facilitating transient engraftment of the haplo-identical stem cell graft without prolonged neutropenia or second nadir prior to durable cord engraftment while also preventing graft versus host disease (GVHD).~This study plans to enroll patients with hematologic malignancies in need of alternate donor transplant. All subjects will be conditioned with fludarabine, melphalan and total body irradiation (TBI), followed by a single dose of tocilizumab 8 mg/kg on Day -1. Patients will be enrolled into 4 successive cohorts, initially administering the current standard 3 doses of ATG 1.5 mg/kg (total 4.5 mg/kg). In the absence of safety signals, we will drop one dose of ATG in successive cohorts until the drug ultimately has been eliminated.~The primary endpoint of the study is successful haplo-derived neutrophil engraftment. Treatment will only be of interest if there is evidence that this rate is greater than 60%. If there are 4 or fewer successes, that dose group will be deemed unacceptable and the next higher ATG dose for which there were 5 or more success will be expanded. | The purpose of this study is to evaluate the safety of reducing and ultimately eliminating anti-thymocyte globulin (ATG) from the haplo-cord transplant conditioning regimen and replacing it with tocilizumab, an IL-6 receptor monoclonal antibody, to improve immune reconstitution and reduce relapse while preserving low rates of graft failure and graft versus host disease (GVHD). |
Purpose: Otitis media with effusion is an important problem in childhood. After proper diagnosis, generally 3 months of follow up has been recommended before surgical tympanostomy tube insertion. If the physician can estimate the status of the middle ear or fluid type better with a non-invasive method, we can suggest an early operation to these patients or decide to follow up more with no intervention. The purpose of the study is to compare the surgically confirmed middle ear effusions with wideband absorbance values and to differentiate them noninvasively before the operation.~Methods: A total of 123 children that were followed 3 months and treated surgically with the diagnosis of OME were included. Eighty-two sex, age-matched children were tested as control with wideband tympanometry. Ears were divided into four groups according to findings in the operation: serous, mucoid, adhesive, empty. Resonance frequency, 226 Hz, 1000 Hz compliance, Wideband Peak pressure, Absorbance measurements used for comparison. | The investigators asked the question if they can better estimate the middle ear status in OME that help them to decide between early intervention or longer follow up. |
See above | A multicentre, interventional, double-blind, placebo-controlled, parallel-arm, phase 3, randomised controlled trial to evaluate the use of co-trimoxazole as primary prophylaxis for spontaneous bacterial peritonitis to improve overall survival |
This study is a prospective observational human factors usability study designed to evaluate the Instructions For Use (IFU) in the SARS-CoV-2 Specimen Collection Materials based on the successful completion of self-collection of a nasal swab sample, which includes a valid SARS-CoV-2 test result. | The primary objective is to determine the usability of the SARS-CoV-2 Specimen Collection Materials for at-home collection and mailing of sample to the testing laboratory. |
BACKGROUND:~In February, the first case of SARS-CoV2 positive patient was recorded in Lombardy (Italy), a virus capable of causing a severe form of acute respiratory failure called Coronavirus Disease 2019 (COVID-19).~Qualitative assessments of lung morphology have been identified to describe macroscopic characteristics of this infection upon admission and during the hospitalization of patients.~At the moment, there are no studies that have exhaustively described the parenchymal lung damage induced by SARS-CoV2 by quantitative analysis.~The hypothesis of this study is that specific morphological and quantitative alterations of the lung parenchyma assessed by means of CT scan in patients suffering from severe respiratory insufficiency induced by SARS-CoV2 may have an impact on the severity of the degree of alteration of the respiratory exchanges (oxygenation and clearance of the CO2) and have an impact on patient outcome.~The presence of characteristic lung morphological patterns assessed by CT scan could allow the recognition of specific patient clusters who can benefit from intensive treatment differently, making a significant contribution to stratifying the severity of patients and their risk of mortality.~This is an exploratory clinical descriptive study of lung CT images in a completely new patient population who are nucleic acid amplification test confirmed SARS-CoV2 positive.~SAMPLE SIZE (n. patients):~The study will collect all patients with the inclusion criteria; a total of 500 patients are expected to be collected.~About 80 patients will be enrolled for each local experimental center.~The following patient data will be analyzed:~blood gas analytical data assigned to the CT scan, checks performed upon entering the hospital, at the time of performing the CT scan, admission to intensive care and 7 days after entry~patient characteristics such as age, gender and body mass index (BMI)~comorbidity~presence of organ dysfunction with the Sequential Organ Failure Assessment (SOFA)~laboratory data relating to hospital admission and symptoms prior to hospitalization.~ventilator and hemodynamic parameters upon entering the hospital, at the time of carrying out the CT scan, upon admission to intensive care and 7 days after entry.~The machine learning approach of lung CT scan analysis will aim at evaluating:~Quantitative and qualitative lung alterations;~The stratification of such morphological characteristics in specific morphological lung clusters identified by the means of artificial intelligence using deep learning algorithms.~ETHICAL ASPECTS:~The lung CT scan images will be collected and anonymized. Images will be subsequently sent by University of Milano-Bicocca Institutional google drive account to the University of Pennsylvania, Department of Anesthesiology and Critical Care and the Department of Radiology in a deidentified format for advanced quantitative analysis taking advantage of artificial intelligence using deep learning algorithms.~The data will be collected in a pseudo-anonymous way through paper Case Report Form (CRF) and analyzed by the scientific coordinator of the project.~Given the retrospective nature of the study and in the presence of technical difficult in obtaining an informed consent of patients in this period of pandemic emergency, informed consent will be waived.~STATISTICAL ANALYSIS:~Continuous data will be expressed as mean ± standard deviation or median and interquartile range, according to data distribution that will be evaluated by the Shapiro-Wilk test. Categorical variables will be expressed as proportions (frequency).~The deep learning segmentation algorithm will segment the lung parenchyma from the entire CT lung. Lung volume, lung weight and opacity intensity distribution analysis will be applied. Second, clustering analysis to stratify the patients will be performed. Both an intensity and a spatial clustering algorithm will be tested. Third, a model will be trained to predict the injury progression using the images and all other patient data. Statistical significance will be considered in the presence of a p<0.05 (two-tailed). | This is a multicenter observational retrospective cohort study that aims to study the morphological characteristics of the lung parenchyma of SARS-CoV2 positive patients identifiable in patterns through artificial intelligence techniques and their impact on patient outcome. |
A prospective, open-ended, single-arm, phase II clinical study.Patients are with metastatic, recurrent, persistent cervical cancer (squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma) To observe the efficacy and safety of ZL-2306 (Niraparib) combined with Brivanib or Toripalimab in patients with metastatic, recurrent and persistent cervical cancer, and to explore the biomarkers of effectiveness. | A Clinical Proof-of-concept Study Evaluating Efficacy and Safety of ZL-2306 (Niraparib) Combined With Brivanib or Toripalimab in Patients With Metastatic, Recurrent, and Persistent Cervical Cancer |
Lung cancer is one of the most common cancers and it represents the main cause of cancer mortality worldwide.~It is histopathological classified into main groups: Small cell lung cancer (15%) and Non-small cell lung cancer (85%). NSCLCs are generally subcategorized into adenocarcinoma, squamous cell carcinoma (SqCC), and large cell carcinoma. Positron emission tomography (PET) is now an important cancer imaging tool, both for diagnosis and staging, as well as offering prognostic information based on response.~PET sets the gold standard in the evaluation of an indeterminate solitary pulmonary nodule or mass, where PET has proven to be significantly more accurate than computed tomography (CT).~For NSCLC chest CT is the standard imaging modality for assessing primary tumor size and identifying its margins. PET-CT may be helpful in assessing a nodule located in same lobe. It can also provide information on parietal or mediastinal involvement. PET is useful for differentiating tumor tissue from atelectasis, which may be helpful if radiotherapy is planned to determine the target volume .~In the evaluation of metastatic spread to loco-regional lymph nodes, PET is significantly more accurate than CT, so that invasive surgical staging may be omitted in many patients with negative mediastinal PET images.~In patients with positive mediastinal PET images, invasive surgical staging remains mandatory because of the possibility of false-positive findings due to inflammatory nodes or granulomatous disorders.~Forty percent of patients with NSCLC have distant metastases at presentation, most commonly in the adrenal glands, bones, liver, or brain .~In the search for metastatic spread, PET is a useful adjunct to conventional imaging. This may be due to the finding of unexpected metastatic lesions or due to exclusion of malignancy in lesions that are equivocal on standard imaging. However, at this time, PET does not replace conventional imaging.~The diagnostic accuracy of initial pre-therapy PET-CT results in improved staging, and thus is of high prognostic value.~Many studies conducted the value of using semi-quantitative measures as metabolic tumor volume (MTV) and Total lesion glycolysis (TLG) in predicting prognosis and survival rather than the traditional method of measuring Standard uptake value (SUV).~Several studies have demonstrated that PET imaging proves useful for assessing the response to chemo therapy or targeted therapy in patients with metastatic NSCLC. | Describe strengths and limitations of FDG PET/CT for staging. Evaluate the utility of PET/CT in assessment of therapy response and restaging |
This is a Phase 2, multicenter, single-arm, open label study of AB-106 in the Chinese patients of NSCLC harboring with ROS1 fusion gene.~The study will consist of 2 parts. The Part 1 portion will evaluate the safety and PK profile of AB-106 by using two doses of 400mg QD and 600mg QD in order to confirm 600mg QD as the most optimal dose.~The Part 2 portion will evaluate the efficacy and safety of AB-106 by using the most optimal dose of 600mg QD.~It is expected to enroll 6 patients in Part 1 and 100 patients in Part 2. The study period of each patient will be comprised of screening, treatment, safety follow-up and survival follow-up.~In the Part 1 portion, 3 patients will receive AB-106 400mg QD and 3 patients will receive AB-106 600mg QD in 21-cycles to evaluate the safety and PK profiles.~In the Part 2 portion, 100 patients will be enrolled and divided into 2 cohorts. 60 crizotinib-naïve patients will be enrolled in Cohort A and 40 crizotinib-pretreated patients will be enrolled in Cohort B.~AB-106 will be administered 600mg once daily in 21-day cycles. Patients will continue with the study treatment until progression of disease as determined by the investigator.~The tumor response evaluation will be conducted in every two cycles in the first 8 cycles, and then every four cycles until progression of disease as determined by the investigator. The long-term survival follow up will be conducted every 12 weeks. | The purpose of the study is to evaluate safety, pharmacokinetics and efficacy of AB-106 monotherapy in the treatment of advanced NSCLC. |
In this Phase I open-label interventional study we will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection. Patients being treated will have severe respiratory symptoms that are at or near requiring the patient be placed on a ventilator. | This is a Phase I open-label interventional study which will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection. |
Cerebral Palsy is responsible for the most common neurological disorders in children. Although the primary lesion is non-evolutionary, the secondary consequences are evolutive, with neuro-orthopaedic degradation leading to soft tissue retraction and osteo-articular deformities. Hemiplegia occurs in approximately 30% of cases of Cerebral Palsy, and tone disorders (spasticity, dyskinesia) affecting the upper limb generally impact function, both in unilateral capacities (range of motion, dexterity, and fluidity of movement), and in bimanual performance. The focal treatment of spasticity by botulinum toxin injections, in combination with specific occupational therapy training, has proven to be effective in improving targeted functional goals. However, there is little evidence today of the effectiveness of treatment for the management of upper limb retraction and deformity, whether by stretching, orthosis/plaster or even surgery. And apart from its effectiveness on body structure, the functional effects of upper limb surgery in Cerebral Palsy have been little explored. The aim of the study is to investigate the impact of individualized multisite neuro-orthopedic surgery of the upper limb in children with Cerebral Palsy on unilateral functional capacities and bimanual performance, by using such tools as the Melbourne Assessment (Version 2) and the Assisting Hand Assessment (Version 5.0). | The aim of the study is to investigate the impact of individualized multisite neuro-orthopedic surgery of the upper limb in children with Cerebral Palsy on unilateral functional capacities and bimanual performance. The investigators also assessed the attainment of individualized goals and tracked any potential factors that may have an impact on final results. |
A detailed description can be found in the study protocol published in Trials in Dec 2020:~Tverring, J., Åkesson, A. & Nielsen, N. Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19: a pragmatic randomised clinical trial (COVID HELMET). Trials 21, 994 (2020). https://doi.org/10.1186/s13063-020-04863-5 | We aim to investigate whether the use of Continuous Positive Airway Pressure using a Helmet device (Helmet CPAP) will increase the number of days alive and free of ventilator within 28 days compared to the use of a High Flow Nasal Cannula (HFNC) in patients admitted to Helsingborg Hospital, Sweden, suffering from COVID-19 and an acute hypoxic respiratory failure. |
Background and project rationale:~Cystic fibrosis (CF), the most common lethal inherited disease in Caucasian populations, affects approximately 1:2500 live births. It is a multisystem disorder with respiratory morbidity and mortality being the leading cause of death. Despite improved survival in successive birth cohorts, the current median survival age of patients with CF is about 40 years. To improve survival, it is essential to understand the development, progression and treatment of CF lung disease throughout early childhood. Therefore tracking of lung function throughout childhood may provide important insights into the development and progression of CF lung disease. Spirometry, the standard lung function test for decades, is sensitive only for airflow limitation arising in large airways and insensitive for assessment of small or peripheral airway involvement, whereby the CF lung disease emerges in the small airways. Two promising techniques to assess small airway function in young children include the multiple breath washout (MBW) lung function test and functional Matrix-Pencil magnetic resonance imaging (MP-MRI).~Project Objectives and Design:~The overall objective of this project is to prospectively assess the clinical utility of MBW and MP-MRI in the longitudinal clinical surveillance of patients with CF. Therefore this study: i) Examines differences in MBW and MP-MRI outcomes between patients with CF and healthy controls. ii) Assesses the short term (over 1h) repeatability of MBW and MP-MRI outcomes in patients with CF and healthy controls. iii) Assesses whether MBW and MP-MRI outcomes are associated with clinical lung disease in patients with CF. iv) Determines whether changes in MBW and MP-MRI outcomes are associated with progression of lung disease in patients with CF. v) Compares the breath-by-breath regional and temporal changes in functional MRI signal with breath-by-breath changes in MBW phase outcomes in patients with CF and healthy controls.~Methods:~Data of MBW, MP-MRI, morphological MRI, Spirometry and body plethysmography, clinical respiratory symptoms and microbiology will be collected during this study.~Recruitment and participation:~Children and adults with CF will be recruited from the outpatient and inpatient clinics at the Inselspital in Bern. Healthy controls will be recruited from the local community in Bern and surrounding areas.~Information collected:~Lung function:~Multiple Breath Washout (FRC, LCI, Scond, Sacin)~Spirometry (FEV1, FVC, FEFx)~Body plethysmography (sReff, FRCpletz, TLC)~Respiratory symptoms and clinical data:~CF:~respiratory symptoms (cough, sputum characteristics, shortness of breath, weight loss, appetite fatigue)~clinical data (increased work of breathing, hypoxemia, wheeze, crackles, differential air entry)~Healthy controls:~Presence of respiratory symptoms in the last four weeks preceding visit.~Functional and structural MRI:~Functional MRI (percentage of the lung volume with impaired fractional ventilation (RFV) and relative perfusion (RQ)~Structural MRI( Eichinger MRI scoring system to assess the presence and extent of bronchiectasis, mucous plugging, and air trapping)~Medical history:~CF: demographics, genetic mutation, pulmonary exacerbations, hospitalisations, regular therapy and medication, complications, microbiological data and laboratory reports~Microbiology:~CF: bacterial analysis of oropharyngeal swabs~Quality of life:~CF: CF-specific quality of life and symptoms~Sputum:~CF:~spontaneously expectorated sputum~Induced sputum~Study database:~All study data is recorded in an Access-database with SQL Servers. The database is accordant to the HFG and was adapted together with the CTU.~Funding:~The Swiss National Foundation (32003B_182719) and Vertex-Pharmaceuticals Cystic Fibrosis Research Innovation Award provide financial and material support for this observational study | Cystic fibrosis (CF) is the most common lethal inherited disease in Caucasian populations. To improve survival, it is essential to understand the development, progression and treatment of CF lung disease throughout early childhood.~Therefore the overall objective is to prospectively assess the clinical utility of novel and non-invasive measuring methods, namely Multiple Breath Washout and functional lung MRI in the longitudinal clinical surveillance of patients with CF and compare the results to those of healthy controls. |
Heart Failure with Preserved Ejection Fraction (HFpEF) is becoming increasingly prevalent, yet diagnostics, characterization and prognosis of the disease is still uncertain. Multiple contributing factors have been implicated in the development of HFpEF such as but not limited to myocardial fibrosis, myocardial edema, ventricular remodeling, metabolic dysfunction, coronary microvascular dysfunction, ischemia, systemic effects and associated ventricular-arterial coupling. However, how the longitudinal progression of these factors is associated with HFpEF and whether a causal effect between the pathologic features in HFpEF exist, is not fully understood.~Using cardiovascular magnetic resonance (CMR), multiple cardiac and extracardiac parameters can be investigated in a single non-invasive imaging exam. This will be a single-centre prospective observational longitudinal study with the formation of a database. Patients will undergo a comprehensive CMR exam upon recruitment, 1- and 5-years after enrolment, and also if re-hospitalisation for heart failure occurs. This exam will investigate multiple measures of cardiovascular function, myocardial deformation, edema, fibrosis and oxygenation, 4D haemodynamical assessments, along with measurements of the aorta, liver and spleen. Furthermore, clinical data will be collected for the patients for the creation of a HFpEF database (ie. patient characteristics, Kansas City Cardiomyopathy Questionnaire (KCCQ), HF and risk scores, laboratory biomarkers, diagnostic results). With this study, the investigator will be able to quantify longitudinal changes in CMR features within the HFpEF population, and investigate what features are associated with poor prognosis. The data collected will lead to a greater understanding of HFpEF, and hopefully show which clinical or imaging features can be used to identify, and better risk stratify this heterogenous population. | Analysis of longitudinal data, cardiovascular magnetic resonance (CMR) imaging and health related data, of patients with heart failure and preserved ejection fraction (HFpEF) over a timeframe of 5 years per patient.~In this study routine clinical data are collected along with additional research parameters measured during CMR. CMR will occur throughout a 5-year follow-up. |
While it is well known that intense physical exercise can generate bronchospasm and limit exercise performance, it recently appeared that regular physical exercise practiced aerobically could improve the clinical status of asthmatic patients.~The investigators are planning a 12-week randomized controlled study to assess the effect of regular aerobic exercise on quality of life, asthma control, bronchial hyperresponsiveness and bronchial and systemic inflammation in patients with persistent asthma~The hypothesis is that regular physical exercise increases control and quality of life and reduces inflammation and bronchial hyperresponsiveness compared to simple physiotherapy sessions. | The effects of regular exercise on asthma control has not yet been well demonstrated.~The aim of this study is to investigate the impact of submaximal physical exercise on quality of life, on symptomatic control, and on bronchial and systemic inflammatory markers in patients with persistant asthma. |
This study will include 5 groups of anesthesia trainees consisting of 5 participants each. Each group will practice a standardized high-fidelity scenario on postpartum hemorrhage (PPH) which will be repeated for four times. All the scenarios will be video recorded.~All groups will receive a technical briefing on the PPH guidelines before the scenario, and after having assigned to each participant a role (leader anesthesiologist, junior anesthesiologist, obstetrician, and midwife) they will practice a standardized 15 minutes scenario with a high fidelity manikin. A debriefing with an expert debriefer will be performed after each scenario.~The participant acting as the leader will practice the scenario while wearing a pair of eye-tracking glasses (Tobii Pro Glasses 50 Hz wearable wireless eye-tracker). All the eye-tracking video-recordings will be stored and analyzed by using a Tobii Pro Lab Software. Specific areas of interest (AOI), to define regions of a displayed stimulus, and to extract metrics specifically for those regions will be selected. Number and duration of fixations, visit counts and their duration for each area of interest and for each scenario will be examined. Eye-tracking metrics will be mapped as gaze plots and heat maps. Two independent observers will review the scenario video recordings and will assing a score to the leader and team behavioral and technical skills. These scores will be correlated to eye tracking metrics. | Eye tracking is the process of measuring an individual's eye movements in order to reflect their attentional behavior by using a device called an eye- tracker.~This study uses eye-tracking methodology to observe the gaze patterns of participants to a high fidelity simulation scenario of postpartum hemorrhage acting in the role of leader to evaluate the relationship between eye-tracking patterns and leadership and team behavioral and technical skills. |
This is a Phase II, open-label, randomized controlled umbrella trial evaluating the efficacy and safety of multiple targeted treatment vs. traditional chemotherapy in patients with unresectable locally advanced or metastatic triple negative breast cancer. The specific grouping of patients' depends on FUSCC 500+ gene panel testing and IHC subtype staining.These tests would be done on their rebiopsy tumor specimen. Specifically, as to TNBC molecular subtyping,FUSCC data identified the genomic aberrations that drive each TNBC subtype by applying an integrative analysis combining somatic mutation, copy number aberrations (CNAs) and gene expression profiles, which classified TNBC patients into four subtypes, namely luminal androgen receptor (LAR), immunomodulatory (IM), basal-like immune suppressed (BLIS), and mesenchymal-like (MES). Then, FUSCC conducted a IHC subtyping model to replace complex genomic sequencing, which have been validated in FUSCC cohort.FUSCC 500+ gene panel was developed combining public database(TCGA, METABRIC, 560WES, MSKCC-IMPACT ect.) and FUSCC private TNBC database. | This is a Phase II, open-label, randomized controlled umbrella trial evaluating the efficacy and safety of multiple targeted treatment in patients with metastaticTNBC. |
The proposed study, is a randomized placebo controlled cross-over study for 6 months, with an open label extension for another 6 months designed to test the benefits and safety of MCT oil in patients with established AD. It will be the first study on MCT oil ever done with this design, and for this duration in AD. | The present study is being done in a scientifically rigorous manner, using readily available MCT oil (refined from coconut oil) versus a placebo oil to assess any cognitive and functional benefits for AD patients. |
This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, selected from those admitted to the Emergency Department of Alexandria University Hospital. Ethical approval for the study was obtained from the regional Ethical Review Board of the Faculty of Dentistry, Alexandria University. A written informed consent was signed by patients before the operation.~Patients were divided equally into two groups, each consisting of eight patients. Assignment of each patient into one of either group was done using computer random numbers.~Group 1: underwent open reduction and internal fixation using two lag screws. Group 2: underwent open reduction and internal fixation using double Y-shaped plates. | This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, to compare Double Y-shaped plates and Lag Screws in fracture fixation from clinical and radiographic perspectives. |
Pancreatic cancer is an aggressive disease whose prognosis is generally unfavorable: less than 20% of patients results eligible for resection treatment with potentially curative purposes and only in 2019 in Italy 13,500 new cases were estimated. It represents one of the poorest prognosis with 8.1% survival at 5 years and 3% at 10 years.~Its treatments can have a negative effect on the quality of life linked to the health of patients (HRQoL). Over the past 20 years, the quality of life assessment has become an important component of evaluating new therapeutic approaches, providing indications on the patient's perception of the benefits of the treatments to which he undergoes. Therefore, an accurate assessment of HRQoL using valid and standardized tools is crucial to highlight the costs and benefits of the different therapeutic options and the clinical utility of the data.~Description of the intervention (schedule of visits):~Visit 1 (screening). Patients will be informed about the study. Once patients agree with the inclusion in the study the investigators will evaluate the inclusion and exclusion criteria. Those patients who meet all the inclusion criteria and none of the exclusion criteria will be finally included in the study. In this visit, patients, tumor-related variables, and general patients' features will be recorded, and all questionnaires will be administered EORTC QLQ 30, EORTC- PAN 26, HADS, Millon Clinical Multiaxial Inventory).~Enrolled patients will make a first psychological visit within one month of the initial diagnosis and before starting active medical treatment (chemotherapy, radiochemotherapy, surgery). During this visit, they will be asked to complete questionnaires aimed at assessing the quality of life (EORCT QLQ 30, EORCT PAN26) of the anxiety-depressant aspects related to the disease (HADS) and of the personological functioning (MCMI-III) to proceed psychological evaluation.~During the visit 2 (2-3 months after the first dose of planned chemotherapy and following an instrumental re-evaluation), the quality of life and the anxiety-depression symptoms related to the disease will be re-evaluated (EORCT QLQ 30, EORCT PAN26; HADS)~The researcher will record in a dedicated database all patient information, such as:~Personal data (gender, age, schooling)~Onset and related timing of anxiety disorders or mood before the disease onset~Psychological or psychiatric visits before the disease onset~Psychotropic drugs use/abuse~Psychotherapeutic or psychological path in progress~Family, social, religious /spiritual resources~Eligibility for surgery~Stage of illness~Clinical treatment (type of chemotherapy, radiochemotherapy)~Therapeutic result (response, progression stability)~Any serious adverse events (SAE).~The same variables recorded at Visit 1 will be checked again.~Power size calculation:~The number of patients was calculated taking into account the main outcome. Assuming a positive correlation coefficient of 0.3 (effect size) between the change in anxiety depression levels and self-perceived quality of life, an 85% power, a 5% significance level and a drop-out percentage / missing data equal to 30%, it is estimated a sample size of 75 patients. | The aim of this study is the evaluation of psychological aspects, such as anxiety-depressive patterns, quality of life, personality and other psychopathological syndromes of patients who receive a diagnosis of pancreatic cancer and who face chemotherapy treatment, radio-chemotherapy or surgery |
Explore survivors' attitudes towards lung cancer and lung cancer screening Explore survivors' understanding of cancer screening as a concept and the benefits of screening and early detection Explore survivors' level of awareness of and attitudes towards their lung cancer risk Explore survivors' views on the barriers and motivating factors that would impact their decision to attend a lung cancer screening test | To explore the topic of lung cancer screening following treatment for Hodgkin lymphoma from the perspective of survivors |
Two different settings will be used. In the first experiment, healthy subjects will make 15, 30, and 45-degree head tilt to the left and right side while they are standing. In every position, 3 measurements will be done. In the second experiment, 40 health subjects will make the same head maneuvers on the 20 cm thick soft surface. We will compare the effects of both head tilt and soft surface. All measurements will be done with a virtual SVV system(Interacoustics). | The sense of gravity is one of the important input of our balance system. The utricle is the key structure on this subject but the contribution of the proprioceptive receptors is also important. The aim of this study is to measure the effect of different angles of head tilt and soft surface on SVV in healthy subjects with a new automated system. |
All patients who will have surgery for ear will be tested before the operation and after the first day and the first week. Virtual SVV(Interacoustics) will be used for testing. The deviation angle from the vertical line will be measured when 15, 30, and 45-degree head tilt to the left and right side while they were standing. | Inner ear trauma during chronic otitis surgery is one of the major concerns of Otolaryngology. Hearing thresholds or semicircular canals were investigated with this purpose. The investigator's aim is to test the utricle for surgical trauma. |
This cross-sectional study was conducted to assess i) the prevalence of probable bruxism ii) the association between probable bruxism and periodontal status dental examination, all participants completed a standardized questionnaire. Sociodemographic findings comprised age, gender and educational level. Periodontal statuses of the participants were defined according to the American Association of Periodontology/European Federation of Periodontology, 2017 consensus. Participants were diagnosed with periodontitis if interdental clinical attachment loss (AL) was detected at ≥2 non-adjacent teeth, or buccal or oral AL was ≥3 mm with probing depth >3 mm was detected at ≥2 teeth. 12 In addition number of missing teeth is recorded.Assessment of probable bruxism was performed according to the 2018 consensus report on the assessment of bruxism.Presence of masticatory muscle hypertrophy, temporomandibular joint pain, indentations on the tongue or lip and/or a linea alba on the inner cheek, damage to the dental hard tissues (eg, cracked teeth), mechanical wear of the teeth (ie, attrition), repetive failures of restorative work/prosthodontics constructions were examined in clinical evaluation. | This cross-sectional study was conducted to assess i) the prevalence of probable bruxism ii) the association between probable bruxism and periodontal status.The age, gender, education level, tooth loss, presence of probable bruxism and periodontal status of patients were evaluated. Periodontal statuses of the participants were defined according to the American Association of Periodontology/European Federation of Periodontology, 2017 consensus and assessment of probable bruxism was performed according to the 2018 consensus report on the assessment of bruxism. |
This study is being done to compare a new, continuous illumination and short Incubation time regimen of aminolevulinic acid photodynamic therapy#painless-PDT) to a conventional regimen for treatment of Actinic Keratosis. The hypothesis is that the continuous illumination approach will be less or even no painful, but equally efficacious, as the old regimen. | This study is being done to compare a new, continuous illumination and short Incubation time regimen of aminolevulinic acid photodynamic therapy#ALA-PDT) to a conventional regimen for treatment of Actinic Keratosis. The hypothesis is that the continuous illumination approach will be less or even no painful, but equally efficacious, as the old regimen. |
An admission to an intensive care unit (ICU) often results in significant muscle weakness and physical deconditioning, which can take many months or even years for recovery. Early and progressive programmes of rehabilitation are recommended to limit any muscle loss and support recovery as early as possible. Patients admitted to intensive care with COVID-19 have been found to require prolonged periods of mechanical ventilation, high sedation and neuromuscular blocking use and as a result require prolonged stays in the ICU. As yet no data exists to examine the specific physical impact this may have, or whether it is safe and feasible to commence this earlier rehabilitation within the ICU for patients with a diagnosis of COVID-19. Our study set out to evaluate the levels of rehabilitation which were delivered in a large acute NHS trust. | This is an observational study exploring the levels of mobility and rehabilitation in patients admitted to critical care with a confirmed diagnosis of COVID-19 |
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