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## Safety and Efficacy of Fillers for Contouring the Jawline - NCT ID: NCT06336759 - Study ID: 2021-10-GAL-JWL - Status: COMPLETED - Start Date: 2021-11-11 - Completion Date: 2023-11-10 - Lead Sponsor: Erevna Innovations Inc. ### Study Description The study aims to evaluate the safety and efficacy of two hyaluronic acid products, Restylane Lyft and Defyne, for contouring the jawline and chin, addressing concerns about contour deficits in patients seeking aesthetic treatments. ### Conditions - Jawline Contour Deficit ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Restylane Defyne - Restylane Lyft ### Outcomes Primary Outcomes - Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS) - Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo (2008) Jawline Scale Secondary Outcomes - Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS) - Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo Jawline Scale ### Location - Facility: Erevna Innovations Inc., Montréal, Quebec, H3R3A1, Canada @@
## Effects of Steep Trendelenburg and Pneumoperitoneum on Cardiac Performance. - NCT ID: NCT06336746 - Study ID: RHenningsson - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-03-31 - Lead Sponsor: Karlstad Central Hospital ### Study Description The field of robotic-assisted laparoscopic surgery increases all the time. Older and more fragile patients which are not suitable for major open surgery could be scheduled for robotic- assisted surgery. The peroperative anesthesiological challenges and stresses during this type of surgery could anyway be even more prominent.The extreme positioning of patients during robotic surgery in the pelvis, often 30 degrees head down tilting (Trendelenburg positioning), should increase the work load of the heart significantly. There are no studies concerning fragile patients with heart failure during these conditions.In this study the circulatory effects in patients with normal heart function and preexisting heart failure will be studied during robotic surgery in extreme Trendelenburg positioningDuring surgery the work load and performance of the heart will be monitored using an esophageal doppler and optical spectrophotometry measuring regional saturation of the brain. This study can identify patients at risk of developing critical circulatory failure during this type of surgery. ### Conditions - Heart Failure, Systolic - Robotic Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Esophageal Doppler ### Outcomes Primary Outcomes - Change of Stroke Volume during Trendelenburg position and pneumoperitoneum. Secondary Outcomes - % Change of Systemic Vascular Resistance;PulsePressureVariation; Peak Velocity; Stroke Volume Variation and FlowTimeCorrected - % change in regional brain saturation rSO2 during Trendelenburg position and pneumooperitoneum. ### Location - Facility: Dpt of Anesthesiology&Intensive Care; Central Hospital of Karlstad, Karlstad, Värmland, 65230, Sweden @@
## Randomized Controlled Trial in Patients on Long-term Colchicine With Colchicine-resistant Familial Mediterranean Fever (FMF) to Evaluate the Efficacy of On-demand Anakinra Treatment for Painful Attacks in Patients Who Refuse Continuous Daily Therapy - NCT ID: NCT06336733 - Study ID: APHP220828 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-09-15 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description To evaluate the efficacy on clinical symptoms in case of FMF attack among FMF patients resistant to Colchicine of* on demand anakinra treatment (100 mg/d from the prodromal phase of the attack until 24 hours of remission (during 7 days maximum) associated with daily colchicine.* compared to analgesic associated with daily colchicine in patients refusing continuous anti-IL-1 treatment. ### Conditions - FMF ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ANAKINRA ### Outcomes Primary Outcomes - Mean number of FMF-attacks per month at 6 months of treatment. Secondary Outcomes - Cumulative days of FMF attack treatment - AIDAI (Auto-inflammatory Diseases activity index) score - Number of painful days and severity of FMF attacks occurring between randomization and M6 - Quality of life score measured by EuroQOL questionnaire (EQ-5D5L) - Number of local cutaneous reactions at 6 months (erythema and oedema involving the injection sites) in the anakinra arm - Proportion of Adverse events ### Location - Facility: Service de Médecine interne Hopital Tenon, Paris, N/A, 75020, France @@
## PoNS® Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Single-Arm Study - NCT ID: NCT06336720 - Study ID: HMI-SA-PoNS-STK001 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-08-30 - Lead Sponsor: Helius Medical Inc ### Study Description Primary Objective: To further evaluate the aspects of safety related to PoNS therapy in chronic stroke survivors.Secondary Objectives: To further evaluate the efficacy of PoNS on improving dynamic gait and balance, establishing durability of effect, risk of falling and fall rate. As well as adherence to PoNS device utilization.Exploratory Objectives: To further evaluate quality of life to measure physical, mental, behavioral, and general health, as well as functional decline (\> 30% on gait or balance improvement at endpoint) during the 12-week follow-up. ### Conditions - Chronic Stroke Survivors ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Portable Neuromodulation Stimulator (PoNS) ### Outcomes Primary Outcomes - Primary safety endpoints Secondary Outcomes ### Location - Facility: Brooks Rehabilitation, Jacksonville, Florida, 32216, United States @@
## HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors - NCT ID: NCT06336707 - Study ID: HS-20089-103 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-08 - Completion Date: 2028-04-08 - Lead Sponsor: Hansoh BioMedical R&D Company ### Study Description HS-20089 is an investigational antibody-drug conjugate (ADC) composed of a humanized IgG1 anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a protease-cleavable linker, with an average drug-to-antibody ratio of about 6.This is a phase Ⅰ, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of HS-20089 in combination with other antitumor agents (Adebrelimab with or without platinum; Bevacizumab with or without platinum) in subjects with advanced solid tumors. ### Conditions - Advanced Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HS-20089 - Adebrelimab - Bevacizumab - Cisplatin / carboplatin ### Outcomes Primary Outcomes - Maximum tolerated dose (MTD) or maximum applicable dose (MAD) of HS-20089 in combination therapy Secondary Outcomes - Incidence and severity of adverse events (AEs) - Observed maximum plasma concentration (Cmax) of HS-20089 - Time to reach maximum plasma concentration (Tmax) of HS-20089 following the first dose - Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20089 - Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞) after single dose of HS-20089 - Objective response rate (ORR) assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 - Duration of response (DoR) assessed by investigators according to RECIST 1.1 - Disease control rate (DCR) assessed by investigators according to RECIST 1.1 - Progression-free survival (PFS) assessed by investigators according to RECIST 1.1 - Overall survival (OS) - Percentage of participants with antibodies to HS-20089 in serum ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Deep Learning Radiomics Model for Predicting Occult Peritoneal Metastases of Pancreatic Adenocarcinoma - NCT ID: NCT06336694 - Study ID: SYSUFAH2021-025 - Status: COMPLETED - Start Date: 2021-01-01 - Completion Date: 2023-07-30 - Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University ### Study Description Occult peritoneal metastases (OPM) in patients with pancreatic ductal adenocarcinoma (PDAC) are frequently overlooked during imaging. We aimed to develop and validate a CT-based deep learning-based radiomics (DLR) model with clinical-radiological characteristics to identify OPM in patients with PDAC before treatment. ### Conditions - Pancreatic Neoplasms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - surgery or diagnostic staging laparoscopy ### Outcomes Primary Outcomes - diagnosed with peritoneal metastases Secondary Outcomes ### Location - Facility: Shi Siya, Guangzhou, Guangdong, 510000, China @@
## Inspiratory Muscle Training on The Severity of Exercise-Induced Bronchoconstriction and Time-Trial Performance (IMT_EIB) - NCT ID: NCT06336681 - Study ID: #12966 - Status: RECRUITING - Start Date: 2022-02-10 - Completion Date: 2025-08 - Lead Sponsor: Indiana University ### Study Description Due to the lack of studies examining the impact of inspiratory muscle training (IMT) on the severity of exercise-induced bronchoconstriction (EIB) and exercise performance, the specific aim of this study is to assess the efficacy of flow-resistive IMT on EIB severity and symptoms, short-acting beta-2-agonist medication use, operating lung volumes, respiratory and limb locomotor muscle deoxygenation during constant-load cycling exercise, exertional dyspnea, and cycling time-trial performance. ### Conditions - Exercise Induced Bronchospasm - Exercise Induced Asthma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PrO2Fit Device ### Outcomes Primary Outcomes - Exercise-Induced Bronchoconstriction (EIB) Severity - Maximum Inspiratory Pressure and Sustained Maximum Inspiratory Pressure - 16-km Cycling Time-Trial Time to Completion - 16-km Cycling Time-Trial Power Output - Constant Load Performance Secondary Outcomes - Perception of Breathing Intensity and Unpleasantness and Leg Fatigue - Deoxygenation of the respiratory and limb locomotor muscles by near-infrared spectroscopy - Femoral blood flow (FBF) of the limb locomotor muscles by ultrasound - Lung Volumes ### Location - Facility: School of Public Health-Bloomington, Bloomington, Indiana, 47405, United States @@
## Source of Human Milk Fortifier and Intestinal Oxygenation in Preterm Infants <30 Weeks Gestation - NCT ID: NCT06336668 - Study ID: REB23-1283 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-02-28 - Lead Sponsor: University of Calgary ### Study Description Preterm infants require higher nutritional intakes during the neonatal phase than they do at any other stage of their development. Standard volumes of human milk alone do not offer sufficient nourishment to these infants. There are multiple options for fortifying human milk, which vary depending on whether the fortifier is derived from bovine sources (B-HMF) or human sources (H-HMF). Fortifying human milk has been proven to enhance growth in preterm infants without raising the risk of necrotizing enterocolitis (NEC), though it could potentially affect feeding tolerance. Changes in blood flow and oxygen levels in the intestines are commonly observed in infants experiencing feeding intolerance. Research indicates that feeding a mother's own milk (MOM) doesn't affect splanchnic (intestinal) oxygenation, whereas it decreases when feeding bovine-derived human milk fortifiers (B-HMF) or preterm formula, indicating greater oxygen requirements in the intestines of preterm infants fed these alternatives.The goal of this clinical trial is to compare the effect of H-HMF and B-HMF on splanchnic oxygenation in infants less than 30 weeks. ### Conditions - Feeding; Difficult, Newborn ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Human milk-based HMF ### Outcomes Primary Outcomes - Change in Splanchnic regional oxygenation(rSO2S) measured by Near Infrared Spectroscopy Secondary Outcomes - Changes in SMA doppler peak flow velocity (PSV) - Changes in SMA doppler end-diastolic velocity (EDV) - Changes in SMA doppler Porcelout's resistance index (RI) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Physiology of Unloading VA ECMO Trial - NCT ID: NCT06336655 - Study ID: 153309 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2029-02-01 - Lead Sponsor: University of Utah ### Study Description The goal of this clinical trial is to compare the use of veno-arterial extracorporeal membrane oxygenation (VA ECMO) with and without left ventricular (LV) unloading in patients being treated for non-postoperative cardiogenic shock (CS). The main aims of the study are:1. To determine the physiologic effects on cardiopulmonary congestion of adding LV unloading to VA ECMO2. To determine the effects on myocardial function of adding LV unloading to ECMO3. To test the effects on myocardial recovery of adding LV unloading to VA ECMOParticipants who are being treated with VA ECMO will be randomized to receive or not receive LV unloading in the form of an intra-aortic balloon pump (IABP). Over the course of the study, the investigators will obtain measurements via lab work, echocardiography, and pulmonary artery catheter that will allow comparison of the two groups. ### Conditions - Cardiogenic Shock ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - IABP ### Outcomes Primary Outcomes - Change in pulmonary capillary wedge pressure Secondary Outcomes - Change in pulmonary artery diastolic pressure - Change in left ventricular end diastolic diameter - Change in N-terminal pro b-type natriuretic peptide - Hemodynamic stability - Global cardiovascular function - Difference in partial pressure of carbon dioxide (pCO2) - Lactate - Cardiac BIN1 - Troponin I - Tumor necrosis factor alpha - Ejection fraction percentage - Interferon gamma - Limb ischemia - Mortality ### Location - Facility: University of Utah, Salt Lake City, Utah, 84132, United States @@
## Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology - NCT ID: NCT06336642 - Study ID: 2023-0933 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-30 - Completion Date: 2032-03-31 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To learn about the effect of Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology (SPOT-ON) treatment on the severity of shortness of breath in patients with cancer. ### Conditions - Dyspnea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - SPOT-ON Early Start - SPOT-ON Delayed Start ### Outcomes Primary Outcomes - Primary Outcome Measure: 1.Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clindamycin) for the Treatment of Acne - NCT ID: NCT06336629 - Study ID: WIN2023 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-11-15 - Completion Date: 2024-10 - Lead Sponsor: Sun Pharmaceutical Industries Limited ### Study Description Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. There is no study assessing Winlevi in combination treatment for acne .Therefore this study assesses Winlevi with Duac gel in combination to emulate real life practice. ### Conditions - Acne Vulgaris ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Winlevi (clascoterone) 1% & Duac gel ### Outcomes Primary Outcomes - The primary endpoint of this study is the percent of patients who achieve clear or almost clear on IGA at week 16. Secondary Outcomes - Percent of total lesion reduction at week 16 compared to baseline - Percent of inflammatory lesion reduction at week 16 compared to baseline - Percent of non-inflammatory lesion reduction at week 16 compared to baseline. - Tolerability measures of erythema based on 5-point severity scale - Tolerability measures of dryness based on 5-point severity scale - Tolerability measures of peeling based on 5-point severity scale - Assessment of skin oiliness based on 5-point severity scale - Tolerability measures of burning/stinging based on 6-point severity scale - Tolerability measures of pruritus based on 6-point severity scale ### Location - Facility: Skin Sciences, PLLC, Louisville, Kentucky, 40217, United States @@
## Getting Out of the House: Using Behavioral Activation to Increase Community Participation - NCT ID: NCT06336616 - Study ID: 31164 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2026-12 - Lead Sponsor: Temple University ### Study Description The goal of this study is to evaluate the effectiveness of an behavioral activation intervention to increase meaningful activity and community participation for people with serious mental illness.The overall objective of this study is to increase engagement in meaningful activities and community participation. The objectives of the project are as follows:1. To determine if the intervention leads to increases the frequency and variety of activities.2. To determine if the intervention leads to increases in community mobility.3. To determine which demographic and environmental factors and mechanisms of action impact the effectiveness of the intervention.4. To determine if the the intervention leads to an improvement in overall well-being (e.g., improved quality of life).Participants will be asked to attend a 2-hour weekly online session for 10 weeks and then a 1-hour online monthly session for a 3 month maintenance period.For data collection, participants will also be asked to:1. Complete three, approximately 1-hour interviews at baseline, after the 10 week intervention, and again at the end of the maintenance period;2. Carry a mobile phone with a global positioning system app to track their movements outside their home for 2 weeks at a time, at three separate times (e.g., baseline, after the intervention, and at the end of the maintenance period); and3. Complete a 15 minute weekly interviews for 26 weeks about their daily activities and participation.The study will enroll 52 participants split into 4 cohorts of 13. The study will use a multiple baseline design and, as such, all participants will receive the intervention and there is no control group. ### Conditions - Major Depressive Disorder - Schizo Affective Disorder - Schizophrenia - Bipolar Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Behavior Activation ### Outcomes Primary Outcomes - Activity Logs - Participation Checklist - Behavior Activation for Depression Scale - Temple University Community Participation Measure - Community Mobility (Global Positioning System; GPS) - Community Mobility (Global Positioning System; GPS) Secondary Outcomes - Lerman Quality of Life Interview - New General Self-Efficacy Scale (adapted to participation) - Recovery Assessment Scale (RAS) - Activity Assessment Scale - Capabilities and Opportunities for Participation Questionnaire - Self-Control and Self-Management Scale - Habit Strength Scale - University of California Los Angeles Loneliness Scale - Lehman Quality of LIfe (QOL) Interview Social Relations sub scale - Hopkins Symptoms Checklist - The Life Engagement Test - The University of Rhode Island Change Assessment Measure (URICA) - Reward Probability Index ### Location - Facility: Temple University, Philadelphia, Pennsylvania, 19120, United States @@
## A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne - NCT ID: NCT06336603 - Study ID: WIN2022 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-11-15 - Completion Date: 2024-09 - Lead Sponsor: Sun Pharmaceutical Industries Limited ### Study Description Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. There is no study assessing Winlevi in combination treatment for acne .Therefore this study assesses Winlevi with Adapalene 0.3% gel in combination to emulate real life practice. ### Conditions - Acne Vulgaris ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Winlevi (clascoterone) 1% & Adapalene 0.3% gel ### Outcomes Primary Outcomes - The primary endpoint of this study is the percent of patients who achieve clear or almost clear on IGA at week 16. Secondary Outcomes - Percent of total lesion reduction at week 16 compared to baseline - Percent of inflammatory lesion reduction at week 16 compared to baseline - Percent of non-inflammatory lesion reduction at week 16 compared to baseline - Tolerability measures of erythema based on 5-point severity scale - Tolerability measures of dryness based on 5-point severity scale - Tolerability measures of peeling based on 5-point severity scale - Assessment of skin oiliness based on 5-point severity scale - Tolerability measures of burning/stinging based on 6-point severity scale - Tolerability measures of pruritus based on 6-point severity scale ### Location - Facility: Skin Sciences, PLLC, Louisville, Kentucky, 40217, United States @@
## Student Exercise and Sleep Timing Study - Part 2 - NCT ID: NCT06336590 - Study ID: Pro2024000249 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-18 - Completion Date: 2026-12-16 - Lead Sponsor: Rutgers, The State University of New Jersey ### Study Description The purpose of this study is to examine the effects of a morning exercise intervention on sleep (quality and duration), mood (positive affect, anxiety, depression, anger), stress and productivity among undergraduate students (18-23 years) evening-exercisers with poor self-reported sleep quality.Aim 1. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit improved sleep quality (increased efficiency, decreased fragmentation) and increased sleep duration.Aim 2. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit improved mood (increased positive affect, decreased depression, anxiety and anger).Aim 3. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit decreased stress and increased productivity. ### Conditions - Sleep - Mood - Stress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Morning Exercise ### Outcomes Primary Outcomes - Sleep Quality Secondary Outcomes - Mood - Stress - Productivity ### Location - Facility: College Avenue Gym, New Brunswick, New Jersey, 08901, United States @@
## Infectious and Non-infectious Lower Respiratory Diseases in Children With Down Syndrome Followed in Pediatric Pulmonology Consultations in Ile-de-France - NCT ID: NCT06336577 - Study ID: 2024/0003 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-31 - Lead Sponsor: Centre Hospitalier Sud Francilien ### Study Description The purpose of this study is to describe infectious and non-infectious lower respiratory tract diseases in children with Down syndrome followed in pediatric pulmonology consultations in Ile de France. ### Conditions - Down Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - lower respiratory tract disease ### Outcomes Primary Outcomes - distribution of lower respiratory tract diseases Secondary Outcomes ### Location - Facility: Centre Hospitalier Sud Francilien, Corbeil-Essonnes, N/A, 91106, France @@
## Microablative Radiofrequency in the Treatment of Urinary Symptoms Associated With Genitourinary Syndrome of Menopause - NCT ID: NCT06336564 - Study ID: 71168623.6.0000.5544 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2026-12 - Lead Sponsor: Centro de Atenção ao Assoalho Pélvico ### Study Description Genitourinary Syndrome fo Menopause (GSM) is made up of a set of changes in the region of the vulva, vagina and lower urinary tract associated with a decrease in estrogen levels in the urogenital tissue, which leads to a reduction in blood supply, disorders in collagen metabolism and skin elasticity. The standard treatment for urinary incontinence during menopause is pelvic floor muscle training, associated or not with local hormone replacement therapy. Although low cost and easy to access, it is associated with low patient's adherence. Physical methods such as laser and radiofrequency in non-ablative, ablative and microablative forms are technologies that have recently been used in the vaginal mucosa to promote neoelastogenesis and neocollagenesis. It is hypothesized that menopausal women, who present symptoms of GSM, may benefit from this new, minimally invasive resource (microablative radiofrequency). This is a randomized clinical trial in which women aged between 40 and 65 years old will be included with clinical complaints of urinary symptoms associated with GSM. A basic anamnestic questionnaire will be used as the study instrument to collect sociodemographic, clinical data and symptoms, following the routine and standard of the service. To evaluate the treatment, the following will be used: voiding diary, pad test, vaginal cytology, histopathology, Female Sexual Function Index (FSFI), Short-Form Health Survey - SF-36 Questionnaire, King's Health Questionnaire, evolution of symptoms (dryness, pain during sexual activity, vaginal laxity, itching, burning sensation and pain in the vaginal introitus) and level of patient's satisfaction. Patients will be randomized into: group 1 or control group, which will perform pelvic floor muscle training, PFMT, with supervision (three times) and at home twice a day, and group 2 or test group, which will perform the same PFMT protocol associated with vaginal microablative radiofrequency. 10% lidocaine spray will be applied three minutes before the procedure and three applications will be made to the vagina/vaginal introitus, with an interval of 30 to 40 days. The purpose of this study is to test the efficacy and duration of effect of microablative radiofrequency in the treatment of urinary symptoms associated with GSM. ### Conditions - Menopause - Urinary Incontinence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pelvic floor muscle training - Microablative Radiofrequency ### Outcomes Primary Outcomes - Resolution or improvement of episodes of urinary loss assessed by pad test - Resolution or improvement of episodes of urinary loss assessed by urinary diary - Number of patients with tolerability related to treatment assessed by Likert Scale. - Number of patients with adverse effects related to treatment assessed by histopathology. - Resolution or improvement of episodes of urinary loss assessed by questionnaire. Secondary Outcomes - Recovery of vaginal health assessed by Vaginal Index Maturation - Recovery of vaginal health assessed by vaginal pH - Improvement of Sexual Function assessed by Female Sexual Function Index - Improvement of quality of life assessed by Short-Form Health Survey (SF-36) - Improvement or resolution of urinary incontinence and the impact on quality of life assessed by King's Health Questionnaire. - Degree of patient satisfaction using a five-point Likert scale. - Evolution of vaginal symptoms assessed by Visual Analogue Scale (VAS) ### Location - Facility: Centro de Atenção ao Assoalho Pelvico, Salvador, Ba, 40.290-000, Brazil @@
## Acceptance and Commitment Therapy for Insomnia - NCT ID: NCT06336551 - Study ID: UniversityAmsterdam - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-01-26 - Lead Sponsor: University of Amsterdam ### Study Description Insomnia is a common sleep problem that impacts both physical and mental health. Acceptance and Commitment Therapy for Insomnia (ACT-I) is proposed as a promising new treatment for insomnia. However, its effectiveness without overlapping behavioral components of the current standard treatment, cognitive behavioral therapy, remains largely unknown.The main goal of this clinical trial is to test the efficacy of stand-alone ACT-I in adults with insomnia, compared to a waitlist control group. The second goal is to explore the potential working mechanisms of ACT-I, using network intervention analysis.Adults with insomnia will be randomized to an ACT-I or waitlist group. Both the ACT-I treatment and waiting period span 7 weeks. Assessments take place at baseline (pre), after 4 weeks (mid), and after 8 weeks (post), followed by a 3- and 6-month follow-up for the ACT-I group.The main questions this RCT aims to answer are:* Is ACT-I superior to a waitlist control group in improving insomnia severity (primary outcome) in addition to sleep diary measures, anxiety, depression, general mental health, and sleep-related quality of life (secondary outcomes)?* How do networks of insomnia symptoms or potential treatment processes (i.e., psychological (in)flexibility, sleep-related arousal, dysfunctional cognitions, and sleep-related safety behaviors) develop during and following ACT-I? ### Conditions - Insomnia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Acceptance and Commitment Therapy for insomnia (ACT-I) ### Outcomes Primary Outcomes - Insomnia severity Secondary Outcomes - Insomnia severity - Insomnia severity - Insomnia severity - General well-being - General well-being - General well-being - General well-being - Sleep-related quality of life - Sleep-related quality of life - Sleep-related quality of life - Sleep-related quality of life - Anxiety symptoms - Anxiety symptoms - Anxiety symptoms - Anxiety symptoms - Depression symptoms - Depression symptoms - Depression symptoms - Depression symptoms - Sleep diary: total sleep time - Sleep diary: total sleep time - Sleep diary: total sleep time - Sleep diary: total sleep time - Sleep diary: sleep onset latency - Sleep diary: sleep onset latency - Sleep diary: sleep onset latency - Sleep diary: sleep onset latency - Sleep diary: wake after sleep onset - Sleep diary: wake after sleep onset - Sleep diary: wake after sleep onset - Sleep diary: wake after sleep onset - Sleep diary: sleep efficiency - Sleep diary: sleep efficiency - Sleep diary: sleep efficiency - Sleep diary: sleep efficiency - Psychological flexibility - Psychological flexibility - Psychological flexibility - Psychological flexibility - Psychological inflexibility - Psychological inflexibility - Psychological inflexibility - Psychological inflexibility - Sleep-related arousal - Sleep-related arousal - Sleep-related arousal - Sleep-related arousal - Dysfunctional sleep-related cognitions - Dysfunctional sleep-related cognitions - Dysfunctional sleep-related cognitions - Dysfunctional sleep-related cognitions - Sleep-related safety behaviors - Sleep-related safety behaviors - Sleep-related safety behaviors - Sleep-related safety behaviors ### Location - Facility: University of Amsterdam, Amsterdam, Noord-Holland, 1018 WS, Netherlands @@
## Abbreviated MBCT for Depression in Older African American/Black Breast Cancer Survivors - NCT ID: NCT06336538 - Study ID: CASE1124 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2025-01-31 - Lead Sponsor: Case Comprehensive Cancer Center ### Study Description The purpose of this research study is to develop and test an intervention designed to improve mood and reduce symptoms of depression. ### Conditions - Breast Cancer - Breast Cancer Female - Breast Cancer Stage I - Breast Cancer Stage II - Breast Cancer Stage III - Mild Depression - Moderate Depression ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - MBCT ### Outcomes Primary Outcomes - Mean participant attendance rate Secondary Outcomes - Acceptability rate using CSQ(Client Satisfaction Questionnaire-8) ### Location - Facility: Cleveland Clinic Department of Wellness and Preventive Medicine, Cleveland, Ohio, 44106, United States @@
## Adult Sleep Health in the Rural Appalachia and Mississippi Delta Region and Its Relationships With Cardiometabolic Health Disparities. - NCT ID: NCT06336525 - Study ID: 2023P001895 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-01-31 - Lead Sponsor: Brigham and Women's Hospital ### Study Description Rural communities in the southern U.S. suffer a disproportionate burden of morbidity and mortality from cardiometabolic disease, with traditional risk factors explaining only a modest proportion of the excess burden of disease. There is considerable evidence that multiple dimensions of sleep health, including sleep duration, efficiency, timing, and regularity, as well as the disorders sleep apnea and insomnia, affect cardiometabolic disease risk. However, there is currently a lack of systematically developed sleep data in rural populations. The RURAL Sleep Study is an ancillary study to a recently initiated longitudinal epidemiology study in rural Appalachia and Mississippi Delta (the RURAL Study). The RURAL Sleep Study will add measures of sleep health to the complex individual, social and environmental factors and health outcome measures being evaluated by the RURAL Study, by incorporating minimally burdensome measures of multiple dimensions of sleep health. The results are expected to inform health care providers, public health officials, and the general public of the prevalence, risk factors, and consequences of impaired sleep health in these rural communities, providing a critical basis for prevention, recognition, and management of sleep disorders and improvement of sleep and cardiometabolic health. ### Conditions - Sleep Apnea - Insomnia - Sleep Deprivation - Sleep Disorders, Circadian Rhythm - Sleepiness, Excessive Daytime - Fatigue ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Oxygen desaturation index - Insomnia Severity Index - Sleep Duration - Sleep Duration Regularity - Sleep Timing - Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment Short Form 8a Secondary Outcomes - Restless Legs Syndrome (RLS) - Chronotype - Sleep Timing Regularity - Global Sleep Quality - Oxygen desaturation index, 3% ### Location - Facility: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States @@
## Trimester Sequential Estimation of Serum Zonulin as a Predictor of Gestational Diabetes Mellitus - NCT ID: NCT06336512 - Study ID: RC.28.1.2024 - Status: COMPLETED - Start Date: 2023-01-15 - Completion Date: 2023-10-01 - Lead Sponsor: Benha University ### Study Description Gestational diabetes mellitus (GDM) is the development of glucose intolerance (GI) during pregnancy in a previously normoglycemic (NG) woman and associated with insulin resistance (IR). GDM is the most prevalent metabolic disorder during pregnancy and became a major public health problem for being usually diagnosed and detected after 24 gestational weeks (GW), while its complications can occur much earlier and this may explain its burden on maternal and fetal welfare. Human zonulin is a surrogate marker of intestinal permeability and can be utilized as biomarker for intestinal barrier function. Zonulin-mediated increase in intestinal permeability plays a role in the pathogenesis of insulin resistance, obesity, DM and metabolic syndrome. The increasing global prevalence of GDM with its associated risk of poor pregnancy and long-term risks for the mother and the offspring may lead to the production of new generation of diabetics. ### Conditions - Gestational Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - ELISA ### Outcomes Primary Outcomes - Estimation of Gestational DM Secondary Outcomes ### Location - Facility: Benha university, Banhā, El- Qalyobia, 13511, Egypt @@
## Risk Stratification of Orbital Tumors Based on MRl and Artificial Intelligence - NCT ID: NCT06336499 - Study ID: TREC2023-KY107 - Status: COMPLETED - Start Date: 2012-01-01 - Completion Date: 2023-12-31 - Lead Sponsor: Beijing Tongren Hospital ### Study Description Orbital tumors can be categorized into benign and malignant tumors, and there are significant variations in their biological behavior, treatment, and prognosis. This study aims to enhance the accurate diagnosis and risk stratification of orbital tumors using artificial intelligence (AI) technology and multiparameter magnetic resonance imaging (MRI) data. It further explores the intrinsic relationship between MRI and the differential diagnosis of benign and malignant orbital tumors, as well as the pathological subtypes of malignant tumors and Ki-67 expression levels. This research aims to aid in guiding personalized diagnosis and treatment decision-making for patients with orbital tumors while promoting the practical application and incorporation of AI technology. ### Conditions - Orbital Neoplasms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Multi-parametric MRI and image analysis by deep learning or machine learning algorithms ### Outcomes Primary Outcomes - The area under the curve of Receiver Operating Characteristic of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and levels of Ki-67 expression in malignant ones. Secondary Outcomes - The area under the Precision-Recall curve of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors. - Sensitivity of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors. - Specificity of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors. - Accuracy of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## the Effectiveness of Intermittent Pneumatic Compression on Neuropathic Pain in Patients With Diabetic Polyneuropathy - NCT ID: NCT06336486 - Study ID: BalikesirU-FTR-BG-01 - Status: COMPLETED - Start Date: 2018-12-04 - Completion Date: 2020-02-01 - Lead Sponsor: Busra Gunes ### Study Description In this study,the effectiveness of intermittent pneumatic compression therapy on neuropathic pain and quality of life in patients with neuropathic pain due to type 2 diabetes was investigated ### Conditions - Diabetic Neuropathic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - intermittent pneumatic compression +pregabalin group - pregabalin group ### Outcomes Primary Outcomes - The Leeds assessment of neuropathic symptoms and signs(LANSS) - Pain quality rating scale(PQAS) - Visual Analog Scale(VAS) Secondary Outcomes - 36-Item Short Form Health Survey(SF-36) ### Location - Facility: Balıkesir University, Balıkesir, Merkez, 10050, Turkey @@
## Evaluation of the Effects of Cross Linking on the Biomechanical Characteristics of Skin Samples From Patients With Classic or Hypermobile Ehlers-Danlos Syndrome - NCT ID: NCT06336473 - Study ID: 2023-A02097-38 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-07-31 - Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche ### Study Description The main aim of this study is to evaluate the effect of cross linking on the elasticity of skin samples from patients with non-vascular Ehlers-Danlos Syndrome (hEDS or cEDS). ### Conditions - Ehlers-Danlos Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - skin biopsy ### Outcomes Primary Outcomes - Young's modulus quantification Secondary Outcomes - Collagen fibril diameter measurement - Collagen fibril D-period length measurement ### Location - Facility: Clinique Maussins-Nollet, Paris, N/A, 75019, France @@
## PENG vs. FIC Blocks in Hip Fractures in the ED - NCT ID: NCT06336460 - Study ID: 2023-537 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: Orange Park Medical Center ### Study Description This study is a prospective, randomized clinical trial assessing the efficacy of physician-performed ultrasound-guided pericapsular nerve group (PENG) block vs fascia iliaca compartment (FIC) block for pain control in acute hip fracture. ### Conditions - Hip Fractures - Nerve Block - Analgesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pericapsular Nerve Group (PENG) Block - Fascia Iliaca Compartment (FIC) Block for Patients with Isolated Hip Fractures ### Outcomes Primary Outcomes - Numeric pain score at 30 minutes - Numeric pain score at 60 minutes Secondary Outcomes - Cumulative Morphine Milligram Equivalents in 24 hours after enrollment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain - NCT ID: NCT06336447 - Study ID: STU00220295 - Status: RECRUITING - Start Date: 2024-01-12 - Completion Date: 2027-02-28 - Lead Sponsor: Northwestern University ### Study Description This study will examine the impact of virtual reality used in conjunction with sedation compared to sedation alone in patients undergoing watervcooled genicular nerve ablations for chronic knee pain.The goals of the study is to determine the relative efficacy of virtual reality as a distraction modality when used as an adjuvant to procedural sedation compared to sedation alone for procedure related pain. To assess procedural satisfaction, and 1-month pain and functional outcomes.To explore whether virtual reality and lower procedure-related pain scores affect 1-month outcomes. And finally to determine whether demographic and clinical characteristics are associated with outcome measures. ### Conditions - Pain, Chronic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Experimental: Group #1: Virtual Reality Headset - Group 2 No Virtual Reality Headset ### Outcomes Primary Outcomes - Procedural related pain Secondary Outcomes - Procedure related satisfaction - Post procedure anxiety - Mean reduction in pain 1 month after procedure - Midazolam administered - Fentanyl administered ### Location - Facility: Northwestern Medicine Pain Center, Chicago, Illinois, 60611, United States @@
## CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy - NCT ID: NCT06336434 - Study ID: IMPAACT 2040 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-24 - Completion Date: 2026-12-24 - Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) ### Study Description This is a Phase I/II, multicenter, open-label, non-randomized study with four groups to characterize the pharmacokinetics and safety of Cabotegravir (CAB) and Rilpivirine (RPV) long-acting injectable (LA) during pregnancy and postpartum among people with HIV-1 viral suppression and their infants. ### Conditions - HIV-1-infection - Pregnancy - Postpartum ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CAB LA 600mg - RPV LA 900mg - CAB LA 400mg - RPV LA 600mg ### Outcomes Primary Outcomes - PK trough of CAB LA measured in plasma in pregnancy and postpartum - Percentage of adults with at least one Grade 3 or higher adverse event in pregnancy and through 18 weeks postpartum - Percentage of adults with at least one serious adverse event in pregnancy and through 18 weeks postpartum Secondary Outcomes - PK trough measured in plasma in pregnancy and postpartum - Percentage of adults with HIV-1 RNA less than 50 copies/mL at delivery - Percentage of adults with HIV-1 RNA less than 50 copies/mL at delivery using the standardized FDA snapshot algorithm - Percentage of adults with virologic escape (single measurement of greater than or equal to 200 copies/mL) from study entry through pregnancy and through 18 weeks postpartum - Percentage of adults with confirmed virologic failure through 18 weeks postpartum - Number of adults with HIV-1 resistance to CAB and/or RPV using IAS-USA in participants who experience confirmed virologic failure, assessed at entry and time of failure - Number of infants with HIV-1 infection - Percentage of infants at least one Grade 3 or higher adverse event through 18 weeks post-birth - Percentage of infants at least one serious adverse event through 18 weeks post-birth - Percentage of infants with a congenital anomaly consistent with the Metropolitan Atlanta Congenital Defects Program (MACDP) definition of defect - Percentage of deaths among infants - Percentage of adults with a spontaneous abortion (less than 20 weeks gestation) - Percentage of adults with a fetal demise/stillbirth (greater than or equal to 20 weeks gestation) - Percentage of neonatal deaths (within 28 days of life) among infants - Percentage of infants born small for gestational age (SGA) at < 10th percentile - Percentage of infants born with low birth weight < 2500 g - Percentage of infants born preterm < 37 weeks gestation - Percentage of adult-infant participant pairs with any adverse pregnancy outcome of spontaneous abortion, fetal demise/stillbirth, neonatal death, SGA, or preterm delivery - CAB and RPV plasma concentrations in infants exposed to CAB LA + RPV LA during pregnancy and via chest/breastfeeding - Percentage of adults who discontinued injections prior to receiving the full course of injections due to intolerability of injection - Frequency of CAB LA + RPV LA injections received - Percentage of adults willing to continue CAB LA + RPV LA postpartum and/or in future pregnancies ### Location - Facility: Site 4601, University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program, La Jolla, California, 92093-0672, United States @@
## The Effect of Virtual Reality Application on Perceived Anxiety and Vital Signs in Primiparous - NCT ID: NCT06336421 - Study ID: Şuletuvanç - Status: COMPLETED - Start Date: 2022-11-01 - Completion Date: 2024-03-22 - Lead Sponsor: Ataturk University ### Study Description Purpose: To determine the effect of virtual reality application on anxiety and vital signs perceived by primiparous women during cesarean section.The research was conducted in a randomized controlled experimental design.The population of the research consisted of primiparous pregnant women with a caesarean section indication in the Ataturk University Health Research and Application Center Gynecology Clinic Operating Room. ### Conditions - Cesarean Section Complications ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Virtual Reality ### Outcomes Primary Outcomes - Personal Information Form - State Anxiety Scale - Pregnant follow-up form Secondary Outcomes ### Location - Facility: Ayse Aydin, Yakutiye, Erzurum, 25000, Turkey @@
## The SLEEP-CARE Study - NCT ID: NCT06336408 - Study ID: B2023-370R - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-12-31 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description Sleep disorder is common in ICU patients, such as reduced sleep time, fragmentation, and abnormal sleep rhythm. In 2023, American Thoracic Society released a research statement on sleep and circadian disruption(SCD) in ICU, which considered SCD is an important potential target for improving critical illness outcomes. Although polysomnography(PSG) is the gold standard of sleep measurement, subjective sleep evaluation tools are still used in most clinical studies related to sleep in ICU. This makes the sleep quality of ICU patients overestimated and difficult to reflect their true sleep conditions. And the answers to how and which outcomes different levels of sleep deprivation affect patient outcomes are still unclear and need to be further explored. ### Conditions - Sleep Disturbance ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Compound outcome index Secondary Outcomes - LOS ### Location - Facility: Zhongshan Hospital, Fudan University, Shanghai, N/A, N/A, China @@
## Ma-Spore ALL 2020 Study - NCT ID: NCT06336395 - Study ID: 2019/00888 - Status: RECRUITING - Start Date: 2020-03-04 - Completion Date: 2030-03 - Lead Sponsor: National University Hospital, Singapore ### Study Description The primary objective of this trial is to improve the overall survival rate of children and young adult with B-lineage acute lymphoblastic leukemia (B-ALL) in Singapore and Malaysia in the context of a multicenter cooperative trial using a risk-stratified therapy. ### Conditions - B Lymphoblastic Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Prednisolone - Dexamethasone - Vincristine - Methotrexate - L-Asparaginase - Pegylated asparaginase - Erwinase - Dasatinib - Imatinib - Cyclophosphamide - Cytarabine - Mercaptopurine - Thioguanine - Rituximab - Doxorubicin - Fludarabine ### Outcomes Primary Outcomes - Overall survival (OS) Secondary Outcomes - Event free survival (EFS) ### Location - Facility: Subang Jaya Medical Centre, Kuala Lumpur, N/A, 47500, Malaysia @@
## Tau Biomarkers in Late-onset Psychosis (LOP) - NCT ID: NCT06336382 - Study ID: 23-0874 - Status: RECRUITING - Start Date: 2024-02-16 - Completion Date: 2027-06-30 - Lead Sponsor: Jeremy Koppel ### Study Description Hallucinations or delusions that occur for the first time in older people with no acute medical problems or mood symptoms may be related to impending dementia. This study aims to confirm this hypothesis using novel blood biomarkers and Positron Emission Tomography (PET) imaging tracers, as well as non-invasive testing. ### Conditions - Late Onset Schizophrenia - Delusional Disorder (Late Onset) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tau PET imaging scan ### Outcomes Primary Outcomes - Quantification of neurofibrillary tangle pathology in subjects via PET [18F]PI-2620 radiotracer uptake. Secondary Outcomes - Measurement of peripheral soluble tau pathology with tau plasma immunoassays. ### Location - Facility: The Feinstein Institutes for Medical Research, Manhasset, New York, 11030, United States @@
## Brown Adipose Tissue Activity in Gilbert's Syndrome - NCT ID: NCT06336369 - Study ID: 1713/2023 - Status: RECRUITING - Start Date: 2024-03-06 - Completion Date: 2027-01-15 - Lead Sponsor: Medical University of Vienna ### Study Description The goal of this case-control study is to investigate energy metabolism and brown adipose tissue (BAT) activity in individuals with Gilbert's syndrome (GS) and controls. The main focus of the study is to analyze:1. the link between bilirubin metabolism and metabolic health.2. energy metabolism and body composition in individuals with Gilbert's syndrome and control subjects3. brown adipose tissue activity in Gilbert's syndrome and healthy controls.Participants will undergo the following investigations:1. cold exposure2. PET-CT imaging with 18-F-FDG3. MRI imaging of liver, abdominal fat and muscle4. blood sampling5. indirect calorimetry6. bioelectrical impedance analysis7. infrared thermographyResearchers will compare individuals with GS and control subjects in terms of metabolic health, body composition and BAT activity. ### Conditions - Gilbert Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - analyzing brown adipose tissue, body composition and metabolic health ### Outcomes Primary Outcomes - cold-induced brown adipose tissue (BAT) activation Secondary Outcomes ### Location - Facility: Medical University of Vienna, Vienna, N/A, 1090, Austria @@
## A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulation Test Following Baxdrostat Treatment Compared to Placebo in Participants With Uncontrolled Hypertension - NCT ID: NCT06336356 - Study ID: D6970C00011 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-13 - Completion Date: 2024-11-05 - Lead Sponsor: AstraZeneca ### Study Description The main purpose of this study is to assess the serum free cortisol response after ACTH stimulation test at baseline and at Week 8 in participants with uncontrolled hypertension. ### Conditions - Uncontrolled Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Baxdrostat - Placebo ### Outcomes Primary Outcomes - Individual Cortisol Level Secondary Outcomes - Number of Participants with Abnormal Stimulated Cortisol ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Bimekizumab in Plaque Psoriasis - NCT ID: NCT06336343 - Study ID: STUDY-23-01698 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2025-10-31 - Lead Sponsor: Icahn School of Medicine at Mount Sinai ### Study Description The purpose of this research study is to evaluate the effectiveness and safety of bimekizumab in individuals with moderate-to-severe psoriasis who have failed similar therapies. Bimekizumab improves psoriasis by suppressing a type of substance found in bodies called interleukins (specifically, interleukins 17a and 17F), which are known to increase inflammation. This study will look at the effectiveness of bimekizumab in psoriasis patients that have failed previous therapies that target interleukin IL-17A or 23. ### Conditions - Plaque Psoriasis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Bimekizumab ### Outcomes Primary Outcomes - Body Surface Area (BSA) of < 1 Secondary Outcomes - Psoriasis and Severity Index Score (PASI) of < 1 - Physician Global Assessment (PGA) of < 1 - Psoriasis and Severity Index Score (PASI) of < 2 - Physician Global Assessment (PGA) of < 2 ### Location - Facility: Windsor Dermatology - Psoriasis Treatment Center of Central New Jersey, East Windsor, New Jersey, 08520, United States @@
## Real-world Study on Dapagliflozin Usage in Patients With Heart Failure (HF) in Germany - NCT ID: NCT06336330 - Study ID: D1699R00050 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2026-09-30 - Lead Sponsor: AstraZeneca ### Study Description Heart failure (HF) is a global, public health issue that affects more than 63 million people worldwide; this burden is expected to increase substantially as the population ages. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality; there is also an immense impact on patients' health-related quality of life (HRQoL). Dapagliflozin was recently granted approval for heart failure by the European Commission, regardless of ejection fraction and whether the patient has diabetes. Real-world observational data are necessary to describe dapagliflozin use in real-world settings in order to assess treatment patterns, HF symptoms and their impact on physical limitation, HRQoL and work productivity, as well as health care utilization of patients treated with dapagliflozin in this setting under local treatment standard conditions in Germany. ### Conditions - Heart Diseases - Cardiovascular Diseases - Heart Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Time to discontinuation of dapagliflozin - Reasons for discontinuation of dapagliflozin - Dose changes of dapagliflozin - Number of patients with dapagliflozin treatment interruptions - Treatment switches from dapagliflozin to other SGLT2i - Time to other heart failure treatment discontinuation - Number of other heart failure treatment initiation - Number of other heart failure treatment dosage changes - Number of other heart failure treatment discontinuation - Number of glucose lowering medication initiation - Number of glucose lowering medication dosage changes - Number of glucose lowering medication discontinuation Secondary Outcomes - Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score - Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire - Absolute change from baseline in Work Productivity and Activity Impairment (WPAI) score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE - NCT ID: NCT06336317 - Study ID: ELIMINATE-2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-12 - Lead Sponsor: Region Örebro County ### Study Description The goal of this randomized, double-blind, placebo-controlled clinical trial is to investigate the immunological effects of influenza vaccination outside of the influenza season on arterial inflammation in patients with a recent acute myocardial infarction (AMI). The primary objective is to compare the effects of influenza vaccination to those of a placebo in reducing post-myocardial infarction coronary inflammation as measured by coronary computed tomography angiography (CCTA). The main questions it aims to answer are:Does influenza vaccination reduce arterial inflammation as measured by CCTA at week 8 after percutaneous coronary intervention (PCI) in comparison to baseline? Does influenza vaccination modulate systemic inflammation as measured by blood biomarkers and in-vitro challenge tests at week 8 after PCI in comparison to baseline? Researchers will compare the effects of influenza vaccination with those of a placebo. ### Conditions - Acute Myocardial Infarction - Cardiovascular Diseases - Inflammatory Response ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Influenza vaccine - Placebo ### Outcomes Primary Outcomes - The right coronary artery Secondary Outcomes - The whole coronary tree - Ascending aorta - Interleukin 1 beta (IL-1β) - Tumor necrosis factor alpha (TNF-α) - Interleukin-2 receptor (IL-2r) - Interleukin Interleukin-6 (IL-6 ) - Ferritin - Troponin-I - N-terminal pro-B-type natriuretic peptide ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## NXT Post-Market Clinical Follow-up - NCT ID: NCT06336304 - Study ID: NXTPMCF-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-12 - Lead Sponsor: Laborie Medical Technologies Inc. ### Study Description NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations ### Conditions - Urinary Incontinence - Urinary Obstruction - Urinary Bladder, Overactive - Urinary Bladder, Neurogenic - Urinary Incontinence, Urge ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Assess NXT system performance - Assess NXT system safety Secondary Outcomes - Assess NXT system performance ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence - NCT ID: NCT06336291 - Study ID: PH-L19TNFLOM-01/23 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-06 - Lead Sponsor: Philogen S.p.A. ### Study Description The trial aims to collect safety, efficacy, exposure, dose- response, pharmacokinetic and pharmacodynamic information of the combination of L19TNF and lomustine at different dose levels in patients with Glioblastoma at progression or recurrence ### Conditions - Glioblastoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - L19TNF - L19TNF - L19TNF - Lomustine - Lomustine ### Outcomes Primary Outcomes - Adverse Events - Serious Adverse Events - Unacceptable Toxicity - DILI assessment - Survival Secondary Outcomes - Overall Survival - Progression Free Survival - Objective Response Rate - Disease Control Rate - Duration of Response - Time to reach maximum drug concentration [Tmax] - Terminal half-life [t1/2] - Area under the drug concentration-time curve, extrapolated to infinity [AUC] - Maximum drug concentration [Cmax] - Human anti-fusion protein antibodies (HAFA) levels against L19TNF ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Relationship Between Central Sensitization and Kinesiophobia in Knee Osteoarthritis - NCT ID: NCT06336278 - Study ID: 19/03/2024 - Status: COMPLETED - Start Date: 2022-10-01 - Completion Date: 2023-12-01 - Lead Sponsor: Selda Sarıkaya ### Study Description Objective: The knee joint is one of most common locations in OA. In recent years, it has been accepted that there are different pain phenotypes and patient subgroups in knee OA and that central sensitization (CS) mechanisms are at the forefront in some patients. It is also known that fear of movement, known as kinesiophobia, develops in patients with chronic pain. The aim of this study is to investigate CS and kinesiophobia in patients with knee OA, their relationships with each other, and their effects on pain intensity, functional status, pain catastrophizing and depression.Materials and Methods: Forty-two patients with knee OA and 42 healthy subjects participated in our study. Demographic data, body mass index, habits, comorbidities, medications of participants and disease duration and radiographic grade of knee OA patients were recorded. VAS was used to assess the severity of pain and WOMAC was used to assess pain and functional status in patients with OA. Algometer (pressure pain threshold measurement) and Central Sensitization Inventory were used to evaluate central sensitization in all participants. Pressure pain threshold (PPT) was measured at 3 different points: knee joint, cruris and forearm. The presence of kinesiophobia was assessed with the Tampa Scale af Kinesiophobia (TSK). Pain Catastrophizing Scale (PCS) and Beck Depression Inventory (BDI) were used to assess chronic pain related symptoms. ### Conditions - Knee Osteoarthritis - Central Sensitisation - Kinesiophobia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pressure Algometer ### Outcomes Primary Outcomes - Pain Pressure Treshold - Central Sensitization - Kinesiophobia Secondary Outcomes - Pain Catastrophizing - Depression - Visuel Analog Scala - Western Ontario and McMaster Universitesies Osteoarthritis Index ### Location - Facility: Zonguldak Bulent Ecevit Universitiy, Zonguldak, N/A, 67100, Turkey @@
## Diaphragmatic Ultrasound to Predict the Therapeutic Effect of High-flow Nasal Cannula Oxygen Therapy - NCT ID: NCT06336265 - Study ID: Diaphragm ultrasound - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-31 - Lead Sponsor: Xingui Dai ### Study Description Follow-up was conducted for every patient requiring high-flow nasal cannula oxygen therapy in district 1 of the Intensive Care Department of Chenzhou NO.1 People's Hospital. Patients who met the inclusion criteria but did not meet the exclusion criteria were included for observation. Respiratory parameters, diaphragmatic activity, and variation rate of diaphragmatic thickness were recorded at the beginning of high-flow nasal cannula oxygen therapy, 1 hour after treatment, 3 hours after treatment, 6 hours after treatment, 9 hours after treatment, and 12 hours after treatment. Throughout the procedure, a panel of experts assessed whether the patient needed endotracheal intubation; If yes, the study was terminated; if no, high-flow nasal cannula oxygen therapy was continued, and observation and evaluation were continued until the end point of the study (12 hours after treatment). If patients or their family members do not want to continue to participate in the study during the study, they will be considered as withdrawal. If patients suffer from sudden malignant arrhythmia or cardiac arrest during the study, resulting in death or transfer to other hospitals or other departments during the study, patients will be excluded. Data from dropped and excluded patients were not included in the final statistical analysis. After the data of 269 patients were collected, the study was concluded, and the results and conclusions were derived by statistical analysis. ### Conditions - Hypoxic Respiratory Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Diaphragm ultrasound ### Outcomes Primary Outcomes - Thickness and thickening fraction of Diaphragm - Diaphragmatic excursion - Respiratory rate - Incidence of tracheal intubation Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Technology Assisted Nudging to Increase Physical Activity Among Hospitalised Medical Patients - NCT ID: NCT06336252 - Study ID: F-23059441 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2026-06-20 - Lead Sponsor: Bispebjerg Hospital ### Study Description Primary Objective To investigate if patients hospitalised for older adults with a decreased level of physical function, either related to a chronic condition e.g., COPD, Congestive heart failure, renal failure; infections; frailty and tendency of falling; orthopaedic surgery - after hip fracture will increase their time spent out of bed during hospitalisation and 3 months after discharge through visual feedback and motivational intervention about physical activities from a new mobile technology.Hypothesis Patients hospitalised for medical disease will increase their physical activity level during hospitalisation and 3 months after discharge through visual feedback and motivational intervention from a new mobile technology. ### Conditions - COPD - Heart Failure - Parkinson Disease - Arthritis - Old Age; Cachexia - Stroke Sequelae ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Digital nudging intervention target to change behavior ### Outcomes Primary Outcomes - Time spent out of bed measured in minutes related to the total accelerometer wear time (minutes) Secondary Outcomes - Readmission within 90 days - Length of stay (days) - Time spent lying down, sitting, standing, and walking measured in minutes related to the total accelerometer wear time (minutes) - Time spent out of bed in hospital in minutes related to the total accelerometer wear time (minutes) - Time spent out of bed after discharge in minutes related to the total accelerometer wear time (minutes) - Quality of life (EQ5D-5L) - - In-hospital fall incidents ### Location - Facility: Christian Dall, Copenhagen, N/A, 2400, Denmark @@
## PrevaLence of Albuminuria in Patients With CARdiovascular Disease and Type 2 Diabetes Mellitus in China: a National Cross-sectional Study - NCT ID: NCT06336239 - Study ID: KS2023097 - Status: RECRUITING - Start Date: 2023-12-21 - Completion Date: 2024-12-30 - Lead Sponsor: Beijing Anzhen Hospital ### Study Description The association between Cardiovascular Disease (CVD) and Chronic Kidney Disease (CKD) is well established. Traditional risk factors for CVD and CKD are similar, with type 2 diabetes mellitus (T2DM) being the most prevalent risk factor. However, CKD is underdiagnosed and undertreated in patients with CVD. Further understanding of the combination of CKD in CVD patients is important to formulate prevention and treatment strategies for CVD patients and high-risk groups, reduce adverse events in CVD patients, and prevent progression of CKD to End Stage Renal Disease (ESRD). ### Conditions - Cardiovascular Disease - Type 2 Diabetes Mellitus ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The prevalence of albuminuria Secondary Outcomes - Lthe prevalence of microalbuminuria and macroalbuminuria evels of microalbuminuria and macroalbuminuria - The prevalence of microalbuminuria and macroalbuminuria - To evaluate the related influence factors of albuminuria and the treatment patterns of CKD patients and non-CKD patients in cardiology departments; - Evaluate the management of patients with type 2 diabetes mellitus and cardiovascular disease across different levels of cardiology departments in hospitals. ### Location - Facility: Beijing Sixth Hospital, Beijing, Beijing, N/A, China @@
## Brachio Basilic Arterio Venous Fistula One Stage vs Two Stage - NCT ID: NCT06336226 - Study ID: BB AVF one stage vs two stage - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: Assiut University ### Study Description The aim of this work was to compare primary failure rates and the primary functional patency of one-stage vs two stage brachiobasilic fistulas to compare the two surgical techniques . ### Conditions - Arterio-venous Fistula ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Brachio basilic arterio venous fistula one stage versus two stage ### Outcomes Primary Outcomes - Comparative study between one stage brachio basilic arterio venous fistula versus two stage Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients - NCT ID: NCT06336213 - Study ID: 20240306 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2024-12-15 - Lead Sponsor: Petrovsky National Research Centre of Surgery ### Study Description According to the literature, presepsin was recommended not only as an effective indicator in the diagnosis of sepsis in intensive care units, but also as a reliable prognostic marker of postoperative inflammatory processes in cardiac surgery. Previous study carried out in Petrovsky NRCS related to biomarkers in cardiac surgery and presepsin in particular showed good sensitivity in infection complications prognosis. ### Conditions - Aortic Aneurysm and Dissection - Cardiac Valve Disease - Thoracic Aortic Aneurysm - Thoracic Aortic Dissection ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Ampicillin-sulbactam ### Outcomes Primary Outcomes - Infectious complications rate Secondary Outcomes - Total amount of complicated patients - Mortality - Length of hospital stay - Length of ICU stay - Multiorgan failure ### Location - Facility: Petrovsky Research National Centre of Surgery (Petrovsky NRCS), Moscow, N/A, 119991, Russian Federation @@
## Knee Osteoarthritis and Kinesiophobia - NCT ID: NCT06336200 - Study ID: Karabuk-006 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-05-30 - Lead Sponsor: Karabuk University ### Study Description Kinesiophobia after total knee arthroplasty is an important parameter affecting recovery. However, the relationship between kinesiophobia and the factors it may cause is not clear. Therefore, this study aimed to examine the relationship between kinesiophobia, pain, fear of falling, mobility and proprioception in the early period after total knee arthroplasty. ### Conditions - Knee Osteoarthritis - Kinesiophobia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Kinesiophobia - Severity of pain - Functional mobility - Proprioception - Fear of falling Secondary Outcomes ### Location - Facility: Ankara Pursaklar Public Hospital, Ankara, N/A, N/A, Turkey @@
## European Active Surveillance of Renal Cell Carcinoma Study (EASE RCC Study) - NCT ID: NCT06336187 - Study ID: UPO 2020 02 - Status: RECRUITING - Start Date: 2018-06-01 - Completion Date: 2030-12 - Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita ### Study Description The goal of this observational, prospective, multi-national clinical study is to assess overall survival of patients who are diagnosed with incidental, histologically (biopsy) confirmed, \<4 cm Renal Cell Carcinoma (RCC) and are managed conservatively with active surveillance.The primary endpoint is overall survival. The Secondary endpoints are tumor growth rate, progression rate, cancer-specific survival, progression-free survival, identification of clinical and pathological variables and molecular and genetic markers that correlate with growth rate and progression.The main question it aims to answer is: patients with RCC (less than 4 cm) diagnosis can be managed with active surveillance instead treated with invasive curative procedure? For all participants a percutaneous biopsy of the renal mass will be arranged in all cases to histologically confirm the diagnosis of RCC (unless a diagnostic biopsy has been acquired in the previous 6 months). As a minimum, two samples will be used for diagnostic purposes while remaining core(s) will be preserved for molecular studies.Then, all patients will be under active surveillance, which is defined as the initial monitoring of tumor size by serial abdominal imaging (US, CT, or MRI) Follow-up visits will be scheduled 3 (optional) and 6 months after diagnosis, every 6 months up to 3 years and yearly thereafter. A follow-up visit will also be carried out at the time of progression when it occurs. Follow-up visits will include medical history and physical examination (optional), and assessment of concurrent medications, blood and urine collection and storage if participating in translational activities, cross-sectional abdominal and chest imaging exams.Follow-up percutaneous biopsies of the renal tumor are not mandatory, but can be performed when considered clinically important. ### Conditions - Renal Cell Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - active surveillance - molecular investigation ### Outcomes Primary Outcomes - Overall Survival Secondary Outcomes - Disease progression - Molecular pattern ### Location - Facility: Ospedale Maggiore della Carità, Novara, N/A, 28100, Italy @@
## Cognitive Decline and Underlying Mechanisms in Symptomatic Intracranial Artery Stenosis Patients: A Cohort Study - NCT ID: NCT06336174 - Study ID: Anhui-SIA-cohort - Status: RECRUITING - Start Date: 2022-11-01 - Completion Date: 2026-12-31 - Lead Sponsor: Anhui Medical University ### Study Description The purpose of this study is to explore the mechanism of cognitive impairment in patients with symptomatic intracranial atherosclerotic stenosis (ICAS), and further plans to explore the impact of different treatment options on cognitive function in symptomatic ICAS patients. ### Conditions - Intracranial Atherosclerosis - Cognitive Impairment - Cerebrovascular Event ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin - Endovascular therapy,Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin ### Outcomes Primary Outcomes - The changes in Memory - Occurrence of ischemic cerebrovascular events Secondary Outcomes - MoCA (Montreal Cognitive Assessment) - MMSE (Mini Mental State Examination) - DST (Digital Span Test; Forward and Backward) - The Stroop Color Test - CTT (Color Trail Test) - CDT (Clock drawing test) - VFT (Verbal Fluency Test) - HAMD (Hamilton Depression Scale) - HAMA (Hamilton Anxiety Scale) - MRI measure- resting state MRI images - MRI measures-structural phase MRI images - MRI measures-3D pCASL images - Ultrasound measures-MCA-PI (middle cerebral artery-pulsatility index) - Ultrasound measures-IMT (intima-media thickness) - Blood Metabolomics measures-CRP (C-reactive protiein) - Blood Metabolomics measures-oxLDL(Oxidized low-density lipoprotein) - Blood Metabolomics measures-miRNA/microRNA ### Location - Facility: Anhui Medical University, Hefei, Anhui, 230032, China @@
## Comparison Between Ultrasound-Guided Erector Spinae Plane Block Versus Ultrasound-Guided Caudal Injection - NCT ID: NCT06336161 - Study ID: ESPB versus CEI - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-05-01 - Lead Sponsor: Al-Azhar University ### Study Description Patient-controlled analgesia is typically used to relieve postoperative pain. Patient-controlled analgesia, on the other hand, is prone to opioid-related side effects. Furthermore, standard postoperative analgesia has a limited analgesic impact. If postoperative lumbosacral spine pain is not successfully treated, it can progress to chronic pain, compromising patients' quality of life.The methods of access for epidural injections are characterized as transforaminal, interlaminar, or caudal. Caudal epidural injections (CEI) are often utilized as a diagnostic or therapeutic tool in a range of lumbosacral-originating spinal pain problems, and they are especially useful in patients with complicated lumbar epidural access diseases, such as post laminectomy syndrome. It is regarded as a very simple treatment in the realm of interventional pain management, and it is also recognized to have a reduced risk of inadvertent Dural puncture than other epidural techniques ### Conditions - Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fentanyl ### Outcomes Primary Outcomes - Measurement of Post-operative Pain Secondary Outcomes ### Location - Facility: Al-Azhar University hospitals, Cairo, N/A, N/A, Egypt @@
## A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors - NCT ID: NCT06336148 - Study ID: ACTM-838-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-07 - Lead Sponsor: Actym Therapeutics, Inc. ### Study Description This is a first in human (FIH) 2-part study using ACTM-838 in patients with advanced solid tumors resistant to standard of care treatment. Part 1a will evaluate dose escalation and Part 1b will evaluate dose expansion. ### Conditions - Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ACTM-838 ### Outcomes Primary Outcomes - Incidence and severity of adverse events and serious adverse events - Part 1a and Part 1b - Proportion of participants experiencing dose limiting toxicities - Part 1a and 1b - Objective response rate (ORR) as defined as complete response (CR) or partial response (PR) - Part 1a and Part 1b - Confirmed ORR defined as confirmed CR or confirmed PR - Part 1b - Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1b - Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1b - Progression free survival (PFS) - Part 1b - Change in tumor markers - Part 1b - Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1b Secondary Outcomes - Objective response rate (ORR) defined as complete response (CR) or partial response (PR) - Part 1a - Confirmed ORR defined as confirmed CR or confirmed PR - Part 1a - Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1a - Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1a - Progression free survival (PFS) - Part 1a - Change in tumor markers - Part 1a - Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1a - Tumor PD colonization as measured by ddPCR and payload delivery as measured by RNA detection - Part 1a ### Location - Facility: Westmead Hospital, Cnr Hawkesbury Road and Darcy Road, Site No: 200, Westmead, New South Wales, 2145, Australia @@
## Reduction in Symptoms After Laser Therapy With Acorn aHFS - NCT ID: NCT06336135 - Study ID: 23-001 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-25 - Completion Date: 2025-12 - Lead Sponsor: Acorn Biolabs Inc. ### Study Description This study evaluates the severity and duration of symptoms experienced after laser therapy comparing four post-procedure topical products. Each product is applied to an individual region of interest (5 cm diameter) on the back or décolleté according to randomization code after laser therapy. The subject, blind to the product applied to each of 4 regions of interest, assesses eight symptoms daily for 14 days. Photography is performed daily. ### Conditions - Skin Aging ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - autologous hair follicle derived secretome ### Outcomes Primary Outcomes - Reduction in severity and duration of symptoms Secondary Outcomes ### Location - Facility: Rejuuv Medi Spa, Markham, Ontario, L3R0M3, Canada @@
## OASIS: Peer Support for T2DM in Appalachia (Peer Participant) - NCT ID: NCT06336122 - Study ID: 83904_1 - Status: RECRUITING - Start Date: 2024-02-21 - Completion Date: 2026-03-31 - Lead Sponsor: University of Kentucky ### Study Description The goal of this clinical trial is to compare the effects of peer coaching models in older adults with unmanaged type two diabetes. The main questions it aims to answer are:Are peer coaching models effective at promoting Type 2 Diabetes Mellitus self-management?If effective, which facets of the peer model are most effective? Peer coaches will Undergo peer coach training.Reach out to peer participants on a weekly/biweekly time frame to discuss self-management and goal setting.Retain records of contact, topics discussed, and general notes on interactions. Researchers will compare differences in the frequency of contact, as well as how peer coaches were matched to peer participants to see if efficacy of the intervention is altered between groups. ### Conditions - Diabetes Mellitus, Type 2 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Peer Coach Training - Weekly - Peer Coach Training - Biweekly ### Outcomes Primary Outcomes - Number of participants with change in A1c Secondary Outcomes - Diabetes Empowerment - Quality of Life Index - Social Support - Depression Scale - Problem Areas in Diabetes - Diabetes Self-Management - Acts of Daily Living - Social Network Scale ### Location - Facility: Barren River Area Development District, Bowling Green, Kentucky, 42101, United States @@
## Fragmented Sleep, Pain, and Biomechanics - NCT ID: NCT06336109 - Study ID: N-20220063-3 - Status: RECRUITING - Start Date: 2024-01-26 - Completion Date: 2024-12-31 - Lead Sponsor: Aalborg University ### Study Description This interventional study aims to test the effects of sleep disruption on pain sensitivity and biomechanics in healthy individuals during experimental knee and shoulder pain. The main question the study aims to answer is:1) Does sleep fragmentation increase experimental knee and shoulder pain and what are the underlying mechanisms?Participants will receive two injections a) Hypertonic saline (painful) in the knee and b) hypertonic saline (painful) in the upper arm. ### Conditions - Pain - Healthy - Sleep Disturbance ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Hypertonic saline knee and shoulder injection ### Outcomes Primary Outcomes - Knee Pain intensity (NRS 0-10) - Shoulder Pain intensity (NRS 0-10) Secondary Outcomes - Pain sensitivity - The Pittsburgh Sleep Quality Index score - The Pain catastrophizing Scale score - The Hospital Anxiety and Depression Scale score - The Knee injury and Osteoarthritis Outcome Score - Rapid Assessment of Physical Activity score - Pain distribution by number of pixels marked on a body chart - Video-based motion capture ### Location - Facility: Aalborg University, Aalborg, Nordjylland, 9000, Denmark @@
## A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation and Strength of Suzetrigine - NCT ID: NCT06336096 - Study ID: VX23-548-017 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2024-10 - Lead Sponsor: Vertex Pharmaceuticals Incorporated ### Study Description The purpose of this study is to evaluate the pharmacokinetics (PK) of suzetrigine (SUZ; VX-548) and its metabolite along with its safety and tolerability, in healthy participants. ### Conditions - Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Suzetrigine - Suzetrigine ### Outcomes Primary Outcomes - Part A: Maximum Observed Plasma Concentration (Cmax) of SUZ - Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of SUZ - Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of SUZ - Part B: Cmax of SUZ - Part B: AUC0-tlast of SUZ - Part B: AUC0-inf of SUZ Secondary Outcomes - Part A: Cmax of SUZ Metabolite - Part A: AUC0-tlast of SUZ Metabolite - Part A: AUC0-inf of SUZ Metabolite - Part A: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) - Part B: Cmax of SUZ Metabolite - Part B: AUC0-tlast of SUZ Metabolite - Part B: AUC0-inf of SUZ Metabolite - Part B: Safety and Tolerability as Assessed by Number of Participants with AEs and SAEs - Part C: Cmax of SUZ and its Metabolite - Part C: AUC0-tlast of SUZ and its Metabolite - Part C: AUC0-inf of SUZ and its Metabolite - Part C: Safety and Tolerability as Assessed by Number of Participants with AEs and SAEs ### Location - Facility: Celerion - Tempe, Tempe, Arizona, 85283, United States @@
## Familial Form of Carotid Web: a Doppler Ultrasound Study - NCT ID: NCT06336083 - Study ID: RC31/23/0618 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-06 - Lead Sponsor: University Hospital, Toulouse ### Study Description There is no evidence of familial forms of carotid web. The aim of this study is to determine the prevalence of carotid web among relatives of patient with carotid web using carotid doppler ultrasound. ### Conditions - Carotid Web ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Doppler ultrasound ### Outcomes Primary Outcomes - Evaluation of the prevalence of carotid web by doppler ultrasound in first-degree relatives of patients with carotid web. Secondary Outcomes - Description of the clinical characteristics of relatives with carotid web and their index case. - Description of the morphological characteristics of relatives with carotid web and their index case. ### Location - Facility: CHU de Toulouse, Purpan, Toulouse, N/A, 31059, France @@
## Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study - NCT ID: NCT06336070 - Study ID: 2024-FIS-3251696 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2028-12-31 - Lead Sponsor: University of Valencia ### Study Description POWER Health is a randomized clinical trial with a two-arm parallel design whose objectives are 1) to study metabolic flexibility and autonomic function (both capacities that describe cardiovascular health) in a sample of postmenopausal oncological women vs postmenopausal untreated controls (CT); and 2) to analyze the impact of two different 8-week physical exercise supervised interventions: HIIT training vs strength training focused on muscle power, on both cardiovascular capacities in these populations. ### Conditions - Breast Cancer Female - Cardiometabolic Syndrome - Metabolism Disorder, Lipid - Autonomic Dysfunction - Cardiovascular Diseases in Old Age ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HIIT program (8 weeks) - MPI program (8 weeks) ### Outcomes Primary Outcomes - Fat oxidation during incremental test - Detrended Fluctuation Analysis Secondary Outcomes - Weight - Height - Calf, waist and hip circumferences. - Lean mass - Fat-free mass - Visceral adipose tissue - Bone Mass - Fat mass - Blood Pressure - Oxygen Saturation - Sarcopenia - Physical activity and sedentariness - Lactate - Rating Perceived Exertion - Visual Analogue Scale of Pain - Cadence - Mechanical Power - Muscle Power 5STS - Basal metabolic rate - Respiratory exheange ratio at rest - Fat oxidation at rest - Carbohydrate oxidation at rest - Carbohydrate oxidation during incremental test - Energy expenditure during incremental test - FATmax intensity - VO2peak - Sample Entropy - SD1/SD2 ratio - The root mean square of successive differences between normal heartbeats (RMSSD) ### Location - Facility: Faculty of Physical Activity and Sport Sciences, Valencia, Comunidad Valenciana, 46010, Spain @@
## Mentalizating in Adults Suffering From Narcolepsy Type 1. - NCT ID: NCT06336057 - Study ID: RC31/23/0408 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: University Hospital, Toulouse ### Study Description The main objective is to examine the potential mentalization impairments affecting a population suffering from narcolepsy type 1. Indeed, the hypothesis of this research is that mentalization could be impaired in narcoleptic patients. ### Conditions - Narcolepsy Type 1 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Mentalization ### Outcomes Primary Outcomes - Comparison of mentalization abilities, in a population of patients with NT1 versus a control group. Secondary Outcomes - Comparison and description of mentalization abilities in a population of patients versus controls. - Better characterization of the clinical impression of an altered subjective experience of the difficulties the patients are going through. - Determination of the existence of a correlation between the time of appearance of the first symptoms and the initiation of treatment and the level of mentalization in NT1 patients, or not. - Determination of the existence of a correlation between the age at the first symptoms of NT1 patients and mentalization abilities, or not. ### Location - Facility: Centre de compétence Narcolepsies et Hypersomnies rares, CHU de Toulouse, Hôpital Pierre-Paul Riquet, Toulouse, N/A, 31059, France @@
## Pre-marketing Clinical Trial to Evaluate the Safety and Efficacy of the Filler of Hyaluronic Acid Recombinant Collagen - NCT ID: NCT06336044 - Study ID: Taufiller/22 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-01 - Lead Sponsor: Taumedika s.r.l. ### Study Description Study to validate the safety and efficacy of the Hyaluronic Acid +Collagen filler 20 patients will undergo through 3 visits one to asses the health and apply the filler one after 4 weeks to check the results one after 16 weeks for the final check and results validation Safety assessed with analysis of the Adverse Events ### Conditions - Wrinkle - Scar - Laxity; Skin ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Karisma ### Outcomes Primary Outcomes - Safety: no adverse events - Efficacy: change of wrinkles and scars - Efficacy: change of wrinkles and scars - Efficacy: change of wrinkles and scars - Efficacy: change of wrinkles and scars Secondary Outcomes - Duration of the efficacy ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of Blood Phobia on Fainting Susceptibility - NCT ID: NCT06336031 - Study ID: 30002163 - Status: RECRUITING - Start Date: 2024-03-30 - Completion Date: 2025-02 - Lead Sponsor: Simon Fraser University ### Study Description The primary purpose of this study is to characterize cardiovascular autonomic function to emotional stimuli (blood-injection-injury phobia \[needle phobia\]) during an orthostatic (upright) challenge in individuals with and without known needle phobia. It is well established that emotional stress can produce hypotensive (low blood pressure) reactions. Interestingly, these hypotensive reactions to venipuncture (even with minimal blood drawn), insulin injections, finger sticks for blood sugar monitoring, dental care, and vaccinations can affect up to a quarter of adults and appear to be uniquely associated with blood-injection-injury phobia rather than other phobias. These hypotensive reactions can ultimately lead to a vasovagal syncope (fainting) response, and lead to increased avoidance of medical and dental procedures as a result of this phobia. Ultimately, this has severe implications on public health and places additional strain on the Canadian healthcare system. Currently, there is limited understanding surrounding the initiation of this response. Additionally, a comprehensive profile of cardiovascular autonomic function during exposure to provoking stimuli during orthostatic stress has not been captured in the literature. We will test individuals with and without blood-injection-injury phobia using our standard approach while exposing them to emotional stimuli. ### Conditions - Syncope, Vasovagal - Blood, Injection, Injury Type Phobia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - blood-injection-injury (BII) phobia stimuli - neutral stimuli ### Outcomes Primary Outcomes - Orthostatic Tolerance Secondary Outcomes ### Location - Facility: Simon Fraser University, Burnaby, British Columbia, V5A 1S6, Canada @@
## A Research Study on Etavopivat in Participants With and Without Liver Disease - NCT ID: NCT06336018 - Study ID: NN7535-7703 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-29 - Completion Date: 2025-07-04 - Lead Sponsor: Novo Nordisk A/S ### Study Description The study investigates an investigational drug called etavopivat in participants with hepatic impairments and participants with normal hepatic function (matched controls). During the study, all participants will be given a single oral dose of etavopivat. All participants will take the etavopivat orally together with water. After dosing, the study will last for 7 to 9 days. ### Conditions - Liver Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Etavopivat ### Outcomes Primary Outcomes - Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose (AUC0-inf, etavopivat) - Maximum observed etavopivat plasma concentration after a single dose (Cmax, etavopivat) Secondary Outcomes - Area under the etavopivat plasma concentration-time curve from 0 hours to the last quantifiable concentration after a single dose (AUC0-last, etavopivat) - Time to maximum observed etavopivat plasma concentration after a single dose (tmax, etavopivat) - Terminal half-life for etavopivat after a single dose (t1/2, etavopivat) - Apparent plasma clearance of etavopivat after a single dose (CL/Fetavopivat) - Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values (Vz/Fetavopivat) - Number of adverse events (AEs) ### Location - Facility: Orlando Clinical Research Center, Orlando, Florida, 32806, United States @@
## A Study to See How Safe a New Medicine (NNC6022-0001) is in Healthy People - NCT ID: NCT06336005 - Study ID: NN6022-7683 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2024-10-17 - Lead Sponsor: Novo Nordisk A/S ### Study Description The study is testing a new study medicine, which is being tested as a potential medicine to treat cardiometabolic diseases.The aim of this study is to see if the study medicine is safe, how it works in participants body, and what the body does to the study medicine.Participants will either get NNC6022-0001 (the new study medicine) or placebo (a "dummy medicine" without the active ingredient). Which treatment participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.The study will last for about 10 months in total. ### Conditions - Healthy Volunteers - Cardiometabolic Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - NNC6022-0001 - Placebo (NNC6022-0001) ### Outcomes Primary Outcomes - Number of treatment emergent adverse events (TEAE) Secondary Outcomes - AUC0-t, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose - AUC0-∞, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to infinity after a single dose - Cmax, SD; the maximum plasma concentration of NNC6022 0001 after a single dose - IL-1β, SD; ratio of <Timepoint> (time of the maximal plasma concentration of NNC6022 0001) to baseline ### Location - Facility: ICON - location Groningen, Groningen, N/A, 9728 NZ, Netherlands @@
## Tissue Regeneration in Patients With Chronic Obstructive Pulmonary Disease After an Exercise Intervention. - NCT ID: NCT06335992 - Study ID: Dnr 2022-00831-01 - Status: RECRUITING - Start Date: 2022-09-01 - Completion Date: 2025-04-30 - Lead Sponsor: Uppsala University ### Study Description The main objective of this project is to identify mechanisms for lung regeneration in patients with COPD induced by exercise training. The hypothesis is that adjusted exercise training improves disease outcome in these patients by decrease remodelling processes linked to oxidative stress, inflammatory and/or immunological pathways in the lung. Along the way, the investigator also expect to identify (or validate) biomarkers mirroring systemic processes such as reduced inflammation and ameliorating the epithelial barrier in these patients. These events may additionally act as potential targets for interventions.Objectives (i) Evaluate biomarkers for regenerative processes, matrix turnover, stem cell activity and inflammatory patterns in lung tissue biopsies, blood- and urine samples correlated to vital lung parameters and physical capacity, before and after attending an exercise-training program.(ii) Study the effects of exercise training on the pulmonary ventilation/perfusion ratio and quality of life.(iii) Evaluate the relation between pathophysiology in the lung evaluated by CT scan, and systemic response measured by muscle biopsies and biomarkers in blood/urine.(iv) Investigate in vitro cell behaviour and remodelling/regenerative processes altered in COPD patients upon exercise training (aim 1). ### Conditions - Chronic Obstructive Pulmonary Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Exercise regime ### Outcomes Primary Outcomes - Pulmonary Function Secondary Outcomes - Physical capacity - Inflammation markers - Level of emphysema - Maximal physical capacity ( Wmax) - COPD Assessment Test (CAT) ### Location - Facility: Lund University, Lund, N/A, N/A, Sweden @@
## An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE). - NCT ID: NCT06335979 - Study ID: CPIT565B12101 - Status: NOT_YET_RECRUITING - Start Date: 2024-12-16 - Completion Date: 2028-08-23 - Lead Sponsor: Novartis Pharmaceuticals ### Study Description The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565 in participants with SLE ### Conditions - Systemic Lupus Erythematosus, SLE ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - PIT565 ### Outcomes Primary Outcomes - Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs) Secondary Outcomes - Maximum Observed Blood Concentrations (Cmax) - Time to Reach Maximum Blood Concentrations (Tmax) - Presence/absence of Anti-drug Antibodies ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## BEST-RPP Pilot: Screening for Esophageal Cancer in Rural Oregon Without an Endoscopy - NCT ID: NCT06335966 - Study ID: STUDY00025975 - Status: RECRUITING - Start Date: 2024-01-25 - Completion Date: 2025-01-30 - Lead Sponsor: OHSU Knight Cancer Institute ### Study Description Recent advancements in swallowable esophageal cell-collection devices (SECD) offer a safe, minimally invasive, accurate, and low-cost alternative to esophageal screening without the need for an upper endoscopy. The BEST-RPP study aims to evaluate the acceptability and feasibility of using this novel approach to screen for Barrett's Esophagus (BE) and Esophageal Carcinoma (EAC) in rural primary care clinic settings in Oregon. ### Conditions - Esophageal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Screening with swallowable esophageal cell-collection devices (SECD) ### Outcomes Primary Outcomes - Feasibility of the use of a SECD: Number of providers who indicate likelihood of using SECD - Feasibility of the use of SECD: Number of providers who indicate willingness to be trained and train clinic staff - Feasibility of the use of SECD: Number of referrals - Feasibility of the use of SECD: Number enrolled - Patient acceptability: Number of interested patients who schedule an appointment to be screened - Patient acceptability: Number of patients who come to their appointments - Patient acceptability: Number of patients interested in being screened via SECD at other care centers Secondary Outcomes - Access: time to full diagnostic work up for patients with positive SECD results ### Location - Facility: OHSU Knight Cancer Institute, Portland, Oregon, 97239, United States @@
## ALIGN: Aligning Medications With What Matters Most (Demonstration) - NCT ID: NCT06335953 - Study ID: IRB00418404 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-18 - Completion Date: 2025-04 - Lead Sponsor: Johns Hopkins University ### Study Description The goal of this clinical trial is to test the effectiveness of a pharmacist-led, primary care-based de-prescribing intervention for people living with dementia (PLWD) and the person's care partners.The intervention consists of the following strategies: 1) a de-prescribing educational brochure designed to activate the patient and care partner; 2) a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of the person's goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored de-prescribing recommendations designed to be useful and actionable for the PCP.The investigators will compare the intervention group with the waitlist control group to see if there is a difference in the primary outcome, the proportion of patients who deprescribe at least one medication by 3 months. ### Conditions - Polypharmacy - Alzheimer's Disease and Related Dementias - Mild Cognitive Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Pharmacist-led deprescribing intervention ### Outcomes Primary Outcomes - Proportion of patients who stop one or more medications Secondary Outcomes - Proportion of patients who start one or more new medications - Proportion of patients who stop one or more potentially inappropriate medication (PIM) - Total number of medications ### Location - Facility: Johns Hopkins Bayview Medical Center, Baltimore, Maryland, 21224, United States @@
## Admission for Respiratory Disease And VIdeo Regulation System - NCT ID: NCT06335940 - Study ID: 38RC23.0376 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-08 - Completion Date: 2024-10-18 - Lead Sponsor: University Hospital, Grenoble ### Study Description Pediatric dyspnea is a major health problem, accounting for up to 27% of admissions to emergency departments in winter. It is estimated that a significant number (13%) of patients presenting to emergency departments are outpatients, at a time when emergency departments are having to cope with an ever-increasing flow of patients.Proper referral of patients calling the SAMU Centre-15 takes on its full meaning in this context, but regulating paediatric calls is more difficult. Indeed, the regulating doctor is most often in contact with the parents, who describe what they see and pass on their concerns, and it is difficult to have direct contact with patients who are often very young. Obtaining objective criteria such as saturation and respiratory rate is also a real challenge.To overcome the complexity of medical regulation, a number of tools and aids have been developed, including visio or video-regulation (regulation via the camera on the caller's smartphone).This device has been evaluated in a number of situations, enabling it to take its place in the daily practice of many doctors, but there is very little data concerning pediatric visio-regulation, particularly with regard to dyspnea.To the best of the investigator knowledge, there is no prospective study looking at the impact of Video-Regulation on the outcome of patients requiring the advice of SAMU Centre-15 for pediatric dyspnea. ### Conditions - Pediatric Respiratory Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Videoregulation ### Outcomes Primary Outcomes - To determine in children under 10 years of age for whom a call to the SAMU38 for dyspnea is made, whether the use of Visio-Regulation reduces the percentage of emergency room admissions compared with standard telephone medical regulation. Secondary Outcomes - Evaluate whether the use of video-regulation has an impact on the dispatcher's referral decision between ambulatory medicine and the emergency department. - Determine whether the use of video-regulation leads to an increase in call time with the regulating doctor - Evaluate parents' satisfaction with videoregulation compared with a standard call - Evaluate the number of rescue vectors (fire brigade, private ambulance) triggered but whose decision will ultimately be to "leave on the spot" after the rescue worker's assessment. - Evaluate whether the increased use of video-regulation is not associated with a higher rate of hospitalization in a conventional ward or intensive care unit ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## HAIC Combined With Cadonilimab and Regorafenib as 2nd-line Treatment for ICC - NCT ID: NCT06335927 - Study ID: GWK2023-001 - Status: RECRUITING - Start Date: 2023-05-11 - Completion Date: 2026-05-10 - Lead Sponsor: Fudan University ### Study Description This study is a single-arm Phase II clinical trial aiming to evaluate the safety and efficacy of HAIC combined with Cadonilimab and Regorafenib as second-line treatment for unresectable intrahepatic cholangiocarcinoma.The study plans to enroll approximately 45 participants. All enrolled participants will receive continuous treatment: HAIC-Gemox: Gemcitabine 1000mg/m2 on Day 1 + Oxaliplatin 85mg/m2 on Day 1, every 3 weeks (Q3W), for up to 6 treatment cycles, Cadonilimab(6mg/kg, D2, Q3W) and Regorafenib (80mg QD, Q3W) until the investigator determines that there is no longer any clinical benefit (based on comprehensive assessment including RECIST v1.1 imaging evaluation and clinical condition), intolerable toxicity, initiation of new anti-tumor therapy, or meeting other criteria for treatment discontinuation, whichever occurs first. ### Conditions - Intrahepatic Cholangiocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - HAIC-GEMOX+Cadonilimab+Regorafenib ### Outcomes Primary Outcomes - Objective Response Rate (ORR) Secondary Outcomes - Hepatic Objective Response Rate (hORR) - Duration of Response (DoR) - Disease Control Rate (DCR) - Time to Response (TTR) - Progression-Free Survival (PFS) - Overall Survival (OS) - Safety and tolerability ### Location - Facility: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China @@
## Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer - NCT ID: NCT06335914 - Study ID: dualPET-mPC - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2029-09-04 - Lead Sponsor: University Health Network, Toronto ### Study Description This study will use Prostate Specific Membrane Antigen (PSMA) and (18)F-Fluorodeoxyglucose Positron Emission Tomography (FDG PET) imaging in patients with advanced prostate cancer to learn about tumor biology across disease stages and during treatment. This may help with treatment selection and potential response monitoring in the future. ### Conditions - Advanced Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Ga 68 PSMA-11 PET - 18F-DCFPyL PET - FDG PET ### Outcomes Primary Outcomes - Proportion of patients with high volume mCSPC having PSMA avid disease Secondary Outcomes - Proportion of patients with PSMA-/FDG+ discordant lesions ### Location - Facility: Princess Margaret Cancer Centre, Toronto, Ontario, M5G 2M9, Canada @@
## Clinical Characteristics and Outcomes of Coronary Heart Disease - NCT ID: NCT06335901 - Study ID: xx20190901 - Status: COMPLETED - Start Date: 2020-02-01 - Completion Date: 2022-04-30 - Lead Sponsor: Xinjiang Medical University ### Study Description This study evaluated and compared the prognostic value of different Baseline data and clinical variables to develop a risk ractor ediction model in patients with CHD. ### Conditions - Coronary Heart Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Drug:Standard therapy ### Outcomes Primary Outcomes - Death （All-cause mortality、Cardiac mortality ） Secondary Outcomes - Major adverse cardiovascular events ### Location - Facility: The First Affiliated Hospital of Xinjiang Medical University, Ürümqi, Xinjiang, 630000, China @@
## A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis - NCT ID: NCT06335888 - Study ID: CRAFT - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2029-05 - Lead Sponsor: Insel Gruppe AG, University Hospital Bern ### Study Description The goal of this open-label clinical trial is to evaluate the efficacy of AzaFol-PET/CT in the diagnosis of GCA (giant cell arteritis), to compare AzaFol- with 2-\[18F\]FDG-PET/CT, and to assess the safety and tolerability of AzaFol in subjects with suspicion of GCA.Participants will undergo AzaFol-PET/CT imaging at a single timepoint. ### Conditions - Giant Cell Arteritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: DIAGNOSTIC ### Interventions - AzaFol - FDG ### Outcomes Primary Outcomes - Specificity of the GCA-diagnosis at the patient level Secondary Outcomes - Lesion detection rate (visual analysis) - Lesion detection rate (semiquantitative analysis) - Sensitivity of the GCA-diagnosis at the patient level ### Location - Facility: Department of Rheumatology and Immunology, University Hospital Bern, Inselspital, Bern, N/A, 3010, Switzerland @@
## Brain Small Chain Fatty Acid Metabolism in Bipolar Disorder: Ketones - NCT ID: NCT06335875 - Study ID: HUM00227568 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2027-03 - Lead Sponsor: University of Michigan ### Study Description Small exploratory open-label pilot study to assess supplementation of a ketone ester (Juvenescence) combined with a 'ketogenic-mimicking diet' as a potential therapy for persons with bipolar disorder. ### Conditions - Bipolar Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Ketone Ester Beverage - Low Glycemic Index Diet ### Outcomes Primary Outcomes - Change in blood beta-hydroxybutyrate level Secondary Outcomes - Change in blood glucose lability - Change in neural network stability ### Location - Facility: Domino's Farms, Ann Arbor, Michigan, 48105, United States @@
## Primary Posterior Tracheopexy Prevents Tracheal Collapse - NCT ID: NCT06335862 - Study ID: NL.84862.041.23 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-03-31 - Lead Sponsor: UMC Utrecht ### Study Description Introduction: Children born with a blind-ending gullet (oesophagus), or Oesophageal Atresia (OA), need to undergo surgical correction in the first week of life. OA is often accompanied by a weakened windpipe (trachea), known as tracheomalacia (TM). TM entails that the windpipe collapses during expiration. Severe TM can cause respiratory symptoms, including frequent respiratory tract infections and blue spells, that can potentially lead to life-threatening events. In some patients, major secondary surgical treatment may be indicated. This surgical procedure involves widening the trachea (using sutures) to prevent collapse, known as secondary posterior tracheopexy (SPT). Prior to performing this SPT, complications and negative consequences of TM may have already occurred. This may be prevented by performing this procedure during the primary OA correction, called a primary posterior tracheopexy (PPT). The aim of this trial is to determine if a PPT can decrease - or prevent - tracheal collapse in newborns with OA and TM, compared to a wait-and-see policy (no-PPT).Methods: This is an international multicentre double-blind randomised controlled trial. Seventy eight children with OA type C will be included. Patients will be included after written parental informed consent. Half of the patients will be randomly allocated to the PPT-group and half to the no-PPT-group. The degree and location of TM are evaluated through preoperative, intraoperative and two postoperative videoscopic examinations of the trachea (tracheobronchoscopy). Whether TM symptoms occur is assessed during three routine follow-up consultations until the age of 6 months. The primary outcome is the degree of collapse of the tracheal wall during the intraoperative tracheobronchoscopy (after performing the PPT/no-PPT), measured in percentages.Risks and burden: Since OA correction with PPT (more recently implemented in centres of expertise) and without PPT (wait-and-see policy) are both accepted and safe treatment options, participating in the trial does not pose an increased risk or burden with regards to the treatment. Performing tracheobronchoscopies may pose a potential burden. However, a tracheobronchoscopy is a routine diagnostic procedure commonly used to safely assess the trachea. Complications of a tracheobronchoscopy are rare. Also, many of the tracheobronchoscopies are routinely performed as part of standard care for these patients, regardless of the trial. ### Conditions - Oesophageal Atresia With Tracheo-Oesophageal Fistula - Tracheomalacia - Oesophageal Atresia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Randomisation between the PPT- and no-PPT-group - Primary Posterior Tracheopexy - Preoperative tracheobronchoscopy - Intraoperative tracheobronchoscopy - Postoperative tracheobronchoscopy through the endotracheal tube during extubation - Postoperative tracheobronchoscopy after 2-6 months ### Outcomes Primary Outcomes - Difference in degree of TM between the PPT-group and no-PPT-group during intraoperative tracheobronchoscopy Secondary Outcomes - Key secondary outcome: Difference in degree of TM between the PPT-group and no-PPT-group during postoperative tracheobronchoscopy - Difference in symptoms between the PPT-group and no-PPT-group - Degree of preoperative TM compared to postoperative TM ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Safety and Immunogenicity Trial of the Recombinant Zoster Vaccine （CHO Cell）, LYB004 in Adults Aged 50 to 70 Years - NCT ID: NCT06335849 - Study ID: LYB004-CT-AUS-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-05 - Lead Sponsor: Guangzhou Patronus Biotech Co., Ltd. ### Study Description This phase 1 study in Australia will evaluate the safety and immunogenicity of the Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 50 to 70 Years. ### Conditions - Herpes Zoster ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - LYB004 25µg - LYB004 50µg - SHINGRIX ### Outcomes Primary Outcomes - Evaluate the reactogenicity of LYB004 vaccine - Evaluate the safety and reactogenicity of LYB004 vaccine - Evaluate the safety of LYB004 vaccine - Evaluate the safety and tolerability in laboratory tests of LYB004 vaccine - Evaluate the SAEs and AESIs of LYB004 vaccine Secondary Outcomes - Observe the humoral immunity of LYB004 vaccine - Observe the cellular immunity of LYB004 vaccine - Observe the persistence of humoral immunity of LYB004 vaccine - Observe the persistence of cellular immunity of LYB004 vaccine ### Location - Facility: Nucleus Network Pty Ltd, Melbourne, Victoria, 3004, Australia @@
## The Effects of Social Isolation and Social Interaction on the Risk of Dementia Progression and Brain Function in SCD (Subjective Cognitive Decline, SCD) - NCT ID: NCT06335836 - Study ID: 2024-SR-127 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2028-12-30 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description The goal of this clinical trial is to learn about the effects of social isolation and social interaction on the risk of dementia progression and brain function in SCD1. To explore the association between social isolation and lonely SCD populations and the occurrence and progression of MCI and AD through cross-sectional studies, cohort studies and randomized controlled trials of SCD;2. To clarify the correlation between different carrier states, resting brain function connectivity characteristics, and dual-task walking ability of APOEε4 allele and the progression of SCD to MCI and AD during the cognitive progress of people with SCD affected by social isolation;3. Establish a predictive model of cognitive decline from SCD to MCI and AD, and apply it to the SCD population to carry out individualized interventions;4. Confirm the protective effect of social interaction on cognitive level and brain function in SCD patients. ### Conditions - Social Isolation - SCD - Subjective Cognitive Decline - MCI - Mild Cognitive Impairment - AD - Alzheimer Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - social isolation ### Outcomes Primary Outcomes - Incidence of Mild Cognitive Impairment (MCI) - Incidence of Alzheimer's disease (AD) Secondary Outcomes - AVLT-H - MoCA - WMS-RLM - WDS - VFT - BNT - LSNS-6 - UCLA - GDS - PSQI - DTC - fMRI - tau - Aβ - APOE genotyping - TMT-A, TMT-B ### Location - Facility: The First Affiliated Hospital of Nanjing Medical University, Nanjing, China, Jiangsu, 210000, China @@
## Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology - NCT ID: NCT06335823 - Study ID: STUDY20231621 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-08-01 - Lead Sponsor: Jean Marino ### Study Description Pain with intrauterine device (IUD) insertion is very common and there are few options for patients to help reduce this pain. Transcutaneous electric nerve stimulators (TENS) are a non-invasive procedure that may help reduce the pain with IUD insertions. The investigators hope that the information gleaned from this study will result in pain control options for future patients who desire an IUD placement. ### Conditions - IUD Insertion Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Transcutaneous electrical nerve stimulation (TENS) - Placebo Transcutaneous electrical nerve stimulation (TENS) ### Outcomes Primary Outcomes - Pain during IUD insertion as measured by the VAS score Secondary Outcomes - Pain during IUD insertion as measured by the VAS score - Pain during IUD insertion as measured by the VAS score - Pain during IUD insertion as measured by the VAS score - Pain during IUD insertion as measured by the VAS score ### Location - Facility: University Hospitals, Cleveland, Ohio, 44106, United States @@
## Reducing Obesity Using Social Ties Program - NCT ID: NCT06335810 - Study ID: 23-10026599 - Status: RECRUITING - Start Date: 2024-04-05 - Completion Date: 2026-03 - Lead Sponsor: Weill Medical College of Cornell University ### Study Description This trial aims to test the feasibility and acceptability of addressing interpersonal barriers to weight-related behavior change. Specifically, the study will test if, by including up to two friends, family members, or co-workers in a lifestyle intervention for weight loss, the person enrolled in the study loses more weight than someone whose friends, family members, or co-workers were not invited to participate. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Social Network Intervention - Individual Lifestyle Intervention - Social Network Member ### Outcomes Primary Outcomes - Number of participants who have attended at least 75 percent of the behavioral coaching sessions - Number of intervention participants who have at least one social network member engage in the study - Number of participants and social network members combined who complete the final study assessment Secondary Outcomes - Change in positive communication and problem solving as measured by the McMaster Family Assessment Device (FAD) Questionnaire - Change in weight related social norms - Change in median Fitbit wear time in minutes - Change in total caloric amounts on three-day food record - Change in median number of days that the Fitbit is worn ### Location - Facility: Weill Cornell Urology, Brooklyn, New York, 11217, United States @@
## Optimization of Postoperative Bowel Habits - NCT ID: NCT06335797 - Study ID: IRB00110733 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-12 - Lead Sponsor: Wake Forest University Health Sciences ### Study Description Project is a trial, in which women undergoing vaginal surgery for pelvic organ prolapse will be randomized 1:1 to a postoperative bowel regimen of either oral senna or rectal bisacodyl suppository. ### Conditions - Constipation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Senna Tab - Dulcolax Suppositories ### Outcomes Primary Outcomes - Time in hours to first bowel movement comparison between the two arms Secondary Outcomes - Change in Overall Satisfaction (TSQM) Scores - Visual Analog Scale (VAS) Pain Scores - Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) Scores - Bristol Stool Form Scale (BSFS) Scores ### Location - Facility: Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States @@
## Mental Imagery and Targeted Memory Reactivation in Insomnia - NCT ID: NCT06335784 - Study ID: 2023-00456 - Status: RECRUITING - Start Date: 2024-04-22 - Completion Date: 2027-08-31 - Lead Sponsor: University Hospital, Geneva ### Study Description In this clinical trial, the investigators test whether mental Imagery Rescripting (IR), a technique where the individual is instructed to transform a negative memory or image into a positive one, and olfactory Targeted Memory Reactivation (TMR), a technique used to strengthen memories, can reduce hyperarousal and insomnia severity in patients with Insomnia Disorder (ID).Patients with ID will be randomized into four groups: in the first group (SH group), patients will have 4 weekly sessions (1 session/week) of a minimal intervention for insomnia (sleep hygiene information) in the presence of an odorless diffuser, which will be also used during the night. In the second group (IR group), patients will use IR during wakefulness to induce a state of relaxation and positive emotionality. More specifically, during 4 weekly sessions of IR, patients will imagine a negative scenario related to their pre-sleep images or current concerns (e.g., social interactions, self-image, sleep problem, nightmares) and transform it into a positive script. They will then perform IR every day for 4 weeks at home in the presence of an odorless diffuser, which will be also used during the night. In the third group, patients will undergo the same 4 weekly IR sessions and an odor will be paired to the positive imagery and will be diffused during the night (TMR group). Patients from this group will also perform IR every day for 4 weeks at home. Finally, the fourth group (OA group) will receive 4 weekly sessions of sleep hygiene instructions in the presence of an odor, which will be also used during the night.Clinical evaluation of insomnia severity before and after the intervention will take place using the Insomnia Severity Index (ISI, primary outcome measure).At the end of these interventions, patients with persistent symptoms will benefit from an alternative experimental treatment ("rocking bed") in which they will be cradled for one night.The investigators hypothesize that patients treated with IR will have significantly reduced insomnia severity compared to participants who received a minimal intervention. They also hypothesize that patients of the TMR group, will have more reduced ID severity compared to participants performing IR and with an odorless diffuser, therefore without an association (IR group). Finally, they hypothesize that one night of sleeping in a rocking bed will improve objective measures of sleep in ID compared to a stationary condition. ### Conditions - Insomnia Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Imagery Rescripting (IR) - Imagery Rescripting (IR) and Targeted Memory Reactivation (TMR) during sleep - Sleep Hygiene - Sleep Hygiene + Odor - "Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the intervention ### Outcomes Primary Outcomes - Insomnia Severity Index (ISI) Secondary Outcomes - Pittsburgh sleep quality index (PSQI) - Total Sleep Time (TST) - Wake After Sleep Onset (WASO) - Beck Depression Inventory II (BDI-II) - State Trait Anxiety Inventory (STAI) - Sleep efficiency (SE) - Micro-arousals ### Location - Facility: Center for Sleep Medicine, Geneva, N/A, N/A, Switzerland @@
## Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity - NCT ID: NCT06335771 - Study ID: 2098077 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2028-03 - Lead Sponsor: Bettina Mittendorfer ### Study Description The goal of this study is to evaluate the role of transcription factor EB (TFEB) in adipose (fat) tissue macrophages (ATM) in regulating adipose tissue and systemic metabolic function in obesity. The investigators will assess the differences in ATM lipid metabolism in people with metabolically abnormal obesity and lean individuals.Both groups will have:* screening visit* imaging (body composition testing - dual-energy x-ray absorptiometry (DEXA) scans, magnetic resonance imaging \[MRI\] and magnetic resonance spectroscopy \[MRS\] scans)* Overnight visit with intravenous infusion (IV), muscle, and fat tissue biopsies Participants with obesity will complete meetings with study team members for a weight loss intervention to achieve a 10% body weight loss. ### Conditions - Obesity - Nonalcoholic Fatty Liver - Diabetes Type 2 - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Dietary consultation weight loss intervention ### Outcomes Primary Outcomes - Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure. - 24-hour plasma glucose concentration - Macrophage isolation in adipose tissue biopsy - Macrophage isolation in skeletal muscle tissue Secondary Outcomes ### Location - Facility: University of Missouri School of Medicine, Columbia, Missouri, 65212, United States @@
## Non-randomized Observational Study to Evaluate ReX® in the Management of Solid Oral Medication. - NCT ID: NCT06335758 - Study ID: EXC-039-2023-CLR - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2026-01-31 - Lead Sponsor: Dosentrx Ltd. ### Study Description The goal of this observational study is to evaluate the safety, efficacy and patient satisfaction with the ReX Remote Digital Nurse by patients receiving solid oral medication.The study will evaluate and monitor use of ReX in respect of:* treatment duration* adverse events* patient adherence and compliance* engagement with ReX via patient-reported outcomesPatients participating in the study will receive their normal medication as standard of care via ReX. Progress will be monitored via patients' responses to questions presented on the ReX touch screen. ### Conditions - Any Solid Oral Medication ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Use of ReX to dispense and monitor solid oral medication therapy. ### Outcomes Primary Outcomes - Treatment duration - Patient satisfaction - Adverse events - Patient adherence - Patient compliance - Patient engagement Secondary Outcomes ### Location - Facility: OHC, Cincinnati, Ohio, 45242, United States @@
## PediCARE Health Equity Intervention in High-Risk Neuroblastoma - NCT ID: NCT06335745 - Study ID: 24-066 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2030-04-01 - Lead Sponsor: Dana-Farber Cancer Institute ### Study Description This is a randomized Phase II trial evaluating the addition of the Pediatric Cancer Resource Equity (PediCARE) health equity intervention to usual supportive care for poverty-exposed children with newly diagnosed high-risk neuroblastoma.The names of the intervention groups in this research study are:* Usual supportive care* PediCARE + usual supportive care ### Conditions - Neuroblastoma - High-risk Neuroblastoma - Pediatric Cancer - Disparities - Financial Stress - Poverty ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - PediCARE Intervention ### Outcomes Primary Outcomes - Change in Kessler-6 Psychological Distress Scale Score Secondary Outcomes - Proportion of Enrolled Participants (Feasibility) - Change in Mean Household Material Hardship (HMH) Score ### Location - Facility: Boston Children's Hospital, Boston, Massachusetts, 02215, United States @@
## Prevalenc Of Lumbosacral Radiculopathy Among Physiotherapists Of Pediatric Rehabilitation OF PEDIATRIC REHABILITATION - NCT ID: NCT06335732 - Study ID: P.T.REC/012/004394 - Status: COMPLETED - Start Date: 2022-12-05 - Completion Date: 2023-08-22 - Lead Sponsor: Kerolous Ishak Shehata ### Study Description Determine the prevalence of lumbosacral radiculopathy among pediatric physiotherapists in the ministry of health in Cairo, Egypt. ### Conditions - Prevalence, Lumbosacral Radiculopathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cross section study; single group related measurement design. ### Outcomes Primary Outcomes - The Roland-Morris disability scale (RMS) - Straight Leg Raising (SLR) Secondary Outcomes ### Location - Facility: Kerolous Ishak Shehata, Cairo, N/A, N/A, Egypt @@
## Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome - NCT ID: NCT06335719 - Study ID: IRB #22-926 - Status: RECRUITING - Start Date: 2023-03-01 - Completion Date: 2025-06 - Lead Sponsor: The Cleveland Clinic ### Study Description A research study to find out if brief intraoperative electrical stimulation therapy improves nerve regeneration and smile outcomes following two-stage cross face nerve graft facial reanimation surgery. ### Conditions - Facial Paralysis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BES - Standard of Care surgery ### Outcomes Primary Outcomes - To evaluate efficacy of an intraoperative dose of brief electrical stimulation (BES) to improve axonal regeneration across a cross-face nerve graft (CFNG) using nerve histology. Secondary Outcomes - To evaluate clinical outcomes of treatment and control groups using patient reported, and IRB approved CCF Facial Nerve Survey. ### Location - Facility: Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States @@
## The Influence of Fit of Underpants Worn on Semen Quality - NCT ID: NCT06335706 - Study ID: 0596/66 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-05 - Lead Sponsor: Chulalongkorn University ### Study Description The goal of this observational study is to investigate the impact of underpants fit among Thai males attending the Infertility Clinic, whether alone or with their spouses. The main questions it aims to answer are:* Assessing the effect of underpants fit on basic semen parameters and sperm DNA integrity.* Determining the prevalence of preferred type of underpants worn by Thai males.The participants will need to provide informed consent, complete a questionnaire consisting of 28 questions, and provide a semen sample. ### Conditions - Infertility, Male - Semen Analysis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Fit of underpants worn ### Outcomes Primary Outcomes - Semen Volume - Total sperm count - Sperm concentration - Sperm motility - Sperm morphology Secondary Outcomes - Sperm DNA integrity ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Adjuvant Hypofractionated Radiotherapy for Prostate Cancer - NCT ID: NCT06335693 - Study ID: CHHHospital - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2027-02-28 - Lead Sponsor: Changhai Hospital ### Study Description Hypofractionated radiation therapy is a new type of radiotherapy which has been shown to play a larger role in the treatment of prostate cancer. The aims of the trial were to evaluate the safety and feasibility of adjuvant hypofractionated radiotherapy following radical prostatectomy for prostate cancer. ### Conditions - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Radiotherapy ### Outcomes Primary Outcomes - Incidence of radiotherapy-related gastrointestinal and genitourinary adverse events Secondary Outcomes - progression-free survival (PFS) - medical expenses - quality of life(QoL) - overall survival (OS) - prostate cancer-specific survival (CSS) ### Location - Facility: The First Affiliated Hospital of Naval Medical University, Shanghai, Shanghai, 200433, China @@
## [Trial of device that is not approved or cleared by the U.S. FDA] - NCT ID: NCT06335680 - Study ID: 21-001493 - 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 @@
## mpMRI Compared to Diagnostic TURBT in Patients With Suspected Muscle-Invasive Bladder Cancer Objectives - NCT ID: NCT06335667 - Study ID: 4565 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2030-04 - Lead Sponsor: University of California, Irvine ### Study Description This is a pilot, single arm, prospective study that aims to validate the accuracy of the VI-RADS score obtained via multi-parametric magnetic resonance imaging (mpMRI) compared to pathologic cancer stage obtained via diagnostic transurethral bladder tumor resection (TURBT) as well as compare the clinical and quality of life outcomes between these diagnostic modalities in patients with suspected muscle-invasive bladder cancer (MIBC). ### Conditions - Urothelial Bladder Cancer - Muscle-Invasive Bladder Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - mpMRI + Diagnostic TURBT ### Outcomes Primary Outcomes - Incidence of concordance between VI-RADS score of 4 or 5 (i.e. muscular propria is likely or very likely) on mpMRI and pathologic muscularis propria invasion (i.e. pT2 tumor stage) on diagnostic TURBT. Secondary Outcomes - Progression free survival (PFS) with mpMRI compared to diagnostic TURBT - Time from intervention that determines invasiveness of bladder tumors (i.e. diagnostic TURBT versus mpMRI) to initiation of cancer-directed therapy - Time from initial cystoscopy to intervention that determines invasiveness of bladder tumors (i.e diagnostic TURBT versus mpMRI). - Incidence of adverse events with mpMRI versus diagnostic TURBT. - Patient Quality of Life with mpMRI versus diagnostic TURBT. - Incidence of repeat TURBT. - Diagnostic healthcare expenditure with mpMRI versus diagnostic TURBT ### Location - Facility: Chao Family Comprehensive Cancer Center University of California, Irvine, Orange, California, 92868, United States @@
## Real-time Artificial Intelligence-based Endocytoscopic Diagnosis of Colorectal Neoplasms - NCT ID: NCT06335654 - Study ID: 24K056-001 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-31 - Lead Sponsor: The First Hospital of Jilin University ### Study Description Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related death worldwide. Colonoscopy is considered the preferred method of screening for colorectal cancer, and resection of colorectal lesions can significantly reduce the incidence and mortality of colorectal cancer. In order to improve the qualitative and quantitative diagnosis of colorectal lesions, many endoscopic techniques, such as image-enhanced endoscopy (IEE), including narrowband imaging (NBI), magnifying endoscopy, pigment endoscopy, confocal laser endoscopy, and endocytoscopy (EC) are applied clinically. However, with the increasing number of endoscopic resection, the costs associated with the pathological diagnosis of endoscopic resection and resection specimens increase year by year. In clinical practice, some non-neoplastic colorectal lesions may not require resection, so it is important to distinguish neoplastic from non-neoplastic during colonoscopy. The application of EC is intended to achieve the purpose of real-time histopathological endoscopic diagnosis without biopsy. Several studies have shown that EC is effective in identifying the nature of colorectal lesions and judging the depth of invasion in CRC. Based on the endoscopic diagnosis, the endoscopist can determine the treatment plan for the colorectal lesions. The latest EC is an integrated endoscope with a contact light microscopy system with a maximum magnification of 520 x. EC can demonstrate the atypical of gland structure and cells after staining and display the super-amplified surface microvessels of the lesion under the EC-NBI mode. However, the judgment of endocytoscopic images needs a lot of experience to improve the diagnostic accuracy. Moreover, endoscopists have certain subjective judgments and errors in endocytoscopic diagnosis. There is an artificial intelligence system which has been developed to identify colorectal neoplasms. However, there is still a lack of prospective clinical verification based on Chinese population. In the study, the investigators performed a prospective clinical study to determine the diagnostic accuracy of artificial intelligence system. ### Conditions - Colorectal Neoplasms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - artificial intelligence system ### Outcomes Primary Outcomes - sensitivity - specificity - accuracy - positive predictive value - negative predictive value - high confidence diagnosis rate Secondary Outcomes ### Location - Facility: First hospital of Jilin University, Changchun, Jilin, 130021, China @@
## Head COOLing in iscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety stuDy - NCT ID: NCT06335641 - Study ID: COOLHD24-CAN - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: University of Calgary ### Study Description This is an investigator-initiated, prospective, open-label, single-arm, non-randomized study to assess the safety and feasibility of external active conductive head cooling during endovascular thrombectomy procedures. ### Conditions - Stroke, Acute ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - External active conductive head cooling ### Outcomes Primary Outcomes - Adherence to the intervention. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix - NCT ID: NCT06335628 - Study ID: RCT: CTG-VCMX - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2029-04 - Lead Sponsor: University of Bern ### Study Description The aim of this research project is to compare two surgical procedures to improve soft tissue volume. Both procedures have already been validated, but despite their great clinical relevance, little data exists in the literature. With this study, the investigators aim to evaluate volumetric changes of connective tissue graft versus biomaterial (membrane). In addition, further clinical measurements will be taken and patient satisfaction will be assessed. ### Conditions - Connective Tissue Graft - Volume Collagen Matrix Xenograft ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Geistlich Fibro-Gide® ### Outcomes Primary Outcomes - Volumetric dimensional changes Secondary Outcomes - Clinical: PPD - Clinical BoP - Clinical: Suppuration - Clinical: Mucosa - Clinical: ktw - Clinical: Mobility - Clinical: Thickness - Clinical: Contributing factors - Patient-reported satisfaction - Patient-reported esthetics - Patient-reported discomfort - Patient-reported pain - Prosthetics Survival - Prosthetics Sucess - Prosthetics Complications - Prosthetics PES-WES - Prosthetics: Occlusal - Prosthetics: Interproximal - Radiographics BL - Radiographics PP - Radiographics distance - Radiographics Contacts ### Location - Facility: University of Bern, Bern, N/A, 3010, Switzerland @@
## A Brief Acceptance Intervention for Stress to Improve Students' Well-Being - NCT ID: NCT06335615 - Study ID: FMG-5790_2023 - Status: COMPLETED - Start Date: 2023-11-27 - Completion Date: 2023-12-19 - Lead Sponsor: VU University of Amsterdam ### Study Description The goal of this randomized controlled trial is to test a brief psychological intervention that focusses on acceptance of stress in a student population. The main questions it aims to answer are:* Does this brief acceptance intervention increase the well-being of students in the short term?* By which mechanisms does this effect occur?* What are moderating factors of this effect?Half of the participants follow a one-hour intervention, which includes* psychoeducation and metaphors about stress and how acceptance can help to deal with it* experiential exercises* mindfulness meditation* mindfulness homework practiceStudents that receive the intervention will be compared to students that merely received psychoeducation about stress and acceptance to see if the intervention lead to larger increases in well-being. ### Conditions - Stress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Brief Acceptance Intervention - Psychoeducation ### Outcomes Primary Outcomes - Psychological Well-Being Secondary Outcomes - State Anxiety - Study Stress - Interoceptive awareness - Psychological Flexibility ### Location - Facility: University of Amsterdam, Amsterdam, Noord-Holland, 1018 WS, Netherlands @@
## TCM for Post-operative Edema - NCT ID: NCT06335602 - Study ID: 202301283A3 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2025-12-31 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description There are loads of research on knee surgery, including surgical methods, rehabilitation strategies, and complication prevention. Whether it is general surgery or endoscopic surgery, there may be postoperative joint swelling, which may last for several weeks depending on the patient's condition. Therefore, reducing swelling as soon as possible is important in post-operative treatment. Swelling of the knee joint may increase soft tissue tension, causing pain and discomfort, and affecting the range of motion and functional recovery of the joint. It may also affect wound healing and increase the risk of complications such as infection and thrombosis. Most clinical research related to traditional Chinese medicine focuses on reducing pain, and little attention is paid to reducing swelling, relatively. Nevertheless most relevant literatures discuss total knee replacement surgery.Cruciate ligament surgery is very common in sports medicine orthopedics. It is expected that ordinary patients get function recovery quickly after surgery, and athletes can return to play as soon as possible. This study is a prospective study, with partially double-blinded, randomized controlled study design. The investigators are aiming to TCM intervention for knee swelling after cruciate ligament surgery, and evaluation of postoperative swelling and functional improvement. TCM intervention methods are laser acupuncture and external application of herbal medicine. ### Conditions - Anterior Cruciate Ligament Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - LASER acupuncture ### Outcomes Primary Outcomes - Leg girth measurement Secondary Outcomes - VAS - WOMAC - Tegner score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Adapting Treatment Delivery to Improve Retention in Evidence-Based PTSD Treatment - NCT ID: NCT06335589 - Study ID: CDX 24-002 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-17 - Completion Date: 2026-12-31 - Lead Sponsor: VA Office of Research and Development ### Study Description Posttraumatic stress disorder (PTSD) is prevalent among Veterans and effective evidence-based psychotherapies (EBPs) for PTSD have been implemented within the Veterans Health Administration (VHA). However, retention in PTSD EBPs is poor. Premature dropout is associated with worse clinical outcomes and greater healthcare utilization. Delivery of PTSD EBPs in a massed format, typically three or more days per week delivered within a month, have shown promise for increasing retention. The present study is a pilot feasibility and acceptability study comparing massed PTSD treatment to treatment as usual (e.g., typically weekly treatment). ### Conditions - Stress Disorders, Post-Traumatic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - EBP-Massed - EBP-TAU ### Outcomes Primary Outcomes - Treatment completion - Acceptability of Intervention (AIM) - Client Satisfaction Questionnaire-8 (CSQ-8) - Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Severity Score - Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Severity Score Secondary Outcomes - Session attendance - Patient Health Questionnaire-9 (PHQ-9) - Patient Health Questionnaire-9 (PHQ-9) - Brief Inventory of Psychosocial Functioning (BIPF) - Brief Inventory of Psychosocial Functioning (BIPF) ### Location - Facility: Durham VA Medical Center, Durham, NC, Durham, North Carolina, 27705-3875, United States @@
## Establishment of Serum Proteomics Subtypes of Gastric Cancer and Its Clinical Application - NCT ID: NCT06335576 - Study ID: ZSGCproteomics - Status: NOT_YET_RECRUITING - Start Date: 2024-03-31 - Completion Date: 2026-12-31 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description This study is a prospective, single-center, observational study aimed at detecting the status of serum protein profiles at key time points in gastric cancer patients receiving neoadjuvant therapy for advanced disease, and constructing a serum protein model for evaluating the efficacy of neoadjuvant therapy for gastric cancer. Subjects will receive neoadjuvant therapy (treatment regimen determined by the primary physician, limited to systemic therapy, with options including immune checkpoint inhibitor-based regimens and non-immune checkpoint inhibitor-based regimens). After four cycles of treatment, the efficacy will be assessed. Patients eligible for R0 resection will undergo D2 radical surgery regardless of tumor regression, while those ineligible for R0 resection will enter the palliative treatment phase (Note: Subjects are all patients who require neoadjuvant therapy even if they do not participate in this clinical study). Patients will receive regular follow-up evaluations for metastasis/recurrence and survival until tumor recurrence/progression or the last known date of patient survival (Note: Regular follow-up in this study follows the frequency of routine clinical follow-ups). The primary endpoint is progression-free survival (PFS), and the secondary endpoint is pathological response rate (based on Becker tumor regression grading, with residual tumor less than 50% considered effective preoperative treatment).Peripheral venous blood samples will be collected before the start of neoadjuvant therapy (blood sampling point 1 - baseline) and before surgery after neoadjuvant therapy (blood sampling point 2 - post-treatment). Approximately 3 ml of blood will be collected each time, and about 1.5 ml of serum will be obtained after processing. Serum protein profiling will be conducted to assess the expression of protein profiles at these treatment time points. ### Conditions - Gastric Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - This study is a single-arm and observational study with no intervention. ### Outcomes Primary Outcomes - C-index Secondary Outcomes - Sensitivity and specificity of model ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Augmented Reality Navigation Versus Traditional CT Guidance for Preoperative Localization of Pulmonary Nodules - NCT ID: NCT06335563 - Study ID: STAR009 - Status: RECRUITING - Start Date: 2024-03-14 - Completion Date: 2024-12-01 - Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China ### Study Description This study aims to conduct a large-sample randomized controlled clinical trial, using traditional CT-guided thoracic puncture localization as a comparison, to explore the accuracy, safety and clinical advantages of Intelligent AR glasses in assisting preoperative localizing of small pulmonary nodules. ### Conditions - Pulmonary Nodule ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AR glasses-assisted pulmonary nodule puncture localization - CT-guided pulmonary nodule puncture localization ### Outcomes Primary Outcomes - Accuracy of puncture localization of pulmonary nodules Secondary Outcomes - Success rate of puncture localization of pulmonary nodules - Adjust the number of needle punctures - Operating time - Radiation dose ### Location - Facility: Shanghai Pulmonary Hospital, Shanghai, Shanghai, 200433, China @@
## Surgical and Patient Reported Outcomes in Robotic Mastectomy - NCT ID: NCT06335550 - Study ID: 2021/2680 - Status: COMPLETED - Start Date: 2022-11-24 - Completion Date: 2024-03-01 - Lead Sponsor: Changi General Hospital ### Study Description Conventional nipple and/or skin-sparing mastectomy (NSM/SSM) with or without immediate reconstruction is becoming one of the mainstream surgical treatment for breast cancer and risk reducing mastectomy in recent years. While this technique provides satisfactory oncologic and aesthetic outcomes, its disadvantages include skin flap and/or nipple-areolar complex (NAC) necrosis, NAC malposition/distortion as well as visible scar(s) on the breast.In terms of technical aspects, NSM/SSM has its inherent challenges in view of limited incisions and thereby difficulties in dissection. Since 2015, a number of institutions worldwide had adopted a new technique of NSM/SSM using robotic surgical system. Institutional experiences worldwide demonstrated feasibility and safety of this technique coupled with improved patients' satisfactions.To date, there is no center in Singapore or the region offering Robotic NSM/SSM (R-NSM/R-SSM). The authors believe that robotic mastectomy is a feasible and safe technique that can be utilized in our institution and it provides superior aesthetic outcomes with less morbidity and higher patient satisfaction if compared to conventional NSM/SSM.The aim of this study is to conduct a single-arm prospective pilot study to investigate the safety and feasibility as well as learning curve of R-NSM/R-SSM. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Robotic mastectomy ### Outcomes Primary Outcomes - Surgical Outcomes - Operative parameters - Surgical Outcomes - Length of stay (days) - Surgical Outcomes- 30-days morbidity/complications Secondary Outcomes - Oncologic outcomes - Learning curve ### Location - Facility: Changi General Hospital, Singapore, N/A, 529889, Singapore @@
## Impact of Sodium Bicarbonate on 24-hour Urine Parameters in Hypocitriuric and Uric Acid Stone Formers - NCT ID: NCT06335537 - Study ID: 2405 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-02 - Lead Sponsor: University of California, Irvine ### Study Description The incidence of kidney stone disease continues to rise globally. Although the treatment of kidney stone disease has dramatically improved in recent years, surgical management remains invasive and expensive. Patients who develop kidney stones are at high risk of recurrence during their lifetime; therefore, prevention of stones should be a primary focus. Low levels of citrate and acidic urine are risk factors for the formation of kidney stones such as calcium oxalate and uric acid, respectively. Calcium oxalate stones are the predominant stone composition in the United States, accounting for over 2/3rds of stones. Citrate is a key inhibitor of calcium oxalate crystal formation and thus increasing it in the urine of a calcium oxalate stone former is quite beneficial. Uric acid stones account for approximately 10 percent of all stone types. These stones form primarily due to an acidic urinary environment which is a prerequisite for crystal formation. Common medications for stone formers include potassium citrate which help to make the urine more alkaline. Although effective, these medications have side effects and may prove to be too expensive (upwards of $450/month). Consuming baking soda (sodium bicarbonate) may prove to be an inexpensive ($0.34/month) equally effective alternative with respect to increasing urinary citrate levels and alkalinizing the urine. Investigators hypothesize that twice a day oral baking soda in a liquid medium (e.g., water, orange juice, soda, etc.) can be an effective, and inexpensive alternative to urocit K with regard to alkalinizing the urine and raising urinary citrate levels. ### Conditions - Uric Acid Stones ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Potassium citrate - Sodium bicarbonate ### Outcomes Primary Outcomes - Change in 24-hour Urinary pH - Change in 24-hour Urinary Citrate Secondary Outcomes - Change in Supersaturation of Calcium Oxalate - Change in Supersaturation of Uric acid ### Location - Facility: University of California, Irvine Medical Center, Orange, California, 92868, United States @@
## Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants - NCT ID: NCT06335524 - Study ID: IRB-300012718 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2028-08 - Lead Sponsor: University of Alabama at Birmingham ### Study Description This study will test the hypothesis that in preterm infants a caregiver-implemented early developmental intervention (EDI) using finger puppets to develop joint attention and encourage interactive communication with routine EDI care including Bookworm training compared with routine EDI care including Bookworm training alone will increase the Ages and Stages Questionnaire® score at 12 months corrected age. ### Conditions - Child Development - Infant Development - Infant, Premature, Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Finger puppet - Bookworm reading intervention training and routine EDI care. ### Outcomes Primary Outcomes - ASQ-3 scores Secondary Outcomes - ASQ-3 scores - ASQ scores below -2SD - ASQ scores below -2SD - ASQ scores below -1SD - ASQ scores below -1SD - ASQ-SE2 scores - ASQ-SE2 scores - Severe neurodevelopmental impairment - Moderate or severe neurodevelopmental impairment - Cognitive Composite Score on BSID-IV - Language Composite Score on BSID-IV - Motor Composite Score on BSID-IV - Edinburgh Postnatal Depression Scale - MCHAT score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease. Clinical and Biomechanical Outcome Study - NCT ID: NCT06335511 - Study ID: 631-2021-OSS-AUSLBO - Status: RECRUITING - Start Date: 2022-10-10 - Completion Date: 2025-02-28 - Lead Sponsor: Azienda Usl di Bologna ### Study Description Identification of clinical and instrumental parameters that could predict the outcome of surgical decompression of lumbar degenerative stenosis. ### Conditions - Lumbar Spinal Stenosis - Degenerative Lumbar Spinal Stenosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - microsurgical decompression - decompression and instrumented fusion ### Outcomes Primary Outcomes - Short Form 12 - Short Form 12 - Short Form 12 - Short Form 12 - Visual Analogue Scale - Visual Analogue Scale - Visual Analogue Scale - Visual Analogue Scale - Oswestry Disability Index - Oswestry Disability Index - Oswestry Disability Index - Oswestry Disability Index - EuroQol-5D - EuroQol-5D - EuroQol-5D - EuroQol-5D - Postural Balance - Postural Balance - Postural Balance - Postural Balance - Locomotor performance - Locomotor performance - Locomotor performance - Locomotor performance - Spinal mobility - Spinal mobility - Spinal mobility - Spinal mobility Secondary Outcomes - Evaluation of costs ### Location - Facility: IRCCS Istituto Ortopedico Rizzolo, Bologna, N/A, 40136, Italy @@
## Further Study of AFGen1 Clinical Performance - NCT ID: NCT06335498 - Study ID: 130-0008P - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-04-02 - Completion Date: 2024-04-19 - Lead Sponsor: TriVirum, Inc. ### Study Description AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib. The purpose of this study is to establish further evidence for the clinical performance of AFGen1 on human participants. ### Conditions - Atrial Fibrillation - Afib - ECG ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ECG co-measurement - Periodic ECG triggered measurement ### Outcomes Primary Outcomes - Bland-Altman Comparison - Qualitative Evaluation - Adhesive performance Secondary Outcomes ### Location - Facility: 1808 49Th St Ct NW, Gig Harbor, Washington, 98335, United States @@
## Cognitive Behavioral Therapy (CBT) Pain Prevention Intervention for Women Undergoing Surgery - NCT ID: NCT06335485 - Study ID: 2020- P123456 - Status: COMPLETED - Start Date: 2021-04-01 - Completion Date: 2022-09-29 - Lead Sponsor: Brigham and Women's Hospital ### Study Description This study investigates a Cognitive Behavioral Therapy (CBT) intervention for women who are undergoing elective surgery. The objective is to provide a toolkit of stress management techniques to decrease pain and opioid use following surgery. ### Conditions - Back Pain - Cognitive Behavioral Therapy - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Cognitive Behavioral Therapy ### Outcomes Primary Outcomes - Numeric Pain Rating Secondary Outcomes - Pain Medication Usage - Activity Tracking (Digital Phenotyping) ### Location - Facility: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States @@
## Three Nerves Versus Suprascapular Nerve Radiofrequency Combined With Hydrodissection in Adhesive Capsulitis - NCT ID: NCT06335472 - Study ID: Three nerves radiofrequency - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-03-05 - Lead Sponsor: Assiut University ### Study Description comparison between effect of three nerves pulsed radiofrequency combined with hydro-dissection versus suprascapular nerve Pulsed Radiofrequency combined with hydrodissection on pain control in adhesive capsulitis within six months follow up. ### Conditions - Analgesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 3 nerves pulsed radiofrequency with hydrodissection - suprascapular nerve pulsed radiofrequency with hydrodissection ### Outcomes Primary Outcomes - The most effective modality on pain management of shoulder adhesive capsulitis using visual analog score. Secondary Outcomes ### Location - Facility: Assiut university Hospital, Assiut, N/A, N/A, Egypt @@

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