Datasets:

hackint0sh
/

md_dataset

Dataset card Viewer Files Files and versions Community

Split (1)

train · 10k rows

record stringlengths 560 23.9k
## Effect of Shoe Cushioning Position and Properties on Running-related Injury Risk - NCT ID: NCT06384872 - Study ID: 230042_RRI_Interv5 - Status: NOT_YET_RECRUITING - Start Date: 2024-10-01 - Completion Date: 2025-12-31 - Lead Sponsor: Luxembourg Institute of Health ### Study Description The main purpose of this project is to investigate the influence of cushioning material at both the rear and the forepart of running shoes on musculoskeletal complaints in leisure-time runners. Therefore, the objectives are to investigate if1. "Extra soft" cushioning materials can reduce injury risk compared to stiffer materials;2. Cushioning under the forepart of the shoe also influences injury risk, independently of the cushioning at the rear part;3. Effects of cushioning material and position depend on the runner's body mass;4. Perception of cushioning is related to both shoe cushioning and injury risk;5. Other weight-bearing locomotion activities (i.e., number of steps per day besides running practice) represents an independent risk factor for running-related injury.This study consists in a 6-month intervention trial during which leisure-time runners are required to follow their usual training schedule. Before the beginning of the study, the participants will receive a pair of running shoes. The three running shoe models will be exactly the same, except for their foam properties at the rear and forepart of the shoe, which will differ by 33 and 37%, respectively. The study shoes will be administered through random allocation. The participants will be required to use these shoes for all running sessions, and only for running activities.Participants will first fill out a baseline questionnaire. During the intervention, data on running practice will be downloaded from sports watches and their respective app via Strava. Information on the use of the study shoes will be collected via a weekly questionnaire. Participants will be asked to fill out a weekly questionnaire on any musculoskeletal complaints experienced during the past 7 days. A questionnaire on the perception of cushioning will be filled in by the participants at three time points (after 5h of running, 25h of running, and at the end of follow-up).Primary hypothesis:- Greater shock absorption properties at the rear part of running shoes are associated with a lower injury risk in recreational runners.Secondary hypothesis:* Greater shock absorption properties under the forepart of the shoe are also associated with lower injury risk in recreational runners.* Runners with low body mass experience a lower injury risk in shoes with greater shock absorption properties.* Greater perceived cushioning is related to lower injury risk. ### Conditions - Running-related Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Shoe Cushioning Position and Properties ### Outcomes Primary Outcomes - First running-related injury with a duration of minimum one week Secondary Outcomes - First one-day time loss running-related injury - First running-related musculoskeletal complaint to the lower limb - First substantial running-related injury - First overuse running-related injury ### Location - Facility: Luxembourg Institute of Health, Strassen, N/A, 1445, Luxembourg @@
## Effectiveness of Extracorporeal Shockwave Therapy Combined With Platelet-rich Plasma in the Treatment of Chronic Insertional Achilles Tendinopathy - NCT ID: NCT06384859 - Study ID: Pending - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-05-01 - Lead Sponsor: Mahidol University ### Study Description The goal of this clinical trial is to learn about the effectiveness of extracorporeal shockwave(ESWT) combined with platelet-rich plasma(PRP) to treat chronic insertional tendinopathy. The main questions it aims to answer are:Does ESWT combined with PRP treatment reduce the symptom and improve functional score after treatment? What medical complication do participants have when receive the treatment?Researchers will compare ESWT combined with PRP to ESWT treatment alone to see if ESWT combined with PRP works to treat chronic insertional tendinopathy.Participants will:* Receive ESWT once a week for 4 weeks then receive PRP injection at a week later or ESWT once a week for 4 weeks* Visit the clinic at 6 weeks, 3 months, 6 months and 1 year after treatment for checkups and record functional score ### Conditions - Insertional Achilles Tendinopathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ESWT - PRP ### Outcomes Primary Outcomes - VAS Secondary Outcomes - VAS-FA - FFI - FAAM ### Location - Facility: Ramathibodi hospital, Ratchathewi, Bangkok, 10400, Thailand @@
## AI Algorithms in Prediction of ACS Based on Leukocyte Properties - NCT ID: NCT06384846 - Study ID: AI ACS - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2026-12-31 - Lead Sponsor: RobotDreams GmbH ### Study Description The goal of this observational study is to find out if artificial intelligence (AI) can accurately predict acute coronary syndrome (ACS) using data on white blood cells in adults. The main question it aims to answer is:- Can AI algorithms based on white blood cell data predict ACS with accuracy comparable to that of high-sensitivity cardiac troponin (hs-cTn)? Researchers will look at how the AI model's predictions stack up against the standard hs-cTn blood tests to see which is more accurate in diagnosing ACS.Participants in this study will have already had blood tests as part of their usual care. Their previously collected health information and blood test results will be used to help train and test the AI algorithms. Participants will not undergo any new procedures for the study itself. ### Conditions - Acute Coronary Syndrome - Angina Pectoris - NSTEMI - Non-ST Segment Elevation MI - STEMI - ST Elevation Myocardial Infarction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Training of AI models - Testing of AI models Secondary Outcomes - Training of AI models - Testing of AI models: ### Location - Facility: Landeskrankenhaus-Universitätsklinikum Graz, Graz, Styria / Steiermark, 8036, Austria @@
## Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair - NCT ID: NCT06384833 - Study ID: Rama - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-01 - Lead Sponsor: Mahidol University ### Study Description The goal of this clinical trial is to learn if vitamin C and N-acetylcysteine work to improve shoulder functional score after rotator cuff repair. It will also learn about the safety of vitamin C and N-acetylcysteine. The main questions it aims to answer are:Do vitamin C and N-acetylcysteine improve the shoulder functional score of participants? Do vitamin C and N-acetylcysteine improve healing of rotator tendon? Researchers will compare vitamin C and N-acetylcysteine to a placebo (a look-alike substance that contains no drug) to see if vitamin C and N-acetylcysteine works to improve shoulder functional score after rotator cuff repair.Participants will:Take vitamin C and N-acetylcysteine or a placebo every day for 45 days. Visit the OPD three times at 2 week, 6 month and 12 month after surgery for checkups and tests. ### Conditions - Rotator Cuff Tears ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ascorbic acid - N-acetyl cysteine - placebo ### Outcomes Primary Outcomes - ASES score Secondary Outcomes - UCLA shoulder scale - WORC index - Tendon healing at 6 months postoperatively ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC) - NCT ID: NCT06384820 - Study ID: R3767-ONC-2330 - Status: NOT_YET_RECRUITING - Start Date: 2024-11-14 - Completion Date: 2030-05-06 - Lead Sponsor: Regeneron Pharmaceuticals ### Study Description This study is researching an investigational drug called REGN2810, also known as cemiplimab, when combined with another investigational drug called REGN3767, also known as fianlimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on a type of skin cancer known as cutaneous squamous cell carcinoma (CSCC).The aim of the study is to see if cemiplimab or cemiplimab in combination with fianlimab can eliminate or reduce the number of living cancer cells in tumor(s) if taken before surgery.The study is looking at several other research questions, including:* Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make it possible to have a less extensive surgery or a different treatment plan after surgery* Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make the cancer less likely to come back after surgery* What side effects may happen from taking the cemiplimab or cemiplimab in combination with fianlimab* How much of the cemiplimab or cemiplimab in combination with fianlimab is in the blood at different times* Whether the body makes antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects) ### Conditions - Cutaneous Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - cemiplimab - fianlimab ### Outcomes Primary Outcomes - Pathological complete response (pCR) rate by blinded independent pathological review (BIPR) Secondary Outcomes - pCR rate by local pathological review - Major pathological response (MPR) - Event-free survival (EFS) - Disease free survival (DFS) - Objective response rate (ORR) prior to surgery - Overall survival (OS) - Occurrence of treatment-emergent adverse events (TEAEs) - Occurrence of immune-mediated adverse events (imAEs) - Occurrence of treatment-related TEAEs - Occurrence of adverse event of special interest (AESI) - Occurrence of treatment-emergent serious adverse events (SAEs) - Occurrence of laboratory abnormalities - Occurrence of death due to TEAE - Occurrence of interruption of study drug(s) due to TEAEs - Occurrence of discontinuation of study drug(s) due to TEAEs - Occurrence of cancellation of surgery due to TEAE - Occurrence of delay to surgery due to TEAE - Concentrations of cemiplimab in serum - Concentrations of fianlimab in serum - Concentrations of other experimental agents (as applicable) in serum - Incidence of anti-drug antibodies (ADA) to cemiplimab - Incidence of ADA to fianlimab - Incidence of ADA to other experimental agents (as applicable) - Titer of ADA to cemiplimab - Titer of ADA to fianlimab - Titer of ADA to other experimental agents (as applicable) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Phase 1/2 Study of PBI-410 in Advanced Solid Tumors - NCT ID: NCT06384807 - Study ID: BHV1510-101 (PBI-410-101) - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-02 - Lead Sponsor: Pyramid Biosciences ### Study Description This is a Phase 1/2, first in human (FIH), open-label, multicenter study of PBI-410 in participants with previously treated, advanced solid tumors. ### Conditions - Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - PBI-410 ### Outcomes Primary Outcomes - Phase 1: Number of patients with adverse events (AEs) - Phase 1: Recommended dose for expansion (RDE) and maximum tolerated dose (MTD) - Phase 2: Objective Response Rate (ORR) - Phase 2: Number of patients with AEs - Phase 2: Duration of Response (DoR) Secondary Outcomes - Phase 1 and 2: Maximum Plasma Concentration (Cmax) of PBI-410 - Phase 1 and 2: Area Under the Concentration versus time Curve (AUClast) from the end of infusion to the last measurable concentration of PBI-410 - Phase 1 and 2: Area Under the Concentration versus time curve extrapolated to infinity (AUCinf) - Phase 1 and 2: Elimination half-life (t1/2) of PBI-410 in plasma - Phase 1: ORR - Phase 1: Duration of Response (DoR) - Phase 1 and 2: Immunogenicity of PBI-410 - Phase 2: Disease control rate (DCR) - Phase 2: Progression free survival (PFS) - Phase 2: Overall survival (OS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of the ZyMōt Sperm Selection Method and Its Effect on Embryo Ploidy. - NCT ID: NCT06384794 - Study ID: 2211-VLC-157-MD - Status: RECRUITING - Start Date: 2023-06-29 - Completion Date: 2026-12-31 - Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA ### Study Description It has been described that 11% of men with semen values within the normal range established by the World Health Organization (WHO) have sperm DNA fragmentation. This has been associated with a lower fertilization rate, lower embryo development and, therefore, lower reproductive success. Focusing on the study of the integrity of the male genome can provide us information to diagnose infertility in the couple. The use of conventional sperm selection methods such as swim-up or density gradients has been a great advance in the improvement of male fertility. However, these methods use centrifugation in their protocol, a procedure that has been associated with sperm DNA damage. The ZyMōt is a chip based on microfluidic properties that allows the recovery of spermatozoa with lower DNA fragmentation rate without centrifugation of the semen sample. This new sperm selection method maintains all the advantages of conventional techniques, but decreasing DNA fragmentation associates to sperm recoveries techniques eventually improving reproductive rates. This quality would be beneficial for patients with unexplained infertility, recurrent pregnancy loss or clinical varicocele, factors that have been associated with a higher index of DNA fragmentation. However up to date there is evidence-based data supporting such improvement. The main objective of the present project is to evaluate the ZyMōt as a new non-invasive sperm selection device and to see its impact on the euploidy rate, comparing it with a sperm selection technique that is routinely used in the clinic: swim-up. At the same time, the effect that this new chip may have on sperm and other reproductive variables will be analyzed clinically, and molecularly with immunohistochemical and transcriptomic analyses in order to observe the impact of SDF(sperm DNA fragmentation) at the molecular and genomic level in oocytes with low reparative potential oocytes. ### Conditions - Infertility, Male - Sperm Count, Low ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Sperm capacitation through the ZyMōt®Sperm Separation Device® - Swim-up ### Outcomes Primary Outcomes - EUPLOIDY RATE Secondary Outcomes - MOBILITY RATE - VITALITY RATE - DNA FRAGMENTATION RATE - SPERM RETRIEVAL RATE - FERTILIZATION RATE - USEFUL BLASTOCYS RATE ### Location - Facility: Ivirma Madrid, Madrid, N/A, 28023, Spain @@
## Development, Refinement, and Validation of a Peer Support Specialist Checklist for Individuals With Opioid Use Disorder / STAMPS: South Carolina Buprenorphine Treatment Initiation, Adherence, and Retention Utilizing Mobile Health Units and Peer Support Specialists - NCT ID: NCT06384781 - Study ID: 2130836 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-01 - Lead Sponsor: Prisma Health-Upstate ### Study Description This study seeks to develop a tool to better guide and operationalize peer recovery coaching service delivery specifically for patients with opioid use disorder. This study will entail the initial development, acceptability, and validity of this tool in a sample of both peer support specialists (PSSs) and patients with opioid use disorder (OUD). This checklist will be adapted from ACE model PSS interventions for SUD broadly. Open-ended qualitative research questions regarding PSSs roles and responsibilities, patients' needs for recovery support, and perceptions of the checklist will be administered. Participants (PSSs and individuals with OUD) will also answer survey questions in which they indicate their satisfaction and likely to use the tool with the proposed services offered in the checklist. Outcome measures include satisfaction, perceived use of use, and perceived helpfulness of the checklist. We hypothesize that using both PSS and patient input will result in a validated intervention protocol with demonstrated acceptability using it with patients with OUD. ### Conditions - Opioid Use Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Phase 1: Conceptualization - Phase 2: Conceptulization - Phase 3: Refinement - Phase 4: Validation - Phase 5: Preliminary efficacy Secondary Outcomes ### Location - Facility: Prisma Addiction Medicine Center - Mobile Health Clinic, Clinton, South Carolina, 29325, United States @@
## Video Training on Pre-Pregnancy Fear of Birth in Male Partners - NCT ID: NCT06384768 - Study ID: EBIst - Status: COMPLETED - Start Date: 2022-02-01 - Completion Date: 2022-08-30 - Lead Sponsor: Istanbul University - Cerrahpasa (IUC) ### Study Description This study aimed to evaluate the effect of an online video training on fears surrounding childbirth given to male partners before the pregnancy of their spouses. The study conducted with 43 male (22 intervention; 21 control) participants. Participants were divided into intervention and control groups. The intervention group was given video training on pregnancy and the birth process. \"Descriptive Information Form\" and the "Male-Childbirth Fear Prior to Pregnancy Scale" was used for data collection. Before the intervention, it was found that the fear level of childbirth was low. The video training given to male partners before the pregnancy of their spouses diminished the fear of birth but did not create a significant difference. These findings support long-term training that includes video tutorials for parents before birth. Interactive, participatory birth preparation training is likely to enhance the training's appeal for male partners. ### Conditions - Fear of Childbirth ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Video training ### Outcomes Primary Outcomes - Fear of Childbirth Secondary Outcomes ### Location - Facility: Istinye University, Istanbul, N/A, N/A, Turkey @@
## Honest Open Proud for Psychotic and Bipolar Disorder in Norway - NCT ID: NCT06384755 - Study ID: 645788 - Status: RECRUITING - Start Date: 2024-04-20 - Completion Date: 2026-12-31 - Lead Sponsor: Oslo University Hospital ### Study Description The purpose of this pilot study is to evaluate the feasibility, acceptability and efficacy of a Norwegian adaptation of the group-based intervention 'Honest Open Proud' among adults with psychotic and bipolar disorders in an outpatient setting. ### Conditions - Psychotic Disorders - Bipolar Disorder - Disclosure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Honest Open Proud program ### Outcomes Primary Outcomes - Stigma Stress Scale (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009) Secondary Outcomes - Disclosure Distress (Rüsch et al., 2014a) - Warwick and Edinburgh Wellbeing Scale (WEMWBS) (Tennant et al 2007) - Satisfaction with life (Lehman, 1988) - The Questionnaire about the Process of Recovery - 15 (QPR-15) (Niel et al 2007) - Internalised Stigma of Mental Illness Inventory (ISMI-10) (Boyd, Otilingam, & Deforge, 2014) - Patient Health Questionnaire-4 (PHQ-9) (Kroenke et al 2009) - Generalized Anxiety disorder (GAD-7) (Spitzer et al, 2006) ### Location - Facility: Nydalen DPS, Division of Mental Health and Addiction, Oslo University Hospital, Oslo, N/A, 0351, Norway @@
## Shift Worker Intervention for Sleep Health - NCT ID: NCT06384742 - Study ID: K23HL157698 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2027-03 - Lead Sponsor: Oregon State University ### Study Description The aim of this study is to pilot test a comprehensive, personalized, media-augmented telehealth intervention ("SWISH") designed to improve sleep health among shift workers. ### Conditions - Shift Work Type Circadian Rhythm Sleep Disorder - Insomnia, Psychophysiological ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Shift Worker Intervention for Sleep Health ### Outcomes Primary Outcomes - Retention Rate - Session Attendance - Implementation Assessment Measure Secondary Outcomes - Patient Adherence - Therapist Fidelity - Acceptability of Study Procedures and SWISH - Mean 24-hour sleep duration and efficiency - Change in Fatigue Severity Scale - Change in Epworth Sleepiness Scale - Executive functioning - PROMIS Sleep Related Impairment - PROMIS Sleep Disturbances ### Location - Facility: Oregon State University, Corvallis, Oregon, 97331-1102, United States @@
## Effectiveness of the EXOPULSE Mollii Ⓡ Suit in Patients With Multiple Sclerosis - NCT ID: NCT06384729 - Study ID: 123 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-09-01 - Lead Sponsor: Universidad Europea de Madrid ### Study Description Abstract:Background:Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system with unknown etiology, causing a variety of symptoms including impaired balance, coordination, and walking difficulties. The Exopulse Mollii Ⓡ suit is an innovative approach for non-invasive, self-administered electrical stimulation designed to alleviate spasticity and improve motor function in various neurological conditions.Objective:To determine the effectiveness of the Exopulse Mollii Ⓡ suit in improving motor control in patients with MS.Methods:A randomized, double-blind clinical trial will be conducted, recruiting patients diagnosed with MS , aged 18 or above, with a Functional Ambulation Category (FAC) score between 2 and 4. Patients will be randomly assigned to two groups receiving either inactive or active Exopulse Mollii Ⓡ treatment for 60 minutes, three times a week, for three weeks. Outcome measures include pain, balance, gait speed, risk of falls, perception of walking difficulties, and quality of life assessed using validated scales. Statistical analysis will be performed using SPSS v.29.0.0.0.Results:Data on age, sex, weight, and MS-related factors will be collected at baseline. Primary outcomes include changes in pain, balance, and gait speed, while secondary outcomes encompass risk of falls, perception of walking difficulties, and quality of life. Analysis will compare mean differences between groups using appropriate statistical tests.Conclusion:This study aims to evaluate the efficacy of the Exopulse Mollii Ⓡ suit in enhancing motor function in MS patients. Findings may contribute to the development of novel therapeutic strategies for managing MS-related symptoms and improving patients' quality of life. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - EXOPULSE Mollii Ⓡ ### Outcomes Primary Outcomes - referred pain - Balance - gait speed and distance Secondary Outcomes - fall risk - perception of walking difficulties - perceived quality of life ### Location - Facility: Cecilia Estrada Barranco, Villaviciosa De Odón, Madrid, 28670, Spain @@
## Evaluation of the Influence of a Core Muscle Control-Based Rehabilitation Program Patients With Multiple Sclerosis - NCT ID: NCT06384716 - Study ID: CEB - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2024-09-01 - Lead Sponsor: Universidad Europea de Madrid ### Study Description Given the structural relationship of the CORE as a whole, in this study we propose an intervention based on the global motor control of all the structures that make up the CORE to assess its effectiveness on urinary incontinence, sexual dysfunction and balance, as well as its relationship with respiratory function. According to our hypothesis, a global intervention could also be taken into account during conventional treatment in the future, helping to prevent genitourinary dysfunctions derived from alterations in motor control. ### Conditions - Multiple Sclerosis - Pelvic Floor Disorders - Incontinence, Urinary ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - rehabilitation programme based on motor control of core muscles ### Outcomes Primary Outcomes - Difference in the percentage of initial and final maximum activity of the pelvic floor muscles. - - Differences between the initial and final thickness of the oblique abdominis and transverse oblique muscles by ultrasound. - - Differences in the assessment of health-related quality of life before and after the intervention measured with the I-QOL questionnaire. - - Differences in the assessment of female UI before and after intervention using the I-CIQ questionnaire Secondary Outcomes - - Difference in the percentage of initial and final maximum activity of the paravertebral musculature activity. - - Differences between initial and final amplitude of initial and final diaphragmatic excursion by ultrasound. - - Difference between initial and final FVC/- Differences between the initial and final peak expired volume (FEV1) - differences between peak expiratory pressure (PEM) and minimum initial and end inspiratory pressure (MIP). - balance ### Location - Facility: Cecilia Estrada Barranco, Madrid, N/A, N/A, Spain @@
## The Relationship Between Microbiota and Coronary Ectasia - NCT ID: NCT06384703 - Study ID: 201518015 - Status: COMPLETED - Start Date: 2020-11-03 - Completion Date: 2021-06-18 - Lead Sponsor: Konya Beyhekim Training and Research Hospital ### Study Description Introduction: It is now known that the microbiota is far beyond the microbial communities living in certain parts of our body and functions like a metabolic organ. In addition, the microbiota, through its metabolites, is involved in the pathophysiology or progression of a wide range of diseases, from atherosclerotic diseases to metabolic diseases and even neurological diseases. Among these metabolites, trimethylamine n-oxide metabolite has been shown to be particularly effective on atherosclerotic heart diseases. ### Conditions - Coronary Ectasia - Microbial Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Taking blood for kit study ### Outcomes Primary Outcomes - death Secondary Outcomes ### Location - Facility: Necmettin Erbakan University, Konya, N/A, 42050, Turkey @@
## Generating Health Evidence From Dietary Supplementation With a Micro-vegetable Blend - NCT ID: NCT06384690 - Study ID: 4331899 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-08-31 - Lead Sponsor: University of Exeter ### Study Description Micro-vegetables (MV) are seedlings of larger vegetables. They can be grown quickly and are a concentrated source of micronutrients. MV are thought to have broad health benefits, including many inflammatory conditions. These include metabolic, cardiovascular, and cognitive diseases. This could have important implications for the health of an ageing UK population. Less than a third of British adults consume 5 portions of fruit and vegetables per day; this is the level that reduces risk of morbidity and mortality. Vegetables, including MV may - at least in part - exert their health effects by changing the level and type of bacteria in the mouth and gut. Despite their promise, the MV scientific literature is not yet extensive enough to support definitive health claims. It requires the addition of high-quality studies that are relevant to humans. This study will firstly investigate the anti-inflammatory effects on skeletal muscle and adipose tissue in older adults, using a proteomics approach. Second, this study will assess concentrations of circulating inflammatory markers in the sera collected from participants at baseline and at the conclusion of a 6-week period. Further, this study will describe the effects of six weeks MV consumption on cognition, and the oral and gut microbiome. As the bioactive compounds in the MV are owed to the potential beneficial effects for human health, these will be characterised in sera collected from participants. ### Conditions - Inflammation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Micro-vegetable blend - Placebo ### Outcomes Primary Outcomes - Tandem Mass Tag (TMT) global proteomics Secondary Outcomes - Concentration of broad panel of inflammatory cytokines - Concentration of circulating bioactive components - Microbiome - Simple Reaction Time - Digit Vigilance - Choice Reaction Time - Pattern Separation ### Location - Facility: Public Health and Sports Sciences, University of Exeter, Exeter, Devon, EX1 2LU, United Kingdom @@
## Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery - NCT ID: NCT06384677 - Study ID: 03.03.2023/371 - Status: COMPLETED - Start Date: 2023-04-20 - Completion Date: 2024-02-01 - Lead Sponsor: Marmara University ### Study Description This study aims to examine the effects of M-TAPA applied for postoperative analgesia in patients who had major intraabdominal surgery on the postoperative pain score, the change in the postoperative total opioid requirement and the side effects. ### Conditions - Abdominal Cancer - Abdomen Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - M-Tapa Block ### Outcomes Primary Outcomes - Opioid Consumption Secondary Outcomes - NRS Scores - the need for rescue analgesia - side effects ### Location - Facility: Marmara University Pendik Research and Training Hospital, Istanbul, N/A, N/A, Turkey @@
## Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy - NCT ID: NCT06384664 - Study ID: HUM00241242 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-04 - Lead Sponsor: University of Michigan ### Study Description The researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. The research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal nerve block. ### Conditions - Pain, Postoperative - Intrathoracic Procedure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Atricure's crysoSPHERE probe - Standard of Care ### Outcomes Primary Outcomes - Severity of pain in the peri-operative period - Inflammatory cytokine levels as measured by blood samples - Inflammatory cytokines (IL-1, IL-6, TNF-a) levels correlations to pain score - Peri-operative pain scores between different surgical incisions (posterolateral thoracotomy vs thoracoscopy) - Peri-operative nerve function between different surgical incisions (posterolateral thoracotomy vs thoracoscopy) Secondary Outcomes - Quality of life score as measured by SF-36 Health questionnaire - Cost (including postoperative epidural management, narcotic pain medication, and outpatient pain management) - Workflow/time ### Location - Facility: University of Michigan, Ann Arbor, Michigan, 48109, United States @@
## Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty - NCT ID: NCT06384651 - Study ID: PRO00037789 - Status: RECRUITING - Start Date: 2023-12-13 - Completion Date: 2027-12 - Lead Sponsor: The Methodist Hospital Research Institute ### Study Description The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA).Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups.Secondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups. ### Conditions - Infections - Ankle Arthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intraosseous Vancomycin Injection - Intravenous Vancomycin ### Outcomes Primary Outcomes - Systemic Sample Vancomycin Tissue Concentration - Start of Case - Systemic Sample Vancomycin Tissue Concentration - End of Case - Capsule or Synovium Sample Vancomycin Tissue Concentration - Distal Tibia Sample Vancomycin Tissue Concentration - Talar Bone Sample Vancomycin Tissue Concentration Secondary Outcomes - 90 day post-operative wound complication and infection rates ### Location - Facility: Houston Methodist Hospital, Houston, Texas, 77030, United States @@
## Coconut Oil in Treatment of Periodontitis - NCT ID: NCT06384638 - Study ID: coconut periodontitis - Status: COMPLETED - Start Date: 2022-02-15 - Completion Date: 2024-02-09 - Lead Sponsor: Misr University for Science and Technology ### Study Description Virgin Coconut Oil (VCO) is a vegetable oil extracted from coconut fleshcontains unsaturated fatty acids in the form of oleic acid and linoleic acid and flavonoids which function as anti-inflammatory. Periodontitis is an inflammatory disease of the periodontal tissues with a high prevalence worldwide. The main etiology of plaque periodontitis is biofilm containing colonies of pathogenic microorganisms. The aim of the study is to evaluate and compare the effect of scaling and root debridement alone versus the use of topically applied coconut oil as adjunctive to scaling and root debridement in treatment of Stage II and III Grade B periodontitis. ### Conditions - Periodontal Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - topical application of coconut oil - scaling and debridement ### Outcomes Primary Outcomes - clinical parameters - clinical parameters Secondary Outcomes - Biological parameters ### Location - Facility: Faculty of dentistry at MUST, Giza, N/A, 02, Egypt @@
## Air Pollution Intervention for Cardiovascular Patients - NCT ID: NCT06384625 - Study ID: 361378 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-02-01 - Lead Sponsor: University of Montana ### Study Description This pilot study (n=20) is a prospective evaluation of the implementation of an indoor air pollution intervention among patients who have undergone recent percutaneous coronary intervention procedures. The intervention, called Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE), is focused on improving indoor air quality through air filtration, education, and behavioral recommendations. All participants will receive the AIRWISE intervention with the objective of evaluating acceptance and use of the individual intervention components. This implementation study will inform the submission of a larger NIH proposal for a randomized trial. The central study hypothesis is that an intervention program with educational strategies and visual behavioral cues will increase knowledge and awareness of air pollution exposures among the participants and lead to improved intervention compliance. ### Conditions - Coronary Heart Disease - Cardiovascular Diseases - Environmental Exposure ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - AIRWISE ### Outcomes Primary Outcomes - Evaluate the implementation of an indoor air pollution intervention. Secondary Outcomes - Fine particulate matter (PM2.5) - Life's Essential 8 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect Of The Use Of Pocket Cards In An Undergraduate Nursıng - NCT ID: NCT06384612 - Study ID: Adnan Menderes U - Status: COMPLETED - Start Date: 2021-09-13 - Completion Date: 2023-07-13 - Lead Sponsor: Aydin Adnan Menderes University ### Study Description The aim of this study is to examine the effect of the use of pocket cards by students taking the "Care of a Child with Special Needs" course on students' self-efficacy perceptions and course success.1. H01. There is no difference between the self-efficacy perception scores of the students in the group who use pocket cards in the care of children with special needs course and the students in the group who do not use pocket cards.2. H02. There is no significant difference between the course success scores of the students in the group who use pocket cards in the care of children with special needs course and the students in the group who do not use pocket cards. ### Conditions - Student - Self Efficacy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - use of pocket cards ### Outcomes Primary Outcomes - Self-Efficacy Perception Scale Secondary Outcomes ### Location - Facility: Bircan Kahraman Berberoğlu, Efeler, Aydin, 0900, Turkey @@
## VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study - NCT ID: NCT06384599 - Study ID: CS-190 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-06-01 - Lead Sponsor: Adagio Medical ### Study Description The PMCF is a prospective, single-arm, multi-center, controlled study of up to 130 patients designed to collect safety and performance data regarding the use of the Adagio VT Cryoablation System in the treatment of recurrent ventricular tachycardia. ### Conditions - Ventricular Tachycardia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - VT Cryoablation System ### Outcomes Primary Outcomes - Primary Performance Endpoint - Primary Safety Endpoint Secondary Outcomes - Secondary Performance Endpoint - Secondary Safety Endpoint ### Location - Facility: Essex Cardiothoracic Centre, Basildon, Essex, SS16 5NL, United Kingdom @@
## Investigation of Dietary Supplement Liquid Shot Products on Mental Energy, Cognition (Acuity),and Mood - NCT ID: NCT06384586 - Study ID: CD J8855 - Status: COMPLETED - Start Date: 2022-11-17 - Completion Date: 2022-12-22 - Lead Sponsor: The Water Street Collective ### Study Description This is a single center, randomized, double blind, placebo-controlled, crossover study to determine the acute effect of a developmental dietary supplement liquid shot product on cognitive task performance and perceived effect measures related to mood and mental energy. The study will be conducted in healthy participants. ### Conditions - Cognition - Mental Fatigue - Mood ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Placebo shot - Functional energy shot ### Outcomes Primary Outcomes - Mental energy via Cognitive Demand Battery (CDB) Performance Index; for the functional energy shot versus placebo shot. Secondary Outcomes - Mental energy via Cognitive Demand Battery (CDB) Accuracy score for the functional energy shot versus placebo shot. - Change in performance on Corsi blocks task for functional energy shot versus placebo - Change in performance on Rapid Visual Information Processing (RVIP) for functional energy shot versus placebo - Change in performance on Numeric working memory for functional energy shot versus placebo - Change in performance on Serial subtraction task for functional energy shot versus placebo - Change in Mood via Visual Analogue Scales (VAS) during Cognitive Demand Battery (CDB), for functional energy shot versus placebo - Change in physiological state via Profile Of Mood States (POMS) during Cognitive Demand Battery (CDB), for functional energy shot versus placebo ### Location - Facility: Schlesinger Group New Jersey, Iselin, New Jersey, 08330, United States @@
## DIAN-TU Amyloid Removal Trial (ART) in Dominantly Inherited Alzheimer's Disease - NCT ID: NCT06384573 - Study ID: DIAN-TU-003 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2029-11 - Lead Sponsor: Washington University School of Medicine ### Study Description This is an open label study to treat dominantly inherited Alzheimer's disease (DIAD) mutation carrier participants from the DIAN-TU-001 gantenerumab Open Label Extension (OLE) period with lecanemab to determine the effects of amyloid removal on age of onset and clinical progression compared to external controls, if amyloid plaque as measured by amyloid PET can be fully removed in DIAD, and the effects of amyloid removal on biomarkers of disease progression. ### Conditions - Alzheimer's Disease - Dementia - Alzheimer's Disease, Familial ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - lecanemab ### Outcomes Primary Outcomes - The primary endpoint for the final analysis is the time to recurrent progression of Clinical Dementia Rating - Sum of Boxes (CDR-SB). Secondary Outcomes ### Location - Facility: University of Alabama in Birmingham, Birmingham, Alabama, 35294, United States @@
## Neoadjuvant Triple Treatment for Borderline Resectable Pancreatic Cancer (PREOPANC-5) - NCT ID: NCT06384560 - Study ID: 2023-508707-20-00 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-03 - Lead Sponsor: Amsterdam UMC, location VUmc ### Study Description Since patients with borderline resectable pancreatic cancer (BRPC) have a limited life expectancy, it is important to improve treatment strategies. Therefore, the objective of this study is to investigate whether neoadjuvant triple treatment chemotherapy, immunotherapy and radiotherapy, followed by surgery and chemotherapy and immunotherapy survival in patients with BRPC. ### Conditions - Borderline Resectable Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Pembrolizumab ### Outcomes Primary Outcomes - Percentage of patients with progression free survival at 18 months (RECIST 1.1) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Randomized, Active Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED) - NCT ID: NCT06384547 - Study ID: VRDN-001-303 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-01 - Lead Sponsor: Viridian Therapeutics, Inc. ### Study Description The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease (TED). The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in patients with TED. ### Conditions - Thyroid Eye Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - VRDN-001 10 mg/kg - VRDN-001 3 mg/kg ### Outcomes Primary Outcomes - Treatment Emergent Adverse Event (TEAE) incidence rate Secondary Outcomes - Change from baseline in proptosis in the study eye as measured by exophthalmometer at Week 15 ### Location - Facility: United Medical Research Institute, Inglewood, California, 90301, United States @@
## Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD) - NCT ID: NCT06384534 - Study ID: PVD_6MWD_SOT - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-11 - Lead Sponsor: University of Zurich ### Study Description The investigators aim to study the effect of SOT in Swiss residents with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH). ### Conditions - Pulmonary Vascular Disorder - Chronic Thromboembolic Pulmonary Hypertension - Pulmonary Arterial Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - 6-minute walk distance (6MWD) test on ambient air - 6-minute walk distance test with supplemental oxygen ### Outcomes Primary Outcomes - 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air Secondary Outcomes - SpO2 at rest and peak 6MWD with SOT vs. ambient air - Heart rate at rest and peak 6MWD with SOT vs. ambient air - Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air - Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air - Blood pressure at rest and peak 6MWD with SOT vs. ambient air ### Location - Facility: University Hospital Zürich, Zurich, N/A, 8091, Switzerland @@
## Lifestyle MIND- Feasibility for Randomized Wait-list Control Trial - NCT ID: NCT06384521 - Study ID: STUDY00000500 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-05 - Lead Sponsor: The University of Texas Health Science Center at San Antonio ### Study Description The goal of this clinical trial is to examine if it is feasible to randomly assign people into two groups and participate in Lifestyle MIND (Mental Illness and/N' Diabetes) at two different times. Lifestyle MIND is a diabetes lifestyle intervention recently developed for people with serious mental illness (SMI). It is known to be helpful for people with SMI who complete it, but the investigators do not know the effect in comparison to those who do not participate in it. The main questions it aims to answer are:* Does Lifestyle MIND improve diabetes control among people with SMI?* Will the effect of Lifestyle MIND be sustained 10 weeks after program completion?* From the provider's perspective, what are the barriers of achieving optimal diabetes treatment outcomes for patients with SMI?Researchers will compare outcomes of participants in the intervention with those in the wait-list control arm, to see if there will be significant differences in blood glucose level, compliance of diabetes self-management, time staying active, number of emergency department (ED) visits and psychiatric hospitalization, and subjective well-being. ### Conditions - Type 2 Diabetes Mellitus - Serious Mental Illness - Schizophrenia - Major Depression - Bipolar Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Lifestyle MIND ### Outcomes Primary Outcomes - Hemoglobin A1c (HbA1c) - Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire - Hours of Active and Sedentary Behavior - Number of emergency department (ED) visits and psychiatric hospitalizations - Satisfaction with Life Scale (SWLS) Secondary Outcomes ### Location - Facility: University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States @@
## Decrease Trauma-related Shame With Virtual Reality: The Effectiveness of SHINE-VR - NCT ID: NCT06384508 - Study ID: NL83340.058.23 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2024-10-31 - Lead Sponsor: Universiteit Leiden ### Study Description Suffering from PTSD in childhood can have detrimental formative consequences. Researchers have been eager to develop effective interventions and to enhance treatment motivation since the introduction of the diagnosis of PTSD in the DSM. With evolving understanding of the disorder, its definition and criteria have changed over the course of time. The most recent change involves the addition of the criterium D of negative affects or emotions in relation to PTSD, the feeling of shame amongst others. Individuals experiencing interpersonal trauma, such as sexual abuse, are at high-risk developing trauma-related shame, which in turn can impact the course and effectiveness of PTSD treatment. Shame-inducing situations are typically being avoided, and the feelings are not disclosed to peers and other people. Hence, acknowledging and sharing feelings of shame as well as practicing self-compassion have been proposed to reduce the impact of that negative self-conscious emotion. These aspects get partially tackled in evidence-based trauma therapies, however, there appears to be a need for a more specific trauma-related shame intervention in addition to existing treatments. Recent research has focused on developing such interventions for adults and has reported positive effects.To our knowledge, there is no intervention specifically tackling trauma-related shame in adolescents. Virtual Reality (VR) is a promising tool for such an intervention. Findings suggest that including VR in a treatment results in high treatment satisfaction and that it is highly motivating for its users, which is a crucial component for treatment success.The goal of this study is to test the effectiveness of a short-term VR shame intervention (SHINE-VR) for adolescents suffering from PTSD after having experienced sexual abuse. The primary objectives of this study to assess the effect of SHINE-VR on trauma-related shame, self-compassion, and PTSD symptom reduction, to investigate whether treatment motivation, an increase in self-compassion, and a decrease in trauma-related shame are associated with PTSD symptom reduction, and the evaluation of SHINE-VR by assessing the feasibility of the intervention. ### Conditions - Shame ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SHINE-VR ### Outcomes Primary Outcomes - Trauma-related shame - Self-compassion Secondary Outcomes - PTSD symptoms - Treatment motivation ### Location - Facility: iMindU Practice for Child, Adolescent and Adult Psychiatry, Leiden, South Holland, 2311 EX, Netherlands @@
## How Does Cerebellar tDCS Alter Intracortical Inhibition Over Time? - NCT ID: NCT06384495 - Study ID: STUDY00021475 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-15 - Completion Date: 2025-03-31 - Lead Sponsor: University of Minnesota ### Study Description Combining cortical tDCS with behavioral interventions has been shown to have beneficial outcomes in individuals post-stroke. However, cerebellar tDCS is a fairly new approach for individuals with unilateral cortical stroke and there has not been reports of duration of effect of tDCS applied to the cerebellum in this population.Information gained from this study will serve to fill knowledge gaps on the duration of effect of cerebellar tDCS and the effects of polarity.The purpose of this study is to determine the duration of effect of ventro-lateral cerebellar transcranial direct current stimulation (tDCS) in healthy adults through cortical excitability (CE), cognitive, language and motor assessment measures. Primary aim: Compare baseline CE from left motor cortex of first dorsal interosseous (FDI) and orbicularis oris (OO) areas to CE post cerebellar tDCS at 15 minutes, 45 minutes and 75 minutes. Single-pulse and paired-pulse transcranial magnetic stimulation (TMS) will be used to measure and compare stimulus response curve (S/R curve), cortical silent period (CSP) and short-interval intracortical inhibition (SICI) in the hand area and facial area of the left primary motor cortex at each time point.Secondary aim: Compare baseline performance on cognition, motor learning and language tasks to performance at 15, 45 and 75 minutes after receiving tDCS. Digit Symbol Substitution Test (DSST), Serial Reaction Time Test (SRTT) and Lexical Decision tasks will be presented via a computer interface. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - REAL-A - REAL-C - SHAM ### Outcomes Primary Outcomes - stimulus/response curve (S/R Curve) - Cortical Silent Period (CSP) - Short-interval Intracortical Inhibition (SICI). Secondary Outcomes - Digit Symbol Substitution Test (DSST) - Serial Reaction Time Test (SRTT) - Lexical Decision Task ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## SNC115 Injections in Patients With Recurrent/Refractory Small Cell Lung Cancer and Lung Large Cell Neuroendocrine Carcinoma - NCT ID: NCT06384482 - Study ID: SNC115-DLL3 CART-101 - Status: RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-12-30 - Lead Sponsor: Shanghai Simnova Biotechnology Co.,Ltd. ### Study Description This study is a FIH dose escalation clinical study, with single arm, open label and design, in order to observe the preliminary safety and Pharmacokinetic of SNC115 Injection in participants with Recurrent/refractory small cell lung cancer and Lung large cell neuroendocrine carcinoma. ### Conditions - Recurrent/Refractory Small Cell Lung Cancer Lung Large Cell Neuroendocrine Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - SNC115 injection ### Outcomes Primary Outcomes - Safety of SNC115 Injection - Safety of SNC115 Injection Secondary Outcomes - -Efficacy of SNC115 Injection - -Efficacy of SNC115 Injection - -Efficacy of SNC115 Injection - -Efficacy of SNC115 Injection - -Efficacy of SNC115 Injection - -Efficacy of SNC115 Injection ### Location - Facility: Shanghai Chest Hospital, Shanghai, Shanghai, 200030, China @@
## The Impact of Rhinoplasty Approach and Used Autologous Cartilage Grafts on the Nasal Skin-soft Tissue Envelope Metabolism - NCT ID: NCT06384469 - Study ID: 98984697615 - Status: NOT_YET_RECRUITING - Start Date: 2025-01-02 - Completion Date: 2026-09-01 - Lead Sponsor: University Hospital "Sestre Milosrdnice" ### Study Description This is a prospective observation cohort investigation. Patients, that is participants, undergoing primary functional rhinoplasty will be evaluated in terms of measuring capillary blood lactic acid concentration in the nasal skin-soft tissue envelope immediately after the procedure and 7 days after the procedure.The aim of our study is to test whether or not different rhinoplasty approaches and volume of the used autologous cartilage grafts impact the nasal skin-soft tissue metabolism. ### Conditions - Rhinoplasty - Nasal Skin-soft Tissue Envelope Metabolism - Lactic Acid - Autologous Cartilage Grafting ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Difference of capillary blood lactic acid concentration in the nasal skin-soft tissue envelope depending on the rhinoplasty approach - Correlation between the used autologous cartilage graft volume and lactic acid concentration in the nasal skin-soft tissue envelope Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following DRF Fixation - NCT ID: NCT06384456 - Study ID: 23-5708 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2026-09 - Lead Sponsor: University Health Network, Toronto ### Study Description The goal of this study is to find out whether the use of topical tranexamic acid (TXA) into the surgical wound will result in less post-operative pain, less pain killer use, and better post-operative use of the wrist in people undergoing surgery for a wrist fracture compared to not using topical TXA (placebo). ### Conditions - Distal Radius Fractures ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Topical TRanexamic Acid - Placebo ### Outcomes Primary Outcomes - acute post-op pain Secondary Outcomes - opioid use - persistent pain - unscheduled hand-related procedures - Patient reported function ### Location - Facility: Toronto Western Hospital, Toronto, Ontario, N/A, Canada @@
## Proton Pump Inhibitors in Cirrhotic Patients - NCT ID: NCT06384443 - Study ID: 01001099646 - Status: COMPLETED - Start Date: 2020-10-01 - Completion Date: 2024-03-01 - Lead Sponsor: National Liver Institute, Egypt ### Study Description Proton pump inhibitors (PPIs) inappropriate use, in patients with cirrhosis, presents a significant clinical challenge. This study evaluates overprescription and misuse of PPIs in cirrhotic patients. The patterns of use of PPIs will be classified into two groups based on adherence to the proven indications: Group A: Inappropriate use of PPI, Group B: Appropriate use of PPI. We will estimate the prevalence of PPI misuse in cirrhotics and correlate it with different factors. ### Conditions - Proton Pump Inhibitor Adverse Reaction - Liver Cirrhosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Inappropriate use of PPIs - Predictors for inappropriate use of PPIs Secondary Outcomes ### Location - Facility: National Liver institute - Menoufia University, Shibīn Al Kawm, Menoufia, 32511, Egypt @@
## Subacromial Impingement Syndrome - NCT ID: NCT06384430 - Study ID: MuğlaSKU-NKO - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-09-01 - Lead Sponsor: Muğla Sıtkı Koçman University ### Study Description Subacromial impingement syndrome is a common shoulder pain disorder. In this study, among the patients who applied to the Physical Medicine and Rehabilitation outpatient clinic of Muğla Training and Research Hospital and were diagnosed with subacromial impingement by anamnesis and clinical tests, inclusion criteria (being between 18-70 years of age, positivity for subacromial impingement syndrome in clinical evaluation (Neer's test, Hawkins Kennedy, supraspinatus palpation test)) and exclusion criteria (under 18 years of age, over 70 years of age, rheumatologic disease diagnosis, symptomatic shoulder osteoarthritis, shoulder instability; shoulder pain in active, passive cervical spine movements, previous shoulder surgery, those with adhesive capsulitis findings (\>50% passive range of motion restriction in 2 planes or full-thickness rotator cuff tear detected on ultrasound), those who received physiotherapy or intra-articular injections in the last 3 months, those with type 2 diabetes or hypothyroidism) will be included in the study. Demographic data of the patients will then be recorded. DASH (Disabilities of the Arm, Shoulder and Hand) and Constant Murley scores will be calculated. 4 years of musculoskeletal ultrasound experience will be recorded by a radiologist using ultrasound (Siemens® V8, LA2-14A probe) in modified Crass position (positioning with the palm of the examined side on the posterior iliac wing) by measuring subacromial bursa thickness, supraspinatus tendon thickness, acromiohumeral distance, supraspinatus tendon thickness/acromiohumeral distance ratio. Demographic data of the patients will then be recorded. DASH (Disabilities of the Arm, Shoulder and Hand) and Constant Murley scores will be calculated. ### Conditions - To Show the Relationship Between Ultrasound Parameters and Shoulder Functional Tests ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Shoulder functional tests and ultrasound ### Outcomes Primary Outcomes - subacromial bursa thickness - supraspinatus tendon thickness - acromiohumeral distance Secondary Outcomes ### Location - Facility: Mugla Egitim Arastima, Mugla, N/A, N/A, Turkey @@
## Using an End-of-life Conversation Game to Engage Patients With Cancer in Advance Care Planning: Phase 2 - NCT ID: NCT06384417 - Study ID: STUDY00024858 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-12 - Lead Sponsor: Milton S. Hershey Medical Center ### Study Description The goal of this clinical trial is to explore feasibility, acceptability, and effectiveness of end-of-life conversation game "Hello" as a tool to help individuals with various solid cancer types (including: breast, gastro-intestinal, lung, melanoma, head and neck, and/or genito-urinary cancers) treated at Penn State Health clinics and their loved ones perform advance care planning (ACP). The main questions it aims to answer are:What modifications and/or adaptations are necessary to Hello for use in cancer populations?What impact does participation in Hello event have on health care usage (e.g., number of hospitalizations, ICU admissions, emergency department visits, etc.)? How feasible is it to randomize participants to play either Hello for Cancer or Table Topics?Participants will:* Complete pre-game questionnaires* Play either Hello or Table Topics game* Complete post-game questionnaires* Participate in a focus group* Complete a telephone follow up interview 1-4 months after their eventThis study is a continuation of NCT06028152. ### Conditions - Breast Cancer - Lung Cancer - Genito-Urinary Cancer - Colorectal Cancer - Gastric Cancer - Pancreatic Cancer - Liver Cancer - Head and Neck Cancer - Melanoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Hello for Cancer game - Table Topics game ### Outcomes Primary Outcomes - Feasibility and Acceptability of modified Hello game - Healthcare Utilization Secondary Outcomes - Advance Care Planning Engagement Measure - Advance Care Planning Surrogate Decision Maker Engagement Measure - Satisfaction of Intervention Measure - Acceptability of Intervention Measure - Preliminary efficacy of Hello on ACP behaviors. ### Location - Facility: Penn State Cancer Institute, Hershey, Pennsylvania, 17033, United States @@
## Upfront Surgical Resection for Osteosarcoma - NCT ID: NCT06384404 - Study ID: 2023-14741 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2029-12-31 - Lead Sponsor: Montefiore Medical Center ### Study Description The goal of this pilot study is to learn about patients with newly diagnosed osteosarcoma of an extremity, and whether surgically removing the tumor prior to the administration of any chemotherapy will improve functional outcomes. In order to learn about the patient's experience, the study team will administer questionnaires to the patient and surgeon at various timepoints to assess recovery and the function of the extremity. ### Conditions - Osteosarcoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaire ### Outcomes Primary Outcomes - Change in Health-Related Quality of Life (HRQoL) score from Historical Controls Secondary Outcomes - Event Free Survival ### Location - Facility: Montefiore Medical Center, Bronx, New York, 10467, United States @@
## Intestinal Ultrasound, Magnetic Resonance Enterography, and Conventional Assessment Tools Before and After Treatment of Intestinal Behcet's Disease - NCT ID: NCT06384391 - Study ID: 4-2023-1730 - Status: RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-12-31 - Lead Sponsor: Yonsei University ### Study Description Background: The "treat-to-target" approach has recently been adopted in the treatment of inflammatory bowel disease (IBD). The basic premise is to define specific measurable targets and then adjust treatment until these targets are achieved and maintained. According to the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE)-Ⅱ statement published in 2021, the long-term treatment targets for IBD are clinical remission, endoscopic healing, absence of disability, restoration of quality of life, and normal growth in children. Symptomatic relief and normalization of serum and fecal markers were determined as short-term targets. Transmural healing in Crohn's disease and histological healing in ulcerative colitis are not formal targets but should be assessed as measures of the remission depth.While endoscopic examination assesses the mucosal inflammatory status of the bowel wall, transmural inflammatory status needs to be evaluated with ultrasound, computed tomography (CT), or magnetic resonance enterography (MRE). Ultrasound is advantageous as it does not utilize ionizing radiation and is less costly and uncomfortable for patients, allowing more frequent use. Recent studies suggest that intestinal ultrasound is beneficial in treatment response assessment and planning in patients with Crohn's disease and ulcerative colitis. However, there is a paucity of study regarding the effectiveness of intestinal ultrasound in management of intestinal Behcet's disease. Furthermore, despite its accuracy and comprehensive imaging capabilities without radiation risk, MRE has not been widely used in the diagnosis and follow-up of the patients with intestinal Behcet's disease, and no studies have reported changes in MRE findings after treatment. ### Conditions - Intestinal Behcet Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Accuracy of intestinal ultrasound in identifying endoscopic remission at 26 weeks after initiation of medical treatment Secondary Outcomes - Accuracy of intestinal ultrasound in identifying clinical remission at 26 weeks after initiation of medical treatment - Accuracies of magnetic resonance enterography in identifying endoscopic and clinical remission at 26 weeks after initiation of medical treatment - Accuracies of magnetic resonance enterography in identifying endoscopic and clinical responses at 26 weeks after initiation of medical treatment ### Location - Facility: Yonsei University Health system, Severance Hospital, Seoul, N/A, 03722, Korea, Republic of @@
## Systemic and Central Inflammation in AD - NCT ID: NCT06384378 - Study ID: FP00006640 - Status: RECRUITING - Start Date: 2023-03-17 - Completion Date: 2025-12-30 - Lead Sponsor: The Methodist Hospital Research Institute ### Study Description Inflammation could provide a new focus for therapeutic intervention. In this study, we will measure blood and cerebrospinal fluid (CSF) inflammation biomarkers and compare them to measurements of brain glial activation obtained by positron emission tomography (PET). In addition, we will determine the effect of low-dose interleukin-2 (IL-2) immunotherapy, given over 22 weeks, on these inflammation biomarkers. ### Conditions - Alzheimer Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - 11C-ER176 ### Outcomes Primary Outcomes - Blood inflammation biomarker levels - CSF inflammation biomarker levels - Voxel-wise, regional and total brain TSPO VT/fP measured with 11C-ER176 PET Secondary Outcomes ### Location - Facility: Houston Methodist Research Institute, Houston, Texas, 77030, United States @@
## Interaction of Inflammation, Taste Perception and Preferences as a Function of Physical Activity and Body Composition - NCT ID: NCT06384365 - Study ID: 706014-4 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-04-30 - Lead Sponsor: University of Vienna ### Study Description The aim of this study is to investigate whether differences in taste perception and preference behavior can be attributed to inflammatory processes induced by physical activity. The focus will be on sweet taste and the perception of fat. A non-invasive, observational study design will be used. ### Conditions - Taste, Altered ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Physical activity ### Outcomes Primary Outcomes - Taste sensitivity - Taste preference - Body composition - Low-grade inflammation Secondary Outcomes - Oxidative Stress - fungiform papillae density ### Location - Facility: Christian Doppler Laboratory for Taste Research, Vienna, N/A, 1090, Austria @@
## A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors - NCT ID: NCT06384352 - Study ID: YL211-INT-101-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-08 - Completion Date: 2029-04-07 - Lead Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. ### Study Description This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of three parts. Part 1 is dose-escalation part. In part 1, the safety and tolerability of YL211 in patients with selected advanced solid tumors will be evaluated and the MTD and RED will be determined.Part 2 is backfill enrollment part. We will further estimate the safety and efficacy of YL211 in patients with selected adcance tumor to select the RED(s) of YL211.Part 3 is dose-expansion part. In this part, we will further evaluate the safety and efficacy of YL211 at the MTD/RED(s) in patients with selected advanced solid tumors YL211 will be administered intravenously (IV) until criteria of treatment discontinuation are met. ### Conditions - Advanced Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - YL211 ### Outcomes Primary Outcomes - To evaluate nature and frequency of AEs of YL211 in patients with advanced solid tumors according to NCI CTCAE version 5.0 - To evaluate nature and frequency of DLTs in part 1. - ORR assessed using RECIST version 1.1 - To determine the MTD and select the recommended expansion dose(s) (RED(s)) of YL211 in patients with advanced solid tumors Secondary Outcomes - To characterize the AUC of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload - To characterize the Cmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload - To characterize the Ctrough of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload - To characterize the Tmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload - To characterize the CL of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload - To characterize the Vd of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload - To characterize the t1/2 of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload - To evaluate the anti-drug immune response after treatment with YL211 - To evaluate DCR of YL211 in patients with advanced solid tumors using RECIST version 1.1 - To evaluate DoR of YL211 in patients with advanced solid tumors using RECIST version 1.1 - To evaluate SD of YL211 in patients with advanced solid tumors using RECIST version 1.1 - To evaluate TTR of YL211 in patients with advanced solid tumors using RECIST version 1.1 - To evaluate PFS of YL211 in patients with advanced solid tumors using RECIST version 1.1 - To evaluate OS of YL211 in patients with advanced solid tumors using RECIST version 1.1 - To evaluate percent change in target lesion of YL211 in patients with advanced solid tumors using RECIST version 1.1 ### Location - Facility: NEXT San Antonio, San Antonio, Texas, 78229, United States @@
## ID-ClimAct. Influence of Social Motives of Clients and Staff on the Social Climate of Secure Settings - NCT ID: NCT06384339 - Study ID: ID-ClimAct-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-31 - Completion Date: 2024-10-20 - Lead Sponsor: University Psychiatric Clinics Basel ### Study Description The social climate in secure settings is an essential element to successful rehabilitation. Previous studies indicate that staff characteristics are a relevant factor contributing to a beneficial social climate. Yet, secure settings form a specific and challenging work environment. Staff members are faced with clients who present a variety of difficult emotional and behavioural problems. Social motives for caring and cooperation can be blocked in a threatening environment, favouring dysfunctional interpersonal dynamics between individuals. This observational study explores the reciprocal influences of social motives between clients and staff on the social climate within secure settings. ### Conditions - Social Environment - Correctional Institutions - Rehabilitation of Criminals - Social Dominance - Interpersonal Relations ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - CSIV, Social motive - Interpersonal messages and behavior - CCS, Social motive ### Outcomes Primary Outcomes - Social Climate Perception Secondary Outcomes ### Location - Facility: University Psychiatric Clinics Basel, Clinic for Forensics, Basel, Basel-Stadt, 4002, Switzerland @@
## Parental Perceptions and Acceptance of Silver Diamine Fluoride in Spain and Italy - NCT ID: NCT06384326 - Study ID: bagattoni3 - Status: COMPLETED - Start Date: 2020-09-01 - Completion Date: 2023-08-01 - Lead Sponsor: University of Bologna ### Study Description Assessing parental aesthetic acceptability of Silver Diamine Fluoride (SDF) staining is crucial for its potential implementation in paediatric dentistry. This study represents the third part of a wider project initially focused on evaluating SDF aesthetic acceptability in Italy, then comparing it between Spanish and Italian parents ### Conditions - Comparative Study - Aesthetic Perception - Acceptability - SDF ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Comparison of SDF's overall acceptance between Spanish and Italian parents Secondary Outcomes - Comparison of SDF's specific acceptability in different scenarios of child's behavior between Spain and Italy - Parental overall acceptability of SD staining according to demographic background ### Location - Facility: Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile, Bologna, N/A, 40125, Italy @@
## Butyrate-enriched Triglyceride and Diabetes Prevention - NCT ID: NCT06384313 - Study ID: NL86266.068.24 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2027-09-01 - Lead Sponsor: Maastricht University Medical Center ### Study Description A body of animal studies as well as observational studies in humans demonstrated that butyrate is one SCFA that has pronounced positive effects on body weight control, inflammation, and insulin resistance. Even though the SCFA hexanoate is less researched, it has been shown to be involved in anti-inflammatory processes. Of note, acute human studies showed that fibre-induced metabolic improvements are linked to higher SCFA levels in the systemic circulation. We previously showed that a butyrate/hexanoate-enriched triglyceride oil enhanced systemic butyrate and hexanoate concentrations for a prolonged time. Yet, it remains to be determined whether a chronic increase in circulating butyrate and hexanoate concentrations translate into long-term benefits. We hypothesize that a chronic increase of butyrate/hexanoate in the circulation may improve host metabolism and metabolic health by improving adipose tissue function, reducing systemic lipid overflow and inflammation thereby increasing peripheral insulin sensitivity in individual with overweight/obesity and prediabetes. ### Conditions - Type 2 Diabetes - PreDiabetes - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - butyrate/hexanoate-enriched triglycerides ### Outcomes Primary Outcomes - Peripheral insulin sensitivity Secondary Outcomes - hepatic insulin sensitivity - adipose tissue insulin sensitivity - Energy expenditure (indirect calorimetry) - Substrate oxidation (indirect calorimetry) - circulating SCFA - Faecal SCFA - Faecal microbiota composition - Circulating hormones such as insulin - Circulating metabolites such as glucose - body composition - body weight - Gut permeability ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Financial Incentives and Motivational Intervention to Improve Gastric Cancer Screening in China - NCT ID: NCT06384300 - Study ID: BMSF - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2027-07-31 - Lead Sponsor: Peking University ### Study Description Gastric cancer, also known as stomach cancer, is a serious disease that affects the stomach. It's one of the most common types of cancer, and sadly, many people die from it each year. But there's hope! We can catch gastric cancer early with a special test called endoscopy. This test helps doctors find cancer or pre-cancerous changes in the stomach early, when it's easier to treat. However, not enough people get this test, especially in places where healthcare isn't easily available. That's why we're doing this study.We want to find out if we can encourage more people to get the endoscopy test for gastric cancer. We're going to try two different ways to encourage people to get the test. First, we'll give some people money or other incentives to help cover the costs of getting the test. Second, we'll give others information and support to help them understand why the test is important and how it can help them.We'll be doing this study in two provinces in China, where gastric cancer is a big problem. We'll ask thousands of people to join the study, and we'll randomly assign them to one of the two groups. Then, we'll see if more people in one group get the endoscopy test compared to the other group.Our hope is that by finding out what works best, we can help more people catch gastric cancer early and get the treatment they need. This could save many lives and make a big difference in fighting this disease. ### Conditions - Gastric Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Financial Incentives - Motivational Intervention - Mixed Intervention ### Outcomes Primary Outcomes - Primary Outcome 1 - Primary Outcome 2 Secondary Outcomes - Secondary Outcome ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Peripheral Tissue Perfusion in Intensive Care - NCT ID: NCT06384287 - Study ID: APHP231342 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-05 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Tissue perfusion has been identified as an early prognosis factor in patients admitted to intensive care. However, little is known about the effects of different hemodynamic interventions performed in clinical routine on peripheral tissue perfusion.The aim of this work is to study the kinetics of CRT and local skin blood flow following therapeutic intervention (fluid challenge, vasopressor or inotropic drug). ### Conditions - Acute Circulatory Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Skin blood flow variations Secondary Outcomes - Capillary refill time - Mottling score - correlation between Skin blood flow and CRT (baseline and variations) - correlation between skin blood flow and Cardiac output - correlation between skin blood flow and mean arterial pressure ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Emotional Freedom Technique and Virtual Reality Glasses on Anxiety and Vital Signs - NCT ID: NCT06384274 - Study ID: NEUniversity - Status: NOT_YET_RECRUITING - Start Date: 2024-10-01 - Completion Date: 2025-06-01 - Lead Sponsor: Necmettin Erbakan University ### Study Description The aim of the study was to examine the effects of the emotional freedom technique and virtual reality glasses applied to individuals receiving hyperbaric oxygen therapy for the first time on anxiety and vital signs. The hypotheses of this research are that there is a difference between the emotional liberation technique and virtual reality glasses groups and the control group in terms of anxiety and vital signs. ### Conditions - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Emotional Freedom Technique - Virtual Reality Glasses ### Outcomes Primary Outcomes - State Anxiety Inventory (STAI) Secondary Outcomes - Blood Pressure - Pulse - Respiration - Body Temperature - Oxygen Saturation ### Location - Facility: Gülsüm Gürsoy Açikgöz, Konya, Meram, N/A, Turkey @@
## A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy - NCT ID: NCT06384261 - Study ID: OV-AML-1231 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-06 - Lead Sponsor: OncoVerity, Inc. ### Study Description The goal of this clinical trial is to learn if participants treated with the experimental drug cusatuzumab added to venetoclax and azacitidine works to treat acute myeloid leukemia (AML) compared to venetoclax and azacitidine. Venetoclax and azacitidine are drugs commonly used to treat AML in patients that are unable to receive chemotherapy to treat AML. The main question the clinical trial aims to answer is does cusatuzumab added to venetoclax and azacitidine prolong the length of time participants live compared to venetoclax and azacitidine? ### Conditions - Leukemia, Myeloid, Acute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cusatuzumab - Venetoclax - Azacitidine ### Outcomes Primary Outcomes - Overall survival Secondary Outcomes - Complete Remission rate (CR) - Event-free survival (EFS) - Composite CR rate (CRc) - Rate of CRh and CRi - Duration of CR - Time to first CR - Rate of minimal residual disease (MRD) negativity in patients achieving CR, CRh, or CRi - Proportion of participants proceeding to hematopoietic stem cell transplantation (HSCT) - OS in participants undergoing HSCT - Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study drug discontinuation - Incidence of dose modifications due to AEs - Number of participants with abnormal laboratory test results - Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) - Overall survival in subgroups of participants according to specified AML risk stratification models - Complete Remission rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Phase II Clinical Study of LTC004 in Patients With Advanced Sarcoma - NCT ID: NCT06384248 - Study ID: LTC004-205 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-26 - Completion Date: 2025-12-28 - Lead Sponsor: Letolab ### Study Description This is a phase II clinical study to evaluate the safety, tolerability and preliminary antitumor activity of LTC004 in patients with locally advanced or metastatic sarcoma；Enrollment of 10 evaluable subjects in Phase I. If ≥2 subjects experience objective remission or SD lasting \>12 weeks, proceed to Phase II to enroll an additional 20 evaluable subjects to further evaluation of the safety and efficacy of LTC004 ### Conditions - Unresectable or Metastatic Sarcoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - LTC004 ### Outcomes Primary Outcomes - ORR Secondary Outcomes - DOR - PFS rate - OS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Phase II Clinical Study of LTC004 in Patients With mCRC - NCT ID: NCT06384235 - Study ID: LTC004-203 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2025-08-23 - Lead Sponsor: Letolab ### Study Description This is a phase II clinical study to evaluate the safety and antitumor activity of LTC004 in patients with locally advanced or metastatic CRC，Enrollment of 10 evaluable subjects in Phase I. If ≥2 subjects experience objective remission，proceed to Phase II to enroll an additional 20 evaluable subjects to further evaluation of the safety and efficacy of LTC004 ### Conditions - Locally Advanced or Metastatic CRC ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - LTC004 ### Outcomes Primary Outcomes - ORR Secondary Outcomes - DOR - PFS - OS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Hyperpolarized (HP) 13C Pyruvate Magnetic Resonance Imaging (MRI) MRI as a Response Monitoring Tool to Neoadjuvant Abiraterone - NCT ID: NCT06384222 - Study ID: 235513 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-30 - Completion Date: 2027-07-31 - Lead Sponsor: Ivan de Kouchkovsky, MD ### Study Description This study will evaluate the use of hyperpolarized 13C MRI (HP 13C MRI) and the HP-derived 13C pyruvate-to-lactate conversion rate constant (kPL) as an early response biomarker in men with treatment-naïve, high-risk, localized or locally advanced prostate cancer receiving neoadjuvant therapy. ### Conditions - High Risk Prostate Carcinoma - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Abiraterone acetate - Prednisone - Hyperpolarized [1-13C] pyruvate (HP 13C) - Magnetic Resonance Imaging (MRI) - Non-investigational radical prostatectomy (RP) - Prostate-Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) PET/Computerized tomography (CT) ### Outcomes Primary Outcomes - Mean changes in intratumoral KPL Secondary Outcomes - Pathological response rate - Proportion of participants with treatment-related adverse events - Proportion of participants completing RP - Median Time to Biochemical Recurrence - Proportion of participants with a >=50% decline in PSA level from baseline (PSA50) response - Proportion of participants with a >=90% decline in PSA level from baseline (PSA90) response - Mean PSA nadir ### Location - Facility: University of California, San Francisco, San Francisco, California, 94143, United States @@
## The Friendship Bench Plus Trial - NCT ID: NCT06384209 - Study ID: FBplus2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2027-02-28 - Lead Sponsor: University of Bern ### Study Description The goal of this randomised controlled trial is to enhance the Friendship Bench intervention with antidepressants in adults with moderate to severe depression. The main questions it aims to answer are:1. Is the combination of the Friendship Bench with nurse-led antidepressants prescribing superior to the Friendship Bench alone?2. What are the barriers and enablers for the prescription of antidepressants by non-specialists in primary care?Type of study: Randomized controlled superiority trialParticipants will be randomly selected and allocated into the control arm or intervention arm. Participants in the control arm will receive six sessions of the Friendship Bench Problem Solving Therapy while those in the intervention arm will receive the Friendship Bench intervention plus Fluoxetine (Sertraline for breastfeeding women). ### Conditions - Major Depressive Disorder - Severe Depressive Episode Without Psychotic Symptoms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Friendship Bench intervention - Antidepressants -Fluoxetine ### Outcomes Primary Outcomes - Treatment response Secondary Outcomes - Remission ### Location - Facility: University of Zimbabwe, Harare, N/A, N/A, Zimbabwe @@
## Identity-Based Transdiagnostic Therapy for Young People With Anxiety and Depression - NCT ID: NCT06384196 - Study ID: PID2022-138902OB-I00 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-02 - Completion Date: 2025-11-02 - Lead Sponsor: University of Barcelona ### Study Description Depression and anxiety are the most prevalent mental disorders among both the general population and young adults, and transdiagnostic treatments for these patients are mostly based on cognitive-behavioral therapy (CBT). Based on common (transdiagnostic) principles of treatment (e.g., emotional exposure), these approaches have proliferated and demonstrated their efficacy in comparison to disorder-specific treatments. Although there are a few transdiagnostic approaches for children and adolescents, we could not find anyone targeting young people. For this reason, we propose the Identity-Based Transdiagnostic Therapy (IBTT) as a new treatment modality ideally created to address the challenge of improving the outcomes of psychotherapy for young adults with anxiety and/or depression. The IBTT is a psychological treatment for emotional disorders specifically designed for the youths in terms of their attitudes to treatment (attractiveness, engagement), and highly personalized to their construal of self and others. This project will allow testing the hypothesis that a novel brief psychotherapeutic intervention, IBTT, will be more efficacious in the treatment of the anxiety and/or depression of young adults than the well-established CBT-based Unified Protocol. ### Conditions - Depression - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Identity-Based Transdiagnostic Therapy (IBTT) - Unified Protocol ### Outcomes Primary Outcomes - Depression, Anxiety and Stress Scales (DASS-21) Secondary Outcomes - Clinical Outcomes in Routine Evaluation-Short Form B (CORE-SFB) - Mini International Neuropsychiatric Interview (MINI) - Session Rating Scale 3.0 (SRS 3.0) - Life Satisfaction Scale (LSS) - Self-Concept Clarity Scale (SCCS) - Rosenberg Self-Esteem Scale (RSES) - Metacognition Self-Assessment Scale (MSAS) - Problem definition form - Change Interview - Consumer Reports Effectiveness Scale (CRES-4) ### Location - Facility: Badalona Serveis Assistencials, Badalona, N/A, 08911, Spain @@
## Kerecis Real World Registry - NCT ID: NCT06384183 - Study ID: KS-1000 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2027-06 - Lead Sponsor: Kerecis Ltd. ### Study Description Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices ### Conditions - Wounds - Pressure Ulcer - Diabetic Foot Ulcer - Venous Leg Ulcer - Surgical Wound - Soft Tissue Reinforcement ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Kerecis Fish Skin Graft ### Outcomes Primary Outcomes - Fish Skin Graft Device Related failure - Fish Skin Graft Device related allergy - Target Wound Infection Secondary Outcomes - Complete Wound Healing - Complete Wound Closure ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Closed Loop Spinal Cord Stimulation for Neuromodulation of Upper Motor Neuron Lesion Spasticity - NCT ID: NCT06384170 - Study ID: IRB00442113 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2026-05 - Lead Sponsor: Johns Hopkins University ### Study Description Spasticity is characterized by increased muscle tension and is a classic consequence of upper motor neuron (UMN) damage in the central nervous system, such as from stroke or trauma. Clinically, it presents as muscle resistance to passive stretching, along with clasp-knife rigidity, clonus, increased tendon reflexes, and muscle spasms. An imbalance of the descending inhibitory and muscle stretch reflexes is thought to be the cause of spasticity. Post-stroke spasticity is a common condition that occurs in 37.5-45% of cases in the acute stage and 19-57.4% in the subacute stage after a stroke. At 6 months post-stroke, spasticity develops in 42.6-49.5% of cases, and at one year, it affects 35-57.4% of individuals. In patients with cerebral palsy (CP), incidence is almost 80% while in those living with spinal cord injury the number approaches up to 93%. Traumatic brain injury (TBI) patients have a higher prevalence on initial admission to neurorehabilitation but one in three patients will have chronic spasticity. However, the Defense and Veterans Brain Injury Center report a rate of TBIs amongst deployed veterans to be around 11-23% mostly from blast and explosive trauma.There have been studies as early as the 1980s exploring the efficacy of SCS for spasticity control, however, the credibility of many of these studies is constrained due to an incomplete comprehension of spasticity's underlying mechanisms, outdated research methods, and early limitations in implantable device technology. Intrathecal pumps for baclofen have remained as the mainstay for refractory spasticity, however, it comes with associated risks such as chemical dependence leading to acute baclofen withdrawal and requiring frequent refill requirement. Most importantly, it does not yield functional improvement of muscle activity, just suppression of spasticity. Botox is also routinely used but due to heterogeneity in muscle involvement as well as variability in provider skill, results may be inconsistent and short-lasting, requiring frequent clinic visits for repeat injections to the affected muscle groups. SCS may be able to address that gap in spasticity management. ### Conditions - Chronic Pain - Spasticity as Sequela of Stroke - Upper Motor Neuron Lesion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Spinal Cord Stimulation- Closed loop ### Outcomes Primary Outcomes - Pain as assessed by Visual Analog Score Secondary Outcomes - Spasticity Reduction as assessed by the Modified Ashworth's Score - Short Form 36 Health Survey (SF-36) score - Medication Use - Health Status as assessed by the EuroQol 5 Dimension 5 Level (EQ-5D-5L) ### Location - Facility: Johns Hopkins Hospital, Baltimore, Maryland, 21287, United States @@
## Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use Disorder - NCT ID: NCT06384157 - Study ID: INDV-2000-201 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-09 - Lead Sponsor: Indivior Inc. ### Study Description The purpose of this study is to measure safety and efficacy and to determine dose-response relationship for INDV-2000 in participants with moderate to severe Opioid Use Disorder (OUD) who are new to treatment, have recently initiated or completed short-term medically supervised withdrawal with transmucosal (TM) buprenorphine, and are interested in transitioning to a non opioid treatment. ### Conditions - Opioid Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - INDV-2000 - Placebo ### Outcomes Primary Outcomes - Proportion (probability) of participants without treatment failure by the end of Week 12 (Day 85). Secondary Outcomes - Proportion (probability) of visits with opioid abstinence while participants are on IMP alone. - Participant's percentage of visits with opioid abstinence during the whole study follow-up. - Incidence, severity and relatedness of adverse events, treatment-emergent adverse events, serious adverse events and events leading to discontinuation and deaths. - Opioid Craving Assessment - Cmax on Day 1 and Day 15/16 - Tmax on Day 1 and Day 15/16 - AUC0-24 on Day 1 and Day 15/16 - Cavg on Day 1 and Day 15/16 - Cmin on Day 1 and Day 15/16 - CL/F on Day 1 and Day 15/16 - Clinical Opiate Withdrawal Scale (COWS) score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Machine Learning Miscarriage Management Clinical Decision Support Tool Study - NCT ID: NCT06384144 - Study ID: 23QC8155 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2026-06-01 - Lead Sponsor: Imperial College London ### Study Description Machine learning used to develop an algorithm to determine chance of success with expectant or medical management for an individual patient. Taking into account the following objective measures:* Demographics: Maternal Age, Parity* History: Previous CS, Previous SMM/MVA, Previous Myomectomy* Gestation by LMP* Presenting symptoms: Bleeding score, Pain score* USS Measurements: CRL, GS, RPOC 3 dimensions, Vascularity* Discrepancy between gestation by CRL and LMPAudit to collate 1000 cases and identify features contributing to an algorithm that can predict outcome of miscarriage management for individualized case management. ### Conditions - Miscarriage in First Trimester ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Expectant Management of First Trimester Miscarriage - Medical Management of First Trimester Miscarriage ### Outcomes Primary Outcomes - Machine learning predictive model development for miscarriage management outcomes. Secondary Outcomes - Prospective audit to test and validate predictive model ### Location - Facility: Imperial College Heatlhcare NHS Trust, London, N/A, W12 0HS, United Kingdom @@
## A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection - NCT ID: NCT06384131 - Study ID: ABI-4334-102 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-04-22 - Lead Sponsor: Assembly Biosciences ### Study Description This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-4334 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. The study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 to receive ABI-4334 or placebo. ### Conditions - Chronic Hepatitis B ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ABI-4334 - Placebo ### Outcomes Primary Outcomes - Primary Outcome Measure Secondary Outcomes - Maximum Plasma Concentration (Cmax) of ABI-4334 in subjects with cHBV - Minimum Plasma Concentration (Cmin) of ABI-4334 in subjects with cHBV - Area Under Plasma Concentration-Time Curve (AUC) of ABI-4334 in subjects with cHBV - Time to Maximum Plasma Concentration (Tmax) of ABI-4334 in subjects with cHBV - Elimination half-life (t1/2) of ABI-4334 in subjects with cHBV - To evaluate the changes in HBV DNA (IU/mL or Log IU/mL) in subjects with cHBV - Proportion of subjects with HBV DNA < lower limit of quantification (LLOQ) and/or limit of detection (LOD) - Mean time elapsed to subjects achieving HBV DNA < LLOQ and/or LOD ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of a Health Intervention on Hypoglycemic Coping : a Pilot Study - NCT ID: NCT06384118 - Study ID: YZUHL20220047 - Status: COMPLETED - Start Date: 2023-08-01 - Completion Date: 2024-01-17 - Lead Sponsor: Yating Liu ### Study Description From August 2023 to January 2024, 100 patients with type 2 diabetes who met the inclusion and exclusion criteria were selected from the endocrinology department of The purpose of this study was to construct a hypoglycemia coping intervention program for type 2 diabetic patients based on the IMB theory and to investigate the feasibility, acceptability, and initial effects of the program. ### Conditions - Type 2 Diabetes Mellitus - Hypoglycemia - Health Education ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Impact of an IMB theory-based health education intervention on hypoglycemic coping in patients with type 2 diabetes: a pilot study ### Outcomes Primary Outcomes - The hypoglycemic coping style Secondary Outcomes - hypoglycemic fear behavioral - Hypoglycemia fear worry - Level of health information access behavior - Level of health beliefs - Level of diabetes knowledge ### Location - Facility: Ya ting Liu, Yangzhou, 未选择, N/A, China @@
## Study of the Patient Radiation Dose During Five Endourological Procedures - NCT ID: NCT06384105 - Study ID: PRDE1 - Status: RECRUITING - Start Date: 2023-12-19 - Completion Date: 2024-12-18 - Lead Sponsor: Universiteit Antwerpen ### Study Description In the medical world more and more procedures are performed with the use of ionizing radiation (x-ray), both diagnostic and therapeutic. The main and most known risk is the development of malignancies as a result of the use of ionizing radiation.Purpose of this study: To examine the patient radiation dose (PRD) if the frames per second (FPS) are set differently during the five most performed endourological procedures where fluoroscopy is used (insertion/replacement of ureteral stent, (mini-)percutaneous nephrolithotomy (PCNL/PNL), ureterorenoscopy (URS) and extracorporeal shock wave lithotripsy (ESWL/SWL)) and to propose an acceptable PRD for these procedures in a multicentric study. ### Conditions - Radiation Exposure - Urolithiasis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - frames per second ### Outcomes Primary Outcomes - Dose limit Secondary Outcomes - Difference in PRD - PRD different centres - PRD difference complicated cases ### Location - Facility: AZ Klina, Brasschaat, Antwerp, 2930, Belgium @@
## Process Validation in Dermatology: Assessing Methods for UV Exposure (Artificial Source vs. Sunlight) and Efficacy Evaluation of Anti-Tanning Agents - NCT ID: NCT06384092 - Study ID: NB240005-NB-V - Status: COMPLETED - Start Date: 2024-03-07 - Completion Date: 2024-03-13 - Lead Sponsor: NovoBliss Research Pvt Ltd ### Study Description The rationale of this study is to establish a robust method for assessing sun protection product efficacy in preventing erythema and tanning. Employing both artificial ultraviolet-A Irradiation and natural direct sunlight exposure, the investigation seeks to provide a reliable methodology, ensuring reproducibility and enabling a direct comparison between these methods. Meticulously determining optimal UV dosages, the study prioritizes inducing skin responses for evaluation while avoiding adverse effects like blistering. The localized validation of UV exposure techniques, tailored to the Indian population, contributes significantly to the field by addressing diverse skin types and environmental conditions. By incorporating both artificial and natural (direct sunlight) UV exposure methods, the study aspires to enhance the safety and effectiveness of future dermatological investigations, benefiting both the scientific community and the broader population. ### Conditions - Skin Pigmentation ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Test Sun Protection Cream - Benchmark Sun Protection Cream ### Outcomes Primary Outcomes - Changes in Melanine index using instrumental assessment - Change in erythema index using instrumental assessment Secondary Outcomes - Change in skin erythema/dryness/wrinkles and oedema using draize scale ### Location - Facility: NovoBliss Research Pvt Ltd, Gandhinagar, Gujarat, 382421, India @@
## Duration of Ureteral Rest Prior to Ureteral Reconstruction Surgery - NCT ID: NCT06384079 - Study ID: STU00219828 - Status: RECRUITING - Start Date: 2024-05 - Completion Date: 2030-11 - Lead Sponsor: Northwestern University ### Study Description Our objective is to assess the effect of duration of ureteral rest, defined as time from conversion of ureteral stent to percutaneous nephrostomy, on stricture length prior to ureteral reconstruction surgery. ### Conditions - Ureteral Stricture ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Antegrade and retrograde pyelogram ### Outcomes Primary Outcomes - Ureteral stricture length measured by antegrade or retrograde pyelogram Secondary Outcomes - Ureteral Stricture Quality will be graded as either narrowed or obliterated segment. ### Location - Facility: Northwestern University, Chicago, Illinois, 60611, United States @@
## Mobile Health Application to Improve Patient Satisfaction After Urethroplasty - NCT ID: NCT06384066 - Study ID: STU00219774 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: Northwestern University ### Study Description Create a custom urethroplasty mobile application that will guide patients through through the surgical process. ### Conditions - Urethral Stricture ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - GetWell Mobile Application - Standard of Care ### Outcomes Primary Outcomes - Improve patient satisfaction, education and reported outcomes - Change in rate of patient phone calls and messages - Rate of emergency department visits Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Skin Cancer and Hyperthermia and Radiotherapy - NCT ID: NCT06384053 - Study ID: SAHARA Trial - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2028-07-01 - Lead Sponsor: Kantonsspital Winterthur KSW ### Study Description The SAHARA trial assesses wether combining ultrahypofractionated accelerated radiotherapy (RT) with hyperthermia is as effective as standard hypofractionated high-dose radiation in treating non-melanoma skin cancer (NMSC). ### Conditions - Basal Cell Carcinoma - Squamous Cell Carcinoma Skin - Non-melanoma Skin Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined - Radiotherapy (RT) ### Outcomes Primary Outcomes - Local control Secondary Outcomes - Analysis - Late toxicities - Quality of life assessment ### Location - Facility: Kantonsspital Winterthur, Winterthur, Kanton Zuerich, 8401, Switzerland @@
## Immuno-based Profiling of knEe OA Patients to Predict reSponse to Regenerative Treatment - NCT ID: NCT06384040 - Study ID: GR-2019-12370692 - Status: RECRUITING - Start Date: 2021-11-01 - Completion Date: 2024-10-30 - Lead Sponsor: Istituto Clinico Humanitas ### Study Description Osteoarthritis (OA) is a highly prevalent degenerative musculoskeletal disease and a major cause of chronic disability worldwide. Its multifactorial origin contributes to determine the heterogeneous phenotypes and one unmet need is the lack of biomarkers to predict the individual response. Platelet-rich-plasma (PRP) injection is a minimally invasive autologous blood-derived approach for which we plan to define specific knee profiles predictive of response. We will take advantage of a unique multidisciplinary approach aimed at analysing clinics, imaging, and biomarkers of associated with clinical response. We will focus on inflammatory (Wnt system, IL1 pathway, PTX3) and antioxidant (primarily, DPP3/Keap1/Nrf2) pathways. We foresee that our results will allow a better allocation of immunomodulatory and regenerative therapies for a personalized approach in knee OA thus maximising the effectiveness of the healthcare allocation. ### Conditions - Osteoarthritis, Knee ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - platelet-rich plasma knee injection ### Outcomes Primary Outcomes - knee OA patients focusing on changes in Wnt and IL1-ß signalling and PTX3 expression Secondary Outcomes - To assess the overall oxidative status and antioxidant capacity of the enrolled OA patients and its possible prognostic role with respect to response to PRP treatment ### Location - Facility: Istituto Clinico Humanitas, Rozzano, Milano, 20089, Italy @@
## Effects of Non-invasive Ventilation on Function Diaphragmatic and Caval Distension - NCT ID: NCT06384027 - Study ID: VNI_USG_2024 - Status: RECRUITING - Start Date: 2024-02-05 - Completion Date: 2024-06-10 - Lead Sponsor: Federal University of Paraíba ### Study Description Introduction: Understanding how the applicability of non-invasive ventilation can directly affect the anatomy and diaphragmatic function, as well as the opening diameter of the inferior vena cava in healthy individuals is fundamental to knowing how this therapy can interfere with treatment results. Objective: Identify the acute effects of PEEP and ventilatory support pressure on thickening fraction, diaphragmatic mobility and vena cava distension in healthy people. Methods: This is a crossover, randomized study, blinded to the evaluator and the researcher responsible for the statistical analysis. Volunteers will undergo a NIV session, randomized into groups: CPAP, Bi-level and spontaneous breathing, without NIV support (control). The outcomes evaluated will be diaphragmatic ultrasound and inferior vena cava distensibility. The CPAP levels will be: 5, 10 and 15 cmH2O after 5 minutes of use and in the Bi-level group we will maintain the PEEP value at 5cmH2O and modify the pressure support values to the values: 5, 7 and 10 cmH2O pressure support, with all outcomes also being assessed after 5 minutes. Participants will remain in a supine position, with the right upper limb positioned behind the head, throughout the protocol and all measurements will be collected in the inspiratory and expiratory phases with volumes basal currents. For statistical analysis, intention-to-treat analysis will be employed and groups will be compared using Student's t-test, for continuous variables, or chi-square, for categorical variables. ANOVA split-plot, repeated measures for primary occurrences. Analyzes of covariance to identify differences between groups using baseline scores as covariates. Effect sizes and confidence intervals will be calculated using eta squared (η²). Expected results: Elucidate the effects of different blood pressure levels on diaphragmatic function and inferior vena cava distension. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Non-invasive ventilation ### Outcomes Primary Outcomes - Diaphragmatic thickening fraction Secondary Outcomes - Diaphragmatic mobility ### Location - Facility: Federal University of Paraiba, João Pessoa, Paraiba, 58051-900, Brazil @@
## Examining the Effect of Different Filling Techniques on Healing in Lesional Teeth - NCT ID: NCT06384014 - Study ID: 2024/56 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-01-01 - Lead Sponsor: TC Erciyes University ### Study Description Microorganisms are an important factor in the development of periradicular diseases. The goal of non-surgical endodontic treatment is to eliminate microorganisms and their byproducts from the root canal system and to create an effective barrier between the root canal system and surrounding tissues. If there is no healing in the periradicular tissues after non-surgical endodontic treatment or if retreatment becomes impossible, surgical endodontic treatment is required. Apical resection is a surgical technique that involves removing the root tip of the tooth and closing the apical portion of the root canal system. An ideal retrograde filling material should be non-toxic, non-carcinogenic and biocompatible. It must also have dimensional stability and sealing properties. Amalgam, glass ionomer cements, and zinc oxide-eugenol based materials have been used for root end fillings in periapical surgery, but the desired success was not achieved. Today, Mineral Trioxide Aggregate (MTA) is preferred as a retrograde filling material due to its superior sealing properties, ability to harden in the presence of blood and moisture, antibacterial effects, biocompatibility and radiopacity.In the researchers' study, the effect of apical resection after orthograde canal filling and retrograde canal filling during apical resection on postoperative recovery will be compared. In both canal filling techniques, Sure-Seal Root MTA (Sure Dent Corporation-Korea) will be used as the filling material. Sure-Seal Root MTA is a calcium silicate based paste that is typically pre-mixed and ready to apply, exhibits excellent physical properties and does not show shrinkage during the curing process. As the manufacturer states, it is hydrophilic, biocompatible, has ideal setting and working time.Our faculty has piezosurgical ultrasonics (Mectron ®, Grassobbio BG, Italy). After the root tip resection is performed, the retrograde cavity will be prepared with Woodpecker ultrasonic tips (Guilin, China) compatible with this device. In our study using these materials and devices, a comparative analysis of the effects of different canal filling techniques on lesion healing and improvement in clinical symptoms will be made. ### Conditions - Apical Cyst ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - retrograde and orthograde root canal filling ### Outcomes Primary Outcomes - Comparison of lesion healing rate after apical resection using different root canal filling techniques Secondary Outcomes ### Location - Facility: Erciyes Üniversitesi Diş Hekimliği Fakültesi, Kayseri, N/A, 38039, Turkey @@
## Meditation for Older Adults With Chronic Low Back Pain - NCT ID: NCT06384001 - Study ID: STUDY00004032 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-12 - Lead Sponsor: Florida State University ### Study Description This pilot randomized controlled trial aims to recruit 66 community-dwelling older adults with chronic low back pain and follow up them for 8 weeks. This study aims to test the preliminary effect of a mindfulness-based meditation (MBM) intervention on pain and symptoms among community-dwelling older adults with chronic low back pain, and also to test the effect of the MBM intervention on the host Gut-Brain Axis (GBA). ### Conditions - Chronic Low Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Active MBM - Sham MBM ### Outcomes Primary Outcomes - Change in pain intensity and interference Secondary Outcomes - Change in pain sensitivities - Change in pain modulation - Change in chronic pain self-efficacy - Change in anxiety - Change in cognitive complaints - Change in depression - Change in fatigue - Change in sleep disturbance - Change in pain-related cortical response - Measurement and comparison of fecal microbiota alpha diversity, beta diversity, and abundance of microbial taxa in the human gut - Chang in inflammatory cytokines ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Web-based Program to Help Caregivers of Lung Patients Learn About Available Supportive Care Resources - NCT ID: NCT06383988 - Study ID: IRB000112187 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2026-01 - Lead Sponsor: Wake Forest University Health Sciences ### Study Description Clinical trial that tests the feasibility of a web based caregiver support resource, along with caregiver navigation sessions for caregivers of patients with stage II-IV lung cancer. The Caregiver Oncology Needs Evaluation Tool (CONNECT) is a novel web-based intervention designed for the community oncology setting, to systematically connect lung cancer caregivers with tailored supportive care resources. Lung cancer caregivers provide critical and challenging care for their loved ones and are at risk for their own negative psychosocial and physical outcomes. Implementing the CONNECT program along with caregiver navigation may provide additional support to caregivers of patients with stage II-IV lung cancer. ### Conditions - Stage II Lung Cancer - Stage III Lung Cancer - Stage IV Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Support for Caregiver - Generic List - Support for Caregiver - Personalized List - Internet-Based Intervention - CONNECT - Patient Navigation ### Outcomes Primary Outcomes - Caregiver retention at 12 weeks Secondary Outcomes - Caregiver accrual rate - Caregiver participation - Caregiver retention at 24 weeks - Caregiver acceptability - Average time (minutes) needed for training for Local Practice Referral Coordinator - Desired modality for training (e.g., live webinar, recorded video, paper materials) for Local Practice Referral Coordinator - Average time (minutes) needed to identify and enter local resources into the Caregiver Oncology Needs Evaluation Tool (CONNECT) database - Frequency of needed resource updates in the CONNECT database - Average time (minutes) spent by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm - Modality of contact (e.g. phone, virtual web meeting, email) made by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm - Number of contacts made by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm - Number of referrals facilitated by the Local Practice Referral Coordinator and Central Caregiver Navigator - Type of referrals (e.g., in person, online) facilitated by the Local Practice Referral Coordinator and Central Caregiver Navigator - Average time (minutes) needed to communicate for Central Caregiver Navigator and Local Practice Referral Coordinator - Modalities used for communication (e.g., phone, virtual web meeting, email) for Central Caregiver Navigator and Local Practice Referral Coordinator - Improvements for the future trial from Local Practice Referral Coordinator's perspectives from a survey at the end of the study ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## VEin of MArshall Ethanolization vs Extended Pulmonary Vein PULSEd Field Ablation After Failed PVI for Persistent AF - NCT ID: NCT06383975 - Study ID: CIV-24-01-045634 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-29 - Completion Date: 2027-04-30 - Lead Sponsor: Sebastien Knecht ### Study Description The goal of this clinical trial is to compare two ablation techniques to treat patients with persistent atrial fibrillation (irregular and often very rapid heart rhythm). An ablation is a procedure during which some scars are made on the inside of the heart to break up the electrical signals that cause the irregular heartbeat. In this trial researchers will compare a new technique, which uses tiny electric shocks to make the scars, to the standard technique, which uses heat.The main question the trial aims to answer is:• Does the new technique work as well as the standard technique to prevent the irregular heartbeat from returning within one year of the procedure?Participants will:* Undergo an ablation with either the new or the standard technique* Visit the hospital 1, 3, 6, 9 and 12 months after the procedure for a check-up* Wear a device to register their heart rhythm for 24 hours before the 3 month visit and for 72 hours before the 6, 9 and 12 month visit* Record their heart rhythm at home every week* Complete a questionnaire 3, 6, 9 and 12 months after the procedure ### Conditions - Persistent Atrial Fibrillation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pulsed field ablation with posterior wall isolation - Radiofrequency ablation and vein of Marshall ethanolization ### Outcomes Primary Outcomes - Atrial tachyarrhythmia recurrence within 12 months Secondary Outcomes - Safety and procedural related adverse event - Duration of the ablation procedure - Fluoroscopy time - Fluoroscopy dose - Effect of the procedure on quality of life - Incidence of repeat ablation - Unscheduled visits and hospitalization ### Location - Facility: AZ Sint-Jan Brugge AV, Brugge, N/A, 8000, Belgium @@
## Post-Market Data Collection to Evaluate the Performance of the Synergy Disc® - NCT ID: NCT06383962 - Study ID: CP 21-001-UK02 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2034-09-01 - Lead Sponsor: Synergy Spine Solutions ### Study Description This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease. ### Conditions - Cervical Degenerative Disc Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Synergy cervical spine disc replacement ### Outcomes Primary Outcomes - Neck Disability Index (NDI) - Device Related or Device Procedure Related Adverse Events Secondary Outcomes - Neck and Arm Pain Measurement - Patient Satisfaction - Motor and Sensory Function in the Arm - Nurick's Criteria - Odom's criteria ### Location - Facility: Royal Orthopaedic Hospital, Birmingham, N/A, N/A, United Kingdom @@
## Real World Data Collection on the Synergy Disc - NCT ID: NCT06383949 - Study ID: CP 21-001-IRE01 - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2033-02-23 - Lead Sponsor: Synergy Spine Solutions ### Study Description This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease. ### Conditions - Cervical Degenerative Disc Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Synergy Cervical Disc system ### Outcomes Primary Outcomes - Neck Disability Index (NDI) - Device Related or Device Procedure Related Adverse Events Secondary Outcomes - Neck and Arm Pain Measurement - Patient Satisfaction - Motor and Sensory Function in the Arm - Nurick's Criteria - Odom's criteria ### Location - Facility: Mater Misericordiae University Hospital, Dublin, N/A, N/A, Ireland @@
## FAldini Sport Total Joint Arthroplasty-Knee II - NCT ID: NCT06383936 - Study ID: FAST-K II - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2025-12-31 - Lead Sponsor: Istituto Ortopedico Rizzoli ### Study Description The majority of patients undergoing total knee arthroplasty are elderly individuals with low functional demands, aiming to alleviate pain. However, there exists a subgroup of younger patients, under the age of 65, with higher functional demands. The purpose of this study is to evaluate the return to sports activities in this patient group following a non-cemented total knee arthroplasty procedure and a specific rehabilitation protocol. The investigators expect that with the use of non-cemented prostheses and a specific rehabilitation protocol, many of these patients will safely resume sports activities. ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - intensive rehabilitation after uncemented TKA ### Outcomes Primary Outcomes - number of patients returning to sports activities assessed by questionnaire - clinical and functional outcomes measured as the variation in the Knee Society Score Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Risk Factors, Prognosis and Prediction Models for Placenta Accreta Without Prior Cesarean Section - NCT ID: NCT06383923 - Study ID: BYSYDL2022015 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2024-12 - Lead Sponsor: Peking University Third Hospital ### Study Description 1. Identify the risk factors for Placenta accreta spectrum (PAS) disorders in women without prior caesarean section (CS).2. Clarify the prognostic factors of the disease and explore individualized treatment options to improve the prognosis of patients with this type of disease;3. Use the cohort's biological sample database to conduct serology, cytology, and histology studies to explore the abnormal uterine immune microenvironment and the impact on uterine spiral artery remodeling in non-scar uterine-placenta accreta disease. ### Conditions - Placenta Accreta Spectrum ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Placenta Accreta Spectrum Secondary Outcomes - Amount of bleeding - Hemostatic measures - hysterectomy - blood transfusion volume ### Location - Facility: Peking University Third Hospital, Beijing, N/A, N/A, China @@
## The Effect Of Square Stepping Exercise Training On Cognitive Functions And Quality Of Life In Geriatric Individuals - NCT ID: NCT06383910 - Study ID: 10.185.1.58 - Status: COMPLETED - Start Date: 2021-10-12 - Completion Date: 2024-01-05 - Lead Sponsor: Pamukkale University ### Study Description This study was designed to investigate the effects of Square-Stepping Exercise Training on cognitive functions and quality of life in geriatric individuals. The volunteer participants in the study were randomly divided into two groups: a square-stepping exercise group and a control group.In the study, participants in the exercise training groups received square stepping exercises three days a week for six weeks, while those in the control group did not undergo any training. Both groups were assessed before and six weeks after the training period.The investigators used several assessment tools including Hodkinson's Mental Test, Montreal Cognitive Assessment, Stroop Test, Trail Making Test, and the Turkish World Health Organization Quality-of-Life Scale. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Square Stepping Exercise ### Outcomes Primary Outcomes - Change on Cognitive Functions from Base on the Montreal Cognitive Assessment In 6 Weeks - Change on Cognitive Functions from Base on the Stroop Test In 6 Weeks - Change on Cognitive Functions from Base on the Trail Making Test In 6 Weeks - Change on Quality of Live from Base on the World Health Organization Quality-of-Life Scale Turkish version In 6 Weeks Secondary Outcomes ### Location - Facility: Pamukkale University, Denizli, N/A, N/A, Turkey @@
## Phase 1 Study in Healthy Participants and Participants With Kidney Dysfunction - NCT ID: NCT06383897 - Study ID: HS-10398-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-31 - Completion Date: 2025-01-31 - Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. ### Study Description A randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and the impact of food on pharmacokinetics of oral HS-10398 in Chinese healthy participants, and a clinical trial to assess the pharmacokinetic characteristics of oral HS-10398 in Chinese participants with kidney dysfunction ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HS-10398 - HS-10398 Placebo ### Outcomes Primary Outcomes - Incidence and severity of adverse events (AEs) - Serious adverse events (SAEs) Secondary Outcomes - Observed maximum plasma concentration (Cmax) - Time to reach maximum plasma concentration (Tmax) - Elimination Halflife (T1/2) - Apparent clearance（CL/F） - Apparent Volume of Distribution（Vd/F） ### Location - Facility: The Affiliated Hospital of Qingdao University, Qingdao, N/A, N/A, China @@
## Patritumab Deruxtecan in Patients With Solid Tumor Harboring an NRG1 Fusion - NCT ID: NCT06383884 - Study ID: 2024-02-134 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2029-04-30 - Lead Sponsor: Samsung Medical Center ### Study Description The NRG1 gene is located on chromosome 8 (8p12 region) and encode NRG1. NRG1 gene is translated to generate six different proteins (I-VI) and at least 31 isoforms. NRG1 proteins are structurally related to EGF and contain an EGF-like motif that binds and activates ErbB3 and ErbB4. Upon ligand binding, these receptors form homodimers or heterodimers, which results in phosphorylation of the intrinsic kinase domain, and activation of the PI3K-AKT, MAPK, and other pathways.The overall incidence of NRG1 fusions is very rare. In many tumor types, only limited numbers of NRG1 fusion variant have been identified. By percentage, there is no organ dominance of the presence of NRG1 fusions. In an analysis of 21, 858 tumor specimens that underwent anchored multiplex PCR for targeted RNA sequencing, the prevalence of NRG1 fusions was 0.2%. Of these, CD74 was the most common partner (29%), followed by ATP1B1 (10%), SDC4 (7%), and RBPMS (5%), and most CD74-NRG1 fusions have been reported in patients with lung IMA. NRG1 fusions result in aberrant expression of the epidermal growth factor (EGF)-like domain of neuregulin-1 (NRG1) on the cell surface binds primarily to ErbB3 and ErbB4, leading to heterodimerization or oligomerization with other ERBB family members. NRG1-mediated activation of ErbB3 promotes dimerization with EGFR, ErbB2, and ErbB4. These partners phosphorylate ErbB3, forming docking sites for SH2-domain proteins, leading to pathologic activation of multiple signal transduction pathways, including the phosphoinositide 3-kinase (PI3K) pathway. Subsequently, ErbB3 expression was noted at high levels, and the proteins were phosphorylated, in fusion-positive cases. Targeting ErbB3 signaling therefore represents a promising therapeutic approach for patients with NRG1 fusion-positive malignancies. ### Conditions - Solid Tumor, Adult ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Patritumab Deruxtecan ### Outcomes Primary Outcomes - Objective response rate(ORR) Secondary Outcomes - Duration of response (DoR) - Progression-free survival(PFS) - Disease-control rate(DCR) - Best percentage change in the SoD of measurable tumors - Overall survival(OS) ### Location - Facility: Samsung Medical Center, Seoul, N/A, 06351, Korea, Republic of @@
## A Phase I Clinical Study of HRS-7058 in Patients With Advanced Malignant Tumour - NCT ID: NCT06383871 - Study ID: HRS-7058-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-06 - Lead Sponsor: Shandong Suncadia Medicine Co., Ltd. ### Study Description This study is a multicentre, open phase I clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in subjects with advanced malignant tumour. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-7058. ### Conditions - Advanced Malignant Tumour ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - HRS-7058 capsule/ HRS-7058 tablet ### Outcomes Primary Outcomes - Dose-limiting toxicity (DLT) - maximum tolerated dose (MTD) - Phase II recommended dose (RP2D) - Safety endpoints: adverse events (AE) Secondary Outcomes - Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion - Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion - Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion - Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion - Efficacy endpoints: overall survival (OS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Project of Gestational Hypertension and Preeclampsia Screening and Prevention Center - NCT ID: NCT06383858 - Study ID: [2023] Ethics Review NO.151 - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2028-12-31 - Lead Sponsor: The Third Affiliated Hospital of Guangzhou Medical University ### Study Description Preeclampsia is the main cause of illness and death in pregnant women and fetuses. Currently, there is no effective treatment for preeclampsia in clinical practice, and the fundamental treatment is still termination of pregnancy and placental delivery.Therefore, early prediction of preeclampsia and targeted strengthening of high-risk pregnant women supervision, early intervention and diagnosis and treatment can greatly reduce the serious obstetric complications and perinatal maternal and fetal deaths caused by preeclampsia, which has significant social and clinical significance. ### Conditions - Preeclampsia - Maternal Deaths ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Preeclampsia Secondary Outcomes - Premature birth - Fetal Growth Restriction - Severe complications of preeclampsia ### Location - Facility: FANG HE, Guangzhou, Guangdong, 510150, China @@
## Comparison of Erector Spinae Plane Block vs Intravenous Lidocaine for Chronic Pain Post Mastectomy. - NCT ID: NCT06383845 - Study ID: MAS ESLI - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-01 - Completion Date: 2024-09-30 - Lead Sponsor: University Tunis El Manar ### Study Description Patients undergoing breast surgery were divided into two groups: Intravenous Lidocaine (Lido-IV) vs Erector Spinae Block (ESP).For Lido-IV group, patients received a loading dose of Lidocaine than a continuous infusion till the end of surgery.For ESP group, an ultrasound guided ESP Block was perormed before anesthetic induction.Persistant pain post mastectomy was assessed by SFM-PQ score at 1, 3 and 6 months post surgery. ### Conditions - Breast Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Lido-IV - ESP Block ### Outcomes Primary Outcomes - Item 5 of Brief Pain inventory score (BPI Score) Secondary Outcomes - Acute pain assessed by Simple Verbal Scale (SVS) - Postoperative nausea and vomiting - Hospital length of stay - DN4 questionnaire (DN4) - The short-form McGill Pain Questionnaire (SFM-PQ) ### Location - Facility: Tunisia, Nabeul, N/A, 8000, Tunisia @@
## Effect of Dapagliflozin on Body Weight in Overweight Women Consuming Different Proportions of Carbohydrate Diet. - NCT ID: NCT06383832 - Study ID: 20240310_GY - Status: COMPLETED - Start Date: 2021-10-28 - Completion Date: 2023-12-26 - Lead Sponsor: Sun Jia ### Study Description In recent years, the prevalence of overweight and obesity has increased dramatically worldwide, of which 34.3% and 16.4% of adults in China are overweight and obese, respectively, ranking first in the world's obese population. Dapagliflozin is a sodium-glucose transporter 2 Inhibitors that inhibits glucose reabsorption and promotes urinary glucose excretion by inhibiting renal proximal tubular sodium-glucose transporter 2 Inhibitors for the treatment of type 2 diabetes mellitus. The urinary glucose excretion induced by dapagliflozin can induce weight loss through energy loss or body water loss caused by osmotic diuresis. In addition, in patients with type 2 diabetes, dapagliflozin may also induce weight loss by reducing body fat as well as subcutaneous and visceral fat.In a randomized controlled trial, type 2 diabetes patients treated with sodium-glucose transporter 2 Inhibitors lost approximately 1-3 kg. Also, sodium-glucose transporter 2 Inhibitors have shown good weight loss in obese people without type 2 diabetes. In real-world studies, a minority of type 2 diabetes patients taking dapagliflozin experienced weight gain. The American Lipid Association defines a low carbohydrate diet as the calorie intake of carbohydrates accounting for 10-25% of the total daily energy intake. In a randomized controlled trial, a low-carbon diet showed a more significant decrease in body weight, fat mass index, whole body fat, and visceral fat after 8 weeks compared to the standard diet. So, this study intends to investigate whether the weight loss effect of dapagliflozin is affected by different dietary structures. ### Conditions - Overweight - Carbohydrate - Sodium-glucose Transporter 2 Inhibitors ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Dapagliflozin ### Outcomes Primary Outcomes - Changes in Body mass index (BMI) i Secondary Outcomes - Changes in fasting blood glucose. - Changes in waist circumference. - Changes in insulin resistance index. - Changes in waist-to-hip ratio. - Changes in abdominal circumference. - Changes in Blood triglycerides - Changes in total cholesterol - Changes in low-density lipoprotein、high-density lipoprotein - Changes in body fat percentage. - Changes in subcutaneous fat volume. - Changes in body fat volume. - Changes in the relative abundance of gut microbiota. - Changes in urine. - Changes in β-hydroxybutyric acid. - Changes in muscle mass. - Changes in fasting insulin. - Changes in visceral fat volume. - Changes in hip circumference. - The incidence of adverse events. ### Location - Facility: Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, N/A, China @@
## Efficacy and Safety of Longidaza® for the Treatment of Patients With Residual Changes in the Lungs After COVID-19 - NCT ID: NCT06383819 - Study ID: Long-Cov-III-21 - Status: COMPLETED - Start Date: 2022-04-08 - Completion Date: 2023-12-31 - Lead Sponsor: NPO Petrovax ### Study Description The goal of this clinical study is to evaluate the efficacy and safety of Longidaza®, lyophilizate for preparation of solution for injection, at a dose of 3000 IU compared to placebo in the treatment of adult patients with residual changes in the lungs after COVID-19 infection ### Conditions - Post-Acute COVID-19 Syndrome - Lung Disease With Polymyositis - Fibrosis - Lung Diseases, Interstitial - Lung; Disease, Interstitial, With Fibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Longidaza® - Placebo ### Outcomes Primary Outcomes - Change in Forced vital capacity (FVC) (visit 4) Secondary Outcomes - Slowing the decline in respiratory function - Change in FVC (visit 5) - The proportion of patients with an increase in the FVC (%) - Dynamics of hemoglobin oxygen saturation (SpO2) - The proportion of patients with SpO2 ≥ 93% and < 93% - The proportion of patients with desaturation - The proportion of patients with an increase in the distance of 6MWT - The proportion of patients with a decrease in the severity of dyspnea on the Borg scale - The proportion of patients with a decrease in the severity of dyspnea on the Modified Medical Research Council Dyspnea Scale (mMRC) - Change in cough severity on the Visual Analogue Scale (VAS) - Change in the assessment of the quality of life according to the European Quality of Life 5-Dimension 5-Level Questionnaire (EuroQol-5D-5L) ### Location - Facility: State Autonomous Healthcare Institution of the Sverdlovsk region "Aramil City Hospital", Aramil, N/A, 624000, Russian Federation @@
## Decreasing Nightmares in Adults With Narcolepsy - NCT ID: NCT06383806 - Study ID: STU00219933 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2026-09 - Lead Sponsor: Northwestern University ### Study Description The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with narcolepsy. All participants will receive the treatment and will complete three assessments. Half of the participants will receive the treatment after the first assessment, and half will receive it after the second assessment. ### Conditions - Narcolepsy - Narcolepsy Type 1 - Narcolepsy With Cataplexy - Narcolepsy Without Cataplexy - Nightmare - Nightmare Disorder With Associated Other Sleep Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Imagery Rehearsal Therapy (IRT) ### Outcomes Primary Outcomes - Disturbing Dream and Nightmare Severity Index (DDNSI) - Nightmare frequency (sleep diary) Secondary Outcomes - PROMIS Anxiety - PROMIS Depression ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparative Analysis of Short-Term Therapeutic Effects Between the π-Shaped and Overlap Methods for Esophagogastrostomy in Totally Laparoscopic Total Gastrectomy - NCT ID: NCT06383793 - Study ID: Northjiangsu000 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-30 - Lead Sponsor: Northern Jiangsu People's Hospital ### Study Description As of now, although the safety of π-shaped anastomosis and the overlap method has been separately discussed in different contexts, there have been few studies considering a direct comparison of the results of these two methods.This article aims to explore the differences in the short-term therapeutic effects, surgical effectiveness, and safety between laparoscopic total gastrectomy with esophagogastrostomy using the overlap method and the π-shaped method. The goal is to provide new reference points for surgeons in the clinical decision-making process regarding the choice of anastomotic techniques during totally laparoscopic total gastrectomy. ### Conditions - Gastric Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - overlap ### Outcomes Primary Outcomes - 1 year survival Secondary Outcomes ### Location - Facility: Yifan Cheng, Yangzhou, Jiangsu, 225000, China @@
## Tislelizumab in Combination With GP or TPC Regimen for the Treatment of Nasopharyngeal Carcinoma With Bone Metastasis. - NCT ID: NCT06383780 - Study ID: SYSKY-2023-901-01 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-05-01 - Lead Sponsor: XIANG YANQUN ### Study Description This is a prospective, open-label phase III clinical trial evaluating the efficacy and safety of the GP（Gemcitabine combined with cisplatin） regimen in combination with Tislelizumab versus the TPC（cisplatin, nab-paclitaxel and capecitabine）regimen in combination with Tislelizumab for the first-line treatment of Nasopharyngeal Carcinoma patients With Bone Metastasis. ### Conditions - Nasopharyngeal Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - GP combined with Tislelizumab - TPC combined with Tislelizumab ### Outcomes Primary Outcomes - 1-year progression-free survival rate Secondary Outcomes - Overall survival - incidence of adverse events - rate of skeletal-related events - Biomarker response (EBV-DNA, bone metabolic markers) ### Location - Facility: SunYat-senU, Guangzhou, Guangdong, 510060, China @@
## A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer - NCT ID: NCT06383767 - Study ID: ESG401-301 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-30 - Completion Date: 2026-12-31 - Lead Sponsor: Shanghai Escugen Biotechnology Co., Ltd ### Study Description The aim of this study is to evaluate the efficacy and safety of ESG401 in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer. ### Conditions - Metastatic Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ESG401 - Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice) ### Outcomes Primary Outcomes - Progression-free survival (PFS) assessed by IRC per RECIST 1.1 Secondary Outcomes - Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1 - Overall Survival (OS) - Objective Response Rate (ORR) - Clinical Benefit Rate (CBR) - Duration of Response (DoR) - Quality of life evaluated using the NCC-BC-A scale - Adverse events(AEs) and severe adverse events (SAEs) - Clearance - Volume of distribution - ADA ### Location - Facility: Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, 100021, China @@
## Clareon Intraocular Lens Stability in Vitrectomy Patients: CLOVE Study - NCT ID: NCT06383754 - Study ID: Clove - Status: COMPLETED - Start Date: 2021-06-07 - Completion Date: 2024-03-15 - Lead Sponsor: The University of Hong Kong ### Study Description This prospective randomized controlled trial will be conducted to investigate Clareon intraocular lens (IOL) stability in vitrectomy patients. The investigator plans to target the patients undergoing cataract surgery. A randomized study will be conducted with 2 arms, one with Clareon IOL versus a second arm using the Tecnis 1 In this non-inferiority study, the investigator will compare Clareon IOL from Alcon with the existing Tecnis 1 IOL from Precision Lens which is the commonly used intraocular lens in combined vitrectomy cases in Hong Kong. ### Conditions - Senile Cataract - Epiretinal Membrane - Vitreous Hemorrhage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Clareon - Tecnis 1 ### Outcomes Primary Outcomes - Position stability of Clareon and Tecnis 1 IOL Secondary Outcomes - Visual acuity - Refraction - Axial movement - Decentration - Compare intra operative and post operative complication ### Location - Facility: Grantham Hospital, Hong Kong, N/A, N/A, Hong Kong @@
## Predicting Outcomes in ICH Patients on Direct Factor Xa Inhibitors - NCT ID: NCT06383741 - Study ID: 2023-00541 - Status: RECRUITING - Start Date: 2023-07-10 - Completion Date: 2026-04-01 - Lead Sponsor: Insel Gruppe AG, University Hospital Bern ### Study Description This study focuses on direct factor Xa inhibitors (apixaban, edoxaban, rivaroxaban) and the thrombin inhibitor dabigatran, commonly used for stroke prevention in atrial fibrillation. Despite lower intracranial bleeding risks with these drugs, around 0.2-1.0% of patients annually experience intracranial hemorrhage (ICH), predominantly intracerebral.Treatment options for factor-Xa inhibitor-associated ICH, such as prothrombin complex concentrate (PCC) and andexanet alfa, lack direct comparison evidence except for ongoing trials like ANNEXA-I. This trial assesses hemostatic efficacy and 30-day functional outcomes but leaves gaps regarding anticoagulant activity's role and long-term effects, especially in patients presenting late after drug intake.The measurement of anti-FXa levels helps guide decisions, yet their link to hematoma expansion remains unknown. Efforts to streamline measurement within 30 minutes for acute decisions have shown variability in levels, with some patients exhibiting high levels even beyond 12 hours post-intake. This lack of data poses challenges, particularly for patients potentially benefiting from treatment beyond the current strict time window.Early hematoma expansion strongly predicts poor outcomes, but preventing it faces challenges like recurrent events (up to 5% by 3 months) and rehabilitation intensity, potentially negating its benefits. The ANNEXA-I trial evaluates short-term outcomes, highlighting the need for additional data to comprehend long-term ICH prognosis.The study's objectives involve linking hematoma expansion to anti-FXa levels, determining late-presenting patients' risk of expansion, and identifying predictors of favorable outcomes at 3, 6, and 12 months. Primary endpoints include functional outcomes, while secondary ones encompass expansion rates, anticoagulant activity, and various events at 12 months.This research aims to bridge gaps in understanding factor-Xa inhibitor-related ICH, addressing both immediate and prolonged outcomes to enhance clinical decision-making. ### Conditions - Intra Cerebral Hemorrhage ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Good functional outcome - Good functional outcome - Good functional outcome Secondary Outcomes - Haematoma expansion - Number of patients with significant anticoagulant activity arriving late - Absolute haematoma expansion (in ml) between baseline and follow-up imaging - Symptomatic haematoma expansion - Resumption of anticoagulant therapy after haemorrhage - Patients living at home - Functionally independent patients (mRS 0-2) - Excellent outcome (mRS 0-1) - Arterial and venous events at 12 months ### Location - Facility: Insel Gruppe AG, Inselspital Bern, Bern, N/A, 3010, Switzerland @@
## Osimertinib as Neoadjuvant Therapy in Patients With Resectable Stage II-IIIB EGFR-mutated Lung Squamous Cell Carcinoma - NCT ID: NCT06383728 - Study ID: ES-2024-014-02 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2029-04-30 - Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University ### Study Description Previous trials, such as ADURA and CTONG, have demonstrated the benefits of neoadjuvant targeted therapy in patient with EGFR mutations , which can effectively reduce the extent of tumors and improve the survival outcomes. However, clinical trials of neoadjuvant targeted therapy in NSCLC have rarely enrolled patients with EGFR-mutated lung squamous cell carcinoma due to its rarity, which means that the safety and feasibility of neoadjuvant osimertinib in patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma remains relatively unknown. ### Conditions - Lung Cancer - Carcinoma, Squamous Cell ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Osimertinib ### Outcomes Primary Outcomes - Objective Response Rate, ORR - Safety: frequency of severe adverse events Secondary Outcomes - Major pathologic response, MPR - R0 rate - Progression-free survival (PFS) - Overall survival (OS) - Disease control rate (DCR) - Duration of remission (DOR) ### Location - Facility: The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, 510120, China @@
## Congitive Behavioral Therapy Workshop for Content Moderators - NCT ID: NCT06383715 - Study ID: 2024-624 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-08-01 - Lead Sponsor: Universidad Europea de Valencia ### Study Description Professional content moderators play a critical role in preventing Internet users from being exposed to more sensitive content. However, recent literature has shown that this work places content moderators at increased risk for several psychological outcomes, including intrusive thoughts and vicarious stress trauma. This pilot study will assess the acceptability and feasibility of a brief (4-session) cognitive-behavioral workshop to reduce these risks. ### Conditions - Work-Related Condition - Work-Related Stress Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cognitive-Behavioral Therapy Workshop for Content Moderators ### Outcomes Primary Outcomes - The Kessler Psychological Distress Scale (K10) Secondary Outcomes - Work Satisfaction Scale, JobStat'73 - Coping Mechanisms Scale - PTSD Checklist-Civilian Version (PCL-C) ### Location - Facility: MEGA cloud services, Salamanca, N/A, 37002, Spain @@
## Phase III Trial to Evaluate the Efficacy and Safety of Pregabalin in the Treatment of Painful Diabetic Peripheral Neuropathy - NCT ID: NCT06383702 - Study ID: HEX1939-002 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-04-15 - Lead Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. ### Study Description This study is designed to evaluate the efficacy and safety of pregabalin extended-release tablets in the treatment of neuropathic pain associated with diabetic peripheral neuropathy. Pregabalin has been approved in more than 130 countries for neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and neuralgia associated with spinal cord injury. Pregabalin extended-release tablets were administered once daily, as a single dose after dinner. Compared with pregabalin capsule formulation, it reduces the frequency of medication and improves patient compliance. ### Conditions - Neuropathic Pain Associated With Diabetic Peripheral Neuropathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - pregabalin sustained-release tablets - Placebo ### Outcomes Primary Outcomes - NRS mean change at week 13 Secondary Outcomes - NRS mean change at Weeks 1-12 and 14 - Proportion of subjects with NRS reduction - MOS-SS score - HADS score - PGIC score - CGIC score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring - NCT ID: NCT06383689 - Study ID: Az. 297/23-EP - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-31 - Lead Sponsor: University Hospital, Bonn ### Study Description The notion of genuine placebo effects on epileptic seizure events (i.e., effects beyond methodological study artifacts) is incompatible with the standard model of epilepsy seizure genesis. In this single-blind controlled study, the effectiveness of a covered placebo on (1) the timing of the occurrence of a first epileptic seizure ("seizure pill") versus (2) the subjective well-being ("comfort pill") during pre-surgical video-EEG monitoring will be examined. It is hypothesized that a placebo effect on subjective well-being can be demonstrated, but that epileptic seizure events are not influenced by placebo. ### Conditions - Symptomatic Epilepsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Seizure placebo pill - Well-being placebo pill ### Outcomes Primary Outcomes - Latency to first epileptic seizure Secondary Outcomes - Occurrence of an epileptic seizure - Early occurrence of an epileptic seizure within the first 72 hours - Number of epileptic seizures during the video-EEG - Number of early occurring epileptic seizures - Daily average frequency of epileptic seizures - Very early first epileptic seizure - Early epileptic seizure - Epileptic seizure within the first three days - Emotional well-being - Dissociative non-epileptic seizures ### Location - Facility: Department of Epileptology, University Hospital Bonn, Bonn, NRW, 53127, Germany @@
## Effect Of Functional Balance Exercise İn Elderly - NCT ID: NCT06383676 - Study ID: 1 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-04-20 - Completion Date: 2025-05-30 - Lead Sponsor: Tarsus University ### Study Description The elderly population is increasing in Turkey and in the world. Many health problems, such as a decrease in physical and psychological abilities and an increase in chronic problems, occur with aging. It is important to encourage and support practices for the development of exercises to increase physical and cognitive capacity in order to early recognize and reduce the effects of problems that develop with aging. To the best of our knowledge, there is no exercise training to increase reaction time in the elderly in the literature. ### Conditions - Older People - Exercise ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Functional reaction balance training - Functional balance training ### Outcomes Primary Outcomes - The Montreal Cognitive Assessment (MoCA) - Stroop Test - The Simple Reaction Time Secondary Outcomes - The Four Square Step Test (FSST) - The short physical performance battery (SPPB) - Timed Up and Go Test (TUG) - Falls Efficacy Scale ( FES) - Mini-BESTest: Balance Evaluation Systems Test ### Location - Facility: Fatma Kübra ÇEKOK, Ankara, N/A, 06000, Turkey @@
## A RCT of Supraclavicular Lymph Node Dissection vs. No-dissection in Supraclavicular Lymph Node Metastatic Breast Cancer - NCT ID: NCT06383663 - Study ID: 308-2019-04-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2029-12-31 - Lead Sponsor: Sun Yat-sen University ### Study Description The purpose of this study was to compare the efficacy of surgical dissection of supraclavicular lymph nodes combined with radiotherapy versus radiotherapy alone in patients with ipsilateral supraclavicular lymph node metastasis. ### Conditions - Breast Cancer - Ipsilateral Supraclavicular Lymph Node Metastasis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Supraclavicular lymph node dissection combined with radiotherapy - radiotherapy ### Outcomes Primary Outcomes - DFS Secondary Outcomes - PFS - OS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Use of 81 vs 325mg of ASA in Treatment of BCVI - NCT ID: NCT06383650 - Study ID: 124532 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-09 - Lead Sponsor: London Health Sciences Centre ### Study Description Blunt cerebrovascular injury (BCVI), or injury to the carotid and vertebral arteries, occurs in 1-3% of blunt traumas, often as a result of injury to the head, neck, or chest. If unrecognized or untreated, BCVI can lead to stroke, which occurs in approximately 20% of untreated patients, potentially causing significant and sometimes permanent disability. Early diagnosis and treatment significantly reduce the risk of stroke.Currently, there is wide variation across centers and trauma care providers in treatment strategies for BCVI and the most recent guidelines are unable to make specific recommendations about the optimal agent and/or dose of treatment to reduce the risk of stroke after BCVI while minimizing bleeding complications in patients with multiple traumatic injuries. Recent systematic reviews and meta-analyses evaluating the most common treatment strategies for BCVI have shown similar stroke rates with the use of anticoagulants (usually heparin) vs. antiplatelets (usually aspirin/ASA), however, treatment with antiplatelets was associated with a lower risk of bleeding complications. The optimal dose of ASA for stroke prevention while minimizing bleeding complications is unknown, and more research is required to inform future care.This project will investigate two doses of antiplatelet therapy (81 mg daily vs. 325 mg daily aspirin) for BCVI treatment, and will look at the risk of stroke and bleeding complications with each strategy. The goal of the research is to determine whether a large-scale study looking at this question is feasible, which will ultimately help determine the best medical therapy for patients with BCVI. ### Conditions - Carotid Artery Injuries - Traumatic Injury - Vertebral Artery Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Acetylsalicylic Acid ### Outcomes Primary Outcomes - Study feasibility Secondary Outcomes - Incidence of stroke - Incidence of Bleeding Complications ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Antibiotic Use and Resistance KAP Among Dental Interns - NCT ID: NCT06383637 - Study ID: KAP-ABR-Interns - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2024-12-01 - Lead Sponsor: Cairo University ### Study Description The study is designed as a cross-sectional online-based questionnaire, and it will be distributed among dental interns. Assess the following among dental interns (1) The knowledge, attitude, and practices (KAP) towards antibiotics and antibiotic resistance; (2) The correlation between their KAP score and where they spend their internship year? (4) Development of the curriculum to provide sufficient training and information about antibiotics and antibiotic resistance. ### Conditions - Antibiotic Side Effect - Antibiotic Resistant Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Knowledge of dental interns regarding antibiotic use and resistance Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact Of Maternal Spinal Anesthesia-Induced Hypotension At Scheduled Cesarean Delivery On Risk Development Of Transient Tachypnea Of Newborn And Fetal Acidosis - NCT ID: NCT06383624 - Study ID: RC18-4-2023 - Status: COMPLETED - Start Date: 2023-04-01 - Completion Date: 2024-03-31 - Lead Sponsor: Benha University ### Study Description We will evaluate the association between transient tachypnea of newborns and fetal acidosis development to the degree and duration of maternal hypotension and anesthesia to delivery time during spinal anesthesia at scheduled cesarean delivery. ### Conditions - Transient Tachypnea of Newborn and Fetal Acidosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Association between transient tachypnea of newborns development to the degree and duration of maternal hypotension during spinal anesthesia at scheduled cesarean delivery - Association between fetal acidosis development to the degree and duration of maternal hypotension and anesthesia to delivery time during spinal anesthesia at scheduled cesarean delivery Secondary Outcomes ### Location - Facility: Benha University Hospital, Cairo, N/A, 13511, Egypt @@
## Expanded Access to Cyclic Irrigation in Patients Undergoing Exchange Arthroplasty - NCT ID: NCT06383611 - Study ID: OTX-0303 - Status: AVAILABLE - Start Date: N/A - Completion Date: N/A - Lead Sponsor: Osteal Therapeutics, Inc. ### Study Description The objective of the protocol is to provide access to the VT-X7 (Vancomycin, Tobramycin Exchanged in 7 Days) system for subjects with periprosthetic joint infection (PJI) of the hip or knee who lack therapeutic treatment alternatives. ### Conditions - Prosthetic-joint Infection ### Study Design - Type: EXPANDED_ACCESS - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - VT-X7 Treatment System ### Outcomes Primary Outcomes Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## PD-L1 Specific [68Ga]-Nb-1 Nanobody Probe for PET Imaging in Solid Tumors - NCT ID: NCT06383598 - Study ID: 2022KT74-ZY01 - Status: RECRUITING - Start Date: 2024-05-09 - Completion Date: 2026-12 - Lead Sponsor: Peking University Cancer Hospital & Institute ### Study Description The objective of the study is to constrcut a noninvasive approach 68Ga-Nb-1 PET/CT to detect the PD-L1 expression of tumor lesions in patients with solid tumors and to identify patients benefiting from anti-PD-L1 treatment. ### Conditions - Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - 18F-FDG ### Outcomes Primary Outcomes - Standardized uptake value（SUV） Secondary Outcomes ### Location - Facility: Beijing Cancer Hospital, Beijing, Beijing, 100142, China @@
## 3D DL Ozteo in the Detection of Osseous Changes in Patients With Inflammatory Arthritis - NCT ID: NCT06383585 - Study ID: 24-001367 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-12 - Lead Sponsor: Mayo Clinic ### Study Description This project intends to explore and validate the utility of new MRI pulse sequence, 3D DL oZTEo, in the detection of osseous erosions of the hand in patients with inflammatory arthritis. The detection of osseous structural changes, such as erosive disease, is routinely assessed in patients with rheumatic conditions such as rheumatoid arthritis, as it alters clinical management, and in some cases assists in diagnosis. Currently, this is most often assessed with radiography and conventional MRI. ### Conditions - Inflammatory Arthritis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - oZTEo ### Outcomes Primary Outcomes - The binary (yes/no) presence of bony erosions as detected by hand MRI with and without the addition of the 3D DL oZTEo sequence. Secondary Outcomes - The number of erosions (continuous) as detected by hand MRI with and without the addition of the 3D DL oZTEo sequence. ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@