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To study the effects of the herbal supplement Lagenbone on Bone Mineral Density. Lagenbone is a supplement based on the Chinese Herbal formula Gui Lu Er Xian Jiao. | To study the effects of the herbal supplement Lagenbone on Bone Mineral Density |
There is concern that wearing a face mask during exercise will reduce oxygen uptake or increase carbon dioxide re-breathing, which can result in low blood oxygen levels, reduced oxygen delivery to muscle and reduced exercise capacity. The purpose of the study is to determine the effect of wearing two different types of commonly-worn face masks (diposable and cloth) during exercise on blood and muscle oxygenation. Twelve participants who are experienced with cycling will take part in this randomized cross-over study that will assess blood oxygenation (i.e. pulse oximetry) and muscle oxygenation (with near infrared spectroscopy) during a progressive step exercise test to exhaustion. The conditions include no mask, a disposable mask, and a cloth mask. Outcome variables include exercise duration, rating of perceived exertion, blood oxygen saturation levels, and oxygenated, deoxygenated, and total hemoglobin at the quadriceps muscle. | There is concern that wearing a face mask during COVID will affect oxygen uptake, especially during intense exercise. This study will assess the effect of wearing two different face masks (disposable and cloth) on blood and muscle oxygenation during cycling exercise. |
Itch is the commonest skin-related symptom, defined as a bodily sensation provoking the urge to scratch. The induction of itch and scratching by mere (audio-) visual stimuli such as pictures of insects on skin or video clips showing individuals scratching themselves, indicates that itch can be perceived in the absence of a pruritogenic somatosensory stimulus. This phenomenon is referred to as contagious itch (CI). CI may play a special role in the content of scabies both for the affected patients as well as the treating staff: It is a very common phenomenon that family members who are not infested by scabies themselves experience itch when watching their infested relatives scratching. The same is very frequently expressed by health care professionals being confronted with scabies patients. Two further important factors may be involved in the context of CI: disgust and empathy. Empathy is defined as a psychological concept that enables individuals to understand and share emotions of others. Disgust is an emotional response of revulsion to potentially contagious and/or harmful objects or subjects. This study is to assess the relationship between CI, disgust and empathy in medical staff treating patients with scabies, to differentiate the impact of visual and verbal stimuli contributing to CI and to assess information about CI, disgust and empathy in a family infested with scabies. | This study is to assess the relationship between CI, disgust and empathy in medical staff treating patients with scabies, to differentiate the impact of visual and verbal stimuli contributing to CI and to assess information about CI, disgust and empathy in a family infested with scabies. |
The CP324 study investigated a novel non-CE marked intermittent catheter, designed in two different variants, Variant 1 and Variant 2, respectively, and was conducted in Denmark. The study was a randomized, single blinded, cross-over investigation comparing the two new variant catheters with a comparator catheter in 15 female IC users.~For each participant, the study thus contained three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 15 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). There were 4-14 days between the test visits. | Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for females with a comparator catheter. |
This first-in-man (FIM) phase I study will evaluate the acute safety, tolerability,and acceptability of the investigational RD19 device among 25 healthy volunteers between the age of 18 and 45. Based on the results of numerous preclinical studies, a short 3 minute use twice a day, separated by at least 4 hours, preferably 8 to 12 hours apart) will be evaluated.~Safety and tolerability (local reactogenicity) will be assessed actively at the following study days: screening (baseline set), 1, 7 and 14, and on non-clinic visit days by collection of these data by history during clinic visits via a memory aid (diary cards). Volunteers will be encouraged to promptly contact designated clinical trial staff or the one of the Sponsor's Emergency Response Team for AEs of a medically urgent nature.~A Comprehensive Metabolic Panel, as well as CBC with differential, urinalysis, and pregnancy testing will be performed at screening and at Day 14 or early termination (and potentially during unscheduled) clinic visits. Hematological safety assessments (evaluation of methemoglobinemia) will be performed at all visits.~Study volunteers will be asked to immediately contact the clinical coordinator and/or the PI in all instances where they experience an AE of greater than moderate intensity. Volunteers will be instructed to report to the clinical trial unit for an unscheduled visit or to seek the appropriate level of medical care based on the nature of their AE/SAE. In all such instances, all relevant information pertaining to these significant medical events will be captured on the appropriate e-CRFs.~Hematology safety laboratory evaluations will be performed at screening, as well during all scheduled clinic visits. Laboratory assessments may be part of the evaluation of medically attended AE evaluation and for all SAEs.~Upon ratification of the CTA, the site began pre-recruitment outreach efforts of potential volunteers within M3-WRA's database to ascertain interest in general in this study. Official recruitment which may include fliers, letters, telephone calls, etc. and specific recruitment of potential subjects who have previously participated in other clinical studies conducted at the site commenced only after formal IRB approval. Other forms and/or mechanisms of recruitment may also be used. The IRB will approved the recruitment process and all materials prior to use. | This first-in-man (FIM) phase I study will evaluate the acute safety, tolerability, and acceptability of the investigational RD19 device among 25 healthy volunteers between the age of 18 and 45. |
The clinical study is aimed to explore the efficacy and safety of erythropheresis in high altitude polycythemia. People reside in highland diagnosed as high-altitude polycythemia were included and randomly divided into two groups. In one group, routine therapy including oxygen inspiration would be performed, while in another erythropheresis would be added. Symptom relief, blood oxygenation, and 6-minute walk test would be assessed and compared in the above two groups. | The clinical study is aimed to explore the efficacy and safety of erythropheresis in high altitude polycythemia. |
Purpose: To determine if using adjunctive TDCS to treat seniors admitted with symptoms of depression and anxiety reduces length of stay and improves quality of life. Hypothesis: Using transcranial direct current stimulation (TDCS) will decrease length of stay because it will reduce symptoms of depression and anxiety enabling patients to engage with their therapy sooner and more effectively. Justification: Anti-depressant or anti-anxiety medications are often used for this inpatient population but there are many reasons why alternative or adjunctive treatments may be desirable. Medications can take weeks to become effective, if they work at all. There are many potential side effects of medications, especially in an older population, including cognitive and other neurologic impairments. There is also an increasing resistance to a polypharmacy approach to treatment in this population. A low-risk, relatively non-invasive, easily applied and well-tolerated treatment to accelerate mood and anxiety disorder resolution would allow earlier and more effective engagement in rehabilitation therapy. This would in turn shorten lengths of stay and improve quality of life. Objectives: to determine if (1) TDCS reduces symptoms of depression and anxiety and (2) if patients in the intervention group are discharged from hospital sooner than those in the sham group. Research Method/Procedure: Direct current of 1.5 milliamp (mA) will be applied for 20 minutes 5x/week for 3 weeks in a hemispheric montage over the homologous dorso-lateral prefrontal cortices, anodal on the left. The Glenrose Rehabilitation Hospital is Canada's largest freestanding rehabilitation institution with programs and services for all age groups. Rehabilitation services cover all disciplines from physical, occupational therapy to social work. Older adults are admitted to 3D and 4C to address issues related to frailty such as weakness and poor balance which affect ability to undertake activities of daily living. Most of the services they receive as inpatients come from physical and occupational therapists with speech therapists and psychologists also available if needed.Patients will be drawn from these seniors admitted to these 2 geriatrics units, 3D and 4C. Candidates who meet the eligibility criteria and are interested in the project will be approached by the RA who is not involved in their care and will seek their consent. Patients will be randomized into standard care (SoC) plus active TDCS and SoC with sham TDCS. TDCS is unique in that effective double blind sham conditions can be created. Effectiveness of treatment will be judged primarily on reduced length of stay with improved Geriatric Depression Score (GDS), Geriatric Anxiety Score (GAS) and Older Person's Quality of Life (OPQOL) as secondary outcome measures. We expect that it will take ~8 months to complete the study: 3 months for ethics review, 4 months to enroll 100 of a possible 200 eligible patients and 1 for data analysis.~This intervention will be judged primarily on its effect on length of stay for this population. It is our working hypothesis that this intervention will shorten length of stay by approximately 5 days. It will do this because TDCS will improve depression (GDS less than 5/15) and anxiety symptoms (score less than 9/30) and thus increase motivation and engagement. Readiness to proceed with therapy is a clinical judgement based on patient demeanour and GDS made by the Unit team who will be blind with respect to whether the patient is receiving TDCS or part of the sham group. Data will include: demographics: gender, age and diagnosis. Geriatric Anxiety Inventory, Geriatric Depression and Quality of Life scales will be completed within 1 week of admission, and at ~ 3 and 5 weeks (+3 days) after intervention initiated. Testing will be coordinated with the Unit Occupational Therapist to avoid duplication or the risk of over testing.~Data analysis:~Baseline group statistics (mean age &, standard deviation, male/female count, diagnostic frequencies, initial mean & standard deviations of GDS, Geriatric Anxiety Inventory and Quality of Life scores).~Effect of length of stay: Student t test will be used to determine if there is a significant difference between the 2 groups, defined as p<0.05.~Changes in Depression, anxiety or quality of life: significant differences from baseline at 3 and 5 weeks intervals will be assessed based on minimum clinical differences using a chi squared test. | Many seniors admitted for rehabilitation have symptoms of depression and anxiety that need to be treated before they can effectively engage in rehabilitation therapy. Anti-depressant or anti-anxiety medications are often used but there are many reasons why alternative or adjunctive treatments may be desirable. Medications can take weeks to become effective, if they work at all. There are many potential side effects of medications, especially in an older population, including cognitive and other neurologic impairments. There is also an increasing resistance to a polypharmacy approach to treatment in this population. A low-risk, relatively non-invasive, easily applied and well-tolerated treatment to accelerate mood and anxiety disorder resolution would allow earlier and more effective engagement in rehabilitation therapy. This would in turn shorten lengths of stay and improve quality of life. Recently, trans-cranial direct current stimulation with 1-2 mA currents has been proposed as a potential innovative alternative treatment modality. This stimulation is safe, easy to use, relatively insensitive to electrode placement, and may have other beneficial cognitive effects. The stimulation device consists of two electrodes placed on either side of the head, a unit that provides the stimulation and wires that connect this unit to the electrodes will be used. The electrodes are held in place with a head band. |
Rib fractures are one of the most common injuries in trauma patients. These fractures are associated with significant pain as well as decreased ability to inspire deeply or cough to clear secretions, which together lead to complications of the lungs and breathing which leads to risks of further injury and even death.~The erector spinae plane block (ESPB) is a nerve block that covers multiple rib fractures with a single injection. This block entails injecting local anesthetic in the back superficial to the vertebral bodies. One study found that the ability to move air into and out of the lungs practically doubled with the administration of a single-injection ESPB while pain levels nearly halved.~A single-injection nerve block lasts less than 24 hours while a perineural local anesthetic infusion (also termed a continuous peripheral nerve block) may be administered for multiple days. This entails inserting a tiny tube through the skin and into the area around the nerves, after which more local anesthetic may be administered prolonging the numbing effects. The possibility of extending the duration of a ESPB with local anesthetic administration via a perineural catheter has not be investigated.~We therefore are conducting a randomized, tripe-masked, placebo-controlled, parallel-arm study to investigate the addition of a continuous ESPB to a single-injection ESPB following traumatic rib fracture. Subjects will be individuals who present with rib fracture(s) and significant pain. Those who consent to participate in this study will have an ESP catheter inserted using ultrasound-guidance on the ipsilateral side at the level of the inferior-most fracture. For bilateral fractures, a second catheter will also be inserted on the remaining side. The single-injection ESPB will be administered to each catheter with 20 mL of ropivacaine 0.5% (with epinephrine).~Subjects with an accurately-inserted catheter based on visualization of local anesthetic spread will be allocated to one of two possible perineural treatments stratified by unilateral vs. bilateral fractures (1:1 ratio in blocks of 2):~active (ropivacaine 0.3%)~placebo (normal saline)~Computer-generated randomization lists will be created by the UCSD Investigational Drug Service which will keep the randomization lists and not release them to the investigators until the study is completed, at which time they will provide lists of subjects who received Treatment A and Treatment B so that the statistician can analyze the data. Only after the analysis is complete will Treatment A and Treatment B be defined for the investigators for manuscript preparation [producing a triple-masked study]. Of note, for bilateral catheters the treatments on both sides will always be identical: each subject will be randomized to a single treatment and not each side of bilateral cases.~Subjects will receive a basal infusion of study fluid (ropivacaine vs. placebo) 1 mL/h to keep the catheter lumen patent as soon as the infusion pump is initiated with a 500 mL reservoir. In addition, intermittent boluses (13 mL programmed automatic bolus every 2 hours) will begin 5 hours after pump initiation. For bilateral catheters, a 6-hour delay for one of the pumps will ensure that the pair of pumps alternate sides for the bolus doses each hour. This protocol will provide nearly 71-72 hours of study fluid administration.~Following local anesthetic reservoir exhaustion, subjects or their caretakers will remove the catheters with instructions provided by phone. This is standard at UC San Diego for all ambulatory continuous peripheral nerve blocks and will not be unique to study participation. The catheter is disposable in the trash and the infusion pump will be returned using a pre-addressed and postage-paid envelope provided to subjects prior to leaving the hospital.~Subjects will be contacted by telephone to collect study data on post procedure days 1, 2, 7, and at months 0.5, 1, 1.5, 2, 3, 6, and 12.~The ultimate objective of the proposed line of research is to determine if the addition of a continuous ESPB to a single-injection ESPB prolongs analgesia following traumatic rib fractures; and, if this analgesic intervention improves pulmonary mechanics measured with incentive spirometry.~Specific Aim 1: To determine if the addition of a continuous ESPB to a single-injection ESPB improves maximum inspiratory volume following traumatic rib fracture(s).~Hypothesis 1a: The maximum inspired volume will be significantly increased in the afternoon following the procedure [primary endpoint] as well as at other time points following the procedure [secondary end points] with the addition of a continuous ESPB to a single-injection ESPB [measured with an incentive spirometer].~Hypothesis 1b: The maximum inspired volume as a percentage of the baseline will be significantly increased in the afternoon following the procedure [secondary endpoint of greatest interest], as well as at other time points following the procedure [secondary end points] with the addition of a continuous ESPB to a single-injection ESPB [measured with an incentive spirometer].~Specific Aim 2: To determine if the addition of a continuous ESPB to a single-injection ESPB decreases the pain associated with rib fracture(s).~Hypothesis 2a: The severity of rib fracture pain at rest will be significantly decreased within the 12 months following the procedure with the addition of a continuous ESPB to a single-injection ESPB [measured using the Numeric Rating Scale for pain].~Hypothesis 2b: The severity of rib fracture pain when using the spirometer or coughing will be significantly decreased within the 12 months following the procedure with the addition of a continuous ESPB to a single-injection ESPB [measured using the Numeric Rating Scale for pain].~Hypothesis 2c: The incidence of chronic rib fracture pain will be significantly decreased 6 and 12 months following a rib fracture with the addition of a continuous ESPB to a single-injection ESPB [measured using the Numeric Rating Scale for pain].~Hypothesis 2d: The severity of chronic rib fracture pain will be significantly decreased 6 and 12 months following a rib fracture with the addition of a continuous ESPB to a single-injection ESPB [measured using the Numeric Rating Scale for pain]. | Rib fractures are one of the most common injuries in trauma patients. These fractures are associated with significant pain as well as decreased ability to inspire deeply or cough to clear secretions, which together lead to complications of the lungs and breathing which leads to risks of further injury and even death.~One recent study found that the ability to move air into and out of the lungs practically doubled with the administration of a single-injection Erector Spainae Plane Block (ESPB) while pain levels nearly halved. However, a single-injection nerve block lasts less than 24 hours while a perineural local anesthetic infusion (also termed a continuous peripheral nerve block) may be administered for multiple days. This entails inserting a tiny tube through the skin and into the area around the nerves, after which more local anesthetic may be administered prolonging the numbing effects.~The possibility of extending the duration of a ESPB with local anesthetic administration via a perineural catheter has not be investigated. We therefore are conducting a randomized, triple-masked, placebo-controlled, parallel-arm study to investigate the addition of a continuous ESPB to a single-injection ESPB following traumatic rib fractures.~The primary outcome of this study will be the maximum inspired volume measured by incentive spirometry on the afternoon following the nerve block procedure. We hypothesize that the maximum inspired volume will be significantly increased in the afternoon following the procedure with the addition of a continuous ESPB to a single-injection ESPB. |
Accurate and early diagnosis of COVID-19 infections are critical for rapid initiation of quarantine interventions to reduce population spread and to provide appropriate medical care to reduce related morbidity and mortality during the current pandemic. The purpose of this study is to assess the feasibility of establishing a drive-through rapid COVID-19 testing site at a federally-qualified health center (FQHC) during a global health crisis to mitigate health consequences in socioeconomically disadvantaged populations. The investigators also seek to evaluate the effectiveness of community-driven communication in increasing access to rapid testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in this population. This will inform public health decisions about improving access to testing for SARS-CoV-2 in underserved populations, particularly those receiving care in FQHCs or community health centers.~The specific aims of the study are to:~Aim 1. To determine the feasibility of a community-engaged research partnership to support rapid SARS-CoV-2 testing for symptomatic patients of all ages in the underserved population during the COVID-19 crisis. A rapid testing strategy (drive-through testing site) at a FQHC using Mayo Clinic Laboratory (MCL) diagnostic processing will be piloted.~Aim 2. To compare the effectiveness of community-driven messaging in increasing uptake of rapid SARS-CoV-2 testing compared with usual sources of health information. A simple random sample will be drawn of FQHC patients (N=1000, age 18+) with 1:1 randomization of communication about COVID-19 and availability of rapid testing from the FQHC versus usual sources (control). | The purpose of this study is to assess the feasibility of establishing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing at a federally-qualified health center (FQHC) during a global health crisis to mitigate COVID-19 disparities in socioeconomically disadvantaged populations. |
This open-label trial aims to analyze the effectiveness and safety of Avigan® (favipiravir) compared to Oseltamivir as an adjuvant therapy among adult COVID-19 patients. This study will be conducted in a hospital setting, recruiting adult COVID-19 patients with mild, moderate, and severe symptoms. Subjects will be randomly given Favipiravir or Oseltamivir as an adjuvant therapy to standard COVID-19 treatment. Patients will be followed up for 21 days after the first dose of intervention given. The primary outcomes of this study are clinical improvements determined by laboratory measurements and radiology results. The secondary outcomes are adverse events, hospital length of stay (LOS), and Case fatality rate (CFR) | This study aims to analyze the effectiveness and safety of Avigan® (favipiravir) compared to Oseltamivir as an adjuvant therapy among adult COVID-19 patients. This study will be conducted in a hospital setting, recruiting adult COVID-19 patients with mild, moderate, and severe symptoms. Subjects will be randomly given Favipiravir or Oseltamivir as an adjuvant therapy to standard COVID-19 treatment. Patients will be followed up for 21 days after the first dose of intervention given. The primary outcomes of this study are the improvement of radiology results and RT PCR negative conversion during follow up. The secondary outcomes are adverse events, hospital length of stay (LOS), and Case fatality rate (CFR) |
Asthma is the most frequent chronic disease in children. Severe asthma is characterized by airway hyperresponsiveness, bronchial inflammation and bronchial remodeling 1. Bronchial remodeling is an abnormal tissue repair process of the bronchial wall components which can include epithelial abrasion, thickening of the reticular basement membrane (RBM), an increase in bronchial fibrosis, blood vessel count, mucosal gland mass and/or bronchial smooth muscle (BSM) mass. At preschool age (before 6 years old), asthmatic children constitute a heterogeneous population and several classifications have been proposed to identify distinct phenotypes according to the chronology of asthma 2, the triggers of asthma 3, the trajectory of lung function as measured by forced expiratory volume in 1 second (FEV1) 4 or according to a combination of clinical and inflammatory variables 5. More recently, we demonstrated for the first time using latent class analysis (LCA) that subgroups of severe asthmatic children could also be identified according to bronchial remodeling parameters (unpublished data). Indeed, we identified two latent classes of patients. Compared to the second class, the first latent class was characterized by an increase in RBM thickness, blood vessel count, BSM mass and a decrease in RBM-BSM distance, seromucosal gland mass and bronchial fibrosis (unpublished data). Since, previous studies showed that bronchial remodeling could have negative impact on the patients' outcomes, we therefore hypothesized that the latent classes identified from the bronchial remodeling data in severe preschool asthmatic children included in the P'tit Asthme study (NCT02806466) could identify children at risk of asthma exacerbations requiring systemic corticosteroids therapy. | Bronchial remodeling is an abnormal tissue repair process of the bronchial wall components that characterizes severe asthma which can include epithelial abrasion, thickening of the reticular basement membrane (RBM), an increase in bronchial fibrosis, blood vessel count, mucosal gland mass and/or bronchial smooth muscle (BSM) mass. We identified using latent class analysis two classes of patients. Compared to the second class, the first class was characterized by an increase in RBM thickness, blood vessel count, BSM mass and a decrease in RBM-BSM distance, mucus gland mass and bronchial fibrosis. We then hypothesized that this first latent class identified children at risk of asthma exacerbations. |
Patients with rectal cancer are assigned to receive preoperative 5 × 5 Gy irradiation over 5 days with total neoadjuvant chemotherapy and camrelizumab, an anti-PD-1 antibody drug. The Primary Objective is to assess clinical complete response of an organ preservation approach and the secondary objective to assess safety in all enrolled patients, local regrowth rate and other cancer specific outcomes (metastasis-free survival, colostomy-free survival and overall survival), longitudinal health-related quality of life of this organ preservation approach. | This is a open-label, single-arm study to investigate the safety and efficacy of Total neoadjuvant chemotherapy with camrelizumab, an anti-PD-1 antibody drug following short course radiotherapy in patients with rectal cancer. |
This is a multi-center, open-label, phase II, single-arm trial evaluating combination of darolutamide and high testosterone doses - extreme bipolar androgen therapy (ExBAT) - in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after abiraterone. Extreme androgen therapy will include alternating 56-day cycles of darolutamide 1,200mg/day (two 300 tablets every 12 hours) p.o. for 28 days followed by testosterone cypionate 400 mg i.m. During the treatment period, patients will be followed with chest, abdomen and pelvis CT and bone scan every 8-9 weeks until cycle 4 and every 12 weeks thereafter during the study period. Patients who present with disease progression but are considered to be benefiting from the treatment may continue receiving it, but will be followed by their treating physician according to local guidelines (follow-up period). All patients who stopped treatment will enter follow-up period and survival data will be collected from medical charts. Additionally, QoL questionnaires (BPI-SF, EQ-5D-3L and FACT-P) will be applied every 8-9 weeks until the end of treatment. | This is a multi-center, open-label, phase II, single-arm trial evaluating combination of darolutamide and high testosterone doses - extreme bipolar androgen therapy (ExBAT) - in patients with metastatic castration-resistant prostate cancer (mCRPC). |
The purpose of this Phase 3 randomized, multicenter, active-comparator controlled, open-label trial is to determine whether LNP023 is efficacious and safe for the treatment in PNH through demonstration of superiority of LNP023 compared to anti-C5 antibody treatment in adult PNH patients presenting with residual anemia despite treatment with anti-C5 therapy.~The study is planned to randomize approx. 91 patients in various countries. | The purpose of this Phase 3 study is to determine whether LNP023 is efficacious and safe for the treatment in PNH through demonstration of superiority of LNP023 compared to anti-C5 antibody treatment in adult PNH patients presenting with residual anemia despite treatment with anti-C5 therapy |
The first phase assesses single ascending doses of EDP-297 or placebo in healthy subjects. A fasted and fed two-part cohort will also assess food effect.~The second phase assesses multiple ascending doses of EDP-297 or placebo for 14-days in healthy subjects.~Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-297 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-297 or placebo | This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects. |
Background: Neuroblastoma is the most frequent extracranial childhood tumor, with an annual incidence of approximately 10.2 per million children. Initial staging of the disease and monitoring of the treatment response can be performed with different imaging modalities that include contrast-enhanced computed tomography (ceCT), ultrasound, magnetic resonance imaging (MRI), bone scintigraphy and 123I-MIBG scintigraphy.~Another potential target for neuroblastoma imaging is the somatostatin receptor (SSTR) that is present in many neuroendocrine tumours (NET). The superior PET imaging technology used with new radiotracers (such as 68Ga-DOTATATE) enables imaging at advantageous resolutions well below what is possible by current clinical SPECT systems that are used for 123I-MIBG.~Design: Prospective single-arm non-randomized clinical trial (phase II) - pilot~Objective: 1) Assess the feasibility and safety of 68Ga-DOTATATE PET/CT imaging in patients with neuroblastoma or suspected of having neuroblastoma. 2) Compare lesion-by-lesion the uptake of 68Ga-DOTATATE and 123I-MIBG in the same participant.~Study population: Children and adults with biopsy-proven or suspected neuroblastoma~Procedure and Follow-up: Few days after 123I-MIBG scan, participants will undergo a 68Ga-DOTA-cTATE PET/CT scan (duration 2 hours). Clinical data will be collected from this imaging and from the participant's medical record (demographic, treatment, medication, pathology, lab test results) for a 2-year follow-up period. | Neuroblastoma is the most frequent extracranial childhood tumor, with an annual incidence of approximately 10.2 per million children. Staging of the disease can be done by different imaging strategies (CT, MRI, scintigraphy and PET/CT). Discrepancies may be observed among these different strategies resulting in different treatment strategies. The goal of this study is to assess the feasibility and safety of 68Ga-DOTATATE and to compare it to 123I-MIBG when investigating neuroblastoma. |
To study if the outcomes for the injection of bone marrow concentrate (BMC) in patients with disc, facet, epidural space, and sacroiliac joint pain create a clinically meaningful improvement in pain and function. Further analysis will determine if there be any variance in patient reported outcome due to the individual's pre-procedure cell count and analysis.~Hypothesis 1: An injection of autologous BMC into discs, facets, sacroiliac joints, and epidural space will improve pain and function in patients with IDD~Hypothesis 2: There will be a direct relationship between an individual's BMC composition and the patient's reported outcomes | Intradiscal delivery of bone marrow concentrate (BMC) into discs, facet, epidural space, and sacroiliac joints |
Background The tools used for fragmentation and stone extraction have been improving over time. Commonly available lithotripsy power sources are classified as ultrasonic, kinetic, electrohydraulic, or combination, however, laser is the most widely used lithotripsy device in mini-PCNL as it is a small diameter power source.~Laser lithotripsy The holmium laser has been very effective in the fragmentation of stones of variable hardness and very safe due to its low depth of penetration (0.5 mm).~One of the advantages of the Ho: YAG laser is that it offers relatively quick lithotripsy while minimizing tissue trauma. Furthermore, it is effective against all stone compositions, including cystine and calcium oxalate monohydrate, where ultrasonic lithotripsy may have difficulties.~The removal of smaller fragments is possible using a vacuum effect where the fragments are moved from a high pressure zone in the pyelocaliceal system to a lower pressure zone in the sheath. If there are too many fragments, this requires multiple insertions and extractions of the nephroscope to facilitate the recovery of all of them. This repeated step can cause inadvertent movements that affect the results.~Combined ballistic-ultrasonic lithotripsy LithoClast Trilogy EMS is the newest model of percutaneous lithotripsy technology that provides electromagnetic and ultrasonic ballistic energy, as well as suction capacity under the control of the surgeon through a single pedal. Laboratory studies have suggested that combined ballistic-ultrasonic lithotripsy offers faster stone clearance than other combined and ultrasonic devices. In an in vitro comparison, LithoClast Trilogy EMS had the fastest average removal time of 23.79 seconds. This was followed by ShockPulse (46.04 seconds), Select-US (54.86 seconds), and Select-USP (102.48 seconds).~In a multi-institutional study, LithoClast Trilogy EMS was evaluated, the experience of surgeons with this device was perceived as highly satisfactory, with an excellent safety and durability profile. The average stone removal rate was 68.9 mm2 / minute. High tissue safety and an optimized aspiration configuration were reported in a prospective clinical trial. In this study, the mean stone volume clearance ratios were 370.5 ± 171 mm3 / min and 590.7 ± 250 mm3 / min for mini-PCNL and PCNL, respectively.~LithoClast Trilogy EMS has a single probe design and connects to the handpiece and oscillates with a piezoelectric ultrasonic generator at a rate of 24 kHz. At the same time, an electromagnetic generator produces ballistic motion of the entire probe at an adjustable speed of up to 12 Hz. As with other ultrasound-based devices, suction is available through the hollow probe, with the foot pedal controlling the aspiration and activation of lithotripsy. The strength of the ultrasonic vibration, the aspiration and the ballistic energy discharge frequency are adjustable through a touch screen on the generator. Various probe sizes are available (3.3 F, 4.5 F, 5.7 F, 10.2 F, and 11.7 F catheter).~JUSTIFICATION The desire to reduce complications related to percutaneous access and morbidity related to tract size has led researchers to evaluate PCNL using smaller-caliber instruments. In this context, mini-PCNL has emerged. Its efficacy and safety have been demonstrated at the cost of a lower stone-free rate.~The effectiveness of existing Ho: YAG lasers is limited by the need for manual removal of stone fragments and mobilization of them due to the lack of a simultaneous aspiration system. Consequently, this has been associated with long surgical times to achieve stone-free status. This requires multiple insertions and extractions of the nephroscope to facilitate the recovery of all fragments. This repeated step can cause the safety rails to be inadvertently removed or the sheaths to be disinserted. Sometimes compromising surgical results.~Faced with this situation, the search for better and more efficient energy sources still continues. With this, modern lithotripters have emerged that combine energy sources and work more efficiently than any of them independently and, consequently, improve stone removal. Cyberwand ™ (Olympus, Tokyo, Japan), Swiss Lithoclast® Master / Select (EMS SA, Switzerland / Boston Scientific, Marlborough, MA, USA) and Shockpulse-SE ™ (Olympus, Tokyo, Japan) are some examples; although they have their own set of advantages, none have proven to be superior to any other.~As previously discussed, ballistic-ultrasonic lithotripsy combines ultrasonic and ballistic energy together with a suction system with encouraging results in terms of a shorter lithotripsy time and the respective economic impact of fewer surgical events and less operating time required for the stone removal.~Therefore, it is convenient to make a comparison between the results of lithotripsy with Ho: YAG laser energy and lithotripsy with LithoClast Trilogy EMS; and thereby determine which is the most effective method in the resolution of kidney stones through a miniaturized percutaneous tract.~PROBLEM STATEMENT What is the difference of the lithotripsy rate with LithoClast Trilogy EMS compared to 100 W Holmium laser for patients with kidney stones GUY's 1 and 2 in percutaneous mini nephrolithotomy?~HYPOTHESIS H0: Lithotripsy performed with LithoClast Trilogy EMS in patients with GUY's 1 and 2 kidney stones undergoing percutaneous mini nephrolithotomy has a higher lithotripsy rate than that performed with a 100W Holmium laser.~Hi: Lithotripsy performed with LithoClast Trilogy EMS in patients with GUY's 1 and 2 kidney stones undergoing percutaneous mini nephrolithotomy has a lower lithotripsy rate than that performed with a 100W Holmium laser. | The desire to reduce complications related to percutaneous access and morbidity related to tract size has led researchers to evaluate PCNL using smaller-caliber instruments. In this context, mini-PCNL has emerged. Its efficacy and safety have been demonstrated at the cost of a lower stone-free rate.~The effectiveness of existing Ho: YAG lasers is limited by the need for manual removal of stone fragments and mobilization of them due to the lack of a simultaneous aspiration system. Consequently, this has been associated with long surgical times to achieve stone-free status. This requires multiple insertions and extractions of the nephroscope to facilitate the recovery of all fragments. This repeated step can cause the safety rails to be inadvertently removed or the sheaths to be disinserted. Sometimes compromising surgical results.~Faced with this situation, the search for better and more efficient energy sources still continues. With this, modern lithotripters have emerged that combine energy sources and work more efficiently than any of them independently and, consequently, improve stone removal. Cyberwand ™ (Olympus, Tokyo, Japan), Swiss Lithoclast® Master / Select (EMS SA, Switzerland / Boston Scientific, Marlborough, MA, USA) and Shockpulse-SE ™ (Olympus, Tokyo, Japan) are some examples; although they have their own set of advantages, none have proven to be superior to any other.~As previously discussed, ballistic-ultrasonic lithotripsy combines ultrasonic and ballistic energy together with a suction system with encouraging results in terms of a shorter lithotripsy time and the respective economic impact of fewer surgical events and less operating time required for the stone removal.~Therefore, it is convenient to make a comparison between the results of lithotripsy with Ho: YAG laser energy and lithotripsy with LithoClast Trilogy EMS; and thereby determine which is the most effective method in the resolution of kidney stones through a miniaturized percutaneous tract. |
The prevalence of mental health disorders in Primary Care (PC) largely exceeds the limited resources available. The main aim of this project is to develop a comprehensive machine learning (ML) digital support platform (PRESTO) to approach people with mental health symptoms in PC. PRESTO will offer a transdiagnostic triage of those cases needing specialized care while most of the mild and moderate cases with anxiety and depressive symptoms will be allocated through ML models to either: 1.a periodic follow-up, 2.symptoms monitoring and brief psychological intervention with a smartphone app, or 3.a specific psychopharmacological treatment. To reach this objective, first, a ML predictive severity model will be build based on all the cases referred to the PC mental health support programme during the last 5 years retrieved from electronic health records from 5 PC centres(PCC) in Barcelona. Simultaneously, a smartphone app (PRESTOapp) monitoring symptoms and delivering a psychological intervention for non-severe anxious and depressive symptomatology will be developed and tested in a feasibility study and in a randomized clinical trial. Finally, the ML models obtained from the first phase of the project and the data from the PRESTOapp study will be integrated in a comprehensive self-learning web platform which will triage and assign to each case a specific intervention based on the predicted outcome. The effectiveness of PRESTO to reduce waiting times in receiving appropriate and specific care of mental health problems will be tested by means of a stepped-wedge randomized controlled trial in 5 PCCs in Barcelona.~Here we register a Randomized controlled clinical trial with PRESTOapp 2.0.~Design: Single-blind randomized controlled clinical trial.~Sample: Referrals to mental health support programme (PCMHSP) by GPs from the 5 primary care centres included in the study.~Sample size calculation: Considering the priority (primary outcome) the reduction of depressive symptoms assessed by PHQ-9 and taking into account two groups (PRESTOapp 2.0 vs. treatment as usual) in addition to previous results of effect sizes between 0.30 - 0.35 from similar studies (similar intervention, same scale), we have established a power of 0.80 and a α of 0.05. Considering the current numbers of visits by all members of the PCMHSP who can potentially be offered inclusion in the study in 6 months (1000 individuals), the total sample should have at least 122 participants. However, experience in similar studies indicates an expected 25-30% drop-out. Therefore, it was decided to add 15 more subjects per branch for preventive purposes and to ensure that at the end of the study there would be a sufficient sample to guarantee the strength of the data.~Intervention Group (PRESTOapp 2.0): 76 participants~Control Group (Treatment as usual): 76 participants TOTAL: 152 participants.~Considering the number of PCMHSP members involved in the project as well as the high number of referrals (which is the main problem this project is trying to solve), reaching these numbers is fully feasible within the stipulated time.~Inclusion criteria: Individuals 18-65 years of age who are referred to or are being followed up by members of the PCMHSP in the 5 PCCs corresponding to the 5 Barcelona catchment areas (ABS), scoring between 4 and 14 points on the PHQ-9 scale, or 6 to 15 on the GAD-7 scale. They must also accept and sign the informed consent for study participation and must have a compatible smartphone (Android or iPhone).~Exclusion criteria: Individuals who do not know and/or do not wish to learn the skills required to operate a smartphone. Estimated IQ less than 70 with functional impairment Patients with a severe mental disorder (Bipolar Disorder, Schizophrenic Disorder, Schizoaffective, Obsessive-Compulsive) or substance use disorder, PHQ-9 >= 15, GAD-7 >= 16. People with moderate to severe suicidal ideation (PHQ-9 Question 9 with a score of 2 or 3)~Recruitment procedure: All users referred to PCMHSPs by GPs from the PCC included in the study will be offered participation in the study. Once the information on the study has been provided, which will also be available in printed form in the waiting room for consultations, any doubts presented by the user will be cleared up and the signature of the informed consent will be requested.~Randomization: Once users are recruited, an independent researcher will randomize the participants using a 1:1 sequential method in two groups of 76 individuals and will assign a 6-digit identification code (IC) to each participant. The IC will be given to the participant on a reminder card and will be used to access the app to guaranteeing its confidentiality. The name of the subjects and their respective code will be stored in independent servers for methodological, security, and legal reasons. The intervention group will be asked to use the app for a period of 2 months. The control group will receive the usual follow-up and treatment during the same time by the PCMHSP team.~Data collection:~* Initial evaluation: The estimated time used for the initial evaluation including an explanation of the study, signing of the informed consent, and data collection is of about 30 minutes.~■ Intervention Group: In this first visit, a brief explanation of how the app works and a brochure explaining PRESTOapp 2.0 will be given. Users will be asked to use the app on their smartphone for the next 2 months. During this first visit, we will help the participant to install the app. Subsequently, the following data will be collected:~Demographic variables: gender, age, marital status, housing condition, number of children, years of education, educational level, employment status.~Clinical variables: medical comorbidities, hospitalizations, number of depressive episodes and previous hospitalizations, history of psychotic symptoms, seasonal pattern, history of melancholy, atypical, psychotic or catatonic symptoms in depressive episodes, comorbidity (axes I, II and III), family history (first degree) of psychiatric disorders and suicide, number of self-initiated attempts and method.~Care variables: Number of visits in MAP in the last 5 years, number of visits in PSP, number of consultations in the emergency department. The 9-items Patient Health Questionnaire (PHQ-9)~The 7-item Generalized Anxiety Disorder Questionnaire (GAD-7)~World Health Organization 5-item General Welfare Index (WHO-5)~Holmes and Rahe Stress Scale~Participants will be informed that the next follow-up visit (and clinical assessment) by the PCMHSP will be in 2 months at the end of the study unless the app indicates or symptoms that require urgent care arise.~■ Control Group: The same information and scales as for the intervention group will be collected.~* Follow-up evaluation: A follow-up appointment will be carried out in both groups after 2 months, lasting approximately 30 minutes, during which the same data collected in the baseline interview will be collected, in addition to the Technology Acceptance Model (TAM), usability with the System usability scale (SUS), and satisfaction with the Health App Usability Questionnaire (MAUQ).~Statistical analysis: All the data will be collected by the project researchers and the PCMHSP team, and stored in encrypted and secure servers. The data from the app will be managed by the researchers only. Statistical analyses will be conducted using specific R packages. The analyses of all the subjects included will be considered until the abandonment or end of the study. The main variable is the change in symptoms measured by PHQ-9, GAD-7, secondarily it will be considered WHO-5, during the 2 months, controlled by life stressors as assessed by the Holmes y Rahe scale. We will use a mixed effects linear model with random interception for each participant. The differences in the primary measures will be analyzed first in an unadjusted manner and then adjusted for sociodemographic and clinical factors collected, if you present a p≤0.1 in univariate analysis. An analysis by intention to treat (ITT) with last observation carried performed (LOCF) will also be employed. A threshold of statistical significance p≤0.05 (two-tailed) will be set.~Study limitations: There is no investigator blinded for logistical and ethical reasons, nor is there a placebo in the case of controls. The main reason for this design is that the methodological effects of providing a placebo app to the control group are unclear. Assumable risks are the placebo effect in the intervention group, natural progression, and regression to the mean. | The prevalence of mental health disorders in Primary Care (PC) largely exceeds the limited resources available. The main aim of this project is to develop a comprehensive machine learning (ML) digital support platform (PRESTO) to approach people with mental health symptoms in PC. PRESTO will offer a transdiagnostic triage of those cases needing specialized care while most of the mild and moderate cases with anxiety and depressive symptoms will be allocated through ML models to either: 1.a periodic follow-up, 2.symptoms monitoring and brief psychological intervention with a smartphone app, or 3.a specific psychopharmacological treatment. To reach this objective, first, a ML predictive severity model will be build based on all the cases referred to the PC mental health support programme during the last 5 years retrieved from electronic health records from 5 PC centres(PCC) in Barcelona. Simultaneously, a smartphone app (PRESTOapp) monitoring symptoms and delivering a psychological intervention for non-severe anxious and depressive symptomatology will be developed and tested in a feasibility study and in a randomized clinical trial. Finally, the ML models obtained from the first phase of the project and the data from the PRESTOapp study will be integrated in a comprehensive self-learning web platform which will triage and assign to each case a specific intervention based on the predicted outcome. The effectiveness of PRESTO to reduce waiting times in receiving appropriate and specific care of mental health problems will be tested by means of a stepped-wedge randomized controlled trial in 5 PCCs in Barcelona.~Here we register a Randomized controlled clinical trial with PRESTOapp 2.0 detailed afterwards: |
This study is a Phase 1b proof-of-concept, open-label study to assess the safety and pilot efficacy of Enbrel administered by the Sofusa® DoseConnect™ delivery system (SOFUSA) for the treatment of patients with moderately to severe RA and an inadequate response to subcutaneous (SC) Enbrel. SOFUSA Enbrel will be administered once weekly to patients for 12 weeks. Patients will start on an Enbrel dose of 25 mg during the induction phase of the study and may be increased to an Enbrel dose of 50 mg during the dose escalation phase of the study based on the dose escalation criteria. Patients will remain on either the 25 mg or 50 mg dose for the final maintenance phase of the study. | This is an open-label pilot study in patients with rheumatoid arthritis (RA). All patients will receive SOFUSA Enbrel 25 mg once weekly. The dose will be increased to 50 mg if the dose escalation criteria are met during the dose escalation phase of the study. |
Low back pain (LBP) is a very common health problem worldwide and a major cause of disability which affecting performance at work and general well-being. Determine the effects of static and dynamic back extensors exercises for chronic low back pain. | This study will help to find the effects of static and dynamic back extensors exercises for chronic low back pain. |
Background: This study aimed to determine the effect of progressive relaxation exercises (PMR) on dyspnea and anxiety level in individuals with COPD Methods: The study was conducted in the pretest-posttest randomized-controlled trial and completed with 44 COPD individuals, 22 interventions and 22 controls. PMR were applied once a day for four weeks in the intervention group in addition to the standard treatments. The control group received standard treatment. For data collection Questionnaire Forms, Patient Follow-Up Schedules, Modified Borg Scale (MBS), Modified British Medical Research Council Dyspnea Scale (mMRC), COPD Assessment Test (CAT), and Beck Anxiety Scale were used. | Background: This study aimed to determine the effect of progressive relaxation exercises (PMR) on dyspnea and anxiety level in individuals with COPD Methods: The study was conducted in the pretest-posttest randomized-controlled trial and completed with 44 COPD individuals, 22 interventions and 22 controls. PMR were applied once a day for four weeks in the intervention group in addition to the standard treatments. The control group received standard treatment. |
This is a multicentric open-labal trial to evaluate the efficacy and safety of transarterial chemoembolization (TACE) in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced hepatocellular carcinoma (HCC). The primary hypotheses are that TACE in combination with Camrelizumab and Apatinib is superior to TACE alone with respect to progression-free survival (PFS). | The purpose of this study is to evaluate the efficacy and safety of TACE in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced HCC. |
Background Information and Scientific Rationale The AdventHealth Orlando NICU is the first U.S. hospital to utilize the Babyleo in a clinical setting. Personnel were trained by Dräger representatives and the units have been in use for over 2 years. During that time, personnel have not used the Audio Port, located on the back of the bed. The Audio Port allows sound to be played inside the incubator at no more than 55 dB, which is within the guidelines set forth by the American Academy of Pediatrics for the target population of this project.~The early birth of a premature baby can be a devastating and unplanned situation for parents. Often, their baby cannot be readily held; they can be very sick and fragile. Parents can feel helpless; bonding may be more difficult, parental control is superseded by medical necessity and parents can feel tremendous guilt whenever they are unable to be present at their baby's bedside.~The investigators will attempt to provide some comfort and control to the parents of premature infants by implementing this project. Research has shown that when used appropriately in the premature to term infant population, specific sounds can result in a shorter hospital stay, improved feeding skills, improved behavior state and improved physiological status.~The investigators believe that giving parents an opportunity to provide comfort in the form of the mother's voice, pre-recorded and played to her baby, will improve her feeling about her baby in the NICU. As the process of recording the mother's voice will be aided by trained Music Therapists, parents will also gain knowledge about developmentally appropriate methods of interacting with their infant.~Consideration also needs to be given to staff education. It has long been ingrained in staff that noise for the premature infant is undesirable and upsetting to their immature nervous system. While this can be true, studies have shown that appropriate sounds, introduced at the right time, can aid in brain development and the later acquisition of language. Babies do not necessarily need to live in a sound-free environment; in the womb, they are continually exposed to sound. However, staff are very protective of keeping premature infants from becoming stressed, and so the mention of introducing sound into their quiet incubator causes a great deal of consternation. Detailed explanation and staff buy-in will be very important for this study.~Multiple studies have shown that providing a recorded maternal voice in the form of conversation, singing, or book reading to her preterm infant can have significant beneficial effects. It has been shown that maternal voice exposure results in improved infants' cardio-respiratory functions, (1-3), relieving pain during noxious procedures (4), improved circadian rhythms (5), reduced incidence of apnea and bradycardia (6) and overall improvement of developmental outcomes (7-9). The mother providing her voice to her fetus during the third trimester of pregnancy also has beneficial effects on her own anxiety and depression (10,11). Several studies have shown the safety and feasibility of introducing sound into an incubator (14,15,16). However, other studies have introduced music into the incubator via speakers, headphones or an audio player with loudspeakers (21).~The investigators propose to use the Babyleo's built-in audio port. The mother will record an audio CD with the guidance of Music Therapy. This will be played on a CD player for no more than 30 minutes at a time, 4 times a day. The recorder is plugged in to the audio port by a standard cable from the headset port of the CD player.~Study Objectives~Primary Objective/Aim/Goal/Hypothesis Preterm birth is associated with a higher rate of postpartum depression disorders (17,18,19,20). This is in part due to feeling of let down because the mothers are unable to care for her baby and has to leave the baby in the NICU for care. The let down feeling may be lessened if mothers are given the opportunity to express their concern by producing a recording for their babies. The investigators hypothesize that playing the mother's recorded voice to her extremely preterm infant while in the incubator when she cannot be present will improve the depression, anxiety and stress as well as overall feeling about her baby. The study team will assess the change in depression, anxiety and stress with the use of a validated tool (the DASS21), as a result of the intervention. The investigators will also assess the improvement of her feelings with a questionnaire () to be administered before and after the intervention. The investigators predict that her depression, anxiety and stress as well as positive feeling will increase after the intervention.~Secondary Objective/Aim/Goal/Hypothesis~The infant's vital signs will remain stable and/or improve when the recording is played. Vital signs for the purpose of this study will be defined as; heart rate and respiratory rate. Blood pressure and temperature will be recorded if available. Vital signs will be assessed both before the recording and during the recording. Over time, the study team predicts vital signs will remain within acceptable parameters.~Playing mother's voice will reduce the incidence of apnea, bradycardia and desaturation of the study infants.~Study Design Research Design This is a randomized, prospective clinical study.~Research Intervention Description As shown in the diagram below, maternal consent will be obtained during the first week of life and the baby will be randomized as shown in the diagram below. Group 1 mothers' voice will be played between week 2 and 3 while group 2 mothers' voice will be played after week 3 but no research data will be collected. Group 2 will therefore serve as control.~Between consent and the infant reaching two weeks of life, the mother will be given time to acclimate to having a child in the NICU, and to adjust to the fact that she has delivered early and not at term. After seven days and prior to meeting with the music therapist, she will be asked to complete the DASS21 and the questionnaire that expresses her feelings about her baby in the NICU. Surveys will be completed in Survey Monkey on a research department tablet or via the mother's own electronic device. She will then work closely with Music Therapy staff, receiving education about appropriate developmental sound for her baby and to record her voice on a CD.~For those who have been randomized to receive the intervention, the mother's recorded voice will be played via the incubator's audio port. At week three (+2 days), the DASS21 and feeling questionnaire will be repeated for both groups. Both groups will then be allowed to play the recording within guidelines, but no further research data will be collected. Staff education will be conducted by research personnel and selected staff members (Ambassadors). Ambassadors will also facilitate playing of the recording, particularly on night shift, to assist with parent education and to support staff efforts.~Research staff will approach the parents of babies born at 260/7 to 306/7 weeks gestation and explain the project, asking for permission to participate and obtaining consent. A Parent Education Sheet, prepared by the Developmental Committee, will be given to each participating family.~Demographic and clinical data, including mother's age, race, level of education, and infant's gestation, gender, birth weight, Apgar score, ventilatory support, and IVH, will be collected from the medical records.~Under the guidance of the Music Therapy Department, the mother will create a sound recording, which could include any and all of the following: the mother's heartbeat, the mother speaking to her child (i.e., reading a book, expressing her love and hopes for the future), the mother singing to her child, etc. Mother can choose the subject matter. She can also choose from a list of available books/songs. The recordings will be played for the infant for 1 week as intervention, when visitors are not present. The recording will be 30 minutes long, and will be played four times a day, at a time the clinical team determines is appropriate for that baby. There will be a 30-minute period of silence after the recording. A cord is inserted into the headphone port of the CD player and then into the Babyleo Audio Port, which is the same type of port as the headphone port (male/male connector). The set-up will be done by a member of the research team, the bedside RN simply has to push play. Data will be collected regarding the infant's tolerance for the recording. Vital signs will be recorded during the study intervention 30 minutes before the recording is played and then once during the intervention. The incidence of daily ABDs (apnea, bradycardia, desaturations) are routinely documented in the EMR and will be obtained from the medical record: A. Apnea for > 20 seconds, B. Heart rate < 80 beats per minute C. Oxygen saturations <80 The study team expect that the incidence of ABDs will decrease by the end of the intervention, although changes in ABDs may be multifactorial and influenced by increased maturity, level of illness or respiratory status.The infant's nurse may, at his/her discretion, discontinue playing the recording for any reason. While multiple studies have shown the safety of introducing voice to the premature baby, if the infant has 3 ABDs during 3 consecutive interventions, the infant will be taken off the study. When the infant comes out of the incubator and into a crib, the study team can give the parent the recording via CD or audio file (mp3 or mp4).~Study Site(s)/Location(s) and Number of Subjects This study will take place at the AdventHealth Orlando NICU. Sample size will be calculated using the DASS21 (our primary outcome) of the first ten mothers enrolled in the study. The investigators will aim for a 30% relative increase in Feeling score with 80% power Plan. | The early birth of a premature baby can be a devastating and unplanned situation for parents. Often, their baby cannot be readily held; they can be very sick and fragile. Parents can feel helpless; bonding may be more difficult, parental control is superseded by medical necessity and parents can feel tremendous guilt whenever they are unable to be present at their baby's bedside. The investigators believe that giving parents an opportunity to provide comfort in the form of the mother's voice, pre-recorded and played to her baby, will improve her feeling about her baby in the NICU. The investigators hypothesize that playing the mother's recorded voice to her extremely preterm infant while in the incubator when she cannot be present will improve the depression, anxiety and stress as well as overall feeling about her baby. The investigators will assess the change in depression, anxiety and stress with the use of a validated tool (the DASS21), as a result of the intervention. The investigators will also assess the improvement of her feelings with a questionnaire () to be administered before and after the intervention. The investigators predict that her depression, anxiety and stress as well as positive feeling will increase after the intervention. The investigators also predict that the infant's vital signs will remain stable and/or improve when the recording is played. |
Burden:~Globally, it is recognized that pre-conception and during pregnancy malnutrition among women is an underlying cause of maternal morbidity, mortality, and poor birth outcomes including low birth weight babies. In Bangladesh, the poor pre-conception and pregnancy nutritional status of women contributes to the prevailing high rates of low birth weight among newborns. Each year, approximately 860,000 or 28% of babies are born with low birth weight (<2500g) greatly increasing their risk of stunting and wasting, and diet-related non-communicable diseases in adult life.~Knowledge gap:~An ideal contact point for pregnant women for delivering nutrition services are antenatal care visits (ANC). However, the provision of maternal nutrition services through government systems is inadequate in terms of coverage and quality. Overall 29% of pregnant women in Bangladesh receive 4 ANC and 18% of women consume at least 100 IFA tablets. Moreover recent WHO context specific recommendation suggest countries with a high prevalence of nutritional deficiencies may choose to adopt multiple micronutrient supplementation (MMS) over iron folic acid (IFA). The health benefits of MMS cannot be harnessed without a properly functioning delivery platform. A multifaceted approach focusing on improving the quality of ANC, the supply system for these services, engagement with communities, in addition to the adoption of MMS may have large benefits to women and children in Bangladesh. UNICEF and the Bill and Melinda Gates Foundation have partnered with several different organizations, including the GoB and icddr, b to build a comprehensive understanding of where gaps in ANC and nutritional care delivery currently exist, how to bridge these gaps, strengthen both the supply and service system, engage with a larger number of pregnant women, and finally encourage the adoption of the programme across Bangladesh.~Relevance:~The most recent State of Food Security and Nutrition in Bangladesh Report found that 66% of women did not consume adequately diversified diets, indicating micronutrient deficiencies. A growing body of evidence has found that multiple micronutrient supplementation (MMS) may result in better neonatal outcomes for undernourished pregnant women. MMS has been associated with reductions in the number of LBW and small for gestational age (SGA) births, as well as a reduction in the number of preterm births among mothers who were underweight in both meta-analysis and a randomized control trial in Bangladesh. Recently in Dhaka, Bangladesh national anaemia consultation workshop was held, which also recommended changing the formulation from IFA only to a multi-micronutrient supplement for pregnant women and to scale up providing children with MNPs.~Objectives:~The study will be conducted in two phases. The specific objectives are;~Phase I:~To conduct a comprehensive situation analysis to identify gaps in the existing maternal nutrition service delivery and coverage of maternal nutrition interventions~To conduct a formative research to inform design of a demonstration programme improving maternal nutrition service delivery through public health ANC platforms~Phase II:~To implement a two parallel arm superiority community based cluster randomized controlled trial (cRCT) to assess whether implementation of the demonstration programme improves coverage and quality of nutrition service delivery through public health ANC platforms~Methods:~During phase I,a comprehensive situation analysis and a formative research will be conducted to inform the design of a demonstration programme improving maternal nutrition service delivery through public health ANC platforms. The study will employ a quantitative approach for comprehensive situation analysis involving health facility assessment, health care provider interviews, ANC observation, exit interviews of the women receiving ANC and household hold survey. The situation analysis will enable the investigators to identify the gaps of in terms of coverage and quality of maternal nutrition services through public health ANC platforms, knowledge, attitude and practices of the health care providers and pregnant women regarding maternal nutrition. A formative research will be conducted to inform the design of the demonstration programme. Demonstration programme will be designed based on the findings from the baseline situation analysis and formative research. During Phase II, a two parallel arm superiority community based cluster randomized control trial (cRCT) will be implemented to assess whether implementation of the demonstration programme improves coverage and quality of Nutrition services through public health ANC platforms. Unit of randomization will be unions. A total of 40 unions will be selected from two districts and paired based on principle component analysis (PCA) score. PCA will take into consideration coverage of ANC and IFA and socio-demographics characteristics (literacy rate, provision of pure drinking water, sanitation facilities). Later each of the pair will be randomized into either intervention or comparison arm. Cross sectional surveys will be conducted to assess coverage of key maternal health and nutrition indicators. Additionally a cohort of pregnant women from intervention and comparison facilities will be followed to measure the change in quality of nutrition service delivery and consumption of 100+ MMS tablets during pregnancy. | Malnutrition among women of reproductive age is a significant public health problem in Bangladesh, with major implications for a woman's own health and that of her newborn child. The principal drivers for maternal malnutrition in Bangladesh are poor-quality diets, care seeking practices and access to health care. An ideal contact point for pregnant women are antenatal care visits (ANC). However, the provision of maternal nutrition services through government systems is inadequate with just 29% of pregnant women attending all 4 ANC visits and 18% of women consuming at least 100 IFA tablets. Moreover, WHO made a context specific recommendation that countries with a high prevalence of nutritional deficiencies may choose to adopt multiple micronutrient supplementation (MMS) over iron folic acid (IFA). The health benefits of MMS cannot be harnessed without a properly functioning delivery platform. A multifaceted approach focusing on improving the quality of ANC, the supply system for these services, engagement with communities, in addition to the adoption of MMS may have large benefits to women and children in Bangladesh. UNICEF and the Bill and Melinda Gates Foundation have partnered with several different organizations, including the GoB, Sight & Life, Pennsylvania State University (PSU) and icddr, b to design and assess outcome of a community based randomized control trial to improve coverage and quality of maternal nutrition service delivery through ANC platform. The investigators hypothesize that implementation of demonstration programme will result in 60% relative improvement in the coverage of 100+ MMS among women who received 4+ANC in the intervention areas compared to the coverage of 100+ IFA among women who received 4+ANC in comparison areas. |
Colorectal cancer is the second most common cancer in Canada. Colonoscopy and removal of precancerous polyps (polypectomy) reduces the incidence and mortality associated with colorectal cancer. However, polypectomy is associated with adverse events. Post-polypectomy bleeding has a significant impact on the life of the patient as it can require hospitalization, transfusions, repeat colonoscopy and rarely death. It is also a substantial cost to the health care system. Post-polypectomy delayed bleeding (PPDB) can occur up to a month following the procedure but is typically seen within the first week. Risk factors include the size of the polyp, antithrombotic or anticoagulation use, age, major comorbidities and proximal colon polyps. The incidence of bleeding after removal of large polyps is estimated to be around 2.6%-9.7%. There currently is no standard of care to prevent bleeding after polypectomy. Tranexamic acid reduces fibrinolysis by slowing down the conversion of plasminogen to plasmin which may prevent bleeding.~This pilot study will examine factors involved in the feasibility of conducting a large-scale RCT. This pilot study will include 25 consecutive patients who are treated with tranexamic acid after endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (LNPCP's) to prevent PPDB. | Colorectal cancer is the second most common cancer in Canada. Colonoscopy and removal of precancerous polyps (polypectomy) reduces the incidence and mortality associated with colorectal cancer. However, polypectomy is associated with adverse events. Post-polypectomy bleeding has a significant impact on the life of the patient as it can require hospitalization, transfusions, repeat colonoscopy and rarely death. It is also a substantial cost to the health care system. There currently is no standard of care to prevent bleeding after polypectomy.~Tranexamic acid reduces fibrinolysis by slowing down the conversion of plasminogen to plasmin which may prevent bleeding. Although this medication is used extensively for other purposes, it has not been studied before to prevent post-polypectomy bleeding.~This pilot study will examine factors involved in the feasibility of conducting a large-scale randomized controlled trial (RCT). This pilot study will include 25 consecutive patients who are treated with tranexamic acid after endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (LNPCP's) to prevent PPDB. |
Due to intrinsic characteristics of ambulance transport raises stress or anxiety in patients. Moreover, other outcomes such as pain and some specific vital signs are affected. In the last years, empowerment patient strategies have been launched in several clinical settings but none in the ER field.~Main objective Comparative assessment of the effectiveness of multimedia exposure vs standard clinical procedures to improve the experience and patient reported outcomes in patients suffering from ST-Elevation myocardial infarction transferred to hospital in an Advanced Life Support ambulance for a percutaneous coronary intervention (PCI).~Methods Randomised clinical trial, single-center, blinded assessment, controlled with usual practice with two-group parallel design.~Eligible patients are those assisted and transferred suffering from STEMI in an Advance Life Support (ALS) ambulance from public Emergency Medical System in the Cadiz region.~Experimental group will watch multimedia content on a tablet (movie or image with sound) ad hoc designed, control group will be assisted as usual procedures.~Main outcomes will be conformed by informed patient results (anxiety State, pain and comfort) and patient experience (transfer experience). | Randomised clinical trial, single-center, blinded assessment, controlled with standard practice with two-group parallel design.~Eligible patients are those assisted and transferred suffering from ST-Elevation myocardial infarction in an Advanced Life Support ambulance from an public Emergency Medical Service in the Cadiz area (Spain).~Experimental group will watch an ad hoc design multimedia content in a tablet (video with sound and subtitles) during the transfer and control group will be assisted as standard procedures.~Main outcome variables will be conformed by patient reported outcomes (anxiety State, pain and comfort) and patient experience (transfer experience). |
This project will investigate the effects of a Narrative and Skills-building Intervention on young stroke survivors' community reintegration and psychosocial outcomes. A randomised controlled trial will be conducted. Participants will be facilitated to narrate their survival experiences and rebuild core life skills. Outcomes including community reintegration, depressive symptoms, health-related quality of life, self-efficacy, outcome expectation and satisfaction with performance of self-management behaviours will be measured. This is a novel trial to test the short and long-term effects of a theory-based intervention on young stroke survivors' community reintegration. | This project will investigate the effects of a Narrative and Skills-building Intervention on young stroke survivors' community reintegration and psychosocial outcomes. A randomised controlled trial will be conducted. This is a novel trial to test the short and long-term effects of a theory-based intervention on young stroke survivors' community reintegration. |
With an incidence of more than 11,600 new cases per year in France and an annual number of deaths close to the incidence rate, adenocarcinoma of the pancreas is a public health problem especially since there is a significant increase in its incidence. incidence (+ 417% between 1980 and 2012).~Most often diagnosed late, pancreatic adenocarcinoma is managed at a metastatic stage in 60 to 70% of cases with a very poor prognosis (8.7 to 11.1 months median survival with current chemotherapies). The first line of chemotherapy therefore represents a major issue in the management of these unresectable patients. There are few predictive markers of response to chemotherapy in pancreatic adenocarcinoma. It is conventionally evaluated by scanner every 2 to 3 months. The response to chemotherapy is associated with a good prognosis while non-response has a poor prognosis and requires a 2nd line of treatment if the patient is able to receive it.~A KRAS mutation is present in approximately 70-90% of pancreatic adenocarcinomas. Its research on tissue sampling (fine needle aspiration or anatomo-pathological specimen) is not carried out routinely because no prognostic or predictive value of KRAS mutations has been demonstrated. New high-throughput DNA sequencing techniques have been developed and now allow a blood sample to detect and quantify circulating tumor DNA (ctDNA), including KRAS mutations.~Very few studies have investigated the change in cDNA levels during 1st line chemotherapy in unresectable pancreatic adenocarcinoma.~The aim of this study is to assess the predictive value of response to the 1st line of chemotherapy of mutated KRAS cDNA in unresectable metastatic or locally advanced pancreatic adenocarcinomas. | With an incidence of more than 11,600 new cases per year in France and an annual number of deaths close to the incidence rate, adenocarcinoma of the pancreas is a public health problem.~The aim of this study is to assess the predictive value of response to the 1st line of chemotherapy of mutated KRAS ctDNA (circulating tumor DNA) in unresectable metastatic or locally advanced pancreatic adenocarcinomas. |
Background:~With increased aging population, there is a higher rate of having chronic diseases and cognitive impairment. In order to achieve successful aging, it is important for community-dwelling older adults to perform better self-management with improved health literacy and various kinds of support.~Objectives:~The study aims to develop a Community-based E-Health Program (CeHP), evaluate the effectiveness of CeHP, and refine the program based on the outcome measurement.~Method:~The research team will develop the Community-based E-Health Program, and assess the effects of the program. A needs assessment will be carried out using focus group discussion with the older adults. A cluster randomized controlled trial (RCT) will be adopted. A follow-up process evaluation will be conducted to assess the acceptability, strengths and limitations of Community-based E-Health Program based on the participants' perspectives~Discussion and conclusion:~The proposed research contributes to engage and empower older adults living in the community to manage their chronic condition, and foster collaboration with the goal of translating evidence into action. This research will offer important insights into the need for educating and engaging older adults in managing chronic conditions to promote health and well-being, and therefore contribute to health and well-being of the elderly population. | With increased aging population, there is a higher rate of having chronic diseases and cognitive impairment. In order to achieve successful aging, it is important for community-dwelling older adults to perform better self-management with improved health literacy and various kinds of support. The study aims to develop a Community-based E-Health Program (CeHP) for Older Adults Living with Chronic Diseases , evaluate the effectiveness of CeHP, and refine the program based on the outcome measurement. A cluster randomized controlled trial (RCT) will be adopted. A follow-up process evaluation will be conducted to assess the acceptability, strengths and limitations of CeHP based on the participants' perspectives. The research contributes to engage and empower older adults living in the community to manage their chronic condition, and foster collaboration with the goal of translating evidence into action. |
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of investigational drugs to learn whether the drugs work in treating a specific disease. Investigational means that the drugs are being studied.~The U.S. Food and Drug Administration (FDA) has approved [1] venetoclax- obinutuzumab and [2] acalabrutinib individually as treatment options for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). However, the combination of all 3 drugs has not yet been approved by the FDA.~Venetoclax is a targeted therapy drug that works by blocking a protein called Bcl-2 in cancer cells. Bcl-2 helps cancer cells survive and resist the effects of cancer treatments. By blocking Bcl-2, venetoclax may kill cancer cells and/or make them more open to the effects of other cancer treatments.~Obinutuzumab is a drug that targets a protein called CD20, which is found on the surface of B cells, the white blood cells that are affected by CLL. When obinutuzumab attaches to CD20, it directly both destroys the B cells and makes them more visible to the immune system. The immune system then attacks and destroys the cancerous B cells.~Acalabrutinib is a small-molecule inhibitor of Bruton's tyrosine kinase (BTK). BTK is a protein inside of the cell that may be over-expressed in malignant B cells. It is involved in the signaling pathway from the B-cell receptor. BTK inhibition caused by taking acalabrutinib results in decreased malignant B-cell growth and survival.~On this study, participants will receive obinutuzumab and venetoclax. We will monitor for minimal residual disease (MRD) using a test called Adaptive ClonoSEQ after treatment with obinutuzumab and venetoclax. MRD is a molecular test, which can detect whether there is any evidence of CLL/SLL in the blood or bone marrow. For participants with detectable MRD despite treatment with obinutuzumab and venetoclax, acalabrutinib will be added with the goal of achieving undetectable MRD. Additionally, for participants who have progressive CLL/SLL despite venetoclax and obinutuzumab, acalabrutinib will be added.~The research study procedures include screening for eligibility, study treatment, end of treatment visit, follow-up visits and an off-study visit.~Participants will receive study treatment for 2 or 3 years.~Participants will be followed for 2 years after completion of the study.~It is expected that 40 people will take part in this research study~Genentech is supporting this research study by providing venetoclax and obinutuzumab. | This research study is studying a combination of drugs as a possible treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).~The names of the study drugs involved in this study are:~obinutuzumab~venetoclax~acalabrutinib |
Between 40% to 60% of individuals with serious mental illness (SMI) are obese. Obesity and physical inactivity result in increased rates of chronic diseases, increased risk of death, and substantial health care costs. Treatment guidelines recommend that individuals with SMI who are overweight should be offered evidence-based weight loss interventions, including psychosocial interventions. The VA's weight management program, MOVE!, is attended by less than 5% of the overweight population and is not adapted to the cognitive needs and patient preferences for the population with SMI. Effective adapted weight management programs are not offered in VA because the programs are time-intensive and require the skills of trained providers who are often in short-supply. CoachToFit can address this gap in care. CoachToFit is a weight management program, adapted for the population with SMI, that includes a smartphone app delivering evidence-based weight management services with weekly telephonic support from a VA peer specialist who acts as a wellness coach. Peer specialists are individuals who draw upon lived experiences with SMI to provide services to others with SMI in clinical settings. CoachToFit was shown to have high rates of acceptability and usability and was efficacious for weight loss in a small sample. VA has an opportunity to address obesity in the population with serious mental illness, currently a substantial gap in care.~Significance/Impact: This project addresses obesity in the population with SMI by evaluating a weight management program that is not only evidence-based, it is sustainable, transportable, appealing to patients, easy to use, and minimally burdensome to the healthcare system. This effort addresses two HSR&D priority areas: 1) Mental Health: Testing new models of care to improve access, cost, and/or outcomes, and 2) Health Care Informatics: Building the evidence base for ehealth/mhealth tools.~Innovation: CoachToFit's use of mobile technology is an important innovation in VA service delivery and its user-centered design involving individuals with SMI was the first of its kind. CoachToFit is enhanced by data visualization in real-time via a web-based dashboard used by VA peer specialists and their supervisor. The investigators are aware of no other evidence-based mobile platforms to help people with SMI reduce their weight. | This project addresses obesity in the population with SMI by evaluating a weight management program that is not only evidence-based, it is sustainable, transportable, appealing to patients, easy to use, and minimally burdensome to the healthcare system. This effort addresses two HSR&D priority areas: 1) Mental Health: Testing new models of care to improve access, cost, and/or outcomes, and 2) Health Care Informatics: Building the evidence base for ehealth/mhealth tools.~Innovation: CoachToFit's use of mobile technology is an important innovation in VA service delivery and its user-centered design involving individuals with SMI was the first of its kind. CoachToFit is enhanced by data visualization in real-time via a web-based dashboard used by VA peer specialists and their supervisor. The Investigators are aware of no other evidence-based mobile platforms to help people with SMI reduce their weight |
The primary objective of this trial is to assess the efficacy of targeted individualised physiotherapeutic treatment on aromatase inhibitor-associated musculoskeletal pain.~This trial asks a critical, previously unaddressed, question of clinical importance about management of musculoskeletal (MSK) pain secondary to aromatase inhibitor (AI) treatment of hormone receptor-positive breast cancer. Many breast cancer survivors taking AIs experience muscle and/or joint pain, which may cause many to stop taking AIs and may inhibit exercise or physical activity, despite its known health benefits.~Physiotherapeutic treatment is considered a standard management strategy for many MSK pain conditions, in which targeted specific exercise therapy is now as an evidence-based management strategy with proven effectiveness and patient satisfaction. Thus, referral to physiotherapy would be a natural strategy in women who experience MSK pain as an adverse effect to AI therapy. However, it is unclear if physiotherapeutic treatment has similar effects on AI induced MSK pain as in primary MSK pain. Two systematic review (one with a meta-analysis) have assessed the effect of different pain management strategies for AI-induced MSK-pain and found great uncertainty in the effects of exercise, relaxation techniques and acupuncture. They also found limited evidence on the subject and moderate to low quality of the studies included. The evidence on the subject is clearly limited but the need for a treatment option to minimize the side-effects of the AI medication real and necessary.~Targeted individualised physiotherapeutic treatment is tailored for the affected (painful) tissue/joint/region specifically and is based on extensive experience and evidence from MSK physiotherapy in rheumatic and orthopedic patient population. Targeted individualised physiotherapy treatment take into account the individual patient, her constitution, the painful tissue/region/joint (e.g. its biomechanics, physiological properties, and inflammatory activity), and is adjusted according to day-to-day variations in pain and progressed based on the interaction between changes in symptoms and function and tissue healing. Such approach is expected to yield a greater effect on MSK pain, than a generic exercise program. Further, targeted treatment programs are delivered by trained physiotherapists, who have specific clinical training and experience in clinical management of patient and handling MSK pain, which is also expected to yield better clinical outcomes than programs delivered by people without clinical training.~Altogether it is very likely that a targeted physiotherapy treatment will be of significant benefit to breast cancer survivors with AI induced MSK pain.~The aim is to compare targeted individualized physiotherapeutic treatment and medical care with medical care alone on aromatase inhibitor associated musculoskeletal pain in female breast cancer survivors.~It is hypothesized that targeted physiotherapeutic treatment and medical care reduces musculoskeletal pain significantly in women with aromatase inhibitor associated musculoskeletal pain when compared to medical care alone.~The plan is to include 120 participants from the oncology department at Rigshospitalet.~Participants will partake in the study for a total of 26 weeks. During the first 12 week the intervention group will receive the physiotherapeutic treatment twice a week. The medical care visits are place at the first visit to the clinic, week 13 and week 26.~Allocation of participants and sequence generation The randomization list will be computer-generated based upon permuted random blocks of variable size (4 to 6 in each block). The allocation ration will be 1:1 (1 targeted physiotherapeutic treatment (TPT)+ medical care (MC) for each 1 MC) stratified according to upper or lower MSK pain site.~The biostatistician or his delegate will develop the randomisation scheme for allocation subjects to the two treatment arms.~Investigators, study coordinators, clinical staff, study staff, and other personnel directly involved in the study, will be blinded to the group allocation.~Participants and staff involved in the physiotherapy treatment are not blinded to the group allocation. Information that could potentially unblind otherwise blinded staff will not be shared, and will be stored in facilities with limited access until the study is completed. Unblinding of blinded personnel does not preclude the related participants' continued participation in the study.~Attendance to the physiotherapy sessions and the medical doctor appointments will be recorded in the case report form (CRF).~The investigator and clinical staff will monitor each participant for evidence of adverse events (AEs) throughout the study. The investigator will assess and record any AE in detail including the date of onset, description, severity, duration and outcome, relationship of the AE to study treatment, and any action(s) taken. AEs, whether in response to a query, observed by site personnel, or reported spontaneously by the participant will be recorded.~A participant may withdraw from the study at any time without this impacting on any future investigations and/or treatments at the site, by the Investigators in this study or by other staff associated with the study.~If a participant withdraws from the study, the procedures outlined for the closest assessment visit is sought to be completed within 2 weeks, and preferably prior to the initiation of another therapy. However, these procedures should not interfere with the initiation of any new treatments or therapeutic modalities that the investigator feels are necessary to treat the participant's condition.~All AEs will be followed to a satisfactory conclusion. The investigator may discontinue any participant's participation for any reason, including an AE, safety concerns or failure to comply with the protocol.~Participants will be discontinued from the study immediately if any of the following occur:~Clinically significant abnormal laboratory results or AEs, which rule out continuation of the study treatment, as determined by the investigator~Death~Other illness~Failure to adhere to the protocol~If at any point in time between randomization and the week-26 visit the investigator feels that the patient's clinical course is not acceptable within the normally applied paradigms of AIMSS, the patient should be taken out of the study. The clinician's judgment will be required to decide on a case-by-case basis whether to implement this step or not.~It is important to avoid any loss to follow-up participants for the efficacy assessment and meaningful analysis of the study.~The principal investigator has the right to terminate this study at any time. Reasons may include the following, but are not restricted to:~The incidence of events in this or other studies that indicate a potential health hazard to participants.~Unsatisfactory participant enrolment. Determination of Sample Size This is a superiority study with the main outcome being change in pain from baseline to end of study (week 13), measured with the BPI.~Given a standard deviation of 2.5 a total sample size of 100 is required to obtain a power of 0.85 (actual power is 0.887) to detect a mean group difference in the change from baseline of 1.5 points at a significance level of 0.05 and using a balanced design (1:1 randomization). Allowing for drop-outs the study aims at recruiting and randomize 120 participants, which would yield a power of 0.935 to detect the above difference at the 0.05 level of significance.~Power and sample size analyses were conducted using 'SAS Power and Sample Size' (SAS Institute Inc., Cary, North Carolina).~Disposition of participants The number of randomized patients will be summarized as total using counts and percentages. The number of patients either completing or permanently discontinuing the study will be summarized using counts and percentages.~For the assessment of superiority, the intention-to-treat (ITT) protocol population is used in the primary analysis, as it is the most conservative approach.~The ITT population consist of all randomized patients irrespective of whether the patient actually received study intervention or the patient's compliance with the study protocol, in the treatment group to which the participant was assigned at randomisation. A patient will be considered randomised as soon as a treatment is assigned by according to the allocation sequence.~A statistical analysis plan that describes the details of the planned statistical analyses will be produced by the principal investigator and a biostatistician or his delegate before last patient's last visit.~Assessments of changes from baseline and construction of confidence intervals (CI) for continuous measures will be based on a repeated measures analysis of covariance (ANCOVA; including group as the main factor and baseline measure as covariate).~Superiority will be claimed if the computed 95% confidence interval of the estimated group difference in the change from baseline in the BPI does not include 0 in the ITT population.~All statistical tests will be two-sided and statistical significance will be claimed if the computed p-value is equal to or less than 0.05.~The study will use paper case report forms (CRF) and an in-house custom built electronic data capture system (Cirkeline) and REDCap (internet survey system for the 6-week assessment).~Paper based CRF allows for on the go registration of participation in the TPT + MC group as well as registration from the structured interview.~Cirkeline allows individual patients to supply questionnaire data at clinical visits via touch-screens in the clinic, as well as entering of study related data by the staff.~REDCap allows the participants to fill out the questionnaires from home via a secure web browser.~At the end of the trial, all data will be merged and stored in a database created by the Parker Institutes database manager.~The applications meet all regulatory standards and allow management of all activities related to clinical trials that ensures optimal resource use and safety according to good clinical practice and data protection legislation.~Regulatory Standards Participant confidentiality Participant medical information obtained by this study is confidential, and disclosure to third parties other than those noted below is prohibited.~With the participant's permission, medical information may be shared with his or her personal physician or with other medical personnel responsible for the participant's welfare.~If the data from this study are published, the presentation format will not include names, recognizable photos, personal information or other data which compromises the anonymity of participating participants.~The study will be conducted in accordance with the Data Protection Act and follow the General Data Protection Regulation. The study data management and data security procedures is approved by the Regional Knowledge Centre on Data Protection Compliance on behalf of the Danish Data Protection agency.~All data will be entered into a study database for analysis and reporting. Any data captured electronically will be stored electronically in a separate database according to standard procedures at The Parker Institute. Upon completion of data entry, the databases will be checked to ensure acceptable accuracy and completeness. System backups and record retention for the study data will be consistent with The Parker Institute standard procedures.~Individuals involved in study evaluations will be trained to perform the efficacy and safety evaluations described in the protocol.~The study has received funding from Danish Physiotherapists Association and The Oak Foundation (OCAY-13-309; covering running cost at the Parker Institute including this study), for the specific purpose to complete this study. None of the investigators have conflicts of interests related to the funding of this study. This information is disclosed to all participants in the written information material.~All sources of support (including technical and financial support) provided for this study is disclosed in the written information material and in publication of the study results. Funding is an ongoing process. All future financial and/or technical support to the study will be reported to the Danish health research ethical committee system and is disclosed to all participants (previous, current and potential).~The participants are insured by the Danish Patient Insurance Association. | The primary objective of this trial is to assess the efficacy of targeted individualised physiotherapeutic treatment on aromatase inhibitor-associated musculoskeletal pain.~This trial asks a critical, previously unaddressed, question of clinical importance about management of musculoskeletal (MSK) pain secondary to aromatase inhibitor (AI) treatment of hormone receptor-positive breast cancer. Many breast cancer survivors taking AIs experience muscle and/or joint pain, which may cause many to stop taking AIs and may inhibit exercise or physical activity, despite its known health benefits.~Physiotherapeutic treatment is considered a standard management strategy for many MSK pain conditions, in which targeted specific exercise therapy is now as an evidence-based management strategy with proven effectiveness and patient satisfaction. Thus, referral to physiotherapy would be a natural strategy in women who experience MSK pain as an adverse effect to AI therapy. However, it is unclear if physiotherapeutic treatment has similar effects on AI induced MSK pain as in primary MSK pain. Two systematic review (one with a meta-analysis) have assessed the effect of different pain management strategies for AI-induced MSK-pain and found great uncertainty in the effects of exercise, relaxation techniques and acupuncture. They also found limited evidence on the subject and moderate to low quality of the studies included. The evidence on the subject is clearly limited but the need for a treatment option to minimize the side-effects of the AI medication real and necessary.~Targeted individualised physiotherapeutic treatment is tailored for the affected (painful) tissue/joint/region specifically and is based on extensive experience and evidence from MSK physiotherapy in rheumatic and orthopedic patient population. Targeted individualised physiotherapy treatment take into account the individual patient, her constitution, the painful tissue/region/joint (e.g. its biomechanics, physiological properties, and inflammatory activity), and is adjusted according to day-to-day variations in pain and progressed based on the interaction between changes in symptoms and function and tissue healing. Such approach is expected to yield a greater effect on MSK pain, than a generic exercise program. Further, targeted treatment programs are delivered by trained physiotherapists, who have specific clinical training and experience in clinical management of patient and handling MSK pain, which is also expected to yield better clinical outcomes than programs delivered by people without clinical training.~Altogether it is very likely that a targeted physiotherapy treatment will be of significant benefit to breast cancer survivors with AI induced MSK pain.~The aim is to compare targeted individualized physiotherapeutic treatment and medical care with medical care alone on aromatase inhibitor associated musculoskeletal pain in female breast cancer survivors.~It is hypothesized that targeted physiotherapeutic treatment and medical care reduces musculoskeletal pain significantly in women with aromatase inhibitor associated musculoskeletal pain when compared to medical care alone.~The plan is to include 120 participants from the oncology department at Rigshospitalet, Denmark.~Participants will partake in the study for a total of 26 weeks. During the first 12 week the intervention group will receive the physiotherapeutic treatment twice a week. The medical care visits are place at the first visit to the clinic, week 13 and week 26. |
This is a randomised, multi-center, open label, adaptive, exploratory trial to assess the efficacy of two different drug regimens in terms of preventing symptomatic COVID-19 disease in healthcare workers at high risk of exposure to SARS-CoV-2. The trial will compare two different experimental medication arms to the control arm comprising the use of standard personal protective equipment (PPE) with no additional pharmacological intervention.~Volunteers will be recruited from participating institutions and community healthcare workers (CHWs) that are responsible for collecting swabs for PCR detection of SARS-CoV-2. Up to 1950 (or 2130 pending funding) eligible participants will be randomised in a 1:1:1 ratio to one of the investigational arms.~Participants will be followed until 65 PCR and serology-confirmed, SARS-CoV-2 infections are identified in the control arm (or 165 in the entire study cohort). For each episode of PCR-confirmed COVID-19 disease, data on self-reported symptoms (modified Flu-PRO) and their duration, and an investigator-assessed severity score (WHO Ordinal Scale for Clinical Improvement) will be recorded. Data on self-reported symptoms and duration will also be collected for other all-cause acute respiratory illnesses. Safety and tolerability of each arm will be assessed through adverse event reporting. Participants who develop COVID-19 disease will have their IMP discontinued but will be followed up in the study until the completion of the trial, where possible. Multiple, discrete occurrences of COVID-19 disease could therefore be identified in a single participant.~Additional arms may be added, or existing ones substituted, should new potential agents be identified or other combinations for prophylaxis be proposed. A formal amendment will be documented should this be considered. | This is a randomised, multi-center, open label, adaptive, exploratory trial to assess the efficacy of two different drug regimens in terms of preventing symptomatic COVID-19 disease in healthcare workers at high risk of exposure to SARS-CoV-2. The trial will compare two different experimental medication arms to the control arm comprising the use of standard personal protective equipment (PPE) with no additional pharmacological intervention. |
Multicenter retrospective chart review of patients admitted to any of the four Methodist Health System hospitals (Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas) between February 1 and April 30, 2020. All study center utilize Epic ® electronic health record (Verona, Wisconsin; www.epic.com) for which all data will be extracted from. | Multicenter retrospective chart review of patients admitted to any of the four Methodist Health System hospitals |
SARITA-1 is a multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms, which aims to study the impact of nitazoxanide for hospitalized patients with pneumonia derived from COVID-19 (Coronavirus Disease-19) Experimental group: 250 patients received nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: 250 patients received placebo 8/8 hours for 5 days.~Population: Patients with clinical symptoms of COVID-19: dyspnoea and/or fever and/or cough) and: either computed tomography scan suggestive of viral pneumonia or confirmatory molecular test by RT-PCR (Real Time polymerase chain reaction), | Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms.~Population: 500 Hospitalized patients with pneumonia derived from COVID-19 (Coronavirus Disease-19), either confirmed by RT-PCR (Real Time polymerase chain reaction), or suggested by typical findings on the computed tomography scan symptomatic.~Experimental group: nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: placebo 8/8 hours for 5 days. |
Patients with pending breast biopsies will have the tumor site's tissue dielectric constant (TDC) measured prior to the biopsy. Similar TDC measurements will be made at a standard breast site on the biopsied breast and on mirrored sites on the non-affected breast. Values obtained at the biopsy site will be compared against the outcome of the biopsy analysis: benign vs. malignant. In addition the measurements obtained at the standardized site for all breasts will be used to establish a set of reference values to characterize breast TDC values. In addition, inter-breast differentials will be used to characterize these ranges for future studies and clinical assessments. | Patients with pending breast biopsies will have the tumor site's tissue dielectric constant (TDC) measured prior to the biopsy. Similar TDC measurements will be made at a standard breast site on the biopsied breast and on mirrored sites on the non-affected breast. |
There is a very limited literature available Active release technique (ART) and Post Facilitation Stretch (PFS) in frozen shoulder. Additionally there is a very limited literature on the evaluation of ART in comparison with PFS in adhesive capsulitis of diabetic patient. Disease such as rheumatoid arthritis (RA), osteoarthritis (OA) etc that cause stiffness of the shoulder joint also present with altered muscle activity, that in long run becomes one of the main causes of reduces joint range of motion. With this study, we will be able to determine the technique that will have better effects in realigning the muscle kinematics and to normalize the muscle activity along with reducing muscle stiffness with mobilizations techniques. This study will also fulfill that research gap and will provide clinicians with an alternative approach in treatment of adhesive capsulitis. | To determine the technique that will have better effects in realigning the muscle kinematics and to normalize the muscle activity along with reducing muscle stiffness with mobilizations techniques |
Severe chronic pain in youth is debilitating, common, and has limited treatment options, rendering it as a major public health problem. Severe chronic pain is defined as pain persisting for three months or more that significantly impacts daily functioning (e.g. sleep, mental health, school, work, activity). It is highly prevalent, occurring in 100,000 to 160,000 youth in Canada - comparable to the rates of autism spectrum disorder. If left unmanaged, it can lead to persistent pain and mental health problems in adulthood, posing enormous costs to society ($7.2 billion CAD/year). Most treatments to address chronic pain take a one-size-fits-all-approach, which does not account for comorbid mental health conditions, contributing to small treatment effects.~In 2014, the Vi Riddell Children's Pain and Rehabilitation Program at the Alberta Children's Hospital (ACH) established the first pediatric Intensive Pain Rehabilitation Program (IPRP) in Canada to target youth with severe chronic pain and consequent functional disability who do not respond to standard outpatient pain therapies. The IPRP at the ACH involves three- to sex-weeks of day-treatment rehabilitation, provided by an interdisciplinary team (e.g. Psychology, Physiotherapy, Family Therapy). This rehabilitative program teaches self-management strategies with the goal of helping youth and their families resume normal daily functioning. Similar to other intensive rehabilitation programs, at discharge from IPRP, youth reported less anxiety, less depressive symptoms and better functioning, although, their self-reported pain intensity remained unchanged. It is generally thought that by returning to normal daily activities, youth will learn to function with their pain, and their pain will dissipate over time. However, there is limited evidence to support this. Long-term follow-up of youth in IPRP revealed a reduction of pain interference in daily activities. However, at one-year post-IPRP, youth's self-reported ratings of depression and quality of life did not differ from their ratings prior to completing IPRP. In order to improve long-term recovery and reduce the burden of suffering on the individual, their family and society, evidence-based and targeted interventions are needed to reduce pain and pain-related disability in youth with severe chronic pain.~For a chronic pain treatment to be evidence-based, it needs to draw on the known neurobiological and psychological processes underlying the development and maintenance of severe chronic pain. In August 2016, investigators began scanning a subset of youth in our IPRP at baseline and again at discharge from the program. Preliminary analysis of this neuroimaging data (23 youth with 2 scans each) suggested decreased functional responses to emotional stimuli in the dorsolateral prefrontal cortex (DLPFC) from baseline to discharge of affected youth, commensurate with decreases in internalizing mental health symptoms.~The DLPFC is a large and functionally heterogeneous brain region. It is generally associated with driving appropriate behavioral responses, and top-down modulation. Therefore, with regards to pain it has been shown to be involved in both pain detection and in pain suppression. Given its involvement in pain modulation, it is feasible that the DLPFC could serve as a therapeutic target.~By targeting the DLPFC using repetitive transcranial stimulation (rTMS), the investigators may be able to enhance outcomes associated with IPRP. Work from our institution demonstrated that rTMS of the DLPFC is a safe and effective method for treating youth with treatment resistant major depressive disorder. In addition to treatment resistant major depressive disorder, rTMS of the DLPFC has also been found to be effective in managing chronic pain in adults. rTMS uses a magnetic field to non-invasively stimulate small targeted regions of the brain. The magnetic coil produces small electric currents in the region of the brain just under the coil via electromagnetic induction. Magnetic resonance imaging (MRI) can be used to help identify and target specific brain regions, such as the DLPFC, providing an individualized approach to treat the patient's symptoms. To date, rTMS has not been utilized to manage pain and comorbid mental health conditions in youth. Using an open-label clinical trial study design, the investigators will examine whether the addition of rTMS to IPRP reduces pain intensity and enhances brain and behavioral changes associated with standard IPRP care to improve outcomes of youth with severe chronic pain.~Aim 1: Determine whether rTMS in addition to IPRP reduces self-reported pain intensity from baseline to discharge in youth with severe chronic pain. Hypothesis 1: The addition of rTMS to IPRP will result in decreases in self-reported pain intensity from baseline to discharge in youth with severe chronic pain.~Aim 2: Examine whether youth that undergo rTMS in addition to IPRP versus IPRP alone have greater improvements in outcomes from baseline to discharge. Hypothesis 2: The addition of rTMS to IPRP will result in greater decreases in DLPFC responsivity to emotional stimuli and greater decreases in self-reported pain intensity, functional disability, anxiety, depressive and post traumatic stress disorder (PTSD) symptoms between baseline and discharge as compared to youth that underwent the standard IPRP.~Aim 3: Examine whether changes following IPRP persist beyond discharge in youth that underwent rTMS in addition to IPRP versus IPRP alone. Hypothesis 3: Parent and self-reported.~Methods: Between November 2020-2023, 25 youth aged 10-18 years with severe chronic pain will be invited to partake in IPRP. In addition to the standard three-week IPRP, youth will receive an rTMS intervention utilizing a robot-controlled, Magstim SuperRapid2, air-cooled 90mm figure-of-8-coil (Magstim, Wales UK). Following standardized protocols for youth with treatment resistant major depressive disorder, rTMS will be applied to the individual's DLPFC as defined by functional imaging for 37.5 minutes per weekday, at the same time of day, for a period of three weeks (15 days total). Participants will be monitored for adverse events and tolerability using a Pediatric TMS Safety and Tolerability Measure (20) on days 1, 6, and 11. Youth will undergo a 3T MRI at baseline and discharge from IPRP. Both structural and functional images will be acquired. At baseline and discharge, youth will also complete a battery of reliable and validated questionnaires assessing pain, functional disability, anxiety, depressive and PTSD symptoms.~rTMS: Motor evoked potentials will be recorded to determine the resting motor threshold. Initially, to locate the DLPFC target site, the five centimetre rule will be applied in which the scalp position five centimetres anterior to the hotspot along a line to the nation will be marked. Using a neuronavigation system (Brainsight2, Rogue Research, Montreal), the TMS coil will be monitored in real time and co-registered with the individual's functional MRI. Neuronavigation will be used to confirm accurate DLPFC targeting. The TMS coil will subsequently be placed tangential to the scalp, and angled at 45 degrees to the midline and fixed over the DLPFC using a mechanical arm.~rTMS will be applied at 10 Hz. Each train will consist of 40 threshold (100% resting motor threshold) pulses over 4 seconds with an inter-train interval of 26 seconds. Treatment sessions will last 37.5 minutes (75 trains/3,000 pulses), and occur at the same time of day on every weekday for a period of three weeks (15 days total). During TMS, only passive activities will be allowed (i.e., watching movies or TV, listening to music). Three weeks of treatment was selected based on existing rTMS evidence in youth with treatment resistant major depressive disorder.~Neuroimaging: Cortical volumes will be acquired from a T1-weighted anatomical scan. FreeSurfer will be used for processing, editing, and segmenting structural brain images. The automated recon-all pipeline will be used to perform brain extraction, image registration, motion and intensity correction, and segmentation/parcellation. Each image will be manually checked, and cortical volumes will be extracted.~Functional magnetic resonance imagine (fMRI) will be used to detect blood oxygen level-dependent (BOLD) signal changes during the presentation of validated pictures of facial affect that were used in the previous IPRP neuroimaging study. This paradigm consists of 36, standardized photos from female and male individuals depicting neutral, happy and fearful facial expressions. These photos will be randomized into 4 blocks presented 4 times, and each face will be presented for 200-ms with a 300-ms interstimulus. The investigators will apply standard preprocessing (slice-time correction, B0-unwarping, motion correction, bandpass temporal filtering, template registration and smoothing) in SPM. Motion will be censored using the ART toolbox. Second-level analyses will be used to compare differences in contrasts over time and between groups. All statistical tests will be corrected for multiple comparisons (cluster-corrected false discovery rate q<0.05, with cluster-forming height threshold of p<0.001).~Finally, a resting-state fMRI scan will be acquired and undergo standard preprocessing in SPM. Motion will be censored using the ART toolbox. Cortical masks derived from FreeSurfer will be used as seed regions for fMRI functional connectivity analysis. Time courses for the DLPFC will be extracted and used as a regressor to identify correlations with all other brain regions. Second-level analyses will be used to test differences in functional connectivity over time and between groups. All statistical tests will be corrected for multiple comparisons. | Severe chronic pain is defined as pain persisting for three months or more that significantly impacts daily functioning. It is highly prevalent, occurring in 100,000 to 160,000 youth. If left unmanaged it can lead to persistent pain and mental health problems in adulthood, posing enormous costs to society ($7.2 billion CAD/year). In 2014, health professionals at the Alberta Children's Hospital (ACH) established a pediatric Intensive Pain Rehabilitation Program (IPRP) to target youth with severe chronic pain and consequent functional disability who do not respond to outpatient pain therapies. The IPRP at the ACH is a three-week intensive day-treatment intervention provided by an interdisciplinary team, which helps youth resume engagement in normal daily functioning. Following IPRP, youth reported less anxiety, less depressive symptoms, and greater function, although their self-reported pain remained unchanged. In August 2016, the investigators began to explore brain areas related to severe chronic pain in youth. The investigators scanned a subset of youth at the start (baseline) and end (discharge) of IPRP (23 youth with 2 brain scans). From baseline to discharge, the investigators saw decreases in activity in the dorsolateral prefrontal cortex (DLPFC). Decrease in DLPFC activity was related to better mental health outcomes. The DLPFC is a well-known target for non-invasive brain stimulation. Repeated brain stimulation has been used to treat adults, but not youth with chronic pain. For the first time, the investigators will use image-guided brain stimulation (37 minutes/day, 5 days/week) to enhance the brain changes observed with IPRP. The investigators will examine whether three weeks of brain stimulation helps to reduce pain symptoms in youth. The investigators will also compare pain, brain, and mental health outcomes to our historical program data. By adding brain stimulation to our pain intervention, the investigators have the chance to target an area of the brain investigators know to be altered by chronic pain to improve outcomes. |
Study of the efficiency of Béfizal® 200 mg in 14 adult patients in whom the diagnosis of LHON obtained on anamnestic, clinical and ancillary testing / laboratory data. LHON should have occurred for less than 5 years and must be genetically proved with a 3460 or 11778 mitochondrial DNA mutation. Given the mode of transmission, genetic research may have been carried out in a maternal relative | Study of the efficiency of Béfizal® 200 mg in 14 adult patients with a LHON that occurred for less than 5 years. Patient must have certain specific mutations |
Hypersensitivity pneumonitis is a syndrome that results in the excessive immune response to inhalation of various antigenic particles in the environment. Patients often experience irreversible physiological disorders and severe dyspnea in the future. Common disorders in these patients are lung function abnormalities, decreased exercise capacity, muscle weakness, oxygen diffusion limitation, impaired quality of life, physical inactivity and fatigue. The aim of this study is to evaluate the effects of pulmonary rehabilitation training on exercise capacity, dyspnea, respiratory functions, respiratory and peripheral muscle strength, inspiratory muscle endurance, physical activity level, quality of life, fatigue, dyspnea, anxiety, depression in patients with chronic fibrotic hypersensitivity pneumonitis. The study was planned as a prospective, double-blind, case-control study. At least 30 patients with hypersensitivity pneumonitis will be included in the study. The cardiopulmonary rehabilitation program will be included inspiratory muscle training, upper extremity aerobic exercise and progressive resistance training will be performed in the exercise training group during 24 sessions. Alternative upper extremity exercises combined with breathing exercises will be performed in the control group. Functional exercise capacity, respiratory functions, respiratory and peripheral muscle strength, inspiratory muscle endurance, physical activity levels, quality of life, fatigue, dyspnea, anxiety and depressions will be evaluated before and after treatment. | The aim is to evaluate exercise capacity, respiratory functions, respiratory and peripheral muscle strength, inspiratory muscle endurance, physical activity level, quality of life, fatigue, dyspnea, anxiety, depression and investigate the impact of 24-session pulmonary rehabilitation training on these parameters in patients with chronic fibrotic hypersensitivity pneumonitis. |
Background: Hyponatremia is the most common electrolyte imbalance in clinical practice, associated with increased mortality and length of stay. In 2014,European guideline have recommended promp infusion of 3%NaCl 150 ml in 20 minutes to raise plasma Na to 5 mmol/L and improve symptoms. The recommendation was the result of studies with small numbers of patients, and expert opinions.~Methods: A single center opened-label randomized controlled-trial,we will randomly assign 40 patients with severe symptomatic hyponatremia (plasmaNa<125mmol/L) in Rajavithi Hospital into two groups:~First group receive intermittent bolus of 3%NaCl 150 ml in 30 minutes and follow plasma sodium until achieve target of goal plasma sodium = 5 mmol/L in 6 hours (no more than 12 mmol/L in 24 hr and 18 mmol/L in 48 hr),another receive traditional continuous drip of 3%NaCl start with rate = 1ml/kg/hr and follow plasma sodium every 1 hour until achieve target of plasma sodium 5 mmol/L in 6 hours .The primary end point is change in plasma sodium in 6 hours and improvement of glasglow coma scale.The secondary end points are change in plasma sodium in 24,48 hours,overcorrection rate in 24 and 48 hours ,ODS rate ,hospitality days and mortality rate. | To compare between intermittent bolus and traditional continuous drip of 3%NaCl in patients with severe symptomatic hyponatremia in Rajavithi Hospital. |
This is a phase II open label, non-randomized, study to evaluate the safety and efficacy of Ipatasertib (GDC-0068) in combination with paclitaxel in platinum-resistant recurrent epithelial ovarian cancer.~The primary objective of the study is to determine - the safety and objective response rate of treatment with ipatasertib (GDC-0068) in combination with paclitaxel in platinum-resistant recurrent epithelial ovarian cancer at week 12 for two cohorts of patients: with PI3K/AKT mutations (altered) and without PI3K/AKT mutations (non-altered)~About 39 patients will participate in the study and the accrual will take place over a course of 30 months Patients will be treated until disease progression and followed for 1 year thereafter.~The two drugs are ipatasertib and paclitaxel.~Ipatasertib will be given 400mg PO daily: day 1-21 of 28 day cycle~Paclitaxel will be given 80mg/m2 IV weekly: day 1, 8, 15 of 28 day cycle~The study hypothesis is that the combination of Ipatasertib (GDC-0068) plus paclitaxel will safely induce a tumor response and increase the objective response rate in patients with platinum-resistant recurrent epithelial ovarian cancer, with or without PI3K/AKT mutations.~This trial will enroll patients with platinum-resistant recurrent epithelial ovarian cancer. Given the relatively poor prognosis and limited treatment options for these patients, this population is considered appropriate for trials of novel therapeutic candidates. The benefit-risk ratio for ipatasertib in combination with paclitaxel is expected to be acceptable in this setting. | This is a phase II open label, non-randomized, study to evaluate the safety and efficacy of Ipatasertib (GDC-0068) in combination with paclitaxel in platinum-resistant recurrent epithelial ovarian cancer. |
The prevalence of Pelvic floor dysfunction is high, affecting millions of women worldwide in different conditions (social, sexual, physical, psychological, domestic relationships, financial, etc.), many people still have no, limited knowledge, or awareness of pelvic floor health and so do not have, or seek how to prevent or correct these disorders . This dysfunction may be presented as pelvic organ prolapse, stress urinary incontinence, fecal incontinence , chronic pelvic pain, sexual problems, and/or chronic constipation . Assessment of pelvic floor muscle activity plays a major role in Urogynecology and physiotherapy as a part of the conservative treatment of pelvic floor disorders (PFD) . Presence of Levator avulsion is a major risk factor for female pelvic organ prolapse (POP) and recurrence after surgical correction . This dysfunction can be diagnosed clinically using vaginal palpation . Palpation is subjective, less reproducible, and difficult to teach than imaging methods [6]. Studies that used ultrasound for assessment of pelvic floor muscle activity and strength are still few . The present study aimed to evaluate the levator ani muscle in both morphology (rest), and function (contraction and valsalva) in symptomatic women using 2D, 3D trans-perineum ultrasound (TPUS), to compare these features to clinical digital palpation and symptoms, and helping in diagnosis of muscle dysfunction. | The present study aimed to evaluate the levator ani muscle in both morphology (rest), and function (contraction and valsalva) in symptomatic women using 2D, 3D trans-perineum ultrasound (TPUS), to compare these features to clinical digital palpation and symptoms, and helping in diagnosis of muscle dysfunction. |
Atrial septal aneurysm (ASA) has been considered a potential cardiac source of embolism, and its prevalence is about 1%. In adult patients with stroke and normal carotid arteries, ASA is an important predictor of recurrent stroke. The most common abnormalities associated are interatrial shunts, that is, a patent foramen ovale (PFO) or an atrial septal defect (ASD). For large ASA with interatrial shunt, it is difficult to cover ASA with conventional devices, which might result in unstability of occluders and related complications . For isolated ASA with high risk, thrombus and emboli have been reported and anticoagulation has been used empirically.~In addition, the left atrial septal pouch can be considered as a special subtype of atrial septal aneurysm, in which thrombus might arise from the cavity of the pouch. Pervious researches have noted that left atrial septal pouch was a site of origin of thrombus formation and a source of embolism, and it was associated with cryptogenic stroke. For patients with ASA, we hypothesizes that transcatheter reconstruction of atrial septum might be achieved with PFO occluder through transseptal perforation. The aim of this study is to investigate the safety and efficacy of transcatheter exclusion of ASA via transseptal perforation.~This study will enroll subjects with ASA (including left atrial septal pouch), and enrollment will be divided into three phases.~Phase 1: large ASA patients with interatrial communication (ASD or PFO). A maximum of 30 patients is reached.~Phase 2: ASA patients with intact septum and high risk of cryptogenic stroke. A maximum of 20 patients is reached.~Phase 3: left atrial septal pouch with high risk of cryptogenic stroke. A maximum of 20 patients is reached. | This study aims to investigate the safety and efficacy of transcatheter exclusion of atrial septal aneurysm (ASA) via transseptal perforation in patients with ASA. |
The primary objective of our study is to determine whether asymptomatic influenza virus carriage is associated with an increased risk of post-operative Acute Respiratory Distress Syndrome (ARDS) after cardiac surgery. Cardiac surgery patients are particularly at risk of developing ARDS, with an estimated incidence of 5-10% based on the most recent data. Acute Respiratory Distress Syndrome (ARDS) is an acute pulmonary attack of inflammatory origin. ARDS is the main cause of hypoxemic postoperative respiratory distress. Hospital mortality associated with ARDS is estimated at 35-46% depending on the degree of severity, and survivors are at increased risk of cognitive decline, depression, post-traumatic stress, or musculoskeletal weakness.~Recently, asymptomatic carriage of respiratory viruses, including the influenza virus, has been identified as a potential risk factor for respiratory complications, including ARDS, after cardiac surgery. In a monocentric observational cohort, Groeneveld et al. recently reported that performing scheduled cardiac surgery during the influenza season was associated with a significantly longer duration of postoperative mechanical ventilation and a higher incidence of postoperative ARDS compared to surgery performed outside the influenza season (OR 1.85 95%CI 1.06-3.23 p=0.03). While it is estimated that up to 77% of patients with positive influenza tests are asymptomatic in the general population, the authors hypothesized that asymptomatic viral lung carriage would act as pulmonary priming, which, in combination with other types of pulmonary attacks encountered during surgery, would predispose to the genesis of ARDS. However, Groeneveld et al. had not tested any respiratory viruses in their cohort. In addition, the relatively higher influenza vaccination rate in the Netherlands in this at-risk population (77%) suggests that other types of respiratory viruses may have contributed to the observed effect.~These data are of major interest. Indeed, in France, during the 2017-2018 epidemic season, the vaccination rate of individuals at risk was only 46%, with an estimated vaccine efficacy of only 54% in elderly patients.~The aim of this study is to determine if there is an association between asymptomatic carriage of respiratory virus, especially influenza virus, and the occurrence of post-operative complications, morbidity and mortality.~If an association between asymptomatic carriage of influenza virus, or other respiratory viruses, and the occurrence of post-operative respiratory complications, including ARDS, is confirmed, a policy of routine immunization prior to cardiac surgery or postponement of scheduled surgery in the event of a positive viral test could be a simple and inexpensive strategy to reduce these complications after cardiac surgery. Pre-emptive antiviral therapy could be discussed when neither of these strategies is possible (e.g., emergency surgery). | The main objective of our study is to determine whether asymptomatic influenza virus carriage is associated with an increased risk of post-operative Acute Respiratory Distress Syndrome (ARDS) after cardiac surgery. Cardiac surgery patients are particularly at risk of developing ARDS with an estimated incidence of 5-10% based on the most recent data. |
The purpose of our current randomized clinical trial is to compare phacoemulsification with endoscopic cyclophotocoagulation (PHE) versus phacoemulsification alone (PHA) in patients with either primary angle closure (PAC) or primary angle closure glaucoma (PACG) presenting with cataract or a clear lens. | Comparison between phacoemulsification with endoscopic cyclophotocoagulation versus phacoemulsification alone in patients with either primary angle closure or primary angle closure glaucoma presenting with cataract or a clear lens. |
Hepatocellular carcinoma (HCC) is the top fourth most common cancer in Taiwan. Approximately 85% of cases of HCC patients had chronic HBV or HCV infection in Taiwan. Metabolic risk factors, such as obesity, fatty liver, high lipidemia, and diabetes mellitus are associated with increased risk for nonviral hepatocellular carcinoma.~The first and second-line systemic therapy approved in advanced hepatocellular carcinoma are multikinase inhubitors .Sorafenib (Nexavar)、Regorafenib and Lenvatinib are significantly improve survival in patients who had unresectable advanced and/or metastatic HCC not amenable to local treatment methods. General fatigue, poor appetite and pain are regarded as common and unavoidable side effect experienced during the course of cancer and its treatment. Anorexia is a common cause of malnutrition and is associated with negative effects on the quality of life (QOL) for patients with cancer. However, quality of life as a prognostic factor for survival in hepatocellular carcinoma. Management of appetite is the key to improving both the QOL and the prognosis for such patients.~Cancer-related anorexia and target therapy-induced anorexia is very important in HCC patients. According to Chinese medicine theory., spleen-deficiency, qi-stagnation and dampness are the most common syndrome in advanced hepatocellular carcinoma patients. Thus, the principles of Chinese medicine treatment are invigorating Pi, regulating qi, dissipating dampness and appetizing wei. Most patients received traditional Chinese medicine treatment as adjuvant therapy to alleviate cancer symptoms, diminishing the side effects and complications of treatment course at late stages. The purpose of the study was search the safety and efficacy of the of Xiang Sha Liu Jun Zi Decoction (XSLJZ) in advanced hepatocellular carcinoma patients with multiple protein kinase inhibitor therapy. Evaluate the treatment effect on the symptoms of appetite and quality of life in advanced hepatocellular carcinoma patients | The purpose of the study was search the safety and efficacy of the of Xiang Sha Liu Jun Zi Decoction (XSLJZ) in advanced hepatocellular carcinoma patients with multiple protein kinase inhibitor therapy. Evaluate the treatment effect on the symptoms of appetite and quality of life in advanced hepatocellular carcinoma patients |
The development and natural history of atherothrombosis involves the pathophysiological interplay between inflammation, dyslipidemia, oxidative stress and endothelial dysfunction. Unregulated, these processes culminate in endothelial dysfunction, and ultimately cardio-metabolic chronic diseases. Aberrant lipid oxidation due to elevated triglycerides and cholesterol primes and activates innate immune cell activity resulting in elevated inflammation and oxidative stress.~The randomized, placebo-controlled REDUCE-IT trial enrolled individuals with established atherosclerotic heart disease, or diabetes and an additional risk factor, who were on pre-existing statin therapy with persistent hypertriglyceridemia. REDUCE-IT reported that the group allocated to the omega-3 fatty acid icosapent ethyl (IPE; 2g BID) exhibited a 25% relative risk reduction for the primary composite endpoint of CV death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina, and a 20% decreased risk of CV death when compared to standard of care. Vascepa® (IPE) is currently approved by Health Canada and the U.S. FDA for the reduction of cardiovascular risk in statin-treated individuals with elevated triglycerides who are either at heightened cardiovascular risk or who have diabetes and at least one risk factor.~The exact mechanism through which IPE decreased cardiovascular events in REDUCE-IT has not yet been elucidated.~The population and function of circulating pro-vascular progenitor cells have been shown to benefit from diminished lipid oxidation, inflammation and oxidative stress. A healthy population of circulating pro-vascular progenitor cells in turn affords timely and efficient blood vessel repair, regeneration and atheroprotection.~The omega-3 fatty acid eicosapentaenoic acid (EPA) has been reported to inhibit M1 macrophage polarization in a murine model and increase human endothelial progenitor cell (EPC) colony formation and functionality in vitro. In vivo, EPA levels have been observed to correlate significantly with circulating EPC number (CD34+CD133+VEGFR2+ cells). Collectively, these findings affirm that EPA, and potentially omega-3 fatty acids, can enhance the number and function of circulating pro-vascular progenitor cells and can alter M1/M2 macrophage balance towards a regenerative blood vessel phenotype.~IPE-PREVENTION is a prospective, 3-month long, open-label study that will randomize a total of 70 individuals with elevated cardio-metabolic risk and heightened triglyceride levels and who are on stable statin therapy to either IPE 2g BID or standard of care. Blood samples will be collected at the baseline and month 3 visits for evaluations of cell populations in the blood as well as measurements of biomarkers that contribute to the proinflammatory and pro-oxidant milieu of individuals at elevated cardio-metabolic risk. The study will utilize the AldefluorTM assay to differentiate between and enumerate hematopoietic progenitor cells, EPCs, granulocyte precursors and macrophage precursors. The overarching goal would be to document how assignment to IPE and standard-of-care impact on circulating progenitor cell depletion and dysfunction. The effect of IPE exposure on the inflammatory and oxidative profile will also be assessed.~The results of this investigation may offer some molecular and cellular insights into the mechanisms underlying the cardiovascular benefits of IPE therapy reported in the REDUCE-IT trial. | IPE-PREVENTION is a prospective, randomized, 3-month long, open-label study. A total of 70 individuals with elevated cardio-metabolic risk and heightened triglyceride levels, and who are on stable statin therapy will be randomized (1:1) to receive either icosapent ethyl (IPE) 2g BID or standard of care.~It is hypothesized that assignment to IPE will lower progenitor cell depletion as well as limit progenitor cell dysfunction. This study may offer some molecular and cellular insights into the mechanisms underlying the cardiovascular benefits of IPE therapy reported in the REDUCE-IT trial. |
The IMMEDIATE study is a multi-centre, randomized controlled, open-label, two-phase cross-over study evaluating the effectiveness of a flash glucose monitor device to increase the proportion of time spent in target glucose range (3.9 to 10.0 mmol/L) among adults with type 2 diabetes inadequately controlled with non-insulin antihyperglycemic therapy compared to a control group not using a flash glucose monitor device. The study will consist of two phases; each 16 weeks long. In Phase 1, study participants who meet eligibility criteria will be randomized to receive a flash glucose monitor device combined with diabetes self-management education, or diabetes self-management education alone. In Phase 2, participants initially assigned to receive education alone will crossover to receive a flash glucose monitor device while participants initially using the flash glucose monitor will continue using their device. No diabetes self-management education will be provided during Phase 2. | The objective of this study is to evaluate the effectiveness of a flash glucose monitor device in achieving optimal glycemic control among adults with type 2 diabetes inadequately controlled with non-insulin antihyperglycemic therapy. |
Colorectal cancer is the second deadliest malignant tumor worldwide, and liver is the most common site of hematogenic metastasis of Colorectal cancer. Surgery is an effective treatment for colorectal cancer with liver metastasis, however, only 10%-20% of patients with liver metastasis are feasible for radical surgical resection.~In the early 1990s, radiofrequency ablation (RFA) was first applied in the treatment of liver metastases. In the late 1990s and early 2000s, microwave ablation (MWA), irreversible electroporation (IRE) and other technologies emerged. Today, with the continuous improvement of ablation techniques, many single-center retrospective studies have demonstrated that thermal ablation for liver metastases is comparable to surgery. Currently, institutions have conducted multi-center randomized controlled trials to compare the outcomes of the two treatment approaches. The expert consensus of tumor ablation therapy has confirmed that the ablation technique has the advantages of minimally invasive, well tolerated and low complications, and has been widely used in the treatment of solid tumors. In the treatment of liver metastases, it also has the advantage of not being limited by residual liver volume.~Postoperative tumor recurrence occurred in about 2/3 of the patients with liver stump, mainly due to the residual microscopic cancer foci. Chemotherapy can kill the microscopic cancer foci of the liver. EORTC (40983) confirmed that: compared with surgery alone, perioperative chemotherapy for resectable liver metastases (<4) could benefit patients with PFS and reduce the incidence of tumor progression-related events. EORTC (40004) proved that in the treatment of non-resectable liver metastases (1 ~ 10, with a maximum diameter <4cm), ablation combined with postoperative chemotherapy was superior to chemotherapy alone. E. Tanis et al compared two randomized controlled trials of EORTC for colorectal cancer liver metastasis, namely 40983 (EPOC) and 40004 (CLOCC), and confirmed the treatment of liver metastasis (<3cm) after integration. There was no significant difference in local recurrence rate between the RFA+ postoperative chemotherapy group and the surgery + perioperative chemotherapy group. At the beginning, neoadjuvant chemotherapy was designed to provide surgical resection opportunities for patients who could not be resected with metastatic tumor. Later, it was gradually applied to resectable liver metastasis. Studies on surgical combination with chemotherapy proved that preoperative chemotherapy was no less effective than postoperative chemotherapy for resectable liver metastasis. However, for isolated small metastatic tumors (<3cm), complete tumor response after neoadjuvant chemotherapy should be avoided, leading to the dilemma of inoperable. Studies have reported that ablation combined with preoperative chemotherapy can cause hepatic steatosis and tumor shrinkage, which makes tumor visualization difficult to a certain extent. If the tumor disappeared on imaging, the pathological specimen confirmed that there were still residues, and the tumor could reappear during follow-up. Therefore, the timing of ablation-related chemotherapeutic administration still needs to be explained, and there is still a lack of high-quality evidence-based medical evidence at home and abroad.~The purpose of this study was to compare the clinical efficacy of thermal ablation or combined with perioperative chemotherapy and postoperative chemotherapy in the treatment of colon cancer with liver metastasis. | Colorectal cancer is the second deadliest malignant tumor worldwide, and liver is the most common site of hematogenic metastasis of Colorectal cancer. Surgery is an effective treatment for colorectal cancer with liver metastasis, however, only 10%-20% of patients with liver metastasis are feasible for radical surgical resection. Many single-center retrospective studies have demonstrated that thermal ablation for liver metastases is comparable to surgery. Chemotherapy can kill the microscopic cancer foci of the liver. The timing of ablation-related chemotherapeutic administration still needs to be explained.~The purpose of this study was to compare the clinical efficacy of thermal ablation or combined with perioperative chemotherapy and postoperative chemotherapy in the treatment of colorectal cancer with liver metastasis. |
Cancer remains the number one cause of non-accidental death in children with leukemia being the most common type of childhood cancer. Although cure rates for pediatric leukemia have greatly improved over the last few years, relapsed disease still carries a poor prognosis. Outcomes for children with multiply relapsed leukemia are dismal ranging from a remission rate of 25% in AML after 2 relapses falling to 17% after 3 or more relapses and 44% in ALL after 2 relapses and 27% after 3 or more relapses.~Leukemia stem cells that are resistant to chemotherapy primarily contribute to treatment failure and targeting these cells remains a challenge. Anthracyclines such as daunorubicin and doxorubicin have been the mainstays of childhood leukemia therapy for over 50 years. Prior investigations found that very low doses, significantly less than traditionally given, of doxorubicin and daunorubicin inhibit the interaction of Akt and beta catenin pathways which is known to drive the development of leukemia stem cells and chemoresistance. Mice models showed that treatment with these very low dose anthracyclines does not suppress the immune system but rather expands cancer targeting T cells while inhibiting populations known to help cancer cells evade the immune system. In addition, targeted treatment reduced immune checkpoint expression, a known cause of resistance, on leukemia stem cells, thus further sensitizing them to cytotoxic T cells. Standard doses of anthracyclines suppress hematopoiesis and in turn the immune system and thus do not permit the expression of these immunologic benefits.~Patients with relapsed and/or refractory acute lymphoblastic leukemia or acute myeloid leukemia, ages 1-21 years, will be approached to participate in this study. These patients must have pathologically confirmed ALL or AML, whose disease is refractory to two induction therapeutic attempts, or who are in 2nd or greater relapse, or who are in 1st relapse or refractory to a single therapeutic attempt but are unable to receive intensive therapy due to other comorbidities. Patients will receive daunorubicin at 6.75mg/m2 daily for 5 consecutive days for a total dose of 33.75mg/m2.~The primary objective of this study is to assess the feasibility and tolerability of low dose daunorubicin. Another objective of the study is to validate if T cell based immune responses against chemoresistant leukemia stem cells are stimulated at these lower doses of daunorubicin, in hopes to provide preliminary pediatric data for further research with the hypothesis being that targeted anthracycline treatment does in fact stimulate T cell based immune responses against chemoresistant leukemia stem cells. Samples will be analyzed by flow cytometry for stem cell and immune markers. The third primary objective is to identify pro vs anti-cancer cellular immune responses of targeted anthracycline treatment in these patients. The mechanism of low dose DNR treatment on activating immunogenic cell death (ICD) will be investigated by determining relative levels of damage-associated molecular patterns. The tumorigenic capacity of resistant populations such as LSCs expressing high levels of immune checkpoints will be tested. The secondary objective of this study is to evaluate the pharmacokinetic parameters of low dose daunorubicin in children with relapsed/refractory AML and ALL. Blood samples for evaluation of low dose daunorubicin pharmacokinetics (area under the time concentration curve, maximum concentration, elimination half-life, clearance) will be drawn prior to dosing and 5min, 20min, 40min, 1hr, 2hrs, 4hrs, 8hrs, and 24hrs only after the first day of dosing.~Once the patient has received 5 doses of daunorubicin, subsequent therapy will be at the discretion of the primary oncology team. | In this pilot study, eligible pediatric patients will be treated with 5 consecutive days of low dose daunorubicin. All patients who receive low dose daunorubicin will be evaluated daily for potential toxicity during those 5 days. Once the patient has received 5 doses of daunorubicin, subsequent therapy will be at the discretion of the primary oncology team. |
The Infinity-Swedeheart trial is a prospective, multicenter, single-blind, randomized registry-based clinical trial. Eligible patients will be randomized 1:1 (DynamX Bioadaptor : Resolute Onyx). 2400 Patients will be randomized in Sweden. Patients will be followed at 30 days and 1 year by phone, and at 6 months and 2 to 5 years through clinical and diagnostic registries. | The Infinity-Swedeheart trial is a prospective, multicenter, single-blind, randomized registry-based clinical trial. Eligible patients will be randomized 1:1 (DynamX Bioadaptor : Resolute Onyx). |
This study is a retrospective cohort study. The PICU children will include all surviving children who were admitted to the pediatric intensive care section of the Department of Neonatology of Copenhagen University Hospital between 1st of January 2002 and 31st of December 2016.~The Strengths-and-Difficulties parental questionnaire evaluating neurodevelopmental- and behavioral impartment is web-based an hosted on a safe hospital server. The link will be sent to the universat digital post-box that all Danish citizens use for contact to the public authorities. For the children aged between 11 and 17 years an additional self-rated questionnaire will be provided. Furthermore, parents will answer questions on chronic illness, motor and sensory handicap, and special pedagogical support in day care institutions and school. | This study is a retrospective cohort study. The PICU children will include all surviving children who were admitted to the PICU of Copenhagen University Hospital between 1st of January 2002 and 31st of December 2016.~A link to a questionnaire including the Strengths-and-Difficulties parental questionnaire evaluating neurodevelopmental- and behavioral impartment as well as question on current impairments and health, will be sent to parents. For the children aged between 11 and 17 years an additional self-rated questionnaire will be provided. |
Despite considerable, replicated evidence of the efficacy and effectiveness of cognitive behavioural therapy, there is an insufficient number of professionals (e.g., psychologists, psychiatrists) in North America to provide evidence-based psychotherapy to all who need it. Seminal work from Statistics Canada has emphasized the need for greater access to psychotherapy in Canada. Moreover, in light of the COVID-19 pandemic, there is a greater need for resources that are scalable to help a large portion of the public to manage anxiety and attendant psychological distress. One promising avenue to increase the availability of evidence-based mental healthcare relies on technological developments, such as smartphone-enabled apps, to disseminate principles derived from existing evidence-based psychotherapies. The internet and smartphones provide a novel format to provide information and relevant skills to a large number of users. Recent research indicates that internet-based variants of cognitive behavioural therapy may be efficacious treatments for anxiety and depressive disorders among other conditions. Critically, internet-based treatments are scalable; resources can be provided to many people instantaneously to help them in crises, such as the COVID-19 pandemic. Further study is needed to identify who may benefit from internet-based treatment or require psychotherapy in a more traditional format. For example, whereas mental health professionals receive extensive training in assessment and case formulation to adapt treatments to individuals, internet-based resources are fixed. However, their fixed nature allows internet-based resources to offer a range of tools for users to try in a process of finding those that benefit them in particular situations. Moreover, the ability to access resources on demand presents a unique benefit of internet-based treatments that may support goals of traditional psychotherapy formats to generalize skills into individuals' daily lives. Anxiety disorders are also frequently comorbid with myriad other psychological and psychiatric conditions. Existing treatments for other conditions are often complicated by the presence of a comorbid anxiety disorder, which may be associated with poorer prognosis. Whereas traditional psychotherapy formats consider how to organize treatment for multiple comorbid conditions, internet- and smartphone-enabled resources may help individuals manage concurrent anxiety to support traditional treatment in addressing comorbid conditions. For example, anxiety disorders are often comorbid with substance use disorders; internet- and smartphone-based resources for anxiety disorders may, therefore, supplement existing treatments for substance use disorders for some individuals.~In recent years, there has been a proliferation of smartphone-based apps advertised to help users' mental health and wellness. While many of these apps may use principles of evidence-based treatments, the efficacy, effectiveness, or clinical utility of most apps has not been empirically supported. Overall, internet-based mental health resources may provide useful help to people for whom traditional psychotherapy is not yet available or to augment existing treatment such as through helping to generalize therapeutic skills into one's daily life. However, further research is needed to understand for whom and in what contexts internet- and smartphone-enabled resources are helpful. The present study will examine the utility of one such smartphone enabled app, MindShift, developed by Anxiety Canada in consultation with Canadian and American experts in evidence-based psychotherapy for anxiety disorders. Specifically, the main aim of the present study is to evaluate the effectiveness of the MindShift app to help users manage anxiety and related psychological distress as compared to anxiety and distress prior to app use. Two secondary, exploratory aims of the present study are to examine possible moderators that indicate for whom or in what contexts use of the MindShift app is particularly helpful. Specifically, the research team will examine person-specific and contextual moderators of change over time. For example, the person-specific moderator of baseline anxiety severity may demonstrate a non-linear association with change in anxiety severity over time, which would indicate that the smartphone-based resource is more helpful for individuals in a given range of baseline anxiety severity (e.g., low to moderate) while other treatment formats should be considered for individuals with severe baseline anxiety. Similarly, differences in the rate of anxiety symptom change over time will examine whether use of the app is associated with greater reductions in anxiety and distress when used alone or as an adjunct to traditional psychotherapy or pharmacotherapy. Finally, by examining comorbid conditions and concurrent treatments as moderators of change in anxiety severity over time, the present study will provide some of the first indications of whether use of the MindShift smartphone app to manage anxiety supports existing treatments for conditions frequently comorbid with anxiety disorders.~Adult participants 18 years of age and older will be recruited from Canada and the United States of America using a variety of online platforms and list serves. Following informed consent, participants will complete baseline assessment of anxiety symptom severity, depressive symptom severity, daily functional impairment, quality of life, alcohol use, use of illicit psychoactive substances, stress associated with the COVID-19 pandemic, and demographic information. Following baseline assessment, participants will be instructed in downloading the MindShift app to their personal mobile phone running either iOS or Android OS software. Participants will then use the MindShift app as they choose for the 16-week duration of the study. Finally, participants will be asked to complete follow-up assessments 2, 4, 8, 12, and 16 weeks following baseline assessment. Follow-up assessments will assess anxiety symptom severity, depressive symptom severity, functional impairment, and quality of life satisfaction on the same measures administered at baseline. | Despite considerable, replicated evidence of the efficacy and effectiveness of cognitive behavioural therapy, there is an insufficient number of professionals (e.g., psychologists, psychiatrists) in North America to provide evidence-based psychotherapy to all who need it. For example, in light of the COVID-19 pandemic, there is a greater need for resources that are scalable to help a large portion of the public to manage anxiety and attendant psychological distress. One promising avenue to increase the availability of evidence-based mental healthcare relies on technological developments, such as smartphone-enabled apps, to disseminate principles derived from existing evidence-based psychotherapies. However, further research is needed to understand for whom and in what contexts internet- and smartphone-enabled resources are helpful. The present study will examine the utility of one such smartphone enabled app, MindShift, developed by Anxiety Canada in consultation with Canadian and American experts in evidence-based psychotherapy for anxiety disorders. Specifically, the main aim of the present study is to evaluate the effectiveness of the MindShift app to help users manage anxiety and related psychological distress as compared to anxiety and distress prior to app use. Two secondary, exploratory aims of the present study are to examine possible moderators that indicate for whom or in what contexts use of the MindShift app is particularly helpful.~Adult participants 18 years of age and older will be recruited from Canada and the United States of America. Following informed consent, participants will complete baseline assessment of anxiety symptom severity, depressive symptom severity, daily functional impairment, quality of life, alcohol use, use of illicit psychoactive substances, stress associated with the COVID-19 pandemic, and demographic information. Following baseline assessment, participants will be instructed in downloading the MindShift app to their personal mobile phone running either iOS or Android OS software. Participants will then use the MindShift app as they choose for the 16-week duration of the study. Finally, participants will be asked to complete follow-up assessments 2, 4, 8, 12, and 16 weeks following baseline assessment. Follow-up assessments will assess anxiety symptom severity, depressive symptom severity, functional impairment, and quality of life satisfaction on the same measures administered at baseline. |
Schizophrenia is a psychiatric disorder that affects 1% of the population worldwide. The diagnostic announcement of this chronic disorder is an essential step in the patient's care. Recommendations specify the importance of including caregivers at the time of the announcement. In practice, caregivers are not systematically associated with the announcement of the diagnosis of schizophrenia, while the daily support of patients is provided in 75% of cases by the family. This support can lead to the exhaustion of caregivers and have repercussions on their sick loved one.~This study will qualitatively describe and explore the experience of the diagnostic announcement in relatives of patients with schizophrenia. Specifically, the investigators will explore the history before the diagnosis is announced, the conditions of the announcement and the experiences of relatives as well as the impact at the personal and family-levels. This study will also explore the expectations of caregivers and avenues for reflection for announcement of schizophrenia diagnosis.~The number of subjects to be included in this study is therefore set at 30. A preselection of each potential participant will be carried out by phone or in person to ensure the presence of inclusion criteria and the absence of non-inclusion criteria. The patients will also be provided with oral information about the study to allow sufficient time to reflect before inclusion. Then, the selection-inclusion-interview visit will take place visually in an intra-hospital or extra-hospital consultation structure of the Center Hospitalier Alpes-Isère. This visit will be unique and will consist of the entire protocol. It will be both a selection, inclusion and interview visit.~Once the results have been analyzed, this study will provide a better understanding of the experiences of relatives of patients when the diagnosis of schizophrenia is announced, the impact of this announcement on caregivers and family relationships and the expectations of caregivers regarding this announcement. In the long term, the data collected will be add value in developing medical recommendations on consultation to announce the diagnosis of schizophrenia to relatives of patients, in order to best meet the expectations of relatives and to minimize as much as possible the harmful impact that can have such announcement. | The diagnostic announcement of a chronic disorder is an essential step in the patient's care. Recommendations specify the importance of including caregivers at the time of the announcement. In practice, caregivers are not systematically associated with the announcement of the diagnosis of schizophrenia, while the daily support of patients is provided in 75% of cases by the family. This support can lead to the exhaustion of caregivers and have repercussions on their sick loved one.~This study will qualitatively describe and explore the experience of the diagnostic announcement in relatives of patients with schizophrenia. Specifically, the investigators will explore the history before the diagnosis is announced, the conditions of the announcement and the experiences of relatives as well as the impact at the personal and family-levels. This study will also explore the expectations of caregivers and avenues for reflection for announcement of schizophrenia diagnosis.~The number of subjects to be included in this study is therefore set at 30. A preselection of each potential participant will be carried out by phone or in person to ensure the presence of inclusion criteria and the absence of non-inclusion criteria. The patients will also be provided with oral information about the study to allow sufficient time to reflect before inclusion. Then, the selection-inclusion-interview visit will take place visually in an intra-hospital or extra-hospital consultation structure of the Center Hospitalier Alpes-Isère. This visit will be unique and will consist of the entire protocol. It will be both a selection, inclusion and interview visit.~Once the results have been analyzed, this study will provide a better understanding of the experiences of relatives of patients when the diagnosis of schizophrenia is announced, the impact of this announcement on caregivers and family relationships and the expectations of caregivers regarding this announcement. In the long term, the data collected will be add value in developing medical recommendations on consultation to announce the diagnosis of schizophrenia to relatives of patients, in order to best meet the expectations of relatives and to minimize as much as possible the harmful impact that can have such announcement. |
Cancer-related cognitive impairment (CRCI) is a research priority due to its rising prevalence and dramatic impacts on survivors' quality of life and health long-term. Strong evidence supports the efficacy of physical activity (PA) for improving cognitive function and key CRCI correlates. The aim of the proposed study is to pilot test an innovative, mHealth intervention designed to ameliorate CRCI in women receiving chemotherapy for breast cancer. This study will employ an efficient 2x2 factorial design to compare PA prescriptions targeting frequent PA of any intensity and reduced daily sitting (Move); aerobic exercise (consistent with PA guidelines for cancer survivors; Exercise); both (Move+Exercise); or none (Core). The main and interactive effects of these intervention components on CRCI and its underlying mechanisms will be tested across the breast cancer trajectory. Aim 1: This pilot study aims to test the feasibility and acceptability of the mHealth intervention in 40 women receiving chemotherapy for breast cancer. Feasibility will be assessed by participant recruitment yield, intervention adherence, contamination, and retention. Acceptability will be assessed by participant ratings and perceptions of intervention components as measured at a baseline orientation and at post-intervention (1 month post-chemotherapy). Aim 2: Examine preliminary efficacy of the intervention components (i.e., Move, Exercise, Core) delivered alone (i.e., main effects) and in combination (i.e., interaction effects) on executive function and working memory at post-intervention. These data will inform the sample size needed for a fully-powered randomized controlled trial. Aim 2 outcomes will be measured at pre-intervention (before the first or second chemotherapy cycle) and post-intervention, and include accelerometry and neurocognitive testing. Exploratory Aim: Explore the effects of the intervention components on CRCI correlates. Exploratory outcomes will be measured at pre- and post-intervention and include patient-reported outcomes (e.g., fatigue, depressive symptoms). Participants will also complete brief ecological momentary assessments (EMAs) on their mobile phones across four 14-day measurement bursts to further explore associations among behavioral patterns, cognition, and CRCI correlates. To test the specific aims, women diagnosed with breast cancer and scheduled to receive 3-6 months of chemotherapy (N=40) will be randomized to receive select mHealth intervention components, including Core (attentional control), Move, Exercise, or Move+Exercise (n=10 each condition). Data will be analyzed using descriptive statistics and axial coding (Aim 1); analysis of covariance and standard mean difference (Aim 2 and Exploratory); and hierarchical linear modeling (Exploratory). Findings will provide the necessary pilot data to support a grant application for a fully-powered trial. | Aim 1: This pilot study tests the feasibility and acceptability of a mobile app-based behavioral intervention in 40 women receiving chemotherapy for breast cancer. Participants will be randomized to receive app components following a 2x2 factorial design. Feasibility will be assessed by participant recruitment yield, intervention adherence, contamination, and retention. Acceptability will be assessed by participant ratings and perceptions of intervention components as measured at post-intervention (1 month post-chemotherapy).~Aim 2: Examine preliminary efficacy of the intervention components (i.e., Move, Exercise, Core) delivered alone (i.e., main effects) and in combination (i.e., interaction effects; Move+Exercise) on executive function and working memory at post-intervention. These data will inform the sample size needed for a fully-powered randomized controlled trial. Aim 2 outcomes will be measured at pre-intervention (before the first or second chemotherapy cycle) and post-intervention, and include accelerometry and neurocognitive testing.~Exploratory Aim: Explore the effects of the intervention components on correlates of cancer-associated cognitive decline. Exploratory outcomes will be measured at pre- and post-intervention and include patient-reported outcomes, specifically cancer-related fatigue. Participants will also completed brief ecological momentary assessments (EMAs) their mobile phones across four 14-day measurement bursts at pre-intervention, mid-chemotherapy, and 1 month post-chemotherapy to further explore associations among behavioral patterns, cognition, and correlates. |
The AEROLITH Clinical Study will evaluate the safety and effectiveness of Applaud Acoustic Enhancer when used in conjunction with conventional ureteroscopic laser lithotripsy (URS-LL) in the treatment of subjects with urinary stones. The clinical study is a prospective, multi-center, two-arm, randomized, double blinded study.~A total of 196 subjects will be enrolled in this study at up to 27 investigational sites located in the U.S. | A pivotal study to evaluate the safety and effectiveness of Applaud Acoustic Enhancer when used in conjunction with conventional ureteroscopic laser lithotripsy (URS-LL) in the treatment of subjects with urinary stones. |
Posttraumatic stress disorder is a psychiatric disorder that can develop in response to a traumatic event, and half of civilians living in inner-city areas with high levels of violence suffer from PTSD. The currently recommended treatment for PTSD is focused on discussing the trauma, but a third to half of patients cannot participate or do not benefit from this treatment, especially individuals with low levels of education or literacy. Therefore, new treatments for PTSD are needed.~The study will (1) assess feasibility of a TMS treatment in an underserved population; (2) determine if this TMS treatment protocol improves PTSD symptoms and biological markers of PTSD such as brain functioning and startle responses; (3) define new brain targets for future TMS studies; (4) provide the first data for individual differences, which will help personalize treatment for PTSD patients; (5) improve knowledge of the neurobiology of PTSD and treatment response. | The study will (1) assess feasibility of a TMS treatment in an underserved population; (2) determine if this TMS treatment protocol improves PTSD symptoms and biological markers of PTSD such as brain functioning and startle responses; (3) define new brain targets for future TMS studies; (4) provide the first data for individual differences, which will help personalize treatment for PTSD patients; (5) improve knowledge of the neurobiology of PTSD and treatment response. |
The objective of this study is to evaluate the effects of video consultation versus face-to-face consultation for patients with obstructive sleep apnea on patients' CPAP use (minutes/per night), self-efficacy, risk outcomes, outcome expectancies, experiences with technology and, patients' and nurses' satisfaction.~This study is a non-blinded randomized controlled trial with an intervention group (video consultations) and a usual care group (face-to-face consultations), with assessements after 1, 2, 3, 4, 12 and 24 weeks.~Patients were recruited from a large teaching hospital (Rijnstate, hospital), and included from January 2, 2019 until June 26, 2019.In total, 140 patients were randomized, (1:1 allocation). | The objective of this study is to evaluate the effects of video consultation versus face-to-face consultation for patients with obstructive sleep apnea on patients' CPAP use (minutes/per night), self-efficacy, risk outcomes, outcome expectancies, experiences with technology and, patients' and nurses' satisfaction. |
This will be a single-site, open-label study in patients with primary Sjogren's syndrome. All patients will receive tibulizumab (LY3090106) 300mg subcutaneously every 2 weeks for a total of 12 weeks.~Primary Sjogren's syndrome was selected as a relevant patient population based on the mechanism of action of the molecule and the current understanding of the pathogenesis of the disease. An open-label design was chosen based on practical considerations regarding the number of patients that could be recruited. Although open-label studies are subject to bias, objective primary endpoints were intentionally chosen to minimize this concern.~The goal of this study is to demonstrate that tibulizumab (LY3090106) treatment improves the mean unstimulated salivary flow rate or the salivary gland total ultrasound score (TUS) in primary Sjogren's syndrome patients at week 12 compared to the baseline visit. | To demonstrate that tibulizumab (LY3090106) treatment improves the mean unstimulated salivary flow rate or the salivary gland total ultrasound score (TUS) in primary Sjogren's syndrome patients at week 12 compared to the baseline visit. |
This is a single center, randomized, double-blind, 2-arm, parallel-group study of DuACT in participants with clinical symptoms of COVID-19 that have begun within the past 72 hours prior to testing. A confirmatory diagnosis of COVID-19 via nasopharyngeal swab, with a positive PCR result within 48 hours of testing.~Consented participants who complete screening and meet study eligibility criteria will be randomized in a 1:1 ratio to receive DuACT or Placebo for 5 days.~Study drugs will be administered BID for 5 days with a loading dose on Day 1. Following randomization, participants will complete a symptom questionnaire, record temperature and record oxygen saturation daily for 10 days and at day 28. A thermometer and pulse oximeter will be provided to each patient at the baseline visit (Day 1).~On study days 3, 6 and 10 participants will have a clinic or home visit by a home healthcare provider. At these visits, a mid-turbinate nasal swab will be obtained, confirmation of the patient's clinical symptoms questionnaire will be completed and any adverse events will be assessed. | This is a single center, randomized, double-blind, 2-arm, parallel-group study of DuACT in participants with clinical symptoms of COVID-19 that have begun within the past 72 hours prior to testing. |
Coronaviruses (CoVs) are enveloped, single positive-strand RNA viruses belonging to the large subfamily Coronavirinae, which can infect mammals and several other animals.The continued spread of coronavirus disease 2019 (COVID-19) has prompted widespread concern around the world, and the World Health Organization (WHO), on 11 March 2020, declared COVID-19 a pandemic. Studies on severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) showed that virus-specific antibodies were detectable in 80-100% of patients at 2 weeks after symptom onset. Currently, the antibody responses against SARS-CoV-2 remain poorly understood and the clinical utility of serological testing is unclear. Little is known about the kinetics, tissue distribution, cross-reactivity and neutralization antibody response in COVID-19 patients. Asymptomatic cases are common but to date there are scarce epidemiological surveys that provide a clear percentage of asymptomatic cases.~A large number of healthcare workers have been infected with the virus worldwide, presenting with severe symptoms to no symptoms at all, in which case being diagnosed on contact tracing only. The seropositivity rate in previously undiagnosed healthcare workers has been reported in different regions of the world. In a combined study of three hospitals of Turkey, the seropositivity rate of the previously undiagnosed HCWs was 2.7%. A study done in China revealed 17.5 % seropositivity rate.~This study will aim to comprehensively review the current knowledge on the immunological changes observed in various healthcare workers in this part of the world, who remained asymptomatic while working in high exposure areas of COVID-19 infection. | This study is about the current knowledge on the immunological changes observed in various healthcare workers in this part of the world, who remained asymptomatic while working in high exposure areas of COVID-19 infection. |
The study used a randomized, dose-escalation, blinded, placebo-controlled trial design.~In this trial, 160 subjects were enrolled. The test vaccines are divided into four dose groups: dose group 1 (0.025mg / 0.1ml / person), dose group 2 (0.05mg / 0.1ml / person), dose group 3 (0.075mg / 0.1ml / person), dose group 4 (0.1mg / 0.1ml / person), each Each dose group was enrolled according to 18-45、 46-65 、6-10、11-17years old .~The 4 doses are in descending order in the order of 18-45, 46-65, 11-17, and 6-10 years old. Each age group in the same dose group was enrolled in 8 experimental BCG subjects and 2 placebo subjects.~Among subjects aged 6-65 years, the dose group 2 study will be carried out after the safety assessment 14 days after the dose group 1 vaccination, and the dose group 3 study will be carried out after completing the safety assessment 14 days after the dose group 2 vaccination. Dose group 3 studies were carried out after safety assessment 14 days after vaccination. Within the same dose group, after completing the safety assessment 14 days after vaccination for the previous age group, vaccination for the next age group is carried out.~BCG-PPD and EC skin test were performed during the screening period, and the skin test results were followed up at 48 hours; blood routine, urine routine, blood biochemistry, HIV antibody test, electrocardiogram, chest X-ray examination, physical examination, vital signs (heart rate, blood pressure) And body temperature), female subjects of childbearing age undergo a blood pregnancy test. Those eligible for entry will receive a dose of the trial vaccine or placebo on the same day (day 0); Observe vital signs (heart rate, blood pressure and body temperature), reactions at the inoculation site, and reactions at the non-inoculation site at 30 minutes, 7 days, and 14 days after vaccination; Blood routine, urine routine, blood biochemistry, electrocardiogram examination on the 14th day after vaccination; BCG-PPD and EC skin tests were performed on the 84th and 180th days after inoculation.~If the blood routine, urine routine, blood biochemistry, electrocardiogram examinations after vaccination are abnormal and have clinically meaningful results, a re-test is required. Under special circumstances, the number of re-tests can be appropriately increased until the follow-up outcome. | The study used a randomized, dose-escalation, blinded, placebo-controlled trial design.~In this trial, 160 subjects were enrolled. The test vaccines are divided into four dose groups: dose group 1 (0.025mg / 0.1ml / person), dose group 2 (0.05mg / 0.1ml / person), dose group 3 (0.075mg / 0.1ml / person), dose group 4 (0.1mg / 0.1ml / person), each Each dose group was enrolled according to 18-45、 46-65 、6-10、11-17years old .~The 4 doses are in descending order in the order of 18-45, 46-65, 11-17, and 6-10 years old. Each age group in the same dose group was enrolled in 8 experimental BCG subjects and 2 placebo subjects.~Among subjects aged 6-65 years, the dose group 2 study will be carried out after the safety assessment 14 days after the dose group 1 vaccination, and the dose group 3 study will be carried out after completing the safety assessment 14 days after the dose group 2 vaccination. Dose group 3 studies were carried out after safety assessment 14 days after vaccination. Within the same dose group, after completing the safety assessment 14 days after vaccination for the previous age group, vaccination for the next age group is carried out. |
This is an investigator initiated prospective open-label, within-patient, masked, randomized study in patients with neovascular AMD, DME, or RVO undergoing bilateral anti-VEGF injections. Patients will be randomized into two cohorts (Cohort 1 and Cohort 2) and then followed for 3 consecutive injection visits. Treatment will be rendered at each injection visit based on the individualized routine established anti-VEGF injection interval for each patient.~Within the respective cohorts, one eye per patient will be randomized to receive either an intracanalicular dexamethasone insert or the control treatment at each injection visit. Cohorts are as follows:~Cohort 1:~Total N= 40 eyes (20 patients). Twenty eyes (one eye per patient) will be randomized to receive an intracanalicular dexamethasone insert. The contra-lateral eye (Control) will receive a sham dilation.~Cohort 2:~Total N= 40 eyes (20 patients). Twenty eyes (one eye per patient) will be randomized to receive an intracanalicular dexamethasone insert. The contra-lateral eye (Control) will receive topical corticosteroids (prednisolone acetate 1%) QID tapered over 4 weeks (QID/ 1 week, TID/ 1 week, BID/1 week, QD/ 1 week).~In eyes randomized to either DEXTENZA or sham dilation, DEXTENZA insertion or sham dilation will be performed prior to injection.~In eyes randomized to either DEXTNEZA or topical steroids, eyes randomized to DEXTENZA will receive insertion prior to injection. Eyes randomized to topical steroid therapy (Control) will receive 1 drop of prednisolone acetate 1% pre-injection and the remaining 3 drops of prednisolone acetate 1% post injection. Control eyes will follow tapered dosing over 4 weeks (QID/ 1 week, TID/ 1 week, BID/1 week, QD/ 1 week) to ensure dose matching between DEXTENZA and Control in Cohort 1.~Pain will be rated at 6 time points: (1) prior to any treatment, (2) after anesthesia, (3) after intravitreal injection, (4) 6 hours by telephone (+/- 2 hours), (5) 24 hours by telephone (+/-3 hours) and (6) 3-6 days at assessment visit. Pain will be evaluated by survey administrators masked to treatment assignment. Patient comfort (right eye vs left eye) will be assessed at each patient visit by masked survey administrator. Anterior cell count and anterior cell flare assessment will be conducted at 3-6 days following each intravitreal injection visit. There will be a final patient preference survey performed. | This is an investigator initiated prospective open-label, within-patient, masked, randomized study in patients with neovascular AMD, DME, or RVO undergoing bilateral anti-VEGF injections. Patients will be randomized into two cohorts (Cohort 1 and Cohort 2) and then followed for 3 consecutive injection visits. Treatment will be rendered at each injection visit based on the individualized routine established anti-VEGF injection interval for each patient. |
Upper extremity functions affect the quality of life at different levels in patients with rheumatoid arthritis (RA). In the current literature; it has been shown that grip endurance is associated with upper limb functions. However, there is no study investigating the relationship between grip endurance and quality of life in patients with RA. The purpose of this study is to investigate the relationship between grip endurance, disability of upper extremity, and quality of life in patients with RA. | The aim of this study is to investigate the relationship between grip endurance, disability of upper extremity and quality of life in patients with rheumatoid arthritis. |
The previous standard of care for high titer antibody eradication in hemophilia A (HA) included a labor-intensive, immune tolerance induction (ITI) regimen administered with concomitant bypassing agent (BPA) prophylaxis, either daily recombinant activated factor VII (rFVIIa) or at least 3 non-consecutive days of activated prothrombin complex concentrate (aPCC) given intravenously (IV) each week.~The purpose of the aPCC-emicizumab safety study is to prospectively investigate the safety and hemostatic efficacy of a personalized dose of aPCC in children and adults with hemophilia A and inhibitors on emicizumab prophylaxis during acute bleeding events or prior to procedures. | The purpose of the aPCC-emicizumab safety study is to prospectively investigate the safety and hemostatic efficacy of a personalized dose of aPCC in children and adults with hemophilia A and inhibitors on emicizumab prophylaxis during acute bleeding events or prior to procedures. |
A single-center, randomized, blinded, multi-cohort, placebo-controlled trial design was adopted.This trial adopts the seamless design of phase I/IIa, which is carried out in two phases, phase I and phase IIa, phase I is the age/dose climbing phase, and phase IIa is the dose expansion phase.It is planned to enroll 580 subjects, divided into 5 age groups, including: young adults (18-59 years old, 60 people), adolescents (6 -17 years old, 60 people), and elderly (≥60 years old, 160 people) , Toddlers (2-5 years old, 140), infants (6 weeks to 23 months old, 160).Research phase and trial grouping: age/dose climbing phase: 340 subjects are planned to be enrolled in Liuzhou City, and they will be enrolled in the group according to the age order of young adults → adolescents and old people → toddlers → infants and young children. There are 10 cohorts, randomly divided into experimental group (low-dose or high-dose), placebo group (containing aluminum), and the random ratio of each entry stage is 2:1. Among them, infants and the elderly will be added a placebo group without aluminum adjuvant, test group (low dose or high dose), placebo group (aluminum), placebo (aluminum-free), the random ratio is 2:1:1; Dose expansion stage: It is planned to enroll 240 subjects in Rong'an County. The elderly, infants, and infants will be divided into 3 cohorts, and each age group will be randomly divided into low-dose or high-dose groups, with a random ratio of 1:1.According to the order of young adults → adolescents and elderly → toddlers → infants and young children, the dose is from low to high, and the investigator (including the main investigator and the field investigator) will review the safety of the low-dose/placebo group 7 days after the first dose. After the safety data is confirmed, you can enter the high-dose/placebo group for this age group to explore. After DSMB examines the safety data of the first dose of young and middle-aged people to 30 days after the full exemption and confirms safety, they can enter the adolescent and elderly age group; DSMB examines the safety and confirms the safety of the first dose of adolescents and the elderly to 30 days after the full exemption After that, you can enter the infant age group; the investigator (including the main investigator and the field investigator) will review the safety data 7 days after the first dose of the infant low-dose/placebo group and confirm the safety, then you can enter the infant age group explore. The three age groups (cohorts 4 and 6, 7 and 8, 9 and 10) of the elderly, toddlers, and infants can be entered into the corresponding age after the DSMB reviews the safety data of the first dose to 30 days after the full exemption and confirms the safety. In the dose expansion phase (cohorts 11, 12, 13), 80 subjects were enrolled in each cohort (of which, 40 were vaccinated with low-dose trial vaccine and 40 were vaccinated with high-dose trial vaccine). | The purpose of the research is to evaluate the safety and tolerability of the tetravalent recombinant Norovirus vaccine at different doses, to initially explore the immunogenicity of the vaccine, and to determine the appropriate dose of the product for later clinical trials.This trial adopts the seamless design of phase I/IIa, which is carried out in two phases, phase I and phase IIa, phase I is the age/dose climbing phase, and phase IIa is the dose expansion phase.It is planned to enroll 580 subjects, divided into 5 age groups, including: young adults (18-59 years old, 60 people), adolescents (6 -17 years old, 60 people), and elderly (≥60 years old, 160 people) , Toddlers (2-5 years old, 140), infants (6 weeks to 23 months old, 160).The test vaccine contains recombinant HuNoV GI.1-VP1 protein, HuNoV GII.3-VP1 protein, HuNoV GII.4-VP1 protein, HuNoV GII.17-VP1 protein, and each dose contains 12.5μg/type/0.5ml/bottle (Low dose), 25μg/type/0.5ml/piece (high dose). |
Atrial fibrillation (AF) is the most common cardiac arrhythmia and a major risk factor for cerebrovascular insults. Paroxysmal AF is defined as an episode of AF that terminates spontaneously or with intervention within 7 days. Patients with AF may present with palpitations, shortness of breath or sensation of light-headedness but asymptomatic episodes are also possible, especially in paroxysmal AF. The lack of continuous heart rate monitoring options makes early diagnosis of paroxysmal AF challenging. In this prospective single-center trial, the PPG wearable Corsano CardioWatch 287 sensor will be used to conduct continuous heart rate and -rhythm monitoring in patients with known paroxysmal AF. Collected data will then be analysed using a Cloud Analytics Service (Preventicus Heartbeats algorithm) and compared with data from simultaneously obtained 48-hour Holter ECG. Correctly identified AF episodes, their cumulative duration per 48 hours (AF burden) and the number of asymptomatic episodes will be assessed. In the primary analyses, the sensitivity of the PPG analysing algorithm to detect AF episodes is estimated by performing a logistic regression on detection (yes/no) with only an intercept as predictor, which is then translated to a proportion (the sensitivity). In the secondary analyses we are comparing the cumulative duration of AF episodes over 48 hours (AF burden) obtained with the PPG-sensor and Holter-ECG. In summary, the purpose of the study is to evaluate the performance and efficacy of the wearable PPG sensor and the cloud analytics service in detecting and quantifying AF episodes in patients with known history of paroxysmal AF. | In this prospective single-center trial, a wearable photoplethysmographic (PPG) sensor coupled with a cloud analytics service will be used to detect and quantify atrial fibrillation (AF) episodes in patients with known paroxysmal AF. Patients will simultaneously receive the PPG sensor in form of a smartwatch or bracelet and a Holter ECG for 48 hours. Correctly identified AF episodes and AF burden determined by both methods will be compared. |
Starting in 2001, the Look AHEAD study randomized 5145 patients with type 2 diabetes to an intensive lifestyle intervention (ILI) focused on weight loss versus a control group receiving diabetes education (Diabetes Support and Education, or DSE).The Look AHEAD study tested whether participants with type 2 diabetes assigned to an intensive lifestyle intervention (ILI) for weight loss exhibited reductions in cardiovascular morbidity and mortality, relative to a control group receiving usual care and diabetes support and education. During the 12-year intervention period, the ILI led to persistent reductions in weight, waist circumference, and hemoglobin A1c and improvements in physical fitness, among other clinical benefits. After the conclusion of the intervention in 2012, participants were consented to be linked with administrative data. The investigators attempted to link 3188 consenting participants with Social Security Administration databases. Of these, the investigators were able to successfully link 3093 participants. In this study, the investigators will compare employment, earnings, and retirement between the ILI and the control group during and after the intervention period (2001-2018). The investigators will determine ILI-versus-control differences in employment, earnings, and retirement in each year after randomization, relative to a pre-randomization assessment period. The investigators will also investigate ILI-versus-control differences in cumulative years of employment and earnings after randomization which occurred between 2001-2004. The investigators will use multivariate regressions controlling for baseline participant characteristics and clinic site and also survival analyses that estimate whether the time until retirement differs between the ILI and control groups. | Starting in 2001, the Look AHEAD study randomized patients with type 2 diabetes to an intensive lifestyle intervention (ILI) focused on weight loss versus a control group receiving diabetes education (Diabetes Support and Education, or DSE). The ILI successfully reduced weight, improved diabetes control, and functional status, among other outcomes. In this study, the investigators will compare employment, earnings, and retirement between the ILI and the control group during and after the intervention period (2001-2018). |
To benefit from early HIV diagnosis, the CDC suggests that groups at higher HIV risk get tested regularly. The study will evaluate the efficacy of an intervention to promote regular HIV testing and prevention (risk reduction and PrEP awareness and referrals) among friendship networks of Latino men who have sex with men and transwomen (LMSMT) in three midsized Midwestern cities. The intervention uses the relationships that permeate networks of LMSMT by training well-positioned members to encourage a collective response to the epidemic and to disseminate HIV testing and prevention messages and resources within the network. Thus, we will (a) recruit 36 friendship networks of LMSMT in Milwaukee, Cleveland, and Indianapolis (N ≈ 432); (b) test them for HIV and recommend that they test regularly; (c) invite key members of 18 randomly selected networks to a 4-session training to promote regular HIV testing and prevention in their networks; (d) conduct chart reviews to verify regular testing and PrEP visits and assess regular testing, PrEP visits, and risk behavior and mediators at 6, 12 and 18-month follow up. | This study is a randomized controlled trial that evaluates the efficacy of a network intervention to promote regular HIV testing and prevention (risk reduction and PrEP awareness and referrals) among friendship networks of Latino men who have sex with men and transwomen (LMSMT) in three mid sized Midwestern cities. |
Neonatal sensorineural hearing loss is a frequent pathology, affecting around 800 newborns per year in France, or an incidence of 0.8 to 1.3 per 1000 births, comparable to other industrialized countries. It can affect the development of speech and language and lead to impaired quality of life.~Studies have shown that children with hearing loss score lower on general quality-of-life measurement tools, compared to their normal-hearing peers. A poorer quality of life in patients with sensorineural hearing loss may also reflect physical, academic, social or emotional difficulties. They are also exposed to an increased risk of poor development of language and social skills, as well as an increased risk of developing psychiatric pathologies.~The care of deafness in children is difficult and the relevance of interventions is difficult to evaluate based on audiometric measurements alone.~Generic pediatric quality of life tools have been validated and used, among other things, to assess the quality of life of children with deafness. However, these non-specific tools do not make it possible to precisely target which factors and interventions are the most important for the quality of life in this population.~Achieving a score to monitor the quality of life objectively over time is fundamental to verify the effectiveness of interventions, and assess the impact on the child. There is currently no validated test in French for any of these uses and populations.~The Parents' Evaluation of Aural/Oral Performance of Children (PEACH) is a hetero-evaluation score used to study the quality of a child's communication from an early age (from 4 months in some studies) and up to 13 years. This tool is specifically designed for children with hearing aids or a cochlear implant. It has been translated into Swedish and Spanish and used in numerous international publications.~The Speech, Spatial and Qualities of Hearing Scale (SSQ) is an adult self-assessment score assessing, in three categories, the performance of speech comprehension, spatial hearing and hearing quality. It is widely used internationally in its adult version.~This adult score has been adapted and used for the pediatric population in a hetero-evaluation score by parents (SSQ-P) from 5 years old, and a simplified score (SSQ-C) usable by children> 11 years.~In addition, the authors of the adult SSQ also prepared and validated a Handicap questionnaire to target the impact of hearing loss on quality of life, and integrated into the SSQ self-assessment.~The objective of the study is to adapt the questionnaires PEACH, SSQ child (SSQ-C) and SSQ parents (SSQ-P) to the French child, and statistically measure their internal and external validity by comparing them to a control group.~The validation of these three tests (PEACH, SSQ-P, SSQ-C) would make it possible to assess the hearing performance and quality of life of almost the entire pediatric population, for use in both clinical and academic practice. | The care of deafness in children is difficult and the relevance of interventions is difficult to evaluate based on audiometric measurements alone.~Generic pediatric quality of life tools have been validated and used, among other things, to assess the quality of life of children with deafness. However, these non-specific tools do not make it possible to precisely target which factors and interventions are the most important for the quality of life in this population.~Achieving a score to monitor the quality of life objectively over time is fundamental to verify the effectiveness of interventions, and assess the impact on the child. There is currently no validated test in French for any of these uses and populations.~The objective of the study is to adapt the questionnaires PEACH, SSQ child (SSQ-C) and SSQ parents (SSQ-P) to the French child, and statistically measure their internal and external validity by comparing them to a control group.~The validation of these three tests (PEACH, SSQ-P, SSQ-C) would make it possible to assess the hearing performance and quality of life of almost the entire pediatric population, for use in both clinical and academic practice. |
Mood disorder carries a major burden in our country as it represents 15% of inpatients and 20% of outpatients in mental hospitals in Egypt~The current work is designed to study the effect of duration of untreated bipolar disorder on clinical outcome ( severity , residual symptoms ,duration of hospital admission) and to study factors affecting duration of untreatment in Upper Egypt.~The current study is cross sectional retrospective study, included 100 patients were diagnosed as mood disorder bipolar I (manic episodes) according to DSM5, patients recruited from inpatient psychiatric unit at department of Neurology and Psychiatry, Assiut University hospitals | The current study is cross sectional retrospective study, included 100 patients were diagnosed as mood disorder bipolar I (manic episodes) according to DSM5, patients recruited from inpatient psychiatric unit at department of Neurology and Psychiatry, Assiut University hospitals The current work is designed to study the effect of duration of untreated bipolar disorder on clinical outcome ( severity , residual symptoms ,duration of hospital admission) and to study factors affecting duration of untreatment in Upper Egypt. |
This was a non-confirmatory, randomized, participant- and investigator-blinded, placebo-controlled, single ascending dose study to investigate the safety, tolerability and PK of LNA043 in Japanese participants with osteoarthritis of the knee. This study consisted of 2 cohorts with a total of 12 participants. | The objective of this study was to determine the safety, tolerability and pharmacokinetics after single ascending dose of LNA043 in Japanese participants with osteoarthritis of the knee. |
There is a lot of data from registries about poor adherence to guidelines. It is connected with a problem that patients usually have a lot of comorbidities and physicians need to know сonsequently the huge number of medications and combinations. It is very difficult to decide quickly according to available data from libraries like PubMed. The Clinical Decision Support Systems (CDSS) based on real clinical data and its own Artificial Intelligence algorithms can help to make the right choice. This trial is designed to assess the difference between retrospective electronic medical cards (EMC) therapy prescriptions and MedicBK prescriptions based on key patient characteristics.~Two groups of experts (cardiologists with clinical practice for more than 5 years) will be participating in the trial.~Using main characteristics from EMC the first group of experts will put this data into MedicBK platform and assess retrospective treatment. The next blinded group of experts will perform prescriptions using MedicBK algorithms based on current guidelines and data from available clinical trials. The main hypothesis is the use Clinical Decision Support Systems (CDSS) better than current clinical practice. This option can help to make the right choice of medical combination based on main patient's clinical characteristics | The Clinical Decision Support Systems (CDSS) based on real clinical data and its own algorithms can help to make the right choice. This trial is designed to assess the difference between retrospective electronic medical cards (EMC) therapy prescriptions and MedicBK prescriptions based on key patient characteristics. |
This is an open-label, randomised, two-arm, phase III, multicentre clinical trial.The total sample size is 210 and 105 per arm. The population to be included are stage IB-IIIA, completely resected, non-small cell lung cancer patients.~Patients randomised to the experimental arm will receive Nivolumab 360mg + Paclitaxel 200mg/m2 + Carboplatin AUC5 for 4 cycles every 21 days (+/- 3 days) as adjuvant treatment followed by maintenance adjuvant treatment for 6 cycles with Nivolumab 480 mg Q4W (+/- 3 days).~Patients randomized to the control arm will receive Paclitaxel 200mg/m2 + Carboplatin AUC5 for 4 cycles every 21 days (+/- 3 days) followed by 2 observation visits.~The primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time.~Patient accrual is expected to be completed within 3.5 years, excluding a run-in-period of 3 months. Treatment and follow-up are expected to extend the study duration to a total of 6.5 years. Patients will be followed 2 years after adjuvant treatment or observation phase. The study will end once survival follow-up has concluded. | This is an open-label, randomised, two-arm, phase III, multi-centre clinical trial.~210 stage IB-IIIA, completely resected, non-small cell lung cancer patients will be enrolled in this trial to evaluate the disease free survival between experimental arm (Adjuvant Chemotherapy-Immunotherapy + maintenance adjuvant Immunotherapy) and control arm (Adjuvant Chemotherapy) |
Pain is a major problem that has to be dealt with in case of hip fracture, as it resembles an obstacle for examination, positioning for receiving neuroaxial anesthesia and postoperative mobility and physiotherapy.~With the introduction of ultrasound in regional anesthesia and peripheral nerve blocks, regional analgesia float to the surface as a substitute for opioids with less side effects. Of the many techniques to provide regional analgesia for hip fractures; fascia iliaca block was widely used with good results. In 2018 Pericapsular Nerve Group Block was introduced to provide regional analgesia for hip fractures with interesting results.~In this study the investigators are going to compare Pericapsular Nerve Group Block and Fascia Iliaca Block to find the best way to provide analgesia for elderly patients with hip fracture in the pre- and post-operative periods. | Clinical controled trial to compare between pericapsular Nerve Group Block and Fascia Iliaca Block to find the best way to provide analgesia for elderly patients with hip fracture in the pre- and post-operative periods. |
High-protein diets have been recently demonstrated to effectively reduce insulin resistance, derangements of the lipid profile and liver fat content in subjects with moderately and severely impaired glucose metabolism and non-alcoholic fatty liver disease (LeguAN, LEMBAS, DiNA-P, DiNA-D). The effects can be attributed to prolonged insulin secretion and improved second meal effect, higher energy expenditure by urea synthesis, suppression of glucagon or other mechanisms. Up to now, it is unclear, if proteins with slower or faster digestibility lead to differential results in these study designs. The proposed study will elucidate this question. The investigators hypothesize, that slowly-digestible proteins induce a prolonged insulin plateau supporting the second-meal effect. They also assume, that these dietary proteins lead to a markedly stronger short-term secretion of glucagon followed by desensitisation of this hormone release. Fast-digestible proteins, on the other hand, will presumably induce a smaller second-meal effect and do not inhibit a second rise of glucagon in a consecutive meal.~The investigators intend to examine the effects of a 3-weeks high-protein diet in subjects with NAFLD (40 subjects without T2DM, 40 subjects with T2DM) on insulin resistance (mixed-meal tolerance tests; MMTT), second meal effect (second, consecutive MMTT on the same day) and liver fat content (MR spectroscopy) as well body-fat distribution (MR tomography). The investigators expect different results for slow protein (casein) and fast protein (whey), thus comparing both protein species. The two major clinical visits before and after the intervention period will also include fasting blood sampling for later analysis, full anthropometric assessment and a set of behavioral tests, investigating postprandial decision making processes.~In order to identify the suitable dosage for protein loads in the 3-weeks intervention trial, the study follows a dose-finding assessment in 40 subjects (20 subjects with Metabolic Syndrome and T2DM; 20 subjects with Metabolic Syndrome without T2DM), which undergo six separate investigation days. On each day of the dose-finding assessment pre-trial one of the following dosages is used in a single oral protein tolerance test (5 g, 20 g and 30 g of whey or casein each). Subjects with NAFLD from this pre-study are eligible for the main trial.~Additional test will assess whether mixes of whey and casein in variable proportions induce different hormonal profiles of glucagon and insulin.~All clinical assessments will be conducted in the Dept. Endocrinology, Diabetes and Nutrition, Charité, Campus Benjamin Franklin (Lead: DIfE, A.F.H. Pfeiffer). Psychobehavioral tests (Prof. Park), assessment of body fat distribution including liver fat (Dr. Machann) and measurements of amino acid levels throughout the meal tests (Prof. Rohn) are secondary work packages. | High-protein diets have been recently demonstrated to effectively reduce insulin resistance, derangements of the lipid profile and liver fat content in subjects with moderately and severely impaired glucose metabolism and non-alcoholic fatty liver disease (LeguAN, LEMBAS, DiNA-P, DiNA-D). The effects can be attributed to prolonged insulin secretion and improved second meal effect, higher energy expenditure by urea synthesis, suppression of glucagon or other mechanisms. Up to now, it is unclear, if proteins with slower or faster digestibility lead to differential results in these study designs. The proposed study will elucidate this question. The Investigators hypothesize, that slowly-digestible proteins induce a prolonged insulin plateau supporting the second-meal effect. The investigators also assume, that these dietary proteins lead to a markedly stronger short-term secretion of glucagon followed by desensitisation of this hormone release. Fast-digestible proteins, on the other hand, will presumably induce a smaller second-meal effect and do not inhibit a second rise of glucagon in a consecutive meal.~The investigators intend to study the effects of a 3-weeks high-protein diet in subjects with NAFLD (40 subjects without T2DM, 40 subjects with T2DM) on insulin resistance (mixed-meal tolerance tests; MMTT), second meal effect (second, consecutive MMTT on the same day) and liver fat content (MR spectroscopy) as well body-fat distribution (MR tomography). The investigators expect different results for slow protein (casein) and fast protein (whey), thus comparing both protein species. The two major clinical visits before and after the intervention period will also include fasting blood sampling for later analysis, full anthropometric assessment and a set of behavioral tests, investigating postprandial decision making processes.~All clinical assessments will be conducted in Charité (Lead: A.F.H. Pfeiffer). Psychobehavioral tests (Prof. Park), assessment of body fat distribution including liver fat (Dr. Machann) and measurements of amino acid levels throughout the meal tests (Prof. Rohn) are secondary work packages. |
The economic burden of DFUs costs the United States over $50 billion each year. The cost to treat one subject with DFUs ranges from $11,700 to $16,883. Although approximately 70% of DFUs are shown to heal with good SOC, at least 30% become chronic wounds. These non-healing wounds are at greater risk for infection and lower extremity amputation. Consequently, good standard of care therapy is important for subjects with chronic DFUs to improve subject outcomes, lower treatment costs and reduce the risk of complications.~The removal of necrotic tissue such as slough, eschar, and underlying biofilm constitutes one of the most important parts of standard of care (SOC). Currently, a variety of techniques are used to debride chronic wounds, such as larval therapy, autolytic and enzymatic methods, monofilament polyester fiber pads or brushes, and mechanical debridement with curettes and scalpels. It has also been demonstrated that more frequent debridement, on average, results in faster wound healing. While regarded as the gold standard, sharp debridement requires considerable experience of clinicians to ensure that contaminated and devitalized tissue is entirely removed without extensively damaging surrounding healthy tissue. Moreover, a recent research has demonstrated that even when surgical debridement is well-conducted so that it removes the majority of biofilm, within 72 hours, biofilm often re-establishes itself. Given that perhaps 60% of chronic wounds have been found to harbor biofilm, it is challenging to keep such wounds free of biofilm so that the wound-healing process can be sustained. Consequently, any method that could potentially remove more biofilm and/or prevent its recurrence could improve the wound healing trajectory. Medaxis Debritom+™ cleans acute and chronic wounds precisely in a tissue-preserving manner. Its high-pressure micro water jet removes slough such as fibrin, necrosis or biofilm, as well as foreign bodies, in effect providing an efficient irrigation and debridement of contaminated wounds. The purpose of this clinical investigation is to assess performance of Medaxis Debritom+™ and to collect subject outcome data in the treatment of diabetic foot ulcers (DFU) vs Standard sharp debridement.~There are two arms in the study:~Arm 1: The Experimental Arm , that will include SOC Therapy. SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), use of the Medaxis Debritom+™ micro jet to clean the wound followed by a wound care covering ( Fibracol dressing or equivalent) along with a moisture retention dressing and a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compression wrap (DynaflexTM or equivalent).~Arm 2: The Standard of Care Arm. The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, followed by a wound care covering ( Fibracol dressing or equivalent) along with a moisture retention dressing and a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compression wrap (DynaflexTM or equivalent). | The purpose of this clinical investigation is to assess performance of the Medaxis Debritom+™ and to collect subject outcome data in the treatment of diabetic foot ulcers (DFU) vs Standard sharp debridement. |
A bioequivalence study of a single dose of the fixed-dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder administered from Fluticasone propionate 500 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals (test-Τ) as 2 inhalations and ADVAIR DISKUS® 500/50 mcg inhalation powder/GSK (reference-R) in healthy volunteers under fasting conditions. The study will be one-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded. | Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder |
This study plans to investigate the relationship between cognitive status pre-procedure, as assessed using the Montreal Cognitive Assessment (MoCA) administered on a tablet, and clinical outcomes at 3 months as assessed by the VARC2 criteria, in patients undergoing transcatheter aortic valve implantation (TAVI) | This study plans to investigate the relationship between cognitive status pre-procedure, and clinical outcomes at 3 months in patients undergoing transcatheter aortic valve implantation (TAVI). |
Cook Medical has reported thrombus formation with or without occlusion of the Zenith Alpha Spiral-Z®. The purpose of this study is to measure the extent of thrombus formation and occlusion of these stent graft limbs in patients with aortic aneurysms treated at St. Olavs Hospital in 2017, 2018 and 2019. Information is collected from the Norwegian registry for vascular surgery (NORKAR), electronic patient journal and the picture archiving and communication system (PACS). The total number of included patients is estimated to be approximately 100. | The purpose of this study is to assess the extent of thrombosis in the Zenith Alpha Spiral-Z® stent graft. |
INTRODUCTION 1.1.1. Background Over the last decade, ride sharing services such as Uber and Lyft have become a popular transportation option, particularly for young people. These services often market themselves as less expensive and/or safer alternatives to taxis or driving while intoxicated (1). Whether ride sharing has a net benefit on rates of driving while intoxicated, or on alcohol and/or drug related crashes is unclear (2-6). Few studies have investigated this relationship, and a literature review showed no studies targeting the question outside of an isolated geographic region. Additionally, Uber has recently released its Safety Report bringing to light the issue of sexual assault associated with ride sharing.~1.1.2. Aim Investigate the relationship between ride sharing services and alcohol- and drug-related motor vehicle collisions within the state of Texas, and to develop understanding of the relationship between ride sharing services and sexual assault.~1.1.3. Rationale for the study The results of this study may be useful in public health initiatives to either incentivize or discourage ride sharing as a way to impact rates of alcohol- and drug-related motor vehicle collisions. Further, hospitals and insurance payors may be interested to note any calculated effect of ride sharing on hospital costs, lengths of stay, etc.~1.1.4. Hypothesis 1.1.4.1. Primary Hypothesis The introduction of ride sharing services such as Uber and Lyft to the state of Texas resulted in fewer alcohol- and drug-related crashes and greater cost savings for hospitals and insurance payors.~1.2. OBJECTIVES AND STUDY OUTCOME MEASURES 1.2.1. Study Objectives 1.2.1.1. Primary Objective(s)~Determine the number and severity of alcohol- and/or drug-related motor vehicle collisions.~Determine the number of auto vs pedestrian (auto-ped) alcohol- and/or drug-related collisions.~Determine the correlation between the introduction of ride sharing services and the number of alcohol- and drug-related crashers as well as with hospital and insurance payor expenditures.~Determine the relationship between ride sharing services and sexual assault. 1.2.2. Study Outcome Measures 1.2.2.1. Primary Outcomes~Number of alcohol- and drug-related motor vehicle collisions~Number of auto-ped alcohol- and drug-related collisions~Results of alcohol screen and drug screens~Mechanism of injury~Metrics indicative of ride sharing service presence, use, and public awareness (i.e. self-reported usage and company reports)~Additional information collected will include patient demographics, injury characteristics, injury severity score, abbreviated injury scale, emergency department vitals, diagnoses, procedures, insurance coverage, treatment cost, hospital length of stay (LOS), ICU LOS, blood product data, vehicle type, number of sexual assaults, miles traveled, and mortality.~STUDY DESIGN This will be a retrospective study with data collected from the trauma registry. We plan to complete the data collection and analysis by 12/31/2021. Data on ride sharing will be obtained from the Uber and Lyft websites. Data pertaining to number of alcohol- and drug-related motor vehicle (and auto-ped) collisions will be obtained from the Texas Department of Transportation website, the National Highway Traffic Safety Administration, the Shared-Use Mobility Center (SUMC) and the Transformation of Public Transit, the Texas A&M Transportation Institute, Texas Department of Public Safety, and the U.S. Department of Transportation website (or equivalent). Sexual assault data will be obtained as available the Sexual Assault Nurse Examiner (SANE) database as well as from Turning Point Rape Crisis Center and surrounding hospitals in the Dallas area as well as the Uber report for sexual assaults.~STUDY ENROLLMENT AND WITHDRAWAL 3.1. Study Inclusion Criteria:~18 years or older~Positive blood alcohol or drug screen~Motor vehicle collision (MVC) or auto-ped 3.2. Study Exclusion Criteria:~Younger than 16 years~Younger than 18 years~Pregnant women 3.3. Premature Termination or suspension of study~This study may be suspended or prematurely terminated if there is sufficient reasonable cause. Written notification, documenting the reason for study suspension or termination, will be provided by the suspending or terminating party. If the study is prematurely terminated or suspended, the principal investigator will promptly inform the IRB and will provide the reason(s) for suspension or termination. Circumstances that may warrant termination include, but are not limited to:~Determination of unexpected, significant, or unacceptable risk to subjects.~Insufficient adherence to protocol requirements.~Data that is not sufficiently complete and/or evaluable.~Determination of futility.~Favorable outcomes at smaller than expected sample size.~STATISTICAL CONSIDERATIONS 4.1. Sample Size Considerations This protocol is intended to be an observational study dependent on occurrence data. No formal sample size calculations were completed as this is limited by reported occurrences and retrospective analysis.~4.2. Statistical Analysis Plan Descriptive analysis will be performed for all variables. Frequencies, percentages, sensitivity, and specificity will be presented to summarize the categorical variables such as patient demographics and the outcomes of the different conditions associated with diaphragmatic injury. Mean and standard deviation will be presented for normally distributed continuous variables and median and interquartile range will be presented for non-normal continuous variables. The categorical outcome variables between the samples will be compared with chi square test or Fisher's exact test (if any cell value ≤ 5). The normally distributed continuous outcome variables will be analyzed with a two-sample t-test and non-normally distributed continuous outcomes will be analyzed with a nonparametric Wilcoxon-Mann-Whitney test. Because there might be potential for confounding patient characteristic variables to influence the outcome, a multiple regression and logistic model will be used to compensate for these factors. Odds ratio along with the confidence interval and p-value will be reported for both the adjusted and unadjusted model. A p-value <0.05 will be considered statistically significant.~ETHICS/PROTECTION OF HUMAN SUBJECTS 5.1. Ethical Standard The investigator will ensure that this study is conducted in full conformity with the principles set forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, as drafted by the US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 1979) and codified in 45 CFR Part 46 and/or the ICH E6. If the study is conducted at international sites, the statement could be as above and/or could reference compliance with the Declaration of Helsinki, CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002), or another country's ethical policy statement, whichever provides the most protection to human subjects.~5.2. Institutional Review Board The protocol will be submitted to the IRB for review and approval. Approval of the protocol must be obtained before any participant is enrolled. Any amendment to the protocol will require review and approval by the IRB before the changes are implemented in the study.~5.3. Informed Consent Waiver Acquiring informed consent is not applicable. This study proposal is requesting a waiver of informed consent. This research only involves the collection or study of existing data, documents, and records and the investigators are recording information in such a manner that patients cannot be identified or possess any identifiers which could somehow be linked back to the patient. This research could not practicably be conducted without the waiver of informed consent because this is a retrospective chart review and it would be extremely time consuming to attempt contact for consent.~Waiver of the HIPAA Authorization has been requested. The following reasons apply to our proposal: the use of the protected health information involves no more than the minimal risk of the privacy of the individuals, the research could not practicably be conducted without the waiver, and the research could not practicably be conducted without access to, and use of, the protected health information.~5.4. Participant Confidentiality All patient records and/or information will be kept under double locked doors or under password protection at all times. Only authorized study personnel as stated in the delegation of responsibility will have access to patient records and/or information.~DATA MANAGEMENT PLAN 6.1. Source Document Management The source data will be collected with the assistance of the electronic medical/health record software, Premier, Midas or other medical/hospital data sources, paper records and/or electronic data collection methods. All data collected will be entered into an Excel sheet and recorded. All data collection methodologies will be maintained under strict surveillance, double locked doors or an encrypted, password protected Methodist Health System (MHS) approved server. All data capture and storage methods will be HIPAA compliant as per MHS policy.~6.2. Data Capture Methods The data will be collected with the assistance of the electronic medical/health record software, Premier, Midas or other medical/hospital data sources, paper records and/or electronic data collection methods. All data collected will be entered into an Excel sheet and recorded. All data collection methodologies will be maintained under strict surveillance, double locked doors, or an encrypted, password protected MHS approved server. All data capture and storage methods will be HIPAA compliant as per MHS policy.~RECORD RETENTION/ARCHIVING All records pertaining to the study will be kept on site at Methodist Dallas Medical Center for three years upon study completion.~PUBLICATION PLAN All studies must comply with GCP of blinding all protected health information of all patients prior to presentation and/or publication. The data obtained will be de-identified prior to sharing via presentation and/or publication in relevant research mediums. The data will be published and/or presented at national, regional, local and international sites. The research gathered will be analyzed and submitted to relevant medical journals for publication to add to the body of knowledge in the science community, as well as to improve on existing policies in trauma. This information may be presented at major surgical and trauma conferences including AAST (American Association for the Surgery of Trauma), SWSC (Southwest Surgical Congress), EAST (Eastern Association for the Surgery of Trauma), WTA (Western Trauma Association), etc. | This will be a retrospective study with data collected from the trauma registry. We plan to complete the data collection and analysis by 12/31/2020. Data on ride sharing will be obtained from the Uber and Lyft websites. Data pertaining to number of alcohol- and drug-related motor vehicle (and auto-ped) collisions will be obtained from the Texas Department of Transportation website, the National Highway Traffic Safety Administration, the Shared-Use Mobility Center (SUMC) and the Transformation of Public Transit, the Texas A&M Transportation Institute, Texas Department of Public Safety, and the U.S. Department of Transportation website (or equivalent). Sexual assault data will be obtained as available the Sexual Assault Nurse Examiner (SANE) database as well as from Turning Point Rape Crisis Center and surrounding hospitals in the Dallas area as well as the Uber report for sexual assaults. |
INTRODUCTION 1.1. Background Vitamin D is an essential hormone involved in bone metabolism, bone mineral density maintenance, and bone health. Vitamin D deficiency is putatively linked to poor pediatric orthopedic outcomes [1]. Further, the risk of low vitamin D associated fractures may be greater in minority pediatric populations [2]. In adults, utility of vitamin D alleles as a biomarker for bone density and fracture risk has been debated for over 10 years [3-5]. Peak bone density is achieved at 25 years old; however, most orthopedic trauma patients less than 25 years of age present with substantial vitamin D deficiencies.~1.2. Aim(s)~Identify the prevalence of vitamin D deficiency in young trauma patients with fractures.~Describe the merits of vitamin D supplementation in healing and long-term outcomes ≤25 year old trauma patients with fractures.~1.3. Rationale for the study Occurrence of stress and low energy mechanism fractures within a population at peak bone density is troubling and suggestive of underlying pathology. Understanding how to combat vitamin D deficiency, and improve outcomes, is essential in the development of comprehensive and preventative trauma care.~1.4. Hypothesis 1.4.1. Primary Hypothesis Patients aged ≤25yrs old with fractures will have low vitamin-D levels.~OBJECTIVES AND STUDY OUTCOME MEASURES 2.1. Study Objectives 2.1.1. Primary Objective Determine the frequency of vitamin D deficiency in fracture patients aged less than 25 years old.~2.1.2. Secondary Objective Report the long-term (one year) outcomes for fracture healing relative to baseline and therapeutic vitamin D levels.~2.2. Study Outcome Measures 2.2.1. Primary Outcome Vitamin D levels at the time of the index injury through one year post-operative follow up.~2.2.2. Secondary Outcomes Patient demographics (age, sex, ethnicity), injury characteristics, lab values, rate of nonunion (i.e., failure of a fractured bone to heal), admit information, discharge disposition, payer type, and mortality.~STUDY DESIGN All patients between 18 and 25 years treated for fractures at Methodist Dallas Medical Center (MDMC) with an index admission vitamin D assessment will be enrolled. This study will consider any patients with an index admission occurring between February 2016 and February 2020. No changes to care or intervention will occur and this study will be conducted completely via chart review. The aim is to identify 100 subjects with a one-year follow-up appointment for their injury to determine the rate of nonunion and vitamin D levels. As patients receive vitamin D supplementation as standard of care if index values are low, impact will be assessed through relative deficiency and clinical outcomes. Data collected from subjects without need for supplementation may be used to generate a threshold. Patient demographics will be considered as practice suggests minority patients may be disproportionally affected. The plan to complete the data collection and analysis by February 2021. | Vitamin D is an essential hormone involved in bone metabolism, bone mineral density maintenance, and bone health. Vitamin D deficiency is putatively linked to poor pediatric orthopedic outcomes [1]. Further, the risk of low vitamin D associated fractures may be greater in minority pediatric populations [2]. In adults, utility of vitamin D alleles as a biomarker for bone density and fracture risk has been debated for over 10 years [3-5]. Peak bone density is achieved at 25 years old; however, most orthopedic trauma patients less than 25 years of age present with substantial vitamin D deficiencies. |
This is a multicentre, parallel group double-blind, placebo-controlled phase 3 registry-based randomised controlled trial (R-RCT) in patients without diabetes presenting with myocardial infarction (MI) (ST segment elevation myocardial infarction (STEMI) or non-ST segment elevation myocardial infarction (NSTEMI)) and evidence of impaired regional or global LV systolic function or definite evidence of Q wave MI on ECG. In the study the effect of dapagliflozin versus placebo, given once daily in addition to SoC therapy will be evaluated for the hospitalisation for HF, CV death, and other cardiometabolic outcomes. | This study will evaluate the effect of dapagliflozin versus placebo, given once daily in addition to Standard of Care (SoC) therapies for patients with myocardial infarction (MI), for hospitalisation for heart failure (HHF), cardiovascular (CV) death, and other cardiometabolic outcomes. |
Stress myocardial perfusion scintigraphy is a reference examination for the detection and monitoring of coronary patients, and this examination has already been the subject of multiple validation studies, including for the stratification of the prognosis of these patients, information that can usefully guide therapeutic choices (medical treatment, myocardial revascularization, ...). The arrival of new solid-state cameras has been a real technological leap for this examination, making it possible to significantly improve the quality of the images and also to drastically reduce the activities of injected radiopharmaceuticals and thus the exposure of patients and staff to ionizing radiation. Today, this reduction in the activity of injected radiopharmaceuticals is taking place in a growing number of nuclear medicine departments. The injected activities are reduced up to a third of those injected in the past (this is indeed the case in the population we propose to study).~However, the value of the prognostic stratification obtained with stress myocardial perfusion scans recorded with low activity on semiconductor cameras is not yet known. In particular, the implications are unknown in terms of the risk of death of the different parameters studied (normal or abnormal examination, extent of myocardial ischemia and infarction sequelae, impact on left ventricular function in post-stress and resting states, etc.). | Stress myocardial perfusion scintigraphy is a reference examination for the detection and monitoring of coronary patients, and this examination has already been the subject of multiple validation studies, including for the stratification of the prognosis of these patients, information that can usefully guide therapeutic choices.~Today, this reduction in the activity of injected radiopharmaceuticals is taking place in a growing number of nuclear medicine departments.~The implications are unknown in terms of the risk of death of the different parameters studied |
This study is designed to explore the efficacy of ORMD-0801 compared to placebo on endogenous glucose production in subjects with type 2 diabetes (T2DM). Subjects will undergo an initial Screening Visit (Visit 0) to establish their eligibility to participate in the study. At Visit 1 (2 weeks after the Screening Visit), qualifying subjects will be randomized to either ORMD-0801 (8 mg) or matching placebo, study medication will be dispensed and subjects will dose, twice a day, once in the morning prior to breakfast and once at night prior to bedtime. Doses will occur at 45 minutes (± 15 minutes) before breakfast and no later than 10 AM each morning, and at 8 PM (± 120 minutes) each night, and no sooner than 1 hour after dinner. Subjects will return to the clinic, 2 weeks later, for Visit 2. At this visit, subject compliance will be assessed, medication will be dispensed, a blood sample will be collected to measure HbA1c and subjects will be questioned for any adverse events. Subjects will be scheduled to return to the clinic in 2 weeks for morning admission (8 AM ± 120 minutes) to the PK unit (Visit 3). Subjects will be provided with standardized meals and the morning dose in-clinic. A light standardized dinner meal will be provided at 6 PM ± 30 minutes. At approximately 8 PM (± 60 minutes, and no sooner than 1 hour after dinner), subjects will be dosed with their study medication and will be started on a 16-hour infusion of [6,6-2H2]-glucose tracer. | This study is designed to explore the efficacy of ORMD-0801 compared to placebo on endogenous glucose production in subjects with type 2 diabetes (T2DM). Subjects will undergo an initial Screening Visit (Visit 0) to establish their eligibility to participate in the study. At Visit 1 (2 weeks after the Screening Visit), qualifying subjects will be randomized to either ORMD-0801 (8 mg) or matching placebo, study medication will be dispensed and subjects will dose, twice a day, once in the morning prior to breakfast and once at night prior to bedtime |
Chronic Kidney Disease-Mineral and Bone Disorder (MBD） is a common complication of chronic kidney disease (CKD), which may lead to defective mineralization, altered bone morphology, and/or bone turnover. Animal research found that bone changes occur even in the early stage of CKD , and with CKD progression, the patient may show symptoms such as bone pain, joint pain, bone deformation, and even spontaneous fractures.~Despite significant advances in understanding bone disease in CKD, most clinical and biochemical targets used in clinical practice remain controversial, resulting in an undermanagement of bone fragility.Our ability to diagnose CKD-MBD and to initiate strategies that could prevent fractures remains limited by the lack of accurate and noninvasive diagnostic tools.~The purpose of this study is to develop a non-invasive method that can improve fracture risk prediction and provide early diagnosis for bone abnormalities in patients with CKD. | Patients with chronic kidney disease (CKD) have a higher risk of fractures than those without. The purpose of this study is to develop a non-invasive Magnetic resonance imaging (MRI) method that can improve fracture risk prediction and provide early diagnosis for bone abnormalities in patients with CKD. |
Healthy controls (n=38), patients with CHD (n=39), periodontitis (n=40), and a combination of periodontitis + CHD (n=38) were enrolled in the present study. The analyzed sample undergo a demographical, clinical and periodontal evaluation and serological analyses including Endothelin-1 (ET-1) and for serum and salivary Galectin-3 levels. | The aim of this study was to analyze the association between serum and salivary Galectin-3 levels in patients with periodontitis. Furthermore, the objective was to determine if the periodontitis influenced serum and salivary Galectin-3 levels |
This is a prospective, open-label, single-arm, historically controlled, multi-center Phase III study to assess the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects aged ≥ 2 years and < 17 years with PHID.~Subjects will receive intravenous infusions of the investigational product at the same dose and interval as used for their previous Immunoglobulin intravenous (IGIV) maintenance therapy. GC5107 will be infused every 21 or 28 days for a period of 12 months. | The purpose of this study is to evaluate the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects with Primary Humoral Immunodeficiency (PHID). |
Posttraumatic stress disorder (PTSD) is a disabling psychiatric disorder that affects 20%-30% of U.S. Veterans. PTSD is strongly associated with increased risk for substance abuse comorbidity, including cannabis use disorder; however, multiple states now include PTSD as a condition for which patients can be legally prescribed medical marijuana, despite the fact that there has not been a single large-scale randomized clinical trial demonstrating the efficacy of cannabis to treat PTSD to date. The overall objective of the current proposal is to prospectively study the impact of reduced cannabis use on psychosocial functioning among Veterans with PTSD. To do so, the investigators will first use ecological momentary assessment (EMA) methods to evaluate the relationship between cannabis use and daily functioning among Veterans with PTSD. Next, the investigators will use mobile contingency management (CM) and EMA to assess the impact of reduced cannabis use on daily functioning among Veterans with PTSD who are heavy cannabis users. The central hypothesis is that reductions in cannabis use will lead to positive changes in the functional outcomes of Veterans. The rationale for this research is that it will provide the first and only real-time data concerning the impact of reduced cannabis use on daily functioning among Veterans with PTSD. As a result, this innovative and timely project has the potential to significantly advance VHA healthcare and will directly inform the ongoing national debate concerning the impact of cannabis use on the long-term functional recovery of Veterans with PTSD. | Posttraumatic stress disorder (PTSD) is a disabling psychiatric disorder that affects 20%-30% of U.S. Veterans. PTSD is strongly associated with increased risk for substance abuse comorbidity, including cannabis use disorder. Multiple states now include PTSD as a condition for which patients can be legally prescribed medical marijuana, despite the fact that there has not been a single large-scale randomized clinical trial demonstrating the efficacy of cannabis to treat PTSD to date. The overall objective of the current proposal is to study the impact of reduced cannabis use on functioning among Veterans with PTSD. The investigators will evaluate the relationship between cannabis use and daily functioning among cannabis users and heavy cannabis users. The central hypothesis is that reductions in cannabis use will lead to positive changes in the functional outcomes of Veterans. The rationale for this research is that it will provide the first and only real-time data concerning the impact of reduced cannabis use on daily functioning among Veterans with PTSD. |
The purpose of this study is to investigate the clinical correlates of the effects of the COVID-19 pandemic on patients with Functional movement disorder (FMD) and Parkinson s Disease (PD).~Primary objectives:~To evaluate the change in neurological symptoms domain of the survey between pre and post-COVID 19 in FMD and PD patients.~Secondary objectives:~To evaluate the change in total score of the survey between pre and post COVID 19 in FMD and PD patients~To evaluate the change in other symptom domains of the survey between pre and post COVID 19 in FMD and PD patients. Domains include: Mood/Energy, sleep, symptoms of abnormal movements related or unrelated to primary disease, physical health and exercise related change~Exploratory objectives:~To evaluate whether there is a modifying effect of disease group in the changes in total score or symptom domains~To evaluate whether there is a relationship between disease severity and changes in total score or symptom domains~To evaluate whether there is a correlation between changes across symptom domains~To evaluate whether there is a correlation in raw score across symptom domains within each period~Research Methods:~Data will be solely collected through the use of online instruments via CiSTAR as a designed questionnaire.~Questionnaire items~A questionnaire aimed at determining the effects of the COVID 19 pandemic and subsequent isolation on functional state of patients with FMD and PD.~The questionnaire items include:~Items investigating Mood/Energy before and after COVID 19 out break~Items investigating Sleep habits before and after COVID 19 out break~Items investigating Neurological symptoms before and after COVID 19 out break~Items investigating daily functioning before and after COVID 19 out break~Items investigating Exercise habits before and after COVID 19 out break~No questionnaire items will be actionable , which are items that would identify an imminent risk for participant safety requiring urgent and immediate medical or psychiatric | The purpose of this study is to investigate the clinical correlates of the effects of the COVID-19 pandemic on patients with Functional movement disorder (FMD) and Parkinson s Disease (PD).~Primary objectives:~To evaluate the change in neurological symptoms domain of the survey between pre and post-COVID 19 in FMD and PD patients.~Secondary objectives:~To evaluate the change in total score of the survey between pre and post COVID 19 in FMD and PD patients~To evaluate the change in other symptom domains of the survey between pre and post COVID 19 in FMD and PD patients. Domains include: Mood/Energy, sleep, symptoms of abnormal movements related or unrelated to primary disease, physical health and exercise related change~Exploratory objectives:~To evaluate whether there is a modifying effect of disease group in the changes in total score or symptom domains~To evaluate whether there is a relationship between disease severity and changes in total score or symptom domains~To evaluate whether there is a correlation between changes across symptom domains~To evaluate whether there is a correlation in raw score across symptom domains within each period~Research Methods:~Data will be solely collected through the use of online instruments via CiSTAR as a designed questionnaire.~Questionnaire items~A questionnaire aimed at determining the effects of the COVID 19 pandemic and subsequent isolation on functional state of patients with FMD and PD.~The questionnaire items include:~Items investigating Mood/Energy before and after COVID 19 out break~Items investigating Sleep habits before and after COVID 19 out break~Items investigating Neurological symptoms before and after COVID 19 out break~Items investigating daily functioning before and after COVID 19 out break~Items investigating Exercise habits before and after COVID 19 out break~No questionnaire items will be actionable , which are items that would identify an imminent risk for participant safety requiring urgent and immediate medical or psychiatric |
Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. We aimed to determine if closed-loop control of oxygen was feasible in patients with COVID-19 and could maintain SpO2 in the specified interval.~Patients were prospectively enrolled in an observational study on a medical ward dedicated to patients with COVID-19. Closed-loop controlled oxygen was delivered by O2matic® which can deliver 0-15 liters/min and adjusts flow every second based on 15 seconds averaging of SpO2 measured by pulse oximetry. Lung function parameters were measured at admission. | Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. We aimed to determine if closed-loop control of oxygen was feasible in patients with COVID-19 and could maintain SpO2 in the specified interval. |
Background: Artesunate-amodiaquine and artemether-lumfantrine are currently being used for the treatment of uncomplicated Plasmodium falciparum in Cameroon. Globally, many studies have reported high efficacy and safety of artemisinin-based combination therapies (ACTs) mostly under strict supervision of drug intake and limited to children less than 5 years of age. Patients over 5 years of age are usually not involved in such studies.~Objective: To assess the genetic markers of antimalarial drug resistance and drug metabolism subsequent to the efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine during a 28-day follow-up period in children with acute uncomplicated P. falciparum malaria in Yaounde, Cameroon.~Study sites: District Hospital Cité Verte and District Medical Centre Minkoa Meyos in Yaounde, Cameroon. The two drugs, artesunate-amodiaquine and artemether-lumefantrine will be tested in each site.~Study period: 9th May 2019 to 30th November 2020.~Study design: This surveillance study is a two-arm, open-label, randomized controlled clinical trial.~Patient population: Febrile patients aged 6 months to 10 years, with confirmed uncomplicated P. falciparum infection. Eligible children for whom parent/guardian informed consents are obtained will be randomized to receive either artesunate-amodiaquine (group A) or artemether-lumefantrine (group B) in the ratio 1:1.~Sample size: A minimum sample of 76 patients will be required for the study. With a 20 % increase to allow loss to follow-up and withdrawals during the 28-day follow-up period, 92 patients will be enrolled for each of the two study arms. The study will recruit a total of 184 patients.~Treatment (s) and follow-up: Drug intake will be partially supervised only for the first dose and subsequent doses administered unsupervised as pertains in routine practice in the field. Patients or their parents/guardians will be advised on the time and mode of administration for the 3 days (D0, D1 and D2) treatment unobserved at home. Follow-up visits will be performed on days 3, 7, 14, 21, and 28 to evaluate clinical and parasitological resolution of their malaria episode as well as adverse events. Polymerase chain reaction (PCR) genotyping of merozoite surface proteins 1 and 2 (msp-1, msp-2) as well as glutamate rich protein (GLURP) will be used to differentiate between recrudescence and new infection.~Classification of treatment outcomes Classification of treatment outcomes will be done based on the WHO 2009 guidelines: treatment failure (Early Treatment Failure-ETF, Late Clinical failure-LCF and Late Parasitological Failure-LPF) and treatment success (Adequate Clinical and Parasitological Response-ACPR). | Artesunate-amodiaquine and artemether-lumfantrine are currently being used for the treatment of uncomplicated Plasmodium falciparum in Cameroon. Globally, many studies have reported high efficacy and safety of artemisinin-based combination therapies (ACTs) mostly under strict supervision of drug intake and limited to children less than 5 years of age. Patients over 5 years of age are usually not involved in such studies. The main objective of this study is to assess the genetic markers of antimalarial drug resistance and drug metabolism subsequent to the efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine during a 28-day follow-up period in children with acute uncomplicated P. falciparum malaria in Yaounde, Cameroon. A randomized, open-labelled, controlled clinical trial comparing artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) will be carried out from 9th May 2019 to 30th November 2020 at two secondary health centres (Cité Verte and Minkoameyos) in Yaounde. The study participants shall include febrile patients aged 6 months to 10 years, with confirmed uncomplicated P. falciparum infection. Eligible children for whom parent/guardian informed consents are obtained will be randomized to receive either artesunate-amodiaquine (group A) or artemether-lumefantrine (group B) in the ratio 1:1. A minimum sample of 76 patients will be required for the study. With a 20 % increase to allow loss to follow-up and withdrawals during the 28-day follow-up period, 92 patients will be enrolled for each of the two study arms. The study will recruit a total of 184 patients. Drug intake will be partially supervised only for the first dose and subsequent doses administered unsupervised as pertains in routine practice in the field. Patients or their parents/guardians will be advised on the time and mode of administration for the 3 days (D0, D1 and D2) treatment unobserved at home. Follow-up visits will be performed on days 3, 7, 14, 21, and 28 to evaluate clinical and parasitological resolution of their malaria episode as well as adverse events. Polymerase chain reaction (PCR) genotyping of merozoite surface proteins 1 and 2 (msp-1, msp-2) as well as glutamate rich protein (GLURP) will be used to differentiate between recrudescence and new infection. |
Passive immunization involves the administration of antibodies against a given agent to a susceptible individual for the purpose of preventing or treating an infectious disease due to that agent. A general principle of passive antibody therapy is that it is more effective when used for prophylaxis than for treatment of disease. When used for therapy, antibody is most effective when administered shortly after the onset of symptoms. The reason for temporal variation in efficacy is not well understood but could reflect that passive antibody works by neutralizing the initial inoculums, which is likely to be much smaller than that of established disease . As an example, passive antibody therapy for pneumococcal pneumonia was most effective when administered shortly after the onset of symptoms, and there was no benefit if antibody administration was delayed past the third day of disease.~Therapeutic and prophylactic significance was explored in influenza and measles . Transfusion of immune plasma is a standard treatment modality for various viral hemorrhagic fevers . Its efficacy in treating Ebola Virus Disease is also well established . Studies have reported reduction viral load in patients with H1N1 influenza .Efficacy of convalescent plasma has been anecdotally reported in SARS-CoV-2 infections .~The largest study involved the treatment of 80 patients with SARS in Hong Kong. Patients treated before day 14 had improved prognosis defined by discharge from hospital before day 22, consistent with the notion that earlier administration is more likely to be effective .~In the case of SARS-CoV-2, the anticipated mechanism of action by which passive antibody therapy mediated protection is viral neutralization. However, other mechanisms may be possible, such as antibody-dependent cellular cytotoxicity and/or phagocytosis. The only antibody type that is currently available for immediate use SARS-CoV-2 is that found in human convalescent sera.~In China for SARS-CoV-2 disease, it has been found that the convalescent plasma therapy is effective for patients with a disease course exceeding three weeks and whose virus nucleic acid tests continuously to show positive from respiratory tracts specimen. It can speed up virus clearance, increase the numbers of the plasma lymphocytes and NK cells, reduce the level of plasma lactic acid, and improve renal functions. | Passive immunization involves the administration of antibodies against a given agent to a susceptible individual for the purpose of preventing or treating an infectious disease due to that agent. A general principle of passive antibody therapy is that it is more effective when used for prophylaxis than for treatment of disease. When used for therapy, antibody is most effective when administered shortly after the onset of symptoms |
Music exposure during care of preterm infants is the subject of increasing research. Many studies have shown positive impact of music exposure such as classical western music, lullabies or Quran on pain and physiological parameters of preterm infants in a neonatal intensive care unit (NICU) setting. No such study have explored the effect of oriental music which is the main popular music listened to in the Levant and Middle East and North Afrika (MENA) region.~We aim in this study to find out if the oriental music exposure in preterm infants improves babies' heart rate variability, physiological parameters and behavior state during their NICU stay. | The goal of this study is to explore the effect of oriental music on premature infants' physiological and behavioral parameters during their hospital stay in the NICU. |
Patients on dialysis are at risk for several infectious diseases, since they have reduced immunological and have to regularly attend dialysis centres from once to thrice a week depending on their residual renal function even if a pandemic is going on.~Dialysis patients and healthcare professionals of dialysis centres can become infected one with the other.~The incident risk of COVID-19 in dialysis centres is still unknown. Given the challenges of an early diagnosis of COVID-19, the likely transmission with outbreaks, the possibility of reciprocal transmission of the infection among patients and healthcare professionals, the frequent clinical severity of COVID-19 in dialysis patients because of the coexistence of several comorbidities, CONTACT TRACING could be an effective and efficient tool to contrast COVID-19 spreading in dialysis centres. This modality keeps trace of the contacts the new COVID-19 case have had and allow the identification of other possible cases in that outbreak~Contact tracing is the key tool to detect and trace COVID-19 cases among patients and health care professionals, i.e. the space-time mapping of the contacts among these two categories:~Daily for healthcare professionals~At every dialysis session for haemodialysis patients~At every hospital visit for patients on peritoneal dialysis~Maximum follow will be up to 12 months excepting in those patients who develop a COVID-19-related clinically significant event:~Diagnosis of symptomatic COVID-19 with or without hospitalisation~Respiratory insufficiency with the need of CPAP or mechanical ventilation~Death associated or related to COVID-19~In the participating centres, the enrolment of patients and healthcare professionals will be prospective, progressive and competitive till the number of cases of COVD-19 will reach 200 subjects. If study participation will be 10% and COVID-19 will be taken by 4% of the patients with no prior exposure to COVID-19, we can estimate to enrol 5000 subjects (dialysis patients and healthcare professionals) over a period of 12 months in 50-150 centres. The length of the enrolment period of 6-12 months will depend also on future evolution of the pandemic in the Italian regions that have not been massively hit by the infection.~Study data will be stored on a web-database, which will be created on purpose. Privacy protection of patients and health care professionals will be pursued and granted by anonymous data collection.~Given the longitudinal and prospective design of the study, Kaplan-Meier curves will be used to describe the incidence of COVID-19 infection and the survival of dialysis patients and their healthcare professionals.~Cox multivariate analysis will be used to:~Estimate the incidence, morbidity and mortality of COVID-19 in the two categories~Estimate predictors and/or confounders associated with the incidence of the three study outcomes (infection, morbidity and mortality) | Patients on dialysis are at risk for several infectious diseases, since they have reduced immunological and have to regularly attend dialysis centres even if a pandemic is going on. Dialysis patients and healthcare professionals of dialysis centres can become infected one with the other. The incident risk of COVID-19 in dialysis centres is still unknown.~Given the challenges of an early diagnosis of COVID-19, the likely transmission with outbreaks, the possibility of reciprocal transmission of the infection among patients and healthcare professionals, the frequent clinical severity of COVID-19 in dialysis patients because of the coexistence of several comorbidities, CONTACT TRACING could be an effective and efficient tool to contrast COVID-19 spreading in dialysis centres. |
Persistent adherence to lifestyle modifications and anti-hypertensive medications were emphasized in hypertension guidelines to control blood pressure effectively. But low adherence to lifestyle modifications and medication were noted in reviews and studies. Low adherence would lead to those received hypertension treatment did not achieve a controlled blood pressure. In this study, an educational program guided by the Health Promotion Model will be conducted to examine the effect on blood pressure, self-efficacy and treatment adherence among hypertensive patients in the community. A 2-arm parallel randomized control trial will be conducted. 148 participants will be recruited and divided into control and intervention group in a ration of 1:1. The intervention group will receive the theory-guided educational program, while the control group will receive the usual care. The study will last for 12 weeks. Data will be collected at baseline, week 8 and week 12. SPSS and generalized estimating equations model will be employed for data analysis. The results will inform community healthcare professionals about the effective way for health promotion, to enhance the adherence to lifestyle modifications and medications among hypertensive clients resulting sustainable benefits to the clients' health. | Persistent adherence to lifestyle modifications and blood pressure lowering medications were the best way to control blood pressure. But low adherence was noted in reviews and studies resulting those taking blood pressure lowering medications could not achieve a controlled blood pressure. In this study, a theory-guided educational program will be developed with an aim to improve the blood pressure, self-efficacy and adherence behaviors among those diagnosed with high blood pressure in the community. 148 participants will be recruited and divided into control group and intervention group randomly in a ratio of 1:1. The intervention group will receive the theory-guided educational program, while the control group will receive the usual care. The study will last for 12 weeks. Data will be collected at baseline, week 8 and week 12. SPSS and generalized estimating equations model will be employed for data analysis. The results will inform an effective way to conduct health promotion in community. The improved adherence to lifestyle modifications and medications will be beneficial to the clients' health. |
Docetaxel plays a key role in reducing the recurrence of early-stage breast cancer as well as improving survival outcomes of advanced breast cancer patients, but it causes a variety of adverse events, including myalgia and arthralgia, peripheral neuropathy, febrile neutropenia, and hypersensitivity reactions and so on. The myalgia and arthralgia induced by docetaxel, which have been together referred to as taxane-associated acute pain syndrome (T-APS), were reported to occur in 3.6% to 70% of patients, and the symptoms usually occurred 24-48 hours after docetaxel infusion and lasted for 3-5 days. Previous studies found that patients who experienced myalgia and arthralgia due to docetaxel administration were more likely to have chronic peripheral neuropathy, which supported that T-APS could be a form of neurologic toxicity. T-APS may significantly influence patients' sleep and daily life, and even caused discontinuation of chemotherapy. Therefore, it is clinically meaningful to explore some prophylactic drugs for the T-APS. Previous studies had used glutamine, corticosteroids, Shakuyaku-Kanzo-To (a Japanese herb), and gabapentin to prevent paclitaxel-induced myalgia and arthralgia, but failed to provide enough evidence for clinical practice. Etoricoxib, a selective COX-2 inhibitor, is a nonsteroidal anti-inflammatory drug (NSAID) that has showed comparable efficacy in acute and chronic pain, with fewer gastrointestinal (GI) adverse events compared with traditional NSAIDs. Therefore, we conducted a phase II randomized clinical trial to investigate whether etoricoxib could prevent or ameliorate the incidence and/or severity of docetaxel-induced acute pain syndrome. We also aimed to determine if there are any improvement of the late-onset peripheral neuropathy as well as quality of life with prophylactic etoricoxib for breast cancer patients who receive docetaxel chemotherapy. | A phase II randomized clinical trial was conducted to determine whether etoricoxib could prevent or ameliorate the incidence and/or severity of docetaxel-induced acute pain syndrome. We also aimed to determine if there are any improvement of the late-onset peripheral neuropathy as well as quality of life with prophylactic etoricoxib for breast cancer patients who receive docetaxel chemotherapy. |
Bacteremia from periodontal treatment to elucidate the underpinnings of sepsis Hypothesis In the context of cardiovascular disease (CVD) and sepsis this study hypothesise that (1) periodontal disease causes a specific CVD phenotype that can, to some extent, be reversed by treating periodontal disease; (2) that non-surgical periodontal treatment can be used as a human bacteremia model for evaluating biomarkers that can be used in the sepsis clinic; (3) that endogenous antimicrobial peptide profile dictate the severity of a bacteremia; (4) that proteinases from the oral biofilm can impact the severity of a bacteremia induced by oral bacteria and their products.~Aims A. What are the long term clinical, and 'omics related CVD-phenotypical effects from treating periodontal disease compared to an untreated group? B. Can biomarkers be used for detecting a bacteremia or previous bacteremia? C. Are the effects from bacteremia on cardiovascular biomarkers related to the individual's antimicrobial peptide profile? D. Does the presence of bacterial proteases, such as gingipain, relate to having a bacteremia from periodontal treatment and the systemic response from a bacteremia? Project description To answer the clinical problems from the dental chair and the sepsis intensity care unit the investigators have designed the Bacteremia Study. Aim 1 is an intervention study, while Aim 2 and 3 are investigating the pathophysiological underpinnings of the association. When studying the long term effects of periodontal treatment on CVD phenotype Malmö Offspring Dental Study (MODS) participants who have not sought dental care despite being told they have periodontal disease, will be invited as non-treated controls. The primary outcome variable will be changes in total carotid plaque area (TPA) per year.~In Aim 2 and 3 the parameters used to dissect the different aspects of the bacteremia. The AMP profile may be different in subjects with more severe bacteremia (measured by blood culturing) versus no bacteremia. The primary outcome will be concentration of CVD biomarkers during and following bacteremia (positive blood culture) compared to those who have negative blood culture.~Recruitment The participants are recruited at the Swedish Dental Service of Skåne in Lund, at the Department for Periodontics. The inclusion criteria is having periodontal disease - one quadrant with ≥2 teeth with > 5mm pocket depth (PD) and this quadrant will be treated when the blood samples are taken. The treatment is mechanical non-surgical periodontal treatment. Exclusion criteria is having a conditions that require prophylactic antibiotics at periodontal treatment.~Number of recruited participants The study will recruit 100 participants plus reexamination of MODS participants who have not sought periodontal treatment. Unfortunately, the available literature on bacteremia at periodontal treatment is very heterogeneous (13-75%), making it difficult to perform a meaningful power calculation. The investigators have decided on 100 participants and this has been approved by the Ethical Review Authority.~Cardiovascular phenotyping At baseline and after 1 year and 2 years the participants undergo cardiovascular phenotyping at Clinical Research Unit at Skåne University Hospital (Kliniska Forskningsenheten, KFE). The cardiovascular phenotyping in this project is based on several subclinical parameters mentioned bellow, however the most important is carotid artery ultrasound for assessment of carotid plaque area and stability. Associate Professor Jönsson is the first author and Olle Melander co-author of a publication investigating the association between periodontal disease and carotid total plaque area has. The carotid imaging in this project is performed by the same personal using the same equipment as in Jönsson et al..~• Carotid artery ultrasound (GE logiq E9) of both carotids.~Presence of carotid plaque.~Number of carotid plaques.~Area of carotid plaque(s).~Visual cap.~Degree of stenosis.~Gray scale medium (GSM) of carotid plaque.~Statistical geometric feature (SGF) - spottiness of the plaque. The GSM and SGF (actually SGF/plaque area or SGF/degree of stenosis) is an expression of heterogeneity of the plaque on ultrasound and is correlated to plaque area stained for lipids, macrophages and hemorrhage as well as cytokine expression. While GSM gives the overall echogenicity in the plaque, SGF is a measurement that describe the distribution of grey scale levels within the plaque.~Other parameters in cardiovascular phenotyping included in the project:~Blood pressure - sitting blood pressure.~BMI and hip/waist measurement.~Total cholesterol (TC), LDL-C and HDL-C.~Fasting blood glucose (FBG) and HbA1c.~GWAS for genes associated with CVD. Blood culture and blood 16S sequencing At all time-points blood is drawn for culturing and blood 16S-sequencing analysis. For culturing the phlebotomists in the study have been trained by the nurses at the infection clinic on how to draw blood for culturing - 4 blood culturing flasks per time point - one anaerobe and one aerobe on each arm.~Blood will be drawn and DNA will be extracted from PBMCs. For subsequent sequencing 16S amplicon sequencing will be used with amplicon sequencing variants (ASV) based bioinformatics pipeline, which increases the resolution and allows a larger fraction of the bacteria to be identified with species resolution. The results from the blood 16S sequencing will then be compared to the content of the oral biofilm.~Biomarkers The biomarkers play two important roles in this project - firstly, they are biomarkers of bacteremia that the investigators evaluate, and the sequencing of blood bacteria is also considered to be a biomarker of previous bacteremia, as described above. Secondly, and perhaps even more importantly, they collectively reflect the systemic response. Bacteremia can initiate sepsis, but the host response is what causes the condition.~For the analysis the biomarkers are divided into those immediately sent to the hospital lab, and biomarkers that the investigators analyze when all samples are collected. The biomarkers analyzed immediately are~Procalcitonin (PCT)~High sensitivity troponin T (hsTNT)~High sensitivity C-reactive protein (hs-CRP)~N-terminal prohormone of brain natriuretic peptide (NT-proBNP)~In a later phase, the investigators will also analyze:~Mid-regional pro-adrenomedullin (MR-pro-ADM)~C-terminal pro-endothelin-1 (CT-pro-ET-1)~When the investigators collected all samples, the investigators will utilize a multiplex approach for novel biomarker detection, such as OLINK proteomics.~Antimicrobial peptides Antimicrobial peptides will be analyzed by quantitative selected reaction monitoring mass spectrometry (SRM-MS), in accordance with previously published work from the group.~Proteases Proteases, and especially gingipain form Porphyromonas gingivalis has gained attention through a recent publication reporting on the effects from gingipain on the disease progression of Alzheimer's disease. Proteinases and gingipain specifically, will be analyzed in GCF, and also in plasma. Thanks to previous funding the investigators have, in collaboration with Innovagen, created anti-gingipain antibodies that will be evaluated in collaboration with Associate Professors Bertil Kinnby and Claes Wickström at Malmö University.~Statistics Aim 1 statistics - The intervention trial aspect will be primarily based on changes in carotid total plaque area (TPA). The annual change in TPA will first be assessed in the non-treated subjects from MODS. Changes in TPA will be treated as a dependent variable in a linear regression. Periodontal treatment versus untreated control will be used as independent variable. Other independent variables will be confounding factors, such as age, smoking status, education, medication, blood pressure etc. The investigators will then continue by using 'omics related biomarkers, such as OLINK proteins, as independent variables.~Aim 2 statistics - To investigate the association between cardiovascular biomarkers and bacteremia the investigators will investigate each time-point (Figure 1) separately. To investigate the association between bacteremia and CVD biomarkers, positive blood culture / previous blood culture / colony forming units (CFU) will be used as dependent variables and the biomarkers as independent variables in logistic/linear regressions, adjusting for confounders. ROC-curves will be constructed to test biomarkers of bacteremia at the respective time-points, to predict positive blood culture / previous blood culture.~Aim 3 statistics - To assess the impact of the AMP-profile, individual peptides will be included in a principal component analysis (PCA). A linear regression model with biomarkers as dependent variables and blood culture and PCA factors as independent variables will be constructed.~Aim 4 statistics - Proteases will be included as independent variables in logistic and linear regression models with blood culture and biomarkers as dependent variables, respectively.~The results from sequencing blood for microbiome will be analyzed in relation to the effects on biomarkers and blood culture, respectively, in the aims of 3 and 4.~Significance A thorough investigation of the underpinning of the association between CVD and periodontal disease and how periodontal disease may impact the course of CVD will be important in understanding the association. Decades of frequent low grade bacteremia may have caused more severe damages to the cardiovascular system in need of more personalized attention from cardiologists. This study elucidates what that cardiologist should look for.~In the context of sepsis the current project has the potential to contribute to more sepsis patients surviving the disease through a more precise and faster targeting of the bacteria initiating the condition. A biomarker that is more sensitive to bacteremia than blood culture and allows fast analysis would contribute to shorter time to correct antibiotics, which is the most important factor for shorter hospital stay and less deaths from sepsis. | Approximately 40,000 Swedes suffer from sepsiseach year, about 20% die. Biomarkers that are sensitive to current or previous bacteremia are needed in the treatment of sepsis. Bacteremia from periodontal treatment is predictive and occurs in 13-75%.~The study's hypothesis is to utilize bacteremia from periodontal treatment to evaluate biological markers for current or previous bacteremia.~A. What are the long term clinical, and 'omics related CVD-phenotypical effects from treating periodontal disease compared to an untreated group? B. Can biomarkers be used for detecting a bacteremia or previous bacteremia? C. Are the effects from bacteremia on cardiovascular biomarkers related to the individual's antimicrobial peptide profile? D. Does the presence of bacterial proteases, such as gingipain, relate to having a bacteremia from periodontal treatment and the systemic response from a bacteremia?~Significance: The project has the potential to shorten the time to treat sepsis, which in turn shortens hospital stay and higher survival. The possible definition of protective AMP-profile could translate to future pharmacologic intervention and improve the treatment of sepsis as well as prophylactic treatment at dental treatments. |
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