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Background and purpose:~Peak oxygen uptake (pVO2) is used extensively in HF to predict prognosis and time for heart transplantation. Many centers are increasingly measuring pVO2 in LVAD supported HF patients, though this has mostly been for research or rehabilitation purposes. It is unknown if pVO2 predicts outcome in LVAD treated HF patients.~The investigators will pool data from all willing centers of the World to investigate the prognostic value of pVO2 (e.g. outcome in LVAD supported patients) and, secondly the investigators will investigate wether the predictive power of pVO2 in LVAD recipients depends on the treatment indication (BTT and DT).~Methods:~Data is collected in anonymized form from all centers willing to contribute data.~Hypothesis:~The hypothesis is that lower pVO2 is associated with higher rates of death or urgent transplantation (primary endpoint).

Pooling of earlier VO2-studies conducted at the dept. of cardiology, Rigshospitalet, Denmark, and all LVAD centres of the World that wish to participate.~The purpose is to investigate the prognostic value of VO2 in recipients of durable LVADs using data from studies already conducted.

This study first presents the organizational path and the health interventions included in the care episode for outpatient bariatric surgery, as compared to the health interventions usually performed in the care episode for bariatric surgery (including a conventional hospitalization with at least one-night inpatient).~This single-center, matched case-control study will be conducted in the Endocrine and Digestive Surgery Unit, Center of Excellence in Bariatric Surgery, of the University Hospital of Strasbourg. All the patients scheduled for bariatric procedures (Roux-en-Y gastric bypass and Sleeve Gastrectomy) and eligible for outpatient ambulatory procedures, will be checked for the inclusion criteria and will be asked if they accepted the outpatient bariatric procedure. If they accept, they will be included in the group A (Outpatients). At the end of the inclusion period, the patients in group A will be paired to patients who were operated in the same period, who had a conventional hospitalization and who will be matched based on the type of intervention, the age and the ASA status. These patients will form the group B (Inpatients).~The integrated care pathway of the outpatients was formalized in order to secure this care pathway. It includes: patient education, enhanced rehabilitation program, first-position surgical planning, follow-up by home nurse twice-a-day, standardized communication to surgeons, and management of possible complications. All the health care interventions (anticipated or not) will be recorded for both groups.~The study aims to estimate and to compare the costs of bariatric surgery inpatient care episode to the costs of outpatient care episode, and also to evaluate the postoperative medical consequences. A cost-minimization analysis will be performed from the perspective of the healthcare provider. The direct costs of care production will be considered and estimated by a micro-costing methodology. The time horizon is set from the pre-operative outpatient appointment with the bariatric surgeon to the one-month post-operative appointment.

This study first presents the organizational path and the health interventions included in the care episode for outpatient bariatric surgery, as compared to the health interventions usually performed in the care episode for bariatric surgery (including a conventional hospitalization with at least one-night inpatient). Then, the study aims to estimate and to compare the costs of bariatric surgery inpatient care episode to the costs of outpatient care episode, and also to evaluate the postoperative medical consequences.

Highly active muscles such as the diaphragm are particularly sensitive to both disuse and training. For example, diaphragm fibers of controlled mechanically ventilated young adults atrophy by more than 50% within 36 hours of complete inactivity, and mechanical ventilation (MV) initiates signaling pathways within the first several hours of inactivity that promote progressive diaphragmatic fiber dysfunction. The investigators have shown that widespread atrophy signaling begins in the operating room during cardiac surgery, after only a few hours of MV. In addition to this fiber atrophy, MV leads to significant declines in the strength of the diaphragm, which can lengthen the time it takes to wean from MV. The clinical occurrence of early onset, progressive contractile dysfunction is defined as ventilator-induced diaphragmatic dysfunction (VIDD). VIDD is regarded as a primary contributor to difficulties with weaning from MV.~Conversely, the investigators have shown that IMT increases the pressure-generating capacity of the diaphragm and inspiratory synergist muscles, and facilitates weaning in patients with VIDD. Preoperative IMT for as little as 1-2 weeks reportedly increases inspiratory muscle strength. IMT prior to cardiothoracic surgery has been shown to reduce post-operative pulmonary complications such as atelectasis, pneumonia, or delayed ventilator weaning. Additionally, strength gains associated with preoperative IMT are associated with shorter ICU and hospital lengths of stay, which may potentially offer a cost benefit.~Unfortunately, very little is understood about the neuromuscular adaptations and signaling mechanisms that contribute to these IMT clinical advantages. A particularly novel aspect of this project is it will be the first study of the mechanisms that contribute to diaphragm strengthening. A greater understanding of these mechanisms may help future investigators to develop more efficient exercise prescriptions to offset MV use in cases such as surgery, and it may help identify molecules and exercise that could protect the diaphragms of individuals who cannot exercise in advance, as in the case of acute infections that compromise breathing.~The overall objective of this study is to investigate diaphragm neuromuscular remodeling associated with pre-operative, telehealth delivered IMT, compared with relaxation breathing training (RLX). Guided RLX exercises have been shown to improve post-operative pain perception and modestly lower systolic blood pressure in hypertensives but are not thought to significantly alter diaphragm strength.~Forty adult volunteers will receive either IMT (n=20) or RLX training (n=20) for 2-4 weeks prior to elective cardiothoracic surgery and undergo breathing performance tests before and after the training period. A full thickness biopsy (approximately 6mm x 20 mm) from the right ventral costal diaphragm will be acquired as soon as the diaphragm is exposed during surgery. Additionally, a biopsy from the pectoralis major will be obtained and used as a non-exercised control muscle. Histological and RNA sequencing analyses will be performed to examine the mechanisms that contribute to neuromuscular adaptations to training.

In light of the corona virus pandemic (COVID-19), there is critical need to conserve scarce mechanical ventilation (MV) resources. This study evaluates an intervention in non-infected cardiac patients as a means to assist with minimizing MV and ICU length of stay (LOS). Pre-op inspiratory muscle training (IMT) has been shown to decrease pulmonary complications, MV dependence, and ICU LOS following thoracic surgery. The investigators aim to determine the mechanism of remodeling in diaphragms of adults who undergo pre-op IMT.

This comparative study will use a two group repeated measure design and mixed methods approach including well-validated questionnaires and qualitative descriptive methodology. Qualitative inquiry will provide data about the overall experience of caregivers in the intervention arm as well as inform web-based, person centered approaches as suggested by caregivers that will be used to inform future work on person-centered self-care strategies, aimed at improving caregiver health. Eligibility Criteria: having approval from the primary care provider to initiate a walking program, being a caregiver of a person with dementia, being greater than 18 years of age and having access to a computer or smartphone. The RSVP [research volunteer program] for Health, a registry comprised of individuals interested in receiving information on research studies conducted at Massachusetts General Hospital (MGH), will be utilized for recruitment. If a person states they are interested, they will be called to set up a screening visit to determine study eligibility at which time they will be given the IRB consent to review and a baseline visit will be set up.~At the baseline visit, the consent will be reviewed by the Principal Investigator (PI) and signed by participants meeting eligibility criteria. A member of the study team will obtain demographic and caregiver health characteristics and complete study questionnaires. After baseline measures are obtained, the study team will: 1) provide all participants with education about the CDC physical activity recommendations for adults, 2) set participants up with a wireless pedometer and 3) invite them to join a walking group on-line where they can monitor their activity as compared to others in the intervention arm. Members of the study team will then provide participants in the intervention arm with health coaching (HC) utilizing motivational interviewing (MI) weekly for 8 weeks by email, text message or telephone. The mode of delivery for the MI will be based on participant preference. The control group will be able to view the web page and monitor their activity compared to others in the control group arm, but will receive no coaching. At the end of the 8 weeks, study measures will be again be obtained in both groups. The PI will conduct semi-structured qualitative interviews with participants in the intervention arm to evaluate acceptability and acquire feedback on the intervention and ideas for other self-care strategies. Caregiver Measures Pre - Post~Demographic variables~General health characteristics~Well-being~Perceived stress~Mini-cog~Perceived Steps And post, a qualitative interview

This study aims to:~Establish the feasibility of a health-coached (HC) walking program utilizing motivational interviewing (MI) and wireless pedometers in family caregivers of persons with dementia.~Examine preliminary outcomes of a HC walking program utilizing MI with wireless pedometers on family caregiver's perception of wellbeing, stress, and activity level.~Explore caregivers' acceptability and experience of participating in a HC walking program utilizing MI with wireless pedometers and to explore additional person centered approaches.

It developed in China Then spread worl wide

Covid 19 is a pandemic infection developed in late 2019

Supracondylar humerus fractures (SHFs) account for approximately 10% of all pediatric fractures in children. Poorly treated SHFs can lead to the most common cubitus varus deformity especially in patients treated conservatively. The cosmetic aspect of this deformity is the main concern of patients, together with reduced remodeling ability. Inevitably, surgery is the first choice for such patients. Several osteotomy techniques and fixation materials have been developed in the last several decades. With the advent of three-dimensional printing techniques and computed tomography reconstruction methods, more accurate computing designs have been applied in the correction of cubitus varus. These techniques make the surgery more complex and require the performance of computed tomography (CT), resulting in high radiation exposure in children. Paley described the principles of deformity correction that are widely used for the lower limbs. These principles represent an alternative with easy application without the need of CT, with less occurrence of prominence and good cosmetic outcome. According to the Paley principles, all the vertex of the triangular osteotomy should site on the center of rotation of angulation (CORA) line, by doing this, the gun-butt deformity was corrected perfectly. More importantly, they help to accurately correct the anatomic axis of the upper limb. According to our knowledge, this is the first study describes the lateral closing wedge osteotomy for correction cubitus varus deformity in children by applying Paley's principles and fixation with K-wires.~Taken together, the investigators aimed at verifying the feasibility of Paley's principles for deformity correction to treat cubitus varus in children.

Humeral osteotomy is the most effective method for evident cubitus varus correction in children. Several osteotomy methods and fixation materials have been developed in the past. By applying the principles of deformity correction described by Paley, the investigators describe a novel corrective technique for cubitus varus involving lateral osteotomy using Kirschner wires.

This research study is a single arm pilot Feasibility Study, which is the first-time investigators are examining this hospital at home intervention for patients with lymphoma.~The research study procedures include screening for eligibility, questionnaires, remote patient monitoring (e.g. patient-reported symptoms and home monitored vital signs) and home-based supportive care (e.g. visits to patients' homes to address and manage any concerning issues identified), and interviews of participants, caregivers, and clinicians asking their perceptions of the Home Hospital for Lymphoma program.~Participants will include 3 groups:~Enrolled participants receiving the hospital at home intervention, caregivers of participants, and clinicians.~Participants will be in the research study for about six months after consent. It is expected that up to 38 participants will take part in this research study.

The goal of this research is to evaluate an intervention, which the investigators call Home Hospital for Lymphoma, that involves remote patient monitoring and home-based supportive care for patients hospitalized with lymphoma at Massachusetts General Hospital.

This is pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical COVID-19.~The aim is to demonstrate a decrease in hospital related complications among patients who are hospitalized with moderate COVID-19 by treating them with nitazoxanide BID 600 mg for 7 days on top of standard care compared to placebo on top of standar care..~Therefore, patients hospitalized with confirmed diagnosis of COVID-19 will be randomized to receive either nitazoxanide 600 mg BID or Placebo.

This is a pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical COVID-19.

Foot pain is common in the general population, with prevalence estimates ranging from 17 to 30% . A systematic review concluded that nearly one-quarter of adults over age 45 experience frequent foot pain. Foot pain has been associated with poor balance, gait problems, the limitation of daily living activities, and health-related quality of life. It has been reported that at least two-thirds of individuals experience moderate functional daily life problems .The etiology of hindfoot pain is mostly associated with Achilles Tendinopathy and Plantar Fasciitis, which are prevalent, affecting millions of people each year . Most cases of hindfoot pain if not treated, they will get worse with time and resistant symptoms. This is why to get more information on prevalence and risk factors in the general population is necessary to organize health care planning and the extent of clinical need.An increase in the use of digital technology and smart phones globally with mobile applications provide an alternative solution to the planning of primary health care services. In the US, approximately 90% of adults have a mobile phone, and 58% of these prefer smart phones, while in Turkey, 98% of adults use mobile phones, and 77% of them are smart phones owners. The popularity of smart phones provides opportunities for reaching information and giving skills to users through applications. These applications offer new opportunities for collecting, evaluating, and monitoring health information and have portability, the flexibility of use, and a width of the access area.With the concept of this approaching (using digital technologies,) several systematic reviews have examined digital programs using for different health conditions/ pathologies (paralysis, lack of balance/stabilization, cardiac disorders, and joint / extremity). A great deal of physiotherapy interventions for hindfoot pain includes electrotherapy agents, 'hands-on' therapy, stretching, and strengthening exercises. The exercise programs are an essential part of rehabilitation programs for hindfoot pain, and patients who involved in this exercise program also need to get feedback by physiotherapist. For this reason, the digital technology-based applications are considered to be contributive for follow-up exercise regularly and detecting the changes and progression. Additionally, to the best of our knowledge, a smartphone application research involving hindfoot pathology with suggesting assessment methods and including exercise program is not available in the literature. Thereby, the study aims to evaluate the status of the individuals with hindfoot pain and to recommend preventive precautions and appropriate exercise programs with Smart Phone-Based Applications and to compare the results of patients who attended through mobile applications (Achilles Tendinopathy and Plantar Fasciitis) with the results of patients included in the hands-on program.

This randomized controlled study aims to evaluate the status of the individuals with hindfoot pain and to recommend preventive precautions and appropriate exercise programs with Smart Phone-Based Applications. Additionally, to compare the results of patients who attended through mobile applications (Achilles Tendinopathy and Plantar Fasciitis) with the results of patients included in the hands-on program.

It is an investigator-initiated, multicentered, randomized controlled clinical study to evaluate the efficacy and safety of mFOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC in contrast to standard chemoradiotherapy. Patients of LARC with EMVI+ evaluated by pelvic magnetic resonance imaging (MRI) are enrolled in this trial. All patients will be randomized divided into two groups.~Experimental group will receive 3 cycles of mFOLFOXIRI, followed to be performed MRI to assess clinical response. If the tumor response is good enough (partial response or complete response), the patient will receive another 3 cycles of mFOLFOXIRI then surgery. On the contrary, if the tumor shows poor response (stable disease or progressive disease) or with mesorectal fascia-positive or ycT4a/b after re-evaluation, radiotherapy will be performed combined with capecitabine before operation. Control group will receive standard capecitabine based chemoradiotherapy.~Patients with mesorectal fascia-positive or ycT4a/b after re-evaluation would receive radiation before surgery, whereas responders would have immediate total mesorectal excision (TME). All patients will receive 4 cycles of XELOX as adjuvant chemotherapy after TME.

Extramural Vascular Invasion Positive(EMVI+) is a high risk of distant metastasis for locally advanced rectal cancer(LARC) after resection. The study is to evaluate the efficacy and safety of FOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC in contrast to the efficacy of standard Chemoradiotherapy (CRT).

In a multi-center pragmatic clinical trial, COVID-19 positive patients admitted to 6 United States medical centers were enrolled between March 10 and June 4, 2020. A machine learning algorithm was used to determine which patients were suitable for treatment with hydroxychloroquine.

The purpose of this study was to assess the performance of a machine learning algorithm which identifies patients for whom hydroxychloroquine treatment is associated with predicted survival.

Myopia is the most prevalent ocular disorder in children worldwide, and one of the major causes of visual deterioration in all age groups. Highest prevalence rates are in East Asian countries (affecting up to 83% of Singaporean teenagers), however, it is very common in all other countries. While mild to moderate myopia usually stabilizes within the third decade, pathological myopia is associated with progressive globe elongation, and development of various macular complications including; foveoschisis, choroidal neovascularization (CNV), myopic macular hole, and myopic vitreomacular traction (VMT).~Refractive surgery has become popular for correcting ametropia including myopia. Most commonly used refractive procedures include corneal refractive surgeries especially laser in-situ keratomileusis (LASIK), and Photorefractive keratectomy (PRK), Phakic Intraocular Lenses (Phakic IOLs) and refractive lens exchange.~In LASIK, the creation of a corneal lamellar flap requires placement of a suction ring on the anterior segment of the eye, which transiently elevates the intraocular pressure (IOP) to levels exceeding 65 mmHg. Experimental studies in animal eyes have found that the IOP can increase to between 80 mmHg and 360 mmHg during this vacuum phase and lamellar cut with the microkeratome. Recent advances utilizing the femtosecond laser may serve as an alternative to the mechanical microkeratome, with a low-pressure suction ring. In studies using porcine eyes, the IOP during the suctioning or laser application phase reached a maximum of 135 mmHg using the femtosecond laser, lower than pressures reached with a traditional microkeratome, but for a longer duration of time. Similarly in refractive lens procedures, intraoperative IOP was found to exceed 60 mmHg.~Intraocular pressure elevation during refractive procedures may cause a reduction in the perfusion of the retina and optic nerve head, posterior displacement of the lamina cribrosa, and a decline in ocular perfusion pressure of the posterior ciliary arteries. Although this IOP elevation is temporary, the potential for ischemic or pressure-induced damage to the optic nerve head and the retinal nerve fiber layer exists.~Optical coherence tomography angiography (OCTA) is a recent noninvasive imaging technique that allows for volumetric visualization of eye vasculature. OCTA has shown promise in better elucidating the pathophysiology of several retinal vascular diseases. Swept-source OCTA uses long wavelength ̰ 1,050nm, which can penetrate through deeper layers of the eye and can traverse opacities of media such as cataracts, hemorrhages and vitreous opacities [6]. Optical coherence tomographic angiograms can further be manually or automatically segmented with preprogrammed software to highlight individual layers of the retina, optic nerve head choriocapillaris, and choroid. The user can either analyze en face images extending from the inner limiting membrane to choroid or use automated views to locate a vascular or structural lesion within the retina.~The purpose of this study is to assess the change of macular and papillary perfusion, using optical coherence tomography angiography (OCTA) imaging of the macula and optic disc of myopic patients subject to various refractive surgery methods. We will compare between these methods to evaluate which one is associated with least adverse effect on ocular perfusion. To date no such evaluation has been done using OCTA, because of relatively recent onset of this technology. Traditional imaging methods such as color fundus photography and fluorescein angiography have limited resolution for retinal vasculature that mad such evaluation in the past using these methods not feasible, however, OCTA is very promising for the proper analysis of changes in the ocular perfusion. Results of this study will have significant clinical and practical implications and may change the approach for surgical correction of such patients.

Refractive surgery for correction of myopia is very common nowadays. However, various refractive techniques may be associated with increase in the IOP, especially during flap creation. It is assumed that marked intraoperative IOP increase lead to macular and optic disc head circulation compromise. The purpose of this study is to assess the change of macular and papillary perfusion, using optical coherence tomography angiography (OCTA) imaging of the macula and optic disc of myopic patients before and after various refractive surgery methods.

Covid-19 patients under mechanical ventilation are currently managed with a lung protective strategy derived from ARDSnet recommendations. In order to minimize the risk of spread of coronavirus, filters and associated respiratory tubing are incorporated to the breathing circuit, thus increasing apparatus dead space with subsequent increase in dead space ventilation. Considering the already often compromised ability for these patients to adequately clear carbon dioxide (VCO2), adding an external dead space can potentially have a substantial impact on CO2 homeostasis. The study will use volumetric capnography (Vcap) to investigate the influence of external dead space on VCO2 and calculated alveolar dead space.~Objective: 1) To investigate the efficacy of Vcap to detect changes in dead space, VCO2 and shape factor parameters before and after disconnection of external dead space.~2) To register the external dead space impact on arterial carbon dioxide tension (PaCO2).~3) To calculate the alveolar dead space based on Vcap data and arterial blood gas analysis results.~Design and setting: Prospective observational study in an intensive care center for Covid-19 patients in a university hospital.~Patients: Covid-19 positive patients of all age groups under mechanical ventilation. Exclusion criteria is ongoing ECMO treatment~Measurements and results: Vcap and Tcap parameters will be registered during mechanical ventilation and correlated to an arterial blood gas sample. Part of the apparatus dead space will then be reduced via removal of the heat and moister exchange filter (HME) with added tubing resulting in a reduction in volume of approximately 80 ml (i.e. the known volume of the HME filter and associated tubing). After the apparatus dead space is removed, the Vcap will be recorded for approximately 15 minutes and an arterial blood gas will be drawn at the end of the period. The HME and associated tubing will then be reattached to the breathing circuit and Vcap and Tcap parameters will be recorded for approximately 30 minutes and an arterial blood gas will be drawn. Vcap data will be analyzed for dead space, slope of phase III, VCO2 and associated shape factor parameters and compared with Tcap parameters. Changes in Vcap parameters will be tested for statistical significance using one and two-way ANOVA for repeated measures and Bland-Altman analysis will be used for comparison.

The objective is to investigate the efficacy of volumetric capnography to detect changes in dead space, CO2 elimination and shape factor parameters before and after disconnection of external dead space in ventilated COVID-19 patients.

Chronic venous disease (CVD) of lower limbs for its high prevalence in adult population represents one of the main causes of morbidity in western countries, and it has also an important effect on healthcare cost absorbing 1-2% of the total health budget in western countries. Clinical manifestations related to CVD are well documented in adults, with clinical guidelines that standardize both diagnosis and treatment. Nevertheless, there is a scarcity of published data regarding CVD in children, and in addition, venous duplex ultrasound test of the lower limbs is performed much less commonly in children than in adults.~Therefore, the natural history of pediatric venous reflux remains unclear, although it is possible that it precedes the onset of CVD in adulthood. In this context, this observational study aims to identify the presence of venous reflux, as well as clinical and morphological data in pediatric subjects, aged between 9 and 18 years old, by performing an office vascular visit and an echo duplex scan of lower limbs. The endpoints of this study are to prospectively assess the prevalence of CVD in children, as well as to evaluate a possible correlation between vein diameter and pathological vein reflux.

Chronic venous disease (CVD) is widespread in adult subjects of western countries and is responsible of important morbidity and healthcare costs. CVD has never been extensively studied in pediatric population where the early pathophysiological alterations may occur undetected. The aim of this study is to assess the prevalence of CVD searching also for the early clinical and instrumental signs of this disease.

Intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal route after the cessation of menstrual period. In the second menstrual period following the PRP injection, the endometrial thickness will be assessed under ultrasound and hormone replacement will be started. As the endometrial thickness reaches adequate thickness during ultrasound follow-up, embryo transfer will be performed. Pregnancy test results will be recorded and followed.

Intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal route after the cessation of menstrual period. The endometrial thickness will be assessed under ultrasound and hormone replacement will be started. As the endometrial thickness reaches adequate thickness during ultrasound follow-up, embryo transfer will be performed.

The study is set up as a randomized controlled trial. Quality of life, depressive symptoms, anxiety, sleep problems and traumatic stress will be measured. Given uncertainties regarding the psychological effects of Covid-19 pandemic a transproblematic tailored treatment approach will be used that has been tested in several previous trials. However, the present program has been adapted for the target population of people who are affected by the societal and individual consequences of the pandemic. The study does not focus on people who have or have had the corona virus.

The study seeks to investigate the effects of a guided internet-based cognitive behavioral therapy (ICBT) programme a on adult mental health problems related to the current coronavirus pandemic. ICBT will be compared to a wait-list control group.~Participants will be recruited in Sweden with a nationwide recruitment.

The proposed study will address the critical need for more precise characterizations of the acute visual effects of the drug psilocybin by measuring the impact of acute psilocybin intoxication on a perceptual task known as visual surround suppression, compared to an active placebo control. The data collected in the proposed experiment will make important contributions to knowledge of how psilocybin impacts contextual processing in the brain. Moreover, this will in turn inform the neurobiology of visual surround suppression in general, providing the first investigation of links between surround suppression and serotonergic pathways in humans. Furthermore, the impact of psilocybin on surround suppression will complement recent discoveries of differences in surround suppression present in certain clinical populations. Taken together, these points suggest that this relatively simple and straightforward study could have significant payoff in its contribution to knowledge, not only of the effects of psilocybin but also of key brain processes underpinning human vision and context processing more broadly.

The prospective study will address the critical need for more precise characterizations of the acute visual effects of the drug psilocybin by measuring the impact of acute psilocybin intoxication on a perceptual task known as visual surround suppression, compared to an active placebo control.

Most gestational diabetes mellitus (GDM) can be well controlled by health education and life style management, expecting a better pregnancy outcome. But standard clinic prenatal care which consist of clinic visit every two weeks may not give full play to the effects of GDM management. Telemedicine shows its potential to fill this gap. A multicenter, randomized controlled trial was designed to investigate whether health education and life style management through WeChat group chat was more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM. Women with GDM diagnosed by oral glucose tolerance test between 23-30+6 gestational weeks were randomized to a WeChat group chat-based blood glucose management group or routine clinic prenatal care. In PUMCH, investigators also equip CGM for m-health group allowing a more detailed BG information. The primary outcome was change of glycemic qualification rate during follow up period in both groups. The second outcome was pregnancy outcomes. Also, a case-control study is designed to compare the glucose control status between rice-richen meal and wheaten-richen meal, and all other macronutrients and micronutrients are all calculated and same between two groups, which may provide more clues for type of carbohydrate recommendation for Chinese women with GDM.

A multicenter, randomized controlled trial was conducted to investigate whether health education and life style management through WeChat group chat was more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM.

This is an open-label, sequential, single centre pharmacokinetic (PK) study investigating the effect of rifampicin on the pharmacokinetics of intracellular tenofovir-diphosphate and plasma tenofovir when coadministered with tenofovir alafenamide fumarate during the maintenance phase of tuberculosis treatment in TB/HIV-1 coinfected participants (EpiTAF).~An open-label, sequential, pharmacokinetic (PK) drug-drug interaction study will be conducted in medically stable virologically suppressed HIV-1 infected adults coinfected with TB, who are in the maintenance phase of their TB treatment. After intensive PK evaluation of IC TFV-DP and pTFV, participants will be switched from their standard-of-care tenofovir disoproxil fumarate (TDF)/FTC/EFV regimen, to TAF + 3TC + EFV at the start of the study treatment period. After 28 days each participant will have intensive PK evaluation of IC TFV-DP and pTFV on TAF + 3TC + EFV with rifampicin (RIF). After the second intensive PK assessment is completed, participants will be switched back to TDF/FTC/EFV, with a final intensive PK evaluation of IC TFV-DP and pTFV 8 days after completion of TB treatment, at the final study visit. Eighteen volunteers will be enrolled for a target of 13 participants completing the study.~The study includes screening and enrolment visits, 1 visit on day 28 and an end of study visit 28 days after the end of TB treatment.

This is a pharmacokinetic study investigating the effect of rifampicin on the pharmacokinetics of intracellular tenofovir-diphosphate and plasma tenofovir when coadministered with tenofovir alafenamide fumarate during the maintenance phase of tuberculosis treatment in TB/HIV-1 coinfected participants (EpiTAF)

This is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy, safety, and immunogenicity of RSVpreF or placebo (1:1 randomization) in infants born to healthy women vaccinated during pregnancy, as well as the safety and immunogenicity in the pregnant women. This will be a global study which will span multiple RSV seasons.

This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in infants.

Currently, with increased load of CT studies, alternative methods of viral pneumonia signs' visualization are required.~Investigators hypothesize that chest MRI could be a test for detecting pulmonary features of COVID-19. They consider using MRI to assess COVID-19 viral pneumonia. Absence of radiation exposure to patients is a clear advantage of MRI.~This is a prospective, observational cohort study assessing patients with suspected COVID-19. It's primary goal is to determine the ability of multiparametric MRI to detect lung abnormalities - ground-glass opacity (GGO), consolidation, crazy paving pattern, pleuritis - in comparison to CT scan. In this study each patient with suspected pneumonia will sequentially undergo both chest CT and MRI during his/her visit. Scan protocols will be identical for each patient. Each participants completed an online questionnaire.

Since the onset of the COVID-19 pandemic, the importance of chest computed tomography (CT) in detecting signs of viral pneumonia has become clear from the literature. However, the increased patient flow creates an additional pressure on CT centers. We believe, the use of chest magnetic resonance imaging (MRI) can help to test patients for CОVID-19 when CT scan is not available. Lung MRI may be useful in routing a patient in a difficult epidemiological situation.

The research will involve patients, who had myocardial infraction and who has the high level of potential adherence to treatment, which will be determined by the usage of Russian generic questionnaire for evaluation of compliance to drug therapy. At the end of a 12 month observation with the registration of unfavorable cardiovascular occasions (death from cardiovascular reasons, nonfatal myocardial infraction, cerebral stroke, necessity for repeated revascularization of the coronary arteries) based on the analysis of non-genetic and genetic factors (polymorphism of genes Thr174Met and Met235Thr in gene angiotensinogen, Arg389Gly and Ser49Gly in gene adrenoceptor beta 1, Ser447Ter in gene lipoprotein lipase and Leu28Pro in gene apolipoprotein E, Trp212Ter and G681A in gene cytochrome P450 family 2 subfamily C member 19) factors of unfavorable prognosis will be identified and considering which group of patients requires the use of remote monitoring system will be formed. From one group of patients we will form two comparable groups, one group will use this remote monitoring system and another will not. The effectiveness of the remote monitoring system will be evaluated after 6-month's observation based on the registration of the unfavorable cardiovascular occasions (death from cardiovascular reasons, nonfatal myocardial infraction, cerebral stroke, necessity for repeated revascularization of the coronary arteries, frequency of hospitalizations).

one-centered, open, prospective, non-randomized, controlled clinical study will be aimed at creating remote monitoring system for patients' condition and the development of methodological approaches and its usage for conducting patients, who had myocardial infraction and who has a very high risk of developing an unfavorable outcome.

Erectile Dysfunction (ED) is broadly defined as the inability to achieve or maintain an erection sufficient for sexual intercourse or activity. Current treatment for ED consists of oral medications, vacuum devices, intracavernosal injections, and surgically placed penile prosthetics. In the literature, this has been described as a Stepwise Approach, offering therapy beginning with the least invasive treatment option.~The low intensity extracorporeal shock wave therapy (LISWT) was recently approved by the FDA for treatment of diabetic ulcers. But it is still under evaluation for treatment of ED. Recently, the European Association of Urology updated their guidelines related to ED and included LISWT for men with mild to moderate ED. Studies have reported that LISWT can be effective in treating ED. This was attributed to increase in angiogenesis, neurogenesis and other rejuvenating tissue effects. Doppler ultrasound studies have demonstrated a sustained increase in blood flow in patients treated with LISWT. Published studies have also reported a response rate of 40-80% with this treatment. In addition, the energy/pulse used in this application is approximately 10% of the energy used for disintegrating kidney stones; and no serious side effects have been reported till date.~Additionally, most completed studies included men who score in the moderate to minimal ranges on the International Index of Erectile Function. In the proposed study, men with severe to moderate ED based on IIEF-EF score will be included. The goal of this study is to improve and/or restore erectile function in men with erectile dysfunction. The investigators hypothesize (Alternate Hypothesis) that patients in the active treatment group (DualStim + Wharton's Jelly) will show an improvement of at least 4 points for moderate ED and at least 7 points for severe ED on IIEF-EF scale/questionnaire, and this difference will be significantly different from their baseline. In addition, patients in the DualStim + Saline group will be significantly different from their baseline, however, will show less improvement compared to DualStim + Wharton's Jelly. Our null hypothesis is that there is no difference between DualStim with Saline and DualStim with Wharton's Jelly groups and no difference between the baseline and after-treatment within the treatment groups for alleviating ED measured using International Index of Erectile Function score (IIEF-EF).

The purpose of this study is to determine the immediate and short-term efficacy of the methodological application of DualStim Therapy - Focused Extracorporeal Shock Wave Therapy (fESWT) and Radial Extracorporeal Shock Wave Therapy (rESWT), with and without intracavernosal administration of formulated umbilical cord derived Wharton's Jelly to improve and/or restore erectile function in patients with erectile dysfunction (ED).

Up to 106 patients with coronary artery disease undergoing elective coronary artery bypass graft (CABG) surgery will be recruited to undergo this single visit study. In the timeframe shortly after the induction of anaesthesia and prior to the start of surgery, myocardial strain as a marker of cardiac function will be measured by transesophageal echocardiography (TEE). Echocardiography measurements will be acquired at two different oxygen states for each patient. The fraction of inspired oxygen (FiO2) will be adjusted to reach a normoxaemic state (FiO2=0.3) and a hyperoxic state (FiO2=0.8). Patients will be randomized to which oxygen level is investigated first. Thereafter, the study intervention is completed and anaesthesia and surgery will be performed as planned by the treating team. Echocardiography images will be analyzed in a blinded manner for cardiac function and systolic and diastolic strain parameters. The results will help anaesthesiologists to better weigh risks and benefits when selecting an inspired oxygen fraction in such patients, and will help to evaluate hyperoxia as a risk factor for myocardial injury.

The purpose of this study is to investigate the impact of supraphysiologic oxygen (hyperoxia) on myocardial function in anaesthetized patients with coronary artery disease.

The most common fracture in children is the elbow fracture, and the three most common elbow fractures are supracondylar, lateral condylar, and medial epicondylar fractures. Elbow fractures are easy to diagnose and the treatment modalities are studied often. However, proximal radius fractures, which include radial neck and head fractures, remain challenging to diagnose and manage. In addition, proximal radius fractures are often combined with other fractures, most commonly, an olecranon fracture. Most radial neck fractures can be treated conservatively if the displacement is less than 3 mm and the angle is less than 30º. However, for severe Judet type III and type IV radial neck fractures, surgery is inevitable.~This study focused on radial neck fractures combined with an olecranon fracture. In this study, absorbable rods were used for fixation of radial head fractures, and with no need for removal of the inner fixation, we performed anatomy reduction via the same incision with direct vision of the olecranon, and we were able to fix the fractures with Kirschner wires (K-wires). In this retrospective study, we aimed to evaluate a treatment method for severe displaced radial neck combined with olecranon fractures in children using a Boyd incision, absorbable rods, and K-wires.

This study aimed to evaluate the outcomes of using absorbable rods and Kirschner Wires technique for severe displaced radial neck fractures combined with olecranon fractures in children.

The purpose of the research is to Describe and compare the evolution of BSCVA after DMEK, DSAEK and UT-DSAEK for Fuchs Endothelial Corneal Dystrophy (FECD) and Moderate Pseudophakic Bullous Keratopathy (PBK). To secondarily research the correlates criterions with best spectacle corrected visual acuity (BSCVA) 12 months postoperatively.~In a retrospective, single-center, observational study, 218 eyes treated with DMEK (n=110), UT-DSAEK (n=58) and DSAEK (n=50) surgeries were studied. Patients requiring posterior lamellar transplantation for FECD or moderate PBK, with preoperative BSCVA of less than 0.3 logmar, were selected. Patients with pathologies that may seriously affect VA postoperatively were excluded. Graft thickness for DSAEK was measured during the surgery and in vivo at D8, D15, M1, M6, M12 and M24. The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 6, 12 and 24 months. We deliberately differentiated our postoperative visual results by comparing DMEK with DSAEK or UT-DSAEK with central graft thickness (CGT) measurements carried out either pre-operatively (less than or greater than 130 µm) or post-operatively at 6 months (less than or greater than 100µm). Type of endothelial graft, Donor and recipient's ages, Graft's endothelial cell density (ECD), Rebubbling rate, preoperative VA, graft's indications and surgical time were also tested to explain BSCVA at 12 months.

Purpose of the research is to describe and compare the evolution of BSCVA after DMEK, DSAEK and UT-DSAEK for Fuchs Endothelial Corneal Dystrophy (FECD) and Moderate Pseudophakic Bullous Keratopathy (PBK). To secondarily research the correlates criterions with best spectacle corrected visual acuity (BSCVA) 12 months postoperatively.

80 patients admitted to King Abdul-Aziz Specialist Hospital in Taif, KSA between May 2017 and December 2019 with polytrauma and severe retroperitoneal bleeding diagnosed by abdominal computerized tomography.~King Abdelaziz research and ethical committee approved the project under heading of ethical approval and heading of human and animal rights along with Helsinki Declaration.~A written consent from the patient or from their 1st degree relative was obtained if patient intubated. The primary outcome of This study divided into 3 parts. 1st 0ne compare the ability of both drugs to stop retroperitoneal bleeding efficiently and in shorter time for these 2 measurable indicators selected in our study the number of packed RBCS needed to achieve hemoglobin level (Hb) > 10 gm% and the time needed to achieve this target Hb. the 2nd part indicators divided into clinical indicators (blood pressure, pulse and urine output) and laboratory indicators [arterial blood gases especially PH, and bicarbonate concentration (HCO3)]. the 3rd part indicators PT, PTT and Platelets count were used as indicator for DIC and hypoxic index and chest x ray were used as indicator for TRALI (transfusion related acute lung injury).~Resuscitation done in all patients in both groups according to hospital protocol by crystalloid (normal saline), colloids [plasma protein fraction-packed RBCs, fresh frozen plasma], until achieve satisfactory stable vital data. All laboratory work samples were collected (CBC complete blood picture, Blood chemistry included liver enzymes and kidney function tests, Coagulation profile, arterial blood gasses).~Urine output collected hourly. Our study included any patient who received more than 50ml/kg blood during the first 8hours after admission in order to achieved a hemoglobin level >10 gram %, with platelet count more than 50, 000/mm3 after resuscitation and Their temperature was more than 36 degree centigrade after warming. Which considered criteria needed to get maximum effect from aFVII if used intravenously. Patient randomized into 2 groups, 40 patients in each, this done by randomization numbers. Patients of group A received aminocaproic acid at dose of 4 gram slowly intravenous infusion over 1 hour and continues slowly intravenous infusion 1 gram/ hour for 8 hours. While patients of group B received aFVII according to the following protocol, First dose 200 microgram/kg. If patient still oozing, vital data not stable and/or could not achieve and keep the target Hb (>10 gm%) another 2 doses of aFVII received each dose 100microgram /kg 1 hour and 3 hours apart from the initial dose if needed. The exclusion criteria in our study, if patient had cardiac arrest before giving aFVII, deeply comatose with Glasgow coma scale (GCS) 3/15 and pupil dilated fixed.~All patient in both groups observed for 48hours and the following indicators recorded.~Indicators for efficacy of stop bleeding (number of packed RBCs needed to keep hemoglobin level >10 gm% and time needed to reach this target Hb).~Indicators for ability of both drugs to treatment the hemorrhagic shock and restore tissue perfusion (and this assessed by clinical indicators blood pressure, pulse and urine output and laboratory indicators as arterial PH and bicarbonate concentration ( HCO3) Indicators for ability of both drugs to protect the patients with retroperitoneal hematoma from complications of massive blood transfusion and in this 2 complications were selected the disseminated intra-vascular coagulopathy (DIC) and PT, PTT, Platelets count were used as indicators and (TRALI) transfusion related acute lung injury and the hypoxic index and chest x ray were used as indicators. The duration of the study only two days and the data recorded every 8 hours.

80 patients with traumatic retro-peritoneal hematoma allocated into two groups 40 patients each. Patients of Group A received aminocaproic acid while patients of group B received aFVII. Number of packed RBCs given to get target Hb level and time to get this target Hb level (>10 gm%) recorded as indicators for control bleeding. Blood pressure, pulse, Arterial blood gasses and urine output recorded as indicator for treatment of hypovolemic shock. hypoxic index, chest X ray and coagulation profile used as indicator for complication.

Systemic lupus erythematosus (SLE), also known simply as lupus, is an autoimmune disease in which the body's immune system mistakenly attacks healthy tissue in many parts of the body.~Symptoms vary between people and may be mild to severe. common symptoms include painful and swollen joints, fever, chest pain, hair loss, mouth ulcers, swollen lymph nodes, feeling tired, and a red rash which is most commonly on the face. Often there are periods of illness, called flares, and periods of remission during which there are few symptoms.painless passage of blood or protein in the urine may often be the only presenting sign of kidney involvement.~Acute or chronic renal impairment may develop with lupus nephritis, leading to acute or end-stage kidney failure. Because of early recognition and management of SLE, end-stage renal failure occurs in less than 5% of cases; except in the black population, where the risk is many times.Nephritis is the most severe manifestation of lupus. Between 1950s and 1970s, corticosteroids were used for the treatment of lupus nephritis (LN) ,and using of cyclophosphamide(CPM), improved the outcome dramatically with 5 years survival increasing from 17% to 80%.Subsequently, intravenous (iv) CPM became the standard of care in induction regimes; however, ivCPM was associated with complications such as bladder toxicity, gonadal problems, and infections. To reduce the toxicity, low-dose of 500mg iv(CPM) every two weeks for six months showed equivalent efficacy and less side effect.~Mycophenolatemofetil(MMF) is widely used in solid organ transplantation and it reduces the rate of acute rejection following renal transplantation.~It has also been used to treat patients with other immune-mediated disorders such as immunoglobulin A nephropathy, small-vessel vasculitides and psoriasis .~Lupus nephritisis inflammation of the kidney that is caused by systemic lupus erythematous (SLE). Lupus nephritis happens when lupus involves the kidneys.its symptoms, though, are not always dramatic. for many, the first noticeable symptom is swelling of the legs, ankles and feet. less often, there can be swelling in the face or hands.

The aim of this work is to study the effect and side effects of the cyclophosphamide versus mycophenolate in lupus nephritis

Idiopathic granulomatous mastitis is an uncommon, benign and chronic inflammatory breast disease that mainly involves women of childbearing age . The disease, was first described by Kessler and Wollock in 1972 .Although it is a benign condition, it is important from different points of view: it poses a diagnostic and treatment dilemma , also, it clinically and mammographically mimics breast cancer, especially inflammatory type . On the other hand, due to lack of a definitive treatment plan, complications of empiric treatment, such as allergic reaction to antibiotics and poor cosmetic procedures result in following repeated surgical interventions which threaten the patients . In fact, the etiology of IGM is unknown but some factors have been stated including reaction to chemical materials such as oral contraceptive pills, infectious disease, autoimmune diseases and immunologic response formilk leakage from the breast's lobule . On the other hand, some conditions such as pregnancy, breast feeding, hyper prolactinemia, galactorrhea, and alpha 1 antitrypsin deficiency have been associated with the risk of the disease . Infection with corynebacterium kroppenstedtii has been suggested but is unconfirmed . The final word about etiology is that although the cause of the disease is unknown the general consensus is that reproductive age, recent pregnancy, breast feeding and history of oral contraceptive pills use are the most associated conditions with the disease, as shown in finding. The most common presenting sign is a defined hard lump of the breast. As the disease progresses nipple inversion, peau d'orange, tumorous in duration, ulcer and fistula can occur that can easily be mistaken for cancer . The most common reported ultrasound (U/S) findings are: an irregular hypo echoic finding that connects with the tubular hypo echo area and parenchymal heterogeneity and an area of mixed echo pattern with parenchymal deformity, both of which can lead to diagnosis of malignant changes . Common findings in mammography imaging are asymmetric diffuse and skin thickness . As mentioned previously, neither U/S nor mammography can differentiate IGM from malignant or other benign lesions, especially inflammatory breast cancers . Because of U/S and mammographic failure, some authors suggested MRI in diagnosis of IGM, but studies have shown that MRI does not provide additional findings for differentiation of IGM from breast cancer. In view of the non-definitive clinical and imaging findings, histopathology is the cornerstone of definitive diagnosis . It must be mentioned that FNA cannot confidently differentiate IGM and histopathological examination remains as the cornerstone . Some studies obtained different results in terms of the treatment of these patients that suggested corticosteroids and methotrexate with surgery or treatment with corticosteroid and azithromycin, and administration of steroids in lesions in these patients .

Assessment of incidence, diagnosis and treatment of idiopathic granulomatous mastitis in Assiut university hospital

The trial is an open-label, multi-center safety trial of GEN1044. The trial consists of two parts: a dose-escalation part (Phase 1) and an expansion part (Phase 2a). The expansion part of the trial will be initiated once the RP2D has been determined from Phase 1.

The purpose of the trial is to evaluate the safety, determine the recommended Phase 2 dose (RP2D), and assess preliminary clinical activity of GEN1044 in patients with solid tumors.

Donor milk pasteurized by an innovative High Temperature Short Time (HTST) system (patented by researchers) retains more immune and trophic compounds than pasteurized milk by traditional Holder method. These compounds are related to the protection conferred by breast milk against nosocomial sepsis and necrotizing enterocolitis in preterm infants, so it would be of interest to study if there is a clinical benefit in these patients when health professionals are supplementing with donor milk pasteurized by both methods.~The purpose of this study is to compare the incidence of microbiological proven late onset sepsis in newborns under 1000 grams that in the first 28 days of life need to be supplemented with donor milk pasteurized by HTST method versus the Holder method.~This is a randomized double-blind clinical trial with parallel assignment. A total of 305 premature babies with a birth weight of less than 1000 grams will be recruited, admitted to the Neonatology Services of the Hospital 12 de Octubre and the Hospital de La Paz and meet the inclusion criteria. Half of the patients will be supplemented exclusively with donor milk pasteurized by the HTST system and the other half with pasteurized milk by the Holder method. Linear generalized models will be used for longitudinal data analysis.

Randomized double-blind clinical trial to compare the incidence of microbiological proven late onset sepsis in extremely preterm infants (<1000 grams) that are supplemented with donor milk pasteurized by High Temperature Short Time (HTST) method versus the Holder method.

BACKGROUND: An Advanced Care Planning (ACP) program of health decisions is the result of a process of reflection and relationship-building between the patient, their relatives and health professionals. It is based on respect for patients' autonomy, involving them in making decisions about their disease in a way that is shared between the medical team, the patient and their relatives. Up until now, the efficacy of an ACP has not been measured in the existing literature, and therefore it is unknown if these programs reach their goal. OBJETIVES: The main objective of our study is to evaluate the efficacy of an ACP program for decision-making in patients with advanced heart failure (HF) in comparison to usual follow up and care. This objective will be evaluated by the Patient Activation Measure test, which measures the participation and self-management of the patient in decision-making. Secondary objectives: to evaluate the effect of the program on quality of life, to know if the patients wishes expressed through the ACP program are fulfilled, to measure the impact of the program on patients' caregivers, to determine the satisfaction of patients included in the program and to evaluate the effect on quality of death. METHODS: randomized multicentre clinical trial at four hospitals in Madrid. Once they are included in the study, patients' allocation to groups (control vs intervention) will be made by alternative sampling. ACP will be applied to the intervention group, whereas in the Control Group usual follow-up will be carried out in HF units. All patients will fulfil questionnaires and tests related to the objectives of the study again after a 12-month follow-up period in order to gauge the effect of ACP in patients with advanced HF.

An Advanced Planning Program of Health Decisions (APPHD) is a process of reflection and relationship between the patient, their relatives and health professionals. It is based on respect for patient's autonomy, to engage patients in making decisions about their disease so that the process is shared between the medical team, the patient and their relatives. Until now, it has not been measured whether the APPHD is effective and, therefore, really fulfills its purpose

A double blinded randomized prospective clinical research study is proposed to validate the hypothesis that Tdap vaccinations at week 28 in pregnancy can reduce the incidence of preeclampsia by more than 50%. This project will recruit 1600 pregnant women with appropriate informed consent in the first trimester of pregnancy, obtain detailed obstetric and health history, and then randomize these subjects so 800 women receive Tdap at week 28, and 800 women receive Tdap at week 36, and all women will be followed during their pregnancies using standard of care with special attention to preeclampsia and fetal outcomes. Blood samples will be obtained at weeks 12, 20, and 36 in order to test the anti-tetanus toxoid antibody levels, anti-diptheria antibody levels, anti-pertussis antibody levels, and also maternal cytokines (IL-2, IL-4, IL-6, IL-10, TNFa, IL-17, and IFNg), and placental biomarkers (sFlt-1, sEng, and PIGF) for preeclampsia on those patients who develop preeclampsia and compare to those who didn't and thereby better understand the biomarkers of preeclampsia and devise a better formula for positive prediction for preeclampsia. To make this change in clinical practice and save lives, this study is asking for funding from NICHD PA-18-480.

Preeclampsia is a significant medical condition occurring in 3-8% of pregnancies and impacts deleteriously both maternal and fetal health. An important discovery has been made by Dr Craig D Scoville showing that early Tdap vaccinations in pregnancy can reduce the incidence of preeclampsia by more than 50%. A prospective clinical research trial is proposed and urgently needed to validate this finding and thereby make a significant contribution in reducing the incidence of this common and severe complication of pregnancy.

High risk patients are referred for the medical oncology consultation to organize oncological surveillance after general staging of the disease. Signature of the informed consent of SALOME study, inclusion in the study and risk-adjusted surveillance schedule :~(i) Liver MRI every 6 months performed at the expert center for UM (according to guidelines).~(ii) For enucleated patients, a blood sample (3 x 6 ml EDTA tubes) is taken every 6 months according to the schedule below. Plasma and mononucleated cells will be isolated and preserved for bio-markers research.~M0 : during the first medical oncology visit.~At each imaging assessment, every 6 months for at least 5 years (M6 to M60) and 10 years maximum (M120).~At the diagnosis of metastasis.~At each significant event during the metastatic disease (surgery, treatment response or progression).

Biomarkers search for early diagnosis of liver metastases in patients with uveal melanoma who benefit from a follow-up tailored to their personalized risk of relapse.

In the first group (group H), the data of patients undergoing HFNC treatment, and in group II (Group K), the data of patients who received COT with a reservoir mask were included.~In HFNC support, the current air temperature is 31-37 degrees, the flow rate is 30-60 lt / min, and the FiO2 value is targeted so that saturation is 93% and above. Initially, continuous treatment was applied intermittently after the partial oxygen pressure / fraction of inspired oxygen(fio2) ratio exceeded 250 and clinical well-being occurred.~In patients in Group K, fingertip saturation was targeted as 93% and above, and a COT was applied with a reservoir mask with a flow rate of 6-15 l / min.~The flow rate was calculated using the formula of FiO2 (%) = 21 + 4 * (liters / min) in patients undergoing COT. Noninvasive mechanical ventilation was applied to patients who could not be provided with adequate clinical and laboratory well-being in both groups (partial oxygen pressure / fraction of inspired oxygen ratio below 150) and invasive mechanical ventilation if this was insufficient.

coronavirus disease 2019 related pneumonia is causing acute respiratory failure and this is the most common reason for ICU admission. We have several different way for respiratory support. HFNC is one of the new technics for oxygen support. Our main purpose to observe the effect of HFNC on coronavirus disease 2019 patients' ICU stay and mortality.

Thorax computed tomography severity score defined by Yang et al. can be used to evaluate the severity of pulmonary involvement in COVID-19 patients. We aimed to investigate whether the initial thorax computed tomography severity score can predict mechanical ventilation requirement and mortality in COVID-19 patients.

The most common thorax Computed tomography (CT) findings are multifocal ground-glass opacities and peripheral consolidation in patients with COVID-19. Septal thickening, bronchiectasis, pleural thickening, and subpleural involvement may also be observed. Although these findings are not specific to COVID-19, the severity of pulmonary involvement is expected to be correlated with thorax CT findings.

The goal of this study is to characterize the performance of a Continuous Glucose Monitoring System in medical food studies. The Freestyle Libre Glucose Sensors will be used to follow subject's 8-day glucose trajectories over the course of a 5-week, double-blind, placebo-controlled, 2x2 crossover, medical-food experiment. The medical food has been designed to increase butyrate production and promote the health of the colonic mucin layer.

This 5-week, double-blind, placebo-controlled, 2x2 crossover pilot study investigate the potential of collecting robust, real-time clinical study measures of glucose levels using Abbott Freestyle Libre Continuous Glucose Monitoring devices associated with a smartphone application

PRV-015-002b is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 3 dose regimens of PRV-015 in adult patients with NRCD who are on a GFD.~Eligible subjects include male or female adults, 18 to 70 years of age, with a diagnosis of celiac disease and have followed a GFD for at least 12 consecutive months, yet continue to experience symptoms.~Study drug (1 of the 3 doses of PRV-015 or placebo) will be administered in a double-blind fashion, followed by a safety follow-up period.

This study will evaluate the efficacy and safety of PRV-015 in adult patients with non-responsive celiac disease (NRCD) who are on a gluten-free diet (GFD).

Eligible patients will be invited to participate in the study by phone call. The research team will visit the included patients. All patients giving the written consent will perform the following tests before being randomly allocated into exercise training or control: 1) blood pressure; 2) anthropometric measures; 3) blood sampling; 4) handgrip test; 5) sit and stand test; 6) exercise capacity; 7) nutritional recalls and 8) health-related questionnaires. Patients will be randomized in a 1:1 ratio to control group (will receive information to keep active and eating healthy) or exercise training group (will receive a telemonitored exercise program through video conference, three times a week, during 3 months). Following 3 months of intervention, the outocomes will be re-assessed.

The aim of this study is to assess the effect of a home-based exercise training during social isolation due to covid-19 pandemic in patients who undertook bariatric surgery.

This is a randomized open-label phase II trial comparing paclitaxel/margetuximab/pertuzumab (TMP) to paclitaxel/trastuzumab/pertuzumab (THP) in patients with anatomic stage II-III HER2 positive breast cancer.~The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.~Participants will be randomized, which means randomly assigned, to one of two treatment arms. The treatment arms in this study and the names of the study drugs in each arm are:~Arm A: Paclitaxel, Pertzumab and Margetuximab~Arm B: Paclitaxel, Pertzumab and Trastuzumab~Participants will receive study treatment for 12 weeks prior to surgery and will be followed for 10 years after surgery. After surgery, some participants will continue to receive the study drug margetuximab for a year in total, if they respond very well to the first 12 weeks of treatment with margetuximab.~It is expected that about 171 people will take part in this research study.~This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug combination to learn whether the drug combination works in treating a specific disease. Investigational means that the drug combination is being studied.~The FDA (the U.S. Food and Drug Administration) has approved paclitaxel, trastuzumab (Herceptin), and pertuzumab as part of a pre-operative treatment option for stage II-III HER2-positive breast cancer.~The U.S. Food and Drug Administration (FDA) has approved margetuximab (Margenza) for advanced HER2-positive breast cancer.

The purpose of this study is to determine how well participants with stage II-III HER2-positive breast cancer respond to pre-operative treatment using one of two different combinations of drugs.~Drugs and Combinations used:~Paclitaxel, Pertzumab and Margetuximab (Margenza)~Paclitaxel, Pertzumab and Trastuzumab (Herceptin)

Acutely ill adult COVID-19 patients with hypoxaemic respiratory failure admitted to the intensive care unit (ICU) are at risk of life-threatening hypoxia, and are provided supplementary oxygen. Liberal use of supplementary oxygen may increase the number of serious adverse events including death. However, the use of supplementary oxygen therapy, and the optimal oxygenation target in COVID-19 patients have not yet been studied.~The World Health Organisation (WHO) recommends an oxygen therapy during resuscitation of COVID-19 patients to achieve an SpO2 of 94% or more, and 90% or more when stable (non-pregnant patients). The Surviving Sepsis Campaing (SSC) recommends a conservative oxygenation strategy for COVID-19 patients targeting an SpO2 no higher than 96%. Both are based on a systematic review and metanalysis from 2018, investigating the association with mortality and higher versus lower oxygenation strategies in critically ill patients in general.~COVID-19 patients admitted to the ICU and treated with positive pressure ventilation fulfil the 2012 Berlin criteria for acute respiratory distress syndrome (ARDS). Current practice regarding supplementary oxygen therapy in patients with ARDS follows the regimen used in an randomised clinical trial (RCT) from 2000 comparing lower versus higher tidal volumes; i.e. a partial pressure of arterial oxygen (PaO2) of 55-80 mmHg (7.3-10.7 kPa) or a peripheral oxygen saturation (SpO2) of 88-95%.~Of note, a recent published RCT demonstrated a lowered all-cause mortality when targeting a higher oxygenation target (PaO2: 12-14 kPa [90-105 mmHg]) compared to a lower oxygenation target (PaO2: 7.3-9.3 [55-70 mmHg]) in ARDS patients.~The quality and quantity of the current body of evidence regarding oxygenation targets in ARDS is still low.~The aim of the HOT-COVID trial is to evaluate the benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in guiding the oxygen therapy in acutely ill adults COVID-19 patients with hypoxaemic respiratory failure at ICU admission.~The HOT-COVID trial is an amendment to the HOT-ICU trial (NCT03174002)

Patients with COVID-19 and hypoxaemic respiratory failure and admitted to the intensive care unit (ICU) are treated with supplementary oxygen as a standard. However, quality of quantity evidence regarding this practise is low. The aim of the HOT-COVID trial is to evaluate the benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in guiding the oxygen therapy in acutely ill adult COVID-19 patients with hypoxaemic respiratory failure at ICU admission.

A study comparing 2 groups: high intensity interval training and control group. Interval training group will perform a two-month physiotherapy program based in exercises, at a high intensity, and stretching of muscles at the end. Intensity will be established based on Borg scale and an effort test.~Control group will not perform any physiotherapy program, but will have usual care with medication.~Several parameters will be evaluated at baseline, 2 months and 6 months: anxiety, depression, functional capacity, blood pressure, lipid profile, physical activity, ecc.

A study comparing 2 groups: interval training and control group. Interval training group will perform a physiotherapy program based in exercises, at a high intensity, and stretching of muscles at the end. Control group will not perform any physiotherapy program. Several parameters will be evaluated at baseline, 2 months and 6 months: anxiety, depression, functional capacity, blood pressure, lipid profile, physical activity, ecc.

This trial is an open-label, multi-center Phase Ib clinical study that will evaluate ATG-010 combined with chemotherapy regimen selected by investigators (ICE regimen ifosfamide+carboplatin+etoposide; Or GEMOX regimen: gemcitabine+oxaliplatin; Tislelizumab) sequential ATG 010 monotherapy maintenance, to evaluate the safety, tolerability, and primary efficacy in R/R PTCL and NK/T-cell lymphoma patients. 97 patients are planned to be enrolled.

This trial is proposed with treatment of ATG-010 combined with chemotherapy regimens which will be chosen by investigators (ICE [ifosfamide+carboplatin+etoposide] or GEMOX [gemcitabine+oxaliplatin] or Tislelizumab), after treatments of 2 to 6 cycles transferring to ATG-010 monotherapy maintenance treatment, to evaluate the safety, tolerability, and primary efficacy of ATG-010 in R/R PTCL and NK/T-cell lymphoma patients.

The study conducted in the Obstetrics and Gynecology Department of the Neihu District of the Taipei Three Military General Hospital. It is expected that 200 cases of polycystic ovary will be diagnosed by specialists; Quality of Life Questionnaire (SF-36) evaluates the quality of life of patients; BAI and BDI-II evaluates patients 'anxiety and depression; Stress Perception Scale evaluates patients' life stress And testing the blood indexes of patients such as FSH, LH, E2, testosterone, TSH, prolactine. Observe the correlation between the quality of life, psychological state, and blood test values of polycystic ovarian patients with physical characteristics of traditional Chinese medicine.

This study is a cross-sectional study. The purpose is to understand the characteristics of Chinese medicine constitutional syndrome in patients with polycystic ovary. In addition, the health-related quality of life (SF-36), mental state (stress, depression) of patients with polycystic ovary , Anxiety) and the relationship between hormone biochemical indicators and TCM constitutional syndromes, to develop a pioneering study on TCM constitution diagnosis and life guidelines for polycystic ovarian patients and future clinical adjuvant therapy.

This is an interventional, multi-site, randomized, double-blind, placebo-controlled study of tACS in patients with FTD. The main aim of this study is to investigate the safety, tolerability and efficacy of gamma-tACS in patients with behavioral variant (bv)-FTD, demonstrating tACS potential mechanisms of action, target engagement, and thus informing the design of larger clinical trials.~Participants will be screened at trial sites for determination of eligibility to enter the study on the basis of diagnostic evaluations, according to current diagnostic criteria for probable bv-FTD and safety assessments.~Baseline assessments will consist of behavioral/cognitive evaluations, blood biomarkers, actigraphy, voice biomarkers, EEG and TMS-EEG and tACS with EEG measures, MRI, FDG-PET imaging (5-8 visits). Once participants have met all inclusion and exclusion criteria, they will be randomly assigned to either 6 weeks of daily tACS sessions or 6 weeks of daily Sham tACS sessions.~Post-intervention visits will include FDG-PET scans, MRI, cognitive testing, tACS with EEG, blood biomarkers and TMS-EEG (5-8 visits). A follow-up visit will occur 3 months after the post-invention visit. This visit will include an EEG registration, cognitive testing and behavioral markers.~tACS is a way of stimulating the brain externally using weak electric currents.~Electrodes are placed into a cap that you wear on your head.~A weak electrical current travels back and forth through the electrodes to your head.~FDG-PET is a way of taking pictures of your brain using a special dye that is absorbed into your body. In this study, the dye will help us to see the glucose uptake in your brain. The PET scans for this study will be done at Massachusetts General Hospital (MGH).~TMS is a noninvasive way of stimulating the brain and will be used in this study to measure your brain's plasticity. Brain plasticity is the brain's ability to change and learn through experience. TMS uses a magnetic field to cause changes in the brain activity. The magnetic field is produced by a coil that is held next to your scalp. We will measure how your brain responds to the TMS before and after the tACS treatment.~EEG is used in routine clinical care to measure the brain's electrical activity. EEG involves placing a cap with electrodes onto your head.~The investigators will enroll a sample of 20 age-matched healthy controls, who will undergo evaluations similar to the bv-FTD baseline assessment except for PET imaging. Healthy subjects will not have the tACS intervention.

This is an interventional, sham controlled, double-blind study designed to investigate the safety, tolerability and efficacy of 40 Hz transcranial alternating current stimulation (tACS), a form of noninvasive brain stimulation, delivered for 6 weeks once daily in frontotemporal dementia (FTD) patients. Cognition, gamma EEG activity and brain metabolism via FDG-PET will be measured before and after the tACS intervention.

This is a prospective single center observational study that will be conducted in adult intensive care unit of Ain Shams University After being approved by local institutional ethic committee (Ain Shams University, Egypt). Informed consent was obtained from each participant's next of kin. The investigator will study mechanically ventilated participants. the attending physician's decision is to give IV fluids to participants due to the presence of at least one clinical sign of inadequate tissue perfusion due to septic shock : (a) systolic arterial pressure <90 mmHg, mean arterial pressure <65 mmHg, or the need for vasopressor infusion; (b) skin mottling; (c) lactate level >2 mmo/L; or (d) urinary output <0.5 mL/kg/h for ≥2 h. Jugular central venous and arterial catheters will be in place by the attending physician. Investigator will confirm the position of the tip of the central venous catheter in the superior vena cava or upper part of the right atrium on chest radiograph. Participants will be monitored by Flo Trac device as a part of routine management in local ICU.~A first set of measurements will be performed, including hemodynamic and tissue oxygenation variables (heart rate, mean arterial pressure, cardiac index (CI), oxygen delivery (DO2), oxygen consumption (VO2), Central venous oxygen saturation (ScvO2), arterial lactic acid level, central venous to arterial carbon dioxide tension difference (∆PCO2), central venous to arterial CO2 content difference (∆ContCO2), arterial-to-central venous oxygen content difference (∆ContO2), ∆ContCO2/∆ContO2 ratio and ∆PCO2/∆ContO2 ratio. 500 ml of isotonic saline 0.9% will be infused to the participants via a specific venous line over 15 minutes. Immediately after volume expansion, a second set of the previous measurements will be recorded. Ventilation parameters, Norepinephrine dose and sedation drugs will be kept constant during the fluid challenge.~After fluid challenge, Participants with an increase in cardiac index ≥15% will be defined as fluid responders. Fluid responders will be divided into 2 groups based on increase in oxygen consumption (VO2) ( < or ≥15%).

The high ratio of central venous to arterial carbon dioxide to arterial to central venous oxygen content is associated with elevated lactate in patients with septic shock.~So, the aim of the present study is to evaluate the ratio of central venous-to-arterial CO2 tension or content to arterial-to-venous O2 content'' as an indicator of anaerobic metabolism in septic shock.

This will be a phase 1a randomized, open label, multi-center study with approximately 24 subjects. All subjects will receive standard of care (SOC) per institutional guidelines for SARS-CoV-2 infection. Subjects will be randomly assigned in a 1:2 ratio to SOC alone or SOC plus brequinar. The SOC plus brequinar group will receive 5 daily doses of brequinar 100 mg on Days 1 - 5 in addition to SOC. Physical examinations, vital signs, laboratory assessments, SARS-CoV-2 testing, and other observations will be conducted by experienced personnel throughout the study based on the Schedule of Events. Blood chemistry tests include blood urea nitrogen (BUN), creatinine, alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), bilirubin, total protein, albumin, glucose, serum electrolytes (sodium, potassium, chloride, carbon dioxide/bicarbonate, and calcium), lactate dehydrogenase (LDH). Plasma will be collected for inflammatory markers such as D-dimer, ferritin, c-reactive protein (CRP), and erythrocyte sedimentation rate (ESR). Pro-inflammatory markers will be measured. Serum is to be collected for research purposes. Hematology tests include hemoglobin, hematocrit, complete blood count with full differential, and platelet count. Nasopharyngeal swabs for viral load will be collected Days 1, 3, 5, 7, and 15. Survival will be assessed through Day 29.

This will be a phase 1a randomized, open label, multi-center study with approximately 24 subjects. All subjects will receive standard of care (SOC) per institutional guidelines for treatment of hospitalized patients with COVID-19 infection. In addition to SOC, the brequinar group will receive 5 daily doses of brequinar 100 mg.

All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after transcranial direct current stimulation (tDCS) treatment. Patients were randomly allocated to real group , sham group or control group. A threshold of 3 points on the Hamilton Depression scale has been specified by the National Institute for Health and Care Excellence to determine a clinically meaningful difference between active pharmacotherapy and placebo. We plan to enroll minimum total sample size of 37 participants in real, sham or control group respectively according to the Power and Sample Size program. The decision to enroll a patient was always made prior to randomization. The tDCS administrators had access to the randomization list. They had minimal contact with the patients, and no role in assessing depression. Each patient would be treated for continuous 14 days by tDCS in real and sham group. The control group was evaluated by clinical symptom scale, behavioral evaluation before and after 14 days.~Before the tDCS treatment, depression symptom of each participant was assessed by the Hamilton Depression Scale and the Beck Depression Self-Rating Scale. The anhedonia severity was evaluated by The Temporal Experience of Pleasure Scale, the Self-Report Apathy Evaluation Scale, Dimensional Anhedonia Rating Scale, the Motivation and Pleasure Scale.The neuroimaging data was collected using event-related potentials during monetary incentive delay task. After the last treatment, the same scales and neuroimaging scan were used again to assess the treatment effect of the tDCS and the underlying brain mechanism. Each participant was interviewed in detail about the adverse event of the tDCS intervention during the past 14 days.Every participant should take part in the study in voluntary and sign an informed consent form before the study.

Study of tDCS intervention on motivational anhedonia of Major Depressive Disorder

Patients with a de novo diagnosis of positional sleep apnoea on a polysomnography performed in our sleep lab will be asked to participate to the study. They should fulfill the Mador definiton of POSA.~A home recording of sleep position with Somnibel Pro will be conduted for 2 consecutive nights. In case of confirmation of supine sleep at home (Mean supine sleep >30% of total sleep time) the patient will be asked to use two different positional therapy devices consecutively (Positional pillow and vibrating belt), 3 nights each, in a random order, with concomitant recording of sleep position with the Somnibel Pro. Global satisfaction questionnaire will be assessed by a simple visual analogic scale (is it easy to use? Is it confortable? Is it efficient on snoring? Is it efficient on sleep apnea? Would you pay for such treatment? Willingness to use it on a long-term basis?) The subjective sleep quality will also be assessed by means of Sleep quality questionnaire, prior to commencing treatment, and consecutively after 3 nights on each individual therapy.~Statistical analysis:~Efficacy of Positional pillow (Posiform) and vibrating belt (Somnofit) Percentage sleep on back on treatment will be compared to mean percentage sleep on back without treatment, at home, for both devices. Comparison on surrogate AHI based on diagnostic polysomnography, with and without each device. Global satisfaction with the devices will also be compared between devices.~The sleep quality will be compared on the two devices using the Sleep quality questionnaire.~The sample size of 52 subjects (26 in each arm), has been calculated to obtain a power of 90% and allow a drop out rate of 10%.

The proposed study is a randomized cross over trial assessing the efficacy of two different positional therapies for positional obstructive sleep apnea (POSA).~The effectiveness of the two different therapeutic devices (Positional pillow and vibrating belt) in reducing the time spent sleeping supine, and therefore at risk of apnoeas, will be evaluated consecutively in 52 subjects with a de novo diagnosis of positional sleep apnoea.~The subjective quality of sleep will also be evaluated prior to treatment and following the use of each separate device by means of a Quality of sleep questionnaire

This is the 4th Burkitt's Lymphoma (LMB) study by the GFAOP group. This study hopes to include at least 14 Sub Saharian countries some of whom have never participated in a LMB study. The evaluation of improvement in early diagnosis should be possible in this study. The study hopes to be able to evaluate children earlier, with stage I and II disease and to evaluate treatment response earlier so that the units can decide if a change in treatment is necessary, it is also hoped to provide an intensification of treatment for children with a stage IV disease.

This is the 4th LMB study by the French African Pediatric Oncology Group (GFAOP). The study hopes to be able to evaluate children earlier with stage I and II disease and to evaluate treatment response earlier so that the units can decide if a change in treatment is necessary, it is also hoped to provide an intensification of treatment for the stage IV disease.

In this study we will try to improve the outcome for children with stage II disease. It is hoped that we will be able to show that with early intervention correct early diagnosis the survival of these children is greatly improved. The collection of data in this observational study will allow us to show this improvement, by analysis of stage, treatment and outcome.

As the survival of children with retinoblastoma in high income countries is higher than 95% including the bilateral forms this study hopes to improve the outcome in low income countries in Africa by improving early diagnosis and early implementation of this protocol of therapeutic recommendations for treatment.

This prospective randomized open label clinical trial will be carried out on 90 male patients undergoing elective idiopathic gynecomastia surgery in Tanta University Hospitals.~Study design:~Patients will be randomly allocated into three equal groups by computer generated sequence through sealed opaque envelopes:~Group C: 30 patients will receive bilateral tumescent local anesthesia as a control group.~Group TPVB: 30 patients will receive bilateral US guided thoracic paravertebral block.~Group TIPB: 30 patients will receive bilateral US guided thoracic interfascial plane block.

The growing increase in the number of gynecomastia surgeries has resulted in an increased need for anesthetic techniques with improved pain reduction, safety, and fewer complications.~The aim of this work is to compare the efficacy of ultrasound guided thoracic interfascial plane block and ultrasound guided thoracic paravertebral block for anesthesia in gynecomastia surgery.

The investigators hypothesize that early institution of TNFα inhibitor therapy in patients with severe COVID-19 infections will prevent further clinical deterioration and reduce the need for advanced cardiorespiratory support and early mortality. To address this hypothesis, a prospective, single center, phase 2 trial is proposed to assess the efficacy of infliximab or infliximab-abda in hospitalized adult patients with severe or critical COVID-19. Observations from this study will inform the conduct of prospective randomized controlled studies to follow.~Infliximab and Infliximab-abda are TNFα inhibitors currently FDA-approved for the treatment of autoimmune disorders, including Crohn's disease and rheumatoid arthritis. The risks and adverse reactions are described in the approved prescribing information for infliximab (or infliximab-abda). Infliximab will be used when available. Should infliximab be unavailable in the pharmacy, infliximab-abda, a biosimilar, will be used.~Treatment with infliximab or infliximab-abda 5mg/kg IV should ideally be administered within 6 hours of enrollment, and no more than 24 hours following enrollment. Pre-medication with Tylenol 650 mg once 30 minutes prior to infusion would be recommended. Other pre-medications may be given at the discretion of the treating physician. These include diphenhydramine 50mg by mouth, as well as prednisone 20mg by mouth, both given 30 minutes prior to infusion. Pulse and blood pressure should be monitored every 30 minutes during the infusion, and patients should be monitored for at least 30 minutes following the infusion.~Retreatment with infliximab is permitted at treating physician discretion 7-21 days following primary therapy and based on initial response; the usual treatment schedule is every 2 weeks, this interval is not strictly enforced given the uncertainty of outcomes with primary therapy.

The investigators hypothesize that early institution of TNFα inhibitor therapy in patients with severe COVID-19 infections will prevent further clinical deterioration and reduce the need for advanced cardiorespiratory support and early mortality. To address this hypothesis, a prospective, single center, phase 2 trial is proposed to assess the efficacy of infliximab or infliximab-abda in hospitalized adult patients with severe or critical COVID-19. Observations from this study will inform the conduct of prospective randomized controlled studies to follow.

This is a randomized phase II prospective study that included 70 (35 in each arm) metastatic Egyptian CRC cancer patients diagnosed at the National Cancer Institute, Cairo University between January 2016 and June 2018). Patients were randomly treated with either classic XELOX (arm A) or with capecitabine (2000 mg daily x 8 weeks) and oxaliplatin (30 mg/m2 weekly X 8 weeks) then 2 weeks rest (arm B). Toxicities and the survival analysis after two years for both regimens were recorded. Blood samples are taken from both groups to assess pharmacokinetics of capecitabine and its relation to dosing.

Colorectal cancer (CRC) in Egypt is advanced tumors at diagnosis. Although, the dramatic increase in efficacy, reduction of mortality, and improvements in survival by the use of standard doses of chemotherapy, some CRC patients suffer from severe toxicities besides disease progression. Use of chemotherapy less than the maximum tolerated dose, with no prolonged drug free breaks incapacitates the cells to engage in progression mechanisms, suggesting that it could be a better alternative to standard dose therapy with better toxicity profile

Levonogesterel (progestin only) IUDs have been used in the adult population for decades and due to their safety and efficacy are now successfully used in the nulliparous and adolescent population for menstrual regulation, dysmenorrhea, and contraception. IUDs have the highest continuation rate among teens of all forms of contraception at 12 months (86%). IUDs reduce menstrual flow by 90% 12 months post insertion, decrease menstrual cramp severity, and have greater than 99% effective contraception. All of this make IUDs an attractive option for our teens and their caregivers~At time of IUD insertion, a uterine sound is used to measure the cavity length. A sound is a rigid instrument that is placed inside the uterus to directly measure the uterine cavity length and is the standard first step prior to IUD insertion. The cavity length will ultimately determine the type and size of IUD that can be placed. Two manufacturers, Mirena ® and Sklya ® are currently being used in clinical practice. Mirena requires uterine cavity length between 6-10 cm and Sklya requires 4-8 cm length. To determine this length requires a pelvic exam and the use of uterine sound, however, approximately 50% of our patient population is unable to tolerate pelvic exams due to a variety of factors, such as developmental disabilities or pain. Thus, this requires patients to go under general anesthesia to have their IUD placed. The goal of this study is to determine if the actual uterine cavity length corresponds to the transabdominal measurement of the uterine cavity length.~Uterine size is largely under the influence of estrogen and as an adolescent progresses through puberty the dimensions of the uterus change. Given that a large portion of families seeking menstrual suppression & regulation present relatively close to menarche (mean age of 12.3 years old) there is a precedent for an institutional standard for pre-IUD insertion transabdominal ultrasound to ensure the uterus is of sufficient caliber~Prior research has focused on those undergoing intra-operative placement of a Mirena IUD. In one retrospective chart review of 56 adolescent patients with developmental disabilities, there was a 3.7% (2/56) failure rate of intra-operative IUD placement (abandoned IUD insertion in the operating room after anesthesia administration). One failure was due to the pelvimetry of the child and the other was due to a uterine cavity length of 4cm which was deemed insufficient for the Mirena IUD. In addition, two other patients had a uterus sound to less than 6 (5cm and 5.5cm) and Mirena was inserted anyways (Skyla was not available). About half of these patients had a pre-operative transabdominal US of the pelvis and the total uterine length was measured with an average length of 8.3cm. All uterine cavities were measured intra-op with an average length of 7.4cm.~Ultimately, all prior research has measured the length of the full uterus (uterine fundus, body of the uterus, and cervix) which is not representative of the measurement in question for IUD placement, the uterine cavity length. We propose a prospective cohort pilot study to compare transabdominal ultrasound measurements with uterine sound measurements to determine uterine cavity length. If these measures correlate, transabdominal US could be a validated pre-insertion tool for the physician and patient to avoid unnecessary anesthetic events and have appropriate IUDs available for insertion.

To determine if uterine cavity length on transabdominal pelvic ultrasound corresponds to uterine cavity length at time of IUD insertion. If transabdominal pelvic ultrasound is validated as a tool for measuring uterine cavity length, it can be used to guide physicians and subsequently patients in IUD insertion planning.

The clinical evaluations will be based on standard, functional and pain parameters Harris Hip Score pre-operatively, and at 6 months, 3, 5, 7.5 and 10 years post-operatively. Postal Oxford questionnaire preoperatively, and yearly thereafter. The objective of this study is to analyse the clinical and radiographic responses and the complication rates for patients undergoing primary total hip arthroplasty using the Anthology Hip Replacement System (Anthology Hip System).

This clinical study will verify the clinical and radiographic performance of the prosthesis when used in human subjects over a period of 10 years. All complications will be documented.

The study is interventional: in children and adolescents (2-17 years), adults with blood malignancy and inherited diseases who underwent autologous or allogeneic HSCT, nutritional status, parenteral nutrition tolerability and effectiveness will be assessed before and one month after HSCT. All patients who require parenteral nutrition will pass randomization via envelope technique - solutions containing glucose/amino acids or glucose/amino acids/lipid emulsions. The results will be compared with a control group which will not receive additional nutritional support. The methods used for measurement of nutritional status are: weight, body mass index, bioimpedance and hand grip strength (for adults only), blood tests, diet amount record.

Nutritional therapy implementation in hematopoietic stem cell transplantation (HSCT) have undergone changes recently due to new conditioning regimen and graft versus disease prophylaxis, novel enteral and parenteral nutrition solutions: the value of enteral nutrition is increasing, the indications for parenteral nutrition are becoming more strict. The study aims to identify the role of parenteral nutrition in the context of rapidly changing supportive care approaches in HSCT

This is a phase 2, open label single arm study to look at the effectives and safety of fludarabine in combination with CPX-351 in patients with untreated AML. The rationale for this combination stems from data which indicated that pre-treatment of the THP-1 cell line with fludarabine for 4 hours prior to CPX-351 administration (Flu-CPX) significantly potentiated intracellular ara-CTP accumulation compared to CPX-351 alone. This suggests that fludarabine combined with CPX-351 may have efficacy against leukemic clones that would be resistant to CPX-351 or standard chemotherapy in first induction. It has been demonstrated that treatment with CPX-351 produces superior clinical outcomes in secondary AML likely due to its novel formulation, which results in sustained exposure of the cytotoxic agents cytarabine and daunorubicin in a synergistic 5:1 ratio within the plasma and bone marrow. Fludarabine can potentially improve upon the outcomes observed with CPX-351 monotherapy and 7+3 by enhancing intracellular ara-CTP accumulation from CPX-351. Patients will received fludarabine and CPX-351 for up to 2 cycles of induction and 2 cycles of consolidation.

This phase 2 clinical trial will evaluate the effectiveness and safety of fludarabine in combination with CPX-351 in patients with untreated AML. Patients will receive fludarabine and CPX-351 during Induction 1 and 2 as well as 2 cycles of consolidation therapy.

the study will compare the effect of ivermectin in comaprison and addition to the standard mode of care for the COVID 19 patients

as Egypt suffered a lot during the pandemic of COVID 19 with limited drug choices, many of the patients could not acheive viral clearence with the standard module of care teh idea of introduction of new medications in the treatment protocol of COVID 19 managment. Ivermectin had shown a promising results in vitro studies and in limited in vivo studies. this clinical trial may open a new hope for COVID 19 patients as a new and cheap line of treatment

Glioma-related epilepsy (GRE) is a very common symptom in patients with diffuse gliomas. Approximately 60% of patients with low-grade gliomas (LGGs) and 40-64% of patients with high-grade gliomas presented with GRE at the onset. Although beneficial for the control of GRE, the overall therapeutic effect was unsatisfied and over 20% of patients still suffered from seizures.~GRE was found to be associated with brain network and functional connectivity. And it has been reported that temporal lobe seizures could induce functional connectivity and decreased network efficiency of brain networks. However, the alterations in functional networks induced by GRE were still unclear. And LGG patients with GRE usually take levetiracetam (LEV) preoperatively, which could effectively reduce abnormal spike activity and further cause connectivity alterations. This makes it more complex to reveal the connectivity alterations of brain networks in LGG patients with GRE.~This study aimed to collect the resting-state functional MRIs of 30 LGG patients who presented with GRE at the onset. Through further applied graph theory analysis, investigators tend to reveal the connectivity alterations of brain networks caused by levetiracetam. The findings of this study will provide a theoretical basis for further study of connectivity alterations of brain networks in patients with GRE.

This study aimed to analyze the connectivity alterations in brain networks of LGG patients with epilepsy who take levetiracetam at short-term preoperatively.

Objective: The aim of this study was to compare the immediate effect of kinesiological and / or sham taping to the tibialis anterior muscle on walking parameters in stroke individuals.~Methods: The study included 28 adults stroke patients . The subjects who received scores of 7 or more in the Hodkinson Mental Test and 3 and above in the Functional Ambulation Classification with subjects who gastrocnemius muscle spasticity 2 and below points according to Modified Ashworth Scale were included in the study. The walking parameters of the participants were evaluated with the BTS G-Walk Spatio-Temporal Walking Analysis System. The walking parameters of the participants who were selected by randomization method were evaluated separately by applying kinesiological taping and sham taping or without any taping or interference on a 10 meter track.

The effect of kinesiological taping applied to the tibialis anterior muscle on gait parameter in stroke patients: Sham controlled study

Toripalimab is a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2). Rituximab is an antibody to CD20 molecules. One of the mechanisms of killing tumor cells is through antibody-dependent cell-mediated cytotoxicity (ADCC). These two drugs may have a synergistic effect on anti-tumor. The purpose of this study is to determine whether Toripalimab with Rituximab is effective and safe for treatment of relapsed refractory CD20 positive diffuse large B-cell lymphoma. This is an exploratory small sample, phase II, single-center clinical trial, which is going to enroll 20 participants.

Exploring the efficacy and safety of Toripalimab with Rituximab for treatment of relapsed refractory CD20 positive diffuse large B-cell lymphoma.

All Healthcare workers (HCW) who had entered contaminated areas at least once and that 14 days or more had passed from their first entrance to contaminated areas were included. They were classified as asymptomatic and pauci-symptomatic. A COVID-19 IgG/IgM rapid test was used for antibody detection, and selected participants were subject to real time polymerase chain reaction (qPCR) for SARS-CoV-2.

Observational, point of prevalence study determining the presence of anti-SARS-CoV-2 antibody

The aim of this study was to assess the effects of an activity training programme on dizziness, imbalance, and level of independence in daily living activities in patients with chronic dizziness. 75 patients between 18-65 years of age who diagnosed chronic peripheral vestibular disorders and individuals with vestibular rehabilitation indications were included in our study. Patients were randomly divided into 3 groups consist of 25 patients as an activity group, exercise group, and control group. Education was given to each group. İn addition, the activity group was performed a training activities program, the exercise group was performed in the Cawthorne-Cooksey exercises program. Therapy programs were prescribed once daily at home for 4 weeks. After demographic information was obtained from all patients, assessments were performed at the beginning and at the end of the treatment program (4 weeks). Dizziness severity was assessed by the Visual Analog Scale (VAS), activities of daily livings were assessed by Vestibular Disorders Activity Questionnaire (VADL) and balance was assessed by Sensory Organization Testing (SOT).

In this study it was aimed to investigate the effects of home treatment program based standard activity on dizziness, balance and daily life activity in patients with dizziness complaint originated from chronic unilateral peripheral vestibular disorder and compare to effects of exercise-based home rehabilitation program.

To investigate the potential role of optical coherence tomography angiography in predicting the postoperative recovery of retinal vascular network of the optic disc in patients before and at 3 months after Endoscopic Endonasal Approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.~The optical coherence tomography angiography represents a novel and non-invasive diagnostic technique that allows a detailed analysis of retinal vascular features.

This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that received endoscopic endonasal approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.

Surgery is the cornerstone in the treatment of non-metastatic sarcomas. Whenever feasible the resection should include a free surgical margin providing a rim of uninvolved tissue surrounding the tumor. In most deep located tumors however, to preserve essential neurovascular and bone structures and thus to preserve function, the margins are often limited. High grade tumors are, even with wider margins, at higher risk of local failure. Radiotherapy can reduce this risk of local failure.~Preoperative radiotherapy does increase the risk for early complications due to unavoidable irradiation of the normal tissues surrounding the sarcoma mass, particularly for lower extremity lesions (6-9).~Preoperative radiotherapy aims to reduce tumor vitality prior to resection, theoretically allowing more conservative surgical therapy. Postoperative RT allows histological examination of the tumor specimen, especially the margins, aiding in further treatment planning; it may also be associated with fewer early wound complications. (10, 11).~In preoperative radiotherapy, as compared to postoperative radiotherapy, lower doses (50 versus 60 to 66 Gy) and smaller field sizes can be used, resulting in a reduced risk of late, often irreversible, complications. Consequently, preoperative RT is the preferred approach in many centers. Although the outcomes of combined RT and surgery are favorable, approximately 15% of the patients may relapse locally and about 30-50% distantly (dependent upon, among others, age, histopathology, size and grade), stressing the need for further improvement. These improvements should not only be sought in the domain of oncological endpoints, but also in decreasing treatment burden. A reduction in treatment duration, maintaining local control rates without increasing the rates of postoperative wound complications would serve the latter endpoints. For this purpose, quality of life questionnaires as well as patient reported outcomes measurements could come of help.Modern radiobiological investigations suggest that, on average, intermediate to high-grade soft tissue sarcomas may have α/β ratio's substantially below 10 Gy, justifying clinical studies exploring the possibility of (modest) hypofractionation. Obviously, various subtype derived cell lines exhibit different characteristics but on average an α/β ratio of 5 Gy would be a reasonable denominator for sarcomas as a group. However, it is important not to exaggerate hypofractionation in a setting where patients still need to undergo surgery.

Currently, soft tissue sarcomas (STS) are preoperatively irradiated in a conventionally fractionated regimen of 25 x 2 Gy in five weeks. Recent radiobiological investigations, however, suggest sensitivity to (modest) hypofractionation. Within this study, patients will be randomized to receive either the conventional schedule of 25 x 2 Gy or a shorter preoperative regimen of 14 x 3 Gy, in the hypothesis that both the postoperative wound complication rate until 30 days after surgery, as well as the local control probability at two years are comparable in both arms.

A total of 52 primary schools were screened comprehensively to determine children conforming specifications of the inclusion criteria. Demographic characteristics (e.g. age, gender, affected side) and severity of functional impairment dealing with cognitive /communication, manual ability and mobility were noted. After a comprehensive screening, a total of 30 children met inclusion criteria (grades 1-4) were randomly assigned to one of two groups (Modified Constraint-Induced Movement Therapy or Bimanual training), at an equal number and probability. Children blinded to group allocation were delivered activity-based upper limb training in the context of Modified Constraint-Induced Movement Therapy or Bimanual training, at a similar dose and frequency (10 weeks/3 days per week/2.5 hours per day). 1 out of 3 sessions per week was carried out in the school time (during the art or physical education class), while 2 out of 3 sessions were carried out in rehabilitation centers which the children regularly attend for regular care 2-day weekly. All participating children continued to receive their standard care (90 minutes per week) throughout the study period.~During the 1-month screening period, physical characteristics of participants were described through classification systems including The Communication Function Classification System, The Manual Ability Classification System , and The Gross Motor Function Classification System. Participating children were evaluated before the study entry (T1), immediately postintervention (T2), and at 16 weeks postintervention (T3) using the KIDSCREEN-27 questionnaire

This study compared the effectiveness of two-mode of activity-based upper limb rehabilitation (Modified Constraint-Induced Movement Therapy and Bimanual training) on health-related quality of life outcomes in school-aged children with cerebral palsy

The investigators will conduct a longitudinal survey to examine the impact of COVID19 on those with SCI and ABI. An a priori sample size of 117 individuals based on an alpha level of .05 and level of acceptable error at 3% was calculated. Anticipating for loss to follow up rate of up to 20%, a total of 142 participants will be recruited. Patients will be recruited among those who attend virtual medical appointments at Parkwood Institute for ABI and SCI. We will also liaise with SCI-Ontario and the Ontario Brain Injury Association to assist in the recruitment of additional participants. Those who consent will complete an online survey on enrollment into the study, and subsequently at 3 and 6 months. Demographic data of the individuals participating in the study will be recorded. Participants' access to health care services will be evaluated using the following subdomains: medical care, complementary care, medications/equipment, satisfaction/acceptability, affordability, ability to engage, and indirect support.

Document and evaluate the impact of societal restrictions due to the pandemic on SCI- and ABI-related disability and functional impairments, and the resultant effects on psychological wellbeing, physical wellbeing and quality of life for those with SCI/ABI.

In this nationwide, case-control study we cross-reference several detailed, high-quality Swedish registers in order to study risk factors associated with severe Covid-19 as well as different disease outcomes, with a focus on cardiovascular disease, chronic kidney disease, different treatments and socioeconomic factors. Cases are identified through the Swedish intensive care register (SIR) and controls through the Swedish population register (RTB). Further information on the study participants is gathered by linkage to registers on: prescribed drugs; history of in- and outpatient care; income, education and migration. Follow-up data such as future hospitalization and mortality will be gathered prospectively.

In this study we cross-reference several nationwide high-quality Swedish registers in order to study risk factors for severe Covid-19 outcomes.

This prospective single arm interventional study involved 13 genetically confirmed spinocerebellar ataxia (SCA) 3 patients with no concomitant diabetes, over 6 months. Following baseline assessment, patients were instructed to ingest 100g of oral trehalose diluted in 500ml of water or other beverages daily. Assessments were performed at baseline, 2, 4 and 6 months using ataxia rating scales (SARA, SCAFI and INAS) and EQ-5D-3L scale for quality of life assessment.

There are no clinically established treatments which have been proven to delay the disease progression in spinocerebellar ataxia (SCA) 3. Most available treatments are only for symptom alleviation, and thus the majority of patients will eventually progress to needing and wheel chair and eventually bedridden.~As trehalose appear to be potentially promising treatment in SCA, the investigators aim to conduct this study using oral trehalose in our genetically confirmed SCA 3 patients.

This prospective trial evaluates the 12-week, multi-domain Memory Boot Camp program for adults ages 55 to 85 with symptoms of mild cognitive impairment. The Memory Boot Camp program incorporates neurofeedback, heart rate variability biofeedback, memory and cognitive training, and one-on-one coaching to encourage behavior change in diet, sleep, physical fitness, and stress reduction. Participants are evaluated via neurocognitive assessments, questionnaires, quantitative electroencephalography parameters, and heart rate variability parameters at four time points: baseline, pre-program, post-program, and follow-up. The trial included a 12-week waiting period between baseline and pre-program, such that each participant acts as their own control, and follow-up takes place six months after completion of the program.

This is a prospective controlled clinical trial to determine the effects of a 12-week Memory Boot Camp (MBC) program on cognitive function in older adults with symptoms of Mild Cognitive Impairment.

It has been postulated that it is possible with the Ziemer Femtosecond LDV laser system to create reproducible flaps in terms of thickness and predictability. The aim of this study was to test the hypothesis that OCT-guided 110 µm targeted flaps will result in accurate, predictable, and precise thickness flaps, with low complication rates when performed and compared using both 2D and 3D flap geometry applications. Patient-reported outcomes are increasingly incorporated into clinical trials as they provide access to valuable information on the physical experience of the patient during and after the treatment. A questionnaire will therefore also be introduced in this study to evaluate how well self-reported pain, visual experience, and quality of life responses are correlated with flap geometries in both groups during the early postoperative period. The study holds direct medical benefit to the patient in this that they received an immediate improvement in his/her unaided vision. Moreover, the patient's participation contributes to the medical knowledge about the use of femtosecond lasers for refractive surgery, in particular in view of the use of intraoperative OCT visualization tools. The patients will gain access to the newest technology available for refractive surgery namely a low pulse energy high-frequency femtosecond laser.

The aim of this study was to test the hypothesis that OCT-guided 110 µm targeted flaps will result in accurate, predictable, and precise thickness flaps, with low complication rates when performed and compared using both 2D and 3D flap geometry applications and how it correlated to visual experience and quality of life responses during the early postoperative period.

Approximately forty-eight (48) participants will be randomized 1:1 to receive~(a) Intramuscular (IM) administration of CYT107 at 10 μg/kg followed, after 72hrs of observation, by 10 μg/kg twice a week for 3 weeks (maximum 7 administrations adjusted to patient's length of stay in the hospital) or (b) Intramuscular (IM) placebo (normal saline) at the same frequency.~The aim of the study is to test the ability of CYT107 to produce an immune reconstitution of these patients and observe possible association with a clinical improvement.~This cohort is dedicated to oncology patients

Comparison of the effects of CYT107 vs Placebo administered IM at 10μg/kg twice a week for three weeks on immune reconstitution of lymphopenic COVID-19 patients

Planned course of the project:~We make the questionnaire using Google Forms.~The link of the online questionnaire is sent to three public groups via the social media website Facebook.~By clicking on the sent link, all participants are able to read information about the project and about the consent to participate in it. Then the participant will be able to give consent to participate in the project. After giving consent, the participant will be able to start filling out the questionnaire. If the participant indicates that he/she does not want to give consent to the study, the website will indicate that the participation of him/her has ended in the project.~Anonymous answers will be automatically saved.~The participants will be given code numbers based on the order in which they filled out the questionnaire.~The data will be analysed by the researchers. For a participant, completing the online questionnaire takes approximately 10-15 minutes.

The aim of the study is to explore the psychological effects of the COVID-19 pandemic among Hungarian adults with the use of an anonymous online questionnaire that consists of 65 items. With these results it will possible to identify coping strategies that can help Hungarian adults to deal with the difficulties arising from the pandemic.

Patients vulnerable for psychosocial suffering due to social distancing measures are recruited by family practitioners in the City of Ghent. The recruited patients are randomly selected into a control and intervention group. Based on the validated Promis instruments, all participants are interviewed face to face on their mental and social health at time 0 and after 6 weeks of intervention. Patients from the intervention group are contacted by Community health workers after the first interview. Community health workers offer emotional support to the patients through at least 8 contacts over 6 weeks. The control group receive care as usual and are offered support by community health workers after the second interview. In depth interviews (qualitative study) will be conducted among community health workers and patients after finalizing the post-intervention questionnaires.~Research questions: What are the psychosocial consequences of social distancing for at-risk groups? Can community health workers reduce the psychosocial impact of physical distancing measures isolation?~Relevance: Understanding community-based psychosocial support for vulnerable people during and after health crises.~Keywords: Community health workers, psychosocial, health crises

Randomized controlled trial among patients from family practices at risk of psychosocial suffering due to social distancing measures. Patients from the intervention group receive support from community health workers. contacted at least 8 times by community health workers. Evolution of psychosocial wellbeing is evaluated by questionnaires at time 0 and after 6 weeks of intervention. Psychosocial outcomes are compared between control and intervention groups. Process evaluation will be done through in-depth interviews.

Bacterial infections are still associated with a high mortality in intensive care unit patients. Especially patients diagnosed with ventriculitis caused by a bacterial infection have a bad outcome. Therefore, antibiotic therapy is the only causal opportunity to treat those infections. However, there are many chances in pharmacokinetic and -dynamic in critically ill patients with unpredictable antibiotic concentrations. Furthermore, it is important that the concentration in the blood as well as in the effect-compartment CSF is sufficient. Less data of the last years describe antibiotic concentrations in the CSF and show subtherapeutic levels, which is endangering for the therapeutic success. The introduced study is a prospective, observational study that analyses antibiotic concentrations in CSF in critically ill patients. The distribution between CSF and blood will be evaluated by comparing these two compartments.

Therapeutic drug monitoring of antibiotics in critically ill patients is a present research topic of the last ten years. Research results have shown subtherapeutic blood concentrations in those patients. However, the amount of antibiotics in the cerebrospinal fluid (CSF) in patients with ventriculitis or meningitis is still unclear. This study is a prospective study to evaluate the concentration of different antibiotics in the CSF in patients with an external ventricular drainage compared to antibiotic blood concentration.

This study was aimed to investigate the effect of metformin on the gut microbiota and glycemic control in newly diagnosed type 2 diabetes patients. All the recurited patients were treated with metformin 1500-2000mg daily for 3 months. Stool specimens and blood samples were collected at the beginning and 3 months later.

This study was aimed to investigate the effect of metformin on the gut microbiota and glycemic control in newly diagnosed type 2 diabetes patients.

Progesterone is an neurosteroid that can help integrity of blood brain barrier . Traumatic subarachinoid hemorrhage disrupts this blood brain barrier facilitating post traumatic vasospasm and neuronal ischemia. Transcranial doppler can detect cerebral vasoconstriction through resistive vasculer indices

Traumatic subarachinoid hemorrhage is associated with serious complications related to mortality . Delayed neuronal ischemia and rebleeding are most common and serious. Progesterone can delay both .

Currently, ultrasound-guided transversus abdominis plane (UTAP) blocks (regional anesthetic blocks) are being employed for the care of urological surgery patients. Local and regional anesthesia is commonly used throughout surgical fields. However, ultrasound-guidance can be challenging, particularly in larger, obese patients. It is unknown how such techniques compare to laparoscopic-guided blockade, with respect to time to perform, learning curve, and postoperative analgesia. The transversus abdominis plane lies deep within the abdominal wall, potentially allowing for greater ease of access from a laparoscopic approach from within than the ultrasound guided percutaneous approach.~Prior randomized studies have been completed comparing UTAP and Placebo. In 2012 Hosgood et al. compared UTAP and placebo (UTAP w/ saline) in 46 live-donor laparoscopic nephrectomy patients (24 UTAP vs. 22 placebo). Pain control (measured using the 0-10 VAS scale) was greater on post-operative day (POD) 1 in patients receiving UTAP than in controls, 19 (15) vs. 37 (20) (presented as mean (SD)), respectively. A similar randomized study in 2014 compared UTAP and placebo (UTAP w/saline) in 21 hand assisted laparoscopic nephrectomy patients (10 UTAP vs. 11 placebo). The study was initially powered for 50 patients but with decreased accrual secondary to a surgeon taking a leave of absence during the study period. Pain scores were recorded using the 0-10 VAS score. Postoperatively at 24 hours (median (IQR)) UTAP patients demonstrated decreased postoperative pain than placebo patients (1 (0-2) vs. 4 (2-6)) on the VAS score, respectively.~A larger study, done in 2016, with 80 randomized patients undergoing retroperitoneal laparoscopic urologic surgery compared UTAP (40) and saline UTAP (40). Pain scores were assessed using the 0-100 VAS score scale. On POD1, UTAP group had lower pain scores (mean (SD)) of 8.4 (5.9) vs. placebo 28.3 (12.2).~The most recent study, done in 2018, examined 100 randomized patients undergoing robotic-assisted laparoscopic prostatectomies. Fifty patients were given UTAP blocks while the others received no block. A Numerical Rating Scale (assumed to range from 0-10 as not otherwise specified) was used to assess pain. Patients receiving the block at 24 hours had better pain control (mean (SD)) (1.8 (0.82) vs. 3.57 (0.64)).~While all of these studies point to potential efficacy of UTAP, no data has been published to date comparing laparoscopic administration of the TAP block (LTAP) to ultrasound guided administration. While these regional anesthetic blocks carry a theoretical risk of hematoma or damage to surrounding structures, none of the above studies report any complications with the injections.~The study team aims to prospectively compare Placebo (local administration), UTAP, and LTAP blocks in patients undergoing robotic surgery of the prostate and kidney. The study team expects to be able to equally efficiently administer the blocks using direct visualization and ultrasound guidance. The study team expects that a negative result would obviate the need for longer operative time by eliminating the need for the separate ultrasound guided block while a positive result would demonstrate the increased utility of preoperative ultrasound blocks in managing postoperative pain.

The study team aims to prospectively compare Placebo (local administration), ultrasound-guided transversus abdominis plane (UTAP) blocks, and laparoscopic-guided transversus abdominis plane (LTAP) blocks in patients undergoing robotic surgery of the prostate and kidney. The study team expects to be able to equally efficiently administer the blocks using direct visualization and ultrasound guidance. The study team expects that a negative result would obviate the need for longer operative time by eliminating the need for the separate ultrasound guided block while a positive result would demonstrate the increased utility of preoperative ultrasound blocks in managing postoperative pain.

Participants with rheumatoid arthritis with recommendation to physiotherapy. All participants have dysfunction and pain of hand.~Inclusion criteria:~II ° and III ° of advancement of radiological changes~II ° and III ° of advancement of functional changes~Remission, low or moderate RA activity: DAS28~Medical order~Magnetotherapy and kinesiotherapy~Kinesiotherapy~Consent to participate in the study~Completion of the research program~Exclusion criteria:~Additional physiotherapy treatments for the hands~Change in type or dose of pharmacotherapy used~Taking steroid anti-inflammatory drugs~Malaise and side effects in the subject~Outcome Measures:~Duration of morning stiffness~The degree of severity of morning stiffness~Pain intensity assessment (VAS)~Test Box & Blocks~Measurement of the palmar surface of the hand~Measuring the range of motion in the joints of the hand~Measurement of compression force in a cylindrical grip~Time to maintain maximum pressure during cylindrical grip~Hand volume measurement~HAQ-20 test~Intervention:~Group 1: Only kinesiotherapy~Group 2: Kinesiotherapy with bipolar magnetic field~Group 3: Kinesiotherapy with unipolar magnetic field~Assessment:~Immediately before start therapy~Immediately after therapy (10 treatments in 2 weeks)

Participants with rheumatoid arthritis with recommendation to physiotherapy.~Created 3 study groups:~Only kinesiotherapy~Kinesiotherapy with unipolar magnetic field~Kinesiotherapy with bipolar magnetic field~Kinesiotherapy with magnetic field give better effects than only kinesiotherapy.

This study will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of arm, lower limb and oblique muscles. The study is a prospective multi-center open-label four-arm study.

Evaluation of HIFEM treatments for strengthening and toning of arms, lower limbs and oblique muscles.

A total of 7,000 Medicare beneficiaries meeting the study's eligibility criteria will be consented and enrolled over 30 months at sites throughout the United States. To ensure diversity, the study will enroll at least 2,000 Blacks/African Americans, at least 2,000 Latinos/Hispanics, and up to 3,000 additional participants from other racial and ethnic backgrounds. Based on disease stage prior to PET, all participants will be classified as having MCI or dementia as their disease stage. Based on their clinical presentation prior to PET, all participants will be classified as having typical (i.e. progressive amnestic) or atypical clinical presentations of AD as the potential cause of dementia or MCI.~Dementia specialists will team with PET facilities that have trained radiologists/nuclear medicine physicians and access to perform amyloid PET. All participating physicians and study staff will complete comprehensive training to ensure adherence of data requirements and study timelines. Amyloid PET will be performed and interpreted at each facility with results provided to the ordering dementia specialist for support in further decision making. The dementia specialists will record their diagnosis and intended management plan based on the current clinical and diagnostic information, and assuming no future access to amyloid PET at the Pre-PET visit. This represents a thought experiment documenting the management plan that would be recommended by the specialist if the participant were not enrolling in New IDEAS and thus had no access to amyloid PET. PET results will be disclosed to patients and any consequent changes in management (if any) will be recommended at the PET disclosure visit. Patients will return 90 ± 30 days following PET for an in person Post-PET visit. At this final visit, the dementia specialists will record the diagnosis and implemented management plan, incorporating amyloid PET into clinical decision making. Medicare claims data will be collected directly from CMS for 12 months prior to the PET imaging and 12 months after the PET imaging, for each participant.~Aim 1 utilizes Medicare claims data to compare 12-month claims-derived outcomes in amyloid PET-positive versus amyloid PET-negative individuals with MCI and dementia across the entire cohort. Aims 2 and 3 investigate these associations in sub-groups of study participants based on self-identified race and ethnicity (Aim 2) and clinical presentation (Aim 3). Aims 2 and 3 additionally evaluate changes in management between the pre- and post-PET visits in the relevant sub-groups, to test whether benefits in health outcomes are mediated by changes in clinical management. The investigator's over-arching hypothesis, supported by preliminary data from the first IDEAS study, is that amyloid PET results will be associated with changes in clinical management, which in turn will translate into improved health outcomes in patients with amyloid PET-positive scans in comparison with patients with amyloid PET-negative scans. We further hypothesize that these effects will be seen across patients of different ethnoracial backgrounds, clinical presentations and disease stages (MCI and dementia).~Optional components of the study include the collection and archival of participant's amyloid PET images, and blood plasma. These repositories will serve as a resource to the field, enabling the testing and validation of emerging genetic and blood biomarkers. Separate consent will be obtained for participation in these components.

New IDEAS is an observational, open-label, longitudinal cohort study designed to address the requirements of the CED provisions of the NCD on beta-amyloid PET. Building on the initial Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) study, New IDEAS will evaluate the association between amyloid PET and patient-centered outcomes in an expanded and more ethnoracially and clinically diverse group of Medicare participants presenting with cognitive impairment.

Dexmedetomidine, an a2-agonist, has none-to-minimal respiratory depressant effects, which is clearly a great advantage in handling a critical (unstable, difficult) airway while inducing sedation in both adult and infants. The aim is to compare intubation conditions between dexmedetomidine and sevoflurane inhalation during fibreoptic intubation in pediatric patients with an anticipated difficult intubation

difficult problem in the paediatric age group because of their small mouth opening and un-cooperativeness.Currently used methods of sedation for fibreoptic intubation such as benzodiazepines, propofol or opioids may cause respiratory depression, especially when used in high doses

Each patient should have at least one resin composite restoration. The restoration will be evaluated by all diagnostic methods. Each examiner will independently record the dental findings using all methods, the visual- tactile assessment method and both fluorescent-aided identification methods. The visual-tactile assessment method includes the use of mirror, probe under good illumination condition, while the fluorescent-aided identification methods will be performed by both light-induced fluorescence intraoral camera and laser-induced fluorescence device. Then Diagnostic performance for caries detection was evaluated, assessing the validity of each diagnostic method in diagnosing secondary caries around margins of resin composite restorations

This study will be conducted to evaluate the clinical performance and validity of both light-induced fluorescence intraoral camera and laser-induced fluorescence device in comparison to visual-tactile assessment method in detection of secondary caries around margins of resin composite restorations.

During the implementation of the project, it is planned to develop a method for the treatment of men urinary incontinence caused by prostatectomy using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen. The positive outlook for the effectiveness of MSCs is due to the following:~the ability of MSCs to stimulate tissue regeneration~positive results of preclinical studies of the method of treatment of urinary incontinence in animals.~In study planing to include 5 patients. MSCs will be isolated from adipose tissue, cultured and then transplanted back to the periurethral area by five point injection in rhabdosphincter and submucosal space of urethra using the cystourethroscope. For injection in submucosal space MSCs (20*10^6 cells) will be mixed with collagen solution (3,5% w|w). Follow up patients monitoring will occur at 1，3，6 and 12 months after injection.

Treatment of patients with urinary incontinence after prostatectomy using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel

Tumor Infiltrating Lymphocytes (TIL) have shown efficacy in certain cancers, principally in melanoma. Efficacy in more common solid tumors has been demonstrated via the selection of cancer neoantigen-specific TIL. Combination cell surface checkpoint inhibitor therapy has also been employed in an attempt to enhance the efficacy of these cell therapies. Genetic engineering of T cells to further increase anti-tumor activity is now possible.~CISH (Cytokine-induced SH2 protein) is a novel intra-cellular immune checkpoint and an important negative regulator of T-cell signaling and function. The inhibition of CISH in mouse anti-tumor lymphocytes results in a marked increase in the ability of these lymphocytes to mediate tumor regression following administration to tumor bearing mice.~Additionally, data in genetically-engineered, neoantigen-specific human T cells in which CISH was inhibited, showed enhanced TCR functional avidity and increased ability of these T cells to detect cancer specific mutations and mount robust polyfunctional cytokine immune responses against their cognate cancer antigens. Thus, these T cells appear to have a significant advantage in inducing anti-tumor responses compared to wild-type anti-tumor lymphocytes.~The researchers have developed and optimized a CRISPR/Cas9 based strategy for precise and efficient genetic engineering in primary human T-cells without sacrificing cell viability or function, allowing for inhibition of a heretofore undruggable intracellular checkpoint.~Thus, in this protocol, the researchers propose to inhibit the gene encoding the intracellular checkpoint target CISH in lymphocytes from patients with metastatic cancers that are selected for anti-tumor activity in order to evaluate the safety and efficacy of genetically engineered T cell therapy for solid tumors in the setting of novel checkpoint inhibition.

A clinical trial to assess the safety and efficacy of genetically-engineered, neoantigen-specific Tumor Infiltrating Lymphocytes (TIL) in which the intracellular immune checkpoint CISH has been inhibited using CRISPR gene editing for the treatment of Gastro-Intestinal (GI) Cancer.

This is an open-label and paralleled study with single oral dose of HMS5552 given to hepatic impaired subjects and matched healthy volunteers.~The primary objective is to access the pharmacokinetic profiles of HMS5552 in 25 mg dose in hepatic impaired subjects and (gender, age and BMI) matched healthy adult subjects.~The secondary objective is to characterize the safety profiles of HMS5552 in single dose in hepatic impaired subjects.~The subjects include mild hepatic impaired subjects (A group), moderate hepatic impaired subjects (B group), and healthy subjects (C Group) matched with hepatic impaired subjects in gender, age and BMI. The number of subjects in each group was no less than 8, and no less than 3 subjects in each gender.

The objectives of this study is to access the pharmacokinetics and safety of HMS5552 in single dose in mild and moderate hepatic impaired subjects and matched healthy adult subjects.

Patients with anterior uveitis are typically treated aggressively with every 1-2 hour (while the patient is awake) potent topical steroid agents, during initial stage of inflammation, and evaluated at frequent intervals, with a schedule of steroid tapering dictated by clinical response. The most common topical corticosteroid prescribed for the treatment of anterior uveitis are prednisolone acetate 1%, dexamethasone 0.1%, prednisolone sodium phosphate 1% and Difluprednate 0.05%. However, topical treatments are limited by the potential for patient non-adherence and variation in drug concentrations due to the intermittent or suspension of use nature of application. A corticosteroid insert placed in the inferior and superior canaliculi provides the advantages of reliable and continuous drug delivery for 24 hours a day for 30 days without the need for patients to adhere to a treatment regimen. Dextenza is a sustained-release dexamethasone intracanalicular insert recently approved by the FDA for pain and inflammation post ophthalmic surgery. Dextenza was shown to decrease inflammation and pain compared with placebo following cataract surgery in a multicenter randomized clinical trial.

This a prospective study review of the clinical efficacy of DEXTENZA for the treatment of anterior uveitis compared to the standard of care topical corticosteroid treatment

Baseline medical information and standard questionnaire to record symptoms are collected from all participants and a gynaecological examination and a 2D and 3D vaginal ultrasonography including saline infusion sonography (SIS), if indicated, are performed. Blood samples for the biobank for extraction of germ line DNA and for identification of possible biomarkers are taken.~The women with submucosal leiomyomas will undergo hysteroscopic myomectomy and the women with intramural leiomyomas will undergo myomectomy per laparoscopy or laparotomy.~For the participants with intramural leiomyomas and the fertile/infertile controls, endometrial samples are taken with an endometrial suction curette in an outpatient setting at day 19-23 of the menstrual cycle. The endometrial sampling in the group of women with submucosal leiomyomas is being done during the hysteroscopic removal of the leiomyoma, also at day 19-23 of the menstrual cycle.~3-6 months after surgery, cycle day 19-23, endometrial samples will be taken from the women who have undergone myomectomy and ultrasound examination is being performed. The women with submucosal leiomyomas will undergo a second look hysteroscopy

We aim to explore some of the molecular factors that reduce fertility for women with leiomyomas, taking into account leiomyoma location, size, number and vascularity. Tissue samples from the endometrium and leiomyomas will be obtained during the mid secretory phase before and 3-6 months after surgical excision for a comprehensive search for key molecular derangements.

The purpose of this study is to explore resting state electroencephalography and transcranial magnetic stimulation and electroencephalography (TMS-EEG) biomarkers that would predict transcranial direct current stimulation (tDCS) response in obsessive-compulsive disorder with cathode electrode targeting orbitofrontal cortex (OFC). 30 OCD patients will be recruited to this study and performed once a day, five times a week direct current stimulation treatment for two weeks. The investigators will assess symptom severity before and after two weeks of tDCS. Through the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, the Obsessive Compulsive Inventory-Revised (OCI-R), the Beck Depression Inventory(BDI), Pittsburgh sleep quality index (PSQI)and side-effect questionnaire will be obtained by a trained investigator. Resting state electroencephalography and TMS-EEG testing will be conducted before and after tDCS treatment.

This study is designed to find Electroencephalogram (EEG) biomarkers to predict transcranial direct current stimulation (tDCS) response in obsessive-compulsive disorder.

Objective: To demonstrate the most effective exercise intervention for women with fibromyalgia syndrome on the pain, quality of life, depression, and body composition through a comparative study of three types of exercise intervention.~Methods: Eighty-four patients women with fibromyalgia syndrome were assigned to three groups: supervised aerobic plus stretching exercises group (group I, n:28), supervised resistance plus stretching exercises group (group II, n:28) and home-based stretching exercises group (group III, n:28). The target heart rate (HR) corresponding to values of 50-70 % ergospirometric VO2max were determined by the submaximal treadmill test. Group I was instructed walking at their target HR on a treadmill. Exercise intensity in group II was determined by one-repetition maximum (1RM) measurements. Group III was instructed to exercise at home. All participants were instructed to perform stretching exercises. Before and after a 12-week exercise program, participants were evaluated by weight, Body Mass Index (BMI), total body fat and muscle percentage, Visual Analog Scale (VAS), Fibromyalgia Impact Questionnaire (FIQ), Short Form-36 (SF-36) and Beck Depression Inventory (BDI).~Study Type: Interventional (Clinical Trial)

Objective: To demonstrate the most effective exercise intervention for women with fibromyalgia syndrome on the pain, quality of life, depression, and body composition through a comparative study of three types of exercise intervention: supervised aerobic plus stretching, supervised resistance plus stretching, and home-based stretching.

Hypertension and obesity or overweight related, even other associated comorbidities, involve a worrying public health problem. The evidence shows that healthy eating and regular physical exercise, monitored by different means (internet, face to face, exercise diaries), play an important prevention role to maintain health while ageing. In this way, Information and Communication Technologies (ICTs) have been demonstrated as a useful tool to promote health, working on barriers at the same time, such as low motivation and difficulties to maintain regular exercise or healthy eating habits. ICTs also allows to reach a wider audience at a lower cost, due to their good cost-benefit relationship and the possibility of increasing the efficiency of interventions. Therefore, this study aims to analyze the effects of a 3 months duration self-applied online program, composed of 9 modules focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on obese or overweight adults with hypertension. Participants will be recruited from a hypertension unit of a public hospital. These patients will be randomized allocated into two interventional groups: experimental group will receive audiovisual instructions from their hypertension specialist doctor, and the control group from a doctor outside the patient. Assessment will include: body composition (BMI), blood pressure, levels of physical activity, functional capacity, fall risk, and quality of life.

This study aims to analyze the effects of a 3 months duration self-applied online program, composed of 9 modules focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on obese or overweight adults with hypertension. Participants will be recruited from a hypertension unit of a public hospital. These patients will be randomized allocated into two interventional groups: experimental group will receive audiovisual instructions from their hypertension specialist doctor, and the control group from a doctor outside the patient. Assessment will include: body composition (BMI), blood pressure, levels of physical activity, functional capacity, fall risk, and quality of life.

CT-P39, containing the active ingredient omalizumab, is a recombinant humanized monoclonal antibody that is being developed and manufactured as a proposed biosimilar to Xolair (omalizumab) by the Sponsor. CT-P39 is identical to Xolair with respect to concentration and presentation. The 150 mg of drug product (CT-P39) will have the same pharmaceutical form and strength as 150 mg Xolair (in a prefilled syringe [PFS] for subcutaneous injection) and is intended to have a similar quality profile compared with Xolair.

A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 3 Study to Compare Efficacy and Safety of CT-P39 and Xolair in Patients with Chronic Spontaneous Urticaria Who Remain Symptomatic despite H1 antihistamine Treatment

In this study, eligible subjects will be randomized into study arm or control arm. Participants receive camrelizumab or placebo + chemotherapy + radiation therapy . The chemotherapy regimens are : paclitaxel plus cisplatin Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) will be the primary outcomes.

This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of treatment with Camrelizumab (SHR-1210) + definitive chemoradiotherapy(dCRT) vs placebo+dCRT for locally advanced esophageal cancer patients in China. Camrelizumab (SHR-1210) is a humanized anti-PD1 IgG4 monoclonal antibody.

The study is a 4-arm parallel design, randomized, double-blind, placebo-controlled, multicenter, dose-effect relationship, phase II clinical trial. The study is designed to assess efficacy and safety of 3 Doses of hepalatide in Combination with Pegylated Interferon Compared to Pegylated Interferon Alone in patients with Chronic Hepatitis B .Subjects will be randomly assigned to the 2.1mg, 4.2mg, and 6.3mg dose groups , 32 subjects in each group . The subjects in each dose group will be randomly and double-blindly administered the corresponding dose of trial drug or placebo in a ratio of 3:1. The subjects in each dose group who received placebo treatment combine as the placebo group. All subjects will receive Pegylated Interferon treatment for 28 weeks as the basic treatment,trial drug or placebo treatment for 24 weeks continuously , followed by a safety follow-up for 4 weeks.

A Phase II Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-effect Relationship Study of Hepalatide for Injection Combined with Pegylated Interferon in Subjects with Chronic Hepatitis B

This is a prospective observational pilot study designed to evaluate feasibility and acceptability as well as preliminary efficacy of a behavioral activation intervention among orthopaedic trauma patients after discharge home following their injury. Behavioral activation is a behavioral treatment that focuses on helping participants engage in more rewarding and enjoyable activities. In the first session, participants will begin to identify domains of their life which are important to them. In the second session, participants will be assisted in creating an action plan to engage in more activities in one or more domains of importance. In session 3-8, participants will be assisted in problem solving any challenges they encountered in implementing their previous action plan and will develop a new action plan. The intervention will continue until participants achieved three action plans or reach the eight-session limit, whichever comes first.

This is a prospective observational pilot study designed to evaluate feasibility and acceptability as well as preliminary efficacy of a behavioral activation intervention among orthopaedic trauma patients after discharge home following their injury.

A retrospective study investigating young adults aged <45 years for males and <55 years for females admitted at Saud Al Babtain Cardiac Center with diagnosis of Acute Myocardial Infarction, determining its risk factors for Coronary Artery Disease (CAD) related to cultural characteristics and common positive consanguinity of parents as well as the prevalent diabetes and smoking.

A retrospective study collecting the data of young patients admitted with diagnosis of Acute Myocardial Infarction.

Approximately 90 patients with advanced or metastatic lung cancer, with these specific mutations in the MET gene but without changes in their epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genes, will be enrolled in this study. Participants will be randomly assigned to get either capmatinib or docetaxel in a 2 to 1 ratio. The randomization will be stratified by prior lines of systemic therapy received for advanced/metastatic disease (one line vs. two lines).~During treatment, visits will be scheduled every 21 days.~For all participants, the respective treatment (either with capmatinib or docetaxel) may be continued beyond initial disease progression as per RECIST 1.1 (as assessed by the investigator and confirmed by BIRC) if, in the judgment of the investigator, there is evidence of clinical benefit, and the participant wishes to continue on the study treatment. After treatment discontinuation, all participants will be followed for safety evaluations during the safety follow-up period, and the participant's status will be collected every 12 weeks as part of the survival follow-up.~Participants randomized to docetaxel treatment will be eligible to crossover to receive capmatinib treatment after BIRC-confirmed, RECIST 1.1-defined progressive disease and after meeting the eligibility criteria prior to crossover.

The purpose of the study is to learn whether the study drug (capmatinib) helps to control lung cancer better compared to a single agent chemotherapy (docetaxel) and whether it is safe when given to patients suffering from a particular type of lung cancer. This type of cancer is called non-small cell lung cancer (NSCLC) with certain specific genetic alterations (called mutations) of a gene called MET, within a specific part of the gene called exon 14.

It is well known from large Medicare and National Inpatient Sample databases that vascular evaluations in patients with critical limb ischemia (CLI) and at risk for amputations remains extremely low. However, this data is largely pulled from the early 2000s with a scarcity in studies from this recent decade. A recent study showed that Medicare patients from 2011 showed that 23% of patients received primary major amputation. In a recent retrospective analysis preformed at this institution, all amputation patients from 2011-2017 were evaluated for vascular work up and long-term mortality. This cohort included 698 patients with 1009 amputated specimens (major and minor). This means that this institution is preforming around 140 amputations per year, which can be considered unacceptably high. Only 50% received any form of vascular study (ankle-brachial index, doppler ultrasound, and computed tomography angiography) within the year prior to amputation. Furthermore, only 30% of patients received an angiogram within the year prior to amputation. In addition, all major amputations received histopathological analysis, which confirmed that 62% the specimens were graded with severe atherosclerosis. Even in this present decade, with the knowledge that CLI patients are not receiving proper evaluation and treatment leading to amputation which is associated with extreme mortality rates and a large economic burden, health care facilities are not improving their care.~Multidisciplinary teams are a recommendation from the American Heart Association/American College of Cardiology guidelines for managing peripheral vascular disease. Multidisciplinary team approaches in other cardiovascular diseases, such as structural heart disease, has long been validated. Literature regarding the implementation of CLI Teams remains scarce and not widely adopted. However, institutions that have implemented a CLI Team that engages with specialists from multiple disciplines have shown successful decrease in amputation rates and increases in vascular evaluations and revascularization in these patients. The goal for this study is to establish a hospital-based, physician and nurse led, multidisciplinary team to deliver comprehensive care to CLI patients. We believe it is important to document the experience of building a CLI Team and care protocols to provide insight and validated data for other programs to implement. The multidisciplinary team will include vascular interventionalists, hospitalists, podiatry, wound care, infectious disease, nephrology, orthopedics, pharmacists, emergency department physicians, mid-level providers, nursing staff, and vascular technologists. The ultimate goal is amputation prevention and wound healing through comprehensive vascular care and data driven patient outcomes.

Single-center, observational registry study with a prospective and retrospective arm to evaluate the impact of multidisciplinary CLI teams and protocol on amputation rates, vascular studies, revascularization, in-hospital and long-term outcomes.

Treatment resistant bipolar depression is a leading cause of disability and socioeconomic burden of disease, and current treatment options all suffer from critical deficiencies of efficacy, capacity, or tolerability, especially given the current COVID-19 pandemic. rTMS and aLFR in particular has the potential to overcome many of these deficiencies, and is safe and well-tolerated. Taken together with the reported findings of other groups, aLFR may be feasible, tolerable, and capable of achieving comparable and potentially better remission rates than longer 20 to 30-day courses and it may also be beneficial to taper treatments and use symptom-based relapse prevention treatments in an aLFR protocol. Importantly, our pilot data in two patients previously responsive to ECT and data from the Cole et al. study suggest that accelerated rTMS may be a potential substitute for ECT as it may be possible to achieve remission in patients with severe depressive symptoms who would otherwise receive ECT. Furthermore, there is a burden of being able to provide care to as many people as possible based on severity of illness during the pandemic.

The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose LFR protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with bipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.