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## Virtual Peer Coaching in Manual Wheelchair Skills - NCT ID: NCT06295146 - Study ID: STUDY23050075 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-12-30 - Lead Sponsor: University of Pittsburgh ### Study Description The objective of this study is to determine the effectiveness of remote manual wheelchair skills training program. First, peer coaches will be enrolled and trained. Then, trainees will be enrolled into one of three interventions: intervention with remote feedback (Group 1), wait list control group (Group 2), and structured self-study (Group 3). ### Conditions - Wheelchair - Paraplegia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - Intervention A: 1-on-1 wheelchair skills training by a peer coach - Intervention B: Training via educational videos ### Outcomes Primary Outcomes - Capacity, confidence, and performance of wheelchair skills will improve following training Secondary Outcomes - Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline following training - Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline (6 months) - Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline (12 months) - Goal Attainment Scale (GAS) improvement from baseline (post training) - Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility improvement (6 months) - Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility improvement (1 year) - Wheelchair Outcome Measure (WhOM) Satisfaction with Participation in Meaningful Activities after baseline (6 months) - Wheelchair Outcome Measure (WhOM) Satisfaction with Participation in Meaningful Activities after baseline (1 year) - Life Space Assessment (LSA) improvement from baseline (6 months) - Life Space Assessment (LSA) improvement from baseline (1 year) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Preventive Remediation of Stress for Optimal MEdical StudentS - NCT ID: NCT06295133 - Study ID: PROMESS - STRESS - Status: RECRUITING - Start Date: 2023-11-11 - Completion Date: 2024-09-30 - Lead Sponsor: Research on Healthcare Performance Lab U1290 ### Study Description Medical students are subjected to a high competitive pressure throughout their curriculum. High levels of stress are associated with a deterioration in quality of life and learning abilities.Our field surveys conducted in 2022 and 2023 at the Lyon Est Medical School revealed that second-cycle students presented a high level of stress. It is expected that these feelings significantly degrade their quality of life as well as their health. Furthermore, a local survey reported that one in two medical students had experienced at least one depressive episode, and one in three had already had suicidal thoughts during their curriculum.Thus, it would become crucial for medical students to manage stressful situations and reduce stress levels during their studies.The PROMESS - STRESS project aims to offer solutions to students to reduce their stress levels during their medical studies. It responds to a demand expressed by students : our previous field study showed that 45% of fourth-year students declared being "very interested" and/or "interested" in following a intervention aimed at stress reduction. An early knowledge of stress remediation tools would allow students to quickly acquire the necessary tools to cope with stressful situations they will encounter during their training and their life as future physicians. The objective of this study is to determine the influence of a stress management intervention on medical students levels of psychophysiological stress and satisfaction. ### Conditions - Health Behavior - Health-Related Behavior - Stress ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Stress ### Outcomes Primary Outcomes - Perceived level of stress : Evolution of the score obtained at the Perceived Stress Scale (PSS). Secondary Outcomes - Scale of Holmes and Rahe : score obtained at the Holmes and Rahe Questionnaire Inventory. - Big-5 : scores obtained at the Big-5 questionnaire. - Coping strategies : scores obtained at the Brief Cope Inventory (BCI). - Perceived level of stress : score obtained at the Perceived Stress Scale - Heart rate variability (HRV) marker: cardiac coherence score during the pre-intervention. - Heart rate variability (HRV) marker: SDNN during the pre-intervention. - Heart rate variability (HRV) marker: RMSSD during the pre-intervention. - Heart rate variability (HRV) marker: Low frequency / High frequency ratio (LF/HF) during the pre-intervention. - Heart rate variability (HRV) marker: pnn50% during the pre-intervention. - Coping strategies : Evolution in scores obtained at the Brief Cope Inventory (BCI). - Heart rate variability (HRV) marker: Evolution in cardiac coherence score during the intervention. - Heart rate variability (HRV) marker: Evolution in SDNN score during the intervention. - Heart rate variability (HRV) marker: Evolution in RMSSD score during the intervention. - Heart rate variability (HRV) marker: Evolution in LF/HF ratio during the intervention. - Heart rate variability (HRV) marker: Evolution in pnn50% score during the intervention. - VAS - stressors quantity - Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived quantity of stressors - VAS - stress quantity - Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of stress. - VAS - stress quality: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the emotional valence associated with the stress level. - VAS - stress coping: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the management of stressful situations. - Advices given by the expert. Score obtained on a Likert scale ranging from 1 to 5 characterizing the nature of the advices given by the expert. - Likert - expert estimation of student's achievements. Score obtained on a Likert scale ranging from 1 to 3 accessing if the expert estimates that the student has achieve the goals previously set. - Likert - expert satisfaction. Scores obtained on a Likert scale ranging from 1 to 5 accessing the expert's satisfaction of his/her intervention. - Likert - expert level of comfort. Score assessing the expert comfort levels in participant relationships on a likert scale ranging from 1 to 5. - Likert - expert estimation of the overall student's achievements. Score obtained on a Likert scale ranging from 1 to 5 accessing the expert's level of satisfaction on the student's progress. - Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the all intervention. ### Location - Facility: RESHAPE, Lyon, N/A, 69008, France @@
## The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark (CAP-D) - NCT ID: NCT06295120 - Study ID: 362-1 - Status: RECRUITING - Start Date: 2023-11-13 - Completion Date: 2024-12-31 - Lead Sponsor: Research Unit for General Practice in Aalborg ### Study Description The aim of this randomised controlled trial is to identify the optimal treatment duration with phenoxymethylpenicillin for community-acquired pneumonia diagnosed in general practice.Eligible participants are adults (≥18 years) presenting in general practice with symptoms of an acute LRTI (i.e., acute illness (≤ 21 days) usually with cough and minimum one other symptom such as dyspnea, sputum production, wheezing, chest discomfort or fever) in whom the GP finds it relevant to treat with antibiotics.Consenting patients who meet all the eligibility criteria will be randomised (1:1:1:1:1) to either three, four, five, six or seven days of treatment with phenoxymethylpenicillin 1.2 MIE four times daily. ### Conditions - Community-acquired Pneumonia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Phenoxymethylpenicillin 1.2 MIE 4 times daily ### Outcomes Primary Outcomes - Treatment failure at day 30 Secondary Outcomes - Clinical recovery at day 8 - The Acute Respiratory Tract Infection Questionnaire (ARTIQ) score - Prolonged antibiotic treatment - Change in type of antibiotic - Relapse of acute Lower Respiratory Tract Infection (LRTI) - Reconsultation - New prescriptions within 30 days - Hospitalisation - Mortality - Adverse events - Treatment adherence ### Location - Facility: The Research Unit for General Practice Aalborg, Gistrup, N/A, 9260, Denmark @@
## Reliability of Range of Movement Measurements in Cerebral Palsy - NCT ID: NCT06295107 - Study ID: 2023-00195-01 - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-07-01 - Lead Sponsor: Region Skane ### Study Description The aim is to investigate the inter-rater reliability of passive range of motion (pROM) measurement with goniometer of knee extension and ankle dorsiflexion for children with unilateral spastic cerebral palsy (USCP) and secondary to explore to what extent spasticity influences the reliability. ### Conditions - Cerebral Palsy - Movement Disorders in Children ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ankle Passive Range of Movement (pROM) - Knee Passive Range of Movement (pROM) ### Outcomes Primary Outcomes - Ankle range of motion - Knee range of motion Secondary Outcomes ### Location - Facility: Children Habilitation Unit, Lund, Skane, 22241, Sweden @@
## The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients. - NCT ID: NCT06295094 - Study ID: PIPAC-OPC6 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2028-01 - Lead Sponsor: Odense University Hospital ### Study Description The goal of this randomized clinical trial is to investigate whether pressurized intraperitoneal chemotherapy (PIPAC), delivered immediately after minimally invasive D2 gastrectomy and repeated 6-8 weeks later, improves 12-month peritoneal disease-free survival in patients with high-risk gastric adenocarcinoma when compared to standard treatment. ### Conditions - Gastric Cancer - Chemotherapy, Adjuvant - Peritoneal Metastases - Minimally Invasive Surgical Procedures ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Cisplatin - Doxorubicin ### Outcomes Primary Outcomes - Peritoneal disease-free survival Secondary Outcomes - Disease-free survival - Overall survival - Length of stay - Postoperative toxicity - Postoperative complications - Postoperative mortality - Rate of positive peritoneal lavage - Patient-reported Quality of life - Patient-reported Quality of life - Number of patients not receiving adjuvant chemotherapy ### Location - Facility: City of Hope, Duarte, California, 91010, United States @@
## TREAT Study - Improving the Interpretation of Troponin Concentrations Following Exercise and Their Clinical Significance - NCT ID: NCT06295081 - Study ID: NL79864.091.22 - Status: RECRUITING - Start Date: 2022-06-15 - Completion Date: 2044-07-01 - Lead Sponsor: Radboud University Medical Center ### Study Description The goal of this observational study is to learn about cardiac biomarker release following exercise in amateur athletes.The main questions it aims to answer are:Question 1: What are the reference values for exercise-induced cardiac troponin elevations following walking, cycling and running exercise? Hypothesis 1: We hypothesize that the exercise-induced cTn release is different following walking, cycling and running exercise. Therefore, we will establish reference values for post-exercise cTn concentrations across each of these sport types.Question 2: Is the prevalence of (subclinical) coronary artery disease higher in individuals with high post-exercise cardiac troponin concentrations in comparison to individuals with low post-exercise cardiac troponin concentrations? Hypothesis 2: We hypothesize that athletes with the highest post-exercise cTn concentrations have a higher prevalence of coronary atherosclerosis compared to athletes matched for sex and age with the lowest post-exercise cTn concentrations.Question 3: What is the association between post-exercise cardiac troponin concentrations and major adverse cardiovascular events (MACE) and mortality during long-term follow-up? Hypothesis 3: We hypothesize that post-exercise cTn concentrations beyond the 99th percentile are associated with an increased risk for MACE and mortality during follow-up.This study consists of three phases:Phase 1: two or three visits to the study location for (amongst other measurements) blood draws to assess cardiac troponin concentrationsPhase 2: CT scan of the heart in 10% of participants to assess the prevalence of (subclinicial) coronary artery disease.Phase 3: longitudinal follow-up to assess the incidence of major adverse cardiovascular events and mortality during 20-year follow-up.Participants will visit our study centre two, three or four times:Visit 1: baseline measurements including height, weight, body composition and blood pressure will be obtained and a blood sample will be drawn.Visit 2: a blood sample will be drawn and activity data will be obtained from participants' own sports watch or bike computer.Optional visit 3: a blood sample will be drawn. Visit 4: 10% of participants will undergo a cardiac CT scan to assess the prevalence of (subclinical) coronary artery disease. ### Conditions - Coronary Artery Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Exercise exposure ### Outcomes Primary Outcomes - High-sensitivity cardiac troponin I (hs-cTnI) - High-sensitivity cardiac troponin T (hs-cTnT) Secondary Outcomes - General CT scan data - Coronary artery calcification score - Coronary stenosis and plaque characteristics - Computed tomography derived Fractional Flow Reserve - Incidence of mortality - Incidence of major adverse cardiovascular events ### Location - Facility: RadboudUMC, Nijmegen, Gelderland, 6525 GC, Netherlands @@
## Evaluation of ARi With OpSens SavvyWire - NCT ID: NCT06295068 - Study ID: PRT-1400-11 - Status: RECRUITING - Start Date: 2023-11-30 - Completion Date: 2024-04-30 - Lead Sponsor: Opsens, Inc. ### Study Description The goal of this observational study is to establish the degree of agreement to Aortic Regurgitation (AR) severity during aortic valve intervention between the Aortic Regurgitation Index (ARi) measured by the Opsens SavvyWire, Echography and Aortography in subjects with severe aortic stenosis (AS) undergoing echo guided valve intervention. The main question it aims to answer is how the ARi measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography. ### Conditions - Aortic Valve Insufficiency ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Transcatheter Aortic Valve Replacement (TAVR) - Balloon Aortic Valvuloplasty (BAV) ### Outcomes Primary Outcomes - Correlation of the Aortic Regurgitation Index (ARi) measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography Secondary Outcomes - Correlation of the Time Integration Aortic Regurgitation Index (TIARI) measured using the SavvyWire compare with regurgitation evaluation derived by Echography (TEE/TTE) and Aortography - Correlation of the Aortic Regurgitation Index Ratio measured using the Opsens SavvyWire compare with regurgitation evaluation derived by Echography and Aortography ### Location - Facility: AHS Morristown Medical Center, Morristown, New Jersey, 07960, United States @@
## Semi-rigid Shell Barrier System for Alveolar Bone Augmentation (SSBS for ABA) - NCT ID: NCT06295055 - Study ID: Dentistry Prince of Songkla - Status: RECRUITING - Start Date: 2024-01-04 - Completion Date: 2025-06-30 - Lead Sponsor: Prince of Songkla University ### Study Description This study aims to compare the clinical outcome before and after augmentation in case series of 10 patients. The main question it aims to answer is Whether the semi-rigid shell system facilitates bone regeneration in moderate to severe alveolar bone defects after 4 months of bone augmentation. Participants with bone defects between 3 to 8 millimeters (moderate to severe bone defect) will be treated with xenograft covered with the semi-rigid shell barrier system as a stage approach technique for implant placement. ### Conditions - Guided Bone Regeneration - Bone Formation - Bone Volume ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Ridge augmentation with semi-rigid shell barrier system ### Outcomes Primary Outcomes - Bone gain evaluation - Biocompatibility evaluation Secondary Outcomes - Ridge volume change of alveolar ridge evaluation ### Location - Facility: Prince of Songkla, Songkhla, Hatyai, 90110, Thailand @@
## Complications and Long-term Satisfaction in Autologous vs. Implant-Based Breast Reconstruction - NCT ID: NCT06295042 - Study ID: 32-235 ex 19/20 - Status: COMPLETED - Start Date: 2019-10-10 - Completion Date: 2024-02-01 - Lead Sponsor: Medical University of Graz ### Study Description Current literature on complications and health-related quality of life in autologous and alloplastic breast reconstruction is inconclusive. Despite the great demand for more in-depth, long-term studies of both techniques, current evidence is low or moderate and there are only few studies focusing on both health-related quality of life and complication rates in the same patient collective.This study aims at investigating the complex relationship between the occurrence of complications and patient-reported long-time satisfaction in autologous and alloplastic breast reconstruction. ### Conditions - Complications, Postoperative/Perioperative - Quality of Life - Satisfaction, Patient ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - BREAST-Q Questionnaire ### Outcomes Primary Outcomes - Complications Secondary Outcomes - Health-related quality of life and satisfaction ### Location - Facility: Medical University of Graz, Graz, N/A, 8036, Austria @@
## Personalized Medication Software for BCL-2 Inhibitor in AML Patients Using Machine Learning and Genomics - NCT ID: NCT06295029 - Study ID: CPA-Z05-ZC-2023-002 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-12-31 - Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School ### Study Description Severe neutropenia caused by venetoclax,a B-cell lymphoma-2(BCL-2) inhibitor, is the main cause of venetoclax tapering, drug discontinuation, and treatment delay. This study combines machine learning and genomics, hoping to develop models to predict venetoclax dose in Acute myeloid leukemia(AML) patients and compare the efficacy and safety differences of model-guided individualized medication regimen with current conventional regimen. According to the demographic information, the drug information, the drug concentration of the target patients, the laboratory examination, the single nucleotide polymorphism(SNP) information and the adverse reactions of the AML patients, and the model was constructed through machine learning. ### Conditions - Acute Myeloid Leukemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Overall survival (OS) - Progression-free survival (PFS) - Overall adverse event rate - Incidence of grade III and above adverse events Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Stressors and Recovery Regulation on the Super-compensation Effect - NCT ID: NCT06295016 - Study ID: NYCU112130AE - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2025-08-31 - Lead Sponsor: National Yang Ming University ### Study Description Purpose: Investigating the effects of stressors and recovery regulation on the super-compensation effect of high-intensity intensive training (IT) in endurance athletes. Methods: This study will recruit 176 competitively trained endurance adult athletes. Participants will conduct a 7-week 3-stage experiment, including 3 weeks of regular training, 3 weeks of 130% progressive IT, and 1 week of 55% taper. Measurement will include training responses (performance and fatigue symptoms), stressors, recovery regulation, and mood state at baseline, during and after regular training, IT, and taper separately. According to the performance after taper, all participants will category into either the responder or non-responder of well-response to supercompensation effect. Statistic analysis: Independent t-test, Chi-squared test, and binary logistic regression will be used to compare the difference in training responses, stressors, recovery regulation, and mood state characteristics between responder and non-responder groups. P value sets at 0.15 for identifying the potential predictors. Logistic stepwise multiple regression will be used further to determine the significant predictors for the responders of well-response to the super-compensation among endurance athletes. P value sets at 0.05. ### Conditions - Exercise Overtraining - Stressor, Psychological ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - High-intensity intensive training - Taper ### Outcomes Primary Outcomes - Stressor - Recovery regulation - Mood state - Peak power output Secondary Outcomes - Maximal heart rate - Fatigue state ### Location - Facility: Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University, Taipei, N/A, 112304, Taiwan @@
## Impact of COVID-19 Pandemic on Headache Evaluations in the Pediatric Emergency Department - NCT ID: NCT06295003 - Study ID: CEFA-COVID - Status: COMPLETED - Start Date: 2022-04-30 - Completion Date: 2022-05-30 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description Background: To evaluate the impact of COVID-19 on evaluations in the pediatric emergency department (ED) because of headache as main symptom.Methods: Number and clinical features of patients evaluated in the pediatric ED of a single site in Milan,Italy, were collected between January 2017 and January 2022. The impact of COVID-19 on evaluation rates was quantified by using the incidence rate ratio (IRR) and 95% confidence intervals (CI) between the pandemic (March 2020 to January 2022) and the prepandemic period (January 2017 to February 2020). ### Conditions - COVID-19 - Headache Disorders - Emergency Service, Hospital ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - During the study period, 890 evaluations were registered: the number of partecipants was 689 over the prepandemic period and 201 over the pandemic period. Mean age at evaluation was 10 years (range: 1 to 17 years). Secondary Outcomes - Evaluation rates per month were 18.1 during the prepandemic period and 8.7 during COVID-19 pandemic, with peaks in autumn and winter and drops in summer. The reduction in evaluation rate was higher for secondary headache when compared with primary one ### Location - Facility: Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, N/A, N/A, Italy @@
## Klinefelter Syndrome and Testosterone Treatment in Puberty - NCT ID: NCT06294990 - Study ID: 2023-505854-16-00 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2029-12-31 - Lead Sponsor: Lise Aksglæde ### Study Description The goal of this randomized clinical trial is to study the effect of testosterone replacement therapy during puberty in boys with Klinefelter syndrome (KS, 47,XXY).The main questions to answer are how treatment with testosterone will affect body fat mass, lipid and glucose metabolism, growth and body proportions, bone mineralization as well as effects on neurocognitive development and emotional and social difficulties.Participants will be randomized to two years treatment with testosterone or placebo. ### Conditions - Klinefelter Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Testosterone gel - Placebo ### Outcomes Primary Outcomes - Changes in body fat mass Secondary Outcomes - Pubertal development and virilization - Height - Weight - Bone mineralization - Neuropsychological evaluation - Neuropsychological evaluation, ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of COVID-19 Pandemic on Epilepsy Evaluations in the Pediatric Emergency Department - NCT ID: NCT06294977 - Study ID: CRISI-COVID - Status: COMPLETED - Start Date: 2022-11-30 - Completion Date: 2022-12-30 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description Background. Seizures are a common cause of evaluation in the pediatric emergency department (ED). Several studies about the impact of COVID-19 pandemic on ED attendances report a considerable reduction in general pediatric care. The aim of our study was to evaluate the impact of COVID-19 on the admission to the pediatric ED for seizures.Materials and methods. We performed a retrospective study to assess the rate of ED admission for seizures at the pediatric ED of the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milan between January 2017 and December 2021, comparing the pre-pandemic (from January 2017 to February 2020) and pandemic periods (from March 2020 to December 2021). ### Conditions - Epilepsy - Emergency Services, Hospital - COVID-19 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - During the study period, 1,091 patients with seizures were admitted to pediatric ED, 776 before the pandemic and 315 during the pandemic. In particular, the evaluation rates per month were 20.4 before the pandemic and 14.3 afterward Secondary Outcomes - Patients with a history of previous seizures showed a greater decrease in the monthly number of ED visits compared to those with a first seizure. An increased rate of unprovoked seizures and a decreased rate of provoked ones were observed in the pandemic ### Location - Facility: Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, N/A, N/A, Italy @@
## Intervention and Effect of Sleep Pattern on Cardio-cerebrovascular Disease - NCT ID: NCT06294964 - Study ID: Sleep Education - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-01 - Completion Date: 2026-11-30 - Lead Sponsor: RenJi Hospital ### Study Description Because of the growing population of older people, cardio-cerebrovascular diseases has been the most important aging-related chronic disease, studying the pathogenesis and early warning mechanisms of cardio-cerebrovascular diseases in depth, exploring optimal strategies for early diagnosis and treatments of cardio-cerebrovascular diseases has becoming the urgent public health problem in China. Aging causes cellular changes that change the sleep status in older adults, leading to an increased risk of disease and death. Meanwhile, the rising prevalence of chronic diseases among older adults also increases the impact of sleep deprivation. Insufficient sleep has being a serious challenge to the health status of the elderly. However, there is no clinically significant treatment for sleep disorders caused by chronic diseases. Medication helps to sleep but will also lead to drug dependence and increasing the risk of recurrent sleep disorders, which is unfavorable for disease control.Studies have shown that older adults who sleep 7-8 hours at night have better physical and mental health, cognition and quality of life. Shorter sleep durations (6 hours or less) and longer sleep durations (greater than 9 hours) had strong associations with adverse health outcomes such as cardiovascular, metabolic, immune, cognitive diseases, other psychiatric disorders, and mortality.Therefore, on the basis of the established Pudong community cohort, the project applicant led the team to adopt an open-label, blind endpoint, and cluster-randomized two-phase trial method to randomly assign cohort members into intervention group and control group. According to the sleep health intervention plan formulated by the clinical team, family doctor provides health education materials according to the actual situation of the intervention group regularly. Family doctors in the control group used conventional management methods. The final assessment was that compared to control group, whether the intervention group improved members' sleep quality, reduced members' cardiovascular disease events, and individual cardiovascular disease morbidity and all-cause mortality during the study period. ### Conditions - Cardiovascular Diseases - Non-Communicable Chronic Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - sleep education, behavioral education ### Outcomes Primary Outcomes - the incidence and/or prevalence of cardiovascular diseases such as myocardial infarction, stroke, heart failure, and cardiovascular death Secondary Outcomes - all cause death ### Location - Facility: Cardiology, Ren Ji Hospital, Shanghai, N/A, N/A, China @@
## fMRI for BPS: A Descriptive Study of Findings and Symptoms - NCT ID: NCT06294951 - Study ID: IIT-2023-0225 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-12-31 - Lead Sponsor: RenJi Hospital ### Study Description The goal of this observational study is to investigate the relationship between functional magnetic resonance imaging (fMRI) findings of the brain and symptom presentation in patients with bladder pain syndrome (BPS). The main questions it aims to answer are:1. To explore the distribution characteristics of fMRI imaging and possible target lesions in the patient population.2. To provide appropriate clues and evidence for etiological exploration and therapeutic targeting of BPS.Participants will undergo fMRI as well as other routine laboratory tests and queries. ### Conditions - Bladder Pain Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - fMRI ### Outcomes Primary Outcomes - fMRI findings Secondary Outcomes ### Location - Facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, 200127, China @@
## Glycemic Index of Cacao Fruit Pulp in Healthy, Human Subjects - NCT ID: NCT06294938 - Study ID: M.WRI-2023-INQ-2224 - Status: COMPLETED - Start Date: 2022-09-30 - Completion Date: 2023-05-23 - Lead Sponsor: Mars Wrigley ### Study Description Cacao fruit pulp is a sweet and fruity carbohydrate-rich edible mucilage that is often discarded. The objective of this study is to assess the glycemic response and determine the glycemic index of cacao fruit pulp. ### Conditions - Blood Sugar; High - Blood Sugar; Low ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Cacao fruit pulp - Dextrose ### Outcomes Primary Outcomes - Plasma Glucose - Incremental area under the curve - Peak plasma glucose Secondary Outcomes ### Location - Facility: INQUIS Clinical Research, Toronto, Onterio, M5C 2N8, Canada @@
## A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis - NCT ID: NCT06294925 - Study ID: C5041041 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2027-04-20 - Lead Sponsor: Pfizer ### Study Description The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for patients with moderate to severe ulcerative colitis.Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment choice according to the treating physician. Additionally, patients have to be between 18 and 65 years of age and should not have taken etrasimod in the past.All patients will be prescribed etrasimod according to standard of care. Assessments will be conducted according to standard of care with the exception of health questionnaires which will be completed by the patients online on their own device.The study duration is 52 weeks with 28 days of safety follow-up. Patients will visit their treating physician as they would if they were not enrolled in the study. During the study duration, patients will be asked to complete health questionnaires on a regular basis either on their mobile phone, tablet or computer.The effects of etrasimod will be analyzed for each patient comparing to their disease activity prior to the start of etrasimod. ### Conditions - Colitis, Ulcerative ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Etrasimod ### Outcomes Primary Outcomes - Proportion of patients with symptomatic remission - Proportion of patients with symptomatic remission Secondary Outcomes - Proportion of patients with clinical response - Proportion of patients with clinical response. - Proportion of corticosteroid-free patients with symptomatic remission ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003) - NCT ID: NCT06294912 - Study ID: 7602-003 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-02 - Completion Date: 2025-03-10 - Lead Sponsor: Merck Sharp & Dohme LLC ### Study Description The purpose of this study is to assess the antimalarial activity, pharmacokinetics, and safety of MK-7602 in healthy adults following Plasmodium falciparum (P. falciparum) infection. ### Conditions - Malaria ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Plasmodium falciparum - MK-7602 - Artemether/lumefantrine - Primaquine - Artesunate - Atovaquone/proguanil ### Outcomes Primary Outcomes - Parasite reduction ratio (PRR48) (Parts 1 and 2) - Parasite Clearance Half-life (PCt1/2) (Parts 1 and 2) - Parasite Regrowth (Parts 1 and 2) - Part 1 Single dose: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of MK-7602 - Part 1 Single dose: Maximum Plasma Concentration (Cmax) of MK-7602 - Part 1 Single dose: Concentration at 24 Hours (C24) of MK-7602 - Part 1 Single dose: Time to Maximum Plasma Concentration (Tmax) of MK-7602 - Part 1 Single dose: Elimination Half-life (t1/2) of MK-7602 - Part 2 Multiple dose: Area Under the Curve Time 0 to End of the Dosing Interval (AUC0-tau) of MK-7602 - Part 2 Multiple dose: Maximum Plasma Concentration (Cmax) of MK-7602 - Part 2 Multiple dose: Time to Maximum Plasma Concentration (Tmax) of MK-7602 - Part 2 Multiple dose: Elimination Half-life (t1/2) of MK-7602 Secondary Outcomes - Number of Participants Who Experience an Adverse Event (AE) - Number of Participants Who Discontinue Study Intervention Due to an AE ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## CRP and Lung Ultrasound in Respiratory Evaluation - NCT ID: NCT06294899 - Study ID: 23/222-P - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-09-01 - Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina ### Study Description Lower respiratory tract infections (LRTIs) are one of the most common reasons for consultation in Primary Care centres. Differentiating between viral and bacterial aetiologies can be challenging, leading to inappropriate antibiotic prescribing. Lung ultrasound (LUS), an imaging test that gained particular relevance since the beginning of the SARS-CoV-2 pandemic, offers several advantages over the classic chest X-ray in detecting and monitoring LRTIs, especially when pleural involvement exists.This study aims to correlate LUS findings with capillary blood C-Reactive Protein (CRP) values in patients with LRTIs, evaluating LUS as a diagnostic tool and its impact on therapeutic decisions. The descriptive observational study, conducted from January 2024 to December 2026 in Lleida, will include LRTI patients attending Primary Care centres. By validating LUS as a rapid and non-invasive diagnostic tool, unnecessary antibiotic prescriptions can be reduced, promoting LUS as a complementary test in Primary Care consultations. This will facilitate appropriate diagnosis and treatment decisions for patients with LRTIs, enhancing the overall management of respiratory infections. ### Conditions - C-Reactive Protein - Ultrasonography - Primary Health Care - Lower Respiratory Tract Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Lung ultrasound ### Outcomes Primary Outcomes - Ultrasound patterns - C-Reactive Protein Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Vaginal Fluid Collection for Detection of Endometrial Cancer - NCT ID: NCT06294886 - Study ID: Innovis RD-2401 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2024-06-01 - Lead Sponsor: Innovis LLC ### Study Description The primary objective of this study is to obtain de-identified vaginal fluid specimens from participants with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer (EC), endometrial hyperplasia (AEH) with atypia or endometrial intraepithelial neoplasia (EIN).The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of EC, AEH and EIN. ### Conditions - Endometrial Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Screening test to detect endometrial cancer and precancer ### Outcomes Primary Outcomes - Detection of endometrial cancer and precancer Secondary Outcomes ### Location - Facility: Trials365, Shreveport, Louisiana, 71118, United States @@
## Stool Sample Collection Study - NCT ID: NCT06294873 - Study ID: Innovis RD-2301 - Status: RECRUITING - Start Date: 2023-07-20 - Completion Date: 2024-04-30 - Lead Sponsor: Innovis LLC ### Study Description The primary objective of this study is to obtain de-identified stool specimens from participants with colonoscopic biopsy-based histopathologic diagnosis of colorectal cancer (CRC) and/or a ≥1 cm colorectal polyp/adenoma/mass found during pre-enrollment colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy.The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of neoplasms of the aerodigestive tract. ### Conditions - Colorectal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - A screening device for the detection of colorectal and other aerodigestive tract cancers ### Outcomes Primary Outcomes - Detection of colon cancer or precancer Secondary Outcomes ### Location - Facility: Associated Gastroenterology Medical Group, Anaheim, California, 92810, United States @@
## Biological Age in Children With GH Deficiency Undergoing Hormone Replacement Therapy - NCT ID: NCT06294860 - Study ID: 01C317 - Status: RECRUITING - Start Date: 2023-06-19 - Completion Date: 2024-12-31 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description The primary objective of the study is to evaluate the epigenetic age in children with GH deficiency, before and after 6 months of treatment with growth hormone replacement therapy. The secondary objective is to correlate the epigenetic age with the auxometric and biochemical parameters used in the clinical-endocrinological practice. The results of the study will be useful to set up the clinical and biochemical follow-up of the hormone replacement therapy with rhGH and to understand the biomolecular mechanisms at the base of the debated "anti" or "pro" aging action of GH, the most important anabolic hormone of the human organism. ### Conditions - Growth Hormone Deficiency - Short Stature ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Measurement of biological (epigenetic) age Secondary Outcomes ### Location - Facility: Istituto Auxologico Italiano, Milano, N/A, 20145, Italy @@
## Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery - NCT ID: NCT06294847 - Study ID: 2021_0025 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-10 - Lead Sponsor: Hopital Foch ### Study Description This study is indicated for patients with extended rhegmatogenous retinal detachment (RRD) (≥ 2 quadrants) with macula OFF lasting 7 days or less, pseudophakic or aphakic, and scheduled to undergo surgical intervention with vitrectomy and gas tamponade in one of the ophthalmology departments participating in the study.The main objective is to assess the effectiveness of UDCA in visual acuity recovery at 3 months (i.e., the difference between preoperative visual acuity and visual acuity 3 months after surgery) in pseudophakic or aphakic patients who have undergone successful surgical intervention (reattachment of the retina) through vitrectomy and gas tamponade following rhegmatogenous retinal detachment (RRD).120 patients will be enrolled and randomized in two groups:* the experimental arm "UDCA Group," with oral administration of ursodeoxycholic acid (Ursolvan®)* the control group "Placebo Group," with oral administration of the placebo. ### Conditions - Retinal Detachment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ursolvan - Placebo ### Outcomes Primary Outcomes - Difference in visual recovery (difference between preoperative and postoperative visual acuity) at 3 months postoperative (after a successful reapplication procedure) of at least 6 letters (ETDRS scale) between the two groups (treatment and placebo) Secondary Outcomes - Central Nervous Epithelium (CNE) thickness - Automated microperimetry at 1, 3, and 6 months: Macular sensitivity difference between the two groups. - Contrast sensitivity measurement using the Clinic CSF2.0 application. - Presence/absence of abnormal signs on optical coherence tomography (OCT) images (cysts, folds, membrane, ellipsoid zone, external limiting membrane). - Retinal thickness measured by OCT (retinal layers and presence of cysts, layer segmentation and measurement in the central 1 and 3 mm in ETDRS quadrants). - Number of macular cones and retinal pigment epithelium (RPE) cells measured by Adaptive Optics at 1, 3, and 6 months with the "Cellularis" device that allows visualization of cones and RPE. - Blood test: liver parameters - AST (SGOT), ALT (SGPT), PAL, and γ-GT. - Evolution of the best visual acuity measured at Day 0, Day 7, Day 30, Day 60, Day 90, and Day 180: Difference between the treated and placebo groups in the progression curves of visual acuity. - Presence of metamorphopsia. - Tolerance and occurrence of adverse events. - National Eye Institute Visual Functioning Questionnaire-25 (NEIVFQ-25) quality of life questionnaire before surgery, at ±7 days postoperative, and at 3 months postoperative. - Correlation between protein levels, bile acids, or other molecular markers in ocular and/or blood fluids and functional and anatomical ocular parameters pre- and post-operatively at different observation times. - Correlation between the effective duration of treatment and functional and anatomical outcomes at different observation times. ### Location - Facility: Hôpital Cochin, Paris, N/A, 75014, France @@
## Improving Clinician Capacity to Provide Interventions for Manual Wheelchair Users - NCT ID: NCT06294834 - Study ID: STUDY22010071 - Status: RECRUITING - Start Date: 2023-02-22 - Completion Date: 2026-12-30 - Lead Sponsor: University of Pittsburgh ### Study Description The objective of this study is to determine the effectiveness of remote manual wheelchair skills training program for clinicians. The study will use three-group approach: intervention with remote feedback (Group 1), control group (Group 2), and structured self-study (Group 3). This demonstrates how the intervention compares not only to a control, but also to the next "best alternative" - therapists sourcing web-based training materials and learning independently. ### Conditions - Wheelchair Skills ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Part 1 of intervention A - Wheelchair skills training modules - Part 2 of intervention A - Asynchronous feedback from a remote trainer - Intervention B: Education on wheelchair provision ### Outcomes Primary Outcomes - Change in Wheelchair Skills Test Questionnaire (WST-Q) score - Change in Self-Efficacy on Assessing, Training, and Spotting (SEATS) score - Change in number of wheelchair users trained - Change in quality of wheelchair skills trained Secondary Outcomes - Change in rehab professional Wheelchair Skills Test Questionnaire (WST-Q) score - Change in rehab professional Self-Efficacy on Assessing, Training, and Spotting (SEATS) score - Change in rehab professional quantity of wheelchair users trained - Change in rehab professional quality of wheelchair training ### Location - Facility: University of Pittsburgh / Rehab Neural Engineering Labs, Pittsburgh, Pennsylvania, 15219, United States @@
## 4AP to Delay Carpal Tunnel Release (CTR) - NCT ID: NCT06294821 - Study ID: 00003845 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2028-07 - Lead Sponsor: John Elfar ### Study Description The investigators have found recent promising data supporting the use of a currently FDA approved drug, 4-aminopyridine, in the treatment of nerve injury including compression neuropathy. The purpose of this research is determine whether 4-aminopyridine can delay the need for formal surgical release in patients with known carpal tunnel syndrome who would otherwise undergo surgery. ### Conditions - Compression Neuropathy - Carpal Tunnel Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 4-Aminopyridine - Placebo ### Outcomes Primary Outcomes - Results of symptomatic improvement in the Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ) - Results of symptomatic improvement in the Michigan Hand Outcomes Questionnaire (MHQ) Secondary Outcomes - Electrodiagnostic improvement following treatment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Predicting Survival After Surgical Resection for the Entire Spectrum of Anatomically Resectable HCC - NCT ID: NCT06294808 - Study ID: 2017-2601 - Status: COMPLETED - Start Date: 2017-07-17 - Completion Date: 2020-06-30 - Lead Sponsor: National Cancer Centre, Singapore ### Study Description Clinical outcomes after surgical resection in HCC is a continuum and is clearly related to tumor burden but needs better definition. The researchers describe the use of the "metro ticket" approach to analyze surgical outcomes over the whole spectrum of anatomically resectable HCC to define overall survival including intermediate stage tumors (BCLC B). The analysis the researchers provide in this study enables the clinician to select the optimal surgical resection candidate based on robust long term survival data.In addition, study compares outcome for open surgery vs laparoscopic surgery, survival outcome for viral and non-viral HCC using Albumin-Bilirubin (ALBI) for more comprehensive study result. ### Conditions - Hepatocellular Carcinoma Resectable ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - 5-year mortality. - Concordance of pre-operative radiological and post operative surgical specimen. - Agreement between TBI calculated from pre-operative imaging versus those obtained from post-surgical pathological assessment. Secondary Outcomes ### Location - Facility: National Cancer Centre, Singapore, Singapore, N/A, 168583, Singapore @@
## Toric Intraocular Lens Implantation in Pediatric Cataract - NCT ID: NCT06294795 - Study ID: 2-2024 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-12-31 - Lead Sponsor: Kazakh Eye Research Institute ### Study Description To evaluate the visual and refractive outcomes after an intraocular lens (IOL) implantation in pediatric eyes with cataract and preexisting corneal astigmatism ### Conditions - Cataract Congenital - Astigmatism - IOL ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - congenital/pediatric cataract surgery - Non-Toric IOLs - Toric IOLs ### Outcomes Primary Outcomes - Uncorrected (UCDVA) and corrected (CDVA) distance visual acuity - Uncorrected (UCNVA) and corrected (CNVA) near visual acuity - Refraction measurements Secondary Outcomes - Keratometry measurements ### Location - Facility: Kazakh Eye Research Institute, Almaty, N/A, 050012, Kazakhstan @@
## PrOsPective Cohort Study for STereotactic Arhythmia Radioablation (STAR) of Refractory Ventricular Tachycardia - NCT ID: NCT06294782 - Study ID: 36/2022 - Status: RECRUITING - Start Date: 2022-04-15 - Completion Date: 2025-02 - Lead Sponsor: University of Turin, Italy ### Study Description This is a multicenter, interventional study. The study will enroll patients that fulfill the inclusion criteria over a 33-month period. Considering the small number of patients who will meet the study criteria, it is also possible to include retrospective patients who already underwent STAR (for instance, as part of a compassionate program) if they meet all the inclusion and exclusion criteria as well as the treatment planning standardized requirements and sign their consent to this trial. All patients prospectively enrolled will undergo a flow of investigations following a standardized approach. ICD programming will be standardized. ### Conditions - Refractory Ventricular Tachycardia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - STereotactic Arhythmia Radioablation (STAR) ### Outcomes Primary Outcomes - VT storm and incessant VT - adverse events Secondary Outcomes ### Location - Facility: University of Turin, Turin, N/A, N/A, Italy @@
## Effect of Aromatherapy on Postoperative Pain: Randomized Clinical Trial - NCT ID: NCT06294769 - Study ID: 022024 Maria Fernanda - Status: NOT_YET_RECRUITING - Start Date: 2024-03-18 - Completion Date: 2024-07-19 - Lead Sponsor: University of Sao Paulo ### Study Description Introduction: Pain is one of the main complications in the immediate postoperative period that can harm the patient and can be managed through pharmacological and non-pharmacological methods. Complementary Integrative Health Practices are non-pharmacological methods that use therapeutic resources based on traditional knowledge to treat symptoms. Among them, aromatherapy stands out, which consists of the use of essential oils through inhalation or topical application for therapeutic purposes and which can be used as a nursing intervention, especially in the context of perioperative care. Objective: To evaluate the effect of aromatherapy on postoperative pain in adult patients in the immediate postoperative period. Method: This is a randomized controlled clinical trial that will be carried out in a teaching hospital. The project was submitted to the Research Ethics Committees of the School of Nursing of the University of Sao Paulo and the University of Sao Paulo Hospital. Adult patients undergoing elective surgical procedures of any surgical specialty under anesthesia of any type will be included. Individuals diagnosed with dementia, cognitive impairment or chronic pain will be excluded; individuals with a history of asthma, allergic bronchitis, chronic obstructive pulmonary disease, contact dermatitis or allergy to cosmetics with lavender fragrance, or hypersensitivity to the compounds used in the intervention; procedure for reoperation for any reason. The intervention will consist of the application of aromatherapy with 2% lavender essential oil through the skin and inhalation by a nurse, associated with usual care, in the immediate postoperative period; the placebo group will only receive the application of grape seed vegetable oil associated with usual care. A numerical verbal scale will be applied to assess pain and vital parameters will be measured upon patient admission, every fifteen minutes in the first hour and every thirty minutes in the second hour or after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after applying the intervention, in the post-anesthesia recovery room. Possible associations between variables will be verified using Pearson's Chi-square or Fisher's exact tests. Comparison between means or medians will be made using the Student's t or Mann-Whitney tests, depending on the normality determined according to the Kolmogorov-Smirnov test. The significance level adopted will be 5%. ### Conditions - Acute Pain - Perioperative/Postoperative Complications - CAM - Nurse's Role ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - essencial oil of lavandula angustifolia - grape seed vegetable oil ### Outcomes Primary Outcomes - Acute pain Secondary Outcomes - Blood pressure (both systolic and diastolic) - Heart rate - Respiratory frequency - Oxygen saturation - Temperature ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Sulfureous Water Therapy in Viral Respiratory Diseases - NCT ID: NCT06294756 - Study ID: acquealbuleroma1 - Status: COMPLETED - Start Date: 2023-05-30 - Completion Date: 2023-09-30 - Lead Sponsor: University of Roma La Sapienza ### Study Description The goal of this double-blind, interventional, randomized case-control, pilot trial is to evaluate the effects of active sulfurous (STW) versus placebo (SDW) inhalations on blood test parameters, serum inflammatory cytokines, spirometry data, as well as qualitative and quantitative changes in the nasal microbiome of subjects affected by long Covid.The main questions it aims to answer are:* if STW inhalations are effective on respiratory issues due to long covid compared to the placebo inhalation (SDW)* if STW inhalations are effective on long covid related fatigue issues compared to the placebo inhalation (SDW)* if H2S inhaled with STW is effective in modulating (decreasing) cytokines which are related to long covid cytokine storm compared to placebo inhalation with no H2S (SDW)* if STW inhalation modify nasal microbiome both from a qualitative and quantitative point of view respect to placebo inhalation (SDW) Participants will be randomly assigned to active inhalations (STW) or placebo inhalations (SDW) arm and subjected to 12 consecutive sessions of 20 minutes.Both arms will be tested for:* cytokines and inflammatory markers concentration (IL1b, IL6, ACE, GSS, S100B, Hs-CRP)* spirometry (resting, forced, DLCO)* exertion response (6 minutes walking test)* nasal microbiome sampling at visit 1 (enrolment), at visit 2(right after the inhalation treatment) and at visit 3 (3 months after treatment).Researchers will compare results reported by STW to those of SDW group to see if significative differences are detectable. ### Conditions - Long-COVID - Post COVID-19 Condition - Chronic COVID-19 Syndrome - Post Acute Sequelae of COVID-19 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Inhalation of Sulfurous Thermal Water - Inhalation of Sterile Distilled non-pyrogenic Water ### Outcomes Primary Outcomes - To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters. - To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters. - To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters - To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID - To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID - To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID Secondary Outcomes - To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients. - To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients. - To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients. - to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection - to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection - to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection ### Location - Facility: Acque Albule, Terme di Roma, Tivoli, Rome, 00019, Italy @@
## Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea - NCT ID: NCT06294743 - Study ID: C202304001 - Status: RECRUITING - Start Date: 2023-11-23 - Completion Date: 2025-12-31 - Lead Sponsor: Taichung Armed Forces General Hospital ### Study Description The goal of this crossover study is to assessed the treatment efficacy of posterior tibia nerve neuroprolotherapy on dysmenorrhea. The primary outcome is the improvement of Visual Analogue Scale. The main question it aims to answer is:•Could the posterior tibial nerve neuroprolotherapy alleviate the pain of dysmenorrhea.Participants will be randomly allocated into two groups, Group-1 will receive neuroprolotherapy in the first 2 menstrual cycles followed by oral acetaminophen(500mg) for the subsequent 2 menstrual cycles. Group02 will received oral acetaminophen(500mg) in initial 2 menstrual cycles, followed by receiving neuroprolotherapy for the subsequent 2 menstrual cycles. ### Conditions - Dysmenorrhea - Prolotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Posterior tibial nerve neuroprolotherapy - Acetaminophen 500Mg Tab ### Outcomes Primary Outcomes - Visual Analogue Scale Secondary Outcomes - The SF-36v2® Health Survey ### Location - Facility: Taichung Armed Forces General Hospital, Taichung, Other (Non US), 41168, Taiwan @@
## COronary Microcirculation and Troponin Elevation in Septic Shock - NCT ID: NCT06294730 - Study ID: 2018/1891-31 - Status: RECRUITING - Start Date: 2019-06-13 - Completion Date: 2024-12 - Lead Sponsor: Karolinska Institutet ### Study Description Plasma cardiac troponin (cTn) elevation is an indicator of increased mortality in patients with sepsis yet the underlying cause of troponin elevation in sepsis is not known. The COMTESS study investigates whether elevated high-sensitive cardiac Troponin T (hs-cTnT) levels in hemodynamically unstable patients with sepsis can be explained by an underlying coronary artery disease or a process within the coronary microcirculation. Fifty patients with sepsis and with hs-cTnT elevation (\>15 ng/L) will undergo coronary angiography, including an assessment of coronary flow using a method called thermo-dilution to record the index of microcirculatory resistance (IMR) in the left anterior descending artery (LAD). The relationship between IMR and hs-cTnT will subsequently be analysed. It is important to identify the underlying causes of elevated cTn during sepsis to target further research with an aim to improve the survival in patients suffering from this condition. ### Conditions - Sepsis - Myocardial Injury - Coronary Microvascular Dysfunction - Endothelial Dysfunction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Relationship between hs-cTnT and IMR Secondary Outcomes - Relationship between hs-cTnT and CFR - Relationship between hs-cTnT and BRI - Relationship between hs-cTnT and number of diseased epicardial coronary vessels - Relationship between hs-cTnT and Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX)-score - Relationship between hs-cTnT and left ventricular end diastolic pressure (LVEDP) - Relationship between hs-cTnT and Tricuspid annular plane systolic excursion (TAPSE) - Relationship between hs-cTnT and echocardiographic measurements of left ventricular global strain - Relationship between hs-cTnT and echocardiographic measurements of left diastolic dysfunction - Relationship between measures of endothelial dysfunction and IMR - Relationship between measures NETs and IMR ### Location - Facility: Karolinska Institutet, Danderyd University Hospital, Stockholm, N/A, 182 88, Sweden @@
## The Effect of Progressive Relaxation Exercises on Physiological Parameters, Pain and Anxiety After Cesarean Section - NCT ID: NCT06294717 - Study ID: AtaturkUPhStudentNeslihanATLI - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-01 - Lead Sponsor: Ataturk University ### Study Description Caesarean section is a surgical procedure that can be performed before or during birth in cases where the life of the mother and fetus is threatened or upon the request of the mother and father. One of the most common problems after cesarean section is abdominal pain. Progressive relaxation exercises are a method that allows certain muscle groups in the body to first contract and then relax. Progressive relaxation exercises have been proven to have positive effects on anxiety. By applying progressive relaxation exercises, the parasympathetic nervous system is activated; Thus, heart and respiratory rate and blood pressure can be kept within normal limits. This study will be conducted to determine the physiological parameters, pain and anxiety levels of progressive relaxation exercises, one of the non-pharmacological methods, on women giving birth by cesarean section. ### Conditions - Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Progressive relaxation exercises will be applied. ### Outcomes Primary Outcomes - Beck Anxiety Scale Secondary Outcomes - Visual Analog Scale (VAS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients With Type 1 Diabetes - NCT ID: NCT06294704 - Study ID: 2024/0004 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-31 - Lead Sponsor: Centre Hospitalier Sud Francilien ### Study Description Bariatric surgery is increasingly performed on patients with type 1 diabetes. It exposes these patients to an increased risk of hypoglycemia, including severe hypoglycemia, and of severe episodes of hyperglycemia, beyond the perioperative period. The long-term efficacy and safety of hybrid closed-loop insulin pump in these patients has not yet been published. ### Conditions - Bariatric Surgery - Type 1 Diabetes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - bariatric surgery ### Outcomes Primary Outcomes - time spent within glycemic target 70-180 mg/dL Secondary Outcomes - Time spent in level 1 hyperglycemia (181-250 mg/dL) - Time spent in level 2 hyperglycemia (>250 mg/dL) - HbA1c - Coefficient of variation - Time spent in level 1 hypoglycemia (51-70 mg/dl) - Time spent in level 2 hypoglycemia (< 50 mg/gdl) ### Location - Facility: Centre Hospitalier Sud Francilien, Corbeil-Essonnes, N/A, 91106, France @@
## Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases - NCT ID: NCT06294691 - Study ID: infusion time & aGVHD-002 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-08-31 - Lead Sponsor: Anhui Provincial Hospital ### Study Description To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with nonmalignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT) ### Conditions - Acute Graft-versus-host Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Time of stem cell infusion ### Outcomes Primary Outcomes - The cumulative incidence of grade III to IV aGVHD Secondary Outcomes - The cumulative incidence of grade II to IV aGVHD - The cumulative incidence of neutrophil engraftment at 28 days after transplantation - The cumulative incidence of platelet recovery at 100 days after transplantation - The cumulative incidence of transplant-related mortality at 180 days after transplantation - The cumulative incidence of transplant-related mortality at 360 days after transplantation - The cumulative incidence of chronic GVHD at 360 days after transplantation - The probability of GVHD-free, relapse-free survival(GRFS) - The probability of disease-free survival(DFS) - The probability of overall survival(OS) ### Location - Facility: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, Anhui, 230036, China @@
## Effect of Stem Cell Infusion Time on aGVHD in Patients With Hematological Malignancies - NCT ID: NCT06294678 - Study ID: infusion time & aGVHD-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-08-31 - Lead Sponsor: Anhui Provincial Hospital ### Study Description To observe the effect of stem cell infusion on the development of acute graft-versus-host disease (aGVHD) in patients with malignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT) ### Conditions - Acute Graft-versus-host Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Time of stem cell infusion ### Outcomes Primary Outcomes - The incidence of grade III to IV aGVHD Secondary Outcomes - The incidence of grade II to IV aGVHD - The cumulative incidence of neutrophil engraftment at 28 days after transplantation - The cumulative incidence of platelet recovery at 100 days after transplantation - The cumulative incidence of transplant-related mortality at 180 days after transplantation - The cumulative incidence of transplant-related mortality at 360 days after transplantation - The cumulative incidence of chronic GVHD at 360 days after transplantation - The probability of GVHD-free, relapse-free survival(GRFS) - The probability of disease-free survival(DFS) - The probability of overall survival(OS) ### Location - Facility: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, Anhui, 230036, China @@
## Comparison Between Bupivacaine-Dexmedetomidine Versus Bupivacaine-Dexamethasone in Pericapsular Nerve Group (PENG) Block - NCT ID: NCT06294665 - Study ID: MD113/2023 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-01-01 - Lead Sponsor: Ain Shams University ### Study Description The aim of this work is to compare the effectiveness of bupivacaine- dexmedetomidine mixture versus bupivacaine-dexamethasone mixture in PENG Block as Post-operative Analgesia in Hip surgeries ### Conditions - Hip Fractures - Post Operative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pericapsular Nerve Group (PENG) Block ### Outcomes Primary Outcomes - The time to the first request of analgesia Secondary Outcomes - Total doses of analgesia (Nalbuphine) given to patients in 24 hours postoperatively - Occurrence of side effects of drugs. ### Location - Facility: Ain Shams University, Cairo, N/A, 11122, Egypt @@
## AGMT Austrian Lymphoma Registry - NCT ID: NCT06294652 - Study ID: AGMT_Lymphoma_Reg - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2033-12-31 - Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie ### Study Description Lymphomas are a group of cancers that originate in the lymphatic system, a key component of the immune system. They can be broadly categorized into two main types: Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL).There are different subtypes of HL, including classical Hodgkin lymphoma (cHL) and nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). The subtypes of cHL include nodular sclerosis, mixed cellularity, lymphocyte-rich, and lymphocyte-depleted.Non-Hodgkin lymphomas are more diverse and comprise a wide range of subtypes, each with distinct genetic, molecular, and clinical features. Common subtypes of NHL include Diffuse large B-cell lymphoma (DLBCL), Follicular lymphoma (FL), Mantle cell lymphoma (MCL), Chronic lymphocytic leukemia (CLL), myeloma, and other rarer subgroups.Many of these diseases typically present with lymph node enlargement, bone marrow infiltration, general and lymphoma subtype specific symptoms and laboratory abnormalities.Novel agents have improved the prognosis of high-risk lymphoma patients in the front-line and relapsed setting and more accurate prognostic tools enable less intensive treatment for low-risk patients, while maintaining their good prognosis.Lymphoma disease have not been systematically assessed in Austria to date. This medical registry of the AGMT is thus the first Austrian-wide standardized documentation of epidemiology, clinical course and molecular and other biologic data of this disease. As lymphomas are a very heterogeneous group, not all subtypes will always be documented simultaneously in this registry. Which lymphoma subtype is to be documented can change over time, depending on which clinical question is currently in focus. ### Conditions - Lymphoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - General Characteristics - Genetic Profiling - Proportion of lymphoma patients in Austria that require treatment - Proportion of lymphoma patients in Austria under active surveillance - Number of patients with concomitant diseases - Number of treatment and outcome of treatment - Patient Outcome - Toxicities Secondary Outcomes ### Location - Facility: Universitätsklinik für Innere Medizin III, PMU Salzburg, Salzburg, N/A, 5020, Austria @@
## ED50 of Esketamine for Laser Treatment in Children - NCT ID: NCT06294639 - Study ID: XJA-20240224 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-27 - Completion Date: 2025-04-27 - Lead Sponsor: Air Force Military Medical University, China ### Study Description There is limited research on the combined use of esketamine and alfentanil for anesthesia during facial laser treatment in pediatric patients, and the effective dosage of esketamine for inhibiting body movement remains unclear. We explore the effective dose of esketamine combined with alfentanil for the inhibition of body movement during facial laser treatment in pediatric patients. ### Conditions - Anesthesia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - Esketamine ### Outcomes Primary Outcomes - half effective dose of inhibition of body movement Secondary Outcomes - number of patients with agitation during awake - number of patients with dizzy during awake - number of patients with nausea and vomiting during awake - number of patients with apnea during awake - satisfaction score of the parents to the anesthesia ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Examination of Neuromotor Development of Cases Diagnosed With Scaphocephaly - NCT ID: NCT06294626 - Study ID: ISozeri - Status: COMPLETED - Start Date: 2019-01-01 - Completion Date: 2023-12-31 - Lead Sponsor: Acıbadem Atunizade Hospital ### Study Description It's an observational study. Purpose of the study: To evaluate the neuromotor development of scaphocephaly cases.21 infants diagnosed with scaphocephaly aged 2-17 months were included.* Is there any delay in the neuromotor development of scaphocephaly cases?* If delay is observed, in which area is it most common?Denver-II Developmental Screening Test and Alberta Motor Infant Scale were applied to the participants. ### Conditions - Craniosynostosis, Sagittal - Scaphocephaly - Developmental Delay ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Group 1 ### Outcomes Primary Outcomes - Denver-II Developmental Screening Test - Alberta Infant Motor Scale Secondary Outcomes ### Location - Facility: Acıbadem Altunizade Hospital, Istanbul, Uskudar, N/A, Turkey @@
## A Prospective, Open-label, Single-center, Study of the ACUSURGICAL Luca System for Treatment of Vitreoretinal Diseases - NCT ID: NCT06294613 - Study ID: CIV-23-07-043672 - Status: RECRUITING - Start Date: 2024-02-08 - Completion Date: 2024-07 - Lead Sponsor: Acusurgical ### Study Description Prospective, interventional, open-label, non-controlled, monocentric study in Belgium of Luca, of up to 7 evaluable subjects, undergoing vitreoretinal surgery to treat intravitreal hemorrhage and macular pucker.Only one eye per subject can be enrolled. ### Conditions - Vitreoretinal Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - vitreoretinal surgery ### Outcomes Primary Outcomes - Safety Outcome Secondary Outcomes ### Location - Facility: UZ Gent, Gent, East Flanders, 9000, Belgium @@
## Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT) - NCT ID: NCT06294600 - Study ID: REACT - Status: RECRUITING - Start Date: 2024-02-12 - Completion Date: 2026-01-30 - Lead Sponsor: Hellenic Institute for the Study of Sepsis ### Study Description The primary objective of the REACT randomized clinical trial (RCT) is to optimize the clinical benefit from adjunctive clarithromycin treatment shown in the ACCESS trial and to provide evidence for the clinical benefit of early start of adjunctive oral clarithromycin guided by suPAR to prevent the progression into sepsis in patients with community-acquired pneumonia (CAP) at risk. This can be achieved by endpoints incorporating clinical benefit with the effect of treatment on the improvement of the immune dysregulation of CAP. The secondary objectives of REACT are to investigate the impact of early adjunctive treatment with clarithromycin on the resolution of CAP at the test-of-cure (TOC) visit. ### Conditions - Community-acquired Pneumonia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Clarithromycin 500mg - Tablets ### Outcomes Primary Outcomes - Change of baseline respiratory symptoms score - Change of baseline total sequential organ failure assessment (SOFA) score - Change of baseline on both plasma PCT and plasma IL-10 or IL-8 to IL-10 ratio Secondary Outcomes - The number of patients that succeeded the resolution of CAP at the test of cure (TOC) visit. - Need for up-escalation of the SoC administered antibiotics. - Survival - Change of baseline sequential organ failure assessment (SOFA) score - Change of baseline on both plasma PCT and plasma IL-10 or IL-8 to IL-10 ratio - Cytokine production - 28-Day Mortality - 90-Day Mortality - Cost ### Location - Facility: 1st Department of Internal Medicine - General Hospital of Athens "Sismanogleio-Amalia Fleming", Athens, N/A, N/A, Greece @@
## Evaluation of Free Gingival Graft Timing - NCT ID: NCT06294587 - Study ID: IRB-300012407 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-07 - Lead Sponsor: University of Alabama at Birmingham ### Study Description This clinical trial aims to compare and evaluate the clinical outcomes between two distinct treatment sequences: free gingival graft surgery preceding guided bone regeneration and guided bone regeneration followed by free gingival graft. ### Conditions - Ridge Augmentation - Alveolar Mucosa ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - FGG Before GBR - FGG after GBR ### Outcomes Primary Outcomes - Volumetric outcome assessment - Buccal soft tissue profile Secondary Outcomes ### Location - Facility: Unversity of Alabama at Birmingham, School of Dentistry, Birmingham, Alabama, 35294-0007, United States @@
## Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker in Comparison to HydroMARK as Well as Improved Surgeon Satisfaction - NCT ID: NCT06294574 - Study ID: 300011943 - Status: NOT_YET_RECRUITING - Start Date: 2024-12 - Completion Date: 2026-12 - Lead Sponsor: University of Alabama at Birmingham ### Study Description The purpose of the study is to test how successful the retrieval rate of the new HydroMARK Plus Breast Biopsy Site Marker in comparison to HydroMARK. ### Conditions - Breast Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - HydroMARK Plus Clip ### Outcomes Primary Outcomes - Retrieval rate of the HydroMARK Plus clip. Secondary Outcomes - Level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip. ### Location - Facility: The Kirklin Clinic, Birmingham, Alabama, 35249, United States @@
## TGRX-326 Pharmacokinetic Drug Interaction - NCT ID: NCT06294561 - Study ID: TGRX-326-1003 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-06-30 - Lead Sponsor: Shenzhen TargetRx, Inc. ### Study Description This is a drug-drug interaction study for TGRX-326 to evaluate the effects of CYP3A inhibitor/inducer drugs on pharmacokinetic profiles of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer. ### Conditions - Non Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Itraconazole+TGRX-326 - Efavirenz+TGRX-326 ### Outcomes Primary Outcomes - Plasma Tmax - Plasma Cmax - Plasma AUC(0-t) - Plasma AUC(0-inf) - T1/2 - Plasma volume of distribution (Vz/F) - Plasma clearance (CL/F) Secondary Outcomes - Adverse events/serious adverse events - Corrected QT Interval ### Location - Facility: Nanjing Drug Tower Hospital, Nanjing, Jiangsu, 210008, China @@
## A Study of Valemetostat Tosylate (DS-3201b) With Atezolizumab and Bevacizumab in HCC - NCT ID: NCT06294548 - Study ID: IRB-300012272 (UAB 23152) - Status: NOT_YET_RECRUITING - Start Date: 2024-05-31 - Completion Date: 2027-12-31 - Lead Sponsor: University of Alabama at Birmingham ### Study Description This is a phase Ib/II, dose escalation and dose expansion study of valemetostat (DS-3201) with atezolizumab and bevacizumab in patients advanced Hepatocellular carcinoma (HCC) who did not receive prior systemic therapy for advanced HCC. ### Conditions - Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Valemetostat - Atezolizumab - Bevacizumab ### Outcomes Primary Outcomes - Phase 1b - Phase II Secondary Outcomes - Safety and pharmacokinetics (PK) - Progression free survival (PFS) - Overall survival (OS) - Duration of response (DoR) - Disease Control Rate (DCR) ### Location - Facility: University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States @@
## The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant - NCT ID: NCT06294535 - Study ID: 2024 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-12-11 - Completion Date: 2024-06-06 - Lead Sponsor: Tanta University ### Study Description under GA, incision to access to orbital walls. Then insertion of prebent titanium mesh or customized titanium implant and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap. ### Conditions - Orbital Fractures ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - reconstruction of orbital walls ### Outcomes Primary Outcomes - restoring the accurate position of eye - motility of eye - volume of orbit Secondary Outcomes ### Location - Facility: Faculty of Dentistry, Tanta University, Tanta, N/A, 3111, Egypt @@
## Reconstruction of Nasal Floor for Three-dimensional Repair of Alveolar Cleft - NCT ID: NCT06294522 - Study ID: 1984 - Status: COMPLETED - Start Date: 2023-07-20 - Completion Date: 2024-02-16 - Lead Sponsor: Tanta University ### Study Description reconstruction of alveolar cleft with autogenous bone after elevation of mucoperiosteal flap and suturing of nasal floor and palatal flap ### Conditions - Alveolar Cleft ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - reconstruction of alveolar cleft ### Outcomes Primary Outcomes - recurrence of oronasal fistula - volume of alveolar cleft after reconstruction - density of bone Secondary Outcomes ### Location - Facility: Faculty of Dentistry, Tanta University, Tanta, N/A, 3111, Egypt @@
## taVNS Application Timing During Robotic Sensorimotor Task - NCT ID: NCT06294509 - Study ID: SMTaVNS 2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04-01 - Lead Sponsor: Olivier Lambercy ### Study Description The goal of this clinical trial is to evaluate the feasibility and effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) in enhancing sensorimotor learning and adaptation. This study will focus on healthy individuals performing a robotic sensorimotor task.Main Questions it Aims to Answer:How does taVNS, with different timing protocols, affect the feasibility and effectiveness of performing a robotic sensorimotor task? What is the impact of taVNS on sensorimotor learning and adaptation?Participants Will:Be pseudo-randomly assigned to one of five experimental groups with different taVNS stimulation timings.Perform a sensorimotor task multiple times across sessions, spanning a maximum of two weeks or until achieving 70% accuracy in two successive sessions.Have kinematic data collected by a robot during the task. Have physiological data measured using external sensors. Fill out questionnaires about the feasibility of taVNS and other subjective measures after each session.Comparison Group:Researchers will compare the four experimental groups to each other to see if different taVNS stimulation timings affect sensorimotor learning outcomes, as well as to a control group that will receive no stimulation. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - in-house developed transcutaneous auricular Vagus Nerve Stimulation device ### Outcomes Primary Outcomes - Subjectively perceived tolerance of taVNS and perceived difficulty of motor task - Success of the sensorimotor challenge - Mean Change from Baseline in Galvanic Skin Response (GSR) - Mean Change from Baseline in Heart Rate (HR) - Mean Change from Baseline in Pupil Diameter (PD) - Mean Change from Baseline in electroencephalogram (EEG) Secondary Outcomes - Subjectively perceived positive effects of taVNS on motor performance - Change of movement parameters from baseline - Associations between outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of Carotid Artery Stenosis Through the Integration of Multimodal Imaging and Computational Fluid Dynamics - NCT ID: NCT06294496 - Study ID: 2023YFS0274 - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2024-12-31 - Lead Sponsor: Sichuan Provincial People's Hospital ### Study Description Ischemic stroke affects 2.5 to 3 million people annually in China, ranking as the leading cause of death and disability. Cervical artery stenosis is a significant contributor to this problem, with about 50% of patients experiencing cognitive impairment due to reduced cerebral blood flow. Two main surgical approaches, carotid endarterectomy (CEA) and carotid artery stenting (CAS), are used to treat severe cervical artery stenosis, but their effects on various factors remain unclear.This project collects multimodal imaging data, including CT perfusion and angiography, to create 3D models of cervical artery stenosis. Computational fluid dynamics and AI analysis are used to assess hemodynamics. By monitoring blood flow, oxygen levels, and evaluating postoperative outcomes, the goal is to tailor surgical approaches for better patient outcomes and improved quality of life. ### Conditions - Carotid Stenosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - CEA/CAS ### Outcomes Primary Outcomes - Perioperative cardio-cerebrovascular adverse events Secondary Outcomes - Compute fluid dynamics parameters - Clinical outcome ### Location - Facility: Sichuan Provincial People's Hospital, Chengdu, Sichuan, 610072, China @@
## Comparison Between Early-onset and Late-onset Patients With Systemic Lupus Erythematosus. - NCT ID: NCT06294483 - Study ID: Soh-Med-24-01-09MS - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-10 - Completion Date: 2024-08-30 - Lead Sponsor: Sohag University ### Study Description The present study aims to:Compare clinical features, hematological indices and disease activity between the early-onset and late-onset patients with systemic lupus erythematosus.Evaluate the relationship between hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and Systemic lupus erythematosus (SLE) disease manifestations and activity. ### Conditions - Systemic Lupus Erythematosus ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - CBC - Antinuclear Antibody tests (ANA) - Rest of ANA profile - C3 and C4 complement level. - Anti phospholipid marker - Serum creatinine and Alb/create ratio - 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. - SLEDAI scores ### Outcomes Primary Outcomes - Evaluate the hematological indices as (mean platelet volume) of our SLE patient. - Evaluate the hematological indices as (neutrophil lymphocyte ratio) of our SLE patient. - Evaluate the hematological indices ( platelet lymphocyte ratio ) of our SLE patient. - Compare the degree of disease activity between the early-onset and late-onset patients with systemic lupus erythematosus. - Evaluate the correlation between hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and Systemic lupus erythematosus (SLE) disease manifestations and activity. Secondary Outcomes ### Location - Facility: Sohag university hospital, Sohag, N/A, N/A, Egypt @@
## Efficacy of Stapled Hemorrhoidopexy for the Treatment of Obstructive Defecation Syndrome - NCT ID: NCT06294470 - Study ID: 01-2023 - Status: COMPLETED - Start Date: 2023-05-01 - Completion Date: 2023-12-15 - Lead Sponsor: Universidad Central de Venezuela ### Study Description The objective of this study is to assess the efficiency of the procedure for hemorrhoidal prolapse and pexia in alleviating symptoms of defecatory obstruction among patients with grade II to IV mucohemorrhoidal prolapse. ### Conditions - Hemorrhoids - Defecation Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ballon expulsion test - Colonic transit time - Stapled hemorrhodopexy ### Outcomes Primary Outcomes - Postoperative improvement of symptoms of defecatory obstruction Secondary Outcomes - Postoperative change of the balloon expulsion test - Postoperative change of the colonic transit time ### Location - Facility: Hospital Domingo Luciani, Caracas, Miranda, 1073, Venezuela @@
## Effectiveness of Non-invasive Neuromodulation for Intestinal Transit in Healthy Subjects - NCT ID: NCT06294457 - Study ID: CI-2024-480 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Universidad Europea de Madrid ### Study Description ObjectivesMain objective:Assess the effectiveness of non-invasive neuromodulation treatment (NESA) for the management of constipation in patients without diagnosed pathology in SpainSecondary objectives:Evaluate the improvement in sleep quality Analyze the improvement in blood pressure quality Measure the improvement in cortisol quality Determine if there is an improvement in heart rate ### Conditions - Constipation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Non-Invasive Neuromodulation NESA ### Outcomes Primary Outcomes - Quality of life by constipation (CVE-20) Secondary Outcomes - Sleep Quality - Cardiac Frecuency - Arterial pressure ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Constraint Induced Movement Therapy and Mirror Therapy - NCT ID: NCT06294444 - Study ID: REC/RCR&AHS/23/0741 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2024-03-15 - Lead Sponsor: Riphah International University ### Study Description Hemiplegia in infants and children is a type of Cerebral Palsy that results from damage to the part (hemisphere) of the brain that controls muscle movements. This damage may occur before, during or shortly after birth. The term hemiplegia means that the paralysis is on one vertical half of the body. The aim of this study will be the to know the effect of mCIMT with and without mirror therapy on upper limb function in children with hemiplegic cerebral palsy. A randomized control trial will be conducted at Sheikh Zayed Hospital, RYK through convenience sampling technique on 30 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. Group A will be treated with mCIMT and Group B will be treated with mCIMT and mirror therapy. Outcome measure will be conducted through pain and disability questionnaire after 6 weeks. Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. mCIMT with and without mirror therapy will be applied in patients with hemiplegic cerebral palsy to see the effect on upper limb function. ### Conditions - Hemiplegic Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Constraint Induced Movement Therapy - Mirror therapy ### Outcomes Primary Outcomes - fine motor skills Secondary Outcomes ### Location - Facility: Imran Amjad, Lahore, Punjab, 54000, Pakistan @@
## Radicle Clarity 24: A Study of Health and Wellness Products on Cognitive Function and Related Health Outcomes - NCT ID: NCT06294431 - Study ID: RADX-P-2406 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-22 - Completion Date: 2024-07 - Lead Sponsor: Radicle Science ### Study Description A randomized, double-blind, placebo-controlled direct-to-consumer study of health and wellness products on cognitive function and related health outcomes ### Conditions - Cognitive Function ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Placebo Control Form 1 - Clarity Active Study Product 1.1 Usage - Placebo Control Form 2 - Clarity Active Study Product 2.1 Usage ### Outcomes Primary Outcomes - Change in cognitive function Secondary Outcomes - Change in fatigue - Change in sleep-related impairment - Minimal clinical importance difference (MCID) in cognitive function ### Location - Facility: Radicle Science, Inc, Del Mar, California, 92014, United States @@
## FCI in Post-operative Low Grade Gliomas - NCT ID: NCT06294418 - Study ID: 1-037-23 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2025-03 - Lead Sponsor: NHS Grampian ### Study Description The aim of this pilot study is to explore the utility of a new imaging technique, called Field Cycling Imaging (FCI), in postoperative low grade gliomas.The main question it aims to answer is if FCI can differentiate subtypes of low grade gliomas. Participants will have one FCI scan. ### Conditions - Glioma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Field Cycling Imaging (FCI) ### Outcomes Primary Outcomes - Differentiation of sub-types of low grade glioma assessed by Field Cycling Imaging (FCI) T1 dispersion profiles Secondary Outcomes ### Location - Facility: Aberdeen Royal Infirmary, Aberdeen, N/A, AB25 2ZD, United Kingdom @@
## Intraocular Lens Implant Registry Study - NCT ID: NCT06294405 - Study ID: 24-0010 - Status: RECRUITING - Start Date: 2024-02-21 - Completion Date: 2029-02-14 - Lead Sponsor: University Hospital Augsburg ### Study Description The goal of this registry study is to optimize the results with intraocular lens implants used in cataract surgery. ### Conditions - Intraocular Lens Complication - Intraocular Lens Rotation - Intraocular Lens Associated Postoperative Inflammation - Lens Opacities ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Intraocular lens Implantation ### Outcomes Primary Outcomes - Functional results with different Intraocular lenses - Contrast sestivitiy with different Intraocular lenses - Anatomical results. Secondary Outcomes ### Location - Facility: University Hospital Augsburg, Augsburg, N/A, N/A, Germany @@
## KEEP Connecting Kin - NCT ID: NCT06294392 - Study ID: 90FA3010 - Status: RECRUITING - Start Date: 2024-02-13 - Completion Date: 2026-04 - Lead Sponsor: Oregon Social Learning Center ### Study Description The current study provides a unique opportunity to conduct a summative evaluation of the KEEP Connecting Kin (KEEP-CK) program by leveraging extant relationships with Oregon's Child Welfare System (CWS), Self-Sufficiency Program (SSP), and our community partners to address the needs of informal kinship families and the youth in their care. Specifically, a randomized "services-as-usual" (SAU) waitlist control design plus qualitative methods will be used to evaluate the immediate (post-intervention) and sustained (10 month) impacts of the KEEP-CK program on child, adult, and service utilization outcomes, and prevention of entry into the CWS. ### Conditions - Internalizing Behavior - Externalizing Behavior - Child Permanency - Parenting - Parent Stress - Service Utilization ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - KEEP-CK ### Outcomes Primary Outcomes - Mean change in youth well-being (i.e., behavioral and emotional functioning, including child internalizing and externalizing behaviors) - Mean change in child permanency (i.e., placement stability and permanency of placements) - Mean change in parenting practices and parent/caregiver stress. - Mean change in parent/caregiver stress. - Mean change in parenting practices. - Mean change in parents' use of services from multiple systems (financial, educational, mental health, medical, legal) Secondary Outcomes ### Location - Facility: Oregon Center Learning Center, Eugene, Oregon, 97401, United States @@
## Shared Decision Making in Melanoma Patients Receiving Adjuvant Therapy - NCT ID: NCT06294379 - Study ID: OUH_SDM - Status: RECRUITING - Start Date: 2022-03-01 - Completion Date: 2024-12-30 - Lead Sponsor: Odense University Hospital ### Study Description This study aims to develop test and evaluate a Patient Decision Aid called "The Decision Helper" among melanoma patients eligible for adjuvant treatment.* Is the Decision Helper an acceptable tool for patients and clinicians and is it feasible in clinical practice?* Are there any differences in the levels of decisional regret in the patients who have not used the Decision Helper (pre-implementation) compared to the ones who have (post-implementation? ### Conditions - Malignant Melanoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Development of a Patient Decision Aid "The Decision Helper" for melanoma patients receiving adjuvant theory - Evaluation of the "The Decision Helper" Secondary Outcomes ### Location - Facility: Odense University Hospital, Odense C, N/A, 5000, Denmark @@
## Bipolar Transurethral Enucleation Versus Resection in the Treatment of Benign Prostatic Hyperplasia: a Comparative Study - NCT ID: NCT06294366 - Study ID: MenoufiaU2022 - Status: RECRUITING - Start Date: 2022-06-12 - Completion Date: 2024-06-12 - Lead Sponsor: Menoufia University ### Study Description Benign prostatic hyperplasia (BPH) is a common chronic progressive disease resulting in the enlargement of the prostate gland and bladder outlet obstruction in aging men .Because of the increasing aged population and advancements in diagnostic tools, the incidence and importance of BPH have increased . BPH can be treated either with watchful waiting, drug therapy, or surgery being the most effective treatment option for BPH .Transurethral resection of the prostate (TURP) has been recognized as the standard treatment for BPH with morbidity rate varies from 18% and 26% Until now, only open prostatectomy and transurethral Holmium laser enucleation of the prostate (HoLEP) have shown an equal efficacy and durability compared to TURP ### Conditions - Prostatic Hyperplasia - Prostate Enucleation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bipolar Bowa device ### Outcomes Primary Outcomes - Assessing and comparing the safety, the surgical efficacy and peri-operative morbidity of bipolar enucleation of the prostate and bipolar transurethral resection of the prostate for the treatment of patients with symptomatizing prostates. Secondary Outcomes ### Location - Facility: Faculty of medicine, Shibīn Al Kawm, Menoufia, 32866, Egypt @@
## Study of Efficacy and Safety of WELT-ED for Eating Disorder (WCTP-ED-B-01) - NCT ID: NCT06294353 - Study ID: WCTP-ED-B-01 - Status: RECRUITING - Start Date: 2023-03-29 - Completion Date: 2024-08-30 - Lead Sponsor: WELT corp ### Study Description The purpose of this clinical trial is to evaluate the safety and efficacy of a digital therapeutic device (WELT-ED) based on Cognitive Behavioral Therapy (CBT) for the treatment of eating disorders.The main questions it aims to answer are:* Is WELT-ED as effective as standard treatment in reducing the symptoms of eating disorders?* Is the WELT-ED safe for use in the target population without causing adverse effects?Participants will:* Undergo assessments to determine their baseline health status and severity of eating disorder symptoms.* Use WELT-ED or receive standard treatment as directed for the duration of the study period (8 weeks).* Participate in assessments to monitor changes in their eating disorder symptoms and any potential side effects. ### Conditions - Eating Disorders - Binge Eating - Binge-Eating Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - WELT-ED (CBT based DTx) - Standard Treatment ### Outcomes Primary Outcomes - Binge Eating Frequency Secondary Outcomes - Eating Disorder Examination Questionnaire (EDE-Q) - Clinical Impairment Assessment (CIA) - Patient health questionnaire-9 (PHQ-9) - Generalized anxiety disorder 7-item scale (GAD-7) - The EuroQol Visual Analogue Scale (EQ-VAS) - Clinical Global Impression of Improvement (CGI-I) - Clinical Global Impression of Severity (CGI-S) ### Location - Facility: Seoul National University Hospital, Seoul, N/A, 03080, Korea, Republic of @@
## Noise, Oxidative Stress and Cardiovascular System - NCT ID: NCT06294340 - Study ID: 1322-IX/42 - Status: NOT_YET_RECRUITING - Start Date: 2025-01 - Completion Date: 2028-12 - Lead Sponsor: University of Belgrade ### Study Description Environmental noise represents a health problem for at least one in five citizens of the European Union. Noise exposure leads to the development of arterial hypertension, myocardial infarction, stroke, and obesity. Given the limited information on noise exposure and noise effects on humans in the Republic of Serbia, the overall objective of NOXYCARD is to collect environmental noise levels data; to identify long-term and short-term noise effects on the cardiovascular system; and to evaluate the levels of blood stress hormones, oxidative stress, and inflammation in individuals with normal body weight and individuals with obesity. ### Conditions - Noise; Adverse Effect - Noise Exposure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Exposure to loud pre-recorded road traffic noise ### Outcomes Primary Outcomes - Systolic blood pressure - Concentration of stress hormone Secondary Outcomes - Diastolic blood pressure - Concentration of inflammation parameters ### Location - Facility: Faculty of Medicine, University of Belgrade, Belgrade, Beograd, 11040, Serbia @@
## RESTART the Prevention of Pressure Ulcers: Comparing the Effectiveness and Cost of a Reactive Static Air Mattress and Alternating Air Pressure Mattress - NCT ID: NCT06294327 - Study ID: EC23027 - Status: RECRUITING - Start Date: 2024-01-22 - Completion Date: 2025-04-30 - Lead Sponsor: Vitaz ### Study Description Pressure ulcers are a global issue and substantial concern for healthcare systems. A review of the literature between January 2000 and December 2012 has revealed that prevalence rate of pressure ulcers in aged care facilities were between 4.1% and 32.2%, and the incidence rates ranged from 1.9% to 59%. Similarly, a systematic review reported that the prevalence of pressure ulcer varied between 0.3% and 46%, and the incidence of pressure ulcer ranged from 0.8% to 34%. Most epidemiological data were obtained from hospitals (38.7%) and institutional long-term care facilities (29.7%).The costs associated with pressure ulcers are considerable. According to the Agency for Healthcare Research \& Quality (2011), the US healthcare system has allocated approximately $ 9.1 - $ 11.6 billion annually for the health care cost of pressure ulcer. In addition to direct treatment-related costs, the development of pressure ulcer also results in litigation and government penalties, and affects hospital performance metrics. A systematic review has reported that the cost for treatment of pressure ulcer was higher than its prevention. That is, the cost per patient per day ranged from € 1.71 to € 470.49 (for treatment) and from € 2.65 to € 87.57 (for prevention) across all settings.This randomized controlled trial will be performed in a general hospital in a random sample of 308 patients (nursing wards geriatric n=3 and orthopedic (n=3)) who are at high risk of developing pressure ulcers. Patients will be included in the study for a period \> 2 hospitalisation days. Skin assessment and risk factor registration will be done on a daily base by the ward nurses. Reliability checks and time measurements will be completed by the researcher. ### Conditions - Pressure Injury - Pressure Ulcer - Decubitus Ulcer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Reactive static air support surfaces ### Outcomes Primary Outcomes - Incidence of pressure ulcer, category > I Secondary Outcomes - Cost of alternating air pressure mattress compared to reactive static air support surfaces - Patient comfort ### Location - Facility: Vitaz (General Hospital), Sint-Niklaas, East Flanders, 9100, Belgium @@
## Return to Play After ACL Reconstruction With Bone Marrow Aspirate, DBM, and an Internal Brace - NCT ID: NCT06294314 - Study ID: 1982669-3 - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2028-07-01 - Lead Sponsor: Marshall University ### Study Description The Investigators are studying the effect of an ACL reconstruction on return to play by capturing outcome measures and biomechanics information. ### Conditions - Anterior Cruciate Ligament Rupture ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Fertilized ACL ### Outcomes Primary Outcomes - Return to play - Biomechanics testing Secondary Outcomes - MRI findings ### Location - Facility: Marshall University, Huntington, West Virginia, 25755, United States @@
## A Study of Single and Multiple Doses of LP-005 in Healthy Adult Participants - NCT ID: NCT06294301 - Study ID: P10-LP005-01 - Status: RECRUITING - Start Date: 2023-11-19 - Completion Date: 2024-10-30 - Lead Sponsor: Longbio Pharma ### Study Description The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-005 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-005 and Part 2, multiple ascending dose (MAD). ### Conditions - Paroxysmal Nocturnal Hemoglobinuria (PNH) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - LP-005 Dose 1 (Single) - LP-005 Dose 2 (Single) - LP-005 Dose 3 (Single) - LP-005 Dose 4 (Single) - LP-005 Dose 5 (Single) - LP-005 Dose 6 (Single) - Placebo (Single) - LP-005 Dose 7 (Multiple) - LP-005 Dose 8 (Multiple) - LP-005 Dose 9 (Multiple) - Placebo (Multiple) ### Outcomes Primary Outcomes - Adverse events Secondary Outcomes - Time to peak concentration (Tmax) of LP-005 - Maximum concentration (Cmax) of LP-005 - Elimination half-life (t1/2) of LP-005 - Area under the concentration-time curve (AUC0-t) of LP-005 - Apparent clearance rate (CL/F) of LP-005 - Assessment of immunogenicity - Assessment of complement C5 activity - Assessment of complement C3b activity ### Location - Facility: Shanghai Public Health Clinical Center, Shanghai, Shanghai, N/A, China @@
## A Study of Single and Multiple Doses of LP-003 in Healthy Adult Participants - NCT ID: NCT06294288 - Study ID: P-10-LP003-2022-01 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-07-01 - Completion Date: 2024-03-15 - Lead Sponsor: Longbio Pharma ### Study Description The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-003 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-003 and Part 2, multiple ascending dose (MAD). ### Conditions - Chronic Spontaneous Urticaria ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - LP-003 Dose 1 (Single) - LP-003 Dose 2 (Single) - LP-003 Dose 3 (Single) - LP-003 Dose 4 (Single) - LP-003 Dose 5 (Single) - Placebo (Single) - LP-003 Dose 6 (Multiple) - LP-003 Dose 7 (Multiple) - LP-003 Dose 8 (Multiple) - Placebo (Multiple) ### Outcomes Primary Outcomes - Adverse events Secondary Outcomes - Time to peak concentration (Tmax) of LP-003 - Maximum concentration (Cmax) of LP-003 - Elimination half-life (t1/2) of LP-003 - Area under the concentration-time curve (AUC0-t) of LP-003 - Apparent clearance rate (CL/F) of LP-003 - Assessment of immunogenicity - Assessment of total immunoglobulin E (IgE) - Assessment of free IgE ### Location - Facility: Shanghai General Hospital, Shanghai, Shanghai, N/A, China @@
## A Study of Single and Multiple Dose Administration of LP-001 in Healthy Subjects - NCT ID: NCT06294275 - Study ID: P-10-LP001-2022-01 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-09-16 - Completion Date: 2024-04-06 - Lead Sponsor: Longbio Pharma ### Study Description The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-001 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-001 and Part 2, multiple ascending dose (MAD). ### Conditions - Myelodysplastic Syndrome (MDS) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - LP-001 Dose 1 (Single) - LP-001 Dose 2 (Single) - LP-001 Dose 3 (Single) - LP-001 Dose 4 (Single) - LP-001 Dose 5 (Single) - LP-001 Dose 6 (Single) - Placebo (Single) - LP-001 Dose 7 (Multiple) - LP-001 Dose 8 (Multiple) - Placebo (Multiple) ### Outcomes Primary Outcomes - Adverse events Secondary Outcomes - Time to peak concentration (Tmax) of LP-001 - Maximum concentration (Cmax) of LP-001 - Elimination half-life (t1/2) of LP-001 - Area under the concentration-time curve (AUC0-t) of LP-001 - Apparent clearance rate (CL/F) of LP-001 - Assessment of immunogenicity - Assessment of hemoglobin (Hb) change - Assessment of red blood cell (RBC) count change - Assessment of reticulocyte (Rtc) count change ### Location - Facility: Shanghai Public Health Clinical Center, Shanghai, N/A, N/A, China @@
## Safety, Tolerability, Immunogenicity and Immunological Mechanisms of TETRALITE, a Novel Seasonal Influenza Vaccine - NCT ID: NCT06294262 - Study ID: 2023-508230-33-00 - Status: RECRUITING - Start Date: 2024-01-29 - Completion Date: 2025-03 - Lead Sponsor: LiteVax BV ### Study Description The effect of LiteVax Adjuvant supplemented to licensed seasonal influenza vaccine on safety and immunogenicity will be investigated in both younger and older healthy participants. Local and systemic adverse events, and humoral and cellular immune responses will be determined at different time intervals after a single administration. Mode of action of LiteVax Adjuvant will examined by detailed genetic analysis and omics approaches such as transcriptomics, proteomics and metabolomics. ### Conditions - Vaccination Reaction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - TETRALITE ### Outcomes Primary Outcomes - Characterise local and systemic AEs, and SAEs, pIMDs and AESIs to TETRALITE - Characterise clinical hematology and biochemistry to TETRALITE Secondary Outcomes - Characterise HI antibody response to the four vaccine strains of TETRALITE in serum - Characterise MN antibody response to the four vaccine strains of TETRALITE in serum ### Location - Facility: University Hospital Gent, Ghent, N/A, 9000, Belgium @@
## Pain Severity in Flapless Dental Implant Placement Using Laser - NCT ID: NCT06294249 - Study ID: 20045125 - Status: COMPLETED - Start Date: 2020-01-01 - Completion Date: 2023-12-04 - Lead Sponsor: Shiraz University of Medical Sciences ### Study Description The goal of this split-mouth randomized clinical trial study was to investigate the effect of using a laser on pain and discomfort following flapless dental implant surgery. It was hypothesized that laser did not have any impact on post-op pain. Therefore, the study aimed to compare pain and discomfort following flapless dental implant surgeries with or without a laser. ### Conditions - Jaw, Edentulous, Partially ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Laser-induced Incision - Punch Incision - Implant Placement ### Outcomes Primary Outcomes - Pain Severity Secondary Outcomes ### Location - Facility: shiraz University of medical sciences, Shiraz, Fars, N/A, Iran, Islamic Republic of @@
## Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM) - NCT ID: NCT06294236 - Study ID: SC291-102 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2028-03 - Lead Sponsor: Sana Biotechnology ### Study Description SC291-102 is a Phase 1 study to evaluate SC291 safety and tolerability, preliminary clinical response, cellular kinetics and exploratory assessments for subjects with severe autoimmune diseases. ### Conditions - Lupus Erythematosus - Systemic Lupus Erythematosus - SLE (Systemic Lupus) - Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis - Granulomatous Polyangiitis - Microscopic Polyangiitis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - SC291 ### Outcomes Primary Outcomes - Evaluate safety and tolerability of SC291 Secondary Outcomes - Evaluate preliminary clinical response to SC291 - Evaluate preliminary clinical response to SC291 - Evaluate preliminary clinical response to SC291 - Evaluate preliminary clinical response to SC291 - Evaluate preliminary clinical response to SC291 (LN and ERL Cohorts) - Evaluate preliminary clinical response to SC291 (LN Cohort) - Evaluate preliminary clinical response to SC291 (ERL Cohort) - Evaluate preliminary clinical response to SC291 (AAV Cohort) - Evaluate preliminary clinical response to SC291 (AAV Cohort) - Evaluate cellular kinetics and persistence of SC291 ### Location - Facility: Swedish Medical Center, Seattle, Washington, 98122, United States @@
## Upper Extremity and Muscle Oxygenation - NCT ID: NCT06294223 - Study ID: SaglikBilU - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-01 - Lead Sponsor: Saglik Bilimleri Universitesi ### Study Description The aim of this study was to measure the acute change in oxygen saturation of skeletal muscle during resistance exercise in the upper extremity using near-infrared spectroscopy. ### Conditions - Near-infrared Spectroscopy - Muscle Oxygenation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Exercise follow up with near-infrared spectroscopy ### Outcomes Primary Outcomes - Determination of Blood Pressure - Saturation Measurement - Muscle Oxygenation Measurement - Determination of Heart Rate Secondary Outcomes ### Location - Facility: Saglik Bilimleri University, Istanbul, N/A, 34010, Turkey @@
## Supporting Secondary School Student Wellbeing Through a Mobile App and Wearable Biofeedback - NCT ID: NCT06294210 - Study ID: REC202307012 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-11 - Completion Date: 2025-07-01 - Lead Sponsor: Royal College of Surgeons, Ireland ### Study Description This study aims to investigate the effects of an app and wearable device on the wellbeing of secondary school students. The app will offer support for stress management, sleep improvement, and time management. Additionally, it will provide access to educational resources, text-based coaching, and biofeedback monitoring through the wearable device. The device, worn around the wrist, will measure heart rate variability as an indicator of stress response. Throughout the study, students will complete bi-monthly surveys on sleep, stress, and overall wellbeing. To assess the specific impact of each feature, the app features will be released incrementally over the course of a year. The intervention group, comprising students in their last two years of secondary school, will have access to the app and wearable device, while a control group within the same class will not use the system but will complete the same wellness surveys. Coaches on this platform will come from the Centre for Positive Health Sciences MSc in Positive Health Coaching as part of their continued training in coaching. Coaching will be asynchronous so that students can post questions at any time during the day, but coaches will respond within 24 hours, during office hours. It will be made clear that this is not a therapeutic service and will be directed to other resources for these services. Coaches will file an incident report if a risk arises from a message with participants. Participants will be given guidelines for the type of questions they can ask such as asking for advice for setting goals related to their digital habits and sleeping better. The study\'s findings will provide valuable insights into the effectiveness of the app and wearable device in enhancing student wellbeing leading up to their leaving certification exams. ### Conditions - No Disease or Condition is Being Studied - Stress Psychological - Overall Wellness ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Mobile app and wrist-worn monitor ### Outcomes Primary Outcomes - Wellbeing Survey Results Secondary Outcomes - Heart Rate Variability Metrics - Routine check-ins - App Engagement ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Examination of the Effects of Pelvic Floor Exercises on Vaginal and Sexual Health in Postmenopausal Women. - NCT ID: NCT06294197 - Study ID: PhD Thesis - Status: RECRUITING - Start Date: 2024-01-13 - Completion Date: 2024-12-13 - Lead Sponsor: Hatice Gulsah Kurne ### Study Description The purpose of this study; To investigate the effects of pelvic floor muscle exercises on vaginal and sexual health in postmenopausal women. Vaginal symptoms such as vaginal dryness, burning and dyspareunia occur in the postmenopausal period. Vaginal symptoms affect sexual function, leading to a decrease in quality of life. In our study, we plan to evaluate vaginal dryness, one of the vaginal symptoms, using Schirmer's Test. Also in our study; Severities of vaginal dryness, burning and dyspareunia will be evaluated with the visual analog scale (VAS), sexual function will be evaluated with the Post-Menopausal Sexuality Questionnaire and Female Sexual Function Scale, vaginal aging will be evaluated with the Daily Effect of Vaginal Aging Scale, and the presence/severity of pelvic floor symptoms will be evaluated with the Pelvic Floor Distress Inventory-20. The cases will be randomized into two groups and pelvic floor exercises will be given to one group. After the exercises are given, vaginal pH and moistness will be evaluated for acute effect. In the other group, vaginal PH and moisture will be measured after 5 minutes. The cases will be followed without any intervention to the control group. After 12 weeks, the same evaluations will be made to both groups and the results will be compared. The data will be compared using appropriate statistical methods (statistical significance value will be taken as p\<0.05) and discussed with the literature. ### Conditions - Sexual Dysfunction - Postmenopausal Symptoms - Pelvic Floor Muscle Weakness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pelvic Floor Exercises ### Outcomes Primary Outcomes - Schirmer's Test Secondary Outcomes - Visual Analogue Scale (VAS) - Female Sexual Function Index (FSFI) - Postmenopausal Sexuality Questionnaire (PMSQ) - Vaginal Daily Impact of Aging Scale (VDIAS) - Disturbing Pelvic Floor Inventory-20 - Evaluation of Pelvic Floor Muscle Strength ### Location - Facility: Istanbul Training and Research Hospital, Istanbul, Fatih, 34098, Turkey @@
## tDCS Interventions for Subthreshold Depressive Symptoms in Young Individuals. - NCT ID: NCT06294184 - Study ID: Guangzhou PH tDCS in SD - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2024-12 - Lead Sponsor: Guangzhou Psychiatric Hospital ### Study Description The purpose of this study is to assess the mechanisms of the effect of transcranial direct current stimulation (tDCS) in alleviating subthreshold depressive symptoms in young individuals, and individualized outcome prediction is carried out. ### Conditions - Subthreshold Depression - Young People - Transcranial Direct Current Stimulation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - tdcs lDLPFC - tdcs rVLPFC - Sham ### Outcomes Primary Outcomes - The effect of tDCS in alleviating subthreshold depressive symptoms Secondary Outcomes - Neuroaffective mechanisms of tDCS in alleviating subthreshold depressive symptoms - To predict the individual effect of tDCS in alleviating subthreshold depressive symptoms ### Location - Facility: Guangzhou Brain hospital(Guangzhou Huiai Hospital), Guangzhou, Guangdong, 510370, China @@
## Efficacy of Modified Piezosurgery Alveolar Bone Cut With Osseodensification Drills in Expanding Narrow Alveolar Bone - NCT ID: NCT06294171 - Study ID: Modified Alveolar Bone Cut - Status: COMPLETED - Start Date: 2022-11-15 - Completion Date: 2023-11-01 - Lead Sponsor: University of Baghdad ### Study Description The aim of the study is to determine the efficacy of modified piezosurgery with osseodensification drills in expanding narrow alveolar bone. ### Conditions - Dental Implant Failed ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - measurement of alveolar ridge width ### Outcomes Primary Outcomes - expansion rate - expansion rate Secondary Outcomes ### Location - Facility: University of Baghdad College of Dentistry, Baghdad, N/A, 10011, Iraq @@
## Light and Noise: Objectively Assessing Environmental Risk Factors for Delirium in the ICU - NCT ID: NCT06294158 - Study ID: LANYARD-ICU-1.1 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-11 - Lead Sponsor: Medical University of Graz ### Study Description Recognition of delirium as a medical entity with relevance to both morbidity and mortality, especially in critically ill patients, is a relatively recent development. However, research into delirium prevention and treatment is now in focus of scientific efforts internationally.Knowledge of intensive care unit (ICU) environment as a potential modifiable risk factor for delirium is insufficient to this date. This study thus seeks to evaluate, whether potentially modifiable environmental factors, such as noise or dazzling, are associated with development of delirium. Knowledge derived from this investigation could change both the process of care provision in intensive care units as well as the design of ICUs in general in the future.This project is planned to be carried out as an observational pilot study at three perioperative ICUs at the University Medical Centre Graz. Adult patients shall be screened for inclusion, if not deeply sedated. Suitable patients shall be included into the study after written informed consent or deferred consent if they can be expected to remain in the ICU for at least another two days, if they are not already in delirium, if the ICU environment is not actively modified for therapeutic reasons and if no treatment limitations are in place. Over a study duration of one year, 250 to 300 patients are expected to be enrolled into the study. Of those, 60 to 120 patients are likely to develop delirium.Baseline data known to be of relevance for outcome prediction in critically ill patients and factors known to predispose for development of delirium during ICU and hospital stay will be collected. Study equipment will be deployed to measure noise levels and illumination repeatedly over the day. Daily assessments for delirium using the Confusion Assessment Method in Intensive Care Units (CAM-ICU) will be performed. Vital status, physiologic parameters and parameters of ongoing treatment will concomitantly be documented on a daily basis.Data on light and noise levels are then to be unified with parameters of physiology and treatment, vital status, and results of daily assessments for delirium. Statistical analysis using methods of descriptive and comparative statistics as well as both unadjusted and adjusted logistic regression analysis will be performed to identify factors significantly associated with the development of delirium (i.e., risk factors). ### Conditions - Delirium - Critical Illness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Brightness measurement - Sound level measurement ### Outcomes Primary Outcomes - Delirium Secondary Outcomes ### Location - Facility: University Medical Centre Graz, Dept. of Anaesthesiology and Intensive Care Medicine, Graz, Styria, 8036, Austria @@
## Effects of a Wellbeing Intervention on Inflammation Through Reward and Threat Processes - NCT ID: NCT06294145 - Study ID: U24AG072699 - Status: RECRUITING - Start Date: 2024-02-07 - Completion Date: 2025-01-31 - Lead Sponsor: University of California, Los Angeles ### Study Description This study aims to evaluate how savoring influences reward and threat processes and downstream inflammation. Savoring is designed to enhance positive affect, which may blunt stress responses and reduce downstream inflammation. The investigators aim to examine changes in the brain following the savoring intervention. The investigators are particularly interested in changes in brain activity that are correlated with changes in inflammation-related markers in the blood. In this single-armed pilot trial, the investigators will assess how savoring alters reactivity to rewarding and threatening experiences, and then examine related changes in downstream inflammation. The investigators intend to recruit 20 undergraduate students to complete a 7-week standardized savoring intervention. Participants will complete brain scans, daily diaries, questionnaires, a behavioral task, and blood collection at pre- and post-intervention assessments. ### Conditions - Low Positive Affect ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Savoring Intervention ### Outcomes Primary Outcomes - Positive affect Secondary Outcomes - Negative affect - Depression - Anxiety - Perceived stress - Psychological wellbeing - Emotions - Reward - Savoring strategies - Interoception - Inflammation - Sustained Attention - Neural Reward Activity - Neural Threat Activity - Daily diary ### Location - Facility: University of California, Los Angeles, Los Angeles, California, 90095, United States @@
## Effect of Lumbar Manipulation on Intervertebral Motion, Pain, and Disability - NCT ID: NCT06294132 - Study ID: 4016601 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2024-10-28 - Lead Sponsor: Ithaca College ### Study Description Background / Purpose:There is an ongoing debate regarding the ability of physical therapists to manually sense intervertebral motion. Physical therapists use intervertebral hypomobility as a clinical indicator for spinal manipulation. Also in question is the mechanism of improvement observed after spinal manipulation. Some argue that the improvement is purely neurophysiologic and unrelated to changes in intervertebral motion. This study aimed to determine the diagnostic accuracy of a physical therapist's manual assessment of lumbar intervertebral motion compared to ultrasound imaging and the effect of lumbar manipulation on intervertebral motion, pain, and disability,Methods:Subjects will complete a Numeric Pain Rating Scale (NPR),Oswestry Disability Index (ODI), and a Central Sensitization Inventory before arriving for the study via Qualtrics survey tool. They will be screened for contraindications to manipulation and neurological signs and symptoms. Active forward bending will be quantified by measuring the distance of the subject's fingertips to the floor. Two experienced physical therapists will evaluate the subject's lumbar intervertebral mobility. They will identify the lumbar segment with the least motion or hypomobility. The subjects will be imaged from L1 to S1 with a 5 MHz curvilinear transducer (Edge II MSK ultrasound unit, SonoSite, Inc, Bothell, WA) in the sidlying position with their trunk and hips flexed to end-range. The examiner will save the sagittal image and then place a digital caliper to measure the distance between the spinous processes from the peak of the hyperechoic curvature of the caudal spinous process to the peak of the hyperechoic curvature of the cranial spinous process of each lumbar segment (L5-S1, L4-L5, L3-L2,L2-L1). Subjects will then be randomized to receive a high-velocity low amplitude thrust manipulation or a sham manipulation. The lumbar spine will be reimaged. The ultrasound examiner will be blinded to the manipulation and the caliper measurements. Finally, subjects will be asked for their Global Rating of Change (GROC) and to actively bend forward to remeasure the distance of their fingertips to the floor. One week later, patients will receive an e-mail containing links to repeat the NPR, GROC, and ODI. ### Conditions - Low Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lumbar Manipulation - Sham Lumbar Manipulation ### Outcomes Primary Outcomes - Diagnostic Ultrasound Secondary Outcomes - Trunk Flexion Range Of Motion Measurement - Oswestry Disability Questionnaire - Numeric Pain Rating Scale - Global Rating of Change ### Location - Facility: Ithaca College, Ithaca, New York, 14850, United States @@
## Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay - NCT ID: NCT06294119 - Study ID: MANCAVA - Status: RECRUITING - Start Date: 2024-02-08 - Completion Date: 2026-02-08 - Lead Sponsor: IRCCS Policlinico S. Donato ### Study Description MANCAVA sets out fundamental methodologies for characterizing human fundamental physiological system interactions at a whole-body level, particularly focusing on the interplay among cortical brain activity, autonomic function, and cerebrovascular autoregulatory mechanisms. By investigating the complex, time-varying mechanisms underlying the multisystem dynamic interactions, novel methods linking various brain areas and reflex functions to target organs and districts such as heart and circulatory system are proposed with the clinical aim linked to the emerging topic of depression.In this scenario, proper new mathematical tools will allow a significant leap from the current state of the art, paving the way towards a new understanding of leading comorbid contributors to global diseases such as cardiac and cerebrovascular morbidity in mood disorders. In turn, this will provide an integration among physiological and psychological dimensions for a more holistic view on depression.Researchers, professionals, and patients will all benefit from a comprehensive assessment of brain-mind-body interplay, leading to the new extended definition of default mode/mood network, neurovascular-evoked responses to autonomic stimuli, brain-autonomic consequences of emotional responses, and physiological substrates of depressive states. ### Conditions - Cardiac Disease - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Major Cardiac surgery ### Outcomes Primary Outcomes - Autoregulation index (ARI) - number of patients developing depression - Baroreflex sensitivity - Cortical activity Secondary Outcomes ### Location - Facility: IRCCS Policlinico San Donato, San Donato Milanese, Milan, 20097, Italy @@
## eTMS for Veterans and First Responders With PTSD - NCT ID: NCT06294106 - Study ID: 24-212 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: Virginia Polytechnic Institute and State University ### Study Description A battery of physiological and behavioral data will be collected before and after application of eTMS. Participants will be veterans or first responders diagnosed with PTSD. Study will be a double-blind, sham-controlled, parallel group, randomized clinical trial. ### Conditions - Post Traumatic Stress Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS) ### Outcomes Primary Outcomes - Adverse Events - Report of Symptoms Secondary Outcomes - PCL-5 ### Location - Facility: Fralin Biomedical Research Institute, Roanoke, Virginia, 24016, United States @@
## Differences Between Long Distance Road Runners and Treadmill Runners in Achilles Tendon Structure - NCT ID: NCT06294093 - Study ID: 026/24 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-02-15 - Lead Sponsor: University of Haifa ### Study Description this study will investigate the structure of the Achilles tendon and functional tests in road runners compared to treadmill runners. ### Conditions - Achilles Tendon Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - ultrasound tissue characterized - Balance test - Proprioception test - muscle strength test - endurance test gastrocnemius muscle Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Dance and Tai Chi on Balance and Wellbeing on Healthy Adults - NCT ID: NCT06294080 - Study ID: DfH2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2025-01 - Lead Sponsor: University of Wolverhampton ### Study Description The aim of the proposed randomised controlled study is to compare the effects and efficacy between a dance, a Tai Chi and a waiting list control group intervention over an eight-week period on physical functions and mental benefits among non-clinical adults aged between 18 and 59. The study's primary outcome is mental wellbeing and secondary parameters are physical functional and mood. A tertiary outcome will examine how the physical and mental parameters change during the learning and practice phases ### Conditions - General Population ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Dance - Tai Chi ### Outcomes Primary Outcomes - Well-being Secondary Outcomes - Leg strength - Balance - Mood ### Location - Facility: University of Wolverhampton, Walsall, West Midlands, WS1 3BD, United Kingdom @@
## A Dose Response Investigation of Docosahexaenoic Acid (DHA) - NCT ID: NCT06294067 - Study ID: 43261 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2025-09 - Lead Sponsor: University of Toronto ### Study Description Docosahexaenoic acid (DHA) is an omega-3 polyunsaturated fatty acid (n-3 PUFA), commonly consumed from fish, that regulates many critical functions within the body including the brain, eye, and heart. While the metabolic precursor to DHA, alpha-linolenic acid (ALA) is considered nutritionally essential and has a set Dietary Reference Intake (DRI), DHA has not yet been deemed essential and does not have a set DRI. Currently, research suggests an intake range of dietary DHA to be anywhere from 0 to over 500mg/d. The aim of our study is to further investigate a feedback mechanism or accumulation that occurs with eicosapentaenoic acid (EPA) as a result of increased dietary DHA to provide insight for potential Recommended Dietary Intake (RDI) values.Hypothesis: The dietary DHA dose at which blood EPA levels increase is the point at which elongation slows, indicating a significant negative feedback pathway is present.Objectives: 1: To determine the dose-response for DHA to increase blood EPA levels in a mixed vegetarian and vegan population. 2: Investigate the DHA dose and time at dose that increases EPA using natural abundance delta carbon-13 (δ13C) as a tracer. 3: To measure DHA turnover and loss rates. 4: Provide data for exploratory analyses related to PUFA metabolism and the effect of DHA on disease related biomarkers.Method: During an 8-week trial, 72 healthy vegan or vegetarian males and females (18-50 years) will be supplemented with 1 of 6 algal-oil based DHA doses: 0, 100, 200, 400, 800 or 1000 mg/d. Blood will be collected at days 0, 3, 7, 14, 28 and 56 and will be analyzed for changes in blood EPA levels as the primary outcome and plasma δ13C EPA signature as the secondary outcome.Significance: Investigating this negative feedback pathway is of great importance in providing evidence to support n-3 PUFA DRIs. EPA and DHA are ecologically sensitive with their major source coming from unsustainably farmed fish stocks and having a set DRI may help to limit the overconsumption of these nutrients. ### Conditions - Nutrition, Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - docosahexaenoic acid (DHA) - soybean oil placebo ### Outcomes Primary Outcomes - Changes in omega-3 polyunsaturated fatty acid (n-3 PUFA) blood levels Secondary Outcomes - Changes in the delta carbon 13 (δ13C) n-3 PUFA signatures - Measure of n-3 LC PUFA turnover rates - Measure of n-3 LC PUFA half-lives ### Location - Facility: Clinical Nutrition and Risk Factor Modification Centre, Toronto, Ontario, M5C 2T2, Canada @@
## Bladder Cancer and Neoadjuvant Chemotherapy Efficiency Before Cystectomy - NCT ID: NCT06294054 - Study ID: 2021/0393/HP - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-04-01 - Completion Date: 2026-03-31 - Lead Sponsor: University Hospital, Rouen ### Study Description This study will allow the investigators to better assess the efficiency of neoadjuvant chemotherapy before cystectomy by training a predictive model on different patient cohorts with bladder cancer. ### Conditions - Bladder Cancer - Genomic Instability ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - neoadjuvant chemotherapy with cisplatine ### Outcomes Primary Outcomes - Progression-free survival Secondary Outcomes - Overall survival ### Location - Facility: Centre de lutte contre le cancer François Baclesse, Caen, N/A, N/A, France @@
## INvestigating the Value of Early Sleep Therapy - NCT ID: NCT06294041 - Study ID: UEC23/52 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-06-01 - Lead Sponsor: University of Strathclyde ### Study Description Twenty percent of breast cancer survivors have insomnia, which is defined as persistent trouble falling and/or staying asleep that results in difficulty functioning during the day. Sleep difficulties often begin at cancer diagnosis, become worse during cancer treatment, and continue into cancer survivorship. Insomnia interferes with daily activities and may cause other mental and physical health problems. It also makes it more difficult to cope with cancer treatment and makes recovery more challenging. For these reasons, it is important to address early signs of sleep problems in cancer patients by offering interventions that may prevent the development of insomnia.Sleep Restriction Therapy is one such intervention, which helps improve night-time sleep by stabilising sleep patterns and reducing time spent in bed awake. Sleep Restriction Therapy has been used successfully to treat chronic insomnia in breast cancer survivors who have completed cancer treatment. However, it has never been tested on newly diagnosed breast cancer patients with early signs of sleep disturbance, who are undergoing cancer treatment.This study will address this knowledge gap by randomly assigning newly diagnosed patients with poor sleep to receive either Sleep Restriction Therapy or a sleep hygiene education (SHE) control intervention. The study will assess sleep and mental health before and after both interventions to determine how feasible and acceptable Sleep Restriction Therapy is to patients and to plan for a future, larger study. Throughout, the investigators will work with patients with lived experience of breast cancer and poor sleep to ensure our study is informed by their expertise. ### Conditions - Acute Insomnia (Disorder) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Sleep Restriction Therapy (SRT) - Sleep Hygiene Education (SHE) ### Outcomes Primary Outcomes - Recruitment rates - Retention rates - Intervention fidelity: Therapist adherence - Intervention fidelity: Patient engagement - Intervention fidelity: Control group contamination - Outcome measure completion - Intervention acceptability Secondary Outcomes - Improvement in insomnia severity - Improvement in mental health [depression] - Improvement in mental health [anxiety] - Improvement in rest-activity rhythms [fatigue]Fatigue (FACT-F) - Improvement in rest-activity rhythms - Improvement in sleep [estimates of subjective sleep] - Measure of health related quality of life ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease With Minimally Impaired Ejection Fraction - NCT ID: NCT06294028 - Study ID: RC31/21/0338 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2029-12-31 - Lead Sponsor: University Hospital, Toulouse ### Study Description Evidence for the usefulness of the defibrillator in cases of preserved left ventricular ejection fraction and well-tolerated ventricular tachycardia (without cardiocirculatory arrest or syncope) is lacking, as no previous trials have included such patients. Additionally, sudden death in this particular population is low compared to other subgroups of patients with malignant ventricular arrhythmias.On the other hand, numerous recent retrospective data show that ablation of ventricular tachycardia can reduce mortality, and also clearly reduces the number of recurrences in prospective studies.Finally, a very low rate of sudden death was observed in a multicenter European retrospective study that we conducted, including patients with well-tolerated ventricular tachycardia in structural heart disease with minimally impaired ejection fraction and benefiting from ablation without implantation of defibrillator. ### Conditions - Ischemic Heart Disease - Ventricular Tachycardia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Adverse events collection - Quality of life questionnaire EQ-5D-5L - Medical-economic evaluation ### Outcomes Primary Outcomes - Monitoring for the occurrence of at least one serious event during the 36 months of follow-up Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy of 20% Autologous Serum Drops in the Treatment of Corneal Epitheliopathy Associated With Antihypertensive Glaucoma Drops. - NCT ID: NCT06294015 - Study ID: 2023-5009 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-04 - Lead Sponsor: Université de Sherbrooke ### Study Description Introduction: Glaucoma is the second leading cause of blindness globally. Most anti-hypertensive drops contain preservatives harmful to the corneal epithelium, with up to 78% of treated patients reporting dry eye symptoms. Autologous serum eye drops (ASED), contains essential growth factors and nutrients which may promote corneal and conjunctival integrity, offering benefits over traditional treatments. This study investigates the efficacy of 20% ASED over placebo in the treatment of corneal epitheliopathies in patients with glaucoma treated with antihypertensive drops.Methods: The present study is a triple-blinded, randomized controlled trial that anticipates to enroll 25 patients (50 eyes) with bilateral corneal epitheliopathy secondary to antihypertensive glaucoma treatments. Patients will receive autologous serum eye drops in one eye and placebo in the contralateral eye for two months, in addition to standard artificial tears treatment.The primary outcome is the comparison of National Eye Institute (NEI) scores between autologous serum drops and placebo-treated eyes at two months. Secondary outcomes include Schirmer's test scores, visual acuity, tear break-up time (TBUT), Ocular Surface Disease Index (OSDI) scores, intraocular pressure, and complication rates.The study aims to analyze the effectiveness of autologous serum eye drops in treating corneal epitheliopathies in glaucoma patients, potentially offering a new therapeutic avenue. ### Conditions - Corneal Epitheliopathy - Glaucoma - Corneal Disease - Dry Eye ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 20% ASED + AT - 0.9% NS + AT ### Outcomes Primary Outcomes - National Eye Index Scores Secondary Outcomes - Schirmer Test - Visual Acuity - Tear Break Up Time - Ocular Surface Disease Index - Intraocular Pressure - Complication rates ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Neuromuscular Training & Postural Stability - NCT ID: NCT06294002 - Study ID: 46-06-04/2020-1 - Status: COMPLETED - Start Date: 2022-02-15 - Completion Date: 2022-06-25 - Lead Sponsor: University of Novi Sad ### Study Description Background: Postural stability (PS) is a vital function that helps maintain equilibrium during standing still, locomotion, and any activities requiring high balance performance. Under static and dynamic conditions, PS is a fundamental factor for the quality of movement in everyday activities or sports. PS and adaptive ability are required in sports due to the interactions between the sensory and motor systems, which regulate postural adjustments by processing information from the visual, vestibular, and somatosensory systems, as reported by previous studies. The interest in using different exercises and protocols for improving PS in sports and physiotherapy has grown in the last few decades. Experts have proposed various training modalities to increase neuromuscular stability, balance, postural control, and general stability. Dynamic Neuromuscular Stabilization (DNS) is a complex of correction exercises with a neuromuscular approach based on improving breathing, fundamental movements, and principles of developmental kinesiology. Whole body vibration training (WBV) is a neuromuscular training approach that has recently become very popular among researchers and practitioners in health and sport. It is usually used as an additional method in a conventional training routine. Designing the training program to achieve the optimal benefits for PS in healthy young adults is important in general personal health management. Although different training protocols have improved PS and general stability in everyday activities, there is still considerable debate regarding the optimal exercise modalities within an exercise program. Aim: The purpose of this study is to determine the effects of dynamic neuromuscular stabilisation (DNS), whole-body vibration (WBV), and a combination of DNS and WBV (MIX) training modalities on postural stability (PS) in healthy recreation participants. Method and materials: 180 gender-balanced groups were divided into four groups, MIX, DNS, VIBRO and CONTROL and underwent two months of treatment. The single and double-leg Center of Force (COF) parameters were collected on the Forceplate. ### Conditions - Postural Stability ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Dynamic neuromuscular stabilisation group - Whole body vibration group - Dynamic neuromuscular stabilisation with whole body vibration group ### Outcomes Primary Outcomes - Double-leg static postural stability sway area - Double-leg static postural stability center of force traveled way - Double-leg static postural stability medio-lateral displacement - Double-leg static postural stability anterior-posterior displacement - Single-leg static postural stability sway area - Single-leg static postural stability center of force traveled way - Single-leg static postural stability anterior-posterior displacement - Single-leg static postural stability medio-lateral displacement Secondary Outcomes - Sex - Date of birth - Weight - Height - Body Mass Index (BMI) - Adherence ### Location - Facility: Faculty of sport and Physical Education, University of Novi Sad, Novi Sad, Vojvodina, 21000, Serbia @@
## Efficacy and Safety of Intravenous Diazepam Given at 2 Different Doses Compared to Placebo in Acute Peripheral Vertigo - NCT ID: NCT06293989 - Study ID: Emergency department - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-03-30 - Lead Sponsor: University of Monastir ### Study Description This is prospective, randomised double-blind study that will be conducted in the emergency department of 3 university hospitals (FB Monastir, Sahloul Sousse, and FH Sousse) to compare the efficacy of two doses of diazepam (Valium®) and placebo for the relief of acute periphery vertigo in the ED ### Conditions - Vertigo, Peripheral ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Diazepam 5mg - Diazepam 10 mg - Placebo ### Outcomes Primary Outcomes - Visual analogue scale (VAS)-3H Secondary Outcomes - the Delta-VAS - the time required to reach the resolution of the vertigo crisis - Patients satisfaction - number of patients with adverse effects ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Susceptibility for Entrainment: Role of Ventilator Settings on the Occurrence of Reverse Triggering and Its Physiological Consequences - the SEVeRe Study - NCT ID: NCT06293976 - Study ID: 4506 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-03-01 - Lead Sponsor: Unity Health Toronto ### Study Description Background: Reverse triggering (RT) is a frequent phenomenon observed in sedated patients under a mechanical ventilation mode called assist-control ventilation. RT is when the ventilator would trigger the patient's respiratory effort instead of the correct order of the patient's respiratory effort triggering the ventilator. Reverse triggering can have negative consequences (loss of protective lung ventilation, and causing double breaths - with the ventilator giving two consecutive breaths and not allowing the patient to exhale) but also offer some protective effects (avoid diaphragm disuse atrophy). The balance of its negative vs positive effects depends on its frequency and magnitude of its associated respiratory effort. Respiratory entrainment is the most often referred mechanism involving a change in patient's rate of breathing effort from that of patient's intrinsic rate to the rate of mechanical insufflation. The specific ventilatory settings associated with or responsible for RT remains unknown.Aims: To assess in mechanically ventilated critically ill patients the influence of the set respiratory rate (RR) and tidal volume (Vt) on the presence/development of RT and to describe the pattern of respiratory muscle activity during Reverse Triggering (RT).Methods. 30 adult patients (15 in each group), sedated and under assist-controlled ventilation will be included. Ventilator settings will be modified to modulate the frequency and magnitude of reverse triggering. Initially, with the ventilator on a mode called volume control, which means the ventilator controls the amount of air (tidal volume) and the number of breaths the patients gets every minute (respiratory rate \[RR\]). The tidal volume will be set at the current standard clinical practice setting (6 ml/kg of predicted body weight). The presence of an intrinsic respiratory rate will be assessed with an end-expiratory occlusion maneuver. Next, the number of breaths the ventilator gives per minute (RR) will be changed from 6 breaths less to 6 breaths more, in steps of 2 breaths every minute. The protocol will be repeated again changing the amount of air the patients gets (tidal volume) from 4, 5, 7 and 8 ml/kg. Continuous recordings of airway pressure, flow, esophageal pressure, electrical activity of the diaphragm, main accessory muscles and frontal electroencephalography will be obtained during the protocol and baseline clinical and physiological characteristics and outcomes will be recorded. A validated software will be used to detect RT and measure the intensity and timing of each muscle electrical activity and the magnitude of the inspiratory effort during RT. ### Conditions - Respiration, Artificial - Reverse Triggering ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Changes in the ventilator respiratory rate and tidal volume ### Outcomes Primary Outcomes - The rate of of reverse triggered breaths occurring after each change in the ventilator respiratory rate and tidal volume. - The magnitude of the effort, measured by the drop in the esophageal pressure in cmH2O, associated with the reverse triggered breaths after each change in the ventilator respiratory rate and tidal volume Secondary Outcomes ### Location - Facility: Unity Health Toronto - St. Michael's Hospital, Toronto, Ontario, M5B 1T8, Canada @@
## Front-of-package Label Effects in Latine and Limited English Proficiency Populations - NCT ID: NCT06293963 - Study ID: 24-0300a - Status: NOT_YET_RECRUITING - Start Date: 2024-03-29 - Completion Date: 2024-04-15 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description The goal of this experiment is to examine the effects of 4 types of front-of-package food labels among a sample of Latino adults. The main questions this experiment aims to answer are:What front-of-package label design is most effective in helping Latino and low English proficiency consumers identify healthier and less healthy food products?What front-of-package label design is most effective in helping Latino and low English proficiency consumers choose healthier food products?Additionally, this experiment also aims to answer the following question:Do the benefits of front-of-package label designs differ by English proficiency and parental status?Participants will be randomly assigned to 1 of 4 types of front-of-package label designs and view their assigned label design on 3 sets of products. Each set will display 3 similar products, each high in either 1, 2, or 3 nutrients of concern. For each set, participants will select the product that they believe to be the healthiest, least healthy, and the product that they would most want to consume. Researchers will compare results across label designs. ### Conditions - Diet, Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Guideline Daily Amounts label - Interpretive text-only label - Interpretive magnifying glass icon label - Separated interpretive magnifying glass icon label ### Outcomes Primary Outcomes - Selection of healthiest product for purchase Secondary Outcomes - Correct identification of healthiest product - Correct identification of least healthy product - Correct identification of products high in nutrients ### Location - Facility: The University of North Carolina at Chapel Hill's Gillings School of Global Public Health, Chapel Hill, North Carolina, 27599, United States @@
## Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism - NCT ID: NCT06293950 - Study ID: AUTISM - Status: RECRUITING - Start Date: 2022-03-09 - Completion Date: 2024-12 - Lead Sponsor: University of Jordan ### Study Description Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities. ### Conditions - Autism ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - WJMSC ### Outcomes Primary Outcomes - safety profile lab tests Secondary Outcomes - efficacy change in Adult ADHD Self-Report Scale (ASRS) ### Location - Facility: Cell Therapy Center, Amman, N/A, 00962, Jordan @@
## Impact of Front-of-package Labels on Weight Bias Among Latines - NCT ID: NCT06293937 - Study ID: 24-0300b - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-04-30 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description The goal of this experiment is to examine the effects on explicit weight bias of a selection task using 4 different types of front-of-package food labels to select healthy or unhealthy foods among a sample of Latine and low English proficiency adults. The main questions this experiment aims to answer are:* Does the use of different front-of-package label designs in a selection task lead to different effects on explicit weight bias among Latine and low English proficiency consumers?* Does the use of different front-of-package label designs in a selection task lead to different effects on attribution of personal responsibility for body weight among Latine and low English proficiency consumers?Participants will be randomly assigned to 1 of 4 types of front-of-package label designs. They will view 3 sets of products (frozen meals, frozen pizzas, and frozen desserts), shown in random order. For each product set, participants will view 3 products shown in random arrangement, each with participants' randomly assigned label shown on the front of package. After viewing all 3 product types, participants will answer questions about explicit weight bias and attribution of responsibility for body weight. Researchers will compare results across label designs. ### Conditions - Weight Prejudice ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Numerical label - Interpretive text-only label - Interpretive magnifying glass icon label - Separated interpretive magnifying glass icon label ### Outcomes Primary Outcomes - Explicit weight bias, mean score Secondary Outcomes - Attribution of personal responsibility for body weight, mean score ### Location - Facility: The University of North Carolina at Chapel Hill's Gillings School of Global Public Health, Chapel Hill, North Carolina, 27599, United States @@
## Pericardial Fluid Analysis in Recurrent Pericarditis - NCT ID: NCT06293924 - Study ID: The PEFLANA Trial - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2031-02 - Lead Sponsor: ASST Fatebenefratelli Sacco ### Study Description This clinical trial aims to examine the biochemical and cytological features of pericardial effusion during acute and recurrent pericarditis and to understand the molecular factors responsible for pathogenesis. The primary objective of this study is to identify and validate diagnostic criteria in pericardial fluid analysis that can differentiate patients with acute and recurrent pericarditis from those with only pericardial fluid but no inflammation.This study will enroll patients with acute pericarditis who require pericardiocentesis for either diagnostic or therapeutic purposes. Two control groups will also be included: one consisting of patients who need cardiac surgery with a collection of pericardial fluid, and the other consisting of patients who require pericardiocentesis for non-inflammatory pericardial effusion. The purpose of the study is to compare the cell activation status and cytokines present in pericardial fluid during acute pericarditis with those present during other pericardial pathologies. ### Conditions - Acute Pericarditis - Pericardial Effusion - Pericardial Disease - Pericardial Fluid Exudate - Autoinflammatory Disorders - Autoinflammatory Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pericardiocentesis - Pericardiotomy - Cytofluorometry and Gene expression analysis ### Outcomes Primary Outcomes - Differences in cell counts among inflammatory and non-inflammatory pericardial effusion. - Difference in biochemical parameters among inflammatory and non-inflammatory pericardial effusion Secondary Outcomes - Difference of IL-1 expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion - Differences of inflammatory cytokine expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion - Differences of gene expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion - Differences of gene expression in pericardial fluid and blood cells during pericarditis - Differences in cytokine and other molecule concentrations between pericardial fluid and blood cells in pericarditis - Correlation of inflammatory mediators in pericardial fluid and clinical features during pericarditis ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Comparison of a Postbiotic-gel With Placebo Gel for Gingival Inflammation in Patients With Down Syndrome - NCT ID: NCT06293911 - Study ID: 2024-POSTBIOTICSDOWNSYNDROME - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-15 - Completion Date: 2025-07-28 - Lead Sponsor: University of Pavia ### Study Description The aim of the study is to evaluate the efficacy of home treatment with a postbiotic-based gel for the management of periodontal inflammation in patients with Down syndrome.Patients will be enrolled at the S.C. Odontostomatologia dell'Azienda Ospedaliera "Ordine Mauriziano di Torino", Turin, Italy. After the collection of the periodontal clinical indexes (BoP%, PCR%, dental mobility, mMGI, compliance and satisfaction questionnaire), patients will undergo a professional mechanical debridement with ultrasonic instruments and glycine powders.Then, they will be randomly divided into two groups according to the home treatment:* in the Trial group Biorepair Plus Parodontgel Intensive (containing microRepair®, hyaluronic acid, Lactobacillus Ferment and Aloe Barbadensis Leaf Juice Powder) will be used once a day for all the duration of the study* in the Control group, a placebo gel without (active ingredients) will be used once a day for all the duration of the study.Indexes will be re-evaluated after 1 (T1), 3 (T2) and 6 months. The professional mechanical debridement will be performed again at T3 timepoint. ### Conditions - Down Syndrome - Gingival Bleeding ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Biorepair Plus Parodontgel Intensive - Placebo gel ### Outcomes Primary Outcomes - Change in Bleeding on Probing (BOP%) - Change in Plaque Control Record (PCR%) - Change in Dental mobility - Change in Modified Gingival Index - Change in compliance - Change in product satisfaction Secondary Outcomes ### Location - Facility: S.C. Odontostomatologia - Azienda Ospedaliera "Ordine Mauriziano di Torino", Turin, N/A, 10128, Italy @@
## Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors - NCT ID: NCT06293898 - Study ID: BL-M07D1-ST-101 - Status: RECRUITING - Start Date: 2024-02-09 - Completion Date: 2027-08-24 - Lead Sponsor: SystImmune Inc. ### Study Description The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors. ### Conditions - Endometrial Cancer - Cervical Cancer - Ovarian Cancer - Urothelial Carcinoma - Biliary Tract Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - BL-M07D1 ### Outcomes Primary Outcomes - Summary of safety - To determine the maximum tolerated dose (MTD) if reached or maximum administered dose (MAD) and two or more recommended doses for dose expansion (RDEs) of BL-M07D1 Secondary Outcomes ### Location - Facility: SystImmune Recruiting Site, Houston, Texas, 77030, United States @@
## Pleurodesis Using Hypertonic Glucose - NCT ID: NCT06293885 - Study ID: PLUG-II - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2025-04-30 - Lead Sponsor: Lawson Health Research Institute ### Study Description Air leaks from unhealed lung tissue following lung resection for benign or malignant lesions are one of the most common complications following thoracic surgery, occurring after 10% of major lung resections. The purpose of this study is to investigate the efficacy of intrapleural administration of Dextrose 50% to resolve air leaks after pulmonary resection. ### Conditions - Air Leak From Lung ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dextrose 50 - Standard of Care - No Dextrose 50 ### Outcomes Primary Outcomes - Prolonged Air Leak Secondary Outcomes - Duration of Chest Tubes - Home with Chest Tube ### Location - Facility: London Health Sciences Centre, London, Ontario, N6A 5W9, Canada @@
## Evaluation of Two Mini-Implant Lengths in the Infra-Zygomatic Crest Region - NCT ID: NCT06293872 - Study ID: IZC miniscrew - Status: COMPLETED - Start Date: 2023-02-25 - Completion Date: 2023-12-28 - Lead Sponsor: University of Baghdad ### Study Description Evaluation of two different lengths of mini-implants in the infrazygomatic area regarding primary stability, pain perception, sinus penetration, secondary stability and failure rate. ### Conditions - Orthodontic Appliance Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 122 mm length miniscrew ### Outcomes Primary Outcomes* - failure rate Secondary Outcomes - primary stability - secondary stability - pain perception ### Location - Facility: University of Baghdad College of Dentistry, Baghdad, N/A, 10011, Iraq @@
## Effect of 12-week Probiotic Consumption Immobilized on Oat Flakes on Blood and Urine Biomarkers and Human Microbiome - NCT ID: NCT06293859 - Study ID: 5047292 - Status: COMPLETED - Start Date: 2023-02-15 - Completion Date: 2023-07-30 - Lead Sponsor: University of the Aegean ### Study Description The purpose of this clinical trial was to evaluate the effects Lactococcus cremoris spp. im-mobilized on oat flakes on human microbiome and blood and urine biomarkers of associated with human health. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Probiotic oat flakes - Conventional oat flakes ### Outcomes Primary Outcomes - Inflammatory biomarkers Secondary Outcomes ### Location - Facility: University of the Aegean, Myrina, Limnos/Lesvos, 81 400, Greece @@

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