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## Electronic Decision-support System to Improve Detection and Care of Patients With Chronic Kidney Disease in Stockholm - NCT ID: NCT06386172 - Study ID: 2023-03537-01 - Status: RECRUITING - Start Date: 2023-09-09 - Completion Date: 2026-12 - Lead Sponsor: Karolinska Institutet ### Study Description One in 10 adults in Region Stockholm have chronic kidney disease (CKD), which dramatically increases healthcare costs and the risk of medication errors or adverse health outcomes, including cardiovascular disease and death. Identification and early management of these patients is done in primary care settings. However, most adults with CKD in our region are under detected, undiagnosed and undertreated, with low rates of referral to nephrology-specialist care.This is a pragmatic cluster randomized controlled trial (RCT) involving 66 primary healthcare centers in Region Stockholm, and testing the effect of an electronic clinical decision support (CDS) triggering system to assist general practitioners through the guideline-recommended processes of CKD care.The centers, providing healthcare to approximately 780.000 citizens, will be randomized 50:50 to this CDS trigger (vs basic advice) for 18 months. Study outcomes will consider the improvement in the indicators of CKD care.As a pragmatic trial there is no active recruitment or active data collection. The trial is embedded into the ongoing Stockholm CREAtinine Measurements (SCREAM) project, a database collection of healthcare use for the complete population of Stockholm. Using this real-world healthcare data collection, the investigators will be able to measure with precision the impact of our CDS trigger and its potential to improve clinical care. ### Conditions - Chronic Kidney Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Clinical decision support trigger ### Outcomes Primary Outcomes - Number of participants screened for creatinine and albuminuria - Number of screened participants with retesting for creatinine and albuminuria Secondary Outcomes - Number of participants with laboratory-determined CKD receiving a clinical diagnosis - Number of participants receiving CKD-modifying agents - Number of participants referred to nephrologist care ### Location - Facility: Karolinska Institutet, Stockholm, N/A, N/A, Sweden @@
## Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism - NCT ID: NCT06386159 - Study ID: 2023-1178 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-07-30 - Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University ### Study Description This study aims to establish a practical comprehensive intervention program for dysphagia after extubation in adult ICU patients based on the best evidence of its assessment and intervention, through expert panel discussion and Delphi method. In addition, combining the preliminary experimental results of vagus nerve stimulation applied to PED patients, we further develop a comprehensive intervention program for dysphagia after extubation based on neural regulation mechanism. Finally, the implementation effect of this PED comprehensive intervention program based on neural regulation mechanism will be verified through clinical application. ### Conditions - Post-extubation Dysphagia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Electrical vagus nerve stimulation ### Outcomes Primary Outcomes - functional oral intake scale（FOIS） - standardized Swallowing Assessment（SSA） Secondary Outcomes - Rate of total oral feeding after the intervention - Duration of Enteral Nutrition Tube Indwelling - Rate of Re-intubation after Endotracheal Intubation - Incidence of aspiration within one week after extubation - The incidence of aspiration pneumonia within one week after extubation - Inflammation-related indicators: serum C-reactive protein (CRP) - Inflammation-related indicators: serum interleukin-6 (IL-6) - Inflammation-related indicators: serum procalcitonin, acetylcholine (ACh) - Inflammation-related indicators: high mobility group box-1 protein (HMGB1) - Days of ICU hospitalization - Total days of hospitalization - In-hospital survival rate ### Location - Facility: Feng Xiuqin, Hangzhou, N/A, 310000, China @@
## JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation - NCT ID: NCT06386146 - Study ID: JAB-30355-1001 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2027-07 - Lead Sponsor: Jacobio Pharmaceuticals Co., Ltd. ### Study Description This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation. ### Conditions - Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - JAB-30355 - JAB-30355 ### Outcomes Primary Outcomes - Dose limiting toxicity (DLT) - Number of participants with adverse events Secondary Outcomes - Peak Plasma Concentration (Cmax) - Time to reach the observed maximum (peak) concentration (Tmax) - Terminal half-life (t1/2) - Objective response rate (ORR) - Duration of response (DOR) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Chronic Fatigue in Multiple Sclerosis: MS Copilot Boost Solution Compared to Standard Care - NCT ID: NCT06386133 - Study ID: MS Boost - Status: NOT_YET_RECRUITING - Start Date: 2024-10-01 - Completion Date: 2026-04-01 - Lead Sponsor: Ad scientiam ### Study Description The main objective of the MS Boost study is to demonstrate the superiority of MSCopilot Boost over standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis (MS).The secondary objectives include validating MSCopilot Boost clinical performance in reducing fatigue and its impact as well as evaluating its functional tests performance and its safety of use. The investigation team will also investigate the effects of MSCopilot Boost on patient symptoms, functional parameters and physical activity levels. The investigation team will evaluate patients and healthcare professionals' perceived clinical benefit as well as adherence, satisfaction and user experience related to the mobile application and the web portal. Ultimately, the investigation team will define the medico-economic and organizational impact of the MSCopilot Boost solution.Patients' expected benefits are the access to additional clinical tests not routinely performed, covering dimensions not addressed by standard tests like the EDSS for example; a remote monitoring of functional tests similar to those of the modified MSFC with the possibility of adding an evaluation of fatigue through digital questionnaires; improvement of symptoms related to MS fatigue through access to a personalised tele-rehabilitation program.Healthcare professionals' expected benefits are to track objective measures of key functional symptoms of the disease between consultations, supporting MS patients' management and to gain time by providing a "big picture" of the patient's condition over time. ### Conditions - Multiple Sclerosis - Fatigue Syndrome, Chronic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - MS Boost - Standard of care ### Outcomes Primary Outcomes - To demonstrate that MSCopilot Boost is superior to standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis Secondary Outcomes - To evaluate the impact of fatigue in both groups. - To compare the effect of MSCopilot Boost in reducing fatigue impact compared to standard practice (Short term and Medium term) - To compare the fatigue impact between the two groups. - To compare the effect of MSCopilot Boost in reducing perceived fatigue compared to standard practice. - Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital. - Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterparts performed under supervised conditions at the hospital. - Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital. - Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital. - Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital. - Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital - Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital - Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital - Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital - Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital - Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home. - Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home. - Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home. - Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home. - To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home. - To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home. - To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home. - To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home. - To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home. - To assess the number of adverse events of using MSCopilot Boost. - To compare the effect of MSCopilot Boost on walking compared to standard practice: -Assessed by the functional standard test performed at the hospital -Assessed at home - To compare the proportion of patients whose symptoms improved in both groups on Fatigue impact. - To compare the proportion of patients whose symptoms improved in both groups on anxiety and depression. - To compare the proportion of patients whose symptoms improved in both groups on Depression. - To compare the proportion of patients whose symptoms improved in both groups on Fatigue. - To compare the proportion of patients whose symptoms improved in both groups on Walking. - To compare the proportion of patients whose symptoms improved in both groups on Dexterity. - To compare the proportion of patients whose symptoms improved in both groups on Cognition. - To compare the proportion of patients whose symptoms improved in both groups on the Low-contrast Vision. - To compare the effect of MSCopilot Boost on quality of life compared to standard practice. - To compare the effect of MSCopilot Boost on the mean overall physical activity compared to standard practice. - To evaluate the satisfaction and user experience of both patients and healthcare professionals regarding MSCopilot Boost. - To assess the clinical benefit of MSCopilot Boost reported by patients and healthcare professionals. - To assess the organizational impact of MSCopilot Boost as reported by healthcare professionals. - To assess user compliance with MSCopilot Boost throughout the follow-up period. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Respiratory Function Monitoring of Mechanical Ventilation in Patients With Chest Blunt Injury - NCT ID: NCT06386120 - Study ID: 2024-z033 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-07 - Lead Sponsor: Peking University People's Hospital ### Study Description The goal of this observational study is to learn about EIT in observing the application of lung protective ventilation strategies in patients with pulmonary contusion, particularly the impact on pulmonary ventilation blood flow ratio, oxygen, and condition. The main question it aims to answer is:Can lung protective ventilation strategies improve respiratory function in patients with severe chest contusion? We will collect clinical data of participants who already taking lung protective ventilation strategies as part of their regular medical care. ### Conditions - Lung Contusion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - PEEP setting strategy ### Outcomes Primary Outcomes - ventilation blood flow ratio Secondary Outcomes - oxygenation index - 28-day mortality - Mechanical ventilation-free from day 1 to 28 - Length of ICU stay - Length of hospital stay - The rate of successful weaning ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Thrombin Generation Parameters and Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis - NCT ID: NCT06386107 - Study ID: 23PH188 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-08 - Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne ### Study Description Pulmonary embolism, the second leading cause of death in cancer patients, is effectively treated with anticoagulants. In patients with cancer-associated thrombosis (CAT), the use of anticoagulants is associated with 10 to 15% of bleeding in the first 6 months. Most of the guidelines propose to integrate the bleeding risk in the choice of therapies. Thrombin generation assay (TGA) reflects an overall hemostatic response and could be a useful biomarker. Proven on the thrombotic side in the CAT population, useful in the assessment of the bleeding risk of hemophiliac patients, the TGA is emerging as a tool. The investigators to measure TGA in cancer patients included prospectively, having recently developed a CAT and to evaluate the association between the measurement and the risk of hemorrhagic complication under anticoagulant during the first 6 month of treatment. ### Conditions - Cancer - Pulmonary Embolism - Thrombosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Thrombin Generation Assay (TGA) ### Outcomes Primary Outcomes - The measurement of the area under the curve ( endogenious thrombin potential) nMxmin - the measurement of the lag time unit = seconds - the measurement of the peak height unit = nm - the measurement of the time to peak unit = seconds Secondary Outcomes - Effect of adding TGT results on the performance of bleeding risk prediction scores - Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT - Occurrence of an event of interest under treatment ### Location - Facility: Chu Clermont-Ferrand, Clermont-Ferrand, N/A, 63003, France @@
## Cardiac Dysfunction in Patients With Non-alcoholic Fatty Liver Disease - NCT ID: NCT06386094 - Study ID: INT/IEC/2023/SPL-902 - Status: RECRUITING - Start Date: 2023-07-15 - Completion Date: 2025-11-15 - Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh ### Study Description Cirrhotic cardiomyopathy is seen as a blunted contractile responsiveness to stress, and/or altered diastolic relaxation with electrophysiological abnormalities, in absence of known cardiac disease. Left ventricular diastolic dysfunction (LVDD) is associated with risk of hepatorenal syndrome (HRS) , septic shock. , heart failure in the perioperative period following liver transplantation, and after trans-jugular intrahepatic portosystemic shunt (TIPS) insertion . The echocardiographic E/e' ratio is a predictor of survival in LVDD, with multiple studies, including prospective data from our Centre. The inability of the heart to cope with stress or sepsis induced circulatory failure is a key concept of the increased mortality risk due to LVDD. In view of the metabolic syndrome and diabetes epidemic and an increasing number of patients being diagnosed with non-alcoholic fatty liver disease, there is increased risk of developing cardiac dysfunction due to multiple comorbidities including coronary artery disease, hypertensive heart disease, cirrhotic cardiomyopathy, which are contributors to overall cardiovascular risk of mortality. ### Conditions - NAFLD - Cardiac Disease - Fatty Liver ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Echocardiographic assessment ### Outcomes Primary Outcomes - To determine the prevalence of cardiac dysfunction in patients with non-alcoholic fatty liver disease Secondary Outcomes - Presence of myocardial abnormalities in CCM dysfunction - Presence of perfusion abnormalities in CCM dysfunction - All cause mortality in NAFLD - Cardiac event related mortality in NAFLD - To determine the severity of cardiac dysfunction in patients with non-alcoholic fatty liver disease ### Location - Facility: Dr. Madhumita Premkumar, Chandigarh, N/A, 160012, India @@
## Dietary Intervention in Food Allergy - NCT ID: NCT06386081 - Study ID: AC18/00031 - Status: COMPLETED - Start Date: 2021-01-01 - Completion Date: 2023-06-30 - Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud ### Study Description The goal of this randomized double-blind placebo-controlled clinical study is to determine whether the dietary intervention with pectins leads to food immunomodulation in non-specific lipid transfer proteins (nsLTP) allergic patients. The main question it aims to answer is if the microbiome is a target of intervention against food allergy through the use of prebiotics such as pectins.Participants will be enrolled to receive a two-month dietary intervention with either two different pectins (citrus or apple pectin) or placebo. Increase in oral tolerance to the peach nsLTP will be measured through a double-blind placebo-controlled food challenge (DBPCFC). Microbiome, proteomic and metabolomic studies will also be performed in blood and stool samples. ### Conditions - Food Allergy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Citrus pectin with low DE - Apple pectin with high DE - Placebo ### Outcomes Primary Outcomes - Clinical efficacy of pectin dietary intervention in nsLTP allergic patients Secondary Outcomes - Changes in Pru p 3 (nsLTP of peach) specific IgE production induced by pectin intervention - Pru p 3-specific maturational changes of dendritics cells induced by pectin intervention - Pru p 3-specific proliferative response of different lymphocytes cell subpopulations after pectin intervention - Changes in Pru p 3-specific basophil activation induced by pectin intervention - Changes induced in the taxonomic diversity of gut microbiota - Changes in feaces metabolome induced by pectin dietary intervention - Changes in serum metabolome induced by the pectin dietary intervention - Epigenomic changes induced by the pectin dietary intervention - Pectin safety profile ### Location - Facility: Hospital Regional Universitario de Málaga, Malaga, N/A, N/A, Spain @@
## Interdisciplinary Value-based Cognitive Behavioral Treatment for People With Persistent Whiplash Associated Disorders. - NCT ID: NCT06386068 - Study ID: 2110041 - Status: RECRUITING - Start Date: 2024-01-23 - Completion Date: 2024-06 - Lead Sponsor: University of Southern Denmark ### Study Description The goal of this clinical trial is to address the critical need for effective interventions by developing and testing an interdisciplinary values-based cognitive behavioral therapy (V-CBT) program for individuals with persistent whiplash. The main question it aims to answer are:* What is the treatment effect of the interdisciplinary values-based cognitive behavioral therapy (V-CBT) program on individuals with persistent whiplash?* What are the temporal relationships between primary and secondary outcome measures in the context of the V-CBT program?Participants will undergo a replicated multiple baselines single-case experimental design (SCED). Twelve participants who meet specific eligibility criteria will be block-randomized to a 1, 2, or 3-week baseline phase, serving as their own controls. The intervention involves an interdisciplinary team delivering a manualized adapted V-CBT program over ten sessions, focusing on psychological and physical rehabilitation. Participants will be required to attend these sessions as part of the treatment protocol. Data collection includes daily online self-reports and comprehensive measurements at pre-treatment, post-treatment, and a three-month follow-up. ### Conditions - Whiplash Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Values-based Cognitive Behavioral Therapy (V-CBT) ### Outcomes Primary Outcomes - Value-based living - Pain interference - Value-based living - Pain interference Secondary Outcomes - Pain catastrophizing - Positive affect - Negative affect - Stress - Fatigue - Pain-related acceptance - Pain-related self-efficacy - Pain severity - Neck Disability - Depression - Anxiety - Stress - Health-related quality of life - Pain-related acceptance - Pain-related self-efficacy - Sleep quality - Pain severity - Self-perceived improvement - Satisfaction with treatment - Pain Disability ### Location - Facility: Specialized Hospital for Polio and Accident Victims, Rødovre, Capital Region Of Denmark, 2610, Denmark @@
## Air Pollution and Physical Activity: A Randomized Controlled Trial - NCT ID: NCT06386055 - Study ID: STUDY00007545 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-15 - Completion Date: 2024-12-01 - Lead Sponsor: State University of New York at Buffalo ### Study Description This is a small pilot intervention trial in which we will collect preliminary data to demonstrate the feasibility of an intervention study. ### Conditions - Physical Inactivity - Pollution; Exposure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Active exercise ### Outcomes Primary Outcomes - blood pressure Secondary Outcomes - Self-report questionnaire ### Location - Facility: University at Buffalo, Buffalo, New York, 14214, United States @@
## Guideline Implementation and Quality of Care in Patients With Heart Failure: the TITRATE-HF Registry - NCT ID: NCT06386042 - Study ID: MEC-2022-0252 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-06-05 - Completion Date: 2029-04 - Lead Sponsor: Erasmus Medical Center ### Study Description SUMMARY Rationale: Quality of Care registries provide valuable insight in guideline adherence and implementation of guideline recommendations in routine clinical practice.Objective: The overall aim of the project is to study the titration of guideline directed medical therapy (GDMT) according to the European Society of Cardiology (ESC) HF 2021 guideline recommendations for patients with heart failure (HF) reduced ejection fraction (HFrEF), and mildly reduced ejection fraction (HFmrEF).Study design: The current study is a prospective multi-center national quality of care registry (longitudinal) of regular HF care (as given).Study population: The study population consists of patients with heart failure (de novo HF, chronic HF and worsening HF). Study setting is outpatient or inpatient (during admission). Patient sample is set at a minimum of 4000 patients, but can be expanded during the course of the registry project.Participating sites: all hospitals with dedicated HF outpatient clinic in the Netherlands can participate.Data: aggregated dataIntervention: none / noMain study parameters/endpoints: The main parameters of quality of HF care are the adherence to guideline recommendation in terms of percentage (%) drug prescription, percentage (%) target dose (order, speed) and reason not to adhere to the guideline (intolerance, side-effects, maximum tolerated dose). The main endpoints for prognosis are the number of HF related hospitalizations and all-cause mortality during follow-up.Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no risk in participation, no intervention and no active involvement of patients for specific activities in the study. The project is a registration of care as given (standard care) to the participating subject with heart failure. ### Conditions - Heart Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no intervention, observational study ### Outcomes Primary Outcomes - Prescription level (percentage,%) and target dose (percentage, %) of guideline-directed medical therapy for HF Secondary Outcomes - All-cause mortality - Hospital admission due to heart failure related event and/or urgent visit with necessity of furosemide iv. - Hospital admission due to non heart failure related event ### Location - Facility: Erasmus MC, Rotterdam, Zuid-Holland, 3015CE, Netherlands @@
## The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol - NCT ID: NCT06386029 - Study ID: STUDY24010191 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: University of Pittsburgh ### Study Description The goal of this pilot intervention study is to examine the feasibility and acceptability of a novel bedtime manipulation protocol called "The Power Down" for autistic youth, ages 6-10. The main questions it aims to answer are:1. Is the Power Down feasible for caregivers to do each night?2. Do the families find the Power Down an acceptable intervention to address their child's difficulties settling down to fall asleep? ### Conditions - Autism - Sleep Disturbance ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Power Down bedtime manipulation ### Outcomes Primary Outcomes - Recruitment rates of participants through the trial - Retention rates of participants through the trial - Caregiver reported acceptability Secondary Outcomes - Treatment adherence - Data collection rates- Questionnaires - Data collection rates- Daily diaries - Data collection rates- Wearing the actigraphy watch - Credibility/Expectancy Questionnaire ### Location - Facility: University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States @@
## Detection of Valvular Heart Disease Using Artificial Intelligence-based Stethoscope - NCT ID: NCT06386016 - Study ID: Stethoscope study - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-09-01 - Lead Sponsor: Xiao-dong Zhuang ### Study Description The aim of this study is to develop a deep learning-based application of heart sounds in the diagnosis of valvular heart disease, which can be used to screen patients with valvular heart disease and promote earlier clinical monitoring and intervention. ### Conditions - Valvular Heart Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - artificial intelligence-based stethoscope ### Outcomes Primary Outcomes - valvular heart disease Secondary Outcomes ### Location - Facility: First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, 510000, China @@
## Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD - NCT ID: NCT06386003 - Study ID: 23-230 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2025-05 - Lead Sponsor: Unity Health Toronto ### Study Description This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD). ### Conditions - Post Traumatic Stress Disorder - PTSD - Chronic PTSD ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Psilocybin ### Outcomes Primary Outcomes - Feasibility and tolerability Secondary Outcomes - Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score - Posttraumatic stress disorder Checklist-5 (PCL-5) - Patient Health Questionnaire-9 (PHQ-9) - Generalized Anxiety Disorder Scale, 7-item (GAD-7) - Dissociative Experiences Scale II (DES-II) - Pittsburgh Sleep Quality Index (PSQI) - World Health Organization Well-Being Index, 5-item (WHO-5) - Quality of relationships inventory (QRI) - Inventory of psychosocial functioning (IPF) - Posttraumatic Maladaptive Beliefs Scale (PMBS) - Brief Experiential Avoidance Questionnaire (BEAQ) - 24-items Multidimensional Psychological Flexibility Inventory (MPFI-24) - Working Alliance Inventory- Short Form (WAI-SF) - Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) - Self-Compassion Scale-Short Form (SCS-SF) - Psychological Insight Questionnaire (PIQ) - Emotional Breakthrough Inventory (EBI) - Altered States of Consciousness Rating Scale (ASC) - Acceptance/Avoidance-Promoting Experiences Questionnaire (APEQ) ### Location - Facility: St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, N/A, Canada @@
## Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy - NCT ID: NCT06385990 - Study ID: 2024ks01 - Status: RECRUITING - Start Date: 2024-03-29 - Completion Date: 2027-03-29 - Lead Sponsor: Hunan Cancer Hospital ### Study Description This trial is a multicenter, single-arm clinical trial to evaluate the efficacy and safety of UTD1 in combination with capecitabine for the adjuvant treatment of TNBC patients who did not achieve pathologic complete remission after neoadjuvant therapy. TNBC patients who did not achieve pathological complete remission or positive lymph node after neoadjuvant chemotherapy received adjuvant treatment with study drug.Solution: UTD1 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles. ### Conditions - Triple Negative Breast Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - UTD1 ### Outcomes Primary Outcomes - 2-year disease-free survival (DFS) Secondary Outcomes - Overall Survival (OS) - Disease Free Survival (DFS) - Invasive Disease free survival (iDFS) - Distant Disease-free Survival (DDFS) ### Location - Facility: Quchang Ouyang, Changsha, Hunan, 410083, China @@
## Risk Factors for Chronic Prostatitis Patients in Northwest China - NCT ID: NCT06385977 - Study ID: ShaanxiPPH - Status: RECRUITING - Start Date: 2016-01 - Completion Date: 2024-06 - Lead Sponsor: Shaanxi Provincial People's Hospital ### Study Description The goal of this observational study is to learn about the risk factors of lifestyle, medication and sexual habits in adult chronic prostatitis / chronic pelvic pain syndrome patients. The main questions it aims to answer are:* Is lifestyle, medication, and sexual habits related to chronic prostatitis / chronic pelvic pain syndrome* Is there any medication available to protect men from chronic prostatitis / chronic pelvic pain syndrome.Participants will:* Independently receive a survey questionnaire on lifestyle, medication, and sexual habits.* Symptomatic individuals will undergo additional prostate fluid examination for diagnosis.Researchers will compare healthy adult males to see if there are differences on lifestyle, medication and sexual habits between the two groups. ### Conditions - Chronic Prostatitis With Chronic Pelvic Pain Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - lifestyle - sexual habits - medication ### Outcomes Primary Outcomes - Odds Ratio Secondary Outcomes ### Location - Facility: Shaanxi Provincial People's Hospital, Xi'an, Shaanxi, 710061, China @@
## A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-4597 Inhalation in Healthy Subjects and Asthmatic Patients - NCT ID: NCT06385964 - Study ID: SHR-4597-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-01 - Lead Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd ### Study Description The primary objective of this randomized, double-blind, single/multiple ascending dose, placebo-controlled Phase I clinical trial was to evaluate the safety and tolerability of SHR-4597 in healthy subjects and asthmatic patients. The study consists of two parts: Part 1 involves single ascending inhalation dose in healthy subjects; Part 2 involves multiple ascending inhalation dose in asthmatic patients, further divided into Part 2A: multiple ascending inhalation dose in mild to moderate asthmatic patients, and Part 2B: multiple ascending inhalation dose in moderate to severe asthmatic patients. Subsequent lung pharmacokinetic studies of SHR-4597 inhalation will be conducted based on patients' PKPD data. ### Conditions - Healthy Subjects - Asthmatic Patients ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SHR-4597 - Placebo ### Outcomes Primary Outcomes - Incidence and severity of inhalant adverse events after 4 days of single inhalation of SHR4597 in healthy subjects - Incidence and severity of inhalant adverse events after 16 days of multiple inhalation of SHR4597 in asthmatic patients, Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Spatial Navigation for the Early Detection of Alzheimer's Disease. - NCT ID: NCT06385951 - Study ID: ONZ-2023-0323 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2028-10-01 - Lead Sponsor: University Hospital, Ghent ### Study Description Alzheimer's Disease (AD) is the most common form of dementia and may contribute to 60-70 % of all cases. An early, accurate diagnosis of AD will become increasingly important with disease-modifying therapies. Different types of fluid and neuroimaging biomarkers are available for the early detection of AD. However, implementation of routine use of these biomarkers in clinical settings is held back due to the risk of overdiagnosis, increased cost and invasiveness of the assessment method. Therefore, novel biomarkers are needed beyond the amyloid and tau pathologies for the early diagnosis of AD. Neuropsychological paper and pencil tests can detect AD and discriminate between different clinical stages. Since medial temporal lobe structures, including the hippocampus and entorhinal cortex (EC), are involved in spatial navigation and degenerate in the earliest stages of AD, spatial navigation can be considered as an early cognitive biomarker of the disease. Nonetheless, the measurement of spatial navigation needs further improvement since the current paper and pencil tests lack ecological validity. Therefore, the test environment should be set up in immersive Virtual Reality (iVR). Dr. Andrea Castegnaro (Space and Memory Lab of University College of London) developed the Allocentric Spatial Update Task (ALLO task), which is an iVR task measuring egocentric and allocentric spatial abilities.Therefore, the main objective of this study is to evaluate whether allocentric and egocentric spatial navigation, measured by the ALLO iVR task can be considered a cognitive biomarker for the early detection of AD. In addition, the investigators want to report on the neuronal correlates of both spatial navigation strategies.Through the Department of Neurology of the University Hospital of Ghent, which has a large cognitive disorders clinic, patients with mild cognitive impairment and mild Alzheimer's dementia will be recruited. Participants will undergo standard clinical assessment, including a neuropsychological examination, Magnetic Resonance Imaging, a 18F-fluorodeoxyglucose PET and a Lumbar Puncture. In addition, participants will also be asked to undergo Tau PET imaging, Amyloid PET imaging and complete the ALLO iVR task. Healthy controls will also be recruited and have to undergo the same investigations, except for the amyloid PET and lumbar puncture. ### Conditions - Mild Cognitive Impairment - Alzheimer Disease - Healthy Aging ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Procedure for patients - Procedure for healthy controls ### Outcomes Primary Outcomes - Spatial navigation abilities Secondary Outcomes - Medial Temporal Lobe atrophy - Amount and spreading of amyloid in the brain - Amount and spreading of tau in the brain - Decreases in cerebral glucose metabolism in the brain - Cognitive functioning - amyloidB1-42 / 40 ratio, total tau and phosphorylated tau ### Location - Facility: University Hospital Gent, Ghent, East-Flanders, 9000, Belgium @@
## Ultrasound Imaging and Quantitative Vibro-Acoustic Assessment of Rickets Under the Age of Ten - NCT ID: NCT06385938 - Study ID: 23-012048 - Status: RECRUITING - Start Date: 2024-05 - Completion Date: 2026-04 - Lead Sponsor: Mayo Clinic ### Study Description The goal of this study is to find out if the use of ultrasound pictures of bones can spot changes in the growth areas of children with rickets, a condition that affects how bones harden. Researchers want to see if these ultrasound pictures can help tell the difference between children who have rickets and those who don't. ### Conditions - Rickets ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ultrasound with quantitative vibro-acoustic assessment ### Outcomes Primary Outcomes - Relationship of quantitative vibro-acoustic ultrasound and rickets severity score Secondary Outcomes - Relationship of ultrasound images with radiographic evidence of rickets - Case-control comparison of quantitative vibro-acoustic ultrasound measurements between children with rickets and control subjects - Longitudinal changes in vibro-acoustic ultrasound measurements with treatment of rickets ### Location - Facility: Mayo Clinic Minnesota, Rochester, Minnesota, 55905, United States @@
## A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation - NCT ID: NCT06385925 - Study ID: TSN1611-2023-101 - Status: RECRUITING - Start Date: 2024-04-30 - Completion Date: 2027-04-30 - Lead Sponsor: Tyligand Bioscience (Shanghai) Limited ### Study Description The study is a first-in-human (FIH), open-label, multi-center phase 1/2 study of TSN1611 in subjects with KRAS G12D mutant advanced solid tumors. This study will consist of a phase 1 dose escalation part and phase 2 dose expansion part. ### Conditions - Malignant Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - TSN1611 ### Outcomes Primary Outcomes - Dose limiting toxicities (DLTs) in phase 1 part - Objective response rate (ORR) in phase 2 part Secondary Outcomes - Adverse events - Area under the plasma concentration-time curve (AUC) - Maximum blood concentrations (Cmax) - Time to maximum blood concentration (Tmax) - Duration of response (DOR) - Time to response (TTR) - Disease control rate (DCR) - Progression free survival (PFS) - Overall survival ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer - NCT ID: NCT06385912 - Study ID: 2024-TJ-SLIDS - Status: COMPLETED - Start Date: 2006-07-01 - Completion Date: 2021-02-10 - Lead Sponsor: Tongji Hospital ### Study Description The study aims to investigate the prognostic and postoperative complication relevance of lymphadenectomy in advanced epithelial ovarian cancer patients who received neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). The main question it aims to answer is:Does systematic lymphadenectomy during interval debulking surgery have a significant impact on survival in patients with advanced epithelial ovarian cancer who have received neoadjuvant chemotherapy?The progression-free survival (PFS), overall survival (OS), and postoperative complication were compared between the lymphadenectomy and no lymphadenectomy groups to answer the question. ### Conditions - Ovarian Cancer - Postoperative Complications - Neoadjuvant Therapy - Lymph Node Excision ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - lymphadenectomy ### Outcomes Primary Outcomes - Progression free survival (PFS) - Overall survival (OS) Secondary Outcomes ### Location - Facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China @@
## Effect of Intensive Monitoring of Patients With Poorly Controlled Type 2 Diabetes With Different Glycemic Background - NCT ID: NCT06385899 - Study ID: : Poorly controlled T2DM-12 - Status: COMPLETED - Start Date: 2021-08-01 - Completion Date: 2023-03-01 - Lead Sponsor: Goztepe Prof Dr Suleyman Yalcın City Hospital ### Study Description In Turkey, only 55% of patients with type 2 diabetes have been diagnosed, and 91% of these patients have been receiving treatment. The rate of patients reaching the treatment target is 50%. The pandemic has also affected diabetic patients. It is aimed to determine the characteristics of patients with type 2 diabetes (HbA1c \>=10) with poor metabolic control and to evaluate the extent to which metabolic control can be achieved in 12 months. ### Conditions - Type 2 Diabetes - Poor Glycemic Control ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Changes in HbA1c levels after 12 months treatment - percentage of patients who reached the HbA1c target of equal to or below 7% Secondary Outcomes - The effect of education on the HbA1c changes - The effect of depression on the HbA1c changes - The effect of the level of physical activity on the HbA1c changes - The effect of weight loss on the HbA1c changes ### Location - Facility: Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Istanbul, N/A, N/A, Turkey @@
## Recruitment and Engagement in Care to Impact Practice Enhancement (RECIPE) for Sickle Cell Disease - NCT ID: NCT06385886 - Study ID: 1R01HL158807-01A1 - Status: RECRUITING - Start Date: 2023-06-08 - Completion Date: 2027-12 - Lead Sponsor: RTI International ### Study Description The goal of this observational study is to help us understand more about the best ways to help individuals living with Sickle Cell Disease (SCD) get the best care. The main question it aims to answer is: How to find individuals unaffiliated from SCD specialist care use three distinct pathways? Once unaffiliated individuals are found using the pathways, Investigators will employ linkage coordinators (trained staff) to engage these patients in care. Participants will be asked to fill out an assessment survey which will cover areas such as previous and current treatment, clinic and hospital experience, pain, and quality of life. Participants will also be given the option of participation in a 1-hour long interview how they feel about treatment for sickle cell disease including clinic experience, pain, and quality of life? ### Conditions - Sickle Cell Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Linkage Coordinator ### Outcomes Primary Outcomes - Identification of unaffiliated patients - Affiliation with a Sickle cell disease (SCD)-specific care with SCD specialist Secondary Outcomes - Scale Out to Other SCD Centers - Implementation in at least 2 other SCD Center study sites ### Location - Facility: University of Alabama, Birmingham (UAB), Birmingham, Alabama, 35233, United States @@
## RC48 Combined With Adebrelimab and Apatinib and S-1 of the Neoadjuvant Therapy of Locally Advanced Gastric Cancer - NCT ID: NCT06385873 - Study ID: 2024-SR-233 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-05-01 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description This study is a prospective, open-label, phase II clinical trial that aims to enroll patients with locally advanced gastric adenocarcinoma who have not received any prior treatment and are candidates for surgery. The study drugs include RC48, Adebrelimab, Apatinib and S-1. The purpose is to evaluate the effectiveness and safety of the combined coordinated treatment of multi-mechanism drugs for perioperative treatment of locally advanced gastric cancer with HER2 overexpression. ### Conditions - Gastric Cancer/Gastroesophageal Junction Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - RC48 - Adebrelimab - Apatinib - S-1 ### Outcomes Primary Outcomes - Pathological Complete Response Rate (pCR) Secondary Outcomes - Major Pathological Response rate (MPR) - R0 Resection rate - Disease-Free Survival (DFS） - Overall Survival (OS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Prediction Model for Early Biliary Stasis After Bariatric Surgery - NCT ID: NCT06385860 - Study ID: GTMGS0423 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2025-04 - Lead Sponsor: China-Japan Friendship Hospital ### Study Description Developing and validating a predictive model to estimate the risk of early biliary stasis following bariatric surgery ### Conditions - Obesity - Diabetes - Gallstones - Biliary Stasis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - early biliary stasis - prediction model Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## To Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer - NCT ID: NCT06385847 - Study ID: GOMIMP - Status: RECRUITING - Start Date: 2024-05 - Completion Date: 2025-12 - Lead Sponsor: The First Affiliated Hospital of Xiamen University ### Study Description The GOMIMP will be a Prospective, Randomized, Cross-over Trial to Explore the Patient Preference for Goserelin Microsphere (Zoladex®) Versus Goserelin Implant (LY01005) in Patients of Prostate Cancer ### Conditions - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Zoladex - LY01005 ### Outcomes Primary Outcomes - Patient preference Secondary Outcomes ### Location - Facility: The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, 361003, China @@
## The Effect of Morning vs Evening Aerobic Exercise Training on Cardiac Remodeling and Function Improvement in Patients After ST Elevation Myocardial Infarction - NCT ID: NCT06385834 - Study ID: LY2014-041-A - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2028-07-30 - Lead Sponsor: RenJi Hospital ### Study Description The aim of the study was to intervene in the Aerobic exercise time of patients with STEMI and to explore the optimal exercise time for STEMI patients ### Conditions - ST-segment Elevation Myocardial Infarction (STEMI) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Morning aerobic exercise - Evening aerobic exercise ### Outcomes Primary Outcomes - left ventricle ejection fraction Secondary Outcomes - Oxygen consumption - Endothelial Function - Skeletal muscle and fat mass - Cardiac structure - One year major Adverse Cardiovascular Events - VE/VCO2-SLOPE - Flow-mediated dilation - glucose - Blood lipid - N-terminal pro-BNP ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus - NCT ID: NCT06385821 - Study ID: GriQv-ch-III-22 - Status: COMPLETED - Start Date: 2022-09-21 - Completion Date: 2023-10-09 - Lead Sponsor: NPO Petrovax ### Study Description The goal of this clinical study is to prove the no less immunogenicity of the Grippol Quadrivalent vaccine compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three identical strains of the compared vaccines in terms of the "proportion of vaccinated with seroconversion in paired sera of the hemagglutination inhibition reaction obtained before and after vaccination". ### Conditions - Influenza - Influenza A - Influenza, Human - Influenza Type B - Flu - Influenza A H3N2 - Influenza A H1N1 - Influenza Epidemic - Flu, Human - Acute Respiratory Infection - Vaccine Reaction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Grippol Quadrivalent - Grippol Plus ### Outcomes Primary Outcomes - To prove non-inferior immunogenicity of the Grippol Quadrivalent vaccine when compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three matching strains of the compared vaccines Secondary Outcomes - Geometric mean antibody titers - Proportion of those vaccinated with seroconversion and geometric mean titer - Multiplicity of the increase in the geometric mean titer - Seroprotection - Incidence of influenza and acute respiratory infections (ARI) - The severity and duration of registered cases of influenza and acute respiratory infections (ARI), the presence of complications - To assess the reactogenicity of the vaccine Grippol Quadrivalent and the vaccine Grippol plus - Frequency and nature of SAEs - Frequency and nature of medically attended AEs ### Location - Facility: State Autonomous Healthcare Institution of the Sverdlovsk Region "Children's City Clinical Hospital No. 11", Ekaterinburg, N/A, 620028, Russian Federation @@
## Efficacy and Safety of MTBF Conditioning Regimen for Salvageable Allo-HSCT in the Treatment of R/R AML - NCT ID: NCT06385808 - Study ID: XJTU1AF-CRF-2023-XK014 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-31 - Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University ### Study Description The primary objective of this study was to evaluate the efficacy of MTBF conditioning regimen of salvageable allo-HSCT in patients with relapsed or refractory acute myeloid leukemia. The secondary purpose of the study was to observe the safety of MTBF regimen in these patients. ### Conditions - Relapse Leukemia - Refractory Acute Myeloid Leukemia - Conditioning - Hematopoietic Stem Cell Transplantation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - MTBF regimen ### Outcomes Primary Outcomes - Recurrence rate Secondary Outcomes - Incidence and Severity of non-hematological adverse events (NCI CTCAE v5.0) - Neutrophil recovery time - Platelet recovery time - OS - PFS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of NOE-115 in Women With Vasomotor Symptoms Due to Menopause - NCT ID: NCT06385795 - Study ID: NOE-PMM-201 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-04-30 - Lead Sponsor: Noema Pharma AG ### Study Description The purpose of this study is to determine the safety, tolerability, and preliminary effectiveness of NOE-115 on moderate to severe vasomotor symptoms (hot flashes) due to menopause in women. ### Conditions - Menopause Syndrome - Menopause - Hot Flashes ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - NOE-115 ### Outcomes Primary Outcomes - Withdrawals Due to Adverse Events While on NOE-115 for Any Reason Secondary Outcomes - Number of Participants Who Experience at Least One or More Adverse Event and the Severity of the Adverse Events (AEs) - Weekly Mean Change in the Severity of Hot Flashes from Baseline to Week 4 - Weekly Mean Change in the Frequency (any severity) of Hot Flashes from Baseline to Week 4 - Effect of NOE-115 as Assessed by Clinical Global Impression of Severity (CGI-S) from Baseline to Week 4 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Exploring HRV in Antarctic Overwintering Members of Asia - NCT ID: NCT06385782 - Study ID: 20dz1207200 - Status: COMPLETED - Start Date: 2021-03-01 - Completion Date: 2023-09-01 - Lead Sponsor: Ya-Wei Xu ### Study Description Extreme changes in the Antarctic environment can cause emotional and autonomic dysfunction. In this study, volunteers from the Antarctica stations in China provided scale scores and heart rate variability (HRV) data, which were used to assess the autonomic nervous system. Enroll twenty-two members from Zhongshan Station and the Great Wall Station who are overwintering. Using the Generalized Anxiety Disorder (GAD-7) scale, the Patient Health Questionnaire-9 (PHQ-9) scale, and the SF-36 quality of life scale to evaluate the individual's general physical and mental health. Analyze HRV and other associated parameters. ### Conditions - Heart Rate Variability ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Antarctic environment ### Outcomes Primary Outcomes - changes in HRV Secondary Outcomes ### Location - Facility: Shanghai Tenth People's Hospital, Shanghai, Shanghai, 200079, China @@
## Transcutaneous Tibial Nerve Stimulation in Patients With Neurogenic Overactive Bladder After Stroke - NCT ID: NCT06385769 - Study ID: PamukkaleU.ftr-NYıldız-3 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2026-02-28 - Lead Sponsor: Pamukkale University ### Study Description The investigators conducted a prospective, randomized, double-blind, placebo-controlled study based on the placebo technique to evaluate the efficacy of TTNS versus placebo in patients with OAB after stroke.The main questions aimed to be answered are:What are the effects of Trans Tibial Nerve Stimulation (TTNS) on incontinence-related clinical parameters and quality of life in patients with overactive bladder (OAB) after stroke compared to the placebo group? Participants (n:22) with post-stroke AAM who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive TTNS (n:11) and the second group will receive placebo TTNS (n:11). Measurements will be performed twice in total, before treatment and at the end of treatment (4th week). ### Conditions - Urinary Bladder, Overactive ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Transcutaneous tibial nerve stimulation (TTNS) - Sham Transcutaneous tibial nerve stimulation (TTNS) ### Outcomes Primary Outcomes - Decreased frequency of increased voiding Secondary Outcomes - Frequency of voiding - The Quality of Life - Barthel Index for Activities of Daily Living (ADL) - The Overactive Bladder Symptom Score (OABSS) - Treatment Satisfaction Level - Cystometric value ### Location - Facility: Pamukkale University, Denizli, N/A, N/A, Turkey @@
## Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions - NCT ID: NCT06385756 - Study ID: TJ-IRB202403020 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-01 - Lead Sponsor: Tongji Hospital ### Study Description At present, there are limited data on perioperative efficacy of barbiturates at home and abroad. The purpose of this clinical trial is to observe the effects of amobarbital sodium combined with low-dose propofol on hemodynamics during induction and perioperative adverse reactions in gynecological laparoscopic surgery patients, and to provide a more reasonable, safe and comfortable anesthesia program for female patients who undergoing laparoscopic surgery.The main questions it aims to answer are:* whether the combination of the two results on more stable hemodynamics during induction in gynecological laparoscopic surgery patients;* whether the incidence of perioperative oxidative stress and inflammation and postoperative nausea and vomiting（ponv） improved after the use of the two combinations of anesthesia induction.Participants will:* Induction of anesthesia with the experimental drug or placebo；* 5 ml of venous blood was retained before, after, and 1 day after surgery for follow-up determination of serum associated factor levels；* To record their vital signs at any point during the anaesthetic process; Serum serological indexes related to oxidative stress and inflammation were determined. The agitation during the recovery period was recorded. The incidence and severity of ponv were recorded at 2h, 2-6h, and 6-24h postoperatively, and the use of palonosetron was also recorded. ### Conditions - Amobarbital Sodium - Hemodynamics Instability ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Amobarbital - Propofol ### Outcomes Primary Outcomes - Mean arterial pressure (MAP) during Induction of anesthesia Secondary Outcomes - MAP at different time points - Incidence of postoperative nausea and vomiting (ponv) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effectiveness of Neuromuscular Training-Based Exercise Program - NCT ID: NCT06385743 - Study ID: yeditepe15 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-04-17 - Completion Date: 2024-12-30 - Lead Sponsor: Yeditepe University ### Study Description This randomised controlled study aimed to investigate the effectiveness of a neuromuscular training-based exercise program on pain, function, risk factors specific to shoulder injuries and performance in overhead athletes with shoulder pain.The main hypothesis is;H0: There is no difference between the "Thrower's Ten" exercise program and the neuromuscular training-based exercise program applied to overhead athletes with shoulder pain, on pain, function, risk factors specific to shoulder injuries, and performance.H1: The effects of a neuromuscular training-based exercise program on pain, function, risk factors specific to shoulder injuries and performance in overhead athletes with shoulder pain are superior to the effects of "Thrower's Ten" exercise program ### Conditions - Pain, Shoulder - Sports Physical Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Neuromuscular Training-based Exercise Program - ''Thrower's Ten'' Exercise Program ### Outcomes Primary Outcomes - Pain Assessment - Disabilities of the Arm, Shoulder and Hand (DASH) Secondary Outcomes - Tampa Kinesiophobia Scale - Hylyght Injury Prevention and Return to the Sports Screening Program ( - Y Balance Test- Upper Quarter - Closed Kinetic Chain Extremity Stability Test - Single Arm Seated Shot Put Test ### Location - Facility: Yeditepe University, Istanbul, N/A, N/A, Turkey @@
## Neoadjuvant PD-1 Blockade for Elderly Esophageal Squamous Cell Carcinoma (BLESS) - NCT ID: NCT06385730 - Study ID: SCE2401 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-05 - Lead Sponsor: Shanghai Chest Hospital ### Study Description The investigators will conduct a prospective phase 2 study to evaluate the efficacy and safety of neoadjuvant PD-1 blockade monotherapy with toripalimab in elderly patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC). ### Conditions - Esophageal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - neoadjuvant anti-PD-1 - neoadjuvant anti-PD-1 with LDRT ### Outcomes Primary Outcomes - MPR rate Secondary Outcomes - pCR rate - Adverse events and treatment-related adverse events - R0 resection rate - Objective Response rate - Event-free survival (EFS) - Overall survival (OS) - Correlation between potential biomarkers and tumor response ### Location - Facility: Shanghai Chest Hospital, Shanghai, Shanghai, 200030, China @@
## Multicenter Cohort Study of ESD and Chemo-radiotherapy for High-risk Early-stage Esophageal Cancer - NCT ID: NCT06385717 - Study ID: ZhejiangU - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2029-01-31 - Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University ### Study Description This multicenter, prospective observational cohort study has the potential to optimize individualized chemoradiotherapy regimen for early-stage esophageal cancer patients who have received endoscopic submucosal dissection. ### Conditions - Esophagus Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - chemo-radiation ### Outcomes Primary Outcomes - Incidence of toxic events Secondary Outcomes - 3-year overall survival - 3-year local-regional recurrence free survival ### Location - Facility: The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310000, China @@
## Research on Changes in Intestinal Barrier Function and Gut Microbiome in Patients With Type 2 Diabetes After Duodenal Mucosal Resurfacing (DMR) - NCT ID: NCT06385704 - Study ID: DMRIBFGM0420 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-12-01 - Lead Sponsor: Wang Siqi ### Study Description The aim of this study is to demonstrate the effects of duodenal mucosal resurfacing (DMR) on intestinal barrier function and gut microbiota when treating uncontrolled type 2 diabetes. Subjects who underwent DMR and those who did not were enrolled, and potential differences were identified by analyzing urine and fecal samples through microbiomic analysis and High Performance Liquid Chromatography（HPLC）, combined with changes in clinical data. ### Conditions - Diabetes Mellitus, Type 2 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - DMR Procedure ### Outcomes Primary Outcomes - Microbiome Analysis - High Performance Liquid Chromatography Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study Evaluating the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer. - NCT ID: NCT06385691 - Study ID: ET22-145 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-29 - Completion Date: 2026-08-31 - Lead Sponsor: Centre Leon Berard ### Study Description This is a prospective, single-center, single-arm Phase II study evaluating the efficacy of the myDIET software tool in the nutritional management of patients with localized and resectable esogastric junction cancer. ### Conditions - Gastric Cancer - Oesogastric Junction Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - myDIET software tool ### Outcomes Primary Outcomes - Proportion of patients starting adjuvant chemotherapy within 2 months Secondary Outcomes - Adherence to the tool - Number of supportive care and emergency consultations initiated by the caregiver - Proportion of patients with malnutrition - Evolution of body composition in L3 section (volumes) - Evolution of body composition in L3 section (indexes) - Evolution of resting energy expenditure - Proportion of patient covering theoretical nutritional requirement >= 30kcal/kg/day - Comparison between theoretical nutritional requirement and measurement of basal metabolic rate using indirect calorimetry - Weight changes - Brachial circumference changes - Triceps skin fold changes - Initiation time for post-operative chemotherapy - Proportion of patient with incomplete scheme of pre operative chemotherapy - Proportion of patient with incomplete scheme of post operative chemotherapy - Proportion of patients with severe post operative complication - Tolerance to perioperative chemotherapy - Changes in food intake - Changes in SEFI (Easy Food Intake Score) - Measurement of quality of life - Average lengh of hospital stay - Recurrence free survival (RFS) - Overall survival (OS) - Adherence to the physical activity program - Physical activity levels - Assessment of muscular function by the 6-min walk test - Assessment of muscular function by muscular strength ### Location - Facility: Centre Léon Berard, Lyon, N/A, 69008, France @@
## A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation - NCT ID: NCT06385678 - Study ID: HRS-4642-201 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-08 - Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd. ### Study Description The study is being conducted to evaluate the safety, tolerability, and efficacy of HRS-4642 in combination with antitumor medicine in patients with advanced solid tumors harboring KRAS G12D mutation. ### Conditions - Advanced KRAS G12D Mutant Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - HRS-4642 - Adebrelimab - SHR-A1921 - Pemetrexed Disodium for Injection、Cisplatin Injection、Carboplatin for Injection ### Outcomes Primary Outcomes - Phase IB: Safety endpoints: adverse events (AEs). - Phase IB： Maximum tolerated dose (MTD) - Phase IB：Recommended phase 2 dose (RP2D) - Phase II: Overall response rate (ORR). Secondary Outcomes - Efficacy endpoints: Overall response rate (ORR). - Efficacy endpoints: Duration of response (DoR). - Efficacy endpoints: Disease control rate (DCR). - Efficacy endpoints: Progression free survival (PFS). - Efficacy endpoints: overall survival (OS). ### Location - Facility: Shanghai East Hospital, Shanghai, Shanghai, 200120, China @@
## The Effect of Appropriate Family Companionship on the Physical and Mental Health of Patients With Advanced Breast Cancer - NCT ID: NCT06385665 - Study ID: Xin Peng - Status: RECRUITING - Start Date: 2024-04-22 - Completion Date: 2024-12-31 - Lead Sponsor: Xin Peng ### Study Description The goal of this clinical trial is to learn about companionship needs in breast cancer patients who are pathologically or cytologically diagnosed as cancer, are alive with the tumor, and have TNM clinical stage IV. The main questions it aims to answer are:1. Patients with advanced breast cancer need family companionship2. Analyze and study the reasons and factors that affect the physical and mental impact of effective family companionship on patients with advanced breast cancer Participants will be divided into a companion group and a non-accompaniment group. Patients in the companion group are given graded companion intervention methods. A comparison group: Researchers will compare a non-accompaniment group to see if the physical and mental impact of companionship on patients. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Graded companionship ### Outcomes Primary Outcomes - Change from Baseline meatal state on GAD-7 at Week 48. - Change from Baseline physical state on kps at Week 48. Secondary Outcomes ### Location - Facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, N/A, 430022, China @@
## PET Imaging Study of 68Ga-NB381 in Multiple Myeloma - NCT ID: NCT06385652 - Study ID: PekingUFH-MM-NB381 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-12-31 - Lead Sponsor: Peking University First Hospital ### Study Description Multiple myeloma (MM) predominantly affects the elderly, often presenting insidiously and with a rising incidence rate. Current diagnostic methods primarily rely on invasive bone marrow biopsies, which can lead to false-negative results if the biopsy site is improperly chosen. CD38 is significantly overexpressed on the surface of malignant plasma cells in MM, making it a characteristic tumor biomarker for this disease.Addressing the limitations in specificity and sensitivity of traditional PET imaging agents, this project is dedicated to developing a new type of nanobody PET/CT imaging probe, 68Ga-NB381, which possesses high affinity and targets CD38. This probe, which is an intellectual property of our institution, aims to enhance the accuracy and specificity of early MM diagnosis. In terms of clinical evaluation, the project will implement a comprehensive assessment process including case selection, collection of baseline information, high-precision imaging, expert-level image interpretation, and follow-up studies, comparing directly with traditional 18F-FDG imaging to thoroughly verify the specificity and safety of 68Ga-NB381. This lays the groundwork for the clinical translation of this radiopharmaceutical in China. Furthermore, the project contributes to formulating more effective precision treatment plans based on CD38 expression levels and provides evidence for monitoring the therapeutic effects of daratumumab, a drug also targeting CD38. This makes the project of significant academic value and clinical importance, thus promoting the development of personalized treatment strategies. ### Conditions - Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: DIAGNOSTIC ### Interventions - 68Ga-NB381 ### Outcomes Primary Outcomes - Specificity and Binding Efficiency of 68Ga-NB381 in CD38 Positive Tumors Secondary Outcomes ### Location - Facility: Peking University First Hospital, Beijing, Beijing, 100000, China @@
## Efficacy and Safety of Probiotic Products for Digestive Health - NCT ID: NCT06385639 - Study ID: WK2024005 - Status: RECRUITING - Start Date: 2024-04-25 - Completion Date: 2024-06-25 - Lead Sponsor: Wecare Probiotics Co., Ltd. ### Study Description The objective of this study is to evaluate the efficacy and safety of the probiotic product as an everyday gut health product in supporting digestive environment and homeostasis of gut microbiota. ### Conditions - Healthy Adult ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Probiotic ### Outcomes Primary Outcomes - Intestinal health Secondary Outcomes ### Location - Facility: Danang@Equilab-Int.Com, Jakarta, Pusat, 10430, Indonesia @@
## The Effects of Raspberry Leaf Tea on Blood Glucose Control - NCT ID: NCT06385626 - Study ID: UREC: 23_15-Raspberry Leaf Tea - Status: RECRUITING - Start Date: 2023-12-18 - Completion Date: 2024-12-23 - Lead Sponsor: University of Reading ### Study Description The aim of the present clinical trial is to assess how raspberry leaf polyphenols impact on postprandial glucose and insulin levels in healthy individuals consuming sucrose.The questions the project will address:* Do raspberry leaf polyphenols lower sucrose-induced increases in plasma glucose in humans?* Do these polyphenols mediate these effects by inhibiting digestion of sucrose or the absorption of glucose. 20 healthy adults will be recruited between the ages of 18-65 years who are non-smokers and not taking certain types of medication (e.g., drugs from a GP for high blood pressure, high blood fats, inflammatory conditions, and depression) or dietary supplements (e.g., cholesterol-lowering spreads, fish oil, probiotics, prebiotics, and natural laxatives), antibiotics in the last three months or if they used any drugs or supplements that could affect their blood glucose or lipid metabolism. No abnormal results for liver function tests, renal function tests, and lipid profile tests. If they have food allergies or consume more than 14 units of alcohol per week (i.e., to help they calculate a alcohol intake, one standard glass of wine (175 ml) or one pint of regular lager is equivalent to just over two units of alcohol), frequently travel for work or are participating in another intervention study, they will not be able to participate. Women who are pregnant or lactating or planning a pregnancy in the next six months will also not be able to take part, not use herbal medicines for at least the previous three months, not be on a weight loss program six months before screening, not involved in clinical trials six months before the screening, and not having severe cardiac, hepatic, or renal function impairment. Not Sufferers of chronic illnesses, not Individuals with food allergies, not people with coeliac disease.They will be asked to attend a four-study visit after an eight-hour overnight fast. Volunteers will be asked to consume 50 g of carbohydrate powder (sucrose and glucose) with or without 10 g of raspberry leaf tea, which will be dissolved in 300 mL of warm water during four visits (every month). Blood samples will be taken at intervals for a period of two hours after the consumption of raspberry leaf or control. Blood glucose and insulin levels will be tested 15 minutes before, at 15,30,60,90, and 120 minutes after carbohydrate intake. ### Conditions - Type II Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Raspberry leaf tea ### Outcomes Primary Outcomes - Blood Glucose Secondary Outcomes ### Location - Facility: Hugh Sinclair Unit of Human Nutrition, University of Reading, Reading, Berkshire, RG6 5SG, United Kingdom @@
## The Effect of Mobile-Based Education on Self-Care, Quality of Life and Complications in Patients With Intestinal Stoma - NCT ID: NCT06385613 - Study ID: TDK-2024-13377 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2025-08-22 - Lead Sponsor: Ataturk University ### Study Description Stomas are most commonly used in the gastrointestinal tract as ileostomy or colostomy. Although colorectal cancers are the most important factor causing intestinal stoma opening, intestinal ostomies are also used in cases such as congenital anomalies, obstructive or inflammatory bowel diseases, traumas requiring surgery, large defects caused by colorectal injuries as well as sigmoid colon volvulus and ischemic colitis. In stoma surgery performed to increase the duration and quality of life of individuals, the patient's compliance with the stoma and awareness of possible complications are important. Conditions such as peristomal skin problems, noisy bowel movements, stool leakage and pain make it difficult to adapt to the stoma.In addition, despite all the advances in stoma care products and surgical techniques, individuals are faced with stoma complications. Therefore, individuals with stoma should be closely monitored for complications. Inappropriately selected stoma site or bag/adapter system, lack of knowledge and skills related to stoma care can be listed among the possible causes of complications. Complications such as edema, bleeding, ischemia and mucocutaneous separation may develop in the first days after stoma surgery. In studies evaluating patients in terms of stoma compliance and complications in the literature, it has been observed that mobile-based trainings given to patients increase their stoma compliance and reduce the incidence of complications. With the mobile-based training planned to be used in the study, it is thought to contribute to the ability of individuals to perform stoma care independently. With the decrease in peristomal skin lesions and stoma complications, it is predicted that the quality of life of patients with stoma will increase, self-care competence will be formed, and health expenditures and therefore national health expenditures will decrease. It is thought that this mobile training application will not only provide support to patients with stoma but also guide healthcare professionals. It will also contribute to closing the shortage of stoma and wound care nurses in hospitals. ### Conditions - Intestinal Stoma Site Hemorrhage - Intestinal Stoma Leakage - Life Style, Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Mobile-based stoma care education group ### Outcomes Primary Outcomes - Adaptation of Quality Life Scale - Ostomy Self-Care Index - Pittman Ostomy Complication Severity Index - Peristomal Skin Tool - Ostomy Adjustment Inventory-23 - Computer System Usability Questionnaire Secondary Outcomes ### Location - Facility: Ataturk University Faculty of Nursing, Erzurum, N/A, N/A, Turkey @@
## Intravenous Labetalol vs Phentolamine for the Management of Severe Preeclampsia. - NCT ID: NCT06385600 - Study ID: severe preeclampsia - Status: NOT_YET_RECRUITING - Start Date: 2024-05-20 - Completion Date: 2026-03-20 - Lead Sponsor: Assiut University ### Study Description The only effective treatment of severe preeclampsia is delivery of the fetus but immediate antihypertensive treatment is given to stabilize the patient and prevent further complications. All antihypertensive medication can potentially cross the placenta. At this time, there are no randomized control trials to base a recommendation for the use of one antihypertensive agent over another. However, certain medications are effective in lowering blood pressure with an acceptable safety profile in pregnancy. The choice of therapy depends on the acuity and severity of hypertension ### Conditions - Severe Pre-eclampsia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Labetalol - Phentolamine ### Outcomes Primary Outcomes - the effect of Labetalol and Phentolamine on MCA flow velocity by transcranial Doppler monitoring. Secondary Outcomes - The effect of labetalol and phentolamine on blood pressure of the patients ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Technology-based Symptom Monitoring Intervention for Locally Advanced Head and Neck Cancer Patients - NCT ID: NCT06385587 - Study ID: ADH-OL-Study-01-23 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-03 - Completion Date: 2025-09-27 - Lead Sponsor: Aptar Digital Health ### Study Description The goal of this observational study is to assess the satisfaction and usability of an interactive and patient-centered mobile application (app), Oleena™, designed to assist head and neck cancer patients undergoing chemoradiation in managing common and distressing symptoms in real-time, as well as to assess the satisfaction and usability of the related HCP web portal. Additional secondary usage and clinical endpoints that would be used to assess intervention efficacy in future trials will be collected. ### Conditions - Head and Neck Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Oleena ### Outcomes Primary Outcomes - Users' satisfaction Secondary Outcomes - Feasibility of the technology enabled symptom management solution - Usability of the technology enabled symptom management solution - Appropriateness of the recommendations - Semi-structured exit interviews ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Technological Based Rehabilitation on Individuals With Rheumatic Disease - NCT ID: NCT06385574 - Study ID: 2023-088 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-05-20 - Lead Sponsor: Akdeniz University ### Study Description Affects such as pain, swelling, tenderness, deformities, limitations, strength and function losses, skill and coordination deficiencies in the hand joints, which are frequently seen in rheumatism patients with hand involvement, are included in body structure and function disorders within the framework of International Classification of Function System. Leap Motion Controller is used in hand rehabilitation because it is small in size, low-cost, portable, non-contact, easy to use and provides visual and auditory feedback. The aim of our study is to examine the effect of technology-based rehabilitation on joint range of motion, grip strength, functionality and disease activity in adult individuals with rheumatic disease with hand involvement; and also to compare these effects with the effects of the hand rehabilitation program implemented under the guidance of a physiotherapist and the control group that continues its routine life. ### Conditions - Rheumatic Diseases - Hand Rheumatism - Virtual Reality Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Virtual reality therapy ### Outcomes Primary Outcomes - Hand grip strength measurement - Jebsen Hand Function Test (JHFT) - Nine Hole Peg Test (NHPT) - Duruoz Hand Index (DHI) - Michigan Hand Outcome questionnaire (MHQ) Secondary Outcomes - Disease Activity Score 28 (DAS 28) - Hand fine grip strength measurement ### Location - Facility: Sebahat Yaprak Cetin, Antalya, Konyaaltı, 07100, Turkey @@
## The Influence of Tramadol on Opioid-induced Bowel Dysfunction - NCT ID: NCT06385561 - Study ID: Tramadol_OIBD - Status: COMPLETED - Start Date: 2022-08-11 - Completion Date: 2023-05-15 - Lead Sponsor: Asbjørn Mohr Drewes ### Study Description Tramadol is a weak opioid and widely used to treat moderate to severe pain. Stronger opioids are known to inhibit gastrointestinal motility and secretion, however the effects of tramadol on gastrointestinal function remains less understood. The aim of this study was to determine to what degree tramadol causes opioid-induced bowel dysfunction by using an objective design to explore gastrointestinal transit, motility pattern, secretion, and colonic volume, in a group of healthy male volunteers. ### Conditions - Opioid-Induced Bowel Dysfunction - Constipation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Tramadol - Placebo ### Outcomes Primary Outcomes - Total gastrointestinal transit time - Colorectal transit time Secondary Outcomes - Constipation symptoms - Bowel movement frequency - Stool consistency - Gastrointestinal symptoms - Opioid-induced constipation - Diagnostic evaluation of opioid-induced constipation - Colonic motility patterns - Opiate withdrawal symptoms - Colon volume - Colonic water content - Gastric half emptying time - Gastric contraction assessment - Gastric contraction assessment - Small bowel motility assessment - Small bowel water content ### Location - Facility: Aalborg University Hospital, Aalborg, N/A, 9000, Denmark @@
## Efficacy and Safety Study of Lurbinectedin and Dostarlimab in Cancer Patients: Protocol VHIO21001 - LiDer - NCT ID: NCT06385548 - Study ID: VHIO21001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: Vall d'Hebron Institute of Oncology ### Study Description Background:Endometrial cancer is a prevalent gynecological malignancy, with a significant number of cases diagnosed at an advanced stage or recurring following initial treatment. Platinum-based chemotherapy represents a standard treatment option for these patients; however, disease progression often occurs, highlighting the need for novel therapeutic approaches. Lurbinectedin, a synthetic analog of marine alkaloid-derived compounds, and dostarlimab, a monoclonal antibody targeting PD-1, have demonstrated promising antitumor activity in various malignancies. This phase I-II clinical trial seeks to evaluate the safety, tolerability, and efficacy of combining lurbinectedin and dostarlimab in patients with advanced or recurrent endometrial cancer who have experienced disease progression following platinum-based chemotherapy.Primary Objectives:To determine the maximum tolerated dose (MTD) and recommended dose for further investigation of lurbinectedin and dostarlimab in combination therapy for advanced or recurrent endometrial cancer.To assess the antitumor activity of lurbinectedin and dostarlimab combination therapy, measured by objective response rate (ORR), in patients with advanced or recurrent endometrial cancer.Secondary Objectives:To evaluate the safety and tolerability of lurbinectedin and dostarlimab combination therapy in patients with advanced or recurrent endometrial cancer.To characterize the pharmacokinetic profile of lurbinectedin and dostarlimab when administered in combination therapy.To explore pharmacogenomic biomarkers predictive of response and/or resistance to lurbinectedin and dostarlimab combination therapy in patients with advanced or recurrent endometrial cancer.To assess progression-free survival (PFS), duration of response (DOR), clinical benefit rate (CBR), and overall survival (OS) in patients receiving lurbinectedin and dostarlimab combination therapy for advanced or recurrent endometrial cancer.To investigate the impact of lurbinectedin and dostarlimab combination therapy on quality of life and symptom control in patients with advanced or recurrent endometrial cancer. ### Conditions - Endometrial Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Lurbinectedin - Dostarlimab ### Outcomes Primary Outcomes - Maximum Tolerated Dose (MTD) and Recommended Dose (RD) Determination - Evaluation of Lurbinectedin and Dostarlimab Combination Therapy in Advanced/Recurrent Cervical Cancer Patients Secondary Outcomes - Safety Evaluation of Lurbinectedin in combination with Dostarlimab - Evaluate the progression-free survival (PFS) - Pharmacokinetic (PK) and Pharmacogenomic Evaluation - Overall Response Rate (ORR) - Evaluate the Duration of Response (DOR) - Evaluate the Clinical Benefit Rate (CBR) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Characteristics and Temporal Properties of Individual Tics in Persistent Tic Disorder - NCT ID: NCT06385535 - Study ID: IRB_00171031 - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2024-12 - Lead Sponsor: University of Utah ### Study Description The goal of this clinical study is to learn more about the timing of tics (sudden, fast movements and sounds that people do and make without meaning to) in people who have multiple tics that have been going on for more than one year. The main questions it aims to answer are:1. See whether a tic's timing is related to other characteristics of the tic, like how long it has been happening and how well the person can control/stop that tic2. See whether the timing of a tic can tell us how well the person can control/stop that tic3. See whether tic treatment changes the timing of tics, and if the timing of a tic has anything to do with how well treatment will work to stop itParticipants will meet with a study researcher to learn more about the study, ask questions, and decide whether or not they would like to be involved. If they decide to do the study, they will meet with the researcher 6 times:1. During the first visit, the study researcher will ask questions about the participant's life, tics, and other psychological symptoms. The researcher will watch the participant's tics for 10 minutes. The participant will do a computer task where they follow instructions to tic or not tic.2. During the second visit, the study researcher will treat one of the participant's tics.3. During the third visit, the study researcher will treat another one of the participant's tics.4. During the fourth visit, the study researcher will treat another one of the participant's tics.5. During the fifth visit, the study researcher will treat another one of the participant's tics.6. During the sixth visit, the study researcher will ask questions about the participant's tics and other psychological symptoms. The participant will do a computer task where they follow instructions to tic or not tic. ### Conditions - Tics - Tic Disorders - Vocal Tic - Motor Tic - Tourette Syndrome - Tourette Syndrome in Children - Tourette Syndrome in Adolescence - Tics/Tremor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Habit Reversal Training (HRT) ### Outcomes Primary Outcomes - Estimates of baseline individual and total tic fractality within free-to-tic (FTT) and differential reinforcement of other behavior (DRO) environmental contingencies - Voluntary tic suppression success at baseline - Total tic severity at baseline as measured by the Yale Global Tic Severity Scale (YGTSS) - Total and individual tic severity at baseline as measured by the Parent Tic Questionnaire (PTQ) - Changes in voluntary individual and total tic suppression success pre- and post-intervention - Changes in individual and total tic fractality within free-to-tic (FTT) and differential reinforcement of other behavior (DRO) environmental contingencies pre- and post-intervention - Changes in individual and total tic severity pre- and post-intervention as measured by the Yale Global Tic Severity Scale (YGTSS) and Parent Tic Questionnaire (PTQ) Secondary Outcomes - Individual and total premonitory urge severity at baseline as measured by the Individualized Premonitory Urge for Tics Scale (I-PUTS) - Individual and total premonitory urge severity post-intervention as measured by the Individualized Premonitory Urge for Tics Scale (I-PUTS) - Changes in individual and total premonitory urge severity pre- and post-intervention as measured by the Individualized Premonitory Urge for Tics Scale (I-PUTS) - Total tic severity post-intervention as measured by the Yale Global Tic Severity Scale (YGTSS) - Individual and total tic severity post-intervention as measured by the Parent Tic Questionnaire (PTQ) - Voluntary tic suppression success post-intervention - Estimates of individual and total tic fractality within free-to-tic (FTT) and differential reinforcement of other behavior (DRO) environmental contingencies post-intervention ### Location - Facility: University of Utah, Salt Lake City, Utah, 84112, United States @@
## A Clinical Trial in Adults With Non-Hodgkin Lymphoma (NHL), With a Particular Emphasis on Cutaneous T Cell Lymphoma (CTCL), Testing the Safety and Activity of a Novel Drug to Inhibit a Protein Called Tumor Necrosis Factor Receptor 2 That Drives Both Lymphoma Growth and Escape of the Immune System - NCT ID: NCT06385522 - Study ID: BITR2101-C-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2027-02 - Lead Sponsor: Boston Immune Technologies and Therapeutics ### Study Description The goal of this trial is to learn if a new drug, BITR2101, works to treat non-Hodgkin lymphoma (NHL) in adults, with CTCL patients being sought in particular. The trial also seeks to learn about the safety of this drug. This drug is a protein called an antibody. The drug prevents a molecule called a receptor, named TNFR2, from being made. TNFR2 regulates the immune system and provides important signals to lymphoma cells to grow, make more of themselves and survive. When the drug prevents TNFR2 from being produced in lymphoma cells from CTCL patients, those cells died in the laboratory. Therefore, the trial seeks to enroll CTCL patients in particular, in addition to other subtypes of NHL. When the drug prevents the receptor from being made in certain immune cells, there is increased immune activity. Thus, the trial will test if this drug is a new immune therapy that helps the immune system to keep lymphoma under control. In particular, we want to find out if the amount of lymphoma in the body decreases while taking the drug. Patients with autoimmune diseases are not permitted because of this potential increase in immunity brought on by this drug. Patients should have NHL that has been previously treated, that is getting worse on their current therapy, and their doctors think a new treatment is needed. All patients will receive BITR2101 by a 3 hour infusion into a vein, periodically, initially every 3 weeks. There is no placebo in this trial. Visits to the clinic facility will be required, initially at least every week and later less frequently. Patients will be expected to report changes in their health to the clinic staff including new findings and any change in the status of their lymphoma they may be aware of. Patients can continue to receive BITR2101 for up to a year or until their lymphoma worsens. For patients who are clearly benefiting, they may be able to receive BITR2101 for another year. ### Conditions - NHL - Cutaneous T Cell Lymphoma - Peripheral T-cell Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - BITR2101 ### Outcomes Primary Outcomes - to assess the safety and tolerability of BITR2101 administered intravenously every 3 weeks in order to determine the MTD, if any, and to inform the RDE Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Phase 4 Study to Evaluate Adrenal Function in Hypogonadal Men Treated With JATENZO® for 12 Months - NCT ID: NCT06385509 - Study ID: TOL-CLAR-20024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-02 - Lead Sponsor: Tolmar Inc. ### Study Description TOL-CLAR-20024 is a Phase 4, multi-center, open-label safety study evaluating the potential effect of JATENZO on adrenal function in hypogonadal men treated with JATENZO for 12 months. ### Conditions - Hypogonadism ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Jatenzo ### Outcomes Primary Outcomes - CST Test Secondary Outcomes - Adrenal Insufficiency ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Testing MLN0128 (TAK-228) as Potentially Targeted Treatment in Cancers With mTOR Genetic Changes (MATCH - Subprotocol L) - NCT ID: NCT06385496 - Study ID: NCI-2024-01145 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2017-03-12 - Completion Date: 2024-12-31 - Lead Sponsor: National Cancer Institute (NCI) ### Study Description This phase II MATCH treatment trial tests how well MLN0128 (TAK-228) works in treating patients with cancer that has certain genetic changes called mTOR mutations. MLN0128 (TAK-228) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ### Conditions - Advanced Lymphoma - Advanced Malignant Solid Neoplasm - Refractory Lymphoma - Refractory Malignant Solid Neoplasm - Refractory Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Biopsy - Biospecimen Collection - Computed Tomography - Magnetic Resonance Imaging - Sapanisertib ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - Overall survival (OS) - 6-month progression free survival (PFS) - Progression free survival ### Location - Facility: ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, 19103, United States @@
## Testing Afatinib as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH - Subprotocol A) - NCT ID: NCT06385483 - Study ID: NCI-2024-01125 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2015-08-11 - Completion Date: 2024-12-06 - Lead Sponsor: National Cancer Institute (NCI) ### Study Description This phase II MATCH treatment trial tests how well afatinib works in treating patients with cancer that has certain genetic changes. Afatinib is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in the EGFR gene. It works by blocking the action of mutated EGFR that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. ### Conditions - Advanced Lymphoma - Advanced Malignant Solid Neoplasm - Refractory Lymphoma - Refractory Malignant Solid Neoplasm - Refractory Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Afatinib - Biopsy - Biospecimen Collection - Computed Tomography - Echocardiography - Magnetic Resonance Imaging - Radionuclide Imaging ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - Overall survival (OS) - 6-month progression free survival (PFS) - Progression free survival ### Location - Facility: ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, 19103, United States @@
## Treatment of Cantonese Speakers With Childhood Apraxia of Speech - NCT ID: NCT06385470 - Study ID: HSEARS20231112001 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-02-01 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description The proposed study aims to investigate the efficacy of the Dynamic Temporal and Tactile Cueing treatment in Cantonese-English bilingual speakers with childhood apraxia of speech. ### Conditions - Childhood Apraxia of Speech ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Dynamic Temporal and Tactile Cueing treatment ### Outcomes Primary Outcomes - Phonemes accuracy - Stress accuracy - Tone accuracy Secondary Outcomes ### Location - Facility: The Hong Kong Polytechnic University, Kowloon, N/A, N/A, Hong Kong @@
## The Effects of Mindhelper on Young People's Well-being, Psychological Functioning, and Intentions to Help-seeking - NCT ID: NCT06385457 - Study ID: 24-2933 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-29 - Completion Date: 2025-01-31 - Lead Sponsor: University of Southern Denmark ### Study Description In this study the investigators will evaluate the effectiveness of Mindhelper.dk, which is the most comprehensive online youth mental health promotion service in Denmark.A minimum of 9,426 young people aged 15 to 25 will be recruited through social media and invited to participate in the study. When responding to the baseline questionnaire participants will be randomized to either the intervention or control group. The intervention group will receive information about Mindhelper.dk and inspiration on how to use Mindhelper through text-messages during the study period. The control group does not receive information about Mindhelper.dk, until after completion of the last follow-up questionnaire.Three follow-up questionnaires will then be sent to the participants 2 weeks, 6 weeks and 12 weeks after randomization.The investigators expect a small, positive effect on participants well-being and psychological functioning in intervention groups as compared to the control group. ### Conditions - Mental Health Issue - Well-Being - Adolescents - Young Adults - Online Intervention - Internet-Based Intervention - Randomized Controlled Trial ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Mindhelper- A national youth mental health promotion website ### Outcomes Primary Outcomes - General well-being measure by "The Well-Being Index WHO-5" (WHO5) Secondary Outcomes - Psychological functioning, measure by "The Short Warwick-Edinburgh Mental Well-Being Scale" (SWEMWBS). - Intentions to help-seeking ### Location - Facility: National Institute of Public Health (NIPH), University of Southern Denmark, Copenhagen, Copenhagen K, 1455, Denmark @@
## IVF Failure and Pregnancy Loss on Couples' Psychological Stress - NCT ID: NCT06385444 - Study ID: 2024-HS-020 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-06-01 - Lead Sponsor: The First Hospital of Jilin University ### Study Description The goal of this observational study is to learn about The purpose of this study was to compare the psychological differences between couples after IVF transplant failure and IVF pregnancy loss, including the differences in anxiety, depression, stress and post-traumatic stress between women and their spouses. The main question it aims to answer is:What are the psychological effects of IVF implantation failure and IVF pregnancy loss on women and the psychological differences between couples? Participants already taking IVF as part of their regular medical care will answer online survey questions about their joint pain for 1 years. ### Conditions - Fertilization in Vitro - Pregnancy Loss - Psychological Stress - Post-traumatic Stress ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - As the number of failed IVF implants increases, does it increase the difference in anxiety and depression between couples? - As the number of failed IVF implants increases, does it increase the difference in fertility stress between couples? - Does pregnancy loss after IVF transplantation have a differential effect on anxiety and depression between couples? - Does pregnancy loss after IVF transplantation have a differential effect on post-traumatic stress responses between couples? Secondary Outcomes ### Location - Facility: the first hospital of Jilin University, Chang chun, Jilin, 130000, China @@
## Obeservational Cohort for Evaluating Future Cardiovascular Disease With High Metabolic Risks - NCT ID: NCT06385431 - Study ID: Charm - Status: NOT_YET_RECRUITING - Start Date: 2024-04-28 - Completion Date: 2026-04-30 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description Cardiovascular and metabolic diseases refer to a large category of cardiovascular diseases accompanied by a series of metabolic disorders (including dyslipidemia, obesity, abnormal glucose tolerance, diabetes, hypertension, thyroid dysfunction, etc.), which is the primary cause of death and disease burden of Chinese residents.The number of deaths from atherosclerotic cardiovascular disease (ASCVD) in China is about 2.4 million, accounting for 61% of the total cardiovascular deaths, accounting for more than 40% of the all-cause deaths. In Chinese patients with coronary heart disease, 52.9% are complicated with diabetes.Despite the 1.1 million coronary stents implanted in China, there has been no reduction in cardiovascular mortality, which highlights the importance of threshold advancement and the management of metabolic risk factors.In recent years, the new concept of cardiovascular and metabolic diseases has been actively promoted at home and abroad, and the focus of prevention and treatment strategy of cardiovascular and metabolic diseases has been called for.The project proposed the concept of co-treatment of metabolic diseases based on disorders of blood pressure regulation, disorders of glucose metabolism and disorders of lipid metabolism. Subjects eligible for cardiovascular and metabolic diseases were screened, their past medical records were registered, education and diagnosis and treatment management were conducted. ### Conditions - Metabolic Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - observational study ### Outcomes Primary Outcomes - incidence rate of cardiovascular and metabolic diseases - treatment rate of cardiovascular and metabolic diseases - control rate of cardiovascular and metabolic diseases. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Fluorouracil Treatment Via Colon for Colorectal Cancer - NCT ID: NCT06385418 - Study ID: WST-CRC-202404 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2029-05-01 - Lead Sponsor: The Second Hospital of Nanjing Medical University ### Study Description Fluorouracil (5-FU) is a commonly used drug for colorectal cancer (CRC). Thermosensitive hydrogel presents a promising carrier for 5-FU to address challenges encountered with traditional administration methods. We propose an integrated approach utilizing colonic transendoscopic enteral tubing to cover the entire colon flexibly, coupled with a thermo-sensitive gel to enhance the adhesion of 5-FU. This clinical trial aims to assess the feasibility, safety, and efficacy of this approach for treating CRC. ### Conditions - Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Colonic local administration of fluorouracil with enhanced adhesion ### Outcomes Primary Outcomes - Objective response rate (according to RECIST1.1, investigator assessment) Secondary Outcomes - Progression-free survival - Overall survival - Disease control rate (according to RECIST1.1, investigator assessment) - Drop period to ensure operation resection - Converted resection rate - Actual R0 resection rate - The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 ### Location - Facility: The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210011, China @@
## Electroencephalography-based Precise Repetitive Transcranial Magnetic Stimulation Treatment - NCT ID: NCT06385405 - Study ID: 2024y0423 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: Shanghai Mental Health Center ### Study Description This study will focus on the hypothesis that repetitive transcranial magnetic stimulation (TMS) based on EEG personalized modulation may be more effective in promoting symptomatic relief of major depressive disorder (MDD), and will rely on the platform of neuroimaging and function brain imaging of Shanghai Mental Health Center (SMHC), an authoritative institution in the field of mental health. We will eventually facilitate optimization of physical therapy for major depressive disorder (MDD). ### Conditions - Major Depressive Disorder (MDD) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Individualized alpha frequency Transcranial Magnetic Stimulation (αTMS) Treatment - 10Hz-frequency TMS treatment over the left dorsolateral prefrontal cortex (DLPFC) ### Outcomes Primary Outcomes - the effective rate Secondary Outcomes - complete remission rate - alpha band spectral connectivity in electroencephalogram (EEG) parameters - Evaluation of therapeutic effect ### Location - Facility: Shanghai Mental Health Center, Shanghai, Shanghai, 200030, China @@
## Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. - NCT ID: NCT06385392 - Study ID: A23-354 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: HealthPartners Institute ### Study Description The proposed system (haptic module and insole device) for daily in-community use that detects the occurrence of freezing of gait (FOG) in people with Parkinson's disease (PD). and triggers external cueing stimuli to unfreeze the individual. The purpose of the overall Phase II study is to: (1) Develop a production ready system, (2) Develop a companion mobile app for the proposed system and refine previously developed FOG detection algorithms, and (3) Validate the proper operation of the system and demonstrate its efficacy through lab and in-community testing. This study will focus on validating the system and demonstrating efficacy through in-community testing. ### Conditions - Parkinson Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Haptic module and insole device ### Outcomes Primary Outcomes - To validate the haptic module and insole device system and evaluate its efficacy with an in-community clinical trial. Secondary Outcomes ### Location - Facility: Struthers Parkinson's Center, Golden Valley, Minnesota, 55427, United States @@
## Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study) - NCT ID: NCT06385379 - Study ID: WQ21-2301 - Status: RECRUITING - Start Date: 2024-04-30 - Completion Date: 2030-12-31 - Lead Sponsor: Hangzhou Endonom Medtech Co., Ltd. ### Study Description A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/pseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study) ### Conditions - Aortic Arch Aneurysm ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system ### Outcomes Primary Outcomes - Rate of all-cause mortality and major stroke within 12 months after surgery Secondary Outcomes - Rate of immediate technical success following surgery - Rate of aortic aneurysm progression under control - Incidence of Type I or Type III endoleak - Incidence of aortic covered stent graft displacement - Postoperative branch vessel patency rate - Rate of conversion to thoracotomy or secondary intervention - Rate of major adverse events - Rate of aortic aneurysm-related mortality - Incidence of severe adverse events - Incidence of device-related adverse events ### Location - Facility: Beijing Anzhen Hospital, Capital Medical University, Beijing, N/A, N/A, China @@
## Developing & Evaluating Models for Early Predicting Obstetrical Diseases in Pregnant Women by Non-invasive Prenatal Test - NCT ID: NCT06385366 - Study ID: GS_NP1 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-06-06 - Lead Sponsor: Gene Solutions ### Study Description This is Observational study, aiming to investigate the potentiality of cffDNA and cfRNA by a non-invasive test, in combination with clinical characteristics, to establish models for early screening and predicting high-risk pregnancy of PE, SPB, and GDM in Vietnam. ### Conditions - Pregnant With Complication - Preeclampsia - Preterm Birth - Gestational Diabetes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Characteristics of pregnant women at 1st trimester (9-13 weeks 6 days of gestation) - Characteristics of pregnant women at recruitment - Define the significant differences between cases and controls - The development of learning machine models - Evaluation of the developed models Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## DVT Burden and the Risk of Post-thrombotic Syndrome - NCT ID: NCT06385353 - Study ID: 2022-CHITS-003 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-06 - Lead Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer ### Study Description Post-thrombotic syndrome (PTS) is the most common chronic complication of deep vein thrombosis (DVT), with major consequences for patient quality of life and cost of management. Identifying patients at high risk of developing PTS could be useful for its prevention and may lead to more appropriate therapeutic strategies to reduce its incidence and severity.Prognostic tools for predicting risk are very useful for choosing the optimum treatment and improving patient management and are a preliminary step before developing predictive models useful for determining sensitivity to treatment. At present, although several prognostic markers and models have been proposed, it is still difficult to predict who will develop a PTS or a moderate to severe PTS. The development of PTS is multifactorial and depends largely on the extent and severity of venous obstruction which supports the theory of thrombosis burden (DVT-Burden) as a potential prognostic marker for PTS. It therefore seems important to study the association between thrombosis burden and the occurrence of PTS.The Venous Volumetric Index or VVI (Ouriel 1999) will be used for quantifying DVT-Burden. The VVI was constructed by calculating the volume from the diameter and length of 14 venous segments from the calf veins to the inferior vena cava. The VVI has been validated for its ability to discriminate between symptomatic and asymptomatic DVT and has shown superior performance to other methods for quantifying DVT.This study aim to assess the performance of baseline DVT-burden estimated by the VVI score on ultrasound for predicting the occurrence and the severity of PTS as assessed by the Villalta scale at 6 months. ### Conditions - Postthrombotic Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome ### Outcomes Primary Outcomes - Presence of moderate to severe Post-thrombotic Syndrome (PTS) - Thrombosis burden Secondary Outcomes - Presence of moderate to severe PTS adjusted to other prognostic factors at baseline - Thrombosis burden adjusted to other prognostic factors at baseline - Presence of moderate to severe PTS adjusted to other prognostic factors at baseline and during follow-up - Thrombosis burden adjusted to other prognostic factors at baseline and during follow-up - Time to complete resolution of the thrombus as a function of thrombosis burden at baseline - Presence of moderate to severe PTS at baseline and at follow-up visits - Thrombosis burden at baseline and at follow-up visits ### Location - Facility: Centre Hospitalier de Carcassonne, Carcassonne, Aude, 11010, France @@
## Investigation of the Effect of Lipikar Baume AP+M - NCT ID: NCT06385340 - Study ID: CentroDerm_LRP22003 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-23 - Completion Date: 2024-10-31 - Lead Sponsor: CentroDerm GmbH ### Study Description Application of Lipikar Baume AP+M at least twice daily for 4 weeks on one of the two arms according to a randomization scheme The purpose of this study is to observe the skin barrier function, transepidermal water loss and microbial changes in study participants with actinic field damage of both arms.It's a randomized, evaluator blinded, intra-individual controlled study conducted in one center in Germany, in adult subjects having AK (grade I to III) lesions on the forearms and back of hands and meeting specific inclusion/exclusion criteria.A total of 20 subjects will be enrolled.The study design consists in 4-week evaluation period, with 2 visits per subject: Screening/Baseline (Day 0, Day 28 (end of Lipikar Baume AP+M application)). ### Conditions - Actinic Keratoses ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Lipikar Baume AP+M ### Outcomes Primary Outcomes - Skin hydration measured by Corneometrie - Transepidermal water loss measured by Tewameter® - Aktinic keratosis area and severity index (AKASI) - S. aureus colonization and S. epidermidis colonization (application area) - Subjects's skin aspect Secondary Outcomes - Absolute lesion count by application site - Olsen Grade evaluation: percentage of lesion with improvement at least 1 grade at D28 by application site - Number of new lesions on application area over the study period by application site - Symptom severity score: percentage across individual scores at each visit by application site - modified Treatment Satisfaction Questionnaire for Medication-9 (mTSQM-9) - Compliance (percentage of subjects using topical agents at all intended days, 90% of days or 75% of days) - Pictures at all time points ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participants Seropositive for HSV-2 With Recurrent Genital Herpes - NCT ID: NCT06385327 - Study ID: ABI-5366-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-07 - Lead Sponsor: Assembly Biosciences ### Study Description This study is designed to assess safety, tolerability, and pharmacokinetics (PK) of single ascending dose (SAD) of ABI-5366 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-5366 in Part B in participants seropositive for Herpes Simplex Virus Type 2 (HSV-2) with recurrent genital herpes. Effect of food will also be evaluated in Part A. ### Conditions - Recurrent Genital Herpes Simplex Type 2 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ABI-5366 - ABI-5366 Placebo ### Outcomes Primary Outcomes - Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results - Area Under the Plasma Concentration Time Curve (AUC) of ABI-5366 - Maximum Observed Plasma Concentration (Cmax) of ABI-5366 - Time to Cmax (Tmax) of ABI-5366 - Apparent Terminal Elimination Half Life (t 1/2) of ABI-5366 - Apparent Systemic Clearance (CL/F) of ABI-5366 - Apparent Volume of Distribution (Vz/F) of ABI-5366 - Dose normalized AUCs and Cmax of ABI-5366 Secondary Outcomes - SAD Cohorts: Comparison of plasma AUC and Cmax between fasted and fed treatments - MAD Cohorts: If applicable, comparison of plasma PK profiles and parameters with and without loading doses - MAD Cohorts: Difference in viral shedding rate (number of anogenital swabs positive for HSV-2 DNA/total number of swabs) across treatments - MAD Cohorts: Difference in mean and median HSV-2 DNA copies/mL for swab samples positive for HSV-2 DNA across treatments - MAD Cohorts: Difference in the proportion of swab samples with HSV-2 DNA >4 log10 copies/mL across treatments (number of swabbing samples with HSV-2 DNA >4 log10 copies/mL / total number of swabs obtained) - MAD Cohorts: Difference in number of shedding episodes during the swabbing period across treatments - MAD Cohorts: Difference in duration of shedding episodes during the swabbing period across treatments - MAD Cohorts: Difference in subclinical shedding rate (number of swabs positive for HSV-2 DNA in the absence of lesions/total number of swabs in the absence of lesions) across treatments - MAD Cohorts: Difference in lesion rate during the swabbing period across treatments - MAD Cohorts: Difference in lesion duration during the swabbing period across treatments - MAD Cohorts: Difference in recurrence rate (number of reappearances of lesions during the swabbing period/total days assessed) across treatments ### Location - Facility: New Zealand Clinical Research, Auckland, N/A, N/A, New Zealand @@
## A Cross Sectional Study on Dental Anxiety and State Anxiety Related to Removal of Fixed Partial Dentures - NCT ID: NCT06385314 - Study ID: Degirmenci1499 - Status: COMPLETED - Start Date: 2022-09-05 - Completion Date: 2023-12-29 - Lead Sponsor: Abant Izzet Baysal University ### Study Description This study aims to evaluate the effect of the clinical removal of fixed partial dentures (FPDs) on oral health-related quality of life (OHRQoL) and the anxiety values of individuals and to determine the risk factors of high anxiety levels. 300 participants were included in this study. Six different reasons for the clinical removal of FPDs (oral examination, denture renewal, root canal treatment, tooth extraction, periodontal treatment, and composite filling restoration) were defined. Questions pertaining to the United Kingdom Oral Health-Related Quality-of-Life Measure (OHQoL-UK), the Modified Dental Anxiety Scale (MDAS), and the Spielberger State-Trait Anxiety Inventory - State (STAI-S) and Trait (STAI-T) were answered. ### Conditions - Dental Anxiety ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Collecting data with oral health related quality of life, dental anxiety and state anxiety ### Outcomes Primary Outcomes - United Kingdom Oral Health-Related Quality-of-Life Measure - Modified Dental Anxiety Scale - Spielberger State Anxiety Inventory - Spielberger Trait Anxiety Inventory Secondary Outcomes ### Location - Facility: Kubra Degirmenci, Bolu, N/A, N/A, Turkey @@
## Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy With Chronic Lung Diseases - NCT ID: NCT06385301 - Study ID: Lung_disease_6MWD_SOT - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-11 - Lead Sponsor: University of Zurich ### Study Description The investigators aim to study the effect of SOT in subjects with chronic lung disease in submaximal exercise. ### Conditions - Lung Disease Chronic - Lung Diseases, Interstitial - Lung Diseases, Obstructive ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - 6-minute walk distance (6MWD) test on ambient air - 6-minute walk distance test with supplemental oxygen (approximately 3l/min, nasal) ### Outcomes Primary Outcomes - 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air Secondary Outcomes - SpO2 at rest and peak 6MWD with SOT vs. ambient air - Heart rate at rest and peak 6MWD with SOT vs. ambient air - Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air - Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air - Blood pressure at rest and peak 6MWD with SOT vs. ambient air ### Location - Facility: University Hospital Zürich, Zurich, N/A, 8091, Switzerland @@
## Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcomas - NCT ID: NCT06385288 - Study ID: 268/2021BO2 - Status: RECRUITING - Start Date: 2021-07-21 - Completion Date: 2031-07-21 - Lead Sponsor: University Hospital Tuebingen ### Study Description "Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcoma" is a prospective study with additional translational research using preoperative and postoperative tissue, blood sampling and advanced imaging. ### Conditions - Soft Tissue Sarcoma Adult ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Blood and tissue collection for immunological studies, advanced imaging. - neoadjuvant Therapy ### Outcomes Primary Outcomes - Description of the cellular immune status via flow-cytometrie from collected blood samples - Description of the cellular immune status on tissue samples ussing komplex immunohistochemie - Measurement of the cellular free DNA from collected blood samples - Measurement of HMGB1 from collected blood samples - Evaluation of morphological tumor characteristics (size, diffusion) with weekly MRIs Secondary Outcomes ### Location - Facility: University Hospital Tuebingen, Tübingen, Baden-Württemberg, 72076, Germany @@
## The Role of Vitamin K on Knee Osteoarthritis Outcomes - NCT ID: NCT06385275 - Study ID: H-44897 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2026-12 - Lead Sponsor: Boston University ### Study Description The appropriate form and dosing of vitamin K to benefit relevant outcomes in knee osteoarthritis (OA) are not known. In intervention studies for conditions other than knee OA (e.g., prevention of cardiovascular disease), the most commonly used forms and doses include phylloquinone (vitamin K1; 1000µg or 500µg daily) or menaquinone-7 (MK-7 or vitamin K2; 360µg daily). However, whether these doses are adequate to increase vitamin K to levels that ameliorate risk of adverse OA outcomes is not known. Furthermore, although some studies suggest enhanced bioavailability of MK-7 over vitamin K1, as well as extra-hepatic effects, whether this is relevant for an older population with knee OA is not known,The overall goal of this pilot randomized clinical trial (RCT) is to test different subtypes and doses of vitamin K supplementation in older adults with knee OA and to measure changes in relevant biochemical measures. ### Conditions - Osteo Arthritis Knee ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vitamin K1 500 µg - K1 1000 µg - Vitamin K2 (MK-7) 360 µg - Placebo ### Outcomes Primary Outcomes - Change in uncarboxylated matrix Gla protein (ucMGP) levels - Change in phylloquinone levels - Sufficient phylloquinone levels - Change in menaquinone-7 (MK-7) levels Secondary Outcomes - Study adherence - Participant acceptability of intervention ### Location - Facility: Boston Medical Center, Rheumatology Clinic, Boston, Massachusetts, 02118, United States @@
## TOP 2301: Neoadjuvant Chemo for NSCLC - NCT ID: NCT06385262 - Study ID: Pro00114645 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2028-06-30 - Lead Sponsor: Duke University ### Study Description In this open-label, two-arm, randomized phase 2 clinical trial, patients with clinical stage 1B-3A non-small cell lung cancer (NSCLC) will receive neoadjuvant chemotherapy and cemiplimab every 3 weeks for 3 cycles with or without alirocumab every 4 weeks prior to surgery.Eligible patients will be randomized with equal allocation to two treatment groups. Permuted block randomization algorithm will be used for treatment assignment with stratification factors: stage (1B, 2A, 2B, 3A), and performance status (0 vs. 1).The study hypothesis is that the addition of alirocumab to neoadjuvant chemoimmunotherapy will make tumor cells more immunogenic to cytotoxic T cells, resulting in an increase in complete pathologic responses in surgically resected tumor. ### Conditions - Non Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Alirocumab - Cemiplimab - Chemotherapy ### Outcomes Primary Outcomes - Compare pathologic complete response (pCR) rate for neoadjuvant chemotherapy plus cemiplimab versus chemotherapy, cemiplimab, and alirocumab. Secondary Outcomes - Assess the preliminary efficacy of chemotherapy and cemiplimab with alirocumab as determined by objective response rate (ORR) - Assess the preliminary efficacy of chemotherapy and cemiplimab with alirocumab as determined by disease-free survival (DFS) - Assess the preliminary efficacy of chemotherapy and cemiplimab with alirocumab as determined by overall survival (OS) - Determine the safety of neoadjuvant chemotherapy and cemiplimab with alirocumab in early-stage non-small cell lung cancer (NSCLC) - Determine the tolerability of neoadjuvant chemotherapy and cemiplimab with alirocumab in early-stage non-small cell lung cancer (NSCLC) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## An Evaluation of Navina Mini, a New Trans-anal Irrigation (TAI) Device in Children and Adolescents - NCT ID: NCT06385249 - Study ID: NAV-0012 - Status: RECRUITING - Start Date: 2024-04-03 - Completion Date: 2024-12 - Lead Sponsor: Wellspect HealthCare ### Study Description The study is designed to deliver further information on clinical benefit, patients' satisfaction, and perception of handling and to confirm safety of Navina Mini when used in children and adolescents. ### Conditions - Bowel Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Navina Mini ### Outcomes Primary Outcomes - Overall patient satisfaction Secondary Outcomes - Incomplete bowel emptying - Episodes of fecal incontinence - Level of independence - Perception of handling of the device - Safety outcome ### Location - Facility: H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset, Linköping, N/A, N/A, Sweden @@
## Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping - NCT ID: NCT06385236 - Study ID: 804913 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2028-01-31 - Lead Sponsor: University of California, San Diego ### Study Description In this study, a new method will be used to evaluate response to 2 approved biologic therapies, and assess how well each patient responds to each asthma treatment. This study will measure the response to these treatments using genomic and biologic measurements obtained from participants biosamples.By evaluating response to 2 different biologic therapies, this study has the potential to provide an in-depth understanding of the mechanisms underlying severe asthma that will inform and change treatment decisions, and may ultimately lead to a change in the way that asthma patients are evaluated for potential personalized therapies and maximize the probability that the subject will respond to treatment. ### Conditions - Moderate to Severe Asthma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Dupilumab - Benralizumab ### Outcomes Primary Outcomes - Predicting asthma outcomes and therapeutic responses - Responses to the biologic therapies at the single cell level - Unique asthma subgroups clinical and molecular endotype approaches Secondary Outcomes - Asthma Control Questionnaire (ACQ) - CompEx events - Asthma Quality of Life Questionnaire (AQLQ) - Forced expiratory volume in 1 second (FEV1) ### Location - Facility: Mayo Clinic, Scottsdale, Arizona, 85259, United States @@
## A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression - NCT ID: NCT06385223 - Study ID: DSRB 2023/00680 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-12-31 - Lead Sponsor: Institute of Mental Health, Singapore ### Study Description The Investigators propose to carry out a randomized, double-blind trial to compare the clinical efficacy of an individualized connectome-guided accelerated iTBS vs an anatomically-guided (Beam F3) accelerated iTBS. The study team will recruit both inpatients and outpatients who had been referred for TMS for the treatment of depression. ### Conditions - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Beam F3 targeted accelerated iTBS - Individualized connectome-guided accelerated iTBS ### Outcomes Primary Outcomes - Montgomery-Åsberg Depression Rating Scale Secondary Outcomes - Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) - Montreal Cognitive Assessment (MoCA) - EQ-5D (EuroQol) - Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Barriers to Routine Surgical Video Recording - NCT ID: NCT06385210 - Study ID: 22SM7855 - Status: COMPLETED - Start Date: 2024-04-01 - Completion Date: 2024-04-24 - Lead Sponsor: Imperial College London ### Study Description In order to improve the implementation of routine surgical video recording, the researchers want to understand what the challenges associated with the uptake of this technology are. The aim of this study is to explore the barriers faced by key stakeholders including the surgical care team, information governance, and patients within the field of surgical video reporting. The data from this qualitative study will allow the researchers to understand better the challenges associated with uptake of surgical video recording. This will allow the researchers to develop strategies to overcome these challenges and subsequently improve uptake of surgical video recording which will promote safer and more transparent surgery. ### Conditions - Minimally Invasive Surgery - Laparoscopic Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Semi structured interviews ### Outcomes Primary Outcomes - Stakeholder perceived barriers to surgical video recording Secondary Outcomes ### Location - Facility: Department of Surgery and Cancer, London, N/A, W2 1NY, United Kingdom @@
## Improving the Effect of Multiple Sclerosis Drugs by Chronobiology - NCT ID: NCT06385197 - Study ID: 170886-HMO-CTIL - Status: COMPLETED - Start Date: 2022-05-08 - Completion Date: 2023-06-02 - Lead Sponsor: Hadassah Medical Organization ### Study Description A trial for evaluating the ability to improve the effect of dimethyl fumarate in patients with Multiple Sclerosis (MS) by chronobiology A controlled-randomization dosing regimen administered to patients with MS and provided by a designated app. The treatment limitations of time interval is pre-defined according to approved therapeutic windows. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - App randomizing dosing regimen ### Outcomes Primary Outcomes - safety assessment Secondary Outcomes ### Location - Facility: Hadassah Medical Center, Jerusalem, N/A, N/A, Israel @@
## Social & QoL Behaviors in Parkinson's Disease - NCT ID: NCT06385184 - Study ID: NCR234859 - Status: RECRUITING - Start Date: 2024-03-08 - Completion Date: 2025-12-31 - Lead Sponsor: Gregory Wallace ### Study Description Adults with Parkinson's Disease experience an array of challenges and changes in daily living, behaviors, and functioning throughout the progression of their condition. The investigators want to learn more about the effects of Parkinson's Disease on individuals' social behavior and quality of life (QoL) compared to people of the same age without Parkinson's Disease. ### Conditions - Parkinson Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No Intervention ### Outcomes Primary Outcomes - Subjective Quality of Life - Social Behavior - Activities of Daily Living - Mental Health - Cognition Secondary Outcomes ### Location - Facility: The George Washington University, Washington, District of Columbia, 20052, United States @@
## Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation - NCT ID: NCT06385171 - Study ID: FFA-BTX-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2027-01-05 - Lead Sponsor: Global Aesthetics LLC ### Study Description A study conducting to see how well a treatment called Botulinum Toxin Type A works for reducing facial wrinkles. The study will help us understand if this treatment is safe and effective for making wrinkles on the face less noticeable. ### Conditions - Wrinkle ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Botulinum toxin type A ### Outcomes Primary Outcomes - Change in facial wrinkles and Lines - Facial Appearance - Assessment of Wrinkle Severity Secondary Outcomes - Assessment of Skin Reaction ### Location - Facility: Global Aesthetics LLC, Cisco, Texas, 76437, United States @@
## A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Dose Escalation of GS1-144 Tablets and the Effects of Food on the Pharmacokinetics of GS1-144 in a Chinese Population - NCT ID: NCT06385158 - Study ID: GenSci074-101 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2024-08 - Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. ### Study Description A Phase I clinical study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral dose escalation of GS1-144 tablets and the effects of food on the pharmacokinetics of GS1-144 in a Chinese population ### Conditions - Vasomotor System; Labile - Healthy Volunteer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - GS1-144 tablet ### Outcomes Primary Outcomes - Part 1:Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) - Part 2: Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). - Part 3: Number of Participants With TEAEs and SAEs Secondary Outcomes - Part1,Part2 and Part3 AUC0-t- Area Under the Drug Concentration-time Curve From Time 0 to the Last Sample Collection Time t for GS1-144 - Part 1 , Part2 and Part 3: AUC0-infinity- Area Under the Drug Concentration-time Curve From 0 to Infinity for GS1-144 - Part 1, Part2 and Part 3: Cmax- Maximum Observed Plasma Concentration for GS1-144 - Part 1 Part2 and Part 3: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for GS1-144 - Part 1 Part2 and Part 3:: T1/2- Terminal Half-life for GS1-144 - Part 1 Part2 and Part 3: CL/F- Apparent Clearance for GS1-144 - Part 1 Part2 and Part 3: Vd/F- Apparent Volume of Distribution for GS1-144 - Cmax,ss- Observed Maximum Concentration at Steady State for GS1-144 - Part 3: Cmin,ss- Observed Minimum Concentration at Steady State for GS1-144 - Part 3: Tmax,ss- Time of Cmax at Steady State for GS1-144 - Part 3: Cavg,ss- Average Concentration at Steady State for GS1-144 - Part 3: AUC0-τ- Area Under the Drug Concentration-time Curve During the Dosing Interval at Steady State for GS1-144 - Part 3: CLss/F- CL for Bioavailability at Steady State for GS1-144 - Part 3: T1/2,ss- Terminal Half-life at Steady State for GS1-144 - Part 3: Accumulation Ratio for GS1-144 - Part 1: Baseline and placebo-adjusted changes in ∆∆QTc and other ECG parameters after oral administration of GF1-144 in healthy subjects ### Location - Facility: Huashan Hospital, Fudan University, Shanghai, Shanghai, 200040, China @@
## A Bioavailability Study of Two Different PEG-rhGH Preparations. - NCT ID: NCT06385145 - Study ID: GenSci004-107 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-08 - Completion Date: 2024-12-26 - Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. ### Study Description The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations. ### Conditions - Pediatric Growth Hormone Deficiency (PGHD) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - PEG-rhGH with new preparation (T) - PEG-rhGH with present preparation (R) ### Outcomes Primary Outcomes - Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation - Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-inf)) of PEG-rhGH with present and new preparation - Pharmacokinetics (Area under the concentration-time curve from time zero to the time of the last quantifiable (AUC0-last)) of PEG-rhGH with present and new preparation - Safety and tolerability (Number of participants with treatment-related adverse events) Secondary Outcomes - Peak Plasma Concentration (Cmax) of Insulin-like growth factor-1 (IGF-1) with present and new preparation - Area under the concentration-time curve from time zero to time infinity (AUC0-inf) of Insulin-like growth factor-1 (IGF-1) with present and new preparation - Anti-drug antibody (Number of Participants with positive ADA) ### Location - Facility: Chengdu Xinhua Hospital, Chengdu, Sichuan, 610000, China @@
## Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer - NCT ID: NCT06385132 - Study ID: 6447 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-10-31 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Approximately 30% of cancer patients may experience psychopathological disorders. The most common psychopathological disorders in cancer patients are mood disorders, anxiety, depression, adjustment disorders, and suicidal ideation. Among depressive disorders, mixed depression, with the simultaneous presence of symptoms of both depressive and manic polarity, is associated to higher levels of chronicity, functional impairment and suicidality. These disorders can also be worsened by loneliness and demoralization.Patients with head and neck cancer (H\&N-C) and Glioblastoma multiforme (GBM) have high psychological and sometimes psychiatric comorbidity probably due to the severity, poor prognosis of these cancers and harsh treatment toxicities.The most important protective factor for psychopathology is psychological resilience, which is "the capacity of a person to protect themselves and their mental health when facing life adversities," such as a GBM or H\&N-C diagnosis. Resilience is influenced by the affective temperament, which refers to basic personality traits related to behavioral and emotional reactivity to environmental stimuli. It is believed to be biologically determined and relatively stable throughout life.To date, the literature does not clarify the role of resilience and temperament in mediating the psychological profile of cancer patients. Furthermore, extensive profiling of the psychological and psychiatric profile of these patients at such a critical and pivotal moment in their journey is currently lacking in the literature.Aim of this study is to evaluate global psychological and psychiatric profile of patients affected by GBM and H\&N-C and the eventual fluctuation over time during RT course. Conducting an early and accurate screening for potential psychopathological issues will give the opportunity to avoid factors that could: worsen patient compliance, lead to suicidal risk, and increase hospitalizations.The results obtained will be utilized for planning precocious psychological or psychiatric take-in-charge aimed at promoting psychological well-being of H\&N-C and GBM patients. ### Conditions - Glioblastoma - Head and Neck Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Psychological Tests' administration ### Outcomes Primary Outcomes - Distress Thermometer Secondary Outcomes - Brief Psychiatric Rating Scale ### Location - Facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, N/A, 00168, Italy @@
## A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Volunteers. - NCT ID: NCT06385119 - Study ID: F8394-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-24 - Completion Date: 2024-11-25 - Lead Sponsor: Fore Biotherapeutics ### Study Description The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixerafenib in healthy volunteers. Healthy male and female participants between the ages of 18 and 55 will be enrolled into this study. This study is looking to examine:* The effect of food on the single dose PK of plixorafenib administered with cobicistat.* The effect of cobicistat administration on the single dose PK of plixorafenib.* The safety of plixorafenib administered alone and with cobicistat in a single dose regimen in healthy participants. ### Conditions - Healthy Volunteer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Plixorafenib - Cobicistat ### Outcomes Primary Outcomes - Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t). - AUC from time 0 extrapolated to infinity (AUC0-inf). - Maximum observed plasma concentration (Cmax). - Time to maximum observed plasma concentration (Tmax). - Terminal elimination rate constant (Kel). - Terminal phase half-life (t1/2). - Apparent oral clearance (CL/F). - Apparent volume of distribution (Vd/F). - Terminal rate constant calculated from the terminal slope of the log-linear regression of concentration with time (z). Secondary Outcomes - Cumulative amount of plixorafenib excreted in urine, calculated as the sum of the product of urine concentration and urine volume (Ae). - Percent of dose excreted in urine in 48 hours calculated as 100Ae/Dose. ### Location - Facility*: PPD - Austin Research Unit, Austin, Texas, 78744, United States @@
## Effects of Repetitive Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease - NCT ID: NCT06385106 - Study ID: rTMS in AD - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-01 - Lead Sponsor: First Affiliated Hospital of Zhejiang University ### Study Description Previous studies have shown that repetitive transcranial magnetic stimulation (rTMS) can improve cognitive function in Alzheimer's disease (AD), but studies on the improvement of sleep disorders in AD are limited. The aim of this study was to evaluate the effects of rTMS on sleep and cognition in patients with mild-to-moderate Alzheimer's disease (AD). ### Conditions - Alzheimer Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Real repetitive transcranial magnetic stimulation - Sham repetitive transcranial magnetic stimulation ### Outcomes Primary Outcomes - Cognitive funtion - Sleep parameters Secondary Outcomes - glymphatic system ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study on the Prevention and Treatment of GIOP With Eldecalcitol - NCT ID: NCT06385093 - Study ID: EDR-IIS-003 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-03 - Lead Sponsor: Chinese SLE Treatment And Research Group ### Study Description The study will be a multi-center, randomized, open label, parallel trial conducted in rheumatoid arthritis patients treated with glucocorticoids. After signing the informed consent, all patients will be screened as per the inclusion and exclusion criteria. Estimated 314 eligible patients will be enrolled. The enrolled patients will be randomly assigned to either Eldecalcitol group or Alfacalcidol group in a 1:1 ratio and followed up for 12 months. On-site follow up visits will be conducted at Month 6 and 12 after enrollment. The study is designed to evaluate the efficacy and safety of Eldecalcitol in preventing glucocorticoid-induced bone loss in rheumatoid arthritis patients. ### Conditions - Rheumatoid Arthritis - Osteoporosis - Osteopenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Eldecalcitol capsules - Alfacalcidol tablets - Calcium carbonate tablets ### Outcomes Primary Outcomes - Percent change from baseline to month 12 in lumbar spine (L1-4) bone mineral density (BMD) Secondary Outcomes - Percent change from baseline to month 6 in lumbar spine (L1-4) BMD - Percent change from baseline in total hip BMD - Percent change from baseline in femoral neck BMD - Percent change from baseline to month 12 in broadband ultrasound attenuation (BUA) and speed of sound (SOS) measured by quantitative ultrasound (QUS) - Percent change from baseline in Procollagen Type 1 N-telopeptide (P1NP) - Percent change from baseline in Type 1 Collagen C-telopeptide (CTX) - Percentage of patients diagnosed with osteoporosis at month 12 - Incidence of new vertebral fracture - Change from baseline in Quality of Life assessed using EQ-5D-5L - Change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) - Change from baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score - Percent change from baseline to month 12 in volumetric bone mineral density (vBMD) measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT) - Percent change from baseline to month 12 in bone microarchitecture measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT) - Percent change from baseline to month 12 in bone geometry measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT) ### Location - Facility: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China @@
## A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/Metastatic Head and Neck Cancer - NCT ID: NCT06385080 - Study ID: 61186372HNC2002 - Status: RECRUITING - Start Date: 2024-04-22 - Completion Date: 2026-07-17 - Lead Sponsor: Janssen Research & Development, LLC ### Study Description The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, and amivantamab in addition to paclitaxel in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel. ### Conditions - Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Amivantamab - Pembrolizumab - Paclitaxel ### Outcomes Primary Outcomes - Cohorts 1, 2, and 3B: Objective Response Rate - Cohort 3A: Number of Participants With Dose-limiting Toxicities (DLT) - Cohort 3A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity Secondary Outcomes - Cohorts 1, 2, and 3B: Duration of Response (DoR) - Cohorts 1, 2, and 3B: Clinical Benefit Rate (CBR) - Cohorts 1, 2, and 3B: Progression-free Survival (PFS) - Cohorts 1, 2, and 3B: Overall Survival (OS) - Cohorts 1, 2, and 3B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity - Cohort 1: Maximum Observed Serum Concentration (Cmax) of Amivantamab - Cohort 1: Time to Maximum Observed Serum Concentration (Tmax) of Amivantamab - Cohort 1: Area Under the Serum Concentration Curve Verses Time Curve From Time t1 to t2 (AUC[t1-t2]) of Amivantamab - Cohort 1: Area Under the Curve From Time Zero to tau (AUC[0-tau]) of Amivantamab - Cohort 1: Trough Serum Concentration (Ctrough) of Amivantamab - Cohort 1: Accumulation Ratio (R) of Amivantamab ### Location - Facility: Cleveland Clinic, Cleveland, Ohio, 44195, United States @@
## Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter - NCT ID: NCT06385067 - Study ID: JW-PM-DCB-2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-10 - Completion Date: 2026-12-30 - Lead Sponsor: JW Medical Systems Ltd ### Study Description The purpose of the study was to further evaluate the long-term safety and efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter in the real world.The study population was patients with primary coronary vascular lesions with a blood vessel diameter of 2.0mm-2.75mm. ### Conditions - Coronary Artery Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Biolimus Coated Coronary Artery Balloon Dilation Catheter ### Outcomes Primary Outcomes - Target lesion failure rate (TLF) Secondary Outcomes - Interventional success rate - Device-related cardiovascular clinical composite endpoint - Patient-related cardiovascular clinical composite endpoint - Major adverse cardiac events (MACEs) - Incidence of thrombotic events as defined by ARC ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Probiotics on Infantile Colic Symptoms - NCT ID: NCT06385054 - Study ID: L-027 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-02 - Lead Sponsor: Lallemand Health Solutions ### Study Description The aim of this clinical trial is to assess the impact of a probiotic formulation on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying duration compared to participants receiving the placebo, after 4 weeks of intervention. ### Conditions - Infantile Colic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Probiotic - Placebo ### Outcomes Primary Outcomes - Change in daily crying duration Secondary Outcomes - Change in crying patterns - Change in sleep duration - Change in maternal quality of life - Change in bowel habits - Change in gut microbiota composition - Probiotic strain recovery ### Location - Facility: Centre Hospitalier de Boulogne-sur-Mer, Boulogne-sur-Mer, N/A, 62200, France @@
## Cardiac Rehabilitation and Frailty Physical Training Program in Elderly Patients After Open Heart Surgery - NCT ID: NCT06385041 - Study ID: BE-2-83 - Status: RECRUITING - Start Date: 2021-05-12 - Completion Date: 2025-09-01 - Lead Sponsor: Vitalija Stonkuvienė ### Study Description The aim of the research - to evaluate the impact of interactive physical therapy tools for functional capacity, fear of falls, motivation and quality of life after open heart surgery due to ischemic heart disease and frailty in the second stage of rehabilitation. ### Conditions - Frailty Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intervention group 1 - Intervention group 2 ### Outcomes Primary Outcomes - Collecting data from the medical history - Frailty level by Edmonton frail scale score - Fear of Falling by Falls Efficacy Scale International; FES-I). - Quality of life by EuroQoL FiveDimensionsEQ-5D-5L. - Motivation by Multidimensional Health Locus of Control scale - Change from baseline functional capacity by six minutes walking test (6MWT) - Change from baseline physical performance by Short Physical Performance Battery (SPPB) - Change from baseline muscular strength by one repetition maximum test (1RM) - Change from baseline grip strength by hydraulic hand dinanometer - Change from baseline balance parameters by Biodex Balance System SD - Change from baseline stance and gait parameters by Zebris Medical GmbH Secondary Outcomes - Change from baseline cardiopulmonary exercise capacity by maximal load (maxWatt) - Change from baseline cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2) ### Location - Facility: LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva, Kaunas, N/A, N/A, Lithuania @@
## Physical Activity Promotion in Osteoarthritis Patients - NCT ID: NCT06385028 - Study ID: 20230213_PIANISSIMO - Status: NOT_YET_RECRUITING - Start Date: 2024-10-01 - Completion Date: 2026-12-31 - Lead Sponsor: Luxembourg Institute of Health ### Study Description The main purpose of this project is to promote physical activity in patients with osteoarthritis. More specifically, this study aims to test the acceptability of an app to promote physical activity in the target population, and consequently the feasibility of such an approach.A mobile phone application - namely PIANISSIMO - will be developed specifically for this project. It aims to spread knowledge on the benefits of physical activity and collect data on how this knowledge can induce behavior changes toward a more physically active lifestyle.The intervention is delivered via the app, which will send daily notifications on physical activity and sedentary behavior, and ask the participants to set their weekly goal (i.e., daily steps). The app will also collect daily steps count and ask the participant to fill in questionnaire on pain once a week. ### Conditions - Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Physical activity promotion ### Outcomes Primary Outcomes - Weekly number of connections to the application over time - Response rate to the weekly questionnaires over time Secondary Outcomes - Evolution of physical activity metrics - influence of pain on physical activity practice - influence of physical activity on pain report ### Location - Facility: Luxembourg Institute of Health, Strassen, N/A, 1445, Luxembourg @@
## T-UP: Engaging Vulnerable Students in Diabetes Prevention - NCT ID: NCT06385015 - Study ID: IRB#23-001257 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-10-04 - Completion Date: 2025-06 - Lead Sponsor: University of California, Los Angeles ### Study Description The goal of this study is to enhance reach and uptake of diabetes prevention among young adults, with a focus on recruiting underserved and high-need students who face additional challenges, including food and financial insecurity.The specific aims are to: 1) Evaluate the efficacy of adolescents and young adults (AYA)-tailored version of the University of California Diabetes Prevention Program (UC DPP) for mitigating type 2 diabetes risk (i.e., weight change) in a pre/post pilot trial. The investigators hypothesize that the AYA-tailored intervention will be effective at producing 5% weight loss from baseline to program completion (at 9-months); and, 2) Assess the feasibility and acceptability of an AYA-tailored version of the UC DPP program. The investigators hypothesize that it will be feasible to recruit the desired number of participants given proposed innovative outreach strategies, and that the AYA-tailored intervention will be deemed acceptable to participants both qualitatively and in regards to their retention in the program at rates similar to the larger UC DPP.The investigators will randomize participants to the AYA-tailored DPP cohort vs control cohort. Control participants will be offered the opportunity to participate in the AYA-tailored DPP in the following academic year. Participants will be organized into groups within their DPP cohort based on their student status and/or place of residence. The intervention will include 19 sessions (18 in-person and 1 on-demand) covering 24 DPP modules; each session is approximately an hour in length and will be moderated by a lifestyle coach. At the end of each session, intervention participants will receive an email/text with a unique link to a brief REDCap survey to ascertain acceptability of the session. Control group will receive access to materials about study habits, alcohol use, and financial literacy. Control group will receive materials via e-mail for participants to review on their own time and will receive acceptability surveys. A research assistant (RA) will meet with control participants via Zoom to explain the materials. Participants will complete baseline and 9-month follow-up assessments. Participants will complete a 30 minute questionnaire via REDCap and height/weight measurements will be collected by a RA. Participants will be asked to self-report weight and physical activity at the end of the fall and winter quarter; data will be collected via brief REDCap survey. ### Conditions - Diabetes Mellitus, Type 2 - PreDiabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Tailored DPP Intervention ### Outcomes Primary Outcomes - Change in weight (pounds, lbs) between baseline and 9-month follow-up - Change in self-reported quality of life (Centers for Disease Control and Prevention Health-Related Quality of Life-14 item (CDC HRQOL-14)) between baseline and 9-month follow-up Secondary Outcomes ### Location - Facility: University of California, Los Angeles, Los Angeles, California, 90095, United States @@
## Effect of Combined Administration of Sevoflurane and Remimazolam on Emergence - NCT ID: NCT06385002 - Study ID: 2024-0158 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2025-05-31 - Lead Sponsor: Pusan National University Yangsan Hospital ### Study Description Enhanced recovery after surgery (ERAS) protocols are being explored to improve patient outcomes. The method of inducing anesthesia and maintenance using inhalation anesthetics is common but may delay recovery. Remimazolam, a benzodiazepine-class drug, is noted for its rapid metabolism and fewer hemodynamic changes. Research suggests combining sevoflurane and propofol for anesthesia in adults enhances recovery, while studies in pediatric patients indicate a reduction in emergence agitation with remimazolam. However, the impact of combining sevoflurane and remimazolam on postoperative recovery in adult patients undergoing gynecologic and laparoscopic surgery is not yet studied. The study aims to compare the time to emergence from anesthesia and tracheal extubation between concurrent sevoflurane and remimazolam administration versus sevoflurane alone. ### Conditions - Gynecological Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Remimazolam ### Outcomes Primary Outcomes - time to emergence - time to tracheal extubation Secondary Outcomes - usage of vasopressors - severity of cough - time to discharge from the recovery room - postoperative pain scores - scores for postoperative nausea and vomiting ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety-Enhancing Motor Vehicle Child Safety Seat - NCT ID: NCT06384989 - Study ID: MinnesotaHealthSolutions_LL - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-08-15 - Lead Sponsor: Minnesota HealthSolutions ### Study Description This study aims to assess the usability of a load leg design for caregivers who must install the child safety seat into a vehicle. The specific aims are to quantify any errors committed by the participants while installing the car seat and to assess participants' opinions on the car seat's load leg design. ### Conditions - Motor Vehicle Injury - Safety Issues ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Child restraint system with load leg feature ### Outcomes Primary Outcomes - Correct use of load leg - Load leg error types Secondary Outcomes - Other installation errors - Opinion on load leg design and instructions ### Location - Facility: The Ohio State University, Columbus, Ohio, 43210, United States @@
## A Study of Anti-CD19 CAR T-Cell Therapy, in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis - NCT ID: NCT06384976 - Study ID: KYV101-007 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2029-01 - Lead Sponsor: Kyverna Therapeutics ### Study Description A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Primary and Secondary Progressive Multiple Sclerosis ### Conditions - Multiple Sclerosis, Primary Progressive - Multiple Sclerosis, Secondary Progressive - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - KYV-101 - Standard lymphodepletion regimen - Anti-CD20 mAB ### Outcomes Primary Outcomes - To evaluate efficacy of KYV-101 Secondary Outcomes - To characterize the safety and tolerability of KYV-101 - To characterize the safety and tolerability of KYV-101 - To characterize the safety and tolerability of KYV-101 - To evaluate efficacy of KYV-101 - To characterize the pharmacokinetics (PK) - To characterize the pharmacokinetics (PK) - To characterize the Pharmacodynamics (PD) - To characterize the Pharmacodynamics (PD) - To evaluate the immunogenicity (humoral response) of KYV-101 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF - NCT ID: NCT06384963 - Study ID: Cer22/02 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-04-01 - Lead Sponsor: Ceryx Medical Australia ### Study Description The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation. The new pacemaker restores respiratory sinus arrhythmia which is a natural pattern where the heart rate increases when the participants breathe in and slows down when participants breathe out.The main questions the trial aims to answer are:* Is the new type of pacemaker safe?* Does the new type of pacemaker improve how patients' hearts work (also known as cardiac output)?Participants will have a range of tests before their operation and during their recovery in hospital while participants have the new type of pacemaker in place, and will be monitored very closely. Participants will also receive a phone call 1 month after their surgery. Researchers will compare the new type of heart pacing against standard treatment to see if it is as safe, and if it is any better for patients. ### Conditions - Heart Failure With Reduced Ejection Fraction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Atrial pacing with respiratory sinus arrhythmia (RSA) variability - Monotonic right atrial overdrive pacing ### Outcomes Primary Outcomes - Number of arrhythmia episodes per patient during pacing Secondary Outcomes ### Location - Facility: Waikato Hospital, Hamilton, N/A, 3240, New Zealand @@
## Evaluating the Role of ChatGPT in Educating Patients With Early-stage Hepatocellular Carcinoma - NCT ID: NCT06384950 - Study ID: 2023-11-005A - Status: RECRUITING - Start Date: 2024-03-22 - Completion Date: 2025-03-21 - Lead Sponsor: Taipei Veterans General Hospital, Taiwan ### Study Description Liver cancer is a leading cause of cancer-related deaths in Taiwan, with its onset linked to factors like chronic liver conditions, cirrhosis, and genetic predispositions. According to the "Barcelona Clinic Liver Cancer (BCLC)" classification, early-stage liver cancer is demarcated by stages 0 to A. Upon such diagnosis, both patients and their families often have numerous questions and concerns, ranging from treatment choices to long-term outcomes. The research proposes a GPT-3.5-based chatbot to assist these patients by providing timely, personalized information, aiming to enrich their understanding of the disease and improve communication between patients and health professionals.The research methodology employs a Randomized Controlled Trial (RCT) design, dividing participants into a control cohort receiving standard patient education routine and an experimental cohort receiving both the AI chatbot and traditional education routine. The comparative analysis of these cohorts will determine the effectiveness of the AI intervention in improving patients' health literacy and satisfaction. ### Conditions - Carcinoma, Hepatocellular ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - ChatGPT - patient education with traditional methods. ### Outcomes Primary Outcomes - Health literacy score of patients - Satisfaction score with medical care Secondary Outcomes - Degree of patient anxiety ### Location - Facility: Taipei Veterans General Hospital, Taipei, Beitou District, 11217, Taiwan @@
## [Trial of device that is not approved or cleared by the U.S. FDA] - NCT ID: NCT06384937 - Study ID: GCA-PRO-2022-001-01 - Status: WITHHELD - Start Date: N/A - Completion Date: N/A - Lead Sponsor: [Redacted] ### Study Description No description available. ### Conditions - No conditions listed. ### Study Design - Type: N/A - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Raman Spectroscopy and Skin Cancer - NCT ID: NCT06384924 - Study ID: SBU-RAMAN-SKINCANCER - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-04-30 - Lead Sponsor: Renee Cattell ### Study Description The goal of this observational study is to find out if Raman Spectroscopy, a type of imaging, can be used to determine the size of skin cancer tumors. The main question it aims to answer is:-Can Raman Spectroscopy help figure out how far a tumor spreads?This study will take measurements using laser light from an experimental, handheld probe by lightly touching the skin. ### Conditions - Skin Cancer - Basal Cell Carcinoma - Squamous Cell Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Raman Spectroscopy handheld probe (EmVision, FL, USA) - Raman Spectroscopy laser source (Hubner Photonics Inc, CA, USA) ### Outcomes Primary Outcomes - Feasibility of Raman Spectroscopy to observe differences in Raman spectra between visible lesion, skin surrounding lesion and contralateral normal skin. Secondary Outcomes - Compare the size of clinically defined margin and Raman-defined margin - Compare the dose delivered to surrounding critical structures when using clinically defined margin and Raman-defined margin ### Location - Facility: Stony Brook Hospital, Stony Brook, New York, 11794, United States @@
## InvesT1D: Promoting Adolescent Investment in Diabetes Care - NCT ID: NCT06384911 - Study ID: STUDY00004543 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-02 - Lead Sponsor: Seattle Children's Hospital ### Study Description The goal of this clinical trial is to see if a financial incentives program called InvesT1D is helpful to support diabetes management in adolescents with type 1 diabetes.Adolescent participants will be randomized to usual care or receive financial incentives for meeting diabetes self-management and clinical outcomes goals during the study. Researchers will compare changes in glucose levels and person-reported outcomes between groups. ### Conditions - Type 1 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Financial Incentives Program ### Outcomes Primary Outcomes - Time In Range Secondary Outcomes - Time Above Range - Time Below Range - Hemoglobin A1c (HbA1c) - Diabetes Distress - Diabetes Family Conflict - Adolescent Quality of Life - Caregiver Quality of Life - Diabetic Ketoacidosis - Severe Hypoglycemia - Insulin Adminstration ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Remote Tai Chi for Knee Osteoarthritis - NCT ID: NCT06384898 - Study ID: STUDY00002259 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2027-10 - Lead Sponsor: Tufts Medical Center ### Study Description The goal of this pragmatic randomized trial is to evaluate the effectiveness of remote Tai Chi to treat knee pain in adults with knee osteoarthritis. The main questions the trial aims to answer are:* Does remote Tai Chi improve the extent to which pain interferes with physical, mental, and social activities (PROMIS-Pain Interference at 3 months, primary outcome), as well as knee pain and function (WOMAC subscales) and analgesic use (secondary outcomes)* Does remote tai chi decreases healthcare utilization?Researchers will compare remote Tai Chi added to routine care to routine care alone to see if remote tai chi works to treat knee osteoarthritis pain. Participants will participate in remotely delivered web-based tai chi sessions, twice a week for 12 weeks, or will continue to receive routine care. Participants will be followed for 12 months after randomization. ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Remote Tai Chi ### Outcomes Primary Outcomes - PROMIS Pain Interference score - PROMIS Pain Interference score - PROMIS Pain Interference score Secondary Outcomes - WOMAC total score - WOMAC total score - WOMAC total score - SF-12 PCS score - SF-12 PCS score - SF-12 PCS score - Number of knee joint injections ### Location - Facility: Tufts Medical Center, Boston, Massachusetts, 02111, United States @@
## Ultrasound Investigation Into Swimming Induced Pulmonary Edema in Open Water Swimming Athletes - NCT ID: NCT06384885 - Study ID: 2024-079 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-12-01 - Lead Sponsor: Rocky Vista University, LLC ### Study Description Swimming-induced pulmonary edema (SIPE) is a potentially life-threatening condition that can affect swimmers of all abilities. The pathophysiology is not well understood and early identification strategies are not established. Handheld ultrasound is a validated tool for the identification of pulmonary edema and is not well-studied in this population. Understanding the incidence of signs of pulmonary edema and its usefulness as a sign of early pulmonary edema would be beneficial This study evaluates triathletes and open water swimmers at endurance events. A validated protocol for lung ultrasound is used to identify the signs of pulmonary edema. The findings will be analyzed for differences in experience level, type of athlete, gender, age, and environmental factors. The findings may then be used in the future to aid in the early identification and treatment of athletes and military personnel in similar situations to decrease morbidity and mortality. ### Conditions - Swimming Induced Pulmonary Edema ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ultrasound ### Outcomes Primary Outcomes - Lung ultrasound Secondary Outcomes ### Location - Facility: Rocky Vista University, Parker, Colorado, 80012, United States @@