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Pseudofolliculitis barbae (PFB), or 'ingrown hairs,' is a common skin disease of the face and neck caused by shaving in predisposed individuals who have naturally curly hair. It affects a disproportionate number of African American Service Members - up to 45% in one study.(Alexander, 1974) Keeping a close shave is a requirement for service in all of the Unites States armed services, and as a result, PFB is a major cause of morbidity in this population. The main rationale behind this policy is that a beard prevents a proper seal when using breathing protection devices, in particular gas masks. A review of various dermatologic conditions seen in wartime found that the incidence of PFB was 5.9% during the Vietnam War and 1.8% during Operation Iraqi Freedom (OIF) (Gelman, 2015). The authors argued that this was due to a relaxing of the shaving standards as part of the update PFB protocol followed during OIF. However, the United States Navy recently announced a change to their PFB protocol, discontinuing the issuance of permanent no-shave chits. Laser hair removal (LHR) using the Nd:YAG laser is the current treatment of choice for the majority of patients who fail conservative treatment with topical retinoids, antibiotics, and optimization of shaving practices. However, LHR treatment can induce a permanent change in facial hair density and patients treated with this modality may have to accept a permanent change in their ability to grow a beard. In addition, laser treatments have a potential for operative discomfort along with blistering and dyspigmentation of skin. Eflornithine is a topical medication that is FDA indicated for the treatment of unwanted terminal hairs in women. It works by its action as an irreversible inhibitor of ornithine decarboxylase, an enzyme responsible for the formation of polyamines which allow for various proliferative activities in the skin. It is the only known topical treatment that can retard the growth of human hair. Xia et al. showed that this medication can be used in conjunction with LHR to enhance the efficacy of the treatment for PFB(Xia, 2012). However, there are no studies to date that look at eflornithine as monotherapy for the treatment of PFB. The Unites States Navy has included topical eflornithine as a potential PFB treatment in their latest Bureau of Medicine and Surgery (BUMED) instruction despite the lack of evidence behind its use. If shown to be efficacious, this medication would provide a cost-effective treatment for PFB, especially in medical practices that do not have a hair removal laser. In addition, the effects of eflornithine are reversible with discontinuation, making it an ideal choice for patients and service members who would like to retain their ability to grow normal beards.~Goal: To study the efficacy of topical eflornithine for pseudofolliculitis barbae from an objective physician-measured lesion count. Our hypothesis is that the hair growth retardation that occurs with eflornithine will perhaps reduce the frequency over time that service members need to shave which could improve the formation of PFB lesions.~Plan~Recruitment of patients that meet inclusion criteria (No LHR treatments in the past year, Not pregnant or breast feeding).~Provide written informed consent.~Patients instructed to discontinue all other treatment modalities for PFB (plucking, waxing, chemical depilatories, topical retinoids).~Patients receive two identical 30-g jars from the Walter Reed Army Medical Center research pharmacist. The jars will be labeled left and right and randomized by the pharmacy using a random number generator.~Initial lesion counts and Skindex-16 QoL measurements taken. Two (left and right) 2-cm circles drawn at the junction of the submental chin and anterior neck for the lesion counts.~Patients begin applying a thin layer of each cream corresponding to the site of application (left and right beard) twice a day.~Follow up at 4 week intervals, at which the number of hairs and inflammatory papules will be counted within the two 2-cm circles on the submental chin by two dermatology residents or staff dermatologists.~Patient then goes to research pharmacist. Pharmacist weighs both eflornithine as well as placebo cream to measure compliance. Re-issue new 30-g jars.~At week 16, final lesions counts administered.~Data is analyzed using Wilcoxon signed-rank tests.~Findings published. | To study the efficacy of topical eflornithine for pseudofolliculitis barbae from a quality of life standpoint and with objective physician-measured lesion counts. Our hypothesis is that the hair growth retardation that occurs with eflornithine will perhaps reduce the frequency over time that service members need to shave which could improve the formation of PFB lesions. |
Randomized clinical trial comparing corneal and retinal changes after intracameral levofloxacin or moxifloxacin administered at the end of surgery among eyes undergoing uncomplicated phacoemulsification. | Comparative safety study of intracameral levofloxacin versus moxifloxacin for postoperative infection prophylaxis |
To demonstrate that α4β2* nAChRs are appropriate therapeutic targets in Parkinson's Disease (PD), it is necessary to study key pharmacokinetic-pharmacodynamic features of α4β2* nAChR in the context of the PD brain with loss of nerve cells that produce the neurotransmitter acetylcholine, a pathologic environment in which they may exhibit unique features. This personalized medicine approach focuses our studies on the subgroup of PD subjects with loss of nerve cells that produce the neurotransmitter acetylcholine identified by Project II and the Clinical Resource Core. The investigators will assess α4β2* nAChR features using PET imaging with the α4β2* nAChR ligand [18-Fluorine]flubatine, subacute administration of the α4β2* nAChR partial agonist Varenicline (VCN), and laboratory measures of gait, balance, and attention. The investigators will use [18-Fluorine] flubatine PET to assess VCN occupancy of brain α4β2* nAChRs (experiments 1 & 2). VCN will be administered to both PD participants (experiment 1) and healthy controls (experiment 2) and both populations will undergo a flubatine PET scan to assess VCN occupancy. Using this PET data to select an appropriate VCN dose, the investigators will perform a pharmacodynamic study (experiment 3) with subacute VCN administration to determine if α4β2* nAChR stimulation improves laboratory measures of gait function, postural control, and attentional function in PD subjects with loss of nerve cells that produce the neurotransmitter acetylcholine. | With an appropriate oral dose of Varenicline (VCN) identified from experiments 1 & 2 of the study (see NCT02933372), the investigators will administer VCN to Parkinson Disease (PD) participants to determine if VCN improves walking speed and measures of balance. PD participants will receive VCN or a placebo (fake drug) for 3 weeks to assess the effects of VCN administration on gait speed and balance. Participants will undergo examinations to assess the intensity of their Parkinsonism and asked questions to assess their mood and thinking. |
Early detection and treatment of insufficient tissue perfusion and oxygenation is the main purpose of perioperative haemodynamic monitoring and management. Hypovolemia, septicaemia, and low flow states affecting central and peripheral perfusion are frequent in patients undergoing emergency laparotomy.~This study aims to assess the effects of Noradrenaline (NA) on cardiac preload, and tissue perfusion in patients undergoing emergency laparotomy, to investigate potential macro/microcirculatory uncoupling.~A single-centre, prospective interventional non-blinded single-arm study at the Department of Anaesthesiology and Intensive care Unit, Copenhagen University Hospital Hvidovre, Denmark. We will include patients undergoing emergency laparotomy. The study start is January 2021. After informed consent, patients will be included if they have an intraoperative need for Noradrenaline infusion >0.1 mcg/kg/min to maintain MAP ≥65 mmHg after resuscitation with a goal-directed fluid therapy algorithm. 20 patients will be included.~Intervention: At a steady state (MAP ≥65 mmHg) during the surgical procedure, we will reduce NA to investigate whether patients will be preload responsive while maintaining MAP > 50 mmHg and limiting stroke volume reduction to no more than 30%. After a subsequent fluid challenge, we will increase the dose of NA to re-establish a MAP ≥65 mmHg. In addition, peripheral and central perfusion indices, including gut perfusion, will be measured. | This study is investigating the effect of intraoperative Noradrenaline on cardiac preload and stroke volume, after initial fluid resuscitation, in order to assess whether there is a masked preload responsiveness and ultimately whether the correction of this potential preload-responsiveness with fluid therapy will translate into increased tissue perfusion in emergency laparotomy. |
Recent research has shown that interventions with assistive technologies could lead to an improvement in the motor and functional abilities of children with cerebral palsy (CP). However they usually miss the functional motor skill learning qualities to match the changes observed in high intensity motor skill learning based interventions.REAtouch® is a new interactive interface based on motor skill learning principles that could be implemented in intensive interventions.~Therefore, the study aims to investigate the effects of intensive interventions with or without the interface on the motor and functional abilities of children with bilateral CP. | Recent research has shown that interventions with assistive technologies lead to an improvement in the motor and functional abilities of children with cerebral palsy (CP). REAtouch® is a new interactive interface based on motor skill learning principles. Its efficiency during intensive motor skill learning interventions has never been tested in children with bilateral cerebral palsy.~Therefore, the study aims to investigate the efficiency of using a virtual reality tool to provide a motor skill learning intervention in a randomized trial. |
In patients who undergo pterygium surgery, eyes will be consecutively assigned to receive either DEXTENZA or topical prednisolone acetate 1%.15 eyes will receive a Dextenza insertion into both the upper and lower puncta at the time of surgery, followed by at postoperative month 1 visit institution of topical prednisolone acetate 1% bid x 2 weeks then qd x 2 weeks then discontinued. 15 eyes will receive starting on postoperative day 1 topical prednisolone acetate 1% q2 hours x 2 weeks then qid for 2 weeks then bid for 2 weeks then qd for 2 weeks then discontinued. | DEXTENZA for the treatment of post-surgical pain and inflammation compared to standard of care topical prednisolone acetate 1% in patients who undergo pterygium surgery (excision of pterygium with conjunctival autograft) |
Once a subject is identified that may meet eligibility criteria, the physician and/or study investigators will be alerted to the potential candidate and will introduce the study to the patient at their standard of care (SOC) appointment or via telephone. Patients will be given the option for enrollment and if they agree, informed consent will be discussed and obtained provided they meet all inclusion/exclusion criteria. Following informed consent, subjects will be assigned to one of the following cohorts:~Cohort 1:~• Ursolic Acid (150 mg) BID (twice a day)~Cohort 2:~• Curcumin (600 mg) BID~Cohort 3:~• Ursolic Acid (150 mg) and Curcumin (600 mg) BID~The study team aim to enroll 10 subjects who will complete the study into each cohort for a total of 30 completers. Subjects will be enrolled on a rolling basis with the first ten subjects assigned to Cohort 1, the next ten subjects assigned to Cohort 2, and the last 10 subjects assigned to Cohort 3. | A proof of concept clinical trial to assess the synergism of curcumin (CURC) and ursolic acid (UA). Before further testing within formal cancer clinical trials, we must (1) evaluate the bioavailability and safety, (2) confirm the presence of metabolites in the target organ, and (3) validate the appropriate mechanism of effect |
Background~Corona virus disease 2019 (COVID-19), an infectious respiratory disease caused by a newly discovered corona virus in December 2019, has been recognized as a serious threat to global health. Since the WHO declared COVID-19 a pandemic in early March 2020, the WHO and the Center for Disease Control and Prevention (CDC) have been considered the most reliable sources of information for the COVID-19 global pandemic. The CDC listed moderate to severe asthma, especially if not well controlled, as high-risk for severe illness from COVID-19.~A large number of cases occurred among health care workers (HCW), which were contracted within the health care facilities. Some of the HCWs even died from the COVID-19 disease. Moreover, it was reported that unrecognized, asymptomatic patients transferred to their family or close contacts. All these factors were alarming and potentially distressing for the hospital staff who worked during the pandemic.~The severe acute respiratory syndrome (SARS) epidemic in 2003 also involved disease transmission to HCWs. Even though the fatality rates for SARS were lower than for COVID-19 infection, nonetheless, they were a cause of significant stress, emotional turmoil, and concern for all the SARS healthcare providers.~The emotions, perceived stressors, complete knowledge assessment and coping strategies of HCWs especially doctors during COVID-19 have not been explored. These issues were the intended focus of the study. | Doctors are at high risk of corona virus infection (COVID-19) during pandemic. The investigators are aiming to explore the emotions, perceived stressors, knowledge and coping strategies of doctors who are working during COVID-19 pandemic in different specialties and in different hospitals by a self assessment questionnaire that was designed and modified from two previously published articles (mentioned in the references), including 7 sections with 88 questions. |
This study will be the first to combine a novel two-pronged approach to the management of spasticity (tightness of the muscle) in the calf muscles. First, investigators will decrease spasticity in an innovative way through dry needling. Second, investigators will follow this spasticity reduction technique using external electrical stimulation applied to the calf, while the participant walks on a harnessed treadmill (for safety). The investigators believe modulating tone in the calf with dry needling will allow for improved strength with electrical stimulation, while simultaneously improving the efficiency of the muscles during walking. The investigators hypothesize that decreasing spasticity will result in enhanced gait efficiency, and lower fatigue, all while allowing the participant to meet their personal mobility goals.10 The investigators are proposing an innovative study design. Assessing changes in muscle spasticity using electromyography and the Modified Ashworth scale before and after each portion of our two-pronged intervention will enable them to understand the immediate effects of dry needling, as well as the combined effects of function electrical stimulation with with treadmill training. Following the intervention assessments with pre-post functional tests will allow us to determine long term changes. This proposal offers a unique approach to management of spasticity in people with Multiple Sclerosis (MS), with the advantage of being minimally invasive and inexpensive. Results of this pilot study will inform the potential use in MS, and will allow for a larger study examining optimal intervention parameters for future use. | Investigators will use muscular dry needling in the calf of one lower extremity, followed by treadmill training with functional electrical stimulation. |
The trial will assess the effects of aggressive hypofractionated radiation therapy in patients with oral cavity, oropharynx, hypopharynx, or larynx cancer after surgical resection with pathology showing intermediate risk factors requiring post-operative radiation therapy without concurrent chemotherapy. During Phase 1, the maximum tolerated dose/fractionation and tolerability will be determined. During Phase 2, patients will be randomized between conventionally fractionated radiation therapy (6 weeks) vs. hypofractionated radiation therapy (3 weeks) to establish non-inferiority of hypofractionated radiation therapy. | There is a strong radiobiological and economic rationale for hypofractionated radiation therapy in head and neck cancer. Phase 1 of the trial aims to assess the acute toxicity and tolerability of hypofractionated radiation therapy in the post-operative setting, and to determine the dose/fractionation for Phase 2. Phase 2 aims to establish non-inferiority of swallowing-related quality of life and to assess the toxicity and efficacy of hypofractionated radiation therapy compared to conventionally fractionated radiation therapy in the post-operative setting. |
There is a need to provide better patient-centered care for acute kidney injury (AKI) in order to improve the adverse health outcomes associated with this common condition. This project involves thorough evaluation of patient and provider feedback on barriers and facilitators to pediatric AKI self-management in order to develop patient-centered pediatric AKI interventions. This will be done through interviews with families of patients diagnosed with AKI and providers who take care of these patients followed by integration of the results into modification of an existing educational tool previously used in adult patients. The study will take place in three parts with the first involving interviews, the second involving tool modification and usability testing, and the third involving pilot testing of the tool's impact. | The purpose of this study is to improve patient-centered care for acute kidney injury (AKI) in order to decrease the adverse health outcomes associated with this common condition. |
The epidemic of 2019 novel coronavirus (causing the disease Covid-19) has expanded from Wuhan throughout China and is being exported to a growing number of countries, some of which have seen onward transmission. COVID-19 caused clusters of severe respiratory illness and was associated with 2% mortality. There is currently no vaccine and no specific antiviral treatment recommended for COVID-19. About 20% of the patients were severe and the mainstay of clinical management is largely symptomatic treatment, with organ support in intensive care for seriously ill patients. Therefore, it is urgent to find a safe and effective therapeutic approach to COVID-19.~Tannins have been shown to have antioxidant, anti-inflammatory, antimicrobial properties and a regulatory effect on the gastrointestinal metabolism.~The investigators will realize a prospective, double-blind, randomized trial to assess the effect of treatment with a dietary supplement (ARBOX), a molecular complex of quebracho and chestnut tannins extract and Vit B12, compared with placebo. 140 COVID-19 patients will be recruited in a single center in Buenos Aires Argentina. 70 patients will receive conventional treatment plus ARBOX (treated group) and 70 patients will receive conventional treatment plus placebo (control group). The effects will be evaluated during the 28 days follow up. The primary end point will be the time of discharge from the hospital. A panel of 27 cytokines level, intestinal microbiota composition and its metabolites will be assessed at day 1 and 14. | There is an urgent need to evaluate interventions that could be effective against the infection with SARS-CoV 2. Tannins based wood extracts are an inexpensive and safe product with protective effect in both bacterial and viral infections likely due to its anti- inflammatory, anti-oxidative effects and their modulation of the intestinal microbiota. This randomized controlled trial seeks to evaluate the efficacy of the tannins based dietary supplement ARBOX in positive COVID-19 patients. |
Coalition VI (TOCIBRÁS) is a prospective phase III randomized controlled trial that evaluates the efficacy and safety of Tocilizumab, an antibody anti-IL-6 receptor in patients with moderate to severe COVID-19 with increased inflammatory markers. This is a superiority open-label study with two arms. The control arm receives the best supportive care, and the experimental receives it plus tocilizumab. Randomization is done centrally by REDCap 1:1. Patients will be followed until Day 29 after randomization. | The trial evaluates the efficacy and safety of Tocilizumab, which rapidly reduces the inflammation process through inhibition of IL-6 in patients with moderate to severe COVID-19 with increased inflammatory markers. There will be two arms in the trial, one receiving the best supportive care, and the other receiving it plus tocilizumab. Patients will be followed until Day 29 after randomization. |
Denosumab discontinuation is associated with a rebound effect in bone turnover and loss in bone mass density. These changes resulted in an increase of fracture incidence in patients with postmenopausal osteoporosis back to background levels. However, no excess in fracture incidence was observed. Amongst patients who presented with vertebral fractures after treatment discontinuation, there was a slightly higher incidence of multiple vertebral fractures in patients discontinuing Prolia versus those who discontinued the placebo treatment.~A 2 year, randomized, crossover study demonstrated that alendronate intake after discontinuing denosumab treatment, lead to remaining stable bone mass densitometry (BMD) values in postmenopausal women.~In a study within a non-osteoporotic study population, ongoing at our department, increases in bone turnover are to be expected as soon as patients end study participation (i.e. open label treatment with denosumab, Prolia, anti-RANK ligand inhibition).~It is currently recommended that alternative anti-resorptive therapy may be warranted after Prolia discontinuation. One study describes the use of oral alendronate after denosumab therapy to maintain bone mineral density. However, gastro-intestinal upset and tolerability, as well as difficulty in swallowing pills may limit oral alendronate compliance. To attenuate this concern, buffered soluble (effervescent) alendronate 70 mg, developed with the aim to improve the gastrointestinal tolerability through full dissolution of alendronate in buffered palatable solution before ingestion, will be used.~This study wants to provide a follow up and study wether the use of effervescent alendronate after previous denosumab treatment can prevent a rebound effect in bone turnover that is to be expected when denosumab is discontinued. Subjects that completed our erosive hand OA study and therefore discontinued denosumab 60 mg/every 3 months, will receive alendronate. Moreover, the study wants to asses if there is difference between using alendronate for six or twelve months, starting at the earliest three months but no later than four months after the last injection of denosumab. | It is hypothesized that effervescent alendronate will be able to maintain bone turnover markers within the pre-menopausal reference range and thereby reducing the likelihood of bone turnover associated changes (rebound effect), after discontinuation of denosumab treatment in a non-osteoporotic population. |
Inguinal hernia repair is one of the most commonly performed surgical procedures worldwide, especially in the day-case setting. It can be accompanied by moderate to severe postoperative pain, which can delay return to normal daily activities or lead to the development of chronic pain. Chronic pain after hernia repair has a reported prevalence ranging between 0% and 43% with both nociceptive and neuropathic features. The transversus abdominis plane (TAP) block is an effective regional anesthetic technique to reduce postoperative pain intensity, time to first rescue anesthetic administration and opioid demand after upper and lower abdominal surgery. Dexmedetomidine is a selective α2-adrenergic agonist with analgesic properties that has been shown to prolong local anesthetic action when used as an adjunct to local anesthetic solutions in neuraxial anesthesia. The aim of this prospective, double-blind placebo controlled randomized study will be to evaluate the analgesic efficacy of ultrasound-guided TAP block where local anesthetic is supplemented by dexmedetomidine in patients undergoing unilateral elective inguinal hernia repair with the Lichtenstein technique under general anesthesia. | This prospective double-blind randomized study will aim at evaluating the short- and long-term postoperative analgesic efficacy of the ultrasound-guided transversus abdominis plane (TAP) block with a combination of local anesthetic and dexmedetomidine in inguinal hernia repair under general anesthesia |
The study takes place in the S.N. Fyodorov Eye Microsurgery Federal State Institution located in Moscow, Russian Federation.~The study will include 50 patients with rhegmatogenous retinal detachment due to a horseshoe-tear. In addition to the standard ophthalmological examination, all patients will undergo wide-field optical coherence tomography to determine the extension and localization of the vitreoretinal traction zone. The obtained data will be used to planning the 1st step of laser-surgical treatment. All patients will undergo a combined laser-surgical technology, which includes 3 steps: 1) Nd-YAG laser excision of the vitreoretinal traction zone 2) pneumatic retinopexy (10% C3F8) 3) barrier laser photocoagulation around retinal break after retinal attachment.~The patients are going to be followed up for at least 1 year, the main outcome measures are postoperative primary and final anatomic outcome, BCVA and complications. | Purpose: to assess the efficacy and safety of combined laser-surgical technology of RRD treatment |
This is a cross-sectional, online survey-based study administered to Dentist in Egypt. A 20-item questionnaire will be developed and distributed using Google Forms.~Participants were recruited through social networking websites and applications (Twitter, Instagram, Facebook, LinkedIn, and WhatsApp). The questionnaire will be conducted from 24 May 2020 and until 30 june 2020.~The survey will be delivered in Enlish. Participants will be able to complete the survey only once and will be allowed to terminate the survey at any time they desired. The survey will be anonymous and confidential. An introductory paragraph outlining the purpose of the study will be posted along with the survey. | Dentist exposed to coronavirus (COVID-19) may not have adequate access to personal protective equipment (PPE), safety procedures, and diagnostic protocols. Our objective will be to evaluate the reality and perceptions about personal safety among dentist in Egypt |
In Vietnam, there is a low level of diabetes knowledge among the general population, and significantly lower awareness in rural areas compared with urban areas. This highlights the urgent need for communication and education to improve the knowledge of the Vietnamese population of patients with type 2 diabetes on risk factors, complications, prevention and treatment. The main goal of this study is to evaluate the effects of a patient education and self-management intervention as add-on to usual diabetes care in a low-resource setting on diabetes knowledge and blood glucose control parameters in Vietnamese patients with type 2 diabetes.~This is a single-center, randomized, controlled study among adult out-patients with type 2 diabetes. Patients meeting the inclusion criteria are randomly assigned to a community intervention or to usual diabetes care alone (control group) for a period of 3 months. The intervention consists of group education on type 2 diabetes, including, in addition to usual diabetes care: information on diet, exercise, drug therapy, and adherence. Each patient should attend the group education monthly over 3 consecutive months. Usual diabetes care is consistent with the ADA guidelines and comprises standard dietary and exercise advice in addition to antidiabetes treatment. Diabetes knowledge is measured with a modified Michigan University Diabetes Knowledge Test (MDKT). Other study outcomes includes change in mean HbA1c, fasting blood glucose, and systolic blood pressure. | This study measures the effect of a 3-month patient education and self-management intervention in a low-resource setting, on diabetes knowledge and levels of blood glucose control. |
50 patients and 50 healthy controls will undergo clinical exams and blood test of inflammatory and other findings as well as magnetic resonance imaging (MRI) with spectroscopy. The patients will undergo csf -sampling and measurements of CSF pressure. | A case control study on patients with ME/CFS and healthy controls on prevalence of cervical obstructions, Cerebro spinal fluid (CSF) pressure and laboratory findings. |
Coronavirus disease 2019 (COVID-19) can induce an exaggerated inflammatory response. Vitamin D is a key modulator of the immune system. We hypothesized that vitamin D deficiency (VDD) could increase the risk of developing severe COVID-19 infection. The COVIT-D study (Increased risk of severe COVID-19 infection in patients with Vitamin D deficiency) is a prospective cohort study recruiting patients with confirmed COVID-19 seen at the emergency department of a tertiary hospital. A measurement of 25-hydroxyvitamin D is obtained at admission and follow-up obtained. The primary outcome is a composite of death, admission to the intensive care unit, and/or a need for higher oxygen flow than that provided by nasal cannula. The primary association between VDD - categorised in groups - and the primary outcome will be evaluated with univariate analyses and multivariable logistic regression including the following prespecified confounders: age, gender, obesity and chronic kidney disease. The estimated sample size is n=500 and the expected inclusion time lapse 3 months. | In this prospective observational study we aim to study the association of vitamin D deficiency with adverse clinical outcomes in patients infected with Coronavirus disease 2019 |
Participants will be classified into three groups, applied twice a day by care givers. Oral colonization will be tested in the baseline, day-3, day-7, and at the discharge. Quantitation of colonization of the oral cavity by oral rinses and respiratory pathogens were measured. | Chlorhexidine is a effective strategy in reducing ventilator associated pneumonia. However, it is unclear if prophylactic 0.12% chlorhexidine oral rinse can reduce the risk of non-ventilator hospital-acquired pneumonia among hospitalized patients. |
The HE10A/13 study is an observational study of the Hellenic Cooperative Oncology Group (HeCOG). Its main purpose is the collection of biological material from patients in search of prognostic / predictive biomarkers. Each patient signed an informed consent for the provision of biologic material for future research purposes. The study was conducted in accordance with the Declaration of Helsinki. The clinical and translational protocol has been approved by the Hellenic Cooperative Oncology Group Scientific Committee and is under review by the Institutional Review Board of Metropolitan Hospital. Patients exclusively with Luminal A or Luminal B (Estrogen Receptors (ER)-positive with or without Progesterone Receptors (PgR) positive, HER-negative) breast cancer who received adjuvant chemotherapy with positive lymph nodes or node-negative with tumor stage or pathological features according to Saint Gallen guidelines suggesting high-risk or when genomic testing determined in favor of adjuvant chemotherapy are eligible for registration in the study.~Before registration to the study, each patient signed an informed consent for the provision of biologic material for research purposes.~Potential biomarkers will be examined using in situ or molecular methods in Formalin fixed paraffin embedded (FFPE) tumor sections. For tumor subtyping immunohistochemistry for ER, PgR, HER2, Ki67 and Fluorescence in Situ Hybridization (FISH) will be performed where needed for the assessment of HER2 status; for Epidermal Growth Factor Receptor (EGFR) and CK5 for the classification of basal-like tumors; and, the expression of CD8, CD3 and FOXP3 on (Tumor- infiltrating Lymphocytes (TILs) will also be evaluated. Moreover, will be evaluated the mutational profile, including actionable genomic alterations, and the immune response -related profile of Greek women with breast cancer, via the application of DNA/RNA Next Generation Sequencing (NGS) technologies, relative also to patient outcome. | This is a translational study in patients with operated early breast cancer of Luminal A or Luminal B sub types.The Hellenic Cooperative Oncology Group (HeCOG) has designed an observational biomarker-driven study in patients with Luminal A or Luminal B breast cancer, with the aim to collect valuable biological material from these patients and investigate biomarkers with potential prognostic value. |
Single-blind (patient) randomized study to compare detection of neoplastic lesions between chromoendoscopy and NBI.~Patients with Inflammatory Bowel Disease who are to undergo chromoendoscopy according to usual clinical criteria will be included. The endoscopic procedure is similar to the one usually performed. All patients will undergo colonoscopy according to the usual procedure, with Olympus HQ190 series endoscopes, with the same bowel preparation. During intubation, the faecal remains will be thoroughly washed.~Patients will be randomly assigned to one of the two techniques: Chromoendoscopy with 0.1% methylene blue or New generation NBI with Near focus.~Biopsies will be taken of all those lesions detected, instead of random biopsies. | Study to compare the detection of neoplastic lesions between chromoendoscopy and NBI |
This is a phase I, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics,and immunogenicity of a single dose of UB-221 in healthy volunteers. | The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of UB-221 in healthy volunteers. |
Mobile health technology, including smartphone apps and wearable monitors, has tremendous potential to transform clinical research. Recording of patient outcomes on a smartphone device and camera in the home setting can greatly reduce the number of in person research visits, saving tremendous costs, time, and effort associated with data entry. This also allows for easier recruitment of study subjects, who can be enrolled in geographic locations beyond academic research centers. After FDA approval of a therapy, mobile health technology can help researchers understand how that particular therapy is being used in a real-world setting, including frequency of use, adverse events, and impact of use on disease symptoms and patient quality of life. In this study, the investigators will create a mobile app to help the atopic dermatitis community understand the types of data and quality of data that can be gathered from atopic dermatitis patients longitudinally. A review of existing atopic dermatitis mobile apps on the market reveals they are consumer-oriented and may not be able to fully capture high-quality research data. The investigator proposed app is specifically geared for research, and thus fills an important gap. The research team will develop SkinTracker, a research-oriented eczema app to longitudinally track atopic dermatitis severity, symptoms, quality of life, physical activity, medication usage, and adverse events in a real-world setting. | Design and beta-test a research-oriented mobile health app to assess disease activity, quality of life, treatment patterns, adverse medication effects, and lifestyle factors in patients with atopic dermatitis. |
A prisoner brought to Camp Jail developed symptoms of and later tested positive for COVID-19. This lead to almost 527 contacts. An outbreak was expected. To manage the situation , a COVID-19 Care Facility was established within the prison. The study describes the steps taken by the team to set up this facility. | Presenting outline of the steps taken by our team to set up a Covid Care facility within the Prison setting. The facility was set up at Camp Jail (Lahore District Jail) located on Ferozpur Road, Lahore. |
Depression is common in pregnancy and affects about 70% of women and, for many women, pregnancy can lead to the first episode of major depression. Complications of intrapartum depression include intrauterine growth restriction, preterm labor, low birthweight, gestational diabetes, preeclampsia, decreased prenatal follow-up and suicide. For this reason, the standard of care has been to screen for depression during pregnancy and treat this illness, reducing maternal and fetal morbidity. Unfortunately, many first-line pharmacological approaches, such as serotonin reuptake inhibitors, may cause fetal malformations, persistent pulmonary hypertension and withdrawal syndrome. Thus, a non-pharmacological approach, without risk of fetal complications, would be ideal. The investigators propose a photobiomodulation based approach that uses non-ionizing near-infrared light (IRL) to upregulate mitochondrial function (through modulation of cytochrome c oxidase activity), which in-turn increase neurosteroid production and modulates GABAA receptor activity, thus alleviating depression. The investigators will perform a pilot study using IRL for the treatment of intrapartum depression. While other trials have shown success using IRL for depression in non-pregnant patients, this will confirm that photobiomodulation can modulate mitochondrial function and mitigate depressive symptoms compared to untreated controls in pregnancy by using real-time app-based depression scoring system and neuroimaging. | Depression during pregnancy can cause fetal and maternal problems such as growth restriction, preterm labor, low birthweight, poor compliance and suicide. Since antidepressant medications have the potential to harm the baby, but since treatment of intrapartum depression is essential to maternal and fetal wellbeing, a non-pharmacological approach would be ideal. This project seeks to apply infrared light noninvasively to depressed patients during pregnancy in order to treat depressive symptoms through alteration of mitochondrial function and modulation of neural cell receptors. |
Study Procedures:~On admission or during the outpatient visit:~Obtaining an informed consent .~Full medical history, concurrent medications, demographic data and epidemiological data (history of contact to a COVID-19 case, history of travel), will be obtained.~A thorough physical examination will be performed.~Body weight, height, BMI, vital signs (blood pressure, heart rate and temperature) and blood oxygen saturation) will be recorded.~Laboratory to perform the following tests:~Complete blood count with differential counts, COVID -19 reverse Transcription Polymerase Chain Reaction (RT-PCR) test by nasopharyngeal swab.~During admission:~Whenever unexplained fever and or respiratory symptoms developed or whenever COVID19 suspected to have the following to be performed:~Symptom developed that necessitates to repeat oropharyngeal and nasopharyngeal swab if indicated will be collected~Chest X-ray or CT chest will be recorded.~Laboratory to perform the following tests:~Complete blood count with differential counts,~COVID-19 RT-PCR test by oropharyngeal and nasopharyngeal swab:~C-reactive protein and serum ferritin level. Coagulation test; D. dimer, prothrombin time and INR. Routine bacteriological study, blood culture and other symptoms/signs based cultures will be recorded~On discharge:~Date of discharge~Period of admission~Period of fever~A thorough physical examination will be performed~Record the outcome | This is a prospective follow-up non-intervention study that will be carried out at Hematology/ Oncology Department, Children's hospital, Ain-Shams University, Cairo, Egypt. All followed-up children below 18 years with cancer during the one year study period from May 2020 till Apr 2021 either at the out-patients clinic or inpatient department will be recruited. |
We will evaluate the efficiency and clinical outcomes of pars plana vitrectomy using a 25-gauge, bevel-tip, 10 and 20000 cpm vitrectomy probe among eyes with 8 main surgical indications. Main outcome measures included efficiency measures, postoperative pain and complications. | Report efficiency and clinical outcomes using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe among eyes with various vitreo-retinal diseases |
Epidemiological cross-sectional study in over 3000 inpatients with a clinical diagnosis of major depressive disorder, validation of the clinical diagnosis in 520 patients, and prospective naturalistic 6-month follow-up study of 260 adults with a research interview-confirmed major depressive disorder, with data collection at the following points: at T0 = time of hospitalization (epidemiological study population 1 with data from clinical routine practice), at time T1 of baseline survey in patients with persistent suicidal tendencies, i.e. at least 48 hours after T0 (study population 2 as a subgroup of study population 1, with study information and consent), and in study population 3 (subgroup of study population 2, with study information and consent) at the time of discharge (T2), 3 months after admission to hospital (T3/ by telephone) and 6 months after inpatient admission (T4).~The aim of the study is to characterize the remission or recurrence of suicidal symptoms in the context of a depressive episode. It is expected that the results will help to improve the understanding of the disease process and the further development of effective intervention options. | This 6-month, naturalistic cohort study examines male and female inpatients aged 18 to 75 years i) with any form of unipolar depressive episode (cohort 1); ii) clinical diagnosis of a moderate or severe unipolar depressive episode and suicidal tendencies who agree to participate in a prospective study (cohort 2); and moderate or severe unipolar depressive episodes validated by research interviews and and suicidal tendencies that persist for at least 48 hours after admission who are followed up for 6 months (cohort 3). |
In recent years, suicidal behaviors have shown substantial increase worldwide. This trend is also prominent in Israel and has led to a dramatic increase in mental health treatment demand resulting in long wait times and low treatment acceptance rate. To address the critical need in crisis intervention for children and adolescents at suicidal risk, the investigators developed an ultra-brief acute crisis intervention, based on Interpersonal Psychotherapy (IPT). IPT is an evidence-based intervention for various psychopathologies among different age groups. The current adaptation of IPT-A is comprised of five weekly sessions, followed by monthly follow-up caring email contacts to the patients and their parents, over a period of three months. | To address the critical need in crisis intervention for children and adolescents at suicidal risk the investigators developed an ultra-brief acute crisis intervention, based on Interpersonal Psychotherapy (IPT). The current adaptation of IPT-A is comprised of five weekly sessions, followed by monthly follow-up caring email contacts to the patients and their parents, over a period of three months. |
This is a Phase 3 randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pacritinib in hospitalized patients with severe COVID-19 with or without cancer. Severe COVID-19 is defined as confirmed disease in patients who are hospitalized with hypoxia (blood oxygen saturation [SpO2] ≤93% on room air at sea level), respiratory rate >30, arterial oxygen partial pressure [PaO2]/ fraction of inspired oxygen [FiO2] <300, or lung infiltrates >50% but do not require IMV.~Patients will be randomized 1:1 to receive pacritinib (400 mg once daily [QD] on Day 1, then 200 mg twice daily [BID] from Day 2 to Day 14) + SOC or placebo + SOC.~Assigned treatment will continue for up to Day 14 or until the patient experiences intolerable adverse events (AEs), withdraws consent, or initiates another investigational therapy or until the study is terminated. Assigned therapy may be given for an additional 7 days (for a total of 21 days) with the approval of the Medical Monitor if, in the opinion of the investigator, the patient's clinical signs and symptoms are improving and the potential benefit outweighs the potential risk.In the event of hospital discharge, patients will complete treatment with the assigned therapy as an outpatient. | This is a Phase 3 randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pacritinib in hospitalized patients with severe COVID-19 with or without cancer. |
Thirty (30) intrabony defects of 18 patients (9 males, 9 females) were randomly divided in two treatment groups: test (n = 15) and control (n = 15). The intrabony defects were filled with A-PRF+ (n=15) in the test group, respectively with EMD in the control group, and fixed with sutures to ensure wound closure and stability. | The aim of this randomized clinical trial was to clinically evaluate and compare the healing of intrabony defects after treatment with advanced platelet-rich fibrin (A-PRF+) to enamel matrix derivatives (EMD) in periodontitis patients. |
The hypothalamic-pituitary-adrenal axis together with the noradrenergic/vasopressinergic system are the main systems of host response to stress. In 2008 the scientific community described a syndrome called critical illness related corticosteroids insufficiency (CIRCI) in which body homeostasis is lost owing to insufficient cortisol production or bioactivity in tissues. Recent updates of international guidelines have spelled out the pathophysiology, diagnosis and management of CIRCI. The prevalence of CIRCI varies according to case mix and severity of illness. The combination of hydrocortisone and fludrocortisone improved outcomes in septic shock, a condition often complicated with CIRCI. However, there is insufficient evidence on the efficacy of corticosteroids in patients with CIRCI and without septic shock. The hypothesis of the study is that the hydrocortisone-fludrocortisone association will improve ventilation and vasopressor free survival in ICU patients with Critical illness related Corticosteroid Insufficiency.~Patients with a SOFA score ≥ 6 will be screened for CIRCI. Patients suffering from CIRCI will be randomized to receive hydrocortisone and fludrocortisone or their placebo. Patients without CIRCI will receive standard of care and will be followed up during 90 days (cohort-observational study). | The study aims at assessing the efficacy and the safety of hydrocortisone combined with fludrocortisone compared to placebo in ICU adults with critical illness related corticosteroid insufficiency. |
Heart failure (HF) affects an estimated 6.2 million Americans over the age of 20 and has a high cost burden worldwide. Many health plans, including CMS, have focused on interventions that monitor patients for early detection of HF decompensation. Earlier interventions can help care teams prevent avoidable hospitalizations.~Health systems have developed outpatient at-home monitoring solutions to predict and prevent HF readmissions with mixed results. Despite equivocal results, telephone monitoring with vital sign and weight scale monitors are the de facto standard for outpatient HF remote monitoring. Invasive hemodynamic sensors have enabled HF care teams to better predict and prevent HF decompensation events and thus rehospitalizations based on fluid status assessment. Unfortunately, these solutions are invasive, costly, typically indicated for late stage heart failure, and have limited availability due to equivocal cost-effectiveness projections.~More recently, researchers have investigated non-invasive sensors that may correlate with fluid status in HF patients. A study in Taiwan demonstrated that outpatient therapy guided by an inpatient device with ECG and sound sensors reduced post-discharge HF utilization by 31% when compared to a control group using symptoms to guide therapy. The LINK-HF study demonstrated that a wearable patch with ECG and sound sensors could predict HF readmissions with sensitivity of 76% to 88%, specificity of 85%, and a median lead time of 6.5 days. Despite promising results, these devices have significant disadvantages. The inpatient device used in the Taiwanese study was not able to be adapted into a portable form factor for outpatient use, which would make it a poor candidate for at-home remote monitoring. Conventional wearable devices also face usability challenges; they can be rigid, uncomfortable, and highly visible, which can interfere with patient functional living and decrease monitoring compliance.~There is an unmet clinical need for a non-invasive, affordable device that can estimate a HF patient's hemodynamic fluid status and potentially guide a remote care team to decrease risk for readmission from the comfort of the patient's home.~Eko has developed the DUO, an FDA-approved portable, hand-held, connected medical device with ECG and sound sensors. Data from this device can be wirelessly streamed to a mobile phone or tablet, which is transmitted to a HIPAA-compliant internet cloud infrastructure. This data can then be analyzed by algorithms to detect disease states. Because patients in active HF decompensation are known to have an audible third heart sound, characteristic ECG findings, and adverse time interval durations between sound and ECG signals, the Eko DUO device may be uniquely positioned to detect these types of changing signals, and predict if patients are at-risk for a HF event, well in advance of the event itself.~Eko has also developed the Eko CORE, an FDA-approved electronic stethoscope with sound sensors only. The CORE has otherwise identical functionality to the DUO in regard to data streaming and transmission. The Eko CORE may be able to detect an audible third heart sound as well, and therefore has the potential to aid clinicians in predicting future HF events. In addition, because heart failure and fluid overload are reflected in the lungs as crackles (and occasionally effusions), the lung examination is and has always been a cornerstone of the overall physical examination of the patient in decompensated HF. By using the CORE to capture lung sounds in patients with decompensated HF, and comparing not only the presence or absence of crackles, but also how they change in correlation with the patient's response to treatment, we will be able to explore the utility of the Eko CORE in helping treat these patients.~This will be a proof-of-concept study to evaluate the feasibility of the Eko DUO to measure signals relevant to HF decompensation, as well as the feasibility to develop an algorithm to model hemodynamic filling pressures in HF patients under active decompensation in a cardiac intensive care unit (CICU) or coronary care unit (CCU). To also assess the performance of the Eko CORE to detect signals of an HF event, this study will also take heart and lung sound measurements with the Eko CORE. | This proof-of-concept study will evaluate the feasibility of the Eko DUO to measure signals relevant to heart failure (HF) decompensation, as well as the feasibility to develop an algorithm to model hemodynamic filling pressures in HF patients under active decompensation in a cardiac intensive care unit (CICU) or coronary care unit (CCU). To also assess the performance of the Eko CORE to detect signals of an HF event, this study will also take heart and lung sound measurements with the Eko CORE. |
Cardiovascular disease (CVD) is the primary cause of death in all women, and as women transition through midlife, the prevalence of CVD exceeds that of men.1 Midlife Black women, defined as ages 40-64,unduly shoulder the burden of CVD (49%), hypertension (40%), and heart failure (50% greater risk). Midlife Black women also report higher levels of chronic stress and greater numbers of stressful life events in comparison to midlife White women, putting them at greater risk for CVD. In addition to the physical impact, coping with chronic stress takes time and energy away from self-care, functioning as a barrier to the adoption of healthy lifestyle behaviors. Existent interventions do not fully address the unique factors contributing to the experience of stress, lifestyle behaviors, and CVD risk in midlife Black women.~The purpose of this research proposal is to develop a midlife Black women's Stress-reduction WELLness intervention, B-SWELL, to promote healthy lifestyle behaviors based on the stressors and themes identified in preliminary research. Community-based participatory research (CBPR) methods will be used to engage the community and include midlife Black women in the development of the B-SWELL. We propose that the skills and knowledge gained through participation in the B-SWELL program will increase receptivity to the healthy lifestyle behaviors outlined in the American Heart Association's Life Simple 7 Success Plan (LS7). The LS7 targets seven risk factors known to increase cardiovascular related health risk: cholesterol, fasting glucose, blood pressure, body mass index, physical activity, diet, and smoking.~Our hypothesis proposes that low stress scores and greater self efficacy will be associated with the adoption of AHA's healthy lifestyle behaviors. Low stress and self efficacy will be facilitated through peer support and culturally relevant content, materials, and themes. B-SWELL participants will show improved self-efficacy in managing life stress and adopting the LS7 behaviors, compared to a control group receiving traditional wellness education (WE group).~Aim 1: Develop the B-SWELL intervention for midlife Black women through the innovative leveraging of CBPR methodology and LS7 modifiable healthy lifestyle behaviors.~To develop components of the B-SWELL intervention prototype for midlife Black women.~Obtain ratings of the new components of the B-SWELL from our community advisory board for degree of accuracy, relevance, and feasibility to inform further refinements.~Aim 2: Determine the feasibility of the B-SWELL intervention with a trial of 50 midlife Black women randomized to the B-SWELL intervention (25) or to a wellness education (WE) control group (25):~Obtain recruitment, retention, treatment fidelity ratings, and satisfaction ratings for the intervention procedures for both groups;~Compare mediator measures (stress, self-efficacy) for participants in the B-SWELL intervention group with those in the WE group at 8 and 12 weeks.~Compare outcome measures (LS7 summary scores, unhealthy days, general health, depressive symptoms) for participants in the B-SWELL intervention group with those in the WE attention control group at 8 and 12 weeks. | This research study examines the unique cultural and gender-based factors that influence how midlife Black women experience stress and incorporate healthy lifestyle behaviors into daily life. The B-SWELL intervention uses stress reduction and goal setting to increase self efficacy in adopting healthy lifestyle behaviors. The B-SWELL intervention will be compared to an inattention control wellness group in a randomized control trial. The long-term outcome is to decrease cardiovascular disease risk in this high-risk population, midlife Black women. |
The emergency service of the city of Essen (NRW, Germany), which is organised by the Essen fire-department, will perform a prehospital triage stroke-score using a smartphone-app (Join-Triage, Allm) when referring patients with suspected stroke to the university clinic Essen. The triage stroke-score FAST-ED (Field Assessment Stroke Triage for Emergency Destination), as well as the expected time of arrival will be transmitted by an additional smartphone-app in advance of the arrival (Join, Allm). Patients will receive emergency workup to identify stroke etiology and presence of large vessel occlusion. Final diagnosis, presence of large vessel occlusion and type of revascularisation treatment will be registered. Sensitivity, specificity and further criteria for test quality will be calculated for the stroke triage by emergency service in field using the FAST-ED. | The aim of this non-interventional study is to evaluate a German version of the triage stroke-score FAST-ED performed by ambulance service personnel in a pre-hospital setting using a smartphone app (Join-Triage, Allm). |
IBD patients in need of intensified adalimumab treatment will be randomized to receive 40mg sc weekly or 80mg sc every two weeks, and after 6 weeks of treatment each of the groups will be allocated to the other dosing regime. Adalimumab blood levels and other features such as specific drug antibodies and disease activity parameters will be compared between both groups. | RCT to evaluate possible pharmacokinetic differences between the two current regimes of intensified adalimumab administration. |
Type 1 diabetes (T1D) treatment adherence is complex and involves glucose monitoring, counting carbohydrates, and intensive insulin delivery via injections or insulin pump in response to food intake, exercise, and illness to achieve near-normal blood glucose levels. Evidence demonstrates that adhering to T1D treatment is challenging, especially during adolescence. Non-adherence leads to suboptimal glycemic levels that severely compromise health and quality of life. Suboptimal adherence to T1D treatment regimen is common in >50% of adolescents and directly related to suboptimal glycemic control, increased risk of hospitalizations for diabetic ketoacidosis, and decreased health-related quality of life (HRQOL). The maximum benefits of current diabetes technology are limited by the knowledge, skills, adherence barriers, and non-adherence behaviors.10-14 Ultimately, adolescents have to overcome these barriers in order to benefit from technological advances. Thus, there is a clear need for behaviorally focused interventions to identify and reduce adherence barriers. The overall objective of this study is to identify adolescents with elevated adherence barriers and provide novel tailored mHealth intervention (Diabetes Journey) targeting these barriers. This study is two phases and includes a small pilot of up to 12 adolescents with type 1 diabetes (Phase 1) and a randomized controlled clinical trial (Phase 2). The randomized controlled clinical trial will examine feasibility, acceptability and preliminary efficacy of Diabetes Journey versus enhanced standard of care (control group) in approximately 256 adolescents with type 1 diabetes. Primary and secondary outcomes include adherence barriers, adherence, health-related quality of life and A1C. Satisfaction and acceptability will also be examined. Mediators and moderators will include executive functioning, diabetes distress, family conflict, depressive symptoms, fear of hypoglycemia and sleep. | The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a web-based intervention addressing adherence barriers in adolescents with T1D. |
Clinical data of adult patients in integrated ICUs of 6 hospitals of Fujian Province China from January 2015 to July 2019 were collected, who had been examined for sputum, urine, blood, pleural effusion, ascites, cerebrospinal fluid and wound secretions and other body fluid samples. And the results showed that Klebsiella pneumoniae was positive, including demographic data, underlying disease status, drug sensitivity test, infection-related indicators, life support, prognostic indicators. | The detection of Klebsiella pneumoniae virulence gene and antibiotics resistance gene takes a long time and high cost with equipment requirements. Distinguishing the Klebsiella pneumoniae by gene were late for clinical treatment. Therefore, the investigators aim to study the clinical characteristics of critically ill patients with Klebsiella pneumoniae infection which expressed different drug sensitivity test results. |
This is an open label, multi-center, Phase 1b/2 clinical trial to evaluate the safety and efficacy of autologous claudin18.2 chimeric antigen receptor T-cell therapy in patients with advanced gastric, pancreatic or other specified digestive system cancers.~Following consent, patients must have tumor tissue evaluated by CLDN18.2 IHC assay. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (CT041). Following manufacture of the drug product, subjects will receive preconditioning prior to CT041 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up. | A Phase 1b/2, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells (CAR-T) targeting claudin18.2 in patients with advanced gastric, pancreatic or other specified digestive system cancers |
Each cohort will include 30 patients. Complete blood count in all patients will be done daily in all patients. Bone marrow aspiration cytology will be done in some selected patients especially those with lymphopenia less than 1000 per cubic mm.~Correlation of the degree of lymphopenia with the status of the patients will be done. Also correlation will be done about the relation of recovery of lymphopenia and status of the patients. | Study of the cause of lymphopenia in Covid19 viral infection will be done in 3 cohorts. First cohort will be patients asymptomatic or with mild symptoms. Second cohort will be patients with severe illness and admitted to ICU. Third cohort will be patients critically ill and on artificial ventilation. |
The aim of this study is to investigate and compare how 18-weeks of computer-based brain training and physical exercise together can improve physical performance, cognitive function and mood in older adults in a cross-over design with participants randomized to receive the intervention first and then be assessed before and after an 18 week period without intervention, or the reverse sequence. 80 adults between the ages of 65 and 105 years old will be invited to participate. After providing informed consent, in the case of subjects who are living on units for individuals with memory or other cognitive compromise, after assent from the individual and approval from facility staff, subjects will be randomly assigned to either receive the intervention for 18 weeks and then be followed for an additional 18 weeks, or to be followed for 18 weeks without intervention and then do the intervention for 18 weeks. The intervention will consist of 18 weeks of 60-minute PE sessions 3-4 times/week and 25-minute CBB training sessions 3-4 times a week.~There will be 3 assessments of participants: before and after the first 18-week period and then again after the second 18-week period. Assessments will be done in 2 sessions over a total of 90 minutes and will include demographic, health, physical activity and social activity questionnaires as well as the self-report measures of cognitive function, emotional state and weekly activities; quantitative assessments of physical balance, strength, flexibility blood pressure and heart rate; and tests of cognitive function. Subject medications will be recorded at each assessment. The wait-list control group will receive the same assessments at the same time points. | The aim of this study is to investigate and compare how 18-weeks of computer-based brain training and physical exercise together can improve physical performance, cognitive function and mood in older adults in a cross-over design with participants randomized to receive the intervention first and then be assessed before and after an 18 week period without intervention, or the reverse sequence. |
Patients can be included in the study if they have one or more malignant liver tumors unsuitable for resection and thermal ablation (due to proximity of major vessels or bile duct) or other established liver directed therapies.~Prior to inclusion all potential participant will be evaluated by the local multidisciplinary team, to insure fulfillment of the above-mentioned criteria. In general, the included patient will have tumors with <1 cm of margin to major hepatic vessels or bile ducts, thereby not allowing for conventional treatments because of risk of i.e. hemorrhage, biliary tract damage, liver failure or ineffective ablation due to heat sink.~IRE will be done under general anesthesia as an in-patient procedure. Patients will be observed for at least 24 hours after IRE.~Patients will attend CT scans 1, 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post-IRE according to national guidelines (for follow-up after radiofrequency ablation (RFA)). Patients will attend the out-patient clinic after 1, 3, 6, 9, 12, 18 and 24 months. During the follow-up period, patients will be asked to fill out electronic forms monitoring pain, quality of life and nutritional status. After 24 months the patients will only be followed with CT scans in accordance with the mentioned schedule. Data collection for scientific purposes will stop when the last included patient has been followed for at least 24 months or when the study period concludes.~In case of multiple liver tumors, where a conventional treatment approach is not possible due to a single lesion being too close to major vessels or bile ducts, IRE may be used in conjunction to conventional therapy. | The aim of this study is to evaluate the safety and feasibility of curative intended irreversible electroporation (IRE) in the treatment of liver tumors neighboring major vessels or bile ducts. |
This Phase Ib/II, open-label, multi-center, single arm study is designed to evaluate the safety and efficacy of AUTO1 in adult patients with B-cell ALL by determining the overall response rate (ORR).~Adult patients with relapsed or refractory ALL will be enrolled in both phases of the study. Consented patients will go through the following five sequential stages: screening, leukapheresis, pre-conditioning, treatment, and follow-up. All patients will receive a total target dose of 410E+6 of CAR T cells as a split dose on Day 1 and on Day 10 (±2 days). | This is a Phase Ib/II study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (ALL). |
Patients with diabetic foot and mild to moderate PAD (WIfI - Ischemia 1 or 2) with baseline TcPO2 values 30-50 mmHg will be included into the study. TcPO2 will be measured on the feet in different angiosomes. During this measurement a stimulation test consisting of a modified Ratschow test involving 2 minutes of exercise will be conducted. Specific TcPO2 parameters will be assessed during the whole procedure (resting TcPO2 before stimulation test, minimal TcPO2, delta TcPO2 (minimum TcPo2 minus resting TcPO2) percentage decrease of TcPO2 during the stimulation test and TcPO2 recovery time (time to the adjustment of TcPO2 to the resting values).~All TcPO2 parameters detected during TcPO2 stimulation test will be correlated with parameters of macrocirculation (systolic blood pressures (SBP) on tibial arteries and their Ankle-Brachial Indexes (ABI), toe pressures (TP) and toe-brachial indexesTBI) and DUS findings (monophasic/triphasic flow in relevant artery supplying measured angiosome) | All diagnostic procedures of peripheral arterial disease (PAD) in the diabetic foot (DF) are limited due to diabetes mellitus and its late complications. The aim of our study is to refine the diagnosis of peripheral arterial disease (PAD) by a new transcutaneous oximetry (TcPO2) stimulation test (a modified Ratschow test) in patients with diabetic foot. |
This study involves in vivo examination of FAAH availability, implicated both in the pathophysiology and therapeutics of disorders including PTSD, substance use disorders (e.g., alcohol use disorder, cannabis/cannabinoid use disorder, nicotine use disorder), psychotic disorders including schizophrenia, and mood disorders. The endocannabinoid system is a neuromodulatory system that has been implicated across a wide range of psychiatric disorders and may be implicated in the regulation of mood, appetitive behaviors, sleep, and cognition. Thus, alterations in the ECS have wide ranging implications. Finally, the ECS is being explored as a novel therapeutic target for several psychiatric disorders. Additionally, the test/retest reliability of the radiotracer, [11C]MK-3168, will be studied in up to 10 healthy control individuals. | The aim of the present study is to examine Fatty Acid Amide Hydrolase (FAAH) availability in humans, including healthy individuals and across a spectrum of psychiatric disorders in which alterations in the endocannabinoid system are observed. |
The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism. This is a prospective, randomized, participant masked, crossover, bilateral dispensing study. | The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism. |
This is a retrospective cross-sectional observational study to characterize the clinical and epidemiological profile of patients with spinal muscular atrophy (SMA) 5q types II and III, in follow-up at the Brazilian Unified Public Health System (SUS). This study aims to provide baseline data, which in the future may be used by the Brazilian Ministry of Health (MS) to assess the effectiveness of nusinersen. The clinical and epidemiological data will be collected from patients´ medical records, such as the score for the Hammersmith Functional Motor Scale - Expanded (HFMSE) and the Revised Upper Limb Module (RULM) at baseline, the WHO motor milestones at baseline, disease duration, age at the time of disease diagnosis, age at the time of disease screening, SMN2 (gene copy number), history of hospitalizations, history and characterization of previous surgical procedures, treatment dosage used, patient caregiver´s profile (ie, a family member or companion, who is responsible for taking care of the patient for most of the time). Other variables of interest that will also be collected are patient´s age and gender, geographic distribution, attending physician expertise and care structure where the patients were treated. The data acquisition will be performed using a paper and eletronic CRF (Case report Form). Written informed consent will be obtained from patients who meet the study elegibility criteria. The study will be performed in Brazilian public hospitals (centers) that are able to provide the treatment with nusinersen under the SUS scope. The total sample of patients and number of participating centers will be defined by the MS - SCTIE (Secretariat of Science, Technology and Strategic Supplies)/ DECIT (Department of Science and Technology). However, the initial estimation is a sample of 100 patients to be included in 10-15 centers. | This study aims to characterize the clinical-epidemiological profile and baseline characteristics of patients with spinal muscular atrophy (SMA) 5q types II and III in follow-up at the Brazilian Unified Public Health System (SUS). The study data will be based on patients´ medical records from several Brazilian public hospitals, which will be defined by the Brazilian Ministry of Health (MS). |
NGS will be performed on voided urine collected as routine care approximately 30 days prior to surgery. Results will be presented to Infectious Disease pharmacist within 48-72 hours to help select the most appropriate antibiotics, and independently as part of routine care, surgeons will choose the antibiotic that they would use in each case, while the Infectious Disease pharmacists would select their optimum choice. Approximately 220 subjects will be randomly assigned in a 1:1 ratio to receive either NGS antibiotic recommendation or standard of care (SOC) prophylaxis prescribed treatment. Subjects assigned to standard of care will have urine cultures sent for analysis, and the physician will choose antibiotics based on results as per usual practice. Subjects assigned to the NGS group, in addition to routine urine culture results, will have NGS urine culture results sent to an investigational drrug (ID) pharmacist, and recommendations will be shared with the physician to determine the antibiotic selection. The physician will ultimately decide the appropriate antibiotics to prescribe. Approximately 7-14 days after surgery, the research staff will conduct a telephone call to ask about any post-operative infections, complications, and any additional antibiotics that were prescribed. | This is a randomized controlled clinical study evaluating the use of next-generation sequencing (NGS) to improve antibiotic prescribing before ureteroscopy or percutaneous nephrolithotomy. |
To evaluate use of the Prolaris score in treatment management decisions in an ethnically and racially diverse population of men who have been newly diagnosed with prostate cancer and who are potential candidates for active surveillance. This registry will evaluate oncologic and co-morbidity outcomes in patients who receive Prolaris testing. Additionally, the registry will measure the prevalence and distribution of pathogenic mutations in hereditary cancer risk-associated genes among men with prostate cancer who meet National Cancer Center Network (NCCN) criteria for hereditary cancer genetic testing.~The primary objective of this registry is to evaluate initial selection of active surveillance (Active Surveillance selection) versus definitive therapy (DT) among men with newly diagnosed prostate cancer who make treatment decisions with Prolaris testing, and among patient subsets defined by race/ethnicity.~The secondary objectives of the registry are to evaluate progression of from Active Surveillance to definitive therapy over time and prostate cancer-associated morbidities that affect quality of life among men with newly diagnosed prostate cancer and who undergo Prolaris testing, and among patient subsets defined by racial/ethnic background and ancestry. | This registry will evaluate treatment selection for patients with newly diagnosed, localized prostate cancer following Prolaris testing. It will measure the proportion of men who initially select treatment with active surveillance, the time frame between active surveillance selection and any change in treatment, and clinical outcomes. |
Aim 1: To develop survey items to assess tanning attitudes and behaviors Nine survey items used by the PI in previous deliberate tanning research were adapted with the expert consensus of members of Northwestern's Institute for Sexual and Gender Minority Health and Wellbeing. Discussions with the PI, research personnel and members of the institute developed the hypothesis that in addition to the previously reported appearance motivations young SMM may be engaging in tanning (indoors or outdoors) as a social activity. A tenth survey item was developed to assess deliberate tanning as a social activity.~Aim 2: Analyze the tanning attitudes and behavior data acquired in an online survey of young adult sexual minority males, who regularly participate in the RADAR study.~RADAR is a longitudinal study with cohorts from the greater Chicago region recruited between 2008 and 2015. The 10 survey items about tanning attitudes and behaviors were added to the online survey that examines SMMs' behavior in the prior 6 months. This is a secondary analysis of registry data acquired by the RADAR study. | The purpose of this study is to: a) identify enablers and barriers to deliberate ultraviolet light exposure by young sexual minority men (SMM), and b) quantify the extent of their deliberate ultraviolet light exposure. |
StOIC-2 is an observational study of routine clinical practice, and will involve four assessments over a period of 28 days (3 face to face; 1 telephone). Participants for StOIC 2 study will be identified from StOIC 1 study (CancerTrials.gov registry reference number - NCT04350112). Visit 1 for StOIC 2 study will correspond to the assessment for StOIC 1 study.~Patients will be managed according to a treatment algorithm (see below), which is based on a review of the evidence (and which is the basis of the Multinational Association for Supportive Care in Cancer (MASCC) guideline on the treatment of constipation in patients with advanced cancer). The decision to change treatment is based on efficacy / lack of efficacy (as determined by the Bowel Function Index (see below), or the development of adverse effects.~Step 1: Conventional Laxatives~Choice of laxatives at the discretion of the clinical team~Combination of softener and stimulant laxative~Laxatives to be prescribed on a regular basis~Step 2: Peripherally acting mu opioid receptor antagonist (PAMORA)~Choice of PAMORA at the discretion of clinical team~Either oral naloxegol or subcutaneous methylnaltrexone~PAMORA to be prescribed on a regular basis~Step 3: PAMORA + Conventional Laxatives~Choice of combination at the discretion of the PI/clinical team~Combination to be prescribed on a regular basis~Step 4: Other options~- Choice of other option at discretion of clinical team:~Bowel cleansing preparations (e.g. Picolax)~Suppositories~Enemas~Manual evacuation~Other drugs (e.g. lubiprostone, prucalopride)~The following data will be collected: a) demographic data - age, gender, ethnicity; b) cancer diagnosis; c) opioid medications - drug, formulation, dose; d) laxative medications - drug, formulation, dose (every visit); e) Eastern Cooperative Oncology Group performance status.~The participants will also be asked to complete;~Bowel Function Index (BFI) - every visit. The BFI is a validated, 3 item, patient reported tool for assessing the treatment of OIC. A BFI score of > 30 indicates suboptimally treated OIC.~Patient Assessment of Constipation - Quality of Life Questionnaire (PAC-QOL) - first and last visit. The PAC-QOL is a validated, 28 item, patient reported tool for assessing the impact of constipation over time.~Memorial Symptom Assessment Scale - Short Form (MSAS-SF) - first and last visit. The MSAS-SF is a validated, 32 item, patient reported tool for assessing physical and psychological symptoms in cancer patients.~Data will also be collected on adverse effects from medication / interventions, and reasons for withdrawal from the study. | The aim of the project is to investigate OIC in a real world / diverse group of patients with cancer.~The objectives of the project are to determine: a) efficacy of a treatment algorithm to manage OIC; b) efficacy of conventional laxatives to manage OIC; c) efficacy of PAMORAs / other interventions to manage OIC. |
Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided.Spinal anesthesia has become the favorable technique for both elective and emergency cesarean section due to a quick and predictable onset of action, however, it can be frequently complicated by hypotension, with incidence exceeding 80% occasionally.~The aim of the current randomized controlled double-blinded trial was to compare the effect of a fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine infusion versus placebo in parturients subjected to elective cesarean section under combined spinal-epidural anesthesia. All parturients will also receive colloid co-hydration. | This will be a double-blind randomized study, aiming at investigating a fixed rate phenylephrine infusion versus a fixed rate norepinephrine infusion versus placebo in combination with co-hydration with colloids for the prevention of maternal hypotension in elective cesarean section |
Geriatric patients suffer from hip fractures very often. Delirium is a perioperative neuropsychiatric complication that is characterized by sudden change of mental status, inattention, disorientation and memory impairment with fluctuations of symptoms during the day. Delirium causes increased morbidity and mortality, decreased postoperative functional activity and may predispose to dementia.~Perioperative pain may be an important predisposing factor to delirium. Intravenous opioids have been widely used to relieve patients with hip fracture from pain, but they have a lot of complications and have been correlated with delirium as well. Fascia Iliaca compartment block is a peripheral compartment nerve block that is used in hip surgeries. Use of this compartment nerve block to protect geriatric patients from delirium has not been studied.~The objective of this trial will be to establish whether the ultrasound-guided suprainguinal fascia iliaca compartment block is capable of protecting geriatric patients with hip fracture from delirium as compared to placebo | The objective of this trial will be to establish whether the ultrasound-guided suprainguinal fascia iliaca compartment block is capable of protecting geriatric patients with hip fracture from delirium as compared to placebo |
Pathophysiological changes following brain death may complicate the care of brain death donors. These complications negatively affects function of donated organs. Understanding these complications and its incidence is crucial for their appropriate management. The aim of this retrospective observational study is to evaluate the incidence of complications in adult brain death organ donors. Date will be collected from medical records of eligible patients admitted to intensive care unit for suspected brain death in whom brain death was confirmed and who become organ donors. | The purpose of the study is to describe the incidence of complications in brain death adult organ donors. |
Arteriovenous fistulas (AVFs) are the preferred type of vascular access for dialysis, but many of them fail to mature. Despite concerted efforts to improve surgical AVF outcomes during the past 20 years, many new AVFs fail to mature, even after interventions to salvage them (assisted maturation). Postoperative ultrasounds of immature AVFs frequently demonstrate decreased flow with narrowing at the anastomosis . Surgically created AVFs typically have a 90o angle at the anastomosis, yet computational fluid dynamics suggest that an anastomotic angle <30o improves the flow hemodynamics. Therefore, there has been great interest in novel AVF technologies to limit vascular injury and improve flow dynamics and maturation rates. The new technology evaluated herein (endovascular AVF (endo-AVF) has the potential to achieve these goals and reduce the cost of vascular access care.~Endo-AVF, a novel per-cutaneous technique of AVF creation, was approved by the FDA in 2018, and has been used in U.S. hemodialysis patients . In contrast to the surgical technique (the current standard), this non-surgical approach (1) minimizes vascular injury at the time of AVF creation and (2) creates a channel between the artery and vein with an angle approaching 0o. These two features provide a scientific rationale for superior maturation compared with that of surgical AVF Investigators will perform a single-center, prospective pilot randomized clinical trial. Investigators will recruit 80 patients who have advanced chronic kidney disease or on hemodialysis with a catheter ,who there pre- operative Ultrasound showed they are eligible to surgical or endo-vascular AVF. Participants will be randomized to one of two groups: an surgical AVF intervention group that will undergo a routine surgical fistula creation, or an endo-vascular AVF intervention group will undergo per-cutaneous fistula creation . Participants will be followed for 2 years. | Arteriovenous fistulas (AVFs) are the preferred type of vascular access for dialysis, but many of them fail to mature. There are two techniques of creating AVFs either the traditional way with surgery( Surgical AVFs) or novel per-cutaneous technique Endo- AVFs.~Investigators will pilot an randomized clinical trial of endo-AVFs and surgical AVFs at University of Alabama at Birmingham to determine the feasibility of patient recruitment, randomization, and retention. This pilot study will set the stage for a full-scale randomized clinical trial in future. |
The number of undetected HCV-infected persons has been extrapolated to 75,000 according to the results of a 2014 study. Screening efforts have been set up in groups of people said to be at high viral risk: drug users, prisoners, precarious persons or migrants from highly endemic countries. Nevertheless, the concept of universal screening has not yet been adopted by the guardians and the Ministry.~It is in this context that hepatitis free hospital projects have been carried out in several French cities such as Nice, Nancy and Marseille.~The aim of the HOSPI-VHC study is to evaluate the feasibility and efficiency of systematic HCV screening in all medical and surgical departments of 4 National Association of Hepato-Gastroenterologists of General Hospitals (ANGH) hospitals. This pilot project is part of a public health screening program. It will evaluate the interest and usefulness of implementing universal screening in hospitalized patients without taking into account the existence of viral risk factors. This study will also make it possible to evaluate the implementation of a dedicated care pathway: number of patients screened, number of patients referred for consultation and number of patients accepting the consultation. | The Ministry of Health has set the target of eradicating hepatitis C (HCV) in France by 2025.~The goal is to validate the feasibility and value of conducting routine HCV screening in hospitalized patients. |
Screening~Explain purpose and nature of the study and obtain signature on the informed consent document.~Screen the subject against protocol inclusion and exclusion criteria, including all pertinent tests, including pregnancy test if needed.~Baseline (may be done as same day as screening procedures)~Obtain general medical history and demographic information and social history~Complete a physical examination, body weight, height, and vital signs, including measurement of resting heart rate, respiratory rate, and blood pressure while seated.~Select target study ulcer~Obtain complete history pertinent to DFU disease including duration of the target ulcer, previous and current treatment.~Perform debridement and obtain tissue collection (3 tissue and 1 bone if applicable).~Perform standardized photography and measurement of the study wound (eKare or available camera with ruler). Assess the post-debridement ulcer area (cm2), perimeter (cm), and greatest depth (cm) using the inSight device (eKare, Fairfax, VA).~Perform hyperspectral imaging of dorsal and plantar aspects of the foot.~Perform neuropathy assessment (monofilament, VPT)~Skin perfusion pressure (Sensilase)~Collect all relevant concomitant medication (antibiotics, steroids, and diabetes medications)~Complete questionnaires~Place Restrata and dress wound or apply NPWT therapy.~Submit subject stipend~Therapy/Treatment Phase~Study Visit 1-11:~Assess target ulcer (if wound has closed, document as such, skip to END OF STUDY VISIT (EOS).~Document time on/off NPWT if applicable.~If Restrata is removed, assess the ulcer area (cm2), perimeter (cm), and greatest depth (cm) using the inSight device - if the wound is deemed healed by the physician, skip to EOS visit.~Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is active or healed.~Debride wound if indicated. Re-measure wound if surgical debridement is performed prior to dressing the wound~Collect all relevant concomitant medication.~If wound is not healed, redress the wound with Restrata dressing (if removed for debridement) or NPWT.~Disburse subject stipend~Note: at week 3, if wound is not ready for surgical closure, remove Restrata and replace with new piece of Restrata (per randomization schedule)~Assess for AE/SAEs and/or follow up on previous AE/SAEs.~Study Visit Closed~When a study wound has closed, we will perform the EOS evaluation.~If a wound has closed, the patient will enter the follow-up phase of the study.~Study Visit 12/EOS:~If the study wound closes prior to the 12-week study mark, subjects will perform EOS visit at the time of wound closure.~Assess target ulcer.~If wound has not closed, assess the ulcer area (cm2), perimeter (cm), and greatest depth (cm) using the inSight device.~Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is active or healed.~If wound has not closed, redress the wound per physician-directed standard of care.~Perform EOS visit documentation~Complete questionnaires~Follow up on AE/SAEs that have not yet been resolved.~Study Visit Follow-up~1. If the wound heals during the treatment phase or if the wound is not healed after 12 weeks, data from their electronic medical record will be evaluated to identify healing, time to heal, adverse events related to the wound. | The purpose of this study is to compare the efficacy of Restrata compared to Negative Pressure Wound Therapy (NPWT) to heal complex diabetic foot wounds. |
In a randomized controlled trials to compare with the same-category medical device (Sequent® Please), 82 patients with in-stent restenosis (ISR) were recruited from a total of 7 institutions, and the enrolled subjects were 1: 1 through randomization. The ratio was assigned to the test group and the control group, and each of the test or control devices was assigned to receive the procedure.~Drug release stents for PCI usually follow 9 months or 12 months, but the medical device for this clinical trial has a drug coated balloon catheter and the mechanism of action is different from the stent and the duration of follow up was set to 6 months. | The purpose of this study is to evaluate the safety and efficacy of Paclitaxel-coated balloon (Genoss® DCB) by demonstrating non-inferiority to in-segment late lumen loss at 6 months after the procedure in patients with in-stent restenosis (ISR) compared with a product of the same category (Sequent® Please) |
Impulsivity and compulsivity are two psychological factors which contribute to addictive behaviors. Impulsivity is characterized by lack of foresight and planning, and excessive risk taking. Impulsivity is a characteristic of poor executive functioning, and reflects deficits in goal-oriented behavior and self-regulation. Compulsivity is characterized by inability to break old habits. Both of these traits may play a role in refractory obesity. Transcranial direct current stimulation (tDCS) coupled with cognitive training may strengthen key circuitry involved in impulse control within the prefrontal cortex. tDCS coupled with cognitive training has the potential to reduce impulsivity and compulsivity in individuals with obesity, with the potential for therapeutic application as a non-pharmacologic approach to management of food-related eating behaviors which may impact weight.~For this double-blind, randomized, placebo (sham) controlled study pilot study the investigators aim to recruit and complete studies in approximately 20 individuals, randomly assigned to receive either active or sham tDCS, both coupled with computerized cognitive training tasks, for five days. Additionally, participants will attend follow up visits at approximately 2, and 4 months after the course of intervention visits is completed. Testing pre- and post-intervention will include the Binge Eating Scale (BES), PHQ-9 Depression Screen, and 4 domains of the NIH Examiner Battery. Weight will be tracked throughout the study. MN-BEST blast exposure screening tool is also conducted at baseline. | Even when they know it can improve health, many individuals with loss of control eating struggle when they are trying to make and sustain new health habits for weight loss and maintenance of weight loss. Impulsivity, characterized by lack of foresight and planning and excessive risk taking, and compulsivity, characterized by inability to break old habitual behaviors, may play a role in refractory obesity. The primary objective of this pilot study is to investigate the effect of a novel neuroplasticity based intervention, cognitive training coupled with transcranial direct current stimulation (tDCS), on measures of impulsivity and compulsivity in individuals with obesity. |
Brain motion is highly sensitive to heart and brain biomechanics, but the impact of brain injury on brain tissue motion has yet to be explored. Preliminary brain tissue motion measurements from a small number of patients suggest that brain biomechanics may be disturbed in the presence of injury. This study combines Transcranial Tissue Doppler ultrasound with brain MRI to establish whether analysis of brain tissue motion provides clinically useful information for emergency diagnosis and monitoring of acute brain injury. | This study uses a Doppler ultrasound technique being developed at the University of Leicester called 'Brain Tissue Velocimetry (Brain TV), to investigate brain tissue motion over the cardiac cycle. |
This retrospective cohort study included 186 female patients who admitted to LUTS. Demographic characteristics, medical history, calcium (Ca) and vitamin D including laboratory studies and uroflowmetry results as maximum urine flow rate (Qmax), average urine flow rate (Qav), and voided volume (V) were recorded. Patients were divided into two groups according to age (18-50 and ≥51) and vitamin D levels (<20 and ≥20).~Laboratory parameters, uroflowmetry results, were compared between groups.~The study was approved by the local ethics committee (approval#22/06/2018-09.29-54132726-000-14136). The study was conducted in accordance to the Helsinki Declaration and Good Clinical Practices Guidelines. | The investigators aimed to evaluate the relationship between LUTS and vitamin D with uroflowmetry parameters in female patients. They found no relation between vitamin D levels and LUTS in respect to uroflowmetry. However, in low vitamin D patients, Ca is related with urologic problems. The investigators believe that there is a need for studies emphasizing serum Ca levels in addition to vitamin D levels in patients with LUTS. |
Tasquinimod has previously been studied as an anti-cancer agent in patients with other cancers, including a phase 3 randomized trial in patients with metastatic prostate cancer that showed an improvement in radiographic progression-free survival. The side effect profile of tasquinimod is well-characterized based on this previous experience. This trial will establish a maximum tolerated dose and optimal schedule for administration of tasquinimod in patients with multiple myeloma and then investigate the maximum tolerated dose of tasquinimod in combination with a standard myeloma regimen of ixazomib, lenalidomide, and dexamethasone (IRd). For both single agent tasquinimod and the combination of tasquinimod with IRd, exploratory expansion cohorts will be enrolled to preliminarily characterize the antimyeloma activity of each regimen. | This study is the first study of tasquinimod, an inhibitor of S100A9, in patients with multiple myeloma. |
Old age is associated with declining skeletal muscle mitochondrial bioenergetics with related decrements in cardiorespiratory fitness (CRF) and physical function that predispose to frailty, disability, and diminished quality of life. While exercise training may moderate and possibly even reverse declines in mitochondrial bioenergetics, potential for such benefit is typically confounded by exercise intolerance with early fatigability that results from the same age-related mitochondrial declines. Consequently, sedentariness is endemic and insidious among the growing population of older adults. This trial is to study the utility of inorganic nitrite salts as a novel means to modify this detrimental pattern. Classic studies demonstrate that nitrite facilitates hypoxic vasodilation in muscle. This investigator's preliminary data suggests that nitrite treatment also augments skeletal muscle mitochondrial bioenergetics in older adults. This investigator proposes improving mitochondrial function will also be reflected in clinical parameters, including CRF as well as broader functional attributes (endurance, strength, and balance) that enable physical activity (PA) and opportunity to mitigate frailty and disability. As such, this application is in line with the National Institute on Aging's mission to develop targeted interventions to prevent and treat age-associated conditions. This multi-disciplinary team has published seminal work indicating that mitochondrial bioenergetics and CRF are significant determinants of physical function in older adults. In parallel efforts, this investigative team showed efficacy of chronic nitrite therapy to improve mitochondrial bioenergetics in older sedentary adults. Only one month of nitrite therapy significantly improved ex vivo assessments of mitochondrial energetics in skeletal muscle biopsies, concomitant with increased skeletal muscle sirtuin-3 expression, a nicotinamide adenine dinucleotide (NAD) dependent lysine deacetylase and key regulator of mitochondrial metabolism. These key data reinforce the premise that nitrite enhances vital mitochondrial metabolism in older adults. Moreover, improvement in muscle energetics in nitrite-treated older adults was linked with increased exercise efficiency as evidenced by reduced oxygen consumption (VO2) during submaximal steady-state walking. This data supports the hypothesis that nitrite will make physical function easier such that physical activity will increase. | This 2-site randomized double blinded controlled trial is to confirm and more definitively clarify the impact of a 12-week course of nitrite versus placebo on mitochondrial bioenergetics in older sedentary adults. This investigator will take an integrative physiology approach to determine the effect of nitrite therapy on a comprehensive assessment of mitochondrial energetics, skeletal muscle vascular function, and whole body physical function (cardiorespiratory function, exercise endurance, strength, balance, and physical activity) and fatigability. |
PVI is cornerstone of AF ablation. However, clinical outcome of only PVI in patients with persistent AF is insufficient due to AF substrate extending to left atrium. Strategy of catheter ablation for persistent AF is not established despite attempts of numerous left atrial substrate modifications. Additional PWI on PVI is one of expected effective strategies for persistent AF, because PW originated from common tissue of PV and is considered to play a part in AF trigger and maintenance. However, this strategy is also not established in the recent international consensus statement. Following two reasons are considered. One is the procedural difficulty in creating durable PWI, and another is the existence of patients who can recover by only PVI. The latest technology, ablation index, can create durable PVI, and may create durable PWI. Several reports suggested that PVI only strategy was sufficient in the patients with persistent AF who could maintain sinus rhythm after pharmacological or electrical cardioversion. Therefore, we planed this randomized clinical trial that compared between PVI alone and additional PWI on PVI using ablation index in the patients with persistent AF without pharmacological sinus rhythm conversion. | The purpose for this study is to determine whether left posterior wall isolation (PWI) in addition to pulmonary vein isolation (PVI) is effective as ablation strategy for persistent atrial fibrillation (AF). |
Randomized, double-blind, placebo-controlled clinical trial. Phase III clinical trial for a new indication~Rationale One of the most affected subgroups during the current pandemic is represented by healthcare workers. In Argentina between 14 and 17% of the total COVID-19 cases are represented by this subgroup. In this sense, it appears as an adequate strategy testing the efficacy of pharmacological PrEP approaches on top of the currently recommended control measures.~The use of placebo is warranted for two main reasons: all healthcare workers will be allowed and encouraged to comply with non-pharmacological infection control measures for the protection of viral transmission. On the other hand, the use of a blinded placebo is intended for avoiding relaxation of the non-pharmacological control measures.~Tenofovir has been identified by both docking and in vitro studies as an inhibitor of RdRp (RNA dependent RNA polymerase) of coronavirus.~FTC/TAF has the additional advantage that is already being used in a pre-exposure prophylaxis setting and its safety is widely known.~Main objective To evaluate the risk of developing SARS-CoV-2 disease (COVID-19) in healthcare workers with high transmission risk in addition to currently recommended control measures. | A randomized parallel double-blinded placebo-controlled clinical trial to evaluate the effect of Emtricitabine/Tenofovir alafenamide (FTC/TAF) compared with placebo on the risk of developing SARS-CoV-2 disease (COVID-19) in healthcare workers with high transmission risk in addition to currently recommended control measures. |
Subjects who have signed informed consent and Health Insurance Portability and Accountability Act (HIPPA) authorization, and are determined to meet all inclusion criteria and no exclusion criteria will be enrolled in this study and receive the ADRC treatment.~The subject will have an injection procedure (ADRC treatment) For this study, a licensed physician trained in liposuction must perform the syringe liposuction procedure. The licensed physician who performs the lipoplasty may be the Investigator or a non-Investigator physician (e.g., a plastic surgeon) who is trained on the study protocol.~All subjects will undergo a minor syringe liposuction procedure to acquire approximately 100 mL of lipoaspirate for preparation of ADRC using the Transpose® RT System. The removed tissue is processed to extract a cell suspension (the cell product). Once the cell product has been obtained, tested, and found to conform to release criteria, the subject will be treated with the ADRCs. | This is a prospective, multi-location safety and effectiveness study, and data registry of autologous adult ADRCs generated by the Transpose® RT System in subjects with OA in the shoulder, wrist, knee, hip, or ankle. |
indication of cesarean section are different from case to case and the use of pain controlling agents is very important to relieve post operative pain | cesarean section rate become increasing nowadays |
Patients will receive up to 11 intramuscular (i.m.) vaccinations of VB10.16, for up to 48 weeks from first vaccination. Patients will receive 5 vaccinations of 3 mg VB10.16 during the first 12 weeks, followed by vaccination every 6 weeks for up to 48 weeks from first immunisation (total of 11 vaccinations). Patients will receive up to 17 infusions of atezolizumab for up to 48 weeks from first treatment. Atezolizumab (1200 mg) will be administered as an intravenous (i.v.) infusion every 3 weeks. A follow-up period of up to 12 months will follow the 48 week treatment period.~Response to the VB10.16 and atezolizumab combination will be assessed by computed tomography (CT)/magnetic resonance imaging (MRI) at every 9 weeks throughout the treatment period according to the RECIST 1.1 criteria. | This phase IIa study is designed to evaluate the safety and efficacy of multiple dosing with VB10.16 immunotherapy in combination with atezolizumab in patients with advanced or recurrent non-resectable HPV16-positive cervical cancer, who failed or are not eligible for current standard of care. |
Pegaspargase is the cornor stone for the treatment of ENKTCL, and gemcitabine has been shown to be active in ENKTCL. For several patients with relapsed/refractory or advance ENKTCL, hemophagocytic sysdrome (HPS) occurs, and the prognosis is very poor. Studies have found that etoposide and dexamethasone may be effective in controlling HPS. Thus, this study aims to evaluate the role of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of relapsed/refractory or advance ENKTCL, wishing to improve the prognosis for these patients. | The purpose of this study is to evaluate the efficacy and safety of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients (ENKTCL). |
Arterial hypertension is a central risk factor for cardiovascular disease, major cardiovascular events and mortality. Treatment of arterial hypertension necessitates lifestyle modifications, but often also requires medical intervention. In most cases, a combination of two or more anti-hypertensive drugs is recommended and necessary for reaching the target blood pressure levels.~Hypotheses / research questions/objectives Spermidine potentiates the blood pressure lowering effect of standard anti-hypertensive medications, particularly when a combination of at least two first-line drugs (as recommended by the European Society of Cardiology guidelines) has not resulted in sufficient and adequate blood pressure control.~Approach/methods Spermidine Anti-Hypertension Study (SMARTEST) is a prospective, randomized and double-blind placebo-controlled single-centre trial with a balanced 2x2 crossover design, where 46 medically pre-treated hypertensive patients will be subsequently treated with spermidine and placebo (each for eight weeks) in two arms of opposite treatment sequence. A washout period of four weeks will separate the two intervention periods in both arms.~Patients will undergo physical examination, ECG (electrocardiogram), echocardiography, and blood draws at four time points coinciding with the baseline and termination of each treatment at: 0, 8, 12, and 20 weeks of/after recruitment at the Department of Cardiology, Medical University of Graz. In addition, 24-hour ambulatory blood pressure (24-h BP) monitoring (BPM; Mobil-O-Graph®) and on-site blood pressure will be obtained (the device will be sent back to the hospital the following day) at these time points. A 6-minute walk test (6MWT) will be performed at every visit.~Spermidine will be administered orally as an approved dietary supplement (spermidine-rich wheat germ extract) at a dose of 4 mg spermidine per day for eight weeks. The primary outcome will be arterial systolic blood pressure at 24h BPM. Further secondary outcomes/safety outcomes will be:~24-h BP: analysis of systolic, diastolic and mean arterial blood pressures and pulse wave analysis; on site ambulatory blood pressure; 6 minute walk test distance (difference in meters); laboratory analysis; ECG - standard parameters; Echocardiography: standard parameters as well as strain analysis | The impact of daily spermidine application on arterial blood pressure and other secondary parameters will be evaluated in a double-blind single center 46 patients cross-over study. |
The investigators will conduct a single-center, and randomized controlled cases study. A total of 120 participants with insomnia will be enrolled, and randomly assigned into two groups, 60 of them are the head-acupoints acupuncture group, who will receive GV20, EX-HN-1, GV21, GV22, GV23, GV24, GV29, and bilateral GB13 head-acupoints acupuncture treatment, and 60 of them are the body-acupoints acupuncture group, who will receive bilateral HT7, PC6, SP6, ST36, KI3, LR3 body-acupoints acupuncture treatment for 4 weeks.~The primary outcomes of therapeutic effect on insomnia are changes of the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and the Hospital Anxiety and Depression Scale (HADS).The time frame of the three primary outcomes are: baseline week 0, week 2, week 4 and week 6.~The secondary outcomes of therapeutic effect on insomnia are sleep parameters including sleep efficiency (SE), sleep awakenings (SA) and total sleep time (TST) recorded by the actigraphy (time frame: baseline week 0, week 2, week 4 and week 6), as well as the heart rate viability(HRV) recorded by the ECG monitor (time frame: baseline week 0, week1, week 2, week 3, week 4 and week 6; and 30 minutes before and 60 minutes after acupuncture through study completion). | The investigators will conduct a single-center, and randomized controlled cases study. A total of 120 participants with insomnia will be enrolled. The aim of the study is to compare the therapeutic effect between head-acupoints acupuncture and body-acupoints acupuncture on Insomnia. |
Anorexia Nervosa (AN) is a life-threatening mental disease with a disappointing treatment outcome. Fear of weight gain and diet restrictions are considered the core symptoms of AN. Although from a diagnostic perspective AN is conceptualized as an eating-related disorder connected to an extremely low Body Mass Index (BMI) and body image distortion, AN might represent a specific phenotype of anxiety disorders characterized by tenacious avoidance behaviors, especially the restrictive subtype. To date, avoidance in AN is often investigated as a general personality trait (e.g. harm avoidance) but poorly examined in its behavioral form (which is life-threatening, such as food-avoidance). Hence, the investigators will perform a systematic investigation of excessive avoidance behaviors within a laboratory setting. Within a learning perspective, the investigators will investigate excessive avoidance in a group of 30 AN patients and 30 healthy volunteers. To achieve this, a well-validated avoidance paradigm will be used. Most critically, the investigators will examine whether patients with a diagnosis of anorexia nervosa show persistent avoidance behaviors compared to a control group. Additionally, the investigators will examine if, in the anorexia group, higher subjective relief to successful omissions of negative events during avoidance learning predicts persistent (excessive) avoidance behaviors after fear extinction. | This study investigates excessive avoidance behaviors in patients with a diagnosis of Anorexia Nervosa (AN) compared to a healthy control group. The study further examines the role of reward (relief) as a putative factor in maintaining excessive avoidance behaviors in AN. |
The aim of this study is to test whether specially developed accelerometer and gyroscope can differentiate pattern of resting postural tremor in healthy and people with multiple sclerosis.~Spectral analysis and the correlation of the average signal spectra will be computed. Moreover, categorization based on the tremor component according to the maximum likelihood estimation will be done. | Early diagnosis is a key factor for effective treatment of multiple sclerosis. Accelerometer and gyroscope measurement of tremor could screen potential motor control dysfunction and predict a risk for development of multiple sclerosis. |
Since initially reported in Wuhan, China, in late December 2019, the outbreak of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) has spread globally, stressing many health systems especially intensive care unit (ICU) capacities thus resulting in high mortality. On 16 March 2020, WHO Director-General called on all countries to ramp up their testing programs as the best way to slow the advance of the coronavirus pandemic. Although the current gold standard for COVID-19 diagnosis remains real time reverse transcription-polymerase chain reaction (rRT-PCR), this technique has many shortcomings such as low sensitivity on nasopharyngeal swabs (70%). Multiple diagnostic test manufacturers have developed and begun selling rapid and easy-to-use devices. Before these tests can be recommended, they must be validated in the appropriate populations and settings.~Funded by French Defense Innovation Agency (AID), ERap-CoV is a prospective clinical study which aims to assess clinical performances of serological and antigenic assays for the diagnosis of SARS-CoV-2 infection, in comparison with current diagnostic tests on the market (immunological, proteomic, molecular). The ERap-CoV research will extend the clinical validation of the first NG-Test IgM-IgG COVID-19 point-of-care immunodiagnostic test (NG Biotech), which has shown excellent biological performance, compatible with the recommendations of the Haute Autorité de Santé (HAS) for serological assays (sensitivity> 90% and specificity> 98%, 15 days after symptoms) (1). Finally, AID funding will be used to develop 100% French-made serological and antigenic RDTs in less than a year. | Prospective study for clinical performance evaluation of COVID-19 diagnostic tests: detection of anti-SARS-CoV-2 antibodies by RDTs or ELISA (manual or automated), rapid diagnostic tests based on antigen detection, molecular or proteomic testing of SARS-CoV-2 (sensitivity, specificity, predictive values) |
A total of 176 patients will be included (88 per group) and each center can not include more than 40% of the sample to avoid bias.~Blood samples will be analyzed at different times of the surgical intervention by an electronic device called thromboelastogram. It evaluates the blood clot characteristics and, depending on the results, assesses the need to correct values by the administration of fibrinogen or platelets.~One of the coagulation parameter evaluated and corrected by thromboelastogram is called A10FIBTEM. In a previous study, the investigators have seen that maintaining some specific ranges in the A10FIBTEM, results in a decrease of the use of blood products. That's why the investigators have created 2 groups:~The control group will be corrected up to a value of A10FIBTEM = 8mm.~The intervention group will be corrected up to a value of A10FIBTEM = 11mm.~Subsequently, results between groups will be compared. The investigators have to consider that the drug used in this study (Riastap) is an authorized and commercial drug.~The main objective is to demonstrate that the administration of fibrinogen in the intervention group compared to the control group changes the administration of red blood cells pack during the liver transplant and in the first 24 hours after.~Secondary objectives consist in demonstrate that in the intervention group, there is also a change in the administration of other blood products, a change in acute renal damage, a change in hours of mechanical ventilation, no changes in thrombotic events in the hepatic graft or in the patient in the first 90 days of the liver transplant and no changes in re operations, re-transplantation, or mortality during the first 90 days of the liver transplant, compared to the control group. | It is a national multicentre clinical study, where 3 hospitals are involved: Bellvitge University Hospital, Clinic Hospital of Barcelona and Cruces Hospital of Bilbao). It is a randomized study based on the Hemoglobin value of the patient with a 1:1 ratio, parallel groups, controlled and single blind, in patients undergoing an orthotopic liver transplant, confirming previously that the participants fulfill all the inclusion criteria and none of exclusion. |
2000 patients with positive tumor protein markers or cancer screening were recruited. All patients were tested for ctDNA at enrollment and followed up at 6 months and 1 year. The study was completed at the time of cancer diagnosis or the longest follow-up time (1 year). | This is a observational, multicenter study, monitoring the circulating tumor DNA (ctDNA) in people who is at risk of cancers，assessing the sensitivity and specificity of ctDNA detection in early screening of pan-carcinoma. |
This was a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of molnupiravir versus placebo as measured by SARS-CoV-2 viral RNA detection in symptomatic adult outpatients with COVID-19. The study was a multicenter trial that was conducted in the United States.~In this study, 204 participants were randomized and 202 received molnupiravir or placebo orally twice a day (BID) for 5 days. The study enrolled participants in 5 parts with each part evaluating molnupiravir doses of either 200 mg BID, 400 mg BID, or 800 mg BID. Doses were chosen based on emerging virology and safety data from this and ongoing studies. New dose groups were started after the selected dose had been studied for safety in a Phase 1 study. | This was a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of EIDD-2801 (molnupiravir) versus placebo as measured by SARS-CoV-2 viral RNA detection in symptomatic adult outpatients with COVID-19. |
Prospective, multicentre, international, follow-up registry to monitor the safety and the performance of the Occlutech AFR device in patients with Heart Failure, evaluated by vital signs, laboratory tests, quality of life questionnaire, ECG, and echocardiography data. Patients will be treated according to the instruction-for-use of the device and according to clinical routine by experienced physicians. | This study aims to monitor the safety and effectiveness of the Occlutech AFR device in patients with heart failure for 3 years following AFR device implantation. |
People with stroke are among the most relevant target groups for unobtrusive monitoring. Worldwide, stroke is the second most frequent cause for lasting disability and causes a substantial burden for the individual, caregivers and society. Thanks to improved treatment, many stroke survivors can be discharged to their homes. However, many have to live with disabilities and are prone to declining function, cognitive impairment and depression. With the acquired data, we want to create a database where digital behavior is analyzed with advanced computational methods. In collaboration with the Department of Cognitive Psychology, University of Leiden, Netherlands, these data will be used to discover specific features for different health issues and to develop tools for the early detection of functional decline for different populations. | In this study, we want to continuously record the interaction of 50 stroke survivors with their smartphones during the first 3 months after discharge. The linkage of smart phone use to function and quality of life will be assessed with standardized outcome measures at defined time points. |
CVS-F3 is a valid questionnaire that includes 26 questions to be responded by the medical students to detect CVS complains and possible complications. The questionnaire includes questions regarding potential ocular, extra-ocular, musclo-skeletal and neuro-psychatric complains caused by CVS. Complete statistical analysis of the survey data will be done using univariate and multivariate logistic and linear regression analysis. | CVS-F3 questionnaire will be used as an instrument to survey CVS prevalence and severity among medical students |
There are still some patients with PD-L1 positive who are ineffective in immunotherapy, which may be related to the complex immune microenvironment. In view of this bottleneck, further refinement of immunotyping and in-depth study of drug resistance mechanism are the most important tasks.~Recently, studies have shown that the core elements of tumor microenvironment that have a significant impact on immunotherapy are:1. Infiltration abundance of specific killer T cells; 2. PD-L1 expression dependent on IFN - γ pathway, down-regulation of various active molecules and up-regulation of inhibitory molecules; 3. Activation and clearance of various inhibitory T cells.~Although the classification has achieved further refinement of immune cells and molecular level, there are still some problems to be solved urgently: first, the classification of TIL cells needs further refinement, and different types of TIL infiltration have different guiding significance for prognosis; second, the subjective second-order semi quantitative scoring is often used for til count scoring, with low repeatability and different centers It is not easy for different pathologists to reach an agreement on the results of reading and interpretation. Thirdly, conventional methods are difficult to meet the requirements of tumor microenvironment analysis. In conclusion, it is urgent to develop a multi molecular marker landscape analysis system for tumor microenvironment, and establish a standardized detection process for each molecule to meet the needs of clinical positioning, quantitative and qualitative analysis for key molecular markers of immune microenvironment.~In this observational study, we evaluated the difference of gene mutation and immune microenvironment and therapeutic effect in primary NSCLC. | Immunotherapy for PD-L1 positive patients is still ineffective in some patients，which may be related to the complex immune microenvironment.In view of this bottleneck, further refinement of immunotyping and in-depth study of drug resistance mechanism are the most important tasks. In this observational study, we evaluated the difference of gene mutation and immune microenvironment and therapeutic effect in primary NSCLC. |
Although EGFR tyrosine kinase inhibitors (TKI) have improved the survival of EGFR mutated NSCLC pts, drug resistance inevitably develops in almost all pts. Tislelizumab (tis), an anti-PD-1 mAb, has shown improved efficacy when combined with chemotherapy in pts with advanced EGFR-wt NSCLC with a tolerable safety profile. This study aims to evaluate the efficacy and safety of tislelizumab plus carboplatin and Nab-paclitaxel（cohort 1）or tislelizumab plus Nab-paclitaxel and bevacizumab （cohort 2） in EGFR-mut nsq-NSCLC pts failed to EGFR TKI therapies. | A phase II, open-label, multicenter, two cohorts, prospective clinical study to investigate the efficacy and safety of tislelizumab (anti-pd1 antibody) combined with chemotherapy with or without bevacizumab in non-squamous non-small cell lung cancer patients with EGFR sensitizing mutation who failed EGFR TKI (Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor) therapy. |
The objective of this follow up study is to evaluate the effectiveness and to analyze the limitations of the existing management and treatment of severe burn injuries. Investigation of the factors affecting the recovery and patients' return to the community in patients with severe burn injury may lead to effective amendments of the existing management, and thus aiding in the development of an integrated diagnosis and treatment guidelines. | In this observational follow-up study, patients with type III-IV head and face soft tissue deformities/defects following reconstructive surgeries will be asked to fill out 3 questionnaires, either through phone calls or video calls, in order to evaluate the post-operative outcomes such as morphological and functional recovery, quality of life and patients' return to the community. |
In part 1 of this study, the investigators will use a mixed prospective and cross-sectional cohort study design to implement a PV program at two health facilities affiliated with the Academic Model Providing Access to Healthcare (AMPATH) in western Kenya. The investigators will analyze these data to examine any associations between antiretroviral treatment (ART) and (a) pregnancy and (b) infant/birth outcomes. In part 2, the investigators will create standardized protocols and data exchange standards within IeDEA to enable the merging and analysis of multiregional IeDEA PV data. This will include establishing a Data Coordinating Center based at Indiana University (IU) to serve as a hub for collecting, disseminating and archiving data from the study in Kenya as well as data collected through a similar, ongoing study at health facilities in South Africa affiliated with IeDEA. This study will establish a multiregional PV infrastructure within IeDEA that can be further scaled within the broader IeDEA network. | The purpose of this study is to develop a pharmacovigilance (PV) surveillance program to monitor adverse pregnancy and infant outcomes, including the presence of congenital abnormalities, among HIV-positive and HIV-negative women and their infants at clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA). |
This multicentric analysis involved of successive patients with ACC ELC between April 2018 and March 2020. Patients were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2), and beyond 7 days (group 3). The primary outcome was the incidence of postoperative complications The secondary outcomes were conversion rate, blood loss, operative times, operational difficulty, the cost-benefit relationship, postoperative stay with each treatment line. | The ideal timing for ELC continues to be debatable in patients with acute calculator cholecystitis (ACC). This study was planned to identify the impact of different ELC timing in ACC on surgical outcomes in terms of safety and efficacy |
Screening~1. Explain purpose and nature of the study and obtain signature on the informed consent document.~2. Screen the subject against protocol inclusion and exclusion criteria, including all pertinent tests, including pregnancy test 3. Complete SF-36, EuroQol 5 dimensions (EQ-5D) and PROMIS® Baseline (may be done as same day as screening procedures or within +2 days of screening and before start of Therapy/Treatment Phase)~Obtain general medical history and demographic information and social history~Complete a physical examination, body weight, height, and vital signs, including measurement of resting heart rate, respiratory rate, and blood pressure while seated.~Select target study ulcer~Obtain complete history pertinent to DFU disease including duration of the target ulcer, previous and current treatment. Document ulcer classification.~Perform debridement and obtain tissue collection (3 tissue and 1 bone).~Perform standardized photography and measurement of the study wound (eKare or available camera with ruler). Assess the post-debridement ulcer area (cm2), perimeter (cm), and greatest depth (cm) using the inSight device (eKare, Fairfax, VA). These values are the baseline measurements for calculating wound closure rate at the two-week run-in visit.~Perform hyperspectral imaging of dorsal and plantar aspects of the foot.~Perform neuropathy assessment~Collect all relevant concomitant medication (antibiotics, antifungals and other anti-infective therapies)~Place Stravix (lyo or cryo per randomization schedule) and dress wound for NPWT therapy.~Document size of Stravix used.~Disburse subject stipend Therapy/Treatment Phase (Weekly visits +/- 4 days)~Study Visit 1-11:~Assess target ulcer (if wound has closed, document as such, skip to step 5).~Document time on/off NPWT if applicable.~Perform standardized photography of the study wound when NPWT is removed.~If Stravix is removed, assess the ulcer area (cm2), perimeter (cm), and greatest depth (cm) using the inSight device - if the wound is deemed closed by the physician, skip to EOS visit.~Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is active or closed.~Debride wound if indicated. Re-measure wound if surgical debridement is performed prior to dressing the wound.~Collect all relevant concomitant medication.~If wound is still active, redress the wound with assigned Stravix (if removed for debridement) and NPWT. Document all dressings applied including size of Stravix.~Disburse subject stipend~Note: at week 4, if wound is not ready for grafting, remove existing Stravix and replace with new piece of Stravix (per randomization schedule)~Assess for AE/SAEs and/or follow up on previous AE/SAEs.~Study Visit Closed 1. When a subject's study wound has closed, they will perform the EOS evaluation.~Study Visit 12/EOS:~At the time of wound closure, subjects will perform EOS visit.~A subject whose wound is not deemed closed (epithelialized with no drainage) by physician at week 12 will exit from the study after the week 12 wound evaluation.~Assess index ulcer.~If wound has not closed, perform standardized photography of the study wound.~If wound has not closed, assess the ulcer area (cm2), perimeter (cm), and greatest depth (cm) using the inSight device.~Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is active or healed.~If wound has not closed, redress the wound per physician-directed standard of care.~Administer Patient Reported Outcome (PRO) (questionnaires).~Collect all relevant concomitant medication~Perform EOS visit documentation~Follow up on AE/SAEs that have been reported that have not yet been resolved.~Study Visit Follow-up:~1. If the wound heals during the treatment phase or if the wound is not healed after 12 weeks, data from their electronic medical record will be evaluated to identify healing, time to heal, adverse events related to the wound. | This study is a prospective, 2-arm parallel assignment, randomized clinical trial to compare lyopreserved vs cryopreserved Stravix as an adjunct therapy to NPWT. |
The study is divided into a screening and enrollment visit (V1) where eligibility for treatment will be confirmed. Ivabradine will be administered to eligible patients with increasing dosage during the titration period (TP) which will last from a minimum of 3 days to a maximum of 15 days. This will be followed by a maintenance period (MP) of the drug for a further 14 days. The follow-up period (FU) will last 4 months.~The dose of ACE inhibitors will be introduced after 72 hours of clinical stability after the introduction of titrated ivabradine at maximum dose according to protocol. The anti-aldosterone will be introduced 24 hours after the introduction of ivabradine. The diuretic will not be modified during the titration phase of the drug, unless there is clinical necessity.~During the FU ivabradine will be continued at stable dosage, in order to maintain the target heart rate (HR) reached during the maintenance phase (HR > 80 bpm, in the group of patients older than 6-12 months, or HR > 70 bpm in patients aged 1-3 years or HR > 50 bpm between 3-18 years). In all patients, the drug dose will be decreased or discontinued in case of bradycardia (HR< 80 bpm in patients 6-12 months, HR< 70 bpm in patients 1-3 years of age or HR< 60 bpm in patients 3-18 years of age) and/or symptoms related to bradycardia or for other safety reasons. | This is a monocentric, prospective, single arm, not for profit study. It is designed to study the early use of ivabradine in patients with dilated cardiomyopathy and Ejection Fraction (EF) < 45%. |
Background To evaluate efficacy, safety, objective and subjective quality of vision after treatment of cornea ectasia performed with transepithelial topographic guided laser simultaneous Central Corneal Remodeling (CCR) and Cross-linking (CXL).~Methods In this retrospective study 8 eyes of 8 patients (mean age 31.50±14.73 years) affected by cornea ectasia underwent simultaneous CCR and CXL. Preoperative and 6 month postoperative uncorrected distance visual acuity (UDVC) and distance corrected visual acuity (DCVA) were measured using the Efficacy and Safety index. Objective and subjective quality of vision were evaluated preoperatively and 6 months postoperatively using corneal morphological irregularity index (CMI), National Eye Institute Visual Function NEI-VFQ25 and NEI-VFQ39 questionnaires. | To evaluate efficacy, safety, objective and subjective quality of vision after treatment of cornea ectasia with transepithelial topographic guided laser simultaneous Central Corneal Remodeling (CCR) and Cross-linking (CXL). |
There is a critical need to identify effective treatments and a number of molecules have been suggested, but The investigators still do not have enough evidence about their efficacy, to treat COVID-19 pneumonia.~One of the most tested treatments was the use of Chloroquine or Hydroxychloroquine associated or not to azithromycin.~Studies have indicated that chloroquine (CQ) shows antagonism against COVID-19 in vitro. It's known to block virus infection by increasing endosomal pH required for virus/cell fusion, as well as interfering with the glycosylation of cellular receptors of SARS-CoV. It's also demonstrated that CQ functioned at both entry, and at postentry stages of the 2019-nCoV infection in Vero E6 cells. Besides its antiviral activity, CQ has an immune-modulating activity, which may synergistically enhance its antiviral effect in vivo.~However, evidence regarding its effects in patients is limited. Among patients with COVID-19, the use of Hydroxychloroquine (HCQ) could significantly shorten time to clinical recovery (TTCR) and promote the absorption of pneumonia. This result has been presented in a randomized controlled trial using two arms HCQ versus conventional treatment. The beneficial effect of HCQ has been proven among mild severity COVID-19 pneumonia but the sample size of this study was limited to 31 patients in each group.~Gautret et al also reported that HCQ treatment is significantly associated with viral load reduction/disappearance in COVID-19 patients and its effect is reinforced by azithromycin. A study showed that azithromycin concentration in phagocytic cells is 40× to 150× higher than plasma concentrations. However, Gautret study has many limitations including selection biases because of non-randomization, a small sample size, and dropout of six patients from the study.~In terms of treatment duration, there is no study supporting a long course treatment of 10 days versus a short course treatment of 5 days for HCQ. This treatment is known to have a large distribution volume of 73 l/kg and a plasma half life going from 22 days to 123 days. This suggests that a short course treatment of Hydroxychloroquine and/or azithromycin could be as effective as a long course treatment.~On the other hand, there are currently no effective specific antivirals or drug combinations supported by high-level evidence, and The investigators don't know if HCQ could be effective or if it's effectiveness may be improved if it's associated with Azithromycin. In fact, this association can lead to improve pneumonia but can also increase the risk of treatment side effects. | This study investigates the efficay and tolerance of 5-days course of hydroxychloroquine or hydroxychloroquine and azithromycin of patients with COVID-19 infection. The investigators will undertake a randomized, double-blind, controlled Trial in the region of Sousse Tunisia |
Inverted prostheses have proven to be effective in the treatment of all those pathologies that involve a deterioration of the rotator cuff (secondary arthropathy, acute fractures, sequelae of fractures, tumor surgery and revision surgery). Despite this, numerous complications have been described after the use of inverted prostheses, such as glenoid erosion, infections, dislocation, or aseptic loosening. The most frequent complication related to the use of inverted prostheses is glenoid erosion that can occur in up to 96% of cases. This complication appears early in the evolution, usually before 2 years after surgery. Its clinical significance is not yet clear, but it seems that it may be a cause of long-term prosthetic loosening. To avoid the development of glenoid erosion, the best option is to place the glenoid component low, so that if the glenoid component is flush with the lower margin of the glena, the chances of developing glenoid erosion are significantly reduced. Two types of approaches have been used to implant these prostheses, the deltopectoral and the superior anterior approach. Each of them has its advantages and disadvantages, so that deltopectoral seems to improve surgical exposure and therefore favors the best placement of the glenoid component, but sacrifices the subscapularis tendon, increasing the risk of dislocation of the components. On the contrary, the superior anterior approach respects the subscapularis tendon, reducing the risk of dislocation of the components but gives worse surgical exposure. | To determine the differences in the placement of the glenoid implant of the inverted prostheses when they are implanted using a superior approach and using an anterior approach. |
This study aims to evaluate the oral administration of Bromhexine hydrochloride for the prevention of SARS-CoV-2 infection and COVID-19 disease in medical personnel assisting patients with a new coronavirus disease. The aim of the study is to determine the preventive role of this drug in the framework of reducing the incidence of coronavirus infection in risk groups (medical personnel). Several studies show, that the acute respiratory syndrome coronavirus SARS-CoV uses endosomal cysteine proteases cathepsin B and L (CatB/L) and the transmembrane protease serine type 2 (TMPRSS2) for the priming of the viral S-protein. The new coronavirus SARS-CoV-2 penetrates into alveolar epithelial type two cells through a similar mechanism. In detail, viral S-protein binds to pneumocyte angiotensin-converting enzyme 2 (ACE2) and then undergoes cleaving by TMPRSS2 in S1- and S2-subunits. This leads to the release of a fusion peptide, which allows the virus to enter the cell via endocytosis. Therefore, the protease TMPRSS2 can serve as a target for pharmacological agents to prevent the penetration of the SARS-CoV-2 into the cell. Bromhexine blocks the TMPRSS2 ability to activate a zymogen precursor of tissue plasminogen activator in vitro. Interestingly, TMPRSS2 is blocked by much lower concentrations then required to inactivate other proteases in the cell culture. However, these data cannot be simply extended to the clinical practice: whether the concentration of bromhexine in the lung tissue of properly treated patients would be enough to prevent the virus entry through the TMPRSS2-inactivation remains unclear. A randomized study in people at risk for coronavirus infection will clarify the role of Bromhexine hydrochloride as a prevention of this disease. | This is a randomized controlled trial of the efficacy and safety evaluation of oral administration of Bromhexine hydrochloride for the prevention of SARS-CoV-2 infection and COVID-19 disease in medical personnel assisting patients with a new coronavirus disease |
Randomization was divided into two groups by using closed envelope method. Postoperative pain scores at rest at 1, 2, 4, 6, 8, 10, 12, and 24 hours with VAS (0 = no pain, very severe pain = 10) using Visual Analogue Scale was made. VAS at rest and movement (coughing and taking a deep Breath) were evaluated. Patients with VAS> 4 received additional analgesics. | The aim of this study is to investigate the analgesic effects of thoracal paravertebral block in the patients undergoing percutaneous nephrolitotomy. Paravertebral block was applied to the study group. Conventional analgesia methods were applied to the control group. |
At least 1 000 individuals, 18 years old and older, are randomly sampled using random digit dialing from the population of Saint Petersburg, Russia. Random sampling is performed by a survey company on the list of mobile phone numbers with designated geography prefixes of St. Petersburg. The baseline questionnaire for computer-assisted telephone interview includes travel history, medical history, and socio-economic status of the respondents. Sampled individuals are then invited to the clinic for blood sampling, their refusal to participate is recorded. Collected blood samples are used for SARS-CoV-2-specific antibodies testing. Data and sample collection spans four weeks and is conducted every two weeks. Participants complete additional questionnaires in the clinic providing information on medical history, history of allergies, chronic disease, smoking, and medication taken regularly. Contact tracing data and environmental conditions of the household are reсorded. | Seroprevalence study of COVID-19 in Saint Petersburg, Russia is a regional longitudinal cohort study aiming to evaluate the spread dynamics of the COVID-19 disease in the population of Saint Petersburg. Clinically asymptomatic adults are sampled from the population using random digit dialing and tested for the presence of SARS-CoV-2-specific antibodies in the blood serum. Data collection and serial sampling of the same individuals spans four weeks and is conducted every two weeks in order to understand both the spread of the virus in the population. |
Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided.Spinal anesthesia has become the favorable technique for both elective and emergency cesarean section due to a quick and predictable onset of action, however, it can be frequently complicated by hypotension, with incidence exceeding 80% occasionally. Recently, noradrenaline has been shown to be effective in maintaining blood pressure in obstetric patients. Another technique widely used to prevent hypotension is fluid administration. Current evidence suggests that the combination of fluid administration and vasoconstrictive medications should be the main strategy for prevention and management of hypotension accompanying neuraxial anesthesia procedures during cesarean section. Research is still underway in relation to the most appropriate timing for fluid administration, the most appropriate fluid volume as well as the type of fluid that should be administered. However, preloading of crystalloids seems to be inefficient as a sole strategy, while co-loading of colloids is more effective than co-loading of crystalloids for prevention of hypotension in the parturient. On the other hand, preloading and co-loading of colloids seem to be of equal effectiveness. Literature is rather scarce regarding the comparison of colloid preloading and crystalloid co-loading.~The aim of this randomized study will be to investigate the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section. | This will be a randomized study aiming at investigating the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section |
Hydrocele is a condition of fluid retention around the testes, which causes swallowing, pain, with interfering with the normal testes function. however, during activity, this can interfere with everyday activity (running, sexual intercourse). The treatment for hydrocele I surgical. The study aim to test the safety and efficacy of the Ligasure (r) device for cutting and coagulating tissues during hydrocelectomy. during the study, males, 18 - 81 who suffer from hydrocele underwent hydrocelectomy using Ligasure (20 cm) without using sutures. | Hydrocele is a condition of fluid retention around the testes, which causes swallowing, pain, with interfering with the normal testes function. however, during activity, this can interfere with everyday activity (running, sexual intercourse). The treatment for hydrocele I surgical. The study aim to test the safety and efficacy of the Ligasure (r) device for cutting and coagulating tissues during hydrocelectomy. |
Since the identification of the first case of Severe Acute Respiratory Syndrome (SARS) CoV-2 infection in December 2019 in Wuhan, China, the global number of confirmed COVID-19 cases is roughly 5 000 000, with 216 involved countries. Increasing evidence shows that SARS-CoV-2 may be associated with neurological manifestations, with up to 36% of patients showing neurological symptoms related to the neurovirulence of the SARS-CoV-2.~It has been reported that roughly 5% of COVID-19 infected patients may present acute ischemic stroke (AIS), and these patients may have an unfavorable clinical evolution due to the systemic involvement of the infective disease. In addition, these patients are quite young: the mean age of COVID-19 patients having AIS is lower (56 years), compared to general population of AIS patients (mean age=73 years). Moreover, most of these patients require an intensive care units (ICU) management. Stroke mechanisms may be multiple and can include hypercoagulability from critical illness, cardioembolism from virus-related cardiac injury, and severe inflammation. Indeed, the dysfunction of endothelial cells induced by infection may promote an increased thrombin generation and fibrinolysis; moreover, the hypoxia found in severe COVID-19 patients can be a trigger for thrombosis, increasing blood viscosity, and inducing hypoxia-inducible transcription factors.~Outcomes related to the treatment of COVID-19 patients harboring large vessel occlusion and requiring MT is substantially unknown, but it is likely that the combined morbidity and mortality rate of the two pathologies is high. Accordingly, patient's selection, treatment-management, and results should be urgently elucidated.~Involving 4 different countries (France, Italy, Spain, and US), this multicentric cohort study aims to analyze the largest possible number of COVID-19 infected patients treated with MT for AIS, with the intention to provide treatment-results and neurological outcomes, elucidating the best patient-selection and treatment-management. | About 5% of COVID-19 patients may present symptoms related to acute ischemic stroke (AIS). Treatment-management and outcomes related to mechanical thrombectomy (MT) for COVID-19 infected patients harboring large vessel occlusion is largely unknown.~This multicentric study aims to investigate morbidity, mortality and neurological outcomes after MT performed in patients with COVID-19 infection. |
Primary hypertension is a most prevalent cardiovascular diseases, and becomes a severe global public health issue because of the high morbidity and potential risk to other cardiovascular diseases. Several animal studies and diverse patient cohorts reported that the disorder of gut microbiome correlated with hypertension. Based on the investigators' previous work findings of metagenomics analysis, fecal transplantation and metabolomics changes in hypertension and pre-hypertension patients, a casual role of gut microbiome disorder was observed in primary hypertension and raised a hypothesis that gut microbiome restoration can be a potential approach to ameliorate hypertension. Recent studies indicated FMT, prebiotics, probiotics, dietary changes and other methodologies can assist gut microbiome restoration in diseases such as type 2 diabetes. The investigators therefore develop two pilot studies respectively utilizing FMT capsules (Pilot Study I) and innovative dietary changes (Pilot Study II) to explore the effect, safety and underlying mechanisms of gut microbiome restoration on hypertension. These pilot studies also present as the clinical translational section of the research project The Role of Gut Microbiome in the Pathogenesis of Essential Hypertension(Project ID 81630014, sponsored by National Natural Science Foundation of China).~This study is the Study I:~Objective: To explore the effect, safety and underlying mechanisms of gut microbiome restoration via FMT on primary hypertension.~Study Design: A multicenter, randomized, double-blinded, placebo-controlled pilot study.~Data quality control and statistical analysis: The investigators have invited professional statistic analysts to assist analyzing data and a third party to supervise data quality.~Ethics: The Ethics Committee of Fuwai Hospital approved this study. Informed consents before patient enrollment are required. | Mounting preclinical and clinical evidences have proved the causal role of gut microbiota on the pathogenesis of primary hypertension. Restoration of gut microbiota ameliorated high BP in rodents and/or human cases.A hypothesis is thus raised that gut microbiome restoration can be a potential approach to ameliorate hypertension. This pilot study will utilize fecal microbiota transplantation (FMT) capsules, in comparison with placebo capsules, to investigate the effect, safety and underlying mechanisms of gut microbiome restoration on primary hypertension. |
In this study the investigators intend to assess the feasibility of surfactant administration via a thin catheter using a specially adapted video laryngoscope, with a groove designed to allow insertion of an endovascular catheter without the use of other instruments in the oral cavity (forceps ect.).~The laryngoscope is manufactured by Peak Medic Ltd, Natania, Israel.~Primary Endpoints~- Number of attempts until surfactant is administrated~- Assessment of the infants' stability during the procedure - saturation, bradycardia, tachycardia.~- Duration of the entire procedure, form laryngoscope insertion to surfactants administration.~4. Secondary Endpoints~- Need of invasive mechanical ventilation in the next 24 hours.~- Complications reports~- Subjective procedure scale of assessment~- Unexpected pitfalls reports~- Safety assessment of the procedure | Surfactant administration via thin catheter using a specially adapted video laryngoscope - a prospective, multicenter trial, assessing the feasibility of the VISUAL method (Video Surfactant Administration Laryngoscopy).~The study will search for the number of attempts until surfactant is administrated, assessment of the infants' stability during the procedure, duration of the entire procedure, form laryngoscope insertion to surfactant administration. |
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