Datasets:

hackint0sh
/

md_dataset

Dataset card Data Studio Files Files and versions Community

Split (1)

train · 10k rows

record stringlengths 560 23.9k
## Motor-cognitive Performance in People With Multiple Sclerosis - NCT ID: NCT06312046 - Study ID: 2018 374-31 - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2027-08-31 - Lead Sponsor: Karolinska Institutet ### Study Description Having a neurological disease such as multiple sclerosis (MS) leads to difficulties in balance and gait with or without concurrent performance of cognitive tasks, hindering activity performance and influencing the possibilities for an independent lifestyle.The investigators have adapted a previously developed balance training program to a highly challenging program specifically directed to MS (HiBalance-MS). This program was recently tested and found feasible in a pilot study. The investigators will now perform a randomized controlled trial in people with MS, in order to determine the effects of the program. The hypothesis is that progressively challenging balance exercise programs that are specific to the balance control domains affected by MS will be effective to improve balance control, walking, motor-cognitive performance, activity performance and health related quality of life. ### Conditions - Multiple Sclerosis - Postural Balance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HiBalance-MS ### Outcomes Primary Outcomes - Mini Balance Evaluation Systems test. Secondary Outcomes - 10-Meter Walk Test, maximum speed. - 10-Meter Walk Test, self-selected speed. - 2-Minute Walk Test, self-selected speed. - Gait speed during simultaneous dual task performance. - Stride length during dual task gait performance. - Step time during dual task gait performance. - Response errors in dual task cognitive performance - Reaction time in dual task cognitive performance - Six-Spot Step Test. - Completion time in the Trail Making Test. - Number of errors in the Trail Making Test. - Immediate and delayed recall in the Ray Auditory Verbal Learning Test. - Cognitive processing speed in the Symbol Digit Modalities Test. - Cognitive function - composite measure of three cognitive tests. - Physical activity level. - Physical activity level, self-reported. - Physical exercise habits, self-reported. - The generic Walk-12 questionnaire. - Falls Efficacy Scale - International. - Assesment of anxiety with the Hospital Anxiety and Depression Scale. - Assesment of depression with the Hospital Anxiety and Depression Scale. - Modified Fatigue Impact Scale. - Occupational Gap Questionnaire. - Acceptance of Chronic Health Condition scale. - Multiple Sclerosis Impact Scale - physical impact. - Multiple Sclerosis Impact Scale - psychological impact. - Euroqol-5 Dimensions-5 Level (EuroQoL-5D-5L). - Euroqol Visual Analogue Scale (EQ VAS). - World Health Organization Disability Assessment Schedule, version 2.0. (WHODAS 2.0) ### Location - Facility: Karolinska Institutet, Stockholm, N/A, 17177, Sweden @@
## Estradiol's Effect on Brain Volume and Connectivity - NCT ID: NCT06312033 - Study ID: MRTG_P01 - Status: COMPLETED - Start Date: 2018-08-01 - Completion Date: 2021-12-31 - Lead Sponsor: International Research Training Group 2804 ### Study Description Ovarian hormones are not only modulators of cognitive function, emotion regulation and mental health, but also seem to affect brain plasticity and functional connectivity, During the menstrual cycle, women experience cyclic fluctuation of the ovarian hormone estradiol, which is closely associated with neuroplasticity/changes in brain structure in regions with high estradiol receptor density, such as the amygdala, hippocampus/parahippocampus, anterior cingulate cortex (ACC), striatum, and prefrontal cortex (PFC). Further functional connectivity between these areas seems to be associated with hormonal changes dependent on the menstrual cycle phase. But next to estradiol, also other hormones like progesterone fluctuate across the menstrual cycle. In the past, effects of ovarian hormone levels were often investigated in combination. However, one way to disentangle the impact of estradiol from that of other hormones on neuroplasticity, emotion regulation and mood states, can be the experimental increase of estradiol via estradiol administration. In this double-blinded within-subject study, women were administered either estradiol valerate or placebo during the early follicular phase (thus when ovarian hormone concentrations are low) before undergoing neuroimaging.Parts of the study are already described in Rehbein et al., 2021 and 2022. ### Conditions - Emotion Regulation - Estradiol ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Estradiol Valerate - Placebo ### Outcomes Primary Outcomes - Impact of E2 concentration on brain structure - Impact of E2 concentration and state emotion regulation on brain structure - Impact of E2 concentration and emotion regulation traits on brain structure - Impact of E2 concentration on resting state functional connectivity - Impact of E2 concentration and state emotion regulation on connectivity - Impact of E2 concentration and emotion regulation traits on functional connectivity - Impact of E2 concentration and associated structural brain changes on connectivity Secondary Outcomes - Impact of E2 concentration and self-esteem on brain structure - Impact of E2 concentration and self-esteem on functional connectivity - Impact of E2 concentration and subjective mood on brain structure - Impact of E2 concentration and state anxiety on brain structure - Impact of E2 concentration and subjective mood on functional connectivity - Impact of E2 concentration and state anxiety on functional connectivity - Impact of E2 administration on E2 concentrations - Impact of E2 administration on E2-progesterone ratio - Impact of E2 administration on testosterone and progesterone concentration ### Location - Facility: University of Tuebingen; Department of Psychiatry & Psychotherapy, Tuebingen, BW, 72076, Germany @@
## A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome - NCT ID: NCT06312020 - Study ID: HZNP-HZN-1116-201 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-11-26 - Lead Sponsor: Horizon Therapeutics Ireland DAC ### Study Description The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS). ### Conditions - Sjogren's Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HZN-1116 - Placebo ### Outcomes Primary Outcomes - Change from baseline in European Alliance of Associations for Rheumatology (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) (Population #1) - Change from baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) (Population #2) Secondary Outcomes - Change from baseline in ESSDAI (Population #1) - Proportion of Participants achieving ESSDAI [5] response (Population #1) - Change from baseline in ESSPRI pain domain score (Population #1) - Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) pain domain score (Population #1) - Change from baseline in ESSPRI fatigue domain score (Population #1) - Change from baseline in DASPRI fatigue domain score (Population #1) - Change from baseline in ESSPRI dryness domain score (Population #1) - Change from baseline in DASSPRI dryness domain score (Population #1) - Change from baseline in tender joint count (TJC) (Population #1) - Change from baseline in swollen joint count (SJC) (Population #1) - Change from baseline in 36-item Short Form Survey (SF-36) physical component score (PCS) (Population #1) - Change from baseline in 36-item Short Form Survey (SF-36) mental component score (MCS) (Population #1) - Change from baseline in patient-reported outcomes measurement information system (PROMIS)-Fatigue SF-10a (Population #1) - Change from baseline in DASPRI (Population #2) - Proportion of Participants achieving ESSPRI [1.5] response (Population #2) - Change from baseline in ESSPRI pain domain (Population #2) - Change from baseline in ESSPRI fatigue domain (Population #2) - Change from baseline in ESSPRI dryness domain (Population #2) - Change from baseline in SF-36 PCS Score (Population #2) - Change from baseline in 36-item Short Form Survey (SF-36) mental component score MCS (Population #2) - Change from baseline in PROMIS-Fatigue SF-10a (Population #2) - Serum concentration of HZN-1116 starting at Week 1 through study completion (Population #1 and #2) - Proportion of Participants who develop anti drug antibodies (ADA) over time (Population #1 and #2) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Semi-seated Holding Position to Reduce Stress Responses in in the Neonatal Intensive Care Unit - NCT ID: NCT06312007 - Study ID: UH23030202 - Status: COMPLETED - Start Date: 2023-07-01 - Completion Date: 2023-12-01 - Lead Sponsor: Hasanuddin University ### Study Description This study to compare half semi seated position and side lying position with cortisol level on the neonate's stress respon ### Conditions - Semi Seated Position - Side Lying Position ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Semi seated position - side lying position ### Outcomes Primary Outcomes - Kortisol level - Oxytocin level Secondary Outcomes ### Location - Facility: Hasanuddin University, Makassar, South Sulawesi, N/A, Indonesia @@
## Applicability and Efficiency of Virtual Reality Intervention in Knee Surgery Patients - NCT ID: NCT06311994 - Study ID: GumushaneUni - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-04-01 - Lead Sponsor: Gümüşhane Universıty ### Study Description The stress experienced by patients in hospital environments can lead to a range of issues, from clinical decision-making to discharge. Although stress levels can contribute to new problems, individual characteristics also play a significant role in clinical recovery. Knee surgery is a commonly performed procedure in our country that provides patients with an effective solution to joint-related issues. However, stress experienced by patients who undergo surgery can have negative consequences, from managing problems during their hospital stay to their overall quality of life. The search for effective stress management methods is ongoing and has gained momentum with the development of new technological products. Virtual reality (VR) applications are a novel approach in the literature for managing various issues. Research is being conducted in different areas of our country using this approach. The aim of this project is to evaluate the feasibility, acceptability, and effectiveness of different environment perceptions using virtual reality glasses on postoperative mobilization and well-being in individuals undergoing knee surgery for the first time. The project sample is a randomized controlled trial consisting of 30 patients who will undergo orthopedic surgery for the first time at the Gümüşhane State Hospital orthopedic clinic and meet the acceptance criteria. In the intervention group, patients will view relaxing virtual environment images with VR glasses after surgery. Following the relaxation session, participants will be presented with content to exercise in the virtual environment. Patients will be instructed to perform breathing exercises set in forest and underwater scenes to aid relaxation. The effectiveness of the intervention will be assessed using the Tampa Kinesiophobia Scale and Patient Mobility Scale. A satisfaction scale with a linear format will be used to evaluate the acceptability of the intervention. In addition, a data collection form, developed by the researcher, will be used to gather information on participant characteristics. The obtained data will be analyzed using t-tests, analysis of variance, correlation, and regression tests. Currently, there is a growing number of studies that explore the relationship between technology and health. This project aims to investigate the impact of virtual reality glasses on symptom management. If the results are positive, this method could be used as a solution for various situations where individuals experience symptoms. The goal is to develop a usable product for postoperative mobilization based on the research findings. ### Conditions - Virtual Reality - Symptom Management - Surgery - Quality of Life ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Virtual reality ### Outcomes Primary Outcomes - Pain measure - Stress Secondary Outcomes - Mobilization - Mobility ### Location - Facility: Gumushane University, Gumushane, N/A, 28010, Turkey @@
## Carbon Ion Radiotherapy for Locally Advanced Lung Cancer in Elderly Patients - NCT ID: NCT06311981 - Study ID: SPHIC-TR-THLC2023-08 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-06-17 - Lead Sponsor: Jian Chen ### Study Description To observe the effect and toxicity of carbon ion radiotherapy on local advanced non-small cell lung cancer over 75 years old patients. Systemic therapy could be targeted therapy, chemotherapy or immunotherapy. ### Conditions - Non-small Cell Lung Cancer - Older People - Carbon Ion Radiotherapy - Radiotherapy Side Effect ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - carbon ion radiotherapy - targeted therapy - single regimen chemotherapy in sequence with radiotherapy ### Outcomes Primary Outcomes - Disease progression-free survival rate - Incidence of Treatment-induced Adverse Events Secondary Outcomes - Local control rate - Cause-specific survival rate - Overall survival rate ### Location - Facility: Shanghai Proton and Heavy Ion Center, Shanghai, Shanghai, 201513, China @@
## The Clinical Study of Post-operative Proton Radiotherapy for Thymus Tumor - NCT ID: NCT06311968 - Study ID: SPHIC-TR-THLC2023-07 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-02-28 - Lead Sponsor: Jian Chen ### Study Description To observe the efficacy and toxicities of post-operative (R0/R1) proton radiotherapy for locally advanced primary thymus epithelial malignancies. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was overall survival and cause-specific survival. ### Conditions - Thymus Epithelial Tumor - Proton Radiotherapy - Radiation Toxicity ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Proton radiotherapy - combined platinum based chemotherapy ### Outcomes Primary Outcomes - Disease progression-free survival rate - Incidence of Treatment-induced Adverse Events Secondary Outcomes - Overall survival rate - Cause-specific survival rate ### Location - Facility: Shanghai Proton and Heavy Ion Center, Shanghai, Shanghai, 201513, China @@
## Clinical Study of Postoperative Carbon Ion Radiotherapy for Thymus Tumor With Residual Tumor - NCT ID: NCT06311955 - Study ID: SPHIC-TR-THLC2023-06 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2029-02-28 - Lead Sponsor: Jian Chen ### Study Description To observe the efficacy and toxicities of heavy ion radiation therapy for locally advanced or advanced primary thymic epithelial malignant tumor received R2 resection. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was local relapse-free survival, overall survival and cause-specific survival. ### Conditions - Thymic Epithelial Tumor - Radiotherapy Side Effect - Carbon Ion Radiotheray - Heavy Ion Radiotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Carbon ion radiotherapy - combined with platinum-based regimen ### Outcomes Primary Outcomes - Disease progression-free survival rate - Incidence of Treatment-induced Adverse Events Secondary Outcomes - Local-progression free survival rate - Overall survival rate - Cause-specific survival rate ### Location - Facility: Shanghai Proton and Heavy Ion Center, Shanghai, Shanghai, 201513, China @@
## Triple vs. Dual Adjuvant Therapy Following Liver Resection for HCC. - NCT ID: NCT06311942 - Study ID: Precision AT-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-12-31 - Lead Sponsor: Chen Xiaoping ### Study Description Vessels that encapsulate tumor clusters (VETC) is an invasive metastatic factor in HCC independent of the epithelial mesenchyme transition (EMT), and VETC-positive patients have a higher rate of postoperative recurrence. What can be done to improve the surgical prognosis of this group of patients needs to be continuously explored. ### Conditions - HCC ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HAIC plus PD-1 inhibitors plus lenvatinib - PD-1 inhibitors plus lenvatinib ### Outcomes Primary Outcomes - DFS Secondary Outcomes - OS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma - NCT ID: NCT06311929 - Study ID: Precision AT-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-12-31 - Lead Sponsor: Chen Xiaoping ### Study Description Vessels that encapsulate tumor clusters (VETC) is an invasive metastatic factor in HCC independent of the epithelial mesenchyme transition (EMT), and VETC-positive patients have a higher rate of postoperative recurrence. How to improve the prognosis of this group of patients is an urgent issue to be addressed. ### Conditions - HCC ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PD-1 monoclonal antibody and lenvatinib - PD-1 monoclonal antibody ### Outcomes Primary Outcomes - Disease-free survival Secondary Outcomes - Overall survival ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy and Safety of Neoadjuvant Therapy in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model. - NCT ID: NCT06311916 - Study ID: Neoadj-Net - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-12-31 - Lead Sponsor: Chen Xiaoping ### Study Description Primary liver cancer is one of the most common malignant tumors in the world, and more than 90% of primary liver cancers are pathologically characterized as hepatocellular carcinoma (HCC). The intermediate stage (BCLC-B) HCC is highly heterogeneous, and there is no consensus on the treatment of this stage of the tumor in Western and Eastern countries. New tools are urgently needed to guide the choice of treatment options for patients with this stage of the tumor in order to reduce the risk of postoperative recurrence and the overall survival rate. ### Conditions - HCC ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HAIC + Tirelizumab +lenvatinib +liver resection - liver resection ### Outcomes Primary Outcomes - Disease-free survival Secondary Outcomes - Safety Assessment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Norepinephrine in Preperiod of Hypotensive Resuscitation in Hemorrhagic Shock - NCT ID: NCT06311903 - Study ID: 36264PR430/11/23 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2024-04-01 - Lead Sponsor: Tanta University ### Study Description The aim of this work was to investigate the effects of low dose of norepinephrine in preperiod of hypotensive resuscitation in hemorrhagic shock. ### Conditions - Norepinephrine - Hemorrhagic Shock - Hypotensive Resuscitation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Low dose of Norepinephrine (NE) - High dose of Norepinephrine (NE) ### Outcomes Primary Outcomes - 24 hours mortality Secondary Outcomes - 28 day mortality - Incidence of acute kidney injury - Length of hospital stay - Length of intensive care unit stay ### Location - Facility: Tanta University, Tanta, El-Gharbia, 31527, Egypt @@
## Study to Evaluate the Efficacy, Safety and Tolerability of Photodynamic Therapy(PDT) With Chlorin-e6 in Treating Moderate to Severe Acne - NCT ID: NCT06311890 - Study ID: 2023XLA141-2 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2026-09-30 - Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences ### Study Description This study aims to evaluate the clinical efficacy, safety and tolerability of a photodynamic therapy(PDT) based on a new photosensitizer, Chlorin-e6, in the treatment of moderate to severe acne. The hypothesis is that the therapy has good efficacy, safety and tolerability. ### Conditions - Acne - Photodynamic Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - N-chlorin e6 triglumine - acne removal surgery ### Outcomes Primary Outcomes - Change in Global Acne Grading System (GAGS) Relative to Baseline Secondary Outcomes ### Location - Facility: Xiyuan Hospital of China Academy of Chinese Medical Sciences Organization, Beijing, N/A, 100091, China @@
## Effects of Flavor Modification for Management of Radiation Induced Dysgeusia - NCT ID: NCT06311877 - Study ID: 6795 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-02-14 - Lead Sponsor: University of South Florida ### Study Description Intervention for dysgeusia in head and neck cancer patients undergoing radiation therapy. This research proposal aims to investigate potential benefits of mBerry in improving quality of life and nutritional outcome in head and neck cancer patients' post-radiation therapy. Our hypothesis is that cancer patients undergoing radiation therapy will benefit from use of miracle berry in treatment of dysgeusia. ### Conditions - Dysgeusia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - mBerry - No intervention ### Outcomes Primary Outcomes - 5-Point Hedonic Rating Scale - Chemotherapy-induced Taste Alteration Scale (CITAS) Secondary Outcomes - M.D. Anderson Dysphagia Inventory (MDADI) - Functional Oral Intake Scale (FOIS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia With Daridorexant in Canada - NCT ID: NCT06311864 - Study ID: PROxy240215 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-09-15 - Lead Sponsor: PeriPharm ### Study Description The purpose of this observational study is to evaluate the impact of daridorexant on quality of life, work productivity and insomnia symptoms in Canadian adults suffering from insomnia. ### Conditions - Insomnia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Daridorexant 50 mg ### Outcomes Primary Outcomes - Change from Baseline in Quality of Life - Change from Baseline in Work Productivity Loss - Change from Baseline in the Severity of Insomnia Symptoms Secondary Outcomes ### Location - Facility: PROxy Network, an initiative of PeriPharm inc., Montreal, Quebec, H2Y 2H4, Canada @@
## Transarterial Chemoembolization (TACE) Plus Bevacizumab for Liver Metastases - NCT ID: NCT06311851 - Study ID: PNCC140201 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-01 - Lead Sponsor: Pardis Noor Medical Imaging and Cancer Center ### Study Description Trans arterial chemoembolization (TACE) has emerged as a treatment option for chemotherapy-refractory diseases in Liver metastases. By delivering chemotherapy agents directly to the tumor site, TACE can maximize local drug concentrations and reduce systemic adverse reactions. Bevacizumab is a monoclonal antibody that functions as an angiogenesis inhibitor. It works by slowing the growth of new blood vessels by inhibiting vascular endothelial growth factor A (VEGF-A). The application of Bevacizumab during TACE has not been reported. In this study, we will evaluate the the overall survival (OS)、efficacy, and safety of the application of Bevacizumab during TACE in patients with Liver Metastases by designing an open, single-arm phase II clinical study. ### Conditions - Cancer - Metastatic Cancer - Liver Metastases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Bevacizumab ### Outcomes Primary Outcomes - Overall Survival Rate - Objective response rate Secondary Outcomes - Adverse event ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness - NCT ID: NCT06311838 - Study ID: 2023H0244 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2029-12 - Lead Sponsor: Ohio State University ### Study Description Homelessness severely affects health and well-being and is particularly negative for youth. Between 70-95% of youth experiencing homelessness (YEH) report problem substance use and 66-89% have a mental health disorder. Youth appear to be at greater risk for living on the streets or being homeless than adults and are more vulnerable to long term consequences of homelessness. Multiple social determinants of health (SDOH) are uniquely associated with homelessness, driving substance use and adverse mental health consequences. However, limited research has identified pragmatic interventions that have a long-term ameliorating impact on the complex, multi-symptomatic issues among these youth. This study overcomes prior gaps in research through testing a multi-component comprehensive prevention intervention targeting SDOH that may affect biopsychosocial health indicators and longer-term health outcomes. In partnership with a drop-in center for YEH, youth between the ages of 14 to 24 years, will be engaged and randomly assigned to conditions using a dismantling design so that essential intervention components can be efficiently identified. In particular, youth (N = 300) will be randomly assigned to a) Motivational Interviewing/Community Reinforcement Approach + Services as Usual (MI/CRA + SAU, n = 80), b) Strengths-Based Outreach and Advocacy + Services As Usual (SBOA + SAU, n = 80), c) MI/CRA + SBOA + SAU (n = 80) or d) SAU (n=60) through the drop-in center. In order to assess the longer-term prevention effects on substance use, mental health and other outcomes, all youth will be assessed at baseline and at 3, 6, 12, 18 and 24-months post-baseline. The primary goal of this study is to establish the impact of a comprehensive intervention embedded within a system that serves YEH, a community drop-in center, on youth's opioid misuse and disorder, other substance misuse and disorders, mental health diagnoses, and other targeted outcomes. This study will offer unique information on the physiological and psychological stress pathways underlying change for specific subgroups of youth along with cost estimates to inform future implementation efforts in drop-in centers around the country. ### Conditions - Opioid Use Disorder - Dual Diagnosis - Housing Problems - Mental Disorder in Adolescence - Risk Behavior - Homelessness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Motivational Interviewing/Community Reinforcement Approach (MI/CRA) - Strengths-Based Outreach and Advocacy (SBOA ) - Services as Usual (SAU) ### Outcomes Primary Outcomes - Form 90 Substance Use interview - Shortened Inventory of Problems - Alcohol and Drugs (SIP-AD) - Presence of drugs of abuse - Beck Depression Inventory II (BDI-II) - Beck Anxiety Inventory (BAI) - Short Form-12 Secondary Outcomes ### Location - Facility: Star House, Columbus, Ohio, 43201, United States @@
## The Effect of Horticultural Therapy on Loneliness and Life Satisfaction in Elderly Adults Living in Nursing Home - NCT ID: NCT06311825 - Study ID: IstanbulUCDH - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-10-31 - Lead Sponsor: Istanbul University - Cerrahpasa (IUC) ### Study Description Loneliness in elderly individuals increases with age and negatively affects individuals by decreasing life satisfaction. In recent years, horticultural therapy is a type of therapy that has developed and is added routine care of elderly individuals living in nursing homes. Social interaction, life satisfaction, feelings of success and responsibility and increase while loneliness and depression levels decrease through human-nature interaction in horticultural therapy.In our country, no study has been found on the effects of horticultural therapy on physical or mental health in elderly individuals. This research will be conducted as a randomized control group study to examine the effects of horticultural therapy on loneliness and life satisfaction in elderly individuals living in nursing homes. ### Conditions - Horticultural Therapy - Loneliness - Satisfaction, Personal - Aging ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Horticultural Therapy ### Outcomes Primary Outcomes - Loneliness Scale for Elderly - Life Satisfaction Scale Secondary Outcomes ### Location - Facility: Istanbul University - Cerrahpasa (IUC), Istanbul, Şişli, N/A, Turkey @@
## Retrospective Review on Uterovaginal Anomalies - NCT ID: NCT06311812 - Study ID: CREC 2023.683 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-02-14 - Lead Sponsor: Chinese University of Hong Kong ### Study Description Review of surgical outcomes of patient who have undergone surgery for uterovaginal anomalies. Case notes of patients would be reviewed and data would be gathered for statistical analysis. ### Conditions - Abnormalities Uterine - Vaginal Abnormality ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Incidence of re-stenosis - Incidence of re-operation - Number of patients with normal menstruation after operation - Number of patients with sexual intercourse after operation - Number of patients with post-operative infection - Number of patients with pregnancy after operation Secondary Outcomes - Background demographics affecting post-operative outcomes for patients with uterovaginal anomalies - Number of participants with Pre-operative factors affecting post-operative outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy - NCT ID: NCT06311799 - Study ID: 2024-0102 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-06-30 - Lead Sponsor: Geisinger Clinic ### Study Description This study is being done to find out if online references to a food management program for Women, Infants, and Children (WIC) made by doctors will get more people to enroll in WIC. Women aged 18 or older who get healthcare at Geisinger, are pregnant, and have one or more heart-related health risks (high blood pressure, diabetes, or obesity) will be asked to join this study. These women need to consent to join this study. There are four groups in this study. Group 1 will get usual care with details about WIC from their doctor. Group 2 will be sent to WIC by their doctor. Group 3 will get details about WIC from their doctor and a dietitian will talk to them about heart-healthy diets and food management. Group 4 will be sent to WIC by their doctor and a dietitian will talk to them about heart-healthy diets and food management. This study will last about 18 months and will have 200 total subjects joining at about 50 per month. Each subject will be in the study for about 6 months. Subjects will be asked to complete surveys at the start and end of the study. Some subjects will also be asked about their experience in the study team after they are done. ### Conditions - Cardiovascular Diseases - Obesity, Maternal - Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - WIC Referral - RDN Referral ### Outcomes Primary Outcomes - Difference in WIC enrollment Secondary Outcomes - WIC retention - WIC adherence - Prenatal clinic visit adherence. - RDN visit adherence ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Look at How a Single Oral Dose of Carbon-14-Labelled [14C] BIIB091 Moves Through and is Processed by the Body in Healthy Male Participants - NCT ID: NCT06311786 - Study ID: 257HV107 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-09 - Completion Date: 2024-05-13 - Lead Sponsor: Biogen ### Study Description The main goal of this study is to learn how \[14C\]-BIIB091 moves through and is processed by the body and to look at how much of BIIB091's metabolites (what is produced when BIIB091 is broken down by the body) appears in the blood, urine, and stool in healthy male participants. The study will also help researchers learn more about the safety of BIIB091 in healthy male participants. ### Conditions - Healthy Volunteer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - [14C]-BIIB091 ### Outcomes Primary Outcomes - Amount of BIIB091 Excreted per Sampling Interval in Urine (Aeu) - Amount of BIIB091 Excreted per Sampling Interval in Feces (Aef) - Cumulative Amount of BIIB091 Excreted per Sampling Interval in Urine (Cum Aeu) - Cumulative Amount of BIIB091 Excreted per Sampling Interval in Feces (Cum Aef) - Percentage of BIIB091 Excreted per Sampling Interval in Urine (%Feu) - Percentage of BIIB091 Excreted per Sampling Interval in Feces (%Fef) - Cumulative Percentage of BIIB091 Excreted in Urine (Cum %Feu) - Cumulative Percentage of BIIB091 Excreted in Feces (Cum %Fef) - Maximum Observed Concentration (Cmax) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood - Time to Reach Maximum Observed Concentration (Tmax) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood - Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood - Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood - Terminal Half-Life (t1/2) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood - Apparent Clearance (CL/F) of BIIB091 in Plasma - Apparent Volume of Distribution (Vz/F) of BIIB091 in Plasma - Quantitative Profile of [14C]-BIIB091 Metabolites in Plasma - Quantitative Profile of [14C]-BIIB091 Metabolites in Urine - Quantitative Profile of [14C]-BIIB091 Metabolites in Feces Secondary Outcomes - Cmax of Plasma Metabolite 23 (M23) - Tmax of Plasma M23 - AUClast of Plasma M23 - AUCinf of Plasma M23 - t1/2 of Plasma M23 - Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) - Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters - Number of Participants With Clinically Significant Vital Sign Abnormalities - Number of Participants With Clinically Significant Physical Examination Abnormalities - Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities as Assessed by 12-Lead ECG Measurements - Number of Participants With Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pivotal Trial of the Boomerang Catheter for pDVA - NCT ID: NCT06311773 - Study ID: Protocol # 24-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2029-01-15 - Lead Sponsor: Aveera Medical, Inc. ### Study Description The purpose of this study is to establish the safety and effectiveness of the Boomerang Catheter for percutaneous Deep Venous Arterialization (pDVA) to treat no-option Chronic Limb-Threatening Ischemia. ### Conditions - Chronic Limb-Threatening Ischemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Boomerang Catheter ### Outcomes Primary Outcomes - Amputation Free Survival (AFS) Secondary Outcomes - Technical success - Procedural success - Limb salvage - Primary patency - Primary assisted patency - Secondary patency - Target wound healing - Complete wound healing ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 In Healthy Participants - NCT ID: NCT06311760 - Study ID: D7700C00001 - Status: RECRUITING - Start Date: 2024-04-09 - Completion Date: 2024-09-24 - Lead Sponsor: AstraZeneca ### Study Description This study will assess the safety, tolerability and pharmacokinetics (PK) of AZD0292 following intravenous (IV) administration of single ascending doses to healthy adult participants. ### Conditions - Healthy Participants Study ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - AZD0292 - Placebo ### Outcomes Primary Outcomes - Number of Participants with Adverse Events - Number of Participants with Adverse Events of Special Interest (AESI) Secondary Outcomes - Maximum Observed Drug Concentration (Cmax) - Area Under Concentration-Curve from Time Zero to the Last Quantifiable Concentration (AUClast) - Area Under Concentration-Time Curve from Time Zero to Infinity (AUCinfinity) - Number of Participants with Positive Anti-drug Antibodies (ADAs) ### Location - Facility: Research Site, Baltimore, Maryland, 21225, United States @@
## The Effect of Oculomotor Exercises in the Warm-up on Forehand and Backhand Stroke Performance in Tennis Players - NCT ID: NCT06311747 - Study ID: 24-1T/45 - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-09 - Lead Sponsor: Ege University ### Study Description 30 tennis players aged 12-18, will be included in the study. After their normal warm-up, the participants will make 30 forehand and 30 backhand strokes. Forehand and backhand stroke accuracy rate will be calculated. After a week, additional oculo-motor exercises will be included in the warm-up and the forehand and backhand stroke accuracy rate will be calculated again. The hypothesis that there will be an improvement in forehand and backhand stroke accuracy after oculo-motor exercises will be tested. ### Conditions - Supportive Care ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Oculo-motor exercises ### Outcomes Primary Outcomes - Forehand and backhand stroke accuracy Secondary Outcomes ### Location - Facility: Ege University Sports Medicine Clinic, İzmir, Bornova, 35100, Turkey @@
## A Study of LW231 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection - NCT ID: NCT06311734 - Study ID: LW231-I-01 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-11-01 - Completion Date: 2024-05-01 - Lead Sponsor: Shanghai Longwood Biopharmaceuticals Co., Ltd. ### Study Description To Evaluate the Tolerability and Pharmacokinetics of LW231 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects . ### Conditions - Chronic Hepatitis B ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - LW231 tablets - Placebo ### Outcomes Primary Outcomes - Number of Participants With Adverse Events (AEs) Secondary Outcomes - Maximum Plasma Concentration (Cmax) of LW231 - Time to Cmax (Tmax) of LW231 - Area Under the Curve From Time 0 to the Last Measurable Concentration (AUClast) of LW231 - Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of LW231 - Half-life (t1/2) of LW231 ### Location - Facility: The First Hospital of Jilin University, Changchun, Jilin, N/A, China @@
## A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer - NCT ID: NCT06311721 - Study ID: 20210033 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-19 - Completion Date: 2027-10-22 - Lead Sponsor: Amgen ### Study Description The primary objective of this study is to compare the efficacy of ABP 234 with the pembrolizumab reference product (Keytruda®). ### Conditions - Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ABP 234 - Pembrolizumab (US) - Pembrolizumab (EU) ### Outcomes Primary Outcomes - Objective response (OR) - Area under the serum concentration-time curve (AUC) from time 0 to 21 days (AUC21d) of ABP 234 - AUC at steady state between Week 16 and Week 19 (AUCtau_ss) of ABP 234 Secondary Outcomes - OR - OR - Duration of response (DOR) - Progression-free survival (PFS) - Overall survival (OS) - Maximum observed serum concentration following the first dose (Cmax_dose1) of ABP 234 - Cmax_dose1 of pembrolizumab (US) - Cmax_dose1 of pembrolizumab (EU) - Time to maximum concentration following the first dose (tmax_dose1) of ABP 234 - Tmax_dose1 of pembrolizumab (US) - Tmax_dose1 of pembrolizumab (EU) - Maximum observed serum concentration (Cmax) at steady state (Cmax_ss) of ABP 234 - Cmax_ss of pembrolizumab (US) - Cmax_ss of of pembrolizumab (EU) - Time to maximum concentration at steady state (tmax_ss) of ABP 234 - Tmax_ss of pembrolizumab (US) - Tmax_ss of pembrolizumab (EU) - Trough serum concentrations at pre-dose of week 4 (Ctrough_w4) of ABP 234 - Ctrough_w4 of pembrolizumab (US) - Ctrough_w4 of pembrolizumab (EU) - Trough serum concentrations at steady state (Ctrough_ss) at pre-dose of ABP 234 - Ctrough_ss at pre-dose of pembrolizumab (US) - Ctrough_ss at pre-dose of pembrolizumab (EU) - AUC21d of pembrolizumab (US) - AUC21d of pembrolizumab (EU) - AUCtau_ss of pembrolizumab (US) - AUCtau_ss pembrolizumab (EU) - Number of participants who experience a Treatment-emergent adverse event - Number of participants who experience a Treatment-emergent serious adverse event - Number of participants who experience a Treatment-emergent adverse event of interest - Number of participants who experience anti-drug antibodies (ADA) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Non-interventional Study of Seroprevalence of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV9) and the Progression of Disease in Patients With Plakophilin 2 (PKP2)-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) - NCT ID: NCT06311708 - Study ID: TN-401-0011 - Status: RECRUITING - Start Date: 2023-01-31 - Completion Date: 2030-07-11 - Lead Sponsor: Tenaya Therapeutics ### Study Description This is a multicenter, non-interventional study to observe the natural progression of the disease and to study the prevalence of pre-existing antibodies to AAV9 used for gene therapy in a population of patients with PKP2 gene-associated ARVC. Participation from all patients is encouraged regardless of interest in or eligibility for gene therapy. ### Conditions - Arrhythmogenic Right Ventricular Cardiomyopathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Investigate the seroprevalence of pre-existing antibodies to AAV9 in patients with PKP2-associated ARVC Secondary Outcomes - To characterize the burden of illness in patients with pathogenic or likely pathogenic PKP2 mutations - To characterize arrhythmic risk in patients with pathogenic or likely pathogenic PKP2 mutations - To evaluate functional status and Quality of Life (QoL) in patients with pathogenic or likely pathogenic PKP2 mutations - To evaluate heart function as assessed by imaging in patients with pathogenic or likely pathogenic PKP2 mutations ### Location - Facility: University of California San Francisco, San Francisco, California, 94143, United States @@
## Contrast-Enhanced Spectral Mammography (CESM) - NCT ID: NCT06311695 - Study ID: IEO 960 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2012-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description The study's objective is to compare the diagnostic accuracy of the contrast-enhanced mammography (CEM) , considering as reference the classification obtained with Vacuum Assisted Breast Biopsy (VABB). ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Contrast Enhanced Mammography ### Outcomes Primary Outcomes - Evaluation of negative predictive value (NPV) of the CEM Secondary Outcomes - Evaluation of sensitivity of CEM - Evaluation of specificity of CEM - Positive Predictive Value (PPV) of CEM ### Location - Facility: Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS, Milan, N/A, 20141, Italy @@
## A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis - NCT ID: NCT06311682 - Study ID: LP0162-1336 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-24 - Completion Date: 2028-04-28 - Lead Sponsor: LEO Pharma ### Study Description The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections \[SC\]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis and its symptoms, as well as general health status and quality of life. The trial will last for up to 4 years. There will be visits every 2 weeks for the first year and every 6 weeks thereafter. Some of the visits will be conducted by phone.The study involves two different age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. This trial compares tralokinumab +TCS to placebo + TCS for children with moderate-to-severe AD and evaluates tralokinumab + TCS for infants with moderate-to-severe AD. Infants will not receive placebo. All subjects will go through a screening process, which is the first part of the trial and will last up to 4 weeks. During this period, it will be checked if the child or infant meets the criteria to participate in the trial.The children will be randomly assigned to receive tralokinumab + TCS or placebo + TCS for the initial 16 weeks, with the treatment being double-blinded. During the first 16 weeks, children will have a 2 out of 3 chance of getting tralokinumab and a 1 out of 3 chance of getting placebo. Thereafter, all subjects will receive tralokinumab + TCS. The infants will receive tralokinumab + TCS as open-label treatment for the entire treatment period, meaning that the participants will know they are receiving tralokinumab. After stopping treatment, all participants will enter a 4-week safety follow-up period. ### Conditions - Atopic Dermatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tralokinumab + TCS - Placebo + TCS ### Outcomes Primary Outcomes - Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening. - Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. Secondary Outcomes - Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. - Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. - Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening. - Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. - Having at least 50% reduction in EASI score in subjects aged 2 to <12 years at screening. - Having at least 50% reduction in EASI score in subjects aged 6 month to <2 years at screening. - Percent change in EASI in subjects aged 2 to <12 years at screening. - Percent change in EASI in subjects aged 6 month to <2 years at screening. - Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 2 to <12 years at screening. - Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 6 month to <2 years at screening. - Percent change in affected BSA in subjects aged 2 to <12 years at screening. - Percent change in affected BSA in subjects aged 6 month to <2 years at screening. - Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening. - Reduction in Child Worst Itch numeric rating score (NRS) (weekly average) ≥4 for subjects aged 6 to <12 years at screening. - Reduction in Scratch Observer-Reported Outcome (ObsRO) (weekly average) ≥4 for subjects aged 2 to <6 years at screening. - Reduction in Scratch Observer-Reported Outcome (ObsRO) (weekly average) ≥4 for subjects aged 6 months to <2 years years at screening. - Reduction of ≥4 in Child Worst Itch NRS (weekly average) for subjects aged 6 to <12 years at screening or Scratch ObsRO (weekly average) for subjects aged 2 to <6 years at screening. - Percent change in Patient-Oriented Eczema Measure (POEM) in subjects aged 2 to <12 years at screening. - Percent change in Patient-Oriented Eczema Measure (POEM) in subjects aged 6 month to <2 years at screening. - Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 2 to <12 years at screening. - Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 6 month to <2 years at screening. - Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening. - Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening. - Change in Child Worst Itch NRS (weekly average) for subjects aged 6 to <12 years at screening. - Change in Scratch Observer-Reported Outcome (ObsRO) (weekly average) in subjects aged 2 to <6 years at screening. - Change in Scratch Observer-Reported Outcome (ObsRO) (weekly average) in subjects aged 6 month to <2 years at screening. - Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥6 for subjects aged 4 to <12 years at screening. - Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening. - Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening. - Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 2 to <12 years at screening. - Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 6 month to <2 years at screening. - Rescue treatment use (yes/no) in subjects aged 2 to <12 years at screening. - Rescue treatment use (yes/no) in subjects aged 6 month to <2 years at screening. - Number of TCS free days in subjects aged 2 to <12 years at screening. - Number of TCS free days in subjects aged 6 month to <2 years at screening. - Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening. - Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening. - Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. - Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. - Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. - Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. - Percent change in EASI in subjects aged 2 to <12 years at screening. - Percent change in EASI in subjects aged 6 month to <2 years at screening. - Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 2 to <12 years at screening. - Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 6 month to <2 years at screening. - Percent change in affected body surface area (BSA) in subjects aged 2 to <12 years at screening. - Percent change in affected body surface area (BSA) in subjects aged 6 month to <2 years at screening. - Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening. - Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening. - Percent change in Children's Dermatology Life Quality Index (CDLQI) in subjects aged 4 to <12 years at screening. - Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥6 for subjects aged 4 to <12 years at screening. - Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 2 to <12 years at screening. - Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 6 month to <2 years at screening. - Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening. - Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening. - Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 2 to <12 years at screening. - Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 6 month to <2 years at screening. - Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening. - Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening. - Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening. - Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening. - Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. - Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. - Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. - Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. - Percent change in EASI in subjects aged 2 to <12 years at screening. - Percent change in EASI in subjects aged 6 month to <2 years at screening. - Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening. - Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening. - Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening. - Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening. - Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening. - Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening. - Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. - Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. - Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. - Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. - Percent change in EASI in subjects aged 2 to <12 years at screening. - Percent change in EASI in subjects aged 6 month to <2 years at screening. - Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening. - Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening. - Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening. - Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening. - Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening. - Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening. - Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. - Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. - Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. - Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. - Percent change in EASI in subjects aged 2 to <12 years at screening. - Percent change in EASI in subjects aged 6 month to <2 years at screening. - Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening. - Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening. - Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening. - Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparative Study Between Isolated Iliac Vein Stenting Versus Concomitant Iliac Vein Stenting With Pelvic Vein Embolization in Patients With Pelvic Venous Insufficiency Secondary to Nonthrombotic Iliac Vein Lesions - NCT ID: NCT06311669 - Study ID: 29409010104798 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03 - Lead Sponsor: Ain Shams University ### Study Description The aim of the study is to compare between Isolated Iliac vein stenting vs Concomitant Iliac vein stenting with pelvic vein embolization in patients with Pelvic Venous Insufficiency secondary to Nonthrombotic iliac vein lesions ### Conditions - Nonthrombotic Iliac Vein Lesions - Pelvic Congestive Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - iliac vein stenting - pelvic vein embolization ### Outcomes Primary Outcomes - Clinical improvement of pain and pelvic symptoms according to the Pelvic Venous Clinical Severity Score (PVCSS) Secondary Outcomes ### Location - Facility: Ainshams University, Cairo, N/A, N/A, Egypt @@
## A Study to Evaluate Safety, Tolerability of LY4100511 (DC-853) in Healthy Asian and Non-Asian Participants - NCT ID: NCT06311656 - Study ID: 18840 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-12 - Completion Date: 2024-05-30 - Lead Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company ### Study Description The main purpose of this study is to assess the safety and tolerability of LY4100511 (DC-853) after single and multiple dose administrations in healthy asian participants and non-Asian participants. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - LY4100511 (DC-853) - Placebo ### Outcomes Primary Outcomes - Number of participants with one or more Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Secondary Outcomes - Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4100511 (DC-853) - Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4100511 (DC-853) ### Location - Facility: Altasciences Clinical Los Angeles, Inc, Cypress, California, 90630, United States @@
## Ameliorative Potential of Relaxing Back Massage on Puerperial Women's Hormones and Infant Weight - NCT ID: NCT06311643 - Study ID: 35 - Status: COMPLETED - Start Date: 2023-03-02 - Completion Date: 2024-03-01 - Lead Sponsor: Kafrelsheikh University ### Study Description Effect of massage on hormone levels in puerperal women ### Conditions - Does Postpartum Massage Affect Leptin, Prolactin and Growth Hormone ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Postpartum back massage in study group ### Outcomes Primary Outcomes - Leptin and prolactin levels increase Secondary Outcomes ### Location - Facility: Kafrelshiekh university, Kafrelshiekh, N/A, 6850001, Egypt @@
## Comparative Study of Analgesic Effect of Ultrasound Guided PENG Block vs FEMORAL BLOCK in Hip Fracture - NCT ID: NCT06311630 - Study ID: 65/23/IEC/JMMC&RI - Status: RECRUITING - Start Date: 2023-05-20 - Completion Date: 2025-03-20 - Lead Sponsor: Jubilee Mission Medical College and Research Institute ### Study Description To study the analgesic effect of ultrasound guided PENG Block vs Femoral nerve block in patients with Hip fracture presenting to Emergency department ### Conditions - Hip Fracture ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Comparative Study of Analgesic Effect of Ultrasound Guided PENG Block With FEMORAL NERVE BLOCK in Patients With Hip Fracture as assessed by NRS pain scoring scale by patient Secondary Outcomes - Time taken for each technique - Time taken for adequate analgesia - Incidence of complications - To note if rescue analgesic is required ### Location - Facility: Jubilee mission medical College and research centre, Thrissur, Kerala, 680005, India @@
## Retinal Vascular Changes During Pregnancy - NCT ID: NCT06311617 - Study ID: 231592 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2027-01 - Lead Sponsor: Vanderbilt University Medical Center ### Study Description The goal of this study is to better understand how the back part of the eye-called the retina and the choroid-changes during pregnancy. Specialized photos of the eye will be taken at three different timepoints: early in pregnancy (first or second trimester), late in pregnancy (third trimester), and after delivery. This imaging is non-invasive and does not require contact with the surface of the eye. The photos taken will allow assessment of specific parameters, like blood flow and the health of specialized cells that support vision. Understanding how the eyes change during pregnancy may help guide how retina specialists understanding of retinal disease during pregnancy and better inform pregnancy outcomes. ### Conditions - Pregnancy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Fundus photography and optical coherence tomography ### Outcomes Primary Outcomes - Imaging Biomarkers: Choroid - Imaging Biomarkers: Vessel density - Imaging Biomarkers: Foveal avascular zone (FAZ) Secondary Outcomes - Fetal Health: delivery - Fetal Health ### Location - Facility: Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States @@
## Evaluation of the Safety of Inhaled Sedation With Isoflurane in Head Trauma Patients - NCT ID: NCT06311604 - Study ID: 38RC22.0272 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-12-01 - Lead Sponsor: University Hospital, Grenoble ### Study Description Intensive care management of patient with severe traumatic brain injury (TBI) includes deep and prolonged sedation with intravenous hypnotics (propofol, midazolam, ketamine) in combination with opioids to prevent and/or treat episodes of intracranial hypertension. However, some patients may develop tachyphylaxis with a gradual increase of administered intravenous hypnotics and opioids to maintain the same level of sedation. This situation leads to a failure in controlling intracranial pressure (ICP) and/or to the risk of adverse effects due to high-dose sedatives: haemodynamic instability, prolonged mechanical ventilation, neuromyopathy, delirium, withdrawal syndrome.Halogenated agents (Isoflurane, Sevoflurane) are a class of hypnotics routinely used in the operating room. However, doses used in surgical patients (\> 1 Minimal Alveolar Concentration, MAC) are not suitable in neuro-intensive care unit (ICU) patients at risk of intracranial hypertension because of the cerebral vasodilator effects of halogenated agents at this dosage, hence the risk of high ICP and compromised cerebral perfusion pressure.The use of halogenated agents has been recently possible in the ICU through dedicated medical devices (Sedaconda ACD, Mirus). Recommended dosage are lower in the ICU, i.e. 0.3-0.7 MAC, because of their association with intravenous hypnotics and the absence of surgical stimuli. Several clinical studies in general ICUs showed improved sedation quality, reduced duration of mechanical ventilation, faster arousal and shorter extubation time, and lower costs in halogenated group compared with control group receiving midazolam or propofol. At low doses, the effects on ICP and intracerebral haemodynamics of halogenated agents are minor according to the available literature. In addition, beneficial effects were found on cerebral ischaemic volume in animal models treated with halogenated agents. However, there is a need to explore the benefit-risk ratio of the use of halogenated agents in the severe TBI population.The investigator hypothesise that 0.7 MAC Isoflurane can be administered in this population without deleterious effect on ICP. ### Conditions - Traumatic Brain Injury ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Isoflurane ### Outcomes Primary Outcomes - To assess the safety of sedation with 0.7 MAC of inhaled isoflurane in cranial trauma patients in terms of intracranial pressure. Secondary Outcomes - To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma. - To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma. - To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma. - To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma. - To assess the extra-neurological effects of inhaled isoflurane sedation in head trauma patients - To assess the extra-neurological effects of inhaled isoflurane sedation in head trauma patients - To assess the extra-neurological effects of inhaled isoflurane sedation in head trauma patients - To assess the savings in intravenous hypnotics associated with isoflurane inhalation sedation in head trauma patients - To assess the feasibility of inhaled sedation with isoflurane in patients with head trauma - To assess the neurological outcome at D28 after inhaled sedation in head trauma patients ### Location - Facility: University Hospital Grenoble, Grenoble, Choisir Une Région, 38043, France @@
## Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part B - NCT ID: NCT06311591 - Study ID: STUDY00000716 Part B - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-04-01 - Lead Sponsor: University of Massachusetts, Worcester ### Study Description This Study will evaluate the implementation of a multi-component suicide prevention technology (Jaspr Health) that facilitates delivery of suicided-related evidence-based practices (EBPs) while replacing wasted waiting time with productive time in the Emergency Departments (EDs). The EBPs satisfy several key performance elements for systems adopting Zero Suicide.A Complementary Randomized Controlled Trial and Real-World Study for Efficacy, Effectiveness, and Implementation Study Design (CREID) will be used ### Conditions - Suicidal Ideation - Suicide Attempt - Self Harm ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Jaspr App ### Outcomes Primary Outcomes - Suicide composite, binary Secondary Outcomes ### Location - Facility: UCHealth University of Colorado Hospital, Aurora, Colorado, 80045, United States @@
## A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors - NCT ID: NCT06311578 - Study ID: 87704916LUC1001 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2033-11-30 - Lead Sponsor: Johnson & Johnson Enterprise Innovation Inc. ### Study Description The purpose of this study is to determine the safety, feasibility, recommended dose(s) and regimen(s) of JNJ-87704916 as monotherapy and in combination with cetrelimab. ### Conditions - Advanced Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - JNJ-87704916 - Cetrelimab ### Outcomes Primary Outcomes - Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) - Number of Participants with Adverse Events (AEs) by Severity Secondary Outcomes - Parts 1 and 2: Percentage of Participants With Objective Response (OR) - Parts 1 and 2: Percentage of Participants With Disease Control (DC) - Parts 1 and 2: Duration of Response (DOR) - Part 2: Progression Free Survival (PFS) - Part 2: Overall Survival (OS) - Parts 1 and 2: Number of JNJ-87704916 Genome Copies per Milliliter - Parts 1 and 2: Payload Concentrations of JNJ-87704916 - Parts 1 and 2: Number of Participants with JNJ-87704916 Antibodies ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## Effects of Education After Colorectal Cancer Screening - NCT ID: NCT06311565 - Study ID: SBU-ISTANBUL-0001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2024-12-30 - Lead Sponsor: Istanbul Saglik Bilimleri University ### Study Description The aim of this study is to examine the effect of the education given to individuals undergoing colorectal cancer screening on their attitudes, beliefs and healthy lifestyle behaviors.This study was planned to be conducted as a prospective randomized controlled study in a family health center in Istanbul. The universe of the research; The sample of individuals registered to the family health center will consist of a total of 70 individuals who meet the inclusion criteria for the study.Patient Diagnosis Form, Colorectal Cancer Screening Attitude Belief Scale, Healthy Lifestyle Behavior Scale II will be used to collect data. Data will be collected at the first encounter, 1 month later, 3 months later, pre-test and post-test. In the research, individuals will be divided into two groups: intervention (n = 35) and control (n = 35). Training will be provided to the intervention group. ### Conditions - Healthy Lifestyle - Education ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Education ### Outcomes Primary Outcomes - Colorectal cancer screening attitude belief scale - Healthy lifestyle behaviors scale II Secondary Outcomes ### Location - Facility: Hilal KARTAL, Istanbul, Beylikdüzü, N/A, Turkey @@
## Optimising CMR Scan Acquisitions for Novel Equipment/Sequences in Clinical Cardiovascular Populations. - NCT ID: NCT06311552 - Study ID: 0856 - Status: COMPLETED - Start Date: 2022-01-31 - Completion Date: 2023-11-30 - Lead Sponsor: University of Leicester ### Study Description The purpose of this study is to develop robust protocols for the optimisation of novel hardware, software and exercise equipment in the magnetic resonance imaging (MRI) environment in various cohorts with cardiovascular disease (CVD) with the first study focusing on those with established heart failure with preserved ejection fraction (HFpEF) or those at risk of or with pre-HFpEF. ### Conditions - Heart Failure With Preserved Ejection Fraction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Participants will undergo a comprehensive CMR scan on either a 1.5- or 3-Tesla scanner ### Outcomes Primary Outcomes - To develop CMR scanning protocols which acquire the highest quality images during incremental exercise using a stepper ergometer (Ergospect Cardio-stepper). Secondary Outcomes - To determine the reproducibility of the exercise CMR protocols in a test-retest reproducibility sub-study - To determine the optimal scan acquisition protocol for Magnetic Resonance Spectroscopy (MRS) both H+ and 31P using the phosphorous coil in each patient group. - To determine the reproducibility of the MRS protocols in a test-retest reproducibility sub-study ### Location - Facility: Glenfield Hospital, Leicester, N/A, N/A, United Kingdom @@
## The Effect of Circadian Rhythm on Physical Performance in Healthy Male Individuals - NCT ID: NCT06311539 - Study ID: IstanbulBUFC4 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-10-01 - Lead Sponsor: Istanbul Bilgi University ### Study Description Little is known about optimizing the timing of exercise periods to maximize the health benefits of exercise. Furthermore, exercise is a potent modulator of skeletal muscle metabolism and it is clear that skeletal muscle has a robust circadian profile. Circadian rhythms can be observed in behavior, physiology, and metabolism. Various studies show that exercise changes the rhythm of the clock machines in skeletal muscle. Studies examining the relationship between exercise, especially strength training, and circadian rhythm are quite limited in the literature. Although some studies have shown that force peaks in the afternoon/evening hours, regardless of muscle group and contraction speed, there are no studies on how much this time interval varies from person to person and chronotype.The aim of this study is to investigate to what extent strength training given at appropriate times for morning, evening and intermediate chronotypes creates changes in performance in healthy adult male individuals. ### Conditions - Chronotype - Exercise ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Theraband Strengthening Exercise Program ### Outcomes Primary Outcomes - Isokinetic strength test - Vertical jump test Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Mechanism of Action of Focal Extracorporeal Shock Waves as a Treatment of Upper Limb Stroke Spasticity: a Pilot Study - NCT ID: NCT06311526 - Study ID: 24C303 - Status: RECRUITING - Start Date: 2023-05-30 - Completion Date: 2025-04-30 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description Spasticity, common after a stroke, aggravates the patient's motor impairment causing pain and limitation in daily activities such as eating, dressing and walking.There are different spasticity treatments, such as botulinum neurotoxin, in the first place. Among the emerging therapies is focal extracorporeal shock wave therapy, consisting of a sequence of sonic (mechanical) impulses with high peak pressure.Systematic reviews highlighted that shock waves effectively improve lower and upper limb spasticity. Moreover, the shock waves therapeutic effect can last up to 12 weeks from the last treatment session.When used to treat stroke spasticity, the shock waves' mechanism of action is poorly detailed.On the one side, shock waves could change the physical properties of the muscular tissue (e.g. viscosity, rigidity).On the other, the shock waves produce a robust mechanical stimulation that massively activates muscle and skin mechanoreceptors (e.g. muscle spindles). This activation would modulate, in turn, the spinal (and supra-spinal) circuits involved in spasticity.To our knowledge, no study investigated the shock waves mechanism of action in stroke upper limb spasticity.Research question: do shock waves exert their therapeutic effect on spasticity by changing the muscle's physical properties or by indirectly modulating the excitability of spinal circuits?Specific aims: To investigate the mechanism of action of shock wave therapy as a treatment of upper limb spasticity after a stroke.Two major hypotheses will be contrasted: shock waves reduce hypertonia 1) by changing the muscle's physical features or 2) by changing the motoneurons excitability and the excitability of the stretch reflex spinal circuits.Shock wave therapy is expected to improve spasticity, thus improving the following clinical tests: the Modified Ashworth Scale (an ordinal score of spasticity) and the Functional Assessment for Upper Limb (FAST-UL, an ordinal score of upper limb dexterity).This clinical improvement is expected to be associated with changes in spastic muscle echotexture assessed with ultrasounds, such as an improvement in the Heckmatt scale (an ordinal score of muscle echotexture in spasticity).Clinical improvement is also expected to be associated with an improvement in the following neurophysiological parameters: a reduction of the H/Mmax ratio (an index of hyperexcitability of the monosynaptic stretch reflex circuit), a decrease in amplitude of the F waves (a neurophysiological signal reflecting the excitability of single/restricted motoneurones) and an increase of the homosynaptic depression (also known as post-activation depression, reflecting the excitability of the transmission between the Ia fibres and motoneurones).Understanding the shock wave mechanism of action will lead to a better clinical application of this spasticity treatment.If the shock waves exert their therapeutic effect by changing the muscle's physical properties, they could be more appropriate for patients with muscle fibrosis on ultrasounds.On the contrary, if the shock waves work on spasticity by indirectly acting on the nervous system's excitability, then a neurophysiology study could be used to preliminary identify the muscle groups with the most significant neurophysiological alterations, which could be the muscles benefitting the most from this treatment. ### Conditions - Stroke - Hemiparesis - Hemiplegia - Spasticity as Sequela of Stroke - Upper Limb Hypertonia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Extracorporeal Shockwave Therapy ### Outcomes Primary Outcomes - M wave and H reflex recruitment curve - H reflex post-activation depression - F waves - T reflex Secondary Outcomes - Upper limb dexterity measures - Ultrasound arm and forearm assessment ### Location - Facility: IRCCS Istituto Auxologico Italiano, Milano, MI, 20122, Italy @@
## Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction - NCT ID: NCT06311513 - Study ID: 2023-1017 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-12 - Lead Sponsor: Hospital for Special Surgery, New York ### Study Description The goal of this pilot randomized clinical trial is to look into the efficacy of concentrated bone marrow aspirate (cBMA) in improving post traumatic osteoarthritis (PTOA) symptoms in patients undergoing revision anterior cruciate ligament reconstruction surgery. The main questions it aims to answer are whether clinical outcomes, such as pain, are improved in patients who get cBMA with surgery, if there is a change in circulating markers of inflammation and what part of the cellular and molecular composition of cBMA may explain its effects. ### Conditions - Anterior Cruciate Ligament Injuries - Post-Traumatic Osteoarthritis of Knee - Bone Marrow Aspirate Concentrate - ACL Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Concentrated Bone Marrow Aspirate Injection - Sham Incision - Revision Anterior Cruciate Ligament Reconstruction ### Outcomes Primary Outcomes - Change from baseline in patient reported knee pain Secondary Outcomes - Expression of local inflammatory biomarkers - Concentration of circulating inflammatory biomarkers - Change from baseline in cartilage morphology - Change from baseline in articular cartilage relative proteoglycan content and collagen fibril organization ### Location - Facility: Emory Orthopaedics & Spine Center, Atlanta, Georgia, 30097, United States @@
## Sleep Health Enhancement in Midlife Adults - NCT ID: NCT06311500 - Study ID: STUDY00151143 - Status: RECRUITING - Start Date: 2024-02-13 - Completion Date: 2025-06-30 - Lead Sponsor: University of Kansas Medical Center ### Study Description Despite the strong links between sleep and AD, a sleep health enhancement has yet to be targeted in mid-life adults (45-64 years old) to delay or prevent AD. An intervention aimed at enhancing sleep health is a critical opportunity for primary prevention to potentially delay the onset of AD. The objective of the proposed study is to develop and assess the feasibility, acceptability, and treatment effect of a comprehensive sleep health intervention (SHI) on improving sleep health in mid-life adults ### Conditions - Sleep Health - Midlife Adults ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sleep health enhancement intervention ### Outcomes Primary Outcomes - 6-item Acceptability Scale - Qualitative interview - Ru-SATED Composite score - Sleep Self-Efficacy Scale - Pittsburgh Sleep Quality Index - Epworth Sleepiness Scale - Dysfunctional Beliefs About Sleep (DBAS-10) consists of 10 statements reflecting beliefs and attitudes about sleep. Each statement is rated from 1 = strongly disagree to 10 = strongly agree - Positive Affect and Negative Affect Schedule - Continuous Performance Test - Stroop Test - Cognitive Failures Questionnaire - Actigraphy Secondary Outcomes ### Location - Facility: University of Kansas Medical Center, Kansas City, Kansas, 66160, United States @@
## Time and Nutrient-Dependent Effects of Aerobic Exercise on Metabolism in Adults (TANDEM Study) - NCT ID: NCT06311487 - Study ID: 23-1388 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-08 - Lead Sponsor: University of Colorado, Denver ### Study Description This study plans to learn more about metabolic responses to aerobic exercise at different times of the day (morning or evening) under fasting versus fed conditions. ### Conditions - Overweight and Obesity - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Fasted-AM - Fed-AM - Fasted-PM - Fed-PM ### Outcomes Primary Outcomes - Exercise Energy Expenditure (kcals) - Substrate Oxidation (Respiratory Quotient) Secondary Outcomes ### Location - Facility: University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States @@
## Remote Assessment and Intervention for Behavior Problems in Kids With TSC - NCT ID: NCT06311474 - Study ID: W81XWH-22-1-0250 - Status: RECRUITING - Start Date: 2022-08-01 - Completion Date: 2025-07-31 - Lead Sponsor: University of California, Los Angeles ### Study Description The RAINBOW study is a fully remote study focused on understanding and treating behavior problems in young children with tuberous sclerosis complex (TSC). The first goal is to enroll a group of 100 children with TSC between the ages of 3 and 6 years old, with and without problem behaviors, to learn about how best to measure behavioral challenges in TSC and how common these behaviors are during this age period. All families will get feedback from the clinical assessments collected. Eligible children who are experiencing behavior problems will be invited to enroll in a pilot clinical trial of internet-based Parent-Child Interaction Therapy (or PCIT), which is meant to help parents better manage their children's challenging behaviors. Adaptations to PCIT are incorporated to suit the needs of TSC children and families. Some participants will be randomly selected to receive the intervention immediately and others after a 6-month delay, but all families will receive the same intervention. Intervention sessions occur on a weekly basis for up to 20 weeks. Follow-up assessments, which include play interactions, parent interviews, and questionnaires occur about 3 and 6 months after the first visit. The delayed treatment group has an extra brief assessment about 12 months from the initial visit. This study will increase what is known about the types of behavior problems that come up during preschool age in TSC and how best to help children and families with TSC who are experiencing these problems. ### Conditions - Tuberous Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Parent-Child Interaction Therapy (PCIT) ### Outcomes Primary Outcomes - Eyberg Child Behavior Inventory (ECBI) Secondary Outcomes - Behavior Assessment Scale for Children-3rd Edition (BASC-3) - Vineland Adaptive Behavior Scales-3rd Edition (Vineland-3) - Parenting Stress Index-4th Edition-Short Form (PSI-4-SF) - Dyadic Parent-Child Interaction Coding System (DPICS) - Therapy Attitude Index (TAI) - Telehealth Usability Questionnaire (TUQ) - Aberrant Behavior Checklist (ABC) ### Location - Facility: University of California, Los Angeles, Los Angeles, California, 90095, United States @@
## Effects of Acupuncture on Symptoms of Stable Angina - NCT ID: NCT06311461 - Study ID: 22-001111 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-06-30 - Lead Sponsor: University of California, Los Angeles ### Study Description The goal of this clinical trial is to determine if a standardized 12-point acupuncture protocol will reduce pain in participants with stable angina.This study addresses the critical need to reduce persistent pain for angina. The investigators long-term goal is symptom management for diverse women and men with angina, targeting additional angina burden borne of social disadvantageParticipants will be randomized to a 10-acupuncture session protocol, two treatments per week for five weeks, or an attention control group. Participants will view designated, non-pain related Technology, Entertainment, Design Talks equal to the time spent receiving acupuncture (\~7.5-10 hrs.).The investigators will test the efficacy of acupuncture for stable angina/chest pain syndrome to reduce pain and symptoms, improve health-related quality of life, reduce healthcare utilization and and improve patient related health outcomes. ### Conditions - Angina, Stable ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Acupuncture - Attention control ### Outcomes Primary Outcomes - Pain Now - Worst Pain - Least Pain - Acute Coronary Syndrome like symptoms (ACS Symptom Checklist) - Anginal Pain (Seattle Angina Questionnaire-7) - Number of Angina Attacks (From American Heart Association Angina Log) - Symptom Triggers (From American Heart Association Angina Log) - Pain from Angina Attack (From American Heart Association Angina Log) - Length of Angina Attack (American Heart Association Angina Log) - Self-treatment for Symptoms (From American Heart Association Angina Log) Secondary Outcomes - Functional Status Related to Angina (Seattle Angina Questionnaire-7) - General Functional Status (PROMIS 29v.2) - Quality of Life (Seattle Angina Questionnaire-7) - Use of Nitrates and Analgesics (AHA Angina log) - Patient Reported Outcomes (Patient Reported Outcomes Measurement Information System-29v.2 - Healthcare Utilization - Ischemia on Electrocardiogram (ECG) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Personalized Targeted Immunomodulation in COVID-19 ARDS - NCT ID: NCT06311448 - Study ID: 10094 - Status: COMPLETED - Start Date: 2020-03-02 - Completion Date: 2022-02-01 - Lead Sponsor: Erasmus Medical Center ### Study Description Rationale: In COVID19 single-targeted immunomodulation, mostly via an IL-6 receptor blocker, was used by a one-size fits all non-targeted approach. In future pandemics the same might occur. However, for individual patients, this might not yield optimal treatment.Objectives: This project aims to identify a way to individualize and target immunomodulation, using COVID19 as a testcase for the future.* Identify immunological pathways which are associated with outcome in C-ARDS.* Test whether an individualized biomarker-based approach has an effect on outcome and costs when using single-target immunomodulation in C-ARDS(Tocilizumab, Anakinra, etc.).* Explore whether other immunological pathways were present in patients with C-ARDS which could have been intervened with medication which is already available and has been described in ARDS or similar diseases.Study type: Retrospective observational multicenter study in the Netherlands.Study population: Adult patients (≥ 18 years) hospitalized and admitted to the ICU with COVID-19 and acute respiratory distress syndrome (ARDS) (i.e., receiving invasive mechanical ventilation) will be included.Intervention (if applicable): Not applicable (retrospective study design).Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Given the retrospective nature of the study, no burden, risks or benefits for the patient are associated with participation. The target population of this study is specific to hospitalized patients with COVID-19. ### Conditions - COVID-19 Acute Respiratory Distress Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Single target immunomodulation - Standard of care ### Outcomes Primary Outcomes - Mortality up to day 90 - Change in SOFA score - Ventilator free days - Change in biomarker values - Costs of immmunomodulation Secondary Outcomes ### Location - Facility: Erasmus Medical Centre, Rotterdam, Zuid-Holland, 3015 GD, Netherlands @@
## Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19 - NCT ID: NCT06311435 - Study ID: FBB-RNA-004 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-03-15 - Lead Sponsor: MaxWell Clinic, PLC ### Study Description The primary objective of this study is to determine, in unblinded samples, whether artificial intelligence can classify specific blood RNA from patients with long COVID together and separately from apparently healthy normals and other medical conditions which share signs and symptoms of long COVID. ### Conditions - Long COVID ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - RNA Biomarker Blood Test ### Outcomes Primary Outcomes - Artificial Intelligence Identified number of RNA Biomarkers for Long COVID Secondary Outcomes - Artificial Intelligence Identified number of RNA Biomarkers for specific Long COVID subgroups ### Location - Facility: The MaxWell Clinic, Brentwood, Tennessee, 37027, United States @@
## A 3-Year Clinical Evaluation Of Endocrown Restorations With Two Different Materials - NCT ID: NCT06311422 - Study ID: CAD/CAM-endocrown - Status: ACTIVE_NOT_RECRUITING - Start Date: 2020-03-15 - Completion Date: 2028-09-15 - Lead Sponsor: Hacettepe University ### Study Description The clinical performance of two different materials in endodontically treated teeth produced with CAD/CAM system will be evaluated and compared. After obtaining a signed informed consert form from all the patients, all restorations will be placed by a single clinician. All endocrown restorations will be produced using the same CAD/CAM system. 52 restorations will be fabricated using Lava Ultimate (LU, 3M Espe, Seefeld, Germany) blocks and 38 restorations will be fabricated using Celtra Duo (CD, Dentsply Sirona, York, PA, USA) blocks. All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after baseline, 6,12,36, 48, 60 months. Descriptive statistics will be performed using Chi-square and Fisher exact test. ### Conditions - Endodontically Treated Teeth ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - resin nanoceramic block - zirconia-reinforced lithium silicate ### Outcomes Primary Outcomes - Clinical performance of two materials Secondary Outcomes ### Location - Facility: Hacettepe University Faculty of Dentistry, Ankara, N/A, 06060, Turkey @@
## Validation Study of the Speedy Meyer Fall Scale for Determining the Fall Risk of the Paediatric Patient - NCT ID: NCT06311409 - Study ID: SMFS2019 - Status: RECRUITING - Start Date: 2020-01-29 - Completion Date: 2024-04 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description Fall prevention is an essential element in ensuring safe care for paediatric patients. The first step in building a risk reduction programme is the adoption of an assessment tool to identify those most at risk at an early stage. From October 2014 to date, a study has been conducted for the linguistic-cultural validation of the Humpty Dumpty Fall Scale (HDFS) in the Italian context, through a multicentre survey with the help of the Clinical Risk Management Group of the Region of Tuscany.The objective of this study is the validation of the new Humpty Dumpty Fall Scale defined as Speedy Meyer-Fall Scale (SMFS) by assessing the comprehension and validity of the scale and items via Content Validity Index (SCVI and ICVI) estimation of inter-item reliability (Crombach's alpha), inter-rater reliability (Cohen's K), sensitivity, specificity, PPV, NPV and ROC curve. ### Conditions - Fall Prevention ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - validation of the SMFS t Secondary Outcomes - identification of patients high risk of falls ### Location - Facility: AUSL Toscana Sud Est, Arezzo, N/A, 51100, Italy @@
## Development of a Neuronal Microscope - NCT ID: NCT06311396 - Study ID: REVEAL - Status: RECRUITING - Start Date: 2021-01-01 - Completion Date: 2025-01-01 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and is a leading cause of cancer-related death worldwide. The prognosis of HCC remains poor, with a 5-year survival rate of 18%. Risk factors for HCC include viral infection, autoimmune hepatitis, chronic alcohol use or metabolic fatty liver disease, obesity, and diabetes mellitus. ### Conditions - Hepatic Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - genetic model ### Outcomes Primary Outcomes - Isolation of epithelial cells - Omics studies and functional morphological studies Secondary Outcomes ### Location - Facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica, Milan, Milano, 20122, Italy @@
## A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Ribociclib + AI/FUL, or With Endocrine Therapy or Chemotherapy as First Line Treatment - NCT ID: NCT06311383 - Study ID: CLEE011ADE03 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2017-10-09 - Completion Date: 2025-02-16 - Lead Sponsor: Novartis Pharmaceuticals ### Study Description This is a non-interventional observational study conducted in Germany to evaluate the real-world effectiveness, tolerability, safety, and quality of life in patients with locally advanced/metastatic HR+/HER2- breast cancer treated with one of the following 1st line treatments: Ribociclib + AI/FUL, or endocrine monotherapy, or chemotherapy ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - First-line Ribociclib + endocrine therapy - First-line endocrine therapy - First-line chemtherapy ### Outcomes Primary Outcomes - Progression-free survival (PFS) Secondary Outcomes - Cox proportional hazard regression for progression free survival in 1st line therapy - Propensity Score matching for progression free survival in 1st line therapy - Sequential progression-free survival (PFS_S) - Conditional progression-free survival - Time to treatment failure (TTF) - Time to first chemotherapy - Time to next treatment / therapy (TTNT) after 1st line treatment - Overall survival (OS) - Dose reduction - Dose interruption - Discontinuations - Adherence - MMAS-8 questionnaire - Number of participants with mutations - Quality of life for specific cohorts and treatment lines - EORTC QLQ-C30 - Quality of life for specific cohorts and treatment lines - EORTC QLQ-B23 - Quality of life for specific cohorts and treatment lines - HADS-D ### Location - Facility: Novartis Investigative Site, Freudenstadt, Baden Wuerttemberg, 72250, Germany @@
## Acceptability, Feasibility, and Development of an AI Driven, Multi-sensor, Non-invasive Digital Mental Health Platform in Children With ADHD and Emotional Symptoms - NCT ID: NCT06311370 - Study ID: 2023-0100 - Status: COMPLETED - Start Date: 2023-08-09 - Completion Date: 2024-02-05 - Lead Sponsor: MaxisHealth ### Study Description This is an observational study collecting data using a wearable to measure the biometric features in youth with Attention deficit hyperactivity disorder(ADHD) and Autism. ### Conditions - ADHD - Autism ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observation ### Outcomes Primary Outcomes - Emotion dysregulation Secondary Outcomes ### Location - Facility: The League School, Brooklyn, New York, 11203, United States @@
## Percent Weight Change in the Medical Supplement Group of Early Breast Cancer - NCT ID: NCT06311357 - Study ID: 100/2566 - Status: RECRUITING - Start Date: 2023-07-12 - Completion Date: 2024-04-30 - Lead Sponsor: Rajavithi Hospital ### Study Description The goal of this RCT is to compare percent weight change in early breast cancer who takes medical supplement or not, during treatment with chemotherapy (standard AC regimen).The main question is• the change of weight (%) before and after complete treatment of breast cancer therapy.Participants will be randomized into 2 group* intervention group - receive medical supplement daily during chemotherapy treatment.* control group - Nutritional advise during chemotherapy treatment. ### Conditions - Early Stage Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Ensure ### Outcomes Primary Outcomes - Percent weight change Secondary Outcomes - EORTC QLQ-C30 - Patient interpretation of the Patient-Generated Subjective Global Assessment - EORTC QLQ-BR23 ### Location - Facility: Rajavithi hospital, Ratchathewi, Bangkok, 10400, Thailand @@
## Filling Key Research Gaps With Clinical Implications in Mansonellosis and Schistosomiasis: a Network Approach - NCT ID: NCT06311344 - Study ID: 2021-06 - Status: RECRUITING - Start Date: 2021-04-14 - Completion Date: 2024-03-31 - Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar ### Study Description This is an experimental, multicenter, non-profit study promoted by the Department of Infectious and Tropical Diseases of the IRCCS (Istituto di Ricerca e Cura a carattere scientifico) Sacro Cuore Don Calabria of Negrar which aims to evaluate the presence of endosymbiont Wolbachia in circulating microfilariae obtained from biological samples of individuals infected with M .perstans and the presence of infection with hybrid Schistosoma species in the population of Schistosoma eggs isolated from biological samples of patients with active schistosomiasis. ### Conditions - Schistosoma Mansoni ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Molecular biology analyses ### Outcomes Primary Outcomes - Number of M. perstans microfilariae - Percentage of M. perstans microfilariae - Number of Schistosoma eggs - Percentage of Schistosoma eggs Secondary Outcomes - Number of samples positive for Wolbachia - Percentage of samples positive for Wolbachia - Number of samples positive for Schistosoma hybrid species - Percentage of samples positive for Schistosoma hybrid species - Identification of hybrid species of Schistosoma spp. ### Location - Facility: IRCCS Sacro Cuore Don Calabria hospital, Negrar, Verona, 37024, Italy @@
## Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM) - NCT ID: NCT06311331 - Study ID: restor3d-007 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2031-05 - Lead Sponsor: Restor3D ### Study Description This is a Humanitarian Device Exemption (HDE) approved device. The purpose of this study is to evaluate the continued safety and probable benefit of the restor3d Total Talus Replacement device in commercial use. ### Conditions - Avascular Necrosis of the Talus - Talar Osteochondral Defect of Ankle - Talar Dysfunction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Total Talus Replacement (TTR) ### Outcomes Primary Outcomes - Proportion of participants who pass a composite of safety and probable benefit outcomes Secondary Outcomes - Change in perceived pain from baseline - Change in Foot and Ankle Outcome Score (FAOS) Composite score from baseline - Change in Foot and Ankle Outcome Score (FAOS) pain subscale score from baseline - Change in Foot and Ankle Outcome Score (FAOS) other symptoms subscale score from baseline - Change in Foot and Ankle Outcome Score (FAOS) activities of daily living (ADL) subscale score from baseline - Change in Foot and Ankle Outcome Score (FAOS) sports/recreation subscale score from baseline - Change in Foot and Ankle Outcome Score (FAOS) quality of life (QOL) subscale score from baseline - Change in ankle range of motion (ROM) from baseline - Proportion of procedure-related Serious Adverse Events - Proportion of Adverse Events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Post-operative Lower Eyelid Massage for Prevention of the Lower Eyelid Scare Contracture After Subciliary Approach - NCT ID: NCT06311318 - Study ID: Department of surgery MED CMU - Status: COMPLETED - Start Date: 2016-11-01 - Completion Date: 2020-09-30 - Lead Sponsor: Chiang Mai University ### Study Description Patients were randomly allocated to the lower eyelid massage (experimental) or standard care (control) groups. The massage group received post-operative instructions. Data on demographics, injury profiles, lower eyelid scar contracture (graded by GLESCO criteria), eyelid malpositioning, comfort scores, and complications were gathered over a 6-month follow-up. ### Conditions - Zygomatic and Lefort II Fractures - Infraorbital Rim Fixation - Subciliary Approach Repair ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - lower eyelid massage ### Outcomes Primary Outcomes - Grading of Lower Eyelid Scar Contracture (GLESCO) - Grading of lower eyelid malpositioning - Comfort scores Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Does Early Laparoscopic Cholecystectomy After ERCP Reduce the Risk of Complications - NCT ID: NCT06311305 - Study ID: Soh-med-24-03-07MS - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-08-20 - Lead Sponsor: Sohag University ### Study Description Gallstones have been recognised since antiquity and have been found during autopsies of Egyptian mummies. Following the first successful open cholecystectomy in 1882, it was Eric Muhe, a German surgeon, who performed the first laparoscopic cholecystectomy (Lapara, the flank; and skopein, to examine) in 1985.The common mechanism of gallstone formation includes cholesterol hypersecretion, alteration in intestinal bile salt, cholesterol absorption and gall bladder hypokinesia, which leads to bile cholesterol supersaturation and nucleation.Incidence of CBD stones in cases of cholelithiasis is around 3.4%-15%.2 Choledocholithiasis can either be primary or secondary. Secondary Choledocholithiasis being more common occurs due to stones originating in gallbladder and then migrating through cystic duct to CBD. Primary bile duct stones originate from within bile ducts and are more common in Asian populations. These stones are associated with biliary stasis and bacteria. ### Conditions - Cholelithiases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Early Laparoscopic cholecystectomy ### Outcomes Primary Outcomes - bile leakage - operative time - intraoperative bleeding - sepsis Secondary Outcomes ### Location - Facility: Sohag University, Sohag, N/A, 82511, Egypt @@
## Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis - NCT ID: NCT06311292 - Study ID: STUDY22090138 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-06 - Lead Sponsor: Daniel J. Weiner ### Study Description This is a small pilot study with the goal of identifying a superior sputum collection method in Cystic Fibrosis patients unable to produce a sputum.Participants will use the Volara System during clinic visit in an attempt to produce sputum. ### Conditions - Cystic Fibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Volara System ### Outcomes Primary Outcomes - Sufficient sputum quantity for a pellet Secondary Outcomes ### Location - Facility: UPMC Presbyterian Hospital, Pittsburgh, Pennsylvania, 15213, United States @@
## End to End Versus Side to End Anastomosis After Anterior Resection of Cancer Rectum - NCT ID: NCT06311279 - Study ID: Soh-Med-24-03-01MD - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2025-03-20 - Lead Sponsor: Sohag University ### Study Description Comparison between end to end and side to end anastomosis after anterior resection of cancer rectum and compare the outcomes of both surgical techniques. The main outcomes were bowel functional outcomes and QoL. Bowel functional outcomes mainly included three indexes: stool frequency, urgency, incomplete defecation, and incontinence. The secondary outcomes were surgical outcomes including operative time, postoperative hospital stay, postoperative complications, reoperation, and mortality. ### Conditions - Rectum Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Anterior resection of Rectal cancer ### Outcomes Primary Outcomes - Operative time - Anastomotic leakage - hospital stay - Mortality - Anastomotic leak amount Secondary Outcomes ### Location - Facility: Sohag university, Sohag, N/A, 82511, Egypt @@
## Robotic Endoscopic Neurosurgical Interventions - NCT ID: NCT06311266 - Study ID: 34-424 ex 21/22 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2025-10 - Lead Sponsor: Medical University of Graz ### Study Description Endoscopic operations have become increasingly important in the field of neurosurgery over the past decade and require a high degree of precision. Current methods for setting the planned trajectory only offer limited precision due to the manual control, which can lead to complications.The EndoGuide robot is a modular positioning device for controlling endoscopic instruments, which can use radiological data from neuronavigation to align the trajectory in real time with an accuracy of \<0.1mm.The previous model of the robot is currently approved for interventional radiology and positioning of electrodes and catheters in the field of neurosurgery and is now to be tested in endoscopic neurosurgery.The investigators therefore expect not only an increase in the accuracy of endoscopic interventions, but also a reduction in morbidity. ### Conditions - Robot for Endoscopic Neurosurgical Interventions ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - Robotic endoscopic neurosurgical intervention ### Outcomes Primary Outcomes - Target Error (TE) Secondary Outcomes - Adverse Effect ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Non-surgical Periodontal Treatment With Adjunctive Use of Lactoferrin Contained in Toothpaste and Mouthwash - NCT ID: NCT06311253 - Study ID: 2024-LACTOFERRINPREGNANT - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-20 - Completion Date: 2024-11 - Lead Sponsor: University of Pavia ### Study Description The aim of the study is to assess the effect of lactoferrin in LBC complex can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients. ### Conditions - Periodontal Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Emoform Glic Toothpaste - Emoform Glic Mouthwash ### Outcomes Primary Outcomes - Change in Recession (R) - Change in Plaque Index (Silness and Loe, 1964) - Change in Bleeding on Probing (BoP) - Change in Probing Pocket Depth (PPD) - Change in modified Marginal Gingival Index (mMGI) - Change in Papillary Marginal Gingival Index (PMGI) - Change in Plaque Control Record (PCR%) - Change in Clinical Attachment Loss (CAL) Secondary Outcomes ### Location - Facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia, Pavia, Lombardy, 27100, Italy @@
## Chronic Pain in Patients in Hemodialysis - NCT ID: NCT06311240 - Study ID: 02-24-108-003 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-09 - Lead Sponsor: Cardenal Herrera University ### Study Description Pain is one of the most common symptoms among patients with End Stage Renal Disease (ESRD), and often goes unrecognized or inadequately managed in hemodialysis patients. More than 50% of patients undergoing hemodialysis suffer from pain, with 75% of them being treated ineffectively due to healthcare professionals\&#39; lack of awareness of this symptom. Therefore, pain management in this population is a complex and challenging task for healthcare providers. The most prevalent pain syndromes in hemodialysis patients include musculoskeletal disorders, metabolic neuropathies, in addition to typical intradialytic pain.The aim of this study is to assess the presence and characteristics of chronic pain in patients with ESRD undergoing hemodialysis to determine whether it is relevant to include the management of chronic pain in the holistic treatment (physical activity, nutrition, and psychological support) already being implemented in various studies for these patients. ### Conditions - Chronic Pain - Chronic Kidney Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Stress level assessed by the salivary cortisol test - Stress level assessed by the perceived stress scale (PSS) Secondary Outcomes - Self- efficacy assessed by questionnaire - Quality of sleep assessed by Pittsburgh Sleep Quality Index - The impact of headaches on life assessed by Headache Impact Test-6 - Anxiety and depression assessed by Hospital anxiety and depression scale (HADS) - Aspects of catastrophic cognitions about pain-rumination, magnification, and helplessness assessed by The Pain Catastrophizing Scale (PCS) - Chronic pain assessd by Chronic Pain Grade Questionnaire ### Location - Facility: Consorci Sanitari de Terrassa, Terrassa, Barcelona, 08227, Spain @@
## Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia - NCT ID: NCT06311227 - Study ID: NCI-2024-01904 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-20 - Completion Date: 2025-07-01 - Lead Sponsor: National Cancer Institute (NCI) ### Study Description This phase II trial tests how well venetoclax works in treating patients with hairy cell leukemia that has come back after a period of improvement (relapsed). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. ### Conditions - Recurrent Hairy Cell Leukemia - Recurrent Hairy Cell Leukemia Variant ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Biospecimen Collection - Bone Marrow Aspiration - Bone Marrow Biopsy - Computed Tomography - Magnetic Resonance Imaging - Venetoclax ### Outcomes Primary Outcomes - Objective response rate Secondary Outcomes - Complete remission (CR) rate - Minimal residual disease (MRD)-negative CR rate - MRD negativilty - Incidence of adverse events - Complete response duration - MRD-negative survival ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The ADC MATCH Screening and Treatment Trial) - NCT ID: NCT06311214 - Study ID: NCI-2024-01903 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-21 - Completion Date: 2024-10-31 - Lead Sponsor: National Cancer Institute (NCI) ### Study Description This phase II ADC MATCH screening and multi-sub-study treatment trial is evaluating whether biomarker-directed treatment with one of three antibody-drug conjugates (ADCs) (sacituzumab govitecan, enfortumab vedotin, and trastuzumab deruxtecan) works in treating patients with solid tumor cancers that have high expression of the Trop-2, nectin-4, or HER2 proteins and that may have spread from where they first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or to other places in the body (metastatic). Precision medicine is a form of medicine that uses information about a person's genes, proteins, and environment to prevent, diagnose, or treat disease in a way that is tailored to the patient. ADCs such as sacituzumab govitecan, enfortumab vedotin, and trastuzumab deruxtecan are monoclonal antibodies attached to biologically active drugs and are a form of targeted therapy. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a drug called govitecan. Sacituzumab attaches to a protein called Trop-2 on the surface of tumor cells and delivers govitecan to kill them. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and delivers vedotin to kill them. Trastuzumab deruxtecan is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Personalized treatment with sacituzumab govitecan, enfortumab vedotin, or trastuzumab deruxtecan may be an effective treatment option for patients with advanced or metastatic solid tumors that screen positive for high expression of Trop-2, nectin-4, or HER2, respectively. ### Conditions - Advanced Malignant Solid Neoplasm - Metastatic Malignant Solid Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Biopsy - Biospecimen Collection - Computed Tomography - Echocardiography - Electronic Health Record Review - Enfortumab Vedotin - Immunohistochemistry Staining Method - Magnetic Resonance Imaging - Multigated Acquisition Scan - Sacituzumab Govitecan - Trastuzumab Deruxtecan ### Outcomes Primary Outcomes - Frequency of high protein expression in patients with high ribonucleic acid (RNA) expression of each antibody-drug conjugate target (screening protocol) - Objective response rate (treatment cohorts) Secondary Outcomes - Frequency that patients with high RNA and immunohistochemistry target expression receive cohort treatment on study (screening protocol) - Progression free survival (treatment cohorts) - Overall survival (treatment cohorts) - Time to progression (treatment cohorts) - Incidence of adverse events (treatment cohorts) - RNA expression of targets of interest (TOIs) (treatment cohorts) - Temporal tumor heterogeneity (treatment cohorts) - Potential predictive biomarkers and other molecular features (treatment cohorts) - Pharmacodynamic changes in the tumor and microenvironment (treatment cohorts) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Pilates Exercises on Diastasis Recti Abdominis in Postpartum Women - NCT ID: NCT06311201 - Study ID: P.T.REC/012/004256 - Status: COMPLETED - Start Date: 2023-09-26 - Completion Date: 2024-01-26 - Lead Sponsor: Cairo University ### Study Description The purpose of the study was to investigate the effect of Pilates exercises on diastasis recti abdominis in postpartum women. ### Conditions - Diastasis Recti ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Abdominal belt - Pilates exercises ### Outcomes Primary Outcomes - Measurement of separation between the two-rectus abdominis muscles above the umbilicus at rest - Measurement of separation between the two-rectus abdominis muscles above the umbilicus during contraction - Measurement of separation between the two-rectus abdominis muscles at level of the umbilicus at rest - Measurement of separation between the two-rectus abdominis muscles at level of the umbilicus during contraction - Measurement of separation between the two-rectus abdominis muscles below the umbilicus at rest - Measurement of separation between the two-rectus abdominis muscles below the umbilicus during contraction - Assessment of trunk flexion strength - Assessment of static trunk flexion endurance Secondary Outcomes - Assessment of functional status ### Location - Facility: Cairo University, Giza, N/A, N/A, Egypt @@
## Exploring PTSD Symptoms, Barriers and Facilitators to Mindfulness - NCT ID: NCT06311188 - Study ID: HUM00240243 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-14 - Completion Date: 2025-01-31 - Lead Sponsor: University of Michigan ### Study Description The purpose of this study is to investigate justice-involved Black/African American female adolescents' (JI BAFAs; N=35) self-reported outcomes: stress, posttraumatic stress disorder (PTSD), recidivism, etc., as well as their parents/caregivers' (P/Cs; N=35) stress and pre- and post- intervention results along with their views of an adapted intervention. ### Conditions - Stress - Trauma - PTSD - HPA ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ITR Healing intervention ### Outcomes Primary Outcomes - PTSD Screen - PTSD Checklist Secondary Outcomes - Stress Psychosocial - Stress Physiological - Parent/Caregiver-Child Relationship - Five Facet Mindfulness Questionnaire (FFMQ) - Recidivism - Personal Agency - Racial Identity - Parenting Stress ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Diet Tracking Prescriptions for Weight Loss - NCT ID: NCT06311175 - Study ID: H20-0114 - Status: RECRUITING - Start Date: 2024-04-30 - Completion Date: 2024-09-01 - Lead Sponsor: University of Connecticut ### Study Description Lifestyle interventions are effective at producing modest weight loss. One of the strongest predictors of weight loss is food tracking, which involves logging all food and beverage consumed each day in an effort to stay within a daily calorie goal. Standard lifestyle interventions prescribe daily food tracking for the length of the program which can range from 3-24 months. This can be a taxing prescription that is not feasible to do long term for many people. The purpose of this pilot feasibility randomized trial is to test the feasibility of 3 tracking prescriptions during an 8 week digital weight loss intervention: 1) tracking daily, 2) tracking two weeks on and one week off, 3) tracking every other week. Feasibility is defined as tracking prescription compliance, burden, acceptability, and perceived efficacy, and tracking self-efficacy. Diet tracking will be evaluated one month after the intervention ends so that groups can be compared on diet tracking maintenance. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dietary Tracking Prescription ### Outcomes Primary Outcomes - Compliance with diet tracking prescription - Persistence with diet tracking prescription - Burden of tracking prescription - Acceptability of tracking prescription - Perceived efficacy of tracking prescription - Self-efficacy of diet tracking Secondary Outcomes - Diet Tracking One Month Post-Intervention ### Location - Facility: University of Connecticut, Storrs, Connecticut, 06269, United States @@
## Early Life Intervention in Pediatrics Supported by E-health - SMOKE - NCT ID: NCT06311162 - Study ID: 2023-01615 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-31 - Completion Date: 2028-07-31 - Lead Sponsor: Insel Gruppe AG, University Hospital Bern ### Study Description Unrestricted parental smoking habits are lifestyle risk behaviors associated with chronic, systemic inflammation, which promotes the pathogenesis of non-communicable diseases (NCDs). Exposure to secondhand tobacco smoke in early life contributes to the development of specific NCDs in children, i.e. asthma. Early preventive measures to improve lifestyle behavior in parents are therefore of utmost importance. The aim of ELIPSE-II is to assess whether an eHealth application intervention for parents is feasible and efficacious in lowering levels of urinary cotinine as a measure of second-hand smoke exposure in their children . ### Conditions - Smoking Reduction - Asthma in Children - Wheezing - Non-Communicable Disease - Life Style - Behavior, Smoking ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Life-Style app - Sham Comparator ### Outcomes Primary Outcomes - Change from baseline in urinary levels of cotinine in children - Change from baseline in urinary levels of cotinine in children Secondary Outcomes - Change from baseline in protective measures taken by parents to protect children from second-hand smoke exposure ### Location - Facility: Department of Paediatrics, Inselspital, Bern University Hospital, Bern, N/A, 3010, Switzerland @@
## Multicenter Evaluation of Patients Using LATITUDE Monitoring System - NCT ID: NCT06311149 - Study ID: 479/2023/Oss/AOUFe - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2043-12-31 - Lead Sponsor: University Hospital of Ferrara ### Study Description The Multitude is a registry of patients who receive commercially available CIEDs that remotely communicate through the LATITUDE monitoring system and transfer data to a central database.The registry is designed to constitute a shared environment for the collection, management, analysis and reporting of clinical and diagnostic data, adopted by a network of European scientifically-motivated physicians who use rhythm management diagnostic and therapeutic solutions from Boston Scientific in their clinical practice.The Multitude study will facilitate the sharing of scientific proposals within a large network of researchers, and it will allow researchers to record the experience with medical devices throughout the device and patient lifecycle. ### Conditions - Cardiovascular Diseases - Arrhythmias, Cardiac - Heart Failure - Sudden Cardiac Death ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Mortality Secondary Outcomes - Hospitalization - Device therapy - Device-related complications ### Location - Facility: Azienda Ospedaliero-Universitaria di Ferrara, Ferrara, N/A, 44124, Italy @@
## Effectiveness of an Ecological Momentary Emotion Regulation Intervention - NCT ID: NCT06311136 - Study ID: PEAK - Status: RECRUITING - Start Date: 2024-01-12 - Completion Date: 2024-12 - Lead Sponsor: Heidelberg University ### Study Description This two-armed randomized controlled trial aims to investigate the effectiveness of an emotion regulation intervention in individuals with and without depressive disorders. The study encompasses participants diagnosed with mild to moderate major depression or persistent depressive disorder and healthy controls without a current depressive disorder.Participants will be randomly assigned to either the intervention group, receiving a valence-specific emotion regulation intervention in daily life, or a monitoring-only control group. The valence-specific intervention supports the implementation of different emotion regulation strategies based on whether a person is experiencing mainly positive or negative emotions. In contrast, participants in the control group will solely monitor their positive and negative emotions and the strategies used to regulate them.Outcome measures include emotion regulation ability, self-efficacy, and strategy use, depressive symptoms, positive and negative affect, and emotion beliefs (controllability, usefulness).A second aim of the study is to compare beliefs about positive emotions and strategies to regulate them between individuals with and without current depressive disorders. Furthermore, the investigators aim to examine why individuals might choose unfavorable emotion regulation strategies even when feeling good. Therefore, another research question is, how emotion beliefs might explain emotion regulation strategy choice. ### Conditions - Depressive Disorder, Major - Persistent Depressive Disorder - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Valence-Specific Ecological Momentary Intervention ### Outcomes Primary Outcomes - Emotion Regulation Ability (Positive, Negative Emotions) - Emotion Regulation Self-Efficacy for Positive and Negative Emotions Secondary Outcomes - Emotion Regulation Strategy Use in Positive and Negative Emotional Contexts - Depressive Symptoms - Positive and Negative Affect - Emotion Beliefs (Controllability, Usefulness) about Positive and Negative Emotions ### Location - Facility: Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Heidelberg University, Heidelberg, N/A, 69117, Germany @@
## Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis - NCT ID: NCT06311123 - Study ID: ISR IM047-059 - Status: RECRUITING - Start Date: 2023-10-06 - Completion Date: 2026-09-30 - Lead Sponsor: University of California, San Diego ### Study Description The goal of this observational study is to learn about the mechanism of action of ozanimod in patients with ulcerative colitis (UC). The main questions it aims to answer are:1. Prospectively assess the effects of ozanimod on the cellular composition of intestinal lamina propria and blood by deep immunophenotyping (CyTOF) of immune cell subsets prior and after the drug's administration.2. Determine whether changes in cell subsets observed via mass cytometry correlate with with clinical or histologic parameters of disease activity.Colonic biopsies and peripheral blood samples will be collected from patients with UC before and after the onset of ozanimod.Researchers will compare intestinal and peripheral leukocytes before and after the drug's administration. ### Conditions - Ulcerative Colitis - Ulcerative Colitis Chronic Moderate ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - difference in leukocyte subsets Secondary Outcomes ### Location - Facility: University of California San Diego, San Diego, California, 92093-006, United States @@
## Impaired Toilet Training, LUTS and Bowel Dysfunction in Children With DCD - NCT ID: NCT06311110 - Study ID: #BC-11326 AM04 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-10-30 - Completion Date: 2024-06-30 - Lead Sponsor: University Hospital, Ghent ### Study Description This cross-sectional case-control study aimed to determine whether there is a significant difference in the prevalence of impaired toilet training, LUTS, and functional bowel problems among children diagnosed with DCD and typically developing children (TDC). ### Conditions - Developmental Coordination Disorder - Lower Urinary Tract Symptoms - Bowel Dysfunction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Vancouver symptom score for dysfunctional elimination symptoms Questionnaire - Developmental Coordination Disorder Questionnaire - Questionnaire concerning impaired toilettraining and comorbities ### Outcomes Primary Outcomes - Impaired toilet training - Daytime incontinence - Enuresis - Fecal incontinence Secondary Outcomes - Toilet training difficulties - General bladder and bowel dysfunction ### Location - Facility: Ghent University Hospital/Ghent University, Ghent, East Flanders, 9000, Belgium @@
## Dairy Products to Your Gut and Brain - NCT ID: NCT06311097 - Study ID: M402 - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2025-09 - Lead Sponsor: University of Copenhagen ### Study Description The goal of this intervention study is to compare the effects of fermented dairy and non-fermented dairy on bowel habits and cognitive performance in healthy women with defecations every other day or less. Furthermore, the study aims to explore underlying mechanisms linking the gut and the brain.In addition, a sub-study will be conducted to explore differences in gut and brain measures between women with daily (reference group) and few (intervention group) weekly bowel movements, respectively, and to explore associations between measures of gut- and brain function. ### Conditions - Healthy - Constipation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Fermented dairy - Non-fermented dairy ### Outcomes Primary Outcomes - Difference in change from baseline in defecation frequency between the interventions Secondary Outcomes - Difference in change from baseline in cognitive performance between the interventions - Difference in change from baseline in phase-amplitude coupling between gastric slow-wave activity and cortical alpha activity between the interventions - Difference in change from baseline in whole gut transit time between the interventions - Difference in change from baseline in stool consistency between the interventions - Difference in change from baseline in stool moisture between the interventions - Difference in change from baseline in fecal abundance of Lactobacillus acidophilus between the interventions - Difference in change from baseline in self-reported gastrointestinal symptoms between the interventions ### Location - Facility: University of Copenhagen, Department of Nutrition, Exercise and Sports, Copenhagen, N/A, N/A, Denmark @@
## IMAGINATOR 2.0: Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People - NCT ID: NCT06311084 - Study ID: 310211 - Status: COMPLETED - Start Date: 2022-11-25 - Completion Date: 2024-01-23 - Lead Sponsor: Imperial College London ### Study Description This study aims to investigate acceptability and feasibility of a new version of the Imaginator intervention, Imaginator 2.0, targeting self-harm behaviour in young people aged 12-25 under mental health services in the UK.Following an initial proof-of-concept study of Imaginator (Di Simplicio et al., 2020), we co-designed a new version of the app that supports consolidation and practice of the techniques learnt in therapy, and adapted the protocol to be extended to younger adolescents.Imaginator 2.0 uses 'functional imagery training', training in individuals to develop and use functional (that is, helpful) mental images to support an alternative behaviour instead of self-harm. Mental imagery is the process of picturing something in the mind, and mental images have strong emotional and motivational characteristics. Functional Imagery Training (FIT) within Imaginator helps young people imagine adaptive behaviours as an alternative to self-harm when dealing with distressing emotions. ### Conditions - Self Injurious Behavior - Adolescent Behavior Problem - Child Behavior Problem - Mental Health Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Imaginator 2.0 ### Outcomes Primary Outcomes - Attrition - Treatment adherence - Scores on User Experience Questionnaire Secondary Outcomes - Number of self harm episodes over 3 months ### Location - Facility: West London NHS Trust, London, N/A, N/A, United Kingdom @@
## The Predictive Value of Coronary Artery Calcium Score - NCT ID: NCT06311071 - Study ID: IR.SUMS.MED.REC.1401.200 - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2023-09-01 - Lead Sponsor: Shiraz University of Medical Sciences ### Study Description In this analytical prospective study 498 patients over 40 years with any cardiovascular symptoms and without pre-established coronary artery disease ( CAD) were enrolled. Patients underwent CT scans to measure coronary artery calcium score (CACS), and total calcium scores were recorded. Then, conventional coronary angiography was performed for all the participants as the gold standard for diagnosing CAD (defined as at least one stenotic coronary artery with ≥ 50%). Framingham risk score (FRS) was also estimated for all the patients ### Conditions - Coronary Artery Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - calcium score - Invasive coronary angiography ### Outcomes Primary Outcomes - coronary artery disease - coronary calcium score Secondary Outcomes - cardiovascular risk score ### Location - Facility: Javad Kojuri, Shiraz, Fars, 7134814336, Iran, Islamic Republic of @@
## Protein Supplementation After ACL Surgery - NCT ID: NCT06311058 - Study ID: PRO00032531 - Status: RECRUITING - Start Date: 2024-02-16 - Completion Date: 2027-12-01 - Lead Sponsor: The Methodist Hospital Research Institute ### Study Description The purpose of the study is to assess the longitudinal post-operative care effects of protein supplementation on muscle atrophy in the post-operative period following ACL reconstruction. The main outcome will be muscle size/mass as measured using dual energy x-ray absorptiometry (DEXA) scanning. The primary objective is to assess for any beneficial impact of protein supplementation, with implications of standardizing a recommended protocol for protein supplementation after ACL reconstruction.Secondary outcomes will be to evaluate the survey data from the KOOS JR and Tampa Scale surveys, as well as functional measures recorded during physical therapy. ### Conditions - ACL Reconstruction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Whey protein isolate - Protein + BAA - Placebo ### Outcomes Primary Outcomes - Muscle mass Secondary Outcomes - Patient Reported Outcomes - Patient Reported Outcomes ### Location - Facility: Houston Methodist, Houston, Texas, 77030, United States @@
## Obstructive Sleep Apnea (OSA) and Sex-Specific Responses to N-acetylcysteine (NAC) - NCT ID: NCT06311045 - Study ID: 23-01469 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-12 - Lead Sponsor: NYU Langone Health ### Study Description This is a randomized controlled trial (RCT) of 4 weeks of study supplement N-acetylcysteine (NAC) versus placebo in persons with significant obstructive sleep apnea (OSA) who are receiving positive airway pressure therapy (PAP), the standard of care therapy. The purpose of the study is to determine if NAC is associated with sex-specific changes in overnight oxidative stress, inflammation, as well as endothelial dysfunction in persons with OSA. ### Conditions - Obstructive Sleep Apnea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - N-acetylcysteine (NAC) - Placebo - Positive Airway Pressure (PAP) Therapy ### Outcomes Primary Outcomes - Percent Change in Overnight Levels of Glutathione (GSH) - Mean Change in Pre- to Post-Sleep GSH Levels - Mean Change in Pre- to Post-Sleep GSH Levels Secondary Outcomes - Ratio of GSH to oxidized GSH (GSSG) (GSH:GSSG) - Ratio of GSH to oxidized GSH (GSSG) (GSH:GSSG) - 8-Isoprostane Level - 8-Isoprostane Level - Plasma Nitrate Level - Plasma Nitrate Level - Plasma Nitrite Level - Plasma Nitrite Level - Organic Nitrite Level - Organic Nitrite Level - Interleukin 6 (IL-6) Level - Interleukin 6 (IL-6) Level - Tumor Necrosis Factor-alpha (TNFα) Receptor-1 (TNFα-R1) Level - Tumor Necrosis Factor-alpha (TNFα) Receptor-1 (TNFα-R1) Level - Tumor Necrosis Factor-alpha (TNFα) Receptor-2 (TNFα-R2) Level - Tumor Necrosis Factor-alpha (TNFα) Receptor-2 (TNFα-R2) Level - Reactive Hyperemia Index (RHI) Score - Reactive Hyperemia Index (RHI) Score - Epworth Sleepiness Scale (ESS) Score - Epworth Sleepiness Scale (ESS) Score - Insomnia Severity Index (ISI) Score - Insomnia Severity Index (ISI) Score - Fatigue Severity Scale (FSS) Score - Fatigue Severity Scale (FSS) Score - Pittsburgh Sleep Quality Index (PSQI) Score - Pittsburgh Sleep Quality Index (PSQI) Score ### Location - Facility: NYU Langone Health, New York, New York, 10016, United States @@
## Clinician Decision Making Regarding Surveillance for Low-risk Intraductal Papillary Mucinous Neoplasms of The Pancreas - NCT ID: NCT06311032 - Study ID: 22-01227 - Status: COMPLETED - Start Date: 2023-03-29 - Completion Date: 2023-07-28 - Lead Sponsor: NYU Langone Health ### Study Description The main objective of this study is to determine how physicians make decisions regarding surveillance of Intraductal Papillary Mucinous Neoplasm's (IPMN) of the pancreas. ### Conditions - Surgery Risk Assessment ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of Decisions to Stop Surveillance Imaging - Number of Decisions to Continue Surveillance Imaging Secondary Outcomes ### Location - Facility: NYU Langone Health, New York, New York, 10016, United States @@
## The Effects of CGM and Connected Pen in T2DM Treated With Multiple Daily Insulin Injections - NCT ID: NCT06311019 - Study ID: 791572 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2026-06-01 - Lead Sponsor: Klavs Würgler Hansen ### Study Description The aim of the study is to evaluate the effect of a combination of 12 months treatment with CGM (Freestyle Libre 2) with hypo and hyper alert in combination with a smart pen for bolus insulin (NOVOpen6) on HbA1c and time in range (TIR) in T2DM patients with baseline HbA1c \>53 mmol/mol (7. 0%, eAG 8,6 mmol/l) as compared with standard care. ### Conditions - Type 2 Diabetes Treated With Insulin ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Continuous glucose monitoring and use of connected insulinpen for bolus insulin ### Outcomes Primary Outcomes - Change in Haemoglobin A1c Secondary Outcomes - Change Time in range - Change in Time above range - Change in Time below range - Mean glucose - Standard deviation - Change in CV - Change in Time with rapid glucose change - Change in ARRC - Fraction of patients with increased number of bolus insulin per day ### Location - Facility: Steno Diabetes Center Aarhus, Aarhus, N/A, 8000, Denmark @@
## Safety Registry of a Fecal Microbiota Transplant Cohort - NCT ID: NCT06311006 - Study ID: K170103J - Status: RECRUITING - Start Date: 2021-01-04 - Completion Date: 2029-01-04 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Clostridium difficile infection (CDI) is a major cause of infectious diarrhea and the most important cause of nosocomial diarrhea. Recurrent forms are a major problem with this infection. The use of fecal microbiota transplantation (FMT), FMT appears in the most recent European and North American recommendations.There is no cohort or multicenter registry in France prospectively collecting FMTs, the methods used, their efficacy and side effects. Likewise, there is no prospective collection focused on the cohort of stool donors. A large national cohort of patients who have undergone FMT as part of routine care as well as donors, is essential for evaluating the safety of FMT. ### Conditions - Clostridium Difficile Infections ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Proportion of hospitalizations attributable to FMT Secondary Outcomes - Proportion of Clostridium difficile relapses - Proportion of relapse - Proportion of reinfections - Efficacy of FMT in CDI (defined as free from relapse) at 10 weeks and 3 years according to clinical characteristics of donors - Efficacy of FMT in CDI (defined as free from relapse) at 10 weeks and 3 years according to clinical characteristics of patients - Efficacy of FMT in CDI (defined as free from relapse) at 10 weeks and 3 years according to the method of preparation and administration of fecal preparation - Evolution of transit (i.e. number of stools per day and their consistency) and mean BMI in patients Correlation between the evolution of transit and the BMI of the donor and the patient. - Patient status (absence of recurrence or relapse or re-infection) according to the composition of the microbiota (by sequencing or metabolomic method or culture) of the donors. - Composition of the patient's microbiota before FMT and at week 10 and composition of the donor's microbiota (by sequencing or metabolomic method or culture) of the raw stool and the preparation to be administered to the patient. - adverse event rate - Metabolomic, immunological analysis (phenotype of peripheral blood immune cells) of the donor and the patient before and after FMT (at W10). ### Location - Facility: Gastroenterology Department of Saint Antoine Hospital, Paris, N/A, 75012, France @@
## Exercise to Boost Immunity in Advanced Cancer - NCT ID: NCT06310993 - Study ID: STH22549 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2026-03-01 - Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust ### Study Description The trial is a prospective feasibility trial conducted in Sheffield. Recruitment will include twenty patients receiving first line palliative immunotherapy for advanced, unresectable or metastatic mesothelioma and patients receiving first line systemic anti-cancer treatment for pancreatic cancer. Patients will attend the AWRC for a supervised exercise session once a week to include aerobic exercise along with an unsupervised weekly exercise session for 3 months. Blood samples will be collected at baseline and then monthly for 3 months, pre and post the supervised exercise session. Cytokine, myokine and immune cell concentration will be analysed using cytokine bead-based multiplex immune assays and RNA-seq to full profile changes in gene and protein expression ### Conditions - Mesothelioma; Lung - Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Exercise ### Outcomes Primary Outcomes - Primary Outcome Measure Secondary Outcomes - Secondary outcome 1 - Secondary Outcome 2 - Secondary Outcome 3 - Secondary Outcome 4 - Secondary Outcome 5 - Secondary Outcome 6 - Secondary Outcome 7 ### Location - Facility: Cancer Research Centre at Weston Park Hospital, Sheffield, England, S1O 2SJ, United Kingdom @@
## Pilot Study to Verify Effect of Smartpen Coordinated With Glucose Sensor. - NCT ID: NCT06310980 - Study ID: SMARTPEN - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04-01 - Lead Sponsor: Giulio Frontino ### Study Description The Aim of this interventional study in to assess the effect of the use of a smartpen connected by an APP to continuous glucose sensors in a cohort of diabetic adolescents in not good metabolic control.Primary endpoint: time in range Secondary endpoints: other glucometrics, Hba1c, treatment satisfaction. ### Conditions - Diabetes Mellitus, Type 1 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - smartpen ### Outcomes Primary Outcomes - Time in range Secondary Outcomes - time below range - time above range - coefficient of variation (CV) - HbA1c - ITSRQ - DIDS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Dose Escalation Study of IG3018 in Subjects With Hyperuricemia With or Without Chronic Kidney Disease - NCT ID: NCT06310967 - Study ID: IG3018-23-02-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-06 - Lead Sponsor: Intelligem Therapeutics Australia Pty Ltd. ### Study Description This is a phase I/II clinical study to evaluate the safety, tolerability, PK, and efficacy of IG3018 tablet in hyperuricemia (HUA) subjects with or without CKD. ### Conditions - Hyperuricemia - Hypouricemia, Renal ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - IG3018 - Placebo matching IG3018 ### Outcomes Primary Outcomes - Safety Assessments (Part 1 and Part 2) - The proportions of change from baseline in serum uric acid to normal level (≤ 0.36 mmol/L) (Part 1 and Part 2) Secondary Outcomes - The proportions of change from baseline in serum uric acid to ≤ 0.30 mmol/L and ≤ 0.24 mmol/L respectively (Part 1 and Part 2) - The actual change of serum uric acid (Part 1 and Part 2) - The percentage change of serum uric acid (Part 1 and Part 2) - Gouty Attacks (Part 1 and Part 2) - Urinary Albumin/Creatinine Ration (U-ACR) (Part 2 only) - Ae of IG3018 (Part 1 only) - Cmax of IG3018 (Part 1 only) - Tmax of IG3018 (Part 1 only) - T1/2 of IG3018 (Part 1 only) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ketogenic Diet in Pediatric Intractable Epilepsy - NCT ID: NCT06310954 - Study ID: 2022-KY-012 - Status: RECRUITING - Start Date: 2022-08-11 - Completion Date: 2024-04-30 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description This study aims to evaluate the efficacy of a ketogenic diet in treating pediatric intractable epilepsy and to explore its relationship with changes in inflammatory markers. The investigators plan to recruit 59 participants with intractable epilepsy, 39 of whom will receive a combination of ketogenic diet and conventional antiepileptic drugs, while 20 will receive only conventional drugs. The study will assess the impact of the ketogenic diet on epilepsy control and inflammatory markers, hoping to discover new treatment strategies. ### Conditions - Epilepsy in Children - Epilepsy Intractable ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Early ketogenic diet combined with conventional pharmacotherapy. - Common diet combined with conventional pharmacotherapy ### Outcomes Primary Outcomes - Epilepsy Control Response Rate Secondary Outcomes - Inflammatory Marker Levels ### Location - Facility: Sun Yat Sen Memorial Hospital， Sun Yat Sen University, Guangzhou, Guangdong, 510000, China @@
## Mechanical Insufflation-exsufflation and Hypertonic Saline in Nosocomial Bacterial Respiratory Tract Infection - NCT ID: NCT06310941 - Study ID: ABSENTA - Status: NOT_YET_RECRUITING - Start Date: 2024-12-01 - Completion Date: 2026-12-30 - Lead Sponsor: Hospital San Carlos, Madrid ### Study Description Randomized open label clinical trial to evaluate IEM and HS as concomitant therapy for respiratory tract infection in patients under artificial ventilation in the ICU.Lung infection is a serious complication that may occur during hospital stay and may need artificial respiration or even develop during artificial ventilation for other causes.Current specific treatment consists of intravenous antibiotics. The current study evaluated whether aspiration and drainage of infected sputum helps curing this severe complication and whether nebulized HS has additional benefits, like eradicating bacteria or reducing inflammation. ### Conditions - Nosocomial Infection - Nosocomial Pneumonia - Tracheobronchitis - Mechanical Ventilation Complication - Endotracheal Intubation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mechanical insufflation-exsufflation - Standard of Care - Hypertonic saline with hyaluronic acid ### Outcomes Primary Outcomes - Median SOFA score increase >2 points on day 4 - Median respiratory support-free days increase at day 28 - Percentage of subjects surviving/dying day 28 Secondary Outcomes - Subjects with bacterial eradication in respiratory samples at day 4 after randomization - Subjects with bacterial eradication in respiratory samples at end of systemic antibiotic therapy - Median Length of ICU stay - Median antibiotic-free days at 28 days ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Thermal Blanket After Peripheral Artery Surgery - NCT ID: NCT06310928 - Study ID: SBU-201001077-2022 - Status: RECRUITING - Start Date: 2022-05-20 - Completion Date: 2024-03 - Lead Sponsor: Saglik Bilimleri Universitesi ### Study Description Peripheral arterial disease is one of the most common clinical conditions associated with cardiovascular morbidity and increased mortality, requiring exercise, antiaggregant and surgical revascularization therapy. As in peripheral arterial surgery, postoperative hypothermia is common in patients who have undergone surgical intervention and the duration of surgery is longer than 30 minutes due to the low temperature of the surgical environment or the suppression of the thermoregulation center by anesthetics and sedatives. With hypothermia, heat loss increases,peripheral vasoconstriction with activation of the sympathetic system, impaired perfusion at the surgical wound site, hypoxemia, coagulopathy, bleeding, postoperative pain, deterioration of thermal comfort, deterioration of patient comfort and prolonged hospital stay are reported. Many heating methods are used to achieve and maintain normal body temperature in the postoperative period, to prevent complications caused by hypothermia.Aluminum-coated thermal blankets are especially preferred. In this way, heat preservation, peripheral vasodilation and perfusion with the effect of temperature, reduction of muscle spasm with increased endorphin release, less pain, and increased comfort of the patient are provided. The thermal blanket is an easy-to-apply material that does not require any tools or electricity for its effectiveness and can come into direct contact with the patient's skin. It provides thermal insulation with its ability to reflect thermal radiation. Peripheral vasodilation and decreased peripheral vascular resistance have been observed with thermal therapy provided by thermal blankets. It is known that thermal blanket methods are used to warm patients in practice. However, the lack of a literature study on the regional effect of these applications on the patient has been noticed. For this purpose, in this study, the regional efficacy of thermal blankets on the patient was evaluated in order to reduce the narrowed arterial lumen and increased peripheral vascular resistance in peripheral arterial diseases and to prevent the vasoconstrictive effect of hypothermia on peripheral vessels. It was predicted that these blankets would maintain heat, increase tissue perfusion with peripheral vasodilation effect, facilitate circulation, reduce pain and facilitate mobilization.In line with this aim, the objectives are;* To increase peripheral tissue perfusion and decrease neurovascular damage by using thermal blankets for heating after peripheral arterial surgery.* To reduce the degree of surgical wound site and ischemic pain by using thermal blankets for warming after peripheral arterial surgery.* To increase the patient's postoperative mobility and mobilization by using thermal blankets in peripheral artery postoperative warming.* To contribute to the control of pain, neurovascular follow-up and reduction of damage and mobilization, which are the main nursing goals after surgery.* To increase the comfort of the patient by utilizing the heat insulation and flexible effect of thermal blankets, thus providing an easy-to-apply, effective care in terms of nursing and increasing the quality of health care service.Research Design This study is a randomized controlled trial to determine the effect of a thermal blanket applied to the area after peripheral arterial surgery on the patient's circulation, pain and mobilization. ### Conditions - Peripheral Arterial Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Thermal Blanket ### Outcomes Primary Outcomes - The Effect of Thermal Blanket Applied to the Area After Peripheral Artery Surgery on Circulation Secondary Outcomes - The Effect of Thermal Blanket Applied to the Area After Peripheral Artery Surgery on Pain ### Location - Facility: Sağlık Bilimleri University, Istanbul, Uskudar, 34674, Turkey @@
## Oral Chemotherapeutic Drugs Were Analyzed in Patients With Driver Gene Negative Locally Advanced/Advanced Non-small Cell Lung Cancer With PS Score 2 A Prospective, Single-arm, Multicenter, Observational Study on the Efficacy and Safety of Radiochemotherapy Combined With PD-1 Inhibitor - NCT ID: NCT06310915 - Study ID: CROC202310 - Status: RECRUITING - Start Date: 2023-03-17 - Completion Date: 2025-05 - Lead Sponsor: Guangzhou Institute of Respiratory Disease ### Study Description Oral chemotherapeutic drugs were analyzed in patients with driver gene negative locally advanced/advanced non-small cell lung cancer with PS score 2 A prospective, single-arm, multicenter, observational study on the efficacy and safety of radiochemotherapy combined with PD-1 inhibitor. ### Conditions - Non-small Cell Lung Cancer Stage IIIB/IV ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Navelbine oral,Pembrolizumab ### Outcomes Primary Outcomes - Progression-free survival time Secondary Outcomes ### Location - Facility: The First Affiliated Hospital of Guangzhou Medical University, Guangdong, Guangzhou, 510000, China @@
## Single-cell Sequencing Analysis of Resectable/Borderline Resectable Pancreatic Cancer Patients - NCT ID: NCT06310902 - Study ID: 2024KY022 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-09-01 - Lead Sponsor: Fujian Medical University Union Hospital ### Study Description Preoperative neoadjuvant chemotherapy is widely used in treating patients with borderline resectable pancreatic cancer (BRPC). However, there are limitations in this field. Treatment strategies and definitions for BRPC patients differ, and the efficacy and prognosis of neoadjuvant chemotherapy vary greatly.This study aims to utilize single-cell sequencing technology to investigate in-depth the composition and interactions of the tumor microenvironment in patients from the surgical-only group and the preoperative neoadjuvant chemotherapy group. ### Conditions - Pancreatic Neoplasms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Single-cell Sequencing Analysis ### Outcomes Primary Outcomes - Bioinformatics analysis of single-cell sequencing results Secondary Outcomes ### Location - Facility: Fujian Medical University Union Hospital, Fuzhou, Fujian, 350001, China @@
## Evaluation of Palliative Care Co-treatment by Attending Physicians and Nurses: an Online Survey as Part of the Project - NCT ID: NCT06310889 - Study ID: EPIC-Baseline-Survey - Status: WITHDRAWN - Start Date: 2024-04-01 - Completion Date: 2024-06-30 - Lead Sponsor: Charite University, Berlin, Germany ### Study Description The subject of the study is an online survey of doctors and nurses who provide (intensive) medical care to patients. ### Conditions - Palliative Medicine ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Barriers 1 - Barriers 2 Secondary Outcomes - Measures 1 - Measures 2 - Resources 1 - Resources 2 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Thorough QT Study of ABBV-CLS-7262 in Healthy Subjects - NCT ID: NCT06310876 - Study ID: M24-852 - Status: RECRUITING - Start Date: 2024-03-14 - Completion Date: 2024-07 - Lead Sponsor: Calico Life Sciences LLC ### Study Description This is a randomized, blinded, placebo and active-controlled, 4-period, crossover design thorough QT/QTc (TQT) study to evaluate the effect of ABBV-CLS-7262 on cardiac repolarization in healthy adult subjects. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - ABBV-CLS-7262 - ABBV-CLS-7262 - Placebo - Moxifloxacin 400mg ### Outcomes Primary Outcomes - To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects Secondary Outcomes - To evaluate the effects of ABBV-CLS-7262 on change in electrocardiogram (ECG) parameters - To evaluate the sensitivity of QTc measurement using moxifloxacin - To evaluate the effect of ABBV-CLS-7262 on T-wave morphology ### Location - Facility: AbbVie Clinical Pharmacology Research Unit (ACPRU), Grayslake, Illinois, 60030, United States @@
## Pivotal Study to Evaluate the Efficacy and Safety of Injection With LASBEAU Strong in Correction of Nasolabial Folds - NCT ID: NCT06310863 - Study ID: EXOCOBIO-NASAL-01 - Status: COMPLETED - Start Date: 2019-10-07 - Completion Date: 2020-11-24 - Lead Sponsor: Asan Medical Center ### Study Description Background: Nonsurgical injectable treatments have become popular for aesthetic purposes. In recent years, cross-linked hyaluronic acid (HA) fillers containing lidocaine have been used to correct the nasolabial folds.Aim: The aim of this study was to demonstrate the efficacy and safety of a new HA filler (LASBEAU Strong) (24 mg/mL) compared with a conventional HA filler (Restylane Lyft) for the restoration of nasolabial folds.Patients/methods: A total of 72 subjects were enrolled and randomized to receive injections of the new HA filler (test group) or the conventional HA filler (control group) on the left or right side of the face. The mean value difference in the Wrinkle Severity Rating Scale (WSRS) scores at week 24 evaluated primary efficacy. The WSRS and the Global Aesthetic Improvement Scale (GAIS) at weeks 8, 16, 24, and 48 evaluated secondary efficacy. Adverse events, laboratory tests, and a check of vital signs at every visit assessed safety. ### Conditions - Dermal Fillers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - LASBEAU Strong or Restylane Lyft injection as hyaluronic acid fillers ### Outcomes Primary Outcomes - Differences in the mean value of the Wrinkle Severity Rating Scale (WSRS) between the test group and the control group Secondary Outcomes - The mean value differences in the WSRS scores between the test group and the control group - Differences in GAIS mean values between test and control groups - Percentage of subjects with WSRS score improvement of at least 1 point ### Location - Facility: Asan mediccal center, Seoul, Songpa-gu, 05505, Korea, Republic of @@
## The Effect of Preprocedural Subanesthetic Ketamine on Pain and Anxiety - NCT ID: NCT06310850 - Study ID: KEAH-238 - Status: COMPLETED - Start Date: 2013-06-01 - Completion Date: 2023-06-01 - Lead Sponsor: Ankara Ataturk Sanatorium Training and Research Hospital ### Study Description The thoracic epidural catheterization (TEC) can be both uncomfortable and fearful for patients when done awake with the thought that the procedure may be painful. The aim of this study was to assess the effect of subanesthetic intravenous ketamine administration on pain and anxiety during the TEC procedure. ### Conditions - Epidural Catheterization - Thoracic - Procedural Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Ketamine - Placebo ### Outcomes Primary Outcomes - Visual analog scale (VAS) Secondary Outcomes ### Location - Facility: Ankara Atatürk Sanatorium Training and Research Hospital, Ankara, Keçiören, 06290, Turkey @@
## Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis - NCT ID: NCT06310837 - Study ID: 2023KYPJ300 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-27 - Completion Date: 2025-06-30 - Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University ### Study Description This is a multi-center, prospective, randomized controlled non-inferior clinical study. A total of 120 subjects with non-infectious intermediate, posterior, or panuveitis were enrolled in Zhongshan Ophthalmic Center and three other centers. They were randomly assigned to the experimental group and the control group according to ( 1 : 1 ). We hypothesized that adalimumab biosimilars combined with immunosuppressive agents in the treatment of non-infectious uveitis is not inferior to glucocorticoids combined with immunosuppressive agents, and there are no additional adverse events and safety issues. ### Conditions - Uveitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Adalimumab Biosimilars Injection - Corticosteroid - Immunosuppressive Agents ### Outcomes Primary Outcomes - Change of ETDRS letter count for BCVA at week 24 from baseline Secondary Outcomes - Proportion of patients with weight gain at week 24 from baseline - Time of treatment failures - Number of treatment failures - Change of Visual Functioning Questionnaire- 25 (VFQ-25) composite score from baseline - Change of anterior chamber inflammation at week 24 from baseline - Change of vitreous opacity at week 24 from baseline - Change of the retinal and choroidal inflammation at week 24 from baseline - Change of the thickness of retina and choroid in macular area at week 24 from baseline - Occurrence of skin abnormalities at the end of study - Occurrence of hypertension at the end of study - Occurrence of hyperglycemia at the end of study - Occurrence of active tuberculosis infection at the end of study ### Location - Facility: Zhongshan Ophthalmic Center, Guangzhou, Guangdong, 510060, China @@
## Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia® - NCT ID: NCT06310824 - Study ID: MAB-22-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-07 - Lead Sponsor: Xentria, Inc. ### Study Description A Randomized, Double-blind, Controlled, Parallel-group, Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia® ### Conditions - Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - MAB-22 - EU-Prolia® - US-Prolia® ### Outcomes Primary Outcomes - Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-∞) - Maximum observed serum concentration (Cmax) Secondary Outcomes - Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last) - Area under the concentration-time curve - Area under the concentration-time curve ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Anti-CD19 CAR-T Cell Therapy in Participants With Moderate to Severe Active Systemic Lupus Erythematosus - NCT ID: NCT06310811 - Study ID: BHCT-RD06-04-01 - Status: RECRUITING - Start Date: 2024-03-07 - Completion Date: 2027-03-01 - Lead Sponsor: Wuhan Union Hospital, China ### Study Description This is an open, Phase I, investigator-initiated study (IIT) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with moderate or severe active SLE.This study will explore the safety of escalating doses of RD06-04 by presetting two dose levels (DL), with 3 to 6 patients enrolled in each dose level. After safety conclusions are reached in each group, the investigator can select the corresponding dose group to expand cases based on treatment response, but the total number of cases will not exceed 12.This study will enroll patients in a 3+3 design with two DLS: 1×105 CAR+T cells /kg for DL1 and 5×105 CAR+T cells /kg for DL2.Dose increment Refer to the 3+3 dose increment principle. Three subjects are expected to be enrolled in each dose group.1. Dose increment should start from the minimum dose, and it is not possible to conduct an incremental study of 2 or more dose groups at the same time.2. If 1 case of DLT occurs in each dose group, the dose level will be extended to 6 subjects. If 6 subjects at this dose level ≥2 subjects develop DLT, the dose level exceeds the MTD. The previous lower dose level will be extended to 6 subjects, and if 6 subjects have already been enrolled in the previous lower dose level, and only ≤1 of these 6 subjects develop DLT, this lower dose level will be considered MTD.3. If DLT occurred in ≥2 subjects in the highest dose group, the researcher could select a dose between the high dose group and the medium dose group according to the specific situation and perform MTD evaluation.4. If the dose increase to the highest dose group still does not reach DLT, researchers can explore the safety and efficacy of higher doses according to specific circumstances.Case expansion:After the completion of DLT evaluation in all dose groups, the investigators could select the corresponding dose group of extended cases according to the treatment response, but the total number of cases should not exceed 12 (extended cases were not evaluated by DLT). ### Conditions - Safety - Effective ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - RD06-04 Cells injection ### Outcomes Primary Outcomes - Incidence of dose-limiting toxicity (DLT) - The incidence of treatment-based adverse events (TEAEs) and the incidence of serious adverse events (SAEs). Secondary Outcomes ### Location - Facility: Wuhan Union, Wuhan, Hubei, 430000, China @@
## Inter-organizational Health Planning for Older Adults: Public Dental Care and Municipal Care - NCT ID: NCT06310798 - Study ID: Dnr. 2020-04603 - Status: NOT_YET_RECRUITING - Start Date: 2025-03-01 - Completion Date: 2026-03-01 - Lead Sponsor: Vastra Gotaland Region ### Study Description Patient participation is key for healthy ageing and essential in health planning and decision-making. Oral health is an important but sometimes neglected part of general health and there is little research on health planning in ordinary home settings where older adults, dental and nursing staff participate. It has been concluded that shared tools, such as common documentation, and working in teams enables person-centered care in ordinary home settings. Therefore, this protocol outlines the design of a randomized controlled trial (RCT) measuring and comparing effect of two models of team based oral health planning with a common tool (digital platform) in ordinary home care settings in Sweden. The overall aim of this project is to evaluate a person-centered inter-professional and inter-organizational model for oral health planning supported by a digital platform to enable healthy ageing.Following ethics approval, a study design was developed guided by the seven action-steps of the knowledge to action framework. In the sixth action-step, older adults within the existing dental care remuneration program in Sweden will serve as a base for the RCT. From there older adults,dental hygienists (DH) and nursing assistants (NA) will be randomized into test and control groups. The test group (n= 12 DH and 12 NA) will participate in a two-day course, where a three-step person-centered oral health model will be taught. Control group will be 12 DH within dental care remuneration program conducting business as usual (with unknown number of NA, due to present guidelines). In total 360 older adults/patients will be asked to participate. Test group and control group will respectively have 180 patients each, as such, each team (DH + NA) have 15 patients. Primary outcomes include diverse oral health aspects - the Revised Oral Assessment Guide and the Geriatric Oral Health Assessment Index. Secondary outcomes include a retrospective record review, a health economic evaluation, Person Centered care Assessment Tool and Oral Hygiene Ability Index. Additionally, qualitative studies from theoretical perspectives of change and learning based on interviews with key stakeholders will be conducted in both test and control group. ### Conditions - Oral Health - Oral Health Related Quality of Life - Participation - Participation, Patient - Health Planning ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Inter-professional team test ### Outcomes Primary Outcomes - Revised oral assessment guide - Revised oral assessment guide - Revised oral assessment guide - Geriatric oral health assessment index - Geriatric oral health assessment index - Geriatric oral health assessment index Secondary Outcomes - Sure of myself; understanding information; risk-benefit ration; encouragement-test - Person centered care assessment tool - Person centered care assessment tool ### Location - Facility: Folktandvården Västra Götaland, Göteborg, Västra Götalandsregionen, 42139, Sweden @@
## Esketamine Anesthesia in Thoracic Surgery - NCT ID: NCT06310785 - Study ID: TJ-IRB20231191 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-08-31 - Lead Sponsor: Hui Xu ### Study Description Esketamine group was induced with esketamine 0.5 mg/kg, propofol 2 mg/kg, and rocuronium bromide 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and esketamine 0.5 mg/kg/h. Anesthesia induction in the opioid group Sufentanil 0.5 ug/kg, propofol 2 mg/kg, rocuronium bromide 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and remifentanil 1 ug/kg/h. ### Conditions - General Anesthesia - Thoracic Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Esketamine - Sufentanil ### Outcomes Primary Outcomes - Dynamic compliance of the ventilator-side lung during 30 minutes of one-lung ventilation during operation Secondary Outcomes - Lung compliance during double lung ventilation during operation - Compliance of the ventilator-side lung during one-lung ventilation during operation - Blood pressure - Heart rate - Blood gas analysis results - Serum inflammatory factor levels - cognitive function - Postoperative nausea and vomiting - Depression and anxiety - Postoperative pain ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Assessing Comorbidities in Epilepsy Using Eye Movement Recordings - NCT ID: NCT06310772 - Study ID: NSF 2304297 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03-01 - Lead Sponsor: Eysz, Inc. ### Study Description This study wants to make it easier to find kids with a type of epilepsy called childhood absence epilepsy (CAE) who might have problems with ongoing seizures and thinking. Right now, doctors use tests that can be expensive and take a long time. Eysz is developing a system that looks at how kids move their eyes which might help find CAE more quickly and accurately. This study will compare Eysz with the usual tests to see if it can predict seizures and thinking problems in kids with CAE. The goal is to find these problems earlier and help kids do better in school and life. ### Conditions - Childhood Absence Epilepsy - Absence Seizures - Epilepsy Comorbidities ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Eye Movements to Diagnose CAE Secondary Outcomes - Eye Movements to Diagnose Attention challenges ### Location - Facility: Children's Hospital Orange County, Orange, California, 92868, United States @@
## Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer - NCT ID: NCT06310759 - Study ID: R21088B - Status: RECRUITING - Start Date: 2024-01-08 - Completion Date: 2029-12-31 - Lead Sponsor: Tampere University Hospital ### Study Description Urothelial cancers of the bladder and upper urinary tract account for over 200,000 deaths and 600,000 diagnoses annually worldwide. The most common presenting symptom is hematuria (blood in urine), triggering a cascade of tests, including an invasive examination of the bladder using a flexible scope (cystoscopy). Millions of cystoscopies are performed every year worldwide for patients presenting with hematuria, but only 10% result in a cancer diagnosis. The UROSCOUT-1 trial is a prospective multicenter observational study that explores the potential of urine tumor DNA (utDNA) testing to replace a significant portion of cystoscopies in the diagnostic setting for hematuria or other reasons to rule out urothelial cancer. The goal is to enhance patient quality of life, reduce healthcare costs, and address increased workloads in urology centers. Sample collection will be conducted by mail, and the samples will be analyzed in a blinded manner, without knowledge of which patients are diagnosed with cancer. Random subsampling will be applied to cancer-negative patients to achieve an approximate 1:1 ratio between cancer-positive and -negative patients. ### Conditions - Urothelial Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Sensitivity and specificity of urine tumor DNA (utDNA) test for urothelial cancer detection Secondary Outcomes - Sensitivity and specificity of cystoscopy for urothelial cancer detection - Sensitivity and specificity of urine cytology for urothelial cancer detection - Time to diagnosis of urothelial cancer in patients with a positive utDNA test but negative cystoscopy - Adverse event rate for cystoscopy - Technical success rate of utDNA test - Estimate of diagnostic cystoscopies avoided - Specificity of high-stringency utDNA threshold ### Location - Facility: Vancouver Prostate Centre, Vancouver, British Columbia, N/A, Canada @@

Subsets and Splits

No community queries yet

The top public SQL queries from the community will appear here once available.