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Low back pain (LBP) is one of the most disabling conditions and has major socio-economic consequences. The prevalence of LBP among the population worldwide ranges between 15 and 45%. In the Kingdom of Saudi Arabia (KSA), the prevalence of LBP reported being around 18.8% among the population. Patient beliefs about back pain, pain self-efficacy, pain catastrophizing and expectation all seem to play a role in recovery. In fact, clinical guidelines recommended the treatment of non-specific chronic LBP should be considered within a multi-factorial biopsychosocial (BPS) framework. Exactly how this treatment should be delivered is not clear.~Pain neuroscience education (PNE) is a cognitive-based education that helps to educate patients about pain by focusing on neurobiology, neurophysiology and the processing and representation of pain. Even though PNE as intervention helps to improve pain, disability and other patient outcome, mixed results on its efficacy have seen in many studies. Since any complicated interventions are usually assessed by their effects on outcomes such as disability and pain, most do not target these outcomes directly; instead, they target mediating factors that are assumed to cause changes in these outcomes. In particular self-efficacy, pain catastrophizing and a patient's beliefs about back pain are thought to mediate the PNE-disability relationship since most of these cognitive factors are either highly correlated with disability or predictors for disability. The justifications for choosing these potential mediating factors: (1) self-efficacy has been shown to mediate the development of disability and is the most commonly identified mediator for psychological and behavior change interventions; (2) a study has shown that higher levels of pain catastrophizing are strongly correlated with higher levels of pain intensity and disability; and (3) a study has shown that beliefs about the consequences of LBP can influence patients' perceived pain and disability. However, the mechanisms underlying PNE effects, or the effect of PNE on mediating factors and its subsequent effect on disability as an outcome, has not been yet investigated. That leads to a knowledge gap in the evidence for understanding how PNE exerts its effect on disability. Also, identifying potential moderating factors that influence the PNE-disability relationship needs further investigation. In particular, expectation is thought to moderate the PNE-disability relationship because there are studies identified a link between expectation and clinical outcomes in patients with LBP. No study has explored the relationship between expectancy and clinical outcomes in the context of PNE. So, the influence of patient expectation on the magnitude of PNE effect on disability needs investigation.~The purpose of this 18-months project is understanding the underlying mechanisms of how PNE impacts disability. This project is significant because it will help us understand how PNE works by studying the underlying mechanisms and for whom and under what circumstances will PNE produces the greatest clinical benefits on the disability for patients with chronic LBP. Knowing how certain factors work will help PTs to enhance the elements of PNE that hopefully will target patient-specific factors and subsequently will reduce disability. | The purpose of this observational study is understanding the underlying mechanisms of how PNE impacts disability in chronic low back pain patients (CLBP). The investigator will explore whether the PNE effect on patient disability is mediated by changes in pain catastrophizing, pain self-efficacy and patient beliefs about pain. Also, the investigator will explore whether the effect of PNE on disability is moderated by patient expectation.The observational multisite pre-post cohort study will be conducted in PT clinics in the Kingdom of Saudi Arabia (KSA). |
Patients will be selected according to inclusion and exclusion criteria.Written informed consent will be taken from each participant after being informed about study .There will be two groups1) cirrhosis patients 2)normal healthy patients.Prevalence of apical periodontitis will be measured in both groups by intraoral examination,digital panoramic radiography.. MELD score will be recorded in cirrhosis patients at this stage.Non surgical root canal treatment will be performed in teeth with apical periodontitis. Periapical healing will be checked with the help of PAI Score given by Orstavik. In Cirrhosis patients MELD Score will be measured before and after treatment. | It has been found that there is an association between prevalence of odontogenic infection and systemic diseases.Cirrhosis has also been associated with poor oral health status.Treating those patients accordingly can help in reducing the source of infection to some extent and may be associated with reduction in mortality. |
It is unknown whether central vein stenosis occurs after temporary or long term hemodialysis catheter in long-term hemodialysis patients. this study will aim to explore this question. Study design is randomized, controlled trial. One arm is temporary catheters in the internal jugular vein, and another arm is tunneled cuffed hemodialysis cather. 2*2 is randomly distributed.~The main outcome: central vein stenosis diagnosed by venography. The secondary outcome: the time of infection, and catheter patency. Study period: one year | Vascular access (VA) is the most important for carrying out hemodialysis, yet it may bring in complications and leads to hemodialysis quality decline. This study aimed to explore the impact of vascular access types, including temporary vs.long term hemodialysis catheter on central vein stenosis. |
39 patients are enrolled in the study They suffer from chronic recurrent cutaneous warts Patients receive Candida antigen immunotherapy vial intra-lesional injection every 2 weeks till complete resolution or the maximum of 5 sessions Blood samples are withdrawn before and after intervention C3, C4, MBL, C3C and TNF alpha serum levels are measured | The investigators explore the role of the complement pathway and T helper 1 immune response in clinical response to Candida immunotherapy via complement component and tumor necrosis factor, respectively. |
Endometriosis is a common disease with endometriotic lesions being found in the ovaries, peritoneum, or as deep endometriosis (DE) involving different pelvic organs and structures. In order to describe DE lesions, the Enzian classification was developed. In the last revision of this Enzian classification, the so-called #Enzian, presence and severity grades of ovarian and peritoneal endometriosis as well as adhesions involving tubes and ovaries are also described in addition to DE lesions.~The Enzian classification is determined intraoperatively by the surgeon. Transvaginal ultrasound (TVS) examination is considered to be the first-line imaging technique for this disease. Therefore, the aim of this study is to compare the assessment of presence and severity grade of endometriotic lesions in different #Enzian compartments by a preoperative ultrasound examination (in the form of an US-#Enzian classification) to the definitive intraoperative Enzian classification (OP-#Enzian) using the latest revision of the Enzian classification (#Enzian). | The Enzian classification, which was developed in order to describe deep endometriotic (DE) lesions, is determined intraoperatively by the surgeon. Transvaginal ultrasound (TVS) examination is considered as the first-line imaging technique for endometriosis. The aim of this study is to compare the assessment of presence and severity grade of endometriotic lesions in different #Enzian compartments by a preoperative ultrasound examination to the definitive intraoperative Enzian classification using the latest revision of the Enzian classification (#Enzian). |
To perform this study, we will use patient DNA and RNA that is isolated from blood samples. DNA will be sequenced (targeted capture and/or whole genome DNA sequencing (WGS)) to identify any non-coding single nucleotide variants (SNVs), smaller insertions/deletions (indels), or larger structural variants (SVs). RNA will be sequenced (RNA-seq) to identify genes that are expressed in a differential and/or allele-specific manner, which may indicate a functional non-coding or splicing variant. We will test the function of non-coding variants using high-throughput reporter assays and CRISPR based methodologies. | The goal of this study is to identify and characterize novel non-coding and splicing variants that may contribute to genetic disorders. We will particularly focus on patients with a diagnosed genetic disorder that has inconclusive genetic findings. |
The study was conducted in one University Endodontic Clinical Department - Dental School between January 2009 and December 2017.~Root canal treatment was performed according previously reported operative protocols. | The aim of this study was to evaluate the survival rate and healing time of compromised teeth and seriously compromised teeth that were endodontically treated in patients which received bisphosphonate therapy . Clinical complications, success and survival rate was reported. Mean clinical parameters, clinical symptoms and presence of periapical radilucency were recorded. |
The COVID-19 virus pandemic has massively affected us all. We now know there is a much larger proportion of British Black, Asian and minority ethnic (BAME) patients suffering from COVID-19 infections. This disproportionate level of infection and severity of disease has raised concerns and worries. Other research from April 2020 showed that 71% of the nurses and midwives and 94% of the doctors and dentists that died of COVID-19 infections were from a BAME background despite this group representing 20% and 44% of the workforce respectively. The survival picture is also grim for Black and Asian members of the public where we see disproportionately high rates of deaths. Research estimates that our DNA and the environment equally influence the risk for infection. This clinical study plans to better understand our DNA. Some of the things we will be looking at is age, sex, ethnicity and any illnesses such as diabetes or blood pressure. We will ask people for some spit and look at their medical records. This may help us find some of the reasons why this virus has different effects on people and how we might protect people from COVID-19. | The COVID-19 virus pandemic has massively affected us all. Moreover, there is a disproportionately high number of COVID-19 severe infections and deaths in British Black, Asian and minority ethnic (BAME) patients. This clinical study plans to discover new ways of protecting people from this virus by looking at our DNA and biology. |
Subjects were randomized to intervention group and control group. The experiment was designed as randomized cross-over control trial. The primary outcome included 11 measures, Fugl-Meyer Assessment, Balance computerized adaptive testing, Mini Mental State Examination, Participation Measure-3 Domains ,4 Dimensions, Canadian Occupational Performance Measure, Barthel Index-based Supplementary Scales, Frenchay Activities Index, Lawnton Instrumental Activities of Daily Living, stroke impact scale, Stroke Self-Efficacy Questionnaire, and Kingston Caregiver Stress Scale. | The purpose of this study was to conduct a randomized clinical trial. Implement instrumental daily activities of daily living (A-IADL) in home rehabilitation. To explore the effect of A-IADL on stroke patients' movement, cognition, social participation, daily life function and quality of life. |
This is a pilot feasibility study, of the quasi-experimental before-after, non-randomized, mono-centric type. Feasibility is assessed on process criteria (adoption, reach implementation, satisfaction). Intermediate effectiveness is assessed on the skill level of patients and their caregivers, before, after and at a distance from education. Patients' anxiety levels will also be assessed before, after and at a distance from the program. The level of health literacy will be assessed at the start of the study. | Feasibility study of a therapeutic education program for the patient and his carers, intended for children suffering from acute lymphoblastic leukemia or having received an allograft of hematopoietic stem cells in the pediatric hematology department of Robert Debré hospital ( Paris, APHP). In addition to feasibility, the intermediate effectiveness of the program will be assessed. |
This research study is assessing the feasibility and safety of implanting and retrieving a 'microdevice' that releases up to 20 drugs directly within the prostate cancer lesion as a possible tool to evaluate the effectiveness of several approved cancer drugs against prostate cancer.~Participants will be identified with confirmed prostate cancer whose treatment plan includes surgery as a component of standard-of-care treatment.~The name of the study intervention involved in this study is:~Implantation of a MR-guided microdevice .~It is expected that about 35 people will take part in this research study; 5 in the Ex Vivo Cohort and 30 in Surgery Cohort.~Ex Vivo Cohort will undergo placement of microdevice in the prostate after its surgical removal.~Surgery Cohort will undergo percutaneous placement of several microdevices in a selected tumor prior to surgery.~This research study is a Pilot Study, which is the first-time investigators are examining this study intervention. The FDA (the U.S. Food and Drug Administration) has not approved the implantation of the microdevice for this specific disease, but usage of this has been approved for other uses. | In this research study, is assessing the feasibility of using an MR-guided implantable microdevice to measure tumor response to chemotherapy and other clinically relevant drugs in participants that have prostate cancer and are scheduled for a radical prostatectomy.~The name of the study intervention involved in this study is:~- Implantation of a MR-guided microdevice |
Hypothermia (core body temperature of <36˚C), is a strong risk factor for mortality and poor outcomes in trauma patients due to its negative hemostatic, cardiovascular, respiratory, and renal effects. Current evidence has reported that massively bleeding hypothermic trauma patients have higher odds of mortality in the first 24 hours of hospital admission, increased length of stay, and increased need for transfusion. Standard hospital blankets are used to passively warm patients through resuscitation and treatment until arrival to the ICU. Interventions such as active heating through thermal blankets should be considered to prevent and treat hypothermia upon arrival of patients than standard warmed hospital blankets to prevent deleterious outcomes in this population. | This study evaluates the feasibility of using thermal blankets to actively warm massively bleeding trauma patients at Sunnybrook Health Sciences Centre. It is hypothesized that either full thermal blankets or half thermal blankets will be a feasible intervention to implement for the care of massively bleeding trauma patients. |
The study protocol is approved by a local Ethics Committee and registered in Domestic Clinical Trial Registry (Identifier 0119U000002). Writing informed consent is obtained from all subjects participating in the study.~The study will enroll 300 participants (250 CKD patients at stage 1-5 and 50 healthy subjects). Routine biochemical parameters including blood and daily dialysate concentration of urea and creatinine, serum albumin, C-reactive protein (CRP), glucose, electrolytes, and lipid profile parameters will carry out. Total oxalate-degrading activity in fecal samples, as well as plasma oxalic acid concentration, daily urinary oxalate excretion and peritoneal dialysis effluent oxalate concentration (if any) will determine. Uric acid will also measure in serum, urine and dialysate of peritoneal dialysis patients.~The study will be followed up for 3 years. The primary endpoint is cardiovascular events, secondary endpoints are dialysis adequacy and all-cause mortality. All the endpoints will be collected, as well as other outcomes, such as chronic inflammation, dyslipidemia and dialysis dose, and so on. The outcomes will be analyzed using statistical software. | The current study primarily aimed to characterize the oxalate and uric acid metabolism in CKD patients and to analyze its association with renal survival prognosis. Secondarily, the study is planned to determine whether hyperoxalemia and hyperuricemia are independent risk factors for cardiovascular events and mortality. |
This is a multicenter prospective observational post-market clinical follow-up study that will include 500 patients who will have total hip replacement with the R3 Acetabular System and either cemented or cementless hip stem.~Effectiveness will be assessed by comparison of changes in parameters contained in the HOOS questionnaire and based upon incidence of revision and change in Harris Hip Score and UCLA Rating. Safety will be measured by assessing all adverse events experienced by patients from study enrolment through to study completion. | The objective of this study is to determine the long-term safety and effectiveness from the R3 Acetabular Hip System. The study hypothesis is that implant survivorship of the R3 cup is at least 97% at 3 years, 95% at 5 years, 93% at 7 years, and 90% at 10 years follow-up. |
This is a 28-day prospective study to evaluate the acceptability of Ketoflo, in terms of GI tolerance, adherence to recommended intakes and palatability. The product's nutritional suitability for use in a ketogenic diet will also be evaluated by recording ketone levels and seizure frequency measured as part of usual clinical care.~Ketoflo is nutritionally complete liquid feed for use in the dietary management of epilepsy or other neurometabolic conditions requiring a ketogenic diet. It is designed to be nutritionally complete from 3-18 years and can be used as a supplementary feed thereafter.~Ketoflo has been designed in liaison with Key Opinion Leaders and will offer an additional choice of prescribe-able feeds for use in the ketogenic diet.~The study will involve 30 participants, aged between three and eighteen years of age (inclusive), who are already established on a ketogenic diet for at least three months before the study begins.~Participants will self-report data in Daily Study Diaries over the course of the study. Data will also be collected by the Investigators in Baseline CRFs and End of Study CRFs for all participants. Any data collected for the study will be anonymised before being relayed to the sponsor.~The data generated by the trial will be used to support a submission by Vitaflo (International) Ltd. to the Advisory Committee on Borderline Substances (ACBS) for Ketoflo to become reimbursable on prescription in the UK. The data will also be used in a submission to the General Medical Services in the Republic of Ireland. | For 28 days, 30 participants aged 3 to 18 years of age (inclusive) with a condition requiring a ketogenic diet will incorporate Ketoflo into their usual dietary regime. Ketoflo is a nutritionally complete Food For Special Medical Purposes and is suitable for administration by both tube feeding and use as a sip feed. Data on gastrointestinal tolerance, participants adherence to recommended intakes and their thoughts on the product's palatability will be self-reported in Daily Study Diaries. |
Smoking is detrimental to the immune system and can cause respiratory tract infection. Growing evidence has suggested that compared to non-smokers, COVID-19 patients who have a history of smoking are at a higher risk of developing severe respiratory and cardiovascular symptoms, consequently may require mechanical ventilation and intensive care. A case series of 1,099 COVID-19 patients in China has found that ever smokers, compared with never smokers, were more likely to have severe COVID-19 disease upon hospital admission and be admitted to intensive care unit, need to use mechanical ventilation, and die. The result is corroborated by a multivariable analysis of 78 COVID-19 pneumonia cases in China, which identified smoking as the only preventable risk factor for disease progression. While the link between smoking and the COVID-19 needs further research, smokers appear to be at a greater risk of suffering from serious symptoms due to COVID-19.~The practice of smoking might also predispose smokers to COVID-19 infection. Smoking behavior is characterized by inhalation and the hand-to-mouth movements which increase the possibility of transmission of virus from contaminated fingers and cigarettes to mouth. In Hong Kong, where smoking is banned in indoor public areas and workplace, smokers often gather and smoke at smoking hotspots outdoor, where ashtrays are available. This increases their risk of infection since the smokers are in close contact with each other and have to remove their mask to smoke. Exhaling smoke also aids the spreading the virus in the air. However, misleading information that smoking can prevent COVID-19 infection is widespread on social media.~Public health strategies (e.g., social distancing, staying at home and working from home) may motivate some smokers to reduce or to quit smoking due to the inconvenience to smoke indoor and to buy cigarettes from retail outlets. However, home confinement may result in social isolation and psychological distress (anxiety and stress) both increasing the need for smoking. Some smokers who are not used to smoke at home might be prompted to smoke at home to cope with their craving during lockdown or work from home, which may also expose their family members from second-hand smoke.~Our RCT in QTW Contest 2017 evaluated the effectiveness of a chat-based intervention delivered through a mobile instant messaging application (WhatsApp) plus active referral to SC services to increase quitting. Chat-based intervention resulted in higher abstinence rate compared with the control group at 6-month follow-up. In QTW Contest 2019, we evaluated the effectiveness of a combined intervention of AWARD advice, active referral, instant messaging and optional cocktail intervention to increase abstinence. The preliminary result showed that the personalized instant messaging (PIM) group and regular instant messaging (RIM) group had similar abstinence rate at 6-month follow-up.~Therefore, the present study will examine (1) the effectiveness of a combined brief advice and personalized chat-based support on COVID-19 related smoking messages and (2) explore the use of CBPR model to build capacity and to engage community partners in taking on this important public health issue for sustainability in the community. In addition, a process evaluation will be conducted to assess the effectiveness of the recruitment activity and how it is linked with the overall program outcomes. | The present study will examine (1) the effectiveness of a combined brief advice and personalized chat-based support on COVID-19 related smoking messages and (2) explore the use of CBPR model to build capacity and to engage community partners in taking on this important public health issue for sustainability in the community. In addition, a process evaluation will be conducted to assess the effectiveness of the recruitment activity and how it is linked with the overall program outcomes. |
This prospective, Phase 2, multi-center, blinded randomized placebo-controlled study is designed to demonstrate that early treatment with mavrilimumab prevents progression of respiratory failure in patients with severe Covid-19 pneumonia and clinical and biological features of hyper-inflammation.~The study population includes patients who have severe pneumonia, defined as hospitalization due to Covid-19 with abnormal chest imaging and SpO2 <92% on room air or requirement for supplemental oxygen.~Enrollment: The study will be performed in approximately 4 months total, starting from the first patient enrolled with enrollment expected to complete within 2 months.~Follow-up period: The follow-up period is 60 days for each patient enrolled.~A total of 60 patients will be randomized using a 1:1 allocation ratio: 30 subjects will receive mavrilimumab, and 30 subjects will receive placebo infusion. The investigator, clinical team, and subject will be blinded to treatment assignment.~Participants will be identified by regular review of hospitalized COVID19 patients to evaluate for inclusion and exclusion criteria. Participants will then be approached in the standard manner by study investigator and coordinator/research nurse.~Research interventions will take place in the hospital in accordance with privacy standards.~The study team is informed on all study procedures and requirements with daily meetings and the opportunity to continuously update through secure channels.~In this multicenter consortium, each participating site will have their own IND for patients enrolled at their site. Data collection will occur at each of the 4 academic centers, and data analysis and randomization scheme will be performed by one site, Cleveland Clinic C5 Research. | The purpose of this prospective, Phase 2, multicenter, blinded, randomized placebo controlled study is to demonstrate that early treatment with mavrilimumab prevents progression of respiratory failure in patients with severe COVID-19 pneumonia and clinical and biological features of hyper-inflammation. |
Nijmegen breakage syndrome (NBS) is a DNA repair disorder. The only curative option for combine immunodeficiency in NBS is allogeneic hematopoietic stem cell transplantation (HSCT). Standard myeloablative conditioning regimens in DNA repair disorders lead to increased morbidity and mortality after HSCT. Low doses of alkylators are used to reduce toxicity rates, which, however, increase the risks of mixed chimerism and graft failure. The data of treosulfan usage in NBS are sparse. To evaluate the safety and efficacy of low dose treosulfan based conditioning regimen in NBS, treosulfan 21g/m2 in combination with fludarabine 150mg/mg, cyclophosphamide 40mg/kg, thymoglobulin (Genzyme) 5mg/kg and rituximab 100mg/m2 will be used from day -6 to -1 day, followed by stem cell infusion. The primary endpoint is event-free survival, where graft failure, death, and malignancies are considered as events. | The aim of the current study is to evaluate the safety and efficacy of low dose treosulfan based conditioning regimen in HSCT in Nijmegen breakage syndrome |
45 patients candidate to primary SG and randomized in 3 study groups (15 per group) GROUP A: no treatment (control group)~GROUP B (standard dose-long term): Lansoprazole buccal tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months~GROUP C (standard dose-short term): Lansoprazole buccal tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months | The trial would to try to establish:~The best post-operative PPI prescription protocol after Sleeve Gastrectomy~The impact of PPI therapy on postoperative peptic diseases (erosive gastropathies, ulcers, duodenitis, esophagitis and/or Barrett)~The impact of PPI therapy on post-operative GERD symptoms (assessed with the use of two standard tests: MRGE-HRQL and GERDQ |
Studies have investigated the relationship between maternal serum progesterone level and low birth weight baby birth, hypertensive disorders of pregnancy, and early pregnancy bleeding. In some cases, patients are supported by oral or vaginal progesterone treatments during pregnancy. We also measure the relationship between maternal serum progesterone by measuring the level of amnion progesterone; We aimed to analyze the effects on pregnancy outcomes by observing preterm birth, premature rupture of membranes, low birth weight, baby gender, maternal problems that may occur during pregnancy, fetal problems. | The aim of this study is to evaluate the amniotic fluid and serum progesterone level and pregnancy outcome |
Global stay-at-home mandates implemented in response to the COVID-19 pandemic are having substantial negative effects on mental health. Developing approaches to maintain the mental health of all individuals during this unprecedented time of physical distancing is of paramount importance. In the proposed low cost randomized controlled trial (RCT), the investigators seek to answer whether the use of a mobile app that provides a variety of physical activities appropriate for home workouts [i.e., high intensity interval training (HIIT), yoga] can improve wellbeing and health in adults mandated to stay at home. Should the results of this trial support the efficacy of the intervention (via app delivery), this has the potential to be implemented and delivered rapidly and at scale.~Engaging in regular physical activity confers reduced risk for mental disorders (e.g. depression, anxiety) in clinical and non-clinical populations. The investigators' recent evidence also suggests that becoming physically active reduces depressive symptoms, as well as negative affect and rumination on a daily basis, while improving daily positive affect and a sense of control in highly stressed adults. With fitness centres currently closed by mandate, becoming physically active during the COVID-19 pandemic could prove to be a challenge for individuals who are typically inactive, those mandated to stay-at-home, or those who do not have opportunities to access outdoor spaces that provide the recommended two meters of distance between people. Thus, the investigators seek to support those living under stay-at-home mandates with access to mobile apps that provide opportunities to be physically active in the home environment.~The study will focus on physical activities requiring little physical space or equipment that are easily completed at home. The study includes yoga, a movement-based activity that promotes relaxation and mindfulness and only requires space for the full length and width of one's body, and a mat as equipment. Yoga has been shown to be effective in improving physical function and quality of life in RCTs. The study also includes whole body weight (WBW)-based HIIT, which also only requires a mat, making it an excellent home-based form of aerobic exercise. HIIT is characterized as bouts of high-intensity exercise combined with periods of recovery or lower intensity activity. Its physical and psychological benefits compared to continuous moderate intensity training are often evidenced to be equal or significantly stronger.~Aims. The primary outcome will be a measure of depressive symptomology. It is hypothesized that those who actively use the yoga and/or WBW-HIIT mobile apps will improve in their depressive symptomatology compared to the waitlist control group over the course of the 6-week RCT. The study will also include measures of, as secondary outcomes, psychological distress, quality of life, and self-reported physical health, and expect decreases in distress and increases in the remaining outcomes. The researchers will also investigate whether effects are stronger in those (a) who currently live alone vs. live with others, or (b) with poorer levels of psychological health pre-randomization. | The COPE Trial is a randomized controlled trial that will provide currently isolated yet generally physically healthy 18-64 year old adults who are pre-retirement with the opportunity to receive a free 3-month subscription to either a yoga or moderate-to-high intensity aerobic exercise app or be randomized to a waitlist control group. Study outcomes include measures of psychological wellbeing and physical health. |
The study duration for each participant will be a total of minimum 29 weeks and up to 41 weeks. This includes 4 weeks +/-1 week screening period, 24 weeks of treatment period and a follow-up period up to 12 weeks or until the patients switch to commercialized dupilumab (or other biologic products), whatever comes first. | Primary Objective:~o To assess the effect of dupilumab on lung function and related changes in airway volumes detectable by functional respiratory imaging~Secondary Objective:~To evaluate the effect of dupilumab at Week 24 on bronchodynamics, hyperinflation, airway resistance, airway wall thickness, ventilation defects and mucus plugging derived from high-resolution computed tomography (HRCT) scans, patient-reported outcomes, FeNO and spirometry.~To evaluate safety of dupilumab |
Podimetrics is a care management company with a temperature-based foot monitoring solution to help prevent diabetic foot ulcers, one of the most debilitating and costly complications of diabetes.~Diabetes educators within the AADE/ADCES encompass a wide array of medical disciplines including nurses, physicians, dieticians, and pharmacists. Diabetes researchers want to better understand the degree to which diabetic foot care and prevention is incorporated into the diabetes education curriculum. To what extent are these topics discussed between diabetes educators and the patients they interact with? And how comfortable are educators in discussing these topics?~To gain insight into these questions Podimetrics researchers have designed an online questionnaire survey for completion by AADE members. The general purpose of the survey is to assess the knowledge base, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings.~The specific aim is to collect generalizable data to characterize the current state of diabetic foot education and identify any gaps in knowledge that may be present. Furthermore, if it is found that educators are lacking important knowledge which supports ample diabetic foot health education, approaches to bridge these gaps may be suggested through published recommendations. | The purpose of the survey is to assess the knowledge base, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings. |
The PORTAL trial is a Phase 3 multicenter non-inferiority randomized controlled trial that aims to address the question of feasibility and efficacy of the robotic minimally invasive approach in pancreaticoduodenectomy.~In the past 10 years there has been an increasing number of retrospective series from major centers for pancreatic surgery worldwide, that demonstrate similar and occasionally improved postoperative outcomes in patients who undergo a robotic pancreaticoduodenectomy (Whipple). The benefits of this minimally invasive approach appear to be decreased intraoperative estimated blood loss, lower postoperative pain levels and smaller length of hospital stay, whereas postoperative complications rates are comparable with the standard open approach.~This trial is conducted in multiple major centers for pancreatic surgery (open and robotic) in China and aims to address these questions in a prospective fashion. All eligible patients who present to these centers within the study period will be randomized in a 1:1 ratio to either of the two arms (open vs. robotic). Patients enrolled in the study will be blinded regarding the type of the procedure by application of identical wound dressings at the trocar sites and the open incision. Patients will be followed up closely and will be evaluated routinely for quality of life parameters for a period of at least 2 years postoperatively. Additionally, patients who undergo surgery in either arm for pancreatic adenocarcinoma will also be evaluated for time to adjuvant chemotherapy postoperatively, as well as recurrence and survival data. | This multicenter randomized trial aims to primarily assess and compare the functional recovery of patients who undergo open versus robotic pancreaticoduodenectomy for benign and malignant lesions of the head of the pancreas. |
This study is an open, two-stage, phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of AB011 injection in patients with CLDN18.2-positive advanced solid tumors. The study is composed of two stages: stage I is single treatment and stage II is combo treatment. | This is an open, two-stage, phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of AB011 injection in patients with CLDN18.2-positive advanced solid tumors. |
Study design: observational mixed cohort study, comparing growth and body composition in a contemporary cohort of very preterm infants fed HM with target fortification, the currently adopted clinical practice, with a historical cohort of very preterm infants fed HM with standard fortification (Macedo AJP 2018).~Study periods: historical cohort from 1 February 2014 to 28 February 2015; contemporary cohort: start February 2020, estimated recruitment period of 16 months; Settings: Neonatal Care Unit (NICU) and Human Milk Bank at Maternidade Dr. Alfredo da Costa and Nutrition Laboratory at Hospital Dona Estefânia, Centro Hospitalar Universitário de Lisboa Central.~Product to be analyzed: HM, including mother's own milk (MOM) and donor's milk (DHM). Donor HM is pasteurized using the Holder method (Peila 2016) which is adopted by the Human Milk Bank of Maternidade Dr. Alfredo da Costa (Macedo MHNP 2018).~Demographic variables: Gestational age, sex, singleton or twin, birth weight, small-, appropriate- or large-for-gestational age (<3rd percentile, ≥3rd percentile and ≤97th percentile, >97th percentile, respectively) (Fenton 2013), severity index (SNAPPE II) (Richardson 2001), use of prenatal corticosteroids, diagnosis of late sepsis (Modi 2009), necrotizing enterocolitis (grade ≥ 3) (Bell 1971), intraperiventricular hemorrhage (grade ≥ 3) (Papile 1978), multicystic periventricular leukomalacia (de Vries 1992), and chronic lung disease (Becker 1984).~Method of collection and analysis of HM: as described in a previous study (Macedo MHNP 2018), in order to minimize daily variability of breast milk composition, mothers are asked to save milk collected through 24 hours in the same container. The HM composition (MOM and DHM) are analyzed using the Miris human milk analyzer (Miris AB, Uppsala, Sweden), following the method described in a previous study (Macedo MHNP 2018). The composition is expressed in densities: Kcal/dL of energy and g/dl of fat, raw and true protein, carbohydrates and ashes.~Energy and macronutrient composition of the multi-component HM fortifier and modular protein and fat supplements. For this purpose, an Excel program to calculate modular protein and fat supplements to be added to fortified HM was developed and registered (Nona R, Cardoso M, Portuguese Directorate of Intellectual Property Services, IGAC-DSPI, nº 480/2020, 26 February 2020).~Daily intakes of energy (Kcal/kg), protein (g/kg) and protein:energy ratio (P:E), based on administered volume of milk (ml/kg).~Anthropometric and body composition measurements in infants: According to the previously described method (Macedo AJP 2018), during the hospital stay, the same observer (MMC) measures daily the body weight (allowing the calculation of weight gain velocity), and weekly the length and the head circumference. Within the first week after discharge, body composition will be assessed using displacement plethysmography, to evaluate fat mass (FM), fat free mass (FFM), percentage of FM (%FM), percentage of FFM (%FFM) and FM index (FMI), as described in a previous study (Macedo AJP 2018). Both FMI and %FM are used as indicators of adiposity.~Estimate of sample size: The study sample size was calculated to detect a difference of 2 g/kg/day in growth velocity with a standard deviation 2.6 (Macedo, 2018; Tremblay, 2017) for normally distributed variables, a significance level of 0.05, and an 80% power; thus, a required sample of 67 infants (n1=33; n2+20%=34) was estimated. | It is reported that the standard method for fortification of human milk (HM) overestimates the energy and protein densities of HM (Macedo MHNP 2018), thus originating infant undernutrition (Macedo AJP 2018). The target fortification, based on analysis of HM composition, is considered the gold-standard method (Rochow 2015, McLeod 2016). This observational mixed cohort study aims to assess if very preterm infants fed HM with target fortification have greater growth during hospital stay and better body composition at term post-menstrual age (PMA), than those fed HM with standard fortification. |
Patients with PAD and elevated LDL-C who are cared for at the University of Colorado (UC) and who provide consent will be randomized 1:1 to Intervention A, a vascular care team approach including pharmacy and healthcare provider assistance with medication adherence, versus Intervention B consisting of standard care augmented with a single consultation with a Vascular Medicine physician who will provide the treating doctor with a personalized risk assessment for the patient and a summary of the 2018 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline on Management of Blood. In order to investigate the efficacy of the CPC Endpoint Quality Intervention Program (EQuIP), subjects will additionally be randomized 1:1 to an investigative site conducted Six-Minute Walk Test or an EQuIP team led Six-Minute Walk Test. Quality of Life data will be collected from all subjects. There will also be an observational cohort (registry) to understand current practice patterns and outcomes in a non-interventional PAD population within the UC Health system in order to assess the potential impact of Intervention A after conclusion of the randomized study. | This study intends to evaluate the efficacy of a multidisciplinary vascular care team utilizing an intensive guideline-based lipid reduction program in improving risk factor modification as measured by LDL-C reduction at 12 months in patients with peripheral artery disease (PAD). An additional objective is to understand the potential reach and impact if this program were extended across the University of Colorado Healthcare (UC Health) System. |
Heart failure with reduced left ventricular ejection fraction (EF) is a relatively common cardiac pathology with major clinical implications. People with reduced left ventricular EF are at increased risk for sudden death, ventricular and atrial arrhythmias, and acute hemodynamic decompensation due to heart failure. There are proven medical interventions that prevent sudden cardiac death and complications in people with decreased left ventricular EF. Unfortunately, some people with decreased left ventricular EF are asymptomatic, or have non-specific symptoms like dyspnea, and would not receive those interventions in a timely manner. Currently, there are no effective ways to screen for asymptomatic decreased left ventricular EF in the population, because detection of low EF requires the use of echocardiography. There is a significant need to identify novel technologies that can help to detect people with decreased left ventricular EF in a simple, effective, and reliable manner.~Eko Devices features a cloud-based platform of point-of-care cardiac screening devices and machine learning algorithms that enables more effective detection and management of cardiovascular disease. In this study, we will use the Eko DUO device to collect single-lead ECG data.~The Eko DUO is an FDA-cleared and CE-marked electronic stethoscope that allows audio recording of heart sound to produce a phonocardiogram (PCG) as well as recording a single-lead electrocardiogram (ECG). The DUO features 60x audio amplification, ambient noise reduction, a 4000Hz sample rate, and 4 audio filters. The ECG component is made up of 2 stainless steel electrodes, 0.01Hz high-pass filter, selectable 50/60Hz mains filter, and a 500Hz sample rate. The de-identified auscultatory DUO recordings transmit wirelessly via Bluetooth to the secure, HIPAA-compliant Eko application on a smartphone or tablet, which allows the user to playback heart sound recordings, annotate notes on recorded audio, and save recordings. This data is synced in real-time to a secure, HIPAA-compliant, cloud-based Amazon Web Services (AWS) database server managed by Eko Devices.~It has been previously demonstrated that artificial intelligence processing information from a 12-lead ECG can help to identify people with decreased left ventricular EF1. Using paired 12-lead ECG and echocardiogram data, including the left ventricular ejection fraction, from 44,959 patients at the Mayo Clinic, a convolutional neural was trained to identify patients with low ejection fraction. When tested on an independent set of 52,870 patients, the model showed an Area Under the Curve (AUC) of 0.93 and an accuracy of 86%. We have also developed a single-lead version of the same algorithm, which will be more easily accessible in a clinical setting since it can be used with a single-lead ECG device like the Eko DUO device. We propose to validate performance of this new model using the current study. | The purpose of this research is to prospectively test and validate the single-lead Low EF algorithm in outpatients in order to test the performance of a single-lead ECG based algorithm to identify people with decreased left ventricular EF. |
DESIGN: An observation cohort study conducted in a tertiary hospital.~METHODS: Data will be collected from patients along the ICU-hospital discharge continuum, will be analysed and non-parametric tests will be used to explore association between variables.~Outcome measures: Muscle strength, as a component of physical function, will be evaluated with the Medical Research Council sum score (MRC- SS) at discharge from ICU and at hospital discharge; the Functional Status Score for the ICU (FSS-ICU) will also be assessed at hospital discharge. Data on participants' demographics, ICU admission and hospital admission will also be collected.~SIGNIFICANCE OF THE RESEARCH: Understanding how physical function is affected in patients with severe COVID-19 may help develop future prevention, therapeutic and follow-up strategies that improve quality of care and outcomes in this specific group of patients. Findings from this study may be useful to design future larger cohort studies and experimental trials. | Little is known about the physical function outcomes in patients with severe COVID-19 patients who are admitted to Intensive Care Unit (ICU) for invasive mechanical ventilation. The purpose of this study is to evaluate the short-term impact on physical function before hospital discharge in subjects with severe COVID-19 who have survived ICU admission for invasive mechanical ventilation. |
All participants will receive Voxelotor as treatment. There will be approximately 13 sites in the US.~Participant safety and tolerability will be monitored during the study using standard measures, including physical examinations, vital signs (including temperature, blood pressure, pulse rate, respiratory rate and peripheral oxygen saturation [SpO2]), clinical laboratory tests, and adverse event (AE) monitoring.~Screening Period (up to 4 weeks in duration): During this period, participants will sign the informed consent form (ICF), after which they will complete the screening assessments as detailed in the Schedule of Assessments (SOA).~Run-in Period (2 weeks in duration): During this period, participants will enter a 2-week run-in period (Day -14 to Day -1) during which baseline actigraphy measures of physical activity and sleep quality, overnight pulse oximetry assessments of oxygen saturation, and Patient-Reported Outcome (PRO) assessments will be collected before initiating treatment with voxelotor.~Treatment Period (24 weeks in duration): After completion of the 14-day Run-in Period, participants will enter the open label treatment period and receive voxelotor 1500 mg once daily for 24 weeks. Repeat actigraphy assessments of physical activity and sleep quality, and overnight pulse oximetry will be performed during the treatment period (Weeks 10 to 12 and Weeks 22 to 24). PRO and Clinical Global Impression (CGI) assessments will be completed at scheduled study visits. The open-label treatment period is considered the continuous 24 weeks of voxelotor treatment from date of first dose (Day 1).~Follow-up Period (4 weeks in duration): Immediately following the 24-week treatment period, participants will enter a 4-week Follow-up Period. | This is a study to evaluate the effect of voxelotor on daily physical activity and sleep quality, as measured by a wrist-worn device in participants with sickle cell disease (SCD) and chronic moderate anemia. |
Single centre prospective non-randomised non-comparative study of patients delivered by ambulance and admitted to the CCU with suspected NSTEACS.~Aims of this study are:~To characterize the contingent of patients admitted to the CCU with suspected NSTEACS.~To evaluate possibilities of fast differential diagnosis and risk stratification in patients admitted to the CCU with suspected NSTEACS using clinical data, ECG, biomarker levels (hsTn, NT-proBNP, hsCPR, cardiac FABP) as well as HEART, ADAPT, EDACS, T-MACS, GRACE, ACTION and TIMI scores.~To evaluate the correlation between clinical data, ECG, biomarker levels (hsTn, NT-proBNP, hsCPR, cardiac FABP) as well as HEART, ADAPT, EDACS, T-MACS, GRACE, ACTION and TIMI scores with presence and severity of coronary atherosclerosis in patients admitted to the CCU (intensive care unit) with suspected NSTEACS. | To evaluate possibilities of rapid differential diagnosis and risk stratification in patients urgently admitted to the CCU with a suspected acute coronary syndrome without persistent ST-segment elevation (NSTEACS). |
The main objective of this study is to evaluate the effectiveness of perioperative oral nutrition supplementation (ONS) on nutritional status in malnourished cancer patients undergoing elective surgery.~The specific objectives are:~To evaluate the baseline nutritional status of cancer patients undergoing elective surgery~To evaluate the effectiveness of pre-operative ONS feeding on nutritional status in malnourished surgical cancer patients~To evaluate the effectiveness of an extended 3 months post-operative ONS feeding after discharge versus ONS feeding only post-operatively during hospital on nutritional status~To evaluate secondary outcomes of perioperative feeding such as sleep quality, post-operative complications and length of hospital stay~Study Design: This is a randomised-controlled-open label-parallel group(s)-trial which will be conducted on malnourished cancer patients undergoing elective surgery.~Study duration: The participation duration for each participant is 4 months. The completion of the study will take around 30 months. | The aim of this study is to evaluate the effectiveness of perioperative oral nutrition supplementation (ONS) on nutritional status in malnourished cancer patients undergoing elective surgery.~The hypothesis is pre-operative ONS feeding in malnourished surgical cancer patients is effective on improving nutritional status. An extended period of 3 months post-operative ONS feeding is effective on improving nutritional status as compared to ONS feeding post-operatively during hospital stay only. Perioperative feeding is effective on improving secondary outcomes such as sleep quality, post-operative complications and length of hospital stay. |
This is a randomized control trial. Participants will be recruited from the psychiatric rehabilitation organizations in Taiwan. They will be randomly assigned to the intervention group or control group. The recovery program has 2 phases and consists of 20 classes, 1.5 hour per class and one class per week. We will introduce concepts of recovery and personal strengths in phase 1. Then, we will help participants to set goals and implement their plans in phase 2. Participants will fill out five questionnaires during the recruitment meeting, including Stages of Recovery Scale, Medical Outcomes Study Social Support Survey, The Hope Scale, Rosenberg Self-Esteem Scale and Brief Symptom Rating Scale-50. They will fill out the same questionnaires plus the course satisfaction survey in the end of phase 1 and 2. Six months later, participants will receive a follow-up interview and fill out the questionnaires again. The control group will receive a spiritual book and complete the questionnaires at the same time as the intervention group. | Recovery-oriented approach has been the main trend in mental health field. However, few recovery-oriented programs are available in Taiwan, and many Taiwanese people with mental illness don't understand the concepts of recovery. A program which provides recovery knowledge and assists in setting recovery goals is beneficial for Taiwanese people with mental illness. Hence, this study aimed to investigate the effectiveness of a recovery program for people with mental illness. |
Randomized interventionist study (ratio 1:1) with two parallel branches, blinded by evaluators (the evaluator does not know the branch of treatment to which the patient belongs )to evaluate if an individualized moderate-to-vigorous physical exercise intensity program as adjuvant therapy to standard drug therapy will improve the functional and neuropsychological status of patients with Bipolar Disorder. The effectiveness of the intervention will be assessed by an extensive battery of clinical tests, physical parameters (e.g. brain structure changes measured by optical coherence tomography) and biological parameters (inflammation, oxidative stress and neurotrophic factors).~The total sample of the study will be 80 patients and a sample of 40 controls (individuals without psychiatric pathology). The sample of patients will be divided into 40 patients in each group at random. In the intervention group, a supervised physical exercise treatment by high-intensity interval training (HIT) will be performed during 16 weeks with 2 sessions per week (32 sessions in total).Three visits will be made in both groups: baseline visit at the beginning of the study, at 4 months (at the end of the intervention) and at 10 months (6 months after the end of the intervention) | This is a study that aimed to deep in the physiopathology of BD and see how, through potential modifiable areas of the patients' lifestyle, the prognosis and evolution of the pathology can be improved. |
Mechanical bowel preparation (MBP) has been routinely used prior to minimally invasive gynaecologic procedures (MIGP) hypothetically to improve intraoperative bowel handling and visualization of the surgical field, and also to reduce faecal contamination in the setting of bowel injury and/or resection.~The studies investigating the effect of MBP on MIGP are limited and most of existing data are extrapolated from the reports of colorectal and urological surgery studies.~Besides, evaluation of the surgical workspace visualization and intraoperative bowel handling are far from being objective since they were mostly measured by a 4/5/10-point Likert scales or rated verbally on scales of excellent to poor by the operating surgeons.~In contrary, it is planned to use objective visualize index, and objective surgical conditions to measure whether MBP has any effect or not. | This RCT aims to investigate the real surgical effects of MBP prior to the gynecological laparoscopic surgeries. Those effects include lowest pneumoperitoneum pressure, lowest Trendelenburg inclination angle, the ease of the surgical view and the preferences of the patients with objective measures. |
This study is a multi-center, randomized, open, parallel control to evaluate the effectiveness and safety of Phase III clinical trials of the efficacy and safety of recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate for the treatment of locally advanced or metastatic breast cancer the study.The low expression of HER2 is defined as: the immunohistochemistry (IHC) confirmed by the central laboratory detects the expression of HER2 protein as IHC 2+ and the fluorescence in situ hybridization (FISH) detection has no amplification. | This study will compare RC48-ADC to physician choice standard treatment. Participants must have HER2-low breast cancer ，previous use of anthracyclines, and have been treated with one or two systemic chemotherapy regimens following recurrence/metastasis. |
A total of 120 subjects will be randomized into three groups (30 per group). Arm A: IV PCIA Arm B: IV PCIA + ultrasound guided Erector spinae block (ESPB, Single shot of 30ml of 0.5% solution of Naropin [Ropivacaine]) Arm C: IV PCIA + multilevel intra-thoracic intercostal nerve block (ICB, Single shot of 30ml of 0.5% solution of Naropin [Ropivacaine]) PCIA pumps for all study cohorts will be programmed according to our institution's standard protocol (Dipidolor [Piritramide] bolus: 2mg, interval: 7 min, max 4h dose: 30mg). The erector spinae block will be placed preoperatively, the intercostal block will be placed at the beginning of the procedure. All patients will receive standard postoperative care. The patients will be blinded for the study arm.~The primary endpoint of this study is postoperative pain and will be recorded by using the numerical rating scale (NRS) pain score. Pain scores will be measured by the investigator at rest and during coughing. Opioid consumption will be monitored and registered for. | This study aims to study the analgesic and respiratory effects of the erector spinae plane block for patients undergoing video-assisted thoracic surgery (VATS) or robotic assisted thoracic surgery (RATS). |
The following points represent, in summary, the rationale for studying the use of thromboprophylaxis in ambulatory patients with COVID-19:~The risk of thromboembolic events in patients with COVID-19 during anticoagulant prophylaxis exceeds that observed in medical patients, usually <3%, even in the presence of seasonal viral infections~The cumulative risk of VTE in hospitalized COVID-19 patients is at least 20%, but possibly higher, as described in several publications~The absolute VTE risk in COVID-19 patients requiring intensive care is 69% if screening strategies are implemented~Half of the VTE events, mostly PE, were diagnosed at hospital admission, suggesting that these events developed during the quarantine period.~Our hypothesis is that early thromboprophylaxis may prevent or limit coagulopathy, and reduce thromboembolic complications leading to hospitalization or death, in the presence of a mild COVID disease among outpatients.~The study will be conducted as a multicentre randomized open-label controlled trial. In the study, a total of 1,000 adult patients aged 50 or older with COVID-19 and candidates to ambulatory treatment will be randomized to receive enoxaparin 40 mg sc qD or no treatment for a total of 14 days. The primary outcome will be assessed within 30 days of enrolment.~We implemented two logistical solutions to integrate the process of SARS-CoV2 testing, pre-screening, screening (hot-line and flyers), in-hospital recruitment, enrolment and randomization/allocation. A nationwide OVID Hot-Line telephone number will be made available in 3 languages (German, French, Italian) for interested patients or test centers to contact the Hot-Line. Standard hygiene precautions will be met at the study centers to avoid spreading of SARS-CoV2 among other patients or health care workers. Principles of patient and investigator safety will be applied. Standard procedures concerning privacy, discussion with patients on details of the study, collection of informed consent, and instruction on how to administer the study medication will be maintained in conformity with GCP recommendations. This will also include outcome measurements to be conducted by telephone with standardized questionnaire.~Enoxaparin (Clexane®) will be given at the recommended dose of 4,000 IU antiXa activity (40 mg/0.4 ml) once daily by SC injection for 14 days.~A single interim analysis is planned at time when the outcomes of 50% of the patients (n=460 plus drop-outs) have been observed (anticipated in February 2022). | The OVID study will show whether prophylactic-dose enoxaparin improves survival and reduces unplanned hospitalizations in ambulatory patients aged 50 or older diagnosed with COVID-19, a novel viral disease characterized by severe systemic, pulmonary, and vessel inflammation and coagulation activation. |
There will be 12 study groups and it is anticipated that a total of 12,390 volunteers will be enrolled. Groups 1, 7 & 9 are adults aged 56-69 years; groups 2, 8 & 10 are adults 70 years and over; groups 4, 5 & 6 are adults aged 18-55 years; group 11 is adults aged 18-55 years who have previously received a ChAdOx vectored vaccine; group 12 is HIV positive adults aged 18-55 years.~The vaccine will be administered intramuscularly into the deltoid of the non-dominant arm (preferably).~All subjects will undergo follow-up for a total of 1 year post last vaccination. Additional visits or procedures may be performed at the discretion of the investigators, e.g., further medical history and physical examination, or additional blood tests and other investigations if clinically relevant | A phase 2/3 study to determine the efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in healthy UK volunteers. |
Malignant tumors are the second leading cause of death in China after accidental casualties, which is consistent with developed countries in Europe and America.~Sintilimab is a human monoclonal antibody against PD-1 receptor which was developed in China. It can block the binding of PD-1 of T-lymphocyte and PD-L1 on the surface of tumor cells, release the immunosuppression of tumor cells on immune cells, making immune cells play the role of anti-tumor cell immunity again and kill tumor cells. In the past, the development of immunocheckpoint drugs mainly focused on adult cancer. Immunocheckpoint inhibition has achieved many successes in the adult population, including metastatic melanoma, non-small cell lung cancer, Hodgkin's lymphoma, bladder cancer and head and neck cancer.~In the past, the development of immunocheckpoint drugs mainly focused on adult cancer. Immunocheckpoint inhibition has achieved many successes in adult population. However, some results of the clinical trials of immunocheckpoint inhibitors in children are also promising especially in Hodgkin's lymphoma.~The investigators aimed to determine the maximum tolerable dose and effectiveness in pediatric malignant tumors, so as to lay the foundation for the future phase II / III clinical research. | This is a single center, single arm, open-label and phase I clinical study. The standard 3 + 3 group design was performed. Patients were enrolled by the design of phase I study standard. Sintilimab was divided into three dose levels: 1 mg / kg, 3 mg / kg, and 10 mg / kg. Dose escalation was carried out from the first level of sintilimab. The study is to evaluate the safety, including dose limited toxicity (DLT) in the treatment of advanced, recurrent, and refractory childhood cancer. |
In the current SARS-COV-2 pandemic there is a concern about an increased risk of venous thromboembolism (VTE) concurrent with the infection, including both pulmonary embolism (PE) and deep venous thrombosis (DVT) (Klok et al. 2020; Cui et al. 2020; Helms et al. 2020; Leonard-Lorant et al. 2020; Poissy et al. 2020). International guidelines now recommend prophylactic anticoagulation for all hospitalized patients with a SARS-COV-2 infection in the absence of any contraindication (Thachil et al. 2020). The majority of the studies on VTE in SARS-COV-2 infections have been carried out in the ICU and show prevalence of VTE of between 20 and 30%.(Klok et al. 2020; Cui et al. 2020; Helms et al. 2020). This is a clear increase compared to the less than 10 % prevalence seen in other ICU patients (Muscedere, Heyland, and Cook 2007; Deborah Cook et al. 2005; D. Cook et al. 2000). However, a single center study on consecutive ICU patients with severe sepsis showed a prevalence of VTE of 37% (Kaplan et al. 2015) and another recent publication of patients with severe influenza A/H1N1 infection had a prevalence of VTE of 44% (Obi et al. 2019).~This raises the question whether the increase in VTE seen in recent publications of SARS-COV-2 infections is the result of the specific pathophysiology of the virus itself or the subsequent sepsis with multiorgan failure seen in most complicated and severe cases. The former would have large implications for patients treated outside the ICU and possibly outside hospitals (Thachil et al. 2020).~The aim of this study will be to investigate the prevalence of VTE in a regional healthcare system prior to, and during the SARS-COV-2 pandemic and the differences between ICU, hospitalized and outpatient cohorts. | The purpose of this study is to investigate the prevalence of venous thromboembolism in a regional health care system (Region Östergötland, Sweden) before and during the SARS-COV-2 pandemic. In a retrospective observational study, we will review patient data, diagnostic data and treatment data over a three-month period since the onset of the SARS-COV-2 pandemic. This data will be compared with data from the corresponding time frame during the years 2015 to 2019. |
This randomized placebo-controlled trial is for the outpatient treatment of (Coronavirus Disease 2019) COVID-19. The purpose of this trial is to evaluate the safety and explore the effectiveness of resveratrol, a plant polyphenol, being re-purposed for patients with early COVID-19. Published in vitro data supports that this polyphenol inhibits coronavirus replication while separately published in silico (computer molecular docking analysis) reports have identified specific molecular targets of resveratrol against (Severe Acute Respiratory Syndrome - Coronavirus 2) SARS-CoV-2. Animal studies also demonstrate that resveratrol is effective at preventing lung injury and death in certain animal models of viral infections. Furthermore, the products long history as an anti-inflammatory might prevent the cytokine storm that is associated with worse outcomes in COVID-19.~200 subjects, 45 and older, (100 receiving the plant polyphenol, 100 receiving placebo) will be enrolled in study to compare whether taking resveratrol will reduce the rate of hospitalization. Subjects will take capsules 4 times a day for a minimum of 7 days (up to 15 days depending on duration of symptoms) plus both groups will receive Vitamin D3 100,000 IU to augment the effects of resveratrol. Resveratrol will be given as 1gm 4 times per day. Placebo tablets will contain brown rice flour in visually identical capsules. The primary outcome measure for this trial is reduction in hospitalization at 21 days from enrollment. | Resveratrol is a plant polyphenol (that is sold commercially as a supplement) that might help fight coronavirus as well as help protect the body from the effects of disease (COVID-19) caused by the infection. In this proof-of-concept pilot study we will compare the effects of resveratrol to placebo to assess the safety of the resveratrol and explore effectiveness. |
PRIMARY OBJECTIVES:~I. To determine whether heart rate variability (HRV) is reduced in patients with pancreatic ductal adenocarcinoma (PDAC) compared with individuals at increased risk of developing PDAC. (Stage I) II. To assess the feasibility of long-term compliance using a wearable device. (Stage II)~SECONDARY OBJECTIVES:~I. To assess compliance with using a wearable device. (Stage I and II) II. To validate effectiveness of virtual device training. (Stage I and II) III. To determine whether HRV is reduced in participants at high-risk of developing PDAC. (Stage II) IV. To characterize timing and occurrence of PDAC among high-risk without disease. (Stage II) V. To characterize timing and occurrence of PDAC among participants at high-risk of developing PDAC. (Stage II)~EXPLORATORY OBJECTIVES:~I. To investigate the relationship between changes in HRV relative to sarcopenia-related body composition characteristics in PDAC patients. (Stage I) II. To investigate the relationship between the pNN50 HRV measure and PDAC diagnosis. (Stage I and II) III. To compare changes in sleep biometrics among all participants. (Stage I and II) IV. To evaluate changes in health-related quality of life assessments among all participants. (Stage I and II) V. To evaluate participant satisfaction with virtual device instruction.~OUTLINE:~Participants undergo HRV monitoring using an activity monitor (WHOOP) for a minimum of 5 days weekly for up to 1 year in patients with newly-diagnosed PDAC and up to 5 years for patients in high risk group. | This study examines heart rate monitoring variability for the early detection of pancreatic cancer. Pancreatic cancer is a very difficult disease to detect early. This study is being done to observe the heart rate variability in patients with pancreatic cancer compared to undiagnosed individuals with increased risk of developing pancreatic cancer. This may help researchers determine if pancreatic occurrences/recurrences (chance of coming back) can be detected sooner through monitoring heart rate and activity. |
Overall, 10% of all uterine myomas are submucosal. These myomas spread into the uterine cavity, lifting the endometrial mucosa, and are a common cause of abnormal uterine bleeding, dysmenorrhea, early miscarriage and they may be a cause of infertility.~Hysteroscopic myomectomy is the surgical procedure of choice for the treatment of submucosal myomas, because it is minimally invasive and has the advantage of preserving the integrity of the uterine wall.~The characteristics of the myomas (size, number and location) enables the surgeon to choose the surgical approach that will provide the best outcome for the patient, and may predict the chances of a complete hysteroscopic resection of myomas in one procedure. | The aim of this observational retrospective analysis is to evaluate predictive factors for complete myoma resection during hysteroscopic myomectomy for developing and validating a nomogram.~This tool can help clinicians to support the patient in making an informed decision about therapeutic options for uterine submucous myomas by defining risk factors predicting a high complexity myomectomy. |
Pharmacological treatments are not effective for all women and therefore, the objective of this study was to assess and compare the effectiveness of kinesio tape and auricular therapy to decrease pain and drug intake in women with primary dysmenorrhoea.~A randomized controlled trial was conducted. 114 university women from 18 to 30 years old were randomized to 5 groups: control, kinesio tape, placebo kinesio tape, auricular therapy and placebo auricular therapy. The study was carried out during 4 menstrual cycles of pre-treatment phase, 4 menstrual cycles of treatment phase and two follow up phases (first and third cycle after the treatments were completed). During the treatment phase, the techniques were applied during 72h in each cycle.~The primary outcome measures were: Mean pain intensity of the 3 first days of bleeding, maximum pain intensity, number of painful days and dose of drug intake measured with the Visual Analogue Scale. | This study analyse the effectiveness of auricular therapy vs. kinesio tape treatment for pain management of women with primary dysmenorrhoea. |
Patients will undergo a telephonic interview 48-96h before the procedure where will ask about the presence of symptoms suggestive of SARS-CoV-2 infection. Optionally, they will also be carried out a scan (PCR) to detect infection 48-96h before procedure, withdrawing from the study patients with positive PCR or infection suspected by clinical data according to the questionnaire, after evaluating the responses to the questionnaire by one of the members of the research team.~Endoscopic examinations will be carried out according to the recommendations of the Spanish Society for Digestive Endoscopy (SEED). The patient will perform a hand wash with solution hydroalcoholic before entering the endoscopy room, and you will be placed a surgical mask and gloves. Staff close to the patient will carry FFP2 mask, exceptionally surgical mask, gown (waterproof in high-risk examinations as established in the SEED guidelines), hat, nitrile gloves and face shield or safety glasses (reusable) and shim covers. The examinations will be carried out using sedation guided by endoscopist according to current clinical guidelines.~Ultrasonographic examinations (US) will be carried out according to clinical guideline. The examinator will wear a filtering face pieces 2 (FFP2) mask, exceptionally surgical mask, gown, cap, nitrile gloves and face shield or goggles safety (reusable) and shoe covers. The gel bottle, the transducer and the gurney will be washed before each US with low level disinfectant.~Patients who meet the inclusion criteria and do not have any exclusion criteria will be invited to participate in the study. The patients who agree to participate will complete the informed consent according to the law 41/2002 of patient autonomy without for that reason alter the relationship with your doctor or cause any harm to your treatment. The monitoring period will have a maximum duration of 17 days. It will consist of a telephone control through a pre-established checklist. In case of any positive answer to the questionnaire, it will be completed the study through the consultation of the investigators by means of a polymerase chain reaction (PCR). | The aim of our study to compare the proportion of patients who develop SARS-CoV-2 disease in 3 groups: patients undergoing a abdominal ultrasound examination in a Specialty Center, patients undergoing endoscopic procedure in a third level hospital with CoronaVirus Disease (COVID-19) hospitalization plants and patients who make a telephonic visit (do not go to the hospital) in the digestive system service. |
About 9.2%-45.8% of Chinese patients with Non-small cell lung cancer were positive for EGFR gene mutation. Gefitinib, Erlotinib, Icotinib, Afatinib showed efficacy superior to that of chemotherapy in the treatment of EGFR mutation positive advanced NSCLC, and lower rates of serious adverse events. However, after a median of 8 to 13 months of disease control, patients ultimately progress due to acquired resistance of EGFR-TKIs. Elemene, a chemotherapeutic isolated from the Chinese medicinal herb Rhizoma Zedoariae, has been shown to have a comprehensive anti-tumor effect and the potential effect on reversing drug resistance.~In this study, about 22 research centers will participate in. We planned to enroll 744 patients with advanced non-small cell lung adenocarcinoma who were positive for EGFR mutations. The dynamic random method will be adopted in this study. Patients will be randomly divided into the experimental group（Elemene plus first or third generation EGFR-TKIs), and control group (First or third generation EGFR-TKIs, only). The purpose of this study is evaluating the synergistic effect and safety of Elemene plus TKIs in EGFR-mutated advanced non-small cell lung cancer. We also try to analyze the correlation between molecular biomarkers and patient prognosis, including but not limited to drug-resistant genes and circulating tumor cells. | This is a nationwide, multicenter and prospective cohort study. The purpose of this study is to evaluate the synergistic effect and safety of Elemene plus TKIs in EGFR-mutated advanced non-small cell lung cancer. |
Background. Research suggests that vitamin C is potentially lifesaving in the intense inflammatory cascade such as that associated with COVID-19. Inflammation and oxidative stress are among the main mechanisms underlying COVID-19-associated acute hypoxemic respiratory failure. Previous evidence had also already established that a dysregulated inflammatory cascade may distinguish patients who transition from a relatively mild viral pneumonitis to acute respiratory distress syndrome and multiorgan failure. As such, adjunct immune modulation therapies may improve outcomes of COVID-19 patients who are hospitalized. Numerous preclinical studies have shown that, in addition to direct scavenging of oxygen radicals, vitamin C limits their production and restores endothelial function.~As the majority of hospitalized patients with COVID-19 are not critically ill, avoiding clinical deterioration and subsequent intensive care unit admission is a high priority. Participation in research should be offered before patients become critically ill, at which time many perceive that treatment may be too late. It is important to ensure that as many COVID-19 patients as possible are offered the opportunity to participate to research since that is generally the only means to access investigational therapies. The proposed trial will address this gap, by evaluating the efficacy of intravenous vitamin C in hospitalized patients with confirmed COVID-19.~Objectives. The overarching objective, which is identical to the objective of the parent LOVIT trial (NCT 03680274), is to determine whether intravenous vitamin C, compared to placebo, reduces morbidity and mortality in patients hospitalized with COVID-19. To ascertain the volume of distribution, clearance, and plasma concentration over a course of 96 hours of intravenous vitamin C 50 mg/kg of weight every 6 hours or matching placebo (pharmacokinetic (PK) substudy).~Methods. Patients will be randomly assigned to vitamin C (intravenous, 50 mg/kg every 6h) or placebo (0.9% NaCl or dextrose 5% in water) for 96 hours. Study personnel at the clinical sites will document the composite of death or persistent organ dysfunction at day 28. Daily assessments will occur for organ function, on days 1, 3, 7 for inflammation, infection, and endothelial injury biomarkers, at baseline for vitamin C level, and at 6 months for mortality and HRQoL. The LOVIT-COVID Trial will be conducted in Canadian and possibly international sites. For the PK substudy: Blood samples will be drawn around the 8th dose at time 0 and then after administration at times 1h, 2h, 4h and 6h (the 6h level will be immediately prior to the next dose). The PK substudy will be conducted with 100 participants in some of the participating centers.~Relevance. A growing body of evidence suggests that vitamin C, an inexpensive and readily available intervention, is potentially lifesaving in sepsis and may also be beneficial in COVID-19. LOVIT-COVID will constitute rigorous assessments of the effect of vitamin C monotherapy on patient-important outcomes. If proven effective, vitamin C could be used worldwide and drastically change outcomes in high- and low-income settings alike. | LOVIT-COVID is a multicentre concealed-allocation parallel-group blinded randomized controlled trial to ascertain the effect of high-dose intravenous vitamin C compared to placebo on mortality or persistent organ dysfunction at 28 days in hospitalized COVID-19 patients. |
Patients will be invited to follow-up visits 3 and 12 months after hospitalization with COVID19.~Inclusion will take place during 2020. We expect to enroll 180 non-ICU patients and 36 ICU patients. | The objective of this study is to assess the long-term outcomes after hospital admission with Covid-19 with respect to pulmonary function, physical capacity, imaging, quality of life and socioeconomic outcomes. |
Although the effects of early mobilization have been studied mainly in the intensive care unit setting, the findings could be applied to the surgical units' patients too, since they share common physiological and clinical characteristics. In the literature the effectiveness of early mobilization in the length of hospital stay and recovery of the patients operated for coronary artery bypass graft and heart valve replacement in the cardiac surgery setting, is unknown.~The term early mobilization is not restricted to a time factor procedure but contains the provision of a customized dynamic set of physical therapy techniques which in studies are variably determined in terms of duration, intensity, frequency and content.~The aim of the study is to determine the clinical effectiveness of the intensive early mobilization physical therapy intervention compared with standard care of physical therapy in the cardio-thoracic surgery clinic of Papageorgiou General Hospital of Thessaloniki.~The present study will investigate the volume and extend of the expected physiological effects of early mobilization on the prevention of the clinical illness' detrimental sequelae and on the functional recovery promotion, hospital mortality and readmission rate of CABG, AVR and MVR patients. Consequently, it will investigate if the improved health outcomes may limit the number and intensity of complications and thus may speed up hospital discharge. In the first group of the experimental design, patients will be treated with an intensive early mobilization protocol and the patients of the second group will receive a standard care physical therapy treatment. Controlling for the detailed baseline characteristics that will be assessed during medical history at admission, potential bias will be limited from unmeasured confounders of the study. | The present study will investigate the volume and extent of the expected physiological effects of early mobilization on the prevention of the clinical illness' detrimental sequelae and on the functional recovery promotion of CABG, AVR and MVR patients. Consequently, it will investigate if the improved health outcomes may limit the number and intensity of complications and thus if it may speed up hospital discharge. |
The first part of this study is to identify the maximum tolerated dose (MTD) of allogeneic SARS-CoV2-specific T cells (SARS-CoVSTs) for patients with COVID19 with high risk of progression to mechanical ventilation.~The 3 dose levels (DL) are:~DL1: 1x10^7 cells (flat dose) DL2: 2x10^7 cells (flat dose) DL3: 4x10^7 cells (flat dose)~Enrollment to the dose escalation phase will be staggered. The first patient enrolled on each of the 3 dose levels (DL1, DL2 and DL3) will have to complete the 14-day toxicity monitoring window prior to enrollment of the next patients. Prior to dose escalation, all patients at a particular dose level should have completed the minimum 14-day toxicity monitoring window before enrolling to a higher dose level.~After the dose finding phase is complete and the MTD established, a randomized trial will be conducted. Patient will be randomized 1:1 using the permuted block method with a block size of 4 (2 in the treatment arm and 2 in the control arm) to receive treatment with SARS-CoVSTs or routine treatment per institutional standards.~All enrolled patients will undergo the following evaluations:~Physical exam and history including height and weight~SARS-CoV-2 test~Blood tests~Chest X-ray or chest CT Scan if not already done in the past 48 hours.~A urine pregnancy test, when applicable~Patients randomized to receive SARS-CoVSTs will be pre-medicated with Benadryl and Tylenol. The cells will be thawed and given through an intravenous line. Patients will be monitored for infusion side effects for up to 14 days or until infusion side effects have completely resolved, whichever is longer.~Blood will be drawn before the infusion and then up to daily for 14 days or until the patient is discharged from the hospital. Optional blood samples will be drawn at 2, 3 and 6 months after infusion. Study participation will last 6 months after the date of infusion. | This is a dose-finding safety trial followed by a randomized pilot trial comparing administration of SARS-CoV2-specific T cells (SARS-CoVSTs) to standard of care treatment in hospitalized patients with COVID19 who are at high risk of requiring mechanical ventilation.~The SARS-CoVSTs lines have been made at Baylor College of Medicine from healthy donors who have made a full recovery from COVID19. These cell lines were frozen for later use and will be thawed and used to treat patients who meet the eligibility criteria. |
Corona virus disease 2019 (COVID-19) has been associated with severe respiratory and multiorgan failure. Research shows that COVID-19 reduces levels of angiotensin-converting enzyme-2 (ACE-2), an enzyme that converts angiotensin II to angiotensin 1-7 (known as TXA127). COVID-19 reduces levels of ACE-2 and therefore angiotensin 1-7 and as a result, angiotensin II levels are going to be increased. Many clinical observations in COVID-19 have shown the high incidence of acute kidney injury that may be due to excessive levels of angiotensin II. The investigators hypothesize that administration of angiotensin (1-7) replaces levels of ACE-2 in COVID-19 and thereby ameliorates deterioration of multi-organ failure and specifically acute kidney injury. | The purpose of this study is to determine if administration of angiotensin-(1-7) (TXA127) prevents acute kidney injury and deterioration into multi-organ failure in patients with severe COVID-19. Participants will undergo a 10-day treatment with either placebo or study drug. The drug will be administered intravenously for 3 hours once each day for 10 days consecutively. |
This Phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Nitrite Injection for treatment of patients infected with COVID-19 who develop lung injury and require mechanical ventilation. The primary objective is to compare the two treatment groups with respect to the proportion of study subjects who are alive and free of respiratory failure at Day 28. | This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Nitrite Injection for treatment of patients infected with COVID-19 who develop lung injury and require mechanical ventilation. |
The investigators will develop novel primers to detect single virus particles in patient samples. The method involves the absorption of light by single virus particles giving a specific pattern. The investigators will develop the device to create a microdroplet of carrier fluid that is run through the trial device. The investigators will develop novel binding receptors for preferential capture of Coronavirus.~The investigators will review the results of the novel test against the standard diagnostic test and identify virus particles in test negative subjects.~The investigators will isolate the viral rna in test negative subjects and perform sequencing to find novel mutations that are not detected by the current test. | Using Laser light to detect COVID 19 virus particles in deep throat swab / nasal swab samples. |
Fractional flow reserve (FFR) is commonly used to search for ischemia-producing lesions during percutaneous coronary intervention (PCI), and its assessment becomes an integral part to guide PCI when objective evidences of inducible myocardial ischemia are not available. A transient imbalance between oxygen supply and demand leads to the ischemic cascade, which are typically accompanied by regional wall motion abnormalities or electrocardiographic changes as objective evidences of inducible myocardial ischemia.~FFR is a pressure-derived surrogate of coronary flow limitation defined as the ratio of distal coronary pressure to aortic pressure during maximal hyperemia. FFR has been indirectly validated against noninvasive stress tests, and large outcome trials support the benefit of FFR-guided PCI strategy. However, FFR is not a direct measurement of coronary flow, and myocardial ischemia depends on coronary flow rather than pressure. In fact, an experimental model shows that myocardial function can be maintained without evidences of myocardial ischemia despite low FFR. Furthermore, FFR did not predict improvement in symptoms or exercise performance after PCI, challenging the current threshold of FFR for discriminating ischemia-producing lesions.~The clinical benefit of FFR-guided PCI is certainly related to relief of inducible myocardial ischemia. However, there is little information to examine a direct link between FFR values and documented inducible ischemia at the time of FFR measurement. Therefore, the investigators investigate the relationship between FFR values and inducible myocardial ischemia at the time of definite ischemia during adenosine stress testing.~A 12-lead ECG recordings, FFR, and two-dimensional echocardiographic monitoring will be continued before, during and after adenosine infusion. When new regional wall motion abnormalities in echocardiography develop, adenosine infusion is ended and echocardiographic monitoring will be continued until left ventricular wall motion returns to normal. Apical (two-chamber, four-chamber and five chamber views) and parasternal long-axis and short-axis views will be recorded for offline analysis. | This is a prospective, single center study involving 150 patients with stable coronary artery disease undergoing coronary angiography for chest pain evaluation. The relationship between FFR values and inducible myocardial ischemia at the time of definite ischemia during adenosine stress testing will be investigated. |
After approval from the IRB of King Edward Medical University, and taking informed consent from parents of the participants, total of 120 neonates fulfilling inclusion and exclusion criteria will be enrolled and randomly allocated in two groups; group A and group B. All demographic details of participants in both groups be collected. In group A, neonates will be given bCPAP for respiratory support while neonates in group B, will be given nasal oxygen as control group. Neonates in both groups will be followed for 48 hours. The effectiveness will be determined by the reduction in Silverman Anderson Retraction Score (SARS) up to or less than 3, at the end of 48 hours. Data will be collected and analysed. | The objective of study is to determine the effectiveness of bubble Continuous Positive Airway Pressure (bCPAP) in neonates presenting with respiratory distress as compared to the control group ( using oxygen via nasal cannula). The effectiveness will be calculated in terms of reduction in Silverman Anderson Retraction Score. |
Patients who are already planning to receive an Transforaminal epidural block from their clinician will be approached by study members on the day of their injection. If enrolled, the patients will be contacted every 2 weeks for 4 weeks to determine the severity of pain and degree of pain relief from the injection. | This is a single-center, randomized, double-blind clinical study to assess the clinical application and outcomes with epidural PDRN versus Normal saline injection in patients with spinal stenosis. |
In this study, approximately 18 to 47 patients who have previously received sorafenib, lenvatinib, or oxaliplatin-containing chemotherapy . After determining the dose of IBI310, the study will enter the expansion phase | An open-label, single-arm, Ib study of the efficacy and safety of IBI310 combined with sintilimab in patients with advanced hepatocellular carcinoma |
The conventional approach: Anesthesia will be given followed by bone sounding using William graduated periodontal probe and measuring the pocket depth (using magnification loupes and microsurgical blades)~Marking the bleeding points~An internal bevel incision is made followed afterwards by a sulcular incision.~The gingival collar is eliminated.~Elevation of the flap is proceeded to allow access for osteoplasty using piezo surgery and an apical position of the bone 2-3mm beyond CEJ.~Mattress suture (6.0) is made~The intervention approach:~Surgery is done the same as in the conventional approach but without opening a flap, gaining access via a tunneling instrument and piezo tips for osteoplasty | Compare pain response following microsurgical conventional flap approach using Piezosurgery versus flapless approach for esthetic crown lengthening in management of patients with short clinical crowns in the upper anterior region. |
Patients with progressive keratoconus, pellucid marginal degeneration, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery. Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, intraocular pressure, and pachymetry. | To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders. |
This clinical trial is performed in postoperative orthopedic unit. In this study, 120 patients were enrolled who had an epidural anesthesia; 60 patients who developed PDPH joined the treatment group (A) and received the SP block. They are assessed before the procedure by NRS and at 30 mins, 2h, 4h, 6h, 12h, and 24h after the procedure. Patients are also assessed by TCD before and after the block. The control group (B) included 60 patients with no PDPH. | This study aims to investigate the ability of SPGB in the management of PDPH. Transcranial Doppler is also used as an measure to assess the block success by detecting the variability in the cerebral hemodynamics before and after the block. |
If eligible and give consent, participants will be asked to complete 2 online questionnaires. The first questionnaire asks basic information such as your age, gender, educational level, and amount of time diagnosed with systemic sclerosis. The second questionnaire asks about your disease symptoms.~You will also be asked to complete questionnaires about your fatigue, pain, mood, confidence in managing your disease and performing daily tasks, and knowledge and use of energy saving techniques.~Once you compete the questionnaires, you will be asked to compete a survey about times and days you would be available to attend the online videoconference fatigue program meeting over a 6 week period of time.~Once the time and dates for the fatigue program are scheduled, you will be expected to attend and take part (using visual and audio) in each 1 ½ hour meeting for 6 weeks online.~The fatigue program includes information on causes of fatigue, ways to protect joint and save energy, ways to manage stress, pain, good eating habits, and exercise. Outside of meetings, you will also be expected to do any homework assignments in between the group meetings such as setting goals and doing activities to reach your goals.~At the end of the 6 weeks, you will be asked to complete the same questionnaires you did at the beginning of the study regarding, fatigue, pain, and ability to perform daily tasks. You will also be asked to complete an evaluation of the course.~3 months later, you will be asked to take part in a 45 minute telephone interview to talk about your fatigue and how you are using the ideas from the program. | This research is being done to evaluate if an online fatigue intervention program will decrease fatigue, pain and increase confidence managing fatigue and being able to do daily tasks. This study involves competing a series of questionnaires before and after the intervention , and attending and participating in the online videoconference fatigue program for 1 1/2 hour meetings each week over a 6-week period of time. |
Wheat cereals are known to be capable of triggering wheat allergy and celiac disease. The prevalence of both diseases is about 1%. Recently, another clinical entity was described, the non-celiac wheat sensitivity (NCWS). The origin and mechanisms of NCWS are unclear at present, but the existence of this new disease entity has been proven by double-blind placebo-controlled challenge tests. Three different grain components have been proposed as triggers of NCWS, gluten, α-amylase trypsin inhibitors or fermentable carbohydrates (FODMAPs).~It is reported that individuals with self-diagnosed NCWS quite often tolerate spelt products much better, even though spelt shows a higher gluten content than bread wheat products. Therefore, the question arises whether this putative spelt tolerance can be confirmed on an objective basis and whether the underlying molecular mechanisms can be elucidated. So far, human study addressing such questions are lacking.~This project aims to verify the hypothesis that spelt products are more tolerable than bread wheat products in a target group of individuals with self-diagnosed wheat sensitivity. In addition, the influence of different manufacturing processes on wheat sensitivity will be revealed.~For this purpose, the trial involves individuals with self-diagnosed wheat sensitivity and spelt tolerance. Six different kinds of bread will be tested, including 4 wheat and spelt breads, each of them produced following a traditional or a conventional way. Aim of this part is to objective bread wheat and spelt intolerance in a defined population. To find out whether FODMAPs or gluten affect the tolerance of bread, two additional breads will be tested, a gluten-free bread with added gluten and a gluten-free bread with added FODMAPs. | This project aims to verify the hypothesis that spelt products are more tolerable than bread wheat products in a target group of individuals with self-diagnosed wheat sensitivity. In addition, the influence of different manufacturing processes will be considered. |
This is a phase II pilot study designed to compare the pCR rate of two neoadjuvant immunotherapies in high-risk resectable melanoma with two integrated biomarkers. The integrated [18F]F-AraG imaging biomarker images activated CD8+ T cells. The CD8+ T cell density biomarker quantitates CD8+ T Cells using an automated method. The primary purpose of the study is to describe the correlation between pCR and the distribution of either biomarkers in patients receiving either neoadjuvant Vidutolimod (CMP-001)/nivolumab or neoadjuvant nivolumab.~Patients with stage IIIB-IIID cutaneous (or unknown primary) melanoma with palpable nodal disease who have yet to undergo definitive surgery are eligible to enroll. Patients with nodal relapse including those who have received prior adjuvant IFN and/or ipilimumab are eligible to enroll.~Suitable patients will be identified pre-operatively. Patients will undergo a 28 day screening evaluation including surgical assessment, clinical assessment, systemic/CNS staging scans, and laboratory studies to confirm suitability. Patients will undergo biopsies of both planned injected and uninjected lesions (Arm A) and target lesion (Arm B). Biopsies of these lesions will occur pre-treatment, at W3 or W4 and the target lesion(s) will be resected at the time of surgery.~Eligible patients will be randomized 1:1 to receive Arm A (neoadjuvant Nivolumab/(CMP) vs. Arm B (neoadjuvant Nivolumab) during the (Prime Phase) pre-operatively. Patients randomized to Arm A will receive: Nivolumab 240mg IV q2 x3 and CMP-001 5mg SC 1st dose then 10mg IT 2nd-7th doses (7 weeks). Patients randomized to Arm B will receive: Nivolumab 240mg IV q2 x3 (6 weeks).~[18F]F-AraG PET-CT scan (18-F PET) is an integrated biomarker and will be performed at 2 imaging time-points: pre-treatment (pre-W1) and on-treatment (W2). At each imaging timepoint, [18F]F-AraG will be administered by a licensed nuclear medicine technologist under the supervision of a nuclear medicine physician on an outpatient basis. Each patient will receive a single bolus injection of 5 mCi [18F]F-AraG IV into a hand or arm vein. At Screening and W2 imaging timepoints, following [18F]F-AraG injection, a 30-min static PET-CT scan will be performed covering the brain to the upper legs.~For CD8+ T cell density assessments, patients will undergo biopsies at 2 timepoints: pre-treatment (Screening) and on-treatment (W3 or W4). In Arm A, patients will undergo biopsies of planned injected and a 2nd uninjected lesion. At each imaging timepoint, biopsies will be performed.~Following the Prime Phase and restaging systemic scans, patients will undergo surgical resection.~Post-operatively, patients will continue to receive maintenance therapy (Boost Phase) per randomization. In the Boost Phase, patients randomized to Arm A (neoadjuvant Nivolumab/(CMP) will receive 480mg IV q4 x12 along with Vidutolimod (CMP-001) 5mg SC q4 x12 over a 48 week period; while patients randomized to Arm B (neoadjuvant Nivolumab) will receive Nivolumab (480mg IV q4 x12 over a 48 week period). In the post-operative period, CMP-001 will be administered subcutaneously (Arm A only). | The main goal of this research study is to determine how nivolumab and nivolumab/Vidutolimod (CMP-001) combination affect the likelihood of destroying melanoma involving lymph node and/or in-transit/satellite areas.~The main goal of the PET/CT scan with 18F]F-AraG is to evaluate how [18F]F-AraG uptake changes before and after administration of either nivolumab or nivolumab/CMP-001 combination. |
This is a Phase 1/2, open-label, multicenter study in Japanese patients with locally advanced or metastatic NSCLC. This study will be conducted in two parts. Phase 1 is designed to observe the maximum tolerated dose (MTD) or maximum administered dose (MAD) of poziotinib when administered once daily or twice daily. Phase 2 will evaluate the safety and efficacy of the dose determined in Phase 1. Study participation includes a 30 day screening period, up to 24 months of treatment, and long-term follow-up for a maximum of 24 months after discontinuation of study treatment.~Phase 1 will enroll up to 36 patients into a dose finding study with two parallel, randomized dose groups. Each group will undergo a dose-finding scheme using a 3+3 design with the assessment of dose-limiting toxicities (DLTs) at up to three dose levels. Patients will be randomized into once daily (QD) or twice daily (BID) dose groups. The DLT assessment will be conducted in the first cycle of treatment and therefore, poziotinib dose modifications are not permitted during this cycle. Patients will be hospitalized for the first 2 weeks.~Phase 2 will enroll 40 additional NSCLC patients with EGFR (20 patients) or HER2 (20 patients) exon 20 insertion mutations. Efficacy and safety of the dose and dosing regimen determined in Phase 1 will be evaluated. All patients will be treated in 28-day cycles for up to 24 months. | A Phase 1/2, open-label, multicenter study to determine dose, tolerability, safety and efficacy of poziotinib in Japanese patients non-small cell lung cancer (NSCLC). |
Limited experimental research has explored the effects of acute exercise training (< 1 week of exercise) on sleep and daytime impairment in samples of adults who meet diagnostic criteria for insomnia. In response to the current literature, the investigators aim to better understand the short-term clinical benefit of adopting exercise training in insomnia. Including multiple bouts of exercise in a short time span while measuring sleep with objective and self-reported measures may be more reflective of capturing true acute effects of exercise implementation on insomnia. The investigators propose to conduct a randomized parallel design to compare the effects of short-term moderate-intensity aerobic exercise on insomnia severity and measures of sleep in a sample of adults who meet diagnostic criteria for insomnia. This project will address prior limitations in the area of acute exercise research by utilizing a sample with diagnosed insomnia, assessing multiple nights of sleep, and implementing multiple bouts of exercise stimuli. This project will examine the following aims:~Aim 1: To examine if implementing 1 week of moderate-intensity aerobic exercise improves objective and subjective sleep compared to 1 week without exercise in a sample of adults who meet diagnostic criteria for insomnia.~Aim 2: To examine if implementing 1 week of moderate-intensity aerobic exercise reduces severity of daytime impairment compared to 1 week without exercise in a sample of adults who meet diagnostic criteria for insomnia. | It has been hypothesized that exercise may have a beneficial effect on sleep quality and insomnia severity in those who have insomnia symptoms as well as those who meet diagnostic criteria for insomnia disorder (e.g., Diagnostic and Statistical Manual 5th edition (DSM-5)). Yet, the studies that have tested this are extremely limited in number and even fewer explore any acute effects of exercise training on subjects who meet diagnostic criteria. Thus, the investigators propose to conduct a randomized parallel design to compare the effects of short-term moderate-intensity aerobic exercise on insomnia severity and measures of sleep in a sample of adults who meet diagnostic criteria for insomnia. |
A rheumatology biorepository will be created to permit comparative analyses between the rheumatic diseases in order to increase the understanding of disease pathogenesis. Patients seen at Yale clinics diagnosed with rheumatic diseases are invited to participate in this study. These rheumatic diseases include, but are not limited to: adult onset Still's disease, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, antiphospholipid syndrome, systemic lupus erythematosus, Behcet's disease, dermatomyositis, polymyositis, giant cell arteritis and other vasculitides, Lyme's disease, mixed connective tissue disease, polymyalgia rheumatica, rheumatoid arthritis, sarcoidosis, systemic sclerosis (scleroderma), Sjogren's syndrome, and undifferentiated connective tissue disease. | To facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases. |
This study was conducted in 893 facilities in Korea from 2 Apr 2012 to 1 Apr 2017. This study was designed to administer 1mg, 2mg, or 4mg pitavastatin to patients with hyperlipidemia at the age of 20 or older for at least 8 weeks. | The prospective, observational, non-comparative trial in South Korea was designed to evaluate the efficacy and safety of pitavastatin (Livalo) in clinical practice in 28,343 patients. |
The project is a 6-month prospective Randomized Controlled Trial evaluating the effects of TargEted MAnageMent Intervention (TEAM, N=80) vs. wait-list (WL, N=80) control in African American men who have experienced a stroke or TIA within the past 5 years. TEAM features a nurse-led, person-centered, holistic intervention that takes advantage of existing strengths in AA families/communities. TEAM uses peer educator dyads (PEDs) to provide support and model behaviors. The PED consists of an AA man peer educator (PE) with experience in managing his own stroke risk and a care partner. A care partner is someone who is the family member, friend or other individual of someone who has had a stroke or TIA. A care partner can be associated with a PE but they do not have to be. PEs and care partners will be matched depending on schedules and availability and may not always be members of the same household. The nurse and PED co-deliver TEAM to an AA male patient who has experienced stroke or TIA. Patients are also encouraged to include a family, friend, or other individual important his stroke recovery in the TEAM programming. The intervention is a practical approach suitable for implementation in specialty, primary care or community settings, and has the potential to reverse the unacceptably high morbidity seen in AA men due to stroke-related disorders. | The project is a 6-month prospective Randomized Controlled Trial evaluating the effects of TargEted MAnageMent Intervention (TEAM, N=80) vs. wait-list (WL, N=80) control in African American men who have experienced a stroke or TIA within the past 5 years. |
Mantle cell lymphoma (MCL) is one of approximately 100 different types of non-Hodgkin's lymphoma (NHL). Due to the aggressive and heterogeneous nature of MCL, majority of patients are diagnosed with advanced stage disease that requires immediate, diverse and aggressive courses of therapy to improve the outcome of the disease. The addition of blood or bone marrow transplantation (BMT) to the chemotherapy regimens is a critical factor to prolong duration of response in patients, however, the benefit of combination chemotherapy followed by BMT is often temporary as patients experience disease progression and mortality and this underscores the need for novel therapies as well as additional maintenance therapy strategies to prevent relapse post-BMT.~Acalabrutinib, a selective, irreversible small molecule inhibitor of Bruton's tyrosine kinase (BTK) is approved for the treatment of adult patients with MCL who have received at least 1 prior therapy~This study is a single arm, multi-center, phase 2 study of subjects who will receive acalabrutinib as maintenance therapy post-BMT. Subjects will undergo a standard of care BMT with conditioning regimen determined by the treating physician per institutional guidelines.The BMT is not considered part of this study. Following completion of the BMT, Maintenance therapy with acalabrutinib will begin on Day 100 in 28-day cycles. Subjects will self-administer 100 mg acalabrutinib BID until they reach 2 years post-BMT (approximately 22 cycles).Subjects will be followed for up to 5 years post-BMT for Progression Free Survival. | This is a phase II study to evaluate efficacy of Acalabrutinib as a maintenance therapy following blood or marrow transplant (BMT) in patients who have been diagnosed with mantle cell lymphoma. |
Localized prostate cancer can be treated in 5 sessions using a precise, targeted form of radiation known as stereotactic body radiation therapy (SBRT), with low toxicity. Despite these advances, overall outcomes for aggressive (high risk) prostate cancer remain poor, with 10-year recurrence-free survival of approximately 65% regardless of treatment modality. Recurrences are typically distant and carry poor prognosis, with 5 year survival of 25%. The investigators propose to utilize the latest advances in cancer imaging (PSMA Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MR)) and radiation delivery (MR-guided radiation therapy with real-time adaptive planning), to deliver a personalized radiation treatment that targets the areas of greatest risk of recurrence in the prostate with improved precision, and as a result improve clinical outcomes for individuals with high risk prostate cancer. PSMA PET/MR is a novel imaging modality, not yet widely available, that augments the tissue detail provided by MR. The combination of PSMA PET with MR results in improved delineation of intraprostatic nodules and higher diagnostic accuracy for detection of metastatic disease compared to conventional imaging. PSMA PET/MR imaging data is readily transferable to a MR-based linear accelerator (MR-LINAC), a novel, innovative platform that allows direct visualization of the tumor during treatment, and permits real-time individualized correction for motion with online adaptive radiation planning. | This is a single-arm Phase II clinical trial assessing the clinical efficacy of prostate specific membrane antigen (PSMA) PET/MR guided MR-LINAC based SBRT-SIB with planned accrual of 50 patients. |
Hyponatremia is the most frequent electrolyte disorder encountered in clinical practice and is often associated with increased mortality, morbidity and risk of hospitalization. The patient approach, however, is still problematic, above all because hyponatremia is a manifestation correlated to various pathological conditions, with complex etiopathogenesis.~The most commonly used classification of hypotonic hyponatremia is, nowadays, the one described in a famous review by Kumar and Berl (see Bibliography). Probably the most crucial point in this classification is represented by the correct assessment of Extracellular Fluid Volume Status (i.e. hypovolemia, euvolemia, hypervolemia).~Even though some algorithms have been proposed to correctly assess hyponatremia subtype classification and patient volume status, there is no single parameter that has proven to be able alone to perfectly achieve this result.~In the current study, the reference test (gold standard) for the definitive assessment of hyponatremia subtype classification and patient volume status was a post-discharge re-evaluation of all the available evidence (with the exception of plasma copeptin levels) carried out by two independent neuroendocrinologists with specific expertise in sodium disorders. In case of disagreement, the experts proceeded to a discussion and comparison of their opinions, in order to produce a shared one.~Using this gold standard, the main aims of this observational prospective study were:~to estimate the diagnostic accuracy of the clinicians in identifying the subtype of hyponatremia at the first evaluation of the patients in the ED and then at the admission to the wards;~to evaluate the diagnostic accuracy of the most important methods suggested by the literature (clinical, imaging, biochemical) for the assessment of Extracellular Fluid Volume.~In addition to this, in recent years copeptin has been shown to be a promising parameter for the evaluation of sodium disorders and water imbalances, but its diagnostic role in the setting of hyponatremic patients is still largely unknown. Therefore, a secondary objective of the study was to specifically evaluate the utility of copeptin (whose values - as specified before - were hidden to the neuroendocrinologists in charge of defining the gold standard diagnoses for each patient) for the assessment of hyponatremia subtype classification and patient volume status. | Hyponatremia is the most frequent electrolyte disorder encountered in clinical practice. The patient approach, however, is still problematic, above all because hyponatremia is a manifestation correlated to various pathological conditions, with complex etiopathogenesis.~Even though some algorithms have been proposed to correctly assess hyponatremia subtype classification and patient volume status, there is no single parameter that has proven to be able alone to perfectly achieve this result. |
Background Crowding and readmissions are common challenges in Emergency departments across Europe. The decision whether to admit or discharge the patient is challenging and is often based on clinical signs and symptoms e.g. blood pressure, pulse, respiratory rate, oxygen saturation and temperature. But some patients are unnecessarily admitted and may have been better off if sent home. Other patients may be discharged without - and one out of five patients are readmitted within a month raising the question whether the patient should have been admitted at first presentation in the ED. suPAR is a strong prognostic biomarker measured routinely in acute medical patients in some emergency department (ED) settings.suPAR is a broadly applicable biomarker of risk, and it has been developed an algorithm for simple interpretation of suPAR in clinical decisions for the study.~Objective To evaluate the use of a clinical decision algorithm in the ED with the aim of improving discharge or admission decisions. | Will the use of a clinical decision algorithm in the ED improve discharge or admission decisions. |
A randomised controlled study in the effect of training in patients with dysphagia.~The patients are randomised for training or for usual care. | Effect of training of patients with dysphagia |
Patients of Group A received meropenem one gram slowly IV infusion every 8 hours for 14 days and gentamicin 7 milligram (mg)/ Kilogram body weight per day slowly IV infusion once daily only for one week, while patients of Group B received ceftazidime 2 grams and avibactam 500 mg every 8 hours for 14 days in solution for injection(sodium chloride 9 mg/mL (0.9%), sodium chloride 4.5 mg/mL, dextrose 25 mg/mL, 0.45% sodium chloride, 2.5% dextrose and/or Lactated Ringer's solution). The solution for injection should be administered over 120 minutes. • Temperature was measured every 3 hours for 2 weeks. • ABG was done every 8 hours for 2 weeks. • CBC including white cell count was done daily and for 2 weeks. • Complete renal functions daily (urea and creatinine serum level) for 2 weeks. Any patient showing rise in the creatinine level was recorded and excluded from the study. • Chest X-ray for all the patients was ordered after intubation and with onset of ventilation and every 24 hours for 2 weeks. • All patients received anti-stress (Omeprazole 20 mg IV every 12 hours). • Oro-gastric tubes were inserted to all patients and feeding was started within 24 hours.Daily evaluation for conscious level and need for sedation and ventilation were done for all patients. • Tracheobronchial lavage was obtained by bronchoscopy 2 times a week and sent for qualitative culture for 2 weeks. • Blood culture was also taken 2 times per week for 2 weeks. • The planned duration of the study is two weeks from diagnosis of VAP and starting the antibiotics so any patients who failed to be weaned within this period were considered morbidity and recorded. | This was a prospective double blind study conducted on 200 polytrauma patients admitted to King Abdul-Aziz Specialized Hospital, Taif, KSA between July 2018 and December 2019 in surgical ICU. All patients were having severe chest trauma, contused lungs either with or without severe head trauma. |
At the baseline visit, women will go through informed consent and review of study eligibility. Objectives of the study, participation requirements, eligibility inclusion and exclusion will be reviewed in detail. If these are not met, the woman is excluded from the study. If she meets inclusion criteria, a checklist of exclusion criteria will be reviewed. If any exclusions are met, the woman is excluded from the study. The consent form will be reviewed in detail. If the woman consents and signs all pages of the form, randomization follows.~Randomization will be done in a 1:1 allocation ratio between the treatment and placebo arms, stratified by blood pressure group (elevated blood pressure and stage 1 hypertension). A computer algorithm will assign participant based on random permuted blocks design with block size between 2-4 within each strata. Each participant will have an assigned Study ID number that is linked to their random assignment.~Participants will be contacted by telephone 1 week after randomization. The purpose of this visit is to ensure the participant has received study medication and initiated the regimen.~The third encounter will be 6 weeks (+/- 1week) after randomization in person to coincide with routine prenatal visit or via telephone. The purpose of this study visit is to review their pregnancy course, use of study medications, any side effects, difficulties with the study, and have opportunities to make comments and/or ask questions. The participants will be asked to bring their study medication for pill count at the time of this encounter, if the study visit is able to be performed in person. Study participants will continue their routine prenatal care with pregnancy management performed routinely per their provider.~The fourth encounter will be 16 weeks (+/- 1week) after randomization in person to coincide with routine prenatal visit or via telephone. If the participant is already delivered by this time, the visit will be performed via telephone postpartum. The purpose of this study visit is to review their pregnancy course, use of study medications, any side effects, difficulties with the study, and have opportunities to make comments and/or ask questions. The participants will be asked to bring their study medication for pill count at the time of this encounter, if the study visit is able to be performed in person.~The rest of the study will be conducted via chart review. Each prenatal visit will be reviewed for blood pressure, evaluation of symptoms, review of any laboratory and/or imaging results. New diagnoses, medications, and hospital admissions will be documented.~Delivery records will be abstracted for outcomes listed below. Neonatal records will be reviewed from birth until 1 year of age. Neonatal and infant chart abstraction will include birthweight, Apgar scores, hospital course, problem visit, diagnoses, medications, emergency department visits, and hospitalizations. Participant's postpartum course will be reviewed for 1 year postpartum, including outpatient visits, emergency department visits, and any hospitalizations.~The study will be performed by an intent-to-treat analysis. Thus, even women who discontinue study medication will be included in final analyses. | To determine if low dose aspirin reduces the incidence of hypertensive disorders of pregnancy (gestational hypertension, preeclampsia, eclampsia, and HELLP syndrome) in pregnant women with stage 1 hypertension and elevated blood pressure. |
This is a multicenter, open-label Phase 1 study of orally administered CB-5339 in participants with R/R AML or participants with R/R intermediate- to high-risk MDS. The study will include two parts:1) a Dose Escalation phase in participants with R/R AML, or R/R intermediate- to high-risk MDS and 2) a Dose Expansion phase in participants with R/R AML for whom there is no standard of care therapy available that is likely to lead to disease remission. Additional cohorts for participants with R/R intermediate- to high-risk MDS following hypomethylating agents or other AML cohorts may be added at a later time. | This is a multicenter, open-label Phase 1 study of orally administered CB-5339 in participants with R/R AML or participants with R/R intermediate- to high-risk MDS. |
Thanks to a better understanding of the pathophysiological mechanisms of inflammatory rheumatism, rheumatology has known for several decades a growth in its therapeutic arsenal (csDMARDs, bDMARDs, tDMARDs). rheumatism control has thus been optimized.~however, patients very often keep pain, anxiety, residual fatigue, poorly controlled by our conventional therapies. patients then turn to non-drug therapies, among which the use of cannabis.~endocannabinoids have an analgesic and anti-inflammatory action recognized in pre-clinical trials. however, investigators currently lack the data to authorize its use in clinical rheumatology.~the aim of this study is to determine the prevalence of cannabis users in patients with rheumatoid arthritis, ankylosing spondyloarthritis or psoriatic arthritis in our unit. as a second intention, investigators will refine the consumption characteristics. Investigators will also look for possible risk factors for consumption (sensitivity to pain, catastrophism, standard of living, anxiety, depression, rheumatic activity and quality of life). | Patients with inflammatory rheumatism very often have residual pain that is not easily relieved by conventional treatments. They can then use non-drug methods, such as physiotherapy, hypnosis or even cannabis.~The aim of this study is to assess the percentage of patients who use cannabis to better relieve their pain or anxiety in chronic inflammatory rheumatism. |
Introduction:~Currently, Rugby is a sport that is giving priority to the well-being of the player. Players are subjected to high training and match loads exposing them to constant stress that can lead to overload injuries in addition to frequent contact injuries. Despite knowing what the situation is like at the international and national level, the Unión Argentina de Rugby lacks conclusive epidemiological data.~Our main purpose was to describe the prevalence, incidence and injury load suffered in male amateur rugby players from Argentina during a competitive season in 2019.~Design:~Observational, descriptive, retrospective and multicenter study.~Participants:~250 male amateur rugby players belonging to three clubs from three rugby unions (Buenos Aires, Córdoba and Rosario) of Argentina.~Methods:~Registration methods were applied according to the consensus of the World Rugby by a single observer per center. Injuries occurred in players from top rosters of 3 amateur rugby clubs (data collection centers) as well as the number of matches and hours of training were recorded. Medical diagnoses were classified under the rules of the OSIICS classification system. The incidence (injuries / 1000 hours-game-player), prevalences (point and period), the severity (days of absence) and the injury load will be calculated as well as the location, type, nature. This study followed the guidelines of the STROBE-SIIS Initiative Declaration. | The aim of this study was to describe the prevalence, incidence and injury load suffered in male amateur rugby players from Argentina during a competitive season in 2019. |
This is a prospective, interventional pilot study that plans to enroll 15 patients who are receiving salvage high dose chemo and bone marrow transplant for relapsed Germ cell Cancer (rGCC). Patients will be asked to go through a series of surveys and screening procedures to determine eligibility. Once enrolled, patients will receive music therapy while they are being treated either inpatient or outpatient for their standard of care treatments.~Primary Objective To evaluate the feasibility of recruitment, retention, and compliance to a mHNMT in patients with CIT and rGCC admitted to BMT service to undergo salvage high-dose chemotherapy with tandem bone marrow rescue.~Secondary Objectives To estimate the effects of mHNMT on severity of CIT, associated distress, anxiety, depression, fatigue, benefit findings, sleep, and audiometry measures and assess number of times homework completed. | Pilot study evaluating the feasibility of recruitment, retention, and compliance to a modified Heidelberg Model of Neuro-Music Therapy (mHNMT) in patients with Cisplatin-induced Tinnitus and relapsed Germ Cell Cancer (rGCC). |
Alcohol use disorder (AUD) is highly prevalent and a major contributor to the global burden of disease. Insomnia symptoms are very common among individuals with AUD, including those in recovery, which may in turn promote alcohol relapse. Specialization and silo phenomena in healthcare organization, separating addiction from other types of psychiatric care, means that individuals with AUD and comorbid sleep problems often have difficulty accessing evidence-treatment for the latter. Offering online treatment for sleep problems to individuals enrolled in traditional routine addiction care is an attractive and pragmatic approach to offering parallel treatments covering the full clinical presentation, which has not yet been evaluated. This pilot and feasibility trial will recruit n=25 from patients in routine addiction care with comorbid sleep problems and AUD, who will complete an online, ten-module, CBT-based treatment program with minimum guidance for sleep problems, tailored for individuals with AUD. | The main goal is to study the effects of internet-delivered cognitive behavioural therapy with minimum guidance for comorbid sleep problems in alcohol use disorder, in routine addiction care. |
Donafenib is a multikinase inhibitor which is acting on various cellular pathways involved in the genesis of acute myeloid leukemia (AML). Donafenib is therefore a promising candidate for improvement of chemotherapy results in AML. This clinical trial evaluates the safety and pharmacokinetics of Donafenib combination with Cytarabine/Daunorubicin for AML in patients between 18 and 55 years of age. | This phase Ⅰ study of Donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess safety and pharmacokinetics in patients with Relapsed AML. |
Ischemic stroke is the main cause of disability in the world. More than 70% of stroke patients show various degrees of neural function impairment. Early rehabilitation in acute phase is beneficial for improving patient's activity of daily livings and motor function. However, it is difficult to obtain effective rehabilitation during the acute phase of stroke because of the insufficiency of professional rehabilitation therapists in stroke wards in China. The investigators assume that implementing program based on modified Barthel Index can realize nursing-directed motor rehabilitation during acute phase of ischemic stroke. The present study is to conduct quasi-experimental research to confirm the feasibility and effectiveness of nursing-directed precision rehabilitation in acute stroke patients. | In the clinical setting, it is difficult to obtain effective rehabilitation during the acute phase, the reasons may include insufficient awareness of early rehabilitation due mainly to a limitation in number and variety of rehabilitation professionals in Low- and middle-income countries. It is necessary to shift tasks to other healthcare providers who are trained to provide rehabilitation like nurses. The purpose of this study is to examine the feasibility and effectiveness of a modified Barthel Index based rehabilitation nursing program on acute stroke inpatients. |
Perioperative pulmonary embolism (PE) is the serious adverse event leading to major morbidity and mortality. The incidence of PE during urologic surgery was previously report at 0.9 - 1.1% with mortality rate less than 2%. But the recent study by Fukazawa et al report the incidence of PE was 11% in renal cancer patients underwent nephrectomy with mortality rate as high as 33%. The risk factors associated with PE included major surgery, cancer, arrhythmia, massive bleeding and level of tumor thrombus in inferior vena cava.~Transesophageal echocardiography (TEE) is a very helpful intraoperative monitoring tool in major, non-cardiac surgery to detect emboli and guide the hemodynamic management in severely unstable patients. But it requires sophisticate machine and well-trained operator, the rate of utilisation was still limited.~The investigators aimed to determine the incidence of perioperative PE in renal cancer patients undergoing nephrectomy. the secondary outcomes include risk factors associated with perioperative PE, clinical outcomes, the rate of TEE utilization in this operation and outcome. | Patients with renal carcinoma was reported at high incidence of perioperative pulmonary embolism from current study. The investigators aimed to determine the incidence and outcome of this group of patient in the tertiary-care, university hospital and the rate of intraoperative transesophageal echocardiography utility and outcome. |
This is a laboratory testing study using the SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene test to determine the presence of IgM and IgG antibodies in subjects who have tested negative or positive for COVID-19. The study is observational and subjects will be assigned to one of two arms depending on the results of their nCOVID-19 test. | The purpose of this study is to evaluate point of care SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene test and correlate it with the standard method of testing in inpatients who have tested positive or negative for COVID19. |
Only 24% of health care workers (HCW) had developed inmunological response to SARS CoV-2 infection in one centre attending thousands of COVID-19 patients, and with shorteness of personal protective equipments. Our hypothesis is that this relatively low number of infected HCW could be secondary to:~Differences in susceptibility to infection mediated by changes in viral receptors. Thus, it is important to characterize and genotyping the main receptor for SARS-CoV-2, ACE2, and other related receptor, such as CD26.~Increased cellular immune response, offering cross-immunity against SARS CoV-2 infection by previous exposure to other coronavirus or respiratory pathogens. A specific CD4/CD8 T cell response to viral peptides could respond this question~Specific KIR phenotypes (Killer Immunoglobulin-like Receptors): Natural killer cells (NK) response to alterations of class I HLA molecules presented in infected cells. An increase in class I HLA expression could lead to an increase in NK activation by increasing its ability to produce IFN-gamma. | The primary objective of this study is to establish differences in susceptibility to SARS CoV-2 infection among health care workers (HCW) highly exposed to patients with COVID-19 diagnosis. To ascertain this issue, we evaluated:~Changes in receptor polymorphism (ACE2 and CD26 receptor study.~SARS-CoV-2 CD4/CD8 T cell response (CTL)~Different KIR phenotypes |
Primary Aim:~• To determine safety of stellate ganglion block (SGB) in ARDS~Secondary Aim:~To determine efficacy of SGB in slowing the progression of ARDS | The purpose of this study is to understand if it is safe and useful to perform SGB (Stellate Ganglion Block) in patients who have severe lung injury Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 infection. |
Part 1 of the study includes up to 3 ascending dose cohorts, each comprised of 8 subjects (6 receiving TD-0903 and 2 receiving placebo).~Part 2 of the study will evaluate one dose of TD-0903 (selected based on the data from Part 1) as compared with placebo. Part 2 is targeting 198 subjects total. | This Phase 2 study will evaluate the efficacy, safety, pharmacodynamics and pharmacokinetics of inhaled TD-0903 compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with confirmed COVID-19 associated acute lung injury and impaired oxygenation. |
As part of the management of COVID-19 related severe ARDS, the World Health Organization (WHO) recommends prone positioned mechanical ventilation. At this time, it is unclear whether there is a role for prone positioning (PP) of non-mechanically ventilated patients.~The objective of this trial is to determine whether PP improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candidates for mechanical ventilation in the ICU. The investigators hypothesize that PP will reduce in-hospital mortality or discharge to hospice, compared with usual care for non-intubated patients with do-not-intubate goals of care with hypoxemic respiratory failure due to probable COVID-19.~Patients randomized to the intervention arm will continue with prone positioning until study inclusion criteria are no longer met, discharge from hospital, day 60 in hospital, or until death or discharge to hospice. Daily assessments will occur until day 60 or until the patient is discharged from hospital or is deceased. The investigators anticipate recruitment to be completed within 12 months of starting the trial. | The purpose of this trial is to determine whether Prone Positioning (PP) improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candidates for mechanical ventilation in the ICU. The investigators hypothesize that PP will reduce in-hospital mortality or discharge to hospice, compared with usual care for non-intubated patients with do-not-intubate goals of care with hypoxemic respiratory failure due to probable COVID-19. |
This study is a parallel group, randomized, third-party blinded, multicenter study to assess safety and efficacy of LSALT peptide versus placebo in hospitalized patients with confirmed infection or recent confirmed infection with complications associated with COVID-19. Following screening and after establishing baseline parameters such as lung and renal function, clinical chemistries, coagulation, hematology, and urinalysis, and satisfying all inclusion and exclusion criteria, patients will be randomized to one of two blinded treatment regimens:~100 mL of 5 mg IV LSALT peptide infusion over 2 hours daily~100 mL drug-free IV saline infusion over 2 hours daily.~Thirty (30) patients will be randomized to active drug (LSALT peptide) and 30 patients will be randomized to matching placebo. This study will be third-party blind with only the Pharmacist at the site unblinded for the purpose of preparing drug/placebo for injection.~Patients will be followed for safety and efficacy up to Day 28, with Day 1 being the day of randomization to assess safety. After assessing the risk of ARDS and satisfying all inclusion and exclusion criteria, the patient will be randomized to 5 mg LSALT peptide or blinded placebo to be given intravenously once daily for a maximum of 14 days. Physical and respiratory examinations, vital signs, and adverse events will be recorded throughout the study, including Day 28 (EOS). Blood chemistries, hematology, coagulation, urinalysis, ECG, SARS-CoV-2 tests, eGFR, and chest x-ray (CXR) will be assessed at Day 1 (Screening/Baseline) prior to initiation of study drug, and on Day 3, EOT, and at EOS, as well as when clinically indicated. The ECG at EOS will only be obtained if clinically indicated. An additional CXR will be obtained at time of clinical improvement. Cytokines/biomarkers and pharmacokinetics (PK) will be assessed at Day 1 (Screening/Baseline) prior to initiation of study drug, at 1 (mid-dose) and 2 hours (end of infusion) of drug therapy on Days 1, 3, EOT, and a single blood sample at EOS for cytokines/biomarkers only. Where applicable, a urinary pregnancy test will be obtained at Screening in women of childbearing potential. Questionnaires (APACHE II, SOFA) will be obtained at Baseline, Day 3, EOT, and EOS; venous blood gas (VBG) or HCO3 (bicarbonate) levels may be substituted for arterial blood gas (ABG) if it is considered standard-of-care (SOC) or in the patient's best interest, and results in comparable APACHE II and SOFA scores. Other questionnaires (Berlin Definition and modified Medical Research Council Dyspnea Scale) will be assessed at Baseline, Day 3, EOT, and EOS. IgG, IgA, and IgM antiviral antibodies will be collected at Baseline and EOS. Patients will be maintained on the SOC per institutional guidelines, including prophylaxis or treatment of VTE, throughout the study.~A Data and Safety Monitoring Board (DSMB) will evaluate patients on a continuing basis for primarily safety assessments. Per the DSMB Charter, the DSMB will meet at least monthly if not more frequently based upon enrollment throughout the study period. | To evaluate the proportion of subjects alive and free of respiratory failure (e.g. need for non-invasive or invasive mechanical ventilation, high flow oxygen, or ECMO) and free of the need for continued renal replacement therapy (RRT) on Day 28. The need for continued RRT at Day 28 will be defined as either dialysis in the past 3 days (Day 26, 27, or 28) or an eGFR on Day 28 <10 mL/min/1.73 m2. |
Problems such as breathlessness, exercise intolerance and loss of peripheral muscle strength can be observed in individuals who have been diagnosed with COVID19 and have been discharged. In our study, it was aimed to investigate the effect of telerehabilitation physical therapy intervention to these cases by using videoconferencing method on the physical condition of the cases. The exercise program will be a total of 6 weeks, 3 days a week. Online access will be carried out synchronously by telephone or computer, and training sessions will not be recorded in order to protect patient personal information. The cases will be evaluated online at the beginning of the study and at the end of the 6-week exercise program. The selected evaluation parameters have been selected considering the ease of online application. | Problems such as breathlessness, exercise intolerance and loss of peripheral muscle strength can be observed in individuals who have been diagnosed with COVID19 and have been discharged. In our study, it was aimed to investigate the effect of telerehabilitation physical therapy intervention to these cases by using videoconferencing method on the physical condition of the cases. |
Primary Performance:~The primary performance endpoint will be assessed as the ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. Conversion* to an alternate approach comprises conversion to open, multiport laparoscopic**, multiport robotic or hand-assisted§ approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned procedure using the alternate approach.~Performing an extracorporeal anastomosis is not considered a conversion ** Use of additional assistant laparoscopic port(s) is not considered a conversion § Laparoscopic or robotic with hand assistance~Primary Safety:~• The primary safety endpoint will be assessed as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period | To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections or right colectomy. |
In response to the pandemic, the Food and Drug Administration (FDA) approved several platforms under emergency use authorization (EUA). These platforms do not have full FDA approval and may be used for COVID-19 testing temporarily in a clinical laboratory until the manufacturer receives full FDA clearance for use in the U.S.~Two point of care (POC) platforms with current EUA approval are the ID NOW COVID-19 (Abbott) and the Accula SARS-CoV-2 tests (Mesa Biotech). Both tests are designated as clinical laboratory improvement amendments (CLIA) waived complexity. POCs play a vital role in the diagnosis of COVID-19, especially in laboratories and clinics where testing including molecular assays and serology is not available.~The purpose of this study is to compare SARS-CoV-2 results from clinical specimens on the ID NOW and the Accula systems. If the Accula system is comparable or demonstrates superior test parameters including sensitivity, then this assay may potentially assist in improving turnaround times for COVID-19 results and facilitate reinstating elective procedures.~Patients with orders for rapid Covid-19 testing and who have consented to participate will be included. For these patients one additional clinical specimen, a nasal specimen will be collected from the patient at the same time as the initial specimen for the ID NOW. If there is a discrepancy between the ID NOW and Accula test results, an additional specimen (nasal) will be collected from the patient, if possible (i.e. if the patient remains in-house) to confirm the COVID-19 results. We will also include patients who did not have an initial swab but tested positive by PCR. They will be swabbed by both systems.~This study will evaluate accuracy by comparing Accula results to the ID NOW, precision (reproducibility) by repeating select specimens with different users and on different analyzers, limit of detection by diluting commercial SARS-CoV-2 controls with a known concentration and cross-reactivity by testing known respiratory viruses (including influenza A, B and RSV) on the Accula. | This study is a comparison of the ID Now COVID-19 (Abbott) assay to the Accula SARS-CoV-2 (Mesa Biotech) assay to assist in the identification of infection with COVID-19. The tests will be compared for sensitivity, specificity, positive predictive value and negative predictive value. |
COVID-19 is a disease with an initial viral phase followed, usually at the 7th day, of an inflammatory state (cytokine storm) leading to respiratory distress, ICU admission and risk of death. Thus, several biological agents, antagonists of the different cytokines (IL-6, IL-1) have been used for patients with severe disease. However, there are no data about the cytokine changes, at admission and after therapy, and its predictive value, a fundamental knowledge to establish the best therapeutic strategy.~The first line of immune defense is the interaction of the virus with innate immunity cell members. The toll like receptors (TLRs) family is a group of pattern recognition receptors that include many different molecules (21-23). These bindings can activate dendritic cells, monocytes, macrophages. There is an important RNA and DNA connection, activation of TLRs, the production of type I interferons, and the development of some autoimmune diseases. TLR7 and TLR8 specifically recognize simple-chain RNA of viruses and are expressed in endosomal membranes. TLR8 is expressed in regulatory cells (Treg) and its activation results in inhibition of its regulatory functions. Natural killer cells (NK) respond to alterations of class I HLA molecules present in infected cells (24-26). An increase in class I HLA expression could lead to an increase in NK activation by increasing its ability to produce IFN-gamma. Therefore, the reasons for KIR binding are often variable between individuals and between populations. | To ascertain globally the changes in the cytokines involved and TLRs/KIR activation in patients admitted to the hospital with a COVID-19 diagnosis, and the changes after initiation of the different therapies |
Chronic pancreatitis is extremely painful and pain management in patients with chronic pancreatitis is challenging. The etiology of abdominal pain in chronic pancreatitis is considered multifactorial. Current treatments for pain control primarily include narcotic & opioid administration; however, these medications require titration of dosage for optimal pain control and are frequently followed by adverse effects such as constipation, nausea or drug addiction. Currently, the FDA has imposed strict regulations regarding the amount, frequency & length of time patients may receive these medications. With tightly controlled regulations for prescribing narcotics and opioids for chronic pain management, the epidemic of street drug usage and overdose has dramatically increased. Alternatively, celiac plexus block and celiac plexus neurolysis performed under EUS guidance have been employed for pain control for at least 2 decades and deemed safe. Celiac plexus block refers to temporary inhibition of nerves of the celiac plexus, by using a combination of steroid and numbing medications injected into the celiac plexus ganglia. Celiac plexus neurolysis (CPN) refers to a temporary to semi-permanent inhibition of nerves of the celiac plexus ganglia. Injection of alcohol as a neurolytic agent is used in place of the steroid which causes neurolysis of the celiac plexus or ganglia.~This study will focus on collecting data related to endoscopic ultrasound procedures performed by Indiana University EUS physicians; specifically for the management of chronic pancreatitis pain. This data will be used for research purposes to determine the clinical impact of EUS-CPN management in chronic pancreatitis pain. The physicians will also be able to better understand the patient's condition and disease process that may lead to improved patient management. | Physicians need a tracking system for specific treatment modalities, and data to determine the impact of endoscopic ultrasound pain management for patients with chronic pancreatitis. |
Feeding and oral motor interventions address different aspects of feeding difficulties, reflecting the range in specific problems associated with feeding and nutrition in CP.~The trunk plays an important role in the organization of postural control and balance reactions because it holds the centre of all body mass and holds therefore, the centre of gravity. The trunk also provides stable attachment points to those muscles that control the head and neck regions. Neck and trunk stabilization exercises were the basis of static and dynamic balance abilities, and that increased neck and trunk stability might have had a positive effect thereon.~To achieve the alignment of the head with the trunk, the pelvis must be stabilized. This has important consequences for the entire process of swallowing. If the head is not stable, then the fine movements of the jaw and tongue needed for feeding will be impaired. With feeding and oral motor interventions and structured neck and trunk stabilization exercises, these parameters are positively affected. | Our study is planned to investigate the effects of neck and trunk stabilization exercises, which are structured from Neurodevelopmental therapy method-Bobath concept (NDT-B) principles, on feeding and swallowing activity in children with Cerebral Palsy (CP) who take feeding and oral motor intervention strategies. The cases were divided into two groups, which is the group receiving feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises (n=20) (Study Group) and those receiving feeding and oral motor intervention strategies (n=20) (Control Group). |
This is an interventional study of vaccination related to infection with varicella zoster virus. We will enroll participants of two age groups. Cohort 1 will be persons between the ages of 30-40; Cohort 2 will be persons who are 70 years of age or older. All participants will receive the FDA-approved recombinant zoster (RZV) vaccine (Shingrix) given at the approved dose and schedule. | To evaluate the effect of intramuscular RZV vaccine on VZV-specific skin TRM and circulating T-cells |
Migration percentage (MP) which is measured from the pelvis radiograph is commonly used to assess lateral displacement of the femoral head and is being used in the Swedish and in the Danish surveillance programme. Most children with an MP > 40 % need surgery to prevent further displacement and prevent dislocation of the hip. In the Swedish surveillance programme they have developed the Cerebral Palsy Follow-Up Programme (CPUP) hip score as a risk score to determine which children are at high or low risk for hip displacement (MP > 40 %) within five years after first radiographic examination.~The aim of this study is to predict the likelihood that a child with cerebral palsy will develop hip displacement (MI> 40) within three years. The design is a prediction study.~Data will be obtained from the national clinical quality database the Danish Cerebral Palsy Follow-up Program and the Danish National Patient Register. | Children with cerebral palsy have an increased risk of hip dislocation, which is a painful and severe complication of cerebral palsy. The 20-years evaluation of the Swedish surveillance programme shows that hip dislocation in children with cerebral palsy can be prevented with regular clinical and radiographic examination and early intervention.~We would like to determine the individual risk for hip displacement for Danish children with CP in The Danish Cerebral Palsy Follow-up Program. This could be a valuable clinical tool in deciding on further follow-up and treatment. |
This prospective double-blind study done on 240 patients admitted to surgical I.C.U after laparoscopic appendectomy. Those who had preoperative Koivuranta vomiting score of more than 3 enrolled in our study. Every group contains 80 patients. Patients of group A received ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours while patients of group B received isopropyl alcohol 70% inhalation every 15 min for 4 times then repeated after 6 hours. The last group C received intravenous normal saline at rate of 20 ml/kg over 30 minute and repeated by the same dose after 6 hours. The duration of the study was 24 hours post-operatively. As PONV is self-limited within 24 hours. | To compare and evaluate the antiemetic effect and the safety of ondansetron, inhalational isopropyl alcohol and super hydration on adult patients after laparoscopic appendectomy. |
This will be a prospective observational trial to better understand the range and variation associated with bone/soft tissue perfusion in fracture patients and examine the relationship between perfusion, measured using quantitative Indocyanine green (ICG) fluorescence and complications such as surgical site infection (SSI), persistent SSI, and fracture nonunion. Primary outcome measure is complication (either infection, recurrent infection or nonunion).~Eligible consenting patients will receive standard of care treatment for their fracture or infection including irrigation and debridement of their operative site and/or fracture fixation. After exposure, 0.1 mg/Kg ICG will be injected intravenously and video rate ICG fluorescence images will be acquired 20 seconds before and 4 minutes after the injection, each before and after debridement.~A subset of 30 post-fracture complication patients will undergo surgical treatment for their infection in Center of Innovation Surgery (CIS) and have either an intraoperative Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) after exposure but before the ICG injection or a preoperative DCE-MRI. Patients receiving surgery in the CIS will be required to sign an additional CIS-specific consent document.~The need for repeat surgical procedure will be left up to the treating surgeon. If repeat procedure is needed, pre- and post-debridement quantitative ICG fluorescence images will be obtained at each procedure.~Study participants will be followed at 2 weeks, 6 weeks, 3 months, 6 months, and one year from their index study surgery. Complication including index infection, recurrent infection or delaying union/nonunion will be identified at the time of diagnosis and/or during each participants assessment that occurs during routine outpatient clinic visit. Detailed information on the infection including date of diagnosis, participant signs and symptoms, culture test results, method of treatment(s), and date of resolution will be documented. | The focus of this prospective observational study is to (1) establish the range and variation associated with bone/soft tissue perfusion in fracture patients, using ICG fluorescence imaging; (2) examine the relationship between perfusion and complications such as surgical site infection (SSI), persistent SSI, and fracture nonunion; (3) to determine whether the quantitative ICG fluorescence can be used to guide bony debridement in the setting of infected fracture to minimize complications. |
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