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## Exercise in People With Cystic Fibrosis on CFTR Modulator Therapy - NCT ID: NCT06322446 - Study ID: PI23/00299 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2025-12-23 - Lead Sponsor: Universidad Politecnica de Madrid ### Study Description Recently, the treatment of Cystic Fibrosis (CF) incorporated new modulators/enhancers of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR). It is thus increasingly important to study the side effects of these drugs, their extrapulmonary effects and possible interaction with other drugs and with exercise. For this purpose, a randomized controlled trial is proposed to determine the effects of a telematic exercise intervention on muscle health, in a group of 48 children and adolescents with CF treated with these new generation CFTR modulators. They will be randomly assigned to two groups (exercise and control group). The effect of the intervention will be analysed measuring the variables of muscle health, cardiorespiratory fitness, lung function, body composition, inflammatory biomarkers and miRNAs. After completion of the intervention program, adherence to exercise and clinical evolution after one year will be analysed. ### Conditions - Cystic Fibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise ### Outcomes Primary Outcomes - Changes in peripheral muscle strength - Changes in inspiratory/expiratory muscle strength (MIP/MEP) (cmH2O) - Changes in functional capacity: lower limbs power capacity - Changes in functional capacity: walking capacity - Change in Cardiorespiratory fitness: maximal oxygen consumption - Change in Cardiorespiratory fitness: Ventilatory threshold VT1 Secondary Outcomes - Changes in Pulmonary Function: forced vital capacity (FVC) - Changes in Pulmonary Function: Forced expiratory volume in the first second (FEV1) - Changes in the anthropometric and body composition: Weight - Changes in the anthropometric and body composition: Height - Changes in the anthropometric and body composition: BMI - Changes in body composition: Total fat mass - Changes in body composition: FMI - Changes in body composition: lean mass kg - Changes in body composition: lean mass % - Changes in quality of life using the Cystic Fibrosis Questionnaire - Changes in plasma levels muscle damage biomarkers - Changes in plasma levels of inflammation: hs-CRP - Changes in plasma levels of inflammation: Interleukins ### Location - Facility: Facultad de Ciencias de la Actividad Física y Deporte - INEF UPM, Madrid, N/A, 28040, Spain @@
## Follow up of High Myopic Eyes - NCT ID: NCT06322433 - Study ID: 37C301 - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2025-11-01 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description In this non-interventional retrospective and prospective observational study, the long-term evolution of clinical and iconographic characteristics of patients with pathological myopia will be considered Changes of some specific clinical, tomographic and angiographic variables evaluated on the baseline and after a minimum of 5 years follow-up will be studied. ### Conditions - Pathologic Myopia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no drugs used for this study ### Outcomes Primary Outcomes - Proportion of subjects with neovascularization at follow-up visit Secondary Outcomes ### Location - Facility: Istituto Auxologico Italiano IRCCS, Milan, N/A, 20145, Italy @@
## Behavioral Activation for Depression and Habitual Rumination - NCT ID: NCT06322420 - Study ID: MoodHab - Status: RECRUITING - Start Date: 2024-02-09 - Completion Date: 2026-02-01 - Lead Sponsor: Ragnar Pétur Ólafsson ### Study Description Depressive rumination, a negative thinking style characterized by repetitive and passive thoughts about the causes, meanings, and consequences of one's feelings and distress, is often described as being a habitual response tendency that forms a vulnerability to depression. Behavioural Activation (BA) is an effective treatment for depression but little is known of mechanisms of changes during a successful treatment completion and for whom the treatment benefits the most. The main purpose of the study is to investigate whether habit-like mood-reactive rumination will change during Behavioral Activation treatment for current depression and mediates symptom changes in the treatment. Important moderators of change will also be investigated (i.e. history of early life stress and cognitive flexibility). We aim to provide individual BA treatment for up to 130 currently depressed participants in 12 treatment sessions over 11 weeks. Measures are obtained at pre-treatment, during treatment, at post-treatment and at 6 month follow up. ### Conditions - Major Depressive Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Behavioural Activation (BA) ### Outcomes Primary Outcomes - Symptom severity measured by the BDI-2 - Disorder severity assessed with the DIAMOND diagnostic interview - Major Depressive Disorder - Diagnostic status assessed with the DIAMOND diagnostic interview - Major Depressive Episode Secondary Outcomes - Symptom severity measured on the PHQ-9 - Momentary negative and positive affectivity using items from the PANAS (Positive and Negative Affect Schedule) - Diagnostic status assessed with the DIAMOND diagnostic interview at follow -up - Major Depressive Episode - Diagnostic status assessed with the DIAMOND diagnostic interview at follow-up- Major Depressive Disorder - The Quality of Life Scale (QOLS) ### Location - Facility: University of Iceland, Reykjavík, N/A, 102, Iceland @@
## Ultrasound-guided Stellate Ganglion Block for Treatment of Chronic Migraine in Adult - NCT ID: NCT06322407 - Study ID: KY2023-263-03-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-12 - Lead Sponsor: Beijing Tiantan Hospital ### Study Description To assess the 6-months effects and safety of stellate ganglion block(SGB) for Chronic Migraine (CM) patients who failure to undergo preventive therapy and are seeking a more suitable non-pharmacological therapy. ### Conditions - Chronic Migraine ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Stellate Ganglion Block (SGB) - standardized drug treatment ### Outcomes Primary Outcomes - the change from baseline in mean monthly migraine days Secondary Outcomes - Proportion of patients achieved≥50% reduction in monthly migraine days - Total effective rate - The mean Numeric Rating Scale(NRS) score during headache attack - Patients satisfaction (PS) - The six item headache impact test (HIT-6) - the Migraine Disability Assessment score(MIDAS) - The Pittsburgh Sleep Quality Index (PSQI) - adverse events ### Location - Facility: Beijing Tiantan Hospital, Beijing, Beijing, 100050, China @@
## BXOS110 Injection in the Treatment of Acute Ischaemic Stroke - NCT ID: NCT06322394 - Study ID: BXOS110-Ⅱ-2023-12 - Status: RECRUITING - Start Date: 2024-02-07 - Completion Date: 2025-09 - Lead Sponsor: Biocells (Beijing) Biotech Co.,Ltd ### Study Description The purpose of this study was to evaluate the effectiveness of early administration of BXOS110 for injection in reducing overall disability in patients with acute ischaemic stroke. ### Conditions - Acute Ischemic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - high-dose BXOS110 - low-dose BXOS110 - Placebo ### Outcomes Primary Outcomes - Proportion of subjects with mRS score 0-2 on day 90 Secondary Outcomes - Proportion of subjects with mRS score 0-1 on day 90 - Day 90 mRS Displacement Analysis - Proportion of subjects with NIHSS scores ≤1 on day 10 (or at discharge) - Proportion of subjects with a ≥4-point reduction in NIHSS score from baseline at day 10 (or at discharge) - Proportion of subjects with ≥4 point increase in NIHSS score during hospitalisation - Proportion of subjects with Barthel Index Scale (BI) scores ≥95 on day 90 - Day 90 European Five Dimensional Health Scale (EQ-5D) Score - Mortality due to stroke within 90 days - Change in infarct volume from baseline after 24 hours of dosing ### Location - Facility: Yuebei People's Hospital, Shaoguan, Guangdong, N/A, China @@
## Reinsertion Achilles Tendon VS Zadek Osteotomy in Insertional Achilles Tendinopathy - NCT ID: NCT06322381 - Study ID: Reinsertion AT VS ZO in IAT - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-04 - Lead Sponsor: Assiut University ### Study Description The aim of this study is to Compare functional outcome and the recovery time of reinsertion of achilles tendon VS zadek osteotomy in insertional achilles tendinopathy. ### Conditions - Insertional Achilles Tendinopathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Reinsertion achilles tendon - Zadek osteotomy ### Outcomes Primary Outcomes - the time needed to return to normal daily activities (functional outcome) assessed by foot and ankle outcome score. Secondary Outcomes - Pain assessed by the visual analogue scale. - Rate of complications ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Myofunctional and Respiratory Intervention on Phonation in Stroke - NCT ID: NCT06322368 - Study ID: DF002 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2024-07-01 - Lead Sponsor: Universidad de Granada ### Study Description Patients with stroke frequently present phonation difficulties. An intervention combining myofunctional and respiratory training is presented in order to improve phonation outcomes. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Myofunctional and respiratory training program - Range of motion and thermal and mechanical stimulation exercising ### Outcomes Primary Outcomes - Volume during monologue - Frequency during monologue Secondary Outcomes - Volumen during sustained phonation of /s/ sound - Communication effectiveness Index - Frequency during sustained phonation of /s/ sound - Volumen during sustained phonation of /a/ sound - Frequency during sustained phonation of /a/ sound ### Location - Facility: Faculty of Health Sciences, Granada, N/A, 18016, Spain @@
## Comparison of UFR With QFR in Stable Coronary Artery Disease - NCT ID: NCT06322355 - Study ID: ZSUFR01 - Status: COMPLETED - Start Date: 2018-07-01 - Completion Date: 2023-12-31 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description Quantitative flow reserve (QFR), derived from coronary angiography, has shown high accuracy in detecting significant lesions. Ultrasonic flow ratio (UFR), a new development from IVUS, integrates physiological estimation with intravascular imaging. Although both QFR and UFR are effective, there's no conclusive evidence favoring one over the other. The study aims to compare UFR and QFR's diagnostic performance against the conventional FFR standard in detecting significant coronary lesions. ### Conditions - Coronary Artery Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Coronary angiography, Fractional Flow Reserve measurement, Intravascular ultrasound ### Outcomes Primary Outcomes - Compare diagnostic performance of QFR with UFR Secondary Outcomes - Correlation and agreement between QFR and UFR ### Location - Facility: Zhongshan Hospital, Fudan University, Shanghai, N/A, 210000, China @@
## Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent - NCT ID: NCT06322342 - Study ID: RVL-102-23 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-03 - Lead Sponsor: Reveal Pharmaceuticals Inc. ### Study Description The Phase 2 trial will assess safety, tolerability, efficacy, imaging pharmacodynamics, and pharmacokinetics of RVP-001, a novel manganese-based MRI contrast agent, at three escalating dose levels when administered as a single IV bolus to subjects with known gadolinium-enhancing central nervous system (CNS) lesions who have recently had a gadolinium-based contrast agent (GBCA)-enhanced MRI of the brain. ### Conditions - Central Nervous System (CNS) Lesions ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: DIAGNOSTIC ### Interventions - RVP-001 ### Outcomes Primary Outcomes - Adverse Events - Lesion visualization criteria for RVP-001 enhanced MRI compared to unenhanced MRI - Lesion visualization criteria for RVP-001 compared to gadolinium-based contrast agent (GBCA) Secondary Outcomes ### Location - Facility: Yale New Haven Hospital, New Haven, Connecticut, 06510, United States @@
## RealMove (Lung): Assessing Tumour Motion With Dynamic MRI - NCT ID: NCT06322329 - Study ID: K 2023-10103 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2036-03-17 - Lead Sponsor: Region Stockholm ### Study Description The study aims to develop an improved method to tailor the geometric safety margin when treating with stereotactic body radiotherapy (SBRT), to avoid tumour cells being missed during irradiation and to limit the exposure of normal tissues as much as possible. Dynamic magnetic resonance imaging (MRI) is assumed to represent the tumour motion during the respiratory cycle more realistically, compared to 4-dimensional computed tomography (4D CT), thanks to its high temporal resolution and the possibility to image the motion over a longer period of time. Patients receiving SBRT for a pulmonary target located below the level of the carina are included in the study, and the hypothesis will be tested through a comparison of the tumour amplitude measured with each modality. Furthermore, the predictive value of the image series acquired at treatment planning, for the motion patterns observed at each treatment fraction, will be evaluated through repeated 4D CBCT acquisitions. ### Conditions - Lung Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Dynamic MRI ### Outcomes Primary Outcomes - Difference in amplitude of the tumour motion, as assessed by dynamic MRI and 4D CT, respectively - Difference in amplitude of the tumour motion, assessed at different times (using dynamic MRI and 4D CBCT) - Difference in the structure of the probability density function, assessed at different times Secondary Outcomes - Anxiety during examinations of tumour motion - Overall survival - Progression-free survival - Grade ≥2 toxicity assessed by CTCAE v.5.0 ### Location - Facility: Karolinska University Hospital, Stockholm, N/A, 17176, Sweden @@
## Analgesic Efficacy of U/S Retrolaminar Block and Erector Spinae Plane Block in MRM - NCT ID: NCT06322316 - Study ID: MS-492-2022 - Status: COMPLETED - Start Date: 2022-10-01 - Completion Date: 2023-04-01 - Lead Sponsor: National Cancer Institute, Egypt ### Study Description Modified radical mastectomy (MRM) is the most commonly performed surgical procedure in breast cancer patients and is usually associated with severe postoperative pain. The peripheral nerve block techniques were suggested to reduce acuter post-mastectomy pain. The study compared the analgesic efficacy of retrolaminar block (RLB) and ESPB in patients undergoing MRM. ### Conditions - Breast Neoplasms - Analgesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - The Ultrasound-guided Retrolaminar Block Group - The Ultrasound-guided Erector Spinae Plane Block Group ### Outcomes Primary Outcomes - the total morphine consumed postoperatively for 24 hours Secondary Outcomes - the total intraoperative fentanyl consumption - duration of analgesia - postoperative nausea and vomiting PONV as side effect of morphine ### Location - Facility: National cancer Insititute Cairo university, Cairo, N/A, 11796, Egypt @@
## Effect of Cannabidiol (CBD) on Vision and Driving - NCT ID: NCT06322303 - Study ID: C-EXP-194-UGR23 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-02-01 - Completion Date: 2025-12-31 - Lead Sponsor: Universidad de Granada ### Study Description The use of cannabis with ∆9-tetrahydrocannabinol (THC) content has been shown to have negative effects on vision and driving. The use of other cannabinoids, such as cannabidiol (CBD), which is not attributed with a psychoactive effect, is increasing significantly. This project aims to investigate whether consuming CBD can negatively affect visual function by assessing a wide range of visual parameters and whether these changes may pose a risk for everyday activities such as driving. ### Conditions - Cannabis Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Placebo (CBD 0%) - CBD 15% - CBD 30% ### Outcomes Primary Outcomes - Change in Overall Driving Performance Score (ODPS) after cannabidiol vaporization - Change in motion detection sensitivity after cannabidiol vaporization - Change in contrast sensitivity after cannabidiol vaporization - Change in visual acuity after cannabidiol vaporization - Change in fixations after cannabidiol vaporization Secondary Outcomes - Driving simulator: standard deviation of the lateral lane position (SDLP) - Distance travelled outside the lane - Mean speed - Angular velocity of the steering wheel ### Location - Facility: University of Granada, Granada, N/A, 18071, Spain @@
## Epidemiological Study on Invasive Bacterial Diseases - NCT ID: NCT06322290 - Study ID: SEMBAI - Status: RECRUITING - Start Date: 2021-12-09 - Completion Date: 2032-03-30 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description Streptococcus pneumoniae (pneumococcus), Neisseria meningitidis (meningococcus), and Haemophilus influenzae (hemophilus) are among the main bacteria responsible for invasive bacterial diseases (MBIs) that result in severe clinical pictures also characterized by a high frequency of serious complications. Surveillance of infections caused by these pathogens and their distribution by serotypes/serogroups is essential to guide public health interventions, assess epidemiologic trends, monitor any secondary cases, estimate the proportion of preventable cases, identify any vaccine failures, and evaluate the impact of vaccine strategies.The present study aims to study the epidemiology of invasive bacterial diseases, characterize the circulating strains also in order to plan treatment and prevention strategies. ### Conditions - Invasive Bacterial Diseases (IBD) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - assessment of pathogens in blood specimens ### Outcomes Primary Outcomes - Incidence rate of Infective Bacterial Diseases from Streptococcus pneumoniae (pneumococcus) during the study period in pediatric age. - Incidence rate of of Infective Bacterial Diseases cases from Neisseria meningitidis during the study period in pediatric age. - Incidence rate of Infective Bacterial Diseases cases from Haemophilus influenzae during the study period in pediatric age. Secondary Outcomes - Frequency of circulating serogroups/serotypes in Italy for S.pneumoniae, N.meningitidis, H.influenzae. - Proportion of these invasive infections (S.pneumoniae, N.meningitidis, H.influenzae) that are preventable by vaccine in Italy - Vaccine failure rate for S.pneumoniae, N.meningitidis, and H.influenzae. ### Location - Facility: Ospedale di Adria, Adria, N/A, N/A, Italy @@
## Use of Low-cost Molecular Diagnostic Techniques as a New Surveillance Model for Diseases Preventable by Vaccinations. - NCT ID: NCT06322277 - Study ID: NETVAC - Status: RECRUITING - Start Date: 2021-05-04 - Completion Date: 2025-03-31 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description Vaccine-preventable disease (VPD) surveillance should be a priority throughout the world. In Italy, however, there is limited attention to the epidemiology of VPDs, with the consequence that their incidence is largely underestimated. Although notification of vaccine-preventable diseases is mandatory, very often the etiologic agents causing VPDs are not identified the etiological agents causing the major and most severe infectious diseases in childhood. Several reasons underlie the underestimation. For example, not having a good surveillance system does not allow us to organize a sustainable prevention project for example based on on the introduction of new vaccinations. For example the limited use of low-cost high-sensitivity techniques such as real-time PCR, which could, if more widely used, improve pathogen identification with 3 times the sensitivity of standard cultural methods. Therefore, the idea of this multicenter, biological sample study is to take advantage of the regional pediatric network with the goal of improving VPD surveillance and increase awareness of the importance of surveillance of preventable diseases with the vaccine within the pediatric network. ### Conditions - Bacterial Infections ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Analysis of biological sample ### Outcomes Primary Outcomes - Incidence rate of major VPDs (vaccine-preventable infectious diseases): pertussis, influenza virus, respiratory syncytial virus, S.pneumoniae, N.meningitidis, H.influenzae. Secondary Outcomes - Frequency of principal serotype, serogroups of pathogens causative for VPDs. - Number of meeting to diffuse the NETVAC results in Tuscany network. ### Location - Facility: Ospedale San Donato, Arezzo, N/A, N/A, Italy @@
## Promoting Children's Participation in Conventional X-ray Examinations - NCT ID: NCT06322264 - Study ID: 2023-05435-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2025-04-04 - Lead Sponsor: Lund University ### Study Description The goal of this explorative observational study is to map the procedure and child centered approach in the examination for children that undergo conventional X-ray examinations. The main questions aim to answer:* How many images need to be retaken during conventional X-ray examinations?* What is the reason why the pictures need to be redone?* What is the time required for the various examinations?* What experience of the procedure of the examination is there among those involved?* Can the physical impact be observed through variation in heart rate in children that undergo conventional X-ray examinations?Participants will answer questionnaires about the children's participation in the procedure and the variation in heart rate will be measured on the children who undergo the examinations. ### Conditions - Heart Rate Determination - Patient Participation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Measurement of variation in heart rate ### Outcomes Primary Outcomes - Variation in heart rate Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Identification of Interpesonal Violence - NCT ID: NCT06322251 - Study ID: 2023-03399-01 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-06-30 - Lead Sponsor: Region Stockholm ### Study Description The goal of this study is to increase primary care professional's ability to identify individuals exposed to intimate partner violence (IPV) in primary health care settings.The main questions it aims to answer are1. To what extent do the following three interventions contribute to identify potential victims of IPV: (1) the use of a standardized questionnaire that screens exposure to IPV, (2) staff using tailored virtual patients for clinical training on IPV and (3) a combination of interventions 1 and 2?2. Which intervention do primary care professionals experience as most effective in increasing the ability to identify and respond to victims of IPV?Participants will be divided to apply one of the three interventions in their health care setting: 1) a standardized questionnaire to patients, 2) virtual patients tailored to health professionals, and 3) a combination of 1 and 2.Pre-and post-measurement of the health professionals identification of patients exposed to IPV will will be used to explore the effect of the interventions.Focus group interviews with the participating health professionals will be a qualitative complement. The participants will be asked about what intervention they experience as the most effective in increasing the ability to identify victims of IPV. ### Conditions - Primary Health Care - Interpersonal Violence - Youth - Pregnancy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Use of instrument to identify exposure to violence in close relationships ### Outcomes Primary Outcomes - Number of identified persons seeking healthcare who have been exposed to violence Secondary Outcomes - Number of identified persons seeking healthcae who have been exposed to violence ### Location - Facility: Linköping University, Linköping, N/A, 581 83, Sweden @@
## Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice: - NCT ID: NCT06322238 - Study ID: 23-008706 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: Mayo Clinic ### Study Description The purpose of this study is to determine whether the implementation of pre-emptive pharmacogenomic (PGx) testing of a panel of clinically relevant PGx markers, to guide the dose and drug selection for 39 commonly prescribed drugs, will result in an overall reduction in the number of clinically relevant drug-genotype associated ADRs which are causally related to the initial drug of inclusion (referred to as 'index drug'). ### Conditions - Pharmacogenomic Drug Interaction - Side Effect of Drug - Ineffective Drug Action - Drug Metabolism, Poor, CYP2D6-Related - Drug Metabolism, Poor, CYP2C19-Related ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - PGx panel test ### Outcomes Primary Outcomes - Adverse Drug Reaction (ADR) Secondary Outcomes - PREPARE-MAYO Clinicians' and pharmacists' Questionnaire. - Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health Questionnaire ### Location - Facility: Mayo Clinic, Rochester, Minnesota, 55902, United States @@
## Establishment of Big Data Platform and Biobank for Colorectal Tubular Adenoma Lesions - NCT ID: NCT06322225 - Study ID: 2023YFC2507401 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-31 - Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University ### Study Description Colorectal tubular adenoma is the most common precancerous lesion of colorectal cancer, and the point is that its precise prevention and treatment can reduce the incidence of colorectal cancer.However, the epidemiological characteristics of colorectal tubular adenoma in China are unclear, the rate of missed diagnosis by colonoscopy is high, and the existing diagnosis and treatment techniques are lack of unified quality control standards,which makes it difficult to diagnose and achieve accurate prevention and control. How to improve the precise prevention and treatment of colorectal tubular adenoma and reduce the incidence of colorectal cancer is a major clinical scientific problem that needs to be solved urgently. For this purpose, this study was conducted in colorectal guided by the needs of accurate prevention and treatment of tubular adenoma lesions,and a multi-center colorectal tubular adenoma data management platform and a high-risk population database covering a full range of data including demographic characteristics, lifestyle factors, clinical information, endoscopic data and pathological images were established, biological sample databases of patients with pathological changes and high-risk populations were established, and data quality control and sample quality control standards were formulated standards-based.The pathological prediction model and accurate risk assessment system of colorectal tubular adenoma were constructed by the pathological database. ### Conditions - Colorectal Tubular Adenoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Clinical information such as demographic characteristics, clinical data, endoscopy and pathological images Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Type 2 Diabetes and Blood Brain Barrier Improvement - NCT ID: NCT06322212 - Study ID: 23-001083 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: University of California, Los Angeles ### Study Description The majority of T2DM adults show thiamine (vitamin B1) deficiency which may contribute to impaired function. This study will examine patients with T2DM through brain MRI scans, cognition assessments, blood tests, and questionnaires. Our goal is to see if a thiamine treatment (taking vitamin B1 capsules) can improve function. Patients will be asked to come to UCLA two times three months apart and each visit will last about 2.5-3 hours. ### Conditions - Type2diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Thiamine - Placebo ### Outcomes Primary Outcomes - Assess if BBB function has been repaired. - Analyze blood serum S100β levels. - Examine cognition in T2DM adults with thiamine treatment. - Cognition assessment in T2DM adults after thiamine treatment. - Examine depression in T2DM adults with thiamine treatment. - Assess anxiety in T2DM adults with thiamine treatment. Secondary Outcomes ### Location - Facility: UCLA, Los Angeles, California, 90095, United States @@
## Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy Attempted Suicide Short Intervention Program (ASSIP) on Neuropsychological Correlates and Psychological Process Factors - Project 3 - NCT ID: NCT06322199 - Study ID: 2021-02504 (Project 3) - Status: RECRUITING - Start Date: 2022-09-23 - Completion Date: 2024-12-31 - Lead Sponsor: University of Bern ### Study Description The present study consists of 3 projects in total. It aims to investigate the (neuro-) psychological patterns from suicidal ideation to suicidal behavior as well as the feasibility and cost-effectiveness of ASSIP flex.The overall aim of Project 3 is to evaluate the feasibility and cost-effectiveness of ASSIP flex over a 12-month follow-up period in terms of suicide reattempts and suicide correlates in a cohort who is attending ASSIP flex after a suicide attempt. ### Conditions - Suicide, Attempted - Suicidal Ideation - Feasibility - Cost-effectiveness - Process Factors ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ASSIP (Attempted Suicide Short Intervention Program) flex ### Outcomes Primary Outcomes - Suicidal ideation (Baseline, t0) - Suicidal ideation and suicidal behavior (Baseline, t0) - Suicidal ideation (Follow-up, t1) - Suicidal ideation and suicidal behavior (Follow-up, t1) - Suicidal ideation (Follow-up, t2) - Suicidal ideation and suicidal behavior (Follow-up, t2) Secondary Outcomes - Treatment costs of treatments 1 ### Location - Facility: Centre Hospitalier universitaire vaudois (CHUV), Lausanne, N/A, N/A, Switzerland @@
## Study to Actively Warm Trauma Patients-2 - NCT ID: NCT06322186 - Study ID: STAYWARM-2 Trial - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-03 - Lead Sponsor: Sunnybrook Health Sciences Centre ### Study Description Massively bleeding trauma patients have higher odds of mortality, increased hospital length of stay, and increased need for transfusion if they become hypothermic. Hypothermia is independently associated with mortality in traumatically injured patients due to its negative physiologic effects on hemostasis, cardiorespiratory and renal function.Current warming strategies increase the logistical difficulty of transferring patients (which is frequent during the initial hours of trauma care) or must be changed at frequent intervals. Prehospital, military, and intraoperative studies have suggested chemical warming blankets as a pragmatic strategy to manage hypothermia. A recent pilot study (manuscript under review) at our institution demonstrated the feasibility of using the Ready-Heat® (TechTrade LLC, Orlando, FL, USA) chemical heating blanket in the initial phases of hospital care in bleeding trauma patients requiring a mass hemorrhage protocol (MHP). These self-warming blankets provide warmth over 8 hours at up to 40 degrees Celsius, carrying the advantage of portability with no continuous electric power requirement. Furthermore, the Ready-Heat blanket may be more effective than current strategies for rewarming patients at high risk of developing hypothermia. STAYWARM-2 will be the first randomized controlled trial performed in-hospital to evaluate a self-warming blanket to address hypothermia in massively bleeding trauma patients within the initial hours of hospital arrival.This study will help to determine the efficacy and feasibility of using chemical heating blankets for hypothermia in the early hours of hospital care. This has potential to reduce the overall workload of direct care clinicians, freeing them for other patient care duties. Additionally, the intervention may achieve enhanced thermoregulation compared to current strategies, improving patient care and comfort, and avoiding the clinical complications related to hypothermia. Findings from this preliminary study may provide data for a future grant to launch a larger randomized controlled trial in the prehospital/in-hospital trauma setting to optimize the care of patients at risk of developing hypothermia. ### Conditions - Trauma Injury - Hypothermia - Massive Hemorrhage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Ready-Heat Chemical Heating Blankets - Warmed blankets or FAWB ### Outcomes Primary Outcomes - An increase of 1⁰C at eight hours from the time of blanket placement - Adherence to the 2 blankets application in the trauma bay in at least 80% of patients. - Adherence to body temperature measurements (in degrees Celsius) 80% of each of the phases of initial care up to 8 hours following admission. - Adherence to maintain the blankets applied on the patient in 80% of each of the phases of initial care up to 8 hours following admission. Secondary Outcomes - Concurrent warming strategies - Blood product usage - Coagulation parameter 1: platelet count - Coagulation parameter 2: INR - Coagulation parameter 3: fibrinogen - Perfusion parameter 1: pH - Perfusion parameter 2: base deficit - Perfusion parameter 3: serum lactate - Hemoglobin level - Blanket placed directly on skin - Skin redness and/or burns ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Advanced NGS Sequencing Methods - NCT ID: NCT06322173 - Study ID: 2022-13 - Status: RECRUITING - Start Date: 2022-06-28 - Completion Date: 2024-12 - Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar ### Study Description This is an experimental study without drug and device, non-profit, on biological samples stored at the Tropica Biobank of the DITM. The aim of the project is to verify the performance of NGS-based assays, which can be used in the field of microbiology. The clinical evaluation investigations of NGS technology will be conducted on an adequate number of clinical blood samples and rectal swabs. The analyzes will be compared with the standard microbiology methods used in the DITM diagnostic routine. ### Conditions - Resistance Bacterial ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - NGS Analysis ### Outcomes Primary Outcomes - Microorganism presence (positive/negative) - Microorganism identification Secondary Outcomes - Identification of Gene mutations that convey resistance to antibiotics (resistant/susceptible) ### Location - Facility: IRCCS Sacro Cuore Don Calabria hospital, Negrar, Verona, 37024, Italy @@
## The Role of tHyroid cAncer Specific Patient Concerns iNventory (PCI-TC) in Enhancing Shared decisiOn Making - NCT ID: NCT06322160 - Study ID: 5714 - Status: RECRUITING - Start Date: 2023-05-03 - Completion Date: 2024-12-31 - Lead Sponsor: Royal Marsden NHS Foundation Trust ### Study Description Multiple clinical equipoises exist for the management of thyroid cancers. Shared decision-making (SDM) process where patients are supported to consider options, to achieve informed preferences with their clinicians have been recommended to improve patients' satisfaction and their overall quality of life. However, SDM can be difficult to achieve in our standard clinical encounters due to clinician's lack of confidence and time limitation to elicit patient's concerns and preferences. PCI as a decision-making support tool has shown to enhances clinician's awareness of patient's needs and allows for a more effective communication while the consultation time is unaffected. The successful development, testing and implementation of a PCI-TC could improve patient satisfaction, clinical efficiency and ensure that unmet need is appropriately addressed. This study will support the development of PCI-TC to better understand the wide-ranging needs of our patients and to improve the SDM process in the thyroid cancer management pathway. ### Conditions - Thyroid Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Interview ### Outcomes Primary Outcomes - To explore patients' and clinicians' view and experience of the current decision-making process for low risk differentiated thyroid cancer - • To explore clinicians' and patients' user experience of thyroid cancer specific patient concerns inventory (PCI-TC) in thyroid cancer outpatient clinics. Secondary Outcomes ### Location - Facility: Guys & St Thomas, London, N/A, N/A, United Kingdom @@
## Chemotherapy With Cetuximab as Conversion Therapy in RAS/BRAF WT Unresectable Liver Metastasis Right-sided Colon Cancer - NCT ID: NCT06322147 - Study ID: KYLL-202304-31 - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2025-12-30 - Lead Sponsor: Qilu Hospital of Shandong University ### Study Description This study was designed as multi-center, ambispective observational trial to evaluate the efficacy and safety of addition of cetuximab to doublet or triplet chemotherapy as conversion therapy in right-sided BRAF/RAS wild-type CRLM with curative intent. The primary endpoint was radical resection rate (R0). The secondary endpoint was response rate, rate of NED, depth of remission, early tumor shrinkage, progression free survival and safety. ### Conditions - Colon Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Doublet or triplet chemotherapy combined with cetuximab ### Outcomes Primary Outcomes - R0 resection rate Secondary Outcomes - Objective response rate - Reported adverse events - Progression free survival - no evidence of disease - depth of response - Early Tumor Shrinkage ### Location - Facility: Qilu hospital of Shandong University, Jinan, Shandong, 250012, China @@
## Drowning Incidents Treated by the Danish SAR Helicopters - NCT ID: NCT06322134 - Study ID: DROWN_SAR - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-31 - Lead Sponsor: Prehospital Center, Region Zealand ### Study Description Improving oxygenation and ventilation in drowning patients early in the field is critical and may be lifesaving. This may be achieved by helicopter emergency medical services (HEMS) such as the Danish Air Ambulance, or the Royal Danish Air Force's Search And Rescue (SAR) helicopters. The SAR operates in all weather conditions and is equipped with a hoist system, able to hoist patients from the sea or small ships without helipads. This study aimed to estimate the incidence of drowning missions attended by the Royal Danish Air Force's SAR helicopter and describe patient characteristics and prehospital interventions. ### Conditions - Drowning - Drown - Drowning; Anoxia - Drowning, Near - Drowning and Nonfatal Submersion - Drowning or Immersion of Unknown Intent - Drowning and Submersion, Undetermined Intent - Drowning and Submersion While in Natural Water - Drowning and Submersion Due to Sailboat Sinking - Drowning and Submersion Due to Fall Off Ship ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Drowning incident ### Outcomes Primary Outcomes - Annual incidence of drowning treated by the Danish SAR helicopters from 2014-2023 - Annual incidence rate of drowning treated by the Danish SAR helicopters from 2014-2023 - Spatial distribution of drowning patients treated by the Danish SAR helicopters from 2014-2023 Secondary Outcomes - Drowning to water rescue ratio ### Location - Facility: Prehospital Center, Næstved, Region Zealand, 4700, Denmark @@
## Vascular Aspects in Dementia: Part 2 - NCT ID: NCT06322121 - Study ID: NL83653.058.23 - Status: RECRUITING - Start Date: 2023-09-04 - Completion Date: 2026-09 - Lead Sponsor: Leiden University Medical Center ### Study Description Cerebral amyloid angiopathy (CAA), a common cerebrovascular small vessel disease (SVD), is a frequently (98%) found co-morbidity at autopsy in patients with Alzheimer's disease (AD). Current in vivo hallmarks of CAA represent changes relatively late in the disease process and leaves CAA in AD often undetected. Recently, it was shown that decreased vascular reactivity (VR) measured with blood oxygen level dependent (BOLD) MRI, after visual stimulus, is an early CAA marker. With BOLD-MRI to detect decreased VR in different stages of AD, it was shown that increasing stages of AD associate with decreasing VR independent of age, classic SVD markers and atrophy. Moreover, VR is associated with cognitive deficits. Therefore, cross-sectional data indicate that decreased VR is an important co-morbidity already in early stages of AD with an independent effect on disease severity. In this respect, the study aim is to determine the natural course of the decrease of VR in both controls and (early stage) AD patients to monitor AD disease progression. This is an essential step to aid in the development and application of effective treatment as it is expected that CAA can cause/worsen AD pathology. ### Conditions - Dementia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - MRI ### Outcomes Primary Outcomes - Vascular reactivity - BOLD amplitude - Vascular reactivity - time-to-peak - Vascular reactivity - time-to-baseline Secondary Outcomes - Intracranial hemorrhage - Lobar microbleeds - Subarachnoidal hemorrhage - Superficial siderosis - Lacunes - Volume of white matter hyperintensities (WMHs) - Perivascular spaces in the basal ganglia - Perivascular spaces in the centrum semiovale - Gray matter volume ### Location - Facility: Leids Universitair Medisch Centrum, Leiden, N/A, 2333 ZA, Netherlands @@
## Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008) - NCT ID: NCT06322108 - Study ID: IMMONC0008 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2030-04 - Lead Sponsor: Immune Oncology Research Institute ### Study Description The goal of this study is to see if the combination of immunotherapy agents botensilimab and balstilimab is safe and effective in participants with metastatic non-small cell lung cancer (NSCLC) as a first-line treatment. ### Conditions - Non-small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Botensilimab + Balstilimab ### Outcomes Primary Outcomes - 12-Month Progression-Free Survival (PFS) Secondary Outcomes - Objective Response Rate (ORR) - Disease Control Rate (DCR) - Duration of Response (DOR) - Time to Next Treatment (TTNT) - Overall Survival (OS) Time - Frequency, severity, and duration of treatment emergent adverse events (TEAEs) (Safety and tolerability) - Health-related quality of life (HRQoL) according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) - Health-related quality of life according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC29) - Health-related quality of life according to the 5 Level EuroQol 5 Dimension (EQ-5D-5L) questionnaire - Correlation between baseline expression of PD-L1 by immunohistochemistry (IHC) and 12-month progression-free survival - Correlation between baseline expression of PD-L1 by immunohistochemistry (IHC) and objective response rate - Correlation between existence of liver metastases on imaging at baseline and 12-month progression-free survival - Correlation between existence of liver metastases on imaging at baseline and objective response rate - Level of circulating tumor DNA (ctDNA) at baseline and at different time points after start of treatment ### Location - Facility: Hematology Center named after prof. R. Yeolyan, Yerevan, N/A, 0014, Armenia @@
## A Study of GH21 Combined With Previous Target Therapy or Immunotherapy in Patients With Advanced Solid Tumors - NCT ID: NCT06322095 - Study ID: GH21C202 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-22 - Completion Date: 2025-12-31 - Lead Sponsor: Suzhou Genhouse Bio Co., Ltd. ### Study Description This study is aim to evaluate the preliminary efficacy of GH21 combined with previous target therapy or immunotherapy in patients with advanced solid tumors. ### Conditions - Patient With Advanced Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - GH21+ Previous Target Therapy or Immunotherapy ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - Number of participants with adverse events - Duration of response (DOR) - Duration of response (DCR) - Progression-free survival (PFS) - Plasma concentration (Cmax) - Time to achieve Cmax (Tmax) - Area under the plasma concentration-time curve (AUC) ### Location - Facility: Cancer Hospital Chinese Academy of Medical Science, Beijing, Beijing, 100029, China @@
## Pilates Training and Low Intensity Shock Wave Therapy for Post-prostatectomy Stress Incontinence - NCT ID: NCT06322082 - Study ID: 1422024 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-20 - Completion Date: 2024-12-15 - Lead Sponsor: Khadra Mohamed Ali ### Study Description 120 Patients with urinary incontinence following radical prostatectomy would be randomly assigned to either 4 groups all receive conventional pelvic floor muscle exercises plus group A receive Pilates exercises and Low Intensity Extracorporeal Shock Wave Therapy, group B receive Low Intensity Extracorporeal Shock Wave Therapy, group C receive Pilates exercises and group D receive conventional pelvic floor muscle exercises. Assessment at baseline, immediately after the intervention, to evaluate the degree of urinary incontinence and quality of life after three months from treatment. ### Conditions - Stress Incontinence, Male ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG) ### Outcomes Primary Outcomes - Cystometry - Severity index scale Secondary Outcomes - body mass index ### Location - Facility: faculty of physical therapy , Cairo university, Giza, N/A, N/A, Egypt @@
## The Effect and Mechanism of Self-compassion on Reducing Materialism - NCT ID: NCT06322069 - Study ID: 202206260077 - Status: COMPLETED - Start Date: 2020-12-14 - Completion Date: 2021-03-15 - Lead Sponsor: Beijing Normal University ### Study Description The current study provided an initial investigation of the effect of self-compassion on reducing materialism and explored the basic psychological needs and self-esteem as potential mechanisms. Two studies would be conducted. Study 1 explored the relationships among variables with cross-sectional data, to explore the relationship between self-compassion and materialism, and test the mediating role of basic psychological needs and self-esteem. Study 2 developed a new online self-help self-compassion intervention and conducted a randomized control trial (i.e., intervention group and waitlist group) to further explore the casual effect of self-compassion on materialism, with the mediating effect of basic psychological needs and self-esteem. ### Conditions - Self-Compassion - Group B ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Self-compassion intervention group ### Outcomes Primary Outcomes - Self-compassion - Self-Esteem - Basic Psychological Needs - Materialism Secondary Outcomes ### Location - Facility: Xianglong Zeng, Beijing, Beijing, 100875, China @@
## Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease - NCT ID: NCT06322056 - Study ID: 4-2023-1654 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-13 - Completion Date: 2029-08-31 - Lead Sponsor: Yonsei University ### Study Description The purpose of this study is to prevent kidney disease progression in adults with advanced chronic kidney disease (estimated glomerular filtration rate \[eGFR\] between 15-45 mL/min/1.73 m2) using intensive blood pressure control and intensive lipid management with 2X2 factorial design. ### Conditions - Chronic Kidney Diseases - Hypertension - Dyslipidemias ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Intensive control of SBP and intensive control of LDL-C - Intensive control of SBP and standard control of LDL-C - Standard control of SBP and intensive control of LDL-C - Standard control of SBP and standard control of LDL-C ### Outcomes Primary Outcomes - Renal composite outcome Secondary Outcomes - Individual components of renal composite outcome - eGFR slopes - Cardiovascular composite outcome ### Location - Facility: Severance Hospital, Seoul, N/A, 03722, Korea, Republic of @@
## Evaluation of Safety of Filler Injection in Subcutaneous Tissues - NCT ID: NCT06322043 - Study ID: VM-APFB-1023 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Volumina Medical S.A. ### Study Description Adipearl is an injectable filler intended to be injected subcutaneously. ### Conditions - Volume Deficiency ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Adipearl ### Outcomes Primary Outcomes - Safety of Investigational Medical Device Secondary Outcomes ### Location - Facility: Summit Clinic, Crans-Montana, N/A, N/A, Switzerland @@
## Weight Loss and ExeRcise - NCT ID: NCT06322030 - Study ID: N4281-R - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-03-31 - Lead Sponsor: VA Office of Research and Development ### Study Description Weight loss interventions for neurologically health individuals have established benefits for improving physical and psychosocial function. The investigators believe that Veterans who have had a stroke would realize similar benefits and that the effects would be enhanced with concurrent exercise training. The investigators will study the effects of a 15-week lifestyle management program to determine if it can effectively improve some of the physical and psychosocial problems common in Veterans who have had a stroke. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - FOCUS-15 Lifestyle Management Program - Exercise Training ### Outcomes Primary Outcomes - Change in distance walk in 6 minute Walk Test Secondary Outcomes - Change in daily step activity - Change in score of Stroke Impact Scale (SIS) - Change in score of Sheehan Disability Scale (SDS) - Change in score of Inventory of Psychosocial Functioning (IPF) ### Location - Facility: Ralph H. Johnson VA Medical Center, Charleston, SC, Charleston, South Carolina, 29401-5703, United States @@
## Prospective Multicenter Randomized and Controlled Study Evaluating the Benefit of Early Pulmonary Vein Isolation Compared to Usual Treatment in Patients Aged Over 75 Years and Presenting With Atrial Fibrillation - NCT ID: NCT06322017 - Study ID: RC22_0450 - Status: RECRUITING - Start Date: 2024-04-09 - Completion Date: 2028-04-09 - Lead Sponsor: Nantes University Hospital ### Study Description Therapeutic management of Atrial Fibrillation (AF) is based either on heart rate control or on rhythm control, a strategy which aims to maintain a normal heart rhythm. The benefit in terms of morbidity and mortality of a normal heart rhythm would, however, be largely offset by the frequent side effects of antiarrhythmic drugs which could even lead to an increase in mortality compared to rate control. This increase has particularly been suggested in people aged over 75.Since the emergence of catheter Pulmonary Vein Isolation (PVI), an effective alternative to antiarrhythmic drugs has become available. This technique makes it possible to isolate the foci triggering AF under local or general anesthesia with greater effectiveness than medications and very low risks. Records in the elderly do not seem to show a reduction in effectiveness or an increase in complications. However, in the absence of a dedicated randomized study, its use is strongly limited in the elderly where rate control (52% of people over 65 years old) and the use of antiarrhythmic drugs are largely favored due to the simplicity of implementation and the low cost of medications.However, an early rhythm control strategy seems to reduce cardiovascular events in relatively old individuals (average age 70 years). The use of PVI in first line could make it possible to further improve these results.The objective of the investigator is therefore to carry out the first randomized comparative study proposing to evaluate the impact of early PVI compared to usual treatment in patients aged 75 and over with AF. ### Conditions - Atrial Fibrillation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rhythm control by Pulmonary Vein Isolation (PVI) procedure - Conventional care by antiarrhythmic drugs (flecainide, sotalol, amiodarone) or bradycardic drugs (all betablocker or calcium channel blocker therapy, digoxin) ### Outcomes Primary Outcomes - Time before occurrence of the first event among cardiovascular death, hospitalization (all causes) and stroke Secondary Outcomes - Number of PVI peri-procedural complications - Number of complications - Quality of life score - Quality of life score - Quality of life score - Quality of life score - Quality of life score - Quality of life score - Number of documented episodes of AF - Number of patients treated by cardiovascular drugs - Doses of cardiovascular drugs - Autonomy score - Autonomy score - Autonomy score - Autonomy score - Autonomy score - Autonomy score - Autonomy score - Autonomy score - Autonomy score - Autonomy score - Autonomy score - Autonomy score - Body weight - Body weight - Body weight - Body weight - Body weight - Body weight - Numbers of falls - Numbers of falls - Numbers of falls - Numbers of falls - Numbers of falls - Numbers of falls - Physical performance score - Physical performance score - Evolution of ADL score according to the results of the Integrated Care for Older People (ICOPE) test at inclusion - Evolution of IADL score according to the results of the ICOPE test at inclusion - Cognitive assessment - Cognitive assessment - Cognitive assessment - Cognitive assessment - Cognitive assessment - Cognitive assessment ### Location - Facility: Nantes University Hospital, Nantes, Loire Atlantique, 44093, France @@
## Video-Interpreting in Prehospital Emergency Medicine - Feasibility Study - NCT ID: NCT06322004 - Study ID: 1718/2022 - Status: RECRUITING - Start Date: 2023-02-06 - Completion Date: 2025-11-01 - Lead Sponsor: Medical University of Vienna ### Study Description 50 responsive patients with language barriers will be included in this study. The prehospital emergency physician will start video-interpreting via a tablet. Feasibility, quality of communication, usability as well as changes in diagnosis and treatment will be gathered and analysed. ### Conditions - Communication Barriers ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Technical Feasibility - Usability of video-interpreting - Impact on emergency physician's decisions Secondary Outcomes - Demographic parameters ### Location - Facility: Medical University of Vienna, Vienna, N/A, 1090, Austria @@
## Nodular Shrinking in Dupuytren Disease - NCT ID: NCT06321991 - Study ID: S68382 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2026-03-01 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description Dupuytren disease (DD) is a common hand disorder with disabling finger contractures that may require surgery to restore function. In the early stages of the disease, the nodules (Tubiana stage 0) are usually painless, but a reason for concern to many patients. Not rarely, lifestyle measures and even risky treatment options as radiotherapy are advised, yet no therapy to prevent disease evolution has a solid proven effect. Furthermore, reliable non-invasive measurement of early stage DD is not validated.Evidence was found that pharmacotherapy may influence DD evolution, but valuable clinical trials are limited. Case series and non-published explorative follow-up suggested local treatment with antioxidant vitamin E to possibly interfere with an evolution of DD nodules to contracting strands. This study aims to provide evidence on efficiency of this non-invasive treatment option.Secure measurement of nodule evolution is a clinical challenge. To measure this evolution, ultrasound and MRI scanning are currently being performed. Stage 0 (nodules) is more challenging to quantify. A strict individual follow-up by the treating clinician is needed to standardize measurement of selected (treated) nodules. Therefore, simple ultrasound by the treating clinician may provide an good tool to collect data. This study aims to introduce and validate this non-invasive scan method and provide a prospective double blind investigation of a measurable effect of non-invasive preventive treatment for stage 0 DD to improve clinical outcome. ### Conditions - Dupuytren's Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vitamin E-creme (Remederm®) vs Vaseline (Placebo) - Ultrasound measurement ### Outcomes Primary Outcomes - Downsizing of the largest nodule diameter Secondary Outcomes - VAS questionnaire on pain - VAS questionnaire on satisfaction - QUICK Dash for functionality - Abe Diathesis scoring - Range of motion - Recurrence rate ### Location - Facility: UZ Leuven, Leuven, Vlaams-Brabant, 3000, Belgium @@
## Mepilex Border Flex Utilization Pilot Spain - NCT ID: NCT06321978 - Study ID: MxBFlexUP ESP - Status: RECRUITING - Start Date: 2024-02-16 - Completion Date: 2024-05-31 - Lead Sponsor: Molnlycke Health Care AB ### Study Description The aim of this study is to assess and describe the utilization of Mepilex® Border Flex and other foam dressings available in routine clinical practice in the management of patients with chronic wounds, in order to understand the pattern of use and the frequency of dressing changes in wound management. The study will also allow to gain information about the opinion of the HCPs and the patient's experience concerning wound management with foam dressings. This information may help to understand patient's health care optimization in terms of quality and efficiency. ### Conditions - Wound ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Mepilex Border Flex ### Outcomes Primary Outcomes - Dressing use Secondary Outcomes - Wound characteristics - Wound management - HCP opinion - Patient Experience - Costs ### Location - Facility: CS Ciudad Expo - Mairena de Aljarafe, Sevilla, Andalusia, 41927, Spain @@
## Characterization of New Phenotypes of Patients With Spinal Muscular Atrophy Treated With SMN Restoring Therapy - NCT ID: NCT06321965 - Study ID: 69HCL22_0599 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-10-01 - Lead Sponsor: Hospices Civils de Lyon ### Study Description With the advent of new treatments for ASI, new phenotypes are emerging. The investigators propose to describe these new phenotypes by prospectively following children with ASI of all types treated with TRS and aged under 16 for 2 years.The investigators also propose to evaluate potential assessment tools to determine whether they are relevant for monitoring this population, either routinely or for future clinical trials. The investigators also aim to collect the total costs associated with ASI in order to propose a first prospective medico-economic study in France. ### Conditions - Spinal Muscular Atrophy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - evaluation of muscle function - First-line cognitive assessment - second-line cognitive assessment - Cardiac evaluation - MRI - Assessment of activity and muscle fatigue - Assessment of bulbar function - Evaluation of body composition and metabolism - Questionnaires - Biocollection - Skinfold measurement ### Outcomes Primary Outcomes - Markers of disease progression and description of different phenotypes, at : muscular and functional - Markers of disease progression and description of different phenotypes, at : muscular and functional - Markers of disease progression and description of different phenotypes, at : muscular and functional - Markers of disease progression and description of different phenotypes, at : muscular and functional - Markers of disease progression and description of different phenotypes, at : muscular and functional - Markers of disease progression and description of different phenotypes, at : Fatigue - Markers of disease progression and description of different phenotypes, at : Fatigue - Markers of disease progression and description of different phenotypes, at : Fatigue - Markers of disease progression and description of different phenotypes, at Orthopaedic level - Markers of disease progression and description of different phenotypes, at Orthopaedic level - Markers of disease progression and description of different phenotypes, at Orthopaedic level - Markers of disease progression and description of different phenotypes, at the cognitive level: Vineland-II - Markers of disease progression and description of different phenotypes, at the cognitive level: Bayley-4 - Markers of disease progression and description of different phenotypes, at the cognitive level: BRIEF (Behavioral Rating Inventory of Executive Function) - Markers of disease progression and description of different phenotypes, at the cognitive level: Conners-3 - Markers of disease progression and description of different phenotypes, at the cognitive level: CELF-5 (Language and communication assessment battery) - Markers of disease progression and description of different phenotypes, at the cognitive level: EQ (Empathy quotient), AQ (Autism Quotient) - Markers of disease progression and description of different phenotypes, at the cognitive level: M-CHAT-R (Modified Checklist for Autism in Toddlers) - Markers of disease progression and description of different phenotypes, at the cognitive level: SRS-2 (Social Responsiveness Scale, Second Edition) - Markers of disease progression and description of different phenotypes, at the cognitive level: PVSE (Basic visuo-spatial perception) - Markers of disease progression and description of different phenotypes, at the brain level - Markers of disease progression and description of different phenotypes, at Cardiology level - Markers of disease progression and description of different phenotypes, at metabolic level : Anthropometric measurement trends - Markers of disease progression and description of different phenotypes, at metabolic level : - Markers of disease progression and description of different phenotypes, at metabolic level : fractures - Markers of disease progression and description of different phenotypes, at metabolic level : renal ultrasound - Markers of disease progression and description of different phenotypes, at metabolic level : Absorptiometry (DXA) - Markers of disease progression and description of different phenotypes, at metabolic level: Calorimetry - Markers of disease progression and description of different phenotypes, at metabolic level : Impedancemetry - Markers of disease progression and description of different phenotypes, at metabolic level : Fibroscan - Markers of disease progression and description of different phenotypes, at biological analysis - Markers of disease progression and description of different phenotypes, at In terms of quality of life and autonomy - Markers of disease progression and description of different phenotypes, at In terms of quality of life and autonomy - Markers of disease progression and description of different phenotypes, at respiratory level : Chest/head circumference ratio (PT/PC ratio) (up to 3 years) - Markers of disease progression and description of different phenotypes, at respiratory level : Chest/head circumference ratio (PT/PC ratio) - Markers of disease progression and description of different phenotypes, at respiratory level : O2 saturation and nocturnal TcPCO2 - Markers of disease progression and description of different phenotypes, at respiratory level: Respiratory function tests (≥ 6 years) - Markers of disease progression at respiratory level - Markers of disease progression and description of different phenotypes, at bulbar level (Evaluation of dysphagia and dysarthria): DDD-pNMD (Diagnostic list for Dysphagia and Dysarthria in pediatric NeuroMuscular Disorders) - Markers of disease progression and description of different phenotypes, at bulbar level (Evaluation of dysphagia and dysarthria): NdSSS (Neuromuscular Disease Swallowing Status Scale). - Markers of disease progression and description of different phenotypes, at the level of Characteristics at inclusion: age of patient - Markers of disease progression and description of different phenotypes, at the level of Characteristics at inclusion : patient gender - Markers of disease progression and description of different phenotypes, at the level of Characteristics at inclusion: SMA TYPE - Markers of disease progression and description of different phenotypes, at the level of Characteristics at inclusion: number of copy - Markers of disease progression and description of different phenotypes, at the level of Characteristics at inclusion: treatment Secondary Outcomes ### Location - Facility: Pediatric Rehabilitation Service - L'Escale Mother and Child Hospital, Bron, Rhone, 69500, France @@
## Comparison of Accuracy and Functional Outcome Between Robotic and Gyroscopic Assisted Surgery in Primary TKA - NCT ID: NCT06321952 - Study ID: GTanareesuchoti - Status: COMPLETED - Start Date: 2021-09-17 - Completion Date: 2024-02-01 - Lead Sponsor: Mahidol University ### Study Description A randomized controlled trial was conducted with 72 participants who had moderate knee osteoarthritis (Kellgren and Lawrence grade 2-3). The patients were randomly assigned to either the robotic-assisted or gyroscopic-assisted group. Baseline characteristics, including age, body mass index, length of stay, and estimated blood loss, were recorded. The primary outcome measure was the accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months. Secondary outcomes included functional outcomes (KOOS, Oxford knee score, EQ-5D-5L, range of motion) assessed preoperatively and postoperatively at 3 months, as well as at 6 months postoperatively. ### Conditions - Knee Arthropathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ROSA robotic assist TKA - iassist TKA ### Outcomes Primary Outcomes - accuracy of Robotic Assisted Surgery and Gyroscopic Based Instrument Secondary Outcomes - Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument - Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument - Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument - Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument ### Location - Facility: Siriraj Hospital, Bangkok, N/A, 10700, Thailand @@
## Sequencing-based Counting of Plasma Epstein-Barr Virus DNA in Non-metastatic Nasopharyngeal Carcinoma - NCT ID: NCT06321939 - Study ID: NPCNS 001 - Status: RECRUITING - Start Date: 2024-01-11 - Completion Date: 2028-12-31 - Lead Sponsor: Hunan Cancer Hospital ### Study Description The investigators aim to explore a new EBV DNA surveillance method with both high sensitivity and specificity in nasopharyngeal carcinoma (NPC) patients. the investigators aim to conduct plasma EBV DNA counting by next generation sequencing (NGS) in non-metastatic NPC patients on their diagnose, after two cycles of induction chemotherapy (IC), and 4-8 weeks after definitive radiotherapy. The investigators aim to explore whether sequencing-based counting is better than PCR analysis in plasma EBV-DNA surveillance, so as to monitoring tumor responses to treatment and for guiding individualized treatment adaptation in the future. ### Conditions - Nasopharyngeal Carcinoma - Herpesvirus 4, Human ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - EBV-DNA next generation sequencing ### Outcomes Primary Outcomes - Positivity rate of plasma EpsteineBarr virus (EBV) DNA by next generation sequencing Secondary Outcomes - Overall survival - Distant metastasis failure-free survival - Locoregional failure-free survival - Failure-free survival - Patient reported quality-of-life score - Biomarker analysis ### Location - Facility: Hunan cancer Hospital, Changsha, Hunan, N/A, China @@
## Evaluation of the "ActiveWaiting App" Encouraging Active Exercise-related Use of Waiting Time - NCT ID: NCT06321926 - Study ID: 154/2023 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-06-30 - Lead Sponsor: Ludwig Boltzmann Institute for Digital Health and Prevention ### Study Description The goal of this study (waitlist control study) is to evaluate the effectiveness of the ActiveWaiting App on increasing physical activity and improving quality of life in physically inactive adults in Austria.The main questions it aims to answer are:1. Does the provision of the ActiveWaiting App lead to increased physical activity behaviour, compared to a no-intervention control group?2. Does the provision of the ActiveWaiting App lead to increased health-related quality of life, compared to a no-intervention control group? Participants will use the ActiveWaiting App over a period of seven days. During this period, they will answer daily questionnaires (3 - 6 questions) in order to gather their actual physical activity behaviour. Before and after the intervention period additional questionnaires on health-related quality of life will be sent to the participants.Participants in the waitlist control group will have a control period (seven days) before using the app.Researchers will compare the intervention group with the waitlist control group to see if the ActiveWating App has an effect* on physical activity behaviour and* on quality of life. ### Conditions - Physical Inactivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - ActiveWaiting App ### Outcomes Primary Outcomes - Amount of physical activity in minutes per day - EQ VAS / EQ-5D-5L Secondary Outcomes - App usage - exercise session length - App usage - total duration per session ### Location - Facility: FH Campus Wien, Vienna, N/A, N/A, Austria @@
## Study of IBI343 in Subjects With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma - NCT ID: NCT06321913 - Study ID: CIBI343Y002 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-12-31 - Lead Sponsor: Harbin Medical University ### Study Description The goal of this clinical trial\] is toevaluate the safety, tolerability and efficacy of IBI343 combined with sintilimab in the treatment of subjects with advanced gastric/gastroesophageal junction adenocarcinoma. The main aim is to evaluate the efficacy and safety of IBI343 combination treatment in subjects with advanced gastric/gastroesophageal junction adenocarcinoma.The secondary aim is to evaluate other efficacy endpoints in subjects with IBI343 combination therapy for advanced gastric/gastroesophageal junction adenocarcinoma.The exploratory purpose is to evaluate the correlation between CLDN18.2 expression levels in tumor tissues and the efficacy of IBI343 combination therapy.Participants will be asked to enroll about 3-12 patients in the safety introduction period.，and about 25 patients are planned to be enrolled in the POC phase. ### Conditions - Advanced Gastric/Gastroesophageal Junction Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - IBI343 combined with IBI308 ### Outcomes Primary Outcomes - ORR - AE - Treatment-Emergent Adverse Event (TEAE) - Adverse Event of Special Interest (AESI) - Serious Adverse Event (SAE) - laboratory examinations - physical examinations - vital signs Secondary Outcomes - PFS - Duration of Response (DoR) - Disease Control Rate (DCR) - Time to Response (TTR) - Overall Survival (OS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Personalized Risk Prediction of Sudden Cardiac Death - NCT ID: NCT06321900 - Study ID: 09M206 - Status: RECRUITING - Start Date: 2023-06-02 - Completion Date: 2025-04-30 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description Sudden cardiac death (SCD) is the final result of cardiac arrest (CA) , defined as an abrupt and unexpected loss of cardiovascular function resulting in circulatory collapse and death. Up to 50% of cardiac deaths in Europe are due to CA. The estimated mortality of CA is approximately 90%, and significant functional and/or cognitive disabilities often persist among those who survive. The advent of the implantable cardioverter-defibrillator (ICD) has revolutionized the prevention of SCD in high-risk patients with reduced left ventricular ejection fraction (LVEF\<35%). However, the algorithm recommended by current guidelines based on LVEF, considered the only parameter to identify high-risk patients, cannot stratify the population and the spectrum of risk with high accuracy. Although the risk of CA is higher among patients with LVEF\<35% and NYHA class\>1, because of the enormity of the population size at risk (i.e., with organic heart disease and LVEF\>35%), most SCD does occur in patients with LVEF\>35%. Additionally, the majority of pts who receive the ICD for primary prevention of SCD will not benefit from the device (in the Sudden Cardiac Death in Heart Failure Trial published in 2005, the rate of appropriate ICD therapy was 21% at five years), and/or will experience some side effects of it. In the Israeli registry of patients who underwent ICD (n= 1729) or cardiac resynchronization therapy (n= 1326), the 12-year cumulative incidence of adverse events was 20% for inappropriate shock, 6% for device-related infection, and 17% for lead failure.Moreover, recent improvements in drug treatment for HF and myocardial revascularization have further reduced the incidence of SCD in pts with low LVEF. Finally, pts with advanced HF are unlikely to benefit from ICD therapy because of the high rates of non-arrhythmic deaths. Therefore, improved risk stratification approaches to guide the selection of pts for ICD implantation are needed, and only a multiparametric approach may aim to personalize the risk prediction of SCD across the broad spectrum of the phenotypes of HF patients.The RESPECT project has been designed to personalize the risk of SCD by integrating and interpreting information highly multidisciplinary: clinical and bio-humoral, genetics and electrocardiography, conventional and advanced cardiac imaging, and data science. The investigators hypothesized that machine learning models capable of dealing with non-linearities and complex interactions among predictors, including genetic, clinical, electrocardiographic, bio-humoral, echocardiographic, cardiac magnetic resonance (CMR), and nuclear cardiology data, would have superior accuracy in predicting the occurrence of SCD compared with the currently recommended metrics of NYHA class and LVEF by two-dimensional echocardiography and that the personalized risk prediction of SCD will translate in more cost-effective use of ICDs. In addition, the investigators will use the multiparametric predictive models to develop a cloud-computing app that will allow clinicians to predict the risk of occurrence of SCD based on specific covariate profiles of individual patients. ### Conditions - Sudden Cardiac Death Due to Cardiac Arrhythmia - Cardiomyopathies - Ischemic Heart Disease - Cardiovascular Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Personalized risk model ### Outcomes Primary Outcomes - Sudden cardiac death Secondary Outcomes ### Location - Facility: Istituto Auxologico Italiano IRCCS, Milan, N/A, 20145, Italy @@
## EffiCacy and sAfEty of Low doSe orAl iRon for Anaemia in IBD - NCT ID: NCT06321887 - Study ID: 5155 - Status: RECRUITING - Start Date: 2023-10-20 - Completion Date: 2025-10-01 - Lead Sponsor: Liverpool University Hospitals NHS Foundation Trust ### Study Description Iron deficiency anaemia (IDA) is common in inflammatory bowel disease (IBD). However, although iron is commonly prescribed, the amount of elemental iron needed to achieve clinical efficacy, and the optimal method of supplementation, are under debate. This pilot study aims to investigate the efficacy and safety of low dose and standard dose oral iron preparations for the treatment of IDA in patients with IBD. ### Conditions - Inflammatory Bowel Disease - Iron Deficiency Anemia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Ferrous fumarate syrup 2.5ml/70mg (22.5mg elemental iron) - Ferrous fumarate syrup 2.5ml/70mg(45mg elemental iron) - Ferrous fumarate syrup 2.5ml/70mg (90mg elemental iron) ### Outcomes Primary Outcomes - Change in haemoglobin concentration from baseline to week 8. Secondary Outcomes - Assessment of iron stores at baseline and week 8 - Assessment of faecal calprotectin at baseline and week 8 - Assessment of IBD severity. For ulcerative colitis this will be done using simple colitis clinical activity index (SCCAI). Values calculated at week 0 and week 8. - Assessment of IBD severity. For Crohn's disease (or IBD-unclassified) the Harvey Bradshaw Index (HBI) will be used. Values calculated at week 0 and week 8. - Assessment of quality of life using the IBD-QUK score at baseline and week 8 - Assessment of patient global assessment of symptom severity by visual analogue score at baseline and week 8. - Assessment of fatigue at baseline and week 8 using IBD-F fatigue score - Assessment of possible drug-related side effects: nausea, diarrhoea, mood disturbance, sleep disturbance - will all be assessed at baseline and week 8. ### Location - Facility: Liverpool University Foundation NHS Trust, Liverpool, N/A, N/A, United Kingdom @@
## Effects of Oxygen After Abdominal Oncological Surgery - NCT ID: NCT06321874 - Study ID: EPHIRAS - Status: COMPLETED - Start Date: 2011-01-01 - Completion Date: 2011-11-01 - Lead Sponsor: Jules Bordet Institute ### Study Description The aims of the research is to determine whether a Hyperoxic intermittent stimuli protocol can increase reticulocyte counts, signififying a rise in EPO production, in patients undergoing abdominal surgery ### Conditions - Abdominal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Oxygen ### Outcomes Primary Outcomes - Percentage change in reticulocyte count Secondary Outcomes - haematocrit levels mesure - haemoglobin levels mesure ### Location - Facility: Khalife Maher, Brussels, N/A, 1000, Belgium @@
## Motivational, Affective and Performance Effects of Caffeine Supplementation - NCT ID: NCT06321861 - Study ID: Caffeine_motivation - Status: RECRUITING - Start Date: 2024-01-19 - Completion Date: 2024-05-01 - Lead Sponsor: Jagiellonian University ### Study Description The main objective of the study is to evaluate the influence of caffeine intake on participants' energetic arousal, affect, motivation to achieve a training goal, satisfaction with training, and the sense of agency during training. Consequently, participants will engage in three sessions: caffeine, placebo, and no substance (in counterbalanced order). During each session, their affective and motivational states will be assessed, along with the performance of a standardized physical exercise test. The investigators hypothesize that participants who consume caffeine (caffeine condition) will exhibit higher levels of energy and motivation compared to the other two groups. Additionally, they are expected to experience greater optimism and expectancy regarding their training goals and achieve better results in the physical exercise test.A secondary aim of the study is to examine the impact of genetic variability on motivational and affective states of participants, as well as their performance in the physical exercise test after caffeine. The investigators will assess the CYP1A2 (-163C \> A, rs762551; characterized such as "fast" (AA genotype) and "slow" caffeine metabolizers (C-carriers)) and ADORA2A (1976T \> C; rs5751876; characterized by "high" (TT genotype) or "low" sensitivity to caffeine (C-carriers)). ### Conditions - Caffeine - Affect - Goals ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Caffeine - Placebo - No substance ### Outcomes Primary Outcomes - Energetic arousal pre-test - Energetic arousal post-test - Optimism - Motivation - Determination - Relative outcome expectancy - Success probability - Prospective effort - Agency - Performance in the 1RM test - Performance in the bar velocity in the bench press test - Performance in the strength-endurance test - Performance in the countermovement jump test - Satisfaction with the results - Retrospective effort - Retrospective agency Secondary Outcomes - Goal importance - Prospective difficulty - Expected performance in the 1RM test - Expected performance in the bar velocity in the bench press test - Expected performance in the strength-endurance test - Expected performance in the countermovement jump test - Retrospective difficulty - Energetic arousal post-training - Perceived effect on agency - Tense arousal - Hedonic tone ### Location - Facility: The Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, N/A, N/A, Poland @@
## Weaning Ventilator Using Heart, Lung And Diaphragm Ultrasound - NCT ID: NCT06321848 - Study ID: DUCGM2426 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-04 - Lead Sponsor: Hanoi Medical University ### Study Description Postextubation distress is detrimental to the prognosis of critically ill patients with successful spontaneous breathing trial. Failure to wean is known to be connected with heart, lung, and diaphragm problems. The aim of this study was to investigate how a composite model comprising diaphragm, lung, and heart ultrasonography indications could predict the weaning outcome.Methods: Ultrasonic features of the diaphragm, heart, and lungs are going to be collected along with clinical data about the patients. Either the successful weaning group or the failed weaning group is going to comprised the patients. Multivariate logistic regression analysis is going to be used to identify the variables that may be associated with the likelihood of weaning failure. A multiindicator combination model is going to be developed to increase the predictive accuracy after the possible indicators' accuracy in foretelling the weaning outcome was assessed. ### Conditions - Ventilator Weaning - Ultrasound ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The ventilator weaning outcome Secondary Outcomes - The hospital length of stay - The ICU length of stay - The duration of mechanical ventilation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Different Patient Positions on Endotracheal Tube Cuff Pressure - NCT ID: NCT06321835 - Study ID: 16-10/13 - Status: COMPLETED - Start Date: 2016-12-09 - Completion Date: 2018-06-15 - Lead Sponsor: Ege University ### Study Description Background: The placement of a cuffed endotracheal tube for the administration of general anesthesia is a routine procedure. In the part of the intubation tube located in the trachea, there is a balloon (cuff) to prevent gase leakage, aspiration of secretions and gastric contents into the lungs. Inadequate inflation of cuff may lead to inadequate ventilation, aspiration and associated complications, while excessive inflation may cause complications in ranging from postoperative pharyngeal complaints to tracheal rupture due to increased cuff pressure. This study aimed to determine the effect of different patient positions on the endotracheal cuff pressure in patients undergoing urological procedures.Methods: This is a prospective study conducted on 200 patients undergoing urological procedures in supine, prone, lateral flank and litotomy positions. After intubation (T0), the cuff pressure was checked with a cuff manometer and adjusted at 25 cmH2O as the baseline and continuously monitored. The cuff pressure was checked again before (T1) and after achieving the final position (T2) and then at 5 (T3), 10 (T4), 15 (T5), 30, 45, 60, 90, 120, 150, 180 minutes after the position, at the end of the procedure (T6) and before extubation (T7). At postoperative 2nd and 12th hours, the patients were interviewed for sore throat, hoarseness and cough. ### Conditions - Endotracheal Tube Cuff Pressure - Patient Positions ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Endotracheal tube cuff pressure measurement ### Outcomes Primary Outcomes - The Effect of Different Patient Positions on Endotracheal Tube Cuff Pressure in Patients Undergoing Urological Procedures: A Prospective Study Secondary Outcomes - The Effect of Different Patient Positions on Endotracheal Tube Cuff Pressure in Patients ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Genetic Diagnosis and Personalized Medicine for Patients With Epilepsy - NCT ID: NCT06321822 - Study ID: EPIEXOME - Status: RECRUITING - Start Date: 2021-08-02 - Completion Date: 2026-12-31 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description Background Epilepsy is a common neurological disorder. It affects 50 million people worldwide and has the highest incidence in pediatric age. According to the latest classification of the ILAE (International League against Epilepsy), epilepsies are divided into lesional (symptomatic) and non-lesional/genetic forms. Symptomatic causes of epilepsy may include scarring, tumors, strokes, and brain developmental disorders such as dysplasias. In approximately 30% of epilepsies a genetic cause of epilepsy can be hypothesized. Since the identification of the first epilepsy gene in 1995, over the next 25 years over 500 genes associated with epilepsy have been identified. The importance of many genes and many gene variants identified in many genes is not yet clear and the mutations identified in different genes require confirmation with functional studies and confirmation on larger series of patients. Furthermore, the genetic defect underlying many patients with epilepsy remains unknown to this day, despite a high level of gene sequencing effort.Molecular studies on these genes have demonstrated how pathogenic variants on these genes determine a protein dysfunction that can cause neuronal hyperexcitability and pathological synchronization of neuronal networks leading to epileptic seizures and brain dysfunction. A notable complication in the field of epilepsy genetics is represented by the fact that the concept of a gene/a disease is valid only in a few cases, as there is a high phenotypic and genotypic heterogeneity so that a gene can present different types of epilepsy even within the same family. This means that there is a complex multigenic and multifactorial genetic substrate for which the impact of a specific genetic variant is conditioned by variants of other genes. This concept is particularly valid for the most common epileptic forms such as idiopathic generalized epilepsies.The integration of genetic analysis with epileptological characterization in clinical practice is increasingly crucial in defining a clear molecular diagnosis in patients whose disease cause would otherwise remain unknown, and potentially allows avoiding other unnecessary diagnostic investigations. It is therefore expected that this will lead to optimizing clinical management and reducing overall costs over time. The genetic finding can constitute a useful biomarker for defining the outcome of the disease and for guiding clinical decisions such as the best choice of therapy. Despite the advantages, before starting the genetic testing process, patients and their family members should be informed about the ethical issues that may arise from genetic testing, the technical limitations, legal aspects and costs of genetic investigation.Aim of the study Characterization of patients with epilepsy recruited at the Hospital Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan (Italy) and analysis with exome NGS sequencing of patients with the highest probability of genetic diagnosis with exome (use of a probability score)Endpoints of study are the following:1. Identification of the genetic cause of the forms of genetic epilepsies with the highest probability of molecular diagnosis with exome2. Clinical-instrumental and epileptological characterization according to the ILAE classification of patients with epilepsy followed at the Fondazione IRCCS Ca' Granda Fondazione Ospedale Maggiore Policlinico3. Correlation of clinical and instrumental parameters (in particular EEG and neuropsychological) of epilepsy recorded on the database with etiology, outcome and response to therapy ### Conditions - Epilepsy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Whole exome sequencing (WES) ### Outcomes Primary Outcomes - Identification of the genetic cause in patients with clinically probable genetic epilepsy using WES Secondary Outcomes - Clinical and epileptological characterization of patients with epilepsy according to ILAE seizure and epilepsy classification - Characterization of qualitative Electroencefagraphy (EEG) features of patients with the different epilepsy types - Quantitative EEG (qEEG) characterization of patients with the different epilepsy types - Characterization of the clinical and instrumental features of patients with specific genetic etiology ### Location - Facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, N/A, 20122, Italy @@
## Intensive Lifestyle Interventions to Overweight and Obese Patients in Primary Care - NCT ID: NCT06321809 - Study ID: HUTF-FM-DABDCO-01 - Status: COMPLETED - Start Date: 2022-01-25 - Completion Date: 2022-12-01 - Lead Sponsor: Duygu Ayhan Baser ### Study Description The goal of this clinical trial is to compare in the effect of different lifestyle interventions in overweight and obese participants. The main questions it aims to answer are:* effect on anthropometric measurements* effect on lipid profile* effect on weight-related quality of life* observe the differences between interventions The study participants were stratified into three groups: intervention, control-1, and control-2.* Intervention group: They were given a calorie-restricted diet and exercise plan by a dietician or physiotherapist at their first visit, and were followed up by telephone calls at weeks 2, 4, 6, 8 and 10 over 12 weeks.* Control-1 group: During the initial medical interview, the participants were given a calorie-restricted diet programme by a dietician and an exercise programme by a physiotherapist; they were followed up over 12 weeks with telephone calls at week 4.* Control-2 group: The participants were not provided with any programme, and the importance of weight loss was emphasised by the family physicians. Dietary and physical activity advice was given according to the recommendations in the Turkish Endocrine and Metabolism Association 2019 Obesity Diagnosis and Treatment Guide, and was followed up with phone calls at weeks 2, 4, 6, 8 and 10 over a 12-weeks. ### Conditions - Obesity - Life Style - Lifestyle, Sedentary ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - intensive lifestyle ### Outcomes Primary Outcomes - primary outcome Secondary Outcomes ### Location - Facility: Hacettepe University, Ankara, N/A, N/A, Turkey @@
## Microbiota Transfer Therapy for Children and Adults With Both Pitt Hopkins Syndrome and Gastrointestinal Disorders - NCT ID: NCT06321796 - Study ID: WCG IRB Protocol #20235847 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2025-05 - Lead Sponsor: Gut-Brain-Axis Therapeutics Inc. ### Study Description The investigators propose to investigate Microbiota Transfer Therapy (MTT) for treating patients with Pitt-Hopkins Syndrome (PTHS) and gastrointestinal problems (constipation, bloating, abdominal pain). MTT involves a combination of 10 days of oral vancomycin (an antibiotic to kill pathogenic bacteria), followed by 1 day of bowel cleanse using magnesium citrate, followed by 4 days of high dose MTP-101P with an antacid, followed by 12 weeks of a lower maintenance dose of MTP-101P with an antacid. ### Conditions - Pitt Hopkins Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MTP-101P - Vancomycin - Magnesium Citrate - Antacid - Placebo MTP-101P - Placebo Vancomycin ### Outcomes Primary Outcomes - Daily Stool Record (DSR) - Safety Measures (Adverse Events) Secondary Outcomes - Gastrointestinal Symptom Rating Scale (GSRS) - Clinical Global Impression - Gastrointestinal (CGI-GI) - Clinical Global Impression - Pitt Hopkins (CGI-PTHS) - Parent Global Impressions - Pitt Hopkins: Change in Symptoms (PGI-PTHS-2-Change) - Gastrointestinal Symptoms common in Pitt Hopkins (GI-PTHS) - Revised Face Legs Activity Crying Consolability Pain Questionnaire (FLACC) - National Survey on treatment Effectiveness for Autism (NSTEA) - Overall Benefit - National Survey on treatment Effectiveness for Autism (NSTEA) - Overall Adverse E ### Location - Facility: Autism/Asperger's Research Group at Arizona State University, Tempe, Arizona, 85287, United States @@
## Relationship Between Cervical Proprioception and Endurance With Hand-eye Coordination and Postural Control - NCT ID: NCT06321783 - Study ID: E-77082166-604.01.02-407303 - Status: RECRUITING - Start Date: 2023-03-06 - Completion Date: 2024-09-06 - Lead Sponsor: Gazi University ### Study Description The aim of our study is to investigate the relationship between cervical proprioception and cervical muscle endurance with hand-eye coordination and postural control in individuals with forward head posture (FHP) and to compare them with a control group with normal head posture. After the demographic information and physical characteristics of the individuals are recorded, their craniovertebral angles (CVA) will be measured and they will be assigned to Group 1 (forward head posture) or Group 2 (normal head posture). Then, the individuals' cervical proprioception, hand-eye coordination, postural control and cervical muscle endurance values will be measured respectively. Cervical muscle endurance will be evaluated last, taking into account possible muscle fatigue, in order not to affect other measurement results. The recorded values will be compared between groups and the relationship of cervical proprioception and muscle endurance with hand-eye coordination and postural control will be examined. All evaluations will be made by the same researcher. ### Conditions - Forward Head Posture ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Assessment ### Outcomes Primary Outcomes - Cervical Proprioception - Hand-Eye Coordination - Postural Stability Test - Stability Limit Test - Modified Sensory Organization Test - Endurance of Cervical Muscles Secondary Outcomes ### Location - Facility: Gazi University, Ankara, Çankaya, 06490, Turkey @@
## Oral Supplementation With Active Collagen Peptides and Skin Health Improvement - NCT ID: NCT06321770 - Study ID: 075-2022 - Status: COMPLETED - Start Date: 2023-03-15 - Completion Date: 2023-05-24 - Lead Sponsor: Gala Servicios Clinicos S.L. ### Study Description The present study aims to investigate the efficacy of daily supplementation with COLLinstant® LMW over a 6-week period in improving visible signs of aging. This in-cludes assessing its impact on skin wrinkle reduction, as well as its potential to en-hance skin elasticity and moisturization. COLLinstant® LMW was administered orally in a single-center, randomized, double-blind, placebo-controlled clinical trial. A sec-ondary objective involves comparing skin improvement, product satisfaction, and monitoring adverse events among middle-aged female volunteers. ### Conditions - Facial Wrinkles - Skin Hydration ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bioactive collagen peptides - Placebo ### Outcomes Primary Outcomes - Skin wrinkling volume (px^3) - Skin wrinkling area (px^2) - Skin wrinkling depth (px) - R0= Skin firmness (mm) - R2= gross elasticity (%) of the skin - R5= Skin net elasticity (%) - R7= Skin elastic recovery (%) - R9= Skin fatigue (mm) - Skin hydration (AU) Secondary Outcomes - Subjective perception of product efficacy - Subjective perception of the organoleptic characteristics of the product - Opinion on the degree of satisfaction with the product ### Location - Facility: GALA Laboratories, Don Benito, Badajoz, 06400, Spain @@
## PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients - NCT ID: NCT06321757 - Study ID: EPIC30-PARIS - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2026-12-30 - Lead Sponsor: Fundación EPIC ### Study Description Post-market, prospective, observational, multicenter, non-intervention study, to demonstrate the effectiveness of drug-coated ballon (DCB)therapy in real-world patients with small native vessel coronary artery disease, and to demonstrate the safety of short dual antiplatelet therapy (7 days) in high-bleeding risk patients with native small vessel coronary artery disease treated with DCB therapy. A percutaneous coronary intervention (PCI) with DCB will be performed in patients with native vessel coronary artery disease based on the criterion of the treating physician. ### Conditions - Coronary Artery Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Percutaneous Coronary Intervention with DCB and DAPT ### Outcomes Primary Outcomes - Effectiveness of DCB therapy Secondary Outcomes - Cardiac death - All-cause mortality - Target vessel myocardial infarction - New target lesion revascularization (TLR) - Target vessel failure (TVF) - Major bleeding - Minor bleeding - 1-year MACE indicende (cardiac mortality, myocardial infarction, and new revascularization of the target lesion) in high-bleeding risk patients treated with a short dual antiplatelet treatment (7 days) ### Location - Facility: Hospital Universitario Clinico San Cecilio, Granada, N/A, 18016, Spain @@
## Study Evaluating the Feasibility of an Adapted Physical Activity Program During the Hospitalization Phase in Cancer Patients Undergoing Treatment - NCT ID: NCT06321744 - Study ID: 2023/825 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Centre Hospitalier Universitaire de Besancon ### Study Description This is a non-randomized, non-controlled feasibility study which will take place at the Besançon University Hospital in the conventional hospitalization department.It will be carried out with patients hospitalized in the conventional hospitalization department of the medical oncology department of Besançon University Hospital.At entry, after presenting the study and obtaining non-opposition from patients, an initial assessment will be carried out before the APA program. This assessment will include an evaluation of physical parameters (measurements of body composition, functional capacities, autonomy in activities of daily living and muscular strength), as well as an evaluation of quality of life relating to health and motivation to practice physical activity.At the end of the initial assessment, an APA program supervised (individually and in a room) by an APA teacher will be offered to patients. The sessions will be offered daily to patients (maximum 5 times/week). They will last on average 20 minutes each depending on the fatigue, pain and fitness of the patients. The objectives pursued are mainly an improvement in functional independence and mobility. ### Conditions - Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - adapted physical activity program (APA Program) ### Outcomes Primary Outcomes - Validate the feasibility of a supervised adapted physical activity (APA) program during the first 7 days of hospitalization in medical oncology for patients with cancer undergoing treatment Secondary Outcomes - Describe the evolution of body composition measured by impedancemetry - Describe the evolution of physical parameters functional capacities - Describe the evolution of autonomy in daily life activities - Describe the evolution of muscular strength - Describe the evolution of the quality of life - Describe the evolution of motivation to practice physical activity - Tolerance with the APA program on perception of effort - Tolerance with the APA program on pain and fatigue - Tolerance with the APA program on fatigue - Compliance with the APA program - Criteria/reasons for non-participation, non-compliance, discontinuation of the intervention and study withdrawals - Patient satisfaction ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Real-World Outcomes in COPD Patients Starting Trixeo (Budesonide/Glycopyrronium/Formoterol) in Spain. - NCT ID: NCT06321731 - Study ID: D5980R00096 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2024-11-30 - Lead Sponsor: AstraZeneca ### Study Description The aim of the ORESTES study is to describe the characteristics of the COPD patients initiating Trixeo (BGF -budesonide/glycopyrronium/formoterol) in Spain and to assess their real-world outcomes up to 12 months afterwards.For that purpose,a descriptive, observational, multi-centre, longitudinal, retrospective cohort study involving \~20 Spanish centres and aiming to include between 500 and 700 patients, has been designed. ### Conditions - Chronic Obstructive Pulmonary Disease (COPD) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Annualized rate of exacerbations after BGF initiation Secondary Outcomes - Demographic and clinical profile of patients initiating BGF. - Lung Function after BGF initiation - Eosinophils count after BGF initiation - Persistence to treatment (BGF) - Need for rescue medication after BGF initiation - Use of oral corticosteroids (OCS) after BGF initiation - HCRUs related to COPD after BGF initiation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pericapsular Nerve Group Block vs Supra Inguinal Fascia Iliaca Compartment Block - NCT ID: NCT06321718 - Study ID: 04-2023-200629 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-04-01 - Lead Sponsor: Assiut University ### Study Description This study aims to assess the efficacy of PENG block performed with LFCN block in controlling postoperative pain and promoting motor function recovery and to compare its effectiveness with S-FICB. ### Conditions - Pain, Postoperative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PENG + LFCN block versus S-FICB ### Outcomes Primary Outcomes - recording time for "return of full muscle power" Secondary Outcomes - • The degree of hip flexion on the operative side - • Static and dynamic pain scores. - postoperative nausea and vomiting (PONV) scale - • The number of rescue analgesia ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety and Efficacy of Continued CS1 Treatment of Patients With Pulmonary Arterial Hypertension - NCT ID: NCT06321705 - Study ID: CS1-004 - Status: AVAILABLE - Start Date: N/A - Completion Date: N/A - Lead Sponsor: Cereno Scientific AB ### Study Description CS1-004 will be an extension of the CS1-003 Study. The primary objective of the CS1-004 study is to evaluate long-term safety and tolerability of continued treatment with CS1. ### Conditions - Pulmonary Arterial Hypertension ### Study Design - Type: EXPANDED_ACCESS - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - CS1 ### Outcomes Primary Outcomes Secondary Outcomes ### Location - Facility: Fredrik Frick, Gothenburg, N/A, N/A, Sweden @@
## Early Identification of Cardiac Involvement in Patients With Carcinoid: Clinical and Prognostic Implications - NCT ID: NCT06321692 - Study ID: IEO 1003 - Status: RECRUITING - Start Date: 2019-10-09 - Completion Date: 2024-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description This study is for patients with neuroendocrine tumours (NET) with or without carcinoid syndrome followed by NET Unit of European Institute of Oncology.The objective of the trial is to evaluate biochemical markers of myocardial injury (high-sensitive troponins), haemodyinamic markers (pro-brain natriuretic peptide (BNP), N-terminal (NT)-BNP (NT-proBNP)), and markers of fibrosis (Suppression of Tumorigenicity 2 (ST2) in patients with neuroendocrine tumours (NET) with or without carcinoid syndrome. ### Conditions - Neuroendocrine Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Evaluation of blood levels of biomarkers of cardiac damage ### Outcomes Primary Outcomes - blood levels of biomarkers of cardiac damage - blood levels of biomarkers of hemodynamic impairment - blood levels of biomarkers of cardiac fibrosis Secondary Outcomes - Correlation between the levels of the biomarkers and the presence/entity of cardiac involvement ### Location - Facility: European Institute of Oncology, Milan, N/A, N/A, Italy @@
## Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer to the Bone - NCT ID: NCT06321679 - Study ID: IEO 1269 - Status: RECRUITING - Start Date: 2020-07-03 - Completion Date: 2027-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description This study is aimed to compare whole body MRI (WB-MRI) with Bone Scintigraphy (BS) and Computerized Tomography (CT) scans in patients receiving treatment for metastatic castration-resistant prostate cancer to the bone.This is a monocentric, prospective observational study. ### Conditions - Castration-resistant Prostate Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Imaging evaluation ### Outcomes Primary Outcomes - Time to disease progression in bone metastasis identify by WB-MRI Secondary Outcomes ### Location - Facility: IEO Istituto Europeo di Oncologia, Milan, N/A, 20141, Italy @@
## Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone - NCT ID: NCT06321666 - Study ID: IEO 0986 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2019-09-12 - Completion Date: 2024-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description This is a non randomized, single arm study, where each patient will undergo imaging with Computed Tomography (CT) and Whole-body magnetic resonance imaging (WB-MRI) at different timepoint. The primary endpoint is time to progression as documented by CT or WB-MRI. ### Conditions - Metastatic Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - WB-MRI ### Outcomes Primary Outcomes - Proportion of disease progression in bone metastasis identified by WB-MRI prior to CT scan Secondary Outcomes ### Location - Facility: IEO Istituto Europeo di Oncologia, Milan, N/A, 20141, Italy @@
## Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes - NCT ID: NCT06321653 - Study ID: IEO 0953 - Status: RECRUITING - Start Date: 2019-04-18 - Completion Date: 2027-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description In this observational prospective studi patients with invasive breast cancer no more than 5 cm and clinically node negative, scheduled for conservative surgery and Sentinel Node Biopsy (SNB), are enrolled in the protocol if they have 1-2 sentinel lymphnodes (SLNs) with macrometastases. SLN status will be checked on definitive sections. ### Conditions - Arm Lymphedema - Breast Cancer - Radiotherapy Side Effect ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Hypofractionated radiotherapy scheme ### Outcomes Primary Outcomes - Percentage of patients with arm lymphedema Secondary Outcomes - Evaluation of cute locoregional toxicity at breast and axilla - Evaluation of chronic toxicity at breast and axilla - Disease free survival - Overall survival - Quality of life (QoL) in order to evaluate pain, itching and burning at breast or axilla ### Location - Facility: European Institute of Oncology, Milan, N/A, N/A, Italy @@
## Study for the Multidimensional Analyses of Resistance and Toxicity to Immune- and Targeted-therapies. - NCT ID: NCT06321640 - Study ID: IEO 1777 - Status: RECRUITING - Start Date: 2022-07-08 - Completion Date: 2025-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description Novel treatment modalities like targeted therapies and Immune checkpoint inhibitors have revolutionised the therapeutic landscape in oncology and hematology, significantly improving outcomes even in clinical contexts in which little improvement had been observed for decades such as metastatic melanoma, lung cancer, and lymphoproliferative neoplasms such as chronic lymphoid leukemia or Hodgkin lymphoma. However, major issues remain unsolved, given the frequent occurrence of primary or secondary resistance and the still incomplete understanding of the physiopathology of adverse events, which represent a major cause of morbidity and treatment interruption and often remain difficult to treat and diagnose. In this complex landscape, identifying the best treatment option for each patient remains challenging. For both targeted therapies and Immune checkpoint inhibitors, several biomarkers have been reported, but their implementation in clinical practice is still uncommon, and most of the decision-making process remains based on purely clinical considerations or constraints dictated by the regulatory bodies. Obstacles to biomarker-driven decision making are manifold and include insufficient understanding of the underlying biology, lack of strong evidence on their predictive power and limited tumor sampling, which may be circumvented by non-invasive techniques such as liquid biopsies. ### Conditions - Breast Cancer - Lung Cancer - Melanoma - Head and Neck Cancer - Urothelial Carcinoma - Colorectal Cancer - Liver Metastases - Lung Metastases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cohort A: primarily operable disease, candidate to adjuvant - Cohort B: locally advanced disease - Cohort C: metastatic disease - Cohort D: Progressive disease - Cohort E: Hematological neoplasms - Cohort F: Toxicity ### Outcomes Primary Outcomes - Percentage of patients in each cohort that will obtain a full "core" omic characterization. Secondary Outcomes - Percentage of patients with complete clinical data collection over the expected follow-up time and with successful biobanking. ### Location - Facility: European Institute of oncology, Milan, N/A, N/A, Italy @@
## Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach - NCT ID: NCT06321627 - Study ID: IEO 1811 - Status: RECRUITING - Start Date: 2023-04-14 - Completion Date: 2024-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description The purpose of this study is therefore to analyze the genomic profiles of prognosis and radiosensitivity of Human Papilloma Virus (HPV) related tumors from different body sites (oropharynx, uterine cervix, and anus), considering them as a unified entity regardless of the site of origin within the body. ### Conditions - HPV-Related Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Radiation therapy as curative treatment ### Outcomes Primary Outcomes - Disease free survival Secondary Outcomes - Genetic patterns of radiosensitivity ### Location - Facility: European Institute of Oncology, Milan, N/A, N/A, Italy @@
## Deep Learning in Classifying Bowel Obstruction Radiographs - NCT ID: NCT06321614 - Study ID: 2022098 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-12-31 - Completion Date: 2024-12-31 - Lead Sponsor: The First Affiliated Hospital of Soochow University ### Study Description Background: Accurate labeling of obstruction site on upright abdominal radiograph is a challenging task. The lack of ground truth leads to poor performance on supervised learning models. To address this issue, self-supervised learning (SSL) is proposed to classify normal, small bowel obstruction (SBO), and large bowel obstruction (LBO) radiographs using a few confirmed samples.Methods: A few number of confirmed and a large number of unlabeled radiographs were categorized based on the ground truth. The SSL model was firstly trained on the unlabeled radiographs, and then fine-tuned on the confirmed radiographs. ResNet50 and VGG16 were used for the embedded base encoders, whose weights and parameters were adjusted during training process. Furthermore, it was tested on an independent dataset, compared with supervised learning models and human interpreters. Finally, the t-SNE and Grad-CAM were used to visualize the model's interpretation. ### Conditions - Digestive System Disease - Polyp of Colon - Bowel Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Diagnostic and classification performance Secondary Outcomes - Visualized interpretation of the self-supervised model ### Location - Facility: TheFirst Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215006, China @@
## Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Years to < 18 Years of Age With AAV - NCT ID: NCT06321601 - Study ID: 20230070 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-31 - Completion Date: 2030-04-28 - Lead Sponsor: Amgen ### Study Description The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV. ### Conditions - Vasculitis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Avacopan ### Outcomes Primary Outcomes - Proportion of Participants Achieving Disease Remission at Week 26 According to the Pediatric Vasculitis Activities Score (PVAS) - Proportion of Participants With Sustained Disease Remission at Week 52 According to the PVAS Secondary Outcomes - Plasma Concentrations of Avacopan - Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) - Proportion of Participants Achieving Disease Remission at Week 26 According to the Birmingham Vasculitis Activity Score (BVAS) - Proportion of Participants Achieving Disease Remission at Week 52 According to the BVAS - Proportion of Participants With PVAS of 0 Over Time Through Week 52 - Proportion of Participants With BVAS of 0 Over Time Through Week 52 - Change From Baseline Over 52 Weeks in Urinary Albumin-Creatinine Ratio (UACR) - Change From Baseline Over 52 Weeks in Estimated Glomerular Filtration Rate (eGFR) - Change From Baseline Over 52 Weeks In Physician Global Assessment (PGA) of Disease Activity - Change From Baseline Over 52 Weeks in Pediatric Vasculitis Damage Index (PVDI) - Number of Glucocorticoid Dosages Administered - Proportion of Participants Across the Taste Score Categories of the TASTY Faces Scale - Taste and Acceptability Score of Avacopan per TASTY Faces Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Autoimmune Dementia: Predictors of Neuronal Synaptic Antibodies in Patients With New-ONset Cognitive Impairment - NCT ID: NCT06321588 - Study ID: GR-2021-12373134 - Status: RECRUITING - Start Date: 2023-05-10 - Completion Date: 2026-06-30 - Lead Sponsor: Azienda Usl di Bologna ### Study Description The goal of this observational study is to investigate the frequency and the possible pathogenic role of neuronal synaptic antibodies (NSAb) in patients with cognitive impairment (CI). The main questions it aims to answer are:1. the frequency and associated features of NSAb in patients with CI and the usefulness of a clinical score in improving autoimmune dementia (AID) diagnosis;2. the clinical significance of NSAb in patients with CI not fulfilling the autoimmune encephalitis (AE) criteria and serum NSAb (NSAb-pos-CI);3. the impact of blood-brain-barrier (BBB) dysfunction on their pathogenicity. ### Conditions - Cognitive Impairment - Dementia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - frequency of antibodies against neuronal antigens - frequency of antibodies against neuronal antigens - creation of a score that predicts the presence of NSAb Secondary Outcomes - changes of neurodegeneration biomarkers - changes of neurodegeneration biomarkers - changes of neuroanatomy - changes of neuroanatomy - changes of inflammatory biomarkers - changes of inflammatory biomarkers - changes of brain blood barrier biomarkers - changes of brain blood barrier biomarkers ### Location - Facility: IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, N/A, 40139, Italy @@
## The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial) - NCT ID: NCT06321575 - Study ID: AVA-CL-5000 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-11 - Lead Sponsor: Avantec Vascular ### Study Description The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System when used as indicated in 159 subjects with symptomatic infrainguinal peripheral arterial disease (PAD) in up to 15 investigational sites in the U.S. ### Conditions - Peripheral Arterial Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS) ### Outcomes Primary Outcomes - Freedom from major adverse events (MAE) - Technical success Secondary Outcomes - Change in % stenosis in target lesion after treatment with Golazo Peripheral AS - Procedural Success Rate - Clinical Success Rate - Rates of all adverse events classified as MAEs - Incidence of minor target limb amputation - Incidence of myocardial infarction - Incidence of target vessel revascularization (TVR) in the target limb - Incidence of angiographic procedural distal embolization in the target limb - Time to primary patency of the target vessels - Time to assisted primary patency of the target vessels - Time to secondary patency of the target vessels ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety and Tolerability of a Timolol Releasing Intraocular Implant in Subjects With Primary Open-angle Glaucoma - NCT ID: NCT06321562 - Study ID: EyeD-010-003 - Status: RECRUITING - Start Date: 2023-03-01 - Completion Date: 2027-07 - Lead Sponsor: EyeD Pharma ### Study Description The purpose of this study is to test a new method to deliver an approved medicine called Timolol in the eye of participants with glaucoma and pseudophakia. The main questions it aims to answer are how safe the investigational drug is and how the body tolerates it.The study will also check:* how safely the implant is placed in and removed from the eye and how the body responds to the procedure,* how safe different doses of timolol are and how the body handles taking it,* the amount of Timolol released in the bloodstream,* if there is any positive effect on the pressure inside the eye. ### Conditions - Primary Open-angle Glaucoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - TimoD implant - Injector system ### Outcomes Primary Outcomes - Number and proportion of participants experiencing one or more serious adverse events (SAEs) - Number and proportion of participants experiencing one or more treatment-emergent adverse events (TEAEs) overall and by dose group Secondary Outcomes ### Location - Facility: CHU - Service d'Ophtalmologie, Liège, N/A, 4000, Belgium @@
## New Era of DIEP With Minimally Invasive Mastectomy - NCT ID: NCT06321549 - Study ID: 202201562B0 - Status: COMPLETED - Start Date: 2022-10-03 - Completion Date: 2023-10-02 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description The free deep inferior epigastric artery perforator (DIEP) flap is the gold standard in autologous breast reconstruction. Asian patients often present with a smaller body mass index with relatively insufficient tissue. To restore appropriate symmetry, a larger flap inset ratio must be transferred. Supercharging of the second vein or inclusion of bilateral pedicle is commonly required. Current paradigm shifts in mastectomy has also resulted in more minimally invasive surgeries (MIS) espousing smaller lateral incisions, leading to a significant change in available recipient vessels. This study aimed to demonstrate our experience in changing strategies of DIEP flaps following the evolution of mastectomy techniques.Between October 2008 and March 2022, retrospective data was gathered for 278 patients who underwent breast reconstruction surgery utilizing DIEP flaps by a single plastic surgeon. These patients were divided into two distinct groups based on their operation dates, with November 2018 marking a pivotal moment when the first MIS was introduced. ### Conditions - Breast Reconstruction - Mastectomy; Lymphedema ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - The reference point of minimally invasive mastectomy procedure conducted ### Outcomes Primary Outcomes - Endoscopy mastectomy - Robotic mastectomy - Incision - Usage of SIEV - Inclusion of bipedicle - Location of recipient artery/vein - Recipient artery/vein selection Secondary Outcomes ### Location - Facility: Chang Gung Memorial Hospital, Taoyuan, N/A, 33305, Taiwan @@
## Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT) - NCT ID: NCT06321536 - Study ID: STUDY00007230 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-06 - Lead Sponsor: Emory University ### Study Description REACT is a phase two, open-label, cluster randomized, crossover study of microbiota therapy (MT) to reduce colonization with multi-drug resistant organisms (MDRO). REACT is designed to assess the safety and efficacy of MT administered to subjects colonized with a MDRO. The overarching hypothesis is that MT can reduce MDRO colonization with safety that is comparable to observation. ### Conditions - Multi-Drug Resistant Organism Colonization ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Allogeneic Microbiota in Glycerol (9%) (AMG) ### Outcomes Primary Outcomes - Difference in number of solicited Adverse Events (AEs) - Difference in severity of solicited AEs - Difference in number of unsolicited AEs - Difference in severity of unsolicited AEs - Difference in proportion of participant stool positive cultures for any target MDRO among AMG-treated compared to Observation participants Secondary Outcomes - Count of serious AEs (SAEs) - Count of AEs of Special Interest (AESIs) - Proportion of stool cultures at Day 28 positive for category-specific MDROs ### Location - Facility: Emory University Hospital, Atlanta, Georgia, 30322, United States @@
## A Study to Learn About the Study Medicine Called Tafamidis 61mg in People Diagnosed With Transthyretin Amyloid Cardiomyopathy (ATTR-CM) - NCT ID: NCT06321523 - Study ID: B3461122 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-19 - Completion Date: 2025-04-30 - Lead Sponsor: Pfizer ### Study Description The purpose of this clinical trial is to learn about the effects of the study medicine (called Tafamidis 61milligrams (mg)) for the potential treatment of Transthyretin amyloid cardiomyopathy (ATTR-CM).This study is seeking participants who were prescribed Tafamidis 61mg after being diagnosed with ATTR-CM and have taken Tafamidis 61mg at least once.We will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe and effective. ### Conditions - Transthyretin Amyloid Cardiomyopathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tafamidis 61 milligrams ### Outcomes Primary Outcomes - Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification - Change from baseline in six-minute walk test - Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS) - Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration - Change From Baseline in Troponin I and Troponin T - number of participants with Any Heart Block - number of participants with Atrioventricular (AV) block - Change From Baseline in Left Ventricular Ejection Fraction - Change From a Baseline in Diastolic function grades - Change from Baseline in Left Ventricular Wall Thickness - Change From Baseline in Global Longitudinal Strain scores Secondary Outcomes - Frequency of cardiovascular hospitalizations - Frequency of death due to any cause ### Location - Facility: Pfizer, Seoul, N/A, N/A, Korea, Republic of @@
## A Study to Learn About Dacomitinib in Patients With Non-small Cell Lung Cancer. - NCT ID: NCT06321510 - Study ID: A7471070 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03-15 - Lead Sponsor: Pfizer ### Study Description The purpose of this study is to learn about dacomitinib for the possible treatment of lung cancer.This study is seeking participants who:* have lung cancer that could not be controlled.* have a type of gene called epidermoid growth factor receptor. A gene is a part of your DNA that has instructions for making things your body needs to work.* have received dacomitinib for their lung cancer.All participants in this study had received dacomitinib. Dacomitinib is a tablet that is taken by mouth at home. They continued to take dacomitnib until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective. ### Conditions - Lung Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Percentage of patients with dacomitinib dosage change and reasons - Percentage of patients with dacomitinib treatment discontinuation Secondary Outcomes - Real-world overall survival (rwOS) - Real-world progression-free survival - Real-world best objective response rate (rwORR) - real-world intracranial response rate (rwIC-ORR) - real-world extracranial response rate (rwEC-ORR) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Extracorporeal Carbon Dioxide Removal Using PrismaLung in Reducing Ventilator Induced Lung Injury - NCT ID: NCT06321497 - Study ID: 85711 - Status: RECRUITING - Start Date: 2024-02-05 - Completion Date: 2028-02-28 - Lead Sponsor: Peninsula Health ### Study Description Lung protective ventilation with low tidal volumes and low driving pressure are known to reduce mortality in mechanically ventilated patients with acute respiratory failure. This reduction in mortality is known be due to reduction of ventilator induced lung injury that occurs due to high tidal volumes and high driving pressure. When receiving such mechanical ventilation, some patients develop hypercapnia and associated hypercapnic acidosis. Such patients have an increased risk of mortality. While the exact reasons for such increase in mortality is not known, it is recommended to minimise hypercapnia and hypercapnic acidosis during lung protective ventilation. Minimally invasive extracorporeal carbon dioxide removal (ECCO2R) devices are shown to reduce hypercapnia and hypercapnic acidosis. There are several devices that are currently available in the current clinical practice. However, the effect of these devices on reduction in ventilator induced lung injury is not clearly demonstrated. This study aims to assess the use of an ECCO2R device called Prismalung in reducing ventilator induced lung injury. PrismaLung is currently used in our intensive care unit. This assessment is done by measuring interleukins in bronchoalveolar lavage fluid and blood interleukin levels as well as clinical assessment including the reduction of driving pressure. ### Conditions - ARDS, Human ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Extracorporeal carbon dioxide removal ### Outcomes Primary Outcomes - Reduction in driving airway pressures Secondary Outcomes - Reduction in pulmonary inflammation assessed by interleukins in lung ### Location - Facility: Frankston Hospital, Frankston, Victoria, 3199, Australia @@
## Intraperitoneal Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cells in Recurrent Ovarian Cancer - NCT ID: NCT06321484 - Study ID: 23-493 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2031-10-31 - Lead Sponsor: Dana-Farber Cancer Institute ### Study Description The goal of this research study is to evaluate the safety and effectiveness of the use of cytokine-induced memory-like (CIML) natural killer (NK) cell therapy combined with IL-15 superagonist (N-803) in recurrent, high grade ovarian cancer (HGOC).Names of the study therapies involved in this study are:* CIML NK (cellular therapy)* N-803 (a novel immune-cell stimulator) ### Conditions - Platinum-resistant Ovarian Cancer - Recurrent Ovary Cancer - Ovarian Cancer - Ovarian Carcinoma - Ovarian Carcinoma, Recurrent ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Cytokine-Induced Memory-like Natural Killer Cells - IL-15 Superagonist ### Outcomes Primary Outcomes - Maximum Tolerated Dose (MTD) (Cohort 1) - Dose Limiting Toxicity (DLT) (Cohort 1) Secondary Outcomes - Overall Response Rate (ORR) - Median Progression Free Survival (PFS) - Clinical Benefit Rate (CBR) - Duration of Response (DOR) - 6 months Progression Free Survival (PFS6) ### Location - Facility: Brigham and Women's Hospital, Boston, Massachusetts, 02215, United States @@
## AeviceMD for Pediatric Asthma Management - NCT ID: NCT06321471 - Study ID: STUDY00002858 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-02 - Lead Sponsor: Irina Dralyuk ### Study Description A wearable remote patient monitor (AeviceMD) is to be used to monitor the respiratory health of pediatric asthma patients in this pilot study. Patients prescribed with AeviceMD should be able to gain better control over their disease during home management. Physicians should be able to optimize treatment for these patients using objective data collected from and of these patients outside of the clinic. The AeviceMD should also be used as a remote auscultation device for teleconsultations. ### Conditions - Asthma - Asthma in Children - Pediatric Asthma - Chronic Respiratory Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - AeviceMD ### Outcomes Primary Outcomes - To evaluate the effectiveness of implementing home monitoring technology for asthma patients in delivering care to patients and in extension determine, if Aevice Medical Device can improve home management of Asthma for pediatrics patients. Secondary Outcomes - To determine if the AeviceMD is effective as a remote auscultation tool for the facilitation of teleconsultations. ### Location - Facility: Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States @@
## Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity - NCT ID: NCT06321458 - Study ID: LightWAY - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2048-12 - Lead Sponsor: Carsten Dirksen ### Study Description In this trial, the aim is to assess the clinical benefits and harms, as well as cost-effectiveness of an intensive weight loss (IWL) intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with existing weight management programmes within primary care for people with severe and complex obesity. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intensive weight loss intervention - Usual care ### Outcomes Primary Outcomes - MetS-Z - Weight Secondary Outcomes - Short-Form-36, mental component score - Gait speed - Weight loss (20%) ### Location - Facility: Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet, Frederiksberg, N/A, 2000, Denmark @@
## The Success of ChatGPT in Providing American Society of Anesthesiologist (ASA) Scores - NCT ID: NCT06321445 - Study ID: ChatGptASAscore - Status: RECRUITING - Start Date: 2024-02-08 - Completion Date: 2024-05-01 - Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital ### Study Description Patients applied to the anesthesia clinics of Health Science University Istanbul Kanuni Sultan Suleyman Training and Research Hospital and Basaksehir Cam and Sakura City Hospital were included in the study. Evaluation forms which will be filled in every preoperative examinations will be saved in the hospitals systems. Patients datas without indentification informations will be asked to ChatGpt to give anesthesiological risc scores. This scores will be compared with the scores already given by anesthesiologists. ### Conditions - Artificial Intelligence - Preoperative Evaluation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - providing ASA score ### Outcomes Primary Outcomes - The Success of ChatGPT in Providing American Society of Anesthesiologist (ASA) Scores Secondary Outcomes - The Success of ChatGPT in clinical decisions ### Location - Facility: Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital, Istanbul, N/A, 34303, Turkey @@
## Intensive Weight Loss Intervention Versus Usual Care for Adults With Obesity - NCT ID: NCT06321432 - Study ID: LightCARE - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2048-12 - Lead Sponsor: Carsten Dirksen ### Study Description In this trial, the aim is to assess the clinical benefits and harms, as well as cost-effectiveness of an intensive weight loss (IWL) intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with existing weight management programmes within primary care for people with obesity class I or uncomplicated obesity class II or higher. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intensive weight loss intervention - Usual care ### Outcomes Primary Outcomes - Weight Secondary Outcomes - Weight loss (20%) - Short-Form-36, mental component score - Gait speed - MetS-Z ### Location - Facility: The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre, Copenhagen, N/A, 2650, Denmark @@
## ATLS vs Standard Care Trial - NCT ID: NCT06321419 - Study ID: atls-vs-standard-care - Status: NOT_YET_RECRUITING - Start Date: 2024-10 - Completion Date: 2029-11 - Lead Sponsor: Karolinska Institutet ### Study Description Rationale:Trauma is a massive global health issue. Many training programmes have been developed to help physicians in the initial management of trauma patients. Among these programmes, Advanced Trauma Life Support® (ATLS®) is the most popular, having trained over one million physicians worldwide. Despite its widespread use, there are no controlled trials showing that ATLS® improves patient outcomes. Multiple systematic reviews emphasise the need for such trials.Aim:To compare the effects of ATLS® training with standard care on outcomes in adult trauma patients.Trial Population:Adult trauma patients presenting to the emergency department of a participating hospital.Eligibility Criteria:Hospitals are secondary or tertiary hospitals in India that admit or refer/transfer for admission at least 400 patients with trauma per year. Clusters are one or more units of physicians providing initial trauma care in the emergency department of tertiary hospitals in India. Patients participants are adult trauma patients who presents to the emergency department of participating hospitals and are admitted or transferred for admission.Ethical Considerations:The study will use an opt-out consent approach for in-hospital collection of routinely recorded data, in which consent is presumed unless actively declined. Informed consent for non-routinely recorded data including out of hospital follow up will be obtained. Patients who are unconscious or lack a legally authorized representative will be included under a waiver of informed consent. Note that consent here refers to consent to data collection, as it will not be possible for patients to opt out from being subjected to the intervention. This approach is justified because the trial can be considered to involve only minimal risk and the data collection is non-invasive and mostly involve extracting routinely collected data from medical records.Funding:Swedish Research Council (reg. no. 2023-03128), Laerdal Foundation (reg. no. 2023-0297).Special considerations:This trial is not yet fully funded. The Trial Management Group has decided to proceed with the trial with the expectation that additional funding will be secured. The Joint Trial Steering and Data Monitoring Committee will be informed of the funding status at each meeting. If funding is not secured, the trial will be stopped. This will likely result in an underpowered trial. The justification for this decision is that the intervention is considered standard of care in many countries and the data collection is considered minimal risk. There is therefore a very small risk of harm to patient participants, but a potential direct benefit to those. ### Conditions - Wounds and Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Advanced Trauma Life Support training ### Outcomes Primary Outcomes - All-cause mortality within 30 days of arrival at the emergency department. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Superficial Neuromuscular Stimulation in Post-stroke Dysphagic Patients. - NCT ID: NCT06321406 - Study ID: KayseriCHdysphagia - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-07-15 - Lead Sponsor: Kayseri City Hospital ### Study Description Swallowing disorder in stroke patients is a significant cause of morbidity and mortality as it can cause aspiration pneumonia. Electrical stimulation has proven to be effective in post-stroke dysphagic patients.10 patients who have symptoms of post-stroke dysphagia, meet the inclusion criteria and volunteer to participate will be included in the study. Included patients will be randomized into 2 groups. The exercise program will be applied to both groups as a home program for 4 weeks. ### Conditions - Dysphagia - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - NMES (neuromuscular electrical stimulation) - Exercise ### Outcomes Primary Outcomes - Ultrasonographic measurements Secondary Outcomes - Functional Oral Intake Scale (FOIS) - Swallowing Function Screening Test (EAT-10) - GUSS (Gagging Swallowing Screening Test) - Modified Mann Swallowing Ability Assessment Test (MMASA) - SWAL-QOL (The impact of swallowing disorders on quality of life questionnaire) ### Location - Facility: health sciences university Kayseri medicine faculty, Kayseri, N/A, 38080, Turkey @@
## Effects of a CSE With ADIM in Chronic Non-specific Low Back Pain With Lumbar Instability Using Telerehabilitation. - NCT ID: NCT06321393 - Study ID: HE662176 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-12-31 - Lead Sponsor: Khon Kaen University ### Study Description The goal of this clinical trial is to compare the effectiveness of telerehabilitation-based and clinic-based methods to deliver a Core Stabilization Exercise Program with the Abdominal Drawing-In Maneuver Technique (CSE with ADIM) on pain intensity, functional ability, quality of life, and satisfaction in chronic low back pain patients with lumbar instability.The main question it aims to answer is: Is there a difference between the effectiveness of telerehabilitation-based and clinic-based CSE with ADIM on pain intensity, functional ability, quality of life, and satisfaction in chronic low back pain patients with lumbar instability?Participants will perform a 7-week core stabilization exercise with the abdominal drawing-in maneuver technique, consisting of an exercise program for 20-minute sessions with 3 sessions per week. These exercise programs will be provided to the participants via a weekly video call with the main researcher as a telerehabilitation program. At the first session of each week, the researcher will provide supervision via video call with the participant for the exercise program. The participants will perform the exercise by following the video demonstration. After completing weekly training, participants will perform their exercise routine as part of their daily home program.If there is a comparison group: researchers will compare The control group (clinical-base group) will be provided the 7-week core stabilization exercise with abdominal drawing-in maneuver technique, the same as the experimental group, but control groups received the exercise program at the clinic according to the usual methods. At the first session of each week, an appointment will be set, and then the specific exercise for each week will be delivered and trained by the main researcher at the clinic. After completing weekly training, participants will perform their exercise routine as part of their daily home program to see if there are any differences in pain intensity, functional ability, quality of life, and satisfaction in chronic low back pain patients with lumbar instability between the experimental and control groups. ### Conditions - Chronic Low-back Pain - Lumbar Instability ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 7-week Core stabilization exercise with abdominal drawing-in maneuver technique ### Outcomes Primary Outcomes - 11-ponits Numerical Rating Scale (0-10 NRS) Secondary Outcomes - Oswestry disability index (ODI) - Roland Morris Disability Questionnaire (RMDQ) - 36-item Short Form Survey (SF-36) - Lumbar joint reposition sense error - Satisfaction questionnaire ### Location - Facility: Miss Chutimon Kongsa, Maha Sarakham, Mahasarakham, 44000, Thailand @@
## Working Memory Functioning in Alzheimer's Disease and Vascular Dementia - NCT ID: NCT06321380 - Study ID: 38RC23.0381 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-10 - Lead Sponsor: University Hospital, Grenoble ### Study Description The aim of the present study is to investigate potential cognitive mechanisms contributing to working memory impairment in Alzheimer's disease and vascular dementia. The investigators consider a new hypothesis suggesting that difficulties in mobilizing maintenance strategies of information could explain this working memory deficit. More specifically, the investigators assume that patient groups will have difficulties in employing both refreshing and elaborative strategies during a working memory task (i.e., complex span task), as compared to a control group. ### Conditions - Alzheimer Disease - Vascular Dementia - Mixed Dementias ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Complex span task - Clinical neuropsychological assessment - Clinical neurospychological assessement ### Outcomes Primary Outcomes - Memory performance in the Working memory task - Processing performance in the Working memory task - Reaction time Secondary Outcomes - Mini-Mental State Examination (MMSE) - Digit span forward WAIS IV (digit number) - Digit span forward WAIS IV (standard note) - Digit span backward WAIS IV (digit number) - Digit span backward WAIS IV (standard note) - Stroop Test - denomination part - Stroop Test - minor interference part (Time) - Stroop Test - minor interference part (errors) - Stroop Test - major interference part (time) - Stroop Test - major interference part (errors) - Trail Making Test - Part A (time) - Trail Making Test - Part A (errors) - Trail Making Test - Part B (time) - Trail Making Test - Part B (errors) - Category fluences - Memory evaluation (16-item Free and Cued Recall, or GERIA-12) - Naming task - Behavior rating inventory of executive function - Instrumental Activities of Daily Living - Activities of Daily Living ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Model to Predict Coinfection in Elderly Patients With COVID-19 - NCT ID: NCT06321367 - Study ID: 202401002 - Status: COMPLETED - Start Date: 2022-12-20 - Completion Date: 2023-06-30 - Lead Sponsor: Xiangya Hospital of Central South University ### Study Description The goal of this observational study is to learn about the clinical characteristics and construction of a predictive model in elderly COVID-19 patients. The main question it aims to answer is the main clinical characteristics and risk factors of elderly COVID-19 patients. Participants will not be asked to do any other intervening measure. ### Conditions - Covid19 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Coinfection Secondary Outcomes ### Location - Facility: Xiangya Hospital of Central South University, Changsha, Hunan, 410000, China @@
## Pre-emptive Infiltration of the Scalp With Diprospan Plus Ropivacaine for Pain After Craniotomy in Children - NCT ID: NCT06321354 - Study ID: KY 2018-066-02-3 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-11-02 - Lead Sponsor: Beijing Tiantan Hospital ### Study Description At present, pediatric postoperative analgesia has not been fully understood and controlled, particularly craniotomy surgery. On the one hand, professional evaluation of postoperative pain for young children is difficult; on the other hand, the particularity of craniotomy adds (such as consciousness obstacle, sleepiness, et al) disturbance to the pain assessment in children. Although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. For the avoidance of side-effects of systemic opioids, local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was unsatisfactory due to its short pain relief duration, steroid as adjuvant can enhance postoperative analgesia and prolong postoperative analgesia time. As is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction. Researchers have clarified that the addition of diprospan to local infiltration of analgesia could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries. To date, no studies have evaluated the addition of diprospan to local infiltration for patients receiving craniotomy.Thus, investigators suppose that pre-emptive scalp infiltration with steroid (Diprospan) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children. ### Conditions - Pain - Postoperative Children ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - The diprospan plus ropivacaine group - The ropivacaine group ### Outcomes Primary Outcomes - modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS) Secondary Outcomes - modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS) - The time to the first rescue analgesic - Patient satisfactory scale (PSS) - Length of stay (LOS) - The occurrence of postoperative nausea and vomiting (PONV) - Ramsay Sedation Scale (RSS) - The occurrence of respiratory depression - Heart rate - Mean arterial pressure - The total consumption of opioids during the operation - The total consumption of anaesthetic during the operation - Wound Healing Score - Incisional related adverse events - The occurrence of the Adverse events (AEs) and serious adverse events (SAEs) ### Location - Facility: Beijing Children's hospital affiliated to capital medical university, Beijing, Beijing, 100045, China @@
## Efficacy and Safety of Vespireit, Sustained-release Tablets, in Patients With Autonomic Dysfunction Syndrome Accompanied by Functional Vertigo - NCT ID: NCT06321341 - Study ID: BUSP-04-04-2023 - Status: RECRUITING - Start Date: 2024-01-24 - Completion Date: 2026-12-31 - Lead Sponsor: Valenta Pharm JSC ### Study Description Study of efficacy and safety of Vespireit, prolonged-release tablets, 15 mg (Valenta Pharm JSC, Russia) in comparison with Arlevert, tablets, 40 mg + 20 mg (Menarini International Operations Luxembourg S.A., Luxembourg) in patients with autonomic dysfunction syndrome accompanied by functional vertigo. ### Conditions - Vertigo - Autonomic Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vespireit - Arlevert ### Outcomes Primary Outcomes - Change in Mean vertigo score (MVS) at Visit 1-3 of the Primary Therapy Period relative to baseline at Visit 1-1 Secondary Outcomes - Change in mean MVS score at Visit 1-2 of the Primary Therapy Period relative to baseline at Visit 1-1. - Change in mean MVS score at Visits 2-2, 2-3, and 2-4 of the Retreatment Period compared with Visit 2-1. - Change in mean MVS score at the visit of completion of study participation compared with the score at Visit 1-1 in patients who completed the study according to the protocol (PP(response)). - Percentage of patients with a ≥50% reduction in total DHI score on Visit 1-3 of the Primary Therapy Period relative to Visit 1-1. - Percentage of patients with a ≥50% reduction in total DHI score on Visits 2-3 and 2-4 of the Retreatment Period relative to Visit 2-1. - Percentage of patients with a ≥25% reduction in total DHI score on Visit 1-3 of the Primary Therapy Period relative to Visit 1-1. - Percentage of patients with a ≥25% reduction in total DHI score on Visits 2-3 and 2-4 of the Retreatment Period relative to Visit 2-1. - Change in total score on the DHI at Visit 1-3 of the Primary Therapy Period compared with Visit 1-1. - Change in total score on the DHI at Visits 2-3 and 2-4 of the Retreatment Period compared with Visit 2-1. - Change in total score on the DHI at the study participation completion visit compared to the score at Visit 1-1 in patients who completed the study according to the protocol (PP(response)). - Change in digital rating scalescore from Visit 1-1 to Visits 1-2 and 1-3 in the Primary Treatment Period. - Change in digital rating scale score from Visit 2-1 to Visits 2-2, 2-3, and 2-4 in the Retreatment Period. - Assessment of quality of life in patients with autonomic dysfunction syndrome accompanied by functional vertigo using the EQ-5D questionnaire at Visit 1-3 of the Primary Therapy Period. - Assessment of quality of life in patients with autonomic dysfunction syndrome accompanied by functional vertigo using the EQ-5D questionnaire at Visits 2-3 and 2-4 of the Retreatment Period. - Change in total score on the Hamilton Anxiety Rating Scale HARS at Visit 1-3 of the Primary Treatment Period compared with Visit 1-1. - Change in total score on the Hamilton Anxiety Rating Scale HARS at Visits 2-3 and 2-4 of the Retreatment Period compared with Visit 2-1. - Change in VSS-SF total score at Visit 1-3 of the Primary Therapy Period relative to baseline at Visit 1-1. - Change in VSS-SF total score at Visits 2- 3 and 2-4 of the Retreatment Period compared with Visit 2-1. - Change in VSS-SF total score at the study participation completion visit compared with the score at Visit 1-1 in patients who completed the study according to protocol (PP(response)). - Evaluation of therapy efficacy on the CGI-i scale by the patient at Visits 1-2 and 1-3 in the Primary Therapy Period. - Evaluation of therapy efficacy on the CGI-i scale by the physician at Visits 1-2 and 1-3 in the Primary Therapy Period. - Evaluation of therapy efficacy on the CGI-i scale by the patient at Visits 2-2, 2-3, and 2-4 in the Retreatment Period. - Evaluation of the effectiveness of therapy on the CGI-i scale by the physician at Visits 2-2, 2-3, 2-4 in the Re-Treatment Period. - Proportion of patients with exacerbation (relapse) of the disease after treatment in the Primary Treatment Period during the entire follow-up period (until the visit of completion of participation in the study) - Duration of remission period after treatment in the Primary Therapy Period. Remission means absence of episodes of exacerbations (relapses) - Clinically significant abnormalities on physical and/or neurologic examination - Adverse events (AEs) - Serious adverse events (SAEs) - Adverse reactions - Рatients with at least one AE - Patients discontinued due to AE ### Location - Facility: Central Clinic LLC, Bryansk, N/A, 241050, Russian Federation @@
## Success of ChatGPT in Determining the Need for Postoperative Intensive Care - NCT ID: NCT06321328 - Study ID: ChatGpt postoperative ICU - Status: NOT_YET_RECRUITING - Start Date: 2024-03-16 - Completion Date: 2024-05-01 - Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital ### Study Description This is a prospective, observational study to be conducted at Sağlık Bilimleri University Istanbul Kanuni Sultan Süleyman Training and Research Hospital and Başakşehir Çam and Sakura City Hospital. The study aims to record various preoperative and postoperative data of patients who have undergone surgeries, specifically those with ASA scores of III and IV or those indicated to potentially need postoperative intensive care. Data points include patient demographics, type of surgery, ASA score, comorbidities, lab and imaging findings, and both actual and ChatGPT version 4 predicted outcomes regarding postoperative intensive care needs, anesthesia methods, duration of stay in intensive care and the hospital, and 30-day mortality rates. ChatGPT version 4's predictions will be compared with actual outcomes and anesthesiologist decisions. ### Conditions - Artificial Intelligence - Intensive Care Unit - PACU Length of Stay ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Intensive care predictions Secondary Outcomes ### Location - Facility: istanbul Kanuni Sultan Süleyman Education and Training Hospital, Istanbul, N/A, 34303, Turkey @@
## The Effect of Case-based Teaching on Midwifery Undergraduate Students - NCT ID: NCT06321315 - Study ID: KSUESRAKARATASOKYAY006 - Status: RECRUITING - Start Date: 2024-03-19 - Completion Date: 2024-04-30 - Lead Sponsor: Kahramanmaras Sutcu Imam University ### Study Description Case-based teaching will be applied to second year midwifery undergraduate students. The intervention group (case-based teaching implementation group) and the control group each consist of 35 students. ### Conditions - Midwifery Students ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Case-based instruction ### Outcomes Primary Outcomes - Determination of Critical Thinking Motivation - Determination of Critical Thinking Motivation Secondary Outcomes - Determining the level of Academic Motivation - Determining the level of Academic Motivation - Determining the status of access to information - Determining the status of access to information - Evaluation of satisfaction with the training methods used and the effect of training methods on perceptions of competence during clinical practice - Evaluation of satisfaction with the training methods used and the effect of training methods on perceptions of competence during clinical practice ### Location - Facility: Kahramanmaras Sutcu Imam University, Kahramanmaraş, Kahramanmaras, 46050, Turkey @@
## A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy - NCT ID: NCT06321302 - Study ID: 1436-0007 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-08 - Completion Date: 2026-11-11 - Lead Sponsor: Boehringer Ingelheim ### Study Description This study is open to adults with diabetic retinopathy. People who have non-proliferative diabetic retinopathy of moderate or high severity can join the study.The purpose of this study is to find out whether a medicine called BI 764524 helps people with diabetic retinopathy. The study also aims to find a suitable treatment plan for BI 764524. Participants are put into 5 groups by chance. Participants in groups 1, 2, and 3 get BI 764524. Over 1 year, they get a different number of injections of the same dose of BI 764524 injected into 1 eye. During some visits, participants may get a sham control, which is done like an eye injection but without a needle, so that participants will not know how many injections of BI 764524 they received. Participants in group 4 only get a sham control. Participants in group 5 (only in the USA) get aflibercept or sham injections during some visits. Aflibercept is a medicine already used to treat diabetic retinopathy.Participants are in the study for one and a half years. During this time, they visit the study site at least 16 times. During this time, doctors regularly do eye exams and visual tests to assess the severity of participants' eye condition. After 1 year of treatment, researchers look at the number of participants with eye improvements. To do so, they compare eye damage and certain severe eye problems between the groups of participants. The doctors also regularly check participants' health and take note of any unwanted effects. ### Conditions - Diabetic Retinopathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BI 764524 - Sham comparator to BI 764524 - Aflibercept (Eylea®) - US only ### Outcomes Primary Outcomes - Occurrence of a ≥2-step improvement compared with baseline in Diabetic Retinopathy Severity Scale (DRSS) level in the study eye at Week 52 Secondary Outcomes - Occurrence of vision threatening complications (VTC)s in the study eye between baseline and Week 52 - Absolute change from baseline of best corrected visual acuity (BCVA) [early treatment diabetic retinopathy study (ETDRS) letters] in the study eye at Week 52 - Absolute change from baseline of central retinal thickness [μm], as assessed by spectral domain optical coherence tomography (SD-OCT), in the study eye at Week 52 - Occurrence of a ≥2-step worsening of Diabetic Retinopathy Severity Scale (DRSS) in the study eye between baseline and Week 52 - Occurrence of proliferative diabetic retinopathy (PDR) and/or anterior segment neovascularisation (NV) in the study eye between baseline and Week 52 - Occurrence of centre-involved diabetic macular edema (CI-DME) in the study eye between baseline and Week 52 - Occurrence of drug-related adverse events (AEs) between baseline and end of study (EOS) - Occurrence of ocular AEs in the study eye between baseline and EOS - Occurrence of ocular AEs of special interest in the study eye between baseline and EOS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Allogeneic TRAC Locus-inserted CD19-targeting STAR T Cell Therapy in r/r B-NHL - NCT ID: NCT06321289 - Study ID: CHN-PLAGH-BT-084 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2027-03-20 - Lead Sponsor: Chinese PLA General Hospital ### Study Description The team has developed the synthetic T cell receptor (TCR) and antigen receptor (STAR) T cells which were demonstrated safety in relapsed or refractory (r/r) B-cell non-Hodgkin' s lymphoma (B-NHL) (NCT05631912). Based on this research, allogeneic STAR-T cell products utilized the CRISPR-Cas9 gene editing tool to knock out endogenous receptor α constant (TRAC), human leukocyte antigen (HLA)-A/B, CIITA, and programmed death 1 (PD-1) genes simultaneously in T cells from healthy donors, and integrated the STAR molecule into the TRAC locus using adenovirus associated virus. This strategy can reduce graft-versus-host-disease (GvHD) toxicity and host-versus-graft response, decrease the sensitivity of STAR T cells to immunosuppressive signals, and improve their anti-tumor activity. In this single center, prospective, open-label, single-arm, phase 1/2 study, the safety and efficacy of allogeneic CD19-targeting STAR T cell therapy will be evaluated in patients with r/r B-NHL. ### Conditions - Non-hodgkin Lymphoma,B Cell ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Allogeneic CD19-STAR T cell - Fludarabine - Cyclophosphamide ### Outcomes Primary Outcomes - Phase 1: Incidence of Adverse Events (AEs) defined as DLT - Phase 1: RP2D - Phase 2: Best objective Response Rate Secondary Outcomes - Phase 2: Overall Survival (OS) - Phase 2: Progression Free Survival (PFS) - Phase 2: Time to response (TTR) - Phase 2: Duration of Response (DOR) - Pharmacokinetics: Number and copy number of CD19-STAR T cells (phase 1 and phase 2) - Pharmacokinetics: Persistence of CD19-STAR T (phase 1 and phase 2) - Pharmacodynamics: Peak level of cytokines in serum (phase 1 and phase 2) ### Location - Facility: Biotherapeutic Department of Chinese PLA General Hospital, Beijing, Beijing, 100853, China @@
## Investigation of the Efficiency of Radial Extracorporeal Shock Wave Therapy at Different Pulses in Carpal Tunnel Syndrome - NCT ID: NCT06321276 - Study ID: AEU-FTR-ID-01 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2024-06-01 - Lead Sponsor: Ahi Evran University Education and Research Hospital ### Study Description Different parameters have been used in studies investigating the efficacy of extracorporeal shock wave therapy in the treatment of carpal tunnel syndrome. Although extracorporeal shock wave therapy has been shown to have a positive effect on carpal tunnel syndrome, there is no consensus on which pulse rate is more effective. Therefore, in this study, the efficacy of extracorporeal shock wave therapy applied at different pulse rates in the treatment of carpal tunnel syndrome will be examined. ### Conditions - Carpal Tunnel Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - extracorporeal shockwave therapy ### Outcomes Primary Outcomes - Visual analogue scale (VAS) - Boston Carpal Tunnel Syndrome Questionnaire Secondary Outcomes - Hand grip strength measurement - Electromyoneurography (EMNG) - Ultrasonography ### Location - Facility: Kirsehir Ahi Evran University, Kırşehir, N/A, 40100, Turkey @@
## Comparison of the Effects of Peripheral Muscle Training and Inspiratory Muscle Training in Geriatric Individuals - NCT ID: NCT06321263 - Study ID: 798307 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-25 - Completion Date: 2025-03-21 - Lead Sponsor: Biruni University ### Study Description In geriatric individuals, there is a decrease in muscle strength, muscle mass and physical performance with ageing. These physiological changes occurring in geriatric individuals make maintaining the physical activity necessary for a healthy life difficult. Weakness of respiratory muscles in geriatric individuals can increase the prevalence of diseases and disability. It has been shown in the literature that peripheral muscle training and inspiratory muscle training increase exercise capacity similarly. The effectiveness of moderate-intensity peripheral muscle training and inspiratory muscle training in sarcopenic geriatric individuals was compared and found to have similar effects on muscle strength.Our study aims to compare the effects of inspiratory and peripheral muscle training in addition to aerobic exercise on muscle strength, physical performance, respiratory muscle strength, functional capacity, sarcopenia, and quality of life. ### Conditions - Muscle Strength ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Peripheral Muscle Training and step aerobics training - Inspiratory Muscle Training and step aerobics training ### Outcomes Primary Outcomes - The sociodemographic data form - Hand grip strength - Maximal inspiratory and expiratory pressures (MIP, MEP) - 6-Minute Walk Test (6MWT) - The Short Physical Performance Battery (SPPB) - Assessment of seniors᾽ quality of life: WHOQOL-OLD questionnaire Secondary Outcomes - SARC-F questionnaire ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of JMKX003948 Tablets in Patients With Renal Cell Carcinoma - NCT ID: NCT06321250 - Study ID: JY-JM3948-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-28 - Completion Date: 2027-04-30 - Lead Sponsor: Jemincare ### Study Description This open-label Phase 1 study will evaluate the safety, tolerability, PK characteristics and preliminarily efficacy of JMKX003948 tablets in patients with renal cell carcinoma. ### Conditions - Renal Cell Carcinoma Metastatic ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - JMKX003948 ### Outcomes Primary Outcomes - Dose Escalation: Number of participants with dose limiting toxicities (DLTs) - Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) - Dose Expansion: Objective Response Rate (ORR) Secondary Outcomes - maximum plasma concentration (Cmax) - maximum plasma concentration (Tmax) - Duration of Response (DoR) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Influence of Ear Vagus Nerve Stimulator on Patients With IBS - NCT ID: NCT06321237 - Study ID: TJ-IRB202402130 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-06-09 - Lead Sponsor: Huaping Xie ### Study Description Irritable bowel syndrome (IBS) is a very common functional digestive disorder characterized by chronic abdominal pain and altered bowel habits in the absence of biological or structural abnormalities. In the field of IBS, effective drug treatments are very limited, and patients are urgently looking for alternatives, including probiotics, hypnotherapy, osteopathy, dietary changes, and fecal microbiota transplants. In recent years, with the continuous elucidation of vagus nerve mechanisms, IBS patients are increasingly interested in bioelectrical regulation, and these patients are often skeptical of traditional drug treatment and believe that drugs are prone to side effects. For several reasons, vagus nerve stimulation (VNS) may be a promising option for improving IBS symptoms. In this experiment, the portable ear nail stimulator produced by Ruishen Medical can accurately stimulate the ear nail, transdermal stimulation of the ear vagus nerve, and give full play to its therapeutic effect. Therefore, the purpose of this clinical trial is to use ear nail stimulator in patients with IBS to explore whether it has therapeutic effects on patients with IBS. To explore the influence of tVNS therapy on irritable bowel syndrome compared with drug therapy, it is hoped that the use of TVNS therapy can reduce the use of related drugs, or even replace drugs. This study intends to recruit a group of patients with irritable bowel syndrome to use the portable ear nail stimulator, (1) to observe whether the symptoms of irritable bowel syndrome patients are improved; (2) To analyze the changes of intestinal microbes in patients with IBS; (3) Verify whether the level of intestinal inflammation is reduced and discover metabolic markers in the intestine. ### Conditions - Irritable Bowel Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Vagus nerve stimulation for 8 weeks - Vagus nerve stimulation for the first 4 weeks - Vagus nerve stimulation for the last 4 weeks - Pseudostimulus ### Outcomes Primary Outcomes - Changes in irritable bowel symptoms - Changes in the diversity of intestinal flora - Changes in the relative abundance of species of intestinal flora - Changes in the number of intestinal flora Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Breathing Exercises on Women With Primary Dysmenorhea - NCT ID: NCT06321224 - Study ID: 2024/03/08 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: Ankara Yildirim Beyazıt University ### Study Description The aim of this study is to examine the effects of breathing exercises in women with primary dysmenorrhea. ### Conditions - Dysmenorrhea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Breathing exercises - Control ### Outcomes Primary Outcomes - Menstrual pain intensity Secondary Outcomes - Menstrual symptoms - Life quality - Stress level - Sleep quality ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Development of a Novel Asian Mediterranean Diet and Its Acceptability in NAFLD - NCT ID: NCT06321211 - Study ID: RECAS-0244 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-12-27 - Lead Sponsor: Singapore Institute of Technology ### Study Description The goal of this pre-intervention study is test the acceptability of Asian version of the Mediterranean diet to NAFLD patients.The main question\[s\] it aims to answer are:1. Whether Asian version of the Mediterranean diet that retains the nutritional composition and can be developed by mapping the components of the Mediterranean diet and finding substitute ingredients commonly eaten in Southeast Asia.2. Whether the 4-week menu cycle of newly developed novel Asian Mediterranean diet is acceptable among Singaporean local population.Participants will participate in taste test sessions to find out if the Asian Mediterranean diet meals are acceptable to people with NAFLD. ### Conditions - Fatty Liver, Nonalcoholic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Sensory Evaluation Test Score NAFLD Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD - NCT ID: NCT06321198 - Study ID: iMSC-2001 - Status: RECRUITING - Start Date: 2024-02-10 - Completion Date: 2027-03-02 - Lead Sponsor: Anhui Provincial Hospital ### Study Description A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD ### Conditions - Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - iMSC ### Outcomes Primary Outcomes - Dose-Limiting Toxicity(DLT) - Adverse Event(AE),Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE) Secondary Outcomes - Objective Response Rate(ORR) - Overall Survival(OS) ### Location - Facility: Anhui Provincial Hospital, Hefei, Anhui, 230036, China @@
## Laparoscopic Cholecystectomy and Quality of Recovery - NCT ID: NCT06321185 - Study ID: 2024/177 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2024-08-25 - Lead Sponsor: Istanbul University ### Study Description This clinical trial aims to compare the Quality of Recovery-15 (QoR-15) scale scores in three groups of patients undergoing laparoscopic cholecystectomy. The first group will be applied subcostal transversus abdominis plane (subcostal TAP) block, the second group will receive local anesthetic infiltration into port sites, and the third group will receive only IV analgesics. ### Conditions - Laparoscopic Cholecystectomy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Subcostal TAP block - Port site local anesthetic infiltration - No intervention or local anesthetic administration ### Outcomes Primary Outcomes - Quality of Recovery-15 (QoR-15) scale Secondary Outcomes - Postoperative rescue analgesic requirement - Consumption of postoperative opioid analgesics - Numerical Rating Scale (NRS) scores - Postoperative nausea and vomiting ### Location - Facility: Istanbul University Istanbul Medical Faculty, Department of Anesthesiology and Reanimation, Istanbul, Fatih, 34093, Turkey @@
## Muscle and Bone Changes After 6 Months of FES Cycling - NCT ID: NCT06321172 - Study ID: 785 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-09-09 - Completion Date: 2024-04-29 - Lead Sponsor: IRCCS Eugenio Medea ### Study Description The goal of this clinical trial is to assess the effectiveness of FES cycling in terms of changes morpho-functional characteristics of the leg muscles, training performance and bone trophism in 5 subjects with Spinal Cord Injury after 6 months of training. The main question\[s\] it aims to answer are:* Do the morpho-functional characteristics of the leg muscles improve after 3 and 6 months of training with FES cycling? If any, the morpho-functional improvements are maintained one month after the end of the training?* Does the quality of the leg bones improve after 3 and 6 months of training with FES cycling?* Does the training performance improve during the training with FES cycling?* Do the data referred to the vegetative nervous system change after 3 and 6 months of training with FES cycling? If yes, the changes in the vegetative nervous system are maintained one month after the end of the training?* Does the intestinal function change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?* Does the level of spasticity of the lower limbs change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?* Does the level of pain perceived by pilots change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?* Does the Psychological General Well-Being of the pilots change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?* Does the pilots' motivation in carrying out a sporting activity change between T1 (3 months after starting the training) and T2(6 months after starting the training)?Participants will train for 6 months with FES-cycling twice a week. Each session includes at most 30 minutes of stimulation. ### Conditions - Spinal Cord Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - FES Bike ### Outcomes Primary Outcomes - Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb Secondary Outcomes - Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb - Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb - Changes in bone quality - Changes in data referring to the vegetative nervous system - Changes in data referring to the vegetative nervous system - Changes in data referring to the vegetative nervous system - Changes in the intestinal function - Changes in the intestinal function - Changes in the intestinal function - Changes in the level of spasticity of the lower limbs - Changes in the level of spasticity of the lower limbs - Changes in the level of spasticity of the lower limbs - Changes in the level of pain perceived - Changes in the level of pain perceived - Changes in the level of pain perceived - Changes in the General Well Being of the pilots while training - Changes in the General Well Being of the pilots while training - Changes in the General Well Being of the pilots while training - Pilots' motivation in carrying out a sporting activity - Pilots' motivation in carrying out a sporting activity ### Location - Facility: Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, 23842, Italy @@
## Investigation of the Effect of Mobile Software Use in Blood Pressure Management of Hypertensive Individuals on Quality of Life and Disease Self-Efficacy - NCT ID: NCT06321159 - Study ID: Nursing Dep. - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2026-01-30 - Lead Sponsor: Inonu University ### Study Description Hypertension is a prevalent health concern, affecting one in three adults globally, with the potential to lead to fatal complications. However, an alarming proportion of those diagnosed-four out of five individuals-struggle to effectively manage this condition. As such, the effective management of hypertension becomes paramount. A study conducted post-earthquake by a principal investigator and a scholarship recipient revealed that 47.9% of participants received a hypertension diagnosis, and a significant 67.8% ceased active management of the condition. Existing literature suggests a notable decline in the quality of life among individuals unable to manage hypertension effectively. While current research emphasizes the components of nutrition, exercise, and medication adherence in hypertension management, the integration of these components into mobile applications is notably lacking. This project seeks to enhance disease management for users by integrating crucial elements, including blood pressure measurement, into a user-friendly mobile application, thereby providing a distinctive contribution. The proposed application encompasses the recording of vital signs, integration of customized diet and exercise programs tailored for hypertension, and provision of consultancy services for identifying deviations in health status and implementing appropriate interventions. The integration of these components is anticipated to contribute to preventing or minimizing potential complications for the patient. Comprehensive studies incorporating such an approach are rarely encountered in the existing literature, enhancing the originality of this research. The project\&#39;s overarching goal is to enable individuals to manage hypertension even in extraordinary circumstances, such as earthquakes. Consequently, the study will assess how the mobile application influences individuals\&#39; quality of life and disease self-efficacy.Conducted between April 2024 and January 2026, the project adopts a pre-test post-test control group experimental design in the four most earthquake-affected provinces. It involves 614 individuals diagnosed with hypertension, residing in temporary living space in Malatya, Hatay, Kahramanmaraş, and Adıyaman, with 78, 77, and 74 participants in Malatya, Hatay, and Adıyaman, respectively. Data collection tools include the Personal Identification Information Form, Hypertension Self-Efficacy Scale, SF-36 Quality of Life Scale, and International Physical Activity Scale-Short Form, administered through face-to-face interviews. The mobile application development will be a collaborative effort with two faculty members from the Department of Computer Engineering and expert academicians. For the diet program within the application, eight questions will be used to uncover individuals\&#39; dietary preferences. Calculations based on Body Mass Index, basal metabolic rate, and daily energy requirements will inform the diet program, which will encompass five food groups and their caloric values. Notifications about diet adherence will be sent for each meal. In the exercise program, individuals will measure and record blood pressure and medication intake. Those with a blood pressure of 140/90 mmHg or higher will be included based on expert physician recommendations, with notifications for those exceeding 160/100 mmHg to consult a physician. A personalized exercise program will be created based on the OMRİ-RİS scale, supported by animations. Training videos for blood pressure measurements and medication adherence will be recorded and supervised by local academic nurse practitioners. Data analysis will utilize appropriate statistical tests conducted through computer programs. The project is anticipated to contribute significantly to researcher development, enhance quality of life and disease management, increase productivity, and establish new projects. ### Conditions - Hypertension, Essential Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - mobile application ### Outcomes Primary Outcomes - SF- 36 Life Quality Scale - Hypertension Self-Efficacy Scale Secondary Outcomes - International Physical Activity Scale-Short Form ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@

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